Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper No. 7
`Entered: July 23, 2018
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
`v.
`MERCK PATENTGESELLSCHAFT,
`Patent Owner
`_______________
`
`Case IPR2018-00423
`Patent 8,673,921 B2
`_______________
`
`
`Before SUSAN L.C. MITCHELL, ROBERT A. POLLOCK, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`SMITH, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
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`Case IPR2018-00423
`Patent 8,673,921 B2
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`
`INTRODUCTION
`I.
`Argentum Pharmaceuticals LLC (“Petitioner”) filed a Petition (Paper 2,
`“Pet.”) to institute an inter partes review of claims 1, 11, 12, 14, and 15 of U.S.
`Patent 8,673,921 (the “’921 patent”). 35 U.S.C. § 311. Merck Patentgesellschaft
`(“Patent Owner”) filed a Preliminary Response to the Petition (Paper 6). (“Prelim.
`Resp.”).
`We have authority to determine whether to institute an inter partes review
`under 35 U.S.C. § 314. Based on the particular circumstances of this case, we
`exercise our discretion under 35 U.S.C. § 325(d) and do not institute inter partes
`review of the challenged claims.
`Related Proceedings
`A.
`Petitioner identifies the ’921 patent as being the subject of the following
`proceedings: Forest Laboratories, Inc. v. InvaGen Pharm. Inc., Civ. Action No.
`15-cv- 272; Forest Laboratories, Inc. v. Alembic Pharm. Ltd., Civ. Action No. 15-
`cv-273; Forest Laboratories, Inc. v. Apotex Inc., Civ. Action No. 15-cv-274;
`Forest Laboratories, Inc. v. Teva Pharm. USA Inc., Civ. Action No. 15-cv-275;
`Forest Laboratories, Inc. v. InvaGen Pharm. Inc., Civ. Action No. 15-cv-277; and
`Forest Laboratories, Inc. v. InvaGen Pharm. Inc., Civ. Action No. 15-cv-1078.
`Pet. 1–2. Patent Owner indicates that the above Civ. Action Nos. 272, 273, 274,
`275, 277, and 1078 are now closed, and consolidated into Forest Laboratories,
`LLC v. Accord Healthcare, Inc., Civ. Action No. 15-cv-272-GMS (consolidated)
`(D. Del. 2015). Paper 3, 2–3.
`
`The ’921 Patent
`B.
`The ’921 patent relates to “new crystalline modifications of the
`hydrochloride of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-
`piperazine.” Ex. 1001, Abstract; see also id. at Title (referencing “Polymorphic
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`Patent 8,673,921 B2
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`Forms” of same compound). The ’921 patent states that “[m]ethods for preparing
`pure crystals of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-
`piperazine hydrochloride [vilazodone hydrochloride (VHCl)] have now been
`found.” Id. at 2:25–27. The ’921 patent further states that the morphologic Forms
`of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`hydrochloride and dihydrochloride (Forms I–XI and XIII–XVI) are referred to as
`the “products of the invention” and can be used to treat and prevent a number of
`disorders. Id. at 14:58–15:19. The ’921 patent also indicates that “[t]he present
`invention further provides pharmaceutical compositions or medicaments
`comprising a Product of the Invention.” Id. at 15:22–26.
`Illustrative Claims
`C.
`Petitioner challenges claims 1, 11, 12, 14, and 15 of the ’921 patent, of
`which claims 1 and 11 are the only independent claims. Claims 1 and 11 are
`reproduced below:
`1. A compound which is 1-[4-(5-cyanoindol-3-yl)butyl]-4-
`(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride in
`its crystalline modification, wherein the compound is an
`anhydrate, hydrate, solvate or dihydrochloride.
`Ex. 1001, 27:13–16.
`11. A pharmaceutical composition comprising a compound
`which is 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-
`benzofuran-5-yl)-piperazine hydrochloride anhydrate in
`its crystalline modification IV, and one or more conventional
`auxiliary substances and/or carriers.
`Id. at 28:5–9.
`
`Claims 12 and 14 generally recite a method of treating certain disorders
`comprising administering the composition of claim 11 or a compound of claim 1,
`respectively. Ex. 1001, 28:10–20; 34–44. Claim 15 recites a “pharmaceutical
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`composition comprising a compound according to claim 1, and one or more
`conventional auxiliary substances and/or carriers.” Id. at 28:45–47.
`According to Patent Owner, the challenged claims “relate to crystalline
`vilazodone hydrochloride including vilazodone hydrochloride Form IV.” Prelim.
`Resp. 1. Vilazodone hydrochloride is the active ingredient in VIIBRYD®, which is
`indicated for the treatment of major depressive disorder. Id. at 3–4; Ex. 2019, 1,
`21. As set forth in the product labeling, “VIIBRYD tablets for oral administration
`contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin
`reuptake inhibitor and a 5HT1A receptor partial agonist.” Ex. 2019, 10.
`The Asserted Grounds of Unpatentability
`D.
`Petitioner contends that the challenged claims are unpatentable under 35
`U.S.C. §§ 102(b) and 103(a) based on the following grounds. Pet. 3.
`Reference[s]
`Basis
`Claims challenged
`’241 patent1 as
`§ 102(b)
`1, 14, and 15
`characterized by Patent
`Owner’s Admissions2
`’241 patent, as
`characterized by Patent
`Owner’s Admissions, in
`view of Bartoszyk3
`
`1, 14, and 15
`
`§ 103(a)
`
`
`1 Böttcher et al., U.S. Patent No. 5,532,241, issued July 2, 1996 (“’241 patent”).
`Ex. 1004.
`2 In referring to the term “Patent Owner’s Admissions,” Petitioner states that “[t]he
`background section of the ‘921 patent makes several admissions” Pet. 4–5. See
`Section II.C.2 infra.
`3 Bartoszyk et al., WO 00/72832 A2, published Dec. 7, 2000 (“Bartoszyk”).
`Ex. 1005.
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`Reference[s]
`’241 patent, as
`characterized by Patent
`Owner’s Admissions, in
`view of Pavia4 and Byrn5
`’241 patent, as
`characterized by Patent
`Owner’s Admissions, in
`view of Bartoszyk, Pavia,
`and Byrn
`
`Basis
`§103(a)
`
`Claims challenged
`1 and 11
`
`
`§103(a)
`
`1, 12, 14, and 15
`
`Petitioner also relies on the Declarations of Dr. Robin D. Rogers, Ph.D.
`(Ex. 1002), Dr. Sanjay J. Mathew, M.D. (Ex. 1003), and Dr. Gabriela Gurau, Ph.D.
`(Ex. 1039).
`
` ANALYSIS
`Person of Ordinary Skill in the Art
`A.
`Petitioner asserts that a “person of ordinary skill in the art (‘POSA’) at the
`time of the alleged invention of the ‘921 patent would have at least a bachelor’s
`degree in chemistry, pharmaceutical sciences, or related discipline, and several
`years of experience working in pharmaceutical solid product development and/or
`solid-state chemistry.” Pet. 11. Petitioner further states that “[t]he POSA would
`have expertise and experience in synthesis, crystallization, and characterization of
`salts and polymorphic forms. A POSA could have a lower level of formal
`education if such a person had a higher degree of relevant working experience.”
`Id. at 11–12.
`
`
`4 Donald L. Pavia et al., Introduction to Organic Laboratory Techniques: A
`Contemporary Approach, 3rd ed., 508–540 (1988) (“Pavia”). Ex. 1032.
`5 Stephen R. Byrn et al., Solid-State Chemistry of Drugs, 2nd ed., 1–219 (1999)
`(“Byrn”). Ex. 1012.
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`Petitioner also states that a POSA “would collaborate with others having
`expertise in methods of treating mood disorders, including depression,” and that
`such a POSA “would have an M.D. with extensive experience in the study and
`treatment of mood disorders. A POSA would understand the references referred to
`herein and would be able to draw inferences from them.” Id. at 12.
`According to Patent Owner, a POSA of the ’921 patent “would have had at
`least a bachelor’s degree in chemistry, pharmaceutical sciences, or a related
`discipline, along with several years of experience working in pharmaceutical solid
`product development and/or solid-state chemistry.” Prelim. Resp. 9. Patent Owner
`also contends that a POSA “also would have had knowledge and experience
`(and/or access to others with knowledge and experience) in treating patients for
`depression or other conditions identified in the ’921 patent and evaluating the
`effects of such treatment.” Id.
`Patent Owner acknowledges, and we agree, that Patent Owner sets forth a
`
`similar definition of a POSA as advanced by Petitioner. Id. However, Patent
`Owner states that Petitioner’s identification of a POSA as including an individual
`having an “M.D. with extensive experience in the study and treatment of mood
`disorders” is flawed “because it does not require any experience in solid-state
`chemistry, which is the primary focus of the ’921 patent claims.” Id.
`On this record and at this stage of the proceeding, we do not discern an
`appreciable difference in the parties’ respective definitions of a person of ordinary
`skill in the art. Accordingly, we find that a person of ordinary skill in the art would
`have (1) at least a bachelor’s degree in chemistry, pharmaceutical sciences, or
`related discipline, and several years of experience working in pharmaceutical solid
`product development and/or solid-state chemistry, and (2) expertise and experience
`in synthesis, crystallization, and characterization of salts and polymorphic forms.
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`We also find that a POSA could have a lower level of formal education if such a
`person had a higher degree of relevant working experience, and may have
`knowledge and experience (and/or access to others with knowledge and
`experience) in treating patients with mood disorders.
`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)).
`Claim Construction
`B.
`In an inter partes review, the Board interprets claim terms in an unexpired
`patent according to the broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo
`Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of
`broadest reasonable construction standard to inter partes review proceedings).
`“Under a broadest reasonable interpretation, words of the claim must be given their
`plain meaning, unless such meaning is inconsistent with the specification and
`prosecution history.” Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir.
`2016). Any special definitions for claim terms must be set forth with reasonable
`clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994).
`Petitioner states that “[t]he broadest reasonable interpretation of the term
`‘crystalline modification’ is ‘crystalline form.’” Pet. 9. Petitioner also states that
`“[t]he broadest reasonable interpretation of ‘administering’ is ‘delivering into the
`body’ of a patient.” Id. at 11. Petitioner contends that such constructions are
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`consistent with the plain or ordinary meanings of the terms, and identical to
`constructions proposed by Patent Owner in district court litigation regarding the
`’921 patent. Id. at 9, 11. Patent Owner does not contest those proposed
`constructions, and notes that “[f]or purposes of this preliminary response, Patent
`Owner does not advance constructions for any other terms in the challenged
`claims.” Prelim. Resp. 10. Accordingly, for purposes of this decision, we adopt
`the constructions that “crystalline modification” means “crystalline form,” and that
`“administering” means “delivering into the body” of a patient.
`Petitioner further argues that the terms “crystalline” and “crystalline
`modification”
`should not be interpreted to mean that Forms I to XVI must be “entirely
`crystalline” and no particular level of purity should be attributed to the
`crystalline compound recited in claims 1, 11, 12, 14, and 15. There is
`no support in the claims, specification, or prosecution history to support
`such a construction. Indeed, neither the claim terms nor the
`specification of the ’921 patent mentions the purity of the crystalline
`compound recited in claims 1, 11, 12, 14, and 15.
`Pet. 10.
`Petitioner supports that argument by referencing the ’921 patent generally
`and by citing a paragraph in the Rogers Declaration that purports to construe
`claims 1 and 11 as not excluding the possibility that “the crystalline modification is
`present in a mixture with the amorphous form and/or the free base or other
`crystalline forms.” Ex. 1002 ¶ 47. However, paragraph 47 of the Rogers
`Declaration does not sufficiently or persuasively address the specific wording of
`claims 1 and 11 as a whole, and only refers generally to the ’921 specification and
`claims. See id. (“neither the ’921 patent specification [nor] the claims of the ’921
`patent require or specify any level of purity.”) Furthermore, although experts may
`address underlying factual matters (“evidentiary underpinngs”) when appropriate,
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`the ultimate issue of claim construction is a question of law. See Teva Pharm.
`USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015) (“‘[e]xperts may be examined
`to explain terms of art, and the state of the art, at any given time,’ but they cannot
`be used to prove ‘the proper or legal construction of any instrument of writing.’”)
`(citations omitted). Here, Petitioner relies on the conclusory statements of Dr.
`Rogers as purportedly establishing that the construction or scope of claims 1 and
`11 does not exclude the possibility that “the crystalline modification is present in a
`mixture with the amorphous form and/or the free base or other crystalline forms.”
`See Pet. 10; Ex. 1002 ¶ 47. Because “the ultimate question of construction []
`remain[s] a legal question,” Teva, 135 S.Ct. at 842, we provide our construction of
`claims 1 and 11 below.
`Petitioner also argues that “[w]hen a patent recites a compound comprising a
`specific polymorphic form, that recitation does not foreclose the possibility that
`other active ingredients are also present” (Pet. 10 (emphasis added)). In support of
`this position, Petitioner relies on a district court decision6 and a Board decision7 on
`appeal from an Examiner’s rejection, both of which were decided on their own
`facts and neither of which are binding on the Board. See id. Moreover, although
`claims 11 and 15 recite a “composition comprising,” none of the challenged claims
`recite a “compound comprising.” Ex. 1001, 27:13–16; 28:5–47.
`Petitioner’s argument and conclusory statements are not a sufficient showing
`to support a claim construction as proposed by Petitioner. Here, the specification
`of the ’921 patent discusses the ’241 patent and describes a “former” vilazodone
`hydrochloride that was a “mixture” of amorphous vilazodone hydrochloride,
`
`
`6 In re Armodafinil Patent Litig., Inc., 939 F.Supp. 2d 456, 474 (D. Del. 2013).
`7 Ex Parte Reddy, 2010 Pat. App. LEXIS 13975, at *9–10 (BPAI March 31, 2010).
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`“crystallized” vilazodone hydrochloride, and the free base vilazodone
`hydrochloride, followed by the statement that “[c]ertain crystalline, i.e.
`morphological forms of pharmaceutical compounds may be of interest to those
`involved in the development of a suitable dosage form.” Ex. 1001, 1:35–48; 1:65–
`2:21 (emphasis added). That background discussion in the ’921 patent is followed
`immediately by the “Summary of the Invention” that begins with “[m]ethods for
`preparing pure crystals of [vilazodone hydrochloride] have now been found,”
`followed by a description of fifteen crystalline forms (I–XI and XIII–XVI). Id. at
`2:25–40 (emphasis added). The ’921 patent further states that “[g]enerally, the
`specific crystalline forms of the present invention have certain advantages over the
`product obtained according to the [’241 patent].” Id. at 5:4–6. A fair reading of
`the specification of the ’921 patent thus suggests that it is directed to the crystalline
`forms that vilazodone hydrochloride can take rather than a compound that is a
`mixture of crystallized vilazodone hydrochloride in combination with amorphous,
`and/or free base forms. However, Petitioner provides no persuasive analysis of
`whether or how its proposed interpretation is reasonable “in light of the
`specification.” See 37 C.F.R. § 42.100(b).
`Petitioner also fails to sufficiently analyze the claims as a whole to support
`its proffered interpretation of “crystalline” and “crystalline modification.”
`Although the challenged claims do not expressly recite that the compound “in its
`crystalline modification” is “entirely” crystalline or a specific level of purity of the
`compound, that is not the end of the inquiry. See Kyocera Wireless Corp. v.
`International Trade Commission, 545 F.3d 1340, 1347 (Fed. Cir. 2008) (claim
`terms are not interpreted “in a vacuum, devoid of the context of the claim as a
`whole.”) (citing cases). We also note that independent claims 1 and 11 recite a
`compound “which is” vilazodone hydrochloride in its crystalline modification
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`(claim 1) and “which is” vilazodone hydrochloride anhydrate in its crystalline
`modification IV (claim 11). Ex. 1001, 27:13–16; 28:5–9. Petitioner provides no
`interpretation of the transitional phrase “which is” in light of the specification. See
`Lampi Corp. v. American Power Prods., Inc., 228 F.3d 1365, 1376 (Fed. Cir.
`2000) (“Transitional phrases . . . must be interpreted in light of the specification to
`determine whether open or closed language is intended.”) (citations omitted).
`In view of the language of the specification discussed above and claim 1 as a
`whole, we find that the phrase “which is” as used in claim 1 is more akin to the
`closed term “consisting of” than the open term “comprising.”8 See AFG Indus.,
`Inc. v. Cardinal IG Co., Inc. 239 F.3d 1239, 1245 (Fed. Cir. 2001) (“[C]losed
`transition phrases such as ‘consisting of’ are understood to exclude any elements,
`steps, or ingredients not specified in the claim.”) (citations omitted); CIAS, Inc. v.
`Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (“In the patent claim
`context, the term ‘comprising’ is well understood to mean ‘including but not
`limited to.’”) (citations omitted).
`Accordingly, on this record, we construe claim 1 as limited to a compound
`which is vilazodone hydrochloride in its crystalline modification or form, wherein
`the compound is an anhydrate, hydrate, solvate, or dihydrochloride. Ex. 1001,
`27:13–16. Claim 11 also uses the phrase “which is” as addressed above in
`connection claim 1, but claim 11 recites a “pharmaceutical composition
`comprising.” Id., 28:5–9. Thus, on this record, we construe claim 11 as a
`pharmaceutical composition that includes at least a compound which is vilazodone
`
`
`8 We also note that, in district court litigation regarding the ’921 patent, neither
`Patent Owner nor Defendants sought to construe “crystalline modification” of
`vilazodone as referring to a form a vilazodone that is not crystalline. Ex. 2013, 3,
`n.6.
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`hydrochloride anhydrate in its crystalline modification (or form) IV, “and one or
`more conventional auxiliary substances and/or carriers,” but the composition is not
`limited to those ingredients. Id.
`In summary, for purposes of our decision herein, we adopt the constructions
`of independent claims 1 and 11 as set forth above, but we decline to further
`interpret “crystalline” or “crystalline modification” as proposed by Petitioner in
`view of the insufficient showing by Petitioner that such interpretation is proper.9
`Anticipation by the ’241 patent as characterized by Patent Owner’s
`C.
`Admissions
`Petitioner asserts that claims 1, 14, and 15 are anticipated by the ’241 patent
`as characterized by Patent Owner’s Admissions. Pet. 17–23. For the reasons set
`forth below, we exercise our discretion to decline institution because the same or
`substantially the same prior art or arguments were previously presented to the
`Office. See 35 U.S.C. § 325(d) (“In determining whether to institute or order a
`proceeding under this chapter . . . the Director may take into account whether, and
`reject the petition or request because, the same or substantially the same prior art or
`arguments previously were presented to the Office.”). When a prior art reference,
`such as the ’241 patent, is presented in a petition and was already considered
`substantively by the Examiner, “the petitioner has the initial burden to identify
`[any] errors made by the examiner with respect to the prior art reference.” Neil
`
`
`9 Petitioner has the burden of establishing a reasonable likelihood that it would
`prevail in showing the unpatentability of a challenged claim. 35 U.S.C. § 314(a).
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`Ziegmann, N.P.Z., Inc. v. Carlis G. Stephens, Case IPR2015-01860, slip op. at 10
`(PTAB Sept. 6, 2017) (Paper 13).10
`The ’241 patent (Ex. 1004)
`1.
`The ’241 patent discloses 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-
`benzofuran-5-yl)-piperazine, its physiologically acceptable salts, a process by
`which it/they can be prepared, and their use in treating certain medical disorders.
`Ex. 1004, 7:30–58; Ex. 1001, 1:35–40. Example 4 of the ’241 patent describes the
`preparation of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-
`piperazine hydrochloride (VHCl). Ex. 1004, 11:17–24; Ex. 1001, 1:42–44. The
`’241 patent also discloses a composition that comprises a disclosed compound and
`a pharmaceutically acceptable carrier. Ex. 1004, 18:12–14. The ’241 patent
`further discloses that its described compounds can be used for treating disorders
`such as depression, side-effects in the treatment of hypertension, and pre-menstrual
`syndrome. Id. at 8:24–38.
`Patent Owner’s Admissions
`2.
`Petitioner describes four “admissions” regarding the ’241 patent that it
`contends appear in the background section of the ’921 patent. Pet. 4–5.
`According to Petitioner, those admission are as follows:
`1. The ’241 patent teaches 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-
`benzofuran-5-yl)-piperazine (“vilazodone”) and its physiologically acceptable
`salts;
`
`
`10 This Decision on Request for Rehearing was before an expanded panel that
`included Chief Administrative Patent Judge David P. Ruschke and Deputy Chief
`Administrative Patent Judge Scott R. Boalick.
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`2. Example 4 of the ’241 patent teaches how to make vilazodone
`hydrochloride (“VHCl”), and that the product achieved is a mixture of crystalline
`HCl salt, amorphous HCl salt, and free base;
`3. The product of Example 4 of the ’241 patent was a mixture of crystalline
`VHCl, amorphous VHCl, and vilazodone free base;11 and
`4. The ’241 patent discloses the use of VHCl in treating certain medical
`disorders. Id.
`Patent Owner contests both the factual and legal basis for characterizing the
`asserted statements in the background section of the ’921 patent as “admissions,”
`particularly with respect to Petitioner’s contention that Example 4 of the ’241
`patent is a mixture of crystalline, amorphous, and free base vilazodone
`hydrochloride. Prelim. Resp. 21–27; see id. at 22 (“the ’241 patent never describes
`or teaches crystalline vilazodone hydrochloride”).
`On this record, and solely for purposes of our decision herein, we find that
`the above four “admissions” reasonably characterize the ’241 patent, and that the
`’241 patent would have been so understood by the Examiner, based on the
`disclosures of the ’241 patent and the specification of the ’921 patent, and the
`Examiner’s statement of reasons for allowance. But to be clear, because we find
`that the four “admissions” reasonably characterize the teachings of the ’241 patent,
`we need not find and do not find that the above four statements are admissions by
`Patent Owner. Any reference herein to “Patent Owner’s Admissions” should only
`
`
`11 Petitioner’s Declarant, Dr. Rogers, acknowledges that “neither the [Patent
`Owner’s Admissions] of the ’921 patent nor Example 4 of the ’241 patent indicate
`how much amorphous VHCl or vilazodone free base is present in the mixture.”
`Ex. 1002 ¶ 142.
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`be understood as a reference to those four statements advanced by Petitioner and
`not as “admissions.”
`
`Prosecution History
`3.
`The specification of the ’921 patent discusses the ’241 patent, and
`distinguishes the ’241 patent from the disclosed invention. See, e.g., Ex. 1001,
`1:35–41; 5:4–6.
`During the prosecution of the ’921 patent, a set of claims was submitted in a
`Preliminary Amendment,12 and allowed without a rejection. Ex. 2012, 1–6; Pet. 7;
`Prelim. Resp. 8. The Examiner issued a Notice of Allowability that stated:
`4. The following is an examiner’s statement of reasons for
`allowance: The instantly claimed crystalline compounds, compositions,
`and methods for using the same, are novel and non-obvious over the
`prior art. The closest prior art is U.S. Patent no. 5,532,241, which does
`not teach the claimed crystalline forms. This reference does not
`encompass the scope of the instant application. This reference lacks
`identical or obvious crystalline forms of 1-[4-(5-cyanoindol-3-
`yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine. A person of
`ordinary skill in the art would not have expected that making
`modifications would retain identical activity as disclosed in the prior
`art.
`Ex. 1006, 8.
`
`Analysis
`4.
`When evaluating whether to exercise our discretion when the same or
`substantially the same prior art or arguments were previously presented to the
`Office under § 325(d), the Board has weighed several non-exclusive factors,
`
`
`12 The claims in the Preliminary Amendment were numbered 56–70, and Patent
`Owner states that the submitted claims “substantially correspond[] to the allowed
`claims.” Prelim. Resp. 8. We discern no difference (and none has been argued)
`between submitted claims 56, 66, 67, 69, and 70 and challenged claims 1, 11, 12,
`14, and 15, respectively.
`
`
`15
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`Case IPR2018-00423
`Patent 8,673,921 B2
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`including, for example: (1) the similarities and material differences between the
`asserted art and the prior art involved during examination; (2) the cumulative
`nature of the asserted art and the prior art evaluated during examination; (3) the
`extent to which the asserted art was evaluated during examination, including
`whether the prior art was the basis for rejection; (4) the extent of the overlap
`between the arguments made during examination and the manner in which
`Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (5)
`whether Petitioner has pointed out sufficiently how the Examiner erred in its
`evaluation of the asserted prior art; and (6) the extent to which additional evidence
`and facts presented in the Petition warrant reconsideration of the prior art or
`arguments. Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-
`01586, slip op. at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (informative). After
`considering these factors, we are persuaded that the Petition presents the same or
`substantially the same prior art or arguments that previously were presented to the
`Office with respect to the asserted ground of anticipation based on the ’241 patent
`as characterized by Patent Owner’s Admissions, and exercise our discretion to
`deny institution on the basis of this anticipation challenge. See 35 U.S.C. § 325(d).
`Petitioner’s Arguments Regarding Section 325(d)
`Petitioner states that “[t]here is no basis to deny the instant petition under 35
`U.S.C. § 325(d).” Pet. 66. In support of that contention, Petitioner states that:
`a. The Petition is the first time the ’921 patent has been challenged before
`the Office since its issuance;13
`
`
`13 Our analysis under 35 U.S.C § 325(d) is not based on prior petitions or other
`post-grant challenges to the ’921 patent, but Section 325(d) is also applicable to
`prior art or arguments set forth in the prosecution history. See Neil Ziegmann, at
`slip op. 29–30.
`
`
`16
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`Case IPR2018-00423
`Patent 8,673,921 B2
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`b. The Examiner never cited Bartoszyk in any office action rejection, and
`did not discuss Bartoszyk in the “Reasons for Allowability;”14
`c. The Examiner was incorrect in finding that the ’241 patent did not teach
`crystalline forms, because the Examiner failed to consider that the specification of
`the ’241 patent disclosed that the Examples were worked up by “crystallization;”
`d. The Examiner did not correctly identify Example 4 of the ’241 patent as
`the closest prior art;
`e. The Patent Owner’s Admissions state clearly that Example 4 of the ’241
`patent was a mixture of amorphous and crystalline VHCl;15 and
`f. The ’241 patent discloses that Example 4 has a discrete melting point
`range, which is indicative of crystallization. Pet. 66–67.
`Patent Owner’s Arguments Regarding Section 325(d)
`Patent Owner contends that we should deny institution because “Petitioner’s
`primary art and arguments were already considered by the Examiner during
`prosecution of the ’921 patent.” Prelim. Resp. 51. Patent Owner argues that the
`’241 patent was expressly considered by the Examiner and found not to teach the
`claimed crystalline forms, and that “the so-called Patent Owner Admissions relied
`on by Petitioner come from the ’921 specification, which was before and
`considered by the Examiner during prosecution.” Id. Patent Owner further argues
`
`
`14 Petitioner also refers to “Brittain” (Ex. 1010) but Brittain was not cited in the
`patentability challenges. Prelim. Resp. 52.
`15 The asserted Patent Owner’s Admissions actually state that Example 4 was a
`mixture of crystalline VHCl, amorphous VHCl, and vilazodone free base. See
`discussion at II.C.2. supra.
`
`
`17
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`Case IPR2018-00423
`Patent 8,673,921 B2
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`that the Examiner considered other patents having the same specification as the
`’921 patent, and that Bartoszyk was considered by the Examiner. Id.
`We address the above factors16 under Section 325(d) in view of the
`prosecution history and the parties’ arguments.17
`Factors 1–3
`
`Both the ’241 patent and Patent Owner’s Admissions were before and
`considered by the Examiner in connection with claims 1, 14, and 15. See
`Ex. 1001, Ex. 1006, 8, and II.C.2, supra.
`Factor 5
`
`Petitioner contends that the Examiner erred in evaluating the art asserted in
`this anticipation challenge because the Examiner incorrectly found that the ’241
`patent did not teach crystalline forms, purportedly because the Examiner failed to
`consider that the specification of the ’241 patent disclosed that the Examples were
`worked up by “crystallization” (Petitioner argument c. above). We do not find this
`to be a sufficient showing of error by the Examiner. First, the Examiner did not
`find “that the ’241 patent did not teach crystalline forms,” but that the ’241 patent
`did not “teach the claimed crystalline forms.” Ex. 1006, 8 (emphasis added).
`Second, as pointed out by Patent Owner (Prelim. Resp. 14–17), the specification of
`the ’241 patent does not state that the Examples were worked up by crystallization,
`but that the phrase “‘working-up in conventional manner’ means: . . . and the
`residue is purified by chromatography and/or crystallization.” Ex. 1004, 9:3–8
`
`
`16 Factor 4 is inapplicable because no arguments regarding the challenged claims
`were made during examination.
`17 For purposes of our decision to decline institutio