Trials@uspto.gov
`571-272-7822
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`
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` Paper No. 9
`Date: January 16, 2024
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MURRAY & POOLE ENTERPRISES LTD.,
`Petitioner,
`v.
`INSTITUT DE CARDIOLOGIE DE MONTREAL,
`Patent Owner.
`____________
`
`IPR2023-01064
`Patent 11,400,063 B2
`____________
`
`
`Before ULRIKE W. JENKS, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`571-272-7822
`
`
`
`
` Paper No. 9
`Date: January 16, 2024
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MURRAY & POOLE ENTERPRISES LTD.,
`Petitioner,
`v.
`INSTITUT DE CARDIOLOGIE DE MONTREAL,
`Patent Owner.
`____________
`
`IPR2023-01064
`Patent 11,400,063 B2
`____________
`
`
`Before ULRIKE W. JENKS, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`IPR2023-01064
`Patent 11,400,063 B2
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`
`I. INTRODUCTION
`On June 16, 2023, Murray & Poole Enterprises Ltd. (“Petitioner”)
`filed a Petition requesting an inter partes review of claims 1–50 (“the
`challenged claims”) of U.S. Patent No. 11,400,063 B2 (Ex. 1001, “the ’063
`patent”). Paper 1 (“Pet.”). On October 18, 2023, Institut de Cardiologie de
`Montréal (“Patent Owner”) filed a Preliminary Response to the Petition.
`Paper 6 (“Prelim. Resp.”). With our authorization, Petitioner filed a Reply to
`the Preliminary Response (Paper 7, “Reply”) on December 6, 2023 and
`Patent Owner filed a Sur-reply (Paper 8, “Sur-reply”) to Petitioner’s Reply
`on December 13, 2023.
`We have authority under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the
`arguments and evidence presented in the parties’ briefs, we determine that
`Petitioner has established a reasonable likelihood that it would prevail in
`showing the unpatentability of at least one claim challenged in the Petition.
`Accordingly, we institute an inter partes review of claims 1–50 of the ’063
`patent.
`
`A. Real Parties in Interest
`Petitioner identifies Murray & Poole Enterprises Ltd., AGEPHA
`Pharma FZ LLC, AGEPHA Pharma USA, LLC, and UPTTON Limited, as
`real parties-in-interest. Pet. 72. Patent Owner identifies Institut de
`Cardiologie de Montréal (“MHI”) and Pharmascience Inc. as real parties-in-
`interest. Paper 5, 2.
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`B. Related Matters
`The parties state that they are not aware of any related matters.
`Pet. 72; Paper 5, 2.
`
`C. The ’063 Patent (Ex. 1001)
`The ’063 patent is titled “Early Administration of Low-dose
`Colchicine After Myocardial Infarctions.” Ex. 1001, code (54). The ’063
`patent issued from Application No. 17/097,285 (“the ’285 application”),
`filed November 13, 2020. Id. at codes (21), (22). The ’063 patent claims
`priority to Provisional Application No. 63/093,988 (“the ’988 provisional
`application”), filed on October 20, 2020 and Provisional Application
`No. 62/935,865 (“the ’865 provisional application”), filed on November 15,
`2019. Id. at code (60). The ’063 patent relates to “a method of treating a
`patient after having a myocardial infarction (MI), the method including
`initiating the administration of colchicine at a daily low dose to the patient
`within about 3 days of the MI.” Id. at code (57).
`According to the ’063 patent, “[i]nflammation appears to play an
`important role in atherosclerosis . . . and coronary artery disease.” Id. at
`1:9–11. The ’063 patent states that “[b]ecause acute coronary syndromes are
`associated with higher risks of recurrent events and exacerbated
`inflammation a need exists in the art for new treatment regimens.” Id. at
`1:60–62. The ’063 patent explains that “[c]olchicine is an inexpensive,
`orally administered, potent anti-inflammatory medication” that is indicated
`for the treatment of gout, familial Mediterranean fever, and pericarditis. Id.
`at 1:28–30, 1:43–47. However, the cardiovascular effects of colchicine have
`also been evaluated in trials in which participants were administered 0.5 mg
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`of colchicine once daily. Id. at 1:52–2:28. In one such example, trial
`participants with stable coronary disease were treated with colchicine at a
`dose of 0.5 mg once daily and had fewer cardiovascular events than those
`not receiving colchicine. Id.
`In a second example, patients who had recently suffered an MI were
`treated with colchicine at a dose of 0.5 mg once daily and had a statistically
`significant lower risk of ischemic cardiovascular events than placebo; had
`significantly reduced rates of death from cardiovascular causes, resuscitated
`cardiac arrest, myocardial infarction, stroke, and urgent hospitalization for
`angina leading to coronary revascularization compared to placebo; and had
`reduced morbidity relative to placebo. Id. In that study, “colchicine reduced
`the risk of ischemic cardiovascular (“CV”) events by 23% in the post-MI
`setting. Id. at 2:41–43.
`In a third example, the time to treatment initiation (“TTI”) was
`evaluated and patients who had recently suffered an MI were treated with
`colchicine at a dose of 0.5 mg once daily starting on days post-MI from 0–3,
`4–7, and 8–30. In that TTI study, initiation of colchicine treatment in days
`from 0–3 post-MI reduced the risk of the composite primary endpoint by
`48%. Id. at 2:43–47. The composite primary endpoint consisted of “a
`composite of CV death, resuscitated cardiac arrest, MI, stroke, or urgent
`hospitalization for angina requiring coronary revascularization.” Id. at 8:5–8.
`The invention claimed in the ’063 patent is based on the treatments used in
`the TTI study.
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`1. Overview of Provisional Patent Application No. 63/093,988
`(Ex. 1003)
`The ’988 provisional application describes patients with coronary
`artery disease (CAD) as being at “an increased risk of cardiovascular events
`including death, myocardial infarction (MI), stroke, and cardiac arrest; a risk
`that is magnified for each subsequent cardiovascular event.” Ex. 1003, 2:3–4
`(footnote omitted). “[I]nflammation has emerged as an important therapeutic
`target in patients with atherosclerosis.” Id. at 2:12–13 (footnote omitted).
`The ’988 provisional application is directed to a contemporary meta-analysis
`evaluating randomized control patient trials comparing colchicine to placebo
`(or no colchicine) for secondary cardiovascular prevention. Id. at 7:21–22.
`“Colchicine has an established safety profile from its centuries of use to treat
`gout.” Id. at 10:5.
`The colchicine trials show improvement in patients with CAD.
`In patients with CAD, the addition of colchicine to standard
`medical therapy was associated with a statistically significant
`reduction in the primary composite endpoint of cardiovascular
`mortality, MI, ischemic stroke, and urgent coronary
`revascularization, compared to patients on placebo or no
`colchicine.
`Ex. 1003, 6:8–12. “[A]ll trials showed a decrease in urgent coronary
`revascularizations among patients randomized to colchicine, [but] only
`COLCOT[1] detected a reduction in ischemic strokes.” Id. 8:11–13.
`The ’988 provisional application explains that
`[t]he anti-inflammatory properties of colchicine work through
`various mechanisms to inhibit the pathogenesis of CAD, and
`subsequently reduce the incidence of ischemic cardiovascular
`
`
`1 Colchicine Cardiovascular Outcomes Trial (COLCOT) (Ex. 1006).
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`events. In addition to targeting the NLRP3 inflammasome
`leading to the reduction of circulating levels of IL-1β and IL-6,
`colchicine also inhibits cholesterol crystals that promote
`inflammation and plaque instability in atherosclerosis.
`Ex. 1003, 9:3–7 (footnote omitted).
`2. Overview of Provisional Patent Application No.62/935,865
`(Ex. 1004)
`The ’865 provisional application describes colchicine as “an
`inexpensive, orally administered, potent anti-inflammatory medication that
`was initially extracted from the autumn crocus and has been used for
`centuries.” Ex. 1004, 1:21–22.
`The ’865 provisional application explains that “[i]n the Low-Dose
`Colchicine (LoDoCo) trial, patients with stable coronary disease treated with
`colchicine at a dose of 0.5 mg once daily had fewer cardiovascular events
`than those not receiving colchicine.” Id. at 1:36–38. In a different clinical
`trial referred to as the COLCOT “the effects of colchicine on cardiovascular
`outcomes as well as its long-term safety profile in patients who had recently
`had a myocardial infarction” was evaluated. Id. at 2:8–10.
`The ’865 provisional application describes that “the method involves
`administering colchicine within 5, 10, 15, 20, or 25 days of the MI.” Id. at
`2:32–33; see also id. at 9 (Table 1 – Patients were enrolled a mean
`13.4±10.2 days after myocardial infarction). The ’865 provisional
`application discloses that “colchicine is administered at 0.4 to 0.6 mg, and is
`preferably administered at 0.5 mg” daily. Id. at 3:12–13.
`The ’865 provisional application concludes that colchicine
`administered at a daily low dose of 0.5 mg led to a statistically significant
`lower risk of ischemic cardiovascular events than placebo. Death from
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`cardiovascular causes, resuscitated cardiac arrest, myocardial infarction,
`stroke, or urgent hospitalization for angina leading to coronary
`revascularization was also significantly lower among the patients who
`received 0.5 mg of colchicine than those who received placebo. Ex. 1004,
`2:13–17.
`
`D. Illustrative Claim
`Claims 1, 8, and 27 are the independent claims challenged by
`Petitioner in this proceeding. Independent claim 27, reproduced below, is
`illustrative of the subject matter:
`27. A method of reducing the risk of a stroke in a patient after
`having an MI, the method comprising initiating the
`administration of colchicine at a daily low dose to the patient
`within about 30 days of an MI.
`Ex. 1001, 42:33–36.
`
`E. Prior Art and Asserted Grounds
`Petitioner asserts that claims 1–50 of the ’063 patent are unpatentable
`based on the following grounds. Pet. 24.
`Claims challenged
`35 U.S.C. §
`
`References/Basis
`
`1–13, 17–26, 28,
`40–46, 49, 50
`27, 29–36, 39
`
`102
`
`102
`
`Bouabdallaoui2
`
`COLCOT protocol3
`
`
`2 Bouabdallaoui et al., Time-to-treatment initiation of colchicine and
`cardiovascular outcomes after myocardial infarction in the Colchicine
`Cardiovascular Outcomes Trial (COLCOT), EUROPEAN HEART J., 41:4092–
`4099 (2020). Ex. 1005 (“Bouabdallaoui”).
`3 “Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT),”
`https://web.archive.org/web/20171020004013/https:/clinicaltrials.gov/ct2/sh
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`1–50
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`1–26, 28, 40–50
`
`103
`
`103
`
`Nidorf,4 COLCOT Protocol,
`ESC Guidelines,5 COLCRYS6
`Bouabdallaoui, COLCRYS
`
`Petitioner relies upon the declaration of Paul Ridker, M.D. (Ex. 1049)
`to support its contentions. In addition, Petitioner relies on the Declaration of
`Raymond Cruitt, M.S. (Ex. 1038) and its appendices to establish the
`availability of the references.
`
`II. ANALYSIS
`
`A. Claim Construction
`The Board applies the same claim construction standard that would be
`used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37
`C.F.R. § 100(b) (2019). Under that standard, claim terms “are generally
`given their ordinary and customary meaning” as understood by a person of
`ordinary skill in the art at the time of the invention. Phillips v. AWH Corp.,
`415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp.
`v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “In determining
`the meaning of the disputed claim limitation, we look principally to the
`intrinsic evidence of record, examining the claim language itself, the written
`
`ow/NCT02551094. Ex. 1006 (“COLCOT protocol”); see also Ex. 1038,
`¶¶ 15–19, 23–25.
`4 Nidorf, US 10,206,891 B2, issued Feb. 19, 2019. Ex. 1007 (“Nidorf”).
`5 Ibanez et al., 2017 ESC Guidelines for the management of acute
`myocardial infarction in patients presenting with ST-segment elevation,
`EUROPEAN HEART J., 39:119–177 (2018). Ex. 1009 (“ESC guidelines”).
`6 Package insert for COLCRYSTM (colchicine, USP) tablets for Oral use,
`available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?
`event=overview.process&App1No=022351. Ex. 1016 (“COLCRYS”); see
`also Ex. 1038, ¶¶30–32.
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`description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v.
`Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006)
`(citing Phillips, 415 F.3d at 1312–17).
`Petitioner proposes constructions for several terms, including the
`preamble of claims 1–26 and 40–50 which recites “a method of treating a
`patient after having a myocardial infarction (MI),” the preamble of claims
`27–39 which recites “reducing the risk of a stroke,” and “wherein the patient
`is at a lower risk of a cardiovascular event” recited in claims 8–11 and 20–
`23. See Pet. 21–24.
`Patent Owner responds to Petitioner’s constructions of “reducing the
`risk of a stroke” and “wherein the patient is at a lower risk of a
`cardiovascular event,” but does not discuss Petitioner’s construction of “a
`method of treating a patient after having a myocardial infarction (MI)” at
`this time. Prelim. Resp. 16–22.
`In rendering our Decision, we construe the terms raised by Petitioner
`and Patent Owner.
`1. “a method of treating a patient after having a myocardial
`infarction (MI)”
`Petitioner contends that the preamble limitation is directed to treating
`a patient population but there is no required clinical efficacy. Pet. 22 (citing
`In re Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012) (“We are skeptical
`that a proper interpretation of [the claim term ‘for the treatment or
`prevention of stroke or its recurrence’] would include an efficacy
`requirement”); Ex. 1048 ¶¶ 97–104).
`Patent Owner does not address this limitation. See generally Prelim.
`Resp.
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`We agree with Petitioner that the preamble does not appear to have an
`efficacy requirement. Accordingly, at this stage of the proceeding, we accept
`Petitioner’s interpretation that the preamble simply describes the patient
`population that is to receive treatment.
`2. “reducing the risk of a stroke”
`Petitioner contends that the limitation of “reducing the risk of a
`stroke” is an intended result. Pet. 23 (citing Bristol-Myers Squibb Co. v. Ben
`Venue Lab’ys, Inc., 246 F.3d 1368, 1375–76 (Fed. Cir. 2001) (finding
`preamble language “a method for treating a cancer patient to effect
`regression of a taxol-sensitive tumor, said method being associated with
`reduced hematologic toxicity” “is only a statement of purpose and intended
`result”); Ex. 1049 ¶¶ 104–108).
`Patent Owner contends that “because the preamble states the purpose
`of the invention of claim 27 and provides the antecedent basis for the
`administration step in the claim, the preamble is limiting.” Prelim. Resp. 19.
`In addition, Patent Owner contends that in the notice of Allowability,
`Examiner stated that claim 27 is allowable “because the prior art ‘does not
`teach, show, suggest or make obvious the instant method of reducing the risk
`of a stroke in a patient having had a myocardial infarction by the
`administration of daily low dose colchicine within about 30 days of the
`myocardial infarction.’” Prelim. Resp. 20.
`If the body of the claim sets out the complete invention, and the
`preamble is not necessary to give “life, meaning and vitality” to the claim,
`“then the preamble is of no significance to claim construction because it
`cannot be said to constitute or explain a claim limitation.” Pitney Bowes, Inc.
`v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed.Cir.1999). Here, the
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`body of claim 27 recites “initiating the administration of colchicine at a daily
`low dose to the patient within about 30 days of an MI.” Ex. 1001, 42:34–36.
`The claim body, therefore, identifies the patient population that is to be
`treated with the low dose colchicine and the time frame in which to initiate
`treatment. The preamble, therefore, does not narrow the patient population
`nor change the way colchicine is administered – all that is required by the
`claim is that colchicine is administered to patients that have suffered a MI
`within a particular time period after the MI event. The step of the method is
`preformed the same way whether or not the patient experiences a reduction
`in the risk of stroke. See, e.g., In re Hirao, 535 F.2d 67, 70 (CCPA 1976)
`(“the preamble merely recites the purpose of the process; the remainder of
`the claim . . . does not depend on the preamble for completeness, and the
`process steps are able to stand alone.”); see Pet. 23 (“‘reducing the risk of a
`stroke’ does ‘not result in a manipulative difference in the steps of the claim’
`and is [therefore] non-limiting.” (citing Bristol-Myers, 246 F.3d at 1375–76;
`Ex. 1049 ¶¶ 104–108)).
`We agree with Petitioner that Examiner’s claim interpretation is in
`error. Here, the body of claim 27 defines a structurally complete invention
`by identifying the target population as any patient that has had a myocardial
`infarction (MI) and the onset of treatment using 0.5 mg colchicine within a
`30-day time window. See Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)
`(“[W]here a patentee defines a structurally complete invention in the claim
`body and uses the preamble only to state a purpose or intended use for the
`invention, the preamble is not a claim limitation.”); IMS Tech., Inc. v. Haas
`Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000) (“If the preamble
`adds no limitations to those in the body of the claim, the preamble is not
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`itself a claim limitation and is irrelevant to proper construction of the
`claim.”). The recitation of “reducing the risk of a stroke” in the preamble,
`therefore, does not result in a difference in the way colchicine is
`administered to the identified patient population. See Pet. 23.
`We have reviewed the parties’ contentions, and determine at this stage
`of the proceedings that Petitioner has provided a requisite showing that the
`body of claim 27 describes a structurally complete invention. The preamble
`of claim 27, therefore, is not limiting because it simply expresses the
`intended result of the positively recited method step within the body of the
`claim. See Pet. 23.
`3. “wherein the patient is at a lower risk of a cardiovascular
`event”
`Claim 8 contains three wherein clauses: (1) “wherein the colchicine is
`administered without pre-loading the patient with a higher dose of colchicine
`before the administration at the daily low dose;” (2) “wherein the
`cardiovascular event is resuscitated cardiac arrest, stroke, or urgent
`hospitalization for angina requiring coronary revascularization;” and (3)
`“wherein the patient is at a lower risk of a cardiovascular event, relative to a
`patient not being administered colchicine.” See Ex. 1001, 41:50–60.
`Petitioner contends that the third “wherein clause” of claim 8 –
`“wherein the patient is at a lower risk of a cardiovascular event” – “‘is only a
`statement of purpose and intended result’ that ‘does not result in a
`manipulative difference in the steps of the claim’ and is thus a non-limiting
`intended result and does not add patentable weight to the claims.” Pet. 23
`(citing Bristol-Myers, 246 F.3d at 1375–76; Syntex (U.S.A.) LLC v. Apotex,
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`Inc., 407 F.3d 1371, 1378 (Fed. Cir. 2005); Minton v. Nat’l Ass’n of Sec.
`Dealers, Inc., 336 F.3d 1373,1381 (Fed. Cir. 2003)).
`Patent Owner disagrees. Patent Owner argues that a wherein clause
`that “states a condition that is material to patentability, . . . cannot be ignored
`in order to change the substance of the invention.” Prelim. Resp. 20 (citing
`Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1376 (Fed. Cir. 2019)
`(quoting Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005))).
`During prosecution, “Dr. Tardif argued that his study showed a reduction in
`risk of specific cardiovascular risks with early administration of colchicine,
`which is different from and not disclosed in the prior art. (EX1002 at 331-
`332.). . . . [The] ‘wherein’ clauses were necessary to overcome the prior art.”
`Prelim. Resp. 21.
`The first wherein clause “wherein the colchicine is administered
`without pre-loading the patient with a higher dose of colchicine before the
`administration at the daily low dose” defines the limitations of how the
`colchicine is administered.
`The second wherein clause “wherein the cardiovascular event is
`resuscitated cardiac arrest, stroke, or urgent hospitalization for angina
`requiring coronary revascularization” defines the type of cardiovascular
`event encompassed by the claim.
`The dispute between the parties is directed to the third wherein clause
`“wherein the patient is at a lower risk of a cardiovascular event, relative to a
`patient not being administered colchicine.” This third wherein clause simply
`asks for a comparison between patients receiving colchicine with a similar
`situated patient population not receiving the colchicine treatment.
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`“An intended use or purpose usually will not limit the scope of the
`claim because such statements usually do no more than define a context in
`which the invention operates.” See Boehringer Ingelheim Vetmedica, Inc. v.
`Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Although
`“[s]uch statements often . . . appear in the claim’s preamble,” a statement of
`intended use or purpose can appear elsewhere in a claim. In re Stencel, 828
`F.2d 751, 754 (Fed. Cir. 1987).
`We have reviewed the parties’ contentions, and determine at this stage
`of the proceedings that Petitioner has provided a requisite showing that this
`third clause merely describes the benefit of the administration of colchicine
`to the identified patient population. We are not persuaded by Patent Owner’s
`contention that this clause is material to how the method is performed. This
`“wherein clause,” therefore, merely defines the result of the positively
`recited method steps. See Pet. 23; see, e.g., Minton, 336 F.3d at 1381 (a
`“whereby clause in a method claim is not given weight when it simply
`expresses the intended result of a process step positively recited.”).
`
`B. Level of Ordinary Skill in the Art
`Petitioner contends a person of ordinary skill in the art (“POSA”), or a
`“skilled cardiologist,” would have:
`• An M.D. degree and be board-certified with a subspecialty in
`the treatment of cardiovascular disease.
`• At least 3-5 years of experience, following board certification,
`in cardiology and cardiovascular disease treatment and
`sufficient clinical experience to understand standard good
`medical practice in patient management.
`• Been familiar with acute coronary syndromes, stable coronary
`diseases, cardiovascular diseases, and their standard treatments,
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`including the acute management and long-term secondary
`preventions of myocardial infarction.
`• Been aware of research relating to cardiovascular disease
`progression, including the role of inflammatory pathways in
`secondary cardiovascular events.
`Pet. 21 (citing Ex. 1049, ¶ 89).
`Patent Owner’s declarant, Hossein Ardehali, M.D., Ph.D., disputes
`Petitioner’s definition of a POSA. Ex. 2001 ¶ 12. Dr. Ardehali posits that Dr.
`Ridker’s definition is too narrow and that “a POSA for the ’063 patent
`would be an M.D. with training and 3-5 years of experience in treating
`cardiovascular disease.” Id. Although Dr. Ardehali disagrees with
`Petitioner’s definition of a POSA, Dr. Ardehali states that his opinions
`remain the same regardless of whether the Board adopts Petitioner’s
`definition or Patent Owner’s definition. Id.
`Based on the present record, we adopt Petitioner’s definition of a
`POSA. We further note that 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)).
`
`C. Discretionary Denial Under 35 U.S.C. § 325(d)
`As a preliminary issue, Patent Owner urges the Board to exercise
`discretion to deny institution of inter partes review under 35 U.S.C.
`§ 325(d). Prelim. Resp. 2–16. Petitioner opposes. Pet. 62–71.
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`1. Legal Standard
`Section 325(d) provides that the Director7 may “reject the petition” if
`“the same or substantially the same prior art or arguments previously were
`presented to the Office.” The Board analyzes this issue under a two-part
`framework:
`(1) [determining] whether the same or substantially the same art
`previously was presented to the Office or whether the same or
`substantially the same arguments previously were presented to
`the Office; and (2) if either condition of [the] first part of the
`framework is satisfied, [determining] whether the petitioner has
`demonstrated that the Office erred in a manner material to the
`patentability of challenged claims.
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469 Paper 6, 8 (PTAB Feb. 13, 2020) (precedential) (footnote
`omitted). “If a condition in the first part of the framework is satisfied and the
`petitioner fails to make a showing of material error, the Director generally
`will exercise discretion not to institute inter partes review.” Id. at 8–9
`(emphasis added).
`In analyzing whether the same or substantially the same art or
`arguments were previously presented to the Office, we consider factors
`including: (i) the similarities and material differences between the asserted
`art and the prior art previously presented to the Office; (ii) the cumulative
`nature of the asserted art and the prior art previously evaluated by the Office;
`and (iii) the extent of the overlap between the arguments made before the
`Office and the manner in which the petitioner relies on the prior art or the
`patent owner distinguishes the prior art. Id. at 8–10; see also Becton,
`
`
`7 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a).
`
`16
`
`
`
`IPR2023-01064
`Patent 11,400,063 B2
`
`Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17–
`18 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton,
`Dickinson”).
`In analyzing whether the petitioner has demonstrated that the Office
`erred in a manner material to the patentability of challenged claims, we
`consider factors including: (iv) the extent to which the asserted art was
`evaluated by the Office, including whether the prior art was the basis for
`rejection during examination; (v) whether the petitioner has pointed out
`sufficiently how the Office erred in its evaluation of the asserted prior art;
`and (vi) the extent to which additional evidence and facts presented in the
`petition warrant reconsideration of prior art or arguments. Advanced Bionics,
`8–10; Becton, Dickinson, 17–18.
`2. Analysis
` Part 1: Whether the same or substantially the same art or
`arguments were presented previously to the Office
`The first part of the Advanced Bionics framework requires us to
`determine whether the Petition advances the same or substantially the same
`art or arguments that were previously presented to the Office. Advanced
`Bionics, 8. For the reasons explained below, we determine that the same or
`substantially the same art was previously presented, and thus, the first part of
`the framework is satisfied.
`Petitioner relies on five references in its asserted grounds of
`unpatentability: Bouabdallaoui (Ex. 1005), COLCOT protocol (Ex. 1006),
`Nidorf (Ex. 1007), ESC guidelines (Ex. 1009), and COLCRYS (Ex. 1016).
`Pet. 24. Petitioner acknowledges that “Bouabdallaoui (EX1005) was
`submitted via IDS” but argues that Examiner did not substantively address
`
`17
`
`
`
`IPR2023-01064
`Patent 11,400,063 B2
`
`the reference on the record. Pet. 63. According to Petitioner, “Bouabdallaoui
`is prior art to all challenged claims not entitled to an effective filing date
`earlier than November 13, 2020, i.e., at least claims 1–26, 28 and 40–50.”
`Pet. 65.
`Petitioner argues that during prosecution of the ’063 patent, Patent
`Owner listed the COLCOT protocol on an IDS (see Ex. 1002, 358) but
`actually submitted a non-prior art version “retrieved from the
`Clinicaltrial.gov website on March 15, 2021, that differs from the 2015
`version.” Pet. 63 (citing Ex. 1002, 315–323, 326); compare Ex. 1006 with
`Ex. 1002, 316–323. Petitioner contends that “this non-prior art was never
`addressed on the record.” Pet. 63.
`Petitioner additionally cites Nidorf (Ex. 1007), ESC guidelines (Ex.
`1009), and COLCRYS (Ex. 1016) and asserts that these references were not
`submitted to the office and are not cumulative with “references ‘extensively
`evaluated during examination’ or were ‘the basis for rejection.’” Pet. 68.
`Petitioner acknowledges that “another Nidorf patent (EX1018)” was
`submitted to the office but asserts that the reference was not discussed by
`Examiner. Pet. 68 n.9.
`Patent Owner responds that “Petitioner does not dispute that
`Bouabdallaoui was provided to the Examiner.” Prelim. Resp. 3, see also id.
`at 8 (citing Ex. 1002, 76, 175-182). Additionally, Patent Owner contends
`that Bouabdallaoui is not prior art because “AIA §102(b) provides a prior art
`exception for any publication disclosing the invention or the subject matter
`of the invention that an inventor makes or is made from information
`obtained directly or indirectly from the inventor.” Prelim. Resp. 5.
`
`18
`
`
`
`IPR2023-01064
`Patent 11,400,063 B2
`
`
`Patent Owner contends that the COLCRYS disclosure of colchicine
`tablets relied on by Petitioner is cumulative to information already before
`Examiner. Prelim. Resp. 9, see also id. at 16 (“Colcrys is cumulative at best
`and also irrelevant as it relates to another condition (gout) and not the
`claimed condition.”). Patent Owner contends that “[t]he Exhibit that
`Petitioner relies upon is merely an earlier version of the Protocol that was
`provided to the Examiner,[] and the earlier and later versions are
`substantively the same. (Compare EX1006 with EX1002 at 315-323.)”
`Prelim. Resp. 10.
`Patent Owner acknowledges that “while the specific Nidorf patent
`cited by Petitioner was not before the Examiner, a related Nidorf patent
`(EX1018) was before the Examiner with substantially the same disclosure.”
`Prelim. Resp. 15. Patent Owner contends that both Nidorf patents “claim
`priority from the same foreign applications and both are subject to a terminal
`disclaimer in view of the same U.S. patent (compare EX1007 at 1 at (*),
`(63), (30) with EX1018 at 1 at (*), (86), (30)). They are therefore
`cumulative.” Id.
`Patent Owner contends that “[t]he ESC Guidelines were not
`themselves cited, but Petitioner ignores the fact that they are too general and
`do not relate at all to treating the specific patients identified in the claims
`with colchicine.” Prelim. Resp. 15, see also id. at 15–16 (“The Guideline
`teachings are too general and would not be applicable to treatment with
`colchicine, which is not mentioned in the Guidelines at all.”).
`There can be no dispute that Bouabdallaoui and the COLCOT
`protocol were before the Office. Bouabdallaoui and the COLCOT protocol
`were listed on an IDS, initialed by Examiner and listed on the face of the
`
`19
`
`
`
`IPR2023-01064
`Patent 11,400,063 B2
`
`’063 patent as a considered-reference. Ex. 1001, code (56); Ex. 1002, 306,
`358. Specifically, Examiner certified that all references listed in the IDS
`“except where lined through” were considered, and Bouabdallaoui and the
`COLCOT protocol are not lined through. Ex. 1002, 306, 358. Patent Owner
`further argues that “the COLCOT Protocol is substantially similar to the
`COLCOT Protocol the Examiner reviewed.” Prelim. Resp. 11; compare Ex.
`1006 with Ex. 1002, 315–323.
`On the other hand, Nidorf, ESC guidelines, and COLCRYS were not,
`themselves, before the Office during examination of the application that
`issued as the ’063 patent and therefore are not the “same art” previously
`presented to the Office. Advanced Bionics, 13–14. But, Patent Owner argues,
`art substantially similar to
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