Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`KINDERFARMS, LLC,
`Petitioner,
`v.
`GENEXA, INC.
`Patent Owner.
`
`
`
` Case No. PGR2023-00051
`U.S. Patent No. 11,617,795
`
`
`
`
`
`PATENT OWNER’S SURREPLY
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`
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
`
`
`TABLE OF CONTENTS
`
`
`I.
`II.
`
`Page
`INTRODUCTION ................................................................................................ 1
`PETITIONER’S REPLY FAILS TO ADDRESS THE UNDISPUTED AND
`DISPOSITIVE ERRORS IN THE PETITION AND IMPROPERLY RAISES NEW
`ARGUMENTS .................................................................................................... 2
`A.
`The Petition’s Assertion that Agave Syrup Has a Viscosity of
`212 cP Is Indisputably Wrong and Dispositive of Non-
`Obviousness .......................................................................................... 4
`1.
`The Petition never once mentioned “selecting an agave
`syrup of appropriate viscosity” but instead wrongly
`presumed that agave syrup “has a viscosity of around
`212 centipoise” ........................................................................... 6
`Petitioner’s Reply cannot salvage the Petition’s failure to
`prove obviousness under Grounds 1 and 2 .............................. 10
`The Petition never mentions adjusting the water content
`to achieve a final desired viscosity .......................................... 15
`Dr. Berkland’s deposition testimony rejects the Reply’s
`new theory and further demonstrates Petitioner’s reliance
`on impermissible hindsight ...................................................... 18
`Petitioner’s Improper New Motivation to Combine Arguments
`on Reply Are Prohibited ..................................................................... 20
`Agave Syrup Was Not Well-Known to a POSA for Performing
`the Function of Achieving a Desired Viscosity in an Oral
`Formulation ........................................................................................ 21
`D. Dr. Berkland’s Testimony that a POSA Would Disregard the
`Clear Error in the ’4666 Patent Is Unrebutted ................................... 23
`The Petition Failed to Establish a Presumption of Obviousness ....... 23
`E.
`III. DR. BERKLAND’S CREDIBLE TESTIMONY SHOULD BE GIVEN MORE
`WEIGHT THAN DR. CROWLEY’S CONCLUSORY AND ERRONEOUS
`OPINIONS ....................................................................................................... 24
`IV. CONCLUSION .................................................................................................. 25
`
`-i-
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`2.
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`3.
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`4.
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`B.
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`C.
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Apple Inc. v. MemoryWeb, LLC,
`PGR2022-00006, Paper 41 (P.T.A.B. June 7, 2023) ............................................ 3
`Apple Inc. v. MemoryWeb, LLC,
`PGR2022-00006, Paper 43 (P.T.A.B. June 7, 2023) ............................................ 3
`ATD Corp. v. Lydall, Inc.,
`159 F.3d 534 (Fed. Cir. 1998) ............................................................................ 14
`Corephotonics, Ltd. v. Apple Inc.,
`84 F.4th 990 (Fed. Cir. 2023) ................................................................... 6, 10, 20
`DynaEnergetics Europe GmbH et al v. QinetiQ Ltd.,
`PGR2023-00003, Paper 19 (P.T.A.B. Apr. 11, 2024) .................................... 2, 14
`Eli Lilly & Co. v. Zenith Goldline Pharms.,
`471 F.3d 1369 (Fed. Cir. 2006) .......................................................................... 24
`Henny Penny Corp. v. Frymaster LLC,
`938 F.3d 1324 (Fed. Cir. 2019) ............................................................................ 3
`Icon Health & Fitness, Inc. v. Strava, Inc.,
`849 F.3d 1034 (Fed. Cir. 2017) ............................................................................ 3
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ........................................................................ 2, 4
`In re Rouffet,
`9 F.3d 1350 (Fed. Cir. 1998) .............................................................................. 20
`Ruiz v. A.B. Chance Co.,
`357 F.3d 1270 (Fed. Cir. 2004) .......................................................................... 15
`Sanofi-Synthelabo v. Apotex, Inc.,
`550 F.3d 1075 (Fed. Cir. 2008) .......................................................................... 14
`Sensonics, Inc. v. Aerosonic Corp.,
`81 F.3d 1566 (Fed. Cir. 1996) ............................................................................ 20
`
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`In re Van Os,
`844 F.3d 1359 (Fed. Cir. 2017) .......................................................................... 23
`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) ...................................................................... 6, 21
`Statutes
`35 U.S.C. § 312(a)(3) ................................................................................................. 2
`35 U.S.C. § 322(a)(3) ............................................................................................. 2, 4
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`-iii-
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`
`
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`Patent Owner’s Exhibit List
`
`Description of Document
`Exhibit
`
`No.
`2001 Genexa Launches First-to-Market Clean Over-the-Counter Medicine,
`BusinessWire (Sept. 29, 2020)
`
`2002
`
`Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(November 2019)
`2003 Declaration of Adam M. Pivovar in Support of Motion to Appear Pro
`Hac Vice
`2004 Biography of Adam Pivovar
`2005 Declaration of Stephen Smith in Support of Motion to Appear Pro Hac
`Vice
`2006 Biography of Stephen Smith
`2007 Declaration of Brianna (Chamberlin) Patterson in Support of Motion
`to Appear Pro Hac Vice
`2008 Biography of Brianna (Chamberlin) Patterson
`2009 Declaration of Dr. Cory J. Berkland in Support of Patent Owner’s
`Response to Petition
`2010 Genexa Kids’ Pain & Fever Blueberry Flavor, available at
`https://www.businesswire.com/news/home/20200929005330/en/
`
`2011
`
`September 2021 OTC Product News, Infants’ Pain and Fever,
`Pharmacy Times, 87:9 (2021), available at
`https://www.pharmacytimes.com/view/september-2021-otc-product-
`news
`
`-iv-
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`
`
`
`Patent Owner’s Exhibit List
`
`Description of Document
`Exhibit
`
`No.
`2012 E. Mellado-Mojica and M. G. Lopez, Identification, classification, and
`discrimination of agave syrups from natural sweeteners by infrared
`spectroscopy and HPAEC-PAD, Food Chemistry, 167, 349-357
`(2015)
`2013 B.I. Maldonado-Guevara et al., Production Process Effect on Mexican
`Agave Syrups Quality: A Preliminary Syrup, J. Food Res., 7:3 (2018)
`2014 E. Hill et al., Sweetener Content of Common Pediatric Oral Liquid
`Medications, Am. J. Hosp. Pharm. 45:135-42 (1988)
`
`2015
`
`SCOGS (Select Committee on GRAS Substances) Database, FDA
`available at:
`https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=SCOGS
`2016 Combined Index to USP 40 and NF 35, Volumes 1-4
`2017
`
`Search Results for “agave,” Combined Index to USP 40, available at:
`https://www.usp.org/search?search_api_fulltext=agave
`
`2018
`
`Search results for “agave syrup,” Merck Index Online, available at:
`https://merckindex.rsc.org/search-results?q=agave+syrup
`2019 L. Hernandez-Ramos et al., Nutritional value and antioxidant activity
`of the maguey syrup (Agave salmiana and A. mapisaga) obtained
`through three treatments, Not. Bot. Horti. Agrobo., 48:3, 1306-1316
`(2020)
`
`2020
`
`P. Subramaniam and N. Nandan, Cariogenic Potential of Pediatric
`Liquid Medicaments– An in vitro Study, J. Clinical Pediatric
`Dentistry, 36:4, 357-362 (2012)
`2021 U.S. Patent No. 10,238,640
`
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`
`Exhibit
`No.
`2022
`
`
`
`
`
`
`Patent Owner’s Exhibit List
`
`Description of Document
`
`
`J.F. Swindells et al., Viscosities of Sucrose Solutions at Various
`Temperatures: Tables of Recalculated Values, Supplement to National
`Bureau of Standards Circular, 440 (1958)
`2023 D. Reker et al., “Inactive” ingredients in oral medications, Sci. Transl.
`Med., 11:483 (2019)
`
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`I.
`INTRODUCTION
`Petitioner’s Reply only confirms the dispositive failures of the Petition to
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`demonstrate obviousness of any claims of the ’795 patent under Grounds 1 and 2.1
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`The Petition and Dr. Crowley’s supporting declaration wrongly premised its theory
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`of obviousness on the erroneous and conclusory assertion that agave syrup has a
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`viscosity of 212 centipoise, despite the cited Exhibit 1031 showing agave syrup with
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`a viscosity of 2,560 cP. (Ex. 1003, ¶¶52, 119 (“As I previously noted at ¶52, a
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`person of ordinary skill in the art would have known that agave syrup has a
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`viscosity of around 212 centipoise.”);2 Ex. 1031; POR, 31, 57.)
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`Rather than defend the Grounds presented in the Petition and for which this
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`Review was instituted, Petitioner’s Reply tacitly acknowledges the fundamental
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`failure of the Petition by abandoning those theories and improperly attempting to
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`assert new ones based solely on attorney argument that is unsupported by any
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`evidence. Indeed, Petitioner failed to provide any new Reply expert declaration.
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`Ultimately, Petitioner’s new Reply arguments contradict the Petition and only
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`further demonstrate that the Petition as instituted failed to satisfy Petitioner’s burden
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`to prove obviousness.
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`1 Petitioner’s Reply does not dispute that Ground 3 is moot. (See POR, 68.)
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`2 All emphasis in this brief has been added, unless noted otherwise.
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`Accordingly, the Board should uphold all claims of the ’795 patent as non-
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`obvious and patentable over the failed arguments and evidence presented by
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`Petitioner.
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`II.
`
`PETITIONER’S REPLY FAILS TO ADDRESS THE UNDISPUTED AND
`DISPOSITIVE ERRORS IN THE PETITION AND IMPROPERLY RAISES NEW
`ARGUMENTS
`Unable to respond directly to the undeniable and dispositive errors in the
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`Petition exposed by Patent Owner’s Response (“POR”), Petitioner’s Reply wrongly
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`seeks to have the Board ignore the theories and evidence presented in the Petition in
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`lieu of improper new arguments that were never previously presented. It is a
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`statutory requirement that the initial Petition must identify with particularity the
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`evidence that supports the grounds for the challenge to each claim. E.g.,
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`DynaEnergetics Europe GmbH et al v. QinetiQ Ltd., PGR2023-00003, Paper 19 at
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`49 (P.T.A.B. Apr. 11, 2024) (“Petitioner shoulders the burden to point out evidence
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`supporting its position with ‘particularity.’”) (quoting 35 U.S.C. § 322(a)(3) and
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`citing cf. Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359
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`(Fed. Cir. 2016) (“It is of the utmost importance that petitioners in the IPR
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`proceedings adhere to the requirement that the initial petition identify ‘with
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`particularity’ the ‘evidence that supports the grounds for the challenge to each
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`claim.”) (citing the analogous 35 U.S.C. § 312(a)(3))).
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`It is neither fair nor necessary for the Board or Patent Owner to address
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`obviousness arguments that were not raised with particularity by the Petition. See,
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`e.g., Apple Inc. v. MemoryWeb, LLC, PGR2022-00006, Paper 41 at 85 (P.T.A.B.
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`June 7, 2023) (“[A]n IPR petitioner may not raise in reply ‘an entirely new rationale’
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`for why a claim would have been obvious.”) (quoting Henny Penny Corp. v.
`
`Frymaster LLC, 938 F.3d 1324, 1331-32 (Fed. Cir. 2019)); Apple Inc. v.
`
`MemoryWeb, LLC, PGR2022-00006, Paper 43 at 5-6 (P.T.A.B. June 7, 2023) (upon
`
`denial of rehearing, the Board recognizing that “Petitioner was required to make its
`
`case in the Petition, not the Reply”). As explained in Patent Owner’s notice
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`submitted with the approval of this Board, the Reply contains several improper new
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`arguments that should be disregarded. (Paper 27.)
`
`The arguments raised in Petitioner’s Reply also fail because they are not
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`supported by any expert testimony, relying instead solely on unsubstantiated
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`attorney argument. But “argument of counsel is not evidence.” See Icon Health &
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`Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017).
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`Here, the Board should disregard and reject Petitioner’s new Reply
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`arguments. The Reply fails to address with any evidence the unrebutted testimony
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`from Dr. Berkland that a POSA would have had no motivation nor any reasonable
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`expectation of success under the Petition’s arguments and evidence in Grounds 1
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`and 2. Petitioner simply failed to carry its burden in the initial petition, and cannot
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`assert new arguments on Reply. See 35 U.S.C. § 322(a)(3); Intelligent Bio-Systems,
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`821 F.3d at 1369.
`
`A. The Petition’s Assertion that Agave Syrup Has a Viscosity of 212
`cP Is Indisputably Wrong and Dispositive of Non-Obviousness
`It is undisputed that the Petition relied on Dr. Crowley’s (incorrect) opinion
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`that “[a]s I previously noted at ¶52, a person of ordinary skill in the art would have
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`known that agave syrup has a viscosity of around 212 centipoise.” (See Ex. 1003
`
`¶119; Pet., 31 (“The viscosity of agave syrup has been reported to be about 212
`
`centipoise. Ex. 1003 at ¶52.”), 57 (“The viscosity of agave syrup is reported to be
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`about 212 centipoise. Ex. 1003 at ¶52”).) As detailed in the POR, despite citing to
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`Exhibit 1031 that reports agave syrup having a viscosity of 2,560 cP, neither
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`Petitioner nor Petitioner’s expert ever acknowledged or posited any other viscosity
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`value for agave syrup with the Petition other than the incorrect, unsupported, and
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`conclusory assertion that a POSA “would have known that agave syrup has a
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`viscosity of around 212 centipoise.” (See POR, 24-28; Ex.2009, ¶¶111-121.)
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`On Reply, Petitioner seeks to cast this dispositive error as merely “a
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`miscitation in Dr. Crowley’s declaration”—but never submitted a reply declaration
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`from Dr. Crowley to substantiate this claim. (See Reply, 10.) Petitioner asserts that
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`“[t]he reference intended to be cited was Exhibit 1030, which reports agave syrup
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`with a viscosity of 212 cP.” (Reply, 10 n.4) But even if Petitioner’s erroneous
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`citation theory is credited, that only demonstrates that the Petition was premised on
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`the erroneous assertion that agave syrup necessarily has a viscosity of 212 cP—never
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`acknowledging or addressing any other of the inherently variable viscosity values
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`for agave syrup, including the 2,560 cP value reported in Dr. Crowley’s Exhibit
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`1031. (See, e.g., POR, 25-27, 30 (“The Petition inexplicably ignores the fact that
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`agave syrup can have viscosity up to at least 2,560 cP as shown in Exhibit 1031”
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`and “never presents any argument” regarding any such viscosity); Ex. 2009, ¶118
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`(“no reasoning is provided for the reliance on the viscosity of agave syrup being at
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`or about 212 cP instead of any other viscosity for agave syrup, such as the 2,560 cP
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`viscosity value reported in Ex. 1031 . . . . Dr. Crowley and Petitioner did not address
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`the vast differences in viscosity agave syrup may have in light of the evidence they
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`have relied on”).)
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`Confronted with this fatal flaw, Petitioner’s Reply attempts to pivot by
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`asserting, without evidence, that “a POSA would be capable of selecting an agave
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`syrup with appropriate viscosity and, if necessary, adjusting the water content and/or
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`other components to achieve the desired final viscosity.” (Reply, 11; see also Reply
`
`at 19 (same), 20 (same).)
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`But Petitioner cannot advance an entirely new theory on Reply simply because
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`its initial Petition failed to present a viable theory of obviousness. “The ‘newness’
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`restriction prohibits the petitioner from raising, in reply, ‘an entirely new theory
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`of prima facie obviousness absent from the petition,’ even if the new theory is
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`responsive to the patent owner’s response or the Board’s institution decision.”
`
`Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1008 (Fed. Cir. 2023)
`
`(quoting Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed.
`
`Cir. 2017). “Shifting arguments in this fashion is foreclosed by statute, [Federal
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`Circuit] precedent, and Board guidelines.” Wasica, 853 F.3d at 1286.
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`Petitioner’s new attorney arguments on Reply are flawed in various ways and
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`should be rejected.
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`1.
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`The Petition never once mentioned “selecting an agave syrup
`of appropriate viscosity” but instead wrongly presumed that
`agave syrup “has a viscosity of around 212 centipoise”
`As noted, the only viscosity value for agave syrup presented in the Petition
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`was about 212 cP. (See Pet., 31, 57.) The only viscosity value for agave syrup in
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`Dr. Crowley’s declaration was about 212 cP (or around 200 cP). (See Ex.1003, ¶¶52,
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`119, 216.) Thus, the Petition and Dr. Crowley undeniably relied on the incorrect
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`assertion that a POSA would have known there was only one value—i.e., around
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`212 cP—for the viscosity of agave syrup. (See, e.g., Ex.1003, ¶119 (“a person of
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`ordinary skill in the art would have known that agave syrup has a viscosity of
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`around 212 centipoise”).)
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`As noted by Dr. Berkland regarding Ground 1, “Dr. Crowley proposed no
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`modifications to FR458-Example 1 and never addresses why there would be any
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`motivation to combine FR458 with the ’4666 patent and/or WO133 if agave syrup
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`has the viscosity reported in Ex. 1031 of 2,560 cP.” (Ex. 2009, ¶150.) Dr.
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`Berkland’s testimony regarding Ground 2 was similar: “I note that neither Petitioner
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`nor Dr. Crowley have addressed how the references in Ground 2 would satisfy the
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`independent claims if utilizing a high-quality agave syrup with a viscosity of 2,560
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`cP found in Ex. 1031.” (Ex. 2009, ¶167.)
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`Additionally, Dr. Berkland’s testimony that a POSA would not have been
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`motivated to select a low quality 212 cP agave syrup within Grounds 1 and 2
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`proposed in the Petition remains unrebutted. (Ex. 2009, ¶121.) As Dr. Berkland’s
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`declaration states, “[a] viscosity of 212 cP indicates to me that the agave syrup has
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`a lower quality” because it is “an apparently watered-down low quality agave
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`syrup.” (Ex. 2009, ¶121; see also Ex.1031; Ex.1051, 130:7-134:19, 136:15-22.)
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`The Reply does not contest Dr. Berkland’s opinion that a POSA would have
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`known that the use of such a low-quality, low-viscosity 212 cP agave syrup within
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`FR458-Example 1 (Ground 1) or WO742-Example IX (Ground 2) would result in
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`formulations that are “readily pourable”—i.e., having low viscosity within the range
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`of 20-150 cP—well below and outside the viscosity values of the ’4666 patent and
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`WO133 in Grounds 1 and 2. (See Ex. 2009, ¶¶147-150 (Ground 1), ¶¶167-171
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`(Ground 2).) Dr. Berkland’s further opinion that a POSA’s understanding of the
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`expected low viscosity of these example formulations using an agave syrup with 212
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`cP viscosity negates any motivation to combine or any reasonable expectation of
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`success in achieving the viscosity ranges in the ’4666 patent or WO133 likewise
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`remains unrebutted:
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`Thus, in my opinion, a POSA would not have had any motivation or
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`reasonable expectation of success in combining an agave syrup with
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`viscosity of 212 cP in FR458-Example 1 with the viscosity ranges
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`1000-3000 cP of the ’4666 patent or 200-900 cP of WO133 because the
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`expected viscosity of such a formulation would fall well below and
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`outside either of these ranges.
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`(Ex. 2009, ¶150 (Ground 1).)
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`A POSA therefore would have had no motivation, nor a reasonable
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`expectation of success, of combining an agave syrup with a viscosity of
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`212 cP or about 200 cP with the remaining ingredients as taught by
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`WO742-Example IX to achieve a formulation with a viscosity in the
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`range of either the ’4666 patent (1000-3000 cP) or WO133 (200-900
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`cP). . . . a POSA would understand the viscosity of WO742-Example
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`IX using an agave syrup of 200 cP would not satisfy these ranges.
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`Moreover, even if there was any motivation to combine WO742-
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`Example IX with the viscosity ranges of the ’4666 patent or WO133,
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`any such motivation would necessarily indicate to a POSA not to use
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`an agave syrup with about 200 cP, contrary to what Petitioner and
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`Dr. Crowley have relied on.
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`(Ex. 2009, ¶171 (Ground 2).)
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`The Petition failed to present any viable theory of obviousness with
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`particularity based on the incorrect assertion that agave syrup has a viscosity of 212
`
`cP, as demonstrated by the POR and Dr. Berkland’s unrebutted testimony. (See
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`POR, 43-51 (Ground 1), 58-63 (Ground 2).) Instead, Petitioner pivots to its new and
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`unsubstantiated Reply argument that a POSA would somehow know to “select[] an
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`agave syrup of appropriate viscosity.” (See Reply, 11, 19, 21.) But, as noted, this
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`new argument must be rejected. See 35 U.S.C. § 312(a)(3); see Henny Penny, 938
`
`F.3d at 1330 (“Board did not abuse its discretion in holding [Petitioner] to its word
`
`and disregarding its new theory first raised in reply.”) Contrary to Petitioner’s
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`apparent belief, a Reply in this proceeding is not an opportunity to make new
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`arguments simply because the initial petition failed. See Corephotonics, 84 F.4th at
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`1008.
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`2.
`
`Petitioner’s Reply cannot salvage the Petition’s failure to
`prove obviousness under Grounds 1 and 2
`Petitioner’s failure to present any defense of the Petition’s theories based on
`
`agave syrup having 212 cP and instead abandoning them in lieu of its new and
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`improper Reply arguments only underscores that Petitioner failed to carry its burden
`
`to prove obviousness, especially since it cannot overcome the nonobviousness
`
`evidence presented by Patent Owner in the POR. Petitioner’s new attorney
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`arguments on Reply with respect to Grounds 1 and 2 now mischaracterize its own
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`Petition, wrongly asserting that “none of [the Petition’s] arguments even relied on
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`a specific viscosity of agave syrup because the relevant viscosity is that of the
`
`formulation—not the agave syrup component only.” (Reply, 10.) The Reply further
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`contradicts the Petition by asserting that it also did not rely on any example
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`formulations from FR458 and WO742: “The Petition makes clear that it relies on
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`the formulation viscosity ranges expressly taught by the ’4666 Patent and WO133,
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`not on any hypothetical viscosity teachings from the examples in FR458 and
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`WO742. Pet., 31-32, 57-58.” (Reply, 11.)
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`But these new attorney arguments, which are not evidence, are undeniably
`
`contrary to the Petition. (See POR, 43-45 (quoting Pet., 31-32), id. at 58-60 (quoting
`
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`Pet., 57-58).) The Petition expressly relied on the supposed prior art teaching that
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`“the viscosity of agave syrup is reported to be 212 centipoise”; it also expressly
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`pointed to “the formulation disclosed in Example 1 of FR458” (Ground 1) and “the
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`formulation disclosed in Example IX of WO742” (Ground 2). (See Pet., 31, 57.)
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`The Petition also relied on evidence from Dr. Crowley’s declaration under Ground
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`1 (Pet., 31 (citing Ex. 1003, ¶119)) and Ground 2 (Pet., 57 (citing Ex. 1003, ¶216))
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`with respect to the claimed viscosity limitation in the ’795 patent. These citations
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`also make clear Dr. Crowley’s reliance on FR458-Example 1 and WO742-Example
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`IX utilizing an agave syrup with viscosity of 212 cP (or around 200 cP):
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`The formulations in Examples 1-4 of FR458 are largely made up of
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`agave syrup. Ex. 1004, pp. 8-10. As I previously noted at ¶ 52, a person
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`of ordinary skill would have known that agave syrup has a viscosity
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`of around 212 centipoise. Therefore, such a person would have known
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`that it was possible for the viscosity of the formulations in Example 1-
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`4 to be less than 1500 centipoise . . .
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`(Ex. 1003, ¶119 (Ground 1).)
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`Such a [POSA] would also know that agave syrup can have a viscosity
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`of around 200 centipoise – which is well under 1,500 centipoise.
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`Considering that the bulk of the formulation disclosed in Example IX
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`of WO742 is agave syrup, none of the added ingredients would be
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`expected to increase the viscosity of the composition above 1,500
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`centipoise. . . . Therefore, a person of ordinary skill in the art would
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`have understood that the viscosity of the final formulation disclosed is
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`likely to be less than 1,500 centipoise.
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`(Ex. 1003, ¶216 (Ground 2).)
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`Dr. Crowley expressly identified “Examples 1-4 of FR458” and “Example IX
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`of WO742,” noting they are “largely made up of agave syrup” or “the bulk of the
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`formulation” is agave syrup, respectively. (See Ex. 1003, ¶¶119, 216.) He also
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`coupled these assertions with his identification of agave syrup having a viscosity of
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`“around 212 centipoise” (or “around 200 centipoise”) to reach his asserted
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`conclusion that “it is possible” or “likely” that the viscosity of the final formulations
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`of Examples 1-4 of FR458 or the final formulation (singular) of “Example IX of
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`WO742” allegedly could be less than 1,500 centipoise, as recited in the independent
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`challenged claims. (Id.) Accordingly, there can be no reasonable debate that Dr.
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`Crowley’s (incorrect) opinions in his declaration were entirely premised on both “a
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`specific viscosity of agave syrup” (i.e., “around 212 cP”), and the example
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`formulations of FR458 and WO742-Example IX.
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`Petitioner’s Reply fails to provide any justification for why Dr. Crowley’s
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`clear testimony should now simply be disregarded, leaving the initial Petition’s
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`theories under Grounds 1 and 2 completely devoid of any evidentiary support.
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`Indeed, Petitioner’s assertion that its Grounds 1 and 2 did not rely on FR458-
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`Example 1 and WO742-Example IX are refuted by the Reply’s continued reliance
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`on those examples as allegedly satisfying limitations within the challenged
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`dependent claims.3 (See, e.g., Reply, 16-17 (relying on “Example IX of WO742
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`(Ground 2)” and “Example 1 of FR458” with respect to dependent claims 5 and 6).)
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`The POR also expressly noted the lack of any particularity in the Petition
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`regarding a motivation to combine and the mere “conclusory identification of: (1) a
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`clearly
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`erroneous viscosity of
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`agave
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`syrup,
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`(2) FR458-Example 1
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`(unmodified)/WO742-Example IX (unmodified), and (3) viscosity ranges from the
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`’4666 patent and WO133.” (POR, 43-44, 58-59; Ex. 2009, ¶147 (“I understand that
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`Petitioner and Dr. Crowley identify: (1) the erroneous assertion that agave syrup has
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`a viscosity of 212 cP; (2) FR458-Example 1; and (3) the viscosity ranges of the
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`3 Petitioner’s attorney arguments on Reply cannot salvage the failure to prove
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`obviousness of those claims, as shown by the POR. (See POR, 53-56, 63-68; Reply,
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`12-22.)
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`‘’4666 patent (1000-3000 cP) and WO1333 (200-900 cP) (See Pet., 31-32; Ex. 1003,
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`¶119.)”); see also Ex. 2009, ¶¶166-168.)
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`Petitioner cannot reasonably deny that Ground 1 and Ground 2 of its Petition
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`and supporting expert declaration from Dr. Crowley expressly relied on an agave
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`syrup with 212 cP (or around 200 cP) within either FR458-Example 1 or WO742-
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`Example IX, respectively, as purportedly being the “formulation” meant to be
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`combined with the viscosity ranges of the ’4666 patent and WO133. (See Ex. 1003,
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`¶¶119, 216; POR, 1, 24-28; Ex. 2009, ¶¶117-121.) No other theory or evidence was
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`ever set forth with particularity. See DynaEnergetics, PGR2023-00003, Paper 19 at
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`59 (it is not proper “to augment[] the Petition with factual findings that are not, in
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`the first instance, pointed out with ‘particularity’ in the Petition”).
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`Moreover, by asking the Board to disregard the only viscosity for agave syrup
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`identified anywhere in the Petition’s Grounds and the only “final formulation(s)”
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`identified from within FR458 and WO742, Petitioner’s Reply further demonstrates
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`that the Petition fails to address the claims as a whole and reveals Petitioner’s
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`reliance on impermissible hindsight. See Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d
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`1075, 1085 (Fed. Cir. 2008) (“The determination of obviousness is made with
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`respect to the subject matter as a whole, not separate pieces of the claim.”); ATD
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`Corp. v. Lydall, Inc., 159 F.3d 534, 546 (Fed. Cir. 1998) (a “[d]etermination of
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`obviousness cannot be based on the hindsight combination of components
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`selectively culled from the prior art to fit the parameters of the patented invention”).
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`Petitioner’s attorney argument that “[t]he Petition makes clear that it relies on
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`the formulation viscosity ranges expressly taught by the ’4666 Patent and WO133,
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`not on any hypothetical viscosity teachings from the examples in FR458 and
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`WO742” transparently rejects any consideration of the challenged claims as a whole.
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`(Reply, 11.) Instead, it impermissibly seeks to view the claim limitations in
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`isolation, rather than requiring all elements of the claim to be satisfied by the
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`proposed combination—i.e., presenting a complete “final formulation” with all of
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`the claimed components and formulated in a manner that allegedly achieves the
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`viscosity values of the ’4666 patent and WO133. Since Petitioner’s Reply argument
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`is based on mere hindsight that wrongly attempts to break apart the claims and find
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`the individual limitations within the cited references without consideration of the
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`combination as a whole, it is legally deficient and cannot support obviousness. See
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`Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1275 (Fed. Cir. 2004).
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`3.
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`The Petition never mentions adjusting the water content to
`achieve a final desired viscosity
`Neither Ground 1 nor Ground 2 of the Petition ever mentioned Petitioner’s
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`additional new Reply theory of “adjusting the water content and/or other
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`components to achieve the desired final viscosity.” (See Reply, 11.) To the contrary,
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`Patent Owner’s Surreply
`PGR2023-00051
`U.S. Patent No. 11,617,795
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`Dr. Crowley’s declaration states that the examples of FR458 under Ground 1
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`“contain water and the water is provided in quantity sufficient (q.s.) for the
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`formulation to achieve a particular final volume” and the examples of WO742
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`under Ground 2 “contain water and the water is provided in quantity sufficient (q.s.)
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`for the formulation to achieve a final volume.” (Ex. 1003, ¶¶117, 212; see also Ex.
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`1003, ¶¶ 155 (“the exact amount of water added will depend on the desired final
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`volume”), 213 (“water is being added to a formulation in a quantity sufficient (q.s.)
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`to bring it to desired final volume”).)
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`The use of water to achieve a desired final volume is indisputably distinct
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`from the use of water to achieve a desired final viscosity. But the Petition undeniably
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`referred only to adding water to bring the example formulations to a final volume—
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`it never once mentioned “adjusting the water content . . . to achieve the desired final
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`viscosity.” As explained by Dr. Berkland, the Petition thus failed to properly address
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`the viscosity limitation of the challenged claims. (See Ex. 2009, ¶161 (“I also note
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`there is no explanation provided by Petitioner or Dr. Crowley for how the change in
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`the amount of diluent w