Sanofi-Aventis Deutschland GmbH

Patent Trials and Appeals Board

May 29, 2020

IPR2018-01676 (P.T.A.B. May. 29, 2020)

Trials@uspto.gov Paper 84
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.,
Petitioner,

v.

SANOFI-AVENTIS DEUTSCHLAND GMBH,
Patent Owner.
_____________

IPR2018-01676
Patent 8,603,044 B21
_____________

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

GERSTENBLITH, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
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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I. INTRODUCTION
A. Background
Mylan Pharmaceuticals Inc. (“Mylan”) filed a Petition (Paper 2,
“Pet.”) requesting institution of an inter partes review of claims 11, 14, 15,
18, and 19 of U.S. Patent No. 8,603,044 B2 (Ex. 1002, “the ’044 patent”).
Sanofi-Aventis Deutschland GmbH (“Patent Owner”) filed a Preliminary
Response (Paper 10). With prior authorization, Mylan filed a Reply to
Patent Owner’s Preliminary Response (Paper 13) limited to addressing
whether we should exercise our discretion under 35 U.S.C. § 314(a) to deny
the Petition, and Patent Owner filed a Sur-Reply in response (Paper 15).
Applying the standard set forth in 35 U.S.C. § 314(a), we instituted an inter
partes review of all challenged claims. Paper 20 (“Inst. Dec.”).
After institution, Pfizer Inc. (“Pfizer”) filed (1) a petition challenging
the same claims of the ’044 patent on the same grounds asserted by Mylan
and instituted in this case and (2) a motion for joinder requesting that Pfizer
be joined as a petitioner in this case. Pfizer Inc. v. Sanofi-Aventis
Deutschland GmbH, IPR2019-00978, Papers 2 (Pfizer’s Petition), 3 (Pfizer’s
Motion for Joinder) (May 2, 2019). For the same reasons set forth in our
Institution Decision in this case, we instituted inter partes review on Pfizer’s
petition and granted Pfizer’s motion for joinder. Id. at Paper 12 (Aug. 15,
2019).2
Patent Owner filed a Patent Owner Response (Paper 31, “PO Resp.”),
Petitioner3 filed a Reply to Patent Owner’s Response (Paper 46, “Pet.
Reply”), and Patent Owner filed a Sur-reply (Paper 56, “PO Sur-reply”).

2 This decision is entered in the record in this case as Paper 41.
3 We refer to Mylan and Pfizer, collectively, as “Petitioner.”
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Petitioner filed a Motion to Exclude (Paper 64, “Mot.”), Patent Owner filed
an Opposition to Petitioner’s Motion (Paper 65, “Opp.”), and Petitioner filed
a Reply in support of its Motion (Paper 70, “Motion Reply” or “Mot.
Reply”). Additionally, Patent Owner filed Observations on the Cross-
Examination of Mr. Karl Leinsing (Paper 68) and Petitioner filed a Response
to Patent Owner’s Observations (Paper 72). And, Petitioner filed
Observations Regarding the Testimony of Alexander Slocum, Ph.D.
(Paper 69), to which Patent Owner filed a Response (Paper 71). An oral
hearing was held on January 15, 2020, and a copy of the transcript was
entered in the record. Paper 78 (“Tr.”).
We have jurisdiction pursuant to 35 U.S.C. § 6. This Decision is a
Final Written Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 as to
the patentability of the claims on which we instituted trial. 35 U.S.C.
§ 316(e); 37 C.F.R. § 42.1(d) (2017). Petitioner bears the burden of proving
unpatentability of the challenged claims, and the burden of persuasion never
shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must prove
unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e)
(2012); 37 C.F.R. § 42.1(d). Having reviewed the arguments and the
supporting evidence, we determine that Petitioner has shown, by a
preponderance of the evidence, that challenged claims 11, 14, 15, 18, and 19
of the ’044 patent are unpatentable. Additionally, for the reasons explained
herein, we deny Petitioner’s motion to exclude.
B. Related Proceedings
The parties indicate that the ’044 patent was asserted in Sanofi-Aventis
U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105 (D.N.J.) (“Sanofi-9105”);
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Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 1:16-cv-
00812 (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly and Co., No. 1:14-cv-
00113 (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly and Co., No. 1:14-cv-
00884 (D. Del.); and Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 1:17-cv-
00181 (N.D. W.Va.). Paper 8, 2; Paper 9, 1–2; IPR2019-00978, Paper 2 at
1–2, Paper 6 at 2.
The same five claims—claims 11, 14, 15, 18, and 19—of the
’044 patent also are challenged in IPR2018-01675.4 Paper 8, 2; Paper 9, 2.
Patents related to the ’044 patent are challenged in IPR2018-01670,
IPR2018-01677, IPR2018-01678, IPR2018-01679, IPR2018-01680,
IPR2018-01682, IPR2018-01684, IPR2018-01696, IPR2019-00122, and
IPR2019-00979. Paper 8, 2–3; Paper 9, 1–2; Pfizer, IPR2019-00978,
Paper 6 at 2–4.
C. Real Parties in Interest
Mylan identifies Mylan Pharmaceuticals Inc., Mylan Inc., Mylan
GmbH, Biocon Research Ltd., Biocon Ltd., and Becton, Dickinson and
Company as real parties in interest. Paper 8, 2.
Pfizer identifies itself and Hospira, Inc. as real parties in interest.
Pfizer, IPR2019-00978, Paper 2 at 1.
Patent Owner identifies Sanofi-Aventis Deutschland GmbH, Sanofi-
Aventis U.S. LLC, and Sanofi Winthrop Industrie as real parties in interest.
Paper 9, 1.

4 Pfizer also challenged the ’044 patent in IPR2019-00978 and was joined
subsequently as a petitioner to IPR2019-01676. Pfizer Inc. v. Sanofi-Aventis
Deutschland GmbH, IPR2019-01676, Paper 41 (Aug. 15, 2019).
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D. The Instituted Grounds of Unpatentability
Petitioner asserts claims 11, 14, 15, 18, and 19 of the ’044 patent are
unpatentable as set forth in the chart below:
Claims Challenged 35 U.S.C. § Reference(s)
11, 14, 15, 18, 19 103(a) Steenfeldt-Jensen5
11, 14, 15, 18, 19  103(a)  Moller6 and Steenfeldt-Jensen
Petitioner supports its challenge with two declarations by Karl R.
Leinsing, dated September 9, 2018 (Ex. 1011, “the Leinsing Declaration”),
and September 18, 2019 (Ex. 1095, “the Leinsing Reply Declaration”).7
Patent Owner supports its arguments with a declaration by Alexander
Slocum, Ph.D. (Ex. 2107) and a declaration by Dr. Robin S. Golan
(Ex. 2111).
E. The ’044 Patent
The ’044 patent “relates to pen-type injectors . . . . where a user may
set the dose.” Ex. 1002, 1:20–24. Figures 1 and 2 of the ’044 patent are
reproduced below.

5 Exhibit 1014 (U.S. Patent No. 6,235,004 B1, issued May 22, 2001).
6 Exhibit 1015 (U.S. Patent Application Pub. No. 2002/0052578 A1,
published May 2, 2002).
7 Petitioner filed a Declaration of Mr. William C. Biggs (Ex. 1049) and a
Declaration of DeForest McDuff, Ph.D. (Ex. 1060), yet neither of these
declarations includes this case number—IPR2018-01676—or the ’044 patent
on the cover sheet. Accordingly, although we reference the declarations
here, it appears that they do not address the issues before us in this
proceeding.

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Figure 1 “shows a sectional view of a pen-type injector . . . in a first,
cartridge full, position,” and Figure 2 “shows a sectional view of the pen-
type injector of FIG. 1 in a second, maximum first dose dialed, position.”
Id. at 2:53–57. The pen-type injector includes first cartridge retaining part 2
and second main housing part 4.8 Id. at 3:27–28. Insert 16 is at a first end of
housing part 4 and is fixed rotationally and axially to main housing 4. Id.
at 3:49–51. Insert 16 includes threaded circular opening 18, through which
piston rod 20 extends. Id. at 3:51–53, 3:57–59. Piston rod 20 includes first
thread 19 that engages threaded circular opening 18. Id. at 3:56–58.

8 The ’044 patent refers to “second main housing part 4” and “main
housing 4” interchangeably. Compare Ex. 1002, 3:28 (“second main
housing part 4”), with id. at 3:30 (“main housing 4”).
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Piston rod 20 also includes pressure foot 22 that abuts piston 10 of
cartridge 8. Id. at 3:36–37, 3:59–60. 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 3:61–62, 4:4, 4:13–14.
Clutch or clutch means 60 is disposed about drive sleeve 30 adjacent
its second end. Id. at 4:33–35, 4:49–50. Clutch 60 is keyed to drive
sleeve 30 by splines to prevent relative rotation between clutch 60 and drive
sleeve 30. Id. at 4:60–62. Clutch 60 also has teeth 66 that engage dose-dial
sleeve 70. Id. at 4:50–52.
Dose dial sleeve 70 is outside of clutch 60 but within main housing 4.
Id. at 5:3–5. 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. Id. at 5:5–6,
5:9–11. Dose dial grip 76 is disposed about and secured to the second end
of dose dial sleeve 70. Id. at 5:24–25, 5:27–28.
In operation, a user rotates dose dial grip 76 to set a dose and cause
dose-dial sleeve 70, clutch 60, and drive sleeve 30 to rotate together out of
main housing 4. Id. at 5:50–53, 5:61–65, Fig. 9. The dose can be reduced
by turning dose dial grip 76 in the opposite direction. Id. at 6:19–20,
Fig. 10. 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 main housing 4. Id. at 6:28–35, 6:38–40,
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 6:44–46.
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F. Illustrative Claim
Claim 11, the sole independent claim challenged in this proceeding, is
illustrative of the claimed subject matter and reproduced below:
11. A housing part for a medication dispensing apparatus, said
housing part comprising:
a main housing, said main housing extending from a distal
end to a proximal end;
a dose dial sleeve positioned within said housing, said
dose dial sleeve comprising a helical groove configured to
engage a threading provided by said main housing, said helical
groove provided along an outer surface of said dose dial sleeve;
a dose dial grip disposed near a proximal end of said dose
dial sleeve;
a piston rod provided within said housing, said piston rod
is non-rotatable during a dose setting step relative to said main
housing;
a drive sleeve extending along a portion of said piston rod,
said drive sleeve comprising an internal threading near a distal
portion of said drive sleeve, said internal threading adapted to
engage an external thread of said piston rod; and,
a tubular clutch located adjacent a distal end of said dose
dial grip, said tubular clutch operatively coupled to said dose dial
grip,
wherein said dose dial sleeve extends
circumferentially around at least a portion of said tubular
clutch, and wherein said helical groove of the dose dial
sleeve has a first lead and said internal threading of said
drive sleeve has a second lead, and wherein said first lead
and said second lead are different.
Ex. 1002, 8:7–36.
II. ANALYSIS
A. Level of Ordinary Skill in the Art
Petitioner asserts that one of ordinary skill in the art would have “had
at least a bachelor’s degree in mechanical engineering, or an equivalent
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degree, and three-year’s experience”9 and would have “understood the
basics of medical-device design and manufacturing, and the basic
mechanical elements (e.g., gears, pistons) in drug-delivery devices.”10
Pet. 14 (citing Ex. 1011 ¶ 104–06). In our Institution Decision, we found
that Petitioner’s proposal was consistent with the level of ordinary skill in
the art reflected by the prior art of record and we preliminarily adopted
Petitioner’s unopposed position. Inst. Dec. 13 (citing Okajima v. Bourdeau,
261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579
(Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978)).
In its Response, Patent Owner contends that one of ordinary skill in
the art would have “a bachelor’s degree in mechanical engineering or an
equivalent degree.” PO Resp. 12 (citing Ex. 2107 ¶ 102). Patent Owner
contends that additional experience beyond the bachelor’s degree is not
required. Id. at 13. In particular, Patent Owner asserts that Petitioner
proposes inconsistent levels of skill across related cases, including that one
of ordinary skill “would have had ‘design experience,’ ‘approximately three
years of experience in medical-device design,’ or ‘three-year’s experience’
depending on the petition.” Id. (citations omitted). Patent Owner further
contends that “Mr. Leinsing testified that three years of experience is not

9 Mr. Leinsing testifies the three years of practical experience would have
been “with medical device design and manufacturing.” Ex. 1011 ¶ 106.
10 The articulated level of ordinary skill in the Petition differs slightly from
the level of ordinary skill proposed in the petition for IPR2018-01675, which
challenges the same patent. Each petition references the same paragraph of
Mr. Leinsing’s Declaration, which was filed in each case.
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required.” Id.11 Patent Owner contends that what is important is that the
level of skill include someone “who understands the mechanical elements
(e.g., lead screws, clutches, gears) used in drug injection delivery devices as
well as the principles governing the interactions of such mechanical
elements, and further understands the basics of device design and
manufacturing.” Id. at 12. Nonetheless, Patent Owner asserts that “the
slight differences between Patent Owner and Petitioner’s level of ordinary
skill do not affect the arguments” in this case. Id. at 13.
We see no reason to disturb our preliminary finding regarding the
level of ordinary skill in the art. Accordingly we maintain and reaffirm that
one of ordinary skill in the art “would have ‘had at least a bachelor’s degree
in mechanical engineering, or an equivalent degree, and approximately three
year’s experience’” and “would have ‘understood the basics of medical-
device design and manufacturing, and the basic mechanical elements (e.g.,
gears, pistons) in drug-delivery devices.’” Inst. Dec. 12–13 (quoting
Pet. 14). We also find that the outcome of this case is not dependent upon
whether we adopt Petitioner’s or Patent Owner’s proposed level of skill.
B. Claim Construction
In an inter partes review based on a petition filed prior to
November 13, 2018, claim terms in an unexpired patent are construed
according to their broadest reasonable interpretation in light of the
specification of the patent in which they appear. See 37 C.F.R. § 42.100(b)

11 Patent Owner does not provide a citation to where Mr. Leinsing so
testified.
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(2017);12 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
(2016). There is a presumption that claim terms are given their ordinary and
customary meaning, as would be understood by a person of ordinary skill in
the art in the context of the specification. See In re Translogic Tech. Inc.,
504 F.3d 1249, 1257 (Fed. Cir. 2007). Nonetheless, 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, 1316 (Fed.
Cir. 2005) (en banc) (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d
1359, 1366 (Fed. Cir. 2002)). Another exception to the general rule that
claims are given their ordinary and customary meaning is “when the
patentee disavows the full scope of a claim term either in the specification or
during prosecution.” Uship Intellectual Props., LLC v. United States, 714
F.3d 1311, 1313 (Fed. Cir. 2013) (quoting Thorner v. Sony Comput. Entm’t
Am., LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)).
Additionally, only terms that are in controversy need to be construed,
and these need be construed only to the extent necessary to resolve the
controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
803 (Fed. Cir. 1999) (holding that “only those terms need be construed that
are in controversy, and only to the extent necessary to resolve the
controversy”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.

12 An amendment to this rule does not apply here because the Petition was
filed before November 13, 2018. 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 (Oct. 11, 2018) (amending 37
C.F.R. § 42.100(b) effective Nov. 13, 2018) (codified at 37 C.F.R.
§ 42.100(b) (2019)).
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Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the
context of an inter partes review).
Petitioner provides interpretations of five terms that were proffered by
Patent Owner in related litigation—“drive sleeve,” “main housing,” “piston
rod,” “threading,” and “tubular clutch.” Pet. 15 (citing Ex. 1019, 19, 21, 23,
27, 30). Petitioner also explains it proffered means-plus-function
interpretations for “tubular clutch” and “clicker” in related litigation and
reiterates those interpretations here. Id. at 15–16 (citing Ex. 1028, 54–59,
62–63, 65–68; Ex. 1002, 2:16–18, 4:49–62, 4:63–65, 6:33–43). Petitioner
states that the grounds presented “also address the ‘tubular clutch’ and
‘clicker’ limitations as means-plus-function limitations.” Id. at 16.
In our Institution Decision, we determined that none of the terms
required an express construction for the purposes of determining whether
Petitioner demonstrates a reasonable likelihood of prevailing in its
challenged. Inst. Dec. 17.
In its Response, Patent Owner agrees with our preliminary
determination from the Institution Decision, arguing that “no express
constructions are required.” PO Resp. 12. Petitioner does not contend
otherwise in its Reply.
Accordingly, we maintain and reiterate our preliminary determination
that no claim terms require express construction to address the issues raised
in this proceeding. Vivid Techs., 200 F.3d at 803.
C. Legal Standards – Obviousness
The U.S. Supreme Court set forth the framework for applying the
statutory language of 35 U.S.C. § 103 in Graham v. John Deere Co. of
Kansas City, 383 U.S. 1, 17–18 (1966):
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Under § 103, the scope and content of the prior art are to be
determined; differences between the prior art and the claims at
issue are to be ascertained; and the level of ordinary skill in the
pertinent art resolved. Against this background, the
obviousness or nonobviousness of the subject matter is
determined. Such secondary considerations as commercial
success, long felt but unsolved needs, failure of others, etc.,
might be utilized to give light to the circumstances surrounding
the origin of the subject matter sought to be patented.
As explained by the Supreme Court in KSR International Co. v. Teleflex
Inc.:
Often, it will be necessary for a court to look to interrelated
teachings of multiple patents; the effects of demands known to
the design community or present in the marketplace; and the
background knowledge possessed by a person having ordinary
skill in the art, all in order to determine whether there was an
apparent reason to combine the known elements in the fashion
claimed by the patent at issue. To facilitate review, this
analysis should be made explicit.
550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006) (“[R]ejections on obviousness grounds 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.”)).
“Whether an ordinarily skilled artisan would have been motivated to
modify the teachings of a reference is a question of fact.” WBIP, LLC v.
Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016). “[W]here a party argues
a skilled artisan would have been motivated to combine references, it must
show the artisan ‘would have had a reasonable expectation of success from
doing so.’” Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876
F.3d 1350, 1360–61 (Fed. Cir. 2017) (quoting In re Cyclobenzaprine
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Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063,
1068–69 (Fed. Cir. 2012)).
D. Obviousness over Steenfeldt-Jensen
1. Level of Ordinary Skill in the Art
As discussed above, we find that one of ordinary skill in the art at the
time of the invention “would have had at least a bachelor’s degree in
mechanical engineering, or an equivalent degree, and approximately three
year’s experience” and “would have understood the basics of medical-device
design and manufacturing, and the basic mechanical elements (e.g., gears,
pistons) in drug-delivery devices.” See supra § II.A.
2. Scope and Content of the Prior Art – Steenfeldt-Jensen
Steenfeldt-Jensen “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”
Ex. 1014, 1:12–15. Figures 15–17 of Steenfeldt-Jensen are reproduced
below.
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Figures 15 and 16 show side sectional views of a syringe, and
Figure 17 shows an exploded view of the syringe of Figures 15 and 16. Id.
at 5:23–28. The syringe of Steenfeldt-Jensen includes tubular housing 1 that
is partitioned so that a first division has ampoule holder 2. Id. at 5:38–40;
see also id. at 14:11(reciting in claim 11 “a housing having proximal and
distal ends”).
“The end of the ampoule holder 2 inserted in the housing 1 is closed
by a 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 extends through
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said bore.” Id. at 5:55–58. Driver tube 85 is disposed about piston rod 6.
See id. at Figs. 15–17. “[E]nd wall 4 with the internal thread 5 is provided in
a separate member 40 which is mounted in an end of the housing.” Id. at
8:35–38.
“To maintain a clockwise rotation of a dose setting button for
increasing the set dose the pawl mechanism working between the driver tube
and the housing . . . bars clockwise rotation . . . of the driver tube.” Id.
at 11:6–11. The “thread of the piston rod and the thread in the end wall of
the housing [are] so designed that an anticlockwise rotation of the piston will
screw the piston rod through said end wall and into the cartridge holder
compartment,” and “[t]he 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 11:11–19.
Within housing 1 is scale drum 80, and “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.” Id. at 11:20–22. “At its proximal end the
scale drum 80 has a diameter exceeding the inner diameter of the housing to
form a dose setting button 81 which on its cylindrical outer wall is knurled
to ensure a good finger grip,” Id. at 11:22–25.
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 can rotate
but not longitudinally move. Id. at 11:30–33. Injection button 88 is
rotatably mounted at an end of bushing 82. Id. at 11:49–51.
“When a dose is set by rotating the dose setting button 81 in a
clockwise direction, the scale drum is screwed out of the housing and the
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dose setting button is lifted away from the proximal end of the housing.” Id.
at 11:52–54. “[I]f a set dose is reduced by rotating the dose setting
button 81 in an anticlockwise direction the pawl mechanism working
between the driver tube and the housing . . . prevent[s] the bushing 82 from
following this anticlockwise rotation.” Id. at 11:57–62.
“When the injection button 88 is pressed to inject the set dose,” “the
thread engagement between the helical track of the scale drum 80 and the
rib 16 in the housing when the scale drum 80 is pressed back into said
housing” induces “anticlockwise rotation of the dose setting button 81,” and
bushing 82 follows that rotation. Id. at 12:4–9. “The bushing will rotate the
driver tube 85 in an anticlockwise direction which the pawl mechanism
reluctantly allows,” and “the piston rod is thereby screwed further into an
ampoule 89 in the ampoule holder 2.” Id. at 12:9–12.
3. Differences Between the Prior Art and the Claims;
Motivation to Modify
Petitioner argues that “Steenfeldt-Jensen disclosed a single device
comprising all claim 11 components, including the same structural
limitations.” Pet. 21. Petitioner contends that “[i]f Steenfeldt-Jensen does
not disclose a ‘drive sleeve[,]’ it would have been routine to modify the
Steenfeldt-Jensen device to include one.” Id. Patent Owner disagrees.
For the reasons below, we determine that Steenfeldt-Jensen teaches or
suggests the limitations of claim 11 and that one of ordinary skill in the art
would have had a reason to make Petitioner’s proposed modification with a
reasonable expectation of success.
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a. Independent Claim 11
i. “A housing part for a medication dispensing
apparatus, said housing part comprising:”
Petitioner contends that “[i]f the preamble is limiting, Steenfeldt-
Jensen taught it.” Pet. 21. In particular, Petitioner asserts that “Steenfeldt-
Jensen describes a medicine-dispensing syringe,” which “includes tubular
housing 1.” Id. at 22 (citing Ex. 1014, 1:12–15, 5:38–44, Figs. 15–17;
Ex. 1011 ¶¶ 261–263). Pointing to Figures 15 and 16 of Steenfeldt-Jensen,
Petitioner argues that “tubular housing 1 holds the drive mechanism for
dispensing medicine from the syringe.” Id. (citing Ex. 1011 ¶ 261). Patent
Owner does not contest Petitioner’s argument that Steenfeldt-Jensen teaches
the preamble of claim 11.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
preamble of claim 11.13
ii. “a main housing, said main housing extending
from a distal end to a proximal end;”
Petitioner contends that Steenfeldt-Jensen teaches this limitation of
claim 11 by disclosing “housing 1,” which “extends from button-end
(proximal end) to needle-end (distal end) of the syringe.” Pet. 23 (citing
Ex. 1011 ¶ 263). Patent Owner does not contest Petitioner’s argument that
Steenfeldt-Jensen teaches this limitation of claim 11.

13 We need not determine whether the preamble of claim 11 is limiting as the
parties have not raised that issue before us. Nonetheless, Patent Owner has
waived any argument for patentability directed to the preamble of claim 11.
See Paper 21 (Scheduling Order), 8 (“Patent Owner is cautioned that any
arguments for patentability not raised in the response may be deemed
waived.”).
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19
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
main housing limitation of claim 11, recited above.14
iii. “a dose dial sleeve positioned within said
housing, said dose dial sleeve comprising a
helical groove configured to engage a
threading provided by said main housing, said
helical groove provided along an outer surface
of said dose dial sleeve;”
Petitioner contends that Steenfeldt-Jensen’s scale drum 80 teaches the
recited dose-dial sleeve of claim 11. Pet. 25 (citing Ex. 1014, 11:20–22).
Pointing to Figures 15 and 16 of Steenfeldt-Jensen, Petitioner asserts that
drum 80 is within housing 1. Id. (citing Ex. 1014, Figs. 15, 16; Ex. 1011
¶¶ 264–265). Petitioner argues that “[t]he drum includes a ‘helical groove
provided along an outer surface’ as a helical track, extending along the
drum’s outer wall,” and that the “helical track is ‘configured to engage a
threading provided by’ housing 1 via helical rib 16, which extends along
housing 1’s inner wall.” Id. at 25–26 (citing Ex. 1014, 11:20–22, Figs. 16,
17; Ex. 1011 ¶¶ 264–265). Patent Owner does not contest Petitioner’s
argument that Steenfeldt-Jensen teaches this limitation of claim 11.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
dose dial sleeve limitation of claim 11, recited above.15

14 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 11. See Paper 21, 8.
15 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 11. See Paper 21, 8.
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iv. “a dose dial grip disposed near a proximal end
of said dose dial sleeve;”
Petitioner contends that Steenfeldt-Jensen’s dose-setting button 81,
which a user rotates to set a dose, teaches the recited dose dial grip of
claim 11. Pet. 26 (citing Ex. 1014, 11:22–25, Figs. 15–17; Ex. 1011 ¶ 266).
Petitioner asserts that “[d]ose-setting button 81 is at the button-end of scale
drum 80.” Id. at 26–27 (citing Ex. 1014, Figs. 15–17; Ex. 1011 ¶ 266).
Patent Owner does not contest Petitioner’s argument that Steenfeldt-Jensen
teaches this limitation of claim 11.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
dose dial grip limitation of claim 11, recited above.16
v. “a piston rod provided within said housing,
said piston rod is non-rotatable during a dose
setting step relative to said main housing;”
Petitioner contends that Steenfeldt-Jensen teaches piston rod 6, which
“is non-rotatable during a dose-setting step relative to housing 1 due to a
pawl mechanism between driver tube 85 and member 40.” Pet. 29 (citing
Ex. 1014, 5:55–58, 11:6–19, 11:52–62, Figs. 15–17; Ex. 1011 ¶¶ 268, 271).
Petitioner asserts the following with respect to Steenfeldt-Jensen’s dose
setting:
The pawl mechanism bars clockwise rotation of driver tube 85
relative to housing 1. When dose-setting button 81 rotates
clockwise to dial-up a dose, corresponding rotation of scale
drum 80 is not transmitted to driver tube 85. To dial-down a
dose, dose-setting button 81 rotates anticlockwise, but
corresponding rotation of scale drum 80 is still not transmitted

16 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 11. See Paper 21, 8.
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to driver tube 85 due to the pawl mechanism’s “sufficient
reluctan[ce]” against anticlockwise rotation. Because piston
rod 6 is coupled to driver tube 85 in such a way that “rotation is
transmitted,” and driver tube 85 does not rotate during dose
setting, piston rod 6 also cannot rotate during a dose-setting
step.
Id. (citing Ex. 1014, 11:6–19, 11:52–62; Ex. 1011 ¶ 271). Patent Owner
does not contest Petitioner’s argument that Steenfeldt-Jensen teaches this
limitation of claim 11.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
poston rod limitation of claim 11, recited above.17
vi. “a drive sleeve extending along a portion of
said piston rod, said drive sleeve comprising an
internal threading near a distal portion of said
drive sleeve, said internal threading adapted to
engage an external thread of said piston rod;
and,”
Petitioner contends that Steenfeldt-Jensen teaches a “drive sleeve” “in
the form of driver tube 85.” Pet. 31 (citing Ex. 1011 ¶¶ 273–274).
Petitioner explains the operation of driver tube 85 as follows:
Driver tube 85 “extend[s] along a portion of” the piston rod 6 by
having a bore with a non-circular cross-section through which
piston rod 6, also having a non-circular cross-section, extends.
Ex. 1014, 11:15–17, Figs. 15, 16; Ex. 1011 ¶¶ 273–274. Drive
tube 85 couples to scale drum 80’s rotational movement only
during the injection process, which causes piston rod 6 to rotate
through an internal threading provided in the member 40 and into
the cartridge holder compartment. See Ex. 1014, 11:6–19; Ex.
1011 ¶ 273. To drive piston rod 6, driver tube 85 rotationally

17 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 11. See Paper 21, 8.
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engages with the rod through the non-circular bore, rather than
“an internal threading near a distal portion.” Ex. 1011 ¶ 274.
Pet. 31. Petitioner asserts that it would have been obvious to one of ordinary
skill in the art “to modify the piston rod drive to provide claim 11’s ‘drive
sleeve.’” Id. at 32 (referring to Pet. § V.F.2).
In particular, Petitioner contends that, although Steenfeldt-Jensen
teaches that driver tube 85 rotationally engages piston rod 6 via a
non-circular bore, it would have been obvious to modify driver tube 85 with
an internal threading near its distal portion, which “would have been
understood to contain a ‘drive sleeve’ having the structural elements of
claim 11.” Id. at 40 (citing Ex. 1011 ¶ 274).
Petitioner asserts “Steenfeldt-Jensen states that ‘[e]mbodiments 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.’” Pet. 40 (quoting Ex. 1014, 7:44–47)
(citing id. at 3:15–20, 3:44–47; Ex. 1011 ¶ 275). Therefore, Petitioner
argues that Steenfeldt-Jensen “expressly contemplates a modification in
which the driver tube contains internal threading that engages the piston
rod’s external threading.” Id. (citing Ex. 1011 ¶ 275).
Additionally, Petitioner contends that Steenfeldt-Jensen “explains the
piston-rod guide allows the piston rod to move axially (but not rotatably)
relative to it, whereas the nut allows relative rotation of the piston rod.”
Pet. 41 (citing Ex. 1014, 2:46–53, 3:15–20; Ex. 1011 ¶ 276). Petitioner
asserts one of ordinary skill in the art would have understood that driver
tube 85, in the context of Figures 15–17, includes a “piston rod guide”
because “it allows relative axial piston-rod movement, while preventing
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relative rotational movement due to its non-circular cross-section.” Id.
(citing Ex. 1011 ¶ 276). Petitioner further argues that one of ordinary skill
in the art would have understood that “member 40 includes a ‘nut element’
due to its internal threading.” Id. (citing Ex. 1011 ¶ 276).
Petitioner, thus, contends that Steenfeldt-Jensen suggests a “nut
element” on a driver tube and a “piston rod guide” on a member and one of
ordinary skill in the art “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.” Pet. 41 (citing Ex. 1011 ¶ 277). Petitioner
asserts that, in this circumstance, one of ordinary skill in the art “would have
considered the driver tube to be a component for driving the piston rod
having internal threading near its distal portion for engaging external
threading of the piston rod.” Id. (citing Ex. 1011 ¶ 277).
Petitioner argues that one of ordinary skill in the art “would have
reasonably expected such modification would have resulted in the device
operating in the same manner”—“that when the driver tube rotates during
injection, the threaded engagement between the driver tube and the piston
rod cause the piston rod to be axially displaced through the member’s
non-circular opening and into the ampoule.” Id. at 41–42 (citing Ex. 1011
¶ 278). Thus, Petitioner asserts that the modified parts would perform the
same function that they were known to perform. Id. at 62 (citing Ex. 1011
¶ 278; KSR, 550 U.S. at 417).
In its Response, Patent Owner observes that Petitioner “concedes that
Steenfeldt-Jensen’s fifth embodiment does not disclose” a “drive sleeve
comprising an internal threading” as recited by claim 11. PO Resp. 29.
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Therefore, Patent Owner’s argument, discussed below, is directed to refuting
Petitioner’s contention that one of ordinary skill in the art would have
modified Steenfeldt-Jensen as proposed.
Patent Owner raises four primary arguments in its Response. We
discuss each.
a) Steenfeldt-Jensen Would Have
Suggested an Internally Threaded
Driver Tube to One of Ordinary Skill
in the Art
As discussed above, Petitioner contends Steenfeldt-Jensen would have
suggested an internally threaded driver tube to one of ordinary skill in the
art. See, e.g., Pet. 40 (citing Ex. 1011 ¶ 275). Patent Owner contends that
Steenfeldt-Jensen does not disclose or suggest an internally threaded driver
tube; instead, the passages cited by Petitioner disclose “an internally
threaded ‘nut member’ or ‘nut element,’ which is rotated by a driver tube –
the driver tube itself is not threaded.” PO Resp. 29. In particular, Patent
Owner asserts that “[a]t best, the passages teach an internally threaded nut
member and a piston rod with relative movement between the two
components.” Id. at 31. But, Patent Owner contends, “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.” Id. (citing Ex. 1014, 3:41–47, 7:41–47, 10:2–10, Fig. 13).
Petitioner replies that “a driver with a nut member is an internally-
threaded driver” and that one of ordinary skill in the art would have
understood “Steenfeldt-Jensen as describing an internally-threaded driver
tube when it refers to a driver rotating a nut member.” Pet. Reply 2 (citing
PO Resp. 21; Ex. 1095 ¶¶ 63–64; Ex. 2107 ¶¶ 215–222). Petitioner
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contends Steenfeldt-Jensen “describes two ways to configure the driver: a
driver can rotate a ‘piston rod guide’ or a ‘nut member’ (also referred to as a
‘nut element’),” and that “[t]hese alternative drivers correspond to . . . well-
known screw/nut principles” that even Dr. Slocum describes in the
background section of his declaration. Id. (citing Pet. 53–56; Ex. 1014,
3:41–47; Ex. 2107 ¶ 30). Petitioner asserts that “[j]ust as no meaningful
distinction exists between a driver tube with an integral piston-rod guide and
a driver tube with a rectangular bore, no meaningful distinction exists
between a driver tube with an integral nut member and a driver tube with a
threaded bore.” Id. at 2–3 (citing Ex. 1095 ¶ 65); see id. at 2 (citing
Ex. 1014, 6:35–36 (describing the driver tube as “integral with the piston rod
guide”), 11:15–19 (describing the piston rod and driver tube bore as having
“not round cross-section[s],” which allows for transmission of rotation but
also permits relative axial movement)). Petitioner contends that Steenfeldt-
Jensen describes a “nut member” in similar terms when it “states that ‘end
wall 4 with its threaded bore forms a nut member.’” Id. at 3 (quoting
Ex. 1014, 7:41–43). Thus, Petitioner argues that one of ordinary skill in the
art would have understood that “a driver tube with a threaded bore similarly
operates as a nut member.” Id. (citing Ex. 1095 ¶ 65).
In its Sur-reply, Patent Owner argues that “the claims specifically
require a threaded driver tube, not a nut member rotated by a driver tube”
and that this is a distinction. PO Sur-reply 9. Patent Owner contends that
the first, third, fourth, and fifth embodiments of Steenfeldt-Jensen teach a
nut member distinct from a driver tube and the disclosure at lines 41–47 of
column 3 do not mention an integrally formed nut member. Id. at 10–11
(citing Ex. 1014, 3:41–47, Figs. 2, 12, 14, 16).
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Patent Owner also contends that Petitioner incorrectly asserts that a
driver tube with integral piston rod guide suggests a driver tube with an
integral nut member because Steenfeldt-Jensen does not equate the piston
rod guide and the nut member. PO Sur-reply 11 (citing Pet. Reply 2–3;
Ex. 1014, 3:41–47). According to Patent Owner, lines 41–47 of column 3
“at best, draw[] a parallel between a piston rod (not a piston rod guide) and
nut member, but in no way suggest[] an integrally formed nut member.” Id.
at 12. Patent Owner further contends that lines 41–43 of column 7 do not
suggest a nut member integrally formed with a driver tube. Id. at 12 (citing
Pet. Reply 3; Ex. 1014, 7:41–43).
We find that Petitioner establishes Steenfeldt-Jensen would have
suggested a driver tube with an integral nut element to one of ordinary skill
in the art at the time of the invention. In particular, Petitioner provides
evidence that one of ordinary skill would have understood lines 41–47 of
column 3 to suggest such a driver tube. See Pet. Reply 2–3 (citing Pet. 21;
Ex. 1014, 3:41–47, 6:35–36, 11:15–19; Ex. 1095 ¶¶ 63–65; Ex. 2107 ¶ 30).
On this record, we find persuasive, and thus credit, Mr. Leinsing’s testimony
that “a driver tube with a nut member is equivalent to a driver tube with an
internally-threaded bore.” Ex. 1095 ¶ 65. Patent Owner’s argument—that
an internally threaded driver tube is not disclosed expressly—does not
detract from Petitioner’s contention and Mr. Leinsing’s testimony that one of
ordinary skill in art would have understood that Steenfeldt-Jensen suggests a
driver tube with an internally-threaded bore. See PO Sur-reply 9–13 (citing
Pet. Reply 2–3, 17–18; Ex. 1014, 3:41–47, 7:41–43, Figs. 2, 12, 14, 16). On
the full record before us, we find that Petitioner sufficiently shows that, even
though Steenfeldt-Jensen does not disclose a driver tube with internal
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threading, one of ordinary skill in the art would have understood Steenfeldt-
Jensen, at lines 41–47 of column 3, to suggest such a driver tube. See
Pet. 21, 30–32, 40–42; Pet. Reply 2–3; Ex. 1011 ¶ 277; Ex. 1095 ¶ 69.
b) One of Ordinary Skill in the Art
Would Have Modified Steenfeldt-
Jensen’s Fifth Embodiment
Patent Owner contends that one of ordinary skill in the art would have
understood that the alternative described in column 7, lines 44–47, relates
only to the structure of the first embodiment (shown in Figures 1–5) of
Steenfeldt-Jensen, not the fifth embodiment (shown in Figures 15–17). PO
Resp. 32–33 (citing Ex. 1014, 5:33–7:47, 11:6–12:16; Ex. 2107 ¶¶ 223–
226). Patent Owner argues that (1) the phrase “shown embodiment” (recited
at column 7, line 41) refers to the embodiment shown in Figures 1–5 (i.e.,
the first embodiment), (2) the description of the fifth embodiment does not
include a statement similar to the statement relied upon in column 7—
“[e]mbodiments 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 (3) the
provisional application (for Steenfeldt-Jensen) includes the alternative for
the first embodiment, but, like the reference itself, does not include a similar
alternative for the fifth embodiment. PO Resp. 30–31 (citing Ex. 1014,
5:33–7:47, 11:6–12:16; Ex. 2127, 11:2–5).
Additionally, Patent Owner contends that one of ordinary skill in the
art would not have understood that the alternative was applicable to each
embodiment of Steenfeldt-Jensen because, for example, applying that
alternative to Steenfeldt-Jensen’s second embodiment would result in a
non-functioning pen injector. Id. at 33 (citing Ex. 2107 ¶ 226). Patent
Owner asserts that, even if applied to the fifth embodiment, the alternative
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would not teach or suggest Petitioner’s proposed modification. Id. at 33–34
(citing Pet. 36; Ex. 2107 ¶ 227; Ex. 2164, 219:18–220:11). According to
Patent Owner, “it teaches putting a 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.” Id. at 34 (citing Ex. 2107
¶ 215).
In its Reply, Petitioner contends that one of ordinary skill in the art
would have applied relevant teachings from one Steenfeldt-Jensen
embodiment to another. Pet. Reply 3–8. Petitioner argues that Steenfeldt-
Jensen teaches alternative driver mechanisms before describing other
embodiments and Patent Owner ignores the broader context. Id. at 4 (citing
Pet. 53–54; PO Resp. 22; Ex. 1014, 2:40–53, 3:10–20, 3:41–47; Ex. 1095
¶ 66). Thus, Petitioner contends that one of ordinary skill in the art would
have known such alternatives would also apply to the fifth embodiment and
such a general suggestion does not have to be repeated. Id. at 5 (citing, e.g.,
Ex. 1095 ¶¶ 66–69).
Additionally, Petitioner asserts that the first and fifth embodiments
each include a driver tube and nut member with analogous structures and
functions for driving the piston rod, even though other structures in the
embodiments are different. Pet. Reply 5–6 (citing, e.g., Ex. 1095 ¶ 68).
Petitioner contends that because the drive mechanisms are analogous, one of
ordinary skill in the art would have understood that the alternative
configuration for the first embodiment applies to the fifth embodiment and
the “modifications to the driver tube (26 or 85) and wall 4 would have been
the same and had the same impact.” Id. at 6–7 (citing Ex. 1095 ¶ 69).
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Further, Petitioner argues that it is irrelevant whether the alternative
configuration could be applied to the second embodiment because the
second embodiment has a different drive mechanism. Id. at 7 (citing
Ex. 1014, 7:3–6, 7:17–21, 7:51–54, 7:55–67, 8:25–33, 11:52–55, 12:4–10,
Figs. 6–10; Ex. 1095 ¶ 70). Petitioner asserts that Dr. Slocum agreed that
the first and fifth embodiments have essentially the same transmission of
force and that the second embodiment is different. Id. at 7–8 (citing
Ex. 1054, 306:23–307:19, 307:20–308:9, 342:3–343:18, 344:7–346:25).
Accordingly, Petitioner contends that “[g]iven the admitted similarities
between the first- and fifth-embodiment drive mechanisms, a [person of
ordinary skill in the art] would have recognized that the first-embodiment
configuration was applicable to the fifth embodiment despite the second
embodiment having its own, different drive mechanism.” Id. (citing
Ex. 1095 ¶ 70).
In its Sur-reply, Patent Owner contends that Petitioner concedes the
disclosure at lines 41–47 of column 7 “is not a blanket statement covering
every embodiment in Steenfeldt-Jensen.” PO Sur-reply 1. Patent Owner
argues that Mr. Leinsing acknowledges that there are differences between
the embodiments, but conveniently dismisses those differences. Id. at 2
(citing Pet. Reply 5–7; Ex. 1095 ¶¶ 68; Ex. 1106 ¶ 69). Rather, Patent
Owner asserts that the “embodiments are not analogous” and one of ordinary
skill in the art “would not apply a teaching specific to the first embodiment
to the fifth embodiment.” Id. (citing PO Resp. 22–25). Patent Owner
further contends that Dr. Slocum’s testimony undercuts Petitioner’s
argument and that Dr. Slocum does not agree that one of ordinary skill in the
art would have undertaken such modification. Id. at 2–3.
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We find that the phrase, “[i]n the shown embodiment,” specifically
refers to Steenfeldt-Jensen’s first embodiment because (1) the language
comes at the end of the written description of the first embodiment and
refers to the shown embodiment (i.e., the embodiment that was shown
previously in the written description of Steenfeldt-Jensen, meaning in
Figures 1–5), (2) the only embodiment previously shown is that of the first
embodiment, and (3) the phrase “piston rod guide 14” is not used in the
written description of the other embodiments. Ex. 1014, 7:41–43.18 Thus,
we find that Steenfeldt-Jensen discloses this alternative in the express
context of the first embodiment.
Nonetheless, we find, as argued by Petitioner, that one of ordinary
skill in the art would have, at a minimum, considered whether the alternative
described therein also would apply to other embodiments, even though the
alternative is not repeated after the discussion of each embodiment.19 In this
regard, we credit Mr. Leinsing’s testimony regarding Steenfeldt-Jensen’s
suggestion because, for the reasons discussed below, the full record before
us supports it. Ex. 1011 ¶ 277.

18 The “shown embodiment” specifically refers to “end wall 4,” “piston rod
guide 14,” and “driver tube 26.” Ex. 1014, 7:41–43.
19 In so finding, however, we recognize, as Patent Owner points out, that one
of ordinary skill in the art may not have applied the alternative to the second
embodiment in Steenfeldt-Jensen because of differences in the structure of
the second embodiment as compared to the first. See PO Resp. 33. That the
alternative arrangement may not have applied to the second embodiment,
however, does not lead to the conclusion that one of ordinary skill in the art
would not have or could not have applied the alternative to Steenfeldt-
Jensen’s other embodiments, particularly the fifth embodiment. See
Ex. 1095 ¶ 70.
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Specifically, we find, as argued by Petitioner, that several
embodiments of Steenfeldt-Jensen have either the same or analogous
components, particularly end wall 4. See Pet. Reply 3–8. 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); the third embodiment includes “piston
rod 6 [that] engages by its external thread 7 the internal thread of the end
wall 4” (id. at 8:45–46); the fourth embodiment also has an internally
threaded wall 4 that is not described but shown in Figure 14; and for the fifth
embodiment, “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 Ex. 1014,
Fig. 2 (showing, for the first embodiment, externally threaded piston rod 6
engaging internally threaded wall 4), Figs. 11–12 (showing, for the third
embodiment, externally threaded piston rod 6 engaging internally threaded
wall 4), Fig. 14 (showing, for the fourth embodiment, internally threaded
wall 4), Figs. 15–16 (showing, for the fifth embodiment, externally threaded
piston rod 6 engaging internally threaded wall 4).
As reflected above, there are common elements, particularly end
wall 4, across at least the first, third, fourth, and fifth embodiments disclosed
in Steenfeldt-Jensen. We also find that the 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). Also as
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discussed above, lines 44 through 47 of column 7 describe an alternative
wherein wall 4 is modified. Because each of these embodiments has the
same “wall 4,” as well as other structural similarities, we find that this
disclosure would have at least suggested that the alternative could be applied
to other similarly structured embodiments, particularly, the fifth
embodiment. In this regard, we find Mr. Leinsing’s testimony more
persuasive for the same reason and, thus, credit his testimony over that of
Dr. Slocum’s. See, e.g., Ex. 1011 ¶ 277; Ex. 1095 ¶¶ 66–69.
For the reasons discussed above, Petitioner persuades us that one of
ordinary skill in the art, reading 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” (Ex. 1014, 7:44–46), “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. 41; Ex. 1011 ¶ 277; Ex. 1095 ¶ 69; see Pet. 41–43
(Petitioner’s full discussion of the modifications). We also agree with
Petitioner that one 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 modification. See Pet. 41–42
(citing Ex. 1011 ¶ 278). We further credit Mr. Leinsing’s testimony
regarding Petitioner’s proposed modification because it finds support in
Steenfeldt-Jensen, as discussed above. Ex. 1011 ¶¶ 275–278 (citing
Ex. 1014, 2:46–53, 3:15–20, 3:44–47, 7:44–47, 8:48–53, Figs. 15–17).
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Accordingly, we determine that Petitioner’s modified driver tube 85
rotating a nut member with internal threading engaging externally threaded
piston rod 6 meets the language “said drive sleeve comprising an internal
threading near a distal portion of said drive sleeve, said internal threading
adapted to engage an external thread of said piston rod,” as recited by
claim 11.
c) One of Ordinary Skill in the Art
Would Not Have Been Dissuaded
from Modifying Steenfeldt-Jensen
Because It Would Have Resulted in an
Inferior Pen
Patent Owner asserts that Petitioner’s proposed modifications to
switch the non-circular opening and threaded opening of Steenfeldt-Jensen’s
fifth embodiment would result in an inferior pen and thus, one of ordinary
skill in the art would not have been motivated to make Petitioner’s proposed
modification. PO Resp. 34–45. In particular, Patent Owner argues that
moving threads to the driver tube and moving the non-circular bore to
member 40 would introduce “a major new source of friction to Steenfeldt-
Jensen’s fifth embodiment.” Id. at 34 (citing Ex. 2107 ¶¶ 232–238).
Patent Owner contends that higher friction would increase injection
force, which is regularly assessed as a benchmark for these products. Id. at
34–35 (citing Ex. 1015 ¶¶ 4–6; Ex. 2107 ¶¶ 37–39, 44–45, 54, 56–57;
Ex. 2163, 80:17–81:5). In support of its argument, Patent Owner points us
to an analytical model “presented in the form of a spreadsheet” and a
physical model, referred to as the “Collar Friction Model.” Id. at 35–36
(citing Ex. 2107 ¶¶ 245–255; Exs. 2211, 2215–2217). Patent Owner asserts
that the analytical models demonstrate that “Petitioner’s proposed
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modification increases the amount of force required from the user to inject a
dose by 51%.” Id. at 36–37 (citing Ex. 2107, ¶¶ 242–244, Appx. A). Patent
Owner contends that the Collar Friction Model demonstrates that “manually
rotating the Collar with the Threaded Insert requires 50% more force on
average to advance the piston rod than rotating the Collar with Guide.” Id.
at 41 (citing Ex. 2107 ¶¶ 252–254); see id. at 41–45 (explaining why
Petitioner’s modification results in higher friction). Thus, Patent Owner
asserts that “[m]odifying the fifth embodiment as Petitioner proposes
increases friction and impairs the device.” Id. at 45 (citing Ex. 2107
¶¶ 229–231).
In Reply, Petitioner raises three main arguments. Pet. Reply 8–16.
First, Petitioner contends that Dr. Slocum’s opinion is based on ignoring
Steenfeldt-Jensen’s expressly stated alternative for the first embodiment,
which, as discussed above, we find one of ordinary skill in the art would
have applied to the fifth embodiment. Pet. Reply 9–10 (citing Ex. 1054,
306:23–313:6 (Dr. Slocum explaining that one of ordinary skill in the art
would not have applied Steenfeldt-Jensen’s modification to either the first or
fifth embodiment)).
Second, Petitioner asserts 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 ’044 patent claims
are not limited to insulin pen injectors. Id. at 10–11 (citing PO Resp. 27–28;
Ex. 2107 ¶¶ 44–61; Ex. 1053, 62:13–71:2, 75:22–76:3). Petitioner asserts
that Dr. Slocum’s focus on insulin pen injectors led him to limit one of
ordinary skill in the art’s “design objectives to reducing injection force at all
costs.” Id. Although injection force is a factor, Petitioner contends it is only
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one factor one of ordinary skill in the art would consider when designing pen
injectors. Id. at 11 (citing Ex. 1048 ¶¶ 28–30, 32 (Dr. Biggs’ testimony
discussing cost and reliability as important factors); 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
Dr. Slocum and Dr. Slocum relied upon Mr. Veasey for many inputs in the
analytical model spreadsheet (id. at 11–14 (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 14 (citing Ex. 1095
¶ 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 14–16 (citing Ex. 1053, 33:5–13, 41:3–42:13;
Ex. 1054, 325:22–327:6; Ex. 1095 ¶¶ 73–75)).
In its Sur-reply, Patent Owner argues first that the models are not
unreliable or biased because “Dr. Slocum independently verified the models,
conducted his own experiments, and gathered his own data.” PO Sur-reply 6
(citing Ex. 2017 ¶¶ 242–255, App’x 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. Even assuming Mr. Veasey is an
interested party, Patent Owner notes that Petitioner has not presented any
opposing evidence regarding increased friction and injection force. Id. at 6–
7. Second, Patent Owner contends that the analytical model does test the
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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. Third, Patent Owner argues that Petitioner’s critique
of the models as not employing common-sense approaches to reducing
friction is inapposite because (1) Petitioner did not inspect the physical
model and (2) those common-sense approaches 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 8.
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 (see id. at 7:41–47) and Petitioner 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 has established
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 10–11 (discussing Dr. Slocum’s testimony
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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
when designing pen injectors, but not the only factor” (id. (citing Ex. 1095
¶ 72)).
d) One of Ordinary Skill in the Art
Would Not Have Been Dissuaded
from Modifying Steenfeldt-Jensen
Because of Potential Failures in the
Flexible Arms of the Driver Tube
Patent Owner contends that there are three other potential failures
associated with Petitioner’s proposed modification that would have
discouraged one of ordinary skill in the art from making the changes. PO
Resp. 45–47. First, Patent Owner asserts the flexible arms on driver tube 85
could break when subjected to additional frictional. Id. at 45. Patent Owner
contends that 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. at 46 (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.
(citing Ex. 2107 ¶ 239; Ex. 1014, Figs. 14, 15).
In its Reply, Petitioner asserts that Patent Owner offers no evidence
that the flexible arms would be affected necessarily, but, even if they were,
Mr. Leinsing explains that “this would be the type of routine task that a
[person of ordinary skill in the art] would have no difficulty addressing.”
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Pet. Reply 16 (citing Ex. 1095 ¶ 76 (referring to Mr. Leinsing’s testimony to
use a collar as the bearing surface).20
In its Sur-reply, Patent Owner asserts that Mr. Leinsing presents no
evidence that addressing these potential failures would be routine. PO Sur-
reply 5 (citing Pet. Reply 16 (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 modifications inevitably result 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 one 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 potentials would dissuade

20 Petitioner also presents arguments based on Exhibit 1016 (U.S. Patent
No. 6,932,794 B2, issued August 23, 2005). Pet. Reply 17–18. Patent
Owner asserts that Petitioner presents a new argument based on
Exhibit 1016, which we should reject. PO Sur-reply 12–13 (citing Pet.
Reply 18–19). We do not need to address Exhibit 1016 because, for the
reasons discussed herein, other arguments and supporting evidence
presented by Petitioner persuade us that one of ordinary skill in the art would
have been prompted to make Petitioner’s proposed modifications.
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one of ordinary skill in the art from modifying Steenfeldt-Jensen’s fifth
embodiment as Petitioner proposes.
For the reasons above, based on the full record before us, Petitioner
persuades us that Steenfeldt-Jensen suggests a “drive sleeve comprising an
internal threading near a distal portion of said drive sleeve, said internal
threading adapted to engage an external thread of said piston rod,” as recited
by claim 11.
vii. “a tubular clutch located adjacent a distal end
of said dose dial grip, said tubular clutch
operatively coupled to said dose dial grip,”
Petitioner contends Steenfeldt-Jensen’s bushing 82 teaches the tubular
clutch of claim 11. Pet. 34. Petitioner asserts that bushing 82 is “a tubular
structure,” which has a “rosette of teeth 93” that releasably engage
corresponding teeth on dose-setting button 81. Id. (citing Ex. 1014, 11:26–
27, 12:4–13, Figs. 15–17; Ex. 1011 ¶ 283). Petitioner argues that “[w]hen
engaged, dose-setting button 81’s rotation transmits to driver tube 85 during
injection.” Id. (citing Ex. 1014, 12:4–12; Ex. 1011 ¶ 283). Thus, Petitioner
asserts “bushing 82 is a clutch because it releasably couples movement of
dose-setting button 81 to driver tube 85.” Id. (citing Ex. 1011 ¶ 283).
Additionally, Petitioner contends “[b]ushing 82 also operatively
couples to dose-setting button 81 by releasable engagement of teeth 93 with
corresponding teeth on the botton,” and that bushing 82 is adjacent
button 81’s needle-end. Id. 34–35 (citing Ex. 1014, 11:34–42, Figs. 15, 16;
Ex. 1011 ¶ 283).
Patent Owner does not contest Petitioner’s argument that Steenfeldt-
Jensen teaches this limitation of claim 11.
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For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
tubular clutch limitation of claim 11, recited above.21
viii. “wherein said dose dial sleeve extends
circumferentially around at least a portion of
said tubular clutch, and”
Petitioner contends Steenfeldt-Jensen teaches the above-recited
relative positioning of the dose-dial sleeve and tubular clutch by “show[ing]
that scale drum 80 ‘extends circumferentially around at least a portion of’
bushing 82.” Pet. 35–36 (citing Ex. 1014, 11:26–28, Figs. 15, 16; Ex. 1011
¶ 285). Patent Owner does not contest Petitioner’s argument that Steenfeldt-
Jensen teaches this limitation of claim 11.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Steenfeldt-Jensen teaches the
above-recited wherein clause of claim 11.22
ix. “wherein said helical groove of the dose dial
sleeve has a first lead and said internal
threading of said drive sleeve has a second
lead, and wherein said first lead and said
second lead are different.”
Petitioner contends that Steenfeldt-Jensen teaches a threaded “dose
dial sleeve” in scale drum 80 and an internally-threaded drive sleeve in
driver tube 85 and member 40, for the reasons discussed above. Pet. 39
(citing Ex. 1014, Abstr., 2:46–53, 8:35–37, 11:20–22, 14:9–40, Figs. 15–17;

21 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 11. See Paper 21, 8.
22 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 11. See Paper 21, 8.
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Ex. 1011 ¶ 286) (relying upon Petitioner’s arguments directed to the dose
dial sleeve and drive sleeve limitations of claim 11 discussed above in
§§ II.C.3.a.iii., vi). Additionally, Petitioner asserts “[t]he spacing of
drum 80’s groove and of the internal thread mating the piston-rod’s thread
are different, indicating that the first and second leads are different.” Id.
(citing Ex. 1011 ¶ 287).
Patent Owner does not contest Petitioner’s argument that Steenfeldt-
Jensen teaches this limitation of claim 11 aside from the arguments directed
to the drive sleeve limitation discussed above.
For the reasons explained by Petitioner above, which we expressly
adopt, and the reasons we discussed in our consideration of Petitioner’s
argument directed to the drive sleeve limitation of claim 11, we find that
Petitioner has shown that Steenfeldt-Jensen teaches the above-recited
wherein clause of claim 11.
b. Dependent Claims 14, 15, 18, and 19
Claims 14, 15, 18, and 19 ultimately depend from claim 11. Petitioner
contends that Steenfeldt-Jensen teaches or renders obvious the additional
limitations recited in these claims. Pet. 42–43 (claim 14), 43–46 (claim 15),
46–47 (claim 18), 48–49 (claim 19). Petitioner relies upon Mr. Leinsing’s
declaration testimony in support of its contentions regarding these claims.
See id.
Patent Owner does not raise an argument directed to the additional
limitations recited expressly by these dependent claims, relying instead on
its arguments directed to independent claim 11. See generally PO Resp.
We have reviewed Petitioner’s argument and evidence cited in
support thereof, which we expressly adopt. See Pet. 42–49. Based on the
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reasons set forth by Petitioner and the evidence in support thereof, see id.,
we find that Petitioner has shown that Steenfeldt-Jensen teaches the
additional limitations recited in claims 14, 15, 18, and 19.23
4. Objective Indicia of Nonobviousness
Neither party presents evidence of objective indicia of
nonobviousness. See Tr. 83:20–23 (counsel for Patent Owner confirming
during the oral hearing that Patent Owner does not rely upon objective
indicia of nonobviousness in this inter partes review).
5. Weighing the Graham Factors
“Once all relevant facts are found, the ultimate legal determination [of
obviousness] involves the weighing of the fact findings to conclude whether
the claimed combination would have been obvious to an ordinary artisan.”
Arctic Cat, 876 F.3d at 1361. As discussed above, Petitioner persuades us
Steenfeldt-Jensen teaches or suggests each of the limiations of the claims,
that one of ordinary skill in the art would have reasonably expected the
structures (as modified by Petitioner) to perform the same function as they
did before modification, and thus, one of ordinary skill in the art would have
had a reasonable expectation of success in making Petitioner’s proposed
modification. See Pet. 41–42 (citing Ex. 1011 ¶ 278) see also Ex. 1011
¶¶ 275–278 (citing Ex. 1014, 2:46–53, 3:15–20, 3:44–47, 7:44–47, 8:48–53,

23 Claims 14 and 15 recite a “clicker.” As we stated supra, we decline to
opine on whether the term “clicker” invokes 35 U.S.C. § 112, ¶ 6. Claim 19
recites that the main housing further comprises a helical rib adapted to be
seated in the helical groove on the outer surface of the dose dial sleeve.
Petitioner relies upon the same modification discussed in the context of
Petitioner’s analysis of the dose dial sleeve and helical groove limitation of
claim 11. Pet. 47–48.
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Figs. 15–17). Further, as also addressed above, despite Patent Owner’s
arguments and evidence to the contrary, we do not find that one of ordinary
skill in the art would have been dissuaded from modifying Steenfeldt-
Jensen’s fifth embodiment as Petitioner proposes. On balance, considering
the record presently before us, we determine that Petitioner has shown, by a
preponderance of the evidence, that Steenfeldt-Jensen would have rendered
the subject matter of claims 11, 14, 15, 18, and 19 obvious to one of ordinary
skill in the art at the time of the invention.
E. Obviousness over Moller and Steenfeldt-Jensen
Petitioner also challenges claims 11, 14, 15, 18, and 19 as
unpatentable over Moller and Steenfeldt-Jensen. Pet. 49–90. Because we
determine that the claims are unpatentable over Steenfeldt-Jensen alone, we
do not reach this additional challenge to the same claims. See SAS Inst. Inc.
v. Iancu, 138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a
final written decision addressing all of the claims it has challenged”); see
also Boston Scientific Scimed, Inc. v. Cook Gr. Inc., No. 19-1594, -1604,
-1605, slip op. at 11 (CAFC Apr. 30, 2020) (nonprecedential) (agreeing, in
the same context, “that the Board need not address issues that are not
necessary to the resolution of the proceeding”).
F. Petitioner’s Motion to Exclude
Petitioner filed a motion to exclude Exhibits 2001–2014, 2017–2026,
2100–2102, 2104–2107, 2111–2153, 2158–2201, 2203–2212, 2214–2218,
2223–2225, and the redirect testimony in Exhibit 1054. 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).
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1. Exhibits 2001–2011 and 2019–2026
Petitioner moves to exclude Exhibits 2001–2011 and 2019–2026
pursuant to Federal Rules of Evidence (“FRE”) 402 and 403 because
purportedly they are not relevant to any contested issue in this proceeding
and risk confusing the issues. Mot. 1–2, 4–5. Patent Owner responds that
these exhibits “were offered to show information that was relevant to
§ 325(d) issues raised during the preliminary stage of this proceeding.”
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. at 2. In its Motion Reply, Petitioner contends that Patent Owner
acknowledges that these exhibits no longer have relevance to the issues in
this proceeding and should therefore be excluded. Mot. Reply 1. Petitioner
asserts that, if not excluded, “their admissibility should be limited to the
purpose for which they were submitted” pursuant to FRE 105. Id.
Petitioner’s only basis to exclude these exhibits is because they were
offered during the pre-institution phase of this proceeding concerning only
our discretion to deny institution, not the merits of the asserted grounds of
unpatentability, and are therefore no longer relevant. Petitioner does not
direct our attention to any prior Board decision that granted a motion to
exclude exhibits that were relevant only to the pre-institution phase of an
inter partes review. And, we do not agree that we should do so here. In an
inter partes review, which is akin to a bench trial, there is little risk of
confusion. Additionally, simply because an exhibit is relevant to the
pre-institution stage and not necessarily the post-institution stage of an inter
partes review proceeding, does not justify excluding it from the record. To
the contrary, the record contains other documents that may similarly be
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characterized as such, e.g., a patent owner’s preliminary response.
Therefore, we are not persuaded to exclude the exhibits or expressly limit
their purpose pursuant to FRE 105 and Petitioner’s Motion is denied with
respect to these exhibits.
2. Exhibit 2012
Exhibit 2012 is an animation purportedly showing the operation of an
embodiment of the injection pen described in the ’044 patent. Mot. 3.
Petitioner contends that Exhibit 2012 should be excluded under FRE
801–804 as hearsay because it is offered for the truth of its content without
satisfying any of the hearsay exceptions. Id. Patent Owner contends that
FRE 703 permits experts to rely upon hearsay if reasonable to do so in the
expert’s field. Opp. 2. Patent Owner asserts that Exhibit 2012 is identical to
Exhibit 2117, which Dr. Slocum relies upon in his declaration. Id. (citing
Ex. 2107 ¶ 65). Patent Owner asserts that “[c]omputer models such as
shown in EX201[2][24] are used and relied upon in mechanical engineering”
and because it was reasonable for Dr. Slocum to rely upon it for his analysis,
it should not be excluded. Id. (citations omitted). In its Motion Reply,
Petitioner contends that although an expert may rely upon hearsay in
forming an opinion, pursuant to FRE 703, that does not make the evidence
admissible in trial. Mot. Reply 1–2. Petitioner asserts that if the exhibit is
not excluded, it should be limited to the purpose for which it was
submitted—showing the basis for Dr. Slocum’s expert testimony—and
should not be used for any other purpose. Id. at 2 (citing FRE 105).

24 Patent Owner incorrectly states “EX2011” in this one instance of
discussing Exhibit 2012. See Opp. 2.
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Patent Owner does not dispute that Exhibit 2012 constitutes hearsay.
Petitioner does not dispute that Dr. Slocum was permitted to rely upon it in
formulating his opinions. Patent Owner does not contend that Dr. Slocum
relied upon Exhibit 2012; rather, Patent Owner asserts Dr. Slocum relied
upon Exhibit 2117, which Patent Owner asserts is identical to Exhibit 2012.
Patent Owner does not explain why it submitted two identical animations as
exhibits or why it needs both Exhibit 2012 and Exhibit 2117 in the record
when Dr. Slocum opined regarding Exhibit 2117. Nonetheless, to the extent
Exhibit 2012 was cited during this proceeding, we do not wish to disturb the
record by excluding it as a duplicate. Accordingly, although Petitioner’s
Motion is denied, we agree that the use of Exhibit 2012 should be, and
hereby is, limited to the purpose of showing the basis for Dr. Slocum’s
testimony.
3. Exhibits 2013 and 2014
Exhibit 2013 is Mylan’s claim construction brief in the related district
court proceeding. Petitioner contends that language quoted from the brief is
“taken out of context.” Mot. 3. Thus, Petitioner contends the exhibit should
be excluded pursuant to FRE 402 and 403.25
Exhibit 2014 is a “Memorandum Opinion” of the U.S. District Court
for the District of Delaware construing claim terms from several related
patents, including the ’044 patent. Ex. 2014. In particular, the district court
construed the term “main housing,” which is recited in several claims of the

25 Petitioner states “FRE 402-402,” but we understand Petitioner to refer to
FRE 402 and 403. See Mot. 3.
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’044 patent. Ex. 2014, 8–10.26 Petitioner contends that the district court’s
claim construction is not relevant to any contested issue in this proceeding,
“lacks relevance, risks confusing the issues, and is prejudicial to Mylan.”
Mot. 3.
Patent Owner responds, contending that Exhibits 2013 and 2014 are
relevant to claim construction. Opp. 2–3. In particular, Patent Owner
asserts that Exhibit 2013 shows the construction to which Mylan agreed in
district court and Exhibit 2014 shows how a district court construed the
same term in the ’044 patent, each of which is relevant to how that term
should be construed here. Id. Petitioner does not address these exhibits in
its Motion Reply.
Petitioner has not shown that these exhibits are not relevant, risk
confusion, or are prejudicial such that they should be excluded. To the
contrary, we agree with Patent Owner that (1) positions taken on claim terms
at issue in this proceeding by parties to this proceeding and (2) district court
claim construction of terms at issue in this proceeding is relevant to our
consideration of the terms. Further, any risk of confusion or prejudice is
extremely minimal because we understand that those constructions are not
binding upon us, but, rather, are informative as to how others have
considered the terms. Accordingly, Petitioner’s Motion is denied with
respect to Exhibits 2013 and 2014.

26 The page numbers cited are those of the exhibit, not the Memorandum
Opinion.
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4. Exhibits 2100–2102, 2104–2106, 2111–2153,
2158–2201, 2203–2212, 2214–2218, and 2225
Petitioner contends the above-listed exhibits should be excluded
pursuant to FRE 402 and 403 “because they were not discussed in the
response, cannot be relevant to it, and consequently serve only to confuse
and create prejudice through belated surprise.” Mot. 7. Patent Owner
asserts that Exhibits 2117, 2118, 2127, 2136, 2147–2150, 2152, 2162–2165,
2175, 2206, 2207, 2211, and 2215–2217 are cited in the Patent Owner
Response. Opp. 5 (citing PO Resp. 5–7, 11, 14, 18–19, 32, 34–37, 40–41,
43–44, 47, 51, 55). Patent Owner contends that Exhibits 2100–2102 and
2104–2106 are exhibits to the deposition of Mr. Leinsing and are relevant
because they “provide necessary context for Mr. Leinsing’s cross-
examination, which Petitioner has not sought to exclude.” Id. Additionally,
Patent Owner asserts that Dr. Slocum “considered and reasonably relied
upon [each of these exhibits] in forming his opinions regarding the validity
of the challenged patent and thus should be admitted under FRE 703.” Id.
Petitioner does not address these exhibits in its Motion Reply.
Several of these exhibits pertain exclusively to Patent Owner’s
arguments regarding objective indicia of nonobviousness. See, e.g.,
Ex. 2196 (described by Patent Owner as “U.S. Dollar Sales of Long-Acting
Pens Among All Pens”). Patent Owner does not rely upon objective indicia
of nonobviousness in its Patent Owner Response in this case, but does rely
upon such evidence in its responses in several related cases. See Tr. 83:20–
23 (counsel for Patent Owner confirming during the oral hearing that Patent
Owner does not rely upon objective indicia of nonobviousness in this inter
partes review). Patent Owner filed the same declaration by Dr. Slocum in
nine related inter partes reviews, including this proceeding. See Ex. 2107,
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caption. Thus, it is likely many of these exhibits are not relevant to this
proceeding. Nonetheless, it is not an efficient use of resources to parse
through Dr. Slocum’s reliance upon each of these exhibits to determine
whether they apply solely to the issue of objective indicia or have a broader
applicability. Additionally, Patent Owner has shown that the sole basis
argued in Petitioner’s Motion for exclusion—that the exhibits were not cited
in Patent Owner’s Response—is not correct for each of these exhibits, as
many were cited. Nontheless, with respect to the exhibits that were not
cited, the lack of citation is not, in and of itself, dispositive as to whether an
exhibit should be excluded. Accordingly, Petitioner has not satisfied its
burden to show that these exhibits should be excluded.
5. Exhibits 2117, 2147–2152, 2162, 2167, 2168, 2206,
2207, 2211, 2215–221827
Petitioner contends the above-listed exhibits are animations “offered
to show animated operations of prior art and non-prior art injection pens”
and should be excluded pursuant to FRE 801–804 “because they are offered
for the truth of their contents without satisfying any of the hearsay
exceptions.” Mot. 8. Patent Owner provides the same response here as it
did with respect to Petitioner’s challenge to Exhibit 2012. Opp. 13.
Namely, Dr. Slocum relied upon each in formulating his opinions. Id.
Petitioner addresses these exhibits along with Exhibit 2012 in its Motion
Reply, contending that if they are not excluded, they should be limited to the

27 Petitioner’s challenge to the admissibility of these exhibits pursuant to
FRE 402 and 403 is discussed above. This section is directed to Petitioner’s
challenge based on FRE 801–804,which Petitioner discusses separately.
Compare Mot. 7 (addressing FRE 402 and 403), with id. at 8 (addressing
FRE 801–804).
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purpose for which they were submitted—showing the basis for Dr. Slocum’s
expert testimony—and not used for any other purpose pursuant to FRE 105.
Mot. Reply 1–2.
For the reasons explained in our discussion of Exhibit 2012, we do not
exclude these exhibits, but we do agree with Petitioner that their use shall be
limited to showing the basis for Dr. Slocum’s testimony.
6. Exhibits 2136, 2137, and 2175
Petitioner contends that Exhibits 2136, 2137, and 2175 should be
excluded pursuant to FRE 402 and 403 because they “relate to commercial
pens and their properties, such as injection force, are irrelevant to the extent
they rely on an improper standard of obviousness and unclaimed features,”
and “are also prejudicial and confuse the issues as a result.” Mot. 8–9.
Patent Owner asserts that these exhibits “were offered to demonstrate the
importance of injection force as a design consideration and how the
commercial embodiment of Steenfeldt-Jensen—i.e., the FlexPen—already
had a problem with high injection force.” Opp. 14 (citing Ex. 2107 ¶ 29).
Patent Owner contends that this information is relevant to its argument that
one of ordinary skill in the art would not have modified Steenfeldt-Jensen if
such modification increased injection force and that the relevance of these
exhibits outweighs any risk of confusion or prejudice. Id. In its Motion
Reply, Petitioner contends that “[a]ll three of these exhibits post-date [Patent
Owner’s] claimed priority date” and therefore “remain irrelevant to any
pending issue” because “motivation is determined at the time of filing.”
Mot. Reply 5.
To the extent, as Patent Owner contends, these exhibits are offered to
demonstrate the importance of injection force as a design consideration, that
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point is noted in our consideration of the parties’ arguments above. It is not
clear that Patent Owner needs these three exhibits to convey that point.
Nonetheless, we reach the findings discussed herein, determining that one of
ordinary skill in the art would have been prompted to modify Steenfeldt-
Jensen as proposed by Petitioner. Accordingly, although we do not exclude
these exhibits, we are cognizant of the time period to which they pertain as
well as the limited purpose for which they were submitted and, in that
regard, do not find that their presence is prejudicial or misleading.
7. Exhibits 2223 and 2224
Petitioner contends that Exhibits 2223 and 2224 are offered to show
objective indicia of nonobviousness, but “[t]hey are hearsay without
exception, lack authentication, and are unreasonably prejudicial because
they are cited for a new purpose.” Mot. 9. Patent Owner contends that these
exhibits are relevant to objective indicia of nonobviousness and that
Exhibit 2224 pertains to an exhibit cited in two declarations directed to the
same issue. Opp. 14–15.
Aside from the obvious burden of determining which exhibits are
applicable to which of the specific inter partes reviews involving the parties
and related patents, it is not clear to us why the parties filed documents and
exhibits pertaining to objective indicia of nonobviousness in this proceeding
when Patent Owner does not rely upon objective indicia of nonobviousness,
as discussed above. Thus, these exhibits have no relevance to the matters
before us. Nonetheless, we are not inclined to exclude exhibits in a
piecemeal fashion because that would undoubtedly leave other exhibits
similarly situated in the record. See, e.g., Ex. 1060 (Declaration of DeForest
McDuff, Ph.D., which was filed by Petitioner in this proceeding even though
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this proceeding is not identified in the caption of the exhibit and the
declaration is directed solely to responding to Patent Owner’s contentions
regarding objective indicia of nonobviousness in other related proceedings).
Accordingly, Petitioner’s Motion is denied as to Exhibits 2223 and 2224.
8. Exhibits 1054 and 2107
Petitioner seeks to exclude Dr. Slocum’s entire declaration (Ex. 2107)
and the deposition redirect examination of Dr. Slocum (Ex. 1054, 391–406)
pursuant to FRE 702, 703, and 705. Mot. 5–8. Petitioner raises three
primary reasons. First, that Dr. Slocum did not have personal knowledge of
injection pens or the industry during the relevant time period. Id. at 5.
Second, that Dr. Slocum relied upon Mr. Veasey, one of the named
inventors of the ’044 patent, for certain data and a model used for various
calculations in Dr. Slocum’s declaration. Id. at 4–6. And, third, that
Exhibit 2017 should be excluded for the additional reason 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. As an example, Petitioner contends 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.
Patent Owner responds to each of Petitioner’s challenges. First, with
respect to Dr. Slocum’s personal knowledge, Patent Owner correctly
observes that neither party’s proposed definition of the ordinary level of skill
in the art requires specific knowledge of, or experience with, pen injectors.
Opp. 7 (citing Ex. 1011 ¶ 106; Ex. 2107 ¶ 102). Additionally, Patent Owner
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contends that there is no requirement that an expert have personal
knowledge of the subject matter upon which the expert’s opinion is based at
the time of the invention. Id. at 7–8. Further, Patent Owner asserts that
Dr. Slocum acquired the relevant knowledge by “(i) research[ing] the prior
art, (ii) canvass[ing] literature on pre-critical date pen injectors, design
considerations, and design standards, and (iii) convers[ing] with those in the
industry (i.e., Mr. Veasey and Dr. Goland).” Id. at 8 (citing Ex. 2107 ¶¶ 25–
61). Patent Owner also contends Dr. Slocum documented his opinions with
facts and data. Id.
Second, Patent Owner asserts that Petitioner’s criticism of
Dr. Slocum’s reliance upon the information and model obtained from
Mr. Veasey are unfounded. In particular, 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 9–10 (citing Ex. 2107 ¶¶ 25–61). Patent Owner notes that Petitioner does
not assert that any of the design considerations noted by Dr. Slocum are
incorrect. Id. at 10. Additionally, Patent Owner raises additional arguments
regarding Dr. Slocum’s reliance upon Mr. Veasey’s measurements of a
FlexPen, “to quantify the impact of Mr. Leinsing’s proposed modification to
Steenfeldt-Jensen’s fifth embodiment” and argues that Petitioner failed to
rebut the accuracy of the data provided. Id. at 10–11.
Third, Patent Owner contends that Petitioner ignores that Patent
Owner “served as supplemental evidence the native spreadsheets that specify
[the] principles and calculations” set forth in Appendices A through F.
Opp. 12 (citing Ex. 2226). Patent Owner further asserts that “the
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measurements provided by Mr. Veasey are corroborated, unrebutted, and
reliable.” Id.
Petitioner’s Motion Reply reiterates Petitioner’s contentions regarding
Dr. Slocum, including that even if he could be an expert, he “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 4. Petitioner also asserts that
Patent Owner hid Mr. Veasey’s involvement in Dr. Slocum’s testimony
precluding Petitioner from cross-examining Mr. Veasey. Id.
To begin, 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,
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. To the extent the credibility of any of the individuals upon which
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Dr. Slocum relied may be in doubt, e.g., Mr. Veasey’s potential bias as a
named inventor on the ’044 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,
as discussed below. Therefore, Petitioner has not shown that Dr. Slocum
should be disqualified as an expert in this proceeding. Accordingly,
Petitioner’s Motion as directed to the redirect examination testimony of
Exhibit 1054 and Dr. Slocum’s declaration (Ex. 2107) is denied.
Additionally, Mr. Veasey’s involvement was discussed extensively
during a conference call. See Ex. 1108 (Transcript of Nov. 18, 2019,
Telephonic Conference). We find that 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).
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III. SUMMARY28
Petitioner has demonstrated, by a preponderance of the evidence, that
claims 11, 14, 15, 18, and 19 would have been obvious over Steenfeldt-
Jensen. Additionally, although we deny Petitioner’s Motion to Exclude, we
limit the use of Exhibits 2012, 2117, 2147–2152, 2162, 2167, 2168, 2206,
2207, 2211, and 2215–2218 as described above.
The chart below summarizes our conclusions regarding the challenged
claims.
Claims
Challenged
35
U.S.C. § Reference(s)
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
11, 14, 15,
18, 19 103(a)
Steenfeldt-
Jensen
11, 14, 15, 18,
19
11, 14, 15,
18, 19 103(a)
Moller,
Steenfeldt-
Jensen29

Overall
Outcome
11, 14, 15, 18,
19

28 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).
29 As explained above in Section II.E, we do not reach the challenge to
claims 11, 14, 15, 18, and 19 based on Moller and Steenfeldt-Jensen because
the same claims are determined to be unpatentable over Steenfeldt-Jensen.
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IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 11, 14, 15, 18, and 19 of U.S. Patent
No. 8,603,044 B2 are determined to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude
(Paper 64) is denied; and
FURTHER ORDERED that, because this a Final Written Decision,
parties to this proceeding seeking judicial review of this 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 W. Guise
Nicole W. Stafford
Lorelei Westin
Arthur Dykhuis
Tasha Thomas
Elham F. 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 Weiswasser
Anish R. Desai
Sudip K. Kundu
Kathryn M. Kantha
Adrian C. Percer
William S. Ansley
Matthew D. Sieger
Brian C. Chang
WEIL, GOTSHAL & MANGES LLP
elizabeth.weiswasser@weil.com
anish.desai@weil.com
sudip.kundu@weil.com
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59
kathryn.kantha@weil.com
adrian.percer@weilcom
sutton.ansley@weil.com
matthew.sieger@weil.com
brian.chang@weil.com

W. Karl Renner
John S. Goetz
Joshua A. Griswold
Matthew S. Colvin
Kenneth W. Darby, Jr.
FISH & RICHARDSON P.C.
PTABInbound@fr.com