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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`———————————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`———————————
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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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`———————————
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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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`———————————
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`PATENT OWNER’S RESPONSE TO PETITIONER’S REQUEST FOR
`REHEARING OF INSTITUTION DECISION
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`(authorized by Order of November 23, 2022, Ex. 3004)
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`TABLE OF CONTENTS
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`TABLE OF AUTHORITIES .................................................................................... ii
`I. Miltenyi Does Not Satisfy the High Standard Required for Rehearing. ......... 2
`II. Miltenyi Cannot Show that the Board’s Assessment of Reasonable
`Expectation of Success Was an Abuse of Discretion. ..................................... 3
`III. Miltenyi Ignores the Reasonable Expectation of Success Requirement. ........ 8
`IV. Milone Was Discussed Extensively During Prosecution. ............................. 13
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`i
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`TABLE OF AUTHORITIES
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`CASES
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`Apple Inc. v. Koss Corp.,
`IPR2021-00381, Paper 15 (PTAB July 2, 2021) ................................................ 15
`Boehringer Ingelheim v. Schering-Plough,
`320 F.3d 1339 (Fed. Cir. 2003) ............................................................................ 6
`Eli Lilly and Co. v. Teva Pharms. Int’l GmbH,
`8 F.4th 1331 (Fed. Cir. 2021) ............................................................................... 9
`EMC Corp. v. PersonalWeb Techs., LLC,
`IPR2013-00085, Paper 29 (PTAB June 5, 2013) ............................................. 4, 7
`Genzyme Therapeutic Prods. v. Biomarin Pharm.,
`825 F.3d 1360 (Fed. Cir. 2016) ...................................................................passim
`OSI Pharms., LLC v. Apotex Inc.,
`939 F.3d 1375 (Fed. Cir. 2019) ...................................................................passim
`Miltenyi Biomedicine GmbH v. Trustees of the Univ. of Pennsylvania,
`IPR2022-00853, Paper 11 (PTAB Oct. 11, 2022) .......................................passim
`Miltenyi Biomedicine GmbH v. Trustees of the Univ. of Pennsylvania,
`IPR2022-00855, Paper 10 (PTAB Oct. 11, 2022) ................................................ 9
`Teva Pharms. USA, Inc. v. Corcept Thers., Inc.,
`18 F.4th 1377 (Fed. Cir. 2021) ....................................................................... 9, 13
`
`Spectrum Solutions LLC v. DNA Genotek Inc.,
`IPR2022-00134, Paper 7 (PTAB June 7, 2022) ................................................. 15
`Univ. of Strathclyde v. Clear-Vu Lighting,
`17 F.4th 155 (Fed. Cir. 2021) ........................................................................... 6, 9
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`ii
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`STATUTES AND REGULATIONS
`35 U.S.C. § 325(d) ............................................................................................. 13, 15
`37 C.F.R. § 42.71(c) & (d) ......................................................................................... 2
`37 C.F.R. § 42.71(d) .............................................................................................. 3, 7
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`iii
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`Miltenyi’s Request for Rehearing of the Board’s decision not to institute trial
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`on U.S. Patent No. 9,464,140 (the “’140 patent”) comes nowhere close to
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`establishing that the Board misapprehended or overlooked a dispositive argument
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`for institution. In a thorough opinion, the Board considered Miltenyi’s arguments
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`and evidence and concluded that given “the inherent unpredictability of the field”
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`and “the history of failures of similar technology,” Miltenyi was not likely to
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`demonstrate a reasonable expectation of success on Grounds 1 and 2. In Ground 3,
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`it then exercised its discretion not to revisit the same reference the Examiner
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`considered in detail. The Board properly denied institution.1
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`Unable to undermine the Board’s critical factual predicates, Miltenyi argues
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`as to Grounds 1 and 2 that the Board got the law wrong when it analogized this
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`case to OSI v. Apotex, 939 F.3d 1375 (Fed. Cir. 2019). But the Board was
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`correct—and certainly did not misapprehend or overlook anything—when it
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`concluded that the facts of this case mirror OSI’s and that there would have been
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`no reasonable expectation of success. Miltenyi’s favored case, Genzyme v.
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`Biomarin, 825 F.3d 1360 (Fed. Cir. 2016), does not permit the Board to sidestep
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`the reasonable expectation analysis when there is a teaching or motivation or a
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`pending clinical trial; it simply held on the facts of that case—where unlike here
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`1 Petitioner does not challenge the Board’s decision to not institute on Ground 4.
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`1
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`there was no history of failure—that there was a reasonable expectation of success.
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`Nor is there inconsistency between non-institution here and the institution decision
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`on the composition patent in IPR2022-00855; whatever Miltenyi has to prove in
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`that other proceeding (which will be contested at trial), the method-of-treatment
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`claims of the ’140 patent unambiguously require efficacy and Miltenyi failed to
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`show a reasonable expectation of success in achieving that efficacy.
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`On Ground 3, Miltenyi hypothesizes that the Examiner did not fully consider
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`Milone because the claims at issue when Patent Owner overcame Milone rejections
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`differ from the present claims. Miltenyi’s argument does not refute the critical
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`point: the Examiner was extremely familiar with Milone and nonetheless allowed
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`the ’140 patent claims. There was no error in the Board’s application of the
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`Advanced Bionics framework, let alone an abuse of the Board’s discretion.
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`I. Miltenyi Does Not Satisfy the High Standard Required for Rehearing.
`Rehearing petitions such as this are routinely denied as a matter of course.
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`As this Board is well aware, Miltenyi has the burden to prove that the Board
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`abused its discretion in the underlying decision. 37 C.F.R. § 42.71(c) & (d).
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`Given this high standard, rehearing petitions seeking to reverse non-institution
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`decisions are very rarely granted. This is not the rare case.
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`To begin with, Miltenyi’s rehearing brief is devoted almost entirely to
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`positions found nowhere in its original Petition or in the reply brief Miltenyi
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`2
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`sought and was granted after Patent Owner’s Preliminary Response (“POPR”).
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`Miltenyi does not even attempt to comply with the requirement that, as to each
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`argument it “believes the Board misapprehended or overlooked,” it “specifically
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`identify” “the place where each matter was previously addressed in a motion, an
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`opposition, or a reply.” 37 C.F.R. § 42.71(d). It does not, because it cannot.
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`It is hard to point to anything in Miltenyi’s rehearing brief that is not new.
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`Patent Owner addressed OSI at length in its POPR. Miltenyi then requested, was
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`granted, and filed an additional brief responding to various aspects of the POPR.
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`Ex. 3001. Yet Miltenyi never addressed OSI until its rehearing request. Miltenyi
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`also makes newly minted KSR obvious-to-try and inherent obviousness arguments.
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`Request for Rehearing Brief, Paper 12, (“Br.”) at 7, 11-12. It attempts a brand new
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`and out-of-place double patenting argument framed as a policy argument. Id. at 9.
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`And it newly tries to stuff Milone’s data into Grounds 1 and 2. Id. at 6 n.2.
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`A rehearing petition is not the place to raise new arguments for the first time.
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`37 CFR § 42.71(d). Miltenyi’s petition is so rife with new arguments, calling it a
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`“rehearing” petition would be charitable; it should be rejected on that basis alone.
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`II. Miltenyi Cannot Show that the Board’s Assessment of Reasonable
`Expectation of Success Was an Abuse of Discretion.
`Without a legitimate basis for rehearing, Miltenyi tries to concoct a legal
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`issue. But the Board did not misapprehend the Federal Circuit’s precedent
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`regarding reasonable expectation of success—it merely disagreed with Miltenyi on
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`3
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`how the facts here align with that precedent. “It is not an abuse of discretion to
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`have made an analysis or conclusion with which a party disagrees.” EMC Corp. v.
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`PersonalWeb Techs., LLC, IPR2013-00085, Paper 29, at 4 (PTAB June 5, 2013).
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`Miltenyi wrongly chastises the Board for describing OSI as “finding that
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`‘erlotinib [] had previously been shown to inhibit the epidermal growth factor
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`receptor (‘EGFR’) in vitro,” saying that “just the opposite was true: the prior art
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`did “not even include in vitro (test tube) data regarding erlotinib’s effect on
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`NSCLC.” Br. at 8. In fact, it is Miltenyi that misapprehends OSI. There was data
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`showing EGFR inhibition in OSI. As the OSI court stated, consistent with the
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`Board’s description, the art taught that “erlotinib inhibits the EGFR and has good
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`anticancer activity in some cancers.” 939 F.3d at 1380, 1384. It did not, however,
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`teach “efficacy in treating NSCLC.” Id. (emphasis added). In light of the complete
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`record, the in vitro data in OSI—like the in vitro data in Campana and Jensen
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`here—were not sufficient to provide a reasonable expectation of success.
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`Miltenyi does not dispute or grapple with the other key evidence that makes
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`this case align with OSI, as opposed to Genzyme—that “[c]ancer treatment is
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`highly unpredictable,” 939 F.3d 1375, 1377, and, as Patent Owner explained, the
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`CAR-T space in particular was riddled with failures. See POPR at 3. Patent
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`Owners submitted evidence that of twenty-five CAR-T clinical trials in the prior
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`art, only four had shown “any ‘CAR-mediated antitumor effort or mere ‘reduction
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`4
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`in biological markers of tumor activity,” Ex. 2037 at 1036, which “even under the
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`most charitable view is an 84% failure rate.” POPR at 26.2 As summarized in a
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`2012 review, “despite promising preclinical results, the majority of . . . initial CAR
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`T cell trials showed little evidence of anti-tumor activity with limited activation,
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`persistence, and homing to tumor sites being the main barriers.” Ex. 2035 at 956.
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`In this context, the mere existence of a Phase I clinical trial protocol without results
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`does not establish a reasonable expectation of success. The Board expressly relied
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`on this evidence—and did not misapprehend or overlook anything—when it
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`concluded that “[c]onsidering the inherent unpredictability of the field and the
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`history of failures of similar technology documented by Patent Owner, we do not
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`find Petitioner’s arguments persuasive.” Paper 11, (“Op.”) at 41.
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`There was no such litany of failures in Genzyme, and that distinguished
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`Genzyme from OSI—and from this case—on its facts. The Genzyme opinion refers
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`to two positive in vivo studies and no failures—clinical or otherwise. 825 F.3d at
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`1365. On that specific record, the court affirmed a finding that there was a
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`reasonable expectation of success because there was “little left to do but to confirm
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`that the strategy suggested by the various prior art references would work.” Id. at
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`2 Even using Miltenyi’s own count of nine “CD-19-directed CAR T-cell trials”
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`only three had results that Miltenyi characterizes as “positive.” Br. at 8-9.
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`5
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`1373. But whether Miltenyi likes it or not, that record bears no similarity to the
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`one here. CAR-T cells were first conceived in the 1980s, yet at the time of the
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`invention thirty years later, not a single CAR-T cell therapy had ever been
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`approved by the FDA for treating cancer. Exs. 2002 at 2; 2006 at 1. Here, like in
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`OSI, many “compounds failed in clinical trials.” 939 F.3d at 1377; POPR at 23-24.
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`Here, like in OSI, in vitro effectiveness is a “poor proxy” for treating patients. 939
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`F.3d at 1377; POPR at 24-25; Ex. 2035 at 956. And here, like in OSI, the
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`references at best “provide no more than hope—and hope that a potentially
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`promising drug will treat a particular cancer is not enough to create a reasonable
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`expectation of success in a highly unpredictable art such as this.” OSI, 939 F.3d at
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`1385. Here, in fact, as of the priority date here, many had lost hope. “Influential
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`scientists [at NIH] didn’t think engineered T cells could ever work.” Ex. 2001 at 9.
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`The Federal Circuit has emphasized repeatedly that evidence of failures
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`undermines the notion that the POSA could have had a “reasonable” expectation of
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`success. As the Court in Boehringer Ingelheim v. Schering-Plough, 320 F.3d
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`1339, 1354 (Fed. Cir. 2003), put it, “there can be little better evidence negating an
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`expectation of success than actual reports of failure.” Similarly, in Univ. of
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`Strathclyde v. Clear-Vu Lighting, 17 F.4th 155, 164 (Fed. Cir. 2021), the Court
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`reiterated that evidence of “failures” is significant in this assessment.
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`Miltenyi argues that institution was required under Genzyme given the
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`6
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`disclosure of a composition, plan to conduct clinical testing, and “promising in
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`vitro results.” Br. 5-6. But fatally for Miltenyi, the Board considered those facts.
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`Op. at 41. The Board even stated that “Petitioner here has a somewhat better
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`position that Appellees in OSI Pharms.” Id. But given the “inherent
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`unpredictability of the field and the history of failures of similar technology
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`documented by Patent Owner,” it rejected Miltenyi’s arguments. Id. This was
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`well within the Board’s discretion to conclude. Nothing in Genzyme dictates a
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`contrary result. The Board assessed the factual record, and that assessment was not
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`an abuse of discretion. “Mere disagreement with the Board’s analysis or
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`conclusion is not a proper basis for rehearing.” EMC Corp., Paper 29, at 4.3
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`It is important to add that Miltenyi did not attempt to support a finding of
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`reasonable expectation of success under the Board’s provisional claim construction
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`of “anti-tumor effective amount,” namely, an amount “that reduces the frequency
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`or severity of at least one clinically relevant sign or symptom of the disease.” Op.
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`3 Miltenyi appears to try to supplement its Grounds 1 and 2 to rely now, for the
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`first time, on Milone’s animal data to support those combinations. That is not a
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`proper basis for reconsideration, which must be based on arguments previously
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`presented. 37 C.F.R. § 42.71(d). In any event, this fares no better for the reasons
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`the Board already found in rejecting Ground 3.
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`7
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`at 20. Instead, its Petition applied a much lower standard, requiring only the death
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`of a single cancer cell. Paper 1, at 15. Furthermore, as the Board explained, Op. at
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`37-38, the proper question is not whether a particular concentration of cells
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`happens to be effective, but whether the POSA would have expected it to be
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`effective. OSI, 939 F.3d at 1382-83. Miltenyi has not proven that either.
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`Finally, Miltenyi attempts a series of improper arguments found nowhere in
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`its original papers. Its new KSR obvious-to-try argument, Br. at 7, fails for being
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`wildly untimely and because there is no support for the laughable suggestion that
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`making CAR-Ts to treat cancer was an art composed of “finite” and “predictable”
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`solutions in 2011. That would be news to the FDA, which described this invention
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`as “a historic action” and “a first-of-its-kind treatment approach that fills an
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`important unmet need for children and young adults with this serious disease.” Ex.
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`2007 at 1. Miltenyi next offers what it calls a “policy argument” about an alleged
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`“profoundly adverse impact on the biopharmaceutical industry,” Br. at 9, via what
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`appears to be a facially flawed, untimely, and jurisdictionally improper double-
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`patenting argument. This is neither the time nor the place for new arguments.
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`III. Miltenyi Ignores the Reasonable Expectation of Success Requirement.
`In Section II of its brief, Miltenyi argues that its Petition challenging the
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`method of treatment patent must be instituted if the composition patent is—another
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`position it never previously articulated. But the foundational premise of the
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`8
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`Board’s institution decision in that case was that method and product claims are
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`different. IPR2022-00855, Paper 10, at 27 (“ ’855 Op.”). Miltenyi’s latest new
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`argument essentially seeks to read out the efficacy limitations in the method claims
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`so as to erase Miltenyi’s obligation to prove reasonable expectation of success. It
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`runs afoul of black-letter law, the claim language, and the Board’s opinions.
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`It is a bedrock principle of obviousness law that the challenger must prove
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`that the POSA would have had a reasonable expectation of success in achieving the
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`claimed invention. Teva Pharms. USA, Inc. v. Corcept Thers., Inc., 18 F.4th 1377,
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`1380-83 (Fed. Cir. 2021); OSI, 939 F.3d at 1382. This law is applied as a matter of
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`course to method of treatment claims to require the challenger to demonstrate that
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`the POSA would have had a reasonable expectation of successfully treating the
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`recited condition as claimed. OSI, 939 F.3d at 1382-83; Eli Lilly and Co. v. Teva
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`Pharms. Int’l GmbH, 8 F.4th 1331, 1344-45 (Fed. Cir. 2021); Corcept, 18 F.4th at
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`1380-83; Genzyme, 825 F.3d at 1372-73; see also Univ. of Strathclyde, 17 F.4th at
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`162-66. This obligation cannot be circumvented.
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`To try to erase this obligation, Miltenyi conjures a supposed inconsistency
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`with the Board’s institution decision in IPR2022-00855 regarding a related
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`composition patent. There, the Board distinguished composition claims, stating:
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`“[t]he patentability of the composition claim . . . ‘depends on the claimed structure,
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`not on the use or purpose of that structure.’” ’855 Op. at 15; id. at 27
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`9
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`(distinguishing method and composition claims, and noting that the OSI claims
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`were to methods). The Board went on to say the anti-tumor effective amount
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`limitation “represents an intended use that is embedded in a composition claim,”
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`and concluded that “‘an intended use or purpose usually will not limit the scope of
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`the claim because such statements usually do no more than define a context in
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`which the invention operates.’” Id. at 15. Following that thread, the Board
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`concluded that in the context of the pharmaceutical composition claims, Miltenyi
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`only needed to prove “success in making the pharmaceutical composition for
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`administration to patients regardless of the clinical outcome.” Id. at 26-27
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`(emphasis added). In other words, in its preliminary opinion regarding the
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`composition claims, the Board viewed there to be a requirement of proving a
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`reasonable expectation of success in “making the pharmaceutical composition,”
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`not in “clinical effectiveness in treating cancer.” Id. But, recognizing that there
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`might be a disagreement about this, the Board specifically invited the parties to
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`brief this issue in the future. Id. at 15-16.
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`Patent Owners respectfully disagree with the Board’s preliminary conclusion
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`regarding the composition claims and will address the issue in that proceeding, as
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`the Board suggested. Regardless, that case relates to composition claims, not
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`method claims. Whatever Miltenyi must prove to establish a reasonable
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`expectation of success in the composition case, the Board’s opinion in that case did
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`10
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`not suggest that in the context of method of treatment claims, Miltenyi need not
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`prove the POSA would have had a reasonable expectation that the method of
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`treatment would work. To the contrary, as the Federal Circuit has held time and
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`time again, an obviousness challenge to a method of treatment patent must prove a
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`reasonable expectation of success in the treatment. Supra p. 9 (collecting cases).
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`That is precisely why patents on new methods of treatment routinely are granted
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`years after compounds are invented—because no one expected the compound to be
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`useful for the new treatment.
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`The efficacy required by the method-of-treatment claims flows from two
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`places: the preamble directed to “a method of treating cancer in a human patient,”
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`and the administration of an “anti-tumor effective amount.” Contrary to Miltenyi’s
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`assertion, the Board did not find that the preamble “was not limiting.” Br. 10. The
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`Board, rather, concluded that whether the effectiveness limitation lay in the
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`preamble or the “anti-tumor effective amount” limitation did not matter, because
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`“even if” the preamble requires “reducing the frequency or severity of at least one
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`sign or symptom of cancer,” “this definition is coextensive with, if not subsumed by
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`the term antitumor effective amount.” Op. at 17-18 (emphases added). The
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`efficacy requirement Miltenyi now seeks to evade is present, one way or another.
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`And if the “anti-tumor effective amount limitation” were not given weight (as
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`Miltenyi argues on the basis of the composition patent opinion), then the preamble
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`11
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`of the method patent would nonetheless still require proof of a reasonable
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`expectation of efficacy. Miltenyi may not selectively jam together pieces of each
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`of the Board’s decisions—keeping only the pieces it likes from each.
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`Miltenyi provides no support for the proposition that a challenger seeking to
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`establish the obviousness of a method-of-treatment claim need not prove a
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`reasonable expectation of success in treating the disease, only an expectation of
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`success in making the composition. That is because the proposition is wrong. The
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`Board committed no error of law in its assessment of the method patent.
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`Finally, Miltenyi turns to yet another new argument. This time it is inherent
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`obviousness, a concept found nowhere in its original Petition, and thus improper
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`here. Br. at 11. But the composition patent claim is not prior art, and cannot be
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`the starting point for Miltenyi’s obviousness argument. Moreover, treating cancer
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`is not an “inherent outcome” of making a composition and putting it on a shelf, Br.
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`at 11; a method of treatment patent does not “merely report[] patient outcomes,” or
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`claim a serum concentration. Br. at 12. (Miltenyi also is wrong that the “clinical
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`trial 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.” Br. at
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`12.) Whatever the inherent properties of a composition may be, nothing suggests
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`that a challenger can establish obviousness of a method of treatment where no one
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`would have reasonably expected that method to work. Miltenyi’s new argument is
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`12
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`nothing more than an attempt to evade the reasonable expectation requirement, and
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`it is simply incorrect that the (preliminary) “obviousness determination” regarding
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`the composition patent claim “must apply equally to the ’140 patent.” Br. at 13.
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`Treating cancer using the claimed method has been hailed as a “major
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`advance,” “a turning point,” and “a Lazarus moment.” POPR at 1. It would be
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`legally improper to evaluate the obviousness of that advance without considering
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`the POSA’s expectations about whether the claimed method would work. See e.g.,
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`Corcept, 18 F.4th at 1383. The Board was right to conclude that Miltenyi failed to
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`establish a reasonable expectation of success, and thus to establish obviousness.
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`IV. Milone Was Discussed Extensively During Prosecution.
`In rejecting Ground 3 of the Petition based on § 325(d), the Board concluded
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`that the Examiner was well aware of Milone and its disclosures when it allowed
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`the ’140 patent. Op. at 41. This conclusion was undeniably correct.
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`As the Board found, Milone was the primary reference and was “discussed
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`at length in the prosecution of the ’622 parent application,” Op. at 46, including in
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`two separate office actions and responses, e.g. Ex. 3002 at 35-41, 45-49, 67-74, 81-
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`84. The same Examiner examined the ’140 patent, and the rejections over Milone
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`in the ’622 application occured prior to the substantive prosecution of the ’140
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`patent. Op. at 47. The Board concluded that “the Examiner understood Milone to
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`disclose successful in vitro and preclinical animal studies using T-cells expressing
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`13
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`a CAR substantially the same as that described in the challenged claims.” Op. at
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`46-47. And the Board emphasized that the “Examiner, having recently allowed
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`claims over Milone in the ’622 parent application, did not lodge a rejection based
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`on this reference in the examination of the related ’140 patent.” Id. at 47.
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`Miltenyi asserts that “the examiner never considered Milone against claims
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`not limited to SEQ ID NO: 24”—i.e., the ’140 patent prosecution. Br. at 15.
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`There is no basis for this unfounded assertion, and it is belied by the undisputed
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`facts and timing recited above, as well as the Examiner’s discussion of Milone
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`throughout the prosecution of the family, before he turned his attention to the ’140
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`patent. As the Board properly found, Milone was discussed extensively during
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`prosecution. Its experiments had been discussed thoroughly, and it had been
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`distinguished on several additional grounds, including that it would not have
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`provided a reasonable expectation of success and that it did not use the patient’s
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`own T cells but instead used T cells of healthy donors. See Ex. 3002 at 71-73. It
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`defies credulity to argue that the Examiner “never considered” Milone just because
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`he did not address it in an office action. On the contrary, the Examiner explicitly
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`noted that he did consider Milone during the examination of the ’140 patent. Ex.
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`2026 at 7; POPR at 46.
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`That the examiner referenced the distinction regarding SEQ ID NO: 24 in
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`allowing the ’622 application—a fact the Board was aware of and referenced in its
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`14
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`opinion, at 12—is immaterial. In fact, the Examiner issued a double-patenting
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`rejection for the claims of the ’140 patent over pending claims of the ’622
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`application—which belies the notion that the Examiner never compared the two
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`claim sets. Ex. 1021 at 228. The Board reasonably concluded that the Examiner
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`consciously allowed the ’140 patent, knowing what Milone did and did not teach.4
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` In short, the fact that the Examiner—who was clearly very familiar with
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`Milone—did not explicitly discuss Milone during this prosecution is without
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`consequence. Miltenyi has not come close to demonstrating that the Board
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`misapprehended or overlooked anything regarding the examination that would
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`warrant reconsideration of the Board’s discretionary ruling not to institute. The
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`Board was well within its discretion to deny institution here under § 325(d), and
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`there is no cause to revisit that well-reasoned determination.
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`4 Miltenyi’s cases are distinguishable. In Spectrum, the reference was cited only
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`once, and the Board emphasized the “strength of the anticipation showing in the
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`Petition.” IPR2022-00134, Paper 7 at 13, 11. In Apple, the examiner “materially
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`err[ed]” in describing the reference. IPR2021-00381, Paper 15, at 28-29. And in
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`Target, the Board was unpersuaded that the Examiner of the challenged patent—a
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`different Examiner from the one who examined the related case—had considered
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`the reference. IPR2020-00980, Paper 11, at 14, 17-18.
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`15
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`
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`Dated: December 1, 2022
`
`Respectfully submitted,
`
`By:
`
`
`/ Brian R. Landry/
`Brian Landry (Reg. No. 62,074)
`SAUL EWING ARNSTEIN & LEHR LLP
`131 Dartmouth Street, Suite 501
`Boston, MA 02116
`Tel: (617) 912-0969
`brian.landry@saul.com
`
`Counsel for Patent Owner
`
`Kathryn Doyle (Reg. No. 36,317)
`SAUL EWING ARNSTEIN & LEHR
`LLP
`Centre Square West
`1500 Market Street, 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 Avenue, N.W.,
`Suite 550
`Washington, DC 20006-3434
`Tel: (202) 295-6687
`alireza.behrooz@saul.com
`Backup Counsel for Patent Owner
`
`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 Avenue SW
`Washington, DC 20024
`Tel: (202) 434-5000
`jberniker@wc.com
`dkrinsky@wc.com
`tfletcher@wc.com
`
`
`Backup Counsel for Real Party in
`Interest and Licensee Novartis
`Pharma AG
`
`
`
`16
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`Certification of Service Under 37 C.F.R. § 42.6(e)(4)
`
`The undersigned hereby certifies that Patent Owner’s Response to
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`Petitioner’s Request for Rehearing of Institution Decision was served in its entirety
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`by filing through the Patent Trial and Appeal Case Tracking System (P-TACTS),
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`as well as providing a courtesy copy via e-mail to the following attorneys of record
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`for Petitioners listed below:
`
`Yite John Lu
`
`Gary N. Frischling
`
`
`
`Date: December 1, 2022
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`
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`
`
`PTABDocketL2Y7@orrick.com
`
`PTABDocketG2F1@orrick.com
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`
`
`By: /Brian R. Landry/
`
`Reg. No. 62,074
`
`
`
`17
`
`
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