Sanofi-Aventis Deutschland GmbH

Patent Trials and Appeals Board

May 29, 2020

IPR2018-01682 (P.T.A.B. May. 29, 2020)

Trials@uspto.gov Paper 108
571-272-7822 Entered: May 29, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

MYLAN PHARMACEUTICALS INC. and PFIZER INC.,1
Petitioner,
v.
SANOFI-AVENTIS DEUTSCHLAND GMBH,
Patent Owner.

IPR2018-01682
Patent 9,526,844 B2

Before HYUN J. JUNG, BART A. GERSTENBLITH, and
JAMES A. TARTAL, Administrative Patent Judges.
TARTAL, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
Denying Patent Owner’s Motion to Amend
Denying Petitioner’s Motion to Exclude
35 U.S.C. § 318(a)

1 Pfizer Inc. was joined as a petitioner in this proceeding.
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We have jurisdiction to conduct this inter partes review under
35 U.S.C. § 6. This Final Written Decision is issued pursuant to 35 U.S.C.
§ 318(a) and 37 C.F.R. § 42.73. For the reasons discussed herein, we
determine that a preponderance of the evidence shows that claims 21‒30 (the
“Challenged Claims”) of U.S. Patent 9,526,844 B2 (Ex. 1004, “the
’844 patent”) are unpatentable. We deny the motion to amend claims filed
by Sanofi-Aventis Deutschland GmbH (“Patent Owner”).2 We also deny the
motion to exclude.
I. INTRODUCTION
A. Summary of Procedural History
Mylan Pharmaceuticals Inc. (“Mylan”)3 filed a Petition (Paper 2,
“Pet.”) requesting inter partes review of the Challenged Claims. Pet. 1.
We instituted an inter partes review of the Challenged Claims on all grounds
of unpatentability asserted in the Petition. Paper 19 (“Inst. Dec.”). After
institution, Pfizer Inc. (“Pfizer”)4 separately filed a petition challenging the
same claims of the ’844 patent on the same grounds asserted by Mylan,
along with a motion for joinder to this case. Pfizer Inc. v. Sanofi-Aventis
Deutschland GmbH, IPR2019-01023, Papers 2, 3 (May 2, 2019). We
instituted inter partes review on Pfizer’s petition and granted Pfizer’s
motion for joinder. Paper 45.

2 Patent Owner identifies itself, Sanofi-Aventis U.S. LLC, and Sanofi
Winthrop Industrie as real parties in interest. Paper 5, 2.
3 Mylan identifies itself, Mylan Inc., Mylan GmbH (Mylan N.V.
subsidiaries), Biocon Research Ltd., Biocon Ltd., and Becton, Dickinson and
Company as real parties in interest. Pet. 1; Paper 7, 2.
4 Pfizer identifies itself and Hospira, Inc., as real parties in interest. Pfizer
Inc. v. Sanofi-Aventis Deutschland GmbH, IPR2019-01022, Paper 2, 1.
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Patent Owner filed a Patent Owner Response (Paper 30, “PO Resp.”).
Mylan and Pfizer (collectively, “Petitioner”) filed a Reply to the Patent
Owner Response (Paper 50, “Pet. Reply”), to which Patent Owner filed a
Sur-reply (Paper 65, “PO Sur-reply”).
Patent Owner also filed a Corrected Revised Contingent Motion to
Amend (Paper 71, “RMTA”).5 Petitioner filed an Opposition to the RMTA
(Paper 78, “RMTA Opp.”), to which Patent Owner filed a Reply (Paper 88,
“RMTA Reply”), and further to which Petitioner filed a Sur-reply (Paper 95,
“RMTA Sur-reply”).
Patent Owner filed Observations on the Cross Examination of
Mr. Karl Leinsing. Paper 82. Petitioner filed Observations Regarding the
Testimony of Alexander Slocum, Ph.D. Paper 83. Patent Owner filed a
Response to Petitioner’s Observations (Paper 84) and Petitioner filed a
Response to Patent Owner’s Observations (Paper 85).
Petitioner filed a Motion to Exclude (Paper 90, “Mot.”). Patent
Owner filed a Response in opposition to the Motion to Exclude (Paper 93,
“Mot. Opp.”), to which Petitioner filed a Reply (Paper 94, “Mot. Reply”).
Oral argument was held and a transcript of the hearing appears in the
record. Paper 102 (Tr.). We have jurisdiction under 35 U.S.C. § 6. This
Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and
37 C.F.R. § 42.73 (2017). Petitioner bears the burden of proving
unpatentability of the Challenged Claims by a preponderance of the
evidence, and the burden of persuasion never shifts to Patent Owner. See

5 Prior to filing its Corrected Revised Contingent Motion to Amend, Patent
Owner filed a Contingent Motion to Amend (Paper 32), to which Petitioner
filed an opposition (Paper 52), and further to which we issued Preliminary
Guidance (Paper 62).
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35 U.S.C. § 316(e) (2012); 37 C.F.R. § 42.1(d) (2017); Dynamic Drinkware,
LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
B. Related Proceedings
Claims 21–30 of the ’844 patent are also challenged by Mylan in
IPR2018-01680, to which Pfizer was joined as petitioner based on its
petition in IPR2019-01022. Patent Owner also filed a Corrected Revised
Contingent Motion to Amend in IPR2018-01680 that, along with the related
briefing of the parties, is substantively the same as the RMTA and related
briefing filed in this case. Mylan also challenged the same claims of
the ’844 patent in IPR2018-01696, however, institution of inter partes
review in that proceeding was denied.
The parties identify the following court proceedings as related
matters:
Sanofi-Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH,
Sanofi Winthrop Industrie v. Mylan GmbH, Biocon Ltd., Biocon
Research Ltd., Biocon Sdn. Bhd. and Biocon S.A., Case
No. 2-17-cv-09105-SRC-CLW (D.N.J.) (the “NJ-9105 Case”);
Sanofi-Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH,
and Sanofi Winthrop Industrie v. Merck Sharp & Dohme Corp.,
Case No. 1-16-cv-00812-RGA-MPT (D. Del.); and
Sanofi-Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH v.
Eli Lilly and Company, Case No. 1-14-cv-00113-RGA-MPT
(D. Del.).
Pet. 1–2; Paper 5, 2; Exs. 1029, 1030. On March 9, 2020, the court in the
NJ-9105 Case issued an order finding that “Mylan has proven that
[claims 21, 22, 25, and 30 of the ’844 patent] are invalid for failure to satisfy
the written description requirement stated in 35 U.S.C. § 112 ¶ 1.”
Ex. 1118, 1–2.
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According to the parties, patents related to the ’844 patent are
challenged in IPR2018-01670, IPR2018-01675, IPR2018-01676, IPR2018-
01677, IPR2018-01678, IPR2018-01679, IPR2018-01684, IPR2019-00122,
IPR2019-00977, IPR2019-00978, IPR2019-00979, IPR2019-00980,
IPR2019-00981, IPR2019-00982, and IPR2019-00987. Pet. 2; Paper 5, 2–3;
Paper 7, 2–3; Paper 24, 2–4; Paper 56, 1–3. Patent Owner also identifies
numerous U.S. patents and U.S. patent applications that claim priority to one
or more of the same applications to which the ’844 patent claims priority.
Paper 5, 4–5; Paper 24, 5–6; Paper 56, 3–5.
C. The ’844 Patent
The ’844 patent, titled “Pen-Type Injector,” issued December 27,
2016, from an application filed May 17, 2016. Ex. 1004, codes (54), (45),
(22). The ’844 patent “relates to pen-type injectors . . . where a user may set
the dose.” Id. at 1:25–29. We next provide a claim of the ’844 patent to
illustrate the subject matter followed by a description of the apparatus
disclosed.
1. Illustrative Claim
Challenged claim 21 is independent. Challenged claims 22–30
depend from claim 21. Claim 21 is illustrative of the claimed subject matter
and is reproduced below:
21. A drug delivery device comprising:
a housing comprising a dose dispensing end and a first thread;
a dose indicator comprising a second thread that engages with
the first thread;
a driving member comprising a third thread;
a sleeve that is (i) disposed between the dose indicator and the
driving member and (ii) releasably connected to the dose
indicator;
a piston rod comprising either an internal or an external fourth
thread that is engaged with the third thread;
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a piston rod holder that is rotatably fixed relative to the housing
and configured to (i) prevent the piston rod from rotating
during dose setting and (ii) permit the piston rod to traverse
axially towards the distal end during dose dispensing;
wherein:
the housing is disposed at an outermost position of the drug
delivery device;
the dose indicator is disposed between the housing and the
sleeve and is configured to (i) rotate and traverse axially
away from the dose dispensing end during dose setting and
(ii) rotate and traverse axially towards the dose dispensing
end during dose dispensing;
the driving member is configured to rotate relative to the piston
rod;
the sleeve is rotatably fixed relative to the driving member and
configured to traverse axially with the dose indicator; and
the piston rod and the driving member are configured to rotate
relative to one another during dose dispensing; and
the piston rod is configured to traverse axially towards the dose
dispensing end during dose dispensing.
Ex. 1004, 8:16–49.
2. Description of the Apparatus Disclosed
Figures 1 and 2 of the ’844 patent are reproduced below, as annotated
by Petitioner with color-coding of certain components that Petitioner
contends correspond to the features recited in claim 21 of the ’844 patent.
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Pet. 6–7. Figure 1 (left) and Figure 2 (right) illustrate “a sectional view of a
pen-type injector” in a “cartridge full” position in Figure 1 and in a
“maximum first dose dispensed” position in Figure 2. Ex. 1004, 2:60–62.
As explained by Petitioner, the injector includes main housing part 4 (grey)
(the recited “housing”), dose-dial sleeve 70 (green) (the recited “dose
indicator”), drive sleeve 30 (red) (the recited “driving member”), clutch 60
(blue) (the recited “sleeve”), piston rod 20 (yellow) (the recited “piston
rod”), and insert 16 (purple) (the recited “piston rod holder”).6 Pet. 4–7;

6 Petitioner notes that the ’844 patent refers to the needle-end of the device
as the “first end” or “distal end” and to the button-end as the “second end” or
“proximal end.” Pet. 8 n.2 (citing Ex. 1004, 3:8–14, claim 1).
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Ex. 1004, 3:37–38, 3:59–62, 4:13–23, 4:42–44. Patent Owner similarly
provides a summary of the components shown in Figures 1 and 2, further
highlighting medicament cartridge 8, cartridge piston 10, clicker 50,
externally-grooved dose dial sleeve 70, dose dial grip 76, and button 82. PO
Resp. 7–8.
As shown in Figures 1 and 2, insert 16 is at a first end of housing
part 4 and is fixed rotationally and axially to housing part 4. Ex. 1004
at 3:58–59. Insert 16 includes threaded circular opening 18, through which
piston rod 20 extends. Id. at 3:59–62. Piston rod 20 includes first thread 19
that engages threaded circular opening 18. Id. at 3:65–4:1. Piston rod 20
also includes pressure foot 22 that abuts piston 10 of cartridge 8. Id.
at 4:1–3. Drive sleeve 30 extends about piston rod 20, and second thread 24
of piston rod 20 engages internal helical groove 38 of drive sleeve 30. Id.
at 4:13–23.
Clicker 50 and clutch 60 are disposed between drive sleeve 30 and
dose-dial sleeve 70. Id. at 4:42–44. Clicker 50 is generally cylindrical and
includes, at one end, extending arm 52 and, at the other end, saw teeth 56.
Id. at 4:46–53. Clutch or clutch means 60 includes, at one end, saw teeth 66,
which interface with saw teeth 56. Id. at 4:59–61, Fig. 7. Clutch 60 is
generally cylindrical and includes a radially inwardly directed flange 62 and
dog teeth 65 at the end opposite of saw teeth 66. Id. at 4:63–67. Clutch 60
is keyed to drive sleeve 30 by splines to prevent relative rotation between
clutch 60 and drive sleeve 30. Id. at 5:2–4.
Dose-dial sleeve 70 is outside of clutch 60 but within housing 4. Id.
at 5:12–14. Dose-dial sleeve 70 has helical groove 74 on its outer surface,
and helical rib 46 of housing 4 is seated in helical groove 70 to allow relative
motion. Id. at 5:14–20. Dose-dial grip 76 is disposed about the second end
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of dose-dial sleeve 70 and secured to dose-dial sleeve 70 to prevent relative
motion. Id. at 5:34–39.
In operation, a user rotates dose-dial grip 76 to set a dose and to cause
dose-dial sleeve 70, clutch 60, and drive sleeve 30 to rotate together out of
housing part 4. Id. at 5:60–64, Fig. 9. The dose can be reduced by turning
dose-dial grip 76 in the opposite direction. Id. at 6:28–30, Fig. 10.
Clicker 50 and clutch 60 provide audible and tactile feedback of the dose
being dialed, as torque is transmitted through the saw teeth 56, 66. Id.
at 5:64–66. Flexible arm 52 deforms and drags toothed member 54 over
splines 42 to produce a click. Id. at 5:67–6:2. Splines 42 may be configured
such that each click corresponds to a unit dose. Id. at 6:2–2. Once the
proper dose is set, the user then presses button 82, which causes clutch 60 to
disengage from dose-dial sleeve 70 so that clutch 60 moves axially and
dose-dial sleeve 70 rotates back into housing part 4. Id. at 6:38–45, Fig. 11.
Drive sleeve 30 also moves axially and causes piston rod 20 to rotate
through threaded opening 18 to dispense medicine from cartridge 8. Id.
at 6:55–57. Drive sleeve 30 is prevented from rotating by the deformation
of flexible arm 52, such that saw teeth 56, 66 are not overhauled during
dispense. Id. at 6:46–48.
D. References and Expert Testimony
Below we provide an abbreviated summary of the qualifications of
each expert that provides testimony on behalf of one of the parties in this
case. We also provide a table identifying the references relied upon, as well
as the exhibits corresponding to the declarations and deposition testimony in
the record for each expert.
Petitioner’s contentions are supported by Mr. Karl R. Leinsing,
MSME, PE; Dr. William C. Biggs; and Dr. DeForest McDuff, Ph.D.
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Mr. Leinsing is the President of a company that develops medical devices,
previously worked as a Director of Biomedical Engineering at a company
that developed implants for heart valve repair, previously worked as a Senior
Principal Design Engineer on medical drug infusion products from 1992
to 2002, and has Bachelor of Science and Master of Science degrees in
mechanical engineering. Ex. 1011 ¶¶ 2–6.
Dr. Biggs has been “Board Certified by the American Board of
Internal Medicine in Internal Medicine since 1985,” is a Clinical Assistant
Professor in the Department of Internal Medicine at Texas Tech School of
Medicine, is the Medical Director of the Diabetes Center at Northwest Texas
Hospital, and works “as the Principal Investigator for numerous clinical
research trials involving diabetes for type 1 and type 2 diabetes, including
trials that look specifically at the effect of insulins, devices, patient
education, and healthcare costs.” Ex. 1048 ¶¶ 3–13.
Dr. McDuff has undergraduate degrees in economics and mathematics
and a Ph.D. in economics, is a Partner at an economics consulting firm, and
has “provided expert analysis and consulting in over 50 cases involving
pharmaceuticals and related products, including evaluations of economic
damages, competition, commercial success, irreparable harm, and other
issues.” Ex. 1060 ¶¶ 1–4.
Patent Owner’s arguments are supported by Dr. Alexander H. Slocum,
Ph.D.; Dr. Henry G. Grabowski, Ph.D.; and Dr. Robin S. Goland.
Dr. Slocum is a Professor of Mechanical Engineering at the Massachusetts
Institute of Technology, has “taught courses on mechanical design, including
precision machine design, continuously since 1991,” has “taught courses on
medical device design continuously since 2001,” is a consultant “for
companies to assist them with various types of design challenges,” is “an
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inventor on approximately 133 United States patents, many of which relate
to machine elements, tools, and medical devices,” and has Bachelor of
Science and Master of Science degrees in mechanical engineering and a
Doctor of Philosophy degree. Ex. 2107 ¶¶ 3–13.
Dr. Grabowski is Professor Emeritus of Economics and the Director
of the Program in Pharmaceuticals and Health Economics at Duke
University, much of his “research has focused on pharmaceutical
competition and the economics of generic medications,” and he has a
Bachelor of Science degree in engineering physics and a doctorate in
economics. Ex. 2109 ¶¶ 1–4.
Dr. Goland is “board-certified in Internal Medicine and
Endocrinology,” has been the Chief of the Diabetes Clinic at New York-
Presbyterian Hospital/Columbia University since 1987, is a Professor of
Clinical Medicine, Clinical Medicine and Clinical Pediatrics, and Clinical
Diabetes, and is “an experienced clinical investigator and principal
investigator in diabetes trials.” Ex. 2111 ¶¶ 2–7.
References and Expert Testimony Date Exhibit No.
US 6,235,004 B1 (“Steenfeldt-Jensen”) May 22, 2001 Ex. 1014
US 6,582,404 B1 (“Klitgaard”) June 24, 2003 Ex. 1017
US 6,932,794 B2 (“Giambattista”) Aug. 23, 2005 Ex. 1016
US 2002/0053578 A1 (“Møller”) May 2, 2002 Ex. 1015
WO 02/092153 (“Atterbury”) Nov. 21, 2002 Ex. 1097
US 4,648,872 (“Kamen”) Mar. 10, 1987 Ex. 2169
US 4,747,824 (“Spinello”) May 31, 1988 Ex. 2170
US 6,248,093 B1 (“Moberg”) June 19, 2001 Ex. 2171
Declaration of Karl R. Leinsing, MSME, PE Sept. 9, 2018 Ex. 1011
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References and Expert Testimony (con’t) Date Exhibit No.
Reply Declaration of Karl R. Leinsing,
MSME, PE
Sept. 18, 2019 Ex. 1095
Declaration of Karl R. Leinsing, MSME,
PE, Supporting Opposition to Motion to
Amend
Sept. 18, 2019 Ex. 1096
Declaration of Karl R. Leinsing, MSME,
PE, Supporting Opposition to Revised
Motion to Amend
Dec. 17, 2019 Ex. 1113
Deposition Transcript of Karl R. Leinsing,
MSME, PE
June 3, 2019 Ex. 2163
Deposition Transcript of Karl R. Leinsing,
MSME, PE
June 4, 2019 Ex. 2164
Deposition Transcript of Karl R. Leinsing,
MSME, PE
Oct. 10, 2019 Ex. 2316
Deposition Transcript of Karl R. Leinsing,
MSME, PE
Dec. 20, 2019 Ex. 2331
Declaration of Dr. William C. Biggs Sept. 16, 2019 Ex. 1048
Deposition Transcript of Dr. William C.
Biggs
Oct. 15, 2019 Ex. 2317
Declaration of DeForest McDuff, Ph.D. Sept. 17, 2019 Ex. 1060
Deposition Transcript of DeForest McDuff,
Ph.D.
Oct. 9, 2019 Ex. 2318
Declaration of Alexander H. Slocum, Ph.D.
in Support of Patent Owner Response
June 24, 2019 Ex. 2107
Declaration of Alexander H. Slocum, Ph.D.
in Support of Motion to Amend
June 24, 2019 Ex. 2302
Declaration of Alexander H. Slocum, Ph.D.
in Support of Revised Motion to Amend
Oct. 30, 2019 Ex. 2325
Declaration of Alexander H. Slocum, Ph.D.
in Support of Reply for Revised Motion to
Amend
Jan. 7, 2020 Ex. 2332
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References and Expert Testimony (con’t) Date Exhibit No.
Deposition Transcript of Alexander H.
Slocum, Ph.D.
Aug. 27, 2019 Ex. 1053
Deposition Transcript of Alexander H.
Slocum, Ph.D.
Aug. 28, 2019 Ex. 1054
District Court Trial Testimony Transcript of
Alexander H. Slocum, Ph.D.
Dec. 4, 2019 Ex. 1114
District Court Trial Testimony Transcript of
Alexander H. Slocum, Ph.D.
Dec. 5, 2019 Ex. 1115
Deposition Transcript of Alexander H.
Slocum, Ph.D.
Dec. 10, 2019 Ex. 1109
Deposition Transcript of Alexander H.
Slocum, Ph.D.
Jan. 10, 2020 Ex. 1117
Declaration of Henry G. Grabowski, Ph.D. June 22, 2019 Ex. 2109
Deposition Transcript of Henry G.
Grabowski, Ph.D.
Sept. 5, 2019 Ex. 1055
Declaration of Dr. Robin S. Goland June 24, 2019 Ex. 2111
Deposition Transcript of Robin S. Goland Sept. 10, 2019 Ex. 1056
E. The Asserted Grounds of Unpatentability
Petitioner alleges unpatentability of the Challenged Claims on the
following grounds:
Claim(s) Challenged 35 U.S.C. § Reference(s)
21–29 103 Steenfeldt-Jensen
30 103 Steenfeldt-Jensen, Klitgaard
F. Date of Priority for the Challenged Claims of the ’844 Patent
The ’844 patent issued December 27, 2016, from U.S. Application
No. 15/156,616 (“the ’616 application”), filed May 17, 2016. Ex. 1004,
codes (21), (22), (45). The ’616 application was a continuation of U.S.
Application No. 14/946,203 (“the ’203 application”), filed November 19,
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2015, which, itself, was one in a series of U.S. continuation and division
applications dating back to March 2, 2004. Id. at code (60). The ’844 patent
also identifies under “Foreign Application Priority Data” a filing date of
March 3, 2003, for Great Britain patent application number 0304822.0
(Ex. 1026, “the GB application”). Id. at code (30).
Petitioner argues that each of the Challenged Claims “lacks written
description support under §112” in any of the priority documents and “is not
entitled to a priority date earlier than May 17, 2016.” Pet. 14–17.
Specifically, Petitioner argues that “[e]ach of claims 21–30 of the’844 patent
lacks support in the ’203 application as well as the filings to which the ’203
application claims priority for a ‘piston rod’ comprising an internal fourth
thread that is engaged with a third thread of a ‘driving member.’” Id. at 15–
16.
In the Institution Decision, the Board did not need to address the
effective filing date of the ’844 patent because Patent Owner conceded that
the asserted references in this case, Steenfeldt-Jensen and Klitgaard, are
prior art to the ’844 patent regardless of whether the ’844 patent has priority
to the GB application. See Inst. Dec. 23 (citing Paper 13 (Patent Owner
arguing in its Preliminary Response that the ’844 patent was entitled to
claim priority to the GB application, but stating that “neither Patent Owner
nor the Board needs to address this issue in this case,” because Patent Owner
concedes that Steenfeldt-Jensen and Klitgaard are prior art to the ’844
patent). After institution, Patent Owner did not address in its Patent
Owner’s Response Petitioner’s contention that the priority date for the
Challenged Claims is May 17, 2016. See generally PO Resp.

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In IPR2018-01680, we are issuing, contemporaneously, a final written
decision in which we determine that Petitioner demonstrates that the
Challenged Claims are not entitled to a priority date prior to May 17, 2016,
the filing date of the ’616 application.
II. ANALYSIS OF PETITION
In our analysis of Petitioner’s unpatentability contentions with respect
to the Challenged Claims, we next address the applicable principles of law;
the level of ordinary skill in the art; the proposed construction of claim
terms; the scope and content of the asserted prior art; and then further
analyze Petitioner’s contentions with respect to each alleged ground of
unpatentability for purposes of determining whether Petitioner shows by a
preponderance of the evidence the unpatentability of the Challenged Claims.
A. Principles of Law
Petitioner’s two asserted grounds of unpatentability are based on
obviousness. Pet. 3. A patent claim is unpatentable as obvious if “the
differences between” the claimed subject matter “and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.” 35 U.S.C. § 103(a).7 An invention “composed of
several elements is not proved obvious merely by demonstrating that each of
its elements was, independently, known in the prior art.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).

7 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103 effective March 16,
2013. We quote the AIA version of 35 U.S.C. § 103, which applies to
applications with an effective filing date after March 16, 2013, however, the
pre-AIA version of § 103 is nearly identical and any differences do not
affect our analysis here.
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The question of obviousness is resolved on the basis of underlying
factual determinations, including: (1) the scope and content of the prior
art; (2) any differences between the claimed subject matter and the prior
art; (3) the level of skill in the art; and (4) objective evidence of
nonobviousness. Graham v. John Deere Co. of Kansas City, 383 U.S. 1,
17–18 (1966). An obviousness determination “cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006)); see In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364,
1380 (Fed. Cir. 2016). Rather, “it can be important to identify a reason that
would have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does.” Id
B. Level of Ordinary Skill in the Art
In determining whether an invention would have been obvious at the
time it was made, 35 U.S.C. § 103 requires us to resolve the level of
ordinary skill in the pertinent art at the time of the invention. Graham,
383 U.S. at 17. The person of ordinary skill in the art is a hypothetical
person who is presumed to have known the relevant art at the time of the
invention. In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).
Petitioner proposes that a person having ordinary skill in the art would
have “had, through education or practical experience, at least the equivalent
of a bachelor’s degree in mechanical engineering, or a related field” and
“would have understood the basics of medical-device design and
manufacturing, and basic mechanical elements (e.g., gears, pistons) involved
in drug-delivery devices.” Pet. 17–18 (citing Ex. 1011 ¶ 106). Patent
Owner proposes a similar level of ordinary skill in the art and states that any
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difference from Petitioner’s proposal is immaterial to the arguments
presented. PO Resp. 11–12. Based on the evidence provided, including the
prior art of record, we agree with Petitioner’s proposed level of ordinary
skill and also find that the prior art of record further reflects the level of
ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355
(Fed. Cir. 2001) (noting that the prior art of record may reflect the level of
ordinary skill in the art).
C. Claim Construction
In an inter partes review, “[a] claim in an unexpired patent . . . shall
be given its broadest reasonable construction in light of the specification of
the patent in which it appears.” 37 C.F.R. § 42.100(b) (2017); Cuozzo Speed
Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (upholding the use of the
broadest reasonable interpretation standard).8 “Under a broadest reasonable
interpretation, words of the claim must be given their plain meaning, unless
such meaning is inconsistent with the specification and prosecution history.”
TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016). If the
Specification “reveal[s] a special definition given to a claim term by the
patentee that differs from the meaning it would otherwise possess[,] . . . the
inventor’s lexicography governs.” Phillips v. AWH Corp., 415 F.3d 1303,

8 Although the claim construction standard applied in inter partes review
was changed to the federal court claim construction standard used in a civil
action under 35 U.S.C. § 282(b), that change does not apply to this
proceeding because the Petition was filed before November 13, 2018, the
effective date of the change. See Changes to the Claim Construction
Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial
and Appeal Board, 83 Fed. Reg. 51,340, 51,344 (Oct. 11, 2018) (now
codified at 37 C.F.R. pt. 42 (2019)).
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1316 (Fed. Cir. 2005) (en banc) (citing CCS Fitness, Inc. v. Brunswick
Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)).
Petitioner asserts that “claim terms should be given their ordinary and
accustomed meaning, consistent with the specification and how they would
have been understood by” a person having ordinary skill in the art. Pet. 18.
Petitioner also asserts that Patent Owner has taken claim construction
positions for certain claim terms in district court proceedings, and that the
broadest reasonable interpretation of those terms should at least encompass
Patent Owner’s proposed constructions in district court. Id. at 19.
In particular, Petitioner identifies the terms in the table below and
provides definitions based on Patent Owner’s district court contentions.
Claim Term Proposed Meaning (supporting citation)
“driving member” “A component releasably connected to the dose dial
sleeve that drives the piston during dose dispensing.”
(Ex. 1019, 28.)
“main housing” “An exterior unitary or multipart component
configured to house, fix, protect, guide, and/or
engage with one or more inner components.” (Id.
at 21.)
“piston rod” “A rod that engages with the driving member to
advance the piston during dose dispensing.” (Id.
at 27.)
“the piston rod and
the driving member
are configured to
rotate relative to
one another during
dose dispensing”
Plain and ordinary meaning such that “during dose
dispensing, the piston rod rotates while the driving
member does not rotate, the driving member rotates
while the piston rod does not rotate, or both rotate at
different rates and/or directions.” (Id. at 27 (citing
Ex. 1004, 6:38–67, FIG. 11; claim 21)).
“thread” “A rib or groove on a first structure that engages a
corresponding groove or rib on a second structure.”
(Id. at 30.)
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Claim Term Proposed Meaning (supporting citation)
“clutch” “A structure that couples and decouples a moveable
component from another component.” (Id. at 24.)
“clicker” “A structure that provides audible and/or tactile
feedback when the dose knob is rotated.” (Id. at 31.)
“holder” Plain and ordinary meaning such that a person of
ordinary skill in the art “would understand to be ‘a
structure that holds a referenced structure’ (e.g., a
piston rod holder holds a piston rod).” Id. at 33.
Pet. 19–20. Petitioner also states that, in district court proceedings, Mylan
proposed means-plus-function constructions for the terms “clutch,”
“clicker,” and “holder.” Id. at 20. Petitioner identifies the functions and
structures related to these three terms. See id. at 20–22.
Patent Owner does not propose alternative constructions and
maintains that “no express constructions are required” to demonstrate that
the Challenged Claims are patentable over the asserted prior art. PO
Resp. 11. We agree with Patent Owner that no claim term requires express
construction. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355,
1361 (Fed. Cir. 2011) (“claim terms need only be construed ‘to the extent
necessary to resolve the controversy’” (internal citation omitted)). In as
much as claim 22, or any other claim, must be construed to some extent, we
address it in our patentability analysis below.
D. Scope and Content of the Prior Art
Petitioner relies on Steenfeldt-Jensen and Klitgaard to show the
unpatentability of the Challenged Claims. Each of these references is
summarized briefly below.
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1. Summary of Steenfeldt-Jensen
Steenfeldt-Jensen, titled “Injection Syringe,” issued May 22, 2001,
from an application filed October 28, 1999. Ex. 1014, codes (54), (45), (22).
Steenfeldt-Jensen relates to “injection syringes of the kind apportioning set
doses of a medicine from a cartridge . . . [and] are mainly made for users
who have to inject themselves frequently, e.g. diabetics.” Id. at 1:12–17.
Petitioner relies primarily on the embodiment illustrated in
Figures 15–17 of Steenfeldt-Jensen, the fifth of five embodiments described
in Steenfeldt-Jensen, which the parties appropriately refer to as “the fifth
embodiment.” See Ex. 1014, 4:60–5:28 (describing illustrations
corresponding to five embodiments); Pet. 22 n.9; PO Resp. 14; Pet.
Reply 5).
Figures 15–17 of Steenfeldt-Jensen are reproduced below:

Figure 15 illustrates “a sectional side view” of an injection syringe,
Figure 16 illustrates a “sectional side view perpendicular to the view in
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[Figure] 15,” and Figure 17 depicts “an exploded view of the syringe in
[Figures] 15 and 16.” Ex. 1014; Id. at 5:23–28. The injection syringe
includes tubular housing 1 that is partitioned so that a first division has
ampoule holder 2. Id. at 5:38–40. Ampoule holder 2 has a central bore with
thread 5 that engages external thread 7 of piston rod 6. Id. at 5:55–58.
Driver tube 85 is disposed about piston rod 6. See id. at Figs. 15–17. “The
piston rod has a not round cross-section and fits through the driver tube bore
which has a corresponding not round cross-section” so that “rotation is
transmitted” and “the piston rod is allowed to move longitudinally through
the driver tube.” Id. at 11:15–19.
Scale drum 80 within housing 1 has on its outer wall a helical track
that engages a helical rib on the inner wall of housing 1. Id. at 11:20–22.
One end of scale drum 80 has a larger diameter so as to form dose setting
button 81. Id. at 11:22–24. Bushing 82 fits within scale drum 80 and over
driver tube 85. Id. at 11:26–29. Bushing 82 is coupled to driver tube 85 so
that both bushing 82 and driver tube 85 can rotate, but not move
longitudinally. Id. at 11:30–33. Injection button 88 is rotatably mounted at
an end of bushing 82. Id. at 49–51. A dose is set by rotating dose setting
button 81, which causes scale drum 80 to rotate out of housing 1. Id. at
11:52–55. Injection button 88 is pressed to inject the set dose, and bushing
82 rotates with dose setting button 81, because of the engagement of the
helical track of scale drum 80 with the rib of housing 1 when scale drum 80
is pressed into housing 1. Id. at 12:4–10. The rotation of bushing 82 rotates
driver tube 85, causing piston rod 6 to rotate and screw into ampoule 89 in
ampoule holder 2. Id. at 12:10–13.
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Steenfeldt-Jensen also teaches audible and tactile clicks formed when
setting the dose that represent one unit of dose. Specifically, Steenfeldt-
Jensen states as follows:
To set a dose the ampoule holder 2 is rotated anticlockwise
in the first division of the housing 1. This rotation is performed
against a resistance presented due to the fact that a protrusion 30
on the outer wall of the ampoule holder rests in one of a number
of depressions 31 circumferentially provided in the inner wall of
said first division of the housing as shown in the cross-sectional
view in FIG. 3. The angular spacing of the depressions are
appropriately made so that a dose of one unit is set when the
protrusion is moved from one depression to the [neighboring]
depression so that the number of clicks heard and felt during the
dose setting rotation corresponds to the size of the set dose.
Id. at 6:42–53.
2. Summary of Klitgaard
Klitgaard, titled “Dose Setting Limiter,” issued June 24, 2003, from
an application filed September 6, 2000. Ex. 1017, codes (54), (45), (22).
Klitgaard is directed to “injection devices where[] the contents of a cartridge
are injected as a number of individually set doses.” Id. at 1:13–15. Figure 3
of Klitgaard is reproduced below:

Figure 3 illustrates “the dose setting member, the driver, and the track
follower of an[] embodiment of an injection syringe.” Id. at 2:60–63.
Relevant to our decision, Klitgaard discloses nut member 32, which is
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disposed between dose setting-member 30 and driver 31. Id. at 4:26–29.
During dose setting, nut member 32 rotates with dose-setting element 30
relative to driver 31 because of the engagement between ridge 35 and
recess 34, such that the position of nut member 32 on driver 31 depends on
the set dose. Id. at 4:33–37. When the medicine is injected, dose-setting
member 30 is forced to rotate relative to the housing and transmits rotational
force to driver 31, but nut member 32 maintains its position on driver 31,
such that the position indicates the total injected dose. Id. at 4:37–58.
E. Alleged Obviousness over Steenfeldt-Jensen
Petitioner contends that claims 21–29 of the ’844 patent would have
been obvious over Steenfeldt-Jensen. Pet. 26–68; Pet. Reply 1–21. Patent
Owner argues that certain limitations of claims 21 and 22 are not taught or
suggested by Steenfeldt-Jensen, and that a person of ordinary skill in the art
would not have been motivated to modify Steenfeldt-Jensen. PO Resp. 21–
41; PO Sur-reply 1–15. We address each of the Challenged Claims below
and determine for the reasons provided that Petitioner shows by a
preponderance of the evidence that Steenfeldt-Jensen teaches or suggests
every limitation of claims 21–29 of the ’844 patent and demonstrates a
persuasive rationale in support of the proposed modification.
1. Differences Between the Subject Matter of Independent Claim 21
and the Teachings of Steenfeldt-Jensen
Petitioner provides claim charts and arguments with citations to where
Steenfeldt-Jensen teaches or suggests the limitations of claim 21, along with
citations to the supporting declaration of Mr. Leinsing. Pet. 56 (citing
Ex. 1011 ¶¶ 612–642, 644, 646, 647, 649–652, 654–657). Patent Owner
primarily argues that Steenfeldt-Jensen fails to teach or suggest the recited
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“driving member comprising a third thread.” See PO Resp. 21–26. We
address each limitation of claim 21 below.
a) A drug delivery device comprising:
To the extent that the preamble is limiting, Petitioner shows, and
Patent Owner does not dispute, that Steenfeldt-Jensen teaches an “injection
syringe” that “relates to injection syringes of the kind apportioning set doses
of a medicine from a cartridge containing an amount of medicine sufficient
for the preparation of a number of therapeutic doses,” corresponding to the
recited “drug delivery device.” Pet. 26–27 (quoting Ex. 1014, Abstract,
1:12–15). We are persuaded that Petitioner shows by a preponderance of the
evidence that Steenfeldt-Jensen teaches the preamble, to the extent it is
limiting, based on the reasons and evidence identified in the portions of the
Petition cited in the preceding sentence, which we adopt as our own
findings.
b) a housing comprising a dose dispensing end and a first thread;
Petitioner shows, and Patent Owner does not dispute, that Steenfeldt-
Jensen teaches an injection syringe with tubular housing 1 into which
ampoule holder 2 is snapped, corresponding to the recited “housing
comprising a dose dispensing end,” and “a helical protruding rib 16
. . . defining an inner thread” on the inner wall of housing 1, corresponding
to the recited “first thread.” Pet. 27–29 (citing Ex. 1014, 3:34–44, 6:7–11,
11:20–22, Figs. 15–17). We are persuaded that Petitioner shows by a
preponderance of the evidence that Steenfeldt-Jensen teaches this limitation
based on the reasons and evidence identified in the portions of the Petition
cited in the preceding sentence, which we adopt as our own findings.
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c) a dose indicator comprising a second thread that engages with the
first thread;
Petitioner shows, and Patent Owner does not dispute, that Steenfeldt-
Jensen teaches scale drum 80 corresponding to the recited “dose indicator.”
Pet. 29–31. Petitioner explains that scale drum 80 includes a helical track,
corresponding to the recited “second thread,” that engages the helical
protruding rib 16 on the inner wall of housing 1, i.e., the “first thread.” Id.
(citing Ex. 1014, 6:7–11, 6:18–21, 7:11–13, 11:20–22, Figs 15–17; Ex. 1011
¶ 615–617); see also Ex. 1014, 11:20–22 (stating that “scale drum 80 is in its
outer wall provided with a helical track which is engaged by a helical rib 16
along the inner wall of the housing 1”). Petitioner also notes that
“Steenfeldt-Jensen explains that analogous elements in different
embodiments are provided with the same reference number,” (citing
Ex. 1014, 7:49–51), and that “[a]s can be seen in [Figure] 17 of Steenfeldt-
Jensen, the embodiment shown in that figure has window 18, thus scale
drum 80 also serves as a dose indicator.” Pet. 31.
We are persuaded that Petitioner shows by a preponderance of the
evidence that Steenfeldt-Jensen teaches this limitation based on the reasons
and evidence identified in the portions of the Petition cited in the preceding
paragraph, which we adopt as our own findings.
d) a driving member comprising a third thread;
Petitioner contends that it would have been obvious to a person of
ordinary skill in the art to modify the “piston rod drive” taught by
Steenfeldt-Jensen to include a “driving member comprising a third thread,”
as recited. Pet. 34. The parties agree that the fifth embodiment of
Steenfeldt-Jensen, illustrated in Figures 15–17, upon which Petitioner
primarily relies, does not show a “driving member comprising a third
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thread.” Most useful on this point is the annotated illustration provided by
Patent Owner of a cropped portion of Figure 17 of Steenfeldt-Jensen, which
we reproduce below.

PO Resp. 15. The portion of Figure 17 reproduced above shows, in an
exploded view, piston rod 6 with external threading 7 (yellow), driver
tube 85 (red), and member 40 (orange), which Patent Owner identifies as a
“threaded bore,” from the fifth embodiment of Steenfeldt-Jensen. Id. Driver
tube 85 is not shown to be threaded.
Petitioner explains, in regard to the fifth embodiment, that Steenfeldt-
Jensen describes syringes with “a ‘piston rod drive’ that includes driver
tube 85 (a sleeve rotationally coupled to the piston rod due to its unthreaded,
non-circular cross-section) and member 40 (an element that has a threaded
circular opening and that is fixed to the housing).” Pet. 33 (citing Ex. 1014,
Abstract, 2:46–53, claims 1, 6, 11; Ex. 1011 ¶ 618). Petitioner
acknowledges that “[t]o drive piston rod 6, driver tube 85 rotationally
engages with the rod through a bore having a non-circular cross-section,
rather than an internal threading near a distal portion.” Pet. 34 (citing
Ex. 1011 ¶ 620). Thus, driver tube 85 is a “driving member,” but driver
tube 85 does not comprise a “third thread.” Petitioner argues that a person
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of ordinary skill in the art “would have considered it obvious to modify the
piston rod drive of the fifth embodiment to provide the “driving member
comprising a third thread” of claim 21.” Id.
Petitioner also explains its proposed modification of driver tube 85
and member 40 as follows:
While driver tube 85 (the driver) does not show internal
threading in the [Figures] 15–17 embodiment, Steenfeldt-Jensen
suggests an alternative embodiment in which (1) driver tube 85
does have such threading and rotates relative to piston rod 6
during injection to drive the piston rod through member 40 and
(2) member 40 operates as a non-threaded piston-rod guide,
preventing rotation of piston rod 6 relative to the housing but
allowing axial displacement. In such an embodiment, a [person
of ordinary skill in the art] would have considered driver tube 85
to meet all limitation of the recited “driving member” and
member 40 to meet all limitations of the recited “piston rod
holder.” See EX1011 ¶¶ 620–621.
Pet. 53.
For purposes of this portion of our analysis, Petitioner shows, and
Patent Owner does not dispute, that driver tube 85, as modified by
Petitioner, corresponds to the recited “driving member comprising a third
thread.” We are persuaded that Petitioner shows by a preponderance of the
evidence that Steenfeldt-Jensen suggests this limitation based on the reasons
and evidence identified in the portions of the Petition cited in the preceding
three paragraphs, which we adopt as our own findings. We address below
Petitioner’s reasons in support of its proposed modification and Patent
Owner’s arguments related to Petitioner’s reasoning (after addressing the
subject matter of each remaining limitation of claim 21, including a “piston
rod holder”).
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e) a sleeve that is (i) disposed between the dose indicator and the
driving member and (ii) releasably connected to the dose
indicator;
Petitioner establishes, and Patent Owner does not dispute, that
Steenfeldt-Jensen teaches bushing 82 corresponding to the recited “sleeve.”
Pet. 34–36. Petitioner explains that “bushing 82 is a tubular structure that is
disposed between dose indicator 80 and drive member 85.” Id. (referencing
Ex. 1014, 11:26–27, 12:4–13; Figs. 15–17; Ex. 1011 ¶ 628). Further,
Petitioner explains that bushing 82 with flange 83 is releasably connected to
a dose indicator, scale drum 80, because flange 83 has rosette of teeth 93
that are configured to releasably engage corresponding teeth on dose-setting
button 81, and dose-setting button 81 is integrally formed with scale
drum 80. Id. (referencing Ex. 1014, 11:22–25; Ex. 1011 ¶ 629).
We are persuaded that Petitioner shows by a preponderance of the
evidence that Steenfeldt-Jensen teaches this limitation based on the reasons
and evidence identified in the portions of the Petition cited in the preceding
paragraph, which we adopt as our own findings.
f) a piston rod comprising either an internal or an external fourth
thread that is engaged with the third thread
Petitioner shows, and Patent Owner does not dispute, that Steenfeldt-
Jensen teaches piston rod 6 having an external thread 7 corresponding to the
recited “piston rod.” Pet. 37–38 (citing Ex. 1014, 5:55–58). Petitioner also
explains that when driver tube 85 is modified as proposed, piston rod 6 with
external threading 7 would engage internal threads, i.e., the recited “third
thread,” of modified driver tube 85. Id. at 38. Patent Owner does not
present any additional arguments regarding the “piston rod” of claim 21
beyond the arguments discussed below concerning Petitioner’s proposed
modification of driver tube 85. See PO Resp. 21–41. For purposes of this
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portion of our analysis, Petitioner shows, and Patent Owner does not dispute,
that piston rod 6 corresponds to the recited “piston rod” and would engage
driver tube 85, as modified by Petitioner.
We are persuaded that Petitioner shows by a preponderance of the
evidence that Steenfeldt-Jensen teaches this limitation based on the reasons
and evidence identified in the portions of the Petition cited in the preceding
paragraph, which we adopt as our own findings.
g) a piston rod holder that is rotatably fixed relative to the housing
and configured to (i) prevent the piston rod from rotating during
dose setting and (ii) permit the piston rod to traverse axially
towards the distal end during dose dispensing
Petitioner shows that Steenfeldt-Jensen teaches member 40 rotatably
fixed relative to housing 1, corresponding to the recited “piston rod holder.”
Pet. 38–43 (citing Ex. 1014, 8:35–42 (longitudinal recesses 43 of member 40
with internal ribs of housing 1 “lock the member 40 against rotation relative
to the housing”); Ex. 1011 ¶ 633). Although Petitioner proposes modifying
the piston rod drive of Steenfeldt-Jensen “so that the internal threads of the
piston rod drive are located on driver tube 85 instead of on member 40 and
so that member 40 (instead of driver tube 85) mates with the not circular
cross-section of the piston rod,” Petitioner shows that modified member 40,
after modification to operate as a “non-threaded piston-rod guide,” would
still be rotatably fixed relative to the housing. Pet. 42, 53 (citing Ex. 1011
¶¶ 636–638).
Petitioner also shows that “[b]y virtue of being rotatably fixed relative
to the housing, member 40 is configured to prevent the piston rod from
rotating relative to the housing during dose setting via the interaction of its
pawl wheel teeth with the pawl wheel of driver tube 85.” Id. at 41–42
(citing Ex. 1014, 8:48–53, 11:6–19, 11:52–62; Ex. 1011 ¶¶ 634–635).
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Petitioner further shows member 40, with or without Petitioner’s proposed
modification, permits piston rod 6 to “traverse axially towards the distal end
during dose dispensing,” as recited. Id. at 42–43 (citing Ex. 1014, 11:11–15,
12:4–12; Ex. 1011 ¶¶ 638–639).
Patent Owner does not present any additional arguments regarding the
“piston rod holder” of claim 21 beyond the arguments discussed below
concerning Petitioner’s proposed modification of driver tube 85. See PO
Resp. 27–43. For purposes of this portion of our analysis, Petitioner shows,
and Patent Owner does not dispute, that member 40, as modified by
Petitioner, corresponds to the recited “piston rod holder.” We are persuaded
that Petitioner shows by a preponderance of the evidence that Steenfeldt-
Jensen suggests this limitation based on the reasons and evidence identified
in the portions of the Petition cited in the preceding two paragraphs, which
we adopt as our own findings.
h) wherein: the housing is disposed at an outermost position of the
drug delivery device;
Petitioner shows, and Patent Owner does not dispute, that Steenfeldt-
Jensen teaches that housing 1 is disposed at an outermost position of
Steenfeldt-Jensen’s syringe. Pet. 43–44 (citing Ex. 1014, 5:38–44,
Figs. 15–17; Ex. 1011 ¶¶ 640–641). We are persuaded that Petitioner shows
by a preponderance of the evidence that Steenfeldt-Jensen teaches this
limitation based on the reasons and evidence identified in the portions of the
Petition cited in the preceding sentence, which we adopt as our own
findings.
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i) the dose indicator is disposed between the housing and the sleeve
and is configured to (i) rotate and traverse axially away from the
dose dispensing end during dose setting and (ii) rotate and
traverse axially towards the dose dispensing end during dose
dispensing;
Petitioner shows, and Patent Owner does not dispute, that Steenfeldt-
Jensen teaches scale drum 80, a “dose indicator,” is disposed between
housing 1, a “housing,” and bushing 82, a “sleeve” and is configured to
“rotate and traverse axially away from the dose dispensing end during dose
setting and (ii) rotate and traverse axially towards the dose dispensing end
during dose dispensing,” as recited. Pet. 44–45 (citing Ex. 1014, 11:20–28,
11:52–54, 12:4–9, Figs. 15–17; Ex. 1011 ¶¶ 642, 644). We are persuaded
that Petitioner shows by a preponderance of the evidence that Steenfeldt-
Jensen teaches this limitation based on the reasons and evidence identified in
the portions of the Petition cited in the preceding sentence, which we adopt
as our own findings.
j) the driving member is configured to rotate relative to the piston
rod;
Petitioner relies on a modified driver tube 85 as the recited “driving
member.” Petitioner explains that, prior to the proposed modification,
Steenfeldt-Jensen teaches that member 40 rotates relative to piston rod 6,
“because the piston rod 6 is coupled to the driver tube 85 in such a way that
“rotation is transmitted.” Pet. 46 (citing Ex. 1014, 11:15–19). Petitioner
proposes modifying driver tube 85 whereby “the internal threads of the
piston rod drive are located on driver tube 85 instead of member 40.” As a
result of the modification, driver tube 85 rotates relative to piston rod 6
during dose dispensing because “member 40 (instead of driver tube 85)
mates with the not circular cross-section of the piston rod.” Pet. 46.
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Patent Owner does not present any additional arguments regarding
this limitation of claim 21 beyond the arguments discussed below
concerning Petitioner’s proposed modification of driver tube 85. See PO
Resp. 21–41. For purposes of this portion of our analysis, Petitioner shows,
and Patent Owner does not dispute, that driver tube 85, as modified by
Petitioner, is “configured to rotate relative to the piston rod.” We are
persuaded that Petitioner shows by a preponderance of the evidence that
Steenfeldt-Jensen teaches and suggests this limitation based on the reasons
and evidence identified in the portions of the Petition cited in the preceding
paragraph, which we adopt as our own findings.
k) the sleeve is rotatably fixed relative to the driving member and
configured to traverse axially with the dose indicator; and
Petitioner shows, and Patent Owner does not dispute, that Steenfeldt-
Jensen teaches that bushing 82, a “sleeve,” is “kept non-rotated,” i.e.,
rotatably fixed, relative to driver tube 85, a “driving member,” “due to its
coupling to the driver tube.” Pet. 47 (quoting Ex. 1014, 11:55–56).
Petitioner explains that bushing 82 and driver tube 85 are coupled so that
they rotate together, but that longitudinal displacement is not transmitted
between the two components. Id. at 48 (citing Ex. 1014, 11:26–33, 11:55–
56; Ex. 1011 ¶ 649). Petitioner further shows that “[b]ushing 82 is also
configured to traverse axially with the dose indicator” and “with scale drum
80 during dose dispensing.” Id. at 47–50 (citing Ex. 1014, 12:4–9,
Figs. 15–17; Ex. 1011 ¶ 652). Mr. Leinsing explains that bushing 82 “is
configured to traverse axially towards the dose dispensing end with scale
drum 80 during dose dispensing,” because, as shown in Figures 15 and 16,
“injection button 88 pushes scale drum 80 back into the housing via
bushing 82.” Ex. 1011 ¶ 652.
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We are persuaded that Petitioner shows by a preponderance of the
evidence that Steenfeldt-Jensen teaches this limitation based on the reasons
and evidence identified in the portions of the Petition cited in the preceding
paragraph, which we adopt as our own findings.
l) the piston rod and the driving member are configured to rotate
relative to one another during dose dispensing; and
This limitation is substantially similar to the limitation addressed
above: “the driving member is configured to rotate relative to the piston
rod.” Petitioner, again, relies on a modified driver tube 85 as the recited
“driving member.” Pet. 50–51. Petitioner explains that, prior to the
proposed modification, Steenfeldt-Jensen teaches that member 40 rotates
relative to piston rod 6 during dose dispensing, “because the piston rod 6 is
coupled to the driver tube 85 in such a way that “rotation is transmitted.”
Pet. 51 (citing Ex. 1014, 8:48–53, 11:6–19, 11:52–62, 12:4–12; Ex. 1011
¶ 654). Petitioner proposes modifying driver tube 85 whereby “the internal
threads of the piston rod drive are located on driver tube 85 instead of
member 40.” Id. As a result of the modification, driver tube 85 rotates
relative to piston rod 6 during dose dispensing because “member 40 (instead
of driver tube 85) mates with the not circular cross-section of the piston
rod.” Id.
Patent Owner does not present any additional arguments regarding
this limitation of claim 21 beyond the arguments discussed below
concerning Petitioner’s proposed modification of driver tube 85. See PO
Resp. 21–41. For purposes of this portion of our analysis, Petitioner shows,
and Patent Owner does not dispute, that piston rod 6 and member 40, as
modified by Petitioner, are “configured to rotate relative to one another
during dose dispensing.” We are persuaded that Petitioner shows by a
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preponderance of the evidence that Steenfeldt-Jensen teaches and suggests
this limitation based on the reasons and evidence identified in the portions of
the Petition cited in the preceding paragraph, which we adopt as our own
findings.
m) the piston rod is configured to traverse axially towards the dose
dispensing end during dose dispensing.
Petitioner shows, and Patent Owner does not dispute, that Steenfeldt-
Jensen teaches piston rod 6 is configured to traverse axially towards the
dose-dispensing end during dose dispensing (with or without Petitioner’s
proposed modification of driver tube 85). Pet. 52–53 (citing Ex. 1011
¶¶ 656–657; Ex. 1014, 11:11–19, 12:4–12). Petitioner explains that
“[s]wapping the location of the threads and the non-circular cross-section as
between driver tube 85 and member 40 still would result in piston rod 6
configured to traverse axially towards the dose dispensing end during dose
dispensing.” Pet. 53.
Patent Owner does not present any additional arguments regarding
this limitation of claim 21 beyond the arguments discussed below
concerning Petitioner’s proposed modification of driver tube 85. See PO
Resp. 21–41. We are persuaded that Petitioner shows by a preponderance of
the evidence that Steenfeldt-Jensen teaches this limitation based on the
reasons and evidence identified in the portions of the Petition cited in the
preceding paragraph, which we adopt as our own findings.
2. Reasons for the Proposed Modification of the Piston Rod Drive of
Steenfeldt-Jensen
Petitioner relies on Steenfeldt-Jensen as expressly providing the
rationale for the proposed modification. Pet. 53–56. Petitioner contends
that Steenfeldt-Jensen suggests an alternative embodiment in which driver
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tube 85 has internal threading “and rotates relative to piston rod 6 during
injection to drive the piston rod through member 40,” and “member 40
operates as a non-threaded piston-rod guide, preventing rotation of piston
rod 6 relative to the housing but allowing axial displacement.” Pet. 53.
As explained by Mr. Leinsing, Steenfeldt-Jensen teaches two
approaches for driving the piston rod: the “fixed-nut approach,” whereby
“rotation of the scale drum can rotate the piston rod relative to the nut
member,” and the “rotating-nut approach,” whereby “rotation of the scale
drum can rotate the nut member relative to the piston rod.” Ex. 1011 ¶ 622–
623 (emphases added). Id. The fifth embodiment applies the “fixed-nut”
approach, where “driver tube 85 is rotationally coupled to piston rod 6 and
rotation of scale drum 80 during injection rotates driver tube 85 and piston
rod 6 relative to member 40, which is essentially a fixed ‘nut member’.”
Ex. 1011 ¶ 623. Petitioner proposes modifying driver tube 85 and
member 40 to utilize the “rotating-nut” approach in place of the “fixed-nut”
approach. In this regard, Mr. Leinsing states, and we agree, that Steenfeldt-
Jensen teaches the alternative “rotating-nut” approach “in general terms” by
describing a “‘piston rod guide’ relative to which the piston rod is “axially
displaceable but not rotatable,’” and a “‘nut member’ that is ‘rotatable but
not axially displaceable in the housing and which has an inner thread mating
the thread of the piston rod.” Id. ¶ 622 (quoting Ex. 1014, 2:40–53); see
also Pet. 53–54. Specifically, Steenfeldt-Jensen states, in relevant part, the
following with regard to obtaining a syringe with advantageous features:
This is obtained by []injection syringes for apportioning
set doses of a medicine from a cartridge containing an amount of
medicine sufficient for the preparation of a number of therapeutic
doses, comprising
a housing
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a piston rod having a not circular cross-section and an outer
thread
a piston rod drive comprising two elements
a) a piston rod guide in relation to which the piston rod is
axially displaceable but not rotatable, and
b) a nut member which is rotatable but not axially
displaceable in the housing and which has an inner
thread mating the thread of the piston rod to form a self
locking thread connection.
Ex. 1014, 2:40–53 (the “General Disclosure”). Thus, Petitioner shows that
its proposed modification of driver tube 85 to include internal threads and
modification of member 40 to operate as a piston rod guide is suggested by
Steenfeldt-Jensen. In particular, as explained by Mr. Leinsing, “Steenfeldt-
Jensen teaches that embodiments using the fixed-nut approach can be
implemented by the rotating-nut approach.” Ex. 1011 ¶ 623. In support of
his opinion, Mr. Leinsing identifies the following Steenfeldt-Jensen
disclosures:
 “When the injection button is pressed the movement of this
button is transformed into a rotation of the piston rod (or the nut
member) relative to the nut member (or the piston rod). When
the button is pressed hard enough the initial reluctan[ce] is
overcome so that the two elements, the piston rod and the nut
member, are rotated relative to each other.” Ex. 1014, 3:15–20
(the “Rotation Disclosure”).
 “The thread connection by which the injection button is screwed
out from the housing by setting a dose may be the thread
connection between the dose scale drum and the housing. In this
case the dose scale drum must be coupled to a driver rotating the
piston rod (or the nut member) relative to the nut member (or the
piston rod) when the injection button is pressed.” Id. at 3:41–47
(the “Driver Disclosure”).
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 “In the shown embodiment the end wall 4 with its threaded bore
forms a nut member relative to which the piston rod is rotated by
the piston rod guide 14 and the driver tube 26. Embodiments
may be imagined wherein the piston rod guide is provided in the
wall 4 and a nut element is rotated by the driver tube and such
embodiment will not be beyond the scope of the invention.”
Ex. 1014, 7:41–47 (the “Rotating-Nut Disclosure”).
Ex. 1011 ¶¶ 622–623. The Rotation Disclosure and the Driver Disclosure
appear in the Specification of Steenfeldt-Jensen in the general description of
the invention, and the Rotating-Nut Disclosure appears in the Specification
in the description of the first embodiment corresponding to Figures 1 to 5.
See Ex. 1014, 5:33–7:47. Petitioner reasons that a person of ordinary skill in
the art “would have interpreted Steenfeldt-Jensen as suggesting that driver
tube 85 could be implemented with internal threading (i.e. as a rotating-nut
element),” for engaging the external threading of piston rod 6, “while
member 40 could be implemented as a fixed piston rod guide (i.e. preventing
rotation of piston rod 6 relative to the housing)” to include a non-circular
cross-section for preventing rotation of piston rod 6 relative to the housing
while permitting axial displacement. Id. (citing Ex. 1011 ¶ 624). We agree
with Petitioner that the four disclosures identified above show that
Steenfeldt-Jensen suggests that fixed-nut and rotating-nut approaches are
interchangeable and expressly contemplated alternative configurations of the
piston rod drive. See Pet. 55.
Further, Petitioner shows, as supported by Mr. Leinsing, that a person
of ordinary skill in the art would have had a reasonable expectation of
success applying the proposed modifications to Steenfeldt-Jensen,
because: (1) such a person “would have been have been familiar with the
structure and operation of drive nuts that rotate to push a non-rotating piston
rod forward,” and (2) such a person would have “expected such
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modifications to involve the use of familiar elements operating in a
predictable manner,” because Steenfeldt–Jensen taught “the
interchangeability of fixed-nut and rotating-nut embodiments.” Pet. 55
(citing Ex. 1011 ¶ 625). Petitioner also shows that a person of ordinary skill
in the art would have recognized that the proposed modifications would not
have changed the principle of operation of the device, because it would have
allowed “all other aspects of the device” to operate the same. Pet. 55–56
(citing Ex. 1011 ¶ 625). Finally, Petitioner shows that the design and
operation of the modified device “would have been routine and predictable,”
and “would have involved the use of well-known, familiar elements
performing their same, predictable functions.” Id. (citing Ex. 1011 ¶ 626).
We find Petitioner’s arguments and evidence persuasively establish
that Petitioner’s proposed modifications to Steenfeldt-Jensen’s fifth
embodiment apply known elements suggested by Steenfeldt-Jensen in a
routine and predictable manner, that a person of ordinary skill in the art
would have reasonably expected the modified parts to perform the same
function as before, and thus, one of ordinary skill in the art would have had a
reasonable expectation of success in making Petitioner’s proposed
modifications of. Id. (citing Ex. 1011 ¶¶ 625, 626). Patent Owner’s
evidence and arguments to the contrary, which we address in detail below,
do not persuasively refute Petitioner’s showing in this regard.
In response to Petitioner, Patent Owner argues that there is no
disclosure or suggestion in Steenfeldt-Jensen of an internally threaded driver
tube, that the Rotating-Nut Disclosure applies only to the first embodiment
(not to the fifth embodiment), and that a person of ordinary skill would have
been dissuaded from making Petitioner’s proposed modification because it
would have resulted in an inferior pen and because of potential failures in
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the flexible arms of the alternative driver. PO Resp. 21–41; PO Sur-reply 1–
16. We address each of these arguments below and conclude on the whole
record that Petitioner shows a legally sufficient rationale for the proposed
modification of the fifth embodiment of Steenfeldt-Jensen.
a) Petitioner Shows that a Person of Ordinary Skill in the Art Would
Have Understood Steenfeldt-Jensen Suggests an Internally
Threaded Driver Tube
For the reasons provided above, Petitioner shows that Steenfeldt-
Jensen suggests an internally threaded driver tube. Patent Owner argues that
Petitioner fails to show how Steenfeldt-Jensen “discloses or suggests an
internally threaded driver tube,” because all of the passages Petitioner relies
on disclose “an internally threaded ‘nut member’ or ‘nut element’, which is
rotated by a driver tube,” such that “the driver tube itself is not threaded.”
PO Resp. 21–23 (citing Ex. 1014, 2:40–53 (the General Disclosure
discussing a threaded “nut element”), 3:15–20, 3:41–47 (the Rotation
Disclosure and the Driver Disclosure discussing a “nut member”); 7:41–47
(the Rotating-Nut Disclosure discussing a “nut member”). According to
Patent Owner, these passages “teach an internally threaded nut member and
a piston rod with relative movement between the two components, [b]ut the
nut member is not the driver tube, and Steenfeldt-Jensen makes clear
throughout its disclosure that the nut member and the driver tube are
different components.” PO Resp. 23; see also Ex. 2107 ¶ 215–220
(supporting Patent Owner’s contentions). In support, Dr. Slocum explains,
for example, that in the third embodiment taught by Steenfeldt-Jensen, the
nut member 48 is distinct from driver tube 45. Ex. 2107 ¶ 221. Thus, Patent
Owner asserts that the teachings from Steenfeldt-Jensen that Petitioner relies
on “do not support the modification suggested by Petitioner.” PO Resp. 23.
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In reply, Petitioner shows that Steenfeldt-Jensen “makes clear that a
driver with a nut member is an internally-threaded driver.” Pet. Reply 3.9
Petitioner supports its argument by drawing a parallel to Steenfeldt-Jensen’s
teachings with regard to the driver and the piston rod guide. According to
Petitioner, Steenfeldt-Jensen teaches a driver rotating a piston rod guide, but
further explains that the piston rod guide is not a separate component from
the driver. Id. (citing Ex. 1095 ¶ 65; Ex. 1014, 6:35–36 (driver tube 26 is
“integral with the piston rod guide”), 11:15–19 (equating the piston rod
guide to the rectangular bore of the driver tube). In this regard, Mr. Leinsing
explains that a “person of ordinary skill, understanding that a driver tube
with a piston rod guide is equivalent to a driver tube with a rectangular bore,
would have also understood that a driver tube with a nut member is
equivalent to a driver tube with an internally-threaded bore.” Ex. 1095 ¶ 65.
Mr. Leinsing supports his opinion by explaining that Steenfeldt-
Jensen describes a “nut member” in a “fixed-nut” embodiment as being
formed by “end wall 4 with its threaded bore.” Id. (quoting Ex. 1014,
7:41–43). According to Mr. Leinsing, “the person of ordinary skill would
have understood that, when Steenfeldt-Jensen refers to a ‘nut member’ or
‘nut elements,’ it is to an internally threaded component for engaging the
piston rod (e.g., end wall 4), and that “a driver tube with an internally
threaded bore would similarly operate as a ‘nut member.’” Id.

9 In its Reply, Petitioner also argues that another reference (Ex. 1016)
supports its contentions, because Petitioner’s proposed modifications are
consistent with the approach applied in the other reference. Pet.
Reply 18–19. Patent Owner argues that Petitioner’s argument is improper
because it was not raised in the Petition. PO Sur-reply 14–15. We need not
resolve the issue raised by Patent Owner, because our Decision does not rely
on the disputed arguments presented by Petitioner.
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Patent Owner argues in sur-reply: (1) that “the claims specifically
require a threaded driver tube, not a nut member rotated by a driver tube,”
and that “the distinction matters;” (2) that “nowhere does Steenfeldt-Jensen
teach an integrally formed nut member,” and instead “universally describes
its nut member as a separate component;” and (3) that “the leap Petitioner
uses to demonstrate its integrally formed nut member is predicated on a
misreading” of the Driver Disclosure. PO Sur-reply 11–14. In support,
Patent Owner shows, and Petitioner does not dispute, that “in the first, third,
fourth, and fifth embodiments” of Steenfeldt-Jensen the nut member is
separate and distinct from the driver tube. Id. at 11–12 (citing Ex. 1014,
Figs. 2, 12, 14, 16). Patent Owner also shows that the Driver Disclosure
“does not mention” an “integrally formed nut member,” because those words
plainly don’t appear in that disclosure. Id. at 12. Patent Owner further
argues that “Steenfeldt-Jensen does not equate the piston rod driver with a
nut member,” and “in no way suggests the nut member may be integrally
formed with the driver tube.” Id. at 13–15. With regard to the Rotating-Nut
Disclosure, Patent Owner argues that it does not suggest a nut member
integrally formed with a driver tube, because it states “end wall 4 with its
threaded bore forms a nut member” and “[e]nd wall 4 is not the driver tube.”
Id. at 14 (citing Ex. 1014, 7:41–43).
Patent Owner’s arguments are not persuasive. Although Patent
Owner argues in various ways that Steenfeldt-Jensen contains no express
teaching of a driver tube with internal threading, that fact was never in
dispute, and the understanding of a person of ordinary skill in the art would
not have been limited to only Steenfeldt-Jensen’s express teachings. See PO
Sur-reply 10–14 (citing Pet. Reply 2–3; Ex. 1014, 3:41–47, 7:41–43, Figs. 2,
12, 14, 16). Patent Owner does not discredit Mr. Leinsing’s explanation that
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there were two well-known approaches for driving the piston rod involving
either a “fixed-nut approach” or a “rotating-nut approach,” and that
Steenfeldt–Jensen taught the interchangeability of the two approaches.
Patent Owner does not otherwise adequately refute Petitioner’s showing,
supported by Mr. Leinsing, that the General Disclosure, the Rotation
Disclosure, the Driver Disclosure, and the Rotating-Nut Disclosure
collectively, and in context, would have suggested to a person of ordinary
skill in the art a driver tube with an integral nut element, i.e., driver tube 85
modified with internal threading, as proposed by Petitioner. See Pet.
Reply 2–3 (citing Pet. 53–56; PO Resp. 21; Ex. 1014, 3:41–47, 6:35–36,
11:15–19; Ex. 1095 ¶¶ 63–65; Ex. 2107 ¶¶ 30, 215–222).
b) Petitioner Shows that the Rotating-Nut Disclosure of Steenfeldt-
Jensen is Not Limited to the First Embodiment and Applies to the
Fifth Embodiment
For the reasons provided above, Petitioner shows that Steenfeldt-
Jensen suggests an internally threaded driver tube in light of the Rotating-
Nut Disclosure, not alone, but in combination with the General Disclosure,
the Rotation Disclosure, and the Driver Disclosure. Patent Owner directs a
number of arguments towards the Rotating-Nut Disclosure, in isolation.
Specifically, Patent Owner argues that the Rotating-Nut Disclosure does not
suggest Petitioner’s proposed modification of driver tube 85 because a
person of ordinary skill in art would have understood that the disclosure “is
not applicable to the fifth embodiment” of Steenfeldt-Jensen.” PO Resp. 24
(citing Ex. 2107 ¶¶ 223–226).
Petitioner reasons that one of ordinary skill in the art would have
known that the Rotating-Nut Disclosure would also apply to the fifth
embodiment and that such a general suggestion does not have to be repeated
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because Steenfeldt-Jensen teaches alternative driver mechanisms before
describing other embodiments. Pet. Reply 3–9 (citing Ex. 1014, 2:40–53,
3:10–20, 3:41–47; Ex. 1095 ¶¶ 66–69). Even though the Rotating-Nut
Disclosure applies expressly to the first embodiment, we find that Petitioner
shows that this disclosure would have suggested, to one of ordinary skill in
the art, to consider a similar alternative for other embodiments, such as
Steenfeldt-Jensen’s fifth embodiment even though the same disclosure is not
repeated after each discussion of each embodiment. Id. (responding to PO
Resp. 24–26). We address each of Patent Owner’s arguments below.
First, Patent Owner argues that the “shown embodiment” referred to
in the Rotating-Nut Disclosure is the first embodiment (corresponding to
Figures 1–5 of Steenfeldt-Jensen) and that the description of the fifth
embodiment “does not include a similar passage.” PO Resp. 24. Patent
Owner also argues that Steenfeldt-Jensen’s provisional application included
the Rotating-Nut Disclosure and first embodiment, but not the fifth
embodiment. According to Patent Owner, when the fifth embodiment was
added, “similar language was not included to cover the fifth
embodiment . . . indicating that the [Rotating-Nut Disclosure] is not
applicable to the fifth embodiment.” PO Resp. 24–25 (citing Ex. 1014,
5:33–7:47, 11:6–12:16; Ex. 2127, 11:2–5).
While each of Patent Owner’s factual assertions appears to be correct,
they do not lead to Patent Owner’s conclusion that the Rotating-Nut
Disclosure would not have suggested to one of ordinary skill in the art that it
could not be applied to the fifth embodiment. Petitioner shows that
Steenfeldt-Jensen discusses an alternative rotating-nut drive mechanism
outside of the first embodiment, for example, the General Disclosure, in a
consistent manner with the Rotating-Nut Disclosure, thereby suggesting to a
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person of ordinary skill in the art that the Rotating-Nut Disclosure is
applicable to more than the first embodiment in which it arises. See Pet.
Reply 4–5 (citing Ex. 1095 ¶ 66). In sum, even though the Rotating-Nut
Disclosure applies directly to the first embodiment, we agree with Petitioner
that this express teaching would have, at least, suggested to one of ordinary
skill in the art to consider a similar alternative for the fifth embodiment as
well, even though the same statement is not repeated after the discussion of
the fifth embodiment. See Pet. 61–62; Pet. Reply 9–11.
Second, Patent Owner argues that a person of ordinary skill in the art
would have understood that the Rotating-Nut Disclosure was not a “general
teaching,” because if it were applied to Steenfeldt-Jensen’s second
embodiment the result would have been a non-functioning pen injector. PO
Resp. 31 (citing Ex. 2107 ¶ 226). Again, we find no rationale for Patent
Owner’s assertion that, because a general teaching may not apply to one
embodiment, a person of ordinary skill in the art would have understood it
does not apply to any of the other embodiments. More specifically, we find
persuasive Petitioner’s explanation that the drive mechanism taught in the
second embodiment of Steenfeldt-Jensen is not analogous to the first or fifth
embodiments, because the second embodiment does not have a driver tube.
See Pet. Reply 7 (citing Ex. 1014, 7:51–54 (“Different from the embodiment
in FIG. 1–5 is the fact that…the driver tube 26 is omitted.”), Figs. 6–10); see
also Ex. 1095 ¶ 70 (explaining that a person of ordinary skill in the art
would have “appreciated that the drive mechanism of the second
embodiment operates in a fundamentally different way” from the first and
fifth embodiments).
Third, Patent Owner argues that the Rotating-Nut Disclosure does not
suggest Petitioner’s proposed modification, but instead “teaches putting a
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piston rod guide in end wall 4 of ampoule holder 2 (of the first embodiment),
and having driver tube 26 (of the first embodiment) rotate a nut element.”
PO Resp. 26 (citing Ex. 2107 ¶ 215). Contrary to Patent Owner’s argument,
we find persuasive Petitioner’s showing that because the first and fifth
embodiments have analogous features, the Rotating-Nut Disclosure would
have suggested to a person of ordinary skill in the art that it could apply to
the fifth embodiment. Petitioner explains in detail that the first and fifth
embodiments of Steenfeldt-Jensen utilize “analogous drive mechanisms”
and that a person of ordinary skill in the art would have recognized that
Petitioner’s proposed modification to the driver tube and wall 4 “would have
been the same and had the same impact” for both embodiments. Pet.
Reply 5–7 (citing Ex. 1014, 5:55–61, 6:35–37, 7:3–8, 7:17–35, 7:41–43,
11:15–21, 11:52–55,12:4–13, FIGS. 2, 3, 16-17; Ex. 1095 ¶¶ 68, 69).
Petitioner further shows in this regard that Dr. Slocum agreed that the driver
tubes in the first and fifth embodiments have “the same engagement
method” with the piston rod and apply torque in the same way. Ex. 1054,
306:23–307:19; see also id., 342:3–343:18 (agreeing that transmission of
force in the first and fifth embodiments was “the same fundamental type of
thing” and that “driver tube 85 . . . essentially is the same as 26”).
Mr. Leinsing similarly explained that “a person of ordinary skill would have
understood the drive mechanisms of the first and fifth embodiments as
structurally and functionally equivalent for injection purposes.”
Ex. 1095 ¶ 70.
Patent Owner argues in its Sur-reply that Petitioner “concedes” the
Rotating-Nut Disclosure “is not a blanket statement” covering every
embodiment, that Mr. Leinsing “acknowledges that there are differences
between the first and fifth embodiments,” and that Patent Owner “had shown
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that the first and the fifth embodiments are not analogous.” Sur-reply 4
(citing Ex. 1095 ¶ 68; PO Resp. 19–21). As explained above, merely
because the Rotating-Nut Disclosure does not apply to the second
embodiment (i.e., because that embodiment does not have a driver tube),
does not detract from Petitioner’s position and our finding that it suggests
applicability to the fifth embodiment (which, like the first embodiment, has a
driver tube). Further, given that the first and fifth embodiments are, in fact,
different embodiments, Patent Owner’s assertion that there are differences
between the two does not detract from our finding. Further, given that the
first and fifth embodiments are, in fact, different embodiments, Patent
Owner’s assertion that there are differences between the two does not detract
from our finding. Likewise, in the portion of Patent Owner’s Response
cited, Patent Owner describes the first and fifth embodiments as “separate
and distinct,” but does not state that they are “not analogous.” PO
Resp. 19–21. Indeed, one would expect two embodiments to be separate and
distinct. The entire explanation of this distinction provided by Patent Owner
consists of the following:
In particular, Steenfeldt-Jensen’s first embodiment
comprises components that are not part of the fifth embodiment
and vice versa. The first embodiment includes an ampoule
holder 2 [] that is rotatable with respect to the housing 1 [] and
includes an end wall 4 with a threaded opening 5 that mates with
the threads on piston rod 6 []. The first embodiment also
identifies a piston rod guide 14 [] and a driver tube 26 []. The
fifth embodiment, however, does not have an ampoule holder 2
with a threaded end wall 4. Instead, the fifth embodiment
includes member 40 [] with a threaded end wall 4.
Id. at 20. Patent Owner fails to show that the differences Patent Owner
identifies have any material impact to the modifications proposed by
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Petitioner, much less that those differences refute Petitioner’s showing that
the embodiments are analogous, as explained above
We agree with Petitioner that (1) the various embodiments of
Steenfeldt-Jensen have either analogous or the same components,
and (2) Steenfeldt-Jensen does not repeat descriptions for those components
in the discussion of each latter embodiment, including wall 4. See Pet.
Reply 5–7 (citing Ex. 1095 ¶¶ 66–69). For example, the first embodiment
includes “wall 4 having a central bore with an internal thread 5” and “piston
rod 6 having an external thread 7 mating the thread 5 of said bore”
(Ex. 1014, 5:56–58) and the discussion of the fifth embodiment states that
“the thread of the piston rod and the thread in the end wall of the housing is
so designed that an anticlockwise rotation of the piston will screw the piston
rod through said end wall” (id. at 11:11–14). See also id. at Fig. 2 (showing,
for the first embodiment, externally threaded piston rod 6 engaging
internally threaded wall 4), Figs. 15–16 (showing, for the fifth embodiment,
externally threaded piston rod 6 engaging internally threaded wall 4). In
other words, Steenfeldt-Jensen need not expressly identify wall 4 in its
description of the fifth embodiment, because wall 4 is sufficiently identified
in the first embodiment and wall 4 is illustrated in Figures 15 and 16 with
regard to the fifth embodiment. See Ex. 1014, 5:55–58, 11:11–14,
Figs. 2, 15, 16.
We find that one of ordinary skill in the art would have understood
that Steenfeldt-Jensen employed this method of description and would have
applied the Rotating-Nut Disclosure to embodiments with the same or
analogous components, such as the fifth embodiment, because the Rotating-
Nut Disclosure relates to, at least, wall 4, which is included in both the first
and fifth embodiments. Ex. 1011 ¶ 277; Ex. 1095 ¶ 69. We also find that the
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first and fifth embodiments have substantially similar arrangements of piston
rods, piston rod guides, and nut members. Compare id. at Fig. 3, with id. at
Fig. 17; see also Ex. 1054, 306:23–308:9 (Dr. Slocum testifying that driver
tubes and piston rods shown in Figures 3 and 17 work similarly), 342:3–
343:19 (Dr. Slocum testifying that driver tubes of the first and fifth
embodiments work similarly). Additionally, we find that the fact that
Steenfeldt-Jensen does not repeat the description of the piston rod guide or
nut element, also discussed in the Rotating-Nut Disclosure, means that these
components are not so different from the first embodiment that further
description of those components was warranted in the fifth embodiments.
In sum, for the reasons provided above, Petitioner persuades us
that one of ordinary skill in the art, reading from the Rotating-Nut
Disclosure that an alternative arrangement can include a “piston rod guide
[that] is provided in the wall 4 and a nut element [that] is rotated by the
driver tube,” “would have reason to modify (1) driver tube 85 to include
an internal threading for engaging the piston rod’s external threading,
and (2) member 40 to include a non-circular cross-section for axially
guiding the piston rod” in Steenfeldt-Jensen’s fifth embodiment. Pet. 61;
Ex. 1011 ¶ 277; Ex. 1095 ¶ 69.
c) A Person of Ordinary Skill in the Art Would Not Have Been
Dissuaded by Inferior Results from Applying Petitioner’s
Proposed Modifications to Steenfeldt-Jensen
Patent Owner argues that a person of ordinary skill in the art would
not have been motivated to modify Steenfeldt-Jensen to move “the threads
on member 40 to the driver tube,” and to move “the non-circular slot on the
driver tube to member 40,” because it would introduce higher friction and
result in an inferior injection pen “with higher injection force,” a
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“benchmark for these products.” PO Resp. 26–28 (citing Ex. 1004, 4:7–9;
Ex. 1015 ¶¶ 4–6; Ex. 2107 ¶¶ 37–39, 44–45, 54, 56–57, 232–238; Ex. 2163,
80:17–81:5). Patent Owner’s argument is supported by Dr. Slocum, who
“created analytical models presented in the form of a spreadsheet” and
explains a physical model (the “Collar Friction Model”) that “directly
compares Steenfeldt-Jensen’s fifth embodiment with Petitioner’s proposed
modification to the fifth embodiment.” Id. at 28 (citing Ex. 2107
¶¶ 245–255; Exs. 2211, 2215–2217).
According to Patent Owner, the analytical model used by Dr. Slocum
shows that “Petitioner’s proposed modification increases the amount of force
required from the user to inject a dose by 51%.” Id. at 29 (citing Ex. 2107
¶¶ 242–244, App. A). Patent Owner also argues that, as explained by Dr.
Slocum, the Collar Friction Model shows that “rotating the Collar with the
Threaded Insert (Petitioner’s proposed modification) is more difficult than
rotating the Collar with the Guide (Steenfeldt-Jensen’s fifth embodiment).”
Id. at 29–34 (citing Ex. 2107 ¶¶ 245–255; Exs. 2215–2217); see also id. at
33–34 (stating that the modified device “requires 50% more force on
average to advance the piston rod” than the unmodified device). Patent
Owner also provides a detailed explanation for why Petitioner’s
modification results in higher friction. Id. at 34–37 (citing Ex. 2107 ¶¶ 233–
238, 242–244; Ex. 1014, 12:10–13, Fig. 16; Ex. 2152). Thus, Patent Owner
asserts that, “contrary to the critical design objectives in this art,”
“[m]odifying the fifth embodiment as Petitioner proposes increases friction
and impairs the device.” Id. at 37 (citing Ex.. 1004, 1:36–40; Ex. 1015
¶¶ 4–6; Ex. 2107 ¶¶ 54–57, 229–231).
In Reply, Petitioner raises three main arguments. Pet. Reply 9–17.
First, Petitioner argues that Patent Owner is improperly disregarding the
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express teachings of Steenfeldt-Jensen. Id. at 9–10. Specifically, as
explained above, Petitioner’s proposed modification of the fifth embodiment
of Steenfeldt-Jensen is based on the express disclosure by Steenfeldt-Jensen
of an alternative arrangement for the first embodiment. Dr. Slocum,
however, suggested that a person of ordinary skill in the art would not have
applied that express teaching to the first embodiment, because it was “a
really stupid idea,” and likewise wouldn’t apply it to the fifth embodiment
either. Id. (citing Ex. 1054, 306:23–313:6).
Second, Petitioner argues that Patent Owner’s position is based on a
flawed premise—that modifications to Steenfeldt-Jensen are only relevant to
insulin pen injectors, whereas Steenfeldt-Jensen and the ’844 patent claims
are not limited to insulin pen injectors. Id. at 11–12 (citing PO Resp. 27–28;
Ex. 2107 ¶¶ 44–61; Ex. 1053, 62:13–71:2, 72:3–11, 75:22–76:3). Petitioner
asserts that Dr. Slocum “mistakenly assumed” that the person of ordinary
skill in the art “was limited to designing a pen for diabetic patients,” which
led Dr. Slocum to “incorrectly limit the [person of ordinary skill in the art’s]
design objectives to reducing injection force at all costs to accommodate the
particular needs of diabetic patients.” Id. Petitioner contends that injection
force is one factor, but not the only factor, a person of ordinary skill in the
art would consider when designing pen injectors, even if directed to diabetic
patients. Id. at 12 (citing Ex. 1048 ¶¶ 25, 28, 32 (Dr. Biggs explaining that
insulin type, cost, reliability, and other factors were more important
considerations than injection force when choosing an injectable insulin
product ); Ex. 1095 ¶ 72).
Third, Petitioner argues that Patent Owner’s models are flawed
because (1) the models are unreliable because the physical model was
designed by Mr. Veasey, a named inventor on the ’044 patent, not by
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Dr. Slocum and Dr. Slocum relied upon Mr. Veasey for many inputs in the
analytical model spreadsheet (id. at 12–17 (citing Ex. 1053, 12:22–13:5,
28:18–29:2, 30:5–33:13; Ex. 1054, 313:10–325:12; Ex. 1095 ¶¶ 73, 74;
Ex. 2107 ¶¶ 242–243)), (2) the models do not asses total change in friction
because they focus on friction at one point in the system, but ignore the
possibility of reducing friction at other points (id. at 15–16 (citing Ex. 1095
¶¶ 73–75; Ex. 2107 ¶ 58)), and (3) the models were designed to fail because
they exaggerate friction losses by not considering changes, within the
ordinary level of creativity, that one of ordinary skill in the art could also
make to minimize friction (id. at 16–17 (citing Ex. 1053, 33:5–13, 41:3–
42:13; Ex. 1054, 325:22–327:6; Ex. 1095 ¶¶ 74, 75, 134)).
In its Sur-reply, Patent Owner argues that an increase in injection
force “demonstrates that a [person of ordinary skill in the art] would be
dissuaded from Petitioner’s modification, even if a [person of ordinary skill
in the art] could do so,” and that Petitioner offers “no motivation that would
outweigh the substantial increase in injection force.” PO Sur-reply 6–7.
Patent Owner further argues that the models are not unreliable or biased
because “Dr. Slocum independently verified the models, conducted his own
experiments, and gathered his own data.” Id. at 7–8 (citing Ex. 2017
¶¶ 242–255, App. B, E). Patent Owner asserts that Mr. Veasey is not an
employee of Patent Owner and does not have a financial stake in this
proceeding. Id. at 8. According to Patent Owner, even assuming
Mr. Veasey is an interested party, Petitioner presents no opposing evidence
regarding increased friction and injection force. Id. Second, Patent Owner
contends that the analytical model does test the total change in friction
because the 51% increase in injection force is “derived from a comparison
between the fifth embodiment and modified fifth embodiment.” Id. at 9–10.
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Third, Patent Owner argues that Petitioner’s critique of the models as not
employing “ordinary creativity” or common-sense approaches to reducing
friction is inapposite because any approach could be used to mitigate friction
in both the unmodified fifth embodiment as well as the modified fifth
embodiment, thus resulting in no offset of total friction. Id. at 10.
In consideration of all of the evidence presented, Patent Owner
presents persuasive evidence that Petitioner’s proposed modifications would
increase friction to some extent. Nonetheless, Steenfeldt-Jensen expressly
teaches an alternative configuration wherein a piston rod guide is in wall 4
and a driver tube rotates a nut element instead of a piston rod guide
Ex. 1014, 7:41–47. Petitioner also provides persuasive evidence that at least
some of the friction increase could be offset by making routine changes well
within the level of ordinary skill in the art and that the increase would not
have dissuaded one of ordinary skill in the art from applying the alternative
disclosed in Steenfeldt-Jensen to the fifth embodiment. See, e.g., Ex. 1095
¶¶ 73–75.
On the full record before us, we find that Petitioner establishes that
despite an increase in friction, one of ordinary skill in the art would not have
been dissuaded from modifying Steenfeldt-Jensen’s fifth embodiment as
Petitioner proposes. In particular, we credit Petitioner’s evidence that
Steenfeldt-Jensen is not limited to insulin injection syringes (see, e.g.,
Ex. 1014, 1:16–17 (discussing diabetics as a non-limiting example of users
who inject themselves frequently and to whom the disclosed injection
syringe is directed); Pet. Reply 11–12 (discussing Dr. Slocum’s testimony
focusing on diabetic patients), and that, even if the focus were solely on
diabetic patients and insulin injection syringes, “[i]njection force is a factor
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when designing pen injectors, but not the only factor” (id. (citing Ex. 1095
¶ 72)).
d) A Person of Ordinary Skill in the Art Would Not Have Been
Dissuaded by Potential Failures in the Flexible Arms of the
Alternative Driver Tube from Modifying Steenfeldt-Jensen
Patent Owner argues that there are three other potential failures
associated with Petitioner’s proposed modification that would have
discouraged a person of ordinary skill in the art from making the
modification. PO Resp. 38–39. First, Patent Owner asserts the flexible arms
on driver tube 85 could break when subjected to additional frictional. Id.
at 38. According to Patent Owner, this occurred when Dr. Slocum
“attempted to build and test Petitioner’s modification.” Id. (citing Ex. 2107
¶ 240). Second, Patent Owner argues that the flexible arms “may get stuck
and prevent the rotation necessary for injection.” Id. (citing Ex. 2107
¶ 239). Third, Patent Owner asserts that the flexible arms “could be pressed
into [an opening in the ring-shaped wall], thereby causing the device to fail
by jamming the driver tube 85 or causing the flexible arms to pass above the
ring-shaped wall such that the driver tube 85 moved proximally into the
housing.” Id. at 38–39 (citing Ex. 2107 ¶ 239; Ex. 1014, Figs. 14, 15).
In its Reply, Petitioner asserts that Patent Owner’s arguments show
that Patent Owner is not applying the perspective of a person of ordinary
skill in the art by treating “simple, straightforward tasks” as something that
“would stump” a person of ordinary skill in the art. Pet. Reply 17–18.
Petitioner asserts that Patent Owner offers no evidence that the flexible arms
would be affected, and that, if they were affected, “this would be the type of
routine task that a [person of ordinary skill in the art] would have no
difficulty addressing,” as explained by Mr. Leinsing. Id. at 18 (citing
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Ex. 1095 ¶ 76 (referring to Mr. Leinsing’s testimony to use a collar as the
bearing surface). In its Sur-reply, Patent Owner argues that Mr. Leinsing
presents no evidence that addressing these potential failures would be
routine. PO Sur-reply 7 (citing Pet. Reply 18 (citing Ex. 1095 ¶ 76)).
As discussed above, Steenfeldt-Jensen expressly describes an
alternative configuration wherein a piston rod guide is in wall 4 and a driver
tube rotates a nut element instead of a piston rod guide. See Ex. 1014,
7:41–47. Steenfeldt-Jensen does not address whether the alternative
configuration results in potential failures in the flexible arms of the
alternative driver tube. See id. Patent Owner’s evidence does not support
the finding that Petitioner’s modification inevitably results in failure or even
that failure is necessarily likely to occur more often. Additionally, we find
that Petitioner sufficiently establishes that if failure were to occur, a person
of ordinary skill in the art would have the means to cure the failure or to
modify the mechanism further to mitigate the potential increased frictional
force resulting in said failure. See, e.g., Ex. 1095 ¶ 76. For these reasons,
we find that even if we accept Patent Owner’s arguments that additional
potential failures may be likely post-modification, we do not find that those
potential failures would dissuade a person of ordinary skill in the art from
modifying Steenfeldt-Jensen’s fifth embodiment as Petitioner proposes.
e) Determination as to the Reason to Modify
For the reasons above, based on the full record before us, Petitioner
persuades us that Steenfeldt-Jensen suggests Petitioner’s proposed
modifications. In particular, Petitioner persuades us that the expressly
taught modification for Steenfeldt-Jensen’s first embodiment would have
suggested that one of ordinary skill in the art would have had reason to make
the same modification to the fifth embodiment in light of the Rotating-Nut
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Disclosure, in combination with the General Disclosure, the Rotation
Disclosure, and the Driver Disclosure. On these issues, we similarly find the
testimony of Mr. Leinsing more persuasive than that of Dr. Slocum, in
particular with regard to how and why a person of ordinary skill in the art
would have applied Steenfeldt-Jensen’s teaching of an alternative rotating-
nut drive mechanism from the first embodiment to the fifth embodiment.
3. Differences Between the Subject Matter of Dependent Claim 22
and the Teachings of Steenfeldt-Jensen
Claim 22 depends from claim 21 and further requires that “the piston
rod has a circular cross-section.” Ex. 1004, 8:50–51. Petitioner contends
that Figures 15–17 of Steenfeldt-Jensen teach a piston rod that has a circular
cross-section. Pet. 56–57 (citing Ex. 1011 ¶ 658). Petitioner provides
partial views of Figures 16 and 17, reproduced below:

Id. at 56. Illustrated above is piston rod 6 of Steenfeldt-Jensen, as shown in
Figure 17 on the left and Figure 16 on the right. Petitioner contends piston
rod 6 is shown to have “a circular cross-section at each of its proximal and
distal ends,” and further asserts that claim 22 does not require that the piston
rod have “a uniformly circular cross-section along its entire length.” Id.
at 57 (citing Ex. 1011 ¶ 658). Patent Owner does not dispute that the ends of
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piston rod 6 of Steenfeldt-Jensen have a circular cross-section. PO Resp.
30–33.
Petitioner also contends that “piston rod 6 has a ‘circular cross-
section’ with flat sides,” as purportedly explained by Mr. Leinsing. Pet. 57
(citing Ex. 1011 ¶ 658). Mr. Leinsing, however, does not support
Petitioner’s argument and does not address “flat sides.” See Ex. 1011 ¶ 658.
We, therefore find Petitioner’s argument unsupported and conclusory. The
only issue remaining is whether the claim language is satisfied if, as shown
in Steenfeldt-Jensen, only a portion of the piston rod has a circular cross-
section.
Patent Owner first argues that piston rod 6 has a non-circular cross-
section. PO Resp. 40. That is only half true – portions of piston rod 6 have
a non-circular cross-section where the sides are flat, and portions of piston
rod 6 have a circular cross-section, most notably at the ends, as shown in the
illustrations above. Thus, while Patent Owner is correct that Steenfeldt-
Jensen states that piston rod 6 has a “not round” and “non-circular” cross-
section, that disclosure does not show that piston rod 6 fails to satisfy the
language of claim 22, because the disclosure does not preclude piston rod 6
from having both a circular cross-section and a non-circular cross-section, as
illustrated above. PO Resp. 40 (quoting Ex. 1014, Abstract, 11:15–17).
Likewise, whether a person of ordinary skill in the art “would understand
that the cross-section of the piston rod in Steenfeldt-Jensen is non-circular so
that it can slot through and is rotationally constrained to the non-circular
bore of driver tube 85,” does not preclude piston rod 6 from having both a
circular cross-section and a non-circular cross-section, as illustrated above.
PO Resp. 41.
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The only responsive argument advanced by Patent Owner is that
Petitioner’s interpretation of the claim language “is baseless and not
reasonable.” Id. at 40–41; PO Sur-reply 15–16. According to Patent Owner:
nowhere in the claim or specification is it suggested that the
cross-section of the piston rod is defined by the very ends (e.g.,
the head) of the piston rod. Rather, the [’]844 Patent
specification shows that the piston rod has a circular cross-
section over its length because it is adapted to engage with and
move rotationally and axially relative to the cylindrical bore in
the drive sleeve. See Ex. 1004 at 3:65–66, 4:13–14, 6:55–58,
Figs. 9–11; Ex. 2107, ¶¶ 418–19.
PO Resp. 41; see also PO Sur-reply 15 (arguing that a person of ordinary
skill in the art “would have recognized that claim 22 requires a piston rod
have a circular cross-section along its length.”). Thus, Patent Owner argues
that we should read into claim 22 a limitation that the entire piston rod must
have a circular cross-section throughout (“over” or “along”) its length
because (1) the specification doesn’t say where the cross-section of the
piston rod is defined, and (2) an embodiment shown in the specification has
a circular cross-section over its length.10
The plain language of the claim is not as limited as Patent Owner now
suggests and requires only that “the piston rod has a circular cross-section.”
The claim does not require a circular cross-section throughout (along or
over) the entire length of the piston rod, and Patent Owner offers no
persuasive reason for reading such a limitation into the claim. If Patent
Owner’s narrow construction of the claim language were correct, a piston

10 Patent Owner belatedly suggests in its Sur-reply that “common sense and
customary usage” would lead a person of ordinary skill to look to the
“functional part of the piston rod” to determine the cross-section. PO Sur-
reply 15–16. This argument was not raised in the Patent Owner Response
and is unsupported by any evidence.
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rod that had a circular cross-section along nearly its entire length would not
have a “circular cross-section” within the scope of claim 22 if any portion of
it did not have a circular cross-section. To the extent Patent Owner implies
that the circular cross-section need not be throughout the “entire” length,
such a construction would be inconsistent with the plain language of the
claim, which does not recite a “circular cross-section” over “most” or “a
majority” of the piston rod. It also would be unreasonably vague and
ambiguous, because Patent Owner offers no explanation for how a person of
ordinary skill in the art would have known whether any particular piston rod
satisfied the claim language. Given the choice between construing “the
piston rod has a circular cross-section” to mean either the entire piston rod
has a circular cross-section or some portion of the piston rod has a circular
cross-section, Petitioner has shown that the broadest reasonable construction
is the latter. There is no dispute that portions of piston rod 6 have a circular
cross-section. Accordingly, we are persuaded that Petitioner shows by a
preponderance of the evidence that Steenfeldt-Jensen teaches every
limitation of claim 22.
4. Differences Between the Subject Matter of Dependent Claims 23–29
and the Teachings of Steenfeldt-Jensen
Claim 23 depends from claim 21 and further requires “a clutch.”
Ex. 1004, 8:52–53. Claim 24 depends from claims 23 and further recites
“where the clutch provides audible and tactile feedback indicative of unit
doses of medicament.” Ex. 1004, 8:54–56 (emphasis added). Claim 25
depends from claim 24 and recites “where the clutch provides audible clicks
during dose cancelling, where each click is equal to a unit dose of
medicament.” Id. at 8:57–59. Claims 26–28 also depend from claim 24 and,
respectively, require additional limitations related to the clutch and a button
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for dose deliver. Id. at 8:57–9:3. Claim 29 depends from claim 21 and,
similar to claim 25, recites “a clicker that provides audible clicks during
dose setting, where each click is equal to a unit dose of medicament.” Id.
at 9:4–7.
Petitioner shows how Steenfeldt-Jensen teaches every additional
limitation of dependent claims 23–29 through a claim chart which provides
citations to the disclosures in Steenfeldt-Jensen that correspond to each
limitation of the claims. Pet. 57–68. Petitioner’s contentions are supported
by Mr. Leinsing. Ex. 1011 ¶¶ 659–684. In sum, Patent Owner does not
dispute that Steenfeldt-Jensen teaches every limitation of claims 23–29. See
generally PO Resp.
Specifically, for example, Petitioner shows that Steenfeldt-Jensen
teaches bushing 82, corresponding to the recited “clutch” of claim 23 (and
notes that the ’844 patent likewise relies on one element, clutch 60, as both a
“sleeve” recited in claim 21 and a “clutch” recited in claim 23). Pet. 58
(citing Ex. 11:34–42; Ex. 1011 ¶¶ 659, 660). With regard to the recited
clicking features, Petitioner shows, and Patent Owner does not dispute, that
“Steenfeldt-Jensen taught a clicking system that operates by having
protrusion 87 extend from bushing 82 into a number of depressions or
recesses such that the spacing of the depressions or recesses causes tactile
and audible feedback as the protrusions snap into the depressions when
dose–setting button 81 is rotated ‘in any direction.’” Pet. 59–60 (citing
Ex. 1014, 6:48–54, 11:37–40, 11:62–67; Ex. 1011 ¶¶ 662, 663). There also
is no dispute that Steenfeldt-Jensen teaches both “audible and tactile
feedback indicative of unit doses of medicament,” as well as “audible clicks
during dose setting, where each click is equal to a unit dose of medicament,”
as recited in the Challenged Claims. See Pet. 59–62; Ex. 1014, 6:42–53.
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Petitioner also shows that Steenfeldt-Jensen teaches dose-setting button 88
corresponding to the recited “button” and features of claims 27 and 28.
Pet. 64–68 (citing, e.g., Ex. 1014, 11:34–42, 11:49–51; Ex. 1011 ¶¶ 671–
674).
We are persuaded that Petitioner shows by a preponderance of the
evidence that Steenfeldt-Jensen teaches every limitation of claims 23–29 for
the reasons identified in the Petition (pages 57–68 (citing Ex. 1014, 1:20–22,
2:24–28; 4:59–60, 5:60–62, 5:64–6:3, 6:48–54, 8:48–53, 11:22–25, 11:34–
67, 12:1–13, Figs. 15–17)), which we adopt as our own findings.
5. Objective Indicia of Nonobviousness
We next consider evidence of objective indicia of nonobviousness
related to a product that Patent Owner asserts practices claims of
the ’844 patent and “satisfied a long-felt need in the industry,” received
industry praise, and attained “overwhelming commercial success.” PO
Resp. 3, 42–54; PO Sur-reply 17–23. Petitioner argues in response that
Patent Owner fails to show a nexus between the purported evidence of
objective indicia of nonobviousness and the Challenged Claims and that the
offered evidence fails to support Patent Owner’s contentions. Pet.
Reply 22–27.
As background to Patent Owner’s arguments, Patent Owner sold an
insulin glargine solution administered as a once-daily subcutaneous injection
for patients diagnosed with either Type 1 or Type 2 diabetes under the
tradename Lantus® in three different forms. Ex. 2109 ¶¶ 6, 17. The first
form launched in the United States in 2001 as “Lantus® vial” and is
administered through a syringe. Id. ¶¶ 6, 18. The second form launched in
the United States in 2005 in a pen injector form as “Lantus® OptiClik®,” but
was subsequently discontinued and allegedly did not practice the
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’844 patent. Ex. 2109 ¶¶ 19, 36; Ex. 2107 ¶¶ 644–648. The third form
launched in the United States in 2007 in a pen injector form as “Lantus®
SoloSTAR®.” Thereafter, in addition to Lantus®, a “long-acting insulin
analog,” Patent Owner also sold “fast-acting” injectable insulin with the
SoloSTAR® pen injector, including Apidra® SoloSTAR® and Admelog®
SoloSTAR®. Ex. 2109 ¶¶ 6, 17, 22; Ex. 1048 ¶ 39. Patent Owner also
explains that at the time of the invention of the ’844 patent “there were
already several pen-type injectors known in the art,” including the
commercially available Novo Nordisk FlexPen® which “closely
corresponds” to an embodiment described in Steenfeldt-Jensen and which
was marketed for administering an insulin analog as the “Levemir®
FlexPen®.” PO Resp. 3–4 (citing Ex. 1014, Figs. 1–17; Ex. 2107 ¶ 28),
45, 50.
According to Patent Owner, the SoloSTAR® pen injector practices
claims 21 and 30 of the ’844 patent. PO Resp. 3; Ex. 2109 ¶ 20; Ex. 2107
¶¶ 551–610. Patent Owner’s contention is persuasively supported by
Dr. Slocum’s unrebutted testimony that the SoloSTAR® pen injector
practices claims 21 and 30 of the ’844 patent. Ex. 2107 ¶ 551–610; see id.
¶ 551 (stating that “it is my opinion that the SoloSTAR® device practices at
least claims 21 and 30 of the ’844 patent”). Accordingly, based on
Dr. Slocum’s testimony, Patent Owner shows that SoloSTAR® practices
claims 21 and 30 of the ’844 patent.
Patent Owner, however, does not focus its arguments of objective
evidence of nonobviousness on SoloSTAR® alone (with the exception of
industry praise), but instead proceeds to argue that “Sanofi’s Lantus®
SoloSTAR® practices claims 21 and 30” of the ’844 patent. PO Resp. 43
(footnote omitted). Importantly, none of the Challenged Claims of the
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’844 patent recite Lantus® or any other medication as a required limitation.
Presumably, Patent Owner implicitly reasons that because SoloSTAR®, a
pen injector for administering a medication, practices the Challenged
Claims, the same pen injector sold as a combination product with
medication, Lantus®, necessarily also practices the claimed invention.
Petitioner does not dispute Patent Owner’s contention and we are persuaded
that Lantus® SoloSTAR® practices claims 21 and 30 of the ’844 patent for
the same reasons Patent Owner sufficiently established that SoloSTAR®
practices the same claims.
As a brief summary of the legal standards we apply with regard to
evidence of objective indicia of nonobviousness, we emphasize that such
indicia are “only relevant to the obviousness inquiry ‘if there is a nexus
between the claimed invention and the [objective indicia of
nonobviousness].’” In re Affinity Labs of Tex., LLC, 856 F.3d 883, 901
(Fed. Cir. 2017) (quoting Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
1312 (Fed. Cir. 2006)). A patentee is entitled to a presumption of nexus
“when the patentee shows that the asserted objective evidence is tied to a
specific product and that product ‘embodies the claimed features, and is
coextensive with them.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366,
1373 (Fed. Cir. 2019) (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882
F.3d 1056, 1072 (Fed. Cir. 2018) (quoting Brown & Williamson Tobacco
Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000))). If the
patented invention is only a component of a commercially successful
machine or process, the patentee is not entitled to a presumption of nexus.
Id. (reaffirming the importance of the “coextensiveness” requirement).
“[T]he purpose of the coextensiveness requirement is to ensure that nexus is
only presumed when the product tied to the evidence of secondary
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considerations ‘is the invention disclosed and claimed.’” Id. at 1374
(quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387,
1392 (Fed. Cir. 1988)). “[T]he degree of correspondence between a product
and a patent claim falls along a spectrum. At one end of the spectrum lies
perfect or near perfect correspondence. At the other end lies no or very little
correspondence.” Id. “A patent claim is not coextensive with a product that
includes a ‘critical’ unclaimed feature that is claimed by a different patent
and that materially impacts the product’s functionality.” Id. at 1375.
Patent Owner does not argue that Lantus® SoloSTAR® is coextensive
(or nearly coextensive) with any of the Challenged Claims, which do not
require medication. Accordingly, to the extent that Patent Owner relies on
evidence based on Lantus® SoloSTAR® to show objective indicia of
nonobviousness, Patent Owner does not show that it is entitled to a
presumption of nexus.
However, “[a] finding that a presumption of nexus is inappropriate
does not end the inquiry into secondary considerations.” Fox Factory, 944
F.3d at 1375. “To the contrary, the patent owner is still afforded an
opportunity to prove nexus by showing that the evidence of secondary
considerations is the ‘direct result of the unique characteristics of the
claimed invention.’” Id. at 1373–74 (quoting In re Huang, 100 F.3d 135,
140 (Fed. Cir. 1996)). “Where the offered secondary consideration actually
results from something other than what is both claimed and novel in the
claim, there is no nexus to the merits of the claimed invention,” meaning that
“there must be a nexus to some aspect of the claim not already in the prior
art.” In re Kao, 639 F.3d 1057, 1068–69 (Fed. Cir. 2011) (emphasis in
original). Additionally, there is no requirement that “objective evidence
must be tied exclusively to claim elements that are not disclosed in a
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particular prior art reference in order for that evidence to carry substantial
weight.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1331 (Fed. Cir. 2016).
A patent owner may show, for example, “that it is the claimed combination
as a whole that serves as a nexus for the objective evidence; proof of nexus
is not limited to only when objective evidence is tied to the supposedly
‘new’ feature(s).” Id.
Indeed, Patent Owner argues, as to the claimed invention of the
’844 patent, that the components recited in the Challenged Claims “work
together” to provide a device that is “easy to use” and that yields “a
combination of desirable features and properties, such as (i) low injection
force, (ii) short injection stroke length or higher maximum dose per
injection, and (iii) a relatively small number of components that decrease the
complexity of the device.” PO Resp. 43 (citing Ex. 2107 ¶ 650). To be
clear, these alleged “features and properties” do not correspond to any
recited limitation in any of the Challenged Claims. As Petitioner explains,
Lantus® SoloSTAR® “is not ‘the invention’ of these claims,” because “the
claims do not require Lantus[®] (or insulin at all), an 80-unit cartridge, a
particular stroke length or injection force.” Pet. Reply 22. Moreover, Patent
Owner offers no objective definition or explanation of what constitutes an
“easy to use” pen injector, a “low injection force,” a “short injection stroke
length,” a “higher maximum dose,” or a “relatively small number of
components.”
Ultimately, the fact finder must weigh the secondary considerations
evidence presented in the context of whether the claimed invention as a
whole would have been obvious to a skilled artisan. WBIP, 829 F.3d
at 1331–32. Once the patentee has presented a prima facie case of nexus,
the burden of coming forward with evidence in rebuttal shifts to the
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challenger “to adduce evidence to show that the commercial success was due
to extraneous factors other than the patented invention.” Demaco, 851 F.2d
at 1393. Below we consider in more detail the evidence and argument
provided by the parties with regard to any purported long-felt need, industry
praise, and commercial success in light of the alleged nexus to the required
features of the Challenged Claims of the ’844 patent.
a) Long-Felt, Unmet Need
Patent Owner contends that “Lantus® SoloSTAR® satisfied long-felt,
but unresolved needs existing in commercially available pen injectors.” PO
Resp. 44–47; PO Sur-reply, 21–23; see also Pet. Reply 23–25 (disputing
Patent Owner’s contentions of long-felt need). Specifically, Patent Owner
contends its product “satisfied a long-felt but unmet need for an easy-to-use
pen that was particularly well suited to administer medication with a low
injection force.” PO Resp. 47.
Based on Dr. Goland’s testimony, Patent Owner asserts that “diabetic
patients need an easy-to-use injection device with a low injection force to
reduce the burden on the patient and increase the likelihood of the patient
adhering to their prescribed therapy.” Id. at 44–45 (citing Ex. 2111 ¶¶ 22–
26). Patent Owner further explains that “[p]rior to the launch of Lantus®
SoloSTAR®, there were multiple injection pens on the market for
administering insulin or an insulin analog,” but they all required “significant
injection force” and that “made the devices difficult to use and thus
increased the risk of patients not adhering to their insulin and insulin-analog
therapy.” Id. at 45 (citing Ex. 2107 ¶ 646; Ex. 2109 ¶¶ 52–55; Ex. 2111
¶¶ 23–25, 33–35; Ex. 2143; Ex. 2144).
Patent Owner argues that “Lantus® SoloSTAR® revolutionized the
injection pen market, in large part because the Lantus® SoloSTAR® was easy
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to use,” and attributes that ease of use to the “reduced injection force,”
which Patent Owner characterizes as “a primary concern.” Id. at 45–46
(citing Ex. 2111 ¶ 33; Ex. 2116, 7; Ex. 2142). According to Patent Owner,
“the primary intent of the invention” of the ’844 patent is described in the
patent as an embodiment that “helps reduce the overall force required for a
user to cause medicinal product to be dispensed.” Id. at 46 (quoting
Ex. 1004, 4:7–9). Patent Owner also identifies a “related patent” that
describes presumably the same “drive mechanism” as the one taught in the
’844 patent as “an alternative for drive mechanisms, wherein reduced force
is needed to actuate the mechanism.” Id. (quoting Ex. 1005, 1:66–2:3).
In support of its contention that “Lantus® SoloSTAR® satisfied a long-
felt, unmet need, Patent Owner argues that “[t]he industry extensively
recognized SoloSTAR® for solving the problem of needing to deliver high
doses with a short dial extension and with low injection force,” and that
patients “expressed a preference for SoloSTAR® for its low injection force.”
Id. at 46–47 (citing Ex. 2117; Ex. 2121, 2, 9; Ex. 2123, 6; Ex. 2128; Ex.
2143; Ex. 2144; Ex. 2184, 2; Ex. 2185, 1).
(1) Patent Owner Fails to Show a Nexus Between the
Purported Evidence of Alleged Long-felt Need and Any
Challenged Claim of the ’844 Patent
There is no dispute that none of the Challenged Claims recite or
otherwise require a low injection force, the ability to deliver high doses, or a
short dial extension. Thus, to show that the Challenged Claims satisfied a
long-felt, unmet need for an injection pen with these features, Patent Owner
must show that the purported low injection force, ability to deliver high
doses, and/or short dial extension is the direct result of the unique
characteristics of the claimed invention. Fox Factory, 944 F.3d at 1373–74.
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Patent Owner fails to carry this burden. The entirety of Patent Owner’s
argument and evidence on this specific issue consists essentially of the
assertion that Dr. Slocum explained that “the inventions in the challenged
claims describe a set of components that elegantly work together.” PO
Resp. 43 (citing Ex. 2107 ¶ 650); see also id. at 44 (stating that “due to the
contributions of the above features described by” Dr. Slocum, “the Lantus®
SoloSTAR® satisfied long-felt, but unresolved needs existing in
commercially available pen injectors”); see also PO Sur-reply 19 (stating
that “the challenged claims enable SoloSTAR®’s low injection force and
other features identified in the Response”).
We have considered Dr. Slocum’s testimony and find it insufficient to
support Patent Owner’s contentions. In his declaration, Dr. Slocum
addressed how SoloSTAR® practices claims of four different patents,
including the ’844 patent. Ex. 2107 ¶¶ 439–649. Dr. Slocum then addresses
in a single paragraph, reproduced below, the “Benefits of the Claims of the
Challenged Patents”:
In my opinion, the claimed components and interfaces,
such as the threaded engagements, piston rod, drive
sleeves/driving members, dose stops, and clutch enable an
injection device with (i) low injection force, (ii) short or long
injection stroke length for low or high dose per injection, and
(iii) a relatively small number of components that decrease the
complexity and cost of the device. The arrangement of
components limits the frictional losses in the mechanism, thereby
providing an efficient force transmission from the user's hand to
the injection piston in the ampoule that contains the medicament.
The challenged claims also enable a device without a “resetting”
operation, thereby making the injection pen easier to use. The
challenged claims further enabled an injection device with a
shorter dial extension, providing additional benefits for patients
lacking dexterity. Specifically, the SoloSTAR® has a maximum
of 80 units, while the FlexPen® only has a maximum of 60 units.
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While the SoloSTAR®’s dial would extend to 25.5mm to inject
60 units, the FlexPen® must extend to 33mm to inject 60 units.
All of these features are evidenced in the SoloSTAR® injector
pen which practices the inventions of the challenged claims. The
embodiments described in the challenged patents also show that
these advantages can be realized by a small number of
components, thereby enabling a device that can be manufactured
at lower cost. Also, because the pen is disposable, the
components can be made of inexpensive materials, thereby
further reducing the production costs.
Ex. 2107 ¶ 650. Dr. Slocum fails to explain which “claimed components
and interfaces” of which patents he is specifically referring to among the
four patents discussed in his declaration, and fails to address how any of the
purported benefits are the “the direct result” of any “unique characteristics of
the claimed invention.” We agree with Mr. Leinsing that Dr. Slocum
“provides no analysis as to how these claims supposedly enabled the benefits
identified in paragraph 650 of his declaration, including low injection force,
dose dial stroke length, and a small number of components.” Ex. 1095 ¶ 156
(further explaining that “a person of ordinary skill would have understood
that the components recited in the claims would not have necessarily
provided any of these benefits, either alone or collectively,” and “would
have understood the claims as broadly including embodiments lacking all of
these supposed benefits”).
More critically, Dr. Slocum’s opinion that some set of components
recited in the ’844 patent “enable an injection device” with certain features,
such as “low injection force” is, on its face, insufficient to establish the
necessary nexus. As we explained above, the evidence of secondary
considerations, here the “low injection force,” must be shown to be the
“direct result of the unique characteristics of the claimed invention.” Fox
Factory, 944 F.3d at 1373–74 (quoting In re Huang, 100 F.3d 135, 140
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(Fed. Cir. 1996)). Merely “enabling” a “low injection force” means that the
injection force may, or may not be “low,” depending upon some other
consideration, and, therefore, it is not “the direct result” of any claimed
feature. In other words, setting aside the ambiguity of what constitutes a
“low injection force,” Patent Owner provides no evidence that a pen injector
made in accordance with any Challenged Claim will necessarily result in a
device with a “low injection force.”
The same is true of the other purported benefits identified by
Dr. Slocum. For example, Dr. Slocum states that some set of components
recited in the ’844 patent “enable an injection device” with “a relatively
small number of components that decrease the complexity and cost of the
device.” The Challenged Claims do not require a “small number of
components,” and Patent Owner provides no evidence that a pen injector
made in accordance with any Challenged Claim will necessarily result in a
device with a “a relatively small number of components that decrease the
complexity and cost of the device.” Likewise, “injection stroke length” and
“dose per injection” are unclaimed features purportedly “enabled,” but not
shown to be a “direct result” of any set of elements recited by any
Challenged Claim. Thus, we find that Patent Owner fails to establish a
nexus between the purported evidence of alleged long-felt need for a pen
with a low or reduced injection force (or the ability to deliver high doses or a
short dial extension) and any claim of the ’844 patent at issue in this
proceeding.
(2) Patent Owner Fails to Show the Existence of a Long-
felt, but Unresolved Need
Patent Owner does not show that a long-felt, but unresolved need
existed at the time of the invention for “an easy-to-use pen that was
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particularly well suited to administer medication with a low injection force.”
See PO Resp. 47. The Federal Circuit has explained that “[l]ong-felt need is
closely related to the failure of others,” and that “[e]vidence] is particularly
probative of obviousness when it demonstrates both that a demand existed
for the patented invention, and that others tried but failed to satisfy that
demand.” Eurand, Inc. v. Mylan Pharms., Inc. (In re Cyclobenzaprine
Hydrochloride Extended-Release Capsule Patent Litig.), 676 F.3d 1063,
1082 (Fed. Cir. 2012). Establishing a long-felt need requires objective
evidence that the invention has provided a long-awaited, widely accepted,
and promptly adopted solution to a problem existent in the art, or that others
had tried but failed to solve that problem. See In re Mixon, 470 F.2d 1374,
1377 (CCPA 1973). Furthermore, one must demonstrate that “widespread
efforts of skilled workers having knowledge of the prior art had failed to find
a solution to the problem.” In re Allen, 324 F.2d 993, 997 (CCPA 1963).
Patent Owner’s contentions and evidence fail to establish any failure of
others, any unsatisfied demand, any long-awaited solution to a problem, or
any other persuasive basis to show the existence of a long-felt need at the
time of invention.
As an initial matter, Patent Owner fails to identify an objective means
to measure or compare the ease of use of pen injectors to support the notion
that a long-felt need existed for an “easy-to-use” injection device. See PO
Resp. 44–48; PO Sur-reply 21–24. Dr. Goland suggests that “prior injection
pen devices available prior to the launch of Lantus® SoloSTAR® were more
difficult to use than Lantus® SoloSTAR® and had a higher injection force,
meaning the devices required significantly more force by the patient’s thumb
to depress the button to administer the medication.” Ex. 2111 ¶ 4.
Dr. Goland does not quantify to what degree SoloSTAR® was easier to use
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and merely suggests that “[m]y patients overall prefer Lantus® SoloSTAR®
over all other available pen injection devices.” Id. ¶ 16; see also id. ¶¶ 27–
30 (stating that OptiClik® “had a much higher injection force,” that
FlexPen® “has a relatively high injection force,” and that “other devices
suffered from the same shortcomings”).
By contrast, Dr. Biggs highlights that “affordability” is more
important to “ease of use” for patients than injection force, particularly in
terms of patient adherence. Ex. 1048 ¶¶ 34, 35. Dr. Biggs states that
SoloSTAR® was “welcomed by Lantus® users as a significant improvement
over Sanofi’s defective OptiClik® pen but was not recognized as an
unusually good pen in itself.” Id. ¶ 43; see also id. ¶¶ 49, 50 (discussing
reasons the OptiClik® pen was unsatisfactory). According to Dr. Biggs,
“insulin drives the prescription, with the delivery mode being determined by
the modes available from the prescribed insulin’s manufacturer,” and
Lantus® SoloSTAR® “is prescribed frequently” because Lantus® “is a
popular insulin,” not because SoloSTAR® “is a remarkable pen.” Id. ¶ 44.
The notion of a long-felt need for an “easy-to-use” device is, at best,
ambiguous in application. Dr. Goland, on behalf of Patent Owner,
demonstrates the ambiguity and lack of objective evidence inherent in Patent
Owner’s argument by explaining that “the primary reason that the
SoloSTAR® pen is so easy-to-use is because of the low injection force,” but
then stating that SoloSTAR® is “easier” because of a “short dial extension
length,” is “also easy to use because it includes the ability to dial up and dial
back a desired dose, and provides tactile and audible feedback, portability,
and ease of handling,” has a “last dose stop” that “patients have found
. . . contribute[s] to the device being easy to use,” and is “disposable.”
Ex. 2111 ¶ 33–39. Patent Owner fails to demonstrate any established
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measure of what constitutes a device that is “easy-to-use,” but rather shows
that there are many considerations that account for the ease of use of any
device.
The evidence developed demonstrates that SoloSTAR® was not the
first “easy to use” injection pen or that all of the competing pen injectors
were not easy to use because they lacked a sufficiently “low” injection force.
In fact, Patent Owner concedes that “[p]rior to the launch of Lantus®
SoloSTAR®, there were multiple injection pens on the market for
administering insulin or an insulin analog – e.g., Levemir® FlexPen® and
Lantus® OptiClik® in the long-acting category, and the Humalog KwikPen in
the rapid-and intermediate-acting categories, among many others.” PO
Resp. 45. Likewise, Dr. Biggs explained that other insulin pens were
available and fungible with Lantus® SoloSTAR®. See Pet. Reply 23–24
(citing Ex. 1046, 9, 37, 39, 57, 62, 63, 75; Ex. 1048 ¶¶ 27, 29, 32–44–47,
51–53, 56; Ex. 2126, 1, 3; Ex. 2143, 1, 5, 9, 10, 70; Ex. 2145, 26).
Dr. Biggs also persuasively establishes that “[a]vailable pens at the 2003
filing date were already considered “easy-to-use, convenient, and accurate.”
Ex. 1048 (citing Ex. 1046, 57, 62). Further, the evidence establishes that:
 “other insulin pens were already considered easy to use both
generally and for patients with special challenges like age or
dexterity issues,” (Pet. Reply 24 (citing Ex. 1048 ¶¶ 45–47, 52;
Ex. 1046, 57, 62, 6311);
 Sanofi’s studies confirm that both SoloSTAR® and FlexPen®
were “very easy to use;” Ex. 2145, 26; see also Ex. 1048 ¶ 55;

11 Unless otherwise noted, citations rely on the pagination of the original
document for articles and studies.
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Ex. 2126, 1157 (stating that “the SoloSTAR® and FlexPen®
were more user-friendly”); Ex. 2143, 650, 659 (stating that
“both the SoloSTAR® pen and FlexPen® were found to have
high patient usability”), 656 (stating that “the FlexPen® was
also found to be user-friendly”);
 Sanofi’s studies concluded both the SoloSTAR® and FlexPen®
were suitable in both elderly and younger patients and those
with visual and dexterity impairments, and “were associated
with comparable usability;” Ex. 2126, 1159; see also Ex. 1048
¶ 56; Ex, 2143, 654, 658; and that,
 SoloSTAR® was a “best-performing pen device in a statistical
tie with FlexPen,” Ex. 2146, 9); see also Ex. 1048 ¶ 52;
Ex. 2146, 37, 39, 75).
We find the evidence provided by Petitioner of no long-felt, unmet need
discussed above more credible than Dr. Goland’s insufficiently supported
statement that “other pen devices . . . had too high of an injection force for
my patients.” See Ex. 2111 ¶ 42.
In sum, Patent Owner’s evidence may demonstrate acceptance of
Lantus® SoloSTAR® (see, e.g., Ex. 2184, 1; Ex. 2185, 1; Ex. 2121, 6), but it
does not show any failure of others, any unsatisfied demand, or any long-
awaited solution to any problem. The mere fact that a pen injector with a
lower injection force might, or might not, be preferable over other readily
available and effective pen injectors, depending upon various considerations,
including cost and medication, fails to show a long-felt, unmet need for a
pen injector with a lower injection force. Accordingly, the evidence
provided by Patent Owner does not demonstrate a long-felt need existed for
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an “easy-to-use” injection device corresponding to any of the features Patent
Owner attributes to SoloSTAR®.
(3) Patent Owner Fails to Show that Lantus® SoloSTAR®
Satisfied a Purported Long-felt, but Unresolved Need
As discussed above, Patent Owner contends its product “satisfied a
long-felt but unmet need for an easy-to-use pen that was particularly well
suited to administer medication with a low injection force.” PO Resp. 47.
Given the ambiguity in Patent Owner’s identification of any purported
“long-felt, but unmet need,” it is virtually impossible to determine whether
SoloSTAR® met the need. What we can conclude is that Patent Owner does
not show that the injection force of SoloSTAR® made it the easiest-to-use
pen “particularly well suited to administer medication” ever invented at the
time. Whether SoloSTAR® even provides a “low injection force” is in
dispute and depends upon what study is relied upon and what other devices
it is being compared to.
Patent Owner relies on the opinions of Dr. Slocum and Dr. Goland,
who, in turn, cite studies and internal marketing materials produced by
Patent Owner to show that SoloSTAR® provides a reduced injection force, at
least with respect to certain devices to which it was compared. PO
Resp. 45–46; (citing Ex. 2111 ¶¶ 23–25; Ex. 2109 ¶¶ 52–55); see also
Ex. 2111 ¶¶ 32, 33 (citing Ex. 2116, 9; Ex. 2123, 6; Ex. 2143, 7; Ex. 2144,
5, 9–11). For example, Dr. Grabowski states that “[o]ne study found that,
with respect to injection force, ‘SoloSTAR® was preferred by a significantly
greater number of patients as their first choice (65%) compared with other
pens assessed,’ including Novolog® FlexPen® and Lilly's disposable pen.”
Ex. 2109 ¶ 53 (citing Ex. 2126, 1159). The study Dr. Grabowski cites,
however, characterizes its finding as “[r]egarding injection performance,”
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not “injection force” as indicated by Dr. Grabowski, who does not otherwise
explain whether the terms are coextensive or whether “injection
performance” includes features other than “injection force.” Dr. Grabowski
also states that another study “compared the injection force of the
SoloSTAR® pen to competitor pens” and “concluded that ‘SoloSTAR®
stands out because of its low injection force, even when compared with
newer insulin pen devices such as the KwikPen and NGFP [Next Generation
FlexPen®].’” Id. (citing Ex. 2100, 150). The study relied upon by
Dr. Grabowski was limited to “Other Disposable Insulin Pen Devices” and
states that it was authored by “an employee of sanofi-aventis” and
acknowledges that “[e]ditorial support was provided by Global Publications
group of sanofi-aventis.” Ex. 2100, 150, 155.
Petitioner argues that, in contrast to the “Sanofi-sponsored injection
force studies” relied upon by Patent Owner (e.g., Ex. 2143; Ex. 2144;
Ex. 2100; Ex. 2126; Ex. 2116; Ex. 2123), other studies found that
SoloSTAR® did not have a lower injection force. Pet. Reply 24 (citing
Ex. 1048 ¶ 58; Ex. 2145, 15 (the “US Lantus SoloSTAR Launch Book,”
stating in regard to SoloSTAR® that “‘[e]asier to inject’ was not supported
by two studies showing data versus FlexPen® and Lilly pen”); see also
Ex. 2145, 17–18 (stating that “SoloSTAR® has one of the lowest injection
forces of all pens, but not the lowest,” that the “Innolet disposable pen has
the lowest injection force of all disposable and reusable pens,” and that
“NovoPen 4 injection force if very similar to SoloSTAR®”). Dr. Biggs also
raised issues with the methodology of at least some of the studies relied on
by Patent Owner. Ex. 1048 ¶ 58 n.3.
With regard to Dr. Slocum’s opinion that SoloSTAR® provided
“a shorter dial extension,” “has a maximum of 80 units, while the FlexPen®
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only has a maximum of 60 units,” and has a dial that “would extend to
25.5mm to inject 60 units, [whereas] the FlexPen® must extend to 33mm to
inject 60 units,” we find no sufficient evidence to show that any of these
purported features provided a benefit over prior art pen injectors that
satisfied any purported long-felt need. See Ex. 2107 ¶ 650. Dr. Biggs
characterizes any difference between the maximum extension of
SoloSTAR® compared to FlexPen® as “difficult to discern visually” and “too
slight to be of practical consequence.” Id. ¶ 55.
We further find unpersuasive Patent Owner’s argument that “[t]he
industry extensively recognized SoloSTAR® for solving the problem of
needing to deliver high doses with a short dial extension and with low
injection force.” PO Resp. 46–47. As support, Patent Owner relies not on
an industry publication, but a study “supported by Sanofi-Aventis” that
received “[e]ditorial support” from “Global Publications group of Sanofi-
Aventis.” Ex. 2128, 121. Under the heading “Unmet needs,” the study
states that “many patients need to administer doses of insulin exceeding
60 units, the maximum dose of many insulin pens.” Id. at 115. Dr. Biggs
explains that there was “no unmet need in 2003 for an 80U pen” because
“the Disetronic pen offered this feature years earlier.” Ex. 1048 ¶ 56 (citing
Ex. 1046, 82–83). We agree. We have considered all of the additional
“industry” recognition cited by Patent Owner, including Exhibit 2123 (a
study funded by Sanofi that found that, when compared to a limited set of
certain other pens, Lantus® pens, ClikSTAR® and SoloSTAR®, “require a
significantly lower injection force compared with the reusable or prefilled
insulin pens containing the insulin glargine copies”) and Exhibit 2184 (an
article from the “Philippine Daily Inquirer” stating “the Lantus® SoloSTAR®
operates with a low injection force?31 [sic] percent less than other insulin
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pens ?that [sic] allows a gentle injection.”).12 PO Resp. 47. Patent Owner
also cites Exhibit 2185 as reflecting a statement from a Professor of
Endocrinology in France that “[i]nsulin injection with SoloSTAR® brings
flexibility, satisfaction for the patients, and an opportunity for earlier
initiation of insulin therapy which may contribute to better long term
glycemic control.” Id. (quoting Ex. 2185, 1). Patent Owner fails to explain
how that statement supports the contention that SoloSTAR® satisfied any
long-felt, unmet need. The same applies to Patent Owner’s purported
evidence of patient preferences. Id. (citing; Ex. 2121, 2, 9; Ex. 2143;
Ex. 2144).
We have further considered and find not persuasive all of Patent
Owner’s additional arguments, including that SoloSTAR® was preferred
over OptiClik, that earlier FlexPens were hard to push, that some patients
did not take their insulin because prior art devices were problematic, and that
patients were transitioned to SoloSTAR® because of its lower injection
force. PO Sur-reply 22 (citing Ex. 1056, 34:3–17, 35:7–12; 66:9–15;
Ex. 2100; Ex. 2111 ¶¶ 31–43; Ex. 2113; Ex. 2116; Ex. 2121; Ex. 2123;
Ex. 2126; Ex. 2128; Ex. 2140; Ex. 2143; Ex. 2144; Ex. 2184; Ex. 2185).
Patent Owner also argues that Mr. Leinsing acknowledges a focus on
reducing injection force (id. (citing Ex. 2316, 80:24–81:1)); that patients
would have disliked Dr. Biggs suggestion that “any long-felt need was
satisfied by the Lantus® vial and syringe, that patients complaining of
injection force could have caregivers . . . administer their treatments, and

12 Patent Owner alters the statement from what appears in Exhibit 2184 and
also attributes it to a particular individual, however, the article does not
make clear from whom the information is coming. Compare PO Resp. 51
with Ex. 2184, 2.
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that patients could carry around . . . preloaded syringes” (id. (citing Ex. 1048
¶¶ 31–32; Ex. 1056, 52:23–53:25, 58:18–59:24; Ex. 2317, 70:10–19, 84:24–
85:14)), and that Dr. Biggs’s testimony is undermined by his admission that
his suggestions may not be covered under Medicare or insurance and that the
majority of his patients switched from Lantus® vial to Lantus® SoloSTAR®,
which most patients preferred (id. at 22–23 (citing Ex. 2317, 38:7–39:3,
115:23–116:6, 118:19–22)).
Based on the entirety of the evidence provided by both parties, we
conclude for the reasons provided above that the evidence does not support
Patent Owner’s argument that SoloSTAR® satisfied a long-felt but unmet
need for a pen with “a low injection force,” because there were other
injection pens that operated with similar and even lower injection forces then
SoloSTAR®. Likewise, Patent Owner does not show persuasively that the
dial extension or maximum dosing of SoloSTAR® exceeded any other
injection pen available when it was introduced or at the time of the invention
of the ’844 patent to support the contention that it satisfied a long-felt but
unmet need.
b) Industry Praise
Patent Owner contends that the “nonobviousness of the [’]844 patent
is further demonstrated by the high level of praise and industry recognition
that Sanofi and DCA, the design firm with whom Sanofi partnered in
creating SoloSTAR®, received for the designs embodied in the SoloSTAR®
device.” PO Resp. 48.
First, Patent Owner states that SoloSTAR® “won the Gold,
International Export, and Grand Prix awards at the Design Business
Association (DBA) Design Effectiveness Awards” in 2009. Id. (citing
Ex. 2121). According to Patent Owner, “[t]he DBA is a design organization
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based in the UK that is interested in how a design commercially impacts a
company’s business.” Id. Patent Owner asserts that “[t]he case study of
SoloSTAR® for the DBA Awards describes the SoloSTAR®’s inventiveness
as ‘suitably ambitious’ and explains that ‘SoloSTAR® is the first disposable
insulin pen to combine very low injection force (which provides a smooth
injection experience for patients) with 80 units maximum dose capability, an
important breakthrough.’” Id. (citing Ex. 2121, 3).
Petitioner responds that the “case study of SoloSTAR®” Patent Owner
relies upon was “written, funded, and sponsored by Sanofi” with DCA, and
is “self-praise, not industry praise.” Pet. Reply 25 (citing Ex. 1055, 79:6–
81:19). Consistent with Petitioner’s argument, the document Patent Owner
relies upon in support of its contentions, Exhibit 2121, bears the names
“DCA” and “Sanofi Aventis” at the top of each page and reflects
information they provided for consideration as part of the “DBA Design
Effectiveness Awards 2009.” Ex. 2121, 1; see also Ex. 1060 (according to
Dr. McDuff, the “DBA web site gives applicants like Sanofi and DCA tips
on how to prepare the case studies applicants write”). Exhibit 2121 does not
indicate any award was given to SoloSTAR®, much less why any award was
given to SoloSTAR®.
The only evidence of actual industry praise offered by Patent Owner
in this regard is Dr. Grabowski’s statement that “[i]n 2009, at the Design
Business Association (“DBA”) Design Effectiveness Awards, Sanofi won
the Gold, International Export, and Grand Prix awards.” Ex. 2109 ¶ 72.
Dr. Grabowski fails to offer any explanation or evidence to show what these
awards mean, how they were awarded, or why they were awarded for
SoloSTAR®. Dr. Grabowski instead refers back to the case study prepared
by Patent Owner and DCA, Exhibit 2121. Id. We find that Exhibit 2121
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does not constitute “industry praise” because it was prepared by Patent
Owner and DCA and does not reflect the opinion of the industry or even the
receipt of praise. Nor can we reach any conclusion about the “Design
Effectiveness Awards” Dr. Grabowski states were given for SoloSTAR® in
the absence of any evidence explaining what any of the awards entail.
Second, Patent Owner states that “SoloSTAR also won the Good
Design Award by the Chicago Athenaeum Museum of Architecture and
Design.” PO Resp. 48 (citing Ex. 2201). According to Dr. Grabowski,
“[t]he criteria for this award are ‘quality design of the highest form,
function, and aesthetics a standard beyond ordinary consumer products and
graphics.’” Ex. 2109 ¶ 73 (purporting to quote a website affiliated with The
Chicago Athenaeum Museum of Architecture and Design). Dr. Grabowski
also states that “Christian K. Narkiewicz-Laine, President of the Chicago
Athenaeum Museum of Architecture and Design noted that ‘SoloSTAR®
represents a design for social good and for humanitarian concerns.’” Id.
Petitioner correctly argues that Exhibit 2201, upon which Patent Owner
relies, does not attribute any award to “inventiveness,” and we further note
that Exhibit 2201 provides no explanation for how or why an award was
given to SoloSTAR®. See Pet. Reply 25.
Dr. Grabowski also states that “the Lantus® and Apidra® SoloSTAR®
devices were put into the permanent Design Collection of the Chicago
Athenaeum Museum of Architecture and Design, as recognition of its
inventiveness.” Ex. 2109 ¶ 73. Dr. McDuff explains that the document
Dr. Grabowski cites in support of his contention that SoloSTAR® was placed
in the permanent Design Collection of the Chicago Athenaeum Museum of
Architecture and Design (see Ex. 2109 ¶ 73 n.95) is a DCA press release that
does not state that this placement resulted from “recognition of its
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inventiveness” and contains no statements attributed to the Chicago
Athenaeum. Ex. 1060 ¶ 59.
Third, Patent Owner submits that “at the Prix Galien USA 2009
Award, which ‘recognize[s] innovative biopharmaceutical drugs and
medical technologies’ and ‘is considered the industry’s highest accolade for
pharmaceutical research and development — equivalent to the Nobel Prize,’
Sanofi and DCA were both finalists.” PO Resp. 49 (citing Ex. 2109 ¶ 74).
Patent Owner offers no further explanation of how this constitutes industry
praise, but asserts without citation that “Patent Owner did not make up the
SoloSTAR® awards or bestow upon itself industry praise.” PO Sur-reply 23.
Patent Owner’s evidence of industry praise appears to be directed to
SoloSTAR®, and not Lantus® SoloSTAR®. Because Patent Owner shows
sufficiently that SoloSTAR® practices Challenged Claims, Patent Owner
would be entitled to a presumption of nexus if Patent Owner shows that
SoloSTAR® “embodies the claimed features, and is coextensive with them.”
Fox Factory, 944 F.3d at 1373 (internal quotations omitted). Patent Owner
does not argue SoloSTAR® is coextensive with any of the Challenged
Claims. For example, the case study of SoloSTAR® Patent Owner relies
upon to show industry praise states that an “important breakthrough” was the
combination of “very low injection force . . . with 80 units maximum dose
capability.” Ex. 2121, 3; see also id. at 5 (emphasizing the attention given to
“visual design” during the development of SoloSTAR® and asserting that it
provides “a total of five differentiation features for improved safety: body
colour, dial colour, button colour, label design and a tactile feature on the
injection button”). None of the Challenged Claims require any maximum
dose capability or “differentiation features.” As with the proffered evidence
of long-felt need discussed above, Patent Owner fails to demonstrate nexus
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between the purported evidence of industry praise and the claims at issue in
this proceeding.
Moreover, even if we assume Patent Owner demonstrates nexus
between the alleged industry praise and the claims at issue, much of the
praise was generated by DCA, Sanofi’s affiliate. See, e.g., Ex. 1055, 76–79.
Such self-generated praise is not persuasive industry praise. Further,
evidence independent of DCA, such as consideration of Lantus®
SoloSTAR® for the Prix Galien USA 2009 award, only generally specifies
the criteria used to judge the nominees. Ex. 2042, 2. It does not evidence
industry praise of any specific feature of the claimed invention. Id.
c) Commercial Success
Patent Owner contends that the “tremendous commercial success of
Lantus® SoloSTAR® is further objective evidence of non-obviousness.” PO
Resp. 49. According to Patent Owner, “commercial success is demonstrated
by the contribution of Lantus® SoloSTAR® to the growth of the Lantus®
franchise overall,” and by the strong performance of Lantus® SoloSTAR®
when compared to other long-acting insulin and insulin analog pens.” Id.
at 49–50; see also id. at 55–57; PO Sur-reply 19–20.
(1) Patent Owner Fails to Show a Nexus Between the
Purported Evidence of Commercial Success and Any
Challenged Claim of the ’844 Patent
First, Patent Owner fails to show that the asserted evidence of
commercial success of Lantus® SoloSTAR is a “direct result of the unique
characteristics of the claimed invention,” and, therefore, fails to show the
necessary nexus. Fox Factory, 944 F.3d at 1373–74 (internal quotation
omitted). Patent Owner argues that “the features of the device disclosed and
claimed in the 844 Patent and used in Lantus® SoloSTAR® contributed to its
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commercial success.” PO Resp. 51 (citing Ex. 2109 ¶ 53; Ex. 2107 ¶¶ 551–
610, 651); see also PO Sur-reply 20 (asserting that the commercial success
of Lantus® SoloSTAR® “is due at least in part to the elegant features that the
challenged claims enable, such as low injection force”). Specifically, Patent
Owner argues that SoloSTAR® satisfied a long-felt but unfulfilled need for
an easy-to-use pen device with low injection force. PO Resp. 51; see also
id. at 53 (arguing that “[t]he tremendous success of Lantus® SoloSTAR®, as
compared to pens with long-acting insulins that failed to address the long-
felt but unfilled need for a low injection force device, therefore shares a
strong nexus with the claimed invention.”).
Patent Owner does not show that the alleged “tremendous success”
may fairly be attributed to the claimed invention, which does not require low
injection force or insulin, let alone the long-acting insulin formulation of
Lantus. Patent Owner’s argument does not show the necessary nexus, and
for the reasons provided above, we found no persuasive evidence in support
of Patent Owner’s allegations of long felt need. We likewise find
unpersuasive Patent Owner’s argument that, because OptiClik® also
dispensed Lantus, but had a “higher injection force” and “performed
significantly worse than SoloSTAR®” such that it was discontinued, the
“nexus between SoloSTAR®’s lower injection force and its commercial
success is further confirmed.” PO Sur-reply 20 (citing Ex. 2109 ¶ 19, 35–
30; Ex. 2111 ¶ 28). While the parties appear to agree that the OptiClik® was
an inferior device, Patent Owner’s implication that it was discontinued only
due to its higher injection force is not even supported by Patent Owner’s
own expert, Dr. Goland, who explained that “Lantus® OptiClik® was thus a
mechanically inferior design to Lantus® SoloSTAR®” because, in addition to
a higher injection force, OptiClik® “did not automatically reset after
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injection and thus required additional steps by the user prior to its next,” and
“was also relatively large, making it less convenient to carry.” Ex. 2111
¶ 28. Dr. Biggs described OptiClik® as “difficult to refill and unreliable
about delivering accurate doses,” (citing Ex. 1045, 528, Table 2) and a “truly
bad pen,” but noted that “injection force” was not a concern with OptiClik®
expressed by his patients. Ex. 1048 ¶¶ 42, 49.
Next Patent Owner asserts that “the SoloSTAR® device won
numerous design awards, and achieved significant industry praise.” PO
Resp. 51. Again, Patent Owner’s argument does not show the necessary
nexus, and for the reasons provided above, we found no persuasive evidence
in support of Patent Owner’s allegations of industry praise. The only
remaining arguments Patent Owner makes is that “the SoloSTAR® device
embodies the challenged claims of the 844 patent,” and “[t]hus, there is a
nexus between the claimed invention in the 844 patent and the commercial
success of Lantus® SoloSTAR®.” Id. Patent Owner is wrong with regard to
what must be shown to establish nexus.
There is no dispute that Lantus® SoloSTAR® is not coextensive with
any of the Challenged Claims. Patent Owner relies on Lantus® SoloSTAR®
to show commercial success, but merely showing that SoloSTAR®
“embodies” any of the Challenged Claims fails to establish the necessary
nexus between the evidence of commercial success and any challenged
claim. Patent Owner suggests that “the success of SoloSTAR® is
attributable at least in part to its unique design covered by the 844 patent.”
PO Resp. 53. Contrary to Patent Owner’s argument, Patent Owner does not
show persuasively that any “feature” purportedly disclosed and claimed in
the ’844 patent contributed to the commercial success of Lantus®
SoloSTAR®. To be clear, that does not mean that the design of SoloSTAR®,
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including unclaimed features and aesthetics, was irrelevant to the purported
commercial success of Lantus® SoloSTAR®. Rather, Patent Owner does not
show that the asserted evidence of commercial success of Lantus®
SoloSTAR is a “direct result of the unique characteristics of the claimed
invention.”
(2) Patent Owner Fails to Show Commercial Success of
Lantus® SoloSTAR®
Patent Owner argues that the following demonstrate the commercial
success Lantus® SoloSTAR®:
 “fast and long-sustained growth in terms of dollar sales, new
prescriptions, and total prescriptions”;
 “the overall levels and shares of dollar sales, new prescriptions,
and total prescriptions, as well as the profitability and
formulary placement”;
 “sales and prescriptions . . . remained strong despite the entry
of several competing long-acting insulin and insulin analog
drugs (all in pen form) starting in 2015”;
 “the highest level of sales among long-acting insulin and insulin
analog pens even though it launched after several other long-
acting insulin and insulin analog pens, including the Levemir®
FlexPen®”;
 “substantial growth relative to Lantus® OptiClik®” based on
new prescriptions and total prescriptions.
PO Resp. 50–51 (citing Ex. 2109 ¶¶ 12, 37). Additionally, Patent Owner
contends that marketing does not explain the commercial success because
“marketing expenditures for Lantus® SoloSTAR® were in line with, or were
lower than, many other long-acting insulin products.” Id. at 52 (citing
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Ex. 2109 ¶¶ 16, 64–69). Regarding “alleged ‘blocking patents’ covering the
glargine molecule that is used in the production of the active ingredient in
Lantus®,” Patent Owner argues that “the law does not mandate across-the-
board-discounting of commercial success simply because other patents cover
components of the product,” and that the Board should “weigh the evidence
on a case-by-case basis, in light of the specific commercial success argument
being made.” Id. at 52–53. According to Patent Owner, “the success of
Lantus® SoloSTAR® cannot be attributed solely to the insulin glargine
molecule because Lantus® OptiClik® used the exact same Lantus®
formulation” and did not achieve SoloSTAR®’s success, thus the design of
SoloSTAR® must have attributed at least in part to the success. Id. at 53.
Patent Owner further argues that “Sanofi’s earlier patents on the insulin
glargine molecule did not prevent others from entering the market for non-
glargine, long-acting insulin products and competing with Lantus®
SoloSTAR®.” Id. Patent Owner identifies Levemir® FlexPen® with its long-
acting insulin as an example of a disposable pen device with long-acting
insulin. Id.
Petitioner disputes Patent Owner’s contentions, arguing, inter alia,
that Patent Owner does not address profitability and “provides no
benchmarks for evaluating success, applies a faulty ‘pens-only’ market
definition, and [that] formulary status does not separately demonstrate
commercial success.” Pet. Reply 25–26 (citing Ex. 1048 ¶¶ 17–28).
Petitioner also argues that “Lantus® SoloSTAR® enjoyed the benefit of a
Lantus® franchise that predated the Levemir® franchise by five years and the
foundation of earlier Lantus® pen (OptiClik®),” which had “twice as many
prescriptions in 2007 as Levemir® FlexPen®.” Pet. Reply 26–27 (citing
Ex. 2186, 2; Ex. 2198). Petitioner contends that “Lantus® SoloSTAR®
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overtook Levemir® FlexPen® not because of any unique SoloSTAR®
attributes,” but because Patent Owner “selected it as the exclusive Lantus®
pen in the United States.” Id. at 27 (citing Ex. 1075 ¶¶ 20–22, 30–35).
Patent Owner replies that Petitioner’s own data shows that Lantus®
SoloSTAR® has been commercially successful (citing Ex. 1060, Attachment
B-10; Ex. 2318, 31:14–17, 31:25–32:8), that the diabetes community has
widely adopted Lantus® SoloSTAR®; that Dr. McDuff acknowledged the
large Lantus® SoloSTAR® sales and admitted that profitability analysis is
not required (citing Ex. 2318, 15:10–13, 28:7–19, 29:20–30:18), and that
Lantus® SoloSTAR® has the largest market share in Petitioner’s asserted
broader market (citing Ex. 1060, Attachment B-10; Ex. 2318, 31:14–17,
31:25–32:8). PO Sur-reply 17–18. Patent Owner further contends that
Lantus® SoloSTAR® prescriptions more than quadrupled that of OptiClik®
in the first four years of each product’s respective launch and that Lantus®
SoloSTAR® grew the Lantus® market and remains the number one product.
Id. at 18 (citing Ex. 1060, Attachment B-10; Ex. 2318, 18:23–19:20, 21:22–
22:8). Patent Owner asserts that “SoloSTAR® enjoys favorable placement in
health,” due, in part as admitted by Dr. McDuff, to its “mechanical features
and attributes.” Id. at 18 (citing Ex. 2318, 33:7–36:3).
Having considered all of the evidence of commercial success
presented by the parties, we find that the data presented in Attachment B-10
of Exhibit 1060 to be the most pertinent evidence regarding the purported
commercial success of Lantus® SoloSTAR® provided in this proceeding.
Attachment B-10 presents total prescription data by year for 40 insulin
delivery products for the 20-year period 1999–2019. Ex. 1060, Attachment
B-10. It also provides corresponding market share data for that same time
period. Id.
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Attachment B-10 shows that from the introduction of Lantus® Vial
in 2002, until 2019, Lantus® delivery products (i.e., Lantus® Vial, Lantus®
OptiClik®, and Lantus® SoloSTAR®) were by far the most proscribed insulin
delivery devices. Ex. 1060, Attachment B-10. As shown, from 2002
to 2011 prescriptions of Lantus® Vial grew from roughly 1.3 to 11 million
prescriptions, while the most successful competing products (Humulin and
Novolog) each grew to prescription levels of roughly 5 million prescriptions.
Id. Thus, Attachment B-10 clearly demonstrates the commercial success of
Lantus® Vial during that time period. Attachment B-10 also demonstrates
that once Lantus® OptiClik® was introduced, prescriptions of Lantus® Vial
decreased as prescriptions of Lantus® OptiClik® increased, with the overall
number of Lantus® OptiClik® prescriptions slowly, but steadily climbing.
Id. We note that during the time period that Lantus® OptiClik® was the only
Lantus® alternative to Lantus® Vial, the number of Lantus® Vial
prescriptions essentially stayed the same.
In 2008, Lantus® SoloSTAR® was introduced. Ex. 1060, Attachment
B-10. From 2008–2011, prescriptions of Lantus® SoloSTAR® steadily rose
while prescriptions of Lantus® OptiClik® declined. Id. During this time
period, prescriptions of Lantus® Vial continued to remain steady. Id. Then
in 2012, things changed. Id. First, prescriptions of Lantus® OptiClik®
dropped off significantly. Id. By 2014, prescriptions of Lantus® OptiClik®
dropped to a mere 382 prescriptions. Id. During the time period from 2011–
2016 (when prescriptions of Lantus® SoloSTAR® hit their peak),
prescriptions of Lantus® Vial began to decrease at a rate of about 500,000
prescriptions per year. It is unknown why prescriptions of Lantus® Vial
began to decline starting in 2012, but it appears that they declined as the
prescriptions of Lantus® SoloSTAR® increased. Regardless of the reason for
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the decline, the evidence clearly shows that the number of Lantus®
SoloSTAR® prescriptions peaked in 2016 and that most of the increase in
prescriptions for Lantus® SoloSTAR® merely offset the decline in
prescriptions for Lantus® Vial. Thus, the evidence does not support a
showing of commercial success for Lantus® SoloSTAR®. Rather, it appears
to show a fairly stable number of prescriptions for Lantus® products from
2009–2016, with a decline in those prescriptions from 2017–2019.
6. Collective Consideration of the Graham Factors
Having considered each of the Graham factors individually, we now
consider them collectively. The scope and content of the prior art, the
differences between the prior art and claims 21–29 of the ’844 patent, and
the level of ordinary skill in the art heavily favor Petitioner’s contention that
claims 21–29 would have been obvious over Steenfeldt-Jensen. Petitioner
also provides a persuasive rationale in support of the asserted modification
of the fifth embodiment of Steenfeldt-Jensen.
Having considered all the evidence of indicia of nonobviousness,
Patent Owner does not show the requisite nexus between the alleged
objective indicia of nonobviousness and the Challenged Claims of the ’844
patent. Moreover, even if Patent Owner had shown nexus, the objective
evidence of nonobviousness identified by Patent Owner fails to show
persuasive evidence of a long-felt, unmet need satisfied by the invention of
any of the Challenged Claims. Patent Owner also fails to show persuasive
evidence of either industry praise of SoloSTAR® or of commercial success
of Lantus® SoloSTAR®. Thus, Patent Owner’s evidence of indicia of
nonobviousness provides very little, if any, support for nonobviousness of
the Challenged Claims.
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On the whole, we find that the information provided by Petitioner and
Patent Owner in consideration of the Graham factors collectively
demonstrates by a preponderance of the evidence that the subject matter of
claims 21–29 of the ’844 patent would have been obvious over Steenfeldt-
Jensen.
F. Alleged Obviousness Over Steenfeldt-Jensen and Klitgaard
Petitioner contends that claim 30 of the ’844 patent would have been
obvious over the combination of Steenfeldt-Jensen and Klitgaard. Pet. 69–
71; Pet. Reply 1. Claim 30 depends from claim 21 and further recites “a nut
that tracks each set dose of medicament delivered.” Ex. 1004, 9:8–10.
Petitioner relies on its analysis of claim 21 to support its contention that
claim 30 would have been obvious over the combination of Steenfeldt-
Jensen and Klitgaard. Pet. 69. Patent Owner argues that Petitioner fails to
show that claim 30 would have been obvious over the combination of
Steenfeldt-Jensen and Klitgaard “for the same reasons” that Patent Owner
argues Petitioner does not show claim 21 would have been obvious over
Steenfeldt-Jensen. PO Resp. 41; PO Sur-reply 1–2. In other words, Patent
Owner makes no argument in opposition to Petitioner’s contentions with
regard to claim 30 beyond the arguments addressed above that Patent Owner
asserted against the alleged obviousness of claim 21, from which claim 30
depends. For the reasons provided above, Petitioner shows by a
preponderance of the evidence that claim 21 would have been obvious over
Steenfeldt-Jensen. Despite the absence of any additional arguments from
Patent Owner directed to claim 30, we nevertheless we must consider
whether Petitioner shows by a preponderance of the evidence that claim 30
would have been obvious over Steenfeldt-Jensen and Klitgaard.
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1. Differences Between the Subject Matter of Claim 30 and the
Teachings of Steenfeldt-Jensen and Klitgaard
Petitioner relies on Klitgaard as teaching the limitation of claim 30
and on Steenfeldt-Jensen as teaching the limitations of claim 21 from which
claim 30 depends. Pet. 69–72. As explained above, Petitioner shows and
Patent Owner does not dispute that Steenfeldt-Jensen teaches or suggests
every limitation of claim 21. Petitioner also shows that Klitgaard teaches an
injection device with nut member 32 that, “[d]uring the setting of a dose”
rotates “with the does setting member 30 relative to the driver 31 so that the
position of the nut member 32 on this driver is dependent on the dose set.”
Pet. 70 (quoting Ex. 1017, 4:33–37). The injector of Klitgaard operates such
that “the nut member 32 on the driver 31 will always indicate the total sum
of set and injected doses.” Id. (quoting Ex. 1017, 4:52–54). Accordingly,
Petitioner shows by a preponderance of the evidence that Klitgaard teaches
nut member 32 corresponding to “a nut that tracks each set dose of
medicament delivered,” as required by claim 30, and that the combination of
Steenfeldt-Jensen and Klitgaard teaches or suggests every limitation of
claim 30.
2. Reasons for the Combination of Steenfeldt-Jensen and Klitgaard
Petitioner shows that a person of ordinary skill in the art would have
had a reasonable expectation of success in incorporating nut member 32 of
Klitgaard into the Steenfeldt-Jensen syringe, because the nut “could be
readily adapted and disposed between the bushing 82 and scale drum 80 [of
Steenfeldt-Jensen] to track each set dose of medicament delivered.” Pet. 71
(citing Ex. 1011 ¶ 692). Petitioner relies on Klitgaard’s explanation that the
nut indicates “the total sum of set and injected doses” and prevents “setting a
dose that exceeds the remaining available supply of medication in the
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cartridge” as the reasons a person of ordinary skill in the art would have
modified Steenfeldt-Jensen. Id. (citing Ex. 1017, 4:52–58, Abstract). The
uncontested reasons Petitioner shows for the asserted combination
establishes a legally sufficient rationale in support of the combination.
3. Objective Indicia of Nonobviousness
Patent Owner relies on the same evidence of objective indicia of
nonobviousness as discussed above with regard to the asserted obviousness
of claim 21 over Steenfeldt-Jensen.
4. Collective Consideration of the Graham Factors
With regard to claim 30 of the ’844 patent, having considered each of
the Graham factors individually, we now consider them collectively. The
scope and content of the prior art, the differences between the prior art and
claim 30, and the level of ordinary skill in the art heavily favor Petitioner’s
contention that claim 30 would have been obvious over the combination of
Steenfeldt-Jensen and Klitgaard. Petitioner shows by a preponderance of the
evidence that the combination of Steenfeldt-Jensen and Klitgaard teaches
every limitation of claim 30. Petitioner’s reliance on Klitgaard’s explanation
that the nut indicates the total sum of set and injected doses and prevents
setting a dose that exceeds the remaining available supply of medication in
the cartridge provides a persuasive rationale for why a person of ordinary
skill in the art would have modified Steenfeldt-Jensen to obtain the benefits
of the nut taught by Klitgaard. See Ex. 1017, 4:52–58.
Additionally, as explained in detail above, having considered all the
evidence of indicia of nonobviousness, Patent Owner does not show the
requisite nexus between the alleged objective indicia of nonobviousness and
the Challenged Claims of the ’844 patent. Moreover, even if Patent Owner
had shown nexus, the objective evidence of nonobviousness identified by
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Patent Owner fails to show persuasive evidence of a long-felt, unmet need
satisfied by the invention of any of the Challenged Claims. Patent Owner
also fails to show persuasive evidence of either industry praise of
SoloSTAR® or of commercial success of Lantus® SoloSTAR®. Thus, Patent
Owner’s evidence of indicia of nonobviousness provides very little, if any,
support for nonobviousness of claim 30.
On the whole, we find that the information provided by Petitioner and
Patent Owner in consideration of the Graham factors collectively
demonstrates by a preponderance of the evidence that the subject matter of
claim 30 of the ’844 patent would have been obvious over the combination
of Steenfeldt-Jensen and Klitgaard.
III. ANALYSIS OF PATENT OWNER’S CORRECTED
REVISED CONTINGENT MOTION TO AMEND
Patent Owner’s Corrected Revised Contingent Motion to Amend
seeks entry of substitute claims 31–38 to the extent that we find the
Challenged Claims unpatentable. RMTA 1–2. As discussed above,
Petitioner shows by a preponderance of the evidence that the Challenged
Claims are unpatentable. We now turn to consider whether to enter any of
the substitute claims proposed by Patent Owner. For the reasons that follow,
we deny Patent Owner’s motion because the substitute claims it proposes
lack written description support, as required by 35 U.S.C. § 316(d) and
37 C.F.R. § 42.121.
A. Principles of Law Concerning a Motion to Amend
In an inter partes review, amended claims are not added to a patent as
of right, but rather must be proposed as a part of a motion to amend.
35 U.S.C. § 316(d). The Board must assess the patentability of proposed
substitute claims “without placing the burden of persuasion on the patent
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owner.” Aqua Prods., Inc. v. Matal, 872 F.3d 1290, 1328 (Fed. Cir. 2017)
(en banc); see also Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129,
Paper 15 at 3‒4 (PTAB Feb. 25, 2019) (precedential). Subsequent to the
issuance of Aqua Products, the Federal Circuit issued a decision in Bosch
Automotive Service Solutions, LLC v. Matal, 878 F.3d 1027 (Fed. Cir. 2017)
(“Bosch”), as well as a follow-up order amending that decision on rehearing.
See Bosch Auto. Serv. Sols., LLC v. Iancu, No. 2015-1928 (Fed. Cir.
Mar. 15, 2018) (Order on Petition for Panel Rehearing).
In accordance with Aqua Products, Bosch, and Lectrosonics, a patent
owner does not bear the burden of persuasion to demonstrate the
patentability of the substitute claims presented in the motion to amend.
Rather, ordinarily, “the petitioner bears the burden of proving that the
proposed amended claims are unpatentable by a preponderance of the
evidence.” Bosch, 878 F.3d at 1040 (as amended on rehearing);
Lectrosonics, Paper 15 at 3–4. In determining whether a petitioner has
proven unpatentability of the substitute claims, the Board focuses on
“arguments and theories raised by the petitioner in its petition or opposition
to the motion to amend.” Nike, Inc. v. Adidas AG, No. 2019-1262, 2020 WL
1802796, at *5 (Fed. Cir. Apr. 9, 2020). The Board itself also may justify
any finding of unpatentability by reference to evidence of record in the
proceeding. Lectrosonics, Paper 15 at 4 (citing Aqua Products, 872 F.3d
at 1311 (O’Malley, J.)).
“Before considering the patentability of any substitute claims” we
“first must determine whether the motion to amend meets the statutory and
regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R.
§ 42.121.” Lectrosonics, Paper 15 at 4. Accordingly, a patent owner must
demonstrate: (1) the amendment proposes a reasonable number of substitute
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claims; (2) the proposed claims are supported in the original disclosure (and
any earlier filed disclosure for which the benefit of filing date is
sought); (3) the amendment responds to a ground of unpatentability involved
in the trial; and (4) the amendment does not seek to enlarge the scope of the
claims of the patent or introduce new subject matter. See 35 U.S.C.
§ 316(d); 37 C.F.R. § 42.121.
B. Substitute Claims 31–38
Patent Owner submits substitute claims 31–38, set forth below, with
additions to the original claim shown in underlining and deletions shown in
brackets or strikethroughs.13 Substitute claim 31 is independent. Substitute
claims 32, 35, and 36 depend from substitute claim 31. Substitute claims 33,
37, and 38 depend from original claim 21, and substitute claim 34 depends
from substitute claim 33.
1. Substitute claim 31 (to replace claim 21)
31. A drug delivery device comprising:
a housing comprising a dose dispensing end and a first thread;
a dose indicator comprising a second thread that engages with
the first thread;
a driving member comprising a third thread;
a sleeve that is (i) disposed between the dose indicator and the
driving member and (ii) releasably connected to the dose
indicator;

13 Patent Owner provides its substitute claims in Appendix A to its Revised
Contingent Motion to Amend (Paper 64, App. A (“Claims Appendix”)), but
did not provide such an appendix of substitute claims with its subsequent
Corrected Revised Contingent Motion to Amend (Paper 71). Patent Owner
confirmed that references to a claims appendix in the Corrected Revised
Contingent Motion to Amend are intended to refer to the claims appendix
provided with the earlier filed Revised Contingent Motion to Amend.
Ex. 1110, 17:14–19:17. We, therefore, rely on and refer to the same earlier-
filed claims appendix.
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a piston rod comprising either an internal or an external a
fourth thread that is engaged with the third thread;
a piston rod holder that is rotatably fixed relative to the
housing and configured to (i) prevent the piston rod from
rotating during dose setting and (ii) permit the piston rod
to traverse axially towards the distal end during dose
dispensing; wherein:
the housing is disposed at an outermost position of the
drug delivery device;
the dose indicator is disposed between the housing and
the sleeve and is configured to (i) rotate and traverse
axially away from the dose dispensing end during
dose setting and (ii) rotate and traverse axially
towards the dose dispensing end during dose
dispensing;
the driving member is configured to rotate relative to
the piston rod;
the sleeve is rotatably fixed relative to the driving
member and configured to traverse axially with the
dose indicator; and
the piston rod and the driving member are configured
to rotate relative to one another during dose
dispensing; and
the piston rod is configured to traverse axially towards
the dose dispensing end during dose dispensing.
Claims Appendix 1–2.
2. Substitute claim 32 (to replace claim 23)
32. The drug delivery device of claim [[21]] 31 wherein the
sleeve further comprising is a clutch;
wherein the drug delivery device has only one arc shaped
body that is both within the housing and configured to track
each set dose of medicament as said dose indicator is rotated
relative to the arc shaped body, the arc shaped body
comprising proximal and distal surfaces, end-most side
surfaces, and inner and outer curved surfaces, the end-most
side surfaces being circumferentially spaced apart, one of the
curved surfaces comprising a fifth thread that is engaged with
a sixth thread, and wherein the arc shaped body is configured
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to (i) during dose setting, move axially relative to the housing
without rotating relative to the housing, and (ii) abut a radial
stop when at a final dose position, said radial stop disposed
separate from the sixth thread;
wherein said drug delivery device further comprises:
a first clicker feature comprising teeth configured to
provide audible clicks (i) by dragging the teeth over
corresponding teeth on said clutch and (ii) only during
dialing down of a dose without dispensing medicament,
where each click relates to a unit dose of medicament; and
a second clicker feature spaced axially apart from the first
clicker feature and disposed adjacent an end of the dose
indicator that is nearest the dose dispensing end, the
second clicker feature comprising a flexible arm
configured (i) to move axially relative to splines in only a
first axial direction during dialing up of a dose and to move
axially relative to the splines in only a second, opposite,
axial direction during dose dispensing and (ii) to provide
audible clicks by dragging a tooth member over the splines
while rotating and moving axially relative to the splines;
and
a zero dose stop on the housing, wherein the zero dose stop
protrudes radially inward and prevents the dose indicator
from rotating in a dialing down direction past an end
position.
Id. at 2–3.
3. Substitute claim 33 (to replace claim 24)
33. The drug delivery device of claim [[23]] 21
wherein the sleeve is a clutch;
wherein the device comprises a first clicker feature with teeth
configured to provide audible clicks by dragging the teeth
over corresponding teeth on the clutch and provide[[s]]
audible and tactile feedback only during dose correction that
is indicative of unit doses of medicament; and
wherein the device comprises a second clicker feature spaced
axially apart from the first clicker feature and disposed
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adjacent an end of the dose indicator that is nearest the dose
dispensing end, the second clicker feature comprising a
flexible arm configured (i) to move axially relative to splines
in only a first axial direction during dialing up of a dose and
move axially relative to the splines in only a second, opposite,
axial direction during dose dispensing and (ii) to provide
audible clicks by dragging a tooth member over the splines
while rotating and moving axially relative to the splines.
Id. at 3.
4. Substitute claim 34 (to replace claim 26)
34. The drug delivery device of claim [[24]] 33
wherein the clutch allows the dose cancelling without
dispensing medicament; and
wherein the drug delivery device has only one arc shaped
body that is both within the housing and configured to track
each set dose of medicament as said dose indicator is rotated
relative to the arc shaped body, the arc shaped body
comprising proximal and distal surfaces, end-most side
surfaces, and inner and outer curved surfaces, the end-most
side surfaces being circumferentially spaced apart, one of the
curved surfaces comprising a fifth thread that is engaged
with a sixth thread, and wherein the arc shaped body is
configured to (i) during dose setting, move axially relative to
the housing without rotating relative to the housing, and (ii)
abut a radial stop when at a final dose position, said radial
stop disposed separate from the sixth thread.
Id. at 3–4.
5. Substitute claim 35 (to replace claim 27)
35. The drug delivery device of claim [[24]] 31
wherein the sleeve is a clutch; and
the drug delivery device further comprising a button seated in
an annular recess of a dose dial grip on a proximal end of the
dose indicator, where the button is rotatable relative to the
dose indicator[.];
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a first clicker feature comprising teeth configured to provide
audible and tactile feedback (i) by dragging the teeth over
corresponding teeth on said clutch and (ii) only during dialing
down of a dose without dispensing medicament, the feedback
being indicative of unit doses of medicament; and
a second clicker feature spaced axially apart from the first
clicker feature and disposed adjacent an end of the dose
indicator that is nearest the dose dispensing end, the second
clicker feature comprising a flexible arm configured (i) to
move axially relative to splines in only a first axial direction
during dialing up of a dose and to move axially relative to the
splines in only a second, opposite, axial direction during dose
dispensing and (ii) to provide audible clicks by dragging a
tooth member over the splines while rotating and moving
axially relative to the splines.
Id. at 4–5.
6. Substitute claim 36 (to replace claim 29)
36. The drug delivery device of claim [[21]] 31
further comprising a clicker that provides audible clicks
during dose setting, where each click is equal to a unit dose
of medicament, wherein said clicker comprises:
a flexible arm extending from a fixed end
circumferentially to a free end thereof, the flexible arm
comprising a tooth on the free end, the flexible arm
configured to: (i) provide audible clicks while rotationally
fixed relative to the sleeve, which is a clutch, and while
the clicker is moving axially relative to the housing in a
first direction during dialing up of a dose, where each click
relates to a unit dose of the medicament, and (ii) not
provide audible clicks while the clicker is moving axially
relative to the housing in a second, opposite, direction
during dialing down of a dose without dispensing the
medicament; and
one-way teeth configured to: (i) provide audible clicks by
dragging over corresponding teeth of the clutch while the
clicker is moving axially relative to the housing in the
second direction during dialing down of a dose without
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dispensing the medicament, where each click relates to a
unit dose of the medicament and, (ii) not provide audible
clicks while the clicker is moving axially relative to the
housing in the first direction during dialing up of a dose;
and
wherein the drug delivery device has only one arc shaped
body that is both within the housing and configured to track
each set dose of medicament as said dose indicator is rotated
relative to the arc shaped body, the arc shaped body
comprising proximal and distal surfaces, end-most side
surfaces, and inner and outer curved surfaces, the end-most
side surfaces being circumferentially spaced apart, one of the
curved surfaces comprising a fifth thread that is engaged with
a sixth thread, and wherein the arc shaped body is configured
to (i) during dose setting, move axially relative to the housing
without rotating relative to the housing, and (ii) abut a radial
stop when at a final dose position, said radial stop disposed
separate from the sixth thread.
Id. at 5–6.
7. Substitute claim 37 (to replace claim 29)
37. The drug delivery device of claim 21
further comprising a clicker that provides audible clicks
during dose setting, where each click is equal to a unit dose
of medicament, wherein said clicker comprises:
a flexible arm extending from a fixed end,
circumferentially to a free end thereof, the flexible arm
comprising a tooth on the free end, the flexible arm
configured to: (i) provide audible clicks while rotationally
fixed relative to the sleeve, which is a clutch, and while
the clicker is moving axially relative to the housing in a
first direction during dialing up of a dose, where each click
relates to a unit dose of the medicament, and (ii) not
provide audible clicks while the clicker is moving axially
relative to the housing in a second, opposite, direction
during dialing down of a dose without dispensing the
medicament; and
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one-way teeth configured to: (i) provide audible clicks by
dragging over corresponding teeth of the clutch while the
clicker is moving axially relative to the housing in the
second direction during dialing down of a dose without
dispensing the medicament, where each click relates to a
unit dose of the medicament and, (ii) not provide audible
clicks while the clicker is moving axially relative to the
housing in the first direction during dialing up of a dose;
and
wherein the drug delivery device has only one arc shaped
body that is both within the housing and configured to
track each set dose of medicament as said dose indicator
is rotated relative to the arc shaped body, the arc shaped
body comprising proximal and distal surfaces, end-most
side surfaces, and inner and outer curved surfaces, the end-
most side surfaces being circumferentially spaced apart,
one of the curved surfaces comprising a fifth thread that is
engaged with a sixth thread, and wherein the arc shaped
body is configured to (i) during dose setting, move axially
relative to the housing without rotating relative to the
housing, and (ii) abut a radial stop when at a final dose
position, said radial stop disposed separate from the sixth
thread.
Id. at 6–7.
8. Substitute claim 38 (to replace claim 30)
38. The drug delivery device of claim 21 further comprises
comprising:
a nut that tracks each set dose of medicament delivered; and
a clicker that provides audible clicks during dose setting, where
each click relates to a unit dose of medicament, wherein said
clicker comprises:
a flexible arm extending from a fixed end, circumferentially
to a free end thereof, the flexible arm comprising a tooth on
the free end, the flexible arm configured to: (i) provide
audible clicks while rotationally fixed relative to the sleeve,
which is a clutch, and while the clicker is moving axially
relative to the housing in a first direction during dialing up
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of a dose, where each click relates to a unit dose of the
medicament, and (ii) not provide audible clicks while the
clicker is moving axially relative to the housing in a second,
opposite, direction during dialing down of a dose without
dispensing the medicament; and
one-way teeth configured to: (i) provide audible clicks by
dragging over corresponding teeth of the clutch while the
clicker is moving axially relative to the housing in the
second direction during dialing down of a dose without
dispensing the medicament, where each click relates to a
unit dose of the medicament and, (ii) not provide audible
clicks while the clicker is moving axially relative to the
housing in the first direction during dialing up of a dose.
Id. at 7–8.
C. Written Description and New Matter Under 35 U.S.C. § 316(d)(3)
and 37 C.F.R. § 42.121(a)(2)(ii) and (b)
An amendment may not enlarge the scope of the claims of the patent
or introduce new matter. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii).
In connection with its motion to amend, a patent owner must set forth
“support in the original disclosure of the patent for each claim that is added
or amended,” and “support in an earlier-filed disclosure for each claim for
which benefit of the filing date of the earlier filed disclosure is sought.”
37 C.F.R. § 42.121(b). Patent Owner’s motion fails to set forth adequate
written description support for the proposed substitute claims.
1. Principles of Law Regarding Written Description
When a priority claim involves a chain of priority documents, “each
application in the chain leading back to the earlier application must comply
with the written description requirement of 35 U.S.C. § 112.” Lockwood v.
Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997). The test for
determining compliance with the written description requirement entails “an
objective inquiry into the four corners of the specification from the
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perspective of a person of ordinary skill in the art,” and, “[b]ased on that
inquiry, the specification must describe an invention understandable to that
skilled artisan and show that the inventor actually invented the invention
claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (en banc). As the Federal Circuit has noted, however, “[i]n order
to satisfy the written description requirement, the disclosure as originally
filed does not have to provide in haec verba support for the claimed subject
matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323
(Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure
of the application relied upon reasonably conveys to those skilled in the art
that the inventor had possession of the claimed subject matter as of the filing
date.” Ariad, 598 F.3d at 1351. “The level of detail required to satisfy the
written description requirement varies depending on the nature and scope of
the claims and on the complexity and predictability of the relevant
technology.” Id. A lower level of detail is required to satisfy the written
description requirement in cases, such as this, where the field of the
invention, a mechanical device, is a predictable art. See Hologic, Inc. v.
Smith & Nephew, Inc., 884 F.3d 1357, 1361 (Fed. Cir. 2018). However,
“[i]t is not sufficient for purposes of the written description requirement of
§ 112 that the disclosure, when combined with the knowledge in the art,
would lead one to speculate as to modifications that the inventor might have
envisioned, but failed to disclose.” Lockwood, 107 F.3d at 1572.
2. Patent Owner Does Not Show Sufficient Written Description Support
for Substitute Claims 31–38
Patent Owner contends substitute claims 31–38 are fully supported by
the original disclosure of the ’616 application and “the line of priority
documents noted on the face of the ’844 Patent, which extend back to” the
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GB application. RMTA 5; see also Ex. 2304; Ex. 2313. In support of its
contentions, Patent Owner provides a table of pin citations to the
’616 application and the GB application, pin citations to Dr. Slocum’s
declaration (Ex. 2302), which purportedly provides “explanatory analysis of
certain disclosures” from the perspective of a person of ordinary skill in the
art, and additional discussion of certain features of the substitute claims.
RMTA 5–18.
Petitioner argues that Patent Owner does not sufficiently identify
written description support for each substitute claim, because Patent Owner
provides “analysis for only a few limitations” and otherwise relies on “a
table of citation without analysis.”14 RMTA Opp. 1. More specifically,
Petitioner contends four limitations lack support. RMTA Opp. 2–8. We
address only one of the four limitations addressed by Petitioner, because we
find it dispositive of the motion, reproduced below as originally provided in
claim 21 and as proposed in substitute claim 31:

14 Petitioner notes that the restriction on grounds of unpatentability that may
be raised to challenge issued claims in an inter partes review under § 311(b)
does not “limit the grounds of unpatentability that can be raised in response
to proposed substitute claims presented in a motion to amend.” RMTA
Opp. 2 n.1 (quoting Amazon.com, Inc. v. Uniloc Luxembourg S.A., IPR2017-
00948, Paper 34 at 5 (PTAB Jan. 18, 2019) (precedential)).
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Claim 21: “a driving member comprising a third
thread” and “a piston rod comprising either an
internal or an external fourth thread that is engaged
with the third thread”
Substitute Claim 31: “a driving member comprising a
third thread” and “a piston rod comprising a fourth
thread that is engaged with the third thread”
Patent Owner proposes substitute claim 31 as an amendment of
challenged claim 21. Challenged claim 21 recites “a driving member
comprising a third thread” and “a piston rod comprising either an internal or
an external fourth thread that is engaged with the third thread.” Ex. 1004,
8:36–49 (emphasis added). Patent Owner proposes amending claim 21 by
deleting the phrase “either an internal or an external,” whereby substitute
claim 31 then recites “a piston rod comprising a fourth thread that is
engaged with the third thread.” Claims Appendix 1 (Element 31[e])
(emphasis added to show “a” was added to substitute claim 31). Patent
Owner proposes no other amendments to claim 21. Thus, substitute
claim 31 is identical to challenged claim 21, but for the omission of “either
an internal or an external” from claim 21 (and the addition to substitute
claim 31 of “a” prior to “fourth thread”). See RMTA 3.
In IPR2018-01680, we are issuing, contemporaneously, a final written
decision in which we determine that Petitioner demonstrates that the
Challenged Claims are not entitled to a priority date prior to May 17, 2016,
the filing date of the ’616 application, because the GB application does not
provide written description support for a “piston rod comprising . . . an
internal . . . fourth thread” (i.e., an internally threaded piston rod), as recited
in claim 21, claim 21 was not entitled to priority to the GB application. See
also Ex. 1026, 2:1–5, 5:19–27, 11:9–11, Figs. 1–7, 9–13 (showing that the
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GB application discloses an externally threaded piston rod, but not an
internally threaded piston rod or a genus of threaded piston rods). As a
result, we further find in IPR2018-01680 that Giambattista is prior art to
claim 21, and that Petitioner shows that Giambattista anticipates claim 21.
In discussing substitute claim 31, Patent Owner begins by seeking “to
be clear at the outset” that the written description analysis of claim 21 “does
not dictate the outcome for amended claim 31,” because substitute claim 31
“is different” and there is no requirement for written description support of
“an un-recited feature.” RMTA 8–9. We emphasize, again, that the only
claim language that is “different” between claim 21 and substitute claim 31
is the omission of “either an internal or an external” from claim 21 (and the
addition of “a”). Claims Appendix 1 (Element 31[e]). We agree with Patent
Owner that an analysis of written description support for claim 21 does not
“dictate” the same outcome with respect to substitute claim 31.
Patent Owner further maintains that by manipulating the language of
claim 21 to eliminate any specific reference to either “an internal” or “an
external” fourth thread in substitute claim 31, Patent Owner can: (1) have the
scope of substitute claim 31 be identical to the scope of claim 21,
and (2) “eliminate[] Giambattista from consideration as a prior art reference”
to substitute claim 31, because a lack of written description for an internally
threaded piston rod is purportedly no longer an issue. RMTA 3, 18–19.
Patent Owner further asserts that “while the test for written description
support of claim 21 requires possession of both external and internal threads,
for [substitute] claim 31, the test only requires possession of a thread.” PO
Sur-reply 3–4. We disagree with Patent Owner that possession by the
inventors of “a thread” provides sufficient written description to support
substitute claim 31 with a scope identical to claim 21, which, as explained
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above, is an unpatentable claim. See supra § II.E. Indeed, Patent Owner
recognizes that a “proper written description inquiry” is focused on “whether
‘the four corners of the specification’ demonstrate ‘the inventor actually
invented the invention claimed.’” RMTA 9 (quoting Ariad Pharm.,
598 F.3d at 1351). The “four corners” of the GB application make clear that
Patent Owner did not invent what Patent Owner now seeks to claim in
substitute claim 31, for the reasons provided below.
The error in Patent Owner’s argument that it need show no more than
possession of a “thread” turns on the fact that the GB application discloses
only an externally threaded piston rod, not an internally threaded piston rod.
A preponderance of the evidence further shows that the GB application, in
light of the knowledge of a person of ordinary skill in the art, does not
disclose or suggest any alternative to an externally threaded piston, much
less that the internally threaded piston rod, as applied in the GB application,
was but a member of a “genus” of threaded piston rods with well-known,
interchangeable options, as explained below. To the contrary, there is no
disclosure or suggestion in the GB application that an internally threaded
piston rod would be functional in light of the required arrangement of other
features of the pen injector disclosed. See generally Ex. 1026.
To the extent that Patent Owner seeks through substitute claim 31 to
claim all threaded piston rods as a “genus” (with purportedly only two
species—internally and externally threaded piston rods),15 Patent Owner
does not show that the GB application provides any broad disclosure of a

15 Assuming only two species ignores the fact that the piston rod is threaded
at both ends, corresponding to what would seem to be four species of
threaded piston rods under Patent Owner’s own reasoning, as discussed
above.
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“thread” sufficient to provide written description for substitute claim 31.
Further, to the extent that Patent Owner alternatively seeks through
substitute claim 31 to claim all threaded piston rods as a “genus,” based on
the disclosure in the GB application of only one species (an externally
threaded piston rod), Patent Owner does not show sufficient written
description support. To be clear, we agree with Patent Owner that it is
possible that the disclosure of a species may provide written description
support for a genus claim. See RMTA 11 (citing In re Rasmussen, 650 F.2d
1212, 1215 (C.C.P.A. 1981) (“[t]hat a claim may be broader than the
specific embodiment disclosed in a specification is in itself of no moment”);
see also id. at 10–12 (discussing Hologic, 884 F.3d at 1362, and Bilstad v.
Wakalopulos, 386 F.3d 1116, 1124–25 (Fed. Cir. 2004)). Thus, although a
narrow disclosure of a species (externally threaded piston rods) theoretically
may provide written description support for a claim directed to a broader
genus (threaded piston rods), such reasoning does not apply to substitute
claim 31, because a preponderance of the evidence: (1) shows that Patent
Owner was in possession of only one of the two species (externally threaded
piston rods) in the supposed genus of threaded piston rods Patent Owner
seeks to claim, and (2) does not show that the second species (internally
threaded piston rods) was well-known in the art or interchangeable with the
first species. See RMTA 10–11; see also Hologic, 884 F.3d at 1362
(explaining that disclosure of a species (a “fibre optics bundle”) provided
written description support for a genus (a “light guide”) where there was no
“dispute that various types of light guides were well-known in the art”).
More specifically, turning to the evidence of written description
Patent Owner provides in support of substitute claim 31 in its motion, Patent
Owner identifies in a table certain portions of the ’616 application and
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corresponding portions of the GB application that Patent Owner asserts
provide written description support for the recited “piston rod comprising a
fourth thread that is engaged with the third thread.”16 RMTA 5–6 (citing
Ex. 2304 ¶¶ 6, 7, 39–41; Ex. 1026, 1:25–2:13, 5:25–6:14, cls. 2, 6 (regarding
Element 31[e] of Claims Appendix at 1); see also Ex. 2325 ¶ 23 (providing
the same table). Rather than address the disclosures Patent Owner cited as
purportedly providing written description support, Patent Owner instead
proceeds to address “original claim 1” of the GB application, which it did
not identify as providing written description support for the piston rod
limitation of substitute claim 31 at issue. See id. Specifically, Patent Owner
argues that “original claim 1” of the GB application “recites a piston rod but
does not specify that it is threaded internally or externally.” RMTA 9 (citing
Ex. 1026). Patent Owner’s argument implicitly mischaracterizes claim 1 of
the GB application, which states as follows:
1. A pen-type injector comprising a housing;
a piston rod adapted to operate through the housing;
a dose dial sleeve located between the housing and the piston rod,
the dose dial sleeve having a helical thread of first lead;

16 Patent Owner explains that citations to the GB application (Ex. 1026) “are
equivalent to the same disclosure” in the ’616 application (Ex. 2304).
RMTA 6 n.5. To the extent the parties and their experts discuss what was
disclosed in either the GB application or the ’616 application, unless noted
otherwise, our understanding is that each application provides an equivalent
disclosure to the other. See also Ex. 2325 ¶ 25 n.7 (Dr. Slocum stating that
he cites “to the US ’616 Application throughout simply as a matter of
convenience, and by doing so, [he does] not mean to imply that the
corresponding disclosure in the GB Application is not also relevant,” and
noting that with regard to disclosures in the ’616 application, the “same
disclosure exists in the GB Application”). We follow the same approach in
that our discussion of either the GB application or the ’616 application
pertains to what both applications equivalently disclose.
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a drive sleeve located between the dose dial sleeve and the piston
rod, the drive sleeve having a helical groove of second lead;
characterised in that the first lead of the helical thread and the
second lead of the helical groove are the same.
Ex. 1026, 12. Patent Owner neglects to explain that not only does “original
claim 1” of the GB application “not specify” whether the piston rod “is
threaded internally or externally,” as Patent Owner asserts, “original
claim 1” does not even specify that the piston rod is “threaded.” See also
Ex. 2325 ¶ 28 (Dr. Slocum noting that original claim 1 “describes the piston
rod without reference to threads”). Yet from this absence of disclosure,
Patent Owner asserts a person of ordinary skill in the art would have
“gleaned that the inventors considered their invention broader than the
externally-threaded piston rod.” RMTA 9 (citing Ex. 2325 ¶¶ 25–32).
Patent Owner’s explanation, on its face, fails to show written description
support for substitute claim 31, even if the disclosure would have suggested
some undisclosed “broader” invention. Moreover, Dr. Slocum’s opinion
that the absence of any disclosure of “threads” in “original claim 1”
constitutes a “signal to a person of ordinary skill that the inventors had not
intended their invention to be limited to external threads” is unsupported and
not credible, because it is inconsistent with the entirety of the GB
application, which expressly describes only an externally threaded piston
rod. See Ex. 2325 ¶ 28.
The remaining evidence Patent Owner presents is summarized in the
following:
 a person of ordinary skill in the art would have known that “it does
not matter which thread (whether on the piston rod or drive sleeve) is
internal or external,” and that the location of these threads were
“interchangeable” (RMTA 9 (citing Ex. 2107 ¶¶ 98–99));
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 a person of ordinary skill in the art would have understood “that the
threads of a piston rod could only be either internal or external” and
“would have immediately understood that the piston rod could have
either internal threads or external threads” in “each instance where the
specification discloses that the piston rod has a ‘thread’” (RMTA 9–
10 (citing Ex. 2325 ¶¶ 21, 28)); and
 a person of ordinary skill in the art would have had “the prior
knowledge of internally threaded piston rods in other related contexts”
(RMTA 10 (citing Ex. 2107 ¶¶ 95–97 (citing Exs. 2169–2171);
Ex. 2325 ¶¶ 25–32)).
According to Patent Owner, the above “understandings” would have led a
person of ordinary skill in the art “to conclude that the inventors here had
possession of a threaded piston rod, without limitation to the specific
position of the threads.” RMTA 10.
We have also considered additional testimony provided by
Dr. Slocum in support of Patent Owner’s motion.17 See Ex. 2325 ¶¶ 23–32.
Dr. Slocum states that the ’616 application describes an externally threaded
piston rod 20. Id. ¶ 27 (citing Ex. 2304 ¶¶ 39–40, Fig. 1). We agree that
the ’616 application (and the GB application) expressly disclose an
externally threaded piston rod. Dr. Slocum also suggests that, because he
was able to draw what he characterizes as “an exemplar of an internally
threaded piston rod interacting with a drive sleeve” during his deposition, “a
person of ordinary skill would read the GB Application and understand that
the inventors were in possession of an invention with a drive sleeve
connected to a piston rod, and that such connection could be with internal or
external threads on the piston rod.” Id. ¶¶ 29–31. The exemplar Dr. Slocum
refers to (Ex. 1051) includes a “stinger.” We find that Dr. Slocum’s drawing

17 Dr. Slocum also provided a declaration (Ex. 2332) in support of Patent
Owner’s reply to RMTA, which we address below.
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in a deposition in 2019 does not provide persuasive evidence of what a
person of ordinary skill in the art would have understood from the ’616
application or the GB application during the relevant time frame.
In this regard, we credit the testimony of Mr. Leinsing, who explains
that Dr. Slocum’s drawing does not reflect what a person of skill in the art
would have considered a “routine or commonly-used component in pen
injectors” and that “it was not conventional for pen injectors to use a drive
with an internal ‘stinger’ that engages an internally thread piston rod.”
Ex. 1113 ¶ 40; see also id. (noting that Steenfeldt-Jensen, Burroughs,
Moller, and Giambattista all teach an externally threaded piston rod and
demonstrate what would have been viewed as conventional and routine).
Mr. Leinsing’s opinion that the ’616 application “provides no discussion on
how to configure, much less describe, an internally threaded piston ‘rod’
with an internal ‘stinger’ that would work” is persuasive as Mr. Leinsing
explains that “a person of ordinary skill would have understood the piston
rod to be already very thin,” and that “additional structural concerns, such as
buckling, would arise by hollowing out an already-thin component to
introduce an even thinner threaded component within its space, thus
requiring a larger size to address those concerns.” Id. ¶ 43.
In opposition to the motion, Petitioner also argues that “substitute
claim 31 suffers the same deficiencies as original claim 21” and that
substitute claims 31–38 lack written description support in the
’616 application. RMTA Opp. 2–4. Petitioner presents arguments relying
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on testimony from Mr. Leinsing.18 Id. (citing Ex. 1096 ¶¶ 25–27).
Petitioner argues that a person of ordinary skill in the art would have
understood from the ’616 application “that external threads on the piston rod
are required to permit connection with the drive sleeve,” because the ’616
application “discloses a drive sleeve located between the dose dial sleeve
and the piston rod,” and “notes that the drive sleeve connects to the piston
rod for rotation along the piston rod’s second threaded portion.” Id. at 3
(citing Ex. 2304 ¶¶ 6, 7; Ex. 1096 ¶¶ 25–27). Petitioner also explains that
the only “driving member” disclosed by the ’616 application is a “drive
sleeve” with inner helical groove 38, which works with external threading
on piston rod 20. Id. at 4 (citing Ex. 1096 ¶¶ 25–27; Ex. 2304 Fig. 1).
Petitioner argues that Patent Owner “fails to explain” how a person of
ordinary skill in the art would have immediately discerned that the thread
could also be on the inner surface of the piston rod and still interact with the
drive sleeve.” Id. (citing Waldemar Link GmbH & Co. v. Osteonics Corp.,
32 F.3d 556, 558 (Fed. Cir. 1994)).
In regard to the disclosures of the ’616 application Patent Owner
identifies as providing written description support (i.e., Ex. 2304 ¶¶ 6, 7,
39–41), Mr. Leinsing states as follows:
As I explained previously, while paragraphs 6 and 7 of the
’616 application do not explicitly specify whether the threading
on the piston rod is internal or external, the paragraphs, like the

18 Mr. Leinsing provided a declaration (Ex. 1096) in support of Petitioner’s
opposition to Patent Owner’s initial motion to amend, as well as a
declaration (Ex. 1113) in support of Petitioner’s opposition to Patent
Owner’s RMTA. Both declarations are relevant to Petitioner’s arguments
against substitute claim 31, which is identical in both the motion to amend
and the revised motion to amend. Compare Paper 34, App. A. at 1–2, with
Paper 66, App. A at 1–2.
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rest of the specification, provides crucial context as to the
concentric nature of the components by disclosing a drive sleeve
that is located between the dose dial sleeve and the piston rod
(and the dose dial sleeve is located between the housing and the
piston rod), where the drive sleeve is connected to the piston rod
for rotation with respect thereto along the second threaded
portion of the piston rod. See EX1095, ¶¶ 9–12; see also
EX1109, 45:24–46:11.
The ordinary artisan would not read those paragraphs of
the ’616 application as suggesting that the threading on the piston
rod could be on either the inner surface or the outer surface of
the piston rod and, similarly, that the threading on the drive
sleeve could be either on the inner surface or the outer surface of
the drive sleeve. That is, given the position of the piston rod
relative to the drive sleeve, such that the drive sleeve is located
between the dose dial sleeve (which is located between the
housing and the piston rod) and the piston rod, the ordinary
artisan would understand that the threads of the piston rod are
necessarily on the outer surface so as to allow for connection
with the inner surface of the drive sleeve. Paragraphs 39-41 of
the ’616 application also do not disclose an internally threaded
piston rod but reinforce the use of an externally threaded piston
rod. Specifically, the piston rod is described as having a second
thread 24 that is adapted to work within helical groove 38 that
extends along the internal surface of the drive sleeve. EX2304,
¶¶ 39-41, 59; see also FIG. 1 (showing external thread 24 on
piston rod 20); EX2325, ¶ 27 (noting that paragraphs 39 and 40
describe a specific embodiment that includes an externally
threaded piston rod 20). Dr. Slocum’s “stinger” approach
overlooks the consistent terminology used in the ’616
application—where a hollow, cylindrical, concentric component
is a “sleeve” and that which is not is a “rod”—and instead sets
forth a configuration where the “piston rod” is now an internally-
threaded “sleeve” and the drive sleeve includes an externally-
threaded “rod” attached to it.
Ex. 1113 ¶¶ 41–42.
Patent Owner’s additional arguments fail to provide evidence that the
inventors of the ’844 patent were in possession of an internally threaded
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piston rod. See RMTA Reply 3–8; Ex. 2332 ¶¶ 11–33. Patent Owner argues
that the GB application “places no special importance” on whether the piston
rod threading is internal or external, refers to the piston rod as “threaded,”
and merely provides one illustrated embodiment with preferable features that
shows an externally threaded piston rod, such that the “thread location is a
mere implementation detail. RMTA Reply 4–5. We disagree, as
Mr. Leinsing explains, the injector pen disclosed in the GB application
includes components, including a drive sleeve, that essentially only function
with an externally threaded piston rod, notwithstanding Dr. Slocum’s
attempt to redesign the device disclosed in the GB application to add a
“stinger” to the drive sleeve to then add an internally threaded piston rod.
Patent Owner also argues in reply at length that Dr. Slocum’s design proves
what a person of ordinary skill in the art “would have ‘immediately
discerned’” because “Dr. Slocum readily envisioned such a device when
prompted by Mylan’s counsel during deposition.” RMTA Reply 6–8.
For the many reasons provided above, we are not persuaded that what
Dr. Slocum envisioned during a deposition in 2019 accurately reflects the
understanding of a person of ordinary skill in the art at the time of the
invention. Dr. Slocum’s declaration in support of the RMTA Reply
highlights the very problem with his opinion–it is not based on sufficient
evidence of what was known to a person of ordinary skill in the art at the
time of the invention, but is instead a reflection of his personal knowledge
and experience as of 2019. See Ex. 2332 ¶ 13–33. Dr. Slocum claims to
show “how simple it is to accomplish” an internally threaded piston rod and
externally threaded drive sleeve, which he calls his “‘stinger’ embodiment”
by literally creating “a CAD model with engineering design calculations of
the design to . . . more clearly show the arrangement of components.”
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Dr. Slocum does not rely on what was disclosed in the GB application, but
instead shows what he has designed in 2019, including in “parallel with the
CAD modeling,” a “spreadsheet to assess force loop of the drawn
embodiment” to evaluate “the efficiency of the system, reasonable stresses
in components, and material/geometry considerations.” Id. ¶¶ 13–15, 33.
Dr. Slocum even suggests that “[w]ith the CAD model of the drawn
embodiment complete, it was easy for me, acting as a person of ordinary
skill, to evolve the model to show the “stinger” design using an internally
threaded piston rod.” Id. ¶ 17. Dr. Slocum does not explain how he was
able to set aside his superior knowledge to act “as a person or ordinary skill”
as he used the model he created to “evolve” it into his “stinger
embodiment.” See id. Dr. Slocum proceeds to attempt to refute
Dr. Leinsing’s opinion that the addition of a stinger would have presented
structural concerns by discussing the properties of polyoxymethylene and
how he “added the details for mechanically joining the stinger to the
modified drive sleeve via a snap fit design.” Id. ¶¶ 19–24. Dr. Slocum also
provides a table showing dozens of entries for “geometries and analysis” and
an illustration comparing the “GB App. Model” (disclosed in the GB
application) to his “‘Stinger’ Model.” Id. ¶¶ 25–33.
On the back of the extensive work Dr. Slocum performed creating a
“Stinger Model,” Patent Owner proceeds to argue that it is “unsurprising”
that a person of ordinary skill in the art “would have immediately discerned
an internally-threaded piston rod in view of the GB Application’s
disclosure,” because such a person would have been “well-versed on
threaded engagements” and would have been familiar with “devices utilizing
an internally-threaded piston rod driven by an externally-threaded driver.”
RMTA Reply 7–8 (citing Kamen, Spinello, Moberg). We note Patent
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Owner does not suggest that Kamen, Spinello, or Moberg actually teaches
the use of a stinger as shown in Dr. Slocum’s Stinger Model. Patent Owner
concludes that Petitioner “fails to account for the real world fact that ‘[a]
patent specification is written for a person of skill in the art, and such a
person comes to the patent with the knowledge of what has come before.”
Id. at 8 (quoting LizardTech, 424 F.3d at 1345).
Petitioner argues in Sur-reply that “it is the specification itself that
must demonstrate possession,” and that “a description that merely renders
the invention obvious does not satisfy the requirement.” RMTA Sur-reply 1
(quoting Ariad, 598 F.3d at 1352). Petitioner further argues that Patent
Owner identifies no guidance or “blaze marks” from the specification
indicating possession of the undisclosed embodiment, and that Patent
Owner’s argument that a person of ordinary skill in the art could have made
the undisclosed embodiments is insufficient. Id. at 1–2. Petitioner also
argues that the GB application “only shows possession of an external
thread,” that “having a threaded drive sleeve necessarily means there is an
externally-threaded piston rod,” and that “having an internally threaded
piston rod requires an entirely different (and definitely undescribed) driving
structure, like a ‘stinger.’” Id. at 3. According to Petitioner, whether
Dr. Slocum can create “a functional stinger does not show written
description support,” even if it “supports the obviousness of the
configuration.” Id. at 3–4. Finally, Petitioner argues that Patent Owner
“fails to direct the Board to any pen-injector art disclosing a stinger
embodiment because it cannot,” and that the references cited “disclose
devices that (1) are not pen injectors, and (2) operate differently, with an
axially-fixed screw rotating (via, e.g., a motor) to move a rotationally-fixed
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nut,” not the drive mechanism of the ’844 patent. Id. at 4 (citing Ex. 2332
¶ 18).
While we acknowledge Dr. Slocum apparently conceived of an
attenuated way to add a “stinger” to the device disclosed in the
GB application to redesign it in a way that arguably creates a functioning
piston rod with internal threading, that design was not disclosed in the
GB application and no evidence provided by Patent Owner sufficiently
shows that a “Stinger Model” was well known or interchangeable with an
externally threaded piston rod, as applied to the device disclosed in the
GB application. We credit the testimony of Mr. Leinsing over the testimony
of Dr. Slocum in this regard.
For these reasons, we find that Patent Owner does not show adequate
support in the ’616 application or the GB application for proposed substitute
claim 31. Substitute claims 32, 35, and 36 depend from substitute claim 31.
Proposed substitute claims 32, 35, and 36 suffer from the same deficiency
for the same reasons. Substitute claims 33, 37, and 38 depend from claim 21
and require “a piston rod comprising either an internal or an external fourth
thread.” As explained above, Patent Owner does not show adequate support
in the ’616 application or the GB application for “a piston rod
comprising . . . an internal . . . fourth thread,” (i.e, and internally threaded
piston rod). Accordingly, substitute claims 33, 37, and 38 lack the necessary
written description support.
D. Conclusion
For these reasons, we find that Patent Owner’s Corrected Revised
Contingent Motion to Amend does not establish adequate support in
the ’616 application or the GB application for proposed substitute
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claims 31–38. Thus, we deny Patent Owner’s Corrected Revised Contingent
Motion to Amend.
IV. ANALYSIS OF PETITIONER’S MOTION TO EXCLUDE
Petitioner moves to exclude the following one hundred and forty-
seven exhibits – Exhibits 2001–2020, 2023, 2100–2107, 2109, 2111, 2113–
2126. 2128–2152, 2157–2162, 2165–2201, 2203–2212, 2214–2218, 2223–
2225, 2302, 2305, 2306, 2308–2312, 2316, 2323–2325, 2327, and 2332–
2334. Mot. 1. Petitioner also moves to exclude “the redirect testimony” in
Exhibits 1054 and 1109. Id. Petitioner states that corresponding objections
to the exhibits sought to be excluded were filed prior to the motion to
exclude. Id. (citing Papers 21, 35, 36, 89). Petitioner further argues that to
the extent any exhibit is not excluded, “use of the exhibit should be
restricted to the use for which it was originally submitted.” Id. at 12 (citing
Federal Rules of Evidence (“FRE”) 105). Petitioner, as the “moving party,”
“has the burden of proof to establish that it is entitled to the requested
relief.” 37 C.F.R. § 42.20 (2017).
A. Exhibits 2001–2011, 2013–2020, and 2023
Petitioner moves to exclude Exhibits 2001–2011, 2013–2020,
and 2023 pursuant to FRE 402 and 403 because these exhibits are
purportedly not relevant to any contested issue in this proceeding and risk
confusing the issues. Mot. 1–4. Patent Owner responds that these exhibits
“were offered to show information relevant to issues raised during this
proceedings preliminary stage.” Mot. Opp. 1. Patent Owner asserts that
these exhibits do not lack relevance, have no risk of confusing the issues,
and should therefore remain in the record. Id. In reply, Petitioner argues
that Patent Owner conceded Exhibits 2001–2017 pertain to pre-institution
issues and failed to identify any issue remaining in the trial for which they
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are relevant. Mot. Reply 1. Petitioner further asserts that, if these exhibits
are not excluded, “they should be limited to the purpose for which they were
submitted.” Id. (citing FRE 105).
We are not persuaded that exhibits offered prior to institution of inter
partes review should be excluded after institution merely because they are
no longer relevant to an issue in dispute between the parties. Indeed, the
record contains other documents that may similarly be characterized as only
relevant prior to institution, such as the preliminary response of the Patent
Owner. These exhibits and papers are a part of the record on which
institution was based and Petitioner fails to identify any persuasive reasons
for their exclusion at this stage of the proceeding. Petitioner shows no risk
of confusion by allowing the exhibits to remain in the record. Petitioner also
fails to direct our attention to any prior Board decision that granted a motion
to exclude exhibits merely because they were relevant only to the pre-
institution phase of an inter partes review. Petitioner does not show a
persuasive reason to exclude the exhibits or expressly limit their purpose
pursuant to FRE 105 over the competing interest of maintaining a full record
of the evidence and arguments provided by the parties, including evidence
introduced only for purposes relevant to our decision on institution.
B. Exhibit 2012
Petitioner contends that Exhibit 2012 is an animation “offered to show
an animated operation of an embodiment of the injection pen described in
the ’844 patent” and should be excluded as hearsay pursuant to FRE 801–
804 “because it is offered for the truth of its content without satisfying any
of the hearsay exceptions.” Mot. 3. Patent Owner responds that an expert
may rely upon hearsay if reasonable to do so in the expert’s filed, and that
Dr. Slocum relied upon Exhibit 2012 “to explain the operation of the injector
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pens in the challenged patents.” Mot. Opp. 1. Petitioner does not address
Exhibit 2012 in its Reply. See generally Mot. Reply.
Patent Owner does not dispute that Exhibit 2012 constitutes hearsay
and Petitioner does not dispute that Dr. Slocum was permitted to rely upon
this exhibit in formulating his opinions. Accordingly, Exhibit 2012 is
limited to the purpose of showing the basis for Dr. Slocum’s testimony.
C. Exhibits 2100, 2102–2106, 2113–2116, 2118–2120, 2122, 2124, 2125,
2129–2135, 2138–2141, 2145, 2146, 2151, 2157–2161, 2165–2174,
2176–2183, 2186–2200, 2203–2210, 2212, 2214, 2218, 2225, 2305,
2306, 2308–2312, 2323, 2324, and 2327
Petitioner contends Exhibits 2100, 2102–2106, 2113–2116, 2118–
2120, 2122, 2124, 2125, 2129–2135, 2138–2141, 2145, 2146, 2151, 2157–
2161, 2165–2174, 2176–2183, 2186–2200, 2203–2210, 2212, 2214, 2218,
2225, 2305, 2306, 2308–2312, 2323, 2324, and 2327 should be excluded
pursuant to FRE 402 and 403 “because they were not discussed in the
substantive papers, cannot be relevant to them, and consequently serve only
to confuse and create prejudice through belated surprise.”19 Mot. 5.
Petitioner further contends that Exhibits 2225, 2323, and 2324 should be
excluded under FRE 403 and 802 because they “were not cited in any
substantive papers and are prejudicial because it risks confusion by diverting
attention away from the actual issues under review,” and they are “hearsay
without exception.” Mot. 11–12. Petitioner offers no additional explanation
of its arguments specific to Exhibits 2225, 2323, or 2324 to show that they
are hearsay. Likewise for all of these exhibits, Petitioner identifies no
support for the broad proposition that an exhibit “not discussed in

19 Exhibits 2151, 2167, 2168, 2206, 2207, and 2218 are further addressed
below (Section V.H.) in light of Petitioner’s additional arguments with
respect to these claims.
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substantive papers” must be excluded, and offers only unsupported bald
assertions that the exhibits “cannot be relevant” and “serve only to confuse
and create prejudice through belated surprise.” See Mot. 4–5, 10; see also
Mot. Reply 2.
Patent Owner explains that Exhibits 2100 and 2102–2106 are exhibits
to the deposition of Mr. Leinsing, that Exhibit 2225 is an exhibit to
Mr. McDuff’s deposition, that Exhibits 2100, 2102, 2103, 2113, 2116, 2120,
2131, 2134, 2135, 2138, 2158–2161, 2165–2171, 2173, 2174, 2176–2183,
2206, 2207, 2214, 2218, 2310, and 2311 are expressly cited in Dr. Slocum’s
declaration, that Exhibits 2116, 2124, 2145, 2146, 2186–2199, 2203–2205,
and 2208–2210 are expressly cited by Dr. Grabowski, and that
Exhibits 2116, 2125, 2140, 2141, and 2200 are expressly cited by
Dr. Goland. Mot. Opp. 2–3. Patent Owner reasons that these exhibits
provide context for understanding the testimony provided by the declarants
and are materials they reasonably relied upon in forming their opinions. Id.;
see also id. at 3–4 (addressing the relevance of Exhibits 2305, 2306, 2308–
2312, 2323, 2324, and 2327). Patent Owner also states that Dr. Slocum
relied upon Exhibit 2151. Id. at 11–12. Petitioner argues in reply that the
exhibits should nonetheless be excluded or “limited to the purpose for which
they were cited.” Mot. Reply 1–2.
We have considered the parties additional arguments and conclude
that Petitioner does not show any persuasive reason any of the exhibits
purportedly not “discussed in the substantive papers” should be excluded.
D. Exhibits 2101, 2121, 2123, 2126, 2128, 2136,
2137, 2142–2144, 2175, 2184, 2185, and 2201
Petitioner contends that Exhibits 2101, 2121, 2123, 2126, 2128, 2136,
2137, 2142–2144, 2175, 2184, 2185, and 2201 “should be excluded under
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FRE 402 and 403 because the properties for which they are cited (e.g.,
injection force and ease of use) are not required by any of the Challenged
Claims so these exhibits serve only to confuse the issues and create
prejudice through needless multiplication of issues.” Mot. 11. Patent
Owner argues the exhibits are relevant. Mot. Opp. 12–13.
Petitioner offers no explanation or support for the notion that exhibits
which pertain to properties Petitioner alleges are not required by any of the
Challenged Claims should be excluded. Petitioner essentially concedes that
the exhibits are relevant to an issue in dispute, but suggests that they be
excluded because Petitioner does not agree with Patent Owner’s contentions.
That simply is not a sufficient reason for exclusion.20
E. Exhibits 2107, 2302, 2316, 2325, 2332,
1054 (redirect), and 1109 (redirect)
Petitioner seeks to exclude Exhibits 2107, 2302, 2316, 2325, 2332,
1054 (redirect), and 1109 (redirect) under FRE 702, 703, and 705. Mot. 5–9.
Petitioner fails to identify at the outset of its argument what these exhibits
correspond to, improperly leaving it to Patent Owner and the Board to fill in
the information absent from the motion. Additionally, Petitioner fails to
expressly address in any substantive manner Exhibits 2302, 2316, and 2325,
and, accordingly, does not satisfy its burden to show that these exhibits
should be excluded.
With respect to Exhibits 2107 and 2332, which are two of the
declarations of Dr. Slocum, as well as the deposition redirect examination of
Dr. Slocum in Exhibits 1054 and 1109, Petitioner argues that Dr. Slocum did

20 In reply, Petitioner argues for the first time that these exhibits should be
“excluded under FRE 801–804.” Mot. Reply 5. Because this argument was
not raised in the Motion, it is improper.
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not have personal knowledge of injection pens or the industry during the
relevant time period and that Dr. Slocum relied upon Mr. Veasey, one of the
named inventors of the ’844 patent, for certain data and a model used for
various calculations. Id. at 5–7. As to Exhibit 2107, Petitioner argues that
“it does not provide sufficient facts or data, is not the product of reliable
principles and methods, and has not applied the proper principles to the facts
of this proceeding.” Id. at 7. Petitioner contends, as an example, that
Appendices A through F “do not set forth the principles used nor do they
demonstrate the calculations used in generating the spreadsheets” and, thus,
“should be excluded for failing to disclose the underlying facts and data, and
failing to set forth the bases of Dr. Slocum’s opinions.” Id. at 7–8. As to
Exhibit 2332, Petitioner argues that “it is not supported by sufficient facts of
record to qualify as expert testimony.” Id. at 8–9.
With respect to Dr. Slocum’s personal knowledge, Patent Owner
correctly explains in response that “an expert need not be qualified in the
pertinent art at the time of the invention,” and that neither party’s proposed
definition of the ordinary level of skill in the art requires specific knowledge
of, or experience with, pen injectors. Mot. Opp. 5 (citing Ex. 1011 ¶ 106;
Ex. 2107 ¶ 102). Further, Patent Owner asserts that Dr. Slocum acquired
knowledge of the pen injector field as of 2003 because he “(i) researched the
prior art, (ii) canvassed literature on pre-critical date pen injectors, design
considerations, and design standards, and (iii) conversed with those in the
industry (i.e., Mr. Veasey and Dr. Goland).” Id. at 6 (citing Ex. 2107
¶¶ 25–61). Patent Owner also contends Dr. Slocum documented his
opinions with facts and data in support of what a person of ordinary skill
would have known in 2003. Id.
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Regarding the information and model obtained from Mr. Veasey,
Patent Owner asserts that Dr. Slocum performed his own investigation and
research into design considerations and the state of the art, as documented in
his declaration. Id. at 7 (citing Ex. 2107 ¶¶ 25–61). Patent Owner further
asserts that much of the information provided by Mr. Veasey is undisputed,
including design considerations and that the FlexPen® is the
commercialization of an embodiment of Steenfeldt-Jensen. Id. at 7–8.
Moreover, Patent Owner states that it “served as supplemental evidence the
native spreadsheets that specify [the] principles and calculations” set forth in
Appendices A through F and that “the measurements provided by
Mr. Veasey are corroborated, unrebutted, and reliable.” Id. at 9–10 (citing
Ex. 2226).
In reply, Petitioner offers no persuasive argument in support of its
motion, but instead baselessly suggests that Dr. Slocum “objectively failed
to act as an expert in this case.” Mot. Reply 2. Petitioner also challenges
Dr. Slocum’s acceptance of Mr. Veasey’s data “without question,”
contending that Dr. Slocum only did so because “he had no relevant
knowledge or experience.” Id. at 3. Petitioner also asserts that Patent
Owner hid Mr. Veasey’s involvement in Dr. Slocum’s testimony precluding
Petitioner from cross-examining Mr. Veasey. Id. at 4.
We find that Dr. Slocum is undisputedly an expert in mechanical
engineering with knowledge and experience beyond the level of ordinary
skill in the art as the parties have proposed and we have adopted. See
Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363 (Fed.
Cir. 2008) (noting that “[a] witness possessing merely ordinary skill will
often be qualified to present expert testimony both in patent trials and more
generally”) (citations omitted). Additionally, as both parties acknowledge,
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there is no requirement that an expert have personal knowledge of the
technology during the specific relevant time period in order to qualify as an
expert. In this regard, we find that Patent Owner and Dr. Slocum have
established sufficient support, as detailed above, as to how he acquired
knowledge of the specific technology at issue—the mechanical operation
and design of injection pens. Further, Dr. Slocum’s reliance upon other
individuals, including Mr. Veasey, to provide information upon which he
based his opinions does not render him unqualified to offer an expert
opinion.
Petitioner’s assertions that Patent Owner hid Mr. Veasey’s
involvement are unfounded. In particular, Dr. Slocum acknowledged in
Appendix B of his declaration that the “[i]nput values were provided by
Mr. Robert Veasey of DCA Engineering.” Ex. 2107, App. B at 2. Thus, we
find that Petitioner could have, but did not, seek to depose Mr. Veasey and
therefore Petitioner’s arguments regarding Mr. Veasey’s involvement do not
justify excluding Dr. Slocum’s declaration (Ex. 2107) or redirect testimony
(Ex. 1054). To the extent the credibility of any of the individuals upon
which Dr. Slocum relied may be in doubt, e.g., Mr. Veasey’s potential bias
as a named inventor on the ’844 patent, those issues are the proper subject of
cross-examination, go to the weight accorded the evidence, and do not
justify excluding Dr. Slocum’s testimony on the facts presented here. And,
to the extent Petitioner questions the data or model provided by Mr. Veasey,
the proper recourse is to probe the bases for such during cross-examination.
Therefore, Petitioner does not show that Dr. Slocum should be disqualified
as an expert in this proceeding or that any of Exhibits 2107, 2302, 2316,
2325, 2332, 1054 (redirect), and 1109 (redirect) should be excluded.
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F. Exhibit 2109
Petitioner contends that Exhibit 2109, the declaration of
Dr. Grabowski, should be excluded under FRE 702, 703, and 705 because
his opinions are based on data that Petitioner failed to provide in accordance
with 37 C.F.R. § 42.65 (“Rule 42.65”). Mot. 9. Patent Owner responds that
“Petitioner cites no authority that a party must file every single document
that an expert considers in forming his opinions,” that it complied with
Rule 42.65 by “disclosing Dr. Grabowski’s reliance on IMS Health data,”
that “the underlying IMS Health data is voluminous,” and that “Petitioner
independently obtained the IMS Health data and moved it into the public
record” in related district court litigation. Mot. Opp. 11.
Petitioner replies that Patent Owner does not cite a rule in support of
its failure to produce the data underpinning Dr. Grabowski’s testimony
merely because it was voluminous, and that, even if Petitioner independently
obtained the data, it was unable to “test” whether it was the same as the data
relied upon by Dr. Grabowski. Mot. Reply 5. Petitioner, however, does not
suggest that it sought an order from the Board requiring Patent Owner to
produce the data, and shows no prejudice in light of Petitioner’s ability to
obtain the data independently. Petitioner had every opportunity needed to
“test” whether it was the same data by deposing Dr. Grabowski. Petitioner
does not show any sufficient basis for excluding Exhibit 2109.
G. Exhibit 2111
Petitioner contends that Exhibit 2111, the Declaration of Dr. Robin S.
Goland, should be excluded under FRE 702 and 703 because “her
unqualified testimony contrary to her own experience demonstrates a stark
failure to provide testimony that ‘is the product of reliable principles and
methods.’” Mot. 9 (quoting FRE 702(c)); Mot. Reply 4–5. Petitioner’s
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argument, on its face, is insufficient to support exclusion. Petitioner offers
no explanation for its frivolous assertion that Dr. Goland is unqualified to
offer an expert opinion in this proceeding. With regard to her experience,
Dr. Goland explains in her declaration the following:
I received a Bachelor of Arts in History from Harvard
University in 1976. After completing my undergraduate studies,
I went on to obtain an M.D. degree from Columbia University in
1980.
After completing my internship in 1981, I undertook a
residency in internal medicine at New York-
Presbyterian/Columbia University from 1980-1984. I completed
a fellowship in endocrinology at Columbia University College of
Physicians and Surgeons in 1987. I am board-certified in
Internal Medicine and Endocrinology.
Since completing my residency and fellowship, I’ve held
a number of academic positions at Columbia University College
of Physicians and Surgeons, including Assistant Professor of
Clinical Medicine (1987-1989), Assistant Professor of Medicine
(1990-1996), Florence Irving Associate Professor of Medicine
(1997-2008), Professor of Clinical Medicine (2008-present),
Professor of Clinical Medicine and Clinical Pediatrics (2010-
present), and J. Merrill Eastman Professor of Clinical Diabetes
(2011-present).
Since 1987, I have been the Chief of the Diabetes Clinic
at New York-Presbyterian Hospital/Columbia University. In
1997, I founded the Naomi Berrie Diabetes Center at Columbia
University, and I have served the center as co-director ever since.
The Naomi Berrie Diabetes Center serves 14,000 patients each
year, approximately 40% of which have Type 1 diabetes. In
addition, the Center conducts clinical research on diabetes.
During my career, I have authored or co-authored over 80
peer reviewed articles. I am a member of the American Diabetes
Association. I also served as a member of the Medical Advisory
Board of the Juvenile Diabetes Foundation, New York Chapter,
the Pharmacy and Therapeutics Committee of Merck Health
Solutions, and the Medical Advisory Board of the NY Stem Cell
Foundation.
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I am an experienced clinical investigator and principal
investigator in diabetes trials. In 1996-1999, I received the Irving
Scholar Award for Clinical Investigation from Columbia
University.
Ex. 2111 ¶¶ 2–7. We find Dr. Goland is more than sufficiently qualified to
offer an expert opinion in this proceeding. Petitioner fails to show any basis
for excluding Exhibit 2111.
H. Exhibits 2117, 2147–2152, 2162, 2167, 2168,
2206, 2207, 2211, and 2215–2218
Petitioner contends that Exhibits 2117, 2147–2152, 2162, 2167, 2168,
2206, 2207, 2211, and 2215–2218 are animations “offered to show animated
operations of prior art and non-prior art injection pens” and should be
excluded as hearsay pursuant to FRE 801–804 “because they are offered for
the truth of their contents without satisfying any of the hearsay exceptions.”
Mot. 10. Patent Owner responds that an expert may rely upon hearsay if
reasonable to do so in the expert’s field, and that Dr. Slocum relied upon
each of these exhibits “to explain the operation of the injector pens in the
challenged patents, the prior art, and Petitioner’s proposed modifications to
the prior art.” Mot. Opp. 11–12. Petitioner argues in reply that the exhibits
are not admissible hearsay merely because they were relied upon by an
expert. Mot. Reply 5.
Patent Owner does not dispute that these exhibits constitute hearsay
and Petitioner does not dispute that Dr. Slocum was permitted to rely upon
these exhibits in formulating his opinions. Accordingly, Exhibits 2117,
2147–2152, 2162, 2167, 2168, 2206, 2207, 2211, and 2215–2218 are limited
to the purpose of showing the basis for Dr. Slocum’s testimony.
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I. Exhibits 2223 and 2224
Petitioner contends that Exhibits 2223 and 2224 are “offered to show
secondary considerations” and should be excluded under FRE 402, 403, 802,
and 901 because they are “hearsay without exception, lack authentication,
and are unreasonably prejudicial because they are cited for a new purpose.”
Mot. 11. Petitioner does not explain what the “new purpose” is, but suggests
that Ex. 2223 is a “self-serving advertisement by an interested party.”
Petitioner does not identify the purported “interested part.” Id. Patent
Owner responds with the following explanation of the exhibits at issue:
EX2223 is a press release from DCA, the designer of the
SoloSTAR pen at issue in this proceeding, announcing that
SoloSTAR won the 2008 Good Design Award from The Chicago
Athenaeum: Museum of Architecture and Design. The exhibit is
relevant to objective indicia of non-obviousness. Dr. Grabowski
obtained the exhibit and cited it in his declaration. See EX2109
at n.92. Dr. Grabowski therefore provided the required
foundation. Finally, as Dr. Grabowski is permitted to rely upon
EX2223 under FRE703, there is no basis to exclude it.
Next, EX2224 was presented without objection to
Petitioner’s expert Dr. McDuff during his deposition. See
EX2318, 73:3-18, 88:7-89:20. The exhibit confirms that an
academic journal (EX2116) cited in both Dr. McDuff’s and Dr.
Grabowski’s declarations, was double-blind peer-reviewed and
thus a reliable source of information. See EX1060 at n.127;
EX2109 n.53. As Petitioner did not object to this exhibit at
deposition, there is no basis to exclude it now.
Mot. Opp. 13–14. Petitioner does not respond to Patent Owner’s arguments
in its Reply. See generally Mot. Reply. Petitioner fails to show any
sufficient basis for excluding Exhibits 2223 and 2224, because the
arguments in the motion are undeveloped, conclusory, and vague.
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J. Exhibits 2333 and 2334
Petitioner contends that Exhibits 2333 and 2334 should be excluded
under FRE 402 and 403 because they “are not cited in the reply and have no
evidentiary value, but instead appear to be illustrated argument,” and are,
therefore, “not relevant.” Mot. 10. Petitioner fails to even explain what
Exhibits 2333 and 2334 are in its motion. Patent Owner explains the
following:
EX2333 and EX2334 are animations of designs discussed
at length in Dr. Slocum’s Declaration in Support of Sanofi’s
MTA Reply (EX2332). Specifically, Dr. Slocum explains that
the designs animated in EX2333 and EX2334 would have been
immediately discerned by a POSITA having read the GB
Application. See EX2332, ¶ 30 (EX2333), ¶ 36 (EX2334).
EX2333 and EX2334 undermine Petitioner’s written description
arguments concerning the claimed “piston rod” and “arc shaped
body,” and therefore have evidentiary value.
Mot. Opp. 12. Petitioner does not specifically address Exhibits 2333
and 2334 in its Reply outside of grouping them with its argument concerning
other exhibits purportedly not cited by Patent Owner. Mot. Reply 1.
Petitioner does not show any persuasive reason Exhibits 2333 and 2334
should be excluded merely because they are “not cited in the reply.”
K. Summary
In summary, many of Petitioner’s arguments purportedly supporting
its attack on a wide range of exhibits are poorly supported, undeveloped, not
credible, and lack on their face the basic information necessary to show
Petitioner is entitled to the relief requested, as explained above. Exhibits
2012, 2117, 2147–2152, 2162, 2167, 2168, 2206, 2207, 2211, and 2215–
2218 are limited to the purpose of showing the basis for Dr. Slocum’s
testimony.
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V. CONCLUSION
Our final determination in this case is summarized below:21

Motion to Amend Outcome Claims
Original Claims Cancelled by Amendment
Substitute Claims Proposed in the Amendment 31–38
Substitute Claims: Motion to Amend Granted
Substitute Claims: Motion to Amend Denied 31–38
Substitute Claims: Not Reached

21 Should Patent Owner wish to pursue amendment of the Challenged
Claims in a reissue or reexamination proceeding subsequent to the issuance
of this decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed.
Reg. 16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue
application or a request for reexamination of the challenged patent, we
remind Patent Owner of its continuing obligation to notify the Board of any
such related matters in updated mandatory notices. See 37 C.F.R.
§ 42.8(a)(3), (b)(2) (2019).
Claim(s) 35 U.S.C. § Reference(s)
Claim(s)
Shown
Unpatentable
Claims
Not shown
Unpatentable
21–29 103 Steenfeldt-
Jensen
21–29
30 103 Steenfeldt-
Jensen,
Klitgaard
30
Overall
Outcome
21–30
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VI. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 21–30 of the ’844 patent have been proven to
be unpatentable;
FURTHER ORDERED that Patent Owner’s Corrected Revised
Contingent Motion to Amend (Paper 71) is denied;
FURTHER ORDERED that Petitioner’s Motion to Exclude
(Paper 90) is denied; and
FURTHER ORDERED that, because this is a Final Written Decision,
the parties to the proceeding seeking judicial review of the Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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FOR PETITIONER:
Richard Torczon
Wesley Derryberry
Douglas Carsten
Jeffrey Guise
Nicole Stafford
Lorelei Westin
Arthur Dykhuis
Tasha Thomas
Elham Steiner
Yahn-Lin Chu
WILSON SONSINI GOODRICH & ROSATI
rtorczon@wsgr.com
wderryberry@wsgr.com
dcarsten@wsgr.com
jguise@wsgr.com
nstafford@wsgr.com
lwestin@wsgr.com
adykhuis@wsgr.com
tthomas@wsgr.com
esteiner@wsgr.com
ychu@wsgr.com

FOR PATENT OWNER:

Elizabeth Stotland Weiswasser
Anish Desai
Sudip Kundu
Kathryn Kantha
Adrian Percer
William Ansley
Matthew Sieger
Brian C. Chang
WEIL, GOTSHAL & MANGES LLP
elizabeth.weiswasser@weil.com
anish.desai@weil.com
sudip.kundu@weil.com
kathryn.kantha@weil.com
adrian.percer@weil.com
IPR2018-01682
Patent 9,526,844 B2
135
sutton.ansley@weil.com
matthew.sieger@weil.com
brian.chang@weil.com

W. Karl Renner
John Goetz
Joshua Griswold
Matthew Colvin
Kenneth Darby, Jr.
FISH & RICHARDSON P.C.
axf-ptab@fr.com
goetz@fr.com
griswold@fr.com
kdarby@fr.com
colvin@fr.com