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` Paper No. 8
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` Entered: September 26, 2019
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`Trials@uspto.gov
`571.272.7822
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SANDOZ INC.,
`Petitioner,
`v.
`PHARMACYCLICS LLC,
`Patent Owner.
`____________
`
`Case IPR2019-00865
`Patent 9,795,604 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL, JENNIFER MEYER CHAGNON, and
`DAVID COTTA, Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
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`IPR2019-00865
`Patent 9,795,604 B2
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`I.
`
`INTRODUCTION
`
`Sandoz Inc. (“Petitioner”) filed a Petition requesting an inter partes
`review of claims 1, 4, 6-10, 13, 15, 24, 28-31, 35, 39, 43-46, 50-53, and 55
`of U.S. Patent No. 9,795,604 B2 (Ex. 1001, “the ’604 patent”).1 Paper 2
`(“Pet.”). Pharmacyclics LLC (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 6 (Prelim. Resp.).2
`Institution of an inter partes review is authorized by statute only when
`“the information presented in the petition . . . and any response . . . shows
`that there is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.” 35 U.S.C.
`§ 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition, the
`Preliminary Response, and the cited evidence, we conclude that Petitioner
`has satisfied the burden under 35 U.S.C. § 314(a) to show that there is a
`reasonable likelihood that it would prevail with respect to at least one of the
`challenged claims.
`
`A.
`
`Related Proceedings
`
`Petitioner and Patent Owner represent that the ’604 patent was
`asserted in Pharmacyclics LLC v. Zydus Worldwide DMCC, Civ. No. 1:18-
`cv-00275-CFC (D. Del.), which has been consolidated with Pharmacyclics
`LLC v. Fresenius Kabi USA, LLC, 1:18-cv-00192-CFC (D. Del). Pet. 2;
`Paper 4, 1. Petitioner and Patent Owner also represent that U.S. Patent
`
`
`1 Petitioner identifies Sandoz Inc. and Lek Pharmaceuticals D.D. as the real
`parties in interest. Pet. 2.
`2 Patent Owner identifies Pharmacyclics LLC, AbbVie Inc, and Janssen
`Biotech, Inc. as the real parties in interest. Paper 4, 1.
`2
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`Patent 9,795,604 B2
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`Application No. 15/586,058, filed May 3, 2017, is related to the ’604 patent.
`Pet. 2; Paper 4, 1.
`
`B.
`
`The ’604 Patent (Ex. 1001)
`
`The ’604 patent issued October 24, 2017, identifying John C. Byrd,
`Jason A. Dubovsky, Natarajan Muthusamy, Amy Jo Johnson, and David
`Miklos as inventors. Ex. 1001, at codes (45), (72). The patent teaches:
`Chronic graft versus host disease (cGVHD) is the most
`common long-term complication following allogeneic stem cell
`transplant (SCT), affecting 30-70% of patients who survive
`beyond the first 100 days. cGVHD and its associated immune
`deficiency have been identified as a leading cause of
`non-relapse mortality (NRM) in allogeneic SCT survivors.
`Id. at 1:29–36. The ’604 patent discloses “methods for treating and
`preventing graft versus host disease using . . . an ACK inhibitor such as
`ibrutinib.” Id. at Abstract.
`
`C.
`
`Challenged Claims
`
`Petitioner challenges claims 1, 4, 6-10, 13, 15, 24, 28-31, 35, 39, 43-
`46, 50-53, and 55 of the ’604 patent. Claim 1 is representative and is
`reproduced below:
`
`1.
`A method of treating chronic graft versus host disease
`(GVHD) comprising administering to a patient having chronic
`
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`Patent 9,795,604 B2
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`GVHD a therapeutically effective amount of a compound of the
`structure:
`
`
`thereby treating the chronic GVHD in the patient.
`
`Ex. 1001, 77:41–68.
`
`D.
`
`Prior Art and Asserted Grounds
`
`Statutory Basis Reference(s)
`§ 102(a)(2)
`The ’085 publication3
`
`Petitioner asserts that claims 1, 4, 6-10, 13, 15, 24, 28-31, 35, 39, 43-
`46, 50-53, and 55 of the ’604 would have been unpatentable on the
`following grounds:
`Claims Challenged
`1, 4, 6–10, 13, 15, 24,
`28–31, 35, 39, 43–46,
`50–53, and 55
`1, 4, 6–10, 13, 15, 24,
`28–31, 35, 39, 43–46,
`50–53, and 55
`
`§ 103(a)
`
`The ’085 publication
`
`
`3 Goldstein, US Patent Publication No. 2015/0140085 A1, published May
`21, 2015 (Ex. 1002, “the ’085 publication”).
`4
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`Patent 9,795,604 B2
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`Statutory Basis Reference(s)
`Claims Challenged
`§ 103(a)
`The ’085 publication,
`1, 4, 6–10, 13, 15, 24,
`Shimabukuro-Vornhagen,4
`28–31, 35, 39, 43–46,
`50–53, and 55
`and Herman5
`The ’085 publication,
`1, 4, 6–10, 13, 15, 24,
`Shimabukuro-Vornhagen,
`28–31, 35, 39, 43–46,
`and Uckun6
`50–53, and 55
`Petitioner submits the Declaration of Dr. James L. Ferrara (Ex. 1006)
`in support of institution of inter partes review.
`
`§ 103(a)
`
`E.
`
`Person 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 the person of ordinary skill “would have had
`an advanced degree in the field of medicine with additional, specialized
`
`
`4 Shimabukuro-Vornhagen, et al., The Role of B Cells in the Pathogenesis of
`Graft-Versus-Host Disease, 114(24) BLOOD 4919–4927 (2009) (Ex. 1003,
`“Shimabukuro-Vornhagen”).
`5 Herman, et al., Bruton Tyrosine Kinase Represents a Promising
`Therapeutic Target for Treatment of Chronic Lymphocytic Leukemia and is
`Effectively Targeted by PCI-32765, 117(23) BLOOD 6287–6296 (2011)
`(Ex. 1004, “Herman”).
`6 Uckun, et al., Bruton’s Tyrosine Kinase as a Molecular Target in
`Treatment of Leukemias and Lymphomas as well as Inflammatory Disorders
`and Autoimmunity, 20(11) EXPERT OPIN. THER. PATENTS 1457–1470 (2010)
`(Ex. 1005, “Uckun”).
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`training, such as a fellowship in Hematology/Oncology as well as several
`years’ experience specializing in transplantation.” Pet. 31; Ex. 1006 ¶¶ 52–
`54. Petitioner also contends that the POSA would “preferably have had
`some experience with pharmaceutical compositions for treating GVHD or
`related conditions.” Pet. 31–32.
`At this stage in the proceeding, Patent Owner does not challenge
`Petitioner’s definition. Prelim. Resp. 19 (“For purposes of this Preliminary
`Response, Patent Owner does not dispute Petitioner’s definition of a
`POSA.”). Accordingly, for purposes of this Decision and based on the
`present record, we accept Petitioner’s definition, as it is consistent with the
`level of skill reflected in the asserted prior art references. See Okajima v.
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can
`reflect the appropriate level of ordinary skill in the art).
`
`F.
`
`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 (2019). 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, 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.,
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`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)).
`For purposes of this decision, we need only construe the limitations in
`claims 6, 7, 8, 29, 30, 31, 44, 45, 46, 51, 52, and 53 that recite particular
`patient outcomes resulting from the administration of ibrutinib. The specific
`claim limitations are summarized in the Table below.
`Dependent Claims
`Text of limitations
`6, 29, 44, 51
`“wherein, following administration
`of the compound, the patient
`achieves partial response (PR),
`wherein the PR is an objective
`response in one involved organ in
`the patient with no evidence of
`progression elsewhere and no
`requirements for additional systemic
`therapy.”
`“wherein, following administration
`of the compound, the patient
`achieves complete response (CR),
`wherein the CR is a complete
`restoration of symptoms attributable
`to GVHD.”
`“wherein, following administration
`of the compound, the severity of the
`GVHD is reduced.”
`
`7, 30, 45, 52
`
`8, 31, 46, 53
`
`
`
`Petitioner argues that these claim limitations merely state the result of
`performing the method set forth in the claim and add nothing to the
`patentability or substance of the claim. Pet. 40. Accordingly, Petitioner
`contends that these limitations are not entitled to patentable weight. Id.
`Patent Owner contends that the recited patient outcomes should be given
`patentable weight because they “relate back to and clarify what is required
`by the [claim],” and “express[] the inventive discovery” of the claim.
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`Prelim. Resp. 26. Based on the record currently before us, we find that
`Petitioner has the better position.
`The Federal Circuit has held that “[a] whereby clause in a method
`claim is not given weight when it simply expresses the intended result of a
`process step positively recited.” Minton v. Nat’l Ass’n of Sec. Dealers, Inc.,
`336 F.3d 1373, 1381 (Fed. Cir. 2003). In Minton, the court was asked to
`construe a claim reciting a method for trading securities that included the
`language “whereby the security is traded efficiently between the first
`[offering] individual and the second [replying] individual.” Id. at 1380. The
`court found that “[t]he term ‘efficiently’ on its face does not inform the
`mechanics of how the trade is executed” and was thus “a laudatory one
`characterizing the result of the executing step.” Id. at 1381. Accordingly,
`the court declined to give weight to the “traded efficiently” phrase in the
`recited whereby clause. Id.
`The limitations in claims 6, 7, 8, 29, 30, 31, 44, 45, 46, 51, 52, and 53
`recite patient outcomes and, like the whereby clause at issue in Minton,
`“simply express the intended result” of the recited method. Patent Owner
`does not identify, and we do not find in the Specification, anything to
`suggest that the recited result affects the steps preformed in connection with
`the recited method. Put another way, the recited results do not affect the
`manner in which ibrutinib is administered to treat cGVHD. Accordingly,
`based on the record now before us, we do not accord these limitations
`patentable weight.
`Although Petitioner proposes several additional claim constructions
`(Pet. 12–18), we determine that no explicit construction of any additional
`claim term is necessary to determine whether to institute a trial in this case.
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`See Nidec, 868 F.3d at 1017 (“[W]e need only construe terms ‘that are in
`controversy, and only to the extent necessary to resolve the controversy’”
`(quoting Vivid Techs., 200 F.3d at 803)); Wellman, Inc. v. Eastman Chem.
`Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be
`construed ‘to the extent necessary to resolve the controversy’”).
`
`II.
`
`35 U.S.C. § 314(a)
`
`Before addressing the merits of the Petition, we consider Patent
`Owner’s contention that we should exercise our discretion under 35 U.S.C.
`§ 314(a) and deny institution. We have considered Patent Owner’s
`arguments, but find them unpersuasive.
`As discussed above, the ’604 patent was asserted in litigation in
`district court. See supra p. 2–3. Patent Owner asserts that this litigation
`(“the ANDA litigation”) involves “the same or substantially similar issues,
`arguments, and evidence” as the present proceeding. Prelim Resp. 64.
`According to Patent Owner, the District Court has already completed claim
`construction, and trial in the ANDA litigation is scheduled to begin on
`October 13, 2020. Id. Patent Owner argues that we should exercise our
`discretion to deny institution because instituting a trial would be an
`inefficient use of Board resources. Id. As support, Patent Owner cites E-
`One, Inc., v. Oshkosh Corp., IPR2019-00161, Paper 16 at 5–9 (PTAB May
`15, 2019) (“E-One”) and NHK Spring Co., v. Intri-plex Technologies, Inc.,
`IPR2018-00752, Paper 8 at 19–20 (PTAB Sept. 12, 2018) (precedential)
`(“NHK”), two Board decisions where the Board considered pending
`litigations in exercising its discretion to deny institution. We are not
`persuaded that we should exercise such discretion in this proceeding.
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`The AIA explicitly contemplates that a party may choose to file an
`inter partes review on a patent that is involved in concurrent litigation. See
`35 U.S.C. § 315(b) (providing that a petitioner involved in concurrent
`litigation may request inter partes review if the Petition is filed within one
`year of being served a complaint alleging infringement of the patent).
`Accordingly, the existence of concurrent litigation set to conclude more than
`a year from the date of this decision, without more, does not persuade us to
`exercise our discretion to deny institution.
`We acknowledge Patent Owner’s argument that the ANDA litigation
`and the present proceeding involve “the same or substantially similar
`issues.” Prelim. Resp. 64. Trial in the ANDA litigation, however, is not
`scheduled to begin until more than a year from the date of this decision, and
`thus, the ANDA litigation will likely not be completed before our final
`decision is due. In addition, although the District Court has completed claim
`construction, the issues in this case do not appear to be fully resolved based
`on resolution of claim construction arguments alone. See infra p. 6–9.7
`These facts distinguish the present proceeding from E-One, where the
`District Court had already “received briefing, heard oral argument, and
`issued detailed decisions” on claim construction and on a motion for a
`preliminary injunction, and where the issues in the Petition “essentially
`duplicate[d]” these issues. E-One, Paper 16 at 7. In addition, the district
`court in E-One, unlike the district court here, was scheduled to complete trial
`in the parallel district court case “before a final decision would be due.” Id.
`at 6.
`
`7 Patent Owner notes that Petitioner did not request that the District Court
`construe any terms of the ’604 patent, suggesting that claim construction is
`not likely to be dispositive in the district court proceeding. Prelim. Resp. 64.
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`The facts in this case are also distinguishable from NHK. In NHK, the
`Board denied institution under 35 U.S.C. § 325(d), finding the arguments
`that the petitioner advanced in the petition were substantially similar to those
`made by the Examiner during prosecution, before considering the “advanced
`state of the district court proceeding” as an additional factor that weighed in
`favor of denying the petition. NHK, Paper 8 at 20. Thus, the district court
`timeline was merely one of many factors considered by the Board when
`denying institution of the petition. Id. Here, Patent Owner does not contend
`that the arguments advanced in the Petition are substantially similar to those
`made during prosecution. In addition, the district court proceeding in NHK,
`where trial was set to conclude six months before a final Board decision
`would be due (id.), appears to have been substantially more advanced than
`the district court proceeding is here. Here, Patent Owner has stated that trial
`will begin on October 13, 2020, over two weeks after any final written
`decision will be issued. Also, we will endeavor to issue a final written
`decision as soon as practicable to assist the District Court with resolution of
`the ANDA proceeding.
`Accordingly, we decline to exercise our discretion under 35 U.S.C.
`§ 314(a) on the basis that the issues duplicate those at issue in the pending
`ANDA litigation.
`
`III. GROUND 1: ANTICIPATION BY THE ’085 PUBLICATION
`
`Petitioner asserts that the ’085 publication anticipates claims 1, 4, 6–
`10, 13, 15, 24, 28-31, 35, 39, 43-46, 50-53, and 55 of the ’604 patent.
`Pet. 34–44. Patent Owner opposes. Prelim. Resp. 26–41. We have
`reviewed Petitioner’s and Patent Owner’s assertions, as well as the evidence
`of record, and, for the reasons discussed below, we conclude that Petitioner
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`has demonstrated a reasonable likelihood of prevailing in showing that the
`’085 publication anticipates at least claim 1 of the ’604 patent.
`A.
`Disclosures of the Asserted Prior Art
`The ’085 Publication
`
`The ’085 publication discloses “[o]ral pharmaceutical formulations of
`ibrutinib . . . and use of these formulations for the treatment of diseases
`treatable by ibrutinib such as . . . autoimmune diseases.” Ex. 1002, Abstract.
`Among the autoimmune diseases disclosed as treatable using the oral
`pharmaceutical formulations of the ’085 publication is graft versus host
`disease. Id. ¶ 98 (“In another embodiment of this aspect, the patient in need
`is suffering from a heteroimmune condition or disease, e.g., graft versus host
`disease.”). According to the ’085 publication, the “therapeutically effective
`amount of ibrutinib . . . can be from about 20 mg per day to about 450
`mg/day, or 20 mg/day to about 420 mg/day; or about 20 mg/day or 30
`mg/day to about 300 or 350 mg/day; or about 30 or 50 mg/day to about 200,
`or 220 or 250 mg/day; or about 30 or 50 mg/day to about 100 or 150 mg/day
`and can be administered in single or multiple doses.” Id. ¶ 30.
`
`B.
`
`Analysis
`
`Claim 1
`
`Petitioner contends that the ’085 publication discloses all of the
`limitations of claim 1. Petitioner acknowledges that the ’085 publication
`discloses treating graft versus host disease rather than chronic graft versus
`host disease, as claimed. Pet. 35. However, Petitioner contends that there
`are only two types of graft versus host disease – chronic and acute. Id.
`Supported by the testimony of Dr. Ferrara, Petitioner asserts that a POSA
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`would have “at once envisaged that this disclosure pertains to both acute and
`chronic GVHD.” Id. Petitioner thus contends that the ’085 publication
`anticipates treatment of chronic GVHD. Id. Petitioner cites Wm. Wrigley
`Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1361 (Fed. Cir. 2012)
`and Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381
`(Fed. Cir. 2015) as supporting the proposition that a claim genus is
`anticipated where the genus was of “such a defined and limited class that
`one of ordinary skill in the art could ‘at once envisage’ each member of the
`genus.” Pet. 35.
`With respect to the requirement of claim 1 for “administering . . . a
`
`therapeutically effective amount,” Petitioner points to the disclosure in the
`’085 publication of “therapeutically effective” amounts of ibrutinib.
`Pet. 36–37 (citing Ex. 1002 ¶¶ 30, 120). Petitioner argues that the term
`“therapeutically effective amount” in claim 1 must encompass the amounts
`recited in claim 5, which depends from claim 1, and which recites amounts
`corresponding to those disclosed in the ’085 publication. Id. at 14.
`
`Based on the information presented at this stage of the proceeding,
`Petitioner has shown sufficiently in the Petition that there is a reasonable
`likelihood that it will prevail in showing the unpatentability of claim 1 over
`the disclosure of the ’085 publication. We focus our further analysis on
`Patent Owner’s arguments against institution in its Preliminary Response.
`
`Patent Owner argues that the ’085 publication does not anticipate
`claim 1 for three reasons. Prelim. Resp. 26–27. First, Patent Owner
`contends that the ’085 publication fails to disclose treatment of chronic
`GVHD. Id. at 38. Second, Patent Owner contends that Petitioner’s
`anticipation arguments require picking and choosing among disclosures. Id.
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`at 39–41. Third, Patent Owner contends that the ’085 publication is not
`enabled. Id. at 27–34. We address each argument in turn.
`
`With respect to Patent Owner’s argument that the ’085 publication
`fails to disclose treatment of chronic GVHD, Patent Owner contends that
`Petitioner improperly relies on the knowledge of the POSA to supply a
`missing claim limitation. Prelim. Resp. 38. Patent Owner argues that unlike
`the prior art in Kennametal and Wrigley, “the ’085 Publication does not
`provide a narrow genus setting forth [the cGVHD limitation] from which a
`single anticipatory species can be readily ascertained.” Id. We are not
`persuaded.
`As discussed above, the ’085 publication discloses treatment of
`GVHD. However, the ’085 publication does not specify whether such
`GVHD is chronic or acute. Petitioner provides evidence that there are two
`types of GVHD, acute and chronic. Ex. 1006 ¶ 29 (cited at Pet. 7).
`Accordingly, absent persuasive evidence to the contrary, we understand the
`’085 publication’s reference to GVHD to disclose a genus comprised of
`acute and chronic GVHD. Petitioner offers the testimony of Dr. Ferrara that
`the POSA, “upon seeing the ’085 Publication’s disclosure directed to
`treating ‘graft versus host disease,’ . . . would have immediately understood
`and envisioned that the ’085 Publication’s disclosure of treating GVHD
`includes specifically chronic GVHD.” Id. ¶ 77. Accordingly, the current
`record tends to suggest that a reasonable likelihood exists that the ’085
`publication anticipates treatment of chronic GVHD.
`We are not persuaded by Patent Owner’s argument that this result is
`contrary to the case law. In Wrigley, the Federal Circuit explained that
`where the “prior art reference . . . discloses a genus and the claim at issue
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`recites a species of that genus . . . the issue of anticipation turns on whether
`the genus was of such a defined and limited class that one of ordinary skill in
`the art could ‘at once envisage’ each member of the genus.” 683 F.3d at
`1361; see also Kennametal, 780 F.3d at 1381–1382 (holding that a prior art
`reference disclosed five binding agents (one of which was ruthenium) and
`three coating techniques (one of which was PVD) anticipated a claim drawn
`to the specific combination of ruthenium and PVD). Here, the ’085
`publication discloses a genus of two species – acute and chronic GVHD –
`and the evidence tends to suggest that the POSA would at once envisage the
`claimed species, chronic GVHD. Nidec Motor Corp. v. Zhongshan Board
`Ocean Motor Co., 851 F.3d 1270 (Fed. Cir. 2017), cited by Patent Owner, is
`not to the contrary. Nidec holds that anticipation does not permit one to “fill
`in missing limitations simply because a skilled artisan would immediately
`envision them.” 851 F.3d at 1274–1275. Here, the limitation of chronic
`GVHD is not missing, but rather a member of a disclosed genus.
`Patent Owner next argues that the ’085 publication does not anticipate
`the claimed method because it requires too much picking and choosing from
`different portions of the ’085 publication’s disclosure. Patent Owner
`explains:
`To construct this allegedly anticipatory embodiment, one would
`have to pick: (1) the eighth out of nine aspects of the
`disclosure, “treating cancer or an autoimmune disease,” (2) the
`third out of six treatment embodiments, “heteroimmune
`conditions or diseases,” (3) GVHD from among nine exemplary
`choices, (4) combine that with a “therapeutically effective
`amount” that is not specific to any one of the numerous recited
`diseases and “will vary” depending on multiple factors,
`including “the disease” chosen, and (5) choose treatment
`instead of prevention, when the ’085 Publication defines
`treatment to encompass both.
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`Prelim. Resp. 40. We are not persuaded.
`To arrive at the claimed method from the disclosure of the ’085
`publication, the POSA would need to connect the disclosure of treating
`GVHD (Ex. 1002 ¶ 98) with the disclosures of therapeutically effective
`doses of ibrutinib (id. ¶¶ 30, 120). We do not view the connection between
`these disclosures as being as attenuated as Patent Owner suggests. The ’085
`publication discloses treating GVHD by “administering . . . a solid oral
`dosage form disclosed herein” (id. ¶¶ 96, 98) and discloses solid oral dosage
`forms having amounts of ibrutinib that overlap with doses encompassed by
`claim 1. Id. ¶¶ 21, 30; Ex. 1001, 75:40–68, 76:7–10. In addition, the ’085
`publication discloses “therapeutically effective amounts” of ibrutinib that
`also overlap with doses encompassed by claim 1. Ex. 1002 ¶ 120.
`Accordingly, based on the current record, the evidence tends to suggest that
`it would not have required an inappropriate amount of “picking and
`choosing” to select amounts of ibrutinib that were disclosed for “solid oral
`dosage forms” and that were taught to be “therapeutically effective” when
`following the teaching of the ’085 publication to treat GVHD with ibrutinib.
`
`Patent Owner argues that the ’085 publication does not enable
`treatment of cGVHD with ibrutinib because it would require undue
`experimentation to practice the claimed invention. Patent Owner asserts that
`cGVHD was “exceedingly difficult to treat, with numerous agents failing in
`the clinic,” and that “cGVHD was poorly understood, and that its treatment
`was extraordinarily difficult, unpredictable, and often based on trial and
`error.” Prelim. Resp. 28. Patent Owner argues that “[i]nvestigation into
`treatments for cGVHD was complicated by insufficiently predictive animal
`models; confusion and debate about the basis of the disease; inappropriate
`
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`diagnoses and application of disease response criteria; and conflicting and
`inconclusive clinical trial data.” Id. at 29. Against this backdrop, Patent
`Owner contends that the ’085 publication provides insufficient guidance to
`enable the POSA to practice the claimed invention. Id. at 31. Patent Owner
`explains:
`[T]he text of the ’085 Publication provides no guidance for
`treating cGVHD. Instead, “graft versus host disease” is
`generically identified among over 150 diseases listed as part of
`the eighth aspect (of nine) of the disclosure. Ex. 1002 [0096]–
`[0100]. The ’085 Publication provides no dose or doses of
`ibrutinib as part of that eighth aspect for treating any particular
`disease, let alone GVHD. Instead, Petitioner relies on a generic
`definition of “therapeutically effective amount.” Pet., 37, 43
`(citing Ex. 1002 [0030], [0120]). That disclosure, however, is
`not tied to any particular disease, and makes clear that the
`“‘therapeutically effective amount’ will vary depending on the
`compound, the disease and its severity[,] and the age, weight,
`etc. of the mammal to be treated.” Ex. 1002 [0120]. In other
`words, many factors must be considered to determine a
`therapeutically effective amount for any particular disease, and
`the ’085 Publication provides no guidance as to how one would
`effectively treat GVHD (let alone cGVHD, which it does not
`mention).
`Prelim. Resp. 31. We are not persuaded.
`
`Prior art publications and patents are presumed to be enabled. In re
`Antor Media Corp., 689 F.3d 1282, 1287–88 (Fed. Cir. 2012); Amgen Inc. v.
`Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). Here,
`the ’085 publication discloses “[o]ral pharmaceutical formulations of
`ibrutinib and/or a pharmaceutically acceptable salt thereof.” Ex. 1002,
`Abstract. It discloses that these formulations may be used to treat a patient
`“suffering from a heteroimmune condition or disease, e.g., graft versus host
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`disease” (id. ¶ 98) by “administering to the patient . . . a solid oral dosage
`form disclosed herein.” Id. ¶ 96.
`We acknowledge Patent Owner’s argument that cGVHD is difficult to
`treat, poorly understood, and lacking in predictive animal models. We
`further acknowledge Patent Owner’s argument that numerous treatment
`agents have failed in clinic. At this point in the proceeding, however, we are
`not persuaded that the alleged failure to develop an effective treatment prior
`to ibrutinib is sufficient to rebut the presumptively enabled teaching of the
`’085 publication that ibrutinib can be used to treat GVHD.
`We also acknowledge Patent Owner’s argument that the ’085
`publication does not specifically disclose how to effectively treat cGVHD.
`However, per claim 1, all that is required to treat cGVHD is to administer a
`therapeutically effective dose of ibrutinib. The ’085 publication provides
`general guidance – not specific to any one disease – on what constitutes a
`therapeutically effective amount of ibrutinib. In describing one of the
`disclosed solid oral dosage forms, it states:
`The therapeutically effective amount of ibrutinib and/or a
`pharmaceutically acceptable salt thereof when administered into
`the intestine by bypassing the stomach can be from about 20 mg
`per day to about 450 mg/day, or 20 mg/day to about 420
`mg/day; or about 20 mg/day or 30 mg/day to about 300 or 350
`mg/day; or about 30 or 50 mg/day to about 200, or 220 or 250
`mg/day; or about 30 or 50 mg/day to about 100 or 150 mg/day
`and can be administered in single or multiple doses.
`Ex. 1002 ¶ 30. Similarly, in defining the term “therapeutically effective
`amount,” the ’085 publication teaches:
`The “therapeutically effective amount” will vary depending on
`the compound, the disease and its severity and the age, weight,
`etc., of the mammal to be treated. The therapeutically effective
`amount of ibrutinib and/or a pharmaceutically acceptable salt
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`thereof when administered in the intestine can be from about 20
`mg per day to about 450 mg/day, or any permu[t]ations and
`combinations thereof. Such as 20 mg/day to about 420 mg/day;
`or about 20 mg/day or 30 mg/day to about 300 or 350 mg/day;
`or about 30 or 50 mg/day to about 200, or 220 or 250 mg/day;
`or about 30 or 50 mg/day to about 100 or 150 mg/day and can
`be administered in single or multiple doses.
`Id. ¶ 120. At this stage in the proceeding, the record does not support a
`conclusion that a POSA, provided with both information regarding
`therapeutically effective amounts of ibrutinib and the teaching that ibrutinib
`can be used to treat GVHD, would have required undue experimentation to
`carry out the claimed method by selecting a patient appropriate ibrutinib
`dosage based on age, weight, and other disclosed parameters.
`Accordingly, based on the information presented at this stage of the
`proceeding, we conclude that Petitioner has shown sufficiently that there is a
`reasonable likelihood that it will prevail in showing the unpatentability of
`claim 1 over the disclosure of the ’085 publication. Having determined that
`Petitioner has demonstrated a reasonable likelihood of success in proving
`that at least claim 1 of the ’604 patent is unpatentable, we institute a review
`as to all of challenged claims and all grounds contained in the Petition. See
`SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); USPTO, Guidance
`on the Impact of SAS on AIA Trial Proceedings (Apr. 26, 2018), available at
`https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-
`board/trials/guidance-impact-sas-aia-trial.
`We offer the following views on the remaining claims for the parties’
`consideration, to the extent they wish to address them during the inter partes
`review.
`
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`Claims 4, 13, an
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