Trials@uspto.gov
`571-272-7822
`
`Paper 34
`Date: November 13, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED,
`Petitioner,
`v.
`BIOVIE, INC.,
`Patent Owner.
`
`IPR2018-00974
`Patent 9,655,945 B2
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`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, MICHELLE N. ANKENBRAND, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`SAWERT, Administrative Patent Judge.
`
`
`
`JUDGMENT
`
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Amend
`35 U.S.C. § 318(a)
`
`Granting-In-Part Petitioner’s Motion to Strike
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 34
`Date: November 13, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED,
`Petitioner,
`v.
`BIOVIE, INC.,
`Patent Owner.
`
`IPR2018-00974
`Patent 9,655,945 B2
`
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, MICHELLE N. ANKENBRAND, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`SAWERT, Administrative Patent Judge.
`
`
`
`JUDGMENT
`
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Amend
`35 U.S.C. § 318(a)
`
`Granting-In-Part Petitioner’s Motion to Strike
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`
`
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`IPR2018-00974
`Patent 9,655,945 B2
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`I.
`
`INTRODUCTION
`This is a Final Written Decision in an inter partes review challenging
`the patentability of claims 1–14 (“the challenged claims”) of U.S. Patent
`No. 9,655,945 B2 (“the ’945 patent,” Ex. 1001). We have jurisdiction under
`35 U.S.C. § 6, and enter this Decision pursuant to 35 U.S.C. § 318(a) and
`37 C.F.R. § 42.73. For the reasons set forth below, we determine that
`Petitioner has shown, by a preponderance of the evidence, that the
`challenged claims are unpatentable. See 35 U.S.C. § 316(e) (2012).
`Additionally, we deny Patent Owner’s contingent Motion to Amend, and
`grant-in-part Petitioner’s Motion to Strike.
`A. Procedural History
`Mallinckrodt Pharmaceuticals Ireland Limited (“Petitioner”) filed a
`Petition for an inter partes review under 35 U.S.C. § 311. Paper 2 (“Pet.”).
`Petitioner supported its Petition with the Declaration of Dr. Paul Gow.
`Ex. 1002. BioVie, Inc. (“Patent Owner”) filed a Preliminary Response.
`Paper 6 (“Prelim. Resp.”).
`On November 14, 2018, pursuant to 35 U.S.C. § 314(a), we instituted
`trial to determine whether any challenged claim of the ’945 patent is
`unpatentable based on the grounds raised in the Petition:
`Claims Challenged
`35 U.S.C. §
`Reference(s)
`1–3, 5
`102
`Robertson1
`7, 8, 10
`103
`Robertson
`
`
`1 Marcus Robertson et al., Continuous Outpatient Terlipressin
`Infusion for Hepatorenal Syndrome as a Bridge to Successful Liver
`Transplantation, HEPATOLOGY 2125–26 (Dec. 2014) (“Robertson,”
`Ex. 1004).
`
`
`2
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`Patent 9,655,945 B2
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`
`Claims Challenged
`1, 2, 6, 12
`1–14
`1–14
`
`35 U.S.C. §
`103
`103
`103
`
`Reference(s)
`
`Angeli2
`Fimiani,3 Robertson
`Fimiani, Angeli
`
`Paper 9, 6, 31 (“Institution Decision” or “Inst. Dec.”).
`Patent Owner filed a Response. Paper 15 (“PO Resp.”). Patent
`Owner supported its Response with the Declaration of Dr. Jaime Bosch.
`Ex. 2023. Patent Owner also filed a contingent Motion to Amend. Paper 16
`(“Motion to Amend” or “Mot. Amend.”). Petitioner filed a Reply to Patent
`Owner’s Response (Paper 18, “Pet. Reply”), and an Opposition to Patent
`Owner’s Motion to Amend (Paper 19, “Opp. Mot. Amend.”). Patent Owner
`filed a Sur-reply (Paper 21, “PO Sur-reply”), and a Reply in support of its
`Motion to Amend (Paper 22, “Reply Mot. Amend.”). Patent Owner’s Sur-
`reply was accompanied by a Supplemental Declaration of Dr. Bosch.
`Ex. 2044. Petitioner filed a Sur-reply to Patent Owner’s Reply. Paper 25
`(“Sur-reply Mot. Amend.”).
`On our authorization (Paper 26), Petitioner filed a Motion to Strike
`(Paper 28, “Mot. Strike”), to which Patent Owner filed an Opposition
`(Paper 29, “Opp. Mot. Strike”).
`An oral hearing was held on August 12, 2019. A transcript of the
`hearing is included in the record. Paper 30 (“Tr.”). After the hearing, and
`
`2 Paolo Angeli, Terlipressin for the treatment of hepatorenal
`syndrome in patients with cirrhosis, 1 EXPERT OPIN. ORPHAN DRUGS 241–48
`(2013) (“Angeli,” Ex. 1005).
`
` 3
`
` Basilio Fimiani et al., The use of terlipressin in cirrhotic patients
`with refractory ascites and normal renal function: A multicentric study,
`22 EUR. J. INTERN. MED. 587–90 (2011) (“Fimiani,” Ex. 1006).
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`3
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`on our authorization (Paper 31), Patent Owner filed a Notice of
`Supplemental Authority (Paper 32, “PO Notice”), to which Petitioner filed a
`Reply (Paper 33, “Pet. Reply to Notice”).
`B. Real Parties in Interest
`Petitioner identifies its real parties-in-interest as Mallinckrodt
`Pharmaceuticals Ireland Limited and Mallinckrodt Hospital Products Inc.
`Pet. 3. Patent Owner identifies its real party-in-interest as BIOVIE, Inc.
`Paper 4, 2.
`C. Related Matters
`According to the parties, there are no pending judicial proceedings
`involving the ’945 patent. Pet. 3; Paper 4, 2. Petitioner states that U.S.
`Patent Application No. 15/491,613 is related to the ’945 patent and is
`currently pending before the Office. Pet. 3.
`D. The ’945 Patent
`The ’945 patent, titled “Treatment of Ascites,” issued on May 23,
`2017. Ex. 1001, code (45). The ’945 patent relates to “a method for treating
`ascites patients by administering the peptide drug terlipressin.” Id. at 1:14–
`15.
`
`According to the ’945 patent, “[a]scites is a frequent and life-
`threatening complication of advanced liver cirrhosis with an expected 40%
`mortality rate within two years of diagnosis.” Id. at 1:18–20. Although
`there is no FDA-approved drug for treating ascites, diuretics are
`administered off-label “with limited and temporary efficacy.” Id. at 1:20–
`23. As liver cirrhosis progresses, however, a patient’s ascites may become
`refractory (i.e., unmanageable) with diuretics. Id. at 1:26–28.
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`Patients suffering from refractory ascites may also develop
`hepatorenal syndrome (HRS)—another complication of advanced liver
`cirrhosis that marks the beginning of renal failure. Id. at 2:26–28. There are
`two types of HRS: type 1 (HRS-1) and type 2 (HRS-2). Id. at 2:43–46.
`HRS-1 is more severe than HRS-2, and thus, HRS-1 patients require
`hospitalization, whereas HRS-2 patients are ambulatory. Id. at 2:42–45.
`The ’945 patent states that HRS-1 patients have been successfully
`treated with intravenous (IV) injections of terlipressin every 4 to 6 hours.
`See id. at 1:23–26 (stating that terlipressin has been used to “save their
`lives”). The ’945 patent also states, “investigational studies have shown that
`IV injections of terlipressin every 4 to 6 hours in combination with diuretics
`may resolve refractory ascites in hospitalized patients and decrease the need
`for large volume paracentesis (ascites fluid withdrawal by needle).” Id. at
`1:28–33. These high-dose IV injections, however, “carry a high risk of side
`effects.” Id. at 1:33–34. The ’945 patent states that “[m]ore recent studies
`with hospitalized HRS patients indicate that a continuous infusion of
`terlipressin can achieve similar efficacy to intermittent injections with a
`much better safety profile.” Id. at 1:34–37. But “to date there have been no
`published studies of using a continuous low-dose infusion terlipressin to
`manage ascites in non-hospitalized patients with cirrhosis.” Id. at 1:37–40.
`The ’945 patent states that the present inventors “have identified a
`need in the art for a method to treat ascites patients on an outpatient basis
`and potentially avoid or delay the need for hospitalization due to HRS or
`other life-threatening complications.” Id. at 1:41–44. In one embodiment,
`terlipressin may be administered continuously by a pump at a dosage range
`of about 0.5 gm to about 20 mg every 24 hours, for a period from about one
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`day to about 12 months or more. Id. at 2:67–3:17. The ’945 patent states
`that the presence, progression, or improvement of disease may be
`determined by measuring one or more of the following factors: serum
`creatinine concentration, plasma sodium concentration, urinary sodium
`excretion, and urea concentration in serum. Id. at 3:36–40. A reduction in
`serum creatinine concentration, for example, indicates an improvement in
`renal function, which in turn “indicates an improvement in disease
`condition.” Id. at 3:40–46.
`The ’945 patent provides two examples of patient groups with ascites:
`one prophetic group to be treated with continuous infusion pump terlipressin
`therapy (Example 1), and one group actually treated with continuous
`infusion pump terlipressin therapy (Example 2). Id. at 4:6–7:40. In
`Example 1, the ’945 patent states that 15 subjects having ascites but not
`HRS “will be administered continuous low dose (escalating from 2.0 to 3.0
`mg per 24 hours) terlipressin via ambulatory infusion pump.” Id. at 4:11–
`15. The ’945 patent states that “[t]hese patients are expected to experience a
`decrease [in] the severity of ascites and the accumulation of ascites fluid
`over the course of treatment,” as well as other health benefits. Id. at 4:15–
`27. Thus, “continuous infusion pump (CIP) terlipressin represents a
`potentially life-saving solution for these seriously ill patients who are still
`ambulatory (have not yet been administered [sic] to the hospital for
`treatment) and have not developed type 1 or type 2 HRS.” Id. at 4:27–31.
`
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`
`E. Illustrative Claims
`Of the challenged claims, claims 1 and 7 are independent and
`illustrative of the claimed subject matter. Claim 1 recites:
` 1. A method for treating a patient diagnosed with ascites due
`to
`liver cirrhosis,
`the method comprising administering
`terlipressin or salt thereof as a continuous infusion dose of about
`1.0 mg to about 12.0 mg per day to the patient for about one day
`to about 12 months.
`Ex. 1001, 8:25–29. Claim 7 recites:
` 7. A method for reducing the accumulation of ascitic fluid in
`the abdominal cavity in an ambulatory ascites patient, the method
`comprising administering to the patient terlipressin or salt
`thereof as a continuous infusion dose of about 1.0 mg to about
`12.0 mg per day for about one day to about twelve months with
`an ambulatory infusion pump.
`Id. at 8:42–47.
`II. PETITIONER’S MOTION TO STRIKE
`Petitioner’s moves to strike Exhibit 2044 and the portions of Patent
`Owner’s Sur-Reply (Paper 21) that cite to, or rely on, Exhibit 2044, from the
`record in this proceeding. Mot. Strike 1. Exhibit 2044 is a Supplemental
`Declaration of Dr. Bosch, Patent Owner’s declarant, filed in support of
`Patent Owner’s Sur-Reply. Petitioner contends that Patent Owner’s filing of
`Exhibit 2044 is contrary to the Board’s instructions in the August 2018
`Update to the PTAB Trial Practice Guide (“2018 Trial Guide Update”),4
`which states that a sur-reply “may not be accompanied by new evidence
`
`
`4 See 83 Fed. Reg. 38,989 (Aug. 13, 2018) (notifying the public of the
`updated “Practice Guide” and its accessibility through the USPTO website:
`https://go.usa.gov/xU7GP).
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`other than deposition transcripts of the cross-examination of any reply
`witness.” Id.
`Patent Owner responds that we should permit the Supplemental
`Declaration under the 2018 Trial Guide Update because “expert testimony
`‘is generally permitted where the expert’s scientific, technical, or other
`specialized knowledge will help the trier of fact to understand the evidence
`or to determine a fact in issue.’” Opp. Mot. Strike 1 (quoting 2018 Trial
`Guide Update, 2). And here, Patent Owner argues, Dr. Bosch’s
`Supplemental Declaration serves “to explain and respond to scientific and
`technical arguments in [Petitioner’s] Reply to Patent Owner’s Response.”
`Id. at 2. Citing ResMed Ltd. v. Fisher & Paykel Healthcare Ltd., IPR2016-
`01724, -01735, Paper 25 (PTAB Sept. 28, 2017), Patent Owner also argues
`that the Board “has permitted a patent owner to submit short, supporting
`expert declarations with sur-replies to respond to arguments in petitioner’s
`reply briefs that included supporting expert declarations containing new
`evidence,” and should do so in this case as well. Id. at 2–3. Finally, Patent
`Owner argues that we should deny Petitioner’s Motion to Strike because
`“‘striking . . . a portion of a party’s brief is an exceptional remedy that the
`Board expects will be granted rarely.’” Id. at 3 (quoting 2018 Trial Guide
`Update, 18).
`The 2018 Trial Guide Update explains that a “sur-reply may not be
`accompanied by new evidence other than deposition transcripts of the cross-
`examination of any reply witness. Sur-replies should only respond to
`arguments made in reply briefs, comment on reply declaration testimony, or
`point to cross-examination testimony.” 2018 Trial Guide Update, 14.
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`Further, the 2018 Trial Guide Update explains that a “sur-reply that raises a
`new issue or belatedly presents evidence may not be considered.” Id. at 15.
`Thus, we agree with Petitioner that Patent Owner’s submission of
`Exhibit 2044 does not follow the procedure set forth in the 2018 Trial Guide
`Update, which prohibits new evidence submitted with a sur-reply. Id. at 14.
`Although Patent Owner is correct that the Board has allowed a patent owner
`to file additional evidence with a sur-reply, it has done so when the Patent
`Owner sought authorization to file the additional evidence in the first place.
`See ResMed Ltd., Paper 25 at 3. Here, Patent Owner did not seek
`authorization from the Board to file additional evidence with its Sur-reply.
`We agree with Petitioner, therefore, that Patent Owner improperly relies
`upon Exhibit 2044 in its Sur-reply.
`Accordingly, we strike the following portions of Patent Owner’s
`Sur-reply as follows:
`• Page 1 – “This Sur-Reply is supported by the Supplemental
`Declaration of Dr. Jaime Bosch (Ex. 2044)”;
`
`• Page 11 – “Ex. 2044, ¶7” and the following “Id.”;
`• Page 16 – “Ex. 2044, ¶¶8-11”;
`• Page 20 – “Ex. 2044, ¶6”;
`• Page 22 – “Ex. 2044, ¶14,” “Ex. 2044, ¶¶15-17,” and
`“Ex. 2044, ¶18.”
`We decline, however, to strike Exhibit 2044 from the record. Patent
`Owner properly relies on Exhibit 2044 in its Reply in support of its Motion
`to Amend. We determine that the better course of action is to disregard
`Patent Owner’s reliance on Exhibit 2044 as to Petitioner’s challenges to the
`patentability of claims 1–14, but not as to the patentability of the proposed
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`substitute claims. See 2018 Trial Guide Update, 17 (explaining that “the
`Board is capable of identifying new issues or belatedly presented evidence
`when weighing the evidence at the close of trial, and disregarding any new
`issues or belatedly presented evidence that exceeds the proper scope of reply
`or sur-reply”). For these reasons, Petitioner’s Motion to Strike is granted in
`part.
`III. PATENTABILITY ANALYSIS
`We have reviewed the parties’ respective briefs as well as the relevant
`evidence discussed in those papers. For the reasons discussed in detail
`below, we determine that Petitioner has shown by a preponderance of the
`evidence that claims 1–3 and 5 of the ’945 patent are unpatentable under
`35 U.S.C. § 102 as anticipated, and that claims 1–14 are unpatentable under
`35 U.S.C. § 103 as having been obvious.
`A. Principles of Law
`To prevail in its challenges to the patentability of all claims of the
`’945 patent, Petitioner must demonstrate by a preponderance of the evidence
`that the claims are unpatentable. 35 U.S.C. § 316(e) (2012); 37 C.F.R.
`§ 42.1(d) (2017). “In an [inter partes review], the petitioner has the burden
`from the onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid. Tech., Inc., 815 F.3d 1356, 1363
`(Fed. Cir. 2016); see also 35 U.S.C. § 312(a)(3) (requiring inter partes
`review petitions to identify “with particularity . . . the evidence that supports
`the grounds for the challenge to each claim”). That burden of persuasion
`never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015); see also In re Magnum Oil Tools
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`Int’l, Ltd., 829 F.3d 1364, 1375–78 (Fed. Cir. 2016) (discussing the burden
`of proof in inter partes review).
`A claim is anticipated and, therefore, unpatentable under 35 U.S.C.
`§ 102, if all of its limitations are disclosed either explicitly or inherently in a
`single prior-art reference. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
`1997). That single prior art reference must disclose all the limitations of the
`claim “arranged or combined in the same way as in the claim.” Net
`MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008).
`A claim is unpatentable for obviousness if, to one of ordinary skill in
`the pertinent art, “the differences between the subject matter sought to be
`patented and the prior art are such that the subject matter as a whole would
`have been obvious at the time the invention was made.” 35 U.S.C. § 103(a)
`(2006); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
`The question of obviousness is resolved on the basis of underlying factual
`determinations including the scope and content of the prior art, any
`differences between the claimed subject matter and the prior art, the level of
`ordinary skill in the art, and objective evidence of nonobviousness. Graham
`v. John Deere Co., 383 U.S. 1, 17–18 (1966). A petitioner cannot satisfy its
`burden of proving obviousness by employing “mere conclusory statements.”
`Magnum Oil, 829 F.3d at 1380. Moreover, a decision on the ground of
`obviousness must include “articulated reasoning with some rational
`underpinning to support the legal conclusion of obviousness.” KSR, 550
`U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
`We analyze Petitioner’s asserted grounds of unpatentability in
`accordance with the above-stated principles.
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`B. Level of Ordinary Skill in the Art
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art, and thus begin with the
`level of ordinary skill in the art. The ordinarily skilled artisan is a “legal
`construct” that “presumes that all prior art references in the field of the
`invention are available to this hypothetical skilled artisan.” In re Rouffet,
`149 F.3d 1350, 1357 (Fed. Cir. 1998).
`Petitioner contends, and Patent Owner does not dispute, that the
`relevant “time of the invention” in this case is July 30, 2015—the earliest
`filing date in the priority chain for the ’945 patent. Pet. 19; see generally
`PO Resp. As of that time, Petitioner contends that an ordinarily skilled
`artisan:
`was typically a person who had a Ph.D. in the areas of pharmacy,
`chemistry, biochemistry, or a related discipline, or a M.D.
`specializing
`in hepatology,
`internal medicine,
`and/or
`gastroenterology, and at least 5 years of experience treating
`patients with ascites due to liver cirrhosis and at least 3 years
`administering vasoconstrictors such as terlipressin for the
`treatment of patients diagnosed with liver cirrhosis.
`Pet. 19–20; Ex. 1002 ¶ 25. Petitioner also contends that the ordinarily
`skilled artisan “would also be well versed in the relevant technical
`publications and be experienced in various routes of administration of drugs
`to treat ascites.” Pet. 20; see also Ex. 1002 ¶¶ 23–26.
`Patent Owner agrees with Petitioner that an ordinarily skilled artisan
`“could have either an M.D. or a Ph.D. in a relevant field, with at least
`several years of experience in their field.” PO Resp. 4 (citing Ex. 2023
`¶¶ 28–30). Patent Owner also agrees that the ordinarily skilled artisan
`“should have exposure to the administration of vasoconstrictor agents for the
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`treatment of patients diagnosed with cirrhosis,” but disagrees with Petitioner
`that the skilled artisan necessarily “would have had direct experience with
`those agents.” Id.
`Patent Owner argues that, although the ordinarily skilled artisan
`“would be well-versed in the technical publications relating to drugs to treat
`ascites,” as Petitioner contends, that artisan “would have understood that, at
`the time of the invention, none of the agents used to treat ascites was
`administered routinely as a continuous infusion.” Id. (citing Ex. 2023 ¶ 30).
`Patent Owner also argues that an ordinarily skilled artisan “would have
`understood that treating ascites is not the same as treating hepatorenal
`syndrome (‘HRS’) or improving renal function.” Id. (citing Ex. 2023 ¶ 30).
`At institution, we preliminarily adopted Petitioner’s definition of an
`ordinarily skilled artisan, and also determined that the prior art itself was
`sufficient to demonstrate the level of ordinary skill in the art at the time of
`the invention. Inst. Dec. 8. For this Decision, we maintain that the prior art
`demonstrates the appropriate level of ordinary skill in the art. See Okajima
`v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can
`reflect appropriate level of ordinary skill in art).
`Nevertheless, for further clarity, we set forth the definition of an
`ordinarily skilled artisan as follows. As to level of education, we agree with
`the parties that an ordinarily skilled artisan would have had either a
`doctorate degree (Ph.D.) in a scientific discipline such as pharmacology,
`chemistry, and/or biochemistry, or a medical degree (M.D.), with
`specialization in hepatology, internal medicine, and/or gastroenterology.
`Ex. 2023 ¶¶ 28–29; Ex. 1002 ¶ 25. We also find that the ordinarily skilled
`artisan would have had several years’ experience in their relevant fields, but
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`disagree with Petitioner that an ordinarily skilled artisan necessarily would
`have had direct experience treating patients with ascites, or with
`administering terlipressin. In this regard, we find credible Dr. Bosch’s
`statement that an ordinarily skilled artisan’s “exposure to [terlipressin] could
`have come from a review of the literature on others’ experience with such
`administration.” Ex. 2023 ¶ 29. We otherwise find no substantive
`difference between the parties’ respective proposed definitions of a person
`of ordinary skill, and find that the outcome of this case would be the same
`regardless of which definition is used.
`We acknowledge Patent Owner’s assertions that an ordinarily skilled
`artisan “would have understood that, at the time of the invention, none of the
`agents used to treat ascites was administered routinely as a continuous
`infusion” and “would have understood that treating ascites is not the same as
`treating hepatorenal syndrome (‘HRS’) or improving renal function.”
`PO Resp. 4. But we conclude that these statements go to the scope and
`content of the prior art under Graham, and thus, are best addressed in
`relation to Petitioner’s asserted grounds of unpatentability based on
`obviousness.
`Finally, we consider each party’s declarant—Dr. Gow and
`Dr. Bosch—qualified to opine as to the perspective of an ordinarily skilled
`artisan at the time of the invention. See Ex. 1003 (Dr. Gow’s curriculum
`vitae); Ex. 2024 (Dr. Bosch’s curriculum vitae).
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`C. Claim Construction
`Having defined the ordinarily skilled artisan, we now turn to claim
`construction. For petitions filed before November 13, 20185—as here—the
`Board interprets claims in an unexpired patent using the “broadest
`reasonable construction in light of the specification of the patent.” 37 C.F.R.
`§ 42.100(b) (2017); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`2144–46 (2016). Under that standard, we presume that a claim term carries
`its “ordinary and customary meaning,” which “is the meaning that the term
`would have to a person of ordinary skill in the art in question” at the time of
`the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). We need not explicitly interpret every claim term for which the
`parties propose a construction. See 35 U.S.C. § 314(a) (2012); Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly
`those terms need be construed that are in controversy, and only to the extent
`necessary to resolve the controversy.”); see also Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(applying Vivid Techs. in the context of an inter partes review).
`1. The preamble of claim 1
`The preamble of claim 1 recites “[a] method for treating a patient
`diagnosed with ascites due to liver cirrhosis.” Ex. 1001, 8:25–26.6
`
`5 See Changes to the Claim Construction Standard for Interpreting
`Claims in Trial Proceedings Before the Patent Trial and Appeal Board,
`83 Fed. Reg. 51,340 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b)
`effective November 13, 2018 to require a federal district court claim
`construction approach) (now codified at 37 C.F.R. § 42.100(b) (2019)).
`
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` Before institution, Petitioner argued that the preamble is not limiting.
`See Pet. 11–12 (contending that the “preamble of claim 1 is merely a
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`IPR2018-00974
`Patent 9,655,945 B2
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`Petitioner contends that the preamble should be broadly construed to
`encompass administering terlipressin for any reason, because “the preamble
`does not limit the claim to the treatment of ascites itself.” Pet. 12. Patent
`Owner argues that the preamble limits the scope of claim 1 to treating a
`patient for ascites. PO Resp. 6–15; PO Sur-reply 2–5.
`We begin with the words of the preamble. See Amgen Inc. v. Hoechst
`Marion Roussel, Inc., 457 F.3d 1293, 1301 (Fed. Cir. 2006) (“claim
`construction must begin with the words of the claims themselves”). We
`observe that the plain language of the preamble requires treating a patient
`diagnosed with ascites due to liver cirrhosis, but does not require treating
`ascites due to liver cirrhosis in the patient. Ex. 1001, 8:25–26. Therefore,
`we agree with Petitioner that the words of the preamble themselves do not
`limit the claim to the treatment of ascites itself.
`We now turn to the intrinsic record. Patent Owner argues that the
`intrinsic record “makes clear that the point of the claimed method . . . was to
`actually treat the patient’s ascites.” PO Resp. 7–8. And thus, Patent Owner
`argues, “[t]he broadest reasonable construction would require that the
`claimed method of ‘administering’ terlipressin actually treat (i.e., improve)
`the patient’s ascites (i.e., treating ascites in a patient diagnosed with ascites
`due to liver cirrhosis).” Id. at 8.
`Patent Owner points to portions of the specification describing the
`prior-art administration of terlipressin to HRS-1 patients. See PO Resp. 8–9
`
`statement of intended use”). In our Institution Decision, we determined that
`the preamble is limiting because it provides antecedent basis for the term
`“the patient” in the body of the claim. Inst. Dec. 9–10. After institution,
`Petitioner states that it “assumes the preamble is limiting,” and no longer
`challenges our determination. Pet. Reply 3 n.1.
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`(citing Ex. 1001, 2:50–59; Ex. 1002 ¶¶ 35, 55; Ex. 2023 ¶¶ 76–81). Patent
`Owner argues that an ordinarily skilled artisan would have understood,
`based on the prior art cited, that “continuous infusion terlipressin had
`already been used in patients with ascites due to liver cirrhosis.” Id. (citing
`Ex. 1002 ¶¶ 74–75; Ex. 2023 ¶ 80). Given these disclosures, Patent Owner
`argues, “it is not reasonable to construe the term ‘treating a patient
`diagnosed with ascites due to liver cirrhosis’ as only requiring treatment of a
`patient diagnosed with ascites due to liver cirrhosis.” Id. at 9. Instead, the
`broadest reasonable interpretation “would recognize the specification’s
`numerous statements that make clear that the invention relates, in one aspect,
`to the use of continuous infusion terlipressin to treat ascites.” Id. at 9–11.
`As further support, Patent Owner cites to the title of the ’945 patent, id. at 10
`(citing Ex. 1001, 1:1 “Treatment of Ascites”), as well as numerous passages
`and two examples in the written description referring to the treatment and
`management of ascites in patients, id. at 9–11 (citing Ex. 1001, 1:19–20,
`1:37–40, 1:28–33, 2:40–50, 4:7–31 (Example 1), 4:33–7:41 (Example 2)).
`Patent Owner also argues that, during prosecution, “both the
`Applicant and the Examiner . . . treated the preamble as requiring the
`terlipressin to actually treat the ascites.” Id. at 14. As support, Patent
`Owner points to applicant’s statements, made during prosecution, that the
`claims “recite methods for the treatment of ascites” and “are directed to the
`use of terlipressin as a treatment for ascites.” Id. at 13 (quoting Ex. 1008,
`307–308). Patent Owner argues that, over the course of prosecution, the
`Examiner modified her prior-art rejections “to identify where the art
`allegedly teaches that terlipressin treats ascites.” Id. at 13–14 (citing
`Ex. 1008, 326–27, 330, 333–34).
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`We recognize that the broadest reasonable interpretation “is an
`interpretation that corresponds with what and how the inventor describes his
`invention in the specification.” In re Smith Int’l, Inc., 871 F.3d 1375, 1383
`(Fed. Cir. 2017). And here, it is true that the title of the ’945 patent recites
`“treatment of ascites,” Ex. 1001, code (12), and the written description of the
`patent consistently recites “treating ascites” and “manag[ing] ascites,” see,
`e.g., id. at 1:19–20, 37–40. It is also true that, during prosecution, the
`applicant and the Examiner characterized the claims as directed to the use of
`terlipressin as a treatment for ascites. See, e.g., Ex. 1008, 308, 326–27, 330,
`333–34. Nevertheless, the plain language of the preamble unambiguously
`recites a method “for treating a patient diagnosed with ascites.” Ex. 1001,
`8:25–26 (emphasis added). It does not recite the more common verbiage of,
`for example, a method for treating a particular disease—i.e., ascites. For
`example, we contrast claim 1 with claim 7, the latter of which makes clear
`that the claimed method is “for reducing the accumulation of ascitic fluid in
`the abdominal cavity in an ambulatory ascites patient.” Id. at 8:42–43
`(emphasis added).
`The Federal Circuit has explained that, in cases where the “claim
`language has as plain a meaning on an issue” that the language “leav[es] no
`genuine uncertainties on interpretive questions relevant to the case, it is
`particularly difficult to conclude that the specification reasonably supports a
`different meaning.” Straight Path IP Grp., Inc. v. Sipnet EU S.R.O., 806
`F.3d 1356, 1361 (Fed. Cir. 2015). Here, even if the applicant intended for
`the preamble to recite a method for treating ascites, the plain words of the
`preamble do not reflect that intention. We may not use the intrinsic record
`as a basis for adopting an interpretation of the preamble that is contrary to its
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`plain language, because “[i]n claim construction, [the Federal Circuit] gives
`primacy to the language of the claims, followed by the specification.”
`Tempo Lighting, Inc. v. Tivoli, LLC, 742 F.3d 973, 977 (Fed. Cir. 2014).
`This rule applies even if the plain language reads on the prior art. See, e.g.,
`Tate Access Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357,
`1372 (Fed. Cir. 2002) (“where claim language is clear we must accord it full
`breadth even if the result is a claim that is clearly invalid”).
`Moreover, this is not a case where the breadth of a particular term is
`at issue. In Smith International, for example, the Federal Circuit held that
`the Board’s interpretation of the claim term “body” was unreasonably broad
`because that interpretation did not correspond with the specification’s
`repeated and consistent descriptions of “body” as a component distinct from
`other components, such as “mandrel” and “piston.” 871 F.3d at 1382. Our
`decision here is not about the breadth of any one particular claim term, but
`rather, is based on the particular order of claim terms. Put differently, the
`preamble unambiguously recites “treating a patient,” instead of treating a
`particular disease, and thus, the order of words themselves do not limit the
`preamble to treating ascites
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