Trials@uspto.gov
`571-272-7822
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` Paper No. 14
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`Entered: November 16, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
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`v.
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`PARAGON BIOTECK, INC.,
`Patent Owner.
`____________
`
`Case PGR2015-00011
`Patent 8,859,623 B1
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
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`YANG, Administrative Patent Judge.
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`
`
`
`DECISION
`Institution of Post-Grant Review
`37 C.F.R. § 42.208
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`571-272-7822
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` Paper No. 14
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`Entered: November 16, 2015
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`____________
`
`Case PGR2015-00011
`Patent 8,859,623 B1
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Post-Grant Review
`37 C.F.R. § 42.208
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`PGR2015-00011
`Patent 8,859,623 B1
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`INTRODUCTION
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`Altaire Pharmaceuticals, Inc. (“Petitioner”) filed a Petition for a post-
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`grant review of claims 1–13 of U.S. Patent No. 8,859,623 B1 (“the ’623
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`patent,” Ex. 1001). Paper 1 (“Pet.”). Paragon Bioteck, Inc. (“Patent
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`Owner”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”).
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`Thereafter, at our request (Paper 8), Petitioner filed a Reply, addressing the
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`issue of whether the Petition properly identifies all real parties in interest
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`(Paper 11). We have jurisdiction under 35 U.S.C. § 324, which provides
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`that post-grant review shall not be instituted unless it is determined that “the
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`information presented in the petition filed under section 321, if such
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`information is not rebutted, would demonstrate that it is more likely than not
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`that at least 1 of the challenged claims in the petition is unpatentable.”
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`35 U.S.C. § 324(a).
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`For the reasons provided below, we determine that Petitioner has
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`demonstrated that it is more likely than not that at least one claim of the ’623
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`patent is unpatentable. Because Petitioner has satisfied the threshold
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`requirement set forth in 35 U.S.C. § 324(a), we institute a post-grant review
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`of claims 1–13 of the ’623 patent.
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`Related Proceedings
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`Patent Owner identifies two district-court cases involving the parties.
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`Paper 5, 1. Those cases, however, appear to involve issues unrelated to the
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`’623 patent. Prelim. Resp. 6 n.7.
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`PGR2015-00011
`Patent 8,859,623 B1
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`The ’623 Patent
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`The ’623 patent “is directed to methods and compositions of
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`stabilizing phenylephrine formations.” Ex. 1001, Abstract. “Phenylephrine
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`is a selective α1-adrenergic receptor agonist used primarily as a
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`decongestant, as an agent to dilate the pupil, and to increase blood pressure.”
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`Id. at 1:6–8. Specifically, the ’623 patent provides “a composition
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`comprising at least 95% R-phenylephrine hydrochloride and an aqueous
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`buffer, wherein the composition substantially maintains an initial chiral
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`purity of R-phenylephrine hydrochloride for at least 6 months stored
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`between –10 to 10 degree Celsius.” Id. at 1:16–21. It also discloses
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`“methods of dilating the pupil comprising administering a composition
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`comprising R-phenylephrine hydrochloride topically to a mammal, wherein
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`the composition substantially maintains the initial chiral purity of R-
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`phenylephrine hydrochloride for at least 6 months.” Id. at 1:38–42.
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`At the time of the ’623 patent invention, it was known that
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`R-phenylephrine, but not S-phenylephrine, was useful to dilate the pupil. Id.
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`at 6:21–30. Thus, “it is important that an eye drop containing Phenylephrine
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`Hydrochloride used for dilation of the pupil contains predominantly the R-
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`isomer in order to maintain maximum efficacy of the ophthalmic solution.”
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`Id. at 6:30–33.
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`According to the ’623 patent, generally, commercially available
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`phenylephrine hydrochloride ophthalmic solutions were stored at 20 to 25
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`degree Celsius, with the container tightly closed. Id. at 2:60–65. A solution
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`under such condition, however, often turns brown over time and cannot be
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`PGR2015-00011
`Patent 8,859,623 B1
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`used. Id. at 2:66–3:3. The ’623 patent states that it “provides the
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`improvement to overcome such instability problem.” Id. at 3:4–5.
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`Illustrative Claim
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`Claims 1 is the sole independent claim. It reads:
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`1.
`A method of using an ophthalmic composition for pupil
`dilation,
`the
`composition
`comprising R-phenylephrine
`hydrochloride having an initial chiral purity of at least 95% and
`an aqueous buffer, wherein the chiral purity of R-phenylephrine
`hydrochloride is at least 95% of the initial chiral purity after 6
`months, the method comprising:
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`administering the composition into an eye of an individual in
`need thereof, wherein the composition is stored between –10 to
`10 degree Celsius prior to administration, and wherein the
`composition comprises R-phenylephrine hydrochloride having
`a chiral purity of at least 95% when administered after storage.
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`Asserted Ground of Unpatentability
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`Petitioner asserts the following grounds of unpatentability:
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`1.
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`claims 1–13 as anticipated by, or in the alternative, rendered
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`obvious over, Altaire’s Product (“the Altaire’s Product ground”);
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`2.
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`claims 1–13 as anticipated by, or in the alternative, rendered
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`obvious over, Altaire’s Package Insert,1 “or alternatively, in view of
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`common knowledge in the art or, alternatively or in addition, in view of U.S.
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`1 Sterile Phenylephrine Hydrochloride Ophthalmic Solution, USP
`(Revised August 2010) (Ex. 1018).
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`PGR2015-00011
`Patent 8,859,623 B1
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`Patent No. 3,966,7492 and in further view of Syn-Tech’s Commercially
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`Available product (“the Altaire’s Package Insert ground”);
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`3.
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`claims 1–13 as “obvious in view of Applicants’ Admitted Prior
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`Art (‘AAPA’), Altaire’s Commercial Product, and/or the common
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`knowledge in the art or, alternatively or in addition, in view of U.S. Patent
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`No. 3,966,749” (“the AAPA ground”); and
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`4.
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`claims 1–13 as unpatentable “under 35 U.S.C. § 112(b) for
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`failing to particularly point out and distinctly claim the subject matter which
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`the joint inventors regard as the invention” (“the indefiniteness ground”).
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`In support of its patentability challenge, Petitioner relies on the
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`Declaration of Assad Sawaya. Ex. 1003.
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`ANALYSIS
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`Eligibility for Post-Grant Review
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`The ’623 patent issued on October 14, 2014, from an application filed
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`on November 14, 2013. Ex. 1001, (22). It does not claim the benefit of any
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`earlier filing date. Because it issued from an application that contains a
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`claim with an effective filing date after March 16, 2013, the ’623 patent is
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`available for post-grant review. See Leahy-Smith America Invents Act
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`(Pub. L. No. 112-29, 125 Stat. 284 (2011), §§ 3(n)(1), 6(f)(2)(A).
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`The Petition was filed on May 11, 2015 (Pet. 69), within 9 months of
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`the grant of the ’623 patent. See 35 U.S.C. § 321(c). Petitioner further
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`2 U.S. Patent No. 3,966,749, issued on June 29, 1976 (Ex. 1011).
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`PGR2015-00011
`Patent 8,859,623 B1
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`certifies that it has standing to seek a post-grant review of the ’623 patent.
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`Pet. 2.
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`Real Party in Interest
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`Patent Owner requests that we dismiss the Petition because Petitioner
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`should have identified Sawaya Aquebogue, LLC (“Saw Aque”) as a real
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`party in interest. Prelim. Resp. 2. Based on the current record, we are not
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`persuaded.
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`A petitioner for a post-grant review must identify all real parties in
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`interest. 35 U.S.C. § 322(a)(2); see also 37 C.F.R. § 42.8(b)(1). The real
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`party in interest may include not only the named petitioner, but also “the
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`party or parties at whose behest the petition has been filed.” Office Patent
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`Trial Practice Guide (“Trial Practice Guide”), 77 Fed. Reg. 48,756, 48,759
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`(Aug. 14, 2012). Whether a non-party is a real party in interest is a highly
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`fact-dependent question. Id.
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`Patent Owner argues that Saw Aque and Petitioner “are related
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`companies under the common control, and are even run by the same
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`individual – Assad Sawaya.” Id. at 3. According to Patent Owner,
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`Mr. Sawaya serves as both the President of Petitioner and the General
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`Manager of Saw Aque. Id. (citing Ex. 2001 ¶ 3). In addition, the two
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`companies share the same address, and Petitioner’s General Counsel accepts
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`service of legal documents for both companies at this same address. Id. at
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`3–4 (citing Exs. 2002, 2003, 2005). Patent Owner refers to an Air State
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`Facility permit issued by the New York State Department of Environmental
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`PGR2015-00011
`Patent 8,859,623 B1
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`Conservation. Id. at 4 (citing Ex. 2005). Although the permit was issued to
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`Saw Aque, the facility bore Petitioner’s name. Id. at 4 (citing Ex. 2005, 1).
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`Patent Owner also refers to a 2011 agreement between itself and
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`Petitioner, which allegedly involves the “manufacturing, marketing, and
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`distribution of a selection of products and subject matter of the ’623 patent.”
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`Id.; Ex. 2001, Ex. A. Saw Aque is not a party to the agreement. Ex. 2001
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`¶ 21. Pursuant to that agreement, however, Patent Owner “agreed to provide
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`certain consideration to Saw Aque.” Id., Ex. A. All the evidence, Patent
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`Owner contends, shows that Saw Aque “has a direct interest in this
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`proceeding and has the motivation and ability to control this proceeding.”
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`Prelim. Resp. 6.
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`Citing the testimony from Mr. Sawaya, Petitioner asserts that
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`“Petitioner and Saw Aque are separate and distinct entities that have no
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`ownership interest in one another.” Reply 4 (citing Ex. 1022 ¶ 6).3
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`According to Mr. Sawaya, the two companies “do not have a
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`parent/subsidiary relationship,” and are not under common control.
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`Ex. 1022 ¶ 6. Petitioner also emphasizes that the two companies are in
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`different fields of businesses—while Petitioner “is in the business of
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`pharmaceutical research, development, manufacturing, supply and
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`3 We recognize that we rely on Mr. Sawaya’s testimony regarding real party
`in interest while Patent Owner has not had an opportunity to cross-examine
`him on this issue. Upon institution, Patent Owner, should it wishes to
`pursue the issue, can cross-examine Mr. Sawaya through routine discovery.
`See 35 U.S.C. § 326(a)(5); 37 C.F.R. § 42.51.
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`PGR2015-00011
`Patent 8,859,623 B1
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`distribution,” Saw Aque is a holding company that holds, among others, real
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`properties. Reply 5 (citing Ex. 1022 ¶¶ 4, 8). According to Petitioner, the
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`two companies “share the same address merely because Saw Aque owns
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`property that it leases to Petitioner at arm’s length rates.” Id. (citing
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`Ex. 1022 ¶ 13).
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`Mr. Sawaya testifies that “Saw Aque does not have an ownership
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`interest in any entity that could infringe the ’623 patent,” and “does not have
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`the capabilities to manufacture or sell products that allegedly could be
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`covered by the ’623 patent.” Ex. 1022 ¶ 9. As a result, Petitioner contends,
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`Saw Aque “has no interest in challenging the claims of the ’623 patent.”
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`Reply 5.
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`To determine whether Saw Aque is a real party in interest to this post-
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`grant review, we analyze whether Saw Aque “exercised or could have
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`exercised control” over Petitioner’s participation in this proceeding. Trial
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`Practice Guide, 77 Fed. Reg. at 48,759. In this inquiry, we are persuaded by
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`Mr. Sawaya’s testimony that Saw Aque, a company unrelated to Petitioner
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`and in a line of business different from Petitioner’s, “did not direct, control,
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`or fund the preparation or filing of the Petition.” See Prelim. Resp. 8 (citing
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`Ex. 1022 ¶ 12). Therefore, based on the current record, we determine that
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`Petitioner has complied with the statutory requirement to identify the correct
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`real party in interest.
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`PGR2015-00011
`Patent 8,859,623 B1
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`Claim Construction
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`In a post-grant review, we interpret a claim term in an unexpired
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`patent according to its broadest reasonable construction in light of the
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`specification of the patent in which it appears. 37 C.F.R. § 42.200(b); see
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`also In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1281 (Fed. Cir. 2015)
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`(concluding that “Congress implicitly adopted the broadest reasonable
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`interpretation standard in enacting the AIA”). Under that standard, and
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`absent any special definitions, we assign claim terms their ordinary and
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`customary meaning, as would be understood by one of ordinary skill in the
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`art at the time of the invention, in the context of the entire patent disclosure.
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`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
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`Petitioner proposes constructions for the following terms: (1) “chiral
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`purity” and “initial chiral purity;” (2) “wherein the chiral purity of R-
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`phenylephrine hydrochloride is at least 95% of the initial chiral purity after 6
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`months;” (3) “administering the composition into an eye of an individual in
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`need thereof, wherein the composition is stored between -10 to 10 degree
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`Celsius prior to administration;” and (4) “allowed to be.” Pet. 31–33. Patent
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`Owner challenges the first two constructions. Prelim. Resp. 21–22.
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`Claim terms need only be construed to the extent necessary to resolve
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`the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
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`(Fed. Cir. 2011). For purposes of this Decision, we determine that no terms
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`require express construction.
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`PGR2015-00011
`Patent 8,859,623 B1
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`The Altaire’s Product Ground
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`Petitioner argues that claims 1–13 of the ’623 patent are unpatentable
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`as obvious over Altaire’s Product.4 Pet. 33–45.
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`Petitioner relies on two lots of Altaire’s products: Lot # 11578 and Lot
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`# 11581. Pet. 34. According to Mr. Sawaya, Lot # 11578, a 2.5%
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`phenylephrine hydrochloride ophthalmic solution, was manufactured in
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`December 2011, and sold and distributed to an Altaire customer in October
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`2012. Ex. 1003 ¶¶ 4, 36; Ex. 1007. Lot # 11581, a 10% phenylephrine
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`hydrochloride ophthalmic solution, was manufactured in January 2012, and
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`sold and distributed to another Altaire customer in October 2012. Ex. 1003
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`¶¶ 5, 6, 36; Ex. 1009. In other words, these products were “in public use, on
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`sale, or otherwise available to the public” before November 14, 2013, the
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`effective filing date of the challenged claims. See 35 U.S.C. § 102(a)(1).
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`Therefore, they qualify as prior art.
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`Relying on the package insert, Petitioner points out that Altaire’s
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`Product contains R-phenylephrine hydrochloride5 and an aqueous buffer, as
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`claim 1 requires. Pet. 38 (citing Ex. 1018, 1). The package insert directs the
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`user to place one drop of the solution in each eye for pupil dilation, also as
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`4 Petitioner asserts two different challenges of claims 1–13 under this single
`ground: anticipation, “or, in the alternative,” obviousness. Pet. 33. We
`exercise our discretion and do not address the anticipation challenge. See
`37 C.F.R. § 42.108.
`5 Petitioner asserts that “(-) m-Hydroxy-α-[(methylamino)methyl] benzyl
`alcohol hydrochloride is the same as R-phenylephrine hydrochloride.”
`Pet. 48.
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`Patent 8,859,623 B1
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`claim 1 requires. Id. at 37 (citing Ex. 1018, 1), 39 (citing Ex. 1018, 2).
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`Furthermore, the package insert instructs that the Altaire’s Product should be
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`stored at 2–8 degree Celsius, within the temperature range recited in claim 1.
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`Id. at 40 (citing Ex. 1018, 2).
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`Petitioner refers to Exhibits 1012, 1016, and 1019 for teaching the
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`chiral-purity limitations of claim 1. Id. at 35–39. According to Mr. Sawaya,
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`Lot # 11578 in Exhibit 1012 and Lot # 11581 in Exhibit 1019 were tested
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`after cold storage for over 13 months and over 12 months, respectively.
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`Ex. 1003 ¶¶ 37, 38. In Exhibit 1012, the optical rotation data showed the
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`chiral purity of Lot # 11578 was 101.5% of the R-phenylephrine
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`hydrochloride control. Pet. 35 (citing Ex. 1012, 8). In Exhibit 1019, the
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`HPLC data showed that no S-form of phenylephrine was detected in Lot
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`# 11581. Id. at 37, 39; Ex. 1019. Thus, Petitioner argues, Altaire’s Product
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`meets the limitation of claim 1, requiring “the chiral purity of R-
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`phenylephrine hydrochloride is at least 95% of the initial chiral purity after 6
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`months.” Pet. 39.
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`Mr. Sawaya further states that both Lot # 11578 and Lot # 11581 in
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`Exhibit 1016 were tested after room-temperature storage for 37 months.
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`Ex. 1003 ¶ 24; Ex. 1016. In both cases, no S-form of phenylephrine was
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`detected using the HPLC method. Ex. 1003 ¶ 25; Ex. 1016. Because the
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`chiral purity of R-phenylephrine hydrochloride remained undiminished after
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`months of storage under either cold or room temperature, Petitioner contends
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`that the initial chiral purity would have been essentially 100%, meeting the
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`PGR2015-00011
`Patent 8,859,623 B1
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`initial-chiral-purity requirement of claim 1. Pet. 36, 39. We find
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`Petitioner’s argument persuasive based on the evidence of record so far.
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`Patent Owner challenges the methodology Petitioner used in
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`determining chiral purity. Prelim. Resp. 12–18. First, according to Patent
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`Owner, only those methods disclosed in the ’623 patent, and not the USP
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`standard HPLC protocol used by Petitioner, can reliably detect chiral
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`impurity. Id. at 12–15. For support, Patent Owner points us to a declaration
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`submitted during prosecution, by Mr. Patrick H. Witham, one of the
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`inventors of the ’623 patent, in which he states that “[n]on-chiral reverse
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`phase column chromatographs (currently published USP HPLC method)
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`show no or little chemical degradation of R-Phenylephrine hydrochloride in
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`both formulations (i) and (ii).” Id. at 14 (citing Ex. 1002, 110). The
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`significance of this statement, however, is not immediately clear to us. Read
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`in context, the sentence appears to indicate neither storing a commercially
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`available R-Phenylephrine hydrochloride at room temperature for six
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`months (as in (i)), nor storing an R-Phenylephrine hydrochloride of the ’623
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`patent at 2–8 degree Celsius (as in (ii)), led to detectable degradation.
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`Ex. 1002, 109–10. We are not persuaded, at this stage, that Mr. Witham’s
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`statement serves to discredit the USP standard HPLC method utilized by
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`Petitioner as a reliable method to detect chiral impurity.
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`Patent Owner also presents Exhibit 2014, purportedly “a study
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`designed specifically to address whether the currently published USP
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`method could reliably detect S-phenylephrine.” Prelim. Resp. 14. Exhibit
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`2014 appears to be pages from a laboratory notebook with handwritten
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`Patent 8,859,623 B1
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`information and certain test results. At this stage of the proceeding, with
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`only attorney argument and no other explanation from Patent Owner, we
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`find Petitioner’s evidence sufficient for institution.
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`Second, Patent Owner contends that the optical rotation method used
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`by Petitioner in Exhibit 1012 provides not quantitative, but rather relative,
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`measurements. Id. at 16–17. Patent Owner points out that Petitioner’s study
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`relied on phenylephrine hydrochloride obtained from Sigma Aldrich as a
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`control. Id. at 17 (citing Ex. 1012, 3). As a result, Patent Owner asserts,
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`“[k]nowing the chiral purity of the Sigma control is critical to drawing any
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`conclusions from the study regarding the absolute chiral purity of Lot
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`# 11578.” Id. According to Patent Owner, the data showing a chiral purity
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`of 101.5% for the tested R-phenylephrine hydrochloride demonstrates the
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`impurity of the control. Id. at 18.
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`We understand Exhibit 1012 shows data generated by Petitioner on
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`behalf of Patent Owner, which was submitted to the FDA. See Pet. 9–11
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`(citing Ex. 1003 ¶¶ 9–10). Petitioner asserts that the study was performed
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`during Patent Owner’s New Drug Application, and in response to the FDA’s
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`request for “adding a chiral purity test to the drug product specification.” Id.
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`at 9–10. We recognize that Patent Owner has raised legitimate concerns
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`about the purity of the Sigma control used, and how that may affect the
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`chiral purity data relied upon by Petitioner. At this stage of the proceeding,
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`however, there is an insufficient basis to conclude that such data are
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`unreliable. Thus, based on the current record, even though Patent Owner’s
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`Patent 8,859,623 B1
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`argument here may be reasonable, we find Petitioner’s evidence sufficient to
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`go forward with trial.
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`Patent Owner argues that Petitioner’s witness, Mr. Sawaya, is a fact
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`witness, and not an expert. Prelim. Resp. 18–20. We agree. Mr. Sawaya
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`states that he makes the Declaration “based upon [his] personal knowledge
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`of the facts stated [t]herein.” Ex. 1003 ¶ 1. In his Declaration, he does not
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`explain his “knowledge, skill, experience, training, or education” that would
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`provide the bases for his qualification as an expert. See Fed. R. Evid. 702.
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`Because Mr. Sawaya is not shown to be an expert witness, we accord no
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`weight to his opinion in that capacity.
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`That said, the lack of expert testimony is not, as Patent Owner argues,
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`fatal to the Petition. See Prelim. Resp. 24. Where the technology is simple,
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`where the references are easily understandable without the need for expert
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`explanatory testimony, or where the factual inquiries underlying the
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`obviousness determination are not in material dispute, expert testimony,
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`though it might be helpful, may not be indispensable. Allergan, Inc. v. Barr
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`Labs., Inc., 501 F. App’x 965, 972 (Fed. Cir. 2013); see also Wyers v.
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`Master Lock Co., 616 F.3d 1231, 1239 (Fed. Cir. 2010) (“[T]he legal
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`determination of obviousness may include recourse to logic, judgment, and
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`common sense, in lieu of expert testimony.”).
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`Patent Owner further challenges portions of Mr. Sawaya’s
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`Declaration, in which he testifies to the temperature and duration of the
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`product storage. Pet. 26–27. According to Patent Owner, Mr. Sawaya fails
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`to corroborate his statement about storing Altaire’s Product at cold
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`temperature for over six months before testing in the studies. Id. at 19, 26–
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`27. Patent Owner’s position is not unreasonable. But, at this stage of the
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`proceeding, Patent Owner’s argument does not persuade us that we should
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`decline to go forward with a trial. We emphasize that, upon institution, a
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`post-grant review proceeding provides the opportunity for discovery of
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`“evidence directly related to factual assertions advanced by either party in
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`the proceeding.” See 35 U.S.C. § 326(a)(5); 37 C.F.R. § 42.51. As a result,
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`factual challenges, like this one, would be better resolved after the parties
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`have had an opportunity to cross-examine each other’s declarants.
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`In sum, based on the current record, we find that Petitioner has offered
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`sufficient evidence to show that it is more likely than not that claim 1 is
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`unpatentable as obvious over Altaire’s Product. After considering
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`Petitioner’s arguments and evidence with respect to the remaining claims
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`(Pet. 42–45), we determine that Petitioner has made a sufficient showing as
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`to those claims, as well.
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`The Altaire’s Package Insert Ground
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`Petitioner asserts that claims 1–13 of the ’623 patent are unpatentable
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`under 35 U.S.C. § 102, or in the alternative, 35 U.S.C. § 103 as
`anticipated or rendered obvious in view of Altaire’s Package
`Insert, or alternatively, in view of common knowledge in the art
`or, alternatively or in addition, in view of U.S. Patent No.
`3,966,749 and in further view of Syn-Tech’s Commercially
`Available product.
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`Pet. 45.
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`Patent 8,859,623 B1
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`Patent Owner argues that this ground of unpatentability “is not
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`presented with the requisite degree of clarity or particularity and could be
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`interpreted as including no fewer than eight separate grounds.” Prelim.
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`Resp. 29. We agree with Patent Owner.
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`Under the statute, a petition for a post-grant review must identify
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`“with particularity, each claim challenged, the grounds on which the
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`challenge to each claim is based, and the evidence that supports the grounds
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`for the challenge to each claim.” 35 U.S.C. § 322(a)(3). In addition, a
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`petition must include a “full statement of the reasons for the relief requested,
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`including a detailed explanation of the significance of the evidence.”
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`37 C.F.R. § 42.22(a)(2). The Petition fails to comply with the requirements
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`specified in the statute and the rules. We decline to identify or analyze all
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`possible permutations of prior art combinations that Petitioner may have
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`sought to include in this ground. We, thus, exercise our discretion and do
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`not institute trial on this ground. See 37 C.F.R. § 42.108.
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`The AAPA Ground
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`Petitioner contends that claims 1–13 of the ’623 patent are
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`unpatentable “under 35 U.S.C. § 103 as being obvious in view of
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`Applicants’ Admitted Prior Art (“AAPA”), Altaire’s Package Insert, and/or
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`the common knowledge in the art or, alternatively or in addition, in view of
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`U.S. Patent No. 3,966,749.” Pet. 57.
`
`The AAPA ground also fails to comply with the requirements
`
`specified in 35 U.S.C. §322(a)(3) and 37 C.F.R. § 42.22(a)(2). First, though
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`Patent 8,859,623 B1
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`presented as a single ground, with language “and/or” and “alternatively or in
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`addition,” the AAPA ground actually represents numerous different grounds.
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`Id. Second, Petitioner asserts this unpatentability ground based on its
`
`analysis of the originally filed claim 1, a claim different from the challenged
`
`claim 1. Id. Because the Petition does not identify with sufficient
`
`particularity either the claim challenged, or the grounds on which the
`
`challenge is based, we, again, exercise our discretion and do not institute
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`trial on this ground.
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`The Indefiniteness Ground
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`Petitioner argues that claim 1 fails to particularly out and distinctly
`
`claim the subject matter of the invention. Pet. 66–68. Petitioner asserts
`
`claim 1 does not require storage at cold temperature for any minimum
`
`duration before use, even though the preamble refers to chiral purity after six
`
`months. Id. at 32–33, 66–67. According to Petitioner, however, during
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`prosecution, both the applicants and the examiner relied on cold storage for
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`six months to distinguish claim 1 from the prior art. Id. at 67 (citing
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`Ex. 1002, 110–13, 167). Thus, Petitioner argues, “claim 1 is unclear as to
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`what it encompasses,” and thus, is indefinite. Id. We are not persuaded.
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`To satisfy the requirement under 35 U.S.C. 112(b), “claims are
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`required to be cast in clear—as opposed to ambiguous, vague, indefinite—
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`terms.” In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014). Petitioner is
`
`correct that claim 1 does not require cold storage for six months before
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`administering the composition to a patient. Indeed, the only step of claim 1
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`Patent 8,859,623 B1
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`recites that the composition is “stored between –10 to 10 degree Celsius
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`prior to administration.” Ex. 1001, 12:45–48. It does not specify how long
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`the storage must be at that cold temperature.
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`Patent Owner contends that claim 1 requires cold storage for six
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`months, “such that the chiral purity after said storage is at least 95% of the
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`initial chiral purity.” Prelim. Resp. 37. Patent Owner, however, relies on
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`not the step of the claim, but the preamble, which explicitly recites the chiral
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`purity “is at least 95% of the initial chiral purity after 6 months.” Ex. 1001,
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`12:42–44 (emphasis added).
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`This language of the preamble is also consistent with the prosecution
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`history, which both parties emphasize. See Pet. 67 (citing Ex. 1002, 110–13,
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`167); Prelim. Resp. 37–38 (citing Ex. 1002, 110, 113, 167). During
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`prosecution, the applicants argued, and the examiner agreed, that claim 1
`
`was patentable because the chiral purity remained at least 95% of the initial
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`chiral purity after cold storage for six months. Ex. 1002, 110, 113, 167.
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`Maintaining at least 95% of the initial chiral purity after six months,
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`however, simply describes a property of the composition to be administered.
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`The characteristic, defined in the preamble, does not add a limitation on the
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`duration of storage at cold temperatures recited in the “administering” step.
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`This is especially so because the preamble requires that, after the six-month
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`storage, the chiral purity is only at least 90.25% (i.e., “at least 95% of the
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`initial chiral purity,” which is already “at least 95%”). See id. at 12:41–44.
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`In contrast, the step of claim 1 requires “a chiral purity of at least 95% when
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`administered after storage.” Id. at 12:49–50.
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`Based on the current record, we determine that claim 1 is directed to a
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`method of administering a composition—wherein the composition
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`comprises R-phenylephrine hydrochloride that exhibits the property of
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`having at least 95% of the initial chiral purity after six months—as long as
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`the composition is stored in cold temperature before the administration.
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`Although perhaps not articulately stated, claim 1 is cast in clear terms. See
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`Packard, 751 F.3d at 1313. We accordingly deny Petitioner’s indefiniteness
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`ground.
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`CONCLUSION
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`For the foregoing reasons, the information presented in the Petition
`
`and accompanying evidence establishes that it is more likely than not that
`
`claims 1–13 of the ’623 patent are unpatentable as obvious over Altaire’s
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`Product.
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`At this stage of the proceeding, the Board has not made a final
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`determination as to the patentability of claims 1–13 or the construction of
`
`any claim term.
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`Accordingly, it is
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`ORDER
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`ORDERED that pursuant to 35 U.S.C. § 324(a), a post-grant review is
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`hereby instituted to determine whether claims 1–13 of the ’623 patent are
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`unpatentable as obvious over Altaire’s Product;
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`FURTHER ORDERED that no other grounds raised in the Petition are
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`Patent 8,859,623 B1
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`instituted;
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`FURTHER ORDERED that pursuant to 35 U.S.C. § 324(d) and
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`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial
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`commencing on the entry date of this decision.
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`PGR2015-00011
`Patent 8,859,623 B1
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`PETITIONER:
`
`Dipu A. Doshi
`DICKSTEIN SHAPIRO LLP
`doshid@dicksteinshapiro.com
`
`PATENT OWNER:
`
`Michael Rosato
`Steven W. Parmelee
`WILSON SONSINI GOODRICH & ROSATI
`mrosato@wsgr.com
`sparmelee@wsgr.com
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