Trials@uspto.gov
`571-272-7822
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`Paper No. 10
`Entered: October 4, 2023
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`NOVO NORDISK A/S,
`Patent Owner.
`
`IPR2023-00724
`Patent 10,335,462 B2
`
`
`Before JOHN G. NEW, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
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`
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`571-272-7822
`
`Paper No. 10
`Entered: October 4, 2023
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`NOVO NORDISK A/S,
`Patent Owner.
`
`IPR2023-00724
`Patent 10,335,462 B2
`
`
`Before JOHN G. NEW, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
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`IPR2023-00724
`Patent 10,335,462 B2
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`I.
`INTRODUCTION
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition (Paper 1,
`“Pet.”), seeking inter partes review of claims 1–10 U.S. Patent No.
`10,335,462 B2 (Ex. 1001, “the ’462 patent”). Novo Nordisk A/S (“Patent
`Owner”) filed a Preliminary Response. Paper 6 (“Prelim. Resp.”).
`In its Preliminary Response, Patent Owner requests that the Board
`exercise its discretion to deny institution under 35 U.S.C. §§ 325(d) and
`314(a). See Prelim. Resp. 59–67. Patent Owner also raises challenges to the
`merits of the grounds in the Petition. Id. at 14–59.
`After considering the arguments and evidence presented at this stage
`of the proceeding, we are persuaded that Petitioner has demonstrated a
`reasonable likelihood that it would prevail with respect to at least one claim
`challenged in the Petition. See 35 U.S.C. § 314(a). We also decline to
`exercise our discretion to deny institution under 35 U.S.C. §§ 325(d) or
`314(a). Accordingly, we institute inter partes review.
`
`BACKGROUND
`
`II.
`A. Real Parties in Interest
`Petitioner identifies Mylan Pharmaceuticals Inc., Mylan Inc., and
`
`Viatris Inc. as real parties in interest. See Pet. 1. Patent Owner identifies
`itself as the real party in interest, but also lists exclusive licensee Novo
`Nordisk Inc. See Paper 4, 1.
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`B. Related Matters
`Petitioner and Patent Owner identify the following litigations as
`related matters, the first three of which involve Petitioner as a defendant.
`Pet. 1–2; Paper 4, 1–2.
`
`1. Novo Nordisk Inc. v. Mylan Pharms. Inc., No. 22-cv-01040-
`CFC (D. Del.)
`2. In re Ozempic (Semaglutide) Patent Litigation, No. 22-md-
`3038-CFC (D. Del.)
`3. Novo Nordisk Inc. v. Mylan Pharms. Inc., No. 22-cv-00023
`(N.D.W. Va.)
`4. Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc., No. 1:22-
`cv-00295 (D. Del.) (dismissed on March 28, 2022)
`5. Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc., No. 1:22-
`cv-00294 (D. Del.)
`6. Novo Nordisk A/S v. Sun Pharm. Indus. Ltd., No. 1:22-cv-
`00296 (D. Del.)
`7. Novo Nordisk Inc. v. Zydus Worldwide DMCC, No. 1:22-cv-
`00297 (D. Del.)
`8. Novo Nordisk Inc. v. Dr. Reddy’s Laby’s Ltd., No. 1:22-cv-
`00298 (D. Del.)
`9. Novo Nordisk Inc. v. Alvogen, Inc., No. 1:22-cv-00299 (D.
`Del.)
`
`C. The ’462 Patent
`The ’462 patent issued on July 2, 2019, and is a continuation of an
`application filed June 21, 2013, now U.S. Patent No. 9,764,003, and claims
`priority from two provisional applications and two foreign applications, the
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`earliest of which was filed on July 1, 2012. Ex. 1001, codes (30), (45), (60),
`(63); 1:6–15.
`The ’462 patent relates to “use of long-acting GLP-1 peptides in
`certain dosage regimes for the treatment of type 2 diabetes, obesity, etc.”
`Ex. 1001, Abstr. The ’462 patent further describes one embodiment as
`follows:
`
`In one embodiment the invention relates to a method for
`a) reduction of HbA1c; b) prevention or treatment of type 2
`diabetes, hyperglycemia, impaired glucose tolerance, or non-
`insulin dependent diabetes; or c) prevention or treatment of
`obesity, reducing body weight and/or food intake, or inducing
`satiety; wherein said method comprises administration of a
`GLP-1 agonist to a subject in need thereof, wherein said GLP-1
`agonist i) has a half-life of at least 72 hours, wherein said half-
`life optionally is determined by Assay (II); ii) is administered to
`an amount of at least 0.7 mg per week, such an amount
`equivalent to at least 0.7 mg semaglutide per week; and iii) is
`administered once weekly or less often.
`
`Ex. 1001, 1:31–44.
`
`The sole example provided in the ’462 patent describes administering
`semaglutide, “a unique acylated GLP-1 peptide with a half-life of 160
`hours,” in order “to investigate HbA1c dose-response of once-weekly doses
`of semaglutide (five dose-levels) in subjects with type 2 diabetes. Safety,
`tolerability and pharmacodynamics of semaglutide versus placebo and open-
`label once-daily liraglutide were also investigated.” Ex. 1001, 20:66–21:5.
`
`Figure 1 set forth below shows the change in HbA1c from
`baseline at week 12 for Example 1. Ex. 1001, 22:5–7.
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`Fig. 1
`The analysis of the results in Figure 1 set forth above shows
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`“semaglutide (≥0.2 mg) dose-dependently reduced HbA1c from baseline
`(FIG. 1), and increased the likelihood of achieving HbA1c˂7% (p˂0.05 vs.
`placebo for doses ≥0.2 mg).” Ex. 1001, 22:2–5. The example also showed
`that “[b]ody weight was dose-dependently reduced from base-line by up to
`4.8 kg vs. placebo 1.2 kg (p˂0.1 for doses 13.8 mg).
`
`The ’462 patent concludes:
`
`Over 12 weeks, semaglutide dose-dependently reduced
`HbA1c and body weight. The effect of semaglutide 0.4 mg on
`glycaemic control and body weight was comparable to that of
`liraglutide 1.2 mg, while semaglutide ≥0.8 mg appeared to
`bring more subjects to target and provided better weight loss
`than liraglutide 1.8 mg. No semaglutide safety concerns were
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`identified. Dose escalation was not a major focus of this trial
`and it will be optimized in future clinical trials.
`Ex. 1001, 23:18–26.
`
`D. Challenged Claims
`The Petition challenges claims 1–10. See Pet. 4. Challenged claim 1 is
`the sole independent claim. See Ex. 1001, 35:42–44. Claim 1 is illustrative
`of the challenged claims. Claim 1 is reproduced below.
`1. A method for treating type 2 diabetes, comprising
`administering semaglutide once weekly in an amount of 1.0 mg
`to a subject in need thereof.
`Ex. 1001, 35:42–44.
`
`E. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability:
`Claim(s) Challenged
`35 U.S.C. §1
`Reference(s)/Basis
`1–3
`102(a), (e)
`WO4212
`1–3
`102(b)
`Lovshin3
`1–10
`103(a)
`WO421, ’424 publication4
`
`
`1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), included revisions to 35 U.S.C. §§ 102 and 103 that became
`effective on March 16, 2013, after the filing of the applications to which the
`’462 patent claims priority. Therefore, we apply the pre-AIA versions of
`Sections 102 and 103.
`2 Thomas Klein et al., WO 2011/138421 A1, published November 10, 2011
`(Ex. 1011, “WO421”).
`3 Julie A. Lovshin and Daniel J. Drucker, Incretin-based therapies for type 2
`diabetes mellitus, 5 NATURE REVIEWS/ENDOCRINOLOGY 262–269 (2009)
`(Ex. 1012, “Lovshin”).
`4 Tina B. Pedersen et al., US 2007/0010424 A1, published Jan. 11, 2007
`(Ex. 1016, “’424 publication”).
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`Claim(s) Challenged
`1–10
`1–10
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`35 U.S.C. §1
`103(a)
`103(a)
`
`Reference(s)/Basis
`WO537,5 Lovshin
`NCT657,6 NCT773,7 ’424
`publication
`
`Pet. 5.
`Petitioner further relies on the declarations of John Bantle, M.D.
`(Ex. 1003), William J. Jusko, Ph.D. (Ex. 1005), and Paul Dalby, Ph.D.
`(Ex. 1007) submitted with the Petition.
`
`Before turning to our analysis of these grounds, we address Patent
`Owner’s arguments that, notwithstanding the merits of Petitioner’s grounds,
`we should exercise discretion to deny institution under 35 U.S.C. §§ 325(d)
`and 314(a).
`
`III. DISCRETION UNDER 35 U.S.C. § 325(d)
`Patent Owner asserts that we should exercise our discretion under
`Section 325(d) to deny institution because:
`Petitioner relies on art that was expressly applied during
`prosecution of the ’462 and its parent (’003), is cited on the
`’462’s face, or is cumulative of such art. Petitioner further fails
`to address the multiple prior-art-based rejections issued during
`
`5 Jesper Lau et al., WO 2006/097537 A2, published Sept. 21, 2006
`(Ex. 1015, “WO537”).
`6 ClinicalTrials.gov, Clinical Trial No. NCT00696657, A Randomised
`Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to
`Placebo and Liraglutide, http://web.archive.org/web/20111020123620/https:
`//clinicaltrials.gov/ct2/show/NCT00696657 (Ex. 1013, “NCT657”).
`7 ClinicalTrials.gov, Clinical Trial No. NCT00851773, Safety, Tolerability,
`and Profile of Action of Drug in the Body of NN9536 in Healthy Male
`Japanese and Caucasian Subjects, https://web.archive.org/web/
`20090911011536/https://clinicaltrials.gov/ct2/show/NCT00851773
`(Ex. 1014, “NCT773”).
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`’003’s prosecution and misstates the Examiners’ findings
`during ’462’s prosecution, and thus also fails to meet its burden
`to show Examiner error material to the challenged claims’
`patentability.
`Prelim. Resp. 59.
`Section 325(d) provides that the Director may elect not to institute a
`proceeding if the challenge to the patent is based on prior art or arguments
`previously presented to the Office. The statute states, in pertinent part, “[i]n
`determining whether to institute . . . the Director may take into account
`whether, and reject the petition . . . because, the same or substantially the
`same prior art or arguments previously were presented to the Office.”
`35 U.S.C. § 325(d).
`The question of whether the petition presents art or arguments that are
`“the same or substantially the same” as art or arguments previously
`presented to the Office is a factual inquiry, which may be resolved by
`reference to the factors set forth in Becton, Dickinson.8 The precedential
`section of that decision sets forth the following non-exclusive factors (“BD
`Factors”) for consideration:
`(a) the similarities and material differences between the
`asserted art and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior art
`evaluated during examination;
`(c) the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for
`rejection;
`
`
`8 Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586,
`Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)
`(“Becton, Dickinson”).
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`(d) the extent of the overlap between the arguments made
`during examination and the manner in which Petitioner relies
`on the prior art or Patent Owner distinguishes the prior art;
`(e) whether Petitioner has pointed out sufficiently how the
`Examiner erred in its evaluation of the asserted prior art; and
`(f) the extent to which additional evidence and facts
`presented in the Petition warrant reconsideration of the prior art
`or arguments.
`Becton, Dickinson, Paper 8 at 17–18.
`Advanced Bionics9 sets out a two-part framework for analyzing these
`factors. In the first part, we consider factors (a), (b), and (d) to determine
`whether the art and arguments presented in the petition are the same or
`substantially the same as those previously presented to the Office. Advanced
`Bionics, Paper 6 at 8–10. “If, after review of factors (a), (b), and (d), it is
`determined that the same or substantially the same art or arguments
`previously were presented to the Office,” we then move on to the second
`part of the analysis to determine “whether the petitioner has demonstrated a
`material error by the Office” in view of factors (c), (e), and (f). Id.
`
`A. Advanced Bionics Part One
`Petitioner asserts that:
`The Examiner’s single rejection—considering claims differing
`significantly from those that ultimately issued—never
`considered, let alone applied, WO421, WO537, the ’424
`publication, NCT773 or Lovshin. Ex. 1002, 308–18. And with
`respect to NCT657—the only primary reference the Examiner
`considered—the Examiner materially misapprehended it.
`
`
`9 Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH,
`IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential)
`(“Advanced Bionics”).
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`WO421 and Lovshin both disclosed ranges of once-
`
`weekly doses of 0.1–1.6 mg that encompass the 1.0 mg dose
`now claimed. Ex. 1011; Ex. 1012. NCT773 disclosed a clinical
`trial using once-weekly doses of semaglutide with a maximum
`dose of 1.2 mg. Ex. 1014. WO537 disclosed details regarding
`semaglutide and specified methods of using it more broadly
`than NCT657. Ex. 1015. And the ’424 publication disclosed
`formulation components not detailed in NCT657. Compare
`Ex. 1016, with Ex. 1013.
`
`The Examiner’s single rejection of the claims concerning
`semaglutide focused on anticipation by NCT657 in view of
`post-priority date pharmacokinetic parameters. Ex. 1002, 312.
`The Examiner never considered WO421 or Lovshin, let alone
`analyzed their disclosed range of doses as related to
`anticipation.
`Pet. 59–61.
`Patent Owner responds that WO421 and WO537 were listed on an
`IDS and were indicated as being considered by the Examiner and WO537 is
`expressly discussed in the Specification of the ’462 patent. Prelim. Resp.
`60–61 (citing Ex. 1001, 9:43–45, 9:1–2, 21:8–9; Ex. 1002, 323). Therefore,
`Patent Owner asserts, these three references are “previously presented” art.
`Id. at 61.
`Patent Owner further asserts that the remaining references relied upon
`by Petitioner in the grounds presented here are cumulative of the “previously
`presented” references. Id. For instance, Patent Owner asserts Lovshin and
`previously-presented WO421 are both relied on as disclosing a range of
`once-weekly doses 0.1 to 1.6 mg of semaglutide, and NCT773 is also relied
`upon for its disclosure of once-weekly administration of semaglutide in
`discreet doses from 0.1 mg to 1.2 mg. Id. Finally, Patent Owner asserts that
`the ’424 publication, which Petitioner only relies upon for claims 4 through
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`10, is cumulative of WO537, which is listed on the face of the ’462 patent
`and is cited in its Specification. Id. at 61; see also id. at 62 (summary of how
`asserted references were previously presented).
`Petitioner responds:
`The Office never applied any of the Petition’s prior art
`combinations during prosecution of the ’00310 and ’462 patents.
`The Office never cited WO421, Lovshin, NCT773, WO537, or
`the ’424 publication. And though the Office cited a version of
`NCT657 as anticipating the originally filed claims of the ’462
`patent, it never applied that reference to the amended claims,
`which limited the dose of semaglutide to 1.0 mg, despite
`previously recognizing that NCT657 taught doses of
`semaglutide up to 1.6 mg.
`Reply 4.
`As Patent Owner points out, whether there was a “meaningful
`discussion” of the asserted art during the prosecution of the ’462 patent is
`not the test under Advanced Bionics first prong; the test is “whether the art
`and arguments presented in the petition are the same or substantially the
`same as those previously presented to the Office.” Advanced Bionics, Paper
`6 at 8–10. Here, there is no question that WO421 and WO537 were
`previously presented to the Office. See Ex. 1002, 323 (Examiner indicating
`both references cited in IDS were considered); Ex. 1001, code (56), 9:43–45,
`21:8–9 (citing and discussing WO537). Advanced Bionics, Paper 6 at 7–8
`(stating “[p]reviously presented art includes . . . art provided to the Office,
`such as on an Information Disclosure Statement (IDS)”).
`
`
`10 U.S. Patent No. 9,764,003 B2 (“the ’003 patent”) is the parent of the ’462
`patent. See Ex. 1001, code (63).
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`There is also no question that a version of NCT657 was applied in a
`rejection of the originally filed claims of the ’462 patent, recognizing as
`Petitioner asserts in Ground 5 that NCT657 teaches “the use of semaglutide
`to treat diabetes at several different doses.” Reply 3 (citing Ex. 2001, 339–
`349, 398–412, 438–450); Pet. 55 (stating “NCT657 and NCT773 both
`disclosed semaglutide as a once-weekly treatment for type 2 diabetes in
`clinical trials where doses spanned between 0.1–1.6 mg in NCT657 and 0.1–
`1.2 mg in the later NCT 773 trial”) (citing Ex. 1003 ¶¶ 140, 145, 398; Ex.
`1005 ¶¶ 277–293; Ex. 1013, 15–16; Ex. 1014, 7). Therefore, we find that
`NCT657 was “previously presented” to the Office.
`We also agree with Patent Owner that Lovshin is cumulative of
`WO421 because both references are offered by Petitioner as teaching
`administering semaglutide at once-weekly doses between 0.1 and 1.6 mg.
`Pet. 6–7 (stating WO421 and Lovshin taught using semaglutide in the dose
`range of 0.1 to 1.6 mg to treat diabetes). Finally, we address whether the
`’424 publication, asserted for dependent claims 4–10, is cumulative of
`WO537, and whether NCT773 is cumulative of NCT657 as asserted by
`Patent Owner. See Prelim. Resp. 61–62.
`Patent Owner asserts that the ’424 publication is cumulative to
`WO537 without further explanation. See Prelim. Resp. 61. Petitioner states
`that challenged claims 4–10 relate to formulations of semaglutide that are
`“straightforward” and relies on the ’424 publication as describing
`formulations “as suitable for any peptide, including GLP-1 and analogues
`thereof.” Pet. 48. Petitioner relies on WO537 for its more specific teachings
`of once-weekly administration of semaglutide to treat type 2 diabetes and its
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`formulations. Pet. 50. Therefore, we determine that the ’424 publication is
`not cumulative of WO537.
`We also determine that NCT773 is not cumulative of NCT657. Each
`of these involves different phases of clinical trials, Phase I and II, that
`Petitioner relies on for disclosing “semaglutide as a once-weekly treatment
`for type 2 diabetes in clinical trials where doses spanned between 0.1–1.6
`mg in NCT657 and 0.1–1.2 mg in the later NCT773 trial.” Pet. 55 (citing
`Ex. 1003 ¶¶ 140, 145, 398; Ex. 1005 ¶¶ 277–293; Ex. 1013, 15–16;
`Ex. 1014, 7). Petitioner uses the tighter dose range in NCT773 excluding the
`1.6 mg maximum does of the NCT657 trial to assert that “[t]his data point
`would have provided POSAs additional reason to believe a 1.0 mg once-
`weekly dose would be efficacious.” Pet. 57 (citing Ex. 1003 ¶¶ 404–405; Ex.
`1005 ¶¶ 288–293; Ex. 1013, 16; Ex. 1014, 7). Therefore, we find that the
`teachings of NCT773 is not cumulative of NCT657.
`Although we disagree with Patent Owner that the ’424 publication and
`NCT773 are cumulative of art previously presented to the Office, we find on
`the whole that the same art and arguments previously before the Office are
`now presented here, namely, a teaching that semaglutide is administered
`once weekly in a dose range of 0.1 to 1.6 mg that includes a dose of 1.0 mg.
`See Pet. 6–7. Therefore, we proceed to the second prong of Advanced
`Bionics.
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`B. Advanced Bionics Part Two
`Regarding BD Factor (c), the Examiner rejected the original claims of
`
`the ’462 patent as anticipated by NCT647. See Ex. 1002, 312. The Examiner
`relied on the teaching in NCT647 of administration of 0.8 mg of semaglutide
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`once weekly as satisfying the original claim limitation requiring
`administration of a GLP-1 agonist to a subject in need thereof “in an amount
`of at least 0.7 mg per week, such an amount equivalent to at least 0.7 mg
`semaglutide per week.” Ex. 1002, 8–9, 312. Patent Owner responded by
`amending claim 1 to recite “a method for treating type 2 diabetes,
`comprising administering semaglutide once weekly in an amount of 1.0 mg
`to a subject in need thereof.” Id. at 332. The Examiner then allowed the
`claims stating:
`The closest prior art to the instant claims is Clinical Trial
`NCT00696657 ((3/25/2011) hereinafter referred to as “the ’657
`clinical trial”—previously cited).
`
`
`The ’657 clinical trial compared semaglutide and
`liraglutide in treatment of type 2 diabetic patients. The
`semaglutide or liraglutide was used as on add-on therapy to
`type 2 diabetic patients already taking metformin. Efficacy of
`treatment was further assessed by a reduction in HbA1c levels.
`Patients in the Arm Labels D and E of the clinical trial were
`administered 0.8 mg once weekly by subcutaneous injection.
`However, the reference does not teach or disclose a higher
`amount of 1 mg semaglutide.
`
`
`Ex. 1002, 344–345. The Examiner did not apply any of the other references
`relied upon by Petitioner against the issued claims of the ’462 patent.
`
`Petitioner asserts that the Examiner erred by failing to properly
`consider the dose ranges for once-weekly semaglutide disclosed in WO421,
`Lovshin, and NCT773. Pet. 36–63. Petitioner explains concerning the
`teaching of both WO421 and Lovshin of “a narrow range of semaglutide
`from 0.1 to 1.6 mg [for the purpose of treating diabetes], which includes
`claim 1’s 1.0 mg dose within the range,” that the “Office never considered
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`the patentability of the issued claims in view of this disclosed range or
`otherwise confronted whether the disclosure of the genera in WO421 and
`Lovshin anticipated the issued species claims as required by MPEP
`2132.02(III), or otherwise rendered the claims obvious. Patentability in view
`of this range is therefore a legal theory raised in the Petition that the Office
`never addressed.” Reply 4–5; Pet. 62.
`Petitioner also asserts that the Examiner’s Reason for Allowance
`finding NCT657 teaches 0.8 mg semaglutide in Arm Labels D and E, but
`does not “teach or disclose a higher amount of 1 mg semaglutide” is
`incorrect. Petitioner states:
`The Examiner failed to recognize experimental arm F in
`NCT657 administered patients 1.6 mg semaglutide once
`weekly. Compare Ex. 100-2, 344–45, with Ex. 1013, 16. It was
`therefore wrong for the Examiner to conclude NCT 657 did not
`disclose administration of any dose of semaglutide higher than
`0.8 mg. Compare Ex. 1002, 344–45, with Ex. 1013, 15–16. The
`Examiner’s obvious error in failing to consider the full scope of
`the reference, e.g., failing to recognize the administration of a
`dose higher than the claimed dose at the time, was material to
`patentability because the Examiner issued the patent on the
`understanding “a” higher amount was not disclosed.
`Pet. 64 (citations omitted).
`
`Patent Owner points to rejections the Examiner made in the parent
`application applying NCT657 “including both obviousness and anticipation
`rejections in which NCT 657’s 1.6 mg dose was expressly discussed.”
`Prelim. Resp. 64–65.
`
`We find that Petitioner has demonstrated material error by the Office.
`The Examiner’s statement that NCT657 “does not teach or disclose a higher
`amount of 1 mg semaglutide” is incorrect and also fails to consider the
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`teachings of the dosing ranges of WO421 and Lovshin, and the maximum
`dose of 1.2 mg of semaglutide taught in NCT773.
`
`For these reasons, we determine that Petitioner has sufficiently
`demonstrated a material error on the part of the Examiner, and we therefore
`decline to exercise our discretion to deny institution of inter partes review
`under 35 U.S.C. § 325(d).
`
`IV. DISCRETION UNDER 35 U.S.C. § 314(a)
`Patent Owner asserts that we should use our discretion to deny the
`Petition under Section 314(a), “particularly in light of the significant §325(d)
`concerns regarding Grounds 1 and 2—which address only claims 1–3—and
`in view of the substantive infirmities of Ground 3–5.” Prelim. Resp. 66–67.
`Patent Owner does not address Petitioner’s assertions that a trial here would
`most likely conclude before the parallel Delaware litigation, and Petitioner’s
`stipulation “that if the Board institutes, Petitioner will not pursue in the
`district court any instituted grounds against the originally-issued claims
`unless a change in law otherwise permits.” Pet. 65–66 (citing Sand
`Revolution II, LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 12
`(PTAB June 16, 2020)).
`We do not agree with Patent Owner’s assertions concerning Section
`325(d) as set forth above, and find nothing here that would warrant the
`exercise of our discretion to deny institution based on 35 U.S.C. § 314(a) to
`deny institution of an otherwise meritorious petition.
`
`
`
`16
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`IPR2023-00724
`Patent 10,335,462 B2
`
`
`V. ANALYSIS OF THE ASSERTED GROUNDS
`A. Legal Standards
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
`petitions to identify “with particularity . . . the evidence that supports the
`grounds for the challenge to each claim”)). This burden of persuasion never
`shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in
`inter partes review).
`To show anticipation under § 102, each and every claim element,
`arranged as in the claim, must be found in a single prior art reference. Net
`MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior
`art need not, however, use the same words as the claims in order to find
`anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). It is also
`permissible to take into account not only the literal teachings of the prior art
`reference, but also the inferences an ordinarily skilled person would draw
`from the reference. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. at
`Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017); In re
`Preda, 401 F.2d 825, 826 (CCPA 1968). A reference may also anticipate a
`claim even if it does not expressly teach all the limitations arranged or
`combined as in the claim, “if a person of skill in the art, reading the
`reference, would ‘at once envisage’ the claimed arrangement or
`combination.” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed.
`
`
`
`17
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`IPR2023-00724
`Patent 10,335,462 B2
`
`Cir. 2017) (quoting Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d
`1376, 1381 (Fed. Cir. 2015)).
`A claim is unpatentable under 35 U.S.C. § 103 if the differences
`between the claimed invention and the prior art are such that the claimed
`invention as a whole would have been obvious before the effective filing
`date of the claimed invention to a person having ordinary skill in the art to
`which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550
`U.S. 398, 406 (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 (4) objective evidence
`of nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17–18
`(1966).
`In analyzing the obviousness of a combination of prior art elements, it
`can be important to identify a reason that would have prompted one of skill
`in the art “to combine . . . known elements in the fashion claimed by the
`patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the
`specific subject matter of a challenged claim is not necessary to establish
`obviousness. Id. Rather, “any need or problem known in the field of
`endeavor at the time of invention and addressed by the patent can provide a
`reason for combining the elements in the manner claimed.” Id. at 420.
`
`Accordingly, a party that petitions the Board for a determination of
`unpatentability based on obviousness must show that “a skilled artisan
`would have been motivated to combine the teachings of the prior art
`references to achieve the claimed invention, and that the skilled artisan
`
`
`
`18
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`IPR2023-00724
`Patent 10,335,462 B2
`
`would have had a reasonable expectation of success in doing so.” In re
`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal
`quotation marks omitted). “Both the suggestion and the expectation of
`success must be founded in the prior art, not in the applicant’s disclosure.”
`In re Dow Chemical Co., 837 F.2d 469, 473 (Fed. Cir. 1988).
`An obviousness analysis “need not seek out precise teachings directed
`to the specific subject matter of the challenged claim, for a court can take
`account of the inferences and creative steps that a person of ordinary skill in
`the art would employ.” KSR, 550 U.S. at 418; see In re Translogic Tech,
`Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). In KSR, the Supreme Court also
`stated that an invention may be found obvious if trying a course of conduct
`would have been obvious to a POSITA:
`When there is a design need or market pressure to solve a
`problem and there are a finite number of identified, predictable
`solutions, a person of ordinary skill has good reason to pursue
`the known options within his or her technical grasp. If this leads
`to the anticipated success, it is likely the product not of
`innovation but of ordinary skill and common sense. In that
`instance the fact that a combination was obvious to try might
`show that it was obvious under § 103.
`550 U.S. at 421. “KSR affirmed the logical inverse of this statement by
`stating that § 103 bars patentability unless ‘the improvement is more than
`the predictable use of prior art elements according to their established
`functions.’” In re Kubin, 561 F.3d 1351, 1359–60 (Fed. Cir. 2009) (citing
`KSR, 550 U.S. at 417).
`We analyze the asserted grounds of unpatentability in accordance with
`the above-stated principles. In making such an analysis, we find that
`
`
`
`19
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`IPR2023-00724
`Patent 10,335,462 B2
`
`Petitioner has shown a reasonable likelihood of prevailing in establishing
`that at least claim 1 of the ’462 patent is unpatentable.
`
`B. Level of Ordinary Skill in the Art
`In determining the level of skill in the art, we consider the type of
`problems encountered in the art, the prior art solutions to those problems, the
`rapidity with which innovations are made, the sophistication of the
`technology, and the educational level of active workers in the field. See
`Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962
`(Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d
`1005, 1011 (Fed. Cir. 1983).
`In addressing the level of ordinary skill in the art, Petitioner contends
`a person of ordinary skill in the art (“POSA”) would have
`(1) an M.D., Pharm.D., or Ph.D. in pharmacy, chemical
`engineering, bioengineering, chemistry, or related discipline;
`(2) at least two years of experience in protein or peptide
`therapeutic development and/or manufacturing or diabetes
`treatments; and (3) experience with the development, design,
`manufacture, formulation, or administration of therapeutic
`agents, and the literature concerning protein or peptide
`formulation and design, or diabetes treatments.
`Pet. 8–9; see Ex. 1003 ¶¶ 26–28; Ex. 1005 ¶¶ 29–31; Ex. 1007 ¶¶ 25–27. 11
`Patent Owner does not offer a different level of ordinary skill in the art at
`this stage of the proceeding. See generally Prelim. Resp.
`On the current record, and for the purposes of this decision, we accept
`Petitioner’s proposed definition, as it appears consistent with the level of
`
`
`11 We need not consider Petitioner’s similar alternative definition. See Pet. 9.
`20
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`IPR2023-00724
`Patent 10,335,462 B2
`
`skill in the art reflected in the prior art of record and the disclosure of the
`’462 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)
`(“the prior art itself [may] reflect[] an appropriate level” as evidence of the
`ordinary level of skill in the art (quoting Litton Indus. Prods., Inc. v. Solid
`State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).
`
`C. Claim Construction
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the
`claim “in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the prosecution
`history pertaining to the patent.” Id. Moreover, “the specification ‘is always
`highly relevant to the claim construction an
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