UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`
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`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.,
`Petitioners,
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`v.
`
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner.
`
`_________________________________________________
`
`
`Case IPR2022-00855
`Patent 9,540,445
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`__________________
`
`SURREPLY OF PATENT OWNER
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`AND REAL PARTY IN INTEREST NOVARTIS PHARMA AG
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`1
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`______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.,
`Petitioners,
`
`v.
`
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner.
`
`_________________________________________________
`
`
`Case IPR2022-00855
`Patent 9,540,445
`
`__________________
`
`SURREPLY OF PATENT OWNER
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`AND REAL PARTY IN INTEREST NOVARTIS PHARMA AG
`
`1
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`TABLE OF CONTENTS
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`I. Porter Is Not The Work Of “Another” ................................................................ 1
`II. Miltenyi’s Claim Construction Arguments Are Meritless .................................. 3
`III. The Board Should Deny Institution Under § 325(d) ........................................ 5
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`i
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`TABLE OF AUTHORITIES
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`CASES
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`In re Katz,
`687 F.2d 450 (C.C.P.A. 1982) .......................................................................... 1, 2
`Riverwood Int’l v. R.A. Jones,
`324 F.3d 1346 (Fed. Cir. 2003) ............................................................................ 2
`Biocon Pharma v. Novartis Pharms.,
`IPR2020-01263, Paper 12 (PTAB Feb. 16, 2021) ................................................ 5
`Fresenius v. Chugai,
`IPR2021-01288, Paper 30 (PTAB Feb. 23, 2022) ................................................ 1
`Nelson Products, Inc. v. BAL Seal Engineering, Inc.,
`IPR2014-00573, Paper 9 (PTAB Sep. 29, 2014) .................................................. 3
`Watson Labs. Inc., v. United Therapeutics Corp.,
`IPR2017-01621, Paper 10 (PTAB Jan. 11, 2018) ................................................ 3
`Sanofi-Aventis U.S. LLC v. Immunex Corp.,
`IPR2017-01879, Paper 19 (PTAB Feb. 15, 2018) ................................................ 3
`Pfizer v. Genentech,
`IPR2018-00373, Paper 12 (Aug. 2, 2018) ............................................................ 1
`R.J. Reynolds v. Altria,
`IPR2021-00793, Paper 7 (PTAB Oct. 27, 2021) .................................................. 1
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`ii
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`Miltenyi’s Reply misconstrues the relevant legal standards and ignores key
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`arguments Patent Owner made in its POPR. Institution should be denied.
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`I.
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`Porter Is Not The Work Of “Another”
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`Miltenyi does not dispute that the Porter clinical trial is the same one reported
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`in the patent: the seminal study demonstrating, after years of failure, that CAR-T
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`therapy would work as a cancer treatment. Instead, Miltenyi suggests that institution
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`should be granted despite proof that Porter is not “by another” because declarations
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`“attempting to disqualify prior art in [POPRs]” should not defeat institution. Reply
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`2. But the Board has denied institution on the basis of declarations, like the one here,
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`showing that alleged prior art is not the “work of another,” In re Katz, 687 F.2d 450,
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`454 (C.C.P.A. 1982). E.g., R.J. Reynolds v. Altria, IPR2021-00793, Paper 7, at 5–7
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`(PTAB Oct. 27, 2021) (denying institution based on author declaration and evidence
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`of “a common inventive entity”); cf. Fresenius v. Chugai, IPR2021-01288, Paper 30
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`at 41–42 (PTAB Feb. 23, 2022) (considering antedation declaration at institution);
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`Pfizer v. Genentech, IPR2018-00373, Paper 12, at 15 (Aug. 2, 2018) (denying
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`institution where Examiner had considered attribution declaration).
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`Miltenyi’s alleged “factual questions” are illusory. Reply 2. As in R.J.
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`Reynolds, the documentary evidence here indicates common inventorship even
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`before considering Dr. Bagg’s declaration. The named inventors are all co-authors
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`of Porter. And on their face, the patent and Porter plainly disclose the very same
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`1
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`clinical trial results. Compare, e.g., Ex. 1001 fig.12 D with Ex. 1012 at 5 (depicting
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`identical patient CT scans).
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`Miltenyi disputes none of this, and is constrained to flyspeck Dr. Bagg’s role.
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`Contrary to Miltenyi’s assertions, both Porter and Dr. Bagg’s declaration
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`consistently indicate that Dr. Bagg analyzed samples, determined laboratory results
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`indicating remission, and passed that information on to the inventors. Ex. 2044 at
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`3; Ex. 1013 at 36, 37; Reply 1–2. In fact, the assays that Miltenyi touts were
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`described in both Porter and the patent. Compare Ex. 1013, 36 (describing MRD
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`assessments, cited at Reply 1), with Ex. 1001, 57:28–34. Dr. Bagg’s contribution—
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`performing “assays and testing” at the inventors’ instruction, Ex. 2044 at 2–3—may
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`warrant discretionary co-authorship of academic papers, but does not constitute legal
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`inventorship; he is not part of the “common inventive entity” that conceived the
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`work reported in both Porter and the patent. Katz at 455; Riverwood Int’l v. R.A.
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`Jones, 324 F.3d 1346, 1356 (Fed. Cir. 2003). There also is no factual dispute
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`because Dr. Bagg did not contribute “the portions of the reference relied on as prior
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`art.” Riverwood, 324 F.3d at 1356. Dr. Bagg’s assays were only one factor in Dr.
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`Porter’s “clinical determination of remission.” Ex. 2044 at 3. Miltenyi equates that
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`determination, not the assays, to the “antitumor effect,” and does not reference the
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`assay results in its Petition. POPR 39–40; compare Pet. 70–78 with Ex. 2044 ¶¶ 7–
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`13.
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`2
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`Miltenyi’s cases involve much closer questions. In Watson, the Board found
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`that the declarations “leave some ambiguity as to whether and to what extent” the
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`relevant portions of the reference were the work of the named inventors, who (unlike
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`here) were not authors of the reference. IPR2017-01621, Paper 10, at 13 (PTAB
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`Jan. 11, 2018). In Nelson Products, the only evidence of who invented large swathes
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`of the cited art, including the cited figure, was the co-author’s say-so, and “nothing
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`further.” IPR2014-00573, Paper 9, at 11 (PTAB Sep. 29, 2014). And in Sanofi-
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`Aventis, the prior art was a publication of a patent application naming a single
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`inventor who was not named as an inventor of the challenged patent. IPR2017-
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`01879, Paper 19, at 13–14 (PTAB Feb. 15, 2018). In each case there was a genuine
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`factual question about who contributed the relevant material. Here, there is no
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`“reasonable likelihood” that the portions of Porter cited by Miltenyi are prior art.
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`II. Miltenyi’s “Claim Construction” Arguments Are Meritless
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`
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`“Anti-Tumor Effective Amount.” Miltenyi argues that the Board should
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`construe this claim term in view of the specification’s definition of “anti-tumor
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`effect” rather than “effective amount,” but ignores the fact that the word “effect” is
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`not part of the claim term, while “effective amount” is. POPR 18. Instead, Miltenyi
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`contends that Patent Owner’s construction reads the word “anti-tumor” out of the
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`claim term. That is false: plainly, the words “anti-tumor” describe the specific type
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`of “therapeutic or prophylactic benefit” conferred. No one has argued that “anti-
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`3
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`tumor” should be ignored, and Miltenyi’s cases are therefore inapposite. Miltenyi
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`also has no response to Patent Owner’s argument that Miltenyi’s construction does
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`not accord with the remainder of the patent. POPR 17–21.
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`Miltenyi argues Patent Owner’s construction “is necessarily satisfied” by the
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`dosages recited in dependent claims. Reply 3–4. But these are separate limitations
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`that must both be satisfied. Moreover, Miltenyi cannot demonstrate that the POSA
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`would have reasonably expected that any dosage—including 104 to 109 cells—
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`would be an “effective amount,” given the prior art. See POPR 21–39.
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`Miltenyi attempts to rebut the POPR’s reasonable expectation of success
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`argument by contending it improperly relies on failures of non-CD19-targeted
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`therapies. In fact, the POPR relies on numerous failed CD19-targeted therapies as
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`well. See, e.g., Ex. 2010 at 1824–25 (failed CD19-targeted therapy); Ex. 2032 at
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`1250–51 (failed CD19 targeted therapy); Ex. 2037 at 1036 (eight CD19-targeted
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`studies that did not report any anti-tumor effect); Ex. 2013 (subject’s death linked to
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`CD19-targeted therapy). And Miltenyi is plainly wrong that experimentation with
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`non-CD19-targeted CARs is not relevant to expectations of success. Indeed,
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`Miltenyi in its Petition relies on numerous references that do not involve CD19-
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`targeted CARs. See Exs. 1005 (Honsik), 1010 (Sadelain), 1011 (Riddell).
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`Moreover, Miltenyi’s argument is logically fallacious; it is the equivalent of arguing
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`that expectations about the efficacy of an arrow would be based solely on arrows
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`having the same arrowhead—even if they use different inserts, shafts, fletching, or
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`nocks, or were fired with different bows—but that those expectations would not be
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`informed by arrows with different arrowheads but having other similarities.
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`III. The Board Should Deny Institution Under § 325(d)
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`The POPR explained how the mountain of art Miltenyi piles up in four-
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`reference obviousness combinations—or art substantially similar to it—was before
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`the Examiner and, at minimum, listed in an IDS initialed by the Examiner. POPR
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`42–51. That warrants discretionary denial under Biocon Pharma v. Novartis
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`Pharms., IPR2020-01263, Paper 12 (PTAB Feb. 16, 2021). The Board in Biocon
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`expressly stated that it “need not reach” the purported distinction Miltenyi relies
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`on—that the grounds were “based on the same arguments” that led to rejection. Id.
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`at 9 n.4. That the Examiner here did not expressly discuss the precise combination
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`of multiple (cumulative) references Miltenyi now cites does not warrant institution.
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`5
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`Respectfully submitted,
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`By:
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`
`/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
`
`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
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`Backup Counsel for Real Party in
`Interest and Licensee Novartis
`Pharma AG
`
`Counsel for Patent Owner
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`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
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`Certification of Service Under 37 C.F.R. § 42.6(e)(4)
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`The undersigned hereby certifies that Patent Owner’s Surreply was served in its
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`entirety by filing through the Patent Trial and Appeal Board End to End (PTAB
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`E2E), as well as providing a courtesy copy via e-mail to the following attorneys of
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`record for Petitioners listed below:
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`Yite John Lu
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`Gary Frischling
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`jlu@milbank.com
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`gfrischling@milbank.com
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`Date: August 19, 2022
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`/Brian R. Landry/
`By:
`Reg. No. 62,074
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`7
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