Sanofi-Aventis Deutschland GmbH

Patent Trials and Appeals Board

May 29, 2020

IPR2019-00122 (P.T.A.B. May. 29, 2020)

Trials@uspto.gov Paper 83
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.
____________

IPR2019-00122
Patent 8,992,486 B21
____________

Before LYNNE H. BROWNE, HYUN J. JUNG, and
JAMES A. TARTAL, Administrative Patent Judges.

BROWNE, 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 1–6, 12–18,
20, 23, 26–30, 32, 33, 36, and 38– 40 of U.S. Patent No. 8,992,486 B2 (Ex.
1003, “the ’486 patent”). Sanofi-Aventis Deutschland GmbH (“Patent
Owner”) filed a Preliminary Response (Paper 9). With prior authorization,
Mylan filed a Reply to Patent Owner’s Preliminary Response (Paper 14)
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 16). Also with prior authorization, Mylan filed a Motion
to Correct the Petition (Paper 7). We granted Mylan’s Motion to Correct
(Paper 11), resulting in a citation change on page 28 of the Petition.
Applying the standard set forth in 35 U.S.C. § 314(a), we instituted an inter
partes review of all challenged claims. Paper 19 (“Inst. Dec.”).
After institution, Pfizer Inc. (“Pfizer”) filed (1) a petition challenging
the same claims of the ’486 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, IPR2019-00982, 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. Pfizer, Paper 12 (Aug. 15,
2019).2

2 This decision is entered in the record in this case as Paper 43.
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Patent Owner filed a Patent Owner Response (Paper 29, “PO Resp.”),
Petitioner3 filed a Reply to Patent Owner’s Response (Paper 45, “Pet.
Reply”), and Patent Owner filed a Sur-reply (Paper 57, “PO Sur-reply”).
With prior authorization, Patent Owner filed a List of Improper Reply
Arguments that Patent Owner asserts exceed the scope of a reply under
37 C.F.R. §§ 42.22 and 42.23 (Paper 55), and Petitioner filed a Response to
Patent Owner’s List (Paper 56). Petitioner also filed a Motion to Exclude
(Paper 63, “Mot.”), Patent Owner filed an Opposition to Petitioner’s Motion
(Paper 64, “Opp.”), and Petitioner filed a Reply in support of its Motion
(Paper 69, “Motion Reply” or “Mot. Reply”). Additionally, Patent Owner
filed Observations on the Cross-Examination of Mr. Karl Leinsing
(Paper 67) and Petitioner filed a Response to Patent Owner’s Observations
(Paper 70). And, Petitioner filed Observations Regarding the Testimony of
Alexander Slocum, Ph.D. (Paper 68), to which Patent Owner filed a
Response (Paper 70). An oral hearing was held on January 15, 2020, and a
copy of the transcript was entered in the record. Paper 77 (“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)

3 We refer to Mylan and Pfizer, collectively, as “Petitioner.”
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(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 1–6, 12–18, 20, 23,
26–30, 32, 33, 36, and 38– 40 of the ’486 patent are unpatentable.
Additionally, for the reasons explained herein, we deny Petitioner’s motion
to exclude.
B. Related Proceedings
The parties indicate that the ’486 patent has been asserted in Sanofi-
Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Winthrop
Industrie v. Mylan GmbH, Biocon Ltd., Biocon Research Ltd., Biocon Sdn.
Bhd. and Biocon S.A., Case No. 2-17-cv-09105-SRC-CLW, U.S. District
Court for New Jersey; Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 2:17-
cv-09105-SRC-CLW (D.N.J.); Sanofi-Aventis U.S. LLC v. Merck Sharp &
Dohme Corp., No. 1:16-cv-00812-RGA-MPT (D. Del.); and Sanofi-Aventis
U.S. LLC v. Eli Lilly and Co., No. 1:14-cv-00113-RGA-MPT (D. Del.). Pet.
1; Paper 5, 2; Paper 8, 2; Exs. 1029, 1030.
The parties also state that related patents are challenged in Cases
IPR2018-01670, IPR2018-01675, IPR2018-01676, IPR2018-01677,
IPR2018-01678, IPR2018-01679, IPR2018-01680, IPR2018-01682,
IPR2019-01684, and IPR2018-01696. Pet. 2; Paper 5, 3; Paper 8, 2–3.
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 10, 2.
Pfizer identifies itself and Hospira, Inc. as real parties in interest.
Pfizer, IPR2019-00977, Paper 2 at 1.
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Patent Owner identifies Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis
U.S. LLC, and Sanofi Winthrop Industrie as real parties in interest. Paper
11, 2.
D. Instituted Ground of Unpatentability
Petitioner asserts claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and
38– 40of the ’486 patent are unpatentable as set forth in the chart below:
Claims Challenged 35 U.S.C. § Reference
1–6, 12–18, 20, 23,
26–30, 32, 33, 36,
38–40
103(a) Burroughs4
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”), and a
declaration by Dr. William C. Biggs (Ex. 1048).
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 ’486 Patent
The ’486 patent issued March 31, 2015, from an application filed June
4, 2013, which is the latest application in a series of continuation
applications, the first of which was filed on March 2, 2004. Ex. 1003, [22],

4 Exhibit 1013 (US 6,221,046 B1, iss. Apr. 24, 2001 (“Burroughs”)).
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[45], [63], 1:6–11. The ’486 patent also claims priority to a foreign
application filed on March 3, 2003. Id. at [30], 1:12–14.
The ’486 patent “relates to pen-type injectors . . . where a user may set
the dose.” Ex. 1001, 1:20–24. Figures 1 and 2 of the ’486 patent are
reproduced below.

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 . . . in a second, maximum first dose dialed, position.” Ex. 1001,
2:53– 57. The injector includes first cartridge retaining part 2 and main
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housing part 4.5 Id. at 3:27–28. Insert 16 is at a first end of main housing 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.
Piston rod 20 also includes pressure foot 22 that abuts piston 10 of
cartridge 8. Ex. 1001, 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.
Ex. 1001, 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.
A user rotates dose-dial grip 76 to set a dose and to cause dose-dial
sleeve 70, clutch 60, and drive sleeve 30 to rotate together out of main
housing 4. Ex. 1001, 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.

5 The ’486 patent refers to “second main housing part 4” and “main housing
4” interchangeably. Compare Ex. 1003, 3:28 (“second main housing part
4”) with id. at 3:30 (“main housing 4”).
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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 6:45–47.
F. Illustrative Claim
The ’486 patent has 57 claims, of which Petitioner challenges claims
1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38– 40. Of those, claim 1,
reproduced below, is the only independent claim.
1. 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;
a dose knob 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 driver extending along a portion of said piston rod, said
driver comprising an internal threading near a distal portion of said
driver, 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
knob, said tubular clutch operatively coupled to said dose knob,
wherein said dose dial sleeve extends circumferentially around
at least a portion of said tubular clutch.
Ex. 1003, 6:59–7:12.
II. ANALYSIS
A petition must show how the construed claims are unpatentable
under the statutory ground it identifies. 37 C.F.R. § 42.104(b)(4). Petitioner
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bears the burden of proving unpatentability of the challenged claims, and the
burden of persuasion never shifts to Patent Owner. Dynamic, 800 F.3d at
1378. To prevail, Petitioner must establish the facts supporting its challenge
by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R.
§ 42.1(d).
A. Level of Ordinary Skill in the Art
Petitioner asserts that “a POSA at the relevant time would have had at
least a bachelor’s degree in mechanical engineering, or an equivalent degree,
and practical design experience.” Pet. 13 (citing Ex. 1011 ¶ 106).
According to Petitioner, “[t]he POSA also would have understood the basics
of medical-device design and manufacturing, and the basic mechanical
elements (e.g., gears, pistons) involved in drug-delivery devices.” Id. ¶¶
104–107. Patent Owner proposes a level of ordinary skill that “is defined by
a person 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.” PO
Resp. 8. Patent Owner contends that “Petitioner’s proposed level of
ordinary skill should [not] be adopted because the level of ordinary skill
proposed by the Petitioner is inconsistent across IPR Nos. 2018-01670, -
01675, -01676, -01678, -01679, -01680, -01682, -01684, and 2019-00122.”
Id. Patent Owner admits, however, that “the slight differences between
Patent Owner and Petitioner’s level of ordinary skill do not affect the
arguments made below.” Id. at 9. We agree with Petitioner’s definition of
the level of ordinary skill in the art as it is consistent with the level of
ordinary skill reflected in the ’486 patent and prior art of record. Further, we
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agree with Patent Owner that “the slight differences between Patent Owner
and Petitioner’s level of ordinary skill do not affect the arguments” made by
the parties such that our analysis below would not change under either
party’s proposed level of ordinary skill. Id.
B. Claim Construction
In this inter partes review, claim terms are interpreted according to
their broadest reasonable construction in light of the Specification of the
’486 patent. 37 C.F.R. § 42.100(b) (2018); Cuozzo Speed Techs. LLC v.
Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest
reasonable interpretation standard).6
Petitioner provides interpretations of seven terms that were proffered
by Patent Owner in related litigation—“driver,” “main housing,” “piston
rod,” “thread/threaded/threading,” “tubular clutch,” “clicker,” and “insert.”
Pet. 14 (citing Ex. 1019, 20, 21, 24, 25, 27, 29). Petitioner also explains it
proffered means-plus-function interpretations for “clutch,” “clicker,” and
“insert” in related litigation and reiterates those interpretations here. Id. at
15 (citing Ex. 1028 (Mylan’s Preliminary Claim Constructions in Sanofi-
Aventis U.S. LLC v. Mylan N.V., No. 17-cv-09105-SRC-CLW (D.N.J.
Sept. 5, 2018) (“Sanofi”)), 101–106, 112–116). Petitioner states that “[t]he

6 On October 11, 2018, the Office revised its rules to harmonize the Board’s
claim construction standard with that used in federal district court. Changes
to the Claim Construction Standard for Interpreting Claims in Trial
Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51340
(Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective November 13,
2018) (now codified at 37 C.F.R. § 42.100(b) (2019)). This rule change,
however, applies to petitions filed on or after November 13, 2018, so the
revised claim construction standard does not apply to this proceeding. Id.;
see Paper 8, 1 (according filing date of September 10, 2018 to the Petition).
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ground presented below relies on the ordinary and customary meaning of the
claim terms as they would be understood by a POSA.” Id. at 16. Petitioner
states further that “[t]he ground [presented] addresses also the ‘clutch,’
‘clicker,’ and ‘insert’ limitations to the extent that those terms may be
construed as means-plus-function limitations.” Id. Patent Owner contends
that “it is only necessary to address the construction of the term ‘tubular
clutch.’” PO Resp. 9. Patent Owner contends further that “clicker” and
“insert” should not be construed as means-plus-function limitations. Id.
Petitioner contends “tubular clutch” is “[a] tubular structure that
couples and decouples a moveable component from another component.”
Pet. 14 (citing Ex. 1019, 21). Petitioner acknowledges that in related
litigation, “Mylan proffered a preliminary means-plus-function construction
for ‘clutch,’” where the functions are “that, during dose setting, it
‘clutch[es], i.e., coupling and decoupling a moveable component from
another component,’ or it ‘operates to reversibly lock two components in
rotation.’” Id. at 15 (citing Ex. 1028, 106). In that case, Petitioner identified
the structure in the ’486 patent that corresponds to those functions as
“component 60.” Id. (citations omitted).
Patent Owner contends that the plain and ordinary meaning of
“clutch” is “a component that can operate to reversibly lock two components
in rotation.” PO Resp. 12. Patent Owner asserts that this is the construction
adopted by the district court in Sanofi.7 Id. at 10–11. Patent Owner

7 “Tubular clutch” was construed by two different district courts. In Sanofi,
the U.S. District Court for the District of New Jersey, construed the term to
mean “a component that can operate to reversibly lock two components in
rotation.” Ex. 2165, 13. Previously, in Sanofi-Aventis U.S. LLC v. Eli Lilly
& Co., 14-cv-113 (RGA) (D. Del.), the U.S. District Court for the District of
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contends that, in construing the term, the district court disagreed with
Mylan’s proposed construction. Id. at 11 (citing Ex. 2165, 12).
Although we agree with the Sanofi district court that “tubular clutch”
does not invoke § 112, ¶ 6,8 we need not decide which party’s proposed
construction is the broadest reasonable construction because under either
construction—“a tubular structure that couples and decouples a moveable
component from another component” or “a component that can operate to
reversibly lock two components in rotation”—we find that Petitioner
sufficiently establishes that Burroughs discloses a “tubular clutch,” for the
reasons discussed below. See infra § II.C.3.a.vii.
Accordingly, we determine that no claim terms require express
construction beyond the discussion above. Vivid Techs., 200 F.3d at 803,
795 (Fed. Cir. 1999).
C. Principles of Law
A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
differences between the claimed subject matter and the prior art are such that
the subject matter, as a whole, would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406

Delaware construed “tubular clutch” to mean “a structure that couples and
decouples a moveable component from another component.” See Ex. 2165,
10 (referring to the Delaware court’s construction).
8 Petitioner fails to present any evidence or argument to overcome the
presumption that “tubular clutch,” which does not recite the word “means,”
is not a means-plus-function limitation. See Williamson v. Citrix Online,
LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (when a claim limitation does
not include the word “means,” there is a presumption that the term is not a
means-plus-function limitation and § 112, ¶ 6 does not apply).
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(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art;
(2) any differences between the claimed subject matter and the prior art;
(3) the level of ordinary skill in the art; and, when presented, (4) objective
evidence of nonobviousness.9 Graham v. John Deere Co., 383 U.S. 1,
17–18 (1966).
We analyze the asserted ground of unpatentability in accordance with
the above-stated principles.
D. Obviousness of Claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and
38–40 in View of Burroughs
Petitioner contends that claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36,
and 38–40 are unpatentable under 35 U.S.C. § 103(a) over Burroughs. Pet.
22–67. Having now considered the evidence in the complete record
established during trial, we are persuaded that Petitioner has demonstrated
by a preponderance of the evidence that these claims would have been
obvious in view of Burroughs. We begin our analysis with a brief overview
of the prior art.
1. Burroughs
Burroughs relates to “medical dispensing devices . . . that permit
selectively measured dosages of a liquid to be dispensed.” Ex. 1013,
1:13–16. Figure 2 of Burroughs is reproduced below:

9 Patent Owner provides no such evidence for our consideration. See
generally PO Resp.
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Figure 2 shows an exploded view of injection medication device 20.
Ex. 1013, 6:42–43, 7:15–16. Medication device 20 includes mechanism
housing 22 made from housing parts 24 and 26, button 32, dial mechanism
34, nut 36, and leadscrew 38 that forms a drive stem. Id. at 7:17–18,
7:32–34, 9:12–13.
In medication device 20, dial mechanism 34 engages button 32. Ex.
1013, 8:9–14, Figs. 6, 8. Dial mechanism 34 also includes outwardly
extending threads 110, 112 that “enter helical groove 158 during
commencement of the dosing process.” Id. at 8:33–36, 8:62–9:1, Figs. 3, 5.
“As a dosage is being set, outwardly extending threads 110 and 112 of dial
mechanism 34 ride in helical groove 158 of housing parts 24 and 26.” Id. at
10:60–63. When button 32 is depressed, dial mechanism 34 travels axially
towards cartridge 40. Id. at 8:15–20. Splines 144 on the interior of dial
mechanism 34 engage teeth 192 of nut 36 when the clutch is engaged to set a
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dosage. Id. at 8:42–48, Fig. 9. A series of numerals are printed on dial
mechanism 34 to indicate a desired dosage. Id. at 10:5–9.
Rotating dial mechanism 34 causes nut 36 to rotate and move relative
to housing 20, but rotation of leadscrew 38 is prevented. Ex. 1013,
10:25–27. Once a desired dosage has been set, button 32 is pushed to move
dial mechanism 34, nut 36, and leadscrew 38 forward to deliver the set
dosage. Id. at 11:13–19, 11:31–34.
2. Differences Between the Prior Art and the Claims: Reasoning
in Support of the Proposed Modifications
Petitioner provides claim charts and arguments with citations to where
Burroughs teaches or suggests the elements of the claims and citations to
supporting declarant testimony. Pet.22–67.
a. Independent Claim 1
i. A housing part for a medication dispensing
apparatus, said housing part comprising:
Petitioner contends that “[t]o the extent the preamble is limiting, it is
taught by Burroughs.” Pet. 23. Specifically, Petitioner asserts that
Burroughs teaches “an injection medication device 20 having the general
appearance of a pen or mechanical pencil. The device comprises a
mechanism housing 22 having a first part 24 and a second part 26 (FIG. 2).”
Id. at 24 (citing Ex. 1013, 7:15–19, Figs. 1–2). Patent Owner does not
contest Petitioner’s argument that Burroughs teaches the preamble of claim
1. See, generally, PO Resp.
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For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Burroughs teaches the
preamble of claim 1.10
ii. a main housing, said main housing extending from a
distal end to a proximal end;
Petitioner contends that Burroughs teaches “a mechanism housing 22
having a first part 24 and a second part 26 (FIG. 2).” Pet. 24. According to
Petitioner, “housing 22 extends from a button-end (referred to as the
proximal end) to a needle-end (referred to as the distal end).” Id. at 25
(citing Ex. 1013, 7:9–13; Ex. 1001 ¶ 160). Patent Owner does not contest
Petitioner’s argument that Burroughs teaches this limitation of claim 1. See,
generally, PO Resp.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Burroughs teaches the
preamble of claim 1.11
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;
Petitioner contends that Burroughs teaches a “[d]ial mechanism 34
[that] is generally cylindrical in shape and is hollow throughout its axial

10 We need not determine whether the preamble of claim 1 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 1.
See Paper 20 (Scheduling Order), 8 (“Patent Owner is cautioned that any
arguments for patentability not raised in the response may be deemed
waived.”).
11 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 1. See Paper 20, 8.
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length.” Pet. 25 (citing Ex. 1013, 7:65–67, Figs. 1–2, 6–9). Petitioner
contends further that ‘“[d]ial mechanism 34 further includes a first U-shaped
groove 100 (FIG. 6) and a second U-shaped groove 101 (FIG. 8) which form
flexible legs 102, 104. Referring to FIG. 9, each leg 102, 104, respectively
includes . . . an outwardly extending threads 110, 112.’” Id. at 26 (quoting
Ex. 1013, 8:24–29, Figs. 6–9). According to Petitioner, ‘“Housing parts 24
and 26 further form a helical spiral groove 158 and a circumferential surface
160. Circumferential surface 160 includes opening 162 and keyed opening
163 to allow threads 110 and 112 respectively to enter helical groove 158
during the commencement of the dosing process.’” Id. at 26–27 (quoting Ex.
1013, 8:63–9:1, 10:31–34, Figs. 3, 5).
Petitioner asserts “[t]hreads 110, 112 are rib-like structures that fit
into and move within helical spiral groove 158 of housing parts 24, 26 to
allow the dial mechanism to rotate and move axially away from the needle-
end of the housing during the dose-setting phase.” Pet. 27 (citing Ex. 1013,
Figs. 6–9; Ex. 1011 ¶¶ 166–167). Relying on Mr. Leinsing’s testimony,
Petitioner contends that “[t]hreads 110, 112 are spaced apart on opposite
sides of dial mechanism 34, so proper engagement of the threads with helical
spiral groove 158 requires that they be positioned helically relative to one
another, thereby forming a discontinuous helical rib corresponding to the
housing’s helical groove.” Id.at 27–28 (citing Ex. 1011 ¶¶ 168–170); cf. Ex.
1003, 3:42–44. Thus, Petitioner argues “Burroughs teaches the recited ‘dose
dial sleeve,’ except it discloses a ‘helical rib’ rather than a ‘helical groove.’”
Id. at 28 (citing Ex. 1011 ¶¶ 170–172).
Petitioner contends that one of ordinary skill in the art “would have
considered it routine to implement the helical rib as a helical groove
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corresponding to helical threading on the housing.” Pet. 28. Mr. Leinsing
testifies that one of ordinary skill in the art “would have found it obvious to
add another helical rib next to the existing one, such that threads 110, 112
form a ‘helical groove’ that engages a threading provided by the housing.”
Ex. 1011 ¶ 166. Petitioner asserts that one of ordinary skill in the art “would
have been familiar with a limited number of interchangeable thread
structures and recognized that Burroughs was merely depicting one such
option.” Pet. 39 (citing Ex. 1011 ¶¶ 189–190). According to Petitioner,
“[p]roviding threads 110, 112 as a protruding helical groove rather than as a
protruding helical rib would have been apparent to a POSA, and a POSA
would have recognized that such groove-to-rib implementation of the
threading would be functionally equivalent and largely interchangeable with
the depicted rib-to-groove implementation.” Id. (citing Ex. 1011
¶¶192–193). Petitioner asserts further that “[s]electing and implementing
such threading was a routine task for a POSA and would have been viewed
as no more than “the predictable use of prior art elements according to their
established functions.” Id. (quoting KSR, 550 U.S. at 417; Ex. 1011
¶¶193–196).
In addition, Petitioner contends that one of ordinary skill in the art
“would have had a reasonable expectation of success in implementing
threads 110, 112 as protruding helical grooves.” Pet. 39. According to
Petitioner, “[g]rooved threading is a common, well-understood, predictable
mechanism . . . and a POSA would have recognized that using a groove
rather than a rib to engage corresponding threading on the housing would
not change the function or the principle of operation of the mechanism.” Id.
(citing Ex. 1011 ¶168). In view of this assertion, Petitioner argues that a
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person of ordinary skill “would have understood that a protruding u-shaped
groove would operate in the same manner and provide the same function as
the depicted ribs” and “would have had no difficulty implementing this
minor variation of the dial mechanism’s threading.” Id. at 39–40 (citing Ex.
1011 ¶¶ 169–170). Thus, Petitioner asserts that “[i]mplementing threads
110, 112 as a groove rather than a rib therefore would have been the use of
well-known, familiar elements performing their same, predictable
functions.” Id. (citing Ex. 1011 ¶ 169; KSR, 550 U.S. at 417).
Patent Owner raises several arguments in response. First, Patent
Owner contends that “Burroughs does not disclose a dose dial sleeve that
comprises a ‘helical groove configured to engage a threading provided by
said main housing.’” PO Resp. 21. As discussed above, Petitioner
acknowledges that Burroughs does not disclose this limitation of claim 1,
and we agree with the parties that Burroughs does not. Our determination
that Burroughs fails to teach this limitation does not end our inquiry because
Petitioner proposes modifying Burroughs as set forth above.
Second, Patent Owner contends that Petitioner and Mr. Leinsing
propose two different, conflicting modifications to Burroughs. PO Resp. at
21–27. Patent Owner explains that it understood Petitioner to propose “a
convoluted modification to Burroughs in which a groove would be cut into
the existing threads 110 and 112, creating ‘grooved thread[s]’ which
subsequently engage with a thread on the inner surface of the housing.” Id.
at 21–22 (citing Pet. 38–40; Ex. 2107 ¶ 170). Patent Owner asserts that this
is what it understood when Petitioner asserted the helical threads 110, 112
would be provided as “u-shaped.” Id. at 22 (citing Pet. 39; Ex. 2107 ¶ 170).
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Patent Owner asserts that, in contrast to cutting into the existing
thread, Mr. Leinsing proposes adding another helical rib next to the existing
one such that threads 110, 112, along with the added thread, form a helical
groove that engages with a threading provided by the housing. PO Resp.
24–25. Thus, Patent Owner describes Mr. Leinsing’s proposal as “plac[ing]
an additional thread behind Burroughs’ existing threads 110 and 112, such
that the space between the threads forms a helical groove.” Id. at 25 (citing
Ex. 2107 ¶ 171). Patent Owner asserts “[n]owhere does the Petition suggest
duplicating threads 110, 112 and then offsetting those new threads to create
a helical grove that mates with the ‘wall’ of the groove on the housing 22.”
Id. at 26.
In reply, Petitioner contends that the Petition and Mr. Leinsing’s
declaration are consistent. Pet. Reply 5–6. In particular, Petitioner asserts
that the Petition “says nothing about cutting into the threads to make this
modification.” Id. at 5. Rather, Petitioner explains that the Petition
proposes changing helical threads 110, 112 into “u-shaped protruding
groove[s]” and Mr. Leinsing’s declaration explains that this is accomplished
by forming the threads as “two, parallel ribs.” Id. at 5–6 (quoting Ex. 1011
¶ 170).12
In its Sur-reply, Patent Owner maintains that the Petition “did not
assert an obviousness theory based on adding another set of threads 110, 112

12 Patent Owner identifies the above portion of Petitioner’s Reply in its List
of Allegedly Improper Reply Arguments (Paper 55). We find that this
discussion in Petitioner’s reply is not an improper reply argument because it
responds to Patent Owner’s argument (raised in its Response) that the
Petition and Mr. Leinsing proposed different modifications to Burroughs.
As discussed infra, the modifications are consistent.
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to Burroughs’ dial mechanism to form a ‘groove’ between two sets of
threads.” PO Sur-reply 7 (citing PO Resp. 21–24). Patent Owner contends
that Petitioner’s Reply does not dispute that the Petition “proposed
‘chang[ing] the helical threads 110, 112 into ‘u-shaped protruding grooves’”
and that Petitioner’s position that this language indicates duplication of the
thread rather than forming a groove in the existing threads is improbable. Id.
(quoting Pet. Reply 5).
We disagree with Patent Owner that Petitioner and Mr. Leinsing
propose different theories of modification. The Petition proposes changing
the helical threads 110, 112 to u-shaped protruding grooves, as discussed
above. The Petition, however, does not indicate precisely how this change
would be accomplished. But, the Petition does not state that one would
“cut” a groove into the thread, as Patent Owner contends. The Petition
expressly relies on the declaration of Mr. Leinsing, and Mr. Leinsing
provides the specific modification when he testifies that “a person of
ordinary skill would have found it obvious to add another helical rib next to
the existing one such that the threads 110, 112 form a ‘helical groove’ that
engages a threading provided by the housing.” Ex. 1011 ¶ 166 (emphasis
added). This testimony is the clearest explanation of precisely how the
existing threads 110, 112 would be modified to form u-shaped protruding
grooves. This paragraph of Mr. Leinsing’s declaration begins his discussion
of how one of ordinary skill in the art would modify Burroughs. See
generally id. ¶¶ 160–172. The discussion that follows, including his
testimony quoted above from paragraph 170, is premised upon that
modification. Although we agree to some extent with Patent Owner that the
Petition could have been written to identify more clearly how the u-shaped
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protruding grooves would be formed, we do not find the Petition deficient in
this regard or that it proposes a theory of obviousness that conflicts with
Mr. Leinsing’s testimony.13
Third, turning to the merits of Petitioner’s modification to
Burroughs’s dose dial sleeve, contends Petitioner provides no rationale for
the proposed modification. PO Resp. 34. Rather, Patent Owner asserts that
the Petition and Mr. Leinsing state only that
rib-to-groove threaded connections were known in the art, that
the relative placement of the ribs and grooves was “largely
interchangeable” and “routine variations,” and that a [person of
ordinary skill in the art] would have understood that positioning
the threads 110, 112 as proposed by Mr. Leinsing to form two
parallel ribs would have preserved the rotational operability of
the components in Burroughs’ injector pen.
Id. (citing Ex. 1011 ¶¶ 168–171; Pet. 39–40). Patent Owner contends that
“these assertions do no more than establish that a [person of ordinary skill in
the art] could have performed the proposed modification,” and do not
provide a “reason or rationale to do so.” Id. at 34–35 (citing Belden Inc. v.
Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2005)).
Petitioner replies that “[w]hen known interchangeable solutions to a
problem exist, the case law fully supports that swapping one solution for the
other is well within the realm of the obvious.” Pet. Reply 6–7 (citing Pet.
38–40; KSR, 550 U.S. at 417); Ex. 1095 ¶ 43).
In its Sur-reply, Patent Owner contends that “[m]erely asserting a
‘design choice’ does not make it obvious” and that “Petitioners’ alleged

13 In light of our finding above, Patent Owner’s assertion that one of
ordinary skill in the art would not have cut a groove into threads 110, 112
(see PO Resp. 29–33) is inapposite.
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‘interchangeability’ at best goes to expectation of success.” PO Sur-reply
8–9 (citing Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069 n. 4
(Fed. Cir. 2018)). Patent Owner asserts that “Petitioners never address what
motivation a [person of ordinary skill in the art] would have to make the
change – a legally distinct concept from reasonable expectation of success.”
Id. at 9 (citing Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821
F.3d 1359, 1367 (Fed. Cir. 2016)).
In KSR, the Supreme Court stated that “when a patent ‘simply
[re]arranges old elements with each performing the same function it had
been known to perform’ and yields no more than one would expect from
such an arrangement, the combination is obvious.” KSR, 550 U.S. at 417
(citing Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976)). The Court stated that
applying the principles from its previous cases “may be more difficult in
other cases than it is here because the claimed subject matter may involve
more than the simple substitution of one known element for another or the
mere application of a known technique to a piece of prior art ready for the
improvement.” Id.
In the circumstances presented here, Petitioner establishes sufficiently
that the addition of a thread to form a groove (where there was a thread) and
the addition of a thread (where there was a groove) is the type of simple
substitution envisioned by KSR where the artisan simply rearranges old
elements (a thread-groove connection) with each performing the same
function, yielding no more than one of ordinary skill in the art would have
expected. As Petitioner explains, this is a question of known
interchangeability. In such circumstance, and on the facts presented here,
we find that Petitioner sufficiently sets forth a basis as to why one of
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ordinary skill in the art would have modified Burroughs—because thread-
groove arrangements and groove-thread arrangements were known to be
interchangeable—and one of ordinary skill in the art would have had a
reasonable expectation of success in producing the same predictable result.
That finding does not end our inquiry, however, because Patent Owner
additionally contends that one of ordinary skill in the art would have been
deterred from making the modifications proposed by Petitioner, which we
now address.
Fourth, Patent Owner contends that one of ordinary skill in the art
would have been deterred from making the modifications Petitioner
proposes. PO Resp. 35–38. Patent Owner asserts that Petitioner’s
modification to add a thread to threads 110 and 112 would have (1) required
that legs 102 and 104 pivot far enough inward to disengage from two threads
(instead of one), (2) required an increase of 30% to 40% in force and stress
during the injection process, and (3) resulted in the legs wearing out faster,
thus decreasing the lifespan of Burroughs’s multi-use injector. PO
Resp. 35–36 (citing Ex. 2107 ¶¶ 186–188).
Patent Owner also contends that although additional modifications to
Burroughs’s device could be made to reduce the negative consequences of
Petitioner’s proposed change, Petitioner does not propose any additional
modifications. Id. at 37 (citing Ex. 2163, 195:14–25). As an example of an
additional modification, Patent Owner asserts that the stress exerted on the
legs could be reduced by changing their dimensions. Id. (citing Ex. 2107
¶ 189). According to Patent Owner, that change, however, would have also
necessitated increasing the internal diameter of the injector “by at least
10 percent in order to accommodate the modified legs when they pivot
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inward during injection.” Id. (citing Ex. 2107 ¶¶ 190–191). Patent Owner
argues that increasing the diameter is undesirable because it is more difficult
to grasp and manipulate, especially for diabetic patients who may suffer
from hand and wrist conditions that decrease their grip strength and
dexterity. Id. Patent Owner asserts that increasing the diameter of the
device would also require more material for manufacturing and would make
the device heavier and less portable. Id.
Further, Patent Owner contends that with or without the modifications
to Burroughs’s legs, the injection force required for a user to dispense a dose
would be increased by 15% because the legs must pivot further in order for
the added threads to clear helical groove 158 during dose injection. PO
Resp. 38 (citing Ex. 2107 ¶ 192). Increasing injection force also is
considered a detriment because of the device’s use by diabetic patients who
have decreased hand and wrist strength as discussed above. Id.
Petitioner does not dispute Patent Owner’s argument that adding
threads would result in an increase in stress and wear on Burroughs’s legs.
Pet. Reply 7. Rather, Petitioner contends that Patent Owner “sets up a
strawman argument that does not represent the actual argument and avoids
addressing the actual rationale.” Id. Petitioner asserts that one of ordinary
skill in the art would have used routine skill to implement the proposed
change (i.e., adding threads) presumably contending that one of ordinary
skill would have also considered modifying the dimensions of the legs.14 Id.

14 Petitioner does not state expressly that modifying the dimensions of the
legs is within the “routine skill” that one of ordinary skill in the art would
have used when adding the additional threads, but Petitioner’s Reply
explains that is what Petitioner meant. Pet. Reply 7.
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Additionally, Petitioner contends that making the device wider is not
necessarily a disadvantage, relying on Dr. Biggs’s testimony that “width . . .
can aid patients with grip or agility problems.” Pet. Reply 8 (quoting
Ex. 1048 ¶ 50). Thus, Petitioner asserts that what Dr. Slocum considers a
disadvantage (i.e., increased width), Dr. Biggs considers an advantage. Id.
at 8. With respect to Patent Owner’s argument of a 15% increase in
injection force, Petitioner contends Dr. Slocum “pulls this ‘significant’
percentage out of thin air.” Id. (citing Ex. 2107 ¶ 192; Ex. 1095 ¶ 41).
Petitioner asserts that Dr. Slocum’s testimony is conclusory and entitled to
no weight, but that, even if injection force were increased, that may only
disadvantage some, not all, patients. Id. at 8–9 (citing In re Kao, 639 F.3d
1057, 1067 (Fed. Cir. 2011); Ex. 1048 ¶¶ 29–30).15,16
In its Sur-reply, Patent Owner contends that the Petition does not
propose the “routine options” Petitioner sets forth in the Reply to mitigate
the additional stress resulting from the addition of threads to Burroughs’s

15 Petitioner further contends, in a footnote, that Patent Owner does not
address routine options one of ordinary skill in the art would employ to
counter an increase in injection force, such as employing different thread
heights and shifting the threading. Pet. Reply 9 n.3 (citing Ex. 1095
¶¶ 42–43). We do not fault Patent Owner for its lack of prescience or ability
to predict Petitioner’s argument. Thus, we disagree with Petitioner’s
suggestion that Patent Owner should have addressed these issues in its
Response.
16 Patent Owner identifies Petitioner’s footnote 3 in its List of Allegedly
Improper Reply Arguments (Paper 55). We find that the position stated in
Petitioner’s footnote is not an improper reply argument because it responds
to Patent Owner’s argument (raised in its Response) regarding potential
negative consequences of making the modification proposed by Petitioner.
Nonetheless, Petitioner is cautioned that a substantive argument generally
should not be placed only in a footnote for full consideration.
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device. PO Sur-reply 9 (citing Pet. Reply 9 n.3). Patent Owner also asserts
that the size and position of the additional threads are necessarily fixed by
the size of the existing threads 110, 112 and the pitch of the existing helical
groove, neither of which Petitioner originally proposed to modify. Id. at 10
(citing Ex. 1054, 277:19–279:2, 281:5–18). Thus, Patent Owner argues that
we should “give no weight to Petitioners’ assertion that a [person of ordinary
skill in the art] could have accommodated the modification through
‘different rib heights’ or ‘shifting of threading.’” Id. at 10.
Additionally, Patent Owner encourages us to reject Petitioner’s “new
contention that the modification could have been accommodated through
other unspecified applications of ‘routine skill.’” PO Sur-reply 11 (quoting
Pet. Reply 7). Patent Owner relies upon Dr. Slocum’s testimony that
Petitioner’s modification would require additional substantive changes to
Burroughs’s device, such as lengthening legs 102, 104 and increasing the
thickness of the injector, and Patent Owner contends that Petitioner provides
no evidence that these are “routine” modifications. Id. Patent Owner asserts
that given the additional changes required, including redesigning the internal
components of the device that are sized for Burroughs’s existing design,
Petitioner’s modification is “hardly an ‘interchangeable solution[].’” Id.
(alteration by Patent Owner).
Further, Patent Owner argues that Petitioner does not contest that
injection force would increase even if Petitioner disputes the precise amount
of that increase. Id. at 12 (citing Pet. Reply 8–9). Patent Owner also points
to the testimony of Dr. Goland, that injection force is one of the reasons she
has switched patients to certain devices over others. Id. (citing Ex. 1056,
66:9–15).
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We find the evidence weighs in Petitioner’s favor as to the question of
whether it would have been obvious to modify Burroughs’s dose dial sleeve.
The evidence reflects, on the facts presented here, that a groove-thread
connection and a thread-groove connection are interchangeable. Patent
Owner’s evidence does not support the finding that Burroughs’s device
would be inoperable if modified as Petitioner proposes. And, we expressly
find, and agree with Petitioner, that Burroughs would be operable. Patent
Owner’s evidence, at best, suggests that Burroughs’s device might not
operate as well for every user. Petitioner’s evidence, however, suggests that
is not necessarily the case for everyone. Specifically, the evidence discussed
above reflects that increased size of the device may be an advantage to some
users of the device while also a disadvantage to others. “[A] given course of
action often has simultaneous advantages and disadvantages, and this does
not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo
S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Further, we find that Patent
Owner establishes that additional stress and force would likely be
experienced by the addition of threads, but Petitioner (and Dr. Slocum’s
testimony17) establishes that one of ordinary skill in the art would understand
how to accommodate that stress and that additional modifications could be
made to alleviate that stress if desired. We do not, however, find that
additional modifications are required because, although added stress is a

17 Even though Dr. Slocum proposes modifications not originally presented
by Petitioner, the modifications proposed are well within the level of
ordinary skill in the art and we find that one of ordinary skill in the art would
have understood them and undertaken them if increased stress were a
concern. See KSR, 550 U.S. at 421 (one of ordinary skill in the art “is also a
person of creativity, not an automaton”).
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potential detriment of the modification, we do not find that it would deter
one of ordinary skill in the art from adding the additional threads and do not
find that it would render Burroughs inoperable for its intended purpose.
Finally, even though we find that injection force may increase, we
again are not persuaded that it is of the order that would render Burroughs
inoperable for all users such that one of ordinary skill in the art would not
undertake the modification. In short, we determine that Petitioner has
established that modifying Burroughs’s thread-groove connection to a
groove-thread connection would have been obvious to one of ordinary skill
in the art at the time of the invention.
iv. a dose knob disposed near a proximal end of said
dose dial sleeve;
Petitioner contends that “Burroughs discloses a ‘dose knob’ in the
form of proximal portion 78 of dial mechanism 34, with this portion
disposed near a proximal end (i.e., button-end) of the dial mechanism.” Pet.
29 (citing Ex. 1013, 8:2–6, Figs. 1, 6–9; Ex. 1011 ¶¶ 173–175). Patent
Owner does not contest Petitioner’s argument that Burroughs teaches this
limitation of claim 1. See, generally, PO Resp.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Burroughs teaches the dose
knob limitation of claim 1, as recited above.18
v. a piston rod provided within said housing, said piston
rod is non-rotatable during a dose setting step
relative to said main housing;

18 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 1. See Paper 29, 8.
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Petitioner contends that “Burroughs discloses a ‘piston rod’ in the
form of leadscrew 38, which is provided within housing 22.” Pet. 31 (citing
Ex. 1013, 9:26–27, Figs. 1, 2, 12–13). Patent Owner does not contest
Petitioner’s argument that Burroughs teaches this limitation of claim 1. See,
generally, PO Resp.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Burroughs teaches the dose
knob limitation of claim 1, as recited above.19
vi. a driver extending along a portion of said piston rod,
said driver comprising an internal threading near a
distal portion of said driver, said internal threading
adapted to engage an external thread of said piston
rod;
Petitioner contends that “Burroughs discloses a ‘driver’ in the form of
nut 36.” Pet 34 (citing Ex. 1013, 9:12-13, Figs. 1, 2, 10–11; Ex. 1011
¶¶ 180–181). According to Petitioner “[n]ut 36 includes helical thread 198
on its interior surface near its distal end (needle-end).” Id. (citing Ex. 1013,
9:13–25, Figs. 1, 2, 10–11). Petitioner contends further that “[t]his thread
engages helical threads 208 on leadscrew 38.” Id. (citing Ex. 1013, 9:30–32,
Figs. 1, 2, 10–13). Patent Owner does not contest Petitioner’s argument that
Burroughs teaches this limitation of claim 1. See, generally, PO Resp.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Burroughs teaches the driver
limitation of claim 1, as recited above.20

19 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 1. See Paper 29, 8.
20 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 1. See Paper 29, 8.
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vii. a tubular clutch located adjacent a distal end of said
dose knob, said tubular clutch operatively coupled to
said dose knob,
Petitioner contends that “Burroughs discloses a ‘tubular clutch’ in the
form of button 32.” Pet. 36. According to Petitioner, “[b]utton 32 is
cylindrical in shape (tubular) and includes an enlarged diameter ring 54. Id.
(citing Ex. 1013, 7:46–51, Figs. 14, 15; Ex. 1011 ¶182). Petitioner asserts
that “when button 32 is depressed for injection, ring 54 pushes onto fingers
94 provided within dial mechanism 34’s internal surface.” Id. (citing Ex.
1013, 8:11–20, Figs. 1, 9, 14, 15). Petitioner asserts further that “[t]his
causes the portion of legs 102, 104 that includes threads 110, 112 to move
radially inward, which causes the threads to disengage from helical groove
158 of the housing.” Id. (citing Ex. 1013 8:15–20; Ex. 1011 ¶ 183).
Petitioner explains that “[t]his disengagement then allows dial mechanism
34 to freely move toward the device’s needle-end without rotating relative to
the housing.” Id. at 37 (citing Ex. 1013, 8:15–20, 11:5–20; Ex. 1011
¶¶ 184–185). Petitioner explains further that “[b]utton 32 also causes splines
144 of dial mechanism 34 to disengage from splines 192 of nut 36, which
rotationally decouples the two components.” Id. (citing Ex. 1013, 11:27–30;
Ex. 1011 ¶¶ 185–187). Thus, according to Petitioner, “button 32 serves as a
clutch that allows dial mechanism 34 to disengage from (1) its rotational
connection with the housing 22, and (2) its rotational connection with nut
36.” Id. (citing Ex. 1011 ¶¶ 184–187).
Patent Owner responds that Burroughs does not disclose or render
obvious the recited tubular clutch. PO Resp. 39–43. First, Patent Owner
asserts that the proper construction for tubular clutch is “a tubular
component that can operate to reversibly lock two components in rotation.”
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Id. Patent Owner contends that Petitioner’s proposed construction of the
term as a means-plus-function limitation included this operation as one of
the functions, yet Petitioner fails to address this function in the Petition. Id.
at 40. Thus, Patent Owner argues that “[i]n view of the construction
advocated by the Petitioner in the Petition and at the District Court, the
Petitioner should not be given a ‘do-over’ in its forthcoming reply.” Id.
Second, Patent Owner contends that the “mere[] . . . capability to
‘rotationally decouple’” two components does not establish the capability to
reversibly lock those components in rotation. PO Resp. 45. Patent Owner
addresses each of the functions identified by Petitioner.
With respect to the engagement between dial mechanism 34 and
housing 22, Patent Owner asserts that “dial 34 is coupled to the housing by
threads 110 and 112, which engage with the housing’s helical groove 158.”
Id. at 41. Patent Owner provides the following:
As Burroughs explains, “[u]pon rotation of dial 34, threads 110,
112 move within housing groove 158 in the proximal direction
as dial mechanism 34 retracts from housing 22 . . . .”
Ex. 1013, 10:34–37. As Professor Slocum explains, this means
that the dial mechanism 34 is rotating relative to the housing
22, and therefore dial mechanism 34 and housing 22 are not
“reversibly locked in rotation.” Ex. 2107 ¶ 207. Thus,
Petitioner’s first theory does not render the claims invalid
because the dial mechanism is never locked rotationally to the
housing.
Id.
With respect to the engagement between dial mechanism 34 and
nut 36, Patent Owner contends button 32 “never locks the dial to the nut;”
rather, “splines 144 and 192 engage to couple the dial to the nut when the
user retracts the dial mechanism from the zero-dose position during dose
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setting.” PO Resp. 42 (citing Ex. 2107 ¶ 208; Ex. 1013, 8:42–48, 10:15–26).
Thus, Patent Owner asserts “button 32 does not reversibly lock two
components in rotation.” Id. (citing Ex. 2107 ¶ 208).
Third, Patent Owner contends that Burroughs discloses a “clutch”
consisting of splines 144 and teeth 192, which “reversibly lock two
components in rotation – dial mechanism 34 and nut 36.” PO Resp. 42.
Patent Owner quotes Burroughs’s description of its “clutching device” as
follows:
The clutch device comprises a series of splines on the inner
cylindrical surface of the dial mechanism which axially
engage corresponding splines on the outer surface of the nut.
The splines are engaged with one another by retracting the dial
mechanism with respect to the nut after the dial mechanism has
been rotated to its zero-dose position.
Id. (quoting Ex. 1013, 2:59–65) (citing Ex. 2107 ¶ 209). Patent Owner
asserts that Petitioner cannot rely upon splines 144 and teeth 192 as teaching
the claimed “tubular clutch” because (1) splines 144 and teeth 192 are not
tubular and (2) they are not located adjacent to a distal end of the proximal
portion 78 of the dial mechanism 34, as required by claim 11. Id. at 42–43.
Petitioner replies by first addressing Patent Owner’s argument
regarding claim construction, asserting that Patent Owner has waived any
argument directed to Petitioner’s non-means-plus-function construction of
“tubular clutch”—“a tubular structure that couples and decouples a
moveable component from another component.” Pet. Reply 9. Petitioner
also asserts that Patent Owner “conceded the reasonableness of the
construction the petition employed when it proffered the same construction
adopted by the earlier court [i.e., the Delaware District Court] to the court in
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the collateral litigation [i.e., the New Jersey District Court].” Id. Thus,
Petitioner contends the construction of the term in this inter partes review
“must be broad enough to include the petition’s construction.” Id. at 10.
Second, Petitioner asserts that the difference in construction “does not
make a practical difference in this case.” Pet. Reply 10. In particular,
Petitioner asserts that button 32 operates to reversibly lock two components
in rotation because it operates to engage and disengage dial mechanism 34
from the housing’s helical groove. Id. (citing Pet. 36–37; Ex. 1095 ¶ 48).
Petitioner contends that “when the user injects a dose, button 32 operates to
disengage the splined connection between dial mechanism 34 and nut 36,
thus reversing the rotational locking of those two components.” Id. (citing
Ex. 1095 ¶¶ 48–49; Ex. 1013, 8:42–48, 10:21–26, 10:38–42, 11:27–30,
Figs. 9, 11; Ex. 1011 ¶¶ 180, 182–183). Thus, Petitioner contends button 32
teaches a tubular clutch under Patent Owner’s new construction. Id.
Third, Petitioner contends that Patent Owner “adopts an even
narrower interpretation of its new construction, requiring the clutch to act
directly on the locked components to ‘operate to reversibly lock two
components in rotation.’” Pet. Reply 10–11. Petitioner asserts that “[w]hen
engaged[,] the splines 144 and teeth 192 define a tubular (‘360°’) structure
(clutching device) within the intermediate portion 80 of the dial
mechanism 34. The intermediate portion 80 lies between the proximal
portion 78 and distal portion 82, together comprising the dial
mechanism 34 . . . .” Id. at 11 (citing Ex. 1013, 8:2–4, Fig. 8). Petitioner
argues that “adjacent” should mean “next to.” Id. (citing MBO Labs., Inc. v.
Becton, Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007). Therefore,
because “intermediate portion 80 in which the clutching device is located is
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on the distal end of the proximal portion 78,” Petitioner contends it is next to
the distal end of the proximal portion. Id. at 12 Thus, Petitioner asserts that
button 32 teaches the recited “tubular clutch” of claim 1 under either
construction. Id.
In its Sur-reply, Patent Owner contends Petitioner’s interpretation of
“tubular clutch” “unreasonably broadens the claim by permitting any
structure to be a clutch as long as it directly or indirectly triggers a locking
of two components.” PO Sur-reply 4. Patent Owner asserts that such
interpretation would permit a “user’s hand” to be a “clutch” because “the
user operates button 32 using her hand, causing splines 144 and teeth 192 to
lock the dial mechanism and nut in rotation.” Id. Patent Owner contends
that whatever scope is given to a claim term, it must be reasonable and
Petitioner’s construction is not. Id. Even if considering an indirect action,
Patent Owner asserts splines 144 and teeth 192 lock due to axial retraction of
dial mechanism 34, not button 32, and, therefore, button 32 still is not a
tubular clutch. Id. at 4–5 (citing Ex. 1013, 10:15–26).
Additionally, Patent Owner contends that we should disregard
Petitioner’s new argument21 that splines 144 and teeth 192 teach the recited

21 Patent Owner identifies Petitioner’s argument that splines 144 and
teeth 192 teach a “tubular clutch” in its List of Improper Reply Arguments
(Paper 63). To the extent Petitioner relies upon splines 144 and teeth 192 as
an alternative teaching of a “tubular clutch,” see Pet. Reply 13–14
(discussing the shape and location of splines 144 and teeth 192), we agree
with Patent Owner that the identification of a different structure in
Burroughs (i.e., splines 144 and teeth 192 as opposed to button 32) would be
an improper new argument impermissibly raised in Petitioner’s Reply.
However, we do not find improper Petitioner’s argument that the tubular
clutch is not required to act directly to operate to reversibly lock two
components in rotation. See id. at 13 (first paragraph). That argument
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“tubular clutch.” PO Sur-reply 5 (citing 37 C.F.R. § 42.23(b); August 2018
Trial Practice Guide Update 15). Even if considered, however, Patent
Owner asserts these structures do not teach the “tubular clutch” because
(1) they are not tubular and (2) they are not adjacent to a distal end of a dose
dial grip. Id. (citing PO Resp. 42–43). Patent Owner contends the distal end
of Burroughs’s dose knob is not next to splines 144 or teeth 192 because
they are separated by the intervening portion of dial 34. Id. And,
splines 144 and teeth 192 are not tubular because the parties’ construction
requires a singular component or structure, which the splines and teeth are
not. Id. at 6.
To begin, we reiterate that under either construction—the broader, “a
tubular structure that couples and decouples a moveable component from
another component” or, the more narrow, “a component that can operate to
reversibly lock two components in rotation”—we find that Burroughs’s
button 32 teaches the recited “tubular clutch” of claim 1. Therefore, we
need not decide which construction is the broadest reasonable construction
to decide the specific issue before us.
First, Patent Owner does not dispute that button 32 satisfies the first
construction of tubular clutch. Patent Owner’s arguments are instead
directed to the second construction. For the reasons explained by Petitioner
and detailed below, we find that Burroughs’s button 32 is a tubular structure
that couples and decouples a moveable component from another component.

maintains Petitioner’s reliance upon button 32 as teaching the “tubular
clutch” and is responsive to Patent Owner’s argument directed to the action
of button 32 in the Patent Owner Response. Our discussion is focused on
Petitioner’s identification of button 32.
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Second, we do not agree with Patent Owner’s restrictive interpretation
of the second construction, requiring that the identified structure operate
directly to reversibly lock two components in rotation. In particular, Patent
Owner has identified no flaw in Petitioner’s position that justifies such
limitation.22 In the context of applying the broadest reasonable construction
in light of the specification, we determine that an identified structure may
teach a tubular clutch even if it operates to indirectly reversibly lock two
components in rotation. In particular, the phrase “a component that can
operate to” does not limit how that component operates to accomplish the
remainder of the construction—“reversibly lock two components in
rotation.”
Turning to Burroughs, Burroughs teaches that after a desired dosage is
set, a user inserts the needle of the device and pushes button 32 to inject the
dosage. Ex. 1013, 11:13–16. This is accomplished by the button moving
out of engagement with legs 102 and 104, which then allows dial
mechanism 34 to move forward because threads 110, 112 are no longer in
engagement with groove 158. Id. at 11:16–20. Burroughs explains that
“[a]s dial mechanism 34 is initially moved forward, splines 144 move out of
engagement with splines 192 of nut 36 to disengage the clutch by

22 By this statement we do not imply that Patent Owner has any specific
burden in this context; rather our statement is directed to the unremarkable
concept that a party seeking to read a construction more narrowly, in the
context of applying the broadest reasonable construction in light of the
specification, should identify some reason and basis why such narrowing is
appropriate. Patent Owner’s hypothetical example of finding a user’s hand
is a clutch is inapposite as a user’s hand is clearly not part of “[a] housing
part for a medication dispensing apparatus” as stated in the preamble of
claim 1.
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rotationally decoupling dial mechanism 34 from nut 36 prior to any axial
movement of nut 36.” Id. at 11:27–30 (emphasis added).
With respect to the first construction, as the above description
indicates, button 32 couples and decouples a moveable component—dial
mechanism 34—from another component—nut 36. With respect to the
second construction, the above description also indicates that button 32
operates to rotationally decouple dial mechanism 34 from nut 36, which
reverses the rotational locking of those two components. See Pet. 35
(identifying dial mechanism 34’s rotational connection with nut 36);
Ex. 1095 ¶ 48 (discussing, inter alia, the releasable engagement between
dial mechanism 34 and nut 36).
Additionally, with respect to the remaining limitations of the tubular
clutch clause of claim 11 recited in the heading above, Patent Owner does
not dispute that button 32 is tubular and located adjacent a distal end of said
dose dial grip (i.e., Burroughs’s proximal portion 78 of dial mechanism 34).
Figure 14 of Burroughs, reproduced below, illustrates the tubular structure
of button 32.

Figure 14 “is a perspective view of the button.” Ex. 1013, 6:66. Figure 1 of
Burroughs, reproduced below, illustrates that button 32 is adjacent (i.e., next
to) proximal portion 78 (unlabeled, but it is located at the leftmost area
identified by numeral 34) of dial mechanism 34.
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Figure 1 “is a sectional assembly view” of Burroughs’s device. Id. at
6:40–41.
Accordingly, for the reasons discussed above, we find that Petitioner
has shown that Burroughs’s button 32 teaches the tubular clutch limitation of
claim 1.
viii. wherein said dose dial sleeve extends
circumferentially around at least a portion of said
tubular clutch.
Petitioner contends that “[f]igure 1 shows that dial mechanism 34 (the
dose-dial sleeve) extends circumferentially around at least a portion of
button 32 (the clutch).” Pet. 38 (citing See Ex. 1013, Fig. 1; Ex. 1011
¶ 188). Patent Owner does not contest Petitioner’s argument that Burroughs
teaches this limitation of claim 1. See, generally, PO Resp.
For the reasons explained by Petitioner above, which we expressly
adopt, we find that Petitioner has shown that Burroughs teaches the dose
knob limitation of claim 1, as recited above.23
3. Dependent Claims 2–6, 12–18, 20, 23, 26–30, 32, 33, 36, and
38–40
Claims 2–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38–40 ultimately
depend from claim 1. Ex. 1003, 7:14–9:31. Petitioner contends that

23 Additionally, we find that Patent Owner has waived any argument for
patentability directed to this limitation of claim 1. See Paper 29, 8.
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Burroughs teaches or renders obvious the additional limitations recited in
these claims. Pet. 40–67. 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 1. See generally PO Resp.; see
also Pet. Reply 1 (noting that Patent Owner only argues claim 1 leaving the
remaining claims to stand or fall therewith).
We have reviewed Petitioner’s argument and evidence cited in
support thereof, which we expressly adopt. See Pet. 40–67. Based on the
reasons set forth by Petitioner and the evidence in support thereof, see id.,
we find that Petitioner has shown that Burroughs teaches the additional
limitations recited in claims 2–6, 12–18, 20, 23, 26–30, 32, 33, 36, and
38–40.
4. Indicia of Nonobviousness
a. Nexus
Objective indicia of nonobviousness are “only relevant to the
obviousness inquiry ‘if there is a nexus between the claimed invention and
the [objective indicia of nonobviousness].’” In re Affinity Labs of Tex., LLC,
856 F.3d 883, 901 (Fed. Cir. 2017) (quoting Ormco Corp. v. Align Tech.,
Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006)). For objective indicia of
nonobviousness to be accorded substantial weight, their proponent must
establish a nexus between the evidence and the merits of the claimed
invention. ClassCo, Inc., v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir.
2016). “[T]here is no nexus unless the evidence presented is ‘reasonably
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commensurate with the scope of the claims.’” Id. (quoting Rambus Inc. v.
Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)).
A patentee is entitled to a presumption of nexus “when the patentee
shows that the asserted objective evidence is tied to a specific product and
that product ‘embodies the claimed features, and is coextensive with them.’”
Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019)
(quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed.
Cir. 2018) (quoting Brown & Williamson Tobacco Corp. v. Philip Morris
Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000))). On the other hand, the
patentee is not entitled to a presumption of nexus if the patented invention is
only a component of a commercially successful machine or process. Id.
(reaffirming the importance of the “coextensiveness” requirement).
“[T]he purpose of the coextensiveness requirement is to ensure that
nexus is only presumed when the product tied to the evidence of secondary
considerations ‘is the invention disclosed and claimed.’” Id. at 1374
(quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387,
1392 (Fed. Cir. 1988)). “[T]he degree of correspondence between a product
and a patent claim falls along a spectrum. At one end of the spectrum lies
perfect or near perfect correspondence. At the other end lies no or very little
correspondence.” Id. “A patent claim is not coextensive with a product that
includes a ‘critical’ unclaimed feature that is claimed by a different patent
and that materially impacts the product’s functionality.” Id. at 1375.
However, “[a] finding that a presumption of nexus is inappropriate
does not end the inquiry into secondary considerations.” Fox Factory, 944
F.3d at 1373. “To the contrary, the patent owner is still afforded an
opportunity to prove nexus by showing that the evidence of secondary
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considerations is the ‘direct result of the unique characteristics of the
claimed invention.’” Id. at 1373–74 (quoting In re Huang, 100 F.3d 135,
140 (Fed. Cir. 1996)). “Where the offered secondary consideration actually
results from something other than what is both claimed and novel in the
claim, there is no nexus to the merits of the claimed invention,” meaning that
“there must be a nexus to some aspect of the claim not already in the prior
art.” In re Kao, 639 F.3d 1057, 1068–69 (Fed. Cir. 2011) (emphasis in
original). On the other hand, there is no requirement that “objective
evidence must be tied exclusively to claim elements that are not disclosed in
a particular prior art reference in order for that evidence to carry substantial
weight.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1331 (Fed. Cir. 2016).
A patent owner may show, for example, “that it is the claimed combination
as a whole that serves as a nexus for the objective evidence; proof of nexus
is not limited to only when objective evidence is tied to the supposedly
‘new’ feature(s).” Id. at 1330.
Ultimately, the fact finder must weigh the secondary considerations
evidence presented in the context of whether the claimed invention as a
whole would have been obvious to a skilled artisan. Id. at 1331–32. Once
the patentee has presented a prima facie case of nexus, the burden of coming
forward with evidence in rebuttal shifts to the challenger “to adduce
evidence to show that the commercial success was due to extraneous factors
other than the patented invention.” Demaco, 851 F.2d at 1393.
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Patent Owner contends that “Sanofi’s LANTUS® SoloSTAR®24
product practices claim 1” of the ’486 Patent. PO Resp. 45 (citing Ex. 2107
¶¶ 513–550). According to Patent Owner,
As explained by Prof. Slocum, the inventions in the challenged
claims describe a set of components that elegantly work together
to provide the user a mechanical device that is easy to use and
includes a combination of desirable features and properties, such
as (i) low injection force, (ii) short injection stroke length or
higher maximum dose per injection, and (iii) a relatively small
number of components that decrease the complexity of the
device.
Id. (citing Ex. 2107 ¶ 650) (emphasis added). Patent Owner, again relying
on the testimony of Prof. Slocum, contends that “the claimed components
and interfaces, such as the threaded engagements, piston rod, driver, and
tubular clutch, are reflected in the LANTUS® SoloSTAR®” device. Id.
(citing Ex. 2107 ¶¶ 513–550). Patent Owner does not explain sufficiently,
however, how these components of the claimed invention embody the
desirable features and properties. See, generally, 45–55; see also
PO Sur-Reply 12–20.
Petitioner notes that Patent Owner “provides identical secondary
consideration arguments without differentiating among claims-at-issue or
patents-at-issue.”25 Pet. Reply 13 (citing Ex. 1060 ¶¶ 36–37, Attachment
B-1; Ex. 1055, 53:9–12). According to Petitioner, Patent Owner’s “failure
to differentiate between claims and patents undermines its secondary

24 As noted by Patent Owner, “LANTUS® is the commercial name for
Sanofi’s insulin glargine formulation, and LANTUS® SoloSTAR® is the
commercial name for LANTUS® packaged in the SoloSTAR® pen injector.
PO Resp. 45, n. 4.
25 We understand Petitioner to be referring to the patents and their claims at
issue in the related proceedings detailed in Section II.A above.
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considerations case.” Id. Noting that Patent Owner “does not argue that
[LANTUS® SoloSTAR®] practices all challenged claims, just claim 1,”
Petitioner asserts that “the claim does not require [LANTUS®] (or insulin at
all), an 80-unit cartridge, a short stroke length, or a low injection force. Id.
“Sanofi’s argument ignores the claims and fails to apportion any secondary
consideration to the active ingredient.” Id. On this basis, Petitioner asserts
that the claims “are not entitled to a presumption of nexus because
LANTUS® SoloSTAR® is not ‘the invention.’” Id.
In its Sur-Reply, Patent Owner asserts that it “showed how
SoloSTAR® practices certain challenged claims.” PO Sur-Reply 14 (citing
Ex. 2107 ¶¶ 551–611). Patent Owner contends, that Petitioner “provide[s]
no credible evidence rebutting these facts, or the fact that the challenged
claims enable SoloSTAR®’s low injection force and other features
identified in the [Patent Owner] Response.” Id. (citing Pet. Reply 20).
Patent Owner asserts the indicia of nonobviousness support a showing
of long-felt need, industry praise, and commercial success. We discuss
Patent Owner’s showing with respect to nexus and each of these alleged
secondary considerations in turn below.
b. Long-felt Need
Patent Owner contends that “diabetic patients need an easy-to-use
injection device with a low injection force to reduce the burden on the
patient and increase the likelihood of the patient adhering to their prescribed
therapy.” PO Resp. 46 (citing Ex. 2111 ¶¶ 24–26). According to Patent
Owner, “[p]rior to the launch of LANTUS® SoloSTAR®, there were
multiple injection pens on the market for administering insulin or an insulin
analog . . . These injection pens, however, had numerous shortcomings and
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design flaws that resulted in significant injection force.” Id. at 46–47. In
support, Patent Owner cites the testimony of Dr. Goland discussing these
shortcomings. Id. at 47 (citing Ex. 2111 ¶¶ 33–35. Patent Owner asserts
that “[t]he LANTUS® SoloSTAR® revolutionized the injection pen market,
in large part because the LANTUS® SoloSTAR® was easy to use.” Id.
(citing Ex. 2142).
In an effort to show nexus to the claimed invention, Patent Owner
submits that “the primary intent of the invention is to address these specific
problems in the prior art – ‘The illustrated embodiment . . . helps reduce the
overall force required for a user to cause medicinal product to be
dispensed.’” PO Resp. 48 (citing Ex. 1003, 3:64–67). Patent Owner
submits further that “[s]urprisingly it was found that the drive mechanism
according to instant invention without having a unidirectional coupling
provides a valuable technical alternative for drive mechanisms, wherein
reduced force is needed to actuate the mechanism.’”26 Id. (citing Ex. 1003,
1:66–2:3). Patent Owner also directs our attention to “a statement by
endocrinologist Sjoberg Kho of the University of Santo Tomas Hospital that
‘self-injection can be a barrier to acceptance of insulin therapy. However,
the LANTUS® SoloSTAR[®] operates with a low injection force 31 percent
less than other insulin pens that allows a gentle injection’” and “a statement
by Denis Raccah, Professor of Endocrinology, University Hospital Sainte
Marguerite, France, that, ‘Insulin injection with SoloSTAR® brings

26 We note that this language does not appear in the ’486 patent. Rather, it
appears in the ’008 patent at issue in related IPR2018-01684. We note that
in the sentence following the quoted sentence, the ’008 patent attributes this
reduction in force to the clutch means. Ex. 1005, 2:3–7.
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flexibility, satisfaction for the patients, and an opportunity for earlier
initiation of insulin therapy which may contribute to better long term
glycemic control.’” Id. at 48–49 (citing Ex. 2184, 2; Ex. 2185, 1). In
addition, Patent Owner asserts that “7 out of 10 patients now prefer the
lower injection force of SoloSTAR® to competitor products and in 2008 it
accounted for “41% of all growth in the global injectable insulin market.’”
Id. at 49 (citing Ex. 2121, 2, 9).
Petitioner replies that, according to the testimony of Dr. Biggs, ‘“there
was no long-felt unmet need for another insulin pen.’” Pet. Reply. 21
(quoting Ex. 1048 ¶ 39). Petitioner also argues that “[i]n more than 30 years
of practice, Dr. Goland never heard from a patient wishing they had a pen
with low injection force, never saw using a syringe prevent a patient from
taking LANTUS®, and never prescribed an insulin solely based on its pen.”
Id. (citing Ex. 1056, 52:6–9, 71:4–16). According to Petitioner, “[i]n
contrast to Sanofi-sponsored injection force studies, (EX2143.010;
EX2144.010; EX2100.006; EX2126.004; EX2116.009; EX2123.007;
EX1048, ¶58), other studies found [SoloSTAR®] did not have a lower
injection force.” Id. at 21–22 (citing omitted). Petitioner asserts further that
Patent Owner’s self-funded, self-authored, or self-edited publications “do
not demonstrate industry recognition of an unmet need.” Id. at 23 (citing
Ex. 2128.009; Ex. 2123.007; Ex. 2185).
Patent Owner asserts that, according to Dr. Goland, SoloSTAR® was
preferred over OptiClik®, earlier FlexPen[®]s were hard to push, and some
patients did not take their insulin because prior art devices were
problematic.” PO Sur-reply 18–19 (citing Ex. 1056, 34:3–17, 35:16–12).
Patent Owner also replies that Dr. Goland transitioned patients to
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SoloSTAR® because of its lower injection force. Id. at 19 (citing Ex. 1056,
66:9–15).
According to Patent Owner, Mr. Leinsing acknowledges a focus on
reducing injection force. PO Sur-Reply 19 (citing Ex. 2316, 80:24–81:1).
Patent Owner also argues that Dr. Biggs suggests “any long-felt need was
satisfied by the L[ANTUS]® vial and syringe, that patients complaining of
injection force could have caregivers . . . administer their treatments . . ., and
that patients could carry around . . . preloaded syringes,” but Dr. Goland
disagrees, opining that those suggestions would be disliked by patients. Id.
(citing Ex. 1048 ¶¶ 31–32; Ex. 1056, 52:23–53:25, 58:18–59:24; Ex. 2317,
70:10–19, 84:24–85:14). Patent Owner further argues that Dr. Biggs’s
testimony is undermined by his admission that his suggestions may not be
covered under Medicare or insurance and that the majority of his patients
switched from [LANTUS®] vial to [LANTUS® SoloSTAR®], which most
patients preferred. Id. (citing Ex. 2317, 115:23–116:6, 118:19–22).
We agree with Petitioner that Patent Owner fails to establish nexus
between evidence of the alleged long-felt need for a pen with a reduced
force requirement and the claims at issue in this proceeding. Although,
Patent Owner has provided evidence supporting its position that the asserted
objective evidence of long-felt need is tied to a specific product (i.e.
LANTUS® SoloSTAR[®]), Patent Owner has not demonstrated that this
product “embodies the claimed features, and is coextensive with them.” Fox
Factory, 944 F.3d at 1373. Specifically, Patent Owner has not sufficiently
explained how the limitations set forth in the claims at issue satisfy the
alleged long-felt need by identifying where these claims require low
injection force as compared to other pens. For this reason, Patent Owner is
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not entitled to the presumption of nexus. For the same reasons, Patent
Owner has not demonstrated nexus for this secondary consideration.
Moreover, even if we assume nexus, Patent Owner fails to sufficiently
demonstrate a long-felt need for a pen with a low injection force. “Long-felt
need is closely related to the failure of others. Evidence is particularly
probative of obviousness when it demonstrates both that a demand existed
for the patented invention, and that others tried but failed to satisfy that
demand.” Eurand, Inc. v. Mylan Pharms., Inc. (In re Cyclobenzaprine
Hydrochloride Extended-Release Capsule Patent Litig.), 676 F.3d 1063,
1082 (Fed. Cir. 2012). Establishing a long-felt need requires objective
evidence that the invention has provided a long-awaited, widely accepted,
and promptly adopted solution to a problem existent in the art, or that others
had tried but failed to solve that problem. See In re Mixon, 470 F.2d 1374,
1377 (CCPA 1973). Furthermore, one must demonstrate that “widespread
efforts of skilled workers having knowledge of the prior art had failed to find
a solution to the problem.” In re Allen, 324 F.2d 993, 997 (CCPA 1963).
Patent Owner’s evidence demonstrates acceptance of the LANTUS®
SoloSTAR® pen. See, e.g. Ex. 2184, 1; Ex. 2185, 1; Ex. 2121, 6. It does
not, however, demonstrate a long awaited need for such a pen. Rather,
Patent Owner’s evidence demonstrates that “[p]rior to the launch of
LANTUS® SoloSTAR®, there were multiple injection pens on the market
for administering insulin or an insulin analog – e.g., Levemir® FlexPen®
and LANTUS® OptiClik® in the long-acting category, and the Humalog®
KwikPen® in the rapid-and intermediate-acting categories, among many
others.” PO Resp. 54. Patent Owner’s evidence does not show that others
tried and failed to make such a pen. While, Patent Owner’s evidence may
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demonstrate that the LANTUS® SoloSTAR® pen is an improvement over
prior art pens, such evidence is insufficient to establish a long-felt need for
this pen.
c. Industry Praise
Patent Owner submits evidence of awards won by its LANTUS®
SoloSTAR® product. See PO Resp. 49–51. Specifically, Patent Owner
directs our attention to evidence indicating that “SoloSTAR[®] won the
Gold, International Export, and Grand Prix awards at the Design Business
Association (DBA) Design Effectiveness Awards” in 2009. Id. at 49–50
(citing Ex. 2121). According to Patent Owner, “[t]he DBA is a design
organization based in the UK that is interested in how a design commercially
impacts a company’s business.” Id. at 50. Patent Owner asserts that “[t]he
case study of [SoloSTAR®] for the DBA Awards describes the
[SoloSTAR®]’s inventiveness as ‘suitably ambitious’ and explains that
‘SoloSTAR® is the first disposable insulin pen to combine very low
injection force (which provides a smooth injection experience for patients)
with 80 units maximum dose capability, an important breakthrough.’” Id.
(citing Ex. 2121, 3).
Patent Owner submits further that SoloSTAR® “also won the Good
Design Award by the Chicago Athenaeum Museum of Architecture and
Design.” PO Resp. 50 (citing Ex. 2201). According to Patent Owner, “[i]n
connection with this award, and as recognition of its inventiveness, the
[LANTUS]® SoloSTAR® . . . device[] was put into the permanent Design
Collection of the Chicago Athenaeum Museum of Architecture and Design.”
Id. at 50–51(citing Ex. 2109 ¶ 73). Patent Owner also submits that “at the
Prix Galien USA 2009 Award, which “recognize[s] innovative
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biopharmaceutical drugs and medical technologies” and “is considered the
industry’s highest accolade for pharmaceutical research and development —
equivalent to the Nobel Prize,” Sanofi and DCA were both finalists.” Id. at
51 (citing Ex. 2109 ¶ 74).
Petitioner contends that “[n]one of the cited documents establish
industry praise for the claimed invention. Pet. Reply 23. Noting that Patent
Owner “relies on a ‘case study of SoloSTAR[®] submitted to the DBA,
implying the DBA awards recognized SoloStar[®]’s ‘inventiveness,’”
Petitioner asserts that “this ‘case study’ was written, funded, and sponsored
by [Patent Owner] (with [SoloSTAR®] designer DCA27).” Id. (citing Ex.
1060 ¶¶ 57–58; Ex. 1075). Thus, according to Petitioner, “[i]t is self-praise,
not industry praise. Id. (citing Ex. 1055, 79:6–81:19).
Regarding the Good Design Award, Petitioner contends that “[t]he
document Sanofi cites does not attribute the award to ‘inventiveness.’ Nor
does the statement that SoloSTAR[®] ‘represents a design for social good.’”
Pet. Reply at 24 (citing PO Resp. 50). Petitioner contends further that
“[n]either the document nor the statement praises what is claimed or the
features (e.g., low injection force) Sanofi argues uniquely flow from what is
claimed.” Id. (citing Ex. 1060 ¶¶ 59–60). Finally, regarding the Prix Galien
USA 2009 Award, Petitioner contends that the fact that Sanofi and DCA
were finalists for this award “fails to demonstrate . . . that [SoloSTAR®]
was ‘inventive,’ much less that the claims were inventive.” Id. (citing Ex.
1060 ¶ 60).

27 According to Patent Owner, DCA is “the design firm with whom [it]
partnered in creating SoloSTAR®.” PO Resp. 49.
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Again, we agree with Petitioner. Patent Owner fails to demonstrate
nexus between the evidence of industry praise and the claims at issue in this
proceeding. The evidence provided indicates that LANTUS® SoloSTAR®
received industry praise based on its visual design and its combination of
low injection force and large maximum dose capability. See, e.g. Ex. 2121,
2–3, 5. But, these features are not coextensive with the claims of the ’486
patent, because the claims do not require low injection force in combination
with high maximum dose capability.
Moreover, even if we assume Patent Owner has demonstrated nexus
between the alleged industry praise and the claims at issue, much of the
praise was generated by Sanofi’s affiliate DCA. See, e.g. Ex. 1055, 76–79.
Such self-generated praise is not persuasive of industry praise. Further, the
evidence independent of DCA, such as consideration of LANTUS®
SoloSTAR® for the Prix Galien USA 2009 award only generally specifies
the criteria used to judge the nominees. Ex. 2142, 2. It does not evidence
industry praise of any specific feature of the claimed invention. Id.
d. Commercial Success
Patent Owner submits that “[t]he tremendous commercial success of
LANTUS® SoloSTAR® is further objective evidence of non-obviousness.”
PO Resp. 51. In support, Patent Owner asserts that “[t]he commercial
success is demonstrated by the contribution of LANTUS® SoloSTAR® to
the growth of the LANTUS® franchise overall, and by the strong
performance of LANTUS® SoloSTAR® when compared to other long-
acting insulin and insulin analog pens.” Id. (footnote omitted). According
to Patent Owner, [t]he commercial success of LANTUS® SoloSTAR® is
also demonstrated by the overall levels and shares of dollar sales, new
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prescriptions, and total prescriptions, as well as the profitability and
formulary placement achieved by LANTUS® SoloSTAR®.” Id. at 52
(citing Ex. 2109 ¶ 12). Specifically, Patent Owner asserts that
the LANTUS® SoloSTAR® achieved the highest level of sales
among long-acting insulin and insulin analog pens even though
it launched after several other long-acting insulin and insulin
analog pens, including the Levemir® FlexPen® (the
commercial embodiment of Steenfeldt-Jensen), which was the
first long-acting insulin or insulin analog product available in a
disposable pen.
Id.
Anticipating one of Petitioner’s arguments, Patent Owner contends
that “[t]o the extent Petitioner argues that Patent Owner’s evidence of
commercial success is not due to the claimed invention, but rather, to factors
beyond the claimed invention such as, e.g., marketing, such arguments
should be rejected.” PO Resp. 53. Patent Owner submits that “Dr.
Grabowski analyzed marketing expenditures for long-acting insulin products
and determined that sales of LANTUS® SoloSTAR® exceeded sales for
other well-marketed long-acting insulin products despite the fact that ‘[t]otal
marketing expenditures for LANTUS® SoloSTAR® were in line with, or
were lower than, many other long-acting insulin products.’” Id. at 53–54
(citing Ex. 2109 ¶¶ 16, 64–69).
Anticipating a different argument, Patent Owner contends that “to the
extent Petitioner argues that Patent Owner’s evidence of commercial success
is due to alleged ‘blocking patents’ covering the glargine molecule that is
used in the production of the active ingredient in [LANTUS]®, any such
argument would be misplaced.” Id. at 54. According to Patent Owner, “the
law does not mandate across-the-board-discounting of commercial success
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simply because other patents cover components of the product” and “the
success of LANTUS® SoloSTAR® cannot be attributed solely to the insulin
glargine molecule because LANTUS® OptiClik® used the exact same
LANTUS® formulation and failed to achieve the success of SoloSTAR®.”
Id. at 53–54. In addition, Patent Owner asserts that its “earlier patents on the
insulin glargine molecule did not prevent others from entering the market for
non-glargine, long-acting insulin products and competing with LANTUS®
SoloSTAR® . . . numerous other competitive pen devices existed prior to
LANTUS® SoloSTAR®. The Levemir[®] FlexPen[®], for example, was a
disposable pen device that delivered long-acting insulin.” Id. at 55.
Petitioner disagrees, contending that Patent Owner “provides no
benchmarks for evaluating success, applies a faulty ‘pens only’ market
definition, and formulary status does not separately demonstrate commercial
success.” Pet. Reply 24 (citing Ex. 1060 ¶¶ 17–22, 25–28). As an example,
Petitioner contends that “Dr. Grabowski relies on a misleading 8,000%
growth rate for [SoloSTAR®] when, as Dr. McDuff points out, the failed
OptiClik[®] pen similarly enjoyed an 8,000% growth rate in its first three
years.” Id. at 25 (citing Ex. 1060 ¶ 20). According to Petitioner, “Dr.
Grabowski argues LANTUS® [SoloSTAR®]’s commercial success is
supported by the ‘strong performance’ of Apidra[®] [SoloSTAR®],
Toujeo[®] [SoloSTAR®], and Admelog[®] [SoloSTAR®], even though
peak annual sales of Apidra[® [SoloSTAR®] and Admelog[®
[SoloSTAR®] fall below the sales of LANTUS® OptiClik[®] that he
describes as ‘deficient.’” Id. (citing Ex. 1060 ¶ 70–71). Petitioner contends
further that Patent Owner “inappropriately excluded insulin injectable
products from its market share analyses to inflate LANTUS®
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[SoloSTAR®]’s market share 2–3 times.” Id. (citing Ex. 1060 ¶ 25–27). In
response, Petitioner asserts that Patent Owner’s “commercial success
arguments thus improperly take LANTUS® [SoloSTAR®]’s commercial
performance out of context.” Id.
Responding to Patent Owner’s contention that “[LANTUS®]
SoloSTAR®] sales and prescriptions remained strong despite the entry of
several competing long-acting insulin pen products beginning in 2015,”
Petitioner asserts that “introduction of competing Basaglar[®] and
Tresiba[®] long-acting insulin products completely changed the trajectory of
both the [LANTUS®] and Toujeo[® SoloSTAR®] products without
practicing the claims-at-issue.” Pet. Reply 25 (citing Ex. 1060 ¶¶ 30–35, 64;
Ex. 1055, 96:13–20). According to Petitioner, “Dr. Grabowski himself
previously explained that generic entry of a biologic is expected to have less
and a slower impact on the sales of the existing biologic than it would have
for a small molecule because of biologics’ increased manufacturing costs”
and “Dr. Goland confirmed that existing diabetes patients are particularly
reluctant to switch to a different insulin product.” Id. at 25–26 (citing Ex.
1055, 143:10–144:10; Ex. 1056, 71:17–22). As a result, Petitioner asserts
that “[t]he change in trajectory for [LANTUS®] and Toujeo[®
SoloSTAR®] product performance upon introduction of competing long-
acting insulins provides strong evidence that [SoloSTAR®] itself is not a
commercial success. Id. at 26.
Petitioner also contends that “[LANTUS®] [SoloSTAR®] overtook
Levemir[®] FlexPen[®] not because of any unique [SoloSTAR®] attributes,
but because of what it shared in common with OptiClik[®]: [Patent Owner]
selected it as the exclusive [LANTUS®] pen in the United States.” Pet.
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Reply 26 (citing Ex. 1048 ¶¶ 20–22, 30–35). According to Petitioner,
“Levemir[®] launched almost five years after [LANTUS®], and the first
Levemir[®] pen (FlexPen[®]) launched more than a year after the first
[LANTUS®] pen (OptiClik[®]).” Id. (citing Ex. 2186). Consequently,
“[LANTUS®] OptiClik[®]® had twice as many prescriptions in 2007 as
Levemir[®] FlexPen[®]” which, Petitioner asserts, accounts for
[LANTUS® SoloSTAR®]’s alleged commercial success. Id. (citing Ex.
2198).
Patent Owner replies that “Petitioner’s own data demonstrates that
L[ANTUS]® SoloSTAR® has been the number one prescribed insulin or
insulin analog product with the greatest market share in every year since
2014, and is overall the third most-prescribed insulin product of the last
twenty years.” PO Sur-Reply 12 (citing Ex. 1060, Attachment B-10; Ex.
2318, 33:7–36:3). Patent Owner contends that “Petitioners’ own economist
Dr. McDuff acknowledged the billions of dollars in sales of SoloSTAR®
and admitted that a separate profitability analysis was not required to prove
its commercial success.” Id. at 13 (citing Ex. 2318, 15:10–13, 28:7–19,
29:20–30:18; In re Sernaker, 702 F.2d 989, 996 (Fed. Cir. 1983)). Patent
Owner asserts further that even considering the much broader market that
Petitioners identify, “SoloSTAR® still has the largest market share of any
insulin product.” Id. (citing Ex. 1060, Attachment B-10; Ex. 2318,
31:14–17, 31:25–32:8). Patent Owner also asserts that “while SoloSTAR®
and OptiClik® enjoyed similar growth rates in their first four years on the
market, even though OptiClik® was an inferior pen, . . . the number of
SoloSTAR® prescriptions more than quadrupled that of OptiClik® in the
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first four years of each product’s respective launch.” Id. (citing Ex. 1060,
Attachment B-10; Ex. 2318, 18:23–19:20).
Turning to Petitioner’s argument that formulary placement does not
demonstrate commercial success, Patent Owner contends that “Petitioners do
not deny that SoloSTAR® enjoys favorable placement in health plans, and
its economist Dr. McDuff admitted that SoloSTAR®’s mechanical features
and attributes would have contributed to that favorable placement. PO
Sur-Reply 14 (citing Ex. 2318, 33:7–36:3).
Central to Patent Owner’s allegations regarding commercial success is
its assertion that the LANTUS® SoloSTAR® pen embodies the claimed
invention.28 PO Resp. 45. We, however, for reasons similar to those
discussed in Sections III.D.10.b–c above, are not convinced that this is the
case. Patent Owner contends that “[t]he tremendous success of
[LANTUS]® SoloSTAR®, as compared to pens with long-acting insulins
that failed to address the long-felt but unfilled need for a low injection force
device” demonstrates “a strong nexus with the claimed invention.” PO
Resp. 55. Patent Owner, however, has not sufficiently demonstrated that
this “tremendous success” can fairly be attributed to claimed invention
which does not require low injection force or insulin, let alone LANTUS®’s
long-acting insulin formulation.
Even if we assume nexus, Patent Owner has not sufficiently
demonstrated commercial success. Both Patent Owner and Petitioner rely
on the evidence in Attachment B-10 to the Declaration of Deforest McDuff,
Ph.D. (Ex. 1060) submitted by Petitioner. See, e.g. Pet. Reply 28; see also

28 We note that the claims do not require “LANTUS®.”
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PO Sur-Reply 18. Attachment B-10 presents total prescription data by year
for 40 insulin delivery products for the 20 year period 1999–2019. Ex.
1060, Attachment B-10. It also provides corresponding market share data
for that same time period. Id. The data presented in this table is the most
pertinent evidence regarding commercial success provided in this
proceeding. Patent Owner submits that it demonstrates commercial success
of the LANTUS® [SoloSTAR®] pen, and thus, the claimed invention. PO
Sur-Reply 13. We find the evidence, at best, to be inconclusive.
Attachment B-10 shows that from the introduction of LANTUS® Vial
in 2002, until 2019, LANTUS® delivery products (i.e. LANTUS® Vial,
LANTUS® OptiClik®, and LANTUS® SoloSTAR®) were by far the most
proscribed insulin delivery devices. Ex. 1060, Attachment B-10. As shown,
from 2002 to 2011 prescriptions of LANTUS® Vial grew from roughly 1.3
to roughly 11 million prescriptions, while the most successful competing
products (Humulin and Novolog) each grew to prescription levels of roughly
5 million prescriptions. Id. Thus, Attachment B-10 clearly demonstrates the
commercial success of LANTUS® Vial during that time period. Attachment
B-10 also demonstrates that once LANTUS® OptiClik® was introduced,
prescriptions of LANTUS® Vial decreased as prescriptions of LANTUS®
OptiClik® increased, with the overall number of LANTUS® OptiClik®
prescriptions slowly, but steadily climbing. Id. We note that during the time
period that LANTUS® OptiClik® was the only alternative to LANTUS®
Vial, the number of LANTUS® Vial prescriptions essentially stayed the
same.
In 2008, LANTUS® SoloStar was introduced. Ex. 1060, Attachment
B-10. From 2008–2011, prescriptions of LANTUS® SoloSTAR® steadily
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rose while prescriptions of LANTUS® OptiClik® declined. Id. During this
time period, prescriptions of LANTUS® Vial continued to remain steady.
Id. Then in 2012, things changed. Id. First, prescriptions of LANTUS®
OptiClik® dropped off significantly. Id. By 2014, prescriptions of
LANTUS® OptiClik® dropped to a mere 382 prescriptions. Id. During the
time period from 2011–2016 (when prescriptions of LANTUS®
SoloSTAR® hit their peak), prescriptions of LANTUS® Vial began to
decrease at a rate of about 500,000 prescriptions per year. It is unknown
why prescriptions of LANTUS® Vial began to decline starting in 2012, but
it appears that they declined as the prescriptions of LANTUS SoloSTAR®
increased. Patent Owner submits that this is because of the superior features
of the LANTUS® SoloSTAR® pen. See PO Sur-Reply 19. Whereas,
Petitioner suggests that it was because of the introduction of competing
products. Pet. Reply 28 (citing Ex 1048 ¶¶ 30–35, 64). Regardless, the
evidence clearly shows that the number of LANTUS® SoloSTAR®’s
prescriptions peaked in 2016 and that most of the increase in prescriptions
for LANTUS® SoloSTAR® merely offset the decline in prescriptions for
LANTUS® Vial. Thus, the evidence does not support a showing of
commercial success for LANTUS® SoloSTAR®. Rather, it appears to
show a fairly stable number of prescriptions for LANTUS® products from
2009–2016, with a decline in those prescriptions from 2017–2019.
5. Conclusion re Indicia of Nonobviousness
Having considered all the indicia of nonobviousness submitted by
Patent Owner, we find that the evidence does not show nexus between the
claimed invention and long-felt need, industry praise, or commercial
success. In re Affinity Labs at 901.
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E. 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 1350, 1361 (Fed. Cir. 2017). On balance, considering
the record presently before us, we determine that Petitioner has shown, by a
preponderance of the evidence, that Burroughs would have rendered the
subject matter of claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38– 40
obvious to one of ordinary skill in the art at the time of the invention.
In particular, we find that Burroughs teaches or suggests each of the
limitations of claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38– 40. We
further find that one of ordinary skill in the art would have had a reason to
modify Burroughs in the manner suggested by Petitioner. Weighing these
findings with our determinations of the level of ordinary skill and the
objective indicia of nonobviousness in the record, a preponderance of the
evidence persuades us that claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and
38– 40 of the ’486 patent is unpatentable over Burroughs. Further, even if
nexus to the objective indicia of nonobviousness were assumed, we do not
find the proffered evidence of long-felt need, industry praise, or commercial
success to outweigh the case of obviousness in this proceeding.
F. Petitioner’s Motion to Exclude
Petitioner filed a motion to exclude Exhibits 2001–2015,
2017–202[4]29, 2026, 2100–2107, 2109, 2113–2115, 2117–2153,

29 In listing the Exhibits to which Petitioner objects, the Motion recites
exhibits “201–2023” after “2017. Mot. 1. All exhibit numbers, however,
are 4 digits. It appears that “201” should be deleted such that the Motion
recited 2017–2013. Further, although it is not included in the listing of the
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2158–2162, 2164, 2166–2183, 2185–2201, 2203–2212, 2214–2218, and
2223–2225, and the redirect testimony in Exhibit 1054. Paper 63 (“Mot.”),
1. Petitioner, as the “moving party,” “has the burden of proof to establish
that it is entitled to the requested relief.” 37 C.F.R. § 42.20 (2017).
a. Exhibits 2001–2011, 2017–2024, 2026
Petitioner contends that the above-listed exhibits should be excluded
pursuant to FRE 402 and 403 because they are “not relevant to any contested
issue in this proceeding.” Mot. 1–4. Patent Owner responds that “[t]hese
exhibits were offered to show information that was relevant to § 325(d)
issues raised during the preliminary stage of this proceeding.” Opp. 1. As
such, according to Patent Owner, “these exhibits do not lack relevance and
should remain in the record.” Id. Petitioner does not dispute that these
exhibits were relevant to the § 325(d) issues raised during the preliminary
stage of this proceeding. Mot. Reply 1. Instead, Petitioner argues that “the
exhibits are no longer relevant for any legitimate purpose.” Id. (citing 35
U.S.C. § 314(d)). Petitioner asserts that “[t]he papers should be excluded
under FRE 402–403 as irrelevant and likely to cause confusion.” Id.
Alternatively, Petitioner contends that “their admissibility should be limited
to the purpose for which they were submitted.” Id. (citing FRE 105).
As these exhibits were cited during this proceeding and we do not
wish to disturb the record by excluding them, Petitioner’s Motion is denied.
We do, however, agree with Petitioner that their use shall be limited to the
purpose for which they were submitted.

challenged exhibits, Petitioner argues that Exhibit 2024 should be excluded.
Id. 1, 3. Thus, “2017, 201–2023” should be read as 2017–2024.
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b. Exhibit 2012, 2117, 2124–2152, 2162, 2167, 2168, 2206, 2207,
2211, 2215–2218
Petitioner moves to exclude Exhibit 2012 under FRE 801–804
because it is offered “to show an animated operation of an embodiment of
the injection pen described in the ’486 patent.” Mot. 3 (citing Prelim. Resp.
32). According to Petitioner, “[t]he animation is hearsay because it is
offered for the truth of its content without satisfying any of the hearsay
exceptions.” Id. Petitioner makes similar allegations regarding Exhibits
2117, 2124–2152, 2162, 2167, 2168, 2206, 2207, 2211, and 2215–2218.
Mot. 9. Patent Owner contends that FRE 703 permits experts to rely upon
hearsay if reasonable to do so in the expert’s field. Opp. 1, 13. Petitioner
does not address this exhibit in its Motion Reply. See generally, Mot.
Reply.
Petitioner does not explain why it was not reasonable for Patent
Owner’s expert to rely on the animations. Thus, Petitioner has not satisfied
its burden to shown that these exhibits should be excluded.
c. Exhibits 2013–2015
Petitioner asserts that Exhibits 2013–2015 should be excluded under
FRE 801–804 because they are offered to define a claim term. Mot. 3
(citing Prelim. Reps. 39–40). Patent Owner agrees that these exhibits were
offered to show how a person of ordinary skill in the art would have
understood a claim term, but argues that the exhibits “are not hearsay
because they were offered to show the effect on the reader and/or the belief
of the author, not for the truth of the matter asserted.” Opp. 2. Petitioner
does not address these exhibits in its Motion Reply.
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As anyone who practices patent law understands, dictionary
definitions are routinely considered extrinsic evidence that may shed light on
the plain and ordinary meaning of a claim term. See, e.g., Phillips, 415 F.3d
1303, 1318 (Fed. Cir. 2005) (“Within the class of extrinsic evidence, the
court has observed that dictionaries . . . can be useful in claim
construction.”) (citation omitted). Additionally, for the reasons explained by
Patent Owner, notably that the definitions were not offered for the truth of
the matter asserted, we do not consider Exhibits 2013–2015 hearsay.
Accordingly, Petitioner’s Motion is denied with respect to Exhibits 2013–
2015.
d. 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. 4–6, 7–8. 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 4.
Second, that Dr. Slocum relied upon Mr. Veasey, one of the named
inventors of the ’486 patent, for certain data and a model used for various
calculations in Dr. Slocum’s declaration. Id. at 4–5. 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
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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. 6 (citing Ex. 1011 ¶ 106; Ex. 2107 ¶ 102). Additionally, Patent Owner
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. Opp. 6–7 (citations omitted). 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 7 (citing Ex. 2107 ¶¶ 25–61). Patent Owner also
contends Dr. Slocum documented his opinions with facts and data. Id. at 8.
Second, Patent Owner asserts that Petitioner’s criticism of
Dr. Slocum’s reliance upon the information and model obtained from
Mr. Veasey are unfounded. Opp. 8. 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 (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. Patent Owner raises additional arguments regarding the specific
discussions between Dr. Slocum and Mr. Veasey, but those arguments
appear directed to a model and data regarding issues raised in several of the
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related inter partes reviews, not this specific proceeding. See id. at 9–11
(discussing measurements of the FlexPen[®] and embodiments in another
reference not at issue in this proceeding).
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. 11 (citing Ex. 2226). Patent Owner further asserts that “the
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 3. Petitioner also asserts that
Patent Owner hid Mr. Veasey’s involvement in Dr. Slocum’s testimony
precluding Petitioner from cross-examining Mr. Veasey. Id.
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
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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
Dr. Slocum relied may be in doubt, e.g., Mr. Veasey’s potential bias as a
named inventor on the ’486 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 further 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.
e. Exhibits 2100–2102, 2104–2106, 2113–2115, 2118–2120, 2122,
2124–2127, 2129–2141, 2145–2153, 2158–2162, 2164, 2166–
2183, 2185–2200, 2203–2212, 2214–2218, 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
contends that Exhibits 2100–2102 and 2104–2106 are exhibits to the
deposition of Mr. Leinsing and are relevant because they “provide the
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necessary context for Mr. Leinsing’s cross-examination, which Petitioner
has not sought to exclude.” Opp. 3. 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. See generally, Mot. Reply.
The sole basis argued in Petitioner’s Motion for exclusion—that the
exhibits were not cited in Patent Owner’s Response—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.
f. Ex. 2103
Exhibit 2103 consists of hand-drawn annotations made by
Mr. Leinsing during his deposition in response to questions pertaining to
Petitioner’s proposed modifications to Burroughs’s device. Mot. 7; Opp. 5.
Petitioner contends that Patent Owner’s use of Exhibit 2103 “lacks
relevance, risks confusing the issues, is misleading, and is prejudicial.” Mot.
7. Petitioner complains that the exhibit “is offered to establish an actual
modification purported to be embodied by the annotations.” Id. Patent
Owner contends that the exhibit is relevant to Mr. Leinsing’s opinions
regarding modifying Burroughs, which is one of the central issues in this
proceeding. Opp. 5 (citing Ex. 2163, 189:3–15). Petitioner does not address
Patent Owner’s arguments in its Motion Reply.
We agree with Patent Owner that Exhibit 2103 is relevant to the
proceeding for the reason explained by Patent Owner. Additionally,
Petitioner’s argument does not provide any explanation as to why the exhibit
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risks confusing the issues, is misleading, or is prejudicial. Accordingly,
Petitioner’s Motion is denied with respect to Exhibit 2103.
g. Ex. 2109
Petitioner moves to exclude paragraphs 19, 20, 31, 35, 45, 49, 50, 52,
53, 56, 71, and 72 of Dr. Grabowski’s declaration (Ex. 2109) “under FRE
801–804 because they constitute hearsay to the extent they repeat and rely
on statements made in an interview.” Mot. 8. Petitioner asserts further that
they should also be excluded under FRE 702, 703, and 705 because these
paragraphs do 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. Petitioner also asserts that these
paragraphs “do not disclose the underlying facts and data, and do not set
forth the bases of their opinions. For example, Dr. Grabowski uses IMS
Health data to form his opinions, which data are not provided.” Id.
Patent Owner responds that “FRE 703 permits experts to rely upon
hearsay if reasonable to do so in the expert’s field. As Dr. Grabowski is a
pharmaceutical economist offering opinions on the commercial success of
the devices at issue, it was reasonable for him to rely upon a device expert
(Dr. Slocum) and an endocrinologist (Dr. Goland), both of whom are
reliable sources and were subject to cross-examination.” Opp. 12.
Patent Owner responds further that “Petitioners’ remaining objections
under FRE 702, 703, and 705 do not argue anything specific for Sanofi to
rebut, other than to state that Dr. Grabowski did not provide IMS Health data
with his declaration.” Opp. 13. Patent Owner notes that “Petitioners cite no
authority that a party must file every single document that an expert
considers in forming his opinions” and that “37 C.F.R. § 42.65(a) only
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requires that expert testimony disclose the underlying facts or data.” Id.
Patent Owner asserts that it complied with that rule. Id. Petitioner replies
that Patent Owner’s “position is contrary to the Board’s rules, which require
the expert’s testimony be given little or no weight” when the data underlying
that opinion is not available. Mot. Reply.4.
Petitioner has not shown that it was unreasonable for Dr. Grabowski
to rely on hearsay in this instance. Further, Petitioner’s argument that the
data underlying Dr. Grabowski’s testimony is not available goes to the
weight that testimony should be given, not to its admissibility. Accordingly,
Petitioner has not satisfied its burden to show that this exhibit should be
excluded.
h. Exhibits 2116, 2117, 2121, 2123, 2128, 2142–2144, 2175, 2184,
2185, 2201
Petitioner contends that the above-listed exhibits should be excluded
pursuant to FRE 402 and 403 because they “are irrelevant to the extent they
rely on an improper standard of obviousness and unclaimed features.” Mot.
9. Petitioner contends further that “[t]hese exhibits are also prejudicial and
confuse the issues as a result.” Id. Noting that Petitioner moves “to exclude
these exhibits as irrelevant because injection force and ease of use are
allegedly not required by the challenged claims,” Patent Owner asserts
further that “Petitioners’ contention that the challenged claims do not enable
low injection force is no basis to exclude these exhibits on relevancy
grounds” and that “as Dr. Grabowski is permitted to rely upon these exhibits
under FRE703, there is no basis to exclude them.” Opp. 14.
Petitioner responds that “case law holds that secondary considerations
cannot be based on unclaimed features.” Mot. Reply 5 (citing Fox Factory at
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6). According to Petitioner, “there is no claim construction issue to be
decided because Sanofi has never proffered the construction necessary to
make these exhibits relevant.” Id. Alternatively, Petitioner contends that
“exhibits should be limited to the purpose for which they were submitted
(showing the benefits of unclaimed features).” Id. (citing FRE 105).
Petitioner’s response does not address Patent Owner’s arguments.
Further, Petitioner has not shown that it was unreasonable for Dr. Grabowski
to rely on these exhibits. Thus, Petitioner has not satisfied its burden to show
that these exhibits should be excluded.
i. Exhibits 2223, 2224
Petitioner moves to exclude Exhibits 2223 and 2224 because they are
“offered to show secondary considerations.” Mot. 9. According to
Petitioner “[t] They are hearsay without exception, lack authentication, and
are unreasonably prejudicial because they are cited for a new purpose.” Id.
at 9–10. Patent Owner responds that Exhibit 2223 was cited in Dr.
Grabowski’s declaration and that Exhibit 2224 was presented to Dr. McDuff
during his deposition. Opp. 15. Patent Owner asserts further that “Dr.
Grabowski is permitted to rely upon E[xhibit] 2223 under FRE[]703, there is
no basis to exclude it” and there is no basis to exclude Exhibit 2224. Id.
Petitioner does not address these exhibits in its Motion Reply. See,
generally Mot. Reply.
Petitioner has not shown that it was unreasonable for Dr. Grabowski
to rely on Exhibit 2223 or adequately explained why Exhibit 2224 should be
excluded. Thus, Petitioner has not satisfied its burden to show that these
exhibits should be excluded.
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III. SUMMARY30
For the reasons discussed above, Petitioner has demonstrated, by a
preponderance of the evidence that claims 1–6, 12–18, 20, 23, 26–30, 32–33,
36, and 38–40 would have been obvious in view of Burroughs.
Additionally, although we deny Petitioner’s Motion to Exclude, we limit the
use of Exhibits 2001–2011, 2017–2024, and 2026 as described above.
The chart below summarizes our conclusions regarding the challenged
claims.

IV. ORDER

30 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).
Claim(s)
35
U.S.C.
§
References
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1–6, 12–18,
20, 23, 26–30,
32–33, 36,
38–40
103(a) Burroughs 1–6, 12–18,
20, 23, 26–30,
32–33, 36,
38–40

Overall
Outcome
1–6, 12–18,
20, 23, 26–30,
32–33, 36,
38–40

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After due consideration of the record before us, and for the foregoing
reasons, it is:
ORDERED that claims 1–6, 12–18, 20, 23, 26–30, 32–33, 36, 38–40
of the ’486 patent are held unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude
(Paper 63) is denied; and
FURTHER ORDERED that, because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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

For Patent Owner:
Elizabeth Stotland
Kathryn M. Kantha
William S. Ansley
Matthew d. Sieger
Adrian C. Percer
Sudip K. Kundu
Anish R. Desai
Brian C. Chang
WEIL, GOTSHAL & MANGES LLP
elizbeth.weiswasser@weil.com
kathryn.kantha@weil.com
sutton.ansley@weil.com
matthew.sieger@weil.com
adrian.percer@weil.com
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sudip.kindu@weil.com
anish.desai@weil.com
brian.chang@weil.com

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