`571-272-7822
`
`
`
`
`
`
`Paper No. 9
`Entered: October 20, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
`
`WYETH LLC,
`Patent Owner.
`____________
`
`Case PGR2017-00016 (Patent 9,399,060)
`Case PGR2017-00017 (Patent 9,399,060)1
`____________
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`ULRIKE W. JENKS, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Post Grant Review
`35 U.S.C. § 324; 37 C.F.R. § 42.208
`
`
`1 This decision addresses issues common to both proceedings; therefore, we
`issue a single decision to be entered in each case. We refer to PGR2017-
`00016 as “PGR016” and PGR2017-00017 as “PGR017.” For convenience,
`unless otherwise noted, citations are to papers and exhibits filed in PGR016.
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`
`I. INTRODUCTION
`Petitioner filed a Petition for post grant review of claims 1–13 of U.S.
`Patent No. 9,399,060 (Ex. 1001, “the ’060 patent”). Paper 1 (“Pet.”). Patent
`Owner filed a timely Preliminary Response. Paper 8 (“Prelim. Resp.”).
`Based on the information presented in the Petition and the Preliminary
`Response, we hold that Petitioner has not demonstrated adequately that
`the ’060 patent is eligible for post grant review.
`Accordingly, we deny the Petition.
`
`Related Proceedings
`Petitioner identifies as related matters three Petitions for inter partes
`review of U.S. Patent No. 8,562,999 (“the ’999 patent”). Pet. 9 (citing Cases
`IPR2017-00378, IPR2017-00380, and IPR2017-00390). The claims in the
`’999 patent are directed to formulations containing polysaccharide-protein
`conjugates. The Board instituted trial in those three proceedings on June 13,
`2017.
`
`Petitioner states that it “is unaware of any other judicial or
`administrative matter that would affect, or be affected by, a decision in this
`proceeding.” Pet. 9. However, Petitioner filed three requests for inter partes
`review of the ’060 patent a few days after filing the instant Petition. See
`Cases IPR2017-01211, IPR2017-01215, and IPR2017-01223. Concurrently
`herewith, we issue decisions in those three related proceedings.
`
`
`
`
`The ‘060 Patent (Ex. 1001)
`The ’060 patent issued from Application No. 14/322,057 (“the ’057
`application”), filed on July 2, 2014. The ’057 application is a continuation of
`Application No. 13/439,111, filed April 4, 2012, now U.S. Patent No.
`8,808,708; which is a continuation of Application No. 12/357,853, filed
`
`2
`
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`January 22, 2009, now U.S. Patent No. 8,895,024; which is a continuation of
`Application No. 11/395,593, filed March 31, 2006, now abandoned; which
`claims the benefit of the filing date of U.S. Provisional Patent Application No.
`60/669,605, filed April 8, 2005. We collectively refer to the non-provisional
`applications, filed prior to the ’057 application, as “the non-provisional ’060
`parent applications.” That history is important because this case turns on
`whether Petitioner shows sufficiently that at least one claim has an effective
`filing date after March 16, 2013—a showing necessary to demonstrate that the
`’060 patent is eligible for post grant review. Pet. 49–63.
`The ‘060 patent, entitled “Multivalent Pneumococcal Polysaccharide-
`Protein Conjugate Composition,” relates to an immunogenic composition
`comprising polysaccharide-protein conjugates containing capsular
`polysaccharides prepared from different Streptococcus pneumoniae serotypes.
`Ex. 1001, Abstract. The different serotypes represented in the immunogenic
`composition include serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19 A, 19F,
`and 23 F. Id. We adopt the parties’ convention and refer to the 13-valent
`pneumococcal conjugate as the “13vPnC” vaccine. See, e.g., Pet. 1; Prelim.
`Resp. 32.
`The polysaccharides were obtained from S. pneumoniae cell cultures
`that were harvested and then lysed to release cell-associated polysaccharides
`into the culture medium. Id. at 11:25–12:10. The polysaccharide containing
`lysate was clarified by continuous flow centrifugation followed by
`microfiltration. Id. at 12:25–27. The purification of the pneumococcal
`polysaccharide consisted of several steps including: concentration/diafiltration
`operations, precipitation/elution, column chromatography, and depth filtration.
`Id. at 12:30–34. These steps were repeated for each individual serotype.
`
`
`
`
`3
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`
`The ’060 patent explains that the purified polysaccharides are
`chemically activated with sodium periodate so that they are able to chemically
`interact with the carrier protein in order to form a glycoconjugate. Id. at 8:1–
`3. The ’060 patent explains that “different serotype saccharides follow
`different pathways for activation (hydrolysis or no hydrolysis prior to [sodium
`periodate] activation) and conjugation (aqueous or DMSO2 reactions).” Id. at
`24:9–12. For example, the ’060 patent explains that for the serotype 1
`polysaccharide the chemical activation involves treating the purified
`polysaccharide with sodium carbonate to achieve partial deacetylation,
`followed by neutralization, and finally oxidation in the presence of sodium
`periodate. Id. at 13:50–56. For the serotype 3 polysaccharide the chemical
`activation process involves treating the purified polysaccharide with acetic
`acid to hydrolyze the polysaccharide, followed by adding sufficient
`magnesium chloride to achieve a final concentration of 0.1M, before
`proceeding to the oxidation step in the presence of sodium periodate. Id. at
`16:39–47. The serotype 19A polysaccharide activation process involves
`adding sodium acetate before reaching the oxidation step with sodium
`periodate. Id. at 21:19–22.
`The ’060 patent explains that the conjugation step involves lyophilizing
`the activated polysaccharide and then mixing in the lyophilized carrier
`CRM197 protein3 and reconstituting the dried components before adding the
`crosslinking agent. Id. at 14:7–12. The lyophilized polysaccharide and
`
`
`2 “DMSO” is dimethylsulfoxide. Ex. 1001, 19:14.
`3 CRM197 (Wyeth, Sanford, N.C.) is a non-toxic variant (i.e., toxoid) of
`diphtheria toxin isolated from cultures of Corynebacterium diphtheria strain
`C7 (β197) grown in casamino acids and yeast extract-based medium.
`Ex. 1001, 8:19–22.
`
`
`
`4
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`lyophilized CRM197 protein are reconstituted in either DMSO or in an aqueous
`buffer before proceeding to the conjugation reaction with sodium
`cyanoborohydride to obtain the polysaccharide-protein conjugate. Id. at 25:1–
`50, 26:28–52; see 16:58–67 (Example 4: Preparation of Serotype 3
`Pneumococcal Saccharide CRM197 Conjugate).
`The ’060 patent specification explains that the final immunogenic
`composition was formulated by combining the individual polysaccharide-
`CRM197 protein conjugates. The formulation contains 2–2.2 µg of each
`saccharide, except for 6B at 4–4.4 µg, approximately 29 µg CRM197 carrier
`protein; 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate)
`adjuvant, as well as sodium chloride and sodium succinate buffer as excipient.
`Id. at 3:9–15, 29:60–30:41.
`
`
`
`Illustrative Claims
`Claims 1 and 2, reproduced below, illustrate the subject matter:
`1.
` A multivalent
`immunogenic composition comprising
`polysaccharide-protein conjugates and a physiologically acceptable
`vehicle, wherein each of
`the conjugates comprises a capsular
`polysaccharide from a different serotype of Streptococcus pneumoniae
`conjugated to a carrier protein, wherein the serotypes comprise 4, 6B,
`9V, 14, 18C, 19F, 23F and at least one additional serotype, wherein the
`additional serotype is serotype 3, and wherein the carrier protein is
`CRM197.
`
`
`2. The immunogenic composition of claim 1, wherein the
`additional serotypes consist of serotypes 1, 3, 5, 6A, 7F and 19A.
`
`Ex. 1001, 35:16–26.
`
`Evidence Relied Upon
`Petitioner raises ten distinct grounds of unpatentability; six in PGR016
`
`(Pet. 10–11) and four in PGR017 (PGR017, Paper 1, 9). Our decision to deny
`
`
`
`
`5
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`the Petitions in both cases turns on a threshold question of whether the ’060
`patent is eligible for post grant review. Pet. 49–63; PGR017, Paper 1, 43–57.
`Petitioner raises essentially the same arguments and evidence in support of
`post grant review eligibility in both cases. Id. That common eligibility issue
`is dispositive and fully supports denial of both Petitions. Accordingly, we
`expressly decline to reach the merits of any ground of unpatentability asserted
`in PGR016 or PGR017.
`
`The Petition is supported by a declaration of Dennis L. Kasper, M.D.
`Ex. 1007; PGR107, Ex. 1008. Based on Dr. Kasper’s statement of
`qualifications and curriculum vitae, filed in each proceeding, for the purposes
`of this decision, we hold that he is qualified to opine from the perspective of a
`person of ordinary skill at the time of the invention. See Ex. 1007 ¶¶ 4–12;
`PGR017, Ex. 1008 ¶¶ 4–12 (Dr. Kasper’s statement of qualifications); see
`also Ex. 1007, Exhibit A; PGR017, Ex. 1008, Exhibit A (Dr. Kasper’s
`curriculum vitae).
`
`II. ANALYSIS
`Post grant review is available only for patents “described in
`
`section 3(n)(1)” of the Leahy-Smith America Invents Act (“AIA”), Pub L. No.
`112-29, 125 Stat. 284 (2011). AIA § 6(f)(2)(A). Those are patents that issue
`from applications “that contain[] or contained at any time . . . a claim to a
`claimed invention that has an effective filing date in section 100(i) of title 35,
`United States Code, that is on or after” “the expiration of the 18-month period
`beginning on the date of the enactment of” the AIA. Id. § 3(n)(1).
`Because the AIA was enacted on September 16, 2011, post grant review
`is available only for patents that issue from applications that, at one point,
`contained at least one claim with an “effective filing date,” as defined by 35
`
`
`
`
`6
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`U.S.C. § 100(i), on or after March 16, 2013. Our rules require a petitioner for
`post grant review to certify that the challenged patent is available for post
`grant review. 37 C.F.R. § 42.204(a) (“The petitioner must certify that the
`patent for which review is sought is available for post-grant review . . . .”).
`Petitioner includes the requisite certification, and further, asserts that each
`challenged claim has an effective filing date of July 2, 2014, which is the
`actual filing date of the ’057 application. Pet. 5, 9.
`
`Petitioner advances two independent arguments in support of a finding
`that at least one challenged claim of the ’060 patent has an effective filing date
`after March 16, 2013. First, Petitioner argues that none of claims 1–13 is
`enabled by any of the non-provisional ’060 parent applications; therefore,
`none can trace priority to a date earlier than the actual filing date of the ’057
`application. Pet. 51–61. Second, Petitioner argues that claims 8 and 13 lack
`written description support in any non-provisional ’060 parent application;
`accordingly, Petitioner argues that neither claim is entitled to priority through
`those applications. Pet. 62–63.
`We assess those two arguments in turn below. As an initial matter,
`however, we observe that no claim term requires express construction for
`purposes of this decision. See, e.g., Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only claim terms in controversy need
`be construed, and then only to the extent necessary to resolve the dispute).
`
`No Post Grant Review Eligibility
`Based on Lack of Enablement of Claims 1–13
`Petitioner’s first basis for asserting post grant review eligibility relates
`to enablement. In Petitioner’s view, claims 1–13 have an effective filing date
`after March 16, 2013, because none are enabled by any non-provisional ’060
`
`
`
`
`7
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`parent application. Pet. 51–61. Specifically, Petitioner argues that claim 1,
`upon which the other claims depend, is “open-ended” and, therefore,
`embraces multivalent immunogenic compositions having any number of the
`“nearly 100 pneumococcal serotypes” identified at the time of the invention—
`“so long as the composition includes the eight serotypes recited in the claim.”
`Pet. 51. Petitioner argues that none of the ’060 parent applications inform
`“how to construct a large fraction of the immunogenic pneumococcal
`conjugates captured by claim 1”; therefore, according to Petitioner, those
`applications fail to enable claim 1. Id. at 52 (citing Ex. 1007 ¶ 136).
`Petitioner also contends that the ’060 patent applications “provide no guidance
`as to the number and identity of serotypes that could be added to 13vPnC.”
`Id.
`
`The Petition is deficient, however, for failure to show sufficiently that a
`person of ordinary skill in the art could not identify the structure of any
`particular serotype without undue experimentation. Our reviewing court
`instructs that undue experimentation is analyzed by applying the factors set
`forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988). Petitioner unpersuasively
`argues that the Wands factors are “illustrative, not mandatory.” Pet. 50 (citing
`Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991)).
`For reasons stated by Patent Owner, notwithstanding the Amgen decision, the
`Wands factors are applicable in this case. Prelim. Resp. 16–17. Petitioner’s
`failure to adequately address the Wands factors supports denial of the
`Petitions in both IPR016 and IPR017.
`The Wands factors require an analysis that is focused on the guidance
`and working examples presented in the disclosure of the patent application at
`
`
`
`
`8
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`issue.4 Instead of providing a cogent analysis grounded in the Wands factors,
`including any guidance or working examples set forth in the ’060 parent
`applications, Petitioner generally refers to statements regarding
`unpredictability previously made by Patent Owner during prosecution of
`foreign counterparts of the ’060 patent, as well as statements made during
`domestic prosecution of a related patent application, which, Patent Owner
`counters, “are taken out of context.” Prelim. Resp. 20; see Pet. 52–54, 59.
`The Petition fails to explain satisfactorily how those statements regarding
`unpredictability of arriving at the claimed invention from the prior art rise to
`the level of admissions pertaining to the disclosures of the ’060 parent
`applications to enable the subject matter of any challenged claim. Nor does
`the Petition provide adequate reasons why those statements substitute for an
`analysis tethered to the Wands factors.
`Petitioner’s arguments relating to undue experimentation, moreover,
`rest on unsupported opinions of Dr. Kasper. For example, without citing any
`objective proof, Dr. Kasper opines that “[m]erely generating conjugates of
`serotypes of unknown polysaccharide structure would have required months
`of undue experimentation” and, for many serotypes, that endeavor “would
`have taken years.” Pet. 58 (Ex. 1007 ¶ 146). We agree with Patent Owner
`that neither Dr. Kasper nor Petitioner directs us to objective support for that
`naked opinion. Prelim. Resp. 17 (citing Ex. 1007 ¶ 146; Pet. 58). One’s
`expertise, even when draped with a skilled-artisan veil, does not entitle a
`
`4 Petitioner lists the Wands factors without addressing them adequately: “(1)
`the quantity of experimentation necessary, (2) the amount of direction or
`guidance presented, (3) the presence or absence of working examples, (4) the
`nature of the invention, (5) the state of the prior art, (6) the relative skill of
`those in the art, (7) the predictability or unpredictability of the art, and (8) the
`breadth of the claims.” Pet. 50 (quoting In re Wands, 858 F.2d at 737).
`
`9
`
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`naked opinion to much weight. See Ashland Oil, Inc. v. Delta Resins &
`Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual
`support for expert opinion going to factual determinations” is sufficient to
`“render the testimony of little probative value in a validity determination.”).
`Further, as Patent Owner observes, even if we accept Dr. Kasper’s
`“unsubstantiated calculation” regarding the length of time it would have taken
`an ordinary artisan to generate conjugated serotypes, Petitioner’s argument
`fails because “neither Dr. Kasper nor Petitioner explains why such
`experiments would be undue.” Prelim. Resp. 18; see Cephalon, Inc. v.
`Watson Pharms., Inc., 707 F.3d 1330, 1339 (Fed. Cir. 2013)
`(“Unsubstantiated statements indicating that experimentation would be
`‘difficult’ and ‘complicated’ are not sufficient” to show that the
`“experimentation would be undue.”). The test for enablement is “not merely
`quantitative.” PPG Indus. v. Guardian Indus. Corp., 75 F.3d 1558, 1564
`(Fed. Cir. 1996) (citation omitted). On the contrary, “a considerable amount
`of experimentation is permissible, if it is merely routine.” Id.
`Dr. Kasper’s opinion that claim 1 “covers over 4 million possible
`combinations,” when one selects additional serotypes from among “the top 30
`most prevalent serotypes,” does not withstand scrutiny. Pet. 52 (citing
`Ex. 1007 ¶ 135) (emphasis in original). Even Petitioner acknowledges that, at
`least as early as 1983, three serotypes (25, 16, and 24F) were recognized as
`most prevalent and, therefore, would have been understood as leading
`“candidates for a pneumococcal vaccine.” Pet. 56. Dr. Kasper does not
`explain “why generating conjugates for three serotypes would amount to
`undue experimentation.” Prelim. Resp. 18. Further, of the “nearly 100
`distinct pneumococcal serotypes” that “had been identified” at the time of the
`
`
`
`
`10
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`invention, there is agreement that 66 structures were known and only “34
`serotypes [structures] had not yet been reported.” Pet. 56 (citing Ex. 1055,
`Ex. 1060, 4–9); Prelim Resp. 18.
`Critically lacking in the Petition, moreover, is any showing that “the
`conjugation chemistry known in the prior art or taught in the ’060
`specification,” which is essentially identical to the disclosures of the ’060
`parent applications, “would not work for these and other serotypes.” Id. And
`the Petition lacks cogent argument sufficient to persuade us that Patent Owner
`was required to disclose in the ’060 parent applications every possible
`additional serotype that would have been immunogenic when conjugated with
`CRM197. In re Goffe, 542 F.2d 564, 567 (C.C.P.A. 1976) (“To demand that
`the first to disclose shall limit his claims to what he has found will work or to
`materials which meet the guidelines specified for ‘preferred’ materials . . .
`would not serve the constitutional purpose of promoting progress in the useful
`arts.”); see In re Fuetterer, 319 F.2d 259, 266 (C.C.P.A. 1963) (holding that to
`ask otherwise, would require the patent applicant “to do research on the
`‘literally thousands’ of inorganic salts and determine which of these are
`suitable for incorporation into his claimed combination, apparently forgetting
`that he has not invented, and is not claiming, colloid suspending agents but . . .
`a combination.”).
`Dr. Kasper’s conclusory statements do not support adequately
`Petitioner’s argument pertaining to undue experimentation, in view of the
`guidance and working examples reflected in the ’060 parent applications,
`which describe how to conjugate serotypes to CRM197 and, further, disclose
`tests to determine whether a resulting composition is immunogenic. Ex. 1001,
`
`
`
`
`11
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`4:23–33:4.5 On this record, and in the context of that disclosure, Petitioner
`fails to establish that claims 1–13 lack enablement in the ’060 parent
`applications. Pet. 49–61. The examples set forth in the ’060 parent
`applications provide adequate guidance enabling “the generation and
`characterization of a representative multivalent composition of the granted
`claims,” for example, “the specific 13-valent composition encompassed by
`claims 1–13.” Id. at 21; Ex. 1001, 11:25–28:67 (Examples 1–16).
`
`No Post Grant Review Eligibility Based on
`Lack of Written Description Support for Claims 8 and 13
`Petitioner also asserts post grant review eligibility based on the
`argument that claims 8 and 13 lack written description support in the non-
`provisional ’060 parent applications. Pet. 62–63. On that basis, Petitioner
`alleges that the effective filing date of claims 8 and 13 is the actual filing date
`of the ’057 application. Id. at 62. We address claims 8 and 13 in turn.
`Claim 8 requires the composition of claim 1, further comprising “one or
`more antigens.” Petitioner, in an attempt to persuade us of lack of written
`description support, directs us to content in the ’060 parent applications that
`describes in detail various antigens suitable for use in the invention. Pet. 62
`(quoting Ex. 1005, 22). Petitioner’s argument pertaining to lack of written
`description for the “antigens” of claim 8 is unpersuasive in view of the plain
`disclosure of the ’060 parent applications. See Ex. 1001, 10:47–11:15
`(providing ample written description support for the antigens of claim 8). In
`
`
`5 The parties agree that the non-provisional ’060 parent applications share
`essentially the same written description as the ’060 patent. Pet. 3; Prelim.
`Resp. 7. Accordingly, for ease of reference, we cite to the ’060 patent
`disclosure when assessing whether the disclosure of any ’060 parent
`application enables or supports the claims identified by Petitioner.
`
`12
`
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`light of the lengthy disclosure of suitable antigens set forth in the ’060 parent
`applications (id.), we agree with Patent Owner that Petitioner fails to show
`sufficiently a lack of written description support for the “antigens” of claim 8.
`Prelim. Resp. 25–27.
`Petitioner presents a similarly ineffective argument regarding claim 13,
`which depends from claim 1 and, further, specifies a composition “formulated
`as a single 0.5 ml dose comprising 2.2 μg of each polysaccharide, except for
`6B at 4.4 μg, and 125 μg aluminum phosphate adjuvant.” Ex. 1001, 36:26–
`29. The additional features of claim 13 are explicitly taught in the ’060 parent
`applications. Id. at 9:64–10:39, 29:58–30:67. For reasons stated by Patent
`Owner, we agree that Petitioner’s argument that the ’060 parent applications
`fail to support certain unclaimed features of the invention (such as buffer or
`protein concentrations (Pet. 63)) is meritless. Prelim. Resp. 27–29. Applying
`Petitioner’s logic, “omission from a claim of any detail set forth in the patent
`specification” would result in invalidity for lack of written description
`support, “without reference whatsoever to whether the detail” omitted from
`the claim would have been understood as conventional or routine to a person
`of ordinary skill in the art. Id. at 29.
`On this record, Petitioner fails to establish that claim 8 or 13 lacks
`written description support in the ’060 parent applications. Pet. 62–63.
`
`Other Arguments Supporting Denial of the Petition
`Patent Owner asserts that the Petition is defective for failure to address
`enablement, written description, and the level of skill in the art from the
`perspective of an ordinary artisan at the particular filing date of each non-
`provisional ’060 parent application. Prelim. Resp. 14–15. Specifically, Patent
`Owner directs us to Petitioner’s failure “to explain why the timeline for
`
`
`
`
`13
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`generating a conjugate of a serotype of unknown polysaccharide structure
`would remain unchanged at each of the filing dates of” those applications.
`Id. at 18. On that point, even Petitioner acknowledges that the level of
`ordinary skill in this particular field of endeavor, including one’s
`understanding of “the universe of clinically relevant serotypes,” would not
`“remain static” during the relevant span of time. Pet. 57 (quoting Ex. 1007
`¶ 144). Yet the Petition does not clearly articulate the level of ordinary skill in
`the art applicable at the time of filing for each of the ’060 parent applications
`filed before March 16, 2013. Instead, Petitioner focuses on the state of the art
`as of the earliest possible priority date of the non-provisional ’060 parent
`applications; namely, “April 8, 2005.” Pet. 11 (heading “A”). Petitioner’s
`failure to address each relevant date bolsters our holding that Petitioner fails to
`show sufficiently that the ’060 patent is post grant review eligible.
`Patent Owner further argues that the Examiner assigned the ’060 patent
`pre-AIA status during patent prosecution; therefore, in Patent Owner’s view,
`the patent should enjoy that same status in the context of post grant review.
`Prelim. Resp. 9–10 (citing non-binding Board decisions in which pre-AIA
`status assigned during patent prosecution was deemed probative of non-
`eligibility for post grant review). The ’060 patent, in fact, was assigned pre-
`AIA status and examined under pre-AIA first-to-invent provisions. Id. (citing
`Ex. 1002, 302 (checking “No” indication in the AIA status box)). That
`circumstance is consistent with our holding that Petitioner fails to demonstrate
`adequately that the ’060 patent is eligible for post grant review. See Mylan
`Pharms. Inc. v. Yeda Research & Dev. Co. Ltd., PGR2016-00010, Paper 9, 7
`(PTAB Aug. 15, 2016) (Examiner’s acknowledgement during prosecution that
`
`
`
`
`14
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`a patent application is entitled to a pre-AIA priority date may be a factor
`supporting a finding that the patent is ineligible for post grant review).
`Finally, Patent Owner contends that only patents that claim “new”
`subject matter, added by amendment on or after March 16, 2013, are eligible
`for post grant review—that is, “new” relative to any claim submitted in a
`parent application—and that the Petition is deficient for failure to address that
`issue. Prelim. Resp. 8, 11–12. On that basis, Patent Owner asserts that the
`Board is compelled to deny the Petition because the AIA was never intended
`to apply to “transition” or “straddle” patents such as the ’060 patent. Id. We
`decline to reach that issue because other deficiencies in the Petition, discussed
`above, are dispositive and fully support our decision to deny institution of post
`grant review.
`
`III. CONCLUSION
`Based on the information in the Petition and the Preliminary Response,
`
`we hold that Petitioner has not demonstrated adequately that the ’060 patent is
`eligible for post grant review.
`
`IV. ORDER
`
`It is
`ORDERED that the Petition is denied and no trial is instituted.
`
`
`
`
`
`
`15
`
`
`
`PGR2017-00016 (Patent 9,399,060)
`PGR2017-00017 (Patent 9,399,060)
`
`PETITIONER:
`Arlene L. Chow
`Ernest Yakob
`HOGAN LOVELLS US LLP
`arlene.chow@hoganlovells.com
`ernest.yakob@hoganlovells.com
`
`PATENT OWNER:
`John Scheibeler
`Dimitrios T. Drivas
`WHITE & CASE LLP
`jscheibeler@whitecase.com
`ddrivas@whitecase.com
`
`
`
`
`16
`
`