Case IPR2018-01096
`U.S. Patent No. 7,816,392
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________________
`
`WILLOWOOD USA, LLC
`Petitioner,
`
`v.
`
`BASF SE
`Patent Owner
`
`_______________________________
`
`Case IPR2018-01096
`Patent No. 7,816,392
`
`_______________________________
`
`PATENT OWNER BASF SE'S PRELIMINARY
`RESPONSE PURSUANT TO 37 C.F.R. § 42.107
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`Case IPR2018-01096
`U.S. Patent No. 7,816,392
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`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES ................................................................................... iii
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND OF THE INVENTION ....................................................... 5
`
`A.
`
`B.
`
`The invention of the '392 patent ............................................................ 7
`
`Prosecution history of the '392 patent ................................................... 9
`
`III. THE PERSON OF ORDINARY SKILL IN THE ART ............................... 12
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`IV. CLAIM CONSTRUCTION .......................................................................... 12
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`V.
`
`CLAIMS 1-3 AND 15-17 ARE NOT ANTICIPATED ................................ 14
`
`A. APVMA lacks critical sample information ......................................... 15
`
`B. APVMA is not prior art because it fails to provide an enabling
`disclosure ............................................................................................. 16
`
`C.
`
`Inherent anticipation requires that the unstated limitation be
`necessarily present in the prior art reference ....................................... 20
`
`D. Willowood has failed to demonstrate that the sample in
`APVMA is necessarily modification IV ............................................. 20
`
`1. Melting point determination is just one part of thermal
`analysis, which does not show that a sample is necessarily
`of a certain polymorph ................................................................. 21
`
`2. Similar or even the same melting points do not necessarily
`indicate the same polymorph ........................................................ 27
`
`3. Willowood has no basis to compare the melting point
`values in APVMA and the '392 patent ......................................... 30
`
`4. Willowood failed to account for the existence of other
`polymorphs ................................................................................... 33
`
`5. Willowood's cases are readily distinguishable ............................. 37
`
`VI. CLAIMS 4-14 ARE NOT OBVIOUS ........................................................... 39
`
`A.
`
`Legal principles of obviousness .......................................................... 40
`
`B. Willowood's Prior Art ......................................................................... 40
`
`1. Vogel ............................................................................................ 41
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`U.S. Patent No. 7,816,392
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`2. Beckmann ..................................................................................... 42
`
`C.
`
`D.
`
`The combined teachings of the prior art references do not
`disclose modification IV ..................................................................... 44
`
`The prior art does not provide a reason or motivation to
`combine the prior art references as Willowood asserts ....................... 46
`
`1. There was no reason or motivation to try to develop
`modification IV ............................................................................ 47
`
`2. There is no motivation to combine the teachings of
`APVMA with solution-based crystallization methods ................. 48
`
`3. A POSA would not have been motivated to combine the
`teachings of APVMA, Vogel and Beckmann .............................. 49
`
`E.
`
`The prior art does not provide a reasonable expectation of
`success in making modification IV of pyraclostrobin ........................ 50
`
`1. Creation of polymorphs is an unpredictable art ........................... 51
`
`2. Knowledge of principles of polymorph screening does not
`provide a reasonable expectation of success in light of the
`prior art's failure to teach any procedure for preparing
`modification IV ............................................................................ 56
`
`3. Willowood relies on an incorrect law on reasonable
`expectation of success .................................................................. 58
`
`4. Prior success in crystallizing pyraclostrobin does not lead
`to a reasonable expectation of success in preparing
`modification IV ............................................................................ 59
`
`5. There cannot be a reasonable expectation of success when
`prior art does not provide basic information for successful
`seeding .......................................................................................... 60
`
`VII. CONCLUSION .............................................................................................. 61
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`Case IPR2018-01096
`U.S. Patent No. 7,816,392
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`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Amgen, Inc. v. Chugai Pharm. Co.,
`927 F.2d 1200 (Fed. Cir. 1991) .......................................................................... 16
`
`Aristocrat Techs. Australia Pty Ltd. v. Int’l Game Tech.,
`709 F.3d 1348 (Fed. Cir. 2013) .......................................................................... 14
`
`Atlas Powder Co. v. IRECO Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) .......................................................................... 37
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ........................................................................................ 13
`
`Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research,
`346 F.3d 1051 (Fed. Cir. 2003) .......................................................................... 16
`
`Exergen Corp. v. Wal-Mart Stores, Inc.,
`575 F.3d 1312 (Fed. Cir. 2009) .......................................................................... 20
`
`Fontaine Engineered Prods., Inc. v. Raildecks, Inc.,
`IPR No. 2013-00361 (P.T.A.B. Dec. 13, 2013) ................................................. 45
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ............................................................................ 49
`
`HTC Corp. v. Cellular Communs. Equip., LLC,
`877 F.3d 1361 (Fed. Cir. 2017) .......................................................................... 20
`
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ........................................................ 40, 50, 58, 59
`
`InTouch Techs., Inc. v. VGO Communications, Inc.,
`751 F.3d 1327,1352 (Fed. Cir. 2014) ................................................................. 49
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 40
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`U.S. Patent No. 7,816,392
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`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) .......................................................................... 47
`
`Mformation Techs., Inc. v. Research in Motion Ltd.,
`764 F.3d 1392 (Fed. Cir. 2014) .......................................................................... 13
`
`nXn Partners, LLC v. Nissan Chem. Indus., Ltd,
`IPR2016-00694 (P.T.A.B. August 31, 2016) ............................................... 37, 38
`
`Oxford Nanopore Techs. Ltd. v. Univ. of Wash.,
`IPR No. 2014-00512 (P.T.A.B. Sept. 15, 2014) ................................................. 44
`
`Par Pharm., Inc. v. TWi Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .................................................................... 45, 46
`
`PersonalWeb Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ............................................................................ 49
`
`Sandoz Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005 (P.T.A.B. April 24, 2015) ........................................................ 44
`
`Takeda Pharm. Co., LTD v. Handa Pharm., LLC,
`2013 U.S. Dist. LEXIS 187604 (N.D. Cal. Oct. 17, 2013) .......................... 51, 60
`
`Titanium Metals Corp. of Am. v .
`Banner, 778 F.2d 775 (Fed. Cir. 1985)............................................................... 37
`
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) ............................................................................ 16
`
`Zetec, Inc. v. Westinghouse Elec. Co., LLC,
`IPR No. 2014-00384 (P.T.A.B. July 23, 2014) .................................................. 44
`
`Statutes
`
`35 U.S.C. § 112 ........................................................................................................ 11
`
`Other Authorities
`
`37 C.F.R. § 42.6(e) ................................................................................................... 64
`
`37 C.F.R. § 42.24 ..................................................................................................... 63
`
`37 C.F.R. § 42.24(a) ................................................................................................. 63
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`37 C.F.R. § 42.24(d) ................................................................................................ 63
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`37 C.F.R. §42.100(b) ............................................................................................... 13
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`37 C.F.R. §§ 42.104(b)(4) .......................................................................................... 1
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`37 C.F.R. § 42.107 ................................................................................................... 64
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`37 C.F.R. § 42.108(c) ................................................................................................. 1
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`Case IPR2018-01096
`U.S. Patent No. 7,816,392
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`I.
`
`INTRODUCTION
`
`Patent Owner BASF SE ("Patent Owner" or "BASF") submits this
`
`Preliminary Response to the Petition filed by Willowood USA LLC ("Petitioner"
`
`or "Willowood") requesting inter partes review ("IPR") of claims 1 through 17 of
`
`U.S. Patent No. 7,816,392 ("the '392 patent"; Ex. 1002). This response is timely
`
`pursuant to the Board's Order in Paper No. 7.
`
`The '392 patent discloses and claims crystalline modification IV (claims 1-3)
`
`of a fungicidal compound known as pyraclostrobin, the process for preparing
`
`modification IV (claims 4-14), and its use for preparing crop protection
`
`compositions (claims 15-17).
`
`Patent Owner respectfully requests that the Board decline to institute IPR
`
`because Petitioner has not satisfied 37 C.F.R. §§ 42.104(b)(4) and 108(c) insofar as
`
`the Petition fails to show that there is a reasonable likelihood that Petitioner would
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`prevail in its assertions that any of claims 1-17 of the '392 patent is unpatentable
`
`over the cited references.
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`As to anticipation (Ground 1; claims 1-3; 15-17): Willowood relies on a
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`reference entitled "Evaluation of the new active PYRACLOSTROBIN in the
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`product CABRIO FUNGICIDE" purportedly published by the Australian
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`Pesticides and Veterinary Medicines Authority (hereinafter, "APVMA").1 APVMA
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`does not expressly disclose modification IV and Willowood does not claim
`
`otherwise. Instead, Willowood relies on a theory of inherent anticipation, arguing
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`that APVMA necessarily discloses modification IV of pyraclostrobin simply
`
`because the melting point range disclosed in APVMA falls within the range
`
`disclosed by the '392 patent for modification IV and outside the ranges disclosed
`
`by the '392 patent for modifications I, II and III.
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`As an initial matter, APVMA fails to provide an enabling disclosure such
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`that one of ordinary skill in the art can make or use modification IV without undue
`
`experimentation. APVMA is completely devoid of any information on how
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`modification IV can be made. Such absence of information is fatal here in light of
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`the fact that prior art does not teach the preparation of modification IV and the
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`field of polymorphism was known to be unpredictable at the time of the invention.
`
`
`1 Relying on a declaration by J. Hindah Weissbrot, Willowood claims that
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`APVMA was publicly available as of 2003. Paper 2 (hereinafter, "Pet.") at 13. In
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`this Preliminary Response, BASF focuses on addressing the merits of APVMA
`
`because, as discussed below, APVMA fails to anticipate the claimed invention as a
`
`matter of law. BASF reserves the right to present relevant facts and law concerning
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`the public availability of APVMA in the Patent Owner Response if a trial is
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`instituted.
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`Even if APVMA provided an enabling disclosure, which it does not,
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`Willowood's inherent anticipation theory is fatally flawed for at least the following
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`reasons:
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` Willowood relies on an analytical technique that has been recognized
`
`as insufficient for proving the existence of specific polymorphs and polymorphism
`
`by many scientists in the field, including Willowood's own expert, Dr. Harry
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`Brittain. Melting point is one of the parameters measured through thermal analysis.
`
`Dr. Brittain and numerous others have long recognized that thermal analysis
`
`(including melting point determination) does not necessarily prove the existence of
`
`polymorphism or its identification.
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` Willowood assumes, without support, that the melting point values
`
`reported in APVMA and the melting point values reported in the '392 patent are
`
`directly comparable. However, it is well-established that measured melting point
`
`values may vary depending on the instrument used as well as the measurement
`
`parameters selected, in particular in the case of low melting point compounds, such
`
`as pyraclostrobin. While the '392 patent provides a detailed description of the
`
`instrument and parameters used for measuring melting point, APVMA does not
`
`provide any such necessary information.
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` Willowood ignores the fact different polymorphs of the same
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`compound have been known to have close, overlapping, or even the same, melting
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`points.
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` Willowood fails to account for the existence of other polymorphic
`
`forms of pyraclostrobin in addition to modification IV, at least one of which has
`
`been reported to possess a melting point that (i) falls squarely within the melting
`
`point of modification IV recited in the '392 patent, and (ii) falls within and/or
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`overlaps with the melting point reported in APVMA.
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`Considering the evidence as a whole, Willowood cannot demonstrate that
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`APVMA inevitably and necessarily discloses the claimed modification IV and,
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`therefore, there is no reasonable likelihood that Willowood would prevail in its
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`assertions that claims 1-3 and 15-17 of the '392 patent are anticipated by this
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`reference.
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`As to obviousness (Ground 2; claims 4-14): Willowood's obviousness
`
`theory is fatally flawed for at least the following reasons:
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` The combined teachings of the prior art references fail to teach all
`
`limitations of the claims.
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` The identified prior art does not show any motivation for developing
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`the claimed modification IV.
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` The identified prior art does not provide a reason or motivation to
`
`combine the prior art references as Willowood alleges and, in fact,
`
`suggests a different route.
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` The identified prior art demonstrates that there is no reasonable
`
`likelihood of success in developing modification IV.
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`Consequently, there is no reasonable likelihood that Willowood would
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`prevail in its assertion that claims 4-14 of the '392 patent are obvious over the
`
`identified references. 2
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`II. BACKGROUND OF THE INVENTION
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`The '392 patent relates to novel crystalline modifications of pyraclostrobin,
`
`the process for their preparation, the use of the novel modifications for preparing
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`crop protection compositions. Ex. 1002 at 1:4-7.
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`Claims 1, 4, 15, and 17 are representative claims that correspond to each of
`
`these three categories. These claims recite:
`
`
`2 While BASF maintains that Willowood has not established that there is
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`reasonable likelihood that any of the challenged claims are unpatentable, to the
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`extent trial is instituted, BASF reserves the right to offer reasons of
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`nonobviousness based on secondary considerations.
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`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:
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`d=6.02 ± 0.01 Å
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`d=4.78 ± 0.01 Å
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`d=4.01 ± 0.01 Å
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`d=3.55 ± 0.01 Å
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`d=3.01 ± 0.01 Å.
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`4. A process for preparing a crystalline modification IV of
`
`pyraclostrobin according to any of the preceding claims, comprising:
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`i) dissolving a pyraclostrobin form different from modification IV in
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`an organic solvent or solvent mixture, where the organic solvent or
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`solvent mixture comprises at least 70% by volume of at least one fully
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`water-miscible organic solvent L1 and up to 30% by volume of water;
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`and
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`ii) effecting crystallization of pyraclostrobin over a period of at least
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`10 hours and/or in the presence of seed crystals of modification IV.
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`15. A composition for crop protection, comprising pyraclostrobin in
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`the form of modification IV, carriers, and/or auxiliaries.
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`
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`17. A method for controlling phytopathogenic fungi comprising
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`contacting a plant, seed, or soil in need of treatment with a crystalline
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`form of modification IV of pyraclostrobin.
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`As indicated by these claims, which are the sole independent claims, all
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`claims of the '392 patent require modification IV as a limitation.
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`A. The invention of the '392 patent
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`Pyraclostrobin is an active compound for controlling phytopathogenic fungi.
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`Ex. 1002 at 1:8-13. Before the invention of the '392 patent, commercial
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`pyraclostrobin products were frequently formulated as emulsion concentrates or
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`suspoemulsion concentrates. Id. at 1:24-27. These forms use large amount of
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`organic solvents, which create both environmental and work hygiene issues. Id. at
`
`1:24-32. The '392 patent specification notes that pyraclostrobin suspoemulsion
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`concentrates and another known pyraclostrobin formulation also suffer from poor
`
`stability during storage, which may manifest itself as irreversible particle size
`
`increases or separation of the particles from the formulation. Id. at 1:33-45.
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`Prior to the invention of the '392 patent, efforts at solving these problems by
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`formulating pyraclostrobin as aqueous suspension concentrates were unsuccessful.
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`Id. at 1:19-23. This was because the commercially available pyraclostrobin was an
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`amorphous substance of low melting point, which would cause the grinding
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`apparatus to get stuck during grinding as a result of the tackiness of the substance.
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`Id. at 1:13-19.
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`The invention of the '392 patent prepared and characterized four crystalline
`
`modifications of pyraclostrobin (I, II, III and IV). In particular, the '392 patent
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`provides an extensive description of the procedures for preparing modification IV.
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`See e.g., id. at 2:31-8:32; 19:50-20:41; 21:16-22:12. The '392 patent also provides
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`a thorough characterization of modification IV, including data on crystallography
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`(id. at 2:11-29), X-ray powder diffraction (id. at 1:51-63 and Fig. 1), melting point
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`(id. at 1:64-67), and heat of fusion (id. at 1:67-2:2). Furthermore, the '392 patent
`
`specifies how the melting point data and heat of fusion data were measured: using
`
`differential scanning calorimetry (DSC) that was run with a heating rate of 5
`
`K/min. Id. at 2:2-6; 19:41-45.
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`The inventors of the '392 patent were able to solve the existing formulation
`
`problems by preparing an aqueous suspension concentrate using modification IV.
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`The inventors surprisingly found modification IV to be particularly advantageous
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`for use in crop protection formulations. Modification IV "allow[s] the preparation
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`of low-solvent or solvent-free aqueous suspension concentrates both of
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`pyraclostrobin on its own and of pyraclostrobin with other crop protection agents."
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`Id. at 19:6-9. Use of modification IV also leads to "better storage stability
`
`compared to the known pyraclostrobin-comprising suspension concentrates and
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`suspoemulsion concentrates." Id. at 19:14-17. Modification IV's superior stability
`
`profile is demonstrated by a comparison between two formulations: one using
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`pyraclostrobin melt adsorbed on silicic acid particles and the other using
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`modification IV in an aqueous suspension concentrate. Id. at 22:25-24:20. The
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`formulation containing modification IV resulted in less sedimentation and
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`maintained smaller particles during storage. Id. at 23:56-24:20.
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`B. Prosecution history of the '392 patent
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`While Willowood offers a lengthy description of the prosecution history of
`
`the '392 patent (Pet. at 9-12), it fails to recount certain critical information that
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`either bears upon Willowood's inherent anticipation theory or the question of
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`obviousness.
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`The '392 patent originates and claims priority from a German patent
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`application filed on June 20, 2005. During the prosecution of the '392 patent,
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`pending claims were rejected as being anticipated by or in the alternative, obvious
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`over U.S. Patent Publ. No. US 2003/0199394 (the '394 application). January 12,
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`2010 office action (Ex. 1004) at 4-6. In describing applicants' April 23, 2010
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`response to the office action, Willowood states:
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`Importantly, the applicants emphasized the different melting points of
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`crystalline modifications I and IV as an important distinction between the
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`'394 publication's alleged disclosure of only crystalline modification I and
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`their claim of crystalline modification IV.
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`Pet. at 11. Such statement is immediately followed by the following quote from
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`applicants' response:
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`Indeed, crystal modification I obtained from the melt-crystallization has a
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`melting point in the range [of] 55-56°C…whereas modification IV obtained
`
`from the solution-recrystallization has a melting point in the range of 65-
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`67°C….Thus, it is clear that [the '394 publication] discloses crystal
`
`modification I and not crystal modification IV.
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`Pet. at 11-12.
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`
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`What Willowood neglected to point out is that the difference in melting
`
`points is not the only information applicants relied on to distinguish modifications
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`I and IV. The second ellipsis in Willowood's quote conveniently omits the
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`following statement by the applicants: "Furthermore, crystal modification I
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`obtained from the melt-crystallization exhibits an X-ray diffraction pattern (Figure
`
`3) that is different from that exhibited by modification IV (Figure 1) of the present
`
`application." April 23, 2010 response (Ex. 1006) at 7. In addition to melting point
`
`and X-ray data, the applicants further compared the enthalpy of fusion of the
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`crystalline pyraclostrobin reported in the '394 application (61.13 j/g) to the
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`enthalpies of fusion of the four modifications disclosed in the '392 patent (63-65
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`j/g, 67-70 j/g, 69-72 j/g and 72-78 j/g for modifications I, II, III and IV,
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`respectively) and concluded that "the enthalpy of fusion of the crystal modification
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`disclosed in the '394 application of 61.13 j/g is also mostly consistent with
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`crystalline modification I above." Id. Furthermore, the applicants noted that the
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`crystal in the '394 application and modification I of the '392 patent are both
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`prepared using "melt-crystallization," while modification IV of the '392 patent is
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`prepared by a "solution-recrystallization process." Id. at 6.
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`Case IPR2018-01096
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`The applicants relied on all of the evidence, not just melting points alone, in
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`concluding that "the '394 application does not anticipate the claims of the present
`
`application." Id. at 7.
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`
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`In response, the examiner did not even discuss melting point and instead
`
`focused on the differences in the preparatory procedures and enthalpy of fusion
`
`data. The examiner stated:
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`Applicants argued that the '394 pyraclostrobin crystal modification is
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`modification I, obtained from melt-crystallization, which is different from
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`the instant crystal modification IV, which is made from solution-
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`recrystallization process. In addition, the modification (I) has enthalpy of
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`fusion of 63-65 j/g, which is close to the '394 teaching of 61.13 j/g; while the
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`instant modification IV has enthalpy of fusion of 72-78 j/g. Therefore, the
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`'394 pyraclostrobin crystal modification is different from the instant crystal
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`modification IV. Applicants' argument is found persuasive. Therefore, the
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`rejection is hereby withdrawn.
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`Ex. 1007 at 5.
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`
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`Willowood also neglected to discuss a rejection for lack of written
`
`description and applicants' argument that overcame it. In the same January 12,
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`2010 office action, the examiner rejected certain pending claims under 35 U.S.C. §
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`112 for lack of written description. Ex. 1004 at 6-7. While these claims define
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`crystalline pyraclostrobin content of 98% or 90% by weight, the examiner stated
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`that the specification does not describe how to determine the content by weight. Id.
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`at 6-7.
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`In response, the applicants explained that "calorimetric methods may be
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`used to determine the purity of a particular sample by analyzing the DSC melting
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`peak shape and melting temperature of the impure crystal modification and
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`comparing it to data collected from a known pure sample." Ex. 1006 at 10. The
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`applicants attached excerpts from a 1984 publication, which recites that it is a
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`"well-known fact that the presence of even minute amounts of impurity in a
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`material broadens its melting range and lowers the final melting point of the
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`material from T0, the melting temperature of an infinitely pure material, to a lesser
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`temperature, Tm." Ex. 2001 at 6. The examiner found the argument persuasive and
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`ultimately withdrew the rejection. Ex. 1007 at 5.
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`III. THE PERSON OF ORDINARY SKILL IN THE ART
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`For the purposes of this preliminary response, BASF does not challenge
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`Willowood's proposed definition of a person of ordinary skill in the art ("POSA").
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`BASF reserves the right to provide an alternate definition if trial is instituted.
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`IV. CLAIM CONSTRUCTION
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`In an IPR proceeding, a claim is interpreted by applying its "broadest
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`reasonable construction in light of the specification of the patent in which it
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`appears." 37 C.F.R. §42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
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`2142 (2016).
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`Willowood proposes a construction for a single term: crystalline
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`modification IV of pyraclostrobin. Willowood construes that the broadest
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`reasonable interpretation for this term is:
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`a crystalline structure of pyraclostrobin having a specific X-ray
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`diffraction pattern at 25°C showing at least three, in particular at least
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`four, and preferably all of the following reflexes: d=6.02 ± 0.01 Å,
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`d=4.78 ± 0.01 Å, d=4.01 ± 0.01 Å, d=3.55 ± 0.01 Å, d=3.01 ± 0.01 Å
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`and having a melting point in the range from 62 to 72°C, in particular
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`in the range from 64 to 68°C, and especially in the range from 65 to
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`67°C, and having a heat of fusion of 72 to 78 J/g, and in particular
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`about 74 ± 1 J/g.
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`Pet. at 22-23.
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`Willowood's proposed construction ignores two key limitations that are
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`expressly recited in the claims: (1) claim 1 expressly specifies the particular
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`reflexes of X-ray powder diffractogram at 25 °C, and (2) claim 2 expressly
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`specifies a melting point in the range from 62 to 72 °C. Thus, Willowood's
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`proposed construction improperly seeks to re-write the claim language, which
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`expressly specifies the reflexes or melting point.
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`There is no reason to construe the claim term to include reflexes or melting
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`point when claims 1 and 2 expressly recite these limitations. See, e.g., Mformation
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`Techs., Inc. v. Research in Motion Ltd., 764 F.3d 1392, 1399 (Fed. Cir. 2014)
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`(favoring a construction that does not render another limitation "superfluous");
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`Aristocrat Techs. Australia Pty Ltd. v. Int'l Game Tech., 709 F.3d 1348, 1356-57
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`(Fed. Cir. 2013) (declining to adopt proposed construction that would render
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`another limitation "superfluous").
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`As discussed below, the absolute values of melting point are influenced by
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`many factors (e.g., the type of instrument used for melting point determination, the
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`operational parameters and the purity of the sample). Such information does not
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`belong to the definition of a polymorph.
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`In light of the claim language requiring the claimed crystalline modification
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`IV of pyraclostrobin to show at least 3 of 5 specific reflexes, BASF maintains that
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`this term does not require construction. However, as discussed below, no trial
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`should be instituted under either party's claim construction proposal.
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`BASF reserves the right to propose a construction for this and any other
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`claim term if a trial is instituted.
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`V. CLAIMS 1-3 AND 15-17 ARE NOT ANTICIPATED
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`Willowood challenges the patentability of claims 1-3 and 15-17 on a single
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`ground, i.e., they are anticipated by APVMA. See Pet. at 23. Recognizing that
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`APVMA does not expressly teach modification IV, Willowood offers an inherent
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`anticipation theory that the sample described in APVMA is necessarily
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`modification IV.
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`Willowood's anticipation challenge should be denied for at least two
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`independent reasons. First, APVMA is ineligible as a prior art reference because it
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`fails to provide an enabling disclosure. Second, Willowood failed to demonstrate
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`that the form of pyraclostrobin disclosed in APVMA is necessarily modification IV
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`as disclosed and claimed in the '392 patent.
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`A. APVMA lacks critical sample information
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`APVMA discloses pyraclostrobin in the form of a "[w]hite to light beige"
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`"[c]rystalline powder" with a melting point range of "63.7 – 65.2 °C." Ex. 1008 at
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`11.
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`It is critical to understand what APVMA does not disclose:
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` APVMA does not state that the powder is modification IV;
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` APVMA does not provide any X-ray diffraction data, let alone the X-
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`ray diffraction data recited in claim 1 of the '392 patent;
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` APVMA does not provide any information about how the melting
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`point was measured, such as the type of instrument and operational
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`parameters, and
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` APVMA does not provide any information about how the crystalline
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`powder was prepared. See Pet. at 38.
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`Willowood does not assert otherwise.
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`B. APVMA is not prior art because it fails to provide an enabling
`disclosure
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`As a threshold issue, APVMA fails to provide an enabling disclosure and,
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`therefore, Willowood's anticipation challenge should be denied. To serve as an
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`anticipating reference, the reference must enable that which is asserted to
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`anticipate. Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346
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`F.3d 1051, 1054 (Fed. Cir. 2003). "[E]ven if the claimed invention is disclosed in
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`a printed publication, that disclosure will not suffice as prior art if it is not
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`enabling." Id. at 1055. Enablement requires that "the prior art reference must teach
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`one of ordinary skill in the art to make or carry out the claimed invention without
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`undue experimentation." Id. at 1054. In determining whether undue
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`experimentation is required to make and use a claimed invention, the following
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`factors may be considered: "(1)