Trials@uspto.gov
`571-272-7822
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` Paper No. 13
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`Entered: April 19, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`ADELLO BIOLOGICS LLC,
`APOTEX INC. and APOTEX CORP.,
`Petitioners,
`v.
`AMGEN INC. and AMGEN MANUFACTURING LIMITED
`Patent Owner.
`
`
`
`
`
`
`
`Case PGR2019-00001
`Patent No. 9,856,287 B2
`____________
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`J. JOHN LEE, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Post-Grant Review
`35 U.S.C. § 324(a)
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`571-272-7822
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` Paper No. 13
`
`Entered: April 19, 2019
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`ADELLO BIOLOGICS LLC,
`APOTEX INC. and APOTEX CORP.,
`Petitioners,
`v.
`AMGEN INC. and AMGEN MANUFACTURING LIMITED
`Patent Owner.
`
`
`
`
`
`
`
`Case PGR2019-00001
`Patent No. 9,856,287 B2
`____________
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`J. JOHN LEE, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Post-Grant Review
`35 U.S.C. § 324(a)
`
`
`
`
`
`
`
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`
`INTRODUCTION
`Adello Biologics, LLC, Apotex Inc., and Apotex Corp. (collectively
`“Petitioners”) filed a Petition (Paper 3, “Pet.”), requesting a post-grant
`review of claims 1–30 of U.S. Patent No. 9,856,287 B2 (Ex. 1001, “the ’287
`patent”). Amgen Inc. (“Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 8 (“Prelim. Resp.”).
`We review the Petition under 35 U.S.C. § 324, which provides that a
`post-grant review may not be instituted unless “it is more likely than not that
`at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C.
`§ 324(a). On April 24, 2018, the Supreme Court held that a decision under
`35 U.S.C. § 314 may not institute review on fewer than all claims challenged
`in the petition.1 SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018).
`Moreover, “if the PTAB institutes a trial, the PTAB will institute on all
`challenges raised in the petition.” See Guidance on the Impact of SAS on
`AIA Trial Proceedings (April 26, 2018) (“USPTO Guidance,” available at
`https://www.uspto.gov/patents-application-process/patent-trial-and-
`appealboard/trials/guidance-impact-sas-aia-trial).
`For the reasons provided below, we determine that Petitioners have
`satisfied the threshold requirement under § 324. Thus, based on the
`information presented, and under SAS and USPTO Guidance, we institute a
`post-grant review of claims 1–30 of the ’287 patent.
`
`
`1 Even though SAS addresses inter partes reviews, we see no reason to
`interpret the statute governing post-grant reviews differently.
`2
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`PGR2019-00001
`Patent No. 9,856,287 B2
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`
`Related Proceedings
`According to the parties, the ’287 patent is the subject of Amgen Inc.
`v. Adello Biologics LLC, Case No. 2:18-03347 (D.N.J.) and Amgen Inc. v.
`Apotex Inc., Case No. 0:18-61828 (S.D. Fla). Pet. 3; Paper 4, 2.
`The ’287 Patent
`The ’287 patent issued on January 2, 2018, from U.S. Patent
`Application No. 15/422,327 (“the ’327 application”), filed February 1, 2017.
`Ex. 1001, (21), (22), (45). On its face, the ’287 patent claims priority to,
`among others, U.S. Application No. 12/820,087 (“the ’087 application”),
`issued as U.S. Patent No. 8,952,138 (Ex. 1004, “the ’138 patent”).2 Id. at
`1:5–12.
`The ’287 patent discloses a method of refolding proteins expressed in
`non-mammalian cells. Ex. 1001, 2:62–64.
`The ’287 patent explains:
`Recombinant proteins can be expressed in a variety of expression
`systems, including non-mammalian cells, such as bacteria and
`yeast. A difficulty associated with the expression of recombinant
`proteins in prokaryotic cells, such as bacteria, is the precipitation
`of the expressed proteins in limited-solubility intracellular
`precipitates typically referred to as inclusion bodies.
`Id. at 1:23–29.
`Before the ’287 patent, “various methods ha[d] been developed for
`obtaining correctly folded proteins from bacterial inclusion bodies.” Id. at
`1:41–43. Specifically, it was known that when cysteine residues are present
`in the protein sequence, “it is often necessary to accomplish the refolding in
`
`2 Previously, the Board concluded that claims 1–17 and 19–24 of the ’138
`patent are unpatentable. Apotex Inc. v. Amgen Inc., IPR2016-01542, Paper
`60 (PTAB Feb. 15, 2018).
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`3
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`Patent No. 9,856,287 B2
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`an environment which allows correct formation of disulfide bonds (e.g., a
`redox system).” Id. at 1:53–57.
`The ’287 patent states that prior-art methods could not refold complex
`molecules, such as molecules comprising two or more disulfide bonds, at
`high concentrations, “with any meaningful degree of efficiency on a small
`scale, and notably not on an industrial scale.” Id. at 1:58–60, 2:25–29.
`According to the ’287 patent, the methods disclosed therein can refold
`proteins at high concentrations and at large scales, which translates into
`higher efficiencies and cost savings to a protein production process. Id. at
`2:29–39.
`
`Illustrative Claim
`Among the challenged claims, claims 1, 10, 16, and 26 are
`independent. Claims 1 and 16 are illustrative. They read:
`1.
`A method of refolding proteins expressed in a non-
`mammalian expression system, the method comprising:
`contacting the proteins with a preparation that supports the
`renaturation of at least one of the proteins to a biologically
`active form, to form a refold mixture, the preparation
`comprising:
`at least one ingredient selected from the group consisting of a
`denaturant, an aggregation suppressor and a protein
`stabilizer;
`an amount of oxidant;
`and an amount of reductant,
`wherein the amounts of the oxidant and the reductant are
`related through a thiol-pair ratio and a thiol-pair buffer
`strength,
`wherein the thiol-pair ratio is in the range of 0.001-100; and
`wherein the thiol-pair buffer strength maintains the solubility
`of the preparation; and
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`4
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`incubating the refold mixture so that at least about 25% of the
`proteins are properly refolded.
`16. A method of refolding proteins expressed in a non-
`mammalian expression system, the method comprising:
`preparing a solution comprising:
`the proteins;
`at least one ingredient selected from the group consisting of a
`denaturant, an aggregation suppressor and a protein
`stabilizer;
`an amount of oxidant;
`and an amount of reductant,
`wherein the amounts of the oxidant and the reductant are
`related through a thiol-pair ratio and a thiol-pair buffer
`strength,
`wherein the thiol-pair ratio is in the range of 0.001-100; and
`wherein the thiol-pair buffer strength maintains the solubility
`of the solution; and
`incubating the solution so that at least about 25% of the
`proteins are properly refolded.
`Each of claims 10 and 26 requires that “about 30–80% of the proteins
`are properly refolded.” They are otherwise similar to claims 1 and 16,
`respectively.
`
`Prosecution History
`“At Least About 25% of the Proteins Are Properly Refolded”
`Each of claims 1 and 16 recites “at least about 25% of the proteins are
`properly refolded.” This language does not appear in any application in the
`priority chain. Instead, in a preliminary amendment filed on February 2,
`2017, the applicant added new claims including the language “wherein the
`thiol-pair ratio and the thiol-pair buffer strength yield at least about 25%
`properly refolded protein.” Ex. 2008, 82. The applicant later amended the
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`claims to recite “wherein the thiol-pair ratio and the thiol-pair buffer strength
`are such that incubating the refold mixture achieves consistent yields of at
`least about 25% properly refolded proteins.” Id. at 153.
`The examiner rejected the new claims “under 35 U.S.C. § 112, first
`paragraph, as containing new matter which was not described in the
`specification.” Id. at 844. Specifically, the examiner stated that “[t]he
`specification or the original claims as filed does not provide a written
`description the phrase ‘. . . refold mixture achieves consistent yield of at
`least 25% properly refolded proteins.’” Id. The examiner also rejected the
`new claims for “nonstatutory obviousness-type double patenting as being
`unpatentable over claims 1–24” of the ’138 patent. Id. at 843.
`In response, the applicant filed a terminal disclaimer to obviate the
`double-patenting rejection over the ’138 patent. Id. at 900–01. The
`applicant also amended the claims to recite “incubating the refold mixture so
`that at least about 25% of the proteins are properly refolded.” Id. at 876, see
`also id. at 880 (adding new claim reciting “incubating the solution so that at
`least about 25% of the proteins are properly refolded”).
`The applicant further argued that “[t]he specification provides support
`for claimed subject matter.” Id. at 885. According to the applicant, “Figures
`1A–1F represent a series of experiments where thiol pair buffer strength and
`thiol-pair ratio were varied and the % species distribution (y-axis) was
`determined. In each case, at least 25% properly refolded protein (solid lines)
`was achieved and was achieved on a consistent basis.” Id. In addition, the
`applicant pointed out that “Example 3 describ[e]s protein refolding wherein
`approximately 30–80% properly refolded protein was obtained.
`Specifically, page 23 states that ‘[y]ields of desired product of
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`approximately 30–80% were obtained . . . depending on the redox condition
`evaluated.’” Id.
`Thereafter, the examiner allowed the claims, stating:
`Upon approval of the terminal disclaimer filed on 9/8/17, the
`nonstatutory obviousness type double patenting rejections have
`been withdrawn.
`. . . Further, the rejection under 35 U.S.C. 112 first paragraph has
`been withdrawn upon entry of response filed on 9/8/17. The
`support for the new matter rejection is found in p. 13, 23 and
`Fig 1A–F of the specification[.]
`Id. at 911.
`Prior Art
`During prosecution, the examiner also rejected then-pending claims as
`obvious over the combination of Schlegl3 and Hevehan,4 two of the
`references asserted in this proceeding. Ex. 2008, 125–26. In response, the
`applicant argued that because “Schlegl discloses that redox chemicals are
`optional for refolding” of the purified model protein bovine -LA,
`Schlegl fails to disclose that the amounts of the oxidant and the
`reductant are related through a thiol-pair ratio and a thiol-pair
`buffer strength. Also, Schlegl fails to disclose that the thiol-pair
`buffer strength maintains the solubility of the preparation and is
`effected based on a desired amount yield of properly refolded
`protein. Further, Schlegl fails to disclose that the thiol-pair ratio
`and the thiol-pair buffer strength are such that incubating the
`refold mixture achieves consistent yields of at least about 25%
`properly refolded proteins.
`
`
`3 Schlegl, U.S. Patent Publication No. 2007/0238860, published October 11,
`2007 (Ex. 1007).
`4 Hevehan and Clark, Oxidative Renaturation of Lysozyme at High
`Concentrations, 54 BIOTECHNOL BIOENG 221–30 (1997) (Ex. 1024).
`7
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`Patent No. 9,856,287 B2
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`Id. at 165. Hevehan, the applicant continued, does not overcome these
`deficiencies of Schlegl. Id.
`The examiner agreed and, thus, withdrew the obviousness rejection.
`Id. at 842. In allowing the claims, the examiner stated that “the most
`pertinent prior art neither teaches nor suggests the final thiol-pair ratio or
`strength as set forth in [the] claims.” Id. at 911.
`Asserted Grounds of Unpatentability
`Petitioners assert the following grounds of unpatentability:
`1.
`claims 1–9 and 16–25 are unpatentable under 35 U.S.C. § 112
`for lack of adequate written-description support;
`2.
`claims 1–305 are unpatentable under 35 U.S.C. § 112 for lack of
`enablement;
`3.
`claims 1–4, 7–19, and 22–30 are unpatentable under 35 U.S.C.
`§ 102(a)(1) as anticipated by Vallejo;6
`4.
`claims 1–4, 8–19, and 23–30 are unpatentable under 35 U.S.C.
`§ 102(a)(1) as anticipated by Schlegl;
`5.
`claims 7 and 22 are unpatentable under 35 U.S.C. § 103 as
`obvious over Schlegl and Vallejo;
`
`
`5 Although the chart of the asserted grounds lists only claims 1–9 and 16–25
`as not enabled, the text of the Petition addresses all challenged claims under
`this ground. See Pet. 33–36 (arguing lack of enablement for “about 30–80%
`of the proteins are properly refolded”).
`6 Vallejo et al., European Patent Application Pub. No. EP1449848 A1,
`published August 25, 2004 (Ex. 1038).
`8
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`6.
`claims 1–4, 7–19, and 22–30 are unpatentable under 35 U.S.C.
`§ 103 as obvious over Ruddon7 and Vallejo;
`7.
`claims 5, 6, 20, and 21 are unpatentable under 35 U.S.C. § 103
`as obvious over Vallejo and Hevehan; and
`8.
`claims 1–15 are unpatentable under 35 U.S.C. § 112 for
`indefiniteness.
`In support of their patentability challenge, Petitioners rely on the
`Declaration of Anne S. Robinson, Ph.D. Ex. 1002.
`ANALYSIS
`Real Party in Interest
`Patent Owner argues that we should deny the Petition because
`Petitioners fail to––in the Petition––name Amneal Pharmaceuticals LLC
`(“Amneal LLC”) as a real party in interest. Prelim. Resp. 7–16.
`The Petition identifies, in addition to Petitioners, Amneal
`Pharmaceuticals, Inc. (“Amneal Inc.”), Apotex Pharmaceuticals Holdings
`Inc., Apotex Holdings, Inc., ApoPharma USA, Inc., and Intas
`Pharmaceuticals Limited as real parties in interest. Pet. 2. Petitioners later
`sought to amend their mandatory notices to add Amneal LLC as a real party
`in interest without altering the petition filing date. Paper 9. Patent Owner
`opposed Petitioners’ request. Paper 10. Because we found Petitioners’
`delay in identifying all real parties in interest did not result in undue
`prejudice against Patent Owner, we exercised our discretion under 37 C.F.R.
`§ 42.5(b) to allow Petitioners to add Amneal LLC as a real party in interest
`
`
`7 Ruddon et al, International Publication No. WO 95/32216, published
`November 30, 1995 (Ex. 1040).
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`Patent No. 9,856,287 B2
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`while maintaining the original filing date. Paper 11. Thereafter, Petitioners
`added Amneal LLC as a real party in interest. Paper 12. Thus, we decline to
`deny the Petition for delayed identification of a real party in interest.
`35 U.S.C. § 325(d)
`Patent Owner asks us to exercise our discretion and deny the Petition
`under 35 U.S.C. § 325(d). Prelim. Resp. 17–31. We decline to do so.
`Under the statute, in determining whether to institute an inter partes
`review, we “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.” 35 U.S.C. § 325(d).
`According to Patent Owner, “the written description and enablement
`arguments on which Petitioners stake their entire argument for PGR
`standing were previously considered by the original Examiner who allowed
`the claims of the ’287 [patent].” Prelim. Resp. 17. We are not persuaded.
`We acknowledge that an issue of whether there was sufficient written
`description was addressed during prosecution with respect to the limitation
`“to consistently yield at least about 25% properly refolded protein . . . refold
`mixtures achieves consistent yield of at least 25% properly refolded
`proteins.” Ex. 2008, 844. But the issued claims of the ’287 patent do not
`require a “consistent yield,” and it is not clear from the prosecution history
`that the examiner sufficiently considered whether the broader language of
`the issued claims also satisfies the written description requirement.
`Moreover, as Patent Owner acknowledges, “there was no express
`discussion of enablement during prosecution.” Prelim. Resp. 23. And as
`explained below, based on the evidence included with the Petition (including
`expert declaration evidence that was not before the Examiner), Petitioners
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`Patent No. 9,856,287 B2
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`have shown that it is more likely than not that they would prevail in the
`enablement challenge. Under the circumstances, we decline to deny
`institution under §325(d) based on the written-description and enablement
`arguments presented in the Petition.8
`Patent Owner also contends that the prior art Petitioners assert in this
`proceeding, as well as the arguments based thereon, are either identical to or
`substantially the same as those already considered and rejected by the
`examiner. Id. at 24–31. We are not persuaded by this argument either.
`We acknowledge that during prosecution, the examiner rejected then-
`pending claims as obvious over the combination of Schlegl and Hevehan.
`Ex. 2008, 125–26. But Patent Owner does not dispute that Ruddon was not
`cited, let alone considered, during prosecution. In addition, Vallejo asserted
`in this proceeding (Ex. 1038) was not cited during prosecution either. Patent
`Owner, however, argues that a similar reference by the same author
`(Ex. 1014) “was considered and expressly acknowledged by the Examiner
`during prosecution of the ’287 as part of an Information Disclosure
`Statement (IDS) by Amgen.” Prelim. Resp. 26. The IDS, however, listed
`hundreds of references, and there is nothing of record to suggest that the
`Examiner considered Exhibit 1014 in particular in determining patentability.
`Ex. 2008, 135–150. Thus, under the circumstances, we do not consider the
`Examiner’s mere acknowledgement of the IDS as a sufficient basis to
`warrant denial of institution under § 325(d). See Becton-Dickinson, slip op.
`
`
`8 The factors set forth in Becton, Dickinson & Co. v. B. Braun Melsungen
`AG, Case IPR2017-01586, Paper No. 8 (PTAB Dec. 15, 2007) (informative)
`(“Becton-Dickinson”) are not relevant to our § 325(d) analysis here because
`they each focus on prior art considered during prosecution.
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`at 17 (identifying “the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for rejection”
`among non-exclusive factors to be considered under § 325(d)).
`Thus, under the circumstances of this case, we decline to deny the
`Petition under 35 U.S.C. § 325(d).
`Level of Ordinary Skill
`Petitioners propose that an ordinary artisan “would have at least a
`Bachelor’s degree (or the equivalent) in biochemistry or chemical
`engineering with several years’ experience in biochemical manufacturing,
`protein purification, and protein refolding, or alternatively, an advanced
`degree (Masters or Ph.D.) in biochemistry or chemical engineering with
`emphasis in these same areas.” Pet. 14 (citing Ex. 1002 ¶¶ 18–19). Patent
`Owner does not dispute, and we adopt, for purposes of this Decision,
`Petitioners’ proposed definition of level of skill.
`We further note that, in this case, 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)).
`Eligibility for Post-Grant Review
`The post-grant review provisions apply only to a patent that contains a
`claim with an effective filing date on or after March 16, 2013. See Leahy-
`Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284
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`(2011), §§ 3(n)(1), 6(f)(2)(A). The statute defines the “effective filing date”
`as
`
`(A) if subparagraph (B) does not apply, the actual filing date of
`the patent or the application for the patent containing a claim to
`the invention; or
`(B) the filing date of the earliest application for which the patent
`is entitled, as to such invention, to a right of priority under section
`119, 365(a), or 365(b) or to the benefit of an earlier filing date
`under section 120, 121, or 365(c).
`35 U.S.C. § 100(i)(1).
`Entitlement to the benefit of an earlier date under §§ 119, 120, 121,
`and 365 is premised on disclosure of the claimed invention in the manner
`provided by § 112(a) (other than the requirement to disclose the best mode)
`in the application for which the benefit of the earlier filing date is sought.
`See 35 U.S.C. §§ 119(e), 120.
`The ’287 patent issued from the ’327 application, filed February 1,
`2017. Ex. 1001, (22). On its face, the ’287 patent claims priority to two
`pre-2013 applications: a provisional application filed on June 22, 2009, and
`the ’087 application, filed June 21, 2010, which issued as the ’138 patent.
`Id. at 1:5–12. Petitioners argue that “at least claims 1–9 and 16–25 were not
`fully disclosed until added via amendments to the claims of the [’]287 patent
`application, and claims 1–30 were not enabled.” Pet. 26. As a result,
`Petitioners conclude that the challenged claims “are not entitled to claim
`priority to any application with a filing date prior to March 16, 2013, the
`critical date for the AIA, and the [’]287 Patent is eligible for post-grant
`review.” Id. at 24–25. Based on the current record, and for the reasons
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`below, we determine Petitioners have sufficiently established that it would
`prevail in this assertion.9
`The written-description inquiry is a question of fact, is context-
`specific, and must be determined on a case-by-case basis. Ariad Pharm.,
`Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The
`test for sufficiency of support is whether the disclosure of the application
`relied upon “reasonably conveys to the artisan that the inventor had
`possession at that time of the later claimed subject matter.” Vas–Cath Inc. v.
`Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). Of course, in some
`instances, a patentee can rely on information that is well known in the art to
`satisfy the written-description requirement. Ariad Pharm., 598 F.3d at 1351
`(“[T]he level of detail required to satisfy the written-description requirement
`varies depending on the nature and scope of the claims and on the
`complexity and predictability of the relevant technology.”).
`Each of independent claims 1 and 16 recites “at least about 25% of the
`proteins are properly refolded.” Petitioners point out that “[t]his claim
`language, or even the range of ‘at least about 25%,’ does not appear
`anywhere in the [’]138 patent specification, or the specifications of the
`intervening priority applications.” Pet. 28. Indeed, as explained earlier, this
`language was added after February 1, 2017, the filing date of the ’327
`application. Ex. 2008, 82, 153, 876, 880. During prosecution, when the
`examiner rejected the language “at least 25% properly refolded proteins” in
`
`
`9 Either insufficient written description or non-enablement would render the
`’287 patent eligible for post-grant review. We focus our analysis of review
`eligibility on written description, and discuss non-enablement later in
`analyzing the patentability of the challenged claims.
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`the then-pending claims as new matter, the applicant argued that Figures 1a–
`1f and Example 3 provided written-description support. Id. at 885.
`Petitioners contend that the figures fail to provide adequate support
`for the full scope of claims 1 and 16. Pet. 18. According to Petitioners, in
`Figures 1a–1f of the ’138 patent,10 the percentage of properly refolded
`protein species, which the applicant argued is represented by the solid lines,
`“never rises above about 35%, and in fact is often lower than 25%.” Id.
`at 29.
`
`Examples 3 and 4 of the ’138 patent disclose refolding yields of
`“approximately 30–80%” and “approximately 27–35%,” respectively.
`Ex. 1004, 15:8–10, 64–65. Petitioners argue that even so, the priority
`applications do not provide support for the full scope of “at least about 25%”
`because they “provide no disclosure for any percentages of properly refolded
`protein over 80%.” Pet. 30.
`Patent Owner faults Petitioners for not explaining whether and why
`the term “so that at least about 25% of the proteins are properly refolded” is
`limiting. Prelim. Resp. 33–37. For purposes of this Decision, we do not
`need to resolve this issue. Generally, whether certain language in a claim is
`“limiting” or not is considered when evaluating the scope of the claim as
`compared to the prior art, or in analyzing infringement. But neither issue is
`presented here. Instead, we are called upon to determine whether the
`
`
`10 The parties agree that the challenged ’287 patent and the priority
`applications, including the one issued as the ’138 patent, “share a common
`specification, varying only in the claims, assertions of priority, and non-
`material corrections.” Pet. 23 n.3, 32; Prelim. Resp. 78. In analyzing the
`priority date of the challenged claims, we cite to the ’138 patent, filed before
`March 16, 2013.
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`priority applications provide written description for the term “so that at least
`about 25% of the proteins are properly refolded.” Even assuming the term is
`not limiting, the cases Patent Owner cited (see Prelim. Resp. 33–37) do not
`stand for the proposition that written-description support under § 112 is
`unnecessary for what is explicitly recited in a claim. Thus, we determine
`that, for purposes of this Decision, claims 1–9 and 16–25 are entitled to the
`pre-2013 priority date only if the priority applications provide written-
`description support for the term “so that at least about 25% of the proteins
`are properly refolded.”
`Also, Petitioners equate “at least about 25%” with “25%–100.”
`Pet. 28. Patent Owner challenges that (1) “Petitioners never addressed the
`claims’ ‘at least about’ language, and do not explain why this range would
`start at exactly 25%” (Prelim. Resp. 37), and (2) Petitioners do not explain
`whether or why an ordinary artisan “would purportedly have understood the
`claimed range for refolding achieved in the claim to include ‘100%’”11 (id.
`at 38). For purposes of this Decision, we do not need to resolve these issues
`either. Petitioners acknowledge that Figures 1a–1f show the percentage of
`properly refolded species “is often lower than 25%,” and Example 4
`discloses refolding yields of “approximately 27–35%.” Pet. 29. Instead,
`Petitioners argue that “the priority applications provide no disclosure for any
`
`
`11 Patent Owner questions whether an ordinary artisan “would have
`understood this term [‘at least about 25%’] to have had an upper limit, even
`if not precisely known.” Prelim. Resp. 38. We are not persuaded by this
`unsupported attorney argument.
`
`16
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`percentages of properly refolded protein over 80%,” such as 85%, 90%, or
`95%. Id. at 30 (emphasis added), 36.12
`Patent Owner contends that the law does not require “explicit
`examples in the specification across the entire range of the results recited” in
`the claim. Prelim. Resp. 44. Patent Owner is correct. See Cordis Corp. v.
`Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003) (explaining that
`a specification may “contain a written description of a broadly claimed
`invention without describing all species that [the] claim encompasses”).
`When there is substantial variation within the genus, however, a sufficient
`variety of species must be described to reflect the variation within the genus.
`See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759
`F.3d 1285, 1300 (Fed. Cir. 2014).
`Based on the current record, we are persuaded that the percentage of
`properly refolded proteins disclosed in Figures 1a–1f and Examples 3 and 4
`of the ’138 patent do not constitute a representative number of species
`within the genus of “at least about 25%.” As Petitioners argue, “the priority
`applications provide no disclosure for any percentages of properly refolded
`protein over 80%.” Pet. 30. Dr. Robinson, Petitioners’ expert, testifies that
`“[t]he higher the percentage of properly folded protein sought, the more
`difficult that percentage is to achieve.” Ex. 1002 ¶ 83. And the
`specification of the ’138 patent, Petitioners argue, “provides no indication
`
`
`12 To the extent that Patent Owner asks us to deny the Petition simply
`because Petitioners do not address the term “at least about 25%” under the
`claim-construction section, we decline to do so. See Vivid Techs., Inc. v.
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (explaining that
`“only those terms need be construed that are in controversy, and only to the
`extent necessary to resolve the controversy”).
`17
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`that the inventors had possession of any percentages of properly refolded
`proteins at the higher end of the range” of “at least about 25%.” Pet. 31.
`At this stage, Petitioners have shown sufficiently that the ’138 patent
`does not provide adequate written description for “at least about 25% of the
`proteins are properly refolded,” and thus, claims 1–9 and 16–25 of the ’287
`patent are not entitled to a priority date before March 16, 2013.
`Accordingly, based on the current record, we determine that the ’287 patent
`is eligible for post-grant review.13
`The Written-Description Ground
`Petitioners argue that claims 1–9 and 16–25 are unpatentable under 35
`U.S.C. § 112(a) because the specification of the ’287 patent does not provide
`adequate written-description support. Pet. 32–33. The parties agree that the
`’138 patent and the ’287 patent “share a common specification.” Pet. 32;
`Prelim. Resp. 78. Thus, for the same reason explained above, we are
`persuaded that, based on the current record, it is more likely than not that
`claims 1–9 and 16–25 are unpatentable under 35 U.S.C. § 112(a) because the
`specification of the ’287 patent does not provide adequate written-
`description support for “at least about 25% of the proteins are properly
`refolded,” as recited in those claims.
`The Enablement Ground
`The test of enablement is “whether one reasonably skilled in the art
`could make or use the invention from the disclosures in the patent coupled
`
`
`13 Other requirements for post-grant review are satisfied also. The Petition
`was filed on October 1, 2018 (Paper 6, 1), within nine months of the grant of
`the ’287 patent. See 35 U.S.C. § 321(c). Petitioners further certify that they
`have standing to seek post-grant review of the ’287 patent. Pet. 2.
`18
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`with information known in the art without undue experimentation.” United
`States v. Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988). Whether
`undue experimentation is needed is not a single, simple factual
`determination, but rather is a conclusion reached by weighing many factual
`considerations. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). These
`factors include, for example, the nature of the invention, the state of the prior
`art, the level of one of ordinary skill, the level of predictability in the art, and
`the amount of direction provided by the inventor. Id.
`Petitioners contend that claims 1–30 are unpatentable under 35 U.S.C.
`§ 112(a) because the specification of the ’287 patent fails to comply with the
`enablement requirement. Pet. 33–36. Petitioners argue that “[t]he
`challenged claims have a broad scope.” Id. at 34. According to Petitioners,
`“[t]he claims recite that the thiol-pair ratio is in the range of 0.001-100, and
`do not place a numerical limit on the thiol-pair buffer strength, resulting in a
`vast number of possible redox conditions. Nor do claims 1, 10, 16 and 26
`place any limitation on the proteins to be refolded.” Id.
`Each of independent claims 1 and 16 recites “at least about 25% of the
`proteins are properly refolded,” and each of independent claims 10 and 26
`recites “about 30–80% of the proteins are properly refolded.” Petitioners
`assert that because of “the vast number of proteins and redox conditions
`covered by the claims,” the specification of the ’287 patent provides
`insufficient guidance as to how to achieve the claimed ranges. Id.
`According to Petitioners, “[a] POSA could not replicate the percentages of
`properly refolded specie
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