Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 10
`Entered: November 29, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WILLOWOOD USA, LLC,
`Petitioner,
`
`v.
`
`BASF SE,
`Patent Owner.
`____________
`
`Case IPR2018-01096
`Patent 7,816,392 B2
`____________
`
`
`Before CHRISTOPHER L. CRUMBLEY, JEFFREY W. ABRAHAM, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`ABRAHAM, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper 10
`Entered: November 29, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WILLOWOOD USA, LLC,
`Petitioner,
`
`v.
`
`BASF SE,
`Patent Owner.
`____________
`
`Case IPR2018-01096
`Patent 7,816,392 B2
`____________
`
`
`Before CHRISTOPHER L. CRUMBLEY, JEFFREY W. ABRAHAM, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`ABRAHAM, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`IPR2018-01096
`Patent 7,816,392 B2
`
`INTRODUCTION
`I.
`Willowood USA, LLC. (“Petitioner”) filed a Petition (Paper 2, “Pet.”)
`requesting inter partes review of claims 1–17 of U.S. Patent
`No. 7,816,392 B2 (Ex. 1002, “the ’392 patent”). BASF SE (“Patent
`Owner”) filed a Preliminary Response to the Petition (Paper 8, “Prelim.
`Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for instituting
`an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that
`an inter partes review may not be instituted “unless the Director
`determines . . . there is a reasonable likelihood that the petitioner would
`prevail with respect to at least 1 of the claims challenged in the petition.”
`After considering the Petition, the Preliminary Response, and the
`evidence of record, we determine that Petitioner has not demonstrated a
`reasonable likelihood that it would prevail with respect to at least one claim
`challenged in the Petition. Accordingly, we deny the Petition, and do not
`institute an inter partes review.
`
`A. Related Proceedings
`The parties indicate that the ’392 patent is at issue in BASF Corp. v.
`Willowood, LLC, No. 1:18-cv-00268 (D. Colo.). Pet. 2; Paper 5, 1.
`
`B. The ’392 Patent
`The ’392 patent, titled “Crystalline Modifications to Pyraclostrobin,”
`issued on October 19, 2010. Ex. 1002, at [45], [54]. The ’392 patent relates
`to “novel crystalline modifications of pyraclostrobin, to processes for their
`preparation and to the use of the novel modifications for preparing crop
`protection compositions.” Id. at Abstract.
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`IPR2018-01096
`Patent 7,816,392 B2
`The ’392 patent explains that pyraclostrobin is “an active compound
`for controlling phytopathogenic fungi,” and, as of the filing date of the ’392
`patent, was commercially available as “an amorphous substance of low
`melting point.” Id. at 1:8–15. The ’392 patent further explains that, as a
`result of this, it was not possible to prepare aqueous suspension concentrates
`including pyraclostrobin in a conventional manner. Id. at 1:15–23. An
`object of the ’392 patent, therefore, was “to provide pyraclostrobin in a form
`which permits the preparation of suspension concentrates having improved
`stability.” Id. at 1:46–48. According to the ’392 patent, “[t]his object is
`achieved by the crystalline modifications II and IV . . . of pyraclostrobin.”
`Id. at 1:49–50.
`The ’392 patent characterizes crystalline modification IV of
`pyraclostrobin based on its X-ray powder diffraction characteristics, melting
`point, and heat of fusion. Id. at 1:51–2:6. The ’392 patent discloses similar
`information for crystalline modifications I–III of pyraclostrobin. Id. at 8:33–
`10:45. The ’392 patent also teaches preparing suspension concentrates of
`pyraclostrobin, both with and without other crop protection agents, and
`states that “[t]he suspension concentrates according to the invention are
`distinguished in particular by better storage stability compared to the known
`pyraclostrobin-comprising suspension concentrates and suspoemulsion
`concentrates.” Id. at 19:6–17.
`
`C. Illustrative Claims
` Petitioner challenges claims 1–17 of the ’392 patent. Independent
`claims 1, 4, 12, 15, and 17 are illustrative of the challenged claims and are
`reproduced below:
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`IPR2018-01096
`Patent 7,816,392 B2
` 1. A crystalline modification IV of pyraclostrobin
`which, in an X-ray powder diffractogram at 25°C, shows at least
`three of the following reflexes:
`d = 6.02 ± 0.01 Å
`
`d = 4.78 ± 0.01 Å
`
`d = 4.01 ± 0.01 Å
`
`d = 3.55 ± 0.01 Å
`
`d = 3.01 ± 0.01 Å.
`Ex. 1002, 25:43–54.
`4. A process for preparing a crystalline modification IV
`of pyraclostrobin according to any of the preceding claims,
`comprising:
`i) dissolving a pyraclostrobin form different from
`modification IV in an organic solvent or solvent
`mixture, where the organic solvent or solvent mixture
`comprises at least 70% by volume of at least one fully
`water-miscible organic solvent L1 and up to 30% by
`volume of water; and
`ii) effecting crystallization of pyraclostrobin over a
`period of at least 10 hours and/or in the presence of
`seed crystals of modification IV.
`
`Id. at 26:1–12.
`12. A process for preparing a crystalline modification IV
`of pyraclostrobin according to claim 1, comprising:
`preparing a suspension of a pyraclostrobin form
`i)
`different from modification IV in an organic
`solvent;
`optionally, adding seed crystals of modification
`IV to the suspension; and
`
`ii)
`
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`IPR2018-01096
`Patent 7,816,392 B2
`agitating the suspension until at least 90% of the
`iii)
`pyraclostrobin comprised therein is present in the
`form of modification IV.
`
`Id. at 26:34–42.
`15. A composition for crop protection, comprising
`pyraclostrobin in the form of modification IV, carriers, and/or
`auxiliaries.
`Id. at 26:50–52.
`17. A method of controlling phytopathogenic fungi comprising
`contracting a plant, seed, or soil in need of treatment with a crystalline
`form of modification IV of pyraclostrobin.
`Id. at 26:55–57.
`
`
`D. The Asserted Grounds of Unpatentability
`Petitioner contends claims 1–17 of the ’392 patent are unpatentable
`based on the following grounds:1
`Reference(s)
`APR2
`
`Basis Claims Challenged
`§ 102
`1–3 and 15–17
`
`APR, Vogel,3 and Beckmann4
`
`§ 103
`
`4–14
`
`
`1 Petitioner also relies on a declaration from Dr. Harry G. Brittain.
`(Ex. 1003).
`2 Public Release Summary on Evaluation of the New Active Pyraclostrobin
`in the Product Cabrio Fungicide, Australian Pesticides and Veterinary
`Medicines Authority, September, 2003 (“Australian Public Release” or
`“APR,” Ex. 1008).
`3 Arthur I. Vogel, A Textbook of Practical Organic Chemistry Including
`Qualitative Organic Analysis, Third Ed. (1956) (Ex. 1010).
`4 Wolfgang Beckmann, Seeding the Desired Polymorph: Background,
`Possibilities, Limitations, and Case Studies, Organic Process Research &
`Development 2000, 4, 372–383 (Ex. 1011).
`
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`Patent 7,816,392 B2
`
`
`II. ANALYSIS
`
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are
`construed according to their broadest reasonable interpretation in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b)
`(2006).5 A claim term, however, “will not receive its ordinary meaning if
`the patentee acted as his own lexicographer and clearly set forth a definition
`of the disputed claim term in either the specification or prosecution history.”
`CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002).
`Although the patentee indeed is free to define the specific claim terms used
`to describe his or her invention, “this must be done with reasonable clarity,
`deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`1994).
`Petitioner contends that the ’392 patent provides a specific definition
`of pyraclostrobin modification IV, and, therefore argues that the claim term
`“crystalline modification IV of pyraclostrobin” should be construed as
`a crystalline structure of pyraclostrobin having a specific X-ray
`diffraction pattern at 25°C showing at least three, in particular at
`least four, and preferably all of the following reflexes: d=6.02 ±
`0.01 Å, d=4.78 ± 0.01 Å, d=4.01 ± 0.01 Å, d=3.55 ± 0.01 Å,
`d=3.01 ± 0.01 Å and having a melting point in the range from 62
`to 72°C, in particular in the range from 64 to 68°C, and especially
`
`
`5 The broadest reasonable construction standard applies to inter partes
`reviews filed before November 13, 2018. 77 Fed. Reg. 48727 (Aug. 14,
`2012) (codified at 37 C.F.R. § 42.100(b)), as amended at 81 Fed. Reg. 18766
`(Apr. 1, 2016); see also 83 Fed. Reg. 51340 (Oct. 11, 2018) (changing the
`standard for interpreting claims in inter partes reviews filed on or after
`November 13, 2018).
`
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`IPR2018-01096
`Patent 7,816,392 B2
`in the range from 65 to 67°C, and having a heat of fusion of 72
`to 78 J/g, and in particular about 74 ± 1 J/g.
`Pet. 22–23 (citing Ex. 1003, ¶ 61). Petitioner further contends that all of the
`remaining terms in claims 1–17 should be given their plain and ordinary
`meaning. Id. at 23.
`Patent Owner argues that “crystalline modification IV of
`pyraclostrobin” does not require construction. Prelim. Resp. 13–14. In
`particular, Patent Owner notes that claim 1 expressly recites specific reflexes
`of an X-ray powder diffractogram at 25 °C, and claim 2 expressly recites a
`specific melting point for crystalline modification IV of pyraclostrobin. Id.
`Patent Owner thus contends “[t]here is no reason to construe the claim term
`to include reflexes or melting point” in the definition of “crystalline
`modification IV of pyraclostrobin.” Id. (citing Mformation Techs., Inc. v.
`Research in Motion Ltd., 764 F.3d 1392, 1399 (Fed. Cir. 2014); Aristocrat
`Techs. Australia Pty Ltd. v. Int'l Game Tech., 709 F.3d 1348, 1356–57 (Fed.
`Cir. 2013)). Finally, Patent Owner asserts that no trial should be instituted
`under either party’s proposed construction.
`We agree with Petitioner that the ’392 patent provides a clear
`definition of pyraclostrobin modification IV. CCS Fitness, 288 F.3d at
`1366. The ’392 patent describes crystalline modification IV of
`pyraclostrobin as having, at a minimum, two required features. First, the
`’392 patent states that crystalline modification IV has at least three specific
`reflexes in an X-ray powder diffractogram at 25 °C. Ex. 1002, 1:49–63.
`Next, the ’392 patent states that the heat of fusion for modification IV is
`“about 72 to 78 J/g.” Id. at 1:67–2:2.
`
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`IPR2018-01096
`Patent 7,816,392 B2
`In view of this language, we determine, for purposes of this Decision,
`that the broadest reasonable construction of the claim term “crystalline
`modification IV of pyraclostrobin” is:
`a crystalline structure of pyraclostrobin having a specific X-ray
`diffraction pattern at 25°C showing at least three of the following
`reflexes: d=6.02 ± 0.01 Å, d=4.78 ± 0.01 Å, d=4.01 ± 0.01 Å,
`d=3.55 ± 0.01 Å, d=3.01 ± 0.01 Å and a heat of fusion of about
`72 to 78 J/g.
`We decline to include the melting point language from Petitioner’s proposed
`definition in our construction because the ’392 patent states only what the
`“typical” melting point range is. Id. at 1:64–67 (stating that modification IV
`“typically” has a melting point in the range from 62 °C to 72 °C). We do not
`find such language to constitute a deliberate and precise definition. In re
`Paulsen, 30 F.3d at 1480. Furthermore, our construction is consistent with
`the doctrine of claim differentiation, because claim 2 requires the crystalline
`modification IV to have the required X-ray diffraction properties of claim 1
`in addition to the recited melting point properties. Kraft Foods, Inc. v. Int’l
`Trading Co., 203 F.3d 1362, 1365–69 (Fed. Cir. 2000).
`We recognize, as Patent Owner points out, that including specific
`diffraction reflexes in the definition of the term itself would render those
`limitations in claim 1 superfluous. Independent claims 15 and 17, however,
`do not recite specific diffraction reflexes in the claim itself. Therefore,
`Patent Owner’s “superfluous” argument does not apply to all claims. In
`addition, based on Patent Owner’s arguments distinguishing the prior art
`references, discussed in detail below, we understand Patent Owner to be
`taking the position that pyraclostrobin modification IV has the diffraction
`and heat of fusion properties recited in our construction. This is consistent
`
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`IPR2018-01096
`Patent 7,816,392 B2
`with Patent Owner’s statement that we should not institute trial even if we
`adopt Petitioner’s proposed construction.
`Furthermore, we note that whereas claims 1–3 include the phrase
`“crystalline modification IV of pyraclostrobin,” independent claim 15 uses
`the phrase “pyraclostrobin in the form of modification IV,” and independent
`claim 17 uses the phrase “crystalline form of modification IV of
`pyraclostrobin.” The parties do not address these minor variations in claim
`language. Nor do the parties dispute that all claims require pyraclostrobin
`modification IV. We, therefore, find that the aforementioned phrases used
`in claims 15 and 17 have the same meaning as “crystal modification IV of
`pyraclostrobin,” which is,
`a crystalline structure of pyraclostrobin having a specific X-ray
`diffraction pattern at 25°C showing at least three of the following
`reflexes: d=6.02 ± 0.01 Å, d=4.78 ± 0.01 Å, d=4.01 ± 0.01 Å,
`d=3.55 ± 0.01 Å, d=3.01 ± 0.01 Å and a heat of fusion of about
`72 to 78 J/g.
`We also determine that no other claim terms of the ’392 patent require
`express construction for purposes of this Decision. See Nidec Motor Corp.
`v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir.
`2017) (citing 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.”)).
`
`B. Claims 1–3 and 15–17 – Anticipated by APR
`Petitioner contends APR anticipates claims 1–3 and 15–17. Pet. 35–
`37.
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`IPR2018-01096
`Patent 7,816,392 B2
`1. APR
`APR is a 2003 report by the Australian Pesticides and Veterinary
`Medicines Authority on Cabrio Fungicide, a product “proposed to be used
`for the control of leaf speckle and leaf spot/Yellow Sigatoka in bananas and
`downy and powdery mildew in grapevines.” Ex. 1008, 9. APR states
`Cabrio Fungicide contains “the new active constituent pyraclostrobin,” and
`describes pyraclostrobin as a “[w]hite to light beige” crystalline powder with
`a melting point range of 63.7–65.2 oC. Id. at 9, 11.
`
`2. Summary of the Parties’ Arguments
`Petitioner contends the pyraclostrobin disclosed in APR is crystalline
`modification IV, as required in claims 1–3 and 15–17, based on the melting
`point values disclosed in APR and the ’392 patent. Pet. 34–37. Specifically,
`Petitioner states that the ’392 patent discloses modification IV has a melting
`point in the range from 62 to 72 °C. Id. at 35. Petitioner also states that the
`pyraclostrobin disclosed in APR has a melting point in the range of 63.7 to
`65.2 °C. Id. Petitioner’s declarant, Dr. Brittain, concludes that APR
`discloses modification IV of pyraclostrobin because
`the melting point of the crystalline powder disclosed in [APR]
`falls squarely within the range disclosed by the ’392 patent for
`crystalline modification IV and outside the ranges disclosed by
`the ’392 patent for crystalline modifications I, II, and III. . . .
`[S]ince the melting point of any particular crystalline structure is
`inherent to that structure, it serves as a fingerprint for the
`structure when compared to the melting points of other
`polymorphs of that same compound.
`Ex. 1003 ¶ 65; see also Pet. 30 (“A melting point for a particular crystalline
`form is an inherent characteristic of that form; meaning that a particular
`crystal form of a compound will always have the same melting point.”), 32
`(“[E]ach polymorph necessarily has a unique melting point and other
`
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`IPR2018-01096
`Patent 7,816,392 B2
`physical properties when compared to the melting point and physical
`properties of other polymorphs of the same compound.”), 35.
`
`To support its position, Petitioner further asserts that the crystal
`structure of a compound defines all of the physical properties of that
`particular compound. Pet. 24. Therefore, according to Petitioner, “so long
`as a compound exists in a particular crystal structure, that compound’s
`physical properties are inherent and will remain constant.” Id. (citing Ex.
`1003 ¶ 40). In view of this, Petitioner argues that the fact APR does not
`expressly disclose X-ray diffraction reflexes for its pyraclostrobin compound
`does not matter because the X-ray diffraction reflexes recited in claim 1
`“were necessarily inherent in the crystalline structure disclosed in [APR].”
`Id. at 36.
`
`Patent Owner contends that Petitioner failed to demonstrate that the
`pyraclostrobin disclosed in APR is necessarily modification IV. Prelim.
`Resp. 15. Patent Owner first asserts that APR does not expressly state the
`pyraclostrobin powder is modification IV, does not provide any X-ray
`diffraction data, does not provide information about how the melting point
`was measured, and does not provide information about how the crystalline
`powder was prepared. Id. Patent Owner contends these points are
`undisputed. Id. at 16.
`Patent Owner also argues that Petitioner’s understanding of the
`relationship between melting point of a sample such as pyraclostrobin and its
`crystalline form, namely that melting point can be relied on to show a
`sample is necessarily a certain polymorph, is incorrect. Id. at 21. Patent
`Owner contends that melting point provides certain information about the
`substance being analyzed, but does not provide direct information about a
`
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`IPR2018-01096
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`compound’s crystal structure. Id. at 22. According to Patent Owner,
`“artisans working in the field of polymorphism have rejected thermal
`analysis alone as a definitive proof of the existence of a specific polymorph
`or the existence of polymorphism. Instead, thermal analysis has been
`accepted as a means for supplementing, but not supplanting, X-ray
`diffraction analysis.” Id. at 23. In support of this statement, Patent Owner
`directs us to statements in a book chapter, authored by Dr. Brittain and
`published in 1999, wherein Dr. Brittain states:
`it cannot be overemphasized that the defining criterion for
`the existence of polymorphic types must always be a
`nonequivalence of crystal structures. For compounds of
`interest, this ordinarily
`implies that a
`pharmaceutical
`nonequivalent x-ray powder diffraction pattern is observed
`for each suspected polymorphic variation. All other
`methodologies must be considered as sources of supporting
`and ancillary information; they cannot be taken as definitive
`proof for the existence of polymorphism by themselves alone.
`Id. at 24 (quoting Ex. 2009, 228–29) (internal footnote omitted). In view of
`this and similar statements in other references, Patent Owner asserts that
`melting point determination does not prove that a sample is necessarily a
`particular polymorph. Id. at 26 (citing Ex. 2012, 2244; Ex. 2013, 51; Ex.
`2014, 136–37; Ex. 2015, 2–3).
`Patent Owner next argues that “melting point measurements may
`yield very close, sometimes exactly the same, values for different
`polymorphs of the same compound.” Id. at 27. Patent Owner presents a
`table of compounds forming different polymorphs with overlapping or
`identical melting points. Id. at 28–29.
`Patent Owner also contends that Petitioner fails to account for the
`possibility that polymorphs of pyraclostrobin other than modification IV
`
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`may have a melting point between 62 °C and 72 °C. Id. at 33. As an
`example, Patent Owner directs us to U.S. Patent Publication No.
`2003/199394 A1 (the ’394 publication),6 cited and addressed during
`prosecution of the application leading to the ’392 patent, which states
`“pyraclostrobin has a melting point of about 64 °C.” Id. at 34 (citing Ex.
`20237 ¶ 31). Patent Owner argues that this value “fits squarely in . . . the
`range recited in claim 2 of the ’392 patent (62 to 72 °C).” Id. (emphasis
`omitted). Patent Owner notes, however, that the applicants for the ’392
`patent argued that the ’394 publication discloses only pyraclostrobin
`modification I. Id. Patent Owner further argues that the enthalpy of fusion
`data reported in the ’394 publication is closest to the enthalpy value reported
`for modification I in the ’392 patent, which further supports the
`characterization of the disclosed pyraclostrobin form in the ’394 publication
`as modification I. Id.
`
`Additionally, Patent Owner points out the melting point of
`pyraclostrobin disclosed in the ’394 publication falls within the melting
`point range of the pyraclostrobin disclosed in APR (63.7–65.2 °C). Id.
`Patent Owner, therefore, argues Petitioner cannot rule out the possibility that
`the pyraclostrobin sample in APR is the pyraclostrobin disclosed in the ’394
`publication. Id. at 34–35. Patent Owner further contends that even more
`unknown polymorphs of pyraclostrobin may exist, and it is impossible to
`
`
`6 Finch et al., U.S. Publication No. 2003/0199394 A1, published Oct. 23,
`2003 (Ex. 1005).
`7 Exhibit 2023 is a copy of the ’394 publication. Exhibit 1005 is also a copy
`of the ’394 publication. We are not aware of any differences between the
`two exhibits. We, therefore, use the exhibit numbers interchangeably.
`
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`rule out the possibility that these additional polymorphs may have a melting
`point that falls within the range recited in claim 2. Id. at 35–36 (citing Ex.
`2020, 228 (“[I]n general, the number of forms known for a given compound
`is proportional to the time and money spent in research on that compound.”);
`Ex. 2027 (a Chinese publication identifying pyraclostrobin modification V
`having a melting point (65–75 °C) that overlaps the melting point of
`modification IV)).
`
`3. Analysis
`A claim is unpatentable under 35 U.S.C. § 102 if a prior art reference
`discloses each and every limitation of the claimed invention, either explicitly
`or inherently. Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047 (Fed. Cir.
`1995). If the prior art reference does not expressly set forth a particular
`element of the claim, that reference still may anticipate if that element is
`“inherent” in its disclosure. In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
`1999). To establish inherency, the extrinsic evidence “must make clear that
`the missing descriptive matter is necessarily present,” or inherent, in the
`single anticipating reference. Continental Can Co. v. Monsanto Co., 948
`F.2d 1264, 1269 (Fed. Cir. 1991). “Inherency, however, may not be
`established by probabilities or possibilities. The mere fact that a certain
`thing may result from a given set of circumstances is not sufficient.” Id. at
`1269 (quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)).
`It is undisputed that APR does not expressly state that its
`pyraclostrobin powder is crystalline modification IV and does not provide
`X-ray diffraction information about its pyraclostrobin powder. Petitioner,
`therefore, relies on the melting point information provided in APR to
`demonstrate that the pyraclostrobin disclosed in APR is crystalline
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`modification IV. Pet. 35–37. In doing so, Petitioner concludes that the
`pyraclostrobin in APR necessarily has a crystalline structure with an X-ray
`diffraction pattern showing at least three of the following reflexes: d=6.02 ±
`0.01 Å, d=4.78 ± 0.01 Å, d=4.01 ± 0.01 Å, d=3.55 ± 0.01 Å, d=3.01 ± 0.01
`Å and a heat of fusion of about 72 to 78 J/g. Petitioner contends that the
`pyraclostrobin in APR has the aforementioned diffraction and heat of fusion
`properties because its melting point falls within the melting point range of
`modification IV and outside the melting point ranges for modifications I
`through III, as disclosed in the ’392 patent. Id.; Ex. 1003 ¶ 65.
`We are not persuaded by Petitioner’s argument that the pyraclostrobin
`disclosed in APR is necessarily modification IV because its melting point
`falls between 62 and 72 °C. Rather, the evidence and arguments presented
`by Patent Owner suggest that melting point, alone, is insufficient to conclude
`that APR necessarily discloses modification IV.
`For example, Dr. Brittain states methodologies such as melting point
`measurements “cannot be taken as definitive proof for the existence of
`polymorphism by themselves alone.” Ex. 2009, 228–229. Rather, Dr.
`Brittain stresses the importance of X-ray diffraction measurements. Id.; see
`also Ex. 2013, 51 (an article authored by Dr. Brittain stating that there are
`many experimental techniques available for characterization of polymorphic
`solids, “but only the direct crystallographic technique yields unequivocal
`information”). These statements contradict the conclusion in Dr. Brittain’s
`declaration that the melting point of a structure can be used as a
`“fingerprint” when compared to the melting points of other polymorphs of
`the same structure. Ex. 1003 ¶ 65. Other references cited by Patent Owner
`also support its argument that melting point, alone, is insufficient evidence
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`of crystalline structure. E.g. Ex. 2015, 2 (stating that X-ray diffraction
`provides “definitive evidence of polymorphism,” whereas methods such as
`thermal analysis are helpful to further characterize polymorphic forms).
`Additionally, evidence of record suggests that pyraclostrobin
`compounds other than modification IV may have a melting point between
`62 °C and 72 °C. For example, during prosecution of the application leading
`to the ’392 patent, the Examiner initially determined that the ’394
`publication discloses pyraclostrobin modification IV. Ex. 1004, 4.8 The
`applicants, however, argued that the ’394 publication discloses
`pyraclostrobin modification I based on the ’394 publication’s use of a melt-
`crystallization process similar to the process used to make modification I in
`the ’392 patent, not the solution-crystallization process used to make
`modification IV. Ex. 1006, 5–7; Ex. 1005 ¶ 60; Ex. 1002, 8:58–59
`(“Modification I of pyraclostrobin is typically obtained on cooling of a
`pyraclostrobin melt . . . .”), 2:30–43 (describing a method for making
`modification IV by dissolving pyraclostrobin in an organic solvent or
`solvent mixture). The applicants also argued that the enthalpy of fusion
`(61.13 J/g) disclosed in the ’394 publication is more consistent with
`modification I (about 63–66 J/g) than modification IV (about 72–78 J/g).
`Ex. 1006, 7; Ex. 1005 ¶ 63; Ex. 1002, 1:67–2:2, 8:54–57. The Examiner
`found these arguments persuasive. Ex. 1007, 2.
`As Patent Owner points out, the ’394 publication generally states
`“pyraclostrobin has a melting point of about 64 °C.” Ex. 1005 ¶ 31.
`Although this value falls within the melting point range for pyraclostrobin
`
`
`8 Page numbers in Exhibits 1004, 1006, and 1007 refer to the original page
`numbers of the Office Action, Reply, and Notice of Allowance, respectively.
`
`16
`
`
`
`IPR2018-01096
`Patent 7,816,392 B2
`modification IV (as disclosed in the ’392 patent), the evidence discussed
`above points to the ’394 publication’s disclosure of pyraclostrobin
`modification I. This information, at the very least, leaves open the
`possibility that a pyraclostrobin compound with a melting point between
`62 °C and 72 °C may be something other than modification IV. Prelim.
`Resp. 33–34; see also Ex. 2027 (disclosing “new crystal form V of
`pyraclostrobin” having a melting point from 65–75 °C, which is
`distinguished over crystal modification IV).
`Additionally, the melting point disclosed for pyraclostrobin in the
`’394 publication (64 °C) falls within the melting point range of the
`pyraclostrobin in APR (63.7–65.2 °C). In view of this, we agree with Patent
`Owner that Petitioner “cannot rule out the possibility that” that the
`pyraclostrobin in APR is the compound disclosed in the ’394 application
`(possibly modification I), and not necessarily modification IV. Prelim.
`Resp. 34; see also id. at 35–36 (presenting a similar argument regarding Ex.
`2027 because modification V disclosed therein has a melting point (65–75
`°C) that overlaps the melting point range (63.7–65.2 °C) of APR’s
`pyraclostrobin).
`Based on our review of the parties’ arguments and information at this
`stage, we find Petitioner’s evidence, which does not include X-ray
`diffraction data for the pyraclostrobin disclosed in APR, suggests, at best,
`that the pyraclostrobin disclosed in APR may be modification IV. This is
`insufficient evidence to establish inherency. See Continental Can, 948 F.2d
`at 1269. Petitioner has thus failed to demonstrate a reasonable likelihood of
`success in proving that APR discloses, either expressly or inherently, every
`limitation of claims 1–3 and 15–17, which all include a crystalline
`
`17
`
`
`
`IPR2018-01096
`Patent 7,816,392 B2
`modification IV of pyraclostrobin. We, therefore, decline to institute review
`of claims 1–3 and 15–17.
`
`C. Claims 4–14 – Obvious in view of APR, Vogel, and Beckmann
`Claims 4–14 all recite “a crystalline modification IV of
`pyraclostrobin.” Petitioner’s challenges to claims 4–14 all rely on the
`aforementioned arguments regarding APR’s disclosure of modification IV.
`Pet. 38–39. Petitioner’s arguments with respect to Vogel and Beckmann
`regarding standard crystallization techniques, do not resolve the deficiencies
`noted above with respect the teachings of APR. Id. at 38–49; Prelim. Resp.
`44–46. For the same reasons discussed above, we find that Petitioner has
`failed to demonstrate sufficiently that APR, Vogel, and Beckmann disclose
`or suggest all limitations in claims 4–14. Accordingly, Petitioner has not
`demonstrated a reasonable likelihood that the subject matter of claims 4–14
`would have been obvious over the combined teachings of APR, Vogel, and
`Beckmann.
`
`III. CONCLUSION
`For the foregoing reasons, Petitioner has not demonstrated a
`reasonable likelihood that at least one challenged claim of the ’392 patent
`would have been obvious over the prior art of record. Accordingly, we do
`not institute inter partes review.
`
`IV. ORDER
`
`It is hereby,
`ORDERED that, pursuant to 35 U.S.C. § 314, the Petition is denied
`and no inter partes review is instituted.
`
`
`
`18
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`
`
`IPR2018-01096
`Patent 7,816,392 B2
`
`For PETITIONER:
`
`Steven Tiller
`Peter Davis
`WHITEFORD TAYLOR & PRESTON LLP
`stiller@wtplaw.com
`pdavis@wtplaw.com
`
`For PATENT OWNER:
`
`Jeffrey Ginsberg
`Zhiqiang Liu
`Ryan Mott
`PATTERSON BELKNAP WEBB & TYLER LLP
`jginsberg@pbwt.com
`zliu@pbwt.com
`rmott@pbwt.com
`
`
`
`
`
`
`
`
`19
`
`
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