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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`NOVO NORDISK A/S,
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`Patent Owner.
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`Case No. IPR2023-00723
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`Patent No. 8,129,343
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`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`TABLE OF CONTENTS
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`A. Ground 3 Does Not Justify Discretionary Denial .......................................... 1
`B.
`The Prosecution History Does Not Justify Discretionary Denial .................. 2
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`i
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`TABLE OF AUTHORITIES
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`CASES
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`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) .................................................. 5
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`GMG Prods. LLC v. Traeger Pellet Grills LLC,
`PGR2019-00024, Paper 17 (PTAB July 17, 2019) .............................................. 4
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`Hum Indus. Tech., Inc. v. Amsted Rail Co.,
`IPR2023-00539, Paper 10 (PTAB July 26, 2023) ................................................ 5
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`Intel Corp. v. Koninklijke Philips N.V.,
`IPR2021-00370, Paper 10 (PTAB July 6, 2021) .................................................. 4
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`ShenZhen Apaltek Co. v. Asetek Danmark A/S,
`IPR2022-01317, Paper 7 (PTAB Feb. 6, 2023) .................................................... 3
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`Teradata Corp. v. SAP SE,
`IPR2020-00943, Paper 12 (PTAB Nov. 25, 2020) ............................................... 3
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`Thorne Rsch., Inc. v. Trs. of Dartmouth Coll.,
`IPR2021-00491, Paper 18 (PTAB Aug. 12, 2021) ............................................... 3
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.23(b) .................................................................................................. 2
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`MPEP 2131.02(I) ....................................................................................................... 3
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`MPEP 2144.08 ........................................................................................................... 3
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`ii
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`With the Board’s authorization, Petitioner submits this Reply to address two
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`bases Patent Owner alleges justify denial of institution. Neither basis has merit.
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`A. Ground 3 does not justify discretionary denial
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`Patent Owner, citing the title of Ground 3, complains of “extraordinary
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`vagueness” and insists with a straight face that it lacks “any meaningful opportunity
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`to respond.” POPR 18. But Patent Owner does respond on the merits to Ground 3.
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`See POPR 49-53. Ground 3 relies on the same prior art as Grounds 1 and 2, and
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`provides specific prior-art and declaration citations for (1) the prior-art disclosures
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`of the structural fragments of semaglutide and their properties and (2) a POSA’s
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`motivation to combine those disclosures. The only difference is the analytical
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`framework for a POSA’s motivation: while Grounds 1 and 2 apply the narrower lead-
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`compound analysis, Ground 3 explains that a POSA would have been motivated to
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`reach semaglutide from the same prior art applying broader obviousness
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`principles—routine optimization of known result-effective variables—because that
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`is how drug-discovery worked at the priority date.
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`In particular, Ground 3 explains that the three requisite modifications to
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`liraglutide involved sites known to affect bioactivity in specific ways, that there was
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`a limited range of realistic options, and that screening those options would have been
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`a routine part of drug discovery. Pet. 56-59. Ground 3 explained with particularity
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`(1) why the Aib8 modification would have been obvious, Pet. 57; (2) why the fatty
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`1
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`diacid modification would have been obvious, Pet. 57-58; and (3) why the di-AEEA
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`spacer modification would have been obvious, Pet. 58-59. Although Patent Owner
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`insists that the number of options was large and unpredictable, those are issues of
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`fact for expert testimony and trial. Ground 3 also relies on the same prior art for each
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`claim limitation as Grounds 1 and 2. See Pet. 17-24. The additional references Patent
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`Owner complains of give context to show a POSA’s skill level and background
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`knowledge; they confirm the declarations are well-reasoned and the references are
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`not used to show disclosures of the limitations. And although Patent Owner
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`complains Petitioner is “empower[ed]” by Ground 3 “to argue whatever it wants
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`throughout the remainder of this proceeding,” that is hyperbole. The rules ensure
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`Petitioner keeps to the Petition’s framing. 37 C.F.R. § 42.23(b).
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`Patent Owner also insists Ground 3 merits denying the whole Petition.
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`POPR 18. But its cases do not support such a draconian request. In Adaptics,
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`EnergySource, InVue, ADT, John Crane, and Sainty Sumex, every obviousness
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`ground was deficient in some way, and many involved a complete failure to explain,
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`or they asserted legally impossible arguments like multi-reference anticipation. Nor
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`is Ground 3 a “catch-all” like in many of those cases—it is a different motivation
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`theory.
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`B.
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`The prosecution history does not justify discretionary denial
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`Even if some art appeared during prosecution, as Patent Owner contends, that
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`2
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`does not warrant discretionary denial because the Petition presents a new
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`combination of art and a new analytical framework never considered by the
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`Examiner during prosecution. During prosecution, the Examiner evaluated the
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`obviousness of the claims—directed first to a subgenus of GLP-1 inhibitors, then a
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`narrower example—in view of the Knudsen Patent, which taught a broad genus of
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`GLP-1 analogues and classes of possible modifications, consistent with MPEP
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`2144.08 (describing obviousness of species/subgenus over genus). The Petition,
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`however, takes an entirely different approach by identifying a single compound
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`(liraglutide) and proposing specific modifications to arrive at an obvious species that
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`falls within the scope of the claims, consistent with MPEP 2131.02(I). The Petition
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`is therefore not repetitive of what happened during prosecution, and the Board
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`should not invoke its discretion.
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`Advanced Bionics part one (same art/argument). For the “same art” prong,
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`the inquiry focuses on whether the totality of the art in the Petition overlaps with that
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`cited during prosecution, not only whether individual references appear in both. See,
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`e.g., ShenZhen Apaltek Co. v. Asetek Danmark A/S, IPR2022-01317, Paper 7, 9
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`(PTAB Feb. 6, 2023) (use of same reference does not constitute “same art” when
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`part of “a significantly different combination than was previously considered by the
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`Examiner”); see also Thorne Rsch., Inc. v. Trs. of Dartmouth Coll., IPR2021-00491,
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`Paper 18, 8-9 (PTAB Aug. 12, 2021); Teradata Corp. v. SAP SE, IPR2020-00943,
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`3
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`Paper 12, 23-24 (PTAB Nov. 25, 2020). Although the Examiner cited the Knudsen
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`Patent as teaching a genus of GLP-1 analogues and possible further modifications
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`generally, the Examiner never considered any of the art combinations proposed in
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`the Petition (e.g., combining Knudsen 2004 or 2001 with the Knudsen Patent,
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`Bridon, and Dong). Indeed, after the applicant narrowed the claims from a subgenus
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`to the compound of Example 4, Ex. 1004, 34, the Examiner allowed the claims
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`without identifying any of the art that taught the specific GLP-1 backbone, spacer,
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`and sidechain, id. at 26-27, in contrast to the Petition here.
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`Patent Owner incorrectly contends Knudsen 2001 and 2004 are cumulative of
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`the Knudsen Patent. POPR 61. But “[b]y merely quoting references without
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`comparing them to [the references before the Patent Office], Patent Owner
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`oversimplifies the analysis.” Intel Corp. v. Koninklijke Philips N.V., IPR2021-00370,
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`Paper 10, 8 (PTAB July 6, 2021). Of the possible GLP-1 analogues, Knudsen 2001
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`and 2004 both identify liraglutide as advancing through clinical trials, Ex. 1010, 3;
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`Ex. 1011, 5—a significant reason to select it as a lead. The Knudsen Patent, while
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`supporting that selection, describes liraglutide as one of over 75 example analogues.
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`Ex. 1012, 174:9-216:14. As for Bridon, even if certain of its teachings overlap to
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`some extent to art cited on the face of the ’343 patent, a reference cited but not
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`previously applied should be given little weight. See GMG Prods. LLC v. Traeger
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`Pellet Grills LLC, PGR2019-00024, Paper 17, 27 (PTAB July 17, 2019).
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`4
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`For the “new argument” prong, Patent Owner contends without support that
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`the Petition “lay[s] out substantially the same argument” as the Examiner, but
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`concedes a lead-compound analysis was never performed. POPR 63-64. This is a
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`new argument. Further, Patent Owner points to no factual finding by the Examiner
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`that this Petition asks the Office to reconsider. Thus, Patent Owner fails at step one.
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`Advanced Bionics part two (material error). Even if the Board were to reach
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`step two, institution is still favored if the Petition demonstrates a reasonable
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`likelihood of unpatentability over references that appeared in the file history, but the
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`Examiner failed to apply in combination. Hum Indus. Tech., Inc. v. Amsted Rail Co.,
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`IPR2023-00539, Paper 10, 51-53 (PTAB July 26, 2023). “[M]aterial error may
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`include misapprehending or overlooking specific teachings of the relevant prior art.”
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`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-
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`01469, Paper 6, 8 n.9 (PTAB Feb. 13, 2020). Here, the Examiner materially erred by
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`failing to identify liraglutide and the specific modifications that could be made to it
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`within the prior art before them, to arrive at an obvious species that would fall within
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`the scope of the claims. The Examiner further erred by failing to apply a lead-
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`compound analysis (or something like it, as in Ground 3), and instead simply
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`performed a genus-to-subgenus obviousness analysis. Moreover, the Examiner
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`identified no reference as teaching the di-AEEA spacer.
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`5
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`Dated: August 10, 2023
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`By:
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`Respectfully submitted,
`PERKINS COIE LLP
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`/Brandon M. White/
`Brandon M. White
`Reg No. 52,354
`Perkins Coie LLP
`700 13th Street NW, Ste 800
`Washington, DC 20005
`Phone: (202) 654-6200
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`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
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`6
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`CERTIFICATE OF SERVICE
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`I certify that I caused to be served the foregoing PETITIONER’S REPLY
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`TO PATENT OWNER’S PRELIMINARY RESPONSE electronically by email
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`on August 10, 2023 in their entirety on the following counsel of record for Patent
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`Owner:
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`J. Steven Baughman
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
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`Megan Raymond
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`megan.raymond@groombridgewu.com
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`Novo-Semaglutide-IPR@groombridgewu.com
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`Dated: August 10, 2023
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`/Brandon M. White/
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`Reg No. 52,354
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`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
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