UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioner
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
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`IPR Trial No. IPR2022-00853
`U.S. Patent No. 9,464,140
`Issue Date: October 11, 2016
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`Title: Compositions and Methods for Treatment of Cancer
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`PETITIONER’S REQUEST FOR REHEARING
`OF INSTITUTION DECISION
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`IPR2022-00853
`Patent No. 9,464,140
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`TABLE OF CONTENTS
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`The ’140 Decision Relied On An Erroneous Interpretation Of Law Concerning
`Reasonable Expectation Of Success For Methods Of Pharmaceutical Treatment ............. 4
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`The Board’s Erroneous Interpretation of OSI Results In Irreconcilable Inconsistency With
`The Institution Decision In Related IPR2022-00855........................................................ 10
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`The Board Misapplied Part 2 of the Advanced Bionics Framework Because Milone Was
`Overcome During Prosecution Of Parent Application In A Manner Inapplicable To
`Challenged Claim Here ..................................................................................................... 13
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`ii
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`I.
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`II.
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`III.
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`IPR2022-00853
`Patent No. 9,464,140
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
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`Advanced Bionics v. MED-EL,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) .................................................3, 4, 13, 14, 15
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`Apple, Inc. v. Koss Corp.,
`IPR2021-00381, Paper 15 (PTAB July 2, 2021) .....................................................................15
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`Emerson Elec. Co. v. SIPCO, LLC
`745 F. App’x 369 (Fed. Cir. 2018) ......................................................................................9, 10
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`Ex Parte Minh Diem Vu et al.,
`2019 WL 7170656 (PTAB Nov. 25, 2019)................................................................................8
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`Genzyme Therapeutic Prods. v. Biomarin Pharm.,
`825 F.3d 1360 (Fed. Cir. 2016)..............................................................................2, 4, 5, 6, 7, 9
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`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................................................7
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`NantKwest, Inc. v. Lee,
`686 F. App’x 864 (Fed. Cir. 2017) ............................................................................................6
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`OSI Pharms., LLC v. Apotex Inc.,
`939 F.3d 1375 (Fed. Cir. 2019)..................................................................................1, 4, 7, 8, 9
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`Persion Pharms. LLC v. Alvogen Malta Operations Ltd.,
`945 F.3d 1184 (Fed. Cir. 2019)......................................................................................6, 11, 12
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`Sand Revolution II, LLC v. Continental Intermodal Grp. - Trucking LLC,
`IPR2019-01393, Paper 24 (PTAB June 16, 2020) .....................................................................1
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`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012)................................................................................................12
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`Spectrum Solutions LLC v. DNA Genotek Inc.,
`IPR2022-00134, Paper 7 (PTAB June 6, 2022) .................................................................14, 15
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`Target Corp. v. Proxicom Wireless,
`IPR2020-00980, Paper 11 (PTAB Dec. 4, 2020).....................................................................14
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`Other Authorities
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`37 C.F.R. § 42.71(d) ........................................................................................................................1
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`iii
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`IPR2022-00853
`Patent No. 9,464,140
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`Petitioner respectfully requests rehearing pursuant to 37 C.F.R. § 42.71(d) of
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`the Board’s Decision Denying Institution, Paper 11 (“’140 Decision”) for
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`Grounds 1-3, with respect to U.S. Patent No. 9,464,140 (“’140 patent”). A request
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`for rehearing of a non-institution decision should be granted “if a decision is based
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`on an erroneous interpretation of law, if a factual finding is not supported by
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`substantial evidence, or if an unreasonable judgment is made in weighing relevant
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`factors.” Sand Revolution II, LLC v. Continental Intermodal Grp. - Trucking LLC,
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`IPR2019-01393, Paper 24, at 4 (PTAB June 16, 2020). That is what happened here.
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`In Grounds 1-2, the ’140 Decision erred in its interpretation of the law
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`governing reasonable expectation of success for a method of treatment. The ’140
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`Decision relied on OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir.
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`2019)—a case mischaracterized by Patent Owner as being “directly on-point”—in
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`concluding that there was no reasonable expectation of success for practicing the
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`method of claim 1 using a prior-art composition with successful in vitro data and a
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`compelling recommendation for clinical use.
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`The ’140 Decision incorrectly described OSI as a case where there was
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`successful in-vitro data in the prior art for the composition employed in the method
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`of treatment claim. There was no such data in OSI. The OSI decision stands only for
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`the uncontroversial proposition that lack of in-vitro data can defeat a reasonable
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`expectation of success. Based on this misreading of OSI, the Board applied an
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`1
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`IPR2022-00853
`Patent No. 9,464,140
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`unduly heightened standard for reasonable expectation of success that is contrary to
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`the Federal Circuit precedent of Genzyme Therapeutic Prods. v. Biomarin Pharm.,
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`825 F.3d 1360 (Fed. Cir. 2016). In Genzyme, like here, the prior art disclosed the
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`claimed composition, provided successful in vitro data, and suggested initiating
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`clinical trials. Id. at 1364. The Federal Circuit reasoned that a method of treatment
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`claim was obvious when “there was little left to do but to confirm that the strategy
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`suggested by the various prior art references would work.” Id. at 1373. So too here.
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`Due to the erroneous interpretation of OSI, the ’140 Decision also is at odds
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`with this Board’s Decision Granting Institution in related IPR2022-00855 (“’445
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`Decision”) for U.S. Patent No. 9,540,445 (“’445 patent”). The independent claim of
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`this sibling is nearly identical: the ’445 patent is directed to a “pharmaceutical
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`composition,” whereas the ’140 patent is directed to a “method of treating cancer in
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`a human patient” using the same pharmaceutical composition of the ’445 patent. In
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`the ’445 Decision, the Board found that a nearly identical claim directed to a
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`“pharmaceutical composition comprising an anti-tumor effective amount”—the very
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`same claim language present in the ’140 patent—was reasonably likely to be found
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`obvious. Under Federal Circuit precedent, including the law of inherency, a method
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`that treats patients with the very same pharmaceutical composition, in the very same
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`“anti-tumor effective amount,” would also be just as obvious.
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`2
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`IPR2022-00853
`Patent No. 9,464,140
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`Lastly, in rejecting Ground 3, the Board misapplied part two of the Advanced
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`Bionics framework. The Board acknowledged that the Milone reference, which
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`includes both in vitro data and in vivo animal data, bolstered Petitioner’s argument
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`for reasonable expectation of success. But the ’140 Decision relied on discussion of
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`Milone during prosecution of a parent application to deny review of Ground 3, even
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`though that discussion of Milone has nothing to do with the claims at issue in the
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`’140 patent. This reliance on the prosecution record was legally erroneous and
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`represents an unreasonable judgment in weighing relevant Advanced Bionics factors.
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`Even Patent Owner did not rely on this prosecution in its Section 325(d) arguments.
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`The Board failed to recognize that Patent Owner overcame the Examiner’s
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`rejections in the parent application through a distinguishing claim limitation—the
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`amino acid sequence for CD3 zeta (SEQ ID NO: 24). This claim limitation is absent
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`from the independent claim challenged here. Pet., 69-70. Patent Owner did not
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`address or overcome Milone in the context that the reference is relied upon here—
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`as supporting a reasonable expectation of success. Rather, Patent Owner
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`distinguished Milone on the ground that it does not disclose the claimed amino acid
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`sequence for CD3 zeta. See Ex. 3002, 35-40 (“Milone does not disclose, inter alia,
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`any nucleic acid encoding a CAR or a CAR comprising a CD3 zeta signaling domain
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`comprising the amino acid sequence of SEQ ID N0:24.” (emphasis in original)).
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`Therefore, the discussion of Milone during prosecution of the parent application is
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`3
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`IPR2022-00853
`Patent No. 9,464,140
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`inapplicable to part two of Advanced Bionics, which must consider “the extent to
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`which the asserted art was evaluated during examination.”
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`I.
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`The ’140 Decision Relied On An Erroneous Interpretation Of Law
`Concerning Reasonable Expectation Of Success For Methods Of
`Pharmaceutical Treatment
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`Relying on an erroneous interpretation of OSI Pharms. v. Apotex, 939 F.3d
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`1375 (Fed. Cir. 2019) urged by Patent Owner, the ’140 Decision applied an
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`improperly onerous standard for reasonable expectation of success that contradicts
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`controlling Federal Circuit precedent for pharmaceutical treatments: Genzyme
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`Therapeutic Prods. v. Biomarin Pharm., 825 F.3d 1360 (Fed. Cir. 2016). Rehearing
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`should be granted. As the Board acknowledged, the prior art in Ground 1 disclosed:
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`• the claimed composition (e.g., Campana);
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`• successful in-vitro results using the composition against human tumor cells
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`(e.g., Campana and Imai);
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`• an academic, peer-reviewed article stating that these successful results
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`were a “compelling justification” for clinical use (e.g., Campana and Imai);
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`• an ongoing clinical trial to assess efficacy of the claimed compound (e.g.,
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`CART-19 ClinicalTrials.gov); and
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`• using a treatment amount that falls within the scope of the patent’s
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`“anti-tumor effective amount” (e.g., CART-19 ClinicalTrials.gov).
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`’140 Decision (“Dec.”), 21-24, 34-37.
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`4
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`IPR2022-00853
`Patent No. 9,464,140
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`And in the related IPR on the ’445 patent, the Board found this same prior art
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`(based on the preliminary record) would likely render obvious “a pharmaceutical
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`composition compromising an anti-tumor effective amount” of the same claimed
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`composition. See, e.g.,’445 Decision, 23-29 (“[T]he ‘initiation of a clinical trial
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`using anti-CD19-BB-ζ is indicative of a reasonable expectation of success’ [and]
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`evidences, based on the preliminary record, that the production of a pharmaceutical
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`composition as recited in the claim would have been obvious.”).1 Under Federal
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`Circuit precedent, such prior-art disclosures also render obvious method of treatment
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`claims, such as claim 1 of the ’140 patent, that are otherwise identical to ’445 patent
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`claims, and merely involve administering the obvious pharmaceutical composition.
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`Although Petitioner relied on Genzyme to demonstrate obviousness, Pet. at 37, the
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`Board overlooked this controlling authority in the ’140 Decision.
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`In Genzyme,
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`the Federal Circuit
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`found obvious “method[s] of
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`treating…Pompe’s disease” by administering “a therapeutically effective amount of
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`human acid alpha glucosidase.” 825 F.3d at 1363, 1369. The prior art in the Grounds
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`there was (1) disclosure of the composition, (2) a press release announcing plans to
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`“begin testing that treatment on human patients,” and (3) references describing
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`1 Bold italics in quotes denotes emphasis added unless otherwise noted.
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`5
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`IPR2022-00853
`Patent No. 9,464,140
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`promising in vitro results.2 Id. at 1364. The patent owner in Genzyme, like here,
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`argued that “a person of ordinary skill in the art would not find those [in vitro]
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`experiments predictive of results in a human patient,” and human “clinical trials had
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`not been conducted as of” the relevant priority date. Id. at 1364-65. The Federal
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`Circuit rejected the patent owner’s argument that “there would have been no
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`reasonable expectation that the treatment would succeed.” Id. at 1365, 1372-73. The
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`Federal Circuit reasoned that the method of treatment claim was obvious when
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`“there was little left to do but to confirm that the strategy suggested by the various
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`prior art references would work.” Id. at 1373. The Federal Circuit has applied this
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`same reasoning in other decisions. E.g., Persion Pharms. v. Alvogen Malta
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`Operations, 945 F.3d 1184, 1189-91 (Fed. Cir. 2019) (“An obvious formulation
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`2 In Genzyme, there were also references with in-vivo animal results which were
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`not identified in the Grounds nor institution decisions. The Federal Circuit did not
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`rely on these in-vivo results for its obviousness holding. Id. at 1373 (“a person of
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`ordinary skill would have had a reasonable expectation of success based on the
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`combinations of references set forth in the institution decisions.”). But the Court
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`noted that such references could “show the state of the art at the time of the
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`invention.” Id. at 1369. Here too, Milone’s successful animal data informs the
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`state of the art despite not being a reference identified in Grounds 1 and 2.
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`6
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`IPR2022-00853
`Patent No. 9,464,140
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`cannot become nonobvious simply by administering it to a patient and claiming the
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`resulting serum concentrations”); NantKwest v. Lee, 686 F. App’x 864, 866-73 (Fed.
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`Cir. 2017) (holding a “method of treating a cancer obvious” where, “[i]ndeed, . . .
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`the in vitro data suggested that the in vivo trials would be successful” and the art
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`“indicated that there was a motivation to seek clinical applications.”).
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`Genzyme’s holding that, in the context of a method of treatment, it is obvious
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`to do what the prior art instructs is also consistent with KSR’s obvious-to-try
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`doctrine. In scenarios where “there are a finite number of identified, predictable
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`solutions, a person of ordinary skill has good reason to pursue the known options
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`within his or her technical grasp.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421
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`(2007). “If this leads to the anticipated success, it is likely the product not of
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`innovation but of ordinary skill and common sense.” Id.
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`The prior art here is even more supportive of reasonable expectation of
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`success than that in Genzyme. For Ground 1, the Board acknowledged the art taught
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`the claimed composition, that in vitro results provided a “compelling justification”
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`for clinical use, and that a clinical trial (with dose information) was in fact ongoing.
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`Dec., 21-24, 34-37. There was nothing left for Patent Owner to do but report the
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`results of the very same clinical trial already disclosed in the prior art. Pet. 19. This
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`cannot be the basis for non-obviousness under Genzyme and KSR.
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`7
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`IPR2022-00853
`Patent No. 9,464,140
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`The ’140 Decision relied on an erroneous interpretation of law, the OSI
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`decision that Patent Owner erroneously described as “directly on-point.” POPR, 24;
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`Dec., 40. But a close reading of OSI shows it is not on point.
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`As the Board noted, “[t]he claims at issue in OSI Pharms., were . . . directed
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`to a method of treating non-small cell lung cancer (‘NSCLC’) in a mammal using a
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`therapeutically effective amount of erlotinib.” Dec., 40. However, the Board
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`misunderstood the OSI decision as finding that “erlotinib [] had previously been
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`shown to inhibit the epidermal growth factor receptor (‘EGFR’) in vitro.” Id. In fact,
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`just the opposite was true: the prior art did “not even include in vitro (test tube) data
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`regarding erlotinib’s effect on NSCLC.” OSI, 939 F.3d at 1383 (“[T]he asserted
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`references do not disclose any data or other information about erlotinib’s efficacy in
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`treating NSCLC.” (emphasis in original)). On that basis, the Federal Circuit found
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`that a reasonable expectation of success was “not supported by substantial
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`evidence.” Id. at 1382-85. OSI thus stands for the unremarkable proposition that the
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`absence of in vitro data can defeat a reasonable expectation of success. Id. at 1383.
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`The reasonable expectation of success in OSI is also distinguishable because,
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`in that context, similar drugs had “over 99.5% rate of failure for drugs entering
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`Phase II clinical studies.” Id. Not so here. In the field of CD19-directed CAR T-cell
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`therapy before 2010, there were nine other trials aside from the one described by
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`CART-19 ClinicalTrials.gov. See Ex. 2037, 1036. Petitioner provided evidence of
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`8
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`IPR2022-00853
`Patent No. 9,464,140
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`positive results in three of them. Pet., 36; Junghans, ¶¶178-84; see Ex Parte Vu et
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`al., 2019 WL 7170656 (PTAB Nov. 25, 2019) (distinguishing OSI where, “[h]ere,
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`there is no evidence of over a thousand, or even a few, clinical trials relating to
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`antibody therapies for blood cancers, much less evidence of a 99.5% failure rate in
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`such an impressive number of clinical trials as in OSI Pharmaceuticals.”).
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`The OSI facts are thus diametrically opposed to the facts here. Ground 1
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`includes not only successful in vitro data, but an express conclusion in peer-reviewed
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`prior art that those in vitro results provide a “compelling justification” for a clinical
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`trial, as well as disclosure that there was, in fact, an ongoing clinical trial.
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`Indeed, from a policy perspective, the reasoning of the ’140 Decision would
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`have a profoundly adverse impact on the biopharmaceutical industry. The prior-art
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`composition here was disclosed in 2005 in a patent family (Campana) that claims a
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`“method for treating a mammal suffering from cancer” and expires in 2025. Patent
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`Owner should not be allowed to obtain a longer monopoly, by an additional six years
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`until 2031, by reporting the results of what the prior art already suggested doing—a
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`clinical trial using the same amount of the same composition. OSI does not support
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`such an outcome and Genzyme expressly holds that a claim is obvious when, as here,
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`“there was little left to do but to confirm that the strategy suggested by the various
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`prior art references would work.” Genzyme, 825 F.3d at 1373.
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`9
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`IPR2022-00853
`Patent No. 9,464,140
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`II. The Board’s Erroneous Interpretation of OSI Results In Irreconcilable
`Inconsistency With The Institution Decision In Related IPR2022-00855
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`The Board’s erroneous interpretation of OSI has resulted in an irreconcilable
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`inconsistency between the ’140 Decision and the ’445 Decision. See Emerson Elec.
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`Co. v. SIPCO, LLC, 745 F. App’x 369, 372-73 (Fed. Cir. 2018) (remanding where
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`“the Board came to opposite conclusions on patentability of these nearly identical
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`claims despite considering nearly identical evidence in both cases.”). This, too,
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`strongly supports granting this request for rehearing of the ’140 Decision.
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`The independent claims of the ’140 and ’445 patents are nearly identical and
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`have no material differences. The ’445 patent recites a “pharmaceutical
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`composition” and the ’140 patent recites a “method of treating cancer” with this very
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`same pharmaceutical composition, both using “an anti-tumor effective amount.”
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`Dec., 7-8; ’445 Decision, 9. There are no additional steps required by the ’140
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`method beyond administering the ’445 pharmaceutical composition to patients. And
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`the Board correctly found that the “method of treating cancer” preamble in the ’140
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`patent—the only purportedly meaningful difference between the independent claims
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`of the two patents—was not limiting.3 Dec., 16-18. The Board reached different
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`3 The independent claim of the ’445 patent also has an additional limitation—
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`“wherein the T cells are from a human having cancer”—not found in the ’140 patent,
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`that was taught by the art. ’445 Decision, 23.
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`10
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`IPR2022-00853
`Patent No. 9,464,140
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`obviousness conclusions for the ’140 patent and ’445 patent because the latter’s
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`“anti-tumor effective amount” was treated as a functional limitation in the context
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`of a product claim. See ’445 Decision, 27. But that does not change the fact that the
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`pharmaceutical composition, i.e., a composition for administration to patients, was
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`(on a preliminary record) found to be obvious. The ’140 patent’s method of using
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`this obvious pharmaceutical composition by administering it to patents—exactly as
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`instructed by the prior art—is also obvious.
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`The irreconcilable nature of the Board’s holdings in IPR2022-00853 and
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`IPR2022-00855 can be illustrated through the doctrine of inherency in obviousness
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`determinations. “[I]nherency may supply a missing claim limitation in an
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`obviousness analysis.” Persion, 945 F.3d at 1190. In the ’445 Decision, the Board
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`held a “pharmaceutical composition comprising an anti-tumor effective amount”
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`was obvious in the art, e.g., based on the disclosure of the CART19
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`ClinicalTrials.gov ongoing efficacy trial in cancer patients using 2.5×107
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` to 6.1×108
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`cells per kg. ’445 Decision, 27 (“Here, there is a sufficient reason in the record to
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`have selected the number of CAR-T cells for use in a patient from the
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`ClinicalTrials.gov’s disclosure to meet the product claim limitation of an “amount”
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`as recited in element 1(b).”). An inherent outcome for cancer patients who receive
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`this “anti-tumor effective amount” is that their tumors will be treated.
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`11
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`IPR2022-00853
`Patent No. 9,464,140
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`Merely reporting patient outcomes does not render non-obvious a method of
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`using the prior-art pharmaceutical composition in the same manner taught by the art.
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`Persion, 945 F.3d at 1189-91 (“‘[A]n obvious formulation cannot become
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`nonobvious simply by administering it to a patient and claiming the resulting serum
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`concentrations,’ because ‘[t]o hold otherwise would allow any formulation—no
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`matter how obvious—to become patentable merely by testing and claiming an
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`inherent property.”’), quoting Santarus, Inc. v. Par Pharm., 694 F.3d 1344, 1354
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`(Fed. Cir. 2012). Indeed, the ’445 Decision itself acknowledged that providing a
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`cancer patient with the claimed amount would necessarily be “anti-tumor effective”:
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`“[A] product with the recited structure in the recited amount would reasonably meet
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`the functional limitation of being “anti-tumor effective” because it is an inherent
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`characteristic of the product.” ’445 Decision, 15-16 n.16 (citing Pet., 41).
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`Patent Owner has never disputed that giving the amounts taught by the prior
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`art (e.g., 2.5×107
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` to 6.1×108
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` cells per kg) would necessarily be “anti-tumor
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`effective.” See Pet., 30-38. Nor can it. The prior art here, an ongoing clinical trial
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`reported in CART-19 ClinicalTrials.gov, is the very same clinical trial that is
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`reported in the patent specification as obtaining successful clinical results. Id. at 19
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`(citing Junghans, ¶104) (“This was the same clinical trial described in the
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`specification of the ’140 patent.”). The ’445 Decision correctly found that this prior
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`art rendered obvious a “pharmaceutical composition comprising an anti-tumor
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`12
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`IPR2022-00853
`Patent No. 9,464,140
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`effective amount.” ’445 Decision, 23-28. Because the claimed “anti-tumor effect[]”
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`of the method of treatment in the ’140 patent is an inherent property of the claimed
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`“anti-tumor effective amount” of the pharmaceutical composition in the ’445 patent,
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`the same obviousness determination must apply equally to the ’140 patent.
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`III. The Board Misapplied Part 2 of the Advanced Bionics Framework
`Because Milone Was Overcome During Prosecution Of Parent
`Application In A Manner Inapplicable To Challenged Claim Here
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`With respect to Ground 3, the Board recognized that “reasonable expectation
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`of success is strengthened by the addition of Milone’s preclinical animal data,” Dec.,
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`41, but exercised discretionary denial because Milone was discussed during
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`prosecution of a parent application, No. 13/992,622 (“’622 application”), id. at 41-
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`48. The Board reached this conclusion in error and without briefing from either
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`party. Not even Patent Owner argued that this discussion of Milone warranted
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`discretionary denial. This is unsurprising given the prosecution history.
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`During prosecution of the ’622 application, the Examiner applied rejections
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`over Milone. See Ex. 3002, 45, 81-82. Every pending claim, however, recited a
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`limitation requiring the CAR-T composition to have a certain amino acid sequence
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`for the CD3 zeta domain—SEQ ID NO: 24. Patent Owner argued to the Examiner
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`that “Milone does not disclose, inter alia, any nucleic acid encoding a CAR or a
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`CAR comprising a CD3 zeta signaling domain comprising the amino acid sequence
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`of SEQ ID N0:24.” Id. at 35-40 (emphasis in original); see also id. at 68-74. The
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`13
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`IPR2022-00853
`Patent No. 9,464,140
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`Examiner then allowed these claims over Milone solely because of this composition
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`limitation, which is not disclosed by Milone. See id. at 17; Pet., 69-70. The Examiner
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`concluded: “SEQ ID NO: 24 adds novelty to the instant claims.” Ex. 3002, 17.
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`In its ’140 Decision, the Board failed to acknowledge that the distinguishing
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`claim limitation directed to the amino acid sequence of CD3 zeta (SEQ ID NO: 24)
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`is notably absent from the independent claim of the ’140 patent. See Pet., 69-70. The
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`independent claim’s omission of SEQ ID NO: 24 is critical to the 325(d) analysis.
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`Part two of the framework laid out in Advanced Bionics v. MED-EL, IPR2019-
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`01469, Paper 6 at 7-11 (Feb. 13, 2020) is controlled in part by “the extent to which
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`the asserted art was evaluated during examination.” See Advanced Bionics,
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`IPR2019-01469, Paper 6 at 7-11. For Section 325(d) evaluations, how a prior-art
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`rejection was overcome bears on this factor. E.g., Spectrum v. DNA Genotek,
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`IPR2022-00134, Paper 7 at 8-14 (June 6, 2022) (described below); Target v.
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`Proxicom, IPR2020-00980, Paper 11 at 14-18 (Dec. 4, 2020) (declining
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`discretionary denial because the challenged independent claim did not recite the
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`distinguishing limitation of a related, non-parent patent).
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`Spectrum Solutions is on point. The Board there held that discretionary denial
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`was improper even though a prior-art reference was discussed during prosecution of
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`a grandparent application. Spectrum, IPR2022-00134, Paper 7 at 8-14. During that
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`prosecution, the patent owner narrowed the claim scope to avoid a prior-art
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`IPR2022-00853
`Patent No. 9,464,140
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`reference. Id. at 9-12. The Board found that such evaluation of a prior-art reference
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`did not satisfy part two of Advanced Bionics for the IPR-challenged claims because
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`“such consideration was in the context of claims that limit the claimed [limitation]
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`in a way that the challenged claims do not.” Id. at 12. Here too, the Examiner
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`considered Milone in the context of claims that were limited in a way the challenged
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`claim is not. The Examiner never considered Milone against claims not limited to
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`SEQ ID NO: 24. This parent application’s allowance over Milone thus is irrelevant
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`to the challenged claim in this IPR petition.
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`The Board further erred by putting weight on the Examiner’s assumed
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`knowledge of Milone in part two of the Advanced Bionics framework. See Dec., 47.
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`Part two assesses whether “the petitioner has demonstrated that the Office erred in a
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`manner material to the patentability of [the] challenged claims.” Advanced Bionics,
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`IPR2019-01469, Paper 6 at 8. The relevant inquiry is not the Examiner’s mere
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`knowledge of Milone, but rather how it was evaluated during prosecution. Apple v.
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`Koss, IPR2021-00381, Paper 15 at 28-29 (PTAB July 2, 2021) (withholding
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`discretionary denial because the reference was not “evaluated sufficiently” during
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`prosecution). Petitioner has satisfied part two of Advanced Bionics because Milone’s
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`strengthening of a reasonable expectation of success was never overcome during
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`prosecution.
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`IPR2022-00853
`Patent No. 9,464,140
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`Respectfully submitted,
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`/Yite John Lu
`Yite John Lu (Reg. No. 63,158)
`jlu@milbank.com
`Tel. (424) 386-4318
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`Counsel for Petitioner
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`/
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`Gary N. Frischling (Reg. No. 35,515)
`gfrischling@milbank.com
`Tel. (424) 386-4316
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`David I. Gindler (to be pro hac vice)
`dgindler@milbank.com
`Tel. (424) 386-4313
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`Milbank LLP
`2029 Century Park East, 33rd Floor
`Los Angeles, CA 91167
`Fax. (213) 629-5063
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`Backup Counsel for Petitioner
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`DATED: November 10, 2022
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`IPR2022-00853
`Patent No. 9,464,140
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`Certificate of Service
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`I hereby certify, pursuant to 37 C.F.R. Sections 42.6 and 42.105, that a
`complete copy of the attached Petitioner’s Request for Rehearing, is being
`served on the twelfth day of August, the same day as the filing of the above-
`identified document in the United States Patent and Trademark Office/Patent
`Trial and Appeal Board, upon the patent owner by serving via electronic mail to
`the following:
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`Counsel for Patent Owner
`Brian R. Landry (Reg. No. 62, 074)
`Saul Ewing Arnstein & Lehr LLP
`131 Dartmouth St, Ste 501
`Boston, MA 02116
`Tel. (617) 912-0969
`Brian.landry@saul.com
`
`Backup Counsel for Patent Owner
`Kathryn Doyle (Reg. No. 36,317)
`Saul Ewing Arnstein & Lehr LLP
`1500 Market St, 38th Floor
`Philadelphia, PA 19102
`Tel. (215) 972-7734
`Kathryn.doyle@saul.com
`
`Alireza Behrooz (Reg. No. 60,882)
`Saul Ewing Arnstein & Lehr LLP
`1919 Pennsylvania Ave, N.W.,
`Ste 550
`Washington, DC 20006-3434
`Tel. (202) 295-6687
`Alireza.behrooz@saul.com
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`Backup Counsel for Real Party in
`Interest and Licensee Novartis Pharma
`AG
`Jessamyn S. Berniker (Reg. No. 72,328)
`David M. Krinsky (Reg. No. 72,339)
`Thomas S. Fletcher (Reg. No. 72,383)
`Williams & Connolly LLP
`680 Maine Ave SW
`Washington, DC 20024
`Tel. (202) 434-5000
`jberniker@wc.com
`dkrinsky@wc.com
`tfletcher@wc.com
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`IPR2022-00853
`Patent No. 9,464,140
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`DATED: November 10, 2022
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`/
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`/Yite John Lu
`Yite John Lu (Reg. No. 63,158)
`Milbank LLP
`2029 Century Park East, 33rd Floor
`Los Angeles, CA 91167
`Tel. (424) 386-4318
`Fax. (213) 629-5063
`jlu@milbank.com
`Counsel for Petitioners
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