IPR2023-00723
` U.S. Patent No. 8,129,343
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00723
`Patent 8,129,343
`______________________
`
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`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107
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` U.S. Patent No. 8,129,343
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00723
`Patent 8,129,343
`______________________
`
`
`
`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107
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`I.
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`IPR2023-00723
`U.S. Patent 8,129,343
`Ground 3’s Amorphous Catch-All Lacks the Required Particularity
`The POPR doesn’t rest on Ground 3’s “title” (cf.R.1 (emph.orig.)1); rather, it
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`shows the Petition’s improper “catch-all” (cf.R.2) ground would require PO to “ad-
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`dress whether each and every claim limitation is not only taught by each” men-
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`tioned reference, “but [also] by each… in combination with one or more of the
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`other[s].”2 POPR.17. The Reply concedes that (at minimum) all of “the same prior
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`art [from] Grounds 1 and 2” is in play (R.1), but never explains how or why the
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`documents in those separate four-reference combinations with different base refer-
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`ences would be combined, let alone how the Petition purportedly identifies, limits,
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`or applies the “common drug development principles” Petitioner invokes as part of
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`“Ground 3.”3 Pet.56. Nor does the Petition point to “specific prior-art and declara-
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`tion citations” for that same Ground 1 and 2 art, as the Reply argues.4 R.1.
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`The Reply states, e.g., that “Ground 3 explained with particularity (1) why
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`1 Unless noted all emphases added, cites omitted, and abbreviations as in POPR.
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`2 That PO “does respond” on some aspects (R.1) doesn’t make Ground 3 proper.
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`3 While the Reply now seeks to cast unspecified “additional references” as mere
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`“background” (R.2), the Petition did not—and the Reply cannot provide a do-over.
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`4 Ground 3 invokes “Grounds 1 and 2” only after arguing “semaglutide [is] obvi-
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`ous,” and only to address “formulation and method of treatment.…” Pet.59.
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`1
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`IPR2023-00723
`U.S. Patent 8,129,343
`the Aib8 modification would have been obvious, Pet.62-63.” R.1. False. Those
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`pages never cite Dong (EX1013)—required for Grounds 1 and 2 (cf.Pet.47)—and
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`never refer back to Ground 1 or 2 for support. Thus, because it lacks substance the
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`Petition in fact allows Petitioner to “argue whatever it wants.” Cf. R.2.
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`Petitioner’s di-AEEA argument belies the Reply’s new claim that “Ground 3
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`relies on the same… art as Grounds 1 and 2,” but with new motivation. R.1. While
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`Grounds 1 and 2 rely on Bridon for the di-AEEA spacer (Pet.37-39), the Petition’s
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`Ground 3 does not cite Bridon (other than for background along with other refer-
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`ences) or Grounds 1 and 2. Pet.58. Instead, it cites Petitioner’s experts, who rely on
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`a host of different art not identified in the Petition. Pet.64. For example, Petitioner
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`cites “EX1020, ¶224,” and “EX1024 ¶¶82-87”—neither cite Bridon—and
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`“EX1022, ¶148,” referring to 12 other paragraphs (“108-119”) that discuss numer-
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`ous references disclosing PEG-like spacers (e.g., EXS1029, 1041, 1019, 1014,
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`1033, 1012, 1043, 1044, 1034, 1045, & 1038). Even when discussing Bridon in
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`¶¶116-118, Petitioner’s expert argues it “was not alone in disclosing the use of an
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`AEEA (or di-AEEA) spacer,” and proposes added references for that teaching. The
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`Petition’s attempt to rely on all of this art belies the Reply’s attempts to rewrite and
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`eliminate that now. And, as PO’s case confirms (POPR.15-17), Petitioner’s dump
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`truck approach to Ground 3 fails the requirements of “particularity” and fairness,
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`justifying full denial. Adaptics, 17 (“Board may consider whether a lack of
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`2
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`IPR2023-00723
`U.S. Patent 8,129,343
`particularity as to one or more of the asserted grounds justifies denial of an entire
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`petition.”); see also Elk Eng’g Sdn. Bhd. v. Wilco Marsh Buggies & Draglines,
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`Inc., IPR2020-00344, Pap.12, 17-22 (Mar. 4, 2021) (denying rehearing where peti-
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`tioner’s four grounds (of 20) lacked particularity and “infected the entire” petition).
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`II.
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`Petitioner Confirms 325(d) Denial Is Warranted
`AB part one. Petitioner’s “totality of the art” arguments (R.3; R.2 (“if some
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`[of the] art appeared”)) ignore that every reference in Petitioner’s Grounds 1 and 2
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`was of record (Knudsen 2004 and the Knudsen Patent) or cumulative of references
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`that were (Knudsen 2001, Bridon, and Dong). POPR.58-64. PO also showed Peti-
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`tioner’s combinations and arguments are cumulative of the Examiner’s arguments,
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`which first rejected the ’343 over the Knudsen Patent’s genus (which included li-
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`raglutide) and Larsen (a reference that disclosed Aib8), but then allowed the claims
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`after PO limited them to semaglutide, despite having in hand a cumulative Bridon
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`reference. Pet.64-65. Thus, PO showed AB part one was doubly met—both sub-
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`stantially the same art and arguments were presented in prosecution.
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`Petitioner’s complaint now that the Examiner erred by applying a more leni-
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`ent approach than the “lead-compound” analysis it complains of as presenting “a
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`too-high burden” and “violat[ing]… Graham and KSR” (Pet.51-56; POPR.63-67)
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`is, to begin with, not an AB part one issue: it is a (faulty) part two complaint that
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`the Examiner—facing substantially the same art and arguments—did not make a
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`3
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`IPR2023-00723
`U.S. Patent 8,129,343
`particular rejection. This is not error for part two. E.g., Ivantis, IPR2022-01533,
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`Pap.14; POPR.70; cf.R.5. It is also nonsensical (POPR.65-67), unsupported (Peti-
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`tioner does not address details of the Examiner’s analysis, but instead concocts a
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`non-existent “conce[ssion]” at POPR.63-64 (argument based on “Petitioner’s own
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`reasoning”)), and conflicts with Petitioner’s own Ground 3 approach (R.1, 5).
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`Petitioner is incorrect that Knudsen 2001 and the Knudsen Patent are not cu-
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`mulative. R.4; cf. POPR.62-63. But, even if true, Petitioner fails to address (and
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`thus concedes) PO’s separate showing that Knudsen 2001 is cumulative of Knud-
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`sen 2004, “cited on” ’343’s face. POPR.58-61. Indeed, the POPR showed “Peti-
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`tioner [] treats Knudsen 2004 and Knudsen 2001 as interchangeable with one an-
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`other… by referring back to and relying on Ground 1’s Knudsen 2004 arguments
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`and reasoning as to Knudsen 2001 in Ground 2 (Pet.44-50),” confirming Knudsen
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`2001 was cumulative of the art of record. POPR.61. Further, Petitioner’s AB part
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`one argument that, even if Bridon is cumulative of cited art, “a reference cited but
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`not previously applied should be given little weight” (R.4), tellingly rests on a pre-
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`AB case. AB itself (like Petitioner’s Intel case (R.4)) makes clear part one is met if
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`the art is cumulative of art of record, whether discussed or not. AB, 7-8.
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`Petitioner’s cases are inapposite. The ShenZhen, Thorne Research, and Te-
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`radata petitioners either presented (1) entire grounds or (2) primary references that
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`were neither of record nor cumulative. Here, all of Petitioner’s references were of
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`4
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`IPR2023-00723
`U.S. Patent 8,129,343
`record or cumulative. And Intel’s patent owner failed to “compare [the quotes]
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`with Petitioner’s [reference] citations” and shifted the burden to the Board to deter-
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`mine cumulativeness. Intel Corp. v. Koninklijke Philips N.V., IPR2021-00370,
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`Pap.10, 7-8 (July 6, 2021). But here, PO showed that the portions Petitioner and
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`Examiner relied on overlapped. POPR.58-59. Indeed, Petitioner only tries to show
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`Knudsen 2001 is non-cumulative (R.4), and, as shown above, fails.
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`AB part two. Despite its Reply, Petitioner still fails to show any error, posit-
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`ing only the Examiner’s “fail[ure] to apply” Petitioner’s combination in a wished-
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`for rejection. R.5. But that is not error, and Petitioner’s case does not support its as-
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`sertion. POPR.65-70. Hum’s petitioner showed error because its new art taught
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`“the very limitation… the examiner [found] to be missing from the prior art.” Hum
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`Indus. Tech., Inc. v. Amsted Rail Co., IPR2023-00539, Pap.10, 52 (July 26, 2023).
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`Unlike in Hum, Petitioner here identifies no evidence the Examiner “misappre-
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`hend[ed] or overlook[ed]” the art—it just asserts this must be so because Bridon
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`was not applied in a rejection. R.5. But an examiner’s “silence” in not making a
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`wished-for rejection is not error. R.5; POPR.70; Ivantis, IPR2022-01533, Pap.14,
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`19; AlmondNet, IPR2022-01319, Pap.9, 11; AB, 8-9 (“If reasonable minds can dis-
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`agree… it cannot be said that the Office erred”).
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`Far from any error, Petitioner’s Reply shows its Petition should be denied.
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`Respectfully submitted: /Megan Raymond/
` Megan Raymond
`5
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`August 17, 2023
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`CERTIFICATE OF SERVICE
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`IPR2023-00723
`U.S. Patent 8,129,343
`
`The undersigned hereby certifies that a copy of PATENT OWNER’S SUR-
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`REPLY TO PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY
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`RESPONSE UNDER 37 C.F.R. § 42.107 has been served in its entirety by causing
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`the aforementioned document to be electronically mailed to the following attorneys
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`of record for the Petitioner listed below:
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`Petitioner’s Counsel of Record:
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`Lead Counsel:
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`Brandon M. White
`Reg. No. 52,354
`White-ptab@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
`
`By Electronic Mail
`Backup Counsel: Emily J. Greb
`Reg. No. 68,244
`Greb-ptab@perkinscoie.com
`Perkins Coie LLP
`33 East Main Street
`Madison, WI 53703
`Telephone: (608) 663-7460
`
`Courtney Prochnow, PhD
`Reg. No. 67,639
`Prochnow-ptab@perkinscoie.com
`Perkins Coie LLP
`633 W. 5th St., Ste 5850
`Los Angeles, CA 90071
`Telephone: (310) 788-9900
`
`Christopher D. Jones
`6
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`IPR2023-00723
`U.S. Patent 8,129,343
`
`Reg. No. 76,472
`Jones-ptab@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
`
`Jonathan I. Tietz, PhD
`Reg. No. 76,753
`Tietz-ptab@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
`
`Matthew A. Lembo
`Reg. No. 75,633
`Lembo-ptab@perkinscoie.com
`Perkins Coie LLP
`1155 Avenue of the Americas
`Floor 22
`New York, NY 10036
`Telephone: (212) 262-6900
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`Semaglutide-Ozempic@perkinscoie.com
`By Electronic Mail
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`Dated: August 17, 2023
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` Respectfully submitted,
`By: /Sayem Osman
`Sayem Osman
`
`7
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