Trials@uspto.gov
`571-272-7822
`
`Paper 68
`Entered: May 11, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INCYTE CORPORATION,
`Petitioner,
`v.
`CONCERT PHARMACEUTICALS, INC.,
`Patent Owner.
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`
`
`
`
`
`
`
`Before CHRISTOPHER G. PAULRAJ, ROBERT A. POLLOCK, and
`DEVON ZASTROW NEWMAN, Administrative Patent Judges.
`NEWMAN, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`Denying in Part and Dismissing in Part
`Patent Owner’s Motion to Exclude Evidence
`Dismissing Petitioner’s Motion to Exclude Evidence
`37 C.F.R. § 42.64
`
`
`
`
`
`571-272-7822
`
`Paper 68
`Entered: May 11, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INCYTE CORPORATION,
`Petitioner,
`v.
`CONCERT PHARMACEUTICALS, INC.,
`Patent Owner.
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`
`
`
`
`
`
`
`Before CHRISTOPHER G. PAULRAJ, ROBERT A. POLLOCK, and
`DEVON ZASTROW NEWMAN, Administrative Patent Judges.
`NEWMAN, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`Denying in Part and Dismissing in Part
`Patent Owner’s Motion to Exclude Evidence
`Dismissing Petitioner’s Motion to Exclude Evidence
`37 C.F.R. § 42.64
`
`
`
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`INTRODUCTION
`I.
`This is a Final Written Decision in a post-grant review challenging the
`patentability of claims 1–21 (the “challenged claims”) of U.S. Patent No.
`10,561,659 B2 (Ex. 1001, “the ’659 patent”). We have jurisdiction under
`35 U.S.C. § 6.
`Having reviewed the arguments of the parties and the supporting
`evidence, we find that Petitioner has not demonstrated by a preponderance
`of the evidence that each of the challenged claims is unpatentable.
`A. Summary of Procedural History
`Incyte Corporation (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`requesting a post-grant review of claims 1–21 of the ’659 patent. Concert
`Pharmaceuticals, Inc., (“Patent Owner”) filed a Preliminary Response (Paper
`11, “Prelim. Resp.”). Petitioner filed a Reply to Patent Owner’s Preliminary
`Response (Paper 17, “Prelim. Reply”) and Patent Owner filed a Preliminary
`Sur-Reply (Paper 19, “Prelim. Sur-Reply”). Based on the record then before
`us, we instituted trial with respect to all challenged claims 1–7 and 9–211.
`Paper 20, 49 (“Dec.”).
`After institution of trial, Patent Owner filed a Request for Rehearing
`(Paper 23), which was denied (Paper 25). Patent Owner filed a Response
`(Paper 37, “Resp.”), Petitioner filed a Reply to Patent Owner’s Response
`(Paper 44, “Reply”), and Patent Owner filed a Sur-reply to Petitioner’s
`Reply (Paper 51, “Sur-reply”).
`
`
`1 Patent Owner disclaimed claim 8 subsequent to filing. See Ex. 2020.
`Hence, claim 8 and the Petition’s Ground 3 challenging only claim 8 are no
`longer at issue in this case.
`
`2
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`Both parties filed motions to exclude evidence and replies in support
`of those motions (Patent Owner: Papers 55, 61; Petitioner: Papers 56, 62).
`Both parties opposed each other’s motions to exclude (Patent Owner: Paper
`59; Petitioner: Paper 60).
`We heard oral argument on February 10, 2022. A transcript of that
`hearing is entered as Paper 67 (“Tr.”). Petitioner bears the burden of
`proving unpatentability of each claim it has challenged by a preponderance
`of the evidence, and the burden of persuasion never shifts to Patent Owner.
`See 35 U.S.C. § 326(e) (2018); 37 C.F.R. § 42.1(d); Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). This
`Final Written Decision is issued pursuant to 35 U.S.C. § 328(a) and 37
`C.F.R. § 42.73.
`
`B. Real Parties in Interest
`Petitioner identifies itself as the real party-in-interest for Petitioner.
`Pet. 91. Patent Owner identifies itself as the real party-in-interest for Patent
`Owner. Paper 50, 1.
`
`C. Related Matters
`As related matters, Petitioner identifies pending U.S. Application No.
`16/704,402, which claims the benefit of priority to U.S. Application No.
`16/098,338, and IPR2017-01256 against Patent Owner’s U.S. Patent No.
`9,249,149. Pet. 91. Patent Owner also identifies U.S. Patent Application
`No. 16/704,402 as a related matter. Paper 50, 1.
`D. The ’659 Patent
`The ’659 patent is entitled “Treatment of Hair Loss Disorders with
`Deuterated JAK Inhibitors” and issued on February 18, 2020. Ex. 1001,
`codes (54), (45). According to the ’659 patent, many current medicines
`
`3
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`suffer from poor adsorption, distribution, metabolism, and/or excretion
`(“ADME”) properties that limit their use for certain indications. Id. at 1:20–
`23. For example, rapid metabolism can cause drugs to be cleared too rapidly
`from the body, decreasing the drugs’ efficacy in treating a disease. Id. at
`1:29–32. Another ADME limitation is the formation of toxic or biologically
`reactive metabolites. Id. at 1:40–41.
`The cytochrome P450 enzyme (“CYP”) is typically responsible for
`the metabolism of drugs. Id. at 1:52–54. As such, the ’659 patent identifies
`deuterium modification as a “potentially attractive strategy for improving a
`drug’s metabolic properties.” Id. at 2:7–8. Deuterium modification involves
`replacing one or more hydrogen atoms of a drug with deuterium atoms in an
`attempt to slow the CYP-mediated metabolism of a drug or to reduce the
`formation of undesirable metabolites. Id. at 2:8–12. Because deuterium
`forms stronger bonds with carbon than hydrogen, in certain cases, that
`stronger bond strength can positively impact the ADME properties of a drug,
`resulting in the potential for improved drug efficacy, safety, and/or
`tolerability. Id. at 2:13–19.
`Ruxolitinib phosphate, a heteroaryl-substituted pyrrolo [2,3-
`d]pyrimidine, is an FDA-approved drug for treating patients with
`intermediate or high-risk myelofibrosis. Id. at 2:51–66. Ruxolitinib also has
`other potential applications, including the treatment of essential
`thrombocytopenia and is currently in clinical trials for the treatment of
`additional conditions. Id. at 2:66–3:5. Thus, according to the Specification,
`“[d]espite the beneficial activities of ruxolitinib, there is a continuing need
`for new compounds to treat the aforementioned diseases and conditions.”
`Id. at 3:3–5.
`
`4
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`The ’659 patent discloses “a method for treating hair loss disorders
`that can be treated by compounds that modulate the activity of Janus
`Associated Kinase 1 (JAKl) and/or Janus Associated Kinase 2 (JAK2).” Id.
`at 3:43–46. The method comprises administering an effective amount of a
`deuterated compound (Compound (I)), or its pharmaceutically acceptable
`salt, once or twice a day, in specific dose ranges. Id. at 3:46–66. The
`method is disclosed as for use in treating the hair loss disorder alopecia
`areata or for generally “inducing hair growth in a subject.” Id. at 3:66–67,
`4:18–20. The level of deuterium incorporation into the drug is disclosed as
`between 52.5% to upwards of 99.5%. Id. at 6:42–52.
`E. Illustrative Claim
`Petitioner challenges claims 1–7, 9–21 of the ’659 patent. Claim 1 is
`illustrative and recites:
`1. A method of treating a hair loss disorder in a mammalian subject, the
`method comprising administering to the subject 16 mg/day or 24 mg/day of
`a compound represented by the following structural formula:
`
`
`
`
`
`
`
`or a pharmaceutically acceptable salt thereof, wherein each position in
`Compound (I) designated specifically as deuterium has at least 95%
`incorporation of deuterium. Ex. 1001, 24:30–53.
`
`5
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`F. Evidence
`The parties rely on the following references and declarations that we
`refer to in this Decision:
`
`Date
`Oct. 27, 2020
`
`Nov. 5, 2021
`
`Nov. 12, 2021
`
`Aug. 17, 2014
`
`Reference or Declaration
`Declaration of Dr. Steven Patterson,
`Ph. D.
`Declaration of Frederick Peter
`Guengerich, Ph. D.
`Declaration of William Damsky, M.D.,
`Ph. D.
`Declaration of Justin Ko, M.D., M.B.A. Aug. 12, 2021
`Silverman et al., U.S. Patent No.
`Feb. 16, 2016
`9,249,149 B2 (“Silverman”)
`Xing et al., Alopecia areata is driven by
`cytotoxic T lymphocytes and is reversed
`by JAK inhibition, NAT. MED.
`20(9):043–1049 (“Xing”)
`Jakafi® (ruxolitinib) Prescribing
`Information, Physicians’ Desk Reference
`1281–1287 (69th ed. 2015) (“Ruxolitinib
`Prescribing Information”).
`Christiano et al., U.S. Patent No.
`9,198,911 B2 (“Christiano”).
`Ni et al., U.S. Patent Pub. 2014/0135350
`A1 (“Ni”).
`
`
`Jan. 6, 2015
`
`Dec, 1, 2015
`
`May 15, 2014
`
`Exhibit No.
`1007
`
`1120
`
`1161
`
`2059
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`G. Weight to Give Expert Testimony
`Patent Owner argues that Dr. Patterson lacks the requisite experience
`and we should give little weight to his testimony. Patent Owner Motion to
`Exclude, Paper 55 (“PO MTE”); Paper 61, PO Reply to Petitioner’s
`Opposition to Patent Owner’s Motion to Exclude (“PO MTE Reply”).
`Patent Owner argues that Dr. Patterson’s testimony should be excluded
`“because he is not an expert in deuteration, Janus kinase (‘JAK’) inhibitors,
`
`6
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`or alopecia areata (‘AA’),” “has no prior experience with JAK inhibitors,”
`and has never “dosed humans or done dosing studies in humans.” PO MTE,
`2–3. Patent Owner argues that Dr. Patterson “stated repeatedly that he is just
`a medicinal chemist and that he had to study AA and JAK inhibitors
`specifically for purposes of this case.” Id. at 3 (citing Dr. Patterson’s
`deposition testimony at Ex. 2055 at 26:4–14, 28:19–23, 29:8–13, 30:1–4,
`31:4–7, 79:6–18, 56:25–57:7, 119:9–22).
`Petitioner opposes exclusion, arguing that “Dr. Patterson has a Ph.D.
`in chemistry with over thirty years of experience in drug development,
`including designing and synthesizing thousands of compounds and serving
`as a primary investigator in drug dosing studies.” Petitioner Opposition to
`Patent Owner Motion to Exclude, Paper 59 (citing Ex. 1008, 1; Ex. 2055,
`40:4–41:22, 43:4–22, 48:22–50:2).
`It is not necessary for an expert’s experience or expertise to precisely
`match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360,
`1373 (Fed. Cir. 2010). However, one offering expert testimony must at least
`have ordinary skill in the art to provide relevant and reliable testimony that
`is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22
`F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to
`assign weight to be accorded expert testimony.” Consolidated Trial Practice
`Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/
`tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30
`years of experience in drug design, drug administration, evaluation of drug
`effectiveness, and participated in drug design for over 20 years. Ex. 1007
`¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-
`reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We
`
`7
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`find this level of skill to meet the qualifications for the level of skill in the
`art under the training and experience portion of the definition we have
`adopted for purposes of this opinion (see § II.B.), reproduced below:
`a Ph.D. in chemistry, pharmaceutical sciences, molecular
`biology, or a similar field, or an M.D. with similar background.
`A POSA would also have had at least several years of experience
`with drug design, drug development, clinical trials, or access to
`other individuals with that knowledge and experience. Likewise,
`a POSA would have had knowledge and experience in treating
`hair loss disorders, or access to a person with that knowledge and
`experience.
`We note that Dr. Patterson himself also proposes this definition. Id.
`¶ 102. However, Dr. Patterson does not have “knowledge and experience in
`treating hair loss disorders” and did not opine that, in regards to his
`testimony, he had access to a person with that knowledge and experience, as
`is proposed in the definition. See generally, Ex. 1007. Accordingly, we find
`Dr. Patterson qualified to opine on the level of ordinary skill with regard to
`issues of drug design, evaluation of effectiveness, and drug administration,
`but we find he is not adequately qualified to opine on the level of ordinary
`skill with regard to issues of treating hair loss disorders.
`
`In reviewing Dr. Patterson’s testimony, as well as the testimony
`provided by the other experts in this proceeding, Dr. Guengerich,
`Dr. Dansky, and Dr. Ko, we consider their opinions on the issues for which
`they are qualified to offer testimony, compare their opinions to the
`disclosures of the prior art references and the challenged patent, and the
`entirety of the evidence of record to weigh each part of their relative opinion
`testimony separately. See Elbit Sys. of Am., LLC v. Thales Visionix, Inc.,
`881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The [Patent Trial and Appeal Board
`(‘PTAB’)] [i]s entitled to weigh the credibility of the witnesses.” (citation
`
`8
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`omitted)); Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1041
`(Fed. Cir. 2017) (“To the extent [a party] challenges the PTAB’s factual
`findings, ... the PTAB is permitted to weigh expert testimony and other
`record evidence and, in so doing, rely on certain portions of an expert’s
`declaration while disregarding others.”).
`H. Asserted Grounds
`Petitioner asserts that claims 1–7 and 9–21 would have been
`unpatentable on the following grounds:
`Claim(s)
`Challenged
`
`35 U.S.C. §2
`
`Reference(s)/Basis
`Silverman, Xing,
`Ruxolitinib Prescribing
`Information
`Silverman, Christiano,
`Ni
`
`1–7, 9–21
`
`1–7, 9–21
`
`103
`
`103
`
`
`
`II. ANALYSIS
`A. Legal Standards
`Petitioner contends under both grounds that the challenged claims are
`unpatentable based on obviousness. Pet. 2. As set forth in 35 U.S.C.
`§ 103(a),
`[a] patent may not be obtained . . . if the differences between the
`subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the
`time the invention was made to a person having ordinary skill in
`the art to which said subject matter pertains.
`The question of obviousness is resolved on the basis of underlying factual
`determinations including (1) the scope and content of the prior art; (2) any
`
`
`2 As all of the filing dates at issue in this case are after March 16, 2013, we
`apply the current versions of 35 U.S.C. §§ 102, 103.
`
`9
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`differences between the claimed subject matter and the prior art; (3) the level
`of ordinary skill in the art; and (4) when in evidence, objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). An
`obviousness analysis “need not seek out precise teachings directed to the
`specific subject matter of the challenged claim, for a court can take account
`of the inferences and creative steps that a person of ordinary skill in the art
`would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
`However, Petitioner cannot satisfy its burden of proving obviousness by
`employing “mere conclusory statements.” In re Magnum Oil Tools Int’l,
`Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Instead, Petitioner must
`articulate a reason why a person of ordinary skill in the art would have
`combined the prior art references. In re NuVasive, 842 F.3d 1376, 1382
`(Fed. Cir. 2016); see also Pers. Web Tech., LLC, v. Apple, Inc., 848 F.3d
`987, 993–94 (Fed. Cir. 2017) (“[O]bviousness concerns whether a skilled
`artisan not only could have made but would have been motivated to make
`the combinations or modifications of prior art to arrive at the claimed
`invention”) (quoting Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073
`(Fed. Cir. 2015)).
`
`B. Level of Ordinary Skill in the Art
`The level of skill in the art is a factual determination that provides a
`primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v.
`VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John
`Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950
`F.2d 714, 718 (Fed. Cir. 1991)). In determining the level of ordinary skill in
`the art, various factors may be considered, including the “type of problems
`encountered in the art; prior art solutions to those problems; rapidity with
`
`10
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`which innovations are made; sophistication of the technology; and
`educational level of active workers in the field.” In re GPAC Inc., 57 F.3d
`1573, 1579 (Fed. Cir. 1995) (citation omitted).
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art. KSR, 550 U.S. at 399
`(stating that obviousness is determined against the backdrop of the scope and
`content of the prior art, the differences between the prior art and the claims
`at issue, and the level of ordinary skill in the art). Factual indicators of the
`level of ordinary skill in the art include “the various prior art approaches
`employed, the types of problems encountered in the art, the rapidity with
`which innovations are made, the sophistication of the technology involved,
`and the educational background of those actively working in the field.”
`Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also
`Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983)
`(quoting with approval Jacobson Bros.).
`Petitioner contends that a person of ordinary skill in the art would
`have had
`a Ph.D. in chemistry, pharmaceutical sciences, molecular
`biology, or a similar field, or an M.D. with similar background.
`A POSA would also have had at least several years of experience
`with drug design, drug development, clinical trials, or access to
`other individuals with that knowledge and experience. Likewise,
`a POSA would have had knowledge and experience in treating
`hair loss disorders, or access to a person with that knowledge and
`experience.
`Pet. 19–20.
`Patent Owner proposes the same definition as Petitioner, but adds that
`the skilled artisan “would also have had experience in JAK inhibition,
`deuteration, and AA [alopecia areata] formulations, or access to a person
`
`11
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14).
`Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as
`“incomplete, because it lacks any requirement for experience, or access to
`individuals with experience, in JAK inhibition, deuteration, and AA
`formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner
`explains what difference this additional direct experience would have
`provided to an artisan with the skill level proposed by Petitioner, particularly
`when Petitioner’s definition includes “experience in treating hair loss
`disorders,” and for which the record contains evidence that existing JAK
`inhibitors such as ruxolitinib had been identified as causing reversal of hair
`loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s
`proposed definition as consistent with the level of skill apparent in the cited
`prior art. In any event, as Patent Owner does not explain why its alternative
`definition would have any bearing on the outcome of the present case, and as
`we discern no appreciable difference in the parties’ definitions, we note our
`findings and conclusions would be the same regardless of which definition
`were adopted.
`We further note that the prior art itself demonstrates the level of skill
`in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding
`ordinary skill level are not required “where the prior art itself reflects an
`appropriate level and a need for testimony is not shown”) (quoting Litton
`Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`1985)).
`
`12
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`C. Claim Construction
`We construe claims using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`§ 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims
`under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303,
`1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are
`given their ordinary and customary meaning, as would have been understood
`by a person of ordinary skill in the art (“POSA”), at the time of the
`invention, in light of the language of the claims, the specification, and the
`prosecution history of record. Id. Only those terms that are in controversy
`need be construed and only to the extent necessary to resolve the
`controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.
`Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am.
`Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`We have considered Petitioner’s claim construction proposals (see
`Pet. 21–23), which are uncontested (see generally Resp., not addressing
`construction), and find that it is not necessary to expressly construe any
`claim term for purposes of rendering this Decision.
`D. Whether Silverman is Prior Art under 35 U.S.C. § 102(a)(1)
`As a preliminary matter, the parties disagree about whether certain
`disclosures in Silverman are prior art under 35 U.S.C. § 102(a)(1) to the
`’659 patent.3 Grounds 1 and 2 of the Petition allege obviousness using
`
`
`3 Petitioner previously argued that Silverman was also prior art under 35
`U.S.C. § 102(a)(2), but did not pursue this argument after Patent Owner
`presented evidence that Silverman falls under the common-owner exception
`of § 102(b)(2)(C). See Reply 6–13; Dec. 18; Resp. 17–19; Tr. 45:23–46:9.
`Petitioner now contends only that Silverman is prior art under 35 U.S.C.
`
`13
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`Silverman as the primary reference. Pet. 1–84. Silverman is owned by
`Patent Owner. Ex. 1002 code (71).
`In its arguments for obviousness, Petitioner relies upon a declaration
`of Dr. Vinita Uttamsingh (“the 2015 Uttamsingh Declaration”) and an
`accompanying applicant response, which were submitted during prosecution
`of the Silverman patent. In particular, Petitioner cites statements made by
`Dr. Uttamsingh as providing motivation for why a skilled artisan would have
`specifically identified Compound (I) (as recited in claim 1 of the ’659
`patent) from among the large number of compounds disclosed within the
`genus of Formula A recited in Silverman. See, e.g., Pet. 15 (citing Ex. 1045,
`407), 34 (citing Ex. 1045, 377, 416), 40 (citing Ex. 1045, 407, 416).
`In our Decision, we found that Silverman is § 102(a) prior art on its
`face because it issued on February 2, 2016 (Ex. 1002, code (45)), before the
`earliest filing date of any provisional application to which the ’659 patent
`claims priority (Ex. 1001, code (60)). Dec. 14. We concluded Petitioner
`had satisfied its initial burden of production of evidence on this issue,
`shifting the burden of production to Patent Owner to argue or produce
`evidence that Silverman is not prior art. Dynamic Drinkware, 800 F.3d at
`1379. Notably, the burden of persuasion on the ultimate issue of the status
`of Silverman as prior art remains with Petitioner. Id. at 1378–80.
`
`
`§ 102(a)(1). Reply 6–13. Accordingly, we confine our discussion to this
`issue.
`
`14
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`As the Federal Circuit stated in Dynamic Drinkware,
`the burden of persuasion is on the petitioner to prove
`“unpatentability by a preponderance of the evidence,” 35
`U.S.C. § 316(e), and that burden never shifts to the patentee.
`* * *
`A second and distinct burden, the burden of production, or the
`burden of going forward with evidence, is a shifting burden,
`“the allocation of which depends on where in the process of
`trial the issue arises.” The burden of production may entail
`“producing additional evidence and presenting persuasive
`argument based on new evidence or evidence already of
`record.”
`Id. (citations omitted).
`Patent Owner argues that key disclosures in Silverman and its
`prosecution history are not prior art under § 102(a)(1) because they fall
`within the exceptions set forth in § 102(b)(1)(A) and § 102(b)(1)(B). Resp.
`16–28; Reply 1–10. Petitioner responds that the exceptions under
`§ 102(b)(1) apply only to disclosures made 1 year or less before the effective
`filing date from an inventor of a claimed invention. Reply 6. Petitioner
`contends that Patent Owner’s Response did not proffer, and therefore Patent
`Owner has waived, the bases for a § 102(b)(1) exception for Silverman. Id.
`For the reasons that follow, we find, based on our review of the record, that
`certain disclosures of Silverman are not prior art because they fall within the
`exceptions set forth in § 102(b)(1). We disagree with Petitioner’s contention
`that Patent Owner waived any such argument by not identifying appropriate
`support in its post-institution Response.
`1. Legal Background
`35 U.S.C. § 102(a)(1) defines the prior art that will preclude the grant
`of a patent on a claimed invention and states:
`
`15
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`
`[a] person shall be entitled to a patent unless—
`(1) the claimed invention was patented, described in a
`printed publication, or in public use, on sale, or otherwise
`available to the public before the effective filing date of the
`claimed invention.
`35 U.S.C. § 102(b) sets out exceptions to AIA 35 U.S.C. § 102(a).
`Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures
`made within one year of the effective filing date. Specifically, 35 U.S.C.
`§ 102(b)(1) provides that a disclosure made one year or less before the
`effective filing date of a claimed invention shall not be prior art under 35
`U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the
`disclosure was made by the inventor or joint inventor or by another who
`obtained the subject matter disclosed directly or indirectly from the inventor
`or a joint inventor; or (B) the subject matter disclosed had, before such
`disclosure, been publicly disclosed by the inventor or a joint inventor or by
`another who obtained the subject matter disclosed directly or indirectly from
`the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).
`With regard to establishing unpatentability, a petitioner retains the
`burden of persuasion throughout the proceeding. See Dynamic Drinkware,
`800 F.3d at 1378. However, with regard to specific evidence supporting the
`unpatentability challenge, such as the priority date of a reference used to
`establish obviousness, a petitioner shifts the burden of production to dispute
`the effective priority date of a prior art reference to the patent owner by
`alleging obviousness based upon a reference that appears to be prior art on
`its face. Id. at 1379–1380 (burden of production satisfied by assertion of
`anticipation, shifting burden to patent owner); see also Pfizer, Inc. v.
`Genentech, Inc., IPR2017-01488, Paper 27 at 13 (PTAB Dec. 1, 2017)
`
`16
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`(initial burden met where prior-art patents “predate the earliest possible
`priority date shown on the face of the” challenged patent).
`2. Patent Owner’s Arguments Regarding Exceptions to § 102(a)(1)
`Patent Owner contends “the central disclosures of Silverman are not
`prior art under §102(a)(1) because they satisfy the inventor-disclosure
`exceptions in either §102(b)(1)(A) or (B).” Resp. 16. Citing the Manual of
`Patent Examining Procedure (“MPEP”) § 717.01(b)(2), Patent Owner argues
`that the disclosures “apply on a disclosure-by-disclosure basis, and a
`particular disclosure is not considered prior art if it falls under either
`exception.” Id. at 19. Patent Owner argues that three essential disclosures
`of Silverman should be excluded from Silverman as exceptions under
`§ 102(b)(1)(A) and (B): 1) the structure of Compound (I); 2) metabolic
`stability data for Compound (I); and 3) metabolic stability date for other
`deuterated compounds disclosed in Silverman. Id.
`Patent Owner alleges that the structure of Compound (I) was disclosed
`in the 2015 Uttamsingh Declaration by an inventor of the ’659 patent. Id. at
`20. As described in our Decision on Institution, the 2015 Uttamsingh
`Declaration was filed during the prosecution of Silverman as evidence of
`nonobviousness. Dec. 15–16. In that Declaration, Compound (I) was
`identified as Compound 111. Ex. 1045, 404.
`Patent Owner argues that Dr. Uttamsingh’s disclosure of Compound
`(I) satisfies § 102(b)(1)(B) because Silverman’s disclosure of Compound (I)
`was 1) made on February 2, 2016, which was less than a year before the
`May 4, 2016 filing date of the earliest priority application of the ’659 patent;
`and 2) Exhibit B of the 2015 Uttamsingh Declaration disclosed the structure
`of Compound (I). Id. at 21. Patent Owner argues that this disclosure also
`
`17
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`satisfies § 102(b)(1)(A) because the disclosure was made less than a year
`before the May 4, 2016, filing date of the earliest priority application of the
`’659 patent by Dr. Uttamsingh. Id. at 23.
`Patent Owner argues a similar analysis (e.g., the disclosure fits both
`§ 102(b)(1)(A) and § 102 (b)(1)(B)) applies to the data disclosing the
`metabolic stability of Compound (I), as presented in the 2015 Uttamsingh
`Declaration: Silverman’s disclosure of Compound (I) was 1) also made on
`February 2, 2016, less than a year before the filing date of the earliest
`priority application of the ’659 patent; and 2) paragraphs 4–8 and Exhibit E
`of the 2015 Uttamsingh Declaration disclosed assay results indicating that
`Compound 111 (a.k.a. Compound (I) as recited in claim 1 of the ’659 patent)
`had improved metabolic stability of 75–80% compared to non-deuterated
`ruxolitinib. Id. at 23 (citing Ex. 1045, 407, 415–416). Both allegedly
`exempted disclosures became public with the publication of the Silverman
`prosecution history on August 27, 2015, prior to the February 2, 2016,
`publication date of Silverman. Id. at 21 (citing Ex. 1046, 1).
`Finally, Patent Owner alleges that the metabolic stability data reported
`in Silverman’s Example 4 and Table 3 regarding deuterated Compounds
`103, 107, and 127 over non-deuterated ruxolitinib, was exempt under both
`§ 102(b)(1)(A) and § 102 (b)(1)(B) because 1) the data was disclosed in
`Silverman on February 2, 2016, less than a year before May 4, 2016, the
`filing date of the earliest priority application of the ’659 patent; and 2) was
`obtained by three inventors of Silverman directly or indirectly from
`Dr. Uttamsingh’s group. Id. at 24–27 (citing various paragraphs of the
`declarations of three inventors of Silverman and Dr. Uttamsingh regarding
`intra-company communications, Exs. 2069–2072). In essence, Patent
`
`18
`
`
`
`PGR2021-00006
`Patent 10,561,659 B2
`
`Owner argues Dr. Uttamsingh’s group was the sole source of metabolic
`assays of the type used to create the data of Example 4 and Table 3, and
`because she directed and controlled this research, disclosure to the
`Silverman inventors of the structure and metabolic stability data of
`Compound (I) flowed directly or indirectly from Dr. Uttamsingh. Id. at 26–
`27.
`
`3. Petitioner’s Reply
`Petitioner responds that Patent Owner has failed to meet its burden of
`production to establish the two prerequisites of § 102(b)(1), namely to show
`that the alleged disclosures were made 1 year or less before the effective
`filing date, and that the disclosure was made by an inventor of the claimed
`invention. Reply 6.
`Petitioner argues that because Silverman and the 2015 Uttamsingh
`Declaration were made public more than a year before the ’659 patent’s
`actual filing date of November 1, 2018, the § 102(b)(1) exceptions could
`only apply if Patent Owner showed that each challenged claim was entitled
`to claim priority to the provisional patent application filed on May 6, 2016,
`as stated in Patent Owner’s Response (Resp. 13). Id. at 7. Petitioner argues
`that Patent Owner’s claim to priority is ineffective without a demonstration
`of entitlement, citing Nat. Alternatives Int’l, Inc. v. Iancu, 904 F.3d 1375,
`1380 (Fed. Cir. 2018). Id. at 7–8.
`Petitioner further argues that Patent Owner has not shown that
`Dr. Uttamsingh is an inventor of any challenged claim. Id. at 8. Petitioner
`argues that Dr. Uttamsingh’s deposition testimony confirms that she did not
`invent or conceive any limitation of independent claims 1, 9, and 11, and
`that a different person “conceived all claims in the ’758 provisional, which
`
`19
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
