UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.,
`
`Petitioners,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`
`Patent Owner.
`
`Case No.: IPR2022-00853
`U.S. Patent No. 9,464,140
`
`PETITIONERS’ REPLY TO REQUEST FOR REHEARING
`
`4138-7552-6211.5
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.,
`
`Petitioners,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`
`Patent Owner.
`
`Case No.: IPR2022-00853
`U.S. Patent No. 9,464,140
`
`PETITIONERS’ REPLY TO REQUEST FOR REHEARING
`
`4138-7552-6211.5
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`Erroneous Interpretation of Law Concerning Reasonable Expectation
`of Success For Methods of Pharmaceutical Treatment .................................. 2
`
`Irreconcilable Inconsistency With Institution In Related
`IPR2022-00855 ............................................................................................... 3
`
`III. Erroneous Application of Advanced Bionics .................................................. 4
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`4138-7552-6211.5
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`i
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`
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`IPR2022-00853
`Patent No. 9,464,140
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`The Board’s Decision is an outlier: declining to institute on a method of
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`treatment claim when the prior art disclosed a clinical trial using the claimed
`
`composition according to the claimed method. This was a situation where “there
`
`was little left to do but to confirm that the strategy suggested by the various prior art
`
`references would work.” Genzyme Therapeutic Prod. v. Biomarin Pharm., 825 F.3d
`
`1360, 1374 (Fed. Cir. 2016). Patent Owner has failed to point to any Federal Circuit
`
`case with similar facts and a finding of non-obviousness.
`
`Patent Owner attempts to characterize the challenged claim as a “new method
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`of treatment.” Resp. at 11. It is not. The reference CART-19 Clinicaltrials.gov
`
`taught using the claimed composition (Campana) in a cancer patient population with
`
`a dose that practices the challenged claims. Claim 1 requires nothing else, so there
`
`is no “new method of treatment” here. Patent Owner did nothing more than report
`
`the results of a prior-art clinical trial that practiced the claimed method.
`
`OSI Pharms. v. Apotex, 939 F.3d 1375 (Fed. Cir. 2019) does not support a
`
`finding of non-obviousness. In OSI, there was no disclosure of details for a clinical
`
`trial practicing the claimed method. Nor was there in-vitro data suggesting the
`
`method claimed: treating non-small cell lung cancer (NSCLC). That is the opposite
`
`of the facts here, where the challenged claims broadly cover all cancers, and the
`
`prior art disclosed successful in-vitro data for leukemia cancer cells.
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`4138-7552-6211.5
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`1
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`
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`IPR2022-00853
`Patent No. 9,464,140
`
`The Board’s Decision is also an outlier in its discretionary denial of Ground 3:
`
`denying institution when the reference (Milone) was overcome only because of a
`
`claim limitation not found in the challenged claim 1 here. Petitioner’s Request for
`
`Rehearing identified two decisions holding that Section 325(d) denial was
`
`inappropriate in this scenario. Patent Owner has pointed to no contrary case law.
`
`I.
`
`Erroneous Interpretation of Law Concerning Reasonable Expectation
`of Success For Methods of Pharmaceutical Treatment
`It is undisputed that in OSI, there was lack of in-vitro data showing success in
`
`treating the disease that was claimed. Not so here.
`
`In OSI, there was in-vitro efficacy data for erlotnib against certain cancers
`
`other than NSCLC. OSI, 939 F.3d at 1380. But there was no in-vitro data against
`
`NSCLC cancer cells. Id. at 1385. The Federal Circuit held, on that basis, there was
`
`no reasonable expectation of success for the challenged, narrow claims directed to
`
`NSCLC treatment: “[H]ope that a potentially promising drug will treat a particular
`
`cancer is not enough to create a reasonable expectation of success in a highly
`
`unpredictable art such as this.” Id.; id. at 1384 (noting that “the lack of erlotnib-
`
`NSCLC efficacy data or other indication of success [was] significant”). Here,
`
`claim 1 broadly claims “anti-tumor effect[]” and is not limited to any particular
`
`cancer. And the successful prior-art in-vitro data was for leukemia, Decision at 21,
`
`indisputably falling within the scope of claim 1.
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`4138-7552-6211.5
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`2
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`
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`IPR2022-00853
`Patent No. 9,464,140
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`The Genzyme case, in contrast, is factually on point and controlling for reasons
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`discussed in the Request at pages 5-7 (and previously in the Petition at page 37). In
`
`Response, Patent Owner mischaracterizes the “record” in Genzyme as showing “no
`
`failure—clinical or otherwise.” Resp. at 5. That is not correct. In Genzyme, there
`
`were decades of failed efforts to treat Pompe disease with enzyme replacement
`
`therapy. Genzyme, 825 F.3d at 1365 (acknowledging that “research efforts were
`
`focused on treating the disease through enzyme replacement therapy” but those
`
`“early efforts failed”); Genzyme, IPR 2013-00534, Paper 81 at 20 (“The evidence
`
`and arguments cited by Patent Owner highlight the difficulties faced in the
`
`development of an enzyme replacement therapy for Pompe disease over a period of
`
`decades.”).
`
`Despite the failures, the Federal Circuit held that because there was successful
`
`in-vitro data and a proposed clinical trial, no patent could be issued for merely
`
`reporting the trial results: “there was little left to do but to confirm that the strategy
`
`suggested by the various prior art references would work.” Genzyme, 825 F.3d
`
`at 1374. That is the exact situation here.
`
`II.
`
`Irreconcilable Inconsistency With Institution in Related IPR2022-00855
`Patent Owner argues that there is no inconsistency with the institution
`
`decision in IPR2022-00855 because the Board only found it obvious to “make the
`
`compound and put it on a shelf.” Resp. at 12. That is not what the Board found.
`3
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`4138-7552-6211.5
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`IPR2022-00853
`Patent No. 9,464,140
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`The Board preliminarily found it obvious to make “a pharmaceutical composition”
`
`with a dose used in the clinical study for leukemia patients (Clinicaltrials.gov).
`
`IPR2022-00855, Paper 10 at 27-28. The Board found that a POSA expected
`
`administration to patients: “The success in making the pharmaceutical composition
`
`for administration to patients regardless of the clinical outcomes supports a finding
`
`of obviousness.” Id. at 26-27. Patent Owner does not dispute that the inevitable and
`
`inherent result of administering this pharmaceutical composition would be the
`
`claimed “anti-tumor effect[].” Request at 11-13 (citing Pet. at 30-38). Nor is this a
`
`new argument. The Petition argued that “the CART-19 ClinicalTrials.gov
`
`dose…necessarily satisfies the limitation of ‘anti-tumor effective amount.’” Pet., 33.
`
`III. Erroneous Application of Advanced Bionics
`Patent Owner incorrectly argues that the “critical point” for Section 325(d) is
`
`that the Examiner knew of the Milone reference. Resp. at 2. No one disputes that
`
`the Examiner was aware of Milone. But knowledge of a reference is not sufficient
`
`for discretionary denial. Apple v. Koss, IPR2021-00381, Paper 15 at 28-29 (PTAB
`
`July 2, 2021) (holding Section 325(d) inappropriate even where “the same examiner
`
`examined ten [related] applications” and was “acutely aware” of the reference).
`
`Petitioner’s Request identified two on-point decisions holding Section 325(d)
`
`inappropriate where a reference was overcome during prosecution on the basis of a
`
`claim limitation that is not present in the IPR challenged claim. Request at 14-15.
`4
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`4138-7552-6211.5
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`IPR2022-00853
`Patent No. 9,464,140
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`Patent Owner has cited no case law supporting discretionary denial in such a scenario
`
`and instead attempts to distinguish Petitioner’s cited decisions in a footnote. Resp.
`
`fn. 4. Patent Owner’s attempt is unpersuasive. In Spectrum, the prior-art reference
`
`at issue was “extensively evaluated” notwithstanding that it was raised during only
`
`one rejection series. Spectrum, IPR2022-00134, Paper 7 at 12. In Target, even
`
`though the examiners were different, the second examiner was presumed to know of
`
`the prior-art reference because it was addressed during related prosecution. See
`
`Target, IPR2020-00980, Paper 11 at 18 (finding Section 325(d) inappropriate “even
`
`if Patent Owner is correct” that the examiners shared knowledge of the reference).
`
`In both cases the Board found Section 325(d) inapplicable because key
`
`distinguishing claim language was missing from the challenged claim. So too here:
`
`the absence of a sequence limitation—SEQ ID NO:24.
`
`With respect to Milone, Petitioner did not try to “stuff” (Resp. at 3) Milone
`
`into Grounds 1 and 2. Instead, Petitioner merely noted that non-Ground references
`
`“can legitimately serve to document the knowledge that skilled artisans would bring
`
`to bear in reading the prior art identified as producing obviousness.” Genzyme, 825
`
`F.3d. at 1369. Therefore, the successful in-vivo data from Milone “document[s] the
`
`knowledge of skilled artisans” when evaluating the Ground references, such as
`
`reasonable expectation of success of the clinical trial disclosed by ClinicalTrials.gov.
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`4138-7552-6211.5
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`5
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`
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`Dated: December 8, 2022
`
`ORRICK, HERRINGTON & SUTCLIFFE LLP
`
`IPR2022-00853
`Patent No. 9,464,140
`
`/Yite John Lu/
`By:
`Yite John Lu
`Lead Counsel for Petitioner
`Reg. No. 63158
`355 South Grand Avenue, Suite 2700
`Los Angeles, CA 90071
`T: (213) 629-2020
`F: (213) 612-2499
`Email: PTABDocketL2Y7@orrick.com
`
`Gary N. Frischling
`Reg. No. 35515
`355 South Grand Avenue, Suite 2700
`Los Angeles, CA 90071
`T: (213) 629-2020
`F: (213) 612-2499
`Email: PTABDocketG2F1@orrick.com
`
`Attorneys for Petitioners
`
`4138-7552-6211.5
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`6
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`
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`IPR2022-00853
`Patent No. 9,464,140
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on December 8, 2022, a copy of the following
`
`was served in its entirety via electronic mail, upon the following attorneys of
`
`record for the Patent Owner:
`
`Brian R. Landry
`SAUL EWING ARNSTEIN & LEHR LLP
`131 Dartmouth Street, Suite 501
`Boston, MA 02116
`
`Kathryn Doyle
`SAUL EWING ARNSTEIN & LEHR LLP
`Centre Square Way
`1500 Market Street, 38th Floor
`Philadelphia, PA 19102
`
`brian.landry@saul.com
`IPGroupMailbox@saul.com
`
`kathryn.doyle@saul.com
`
`Alireza Behrooz
`SAUL EWING ARNSTEIN & LEHR LLP
`1919 Pennsylvania Avenue, N.W., Suite 550
`Washington, D.C. 20006
`
`alireza.behrooz@saul.com
`
`tfletcher@wc.com
`NovartisCART@wc.com
`
`Thomas S. Fletcher
`Jessamyn S. Berniker
`David M. Krinsky
`David M. Horniak
`Kathryn S. Kayali
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW
`Washington, DC 20024
`
`Attorneys for Patent Owner The Trustees of the University of Pennsylvania
`
` /Karen Johnson/
` Karen Johnson
`
`7
`
`4138-7552-6211.5
`
`
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