UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners
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`v.
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`INDIVIOR UK LIMITED.
`Patent Owner
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`U.S. PATENT NO. 9,687,454
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`TITLE: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
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`Case No. IPR2019-00329
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`Petitioners’ Reply to Patent Owner’s Response
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners
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`v.
`
`INDIVIOR UK LIMITED.
`Patent Owner
`
`
`
`U.S. PATENT NO. 9,687,454
`
`TITLE: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
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`Case No. IPR2019-00329
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`
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`Petitioners’ Reply to Patent Owner’s Response
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` 1
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`Table of Contents
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`I. THE CHALLENGED CLAIMS ARE NOT ENTITLED TO CLAIM
`PRIORITY TO THE ’571 APPLICATION, AND PATENT OWNER HAS
`NOT SHOWN OTHERWISE ................................................................................. 2
`A. The Claimed Polymer Weight Percentages Lack Written Description
`Support in the ’571 Application ............................................................................. 2
`1. The ’571 Application Does Not Disclose a Bounded Range ........................ 5
`2. Dr. Cremer’s “Example” Formulations Based on Allegedly Optional
`Ingredients Are Arbitrary and Speculative .......................................................... 9
`B. The Claimed (b):(a) Ratio Lacks Written Description in the ’571
`Application ............................................................................................................14
`1. The Values Calculated from Tables 1 and 5 Do Not Support the Claimed
`Range .................................................................................................................15
`2. The Buprenorphine:Polymer Ratio Is Not Disclosed as an Aspect of the
`Invention of the ’571 Application .....................................................................18
`a) There Is Nothing in the ’571 Application Directing a POSA to Calculate
`the Buprenorphine:Polymer Ratio or Indicating That the Ratio Has Any
`Significance to the Invention ..........................................................................18
`b) “Consistency” Across the Example Formulations in the ’571 Application
`Does Not Support a Finding That the Ratio Was Part of the Invention .........21
`II. CONCLUSION ................................................................................................22
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`Table of Authorities
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` Page(s)
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`Cases
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) .......................................................................... 13
`Ex Parte Mark Andrew Lomaga,
`No. 2016-003407, 2017 WL 657405 (P.T.A.B. Feb. 10, 2017) ......................... 20
`Ex Parte Michael Molenda, Martin Hoffmann, & Sabine Forster,
`No. 2016-007717, 2017 WL 3620343 (P.T.A.B. Aug. 18, 2017) ........................ 8
`Nalpropion Pharm., Inc. v. Actavis Labs. Fl., Inc.,
`934 F.3d 1344 (Fed. Cir. 2019) ............................................................................ 8
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ................................................................ 6, 18, 21
`Research Corp. Techs., Inc. v. Microsoft Corp.,
`627 F.3d 859 (Fed. Cir. 2010) ............................................................................ 13
`Rimfrost AS v. Aker Biomarine Antarctic AS,
`2018 WL 4183083 (P.T.A.B. Aug. 29, 2018) ...................................................... 8
`Ex Parte Siemens Energy, Inc.,
`No. 2010-012109, 2010 WL 5137101 (B.P.A.I. Dec. 15, 2010) ....................... 20
`In re Wertheim,
`541 F.2d 257 (CCPA 1976) .................................................................................. 8
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`ii
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`Patent Owner does not dispute that Myers (the publication of the ’571
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`application) substantively destroys the novelty of the subject claims of the ’454
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`patent. Patent Owner simply contests the issue of priority, leaving as the only
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`disputed issue before the Board whether the disclosure of the ’571 application
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`provides written description support for the challenged claims such that Patent
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`Owner can claim priority thereto. As set forth in the Petition, and as the Board
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`found in its decision on institution, the ’571 application fails to provide such
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`support, and Patent Owner fails to show otherwise. To the contrary, Patent Owner
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`and its declarant, Dr. Cremer, who is a European patent attorney and IP consultant,
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`concede that there is no express disclosure of either the claimed polymer weight
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`percentage ranges or the claimed range of buprenorphine:polymer ratios in the
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`’571 application. Lacking any “blaze marks” that would enable a POSA to
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`understand the applicants to be in possession of these limitations, Patent Owner is
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`left to try and backfill using calculated values derived by Dr. Cremer from cherry-
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`picked portions of the application, notwithstanding any direction in the application
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`to do so, and unsupported speculation concerning possible variations on the
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`example formulations that are disclosed in the application. That Patent Owner
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`must resort to these machinations shows that there is no basis in the specification
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`for a POSA to have understood the inventors to be in possession of the claimed
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`polymer weight percentages or buprenorphine:polymer ratios. And regardless, Dr.
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`1
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`Cremer’s calculated values—which are wholly divorced from any direction in the
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`application—do not provide written description support for these limitations. The
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`Board should therefore conclude, as it did at the Institution stage, that the
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`challenged claims are not entitled to a priority date of August 7, 2009, that Myers
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`is prior art to the ’454 patent and, as Patent Owner does not dispute, Myers
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`anticipates the challenged claims. The challenged claims should therefore be
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`canceled.
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`I.
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`THE CHALLENGED CLAIMS ARE NOT ENTITLED TO CLAIM
`PRIORITY TO THE ’571 APPLICATION, AND PATENT OWNER
`HAS NOT SHOWN OTHERWISE
`A. The Claimed Polymer Weight Percentages Lack Written
`Description Support in the ’571 Application
`The challenged claims of the ’454 patent recite three different polymer
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`weight percentages: “about 40 wt % to about 60 wt %” (claim 1), “about 48.2 wt %
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`to about 58.6 wt %” (claims 7 and 12), and “about 48.2 wt %” (claim 8). Patent
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`Owner points to only four portions of the ’571 application as support for these
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`claimed ranges: paragraph [0065], claim 5, and Tables 1 and 5 (Test Formulation 2
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`only).1 (Paper 33 at 12, 15–16, 29–30; Ex. 2008 at 15–18, 25.)
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`1 During prosecution, the applicants identified paragraph [0032] as providing
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`written description support for the claim amendment that added the “about 40 wt %
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`to about 60 wt %” limitation. (See Paper 1 at 23–24, n.6.) Paragraph [0032] states
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`2
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`However, taken alone or together, these four portions of the ’571 application
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`are insufficient to provide written description support. Paragraph [0065] states
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`only that “[t]he film may contain any desired level of self-supporting film forming
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`polymer,” and describes two embodiments of “in an amount of at least 25% by
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`weight” and “in an amount of least 50% by weight.” (Ex. 1011, [0065]; see also
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`Paper 1 at 21.) Similarly, claim 5 recites “at least one polymer in an amount of at
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`least 25% by weight.” (Ex. 1011, cl. 5.) Neither of these disclosures provide any
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`upper endpoint for the polymer weight range. (Ex. 1030, 51:7–53:5, 54:1–15 (“Q.
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`But there’s no upper limit identified in paragraph 65 numerically, right? A. That’s
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`what I said.”), 55:3–16 (“Q. And similar to paragraph 65, Claim 5 does not
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`“[i]n accordance with some embodiments, polyethylene oxide may range from
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`about 20% to 100% by weight in the polymer component, more specifically about
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`30% to about 70% by weight, and even more specifically about 40% to about 60%
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`by weight.” (Ex. 1011, [0032].) This is not related to the total polymer weight
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`range in the claim, but rather to the amounts of individual polymer as part of the
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`total polymer component. Patent Owner and Dr. Cremer do not dispute this, and it
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`is thus undisputed that paragraph [0032] does not provide written description
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`support for the “about 40% to about 60%” polymer weight percentage limitation.
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`(Ex. 1030, 87:11–89:15; Paper 33 at 29–30.)
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`3
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`numerically identify an upper endpoint to the polymer weight percentage, right? A.
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`Claim 5 does not expressly provide an upper limit, a numerical upper limit.”).) As
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`for Tables 1 and 5, neither discloses the total polymer weight percentage. (Ex.
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`1011, Table 1, 5; Ex. 1030, 57:10–58:17, 59:14–60:1, 62:3–19, 63:10–20, 121:11–
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`122:8.) Instead, Dr. Cremer back-calculated for Patent Owner the total polymer
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`weight percentage values from these example formulations by summing the
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`concentrations of each of the individual polymer weights and calculating the
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`percentage of the total polymer component as compared to the total weight of the
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`formulation. (Ex. 2008, ¶¶ 31–33.) The ’571 application provides no direction to
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`perform these calculations, and even then Dr. Cremer obtains only two fixed
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`values (48.2% and 58.6%), not a range. (Id.)
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`Patent Owner’s arguments, based on these scant disclosures, essentially boil
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`down to the following two points: (1) that a POSA would understand the ’571
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`application to disclose bounded ranges of polymer weight percentages based on the
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`values derived from Tables 1 and 5; and (2) that the application states that certain
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`ingredients in the formulations are optional, from which (after a series of steps
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`disconnected from the application) a POSA could derive ranges of the polymer
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`component. Neither of these arguments are sufficient to overcome the dearth of
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`information on the polymer weight percentages in the ’571 application, and both
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`should be rejected.
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`4
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`The ’571 Application Does Not Disclose a Bounded Range
`1.
`Patent Owner’s attempts to cast the ’571 application as disclosing bounded
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`ranges of polymer weights all fail. First, Patent Owner repeatedly refers to
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`“disclosed” ranges of about 25–58.6% (Paper 33 at 16, 21– 22, 24–25) and about
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`25–60% (id. at 26, 30–33) as if they are explicitly discussed on the face of the ’571
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`application. In reality, all the ’571 application discloses are polymer weights of “at
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`least 25%” and “at least 50%.” (Ex. 1011, [0065], cl. 5.) As the Board previously
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`found, while these ranges are “are necessarily limited to some end point, that end
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`point is not disclosed in the ’571 application.” (Paper 21 at 19.) Dr. Cremer
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`conceded as much at his deposition. (Ex. 1030, 52:1–53:5, 54:1–15, 55:3–16,
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`57:10–58:17, 59:14–60:1, 62:3–19, 63:10–20.) Thus, despite Patent Owner’s
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`characterizations to the contrary, there is no bounded range “disclosed” by the ’571
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`application in any respect.
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`As for the lower claimed boundary, Patent Owner takes the position, based
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`on Dr. Cremer’s declaration, that the claimed 40% lower endpoint is supported by
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`the specification because it is “closer to” 48.2% (as calculated from Tables 1 and
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`5) than 25% (as disclosed as a lower endpoint in paragraph [0065]). (Paper 12 at
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`5
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`13 (citing Ex. 2001, ¶ 42).)2 This position is nonsensical. Under this “closer to”
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`logic, the patentee could have claimed any percentage value between 25% and
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`48.2% as the lower boundary, so long as the chosen number was “closer to” 48.2%
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`than 25% (i.e. anything greater than 36.6%). Despite this logical problem, at his
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`deposition, Dr. Cremer refused to offer an opinion as to whether 41%, 42%, etc.
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`could have also been claimed as the lower endpoint, stating that he only considered
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`whether “about 40%” was supported by the ’571 application. (Ex. 1030, 101:4–
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`102:11, 104:1–10.) This indicates a further defect in Dr. Cremer’s analysis: that he
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`proceeded by looking at the claim limitation and then attempting to find support
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`for the lower endpoint of 40% in the specification, rather than relying on “blaze
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`marks” in the specification that would convey to a POSA that the inventor was in
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`possession of the claimed invention. See Purdue Pharma L.P. v. Faulding Inc.,
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`230 F.3d 1320, 1326–27 (Fed. Cir. 2000) (“[O]ne cannot disclose a forest in the
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`original application, and then later pick a tree out of the forest and say here is my
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`invention.”).
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`2 Dr. Cremer confirmed at his deposition that he is not withdrawing any of the
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`opinions contained in his first declaration (Ex. 2001), and that his second
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`declaration (Ex. 2008) was intended to supplement the opinions contained in his
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`first. (Ex. 1030, 11:19–12:13; see also Ex. 2008, ¶ 3.)
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`6
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`In addition to not expressly disclosing any bounded ranges, the ’571
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`application is also devoid of discussion linking the amount of polymer with any
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`allegedly inventive characteristics of the film. As the Board previously found,
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`there is no “description suggesting the importance or criticality of the recited
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`endpoints.” (Paper 21 at 21.) Patent Owner now argues that films within the two
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`fictional ranges of 25%–58.6% and 25%–60%, as well as the claimed ranges of
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`48.2%–58.6% and 40%–60%, “pertain to the same invention with generally the
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`same properties, operability, and ability to achieve any desired result.” (Paper 33
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`at 22 (citing Ex. 2008, ¶ 45), 32 (citing Ex. 2008, ¶ 50).) This argument, however,
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`is based on Dr. Cremer’s conclusory opinion that changes in polymer weight
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`percentages within these ranges would have no effect on the “operability” of the
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`films. (Ex. 2008, ¶¶ 45, 49–50.) But Dr. Cremer performed no testing and does
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`not rely on any discussion in the ’571 application to support this conclusion. (Id.)
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`Dr. Cremer also cited no scientific literature anywhere in his declarations, despite
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`his assertion that his opinions in this regard are based on the “variability that would
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`be typical in this field.” (Ex. 1030, 105:17–106:5, 152:7–22; Ex. 2008, ¶¶ 45, 49–
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`50.) Indeed, when pressed, Dr. Cremer testified that he did not even consider
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`whether there would be any difference in operability between films with 40% (as
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`in claim 1) or 48.2% (as in claim 8) total polymer weight. (Ex. 1030, 102:22–
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`104:10, 106:20–108:11.)
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`7
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`Because there are no bounded ranges disclosed in the ’571 application, the
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`cases that Patent Owner relies on do not support its position. (Paper 33 at 22–25.)
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`For instance, Nalpropion is distinguishable because, unlike here, both upper and
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`lower boundary limits of the claimed range were actually disclosed in the
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`specification. Nalpropion Pharm., Inc. v. Actavis Labs. Fl., Inc., 934 F.3d 1344,
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`1349 (Fed. Cir. 2019). Similarly, and as the Board previously explained, “Patent
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`Owner’s reliance on Wertheim is misplaced,” because the disclosure in that case
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`included a range of 25% to 60% with a specifically disclosed endpoint of 60%.
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`(See Paper 21 at 21 (citing In re Wertheim, 541 F.2d 257, 264 (CCPA 1976)).)
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`Rimfrost and Ex Parte Molenda are likewise inapposite. In Rimfrost, the limitation
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`at issue set forth only the minimum amount of astaxanthin esters, not a bounded
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`range as claimed here, and the specification contained over 50 recitations of such
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`amounts. Rimfrost AS v. Aker Biomarine Antarctic AS, 2018 WL 4183083, at *7
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`(P.T.A.B. Aug. 29, 2018). In Ex Parte Molenda, the Board found that the claimed
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`concentration was within a range disclosed in the specification and was therefore
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`adequately supported. Ex Parte Michael Molenda, Martin Hoffmann, & Sabine
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`Forster, No. 2016-007717, 2017 WL 3620343, at *6–7 (P.T.A.B. Aug. 18, 2017)
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`(“The range of ‘about 5 wt%’ is not expressly disclosed in the original application
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`. . . [but] falls within the broader disclosed ranges of 0.1 to 20%, 0.5 to 15%, and
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`0.5 to 10%”).
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`8
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`Thus, the ’571 application does not disclose bounded ranges of polymer
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`weights, and Patent Owner’s arguments to the contrary should be rejected.
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`2.
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`Dr. Cremer’s “Example” Formulations Based on Allegedly
`Optional Ingredients Are Arbitrary and Speculative
` Patent Owner argues, based on Dr. Cremer’s declaration, that “optional
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`ingredients, like a sweetener, could be removed, added, or varied in amount,
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`thereby changing the polymer weight percentage of the film, while staying within
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`the invention.” (Paper 33 at 15, n. 9, 18–22, 31.) According to Patent Owner,
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`relying on Dr. Cremer, this would convey to a POSA that the inventors possessed
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`the claimed polymer weight percentage ranges because the imagined change in
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`concentration of these optional ingredients would have a corollary effect on the
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`polymer weight percentage in such a film. (Paper 33 at 15, n.9, 18–22, 31; Ex.
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`2008, ¶¶ 36 n.2, 37, 39–44, 46–48, 56–60.) Dr. Cremer’s opinions based on
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`altering the presence or quantity of particular “optional ingredients” in the
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`formulations of Tables 1 and 5—and his examples based thereon (Ex. 2008, ¶¶ 40–
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`41)—are arbitrary, unsupported, and inconsistent with his other opinions. Patent
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`Owner’s arguments based on Dr. Cremer’s opinions regarding “optional
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`ingredients” should therefore be disregarded.
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`To obtain these “exemplary” formulations resulting in various polymer
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`weight percentage values, Dr. Cremer undertook multiple steps ungrounded in the
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`explicit disclosure of the ’571 application, and each step is questionable in its
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`9
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`reasoning. First, Dr. Cremer looked at Tables 1 and 5 in the ’571 application and
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`determined which of the ingredients in those formulations could be considered
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`optional. For example, referring to the Table 1 formulations, Dr. Cremer testified
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`that the optional ingredients included the sweetener (Ace-K), colorant, and flavor.
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`(Ex. 1030, 66:12–67:11.) Yet, Dr. Cremer would not say whether maltitol, another
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`ingredient identified as optional in the ’571 application,3 should also be understood
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`as an optional ingredient in the Table 1 formulations. For reasons he could not
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`explain, Dr. Cremer said that he had not “performed that analysis for maltitol”
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`even though he would offer the opinion that other ingredients were optional with
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`no testing or other basis to say so. (Ex. 1030, 70:8–71:6, 74:10–77:21.) He further
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`admitted that his analysis would have changed had he considered maltitol to be
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`optional in the Table 1 formulations. (Ex. 1030, 76:11–77:21, 82:4–84:5.) Thus,
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`his analysis fails at step one, and shows the degree of speculation and unbounded
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`variation required by a POSA to proceed with Dr. Cremer’s “optional ingredients”
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`theory.
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`Dr. Cremer’s decision of which component he deems “optional” is further
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`flawed in that he bases his opinion on which components could be added or
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`3 Maltitol is a sugar alcohol similar to mannitol or sorbitol, which are described as
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`optional in the ’571 application. (Ex. 1030, 67:12–69:4; Ex. 1011, [0034], [0039].)
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`10
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`removed without “substantially affect[ing]” the overall formulation. (Ex. 1030,
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`72:3–12.) Dr. Cremer testified in a conclusory manner that if an optional
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`component is varied in a “reasonable” amount, it will not “substantially affect”
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`product characteristics—yet, he refused to explain what he meant by “reasonable.”
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`(Id. at 72:3–73:2, 73:18–21 (explaining that when he says “reasonable” amounts,
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`he “mean[s] not unreasonable amounts” and that he has “not worked on a
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`definition of what the scope of reasonable is”).) He then said that the particular
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`examples he proposed would not require testing to determine whether the presence
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`or absence of a specific component would affect the product characteristics, but
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`admitted that he relied on no scientific literature to support this opinion. (Id. at
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`74:10–76:10.) Dr. Cremer’s opinion about which ingredients are properly
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`considered “optional” in the Table 1 and Table 5 formulations is therefore
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`speculative and not credible.
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`Next, Dr. Cremer took the ingredients he determined to be optional, varied
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`their amounts within the formulations disclosed, and re-calculated the polymer
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`weight percentage amounts that resulted from his decisions on what to add or
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`remove. (Ex. 2008, ¶¶ 41–42; Ex. 1030, 78:14–82:19.) However, Dr. Cremer
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`made the decision of how to vary, add, or remove the “optional” ingredients
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`without relying on any direction from the specification. (Ex. 1011, Tables 1 and 5;
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`Ex. 2008, ¶ 41; Ex. 1030, 80:18–81:4 (“Q. There’s no instruction in Example 1 to
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`11
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`
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`disregard the flavor and the sweetener in the Table 1 formulations, right? A.
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`POSA would not expect instructions like that in the table . . .”).) Based on the ’571
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`application, there is simply no reason for a POSA to alter the disclosed
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`formulations by adding, removing, or changing the amounts of the ingredients, and
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`Dr. Cremer’s explanation for doing so anyway—“a POSA would not expect
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`instructions like that”—is neither supported by objective evidence, nor credible.
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`Last, Dr. Cremer used his re-calculated values, which are divorced from any
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`disclosure in the ’571 application, to support a theory that the application actually
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`discloses polymer weight percentages of 52.9%, 64.4%, 61.0%, 42.2%, and 51.4%.
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`(Ex. 2008, ¶¶ 41–42.) For example, for his “Example 3,” Dr. Cremer took Test
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`Formulation 2 in Table 5, originally with 48.2% polymer weight, removed the
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`flavor and sweetener, and then recalculated the polymer weight percentage to be
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`61.0%, an increase of 12.8%. (Id.) For his “Example 5,” Dr. Cremer took the
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`2.0/0.5 formulation in Table 1, originally with 58.6% polymer weight percentage,
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`increased the sweetener from 3.0% to 15.0%, and recalculated the polymer weight
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`percentage to be 51.4%, a decrease of 7.2%. (Id.)
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`In the next paragraph, referring to these recalculated values as if they were
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`expressly disclosed in the specification, Dr. Cremer opines that a POSA would
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`understand that the polymer weight percentages of the films could be decreased by
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`at least 7.2% or increased by at least 12.8% while staying within the scope of the
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`12
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`
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`invention. (Ex. 2008, ¶ 42; Paper 33 at 19–20 (citing Ex. 2008, ¶¶ 41–42); Ex.
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`1030, 116:20–117:6.) Yet Dr. Cremer admitted that he crafted his examples of
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`potential formulations by choosing at random how to vary the amounts or presence
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`of “optional” ingredients. (Ex. 1030, 82:4–84:4.) Indeed, Dr. Cremer emphasized
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`that one could obtain different values depending on the variation of optional
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`ingredients and amounts chosen. (Id. at 82:4–84:4, 117:3–6, 134:8–135:15.)
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`As can be seen, Dr. Cremer’s analysis of the “optional ingredients” is
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`arbitrary and not based on any express disclosure or direction in the ’571
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`application. Dr. Cremer even admitted that his examples are “formulations that
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`are not specifically disclosed in here.” (Ex. 1030, 134:8–135:5 (emphasis
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`added).) And even if Dr. Cremer’s “optional ingredients” analysis would have
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`been obvious to a POSA reading the ’571 application, that would still be
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`insufficient to render the subject matter disclosed for purposes of priority. See,
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`e.g., Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859, 870 (Fed. Cir.
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`2010); Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571–72 (Fed. Cir. 1997)
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`(the standard is “not whether a claimed invention is an obvious variant of that
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`which is disclosed in the specification”).
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`Dr. Cremer’s “optional ingredients” opinions should be further disregarded
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`because he problematically uses the value he obtained in one of his examples to
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`support two different claimed values. In particular, for Dr. Cremer’s “Example 3,”
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`13
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`as derived from Test Formulation 2 in Table 5, Dr. Cremer obtains a 61% polymer
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`weight. (Paper 33 at 19; Ex. 2008, ¶ 41.) Dr. Cremer first opines that this 61% is
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`“about 58.6%” and therefore supports the upper endpoint in claims 7 and 12. (Ex.
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`2008, ¶ 42; see also Paper 33 at 20.) This conflicts with Dr. Cremer’s opinion that
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`the 61% polymer weight derived from the very same formulation in Table 5 (Test
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`Formulation 2) provides written description support for the 60% upper bound in
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`claim 1. (Ex. 2008, ¶ 48; Ex. 1030, 119:14–18; see also Paper 33 at 31.) That Dr.
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`Cremer, and by extension Patent Owner, use the same formulation to support two
`
`different claimed endpoints highlights the flawed nature of his opinions.
`
`As the Board previously found, “the ’571 application provides no disclosure
`
`of a range endpoint, leading a POSA to speculate as to what that endpoint might
`
`be.” (Paper 21 at 21.) Dr. Cremer’s opinions regarding “optional ingredients” do
`
`not solve this problem for Patent Owner, as they show the degree of speculation
`
`required by a POSA to derive a bounded range from the disclosure in the ’571
`
`application, or even to reach the conclusion that a range is disclosed at all.
`
`B.
`
`The Claimed (b):(a) Ratio Lacks Written Description in the ’571
`Application
`Claims 5 and 12 of the ’454 patent recite a (b):(a) ratio range of “about 1:3
`
`to about 1:11.5.” There is no dispute that there is no express disclosure of
`
`buprenorphine:polymer ratios in the ’571 application. As the Board previously
`
`recognized, “[a]t most, a POSA having a reason to do so, could calculate specific
`
`
`
`14
`
`
`
`ratios of 1:2.8 and 1:10.9 from Tables 1 and 5 of the ’571 application. But we find
`
`no reason for a POSA to calculate the (b):(a) ratio from the ’571 application,
`
`notwithstanding that it may be easy for a POSA to do so.” (Paper 21 at 24
`
`(emphasis in original).) Patent Owner has not shown any reason for a POSA to
`
`calculate the (b):(a) ratio in the ’571 application, nor could it. There is no mention
`
`of the buprenorphine:polymer ratio anywhere in the specification. Nor is there any
`
`discussion of mucoadhesive, absorption, dissolution, or pharmacokinetic properties
`
`based on the (b):(a) ratio that would give a POSA a reason to calculate the ratios.
`
`(Ex. 1030, 148:13–22, 150:4–19.) Despite the fact that the ’571 application is
`
`devoid of any disclosure of the claimed ratios, Patent Owner argues that a POSA
`
`would have understood the inventors to have possessed the claimed range and that
`
`the ’571 application discloses the ratio as an aspect of the invention. (Paper 33 at
`
`46.) But as discussed in more detail below, Tables 1 and 5 do not provide support
`
`for the claimed range, and the ’571 application does not identify the
`
`buprenorphine:polymer ratio as an aspect of the invention.
`
`1.
`
`The Values Calculated from Tables 1 and 5 Do Not Support the
`Claimed Range
`Patent Owner points only to values Dr. Cremer calculated from Tables 1 and
`
`5 as support for the claimed ratio range. (Paper 33 at 46–47; Ex. 1030, 156:8–
`
`157:1.) Although Dr. Cremer did not include the mathematical calculations in his
`
`declaration, in order to obtain the ratios from Tables 1 and 5, a POSA would need
`
`
`
`15
`
`
`
`to look at the weight content of buprenorphine, add up the weight content of all
`
`polymers,4 and divide to obtain the ratio. (Ex. 2008, ¶ 71, n. 8–9; Paper 33 at 47–
`
`48; Ex. 1030, 153:10–154:20.) These calculations result in a ratio of 1:2.8 for the
`
`16/4, 12/3, and 8/2 formulations in Table 1 and Test Formulation 2 in Table 5, and
`
`a ratio of 1:10.9 for the 2/0.5 formulation in Table 1. As is apparent, even these
`
`two calculated values are not the endpoints of the claimed (b):(a) ratio ranges.
`
`In the face of this reality, Patent Owner first argues, based on Dr. Cremer’s
`
`opinions, that a POSA would have understood that the formulations with a (b):(a)
`
`ratio of 1:2.8 “pertain to the same invention with generally the same properties” as
`
`the formulation with a (b):(a) ratio of 1:10.9. (Paper 33 at 48.) Dr. Cremer’s
`
`opinions in this regard are arbitrary and unsupported. Dr. Cremer cites no
`
`literature or other support for his assumptions concerning the properties of films
`
`with the various ratios. (See Ex. 2008, ¶¶ 72–73.) Notably, he did not conduct any
`
`
`4 Because it is necessary to calculate the total weight content of the polymer to
`
`derive the (b):(a) ratio from the disclosed formulations, Dr. Cremer’s opinions on
`
`the (b):(a) ratio necessarily encompass and rely on his flawed opinions concerning
`
`the total weight percentage discussed above. (Ex. 1030, 155:13–156:1.) For this
`
`additional reason, Dr. Cremer’s opinions regarding the ratio should be rejected.
`
`
`
`16
`
`
`
`testing or experiments that could have shown the ratio had no effect on the ultimate
`
`film within this range. (Id.)
`
`Second, Patent Owner’s argument that the calculated (b):(a) ratio of 1:2.8 is
`
`“about” the claimed 1.3 and the calculated 1:10.9 is “about” the claimed 1:11.5
`
`lacks any credible support from Dr. Cremer. (Paper 33 at 48.) Despite Dr.
`
`Cremer’s assertions in his declaration and testimony that he “looked at 1:11.5” and
`
`determined it was the “same” as 1:10.9, 1:11.5 has no logical connection to 1:10.9
`
`and Dr. Cremer did not identify one. (Ex. 1030, 158:16–160:10; Ex. 2001 ¶ 76;
`
`Ex. 2008, ¶ 73.) Under this theory, the inventors could have claimed any value
`
`between 1:10.9 and 1:11.5, evincing the arbitrariness of the claimed ratio. As the
`
`Board explained in its institution decision, “[t]he fact that a POSA might be able to
`
`piece together a (b):(a) ratio from examples in the ’571 application does not
`
`establish written description support on this record.” (Paper 21 at 24.) Nothing
`
`argued or identified by Patent Owner effectively overcomes this stark conclusion.
`
`Dr. Cremer also incredibly would not offer an opinion as to whether a value
`
`of 1:10.9 would have also supported a claimed range up to 1:11, rather than 1:11.5.
`
`(Ex. 1030, 159:14–160:16.) When asked at his deposition, he testified that he
`
`“ha[dn’t] really thought it through,” because there is no claim limitation directed
`
`toward a ratio of 1:11, thus “[i]t’s not a question that [he] analyzed.” (Ex. 1030,
`
`155:9–156:5.) This again speaks to the fact that Dr. Cremer’s analysis here
`
`
`
`17
`
`
`
`proceeded by first looking at the claim limitation and then attempting to find
`
`support for it in the specification, contrary to the requirement that a POSA
`
`“immediately discern the limitation at issue in the claims” based on the disclosure
`
`in the specification. See Purdue Pharma, 230 F.3d at 1323. Given the many flaws
`
`in Dr. Cremer’s opinions, Patent Owner’s arguments based thereon should be
`
`rejected.
`
`2.
`
`The Buprenorphine:Polymer Ratio Is Not Disclosed as an Aspect
`of the Invention of the ’571 Application
`Contrary to Patent Owner’s assertions, (1) the ’571 application does not
`
`direct a POSA to calculate the (b):(a) ratio and does not indicate that the ratio has
`
`any significance to the invention, and (2) the supposed “consistency” across the
`
`formulations disclosed in the ’571 application does not support a finding that the
`
`ratio was part of the invention.
`
`a)
`
`There Is Nothing in the ’571 Application Directing a
`POSA to Calculate the Buprenorphine:Polymer Ratio
`or Indicating That the Ratio Has Any Significance to
`the Invention
`Dr. Cremer’s opinion, and Patent Owner’s arguments based thereon, that a
`
`POSA would recognize the importance of the buprenorphine and polymer in the
`
`film and thus be motivated to calculate the ratio of buprenorphine:polymer should
`
`be rejected. (Ex. 2008, ¶¶ 75–79; Paper 33 at 49–50.) Dr. Cremer opines that a
`
`saPOSA would recognize buprenorphine and polymer as individually “important”
`
`
`
`18
`
`
`
`components of the film because buprenorphine is the active ingredient and the
`
`largest active ingredient by mass and the polymer is the largest inactive ingredient
`
`by mass (See Paper 33 at 50 (citing Ex. 2008, ¶ 77 ).) The relative weights of the
`
`components alone, however, cannot inform a POSA of the “importance” of these
`
`components, let alone the “importance” of the ratio between these two
`
`components. As Dr. Cremer admitted, components of a formulation may be
`
`“important” regardless of their concentration. (Ex. 1030, 142:5–17.)
`
`Indeed, the data in the specification of the ’571 application would, if
`
`anything, direct a POSA away from concluding the buprenorphine:polymer ratio
`
`had any significance to the inventors. Test Formulation 3 in Table 5 had a ratio of
`
`1:2.8—the same ratio calculated for the 16/4,
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