Case: 20-2073
`
`Document:45
`
`Page:1_
`
`Filed: 11/24/2021
`
`GAnited States Court of Appeals
`for the Federal Circuit
`
`INDIVIOR UK LIMITED,
`Appellant
`
`Vv.
`
`DR. REDDY'S LABORATORIESS.A., DR. REDDY'S
`LABORATORIES,INC.,
`Cross-Appellants
`
`2020-2073, 2020-2142
`
`Appeals from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2019-
`00329.
`
`Decided: November 24, 2021
`
`RICHARD L. RAINEY, Covington & Burling LLP, Wash-
`ington, DC, argued for appellant. Also represented by
`JEFFREY B. ELIKAN, NICHOLAS LANE Evoy, MATTHEW
`AARON KUDZIN; PETER P. CHEN, Palo Alto, CA.
`
`KEVIN PAUL MARTIN, Goodwin Procter LLP, Boston,
`MA, argued for cross-appellants. Also represented by
`ELAINE BLAIS, EDWINA CLARKE, ROBERT FREDERICKSON,III;
`IRA J. LEVY, ALEXANDRA D. VALENTI, New York, NY.
`
`

`

`Case: 20-2073
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`Document:45
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`Filed: 11/24/2021
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`2
`
`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
`
`Before LOURIE, LINN, and DYK, Circuit Judges.
`
`Opinionfor the court filed by Circuit Judge LOURIE.
`
`Opinion concurring in part and dissentingin part filed by
`Circuit Judge LINN.
`
`LOURIE, Circuit Judge.
`
`Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Labora-
`tories, Inc. (collectively, “DRL”) petitioned for inter partes
`review of U.S. Patent 9,687,454 (the “454 patent”), owned
`by Indivior UK Limited (“Indivior”’). The United States Pa-
`tent and Trademark Office Patent Trial and Appeal Board
`(the “Board”) held that claims 1-5, 7, and 9-14 are un-
`patentable as anticipated, but that DRL failed to demon-
`strate that claim 8 is anticipated. See Dr. Reddy’s Lab’ys
`S.A. v. Indivior UK Lid., No. IPR2019-00329, 2020 WL
`2891968 (P.T.A.B. June 2, 2020) (“Decision”). Indivior ap-
`peals from the Board’s decision holding that claims 1-5, 7,
`and 9-14 are unpatentable, and DRL cross-appeals the
`Board’s decision holding that DRL failed to demonstrate
`unpatentability of claim 8. For the reasons detailed below,
`we affirm.
`
`BACKGROUND
`
`Indivior owns the ’454 patent, which generally de-
`scribes orally dissolvable films containing therapeutic
`agents. The ’454 patent issued as the fifth continuation of
`U.S. Patent Application 12/537,571 (the “571 application”),
`which wasfiled on August 7, 2009. This appeal involves
`the question whether Indivior can get the benefit of that
`2009 filing date for the claims at issue.
`
`DRLpetitioned for inter partes review of claims 1—5 and
`7-14. DRL alleged that the polymer weight percentage
`limitations, added to the claims by amendment, do not
`have written description support in the ’571 application as
`filed and thus are not entitled to the benefit of its filing
`date.
`DRL argued that claims1—5 and 7-14 were
`
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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A.
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`3
`
`anticipated by U.S. Patent Publication 2011/0033541 (“My-
`ers”), the February 10, 2011 publication of the 571 appli-
`cation.
`Indivior had argued that the polymer weight
`percentage limitations were supported by the ’571 applica-
`tion and that the claims were therefore entitled to the ’571
`application’s priority date. Indivior did not disputethat,if
`the ’571 application lacked written description of the
`claims and hence that Myers was deemedprior art, Myers
`would anticipate claims 1-5 and 7-14. Indivior contended
`that Myers wasnot priorart to the ’454 patent, and there-
`fore that DRL failed to demonstrate anticipation.
`
`Claims 1, 7, 8, and 12 of the ’454 patent are specifically
`relevant to this appeal because they include the polymer
`weight percentage limitations at issue.
`
`1. An oral, self-supporting, mucoadhesive film
`comprising:
`
`(a) about 40 wt % to about 60 wt % of a water-
`soluble polymeric matrix;
`
`(b) about 2 mg to about 16 mg of buprenorphine or
`a pharmaceutically acceptable salt thereof;
`
`(c) about 0.5 mg to about 4 mg of naloxone or a
`pharmaceutically acceptable salt thereof; and
`
`(d) an acidic buffer;
`
`whereinthefilm is mucoadhesiveto the sublingual
`mucosaor the buccal mucosa;
`
`wherein the weightratio of (b):(c) is about 4:1;
`
`wherein the weightratio of (d):(b) is from 2:1 to 1:5;
`and
`
`wherein application of the film on the sublingual
`mucosa or the buccal mucosa results in differing
`absorption between buprenorphine and naloxone,
`with a buprenorphine Cmax from about 0.624 ng/ml
`to about 5.638 ng/ml and a buprenorphine AUC
`
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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
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`to about 56.238
`from about 5.431 hr*ng/ml
`hr*ng/ml; and a naloxone Cmax from about 41.04
`pg/ml to about 323.75 pg/ml and a naloxone AUC
`from about 102.88 hr*pg/ml
`to about 812.00
`hr*pg/ml.
`
`"454 patent col. 24, ll. 25-46 (emphasis added).
`
`7. The film of claim 1, wherein the film comprises
`about 48.2 wt % to about 58.6 wt % of the water
`soluble polymeric matrix.
`
`Id. at col. 24, Il. 57-59 (emphasis added).
`
`8. The film of claim 7, wherein the film comprises
`about 48.2 wt % of the water soluble polymeric
`matrix.
`
`Id. at col. 24, Il. 60-61 (emphasis added).
`
`12. The film of claim 1, wherein the weight ratio of
`(d):(b) is from about 1:1 to 1:5; wherein the weight
`ratio of (b):(a) is from about 1:3 to about 1:11.5; and
`wherein the film comprises about 48.2 wt % to
`about 58.6 wt % of the water soluble polymeric
`matrix.
`
`Id. at col. 25, Il. 3-7 (emphasis added).
`
`In its review, the Board analyzed whether the chal-
`lenged claims have written description support in the ’571
`application. Regarding claim 8’s polymer weight percent-
`age limitation of “about 48.2 wt %,” the Board found that
`Tables 1 and 5 in the’571 application disclose formulations
`from which a polymer weight of 48.2% could be calculated
`by a person of ordinary skill in the art. Decision at *27.
`The Board determined that DRL did not establish that the
`571 application lacked written description of claim 8’s pol-
`ymer weight percentage limitation and thus did not show
`that claim 8 is anticipated by Myers. Id. at *35.
`
`

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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A.
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`5
`
`In contrast, claims 1, 7, and 12 recite polymer weight
`percentage limitations as ranges: “about 40 wt % to about
`60 wt %”(claim 1) and “about 48.2 wt % to about 58.6 wt
`%” (claims 7 and 12). The Board found that the ’571 appli-
`cation does not “discussor refer to bounded or closed ranges
`of polymer weight percentages.” Id. at *33. It found some
`of Indivior’s expert’s testimony regarding written descrip-
`tion support for rangesto be not credible. Jd. at *31. The
`Board also found that a person of ordinary skill would have
`been led away from a particular bounded rangeby the ’571
`application’s teaching that “[t]he film may contain any de-
`sired level of self-supporting film forming polymer.” Id.
`The Board determined that claims 1—5, 7, and 9-14 do not
`have written description support in the ’571 application.
`Id. at *34. It therefore determined that Myersis prior art
`to claims 1—5, 7, and 9-14 because the claims have anef-
`fective filing date of no earlier than June 21, 2013, the date
`of the ’454 patent’s next oldest application in the series. Id.
`The Board then evaluated Myers, noted that Indivior did
`not contest DRL’s anticipation arguments, and found that
`DRL showedthat claims 1—5, 7, and 9-14 are anticipated
`by Myers. Id. at *34—36.
`
`Indivior appealed, and DRL cross-appealed. The valid-
`ity questions hinge on whether each of the *454 patent
`claimsis entitled to the benefit of the 571 application’sfil-
`ing date. We have jurisdiction under 28 U.S.C.
`§ 1295(a)(4)(A).
`
`DISCUSSION
`
`Wereview the Board’s legal determinations de novo, In
`re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we re-
`view its factual findings underlying those determinations
`for substantial evidence, In re Gartside, 203 F.3d 13805,
`1316 (Fed. Cir. 2000). A finding is supported by substan-
`tial evidence if a reasonable mind might accept the evi-
`dence as adequate to support the finding. Consol. Edison
`Co. v. NLRB, 305 U.S. 197, 229 (1938). Whether a claim
`
`

`

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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
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`satisfies the written description requirement is a question
`of fact. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
`1336, 1351 (Fed. Cir. 2010) (en banc). Anticipation is also
`a question of fact. In re Rambus, Inc., 753 F.3d 1253, 1256
`(Fed. Cir. 2014).
`
`I. INDIVIOR’S APPEAL
`
`Indivior argues that the Board erredin finding that the
`polymer rangelimitations in claims 1, 7, and 12 lack writ-
`ten description support in the 571 application. Indiviorar-
`gues that Tables1 and 5 disclose formulations with
`48.2 wt % and 58.6 wt % polymer.
`It notes that the 571
`application also discloses that “the film composition con-
`tains a film forming polymerin an amountofat least 25%
`by weight of the composition.” ’571 application 7 65.
`In-
`divior argues that the combination of these disclosures en-
`compasses the claimed ranges. DRL, on the other hand,
`contends that a skilled artisan would not have discerned
`the claimed ranges because the ’571 application does not
`disclose any bounded range, only a lower endpoint and
`some exemplary formulations. DRL contends that a skilled
`artisan would not have discerned any upper range end-
`point.
`
`

`

`Case: 20-2073
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`Document:45
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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A.
`
`7
`
`Tables 1 and 5 are as follows:
`
`TABLE1
`
`
`Various Compositions of Film Dosages
`
`Buprenorphine/
`Naloxone Films
`
`Unit Formula
`(mg perfilm strip)
`Buprenorphine/
`Naloxone Ratios
`
`Components
`
`16/4
`
`12/3
`
`8/2
`
`2/0.5
`
`Active Components
`
`Buprenorphine HCI
`Naloxone HCI Dihydrate
`Inactive Components
`
`Polyethylene Oxide, NF
`(MW 200,000)
`Polyethylene Oxide, NF
`(MW 100,000)
`Polyethylene Oxide, NF
`(MW 900,000)
`Maltitol, NF
`Flavor
`Citric Acid, USP
`HPMC
`
`Ace-K
`Sodium Citrate, anhydrous
`Colorant
`
`17.28
`4.88
`
`12.96
`3.66
`
`8.64
`2.44
`
`2.16
`0.61
`
`27.09
`
`20.32
`
`13.55
`
`—
`
`12.04
`
`9.03
`
`6.02
`
`19.06
`
`4,82
`
`3.62
`
`2.41
`
`2.05
`
`12,04
`6.0
`5.92
`4.22
`
`3.0
`2.68
`
`0.03
`
`9.03
`4.5
`4.44
`3.16
`
`225
`2.01
`0.02
`
`6.02
`3.0
`2.96
`2.11
`
`1.5
`1.34
`0.01
`
`5.87
`2.4
`2.96
`2.34
`
`i
`1.34
`0.01
`
`Total (mg)
`
`100
`
`75
`
`50
`
`40
`
`

`

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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
`
`TABLE 5
`
`Formulations of Test Films at Various pH Levels
`
`Test
`formulation 1
`8 mg/2 mg
`pH =6.5
`
`Test
`formulation 2
`8 mg/2 mg
`pH = 3-3.5
`
`Test
`formulation 3
`8 mg/2 mg
`pH = 5-5.5
`
`Component
`
`%wiw Me/film %whw Mo/flm %wiw Mg/film
`
`Buprenorphine
`Hcl
`Naloxone HCl
`Dihydrate
`Polymer
`Polymer
`Polymer
`Polymer
`Sweetener
`Sweetener
`Flavor
`Citric acid
`Sodium citrate
`FD&C yellow
`#6
`
`21.61
`
`8.64
`
`17.28
`
`8.64
`
`17.28
`
`8.64
`
`6.10
`
`244
`
`4.88
`
`2.44
`
`4.88
`
`2.44
`
`5,05
`28.48
`12.65
`4,43
`12.65
`3
`6
`0
`0
`0.025
`
`2.02
`11.39
`5.06
`1.77
`5.06
`1.2
`2.4
`0
`0
`0.01
`
`4,82
`27,09
`12,04
`4,22
`12.04
`3
`6
`5.92
`2.68
`0.03
`
`2.41
`13.55
`6.02
`2.11
`6.02
`1.5
`3
`2.96
`1.34
`0.02
`
`4.82
`27.09
`12.04
`4.22
`12.04
`3
`6
`2.51
`6.08
`0.03
`
`2.41
`13.55
`6,02
`2.11
`6.02
`1.5
`3
`1.26
`3.04
`0.02
`
`Total
`
`100
`
`40
`
`100
`
`50
`
`100
`
`30
`
`Regarding claim 1, we agree with the Board that there
`is no written description support in the 571 application for
`the range of “about 40 wt % to about 60 wt %.” First, the
`range was not expressly claimed in the ’571 application;if
`it had been, that could have constituted written description
`support.
`Furthermore,
`the values of “40 wt%” and
`“60 wt %” are not stated in the ’571 application. Most im-
`portantly, neither is a range of 40 wt % to 60 wt %.
`
`Whatis neededto satisfy written description in patent
`law is highly fact-dependent, but the contours are well-
`known. Under 35 U.S.C. § 112, “[t]he specification shall
`
`

`

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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A.
`
`9
`
`contain a written description of the invention.” Thetest for
`adequate written description “is whether the disclosure of
`the application relied upon reasonably conveys to those
`skilled in the art that the inventor had possession of the
`claimed subject matter as of the filing date.” Ariad
`Pharms., 598 F.3d at 1351. We have said thatit is not nec-
`essary that the limitations of a claim be set forth in haec
`verba, id. at 1352, or, presumably, in the case where num-
`bers, not words, are at issue, in haec numera. But the spec-
`ification must indicate with some clarity what the claim
`recites.
`In the case of a claimed range, a skilled artisan
`must be able to reasonably discern a disclosure of that
`range. No range of “about 40 wt % to about 60 wt %”ap-
`pears in the ’571 application. Moreover, various other in-
`dications of the polymeric content of the film are present in
`the ’571 application, rendering it even less clear that an
`invention of “about 40 wt % to about 60 wt %” was contem-
`plated as an aspect of the invention.
`
`As the Board noted, the 571 application’s paragraph 65
`states that “[t]he film may contain any desired level of...
`polymer.” That statement is contrary to Indivior’s asser-
`tion that the level of polymer should be closed and between
`“about 40 wt % to about 60 wt %.” In the same paragraph,
`one embodiment is stated as containing “at least 25%,”
`quite out of the range of “about 40 wt % to about 60 wt %.”
`That paragraph also refers to “at least 50%” as an alterna-
`tive, this time, being right within the “about 40 wt % to
`about 60 wt %” range, but hardly clear support in light of
`other inconsistent language.
`
`Neither Table 1 nor Table 5 describes the claimed
`ranges.
`It is true that in Table 1 there are four polymer
`componentsof the described formulations, polyethylene ox-
`ide, NF (MW 200,000); polyethylene oxide, NF (MW
`100,000); polyethylene oxide, NF (MW 900,000); and
`HPMC, and when they are added up, each total is within
`the “about 40 wt % to about 60 wt %” range, but these val-
`ues do not constitute ranges;
`they are only specific,
`
`

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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
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`particular examples. For written description support of a
`claimed range, moreclarity is required. Here, one must
`select several components, add up the individual values,
`determine the aggregate percentages, and then couple
`those aggregate percentages with other examples in the
`571 application to create an otherwise unstated range.
`That is not a written description of the claimed range. The
`same shortcoming exists with Table 5, where four separate
`componentsarelisted as “polymer.”
`
`Regarding claims 7 and 12, we also agree with the
`Board that there is no written description support for the
`range of “about 48.2 wt % to about 58.6 wt %” in the ’571
`application. This range also does not appear in the ’571
`application.
`Indivior argues that if one looks to Tables 1
`and 5, plucks out the polymer components and creates a
`range from the percentage totals (while ignoring contradic-
`tory statements in paragraph 65), then one has obtained
`the rangerecited in claim 7. But that amounts to cobbling
`together numbersafter the fact. Indivior failed to provide
`persuasive evidence demonstrating that a person of ordi-
`nary skill would have understood from reading the ’571 ap-
`plication that it disclosed an invention with a range of
`48.2 wt % to 58.6 wt %. A written description sufficient to
`satisfy the requirement of the law requires a statementof
`an invention, not an invitation to go on a hunting expedi-
`tion to patch together after the fact a synthetic definition
`of an invention. “[A] patent is not a hunting license. It is
`not a reward for the search, but compensation for its suc-
`cessful conclusion.” Brenner v. Manson, 383 U.S. 519, 536
`(1966). The Board thus had substantial evidence on which
`to base its conclusion that the ’571 application did not pro-
`vide written description support for claims1, 7, and 12.
`
`Indivior argues that our case law supports its position.
`See, e.g., Appellant’s Br. 3-6, 31-47, 63-66 (citing Nal-
`propion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d
`1344 (Fed. Cir. 2019); In re Wertheim, 541 F.2d 257 (CCPA
`1976)). But written description cases are intensively fact-
`
`

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`11
`
`oriented, and the cases vary, just as ranges vary. Wertheim
`specified that the court was “not creating a rule applicable
`to all description requirementcases involving ranges” and
`that “[b]roadly articulated rules are particularly inappro-
`priate in this area.” Wertheim, 541 F.2d at 263-65 (Rich,
`J.). “Mere comparison of ranges is not enough, nor are me-
`chanical rules a substitute for an analysis of each case on
`its facts to determine whether an application conveys to
`those skilled in the art the information that the applicant
`invented the subject matter of the claims. In other words,
`we must decide whether the invention appellants seek to
`protect by their claimsis part of the invention that appel-
`lants have described as theirs in the specification.” Id. at
`263. Thus, no case, with necessarily varied facts, controls
`the resolution of the written description issue in this case.
`
`Indivior has not contested that Myers would anticipate
`claims 1—5, 7, and 9-14 if Myers is deemedprior art. See,
`e.g., Appellant’s Br. 21—22; Cross Appellants’ Br. 6. Indeed,
`the only arguments against anticipation that Indivior pre-
`sents on appeal concern whether the ’454 patent claims
`were entitled to the 571 application’s filing date, thus dis-
`qualifying Myers asprior art based on its publication date.
`Since we conclude that the Board properly determined that
`claims 1, 7, and 12 do not have written description support
`in the ’571 application, we must affirm the Board’s antici-
`pation determination.
`
`Accordingly, we affirm the Board’s decision that
`claims 1—5, 7, and 9-14 are anticipated by Myers.
`
`II. DRL’s Cross-APPEAL
`
`DRL argues that the Board erred in finding that the
`571 application contains written description support for
`claim 8. DRL asserts that a person of ordinary skill in the
`art would not have immediately discerned that the 571 ap-
`plication discloses a polymer component comprising
`48.2 wt % of a film because the tables do not state the total
`polymer weight of various formulations. Indivior contends
`
`

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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
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`that the Board’s determination was supported by substan-
`tial evidence. Indivior states that the Board’s finding was
`based on Tables 1 and 5 but also supported by admissions
`of DRL andits expert.
`
`The Board upheld the validity of claim 8, which recites
`“about 48.2 wt %” as the amount of polymer. Weaffirm
`that determination, even though, as DRL argues, the num-
`ber “48.2 wt %” is not explicitly set forth in the ’571 appli-
`cation. We do so out of deference to the Board’s fact-
`finding, even though one might see some inconsistency be-
`tween this result and our above holding concerning the
`principal appeal. But, given that claim 8 doesnotrecite a
`range, but only a specific amount, which can be derived by
`selection and addition of the amountsof selected, but iden-
`tified, components, we accept that there is substantial evi-
`dence to support the Board’s decision concerning claim 8.
`
`Accordingly, we affirm the Board’s decision that the
`571 application provides written description support for
`claim 8 and that, since claim 8 is entitled to the ’571 appli-
`cation’s filing date, DRL failed to demonstrate that Myers
`anticipates claim 8.
`
`CONCLUSION
`
`Wehaveconsidered the parties’ remaining arguments
`but find them unpersuasive. For the foregoing reasons, we
`affirm the Board’s decision.
`
`AFFIRMED
`
`COSTS
`
`No costs.
`
`

`

`
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`Case: 20-2073 Page:13_Filed: 11/24/2021Document:45
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`
`
`GAnited States Court of Appeals
`for the Federal Circuit
`
`INDIVIOR UK LIMITED,
`Appellant
`
`Vv.
`
`DR. REDDY'S LABORATORIESS.A., DR. REDDY'S
`LABORATORIES,INC.,
`Cross-Appellants
`
`2020-2073, 2020-2142
`
`Appeals from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2019-
`00329.
`
`LINN, Circuit Judge, concurring-in-part and dissenting-in-
`part.
`
`The majority—dismissing the long-standing guidance
`on written description support for claimed ranges in In re
`Wertheim, 541 F.2d 257 (C.C.P.A. 1976) and ignoring the
`factually indistinguishable case of Nalpropion Pharms.,
`Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir.
`2019)—incorrectly concludes that claims 1, 7 and 12 of the
`*454 patent do not have written description support in the
`‘571 application and are thus anticipated by Myers. Be-
`cause the majority’s decision rests on an improper reading
`of paragraph 65 and the embodiments disclosed in Tables
`1 and 5 of
`the ’571 application, applies an overly
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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
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`demanding standard for written description for ranges,
`and fails to follow our precedent in Wertheim and Nal-
`propion, I respectfully dissent from that part of the major-
`ity’s opinion.
`
`The majority takes from paragraph 65 of the ‘571 ap-
`plication the truncatedtext “[t]he film may contain any de-
`sired level of ... polymer” to wrongly suggest that the
`statements about film polymerlevels of “at least 25%”or
`“at least 50%”fail to provide clear support for the claimed
`“about 40 wt % to about 60 wt %” range. Maj. Op. at 9:19-
`29. But the quoted passageis taken out of context and ig-
`nores the remaining part of the sentence, which expressly
`links the aggregate polymer percentage to the key claimed
`characteristics of mucoadhesion and rate of film dissolu-
`tion sharedby films having the stated polymerlevels. The
`full text from paragraph 65 readsas follows: “The film may
`contain any desired level of self-supporting film forming
`polymer, such that a self-supporting film composition is
`provided .... As explained above, any film forming poly-
`mers that impart the desired mucoadhesion andrateoffilm
`dissolution may be used as desired.” J.A.3367 (emphasis
`added). Properly read in its entirety, this statement does
`not suggest that any polymer percentage is acceptable or
`that the specified polymer levels are unrelated to the in-
`vention. To the contrary, the disclosed paragraph explic-
`itly identifies
`the
`essential desired characteristics
`possessedbythe films of the claimed invention andidenti-
`fies the polymer levels needed to impart those characteris-
`tics.
`
`As the majority recognizes, paragraph 65 also identi-
`fies two preferred aggregate polymer percentage ranges:
`“at least 25%”or, alternatively, “at least 50%.” J.A.38367.
`Both claimed ranges are within that expressly disclosed
`preference. The majority acknowledges that the “at least
`50%” range is “right within” the ranges recited in the
`claims, but rejects this support “in light of other incon-
`sistent language.” Maj. Op. at 9:26-29. But the referenced
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`“inconsistent language” is nowhere to be found. Disclo-
`sures of “at least 25%” and “at least 50%” are not “contrary
`to Indivior’s assertion that the level of polymer should be
`closed” or “inconsistent” with the selection of a particular
`claimed range. See Maj. Op. at 9:21, 9:29. Rather, the
`“about 40 wt % to about 60 wt %” polymer range in claim 1
`and the “about 48.2 wt % to about 58.6 wt” in claims 7 and
`12 are selections of aggregate polymer ranges that a rea-
`sonable artisan would understand endowthefilm with the
`identified and desired properties.
`
`Moreover, the majority cites no authority that written
`description support for a “closed range” requires a disclo-
`sure of a closed range rather than discrete values, and
`there is no logical reason why such a disclosure should be
`required as a strict rule to show possession. As recognized
`in Wertheim, “[b]roadly articulated rules are particularly
`inappropriate in this area.” Wertheim, 541 F.2d at 263-65
`(Rich, J.). An obvious example would be a disclosure with
`express embodiments of 5%, 6%, 7%, 8%, 9% and 10% of'a
`particular substance, and a continuation application that
`claims a range of 5-10%. More importantly, the disclosure
`in paragraph 65 does disclose a closed range of “at least
`25%” and “at least 50%.” Those ranges are no different
`than if restated as “25%-100%” and “50%-100%,” respec-
`tively.
`
`I also disagree with the majority’s reading of the poly-
`mer percentage levels disclosed in Tables 1 and 5. Those
`Tables disclose 48.2% and 58.6% aggregate polymer per-
`centages.
`Identifying the 48.2% and 58.6% values in the
`embodiments in Tables 1 and 5 does not require “pluck[ing]
`out the polymer components,” or “cobbling together num-
`bers after the fact” as the majority states. Maj. Op. at
`10:14-19. An ordinary artisan need not “select several
`components, add up the individual values, determine the
`aggregate percentages, and then couple those aggregate
`percentages with other examples in the ’571 application to
`create an otherwise unstated range.” Maj. Op. at 10:2-6.
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`INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIESS.A.
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`There is no selection of polymers that must be made to
`reach those values—the aggregate sum of all polymers in
`every embodiment in Tables 1 and 5 is either 48.2% or
`58.6%. As noted above, paragraph 65 unambiguously fo-
`cuses on the aggregate polymerpercentage as an important
`characteristic for mucoadhesion andrate of film dissolu-
`tion. Summingthevaluesto reach an identified character-
`istic is not an obstacle to possession, and neitheris dividing
`the aggregate sum of polymers by the total composition
`weight. And that simple mathematical calculation is well
`within the capabilities of the experienced person with a
`Master’s or Ph.D. in pharmaceutical sciences found by the
`Boardto be the person of ordinary skill in this case.
`
`I disagree with the majority’s rejection of
`Finally,
`Wertheim andits failure to address Nalpropion. I consider
`both cases directly on point. In Wertheim, the specification
`disclosed a solids content range of 25-60% and included
`specific embodiments showing 36% and 50%. Wertheim,
`541 F.2d at 265. Our predecessor court held in that case
`that claims that included solids content of “between 35%
`and 60%”had written description support, id. at 264, even
`though the 36% and 50% embodiments werediscrete val-
`ues and not identified as range endpoints. Similarly here,
`the “at least 25%” disclosure in paragraph 65 coupled with
`the 48.2% and 58.6% embodiments provide ample written
`description support.
`
`In Nalpropion, this court came to the sameresult in a
`substantially identical circumstance.
`In that case, the
`claims called for a sustained release formulation with a
`one-hourrelease of “between 39% and 70%” and a two-hour
`release of “between 62% and 90%). Nalpropion, 934 F.3d
`at 1349. We affirmed the district courts determination that
`these claims had written description support based on en-
`tries in two tables in the specification that showed discrete
`dissolution values of 39% and 67% at 1 hour, and 62% and
`85% at 2 hours. Id. The specification also disclosed release
`rates of “less than about 80% or than about 70% in about 1
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`hour,” and “less than about 90%, or less than about 80%, in
`2 hours.” U.S. Pat. No. 8,916,195 (13:35-43). We specifi-
`cally held that the disclosure of the discrete examplespro-
`vided written description support for the claimed ranges.
`So should the discrete examples and the disclosed range
`here. The majority does not addressthis decision, and I see
`no basis on which to distinguish it.
`
`For the above reasons, I would reverse the Board’s
`holding that claims 1, 7 and 12 do not have written descrip-
`tion support in the ‘571 application and are thus antici-
`pated by Myers.
`
`The majority correctly recognizes that Indivior was in
`possession of a film with 48.2 wt % polymeric matrix as
`claimedin claim 8, tacitly acknowledging that the mathe-
`matical calculation needed to discern that percentage from
`the written description in the Tables of the ‘571 application
`is within the grasp of the ordinary artisan. For that rea-
`son, I am pleasedto join that part of the majority’s opinion.
`
`