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. IPR2022-00855
`U.S. Patent No. 9,540,445
`Issue Date: January 10, 2017
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`Title: Compositions and Methods for Treatment of Cancer
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`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY
`RESPONSE
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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. IPR2022-00855
`U.S. Patent No. 9,540,445
`Issue Date: January 10, 2017
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`Title: Compositions and Methods for Treatment of Cancer
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`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY
`RESPONSE
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`IPR2022-00855
`Patent No. 9,540,445
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`TABLE OF CONTENTS
`Porter is Prior Art .............................................................................................. 1
`I.
`II. Claim Construction - “Anti-Tumor Effective Amount” ................................... 3
`III. The Board Should Not Deny Institution Under Section 325(d) ....................... 5
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`IPR2022-00855
`Patent No. 9,540,445
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`Biocon Pharma v. Novartis Pharms.,
`IPR2020-01263, Paper 12 (P.T.A.B. Feb. 16, 2021) ............................................ 5
`Innova/Pure Water v. Safari Water Filtration,
`381 F. 3d 1111 (2004) ........................................................................................... 4
`Nelson Products v. Bal Seal Engineering,
`IPR2014-00573, Paper 9 (P.T.A.B. Sept. 29, 2014)............................................. 2
`Playtex Prod. v. Procter & Gamble,
`400 F.3d 901 (2005) .............................................................................................. 4
`Samsung Electronics Co. v. Evolved Wireless LLC,
`IPR2021-00943, Paper 9 (P.T.A.B. Dec. 1, 2021) ............................................... 5
`Sanofi-Aventis U.S. LLC et al. v. Immunex Corp.,
`IPR2017-01879, Paper 19 (P.TA.B. Feb. 15, 2018) ............................................. 3
`Satco Products Inc. v. The Regents of the Univ. of California,
`IPR2021-00662, Paper 13 (P.T.A.B. Nov. 8, 2021) ............................................. 5
`Watson Labs., Inc. v. United Therapeutics Corp.,
`IPR2017-01621, Paper 10 (P.T.A.B. Jan. 11, 2018) ............................................ 2
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`IPR2022-00855
`Patent No. 9,540,445
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`As authorized by the Board, Petitioner submits this Reply to address three
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`issues raised in Patent Owner’s (“PO”) Preliminary Response: (1) Porter as prior art;
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`(2) claim construction; and (3) Section 325(d).
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`I.
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`Porter is Prior Art
`Porter discloses results for a clinical study that treated cancer patients with the
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`prior art Campana CAR. Pet., 26-27; Junghans (Ex. 1002), ¶¶104-112. Other than
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`attacking Porter’s status as prior art, PO has provided no argument against Ground 4.
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`POPR, 39-40. Because there is sufficient evidence that the relevant Porter
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`disclosures are “by another,” Ground 4 should be instituted.
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`Non-inventor Dr. Adam Bagg is an author of Porter. Ex. 1012, 725. Relying
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`upon a declaration from Dr. Bagg, PO argues that Dr. Bagg did not contribute to any
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`disclosure in Porter that is relevant to obviousness. POPR, 40. Dr. Bagg, who is
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`employed by PO, states in his declaration that “all of the portions of Porter cited by
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`the Petitioners reflect the work of my co-authors and not me.” Ex. 2044, ¶7. PO’s
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`argument and Dr. Bagg’s declaration are inconsistent with Porter itself, which states
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`that Dr. Bagg determined the anti-tumor effect reported in the paper.
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`In its Protocol section, Porter describes Dr. Bagg as evaluating effectiveness
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`by performing “MRD assessments” after CAR T-cell therapy. Ex. 1013, 36. MRD
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`(or minimal residual disease) assessments refer to the measurement of residual tumor
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`cells remaining in the body after treatment, which is relevant to anti-tumor
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`IPR2022-00855
`Patent No. 9,540,445
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`effectiveness. Porter states: “Subjects will undergo … MRD assessments by
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`Dr. Bagg” on “[d]ay 28” following CAR T-cell therapy. Id., 37. Dr. Bagg’s
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`declaration also acknowledges that he “determined the laboratory result indicating
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`remission ….” Ex. 2044, ¶8. Petitioner cited the antitumor effect disclosed in Porter
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`as supporting obviousness. Pet., 75-76.
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`At the very least, Dr. Bagg’s declaration raises factual questions about
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`whether a portion of Porter, e.g., determination of antitumor effect, was “by
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`another.” The Board has consistently instituted proceedings when patent owners
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`submit testimony attempting to disqualify prior art in preliminary responses.
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`In Nelson, the Board “decline[d] to disqualify” prior art when presented with
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`a declaration from a prior-art author, Mr. Poon, to argue that relied-upon portions of
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`the reference were not “by another.” Nelson Products v. Bal Seal Engineering,
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`IPR2014-00573, Paper 9 at 9-12 (P.T.A.B. Sept. 29, 2014). The Board instituted,
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`holding that “[o]n this record, we have no reason to doubt Mr. Poon’s credibility,
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`however, we hesitate to rely solely on Mr. Poon’s testimony at this stage of the
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`proceeding where it would result in a final, non-appealable denial of institution on a
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`ground of unpatentability.” Id., 11. The Board has come to similar conclusions in
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`other decisions. See, e.g., Watson Labs., Inc. v. United Therapeutics Corp.,
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`IPR2017-01621, Paper 10, 11-14 (P.T.A.B. Jan. 11, 2018) (finding that “for the
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`purposes of institution … Petitioner has provided a sufficient basis on which to
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`Patent No. 9,540,445
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`conclude that [the journal article] was the work of another” despite the patent
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`owner’s pre-institution declarations); Sanofi-Aventis U.S. LLC v. Immunex Corp.,
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`IPR2017-01879, Paper 19, 14 (P.TA.B. Feb. 15, 2018) (accord).
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`II.
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`Claim Construction - “Anti-Tumor Effective Amount”
`Petitioner construed “anti-tumor effective amount” as an amount that
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`encompasses at least “104 to 109 cells/kg body weight,” and any other amount that
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`would have at least one of the biological effects specifically described in the
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`specification, including “a decrease in the number of tumor cells.” Pet., 20-21.
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`Notably, PO does not dispute that “anti-tumor effective amount” is necessarily
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`satisfied by a dosage of 104 to 109 cells per kg, as recited in a dependent claim. Pet.,
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`19-21. And PO has not rebutted Petitioner’s evidence that using such a dosage would
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`have been obvious. E.g., id., 38-41; Junghans, ¶¶155-64. It is thus unnecessary for
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`the Board to address PO’s argument that “anti-tumor effective amount” requires a
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`therapeutic effect more than “a decrease in the number of tumor cells.”
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`That said, a POSA would understand that the claim term “anti-tumor effective
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`amount” is informed by the specification definition of “anti-tumor effect,” which
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`recites “a decrease in the number of tumor cells.” Pet., 20-21; Junghans, ¶¶54-59.
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`PO argues that the specification’s definition of “effective amount” requires some
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`level of therapeutic efficacy more than “a decrease in the number of tumor cells.”
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`POPR, 18-19. PO’s construction must be rejected because it would read the word
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`IPR2022-00855
`Patent No. 9,540,445
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`“anti-tumor” out of the phrase “anti-tumor effective amount.” See Innova/Pure
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`Water v. Safari Water Filtration, 381 F. 3d 1111, 1119 (Fed. Cir. 2004) (rejecting
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`construction that would read “operatively” out of “operatively connected”); Playtex
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`Prod. v. Procter & Gamble, 400 F.3d 901, 909–10 (Fed. Cir. 2005) (rejecting
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`construction that would read “substantially” out of “substantially flattened”). Nor
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`has PO explained how much additional therapeutic efficacy its construction requires
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`beyond the specification’s description of “anti-tumor effect.”
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`Even if the Board finds that claim 1 requires some heightened level of
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`therapeutic efficacy beyond “anti-tumor effect,” there is sufficient evidence a POSA
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`would reasonably expect that outcome. E.g., Junghans, ¶177 (opining there was “a
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`reasonable expectation of success that applying this dose [in the art] would have an
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`anti-tumor effect because the dose range falls within the range of ‘therapeutically
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`effective’ doses disclosed for other CD19-targeted CAR T cells”), 174-76, 178-184,
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`235-40; Pet., 43-45, 58-59. The POPR misleadingly relies on alleged failures of non-
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`CD19 therapies to argue there was no reasonable expectation of success. E.g., Ex.
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`2038 (anti-FR CAR); Ex. 2039 (anti-CAIX CAR). The POPR also ignores Petition
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`art that supports a reasonable expectation of success for CD19 CARs: Jensen (Ex.
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`1007), Milone (Ex. 1008), and Dr. Junghans’ reasons that a POSA would understand
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`Patent No. 9,540,445
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`CART-19 ClinicalTrials.gov to be descriptive of the Campana CAR. Pet., 25-26;
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`Junghans, ¶¶157-64.
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`III.
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`The Board Should Not Deny Institution Under Section 325(d)
` Biocon Pharma v. Novartis Pharms., IPR2020-01263, Paper 12 (P.T.A.B.
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`Feb. 16, 2021) does not hold that discretionary denial is appropriate whenever a
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`subset of the Petition’s art is buried in a multitude of references (here, 174) cited in
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`an IDS. In Biocon, the relevant art was extensively addressed during examination
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`and not merely listed on an IDS. Biocon, 8-9 (agreeing that “Petitioner’s grounds of
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`unpatentability are based on the same arguments that led the Examiner to twice reject
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`the claims of the application….”). Here, in contrast, none of the art in Ground 1 was
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`the basis for rejection or discussed at all during prosecution. Pet., 78.
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`Even after Advanced Bionics, the Board has consistently held that citation of
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`the petition’s prior art in an IDS is, by itself, insufficient to avoid institution where,
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`as here, the art was not discussed during examination. Pet., 79 (citing Trend Micro
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`Inc. v. CUPP Computing AS, IPR2021-00813, Paper 7 at 21-23 (P.T.A.B. Oct. 25,
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`2021)); Samsung Electronics Co. v. Evolved Wireless LLC, IPR2021-00943, Paper
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`9 at 11-12 (P.T.A.B. Dec. 1, 2021); Satco Products Inc. v. The Regents of the Univ.
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`of California, IPR2021-00662, Paper 13 at 25 (P.T.A.B. Nov. 8, 2021).
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`IPR2022-00855
`Patent No. 9,540,445
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`/
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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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`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: August 12, 2022
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`IPR2022-00855
`Patent No. 9,540,445
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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 Petitioners’ Reply to Patent Owner’s
`Preliminary Response, 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:
`Counsel for Patent Owner
`Backup Counsel for Real Party in
`Brian R. Laundry (Reg. No. 62, 074)
`Interest and Licensee Novartis Pharma
`Saul Ewing Arnstein & Lehr LLP
`AG
`131 Dartmouth St, Ste 501
`Jessamyn S. Berniker (Reg. No. 72,328)
`Boston, MA 02116
`David M. Krinsky (Reg. No. 72,339)
`Tel. (617) 912-0969
`Thomas S. Fletcher (Reg. No. 72,383)
`Williams & Connolly LLP
`Brian.landry@saul.com
`680 Maine Ave SW
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`Washington, DC 20024
`Backup Counsel for Patent Owner
`Tel. (202) 434-5000
`Kathryn Doyle (Reg. No. 36,317)
`jberniker@wc.com
`Saul Ewing Arnstein & Lehr LLP
`drinsky@wc.com
`1500 Market St, 38th Floor
`tfletcher@wc.com
`Philadelphia, PA 19102
`Tel. (215) 972-7734
`Kathryn.doyle@saul.com
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`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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`DATED: August 12, 2022
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`IPR2022-00855
`Patent No. 9,540,445
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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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