Trials@uspto.gov
`571-272-7822
`
`
`Paper: 17
`Entered: January 16, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Petitioner,
`
`v.
`
`PLEXXIKON INC.,
`Patent Owner.
`____________
`
`Case IPR2018-01287
`Patent 9,469,640 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, JO-ANNE M. KOKOSKI, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KOKOSKI, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`571-272-7822
`
`
`Paper: 17
`Entered: January 16, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Petitioner,
`
`v.
`
`PLEXXIKON INC.,
`Patent Owner.
`____________
`
`Case IPR2018-01287
`Patent 9,469,640 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, JO-ANNE M. KOKOSKI, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KOKOSKI, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`IPR2018-01287
`Patent 9,469,640 B2
`
`
`I. INTRODUCTION
`Novartis Pharmaceuticals Corporation (“Petitioner”) filed a Petition to
`institute an inter partes review of claims 1, 2, 4–6, 9, 11, and 12 of U.S.
`Patent No. 9,469,640 B2 (“the ’640 patent,” Ex. 1001). Paper 2 (“Pet.”).
`Plexxikon Inc. (“Patent Owner”) filed a Preliminary Response. Paper 10
`(“Prelim. Resp.”).
`Institution of an inter partes review is authorized by statute 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. Upon consideration of the Petition, the Preliminary
`Response, and the evidence of record, we determine that the Petition
`presents substantially the same arguments as those previously presented to
`the Office, and, thus, exercise our discretion under 35 U.S.C. § 325(d) to
`deny institution of an inter partes review as to claims 1, 2, 4–6, 9, 11, and 12
`of the ’640 patent.
`Related Proceedings
`A.
`The parties indicate that the ’640 patent is being asserted in Plexxikon
`Inc. v. Novartis Pharmaceuticals Corp., Civil Action No. 4:17-cv-04405
`HSG (EDL) (N.D. Cal.). Paper 8, 2; Pet. 4.
`The ’640 Patent
`B.
`The ’640 patent, titled “Compounds and Methods for Kinase
`Modulation, and Indications Therefor,” is directed to compounds “that are
`active on protein kinases in general,” and methods for the use of such
`compounds “in treating diseases and conditions associated with regulation of
`the activity” of the protein kinases. Ex. 1001, 1:26–46. The ’640 patent
`
`
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`Patent 9,469,640 B2
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`describes a genus of compounds that have the following generic formula
`(“Formula I”):
`
`
`Id. at 1:51–3:64. The ’640 patent identifies a number of options for each of
`Ar, R1, R2, R3, R4, L1, L2, and m. Id. For example, the ’640 patent states
`that “Ar is optionally substituted heteroaryl,” “R2 is hydrogen, lower alkyl or
`halogen,” and “R3 is optionally substituted lower alkyl, optionally
`substituted C3–6 cycloalkyl, optionally substituted heterocycloalkyl,
`optionally substituted aryl or optionally substituted heteroaryl.” Id. at 1:65,
`2:13, 2:17–20. The ’640 patent further discloses a number of sub-genera of
`Formula I that it identifies as Formulae Ia, Ib, Ic, Id, Ie, If, Ig, Ih, Ii, and Ij.
`Id. at 3:65–13:41.
`Challenged Claims
`C.
`Petitioner challenges claims 1, 2, 4–6, 9, 11, and 12 (“the challenged
`claims”) of the ’640 patent. Claim 1, the only independent claim, is
`reproduced below.
`1.
`
`A compound of formula (Ia):
`
`
`or a pharmaceutically acceptable salt thereof, wherein:
`3
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`IPR2018-01287
`Patent 9,469,640 B2
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`
`L1 is a bond or —N(H)C(O)—;
`each R1 is optionally substituted lower alkyl or optionally
`substituted heteroaryl;
`R2 is hydrogen or halogen;
`R4 is hydrogen;
`R3 is optionally substituted lower alkyl or optionally substituted
`aryl;
`m is 0, 1, 2, 3, 4, or 5; and
`Ar is a monocyclic heteroaryl containing 5 to 6 atoms wherein
`at least one atom is nitrogen.
`Ex. 1001, 150:25–47.
`The Asserted Ground of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1, 2, 4–6, 9, 11, and
`12 of the ’640 patent under 35 U.S.C. § 102(a) as being anticipated by U.S.
`Patent No. 7,994,185 B2, issued on August 9, 2011 (“the ’185 patent,”
`Ex. 1006).
`
`II. ANALYSIS
`Institution of inter partes review is discretionary. See 35 U.S.C.
`§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is
`guided by 35 U.S.C. § 325(d), which states that “the Director may take into
`account whether, and reject the petition or request because, the same or
`substantially the same prior art or arguments previously were presented to
`the Office.” Patent Owner contends that Petitioner’s challenge relies on the
`same or substantially the same arguments that were already considered
`during the prosecution of the ’640 patent. Prelim. Resp. 9–16.
`When evaluating whether the same or substantially the same prior art
`or arguments previously were presented to the Office under § 325(d), the
`Board has considered a number of non-exclusive factors, including: (1) the
`
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`IPR2018-01287
`Patent 9,469,640 B2
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`similarity of the asserted art and the prior art involved during the
`examination; (2) the extent to which the asserted art was considered during
`examination, including whether the prior art was the basis for rejection; (3)
`the cumulative nature of the asserted art and the prior art considered during
`examination; (4) whether Petitioner has pointed out sufficiently how the
`Examiner erred in its consideration of the asserted prior art; (5) the extent to
`which the arguments made during examination and the manner in which
`Petitioner relies on the prior art or the applicant’s arguments during
`examination overlap; and (6) the extent to which additional evidence and
`facts presented in the Petition warrant reconsideration of the asserted prior
`art. Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-
`01586, slip op. at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (informative).
`After considering all of the relevant factors and the parties’ arguments, we
`are persuaded, for the reasons set forth below, that the Petition presents
`substantially the same arguments previously presented to the Office.
`A.
`Relevant Prosecution History of the ’640 Patent
`The ’640 patent issued from U.S. Patent Application Serial
`No. 15/048,851 (“P5”) filed on February 19, 2016 as a continuation of U.S.
`Patent Application Serial No. 13/926,959 (“P4”), filed on June 25, 2013 as a
`continuation of U.S. Patent Application Serial No. 13/866,353 (“P3”), filed
`on April 19, 2013 as a continuation of U.S. Patent Application Serial
`No. 12/669,450 (“P2”), which is the national phase entry of PCT
`Application No. PCT/US2008/070124, filed on July 16, 2008. Ex. 1001,
`(21), (22), (63); see Pet. 8–9. P2 claims the benefit of priority to Provisional
`Application No. 60,959,907 (“P1”), filed on July 17, 2007. Ex. 1001, (60);
`Pet. 9.
`
`
`
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`5
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`IPR2018-01287
`Patent 9,469,640 B2
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`
`During the prosecution of P4, pending claim 1, and claims 2–8, 10,
`16, and 18 that depended, directly or indirectly, therefrom, were rejected for
`failing to comply with the written description requirement. Ex. 1008, 3.1
`Then-pending claim 1 is reproduced below:
`
`
`
`See id. at 5–6. The Examiner stated that “[t]he only disclosure, is in the
`form of general formula with lists of possible groups,” and “[t]his kind of
`disclosure is not representati[ve] of any species.” Id. at 6. The Examiner
`also stated that “[a]ll disclosed compounds have a linker moiety between the
`
`
`1 Citations to Exhibits 1004, 1005, and 1007–1017 are to the page numbers
`added by Petitioner to the bottom right-hand corner of the page.
`
`6
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`phenyl and the Ar[,] i.e., L1 in formula I is not a bond,” and P4 does not
`provide any “convincing evidence, or rationale that the biological activity of
`disclosed compounds would have been retained if the L1 in formula I is a
`bond instead of those linking moieties.” Id. at 7. Therefore, according to
`the Examiner, “it is not understood what specific structures for the claimed
`variables will lead to compounds that have the instantly claimed activity.”
`Id. at 7. Finally, the Examiner stated that
`[t]he structure/activity relationship (SAR) for binding and
`activity is elucidated upon analysis of IC50 data of multiple
`compounds with various types of structural modifications.
`These types of studies provide insight into the structural
`limitations that are required for activity, i.e.[,] specific
`structural elements tolerated for the claimed activity. In the
`absence of such correlation, it is not possible to determine what
`structural modifications will allow for the preservation of the
`desired activity.
`
`Id.
`
`In response, Applicant amended the claims “to be directed to a more
`focused genus of compounds.” Ex. 1009, 6. The amended claims were also
`rejected for failure to comply with the written description requirement, for
`the same reasons set forth above. Ex. 1010, 3–8. In a subsequent Examiner
`Interview, the Examiner “agreed that the application has support for L1 as
`amide or a bond, and Ar as bicyclic nitrogen-containing heteroaryl with the
`proviso in the claims.” Ex. 1011, 1 (emphasis omitted).
`P5 was then filed as a continuation of P4, wherein claims 1–20 were
`cancelled and new claims 21–33 were added. Ex. 1014, 3–4. Claim 21 was
`the only independent claim, and is reproduced below:
`
`
`
`
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`IPR2018-01287
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`Id. at 3. In the accompanying remarks, Applicant requested that “the Office
`review the Interview Summary of parent application [P4], filed on even date
`herewith,” and noted that “the Office agreed that the application has support
`for L1 as amide or a bond, and Ar as nitrogen-containing bicyclic heteroaryl
`and monocyclic heteroaryl.” Id. at 7. In the P4 Interview Summary,
`Applicant stated that
`numerous embodiments of the claimed compounds wherein L1
`is a bond can be found throughout the specification, including
`but not limited to paragraphs [0007], [0009], and [0021].
`Further, Scheme 2 provides exemplary methods of making
`compounds where L1 is a bond. The Office agreed that “the
`8
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`IPR2018-01287
`Patent 9,469,640 B2
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`
`application has support for L1 as amide or a bond . . . [.]”
`Applicant-Initiated Interview Summary dated January 22, 2016.
`Ex. 1012, 2. Thereafter, P4 went abandoned. Ex. 1013.
`The Examiner rejected pending claims 21–33 in P5 as “failing to
`comply with the written description requirement,” repeating the rationale
`from rejections of similar claims during the prosecution of P4. Ex. 1015, 3–
`7. In particular, the Examiner concluded that
`(i) substantial structural variation exists in the genus/subgenus
`embraced by claims 21-33; (ii) No disclosure of species
`supporting the genus; (iii) common structural attributes of the
`claimed genus/subgenus, combined with a correlation between
`structure and function, is neither disclosed in the instant
`application nor commonly known in the art. Thus, the
`specification fails to provide adequate written description for
`the genus of compounds claimed and does not reasonably
`convey to one skilled in the relevant art that the inventor(s), at
`the time the application was filed, has possession of the entire
`scope of the claimed invention.
`Id. at 7.
`In response, Applicant amended claim 21 to recite that “L1 is a bond
`or –N(H)C(O)–” and “Ar is a monocyclic heteroaryl containing 5 to 6 atoms
`wherein at least one atom is nitrogen,” and cancelled claim 29. Ex. 1016, 2–
`3. In the accompanying remarks, Applicant stated that during an interview
`with the Examiner “the Office agreed that the application provides support
`for L1 as amide or a bond and support for Ar as a monocyclic or bicyclic
`nitrogen-containing heteroaryl as discussed below and during the
`prosecution of the parent application” P4. Id. at 5. Applicant pointed to
`paragraphs [0007], [0009], [0011], and [0021] of the specification as
`providing “embodiments for claimed L1, including L1 is a bond,” and further
`
`
`
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`IPR2018-01287
`Patent 9,469,640 B2
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`pointed to Scheme 2 as providing “exemplary methods [for] making
`compounds where L1 is a bond.” Id. at 6.
`In response to Applicant’s amendment, a Notice of Allowability of
`pending claims 21–28 and 30–33 was issued. Ex. 1017. In the Reasons for
`Allowance, the Examiner stated that “[t]he amendments of the claims,
`limiting the Ar in general formula (Ia) to monocyclic heteroaryl, and the L1
`is limited to a bond or –N(H)C(O)– is sufficient to overcome the rejections
`under 35 U.S.C. [§] 112, first paragraph as set forth in prior office action.”
`Id. at 6.
`B.
`Same or Substantially the Same Arguments
`Petitioner contends that the challenged claims “are not entitled to the
`benefit of the July 16, 2008 filing date of P2 or the earlier provisional
`application because P2 does not satisfy the written description and
`enablement requirements of 35 U.S.C. § 112 (pre-AIA) as required for
`benefit under 35 U.S.C. § 120.” Pet. 1. Petitioner contends that “P2
`discloses enormous genera of chemical compounds which cover an
`effectively incalculable number of compounds, but provides no ‘blaze
`marks’ to direct a person of ordinary skill to the subgenera of the Challenged
`Claims.” Id. at 1–2. Petitioner contends that “while the subgenera of the
`Challenged Claims cover trillions of compounds, there are only three
`examples in P2 that fall within the scope of the claims, and none where L1 is
`a bond.” Id. at 2. Petitioner further contends that “P2 does not enable a
`person of ordinary skill to make the full scope of compounds in these claims
`where L1 is a bond, which constitute approximately half of the compounds
`covered by the claims.” Id. at 41. According to Petitioner, P2 also “fails to
`disclose how to use such compounds where L1 is a bond” because “P2
`
`
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`IPR2018-01287
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`provides no data showing that any of the claimed compounds where L1 is a
`bond has activity on kinase proteins and a person of ordinary skill would not
`have believed such compounds where L1 is a bond would have such
`activity.” Id. (citing Ex. 1002 ¶ 106).
`Patent Owner responds that, during the prosecution of the ’640 patent,
`“the Examiner explicitly consider[ed] the § 112 support for the challenged
`claims” and “addressed head-on the specific arguments about the L1
`substituent, which are now at the heart of Petitioner’s case.” Prelim. Resp.
`9. In that regard, Patent Owner argues that the Examiner “rejected the
`claims several times because they ‘read on numerous possible distinct
`species [and] there is no substantial feature shared by all species.’” Id. at 10
`(quoting Ex. 2001, 4). Patent Owner argues that “the Examiner, like the
`Petitioner here, focused on the L1 substituent,” namely, when the L1
`substituent is a bond, and that “Applicant amended the claims to be directed
`to a more focused genus of compounds claiming L1 as, inter alia, a bond,
`and identified where its amendments found support in the specification
`under § 112.” Id. at 10–11 (citing Ex. 1008, 6–7; Ex. 1009, 2–5).
`Patent Owner further argues that, in allowing the claims, the Examiner
`explicitly stated that “[t]he amendments of the claims, limiting the Ar in
`general formula (Ia) to monocyclic heteroaryl, and the L1 is limited to a
`bond of –N(H)C(O)– is sufficient to overcome the rejections under
`35 U.S.C. § 112, first paragraph, as set forth in the prior office action.” Id.
`at 12 (quoting Ex. 1017, 6). According to Patent Owner, because “the
`Office has already decided the dispositive § 112 issue and Petitioner has not
`presented any new argument or evidence to justify reaching a different
`
`
`
`
`11
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`IPR2018-01287
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`
`conclusion,” the Board should “deny institution pursuant to § 325(d).” Id. at
`15–16.
`We agree with Patent Owner that Petitioner’s arguments regarding
`whether P2 provides § 112 support for the challenged claims are
`substantially the same as those considered by the Examiner during the
`prosecution of the ’640 patent.
`As set forth above, the Examiner repeatedly rejected the pending
`claims because: (1) “[t]he only disclosure, is in the form of general formula
`with lists of possible groups,” and “[t]his kind of disclosure is not
`representati[ve] of any species” (Ex. 1005, 9; Ex. 1008, 6; Ex. 1010, 6;
`Ex. 1015, 6); (2) “[a]ll disclosed compounds have a linker moiety between
`the phenyl and the Ar,” but the application does not provide any “convincing
`evidence, or rationale that the biological activity of [the] disclosed
`compounds would have been retained if the L1 in formula I” vary with the
`scope defined in the pending claims (Ex. 1005, 9; Ex. 1008, 7; Ex. 1010, 6;
`Ex. 1015, 7); and (3) in the absence of information regarding “the structural
`limitations that are required for activity, i.e. specific structural elements
`tolerated for the claimed activity,” “it is not possible to determine what
`structural modifications will allow for the preservation of the desired
`activity” (Ex. 1005, 9–10; Ex. 1008, 7; Ex. 1010, 7; Ex. 1015, 7). Here,
`Petitioner argues that: (1) P2 does not provide sufficient disclosure of the
`subgenera (i.e., species) (Pet. 1–2, 14–40); (2) “P2 does not guide one of
`ordinary skill to focus on” the bond or –N(H)C(O)– options for L1,
`“particularly in combination with each of the other specific substituents in
`the Challenged Claims” (id. at 27–35); and (3) P2 does not provide
`information regarding activity data or other guidance to establish “that
`
`
`
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`12
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`IPR2018-01287
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`
`compounds in which L1 is a bond might work as kinase inhibitors, or for any
`other pharmacological purpose” (id. at 57; see generally id. at 56–61). We
`conclude that Petitioner’s arguments are substantially the same as those
`considered by the Examiner during the prosecution of the ’640 patent.
`C. Discretion to Deny Institution of Trial
`Petitioner contends that claims 1, 2, 4–6, 9, 11, and 12 of the ’640
`patent are unpatentable under 35 U.S.C. § 102(b) as anticipated by the ’185
`patent, which issued on August 9, 2011. Pet. 61–64. Petitioner’s
`contentions are premised on its argument that the challenged claims are not
`entitled to the benefit of the July 16, 2008 filing date of P2 for failure to
`satisfy the requirements of § 112. Id. at 62 (“Because the Challenged
`Claims are not entitled to the benefit of the July 16, 2008 filing date of P2,
`their earliest possible priority date is April 19, 2013. As such, the
`Challenged Claims are anticipated under § 102(b) by the ’185 patent, which
`issued on August 9, 2011, more than one year prior to the earliest possible
`priority date of the Challenged Claims.”). Having found that the Petition
`raises the same arguments regarding § 112 as those previously considered by
`the Office, we now decide whether to exercise our discretion to deny
`institution under § 325(d).
`Our discretion under § 325(d) involves a balance between several
`competing interests. See Neil Ziegman, N.P.Z., Inc. v. Stephens, Case
`IPR2015-01860, slip op. at 12–13 (PTAB Feb. 24, 2016) (Paper 11). “On
`the one hand, there are the interests in conserving the resources of the Office
`and granting patent owners repose on issues and prior art that have been
`considered previously.” Fox Factory, Inc. v. SRAM, LLC, Case IPR2016-
`01876, slip op. at 7 (PTAB Apr. 3, 2017) (Paper 8). “On the other hand,
`
`
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`13
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`IPR2018-01287
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`there are the interests of giving petitioners the opportunity to be heard and
`correcting any errors by the Office in allowing a patent—in the case of an
`inter partes review—over prior art patents and printed publications.” Id.
`As discussed in Section II(B) above, Petitioner relies on substantially
`the same arguments with respect to whether P2 provides § 112 support for
`the challenged claims as those considered by the Examiner during the
`prosecution of the ’640 patent. Petitioner does not present any argument
`distinguishing the Office’s previous decisions on substantially the same
`issues or to provide a compelling reason why we should readjudicate
`substantially the same arguments considered by the Examiner during
`prosecution. Petitioner argues that the Examiner failed to provide an
`explanation as to why he agreed that there was adequate support in the
`application for L1 as a bond or amide, but does not point us to additional
`facts or evidence that would warrant our reconsideration of the arguments on
`the basis of Examiner error. 2 Pet. 33–35 (“[W]hile the Examiner ultimately
`did allow claims where L1 is a bond, no meaningful reasons were provided
`to explain the change in position or basis for this allowance.”). The
`Declaration of Phil S. Baran, Ph.D. (Ex. 1002), which Petitioner submitted
`to support the challenges presented in the Petition, does not provide
`additional evidence or facts that warrant reconsideration of the disclosures in
`
`
`2 We note that Petitioner also argues that “[t]he proper question is whether
`the entire claimed subject matter, including each specific selection of each of
`the variable (L1, R1, R2, R3, R4, m, and Ar) in combination as they appear in
`the Challenged Claims, was disclosed in P2.” Pet. 35. Given the
`Examiner’s thorough consideration of the § 112 support for L1 and Ar, we
`infer the Examiner did not consider such support to be lacking for the other
`listed variables.
`
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`P2 that are substantially the same as the disclosures already considered by
`the Office.
`We recognize that Petitioner has a direct interest in pursuing the
`instant Petition, but we also recognize the burden and expense to Patent
`Owner in having to defend the ’640 patent based on substantially the same
`arguments already considered by the Office. We find that the disclosures in
`P2 were substantively considered by the Examiner with respect to whether
`the challenged claims met the requirements of § 112, and that we have been
`shown no reason sufficient to reevaluate those disclosures with respect to
`any of the challenged claims. See Unified Patents Inc. v. John L. Berman,
`Case IPR2016-01571, slip. op. at 12 (PTAB Dec. 14, 2016) (Paper 10)
`(informative); see also Cultec, Inc. v. StormTech LLC, Case IPR2017-00777
`(PTAB Aug. 22, 2017) (Paper 7) (informative) (denying institution of inter
`partes review under § 325(d) because the same or substantially the same
`prior art or arguments previously were presented to the Office during
`prosecution); Hospira, Inc. v. Genentech, Inc., Case IPR2017-00739 (PTAB
`July 27, 2017) (Paper 16) (informative) (denying institution of inter partes
`review under § 325(d) because the Office already decided the dispositive
`issue of whether the asserted references qualified as prior art with respect to
`the challenged patent). Consequently, we exercise our discretion and
`decline to institute review of claims 1, 2, 4–6, 9, 11, and 12 under 35 U.S.C.
`§ 102 as anticipated by the ’185 patent.
`
`III. CONCLUSION
`Based on the arguments in the Petition and the Preliminary Response,
`and the evidence of record, we conclude that the instant Petition raises the
`
`
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`
`same or substantially the same arguments as those previously presented to
`and considered by the Office. In light of the circumstances of the present
`case, we exercise our discretion under 35 U.S.C. § 325(d) and decline to
`institute inter partes review of the ’640 patent.
`
`IV. ORDER
`In consideration of the foregoing, it is hereby
`ORDERED that the Petition is denied.
`
`
`
`
`PETITIONER:
`
`Robert H. Underwood
`MCDERMOTT WILL & EMERY LLP
`runderwood@mwe.com
`
`
`
`
`PATENT OWNER:
`
`Elizabeth Stotland Weiswasser
`Derek C. Walter
`Brian Chang
`WEIL, GOTSCHAL & MANGES LLP
`elizabeth.weiswasser@weil.com
`derek.walter@weil.com
`brian.chang@weil.com
`
`
`
`
`16
`
`
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