`Tel: 571-272-7822
`
`
`
`
`Paper No. 7
`Entered: May 24, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK), INC.,
`Petitioner
`v.
`GILEAD PHARMASSET LLC
`Patent Owner
`_______________
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`_______________
`
`
`Before LORA M. GREEN, ERICA A. FRANKLIN, and RICHARD J. SMITH,
`Administrative Patent Judges.
`
`SMITH, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`
`INTRODUCTION
`I.
`Initiative for Medicines, Access & Knowledge (I-MAK), Inc. (“Petitioner”)
`filed a Petition (Paper 2, “Pet.”) to institute an inter partes review of claims 1–4 of
`U.S. Patent 9,284,342 B2 (the “’342 patent”). 35 U.S.C. § 311. Gilead Pharmasset
`LLC (“Patent Owner”) filed a Preliminary Response to the Petition. Paper 6
`(“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes review
`under 35 U.S.C. § 314. To institute an inter partes review, we must determine that
`the information presented in the Petition shows “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(a). For the reasons set forth below, we conclude that
`Petitioner has not established a reasonable likelihood that it would prevail in
`showing the unpatentability of any challenged claim of the ’342 patent. Therefore,
`we do not institute an inter partes review for any challenged claim of the ’342
`patent.
`
`Related Proceedings
`A.
`Petitioner also filed two petitions for inter partes review of U.S. Patent No.
`7,964,580 (Case Nos. IPR2018-00119 and IPR2018-00120); two petitions for inter
`partes review of U.S. Patent No. 8,334,270 (Case Nos. IPR2018-00121 and
`IPR2018-00122); one petition for inter partes review of U.S. Patent No. 7,429,572
`(Case No. IPR2018-00103); and one petition for inter partes review of U.S. Patent
`No. 8,633,309 (Case No. IPR2018-00125). Pet. 2; Paper 3, 3.
`The ’342 Patent
`B.
`The ’342 patent relates to nucleoside phosphoramidates and their use as
`agents for treating viral diseases, such as hepatitis C. Ex. 1001, Abstract; 1:21–26.
`The ’342 patent discloses a compound represented by formula 4 and its respective
`
` 2
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`phosphorous-based diastereomers represented by formulas Sp-4 and Rp-4, as
`shown below:
`
`
`
`
`Id. at 4:65–5:34. The ’342 patent states that “[t]he term ‘P*’ means that the
`phosphorus atom is chiral and that it has a corresponding Cahn-Ingold-Prelog
`designation of ‘R’ or ‘S’ which have their accepted meanings.” Id. at 6:28–30.
`The compound of formula Sp-4 is sofosbuvir. Prelim. Resp. 9.
`The ’342 patent discloses six crystalline forms of Sp-4 (Forms 1–6).
`Ex. 1001, 73:51–76:43. X-ray powder diffraction (XRPD) 2θ-reflections are
`attributed to Form 6, and recited in claim 1. Id. at 76:10–43. The ’342 patent
`
` 3
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`characterizes Form 6, such as by X-ray powder diffraction, and describes methods
`for preparing Form 6. Id. at 73:10–50; 82:1–11, 41–42.
`The ’342 patent states that “U.S. patent application Ser. No. 12/053,015,
`which corresponds to WO 2008/121634 [Sofia ’634, Ex. 1005] . . . discloses a
`number of phosphoramidate nucleoside prodrugs, many of which show activity in
`an HCV assay.” Id. at 4:55–59. During prosecution, the Examiner expressly
`addressed Sofia ’634, stating in the Notice of Allowance that:
`The claimed invention is seen to be novel and non-obvious over
`the prior art. The prior art does not disclose a crystalline composition
`of the claimed compound having the claimed XRPD peaks. References
`to the claimed compound in the prior art (see for example [Sofia ’634])
`[do] not disclose the specific crystal structure described in the claims,
`or a method of preparing a crystalline form of the compound that would
`have resulted in that particular crystal. Because of the unpredictability
`of crystalline polymorphs, one of ordinary skill in the art would not
`have been able to, based on the prior art disclosure, predict or make this
`particular crystal form.
`Ex. 1004, 183–184.
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1–4 of the ’342 patent, of which claim 1 is the
`only independent claim. Claim 1 is reproduced below:
`1. A crystalline compound represented by the formula (Sp-4):
`
`
`
`having XRPD 2θ-reflections (°) at about: 6.1 and 12.7.
`
` 4
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`Ex. 1001, 89:42–65.
`Claims 2–4 depend directly or indirectly on claim 1.1 Id. at 90:1–9.
`
`
`
`The Asserted Grounds of Unpatentability
`D.
`Petitioner contends that the challenged claims are unpatentable under 35
`U.S.C. §103(a) based on the following specific grounds. Pet. 3.
`Reference[s]
`Basis
`Claims challenged
`Sofia ’6342 and Sofia
`§ 103(a)
`1–4
`20103
`Sofia ’634 and Ma4
`
`§ 103(a)
`
`1–4
`
`Clark ’1475 and Ma
`
`§103(a)
`
`1–4
`
`
`Petitioner also relies on the Declaration of Joseph M. Fortunak, Ph.D.
`Ex. 1002.
`
`
`1 For example, claim 3 recites “[a] method of treating a hepatitis C virus infection
`in a human comprising administering to the human an effective amount of the
`crystalline compound according to claim 1.” Ex. 1001, 90:4–6.
`2 Sofia et al., WO 2008/121634 A2, published Oct. 9, 2008 (“Sofia ’634”).
`Ex. 1005.
`3 M.J. Sofia et al., Discovery of a β-D-2'-Deoxy-2'-α-fluoro-2'-β-C-methyluridine
`Nucleotide Prodrug (PSI-7977) for the Treatment of Hepatitis C Virus, J. MED.
`CHEM. 53, 7202–18 (2010) (“Sofia 2010”). Ex. 1014.
`4 H. Ma et al., Characterization of the Metabolic Activation of Hepatitis C Virus
`Nucleoside Inhibitor β-D-2'-Deoxy-2'-fluoro-2'-C-methylcytidine (PSI-6130) and
`Identification of a Novel Active 5'-Triphosphate Species, J. OF BIOLOGICAL CHEM.,
`282, 29812–20 (2007) (“Ma”). Ex. 1010.
`5 Clark, WO 2005/003147 A2, published Jan. 13, 2005 (“Clark ’147”). Ex. 1007.
`
` 5
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`
` ANALYSIS
`Person of Ordinary Skill in the Art
`A.
`Petitioner asserts that a person of ordinary skill in the art would have either
`“(1) a Ph.D. in chemistry or a closely related field with some experience in an
`academic or industrial laboratory focusing on drug discovery or development, and
`would also have some familiarity with antiviral drugs and their design and
`mechanism of action,” or “(2) a Bachelor’s or Master’s degree in chemistry or a
`closely related field with significant experience in an academic or industrial
`laboratory focusing on drug discovery and/or development for the treatment of
`viral diseases.” Pet. 7–8.
`Patent Owner’s definition of a person of ordinary skill in the art differs from
`Petitioner’s definition. Prelim. Resp. 11. Patent Owner contends that a person of
`ordinary skill in the art (“POSA”) “would have at least a bachelor’s degree in
`chemistry, pharmaceutical sciences or a related discipline, along with experience
`working in pharmaceutical solid product development and/or solid-state chemistry.
`Additionally, a POSA would have knowledge and experience, and/or access to
`others with knowledge and experience, in developing antiviral drugs.” Id.
`On this record and at this stage of the proceeding, we do not discern an
`appreciable difference in the parties’ respective definitions of a person of ordinary
`skill in the art. Accordingly, we find that a person of ordinary skill in the art would
`have either (1) a Ph.D. in chemistry or a closely related field with some experience
`in an academic or industrial laboratory focusing on drug discovery or development,
`including solid-state chemistry, and would also have some familiarity with
`antiviral drugs and their design and mechanism of action, or (2) a Bachelor’s or
`Master’s degree in chemistry or a closely related field with significant experience
`in an academic or industrial laboratory focusing on drug discovery and/or
`
` 6
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`development, including solid-state chemistry, for the treatment of viral diseases.
`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)).
`Claim Construction
`B.
`In an inter partes review, the Board interprets claim terms in an unexpired
`patent according to the broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of
`broadest reasonable construction standard to inter partes review proceedings).
`Under that standard, and absent any special definitions, we generally give claim
`terms their ordinary and customary meaning, as would be understood by one of
`ordinary skill in the art at the time of the invention. See In re Translogic Tech.,
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms
`must be set forth with reasonable clarity, deliberateness, and precision. See In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Neither Petitioner nor Patent Owner raise any claim construction issues or
`proposed constructions, and both acknowledge that the claim terms should be
`given their ordinary and customary meaning. Pet. 8; Prelim. Resp. 12.
`Accordingly, we apply the ordinary and customary meaning to the claims at issue.
`See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013,
`1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy,
`and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs.,
`
` 7
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`C. Principles of Law
`Obviousness “requires a suggestion of all limitations in a claim.” CFMT,
`Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re
`Royka, 490 F.2d 981, 985 (CCPA 1974)). “In determining whether obviousness is
`established by combining the teachings of the prior art, the test is what the
`combined teachings of the references would have suggested to those of ordinary
`skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
`quotations omitted).
`Obviousness also requires “a reason that would have prompted a person of
`ordinary skill in the relevant field to combine the elements in the way the claimed
`new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). A
`conclusion of obviousness “cannot be sustained by mere conclusory statements;
`instead, there must be some articulated reasoning with some rational underpinning
`to support the legal conclusion of obviousness.” Id. (quoting In re Kahn, 441 F.3d
`977, 988 (Fed. Cir. 2006)).
`We analyze the asserted grounds of unpatentability in accordance with the
`above-stated principles.
`D. Obviousness over Sofia ’634 and Sofia 2010
`Petitioner asserts that claims 1–4 are obvious over Sofia ’634 and Sofia
`2010. Pet. 32–39. On this record, we determine that Petitioner has not established
`a reasonable likelihood that it would prevail in showing that any of claims 1–4 are
`obvious over Sofia ’634 and Sofia 2010.
`Sofia ’634 (Ex. 1005)
`1.
`Sofia ’634 discloses phosphoramidate prodrugs of nucleoside derivatives
`represented by formula (I):
`
` 8
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`
`
`Ex. 1005, Abstract. Sofia ’634 further describes nucleoside phosphoramidates and
`their use as agents for treating viral diseases, such as hepatitis C virus (HCV)
`infection. Id. at 2:15–21. Example 25 of Sofia ’634 is the same as that represented
`by formula (4) in the ’342 patent, except that Example 25 is a mixture of
`diastereomers at phosphorus. Id. at 684. Example 81 of Sofia ’634 describes the
`separation of diastereomeric mixtures of Examples 15, 39, and 49. Id. at 693–94.
`Sofia ’634 is referenced in the ’342 patent. Ex. 1001, 4:55–59.
`Sofia 2010 (Ex. 1014)
`2.
`Sofia 2010 relates to a nucleotide prodrug (PSI-7977) for the treatment of
`hepatitis C virus. Ex. 1014, Title. Sofia 2010 states that “[t]he single diastereomer
`51 [PSI-7977] of diastereomeric mixture 14 was crystallized, and an X-ray
`structure was determined establishing the phosphoramidate stereochemistry as Sp,
`thus correlating for the first time the stereochemistry of a phosphoramidate prodrug
`with biological activity.” Id., Abstract. Sofia 2010 discloses the methylene
`chloride solvate of sofosbuvir (compound 51). Id., Figure 5 at 8. Sofia 2010 was
`cited during the prosecution of the ’342 patent. Ex. 1001, 10.
`Analysis
`3.
`Petitioner contends that, based on the asserted teachings of Sofia ’634 and
`Sofia 2010, “a POSA would have been motivated to combine the teachings of
`Sofia ’634 and Sofia 2010 to pursue isolation and testing of the diastereomers of
`
` 9
`
`
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`the compounds taught in Sofia ’634, as well as to search for alternative crystalline
`forms. EX1002 at ¶ 111. These crystalline forms would be structurally and
`functionally identical to the form claimed in claim 1 of the ’342 patent. Id.”
`Pet. 36. The cited paragraph of the Fortunak Declaration repeats Petitioner’s
`statement, without citation to any evidentiary support. See Ex. 1002 ¶ 111.
`Petitioner further contends that “[t]he only difference between claim 1 of the
`‘342 patent and the crystalline forms of Sophia ‘634 that a POSA would have
`isolated, tested and determined had superior properties – as taught by Sophia 2010
`– is the recitation of certain XRPD 2Ɵ-reflections, such reflections having no
`utility in themselves. EX1002 at ¶112.” Pet. 36. The cited paragraph of the
`Fortunak Declaration repeats Petitioner’s statement, without citation to any
`evidentiary support. See Ex. 1002 ¶ 112. Nevertheless, according to Petitioner,
`“the XRPD 2Ɵ-reflections recited in claim 1 do not provide the stereoisomer any
`of its properties or any functionality,” “are of no scientific or technical
`significance,” and “are merely descriptive of some non-functional aspects of the
`XRPD 2Ɵ-reflections.” Pet. 36. Again, Petitioner supports these statements by
`reference to the Fortunak Declaration, which merely repeats Petitioner’s statements
`without citation to any evidentiary support. See Ex. 1002 ¶ 113.
`Patent Owner states that “neither [Sofia ’634 nor Sofia 2010] teaches or
`suggests Form 6 of sofosbuvir, or a crystalline form of sofosbuvir characterized by
`the recited XRPD reflections.” Prelim. Resp. 17. In response to Petitioner’s
`arguments regarding the claimed XRPD limitations, Patent Owner points to
`Petitioner’s acknowledgement that the “difference in crystalline packing [is] a
`potential source of variability in properties, such as melting point, stability,
`aqueous solubility, formulation characteristics, bioavailability, bioequivalence, that
`are critical for understanding and controlling drug performance.” Id. at 19, citing
`
`10
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`Pet. 20. Patent Owner also characterizes Petitioner’s motivation argument as “a
`general motivation to identify new crystalline forms,” and therefore insufficient
`motivation to support an obviousness conclusion. See Prelim. Resp. 20–25.
`On this record, Petitioner does not persuasively explain how Sofia ’634 or
`Sofia 2010, alone or in combination, suggest the limitations of claim 1, or
`persuasively explain a reason that would have motivated a person of ordinary skill
`in the art to modify or combine the teachings of Sofia ’634 and Sofia 2010 to
`arrive at the claimed invention. Claim 1 specifically recites crystalline compound
`Sp-4 “having XRPD 2θ-reflections (°) at about: 6.1 and 12.7.” Ex. 1001, 89:42–
`65. Those limitations define a crystal structure of the claimed compound. See In
`re Grose, 592 F.2d 1161, 1165 (CCPA 1979). But Petitioner does not persuasively
`establish that those limitations are suggested by Sofia ’634 and/or Sofia 2010. See
`CFMT, 349 F.3d at 1342; GPAC Inc., 57 F.3d at 1581.
`Petitioner essentially disregards the crystalline structure limitations of claim
`1 and argues that “[a]lthough a POSA would not have been able to predict this
`exact recitation of 2 XRPD 2Ɵ-reflections, a POSA would be able to prepare the
`Sp-4 compound with such 2Ɵ-reflections.” Pet. 36. But the argument that a POSA
`could have prepared the Sp-4 compound having that structure is unpersuasive
`because “obviousness 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.” Belden Inc. v. Berk-Tek LLC, 805 F.3d
`1064, 1073 (Fed. Cir. 2015). Moreover, we find that Petitioner’s arguments are
`generally conclusory in nature, without evidentiary support. See KSR, 550 U.S. at
`418. Thus, Petitioner fails to persuasively establish that the claimed crystalline
`structure limitations are suggested by the prior art, or that a person of ordinary skill
`in the art would have been motivated to modify or combine Sofia ’634 and/or Sofia
`
`11
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`2010 to arrive at the invention of claim 1.
`Accordingly, we determine that Petitioner has not shown a reasonable
`likelihood that it would prevail on its assertion that claim 1 (and dependent claims
`2–4, which include the limitations of claim 1) are obvious over Sofia ’634 and
`Sofia 2010. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988) (“Dependent
`claims are nonobvious under section 103 if the independent claims from which
`they depend are nonobvious.”).
`E. Obviousness over Sofia ’634 and Ma
`Petitioner asserts that claims 1–4 are obvious over Sofia ’634 and Ma. Pet.
`39–45. On this record, we determine that Petitioner has not established a
`reasonable likelihood that it would prevail in showing that any of claims 1–4 are
`obvious over Sofia ’634 and Ma.
`1. Ma (Ex. 1010)
`Ma relates to the metabolism and mechanism of action of the compound
`PSI-6130, illustrated below:
`
`
`Ex. 1010; Pet. 31; Prelim. Resp. 15. Ma states that PSI-6130 “has been identified
`as a potent and selective inhibitor of HCV replication.” Ex. 1010, 2. Ma was cited
`during the prosecution of the ’342 patent. Ex. 1001, 10.
`
`
`12
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`
`Analysis
`2.
`Petitioner repeats essentially the same arguments as above regarding Sofia
`’634 and the crystalline structure limitations of claim 1, and our response to those
`arguments is as set forth above. Compare Pet. 36–38 with Pet. 42–44. Petitioner
`further argues that Ma teaches “the conversion of PSI-6130 into the uridine analog
`RO2433” and that the teachings in Ma “indicate that a monophosphate prodrug
`form of compound 1D/RO2433 was a very attractive drug candidate for the
`treatment of hepatitis C viral infections.” Pet. 41–42. Petitioner supports its
`arguments by reference to page 1 of Ma (without pointing to any specific text) and
`a quote from page 8 of Ma regarding “longer intracellular half-life of RO2433-
`TP.”6 Id. Petitioner further advances the conclusory argument that
` [t]herefore, although Sofia ‘634 did not disclose the polymorph
`claimed in claim 1 of the ‘342 exactly (i.e., SP-4), Ma highlighted
`RO2433 as a lead compound to pursue, and it would have been obvious
`for a POSA to take RO2433 and create stereoisomers as taught by Sofia
`‘634 to arrive at multiple crystalline forms of its compounds.
`Pet. 44. As support for that conclusory statement of obviousness, Petitioner again
`cites to the Fortunak Declaration that repeats the same statement without citing
`evidentiary support. Ex. 1002 ¶ 137.
`Although Petitioner states that a POSA “would have been motivated to
`search for crystalline forms of RO2433” and “motivated to screen the limited
`number of crystalline forms possible” (Pet. 43–44), Petitioner does not
`persuasively establish that the crystalline structure limitations of claim 1 are
`suggested by Sofia ’634 and/or Ma. See CFMT, 349 F.3d at 1342; GPAC Inc., 57
`
`
`6 Petitioner also refers to the Fortunak Declaration which merely repeats the same
`statements advanced by Petitioner. See Ex. 1002 ¶¶ 127–130.
`
`13
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`F.3d at 1581. Moreover, we again find that Petitioner’s arguments are generally
`conclusory in nature, without evidentiary support. See KSR, 550 U.S. at 418.
`Accordingly, we determine Petitioner has not established a reasonable
`likelihood that it would prevail in showing that claim 1 (and dependent claims 2–4
`which include the limitations of claim 1) are obvious over Sofia ’634 and Ma. See
`Fine, 837 F.2d at 1076.
`F. Obviousness over Clark ’147 and Ma
`Petitioner asserts that claims 1–4 are obvious over Clark ’147 and Ma. Pet.
`45–51. On this record, we determine that Petitioner has not established a
`reasonable likelihood that it would prevail in showing that any of claims 1–4 are
`obvious over Clark ’147 and Ma.
`Clark ’147 (Ex. 1007)
`1.
`Clark ’147 is directed to compositions and methods for treating a
`Flaviviridae infection, such as hepatitis C virus, using (2'R)-2'-deoxy-2'-fluoro-2'-
`C-methyl nucleosides. Ex. 1007, Abstract. Clark ’147 claims:
`A (2'R)-2'-deoxy-2'-fluoro-2'-C-methyl nucleoside (β-D or β-L) or its
`pharmaceutically acceptable salt or prodrug thereof of the structure:
`
`
`wherein Base is a purine or pyrimidine base; and substituents X, R1, and R7 are
`respectively one of a group of elements or compounds. Id. at 101. Clark ’147 was
`cited during the prosecution of the ’342 patent. Ex. 1001, 4.
`
`
`14
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`
`Analysis
`2.
`Petitioner argues that “[t]hese disclosures in Clark, combined with common
`knowledge in the art regarding polymorphs, polymorph screening, and
`crystallization of crystalline forms, would have motivated a POSA to pursue
`crystalline forms as drug candidates.” Pet. 47. Petitioner supports this statement
`by reference to the same statement in the Fortunak Declaration that lacks any
`citation to evidentiary support. Ex. 1002 ¶ 147. Petitioner repeats the same
`arguments regarding Ma and the crystalline structure limitations of claim 1 as set
`forth above, and our response to those arguments is as set forth above. Compare
`Pet. 40–44 with Pet. 47–50. Similar to the argument set forth above, Petitioner
`concludes that
`[t]herefore, although Clark ‘147 did not disclose the polymorph
`claimed in claim 1 of the ‘342 exactly (i.e., SP-4), Ma highlighted
`RO2433 as a lead compound to pursue, and it would have been obvious
`for a POSA to take RO2433 and create stereoisomers as taught by Clark
`‘147 to arrive at multiple crystalline forms of its compounds.
`Pet. 50. As support for that conclusory statement of obviousness, Petitioner again
`cites to the Fortunak Declaration that repeats the same statement without citing
`evidentiary support. Ex. 1002 ¶ 158.
`Again, Petitioner does not persuasively establish that the crystalline structure
`limitations of claim 1 are suggested by Clark ’147 and/or Ma. See CFMT, 349
`F.3d at 1342; GPAC Inc., 57 F.3d at 1581. Moreover, we again find that
`Petitioner’s arguments are generally conclusory in nature, without evidentiary
`support. See KSR, 550 U.S. at 418.
`Accordingly, we determine Petitioner has not established a reasonable
`likelihood that it would prevail in showing that claim 1 (and dependent claims 2–4
`
`
`15
`
`
`
`
`
`Case IPR2018-00126
`Patent 9,284,342 B2
`
`which include the limitations of claim 1) are obvious over Clark ’147 and Ma. See
`Fine, 837 F.2d at 1076.
`
` CONCLUSION
`For the foregoing reasons, we conclude that Petitioner has not established a
`reasonable likelihood of prevailing on its assertion that any of claims 1–4 of the
`’342 patent are unpatentable.
`
`
` ORDER
`In consideration of the foregoing, it is hereby ORDERED that the Petition is
`denied.
`
`
`
`
`
`
`
`PETITIONER:
`
`Daniel Ravicher
`dan@ravicher.com
`
`PATENT OWNER:
`
`David Cavanaugh
`Emily Whelan
`david.cavanaugh@wilmerhale.com
`emily.whelan@wilmerhale.com
`
`Dorothy Whelan
`Mike Kane
`Chad Shear
`whelan@fr.com
`kane@fr.com
`shear@fr.com
`
`
`
`
`16
`
`