UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners
`
`
`v.
`
`
`INDIVIOR UK LIMITED.
`Patent Owner
`
`________________________
`
`
`U.S. PATENT NO. 9,687,454
`
`SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`
`Case No. IPR2019-00329
`________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 9,687,454
`
`
`
`TITLE:
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`

`

`
`
`Table of Contents
`
`Page
`
`I.
`
`INTRODUCTION ......................................................................................... 5
`
`II. REQUIREMENTS FOR INTER PARTES REVIEW UNDER 37 C.F.R.
`§ 42.104 ........................................................................................................... 7
`
`
`
` Grounds for Standing ............................................................................ 7 A.
`
`
`
` B.
`
`Identification of Challenge .................................................................... 7
`
`III. TECHNOLOGY BACKGROUND .............................................................. 8
`
`
`
` A.
`
`
`
` B.
`
`
`
` C.
`
`Buprenorphine and Naloxone ................................................................ 8
`
`Suboxone® Tablets ............................................................................... 8
`
`Role of Buffers In Controlling the pH of Suboxone ® Tablets ............ 9
`
`IV. OVERVIEW OF THE ’454 PATENT .......................................................10
`
`
`
` A.
`
`
`
` B.
`
`Challenged Claims ..............................................................................10
`
`Patent Holder Resumed Prosecution of the ’454 Patent After the
`Delaware Court Invalidated the ’832 Patent Claims ...........................12
`
`V.
`
`THE ASSERTED PRIOR ART PUBLICATION: MYERS (EX. 1010)
` .......................................................................................................................15
`
`VI. PERSON OF ORDINARY SKILL IN THE ART ....................................16
`
`VII. CLAIM CONSTRUCTION ........................................................................17
`
`VIII. THE CHALLENGED CLAIMS ARE NOT ENTITLED TO CLAIM
`PRIORITY TO AUGUST 7, 2009 ..............................................................18
`
`
`
` A.
`
`Legal Standard for Priority ..................................................................18
`
`
`
`i
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`

`

`
`
`
`
` B.
`
`The ’571 Application Does Not Contain Written Description Support
`for the Polymer Weight Ranges and Ratios of Polymer in the
`Challenged Claims ..............................................................................20
`
`1.
`
`2.
`
`The Text of the ’571 Application Does Not Contain Any Blaze
`Marks Directing a POSA to the Polymer Weight Percentages or
`(b):(a) Ratios. ............................................................................21
`
`Table 1 of the ’571 Application Does Not Demonstrate that the
`Inventors Were “In Possession” of the Specific Ranges and
`Ratios Claimed In The ’454 Patent. ..........................................26
`
`IX. CLAIMS 1-5 AND 7-14 ARE ANTICIPATED BY MYERS ..................30
`
`
`
` A.
`
`
`
` B.
`
`Legal Standards for Anticipation ........................................................31
`
`Independent Claim 1 ...........................................................................33
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Preamble ....................................................................................33
`
`“About 40 wt % to about 60 wt % of a water-soluble polymer
`matrix” [1(a)] ............................................................................33
`
`“About 2 mg to about 16 mg of buprenorphine or a
`pharmaceutically acceptable salt thereof” [1(b)]. .....................34
`
`“About 0.5 mg to about 4 mg of naloxone or a pharmaceutically
`acceptable salt thereof” [1(c)]. ..................................................34
`
`“An acidic buffer” [1(d)] ..........................................................35
`
`“Mucoadhesive to the sublingual mucosa or the buccal mucosa”
`[1(e)]. .........................................................................................35
`
`“Weight ratio of [buprenorphine]:[naloxone] [of] about 4:1.”
`[1(f)] ..........................................................................................35
`
`“Weight ratio of [buffer]:[buprenorphine] is from 2:1 to 1:5”
`[1(g)]. ........................................................................................36
`
`
`
`ii
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`

`

`
`
`
`
`9.
`
`Pharmacokinetic parameters in element 1(h)............................36
`
`
`
` Dependent Claims 2-5, 7-14................................................................36 C.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`11.
`
`“Weight ratio of [buffer]:[buprenorphine] is from 1:1 to 1:5”
`(claim 2). ...................................................................................36
`
`“Weight ratio of [buffer]:[buprenorphine] is from 1.4:1 to 1:3”
`(claim 3). ...................................................................................37
`
`“Acidic buffer is citric acid” (claim 4) .....................................37
`
`“Weight ratio of [buprenorphine]:[polymer]of from about 1:3 to
`about 1:11.5” (claim 5). ...........................................................37
`
`“About 48.2 wt % to about 58.6 wt % of the water-soluble
`polymeric matrix” (claim 7). .....................................................38
`
`“About 48.2 wt % of the water-soluble polymeric matrix”
`(claim 8) ....................................................................................38
`
`“Wherein the water-soluble polymer matrix comprises a
`polyethylene oxide polymer alone or in combination with a
`hydrophilic cellulosic polymer” (claim 9) ................................38
`
`“Wherein the hydrophilic cellulosic polymer is hydroxypropyl
`cellulose, hydroxylpropylmethyl cellulose, or a combination
`thereof” (claim 10). ...................................................................39
`
`“Wherein the hydrophilic cellulosic polymer is
`hydroxylpropylmethyl cellulose” (claim 11). ...........................39
`
`“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 comprise about 48.2 wt% to about
`58.6 wt % of the water-soluble polymer matrix” (claim 12) ....39
`
`“A method of treating opioid dependence in a patient in need
`thereof comprising sublingually or buccally administering the
`iii
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`

`

`
`
`mucoadhesive film of claim 1 to a sublingual or buccal mucosal
`tissue of the patient to treat the opioid dependence” (claim 13)
` ...................................................................................................40
`
`12.
`
`“Weight ratio of [buffer]:[buprenorphine] is from 2:1 to 1:1”
`(claim 14) ..................................................................................40
`
`X.
`
`EVIDENCE SUBMITTED IN THIS PETITION WAS NOT
`PREVIOUSLY CONSIDERED BY THE OFFICE .................................41
`
`XI. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ..............................42
`
`
`
` A.
`
`
`
` B.
`
`
`
` C.
`
`
`
` D.
`
`Real Parties-in-Interest ........................................................................42
`
`Related Matters ....................................................................................42
`
`Lead and Backup Counsel ...................................................................43
`
`Service Information .............................................................................43
`
`XII. PAYMENT OF FEES .................................................................................44
`
`XIII. CONCLUSION ............................................................................................44
`
`CERTIFICATE OF COMPLIANCE ..................................................................45
`
`CERTIFICATE OF SERVICE ............................................................................48
`
`
`
`
`
`
`
`
`
`iv
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`

`

`
`
`I.
`
`
`
`INTRODUCTION
`
`Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc.
`
`(“Petitioners”) petition for Inter Partes Review (“IPR”) of claims 1-5, 7-14 (the
`
`“challenged claims”) of U.S. Patent No. 9,687,454 (the “’454 patent,” Ex. 1001).
`
`These claims are generally directed toward a film dosage form of the prior art
`
`Suboxone®
`
`tablet—a sublingual tablet containing the active ingredients
`
`buprenorphine and naloxone. (Ex. 1001, 1:65-2:65.) According to the
`
`specification, Patent Owner claims to have “discovered” using a buffer to control
`
`the pH of the film dosage form “to provide[] a system in which the desired
`
`release and/or absorption of the components [i.e., the buprenorphine and
`
`naloxone] is bioequivalent to that of a similar Suboxone® tablet.” (Id., 12:13-
`
`25.)
`
`The ’454 patent claims priority through a series of continuation
`
`applications to U.S. Application No. 12/537,571, filed on August 7, 2009 (the
`
`“’571 application”) (Ex. 1001, 1), which issued as U.S. Patent No. 8,475,832
`
`(the “’832 patent,” Ex. 1005). On June 3, 2016, the United States District Court
`
`for the District of Delaware found claims 1, 3, 6, and 15-19 of the ’832 patent
`
`invalid after a multiple-day bench trial. See Reckitt Benckiser Pharms., Inc. v.
`
`Watson Labs., Inc., 2016 WL 3186659 (D. Del. June 3, 2016). Shortly after the
`
`Delaware court’s decision—and years after filing the original ’571 application—
`
`Patent Owner submitted a wholesale amendment to the then-pending claims in
`5
`
`
`

`

`
`
`the application that issued as the ’454 patent. In the amendment, Patent Owner
`
`cancelled all of the then-pending claims and added new claims.
`
`The new claims, however, contain limitations that are not supported by the
`
`original ’571 application for two reasons. First, all of the claims require that the
`
`total weight of the polymers in the film fall within a particular range, measured as
`
`a percentage of the overall weight of the film (the “polymer weight ranges”). For
`
`example, claim 1 requires the film to contain “about 40 wt % to about 60 wt % of
`
`a water-soluble polymer matrix.” Second, certain dependent claims specify a
`
`weight ratio of buprenorphine-to-polymer in the films to fall within specified
`
`ranges (expressed as “(b):(a) ratios”). For example, claim 5 requires a weight-
`
`ratio of buprenorphine (“(b)”) to polymer (“(a)”) to be between “about 1:3 to
`
`about 1:11.5.” As set forth in more detail below, the ’571 application has no
`
`“blaze marks” from which a person of ordinary skill in the art (“POSA”) would
`
`understand the applicants to be in possession of these newly added limitations.
`
`See Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000).
`
`Accordingly, the Board should find that the challenged claims are not entitled to
`
`claim priority to the original application filed in the ’454 patent family.
`
`Should the Board conclude that the challenged claims are not entitled to a
`
`priority date of August 7, 2009, then the effective filing date for the challenged
`
`claims is the filing date of the application that issued as the ’454 patent, January
`
`
`
`6
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`

`
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`6, 2016, (see 35 U.S.C. § 100(i)), and the challenged claims of the ’454 patent are
`
`anticipated by Myers. See Chester v. Miller, 906 F.2d 1574, 1577 (Fed. Cir.
`
`1990).1
`
`II. REQUIREMENTS FOR INTER PARTES REVIEW UNDER 37
`C.F.R. § 42.104
`
` Grounds for Standing A.
`Petitioners certify that the ’454 patent is available for IPR and that
`
`Petitioners are not barred or estopped from requesting this review. Patent Owner
`
`filed its waiver of service in the related district court litigation on December 7,
`
`2017, which is less than one year from the filing of the instant petition. See e.g.,
`
`Brinkmann Corp. v. A&J Manufacturing, LLC, IPR2015-00056, Paper No. 10
`
`(P.T.A.B. March 23, 2015).
`
`Identification of Challenge
`
`B.
`
`Petitioner requests that the Patent Trial and Appeal Board (the “Board”)
`
`institute a trial for IPR of claims 1-5, 7-14 of the ’454 patent as anticipated by
`
`Myers under post-AIA 35 U.S.C. § 102(a)(1), and cancel those claims as
`
`unpatentable.
`
`
`1 On the same day this instant petition was filed, Petitioners also filed IPR2019-
`
`00328, requesting that the Board institute trial on claims 1-3 and 5-14 of the ’454
`
`patent on the ground that they were obvious to a POSA as of August 7, 2009.
`
`
`
`7
`
`

`

`
`
`III. TECHNOLOGY BACKGROUND
` Buprenorphine and Naloxone A.
`
`Buprenorphine is an opioid agonist that was first discovered in the mid-
`
`1960s and is used to treat opioid dependence and chronic pain. (Ex. 1003, ¶ 17.)
`
`Buprenorphine is extensively broken down in both the gastrointestinal (“GI”)
`
`tract and the liver prior to absorption into systemic circulation (known as “first
`
`pass effects”). (Id. ¶ 18.) As a result, when swallowed, the efficacy of
`
`buprenorphine may be compromised. (Id.) As an alternative, by the early 1980s,
`
`sublingual (under the tongue) administration of buprenorphine was reported to be
`
`effective, as the uptake of buprenorphine is rapid and absorption via the mucosa
`
`minimizes first-pass effects. (Id.)
`
`Naloxone is a well-known opioid antagonist that reverses or prevents the
`
`effects of opioid agonists. (Id. ¶ 19.)
`
`Suboxone® Tablets
`
`B.
`
`In 2003, Reckitt Benckiser (a predecessor-in-interest to Patent Owner)
`
`began selling a sublingual tablet containing buprenorphine and naloxone under
`
`the tradename Suboxone®. (Ex. 1003, ¶ 19; Ex. 1008, 37; Ex. 1007, 3-4.) When
`
`
`
`8
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`

`

`
`
`administered properly, the buprenorphine is delivered transmucosally2, avoiding
`
`first-pass effects. (Ex. 1003, ¶ 20.) The naloxone, however, is not significantly
`
`absorbed transmucosally and is not bioavailable from the GI tract because of
`
`first-pass effects. (Id.; Ex. 1008, 6.) This is intentional—as the naloxone is not
`
`intended to be absorbed when administered orally, but rather is used as a
`
`deterrent “to stop people from injecting (‘shooting up’) SUBOXONE® tablets.”
`
`(Ex. 1003, ¶ 20; Ex. 1024, 20.)
`
`As of 2009, Suboxone® sublingual tablets were available in two dosage
`
`strengths, both of which maintained a 4:1 drug ratio of buprenorphine to
`
`naloxone: 2 mg/0.5 mg and 8 mg/2 mg. (Ex. 1003, ¶ 21; Ex. 1007, 3.)
`
`
` Role of Buffers In Controlling the pH of Suboxone ® Tablets C.
`Absorption of a drug across a mucosal membrane is primarily dependent
`
`on the solubility and permeability of the drug. (Ex. 1003, ¶ 22; Ex. 1012, 18, 36,
`
`53-55, 57-79.) Solubility generally refers to the degree to which a drug dissolves
`
`in a particular environment. (Ex. 1003, ¶ 22.) Permeability refers to the
`
`movement of a drug across biological membranes (e.g., sublingual mucosa), and
`
`is affected in large part by the lipophilicity of the drug molecule. (Id.)
`
`
`2 Transmucosal here refers to the route of administration (through a mucous
`
`membrane) versus the location of administration, such as sublingually (under the
`
`tongue).
`
`
`
`9
`
`

`

`
`
`Both solubility and permeability of a drug are often dependent on the pH
`
`of the environment. (Ex. 1003, ¶ 24; Ex. 1012, 18, 36, 53-55, 57-79.) The pH of
`
`an environment is a measure of the level of acidity or basicity. (Ex. 1003, ¶ 24.)
`
`Buffers can be used to control the pH of a drug formulation. (Id., ¶ 31.) Buffers
`
`usually contain mixtures of a weak acid or weak base and one of its salts (i.e.
`
`conjugate base or conjugate acid). (Id.) Buffers will maintain a constant pH
`
`even when small amounts of acid or base are added to the solution. (Id.; Ex.
`
`1012, 47.) A POSA would have understood that the combination of citric acid
`
`(weak acid) and sodium citrate (conjugate base) in Suboxone® tablets was a
`
`known buffering system that provided an acidic pH range of 3.0 to 6.2. (Ex.
`
`1003, ¶ 21; Ex. 1013, 23.)
`
`IV. OVERVIEW OF THE ’454 PATENT
`The ’454 patent descends from the ’832 patent and shares a specification
`
`with the ’832 patent. (Compare Ex. 1001 with Ex. 1005; Ex. 1003, ¶ 39.) The
`
`’832 patent was filed as Application No. 12/537,571 on August 7, 2009 (the
`
`“’571 application”). (Ex. 1005, 1).
`
`
` Challenged Claims A.
`The claims at issue in this Petition are claims 1-5 and 7-14. Claim 1 is the
`
`only independent claim. It reads:
`
`
`
`10
`
`

`

`
`
`[1.preamble] An oral, self-supporting, [] mucoadhesive film comprising:
`
`[1.a] about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;
`
`[1.b] about 2 mg to about 16 mg of buprenorphine or a pharmaceutically
`
`acceptable salt thereof;
`
`[1.c] about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable
`
`salt thereof; and
`
`[1.d] an acidic buffer;
`
`[1.e] wherein the film is mucoadhesive to the sublingual mucosa or the buccal
`
`mucosa;
`
`[1.f] wherein the weight ratio of (b):(c) is about 4:1;
`
`[1.g] wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and
`
`[1.h] 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 from about 5.431 hr*ng/ml to about 56.238 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.
`
`
`Dependent claims 2, 3, 7, 8, 12, and 14 further narrow the ratios and ranges in
`
`claim 1. Dependent claim 4 requires the buffer to be citric acid. Dependent
`
`claims 5 and 12 introduce limitations directed toward a weight ratio of
`
`
`
`11
`
`

`

`
`
`buprenorphine-to-polymer (the “(b):(a) ratios”). Dependent claims 9, 10, and 11
`
`specify particular types of polymers for the “water soluble polymer component.”
`
`Dependent claim 13 recites a method of treating opioid dependence in a patient
`
`by administering the film of claim 1.
`
`B.
`
`
`Patent Holder Resumed Prosecution of the ’454 Patent After the
`Delaware Court Invalidated the ’832 Patent Claims
`
`Patent Owner delayed prosecution of additional applications in the ’832
`
`patent family after issuance of the ’832 patent. After filing the original
`
`application, Patent Owner filed and quickly abandoned four continuation
`
`applications from 2013 through 2015. In the four applications that preceded the
`
`application that led to the ’454 patent, Patent Owner responded to only one
`
`Office Action, but eventually abandoned that application. Each of the other three
`
`applications was abandoned shortly after the issuance of a first Office Action.
`
`The application
`
`that
`
`led
`
`to
`
`the ’454 patent—application number
`
`14/989,669—was filed on January 6, 2016 with ten method claims. (Ex. 1002,
`
`701-702.) The two independent method claims were directed toward a “method
`
`for treating an opioid narcotic dependence in a patient in need thereof comprising
`
`sublingually or buccally administering a mucoadhesive film to a sublingual or
`
`buccal mucosal tissue of the patient…” (Id.) All claims were rejected by the
`
`Examiner as obvious over Oksche et al. (WO2008/025791A1) on March 10,
`
`2016. (Id., 647-655.)
`
`
`
`12
`
`

`

`
`
`On June 3, 2016, the Delaware court found that several claims in the ’832
`
`patent were obvious in light of prior art that described film formulations and the
`
`formulation and pharmacokinetic properties of Suboxone® tablets. See Reckitt,
`
`2016 WL 3186659 at *9-*10. Three months later, on September 9, 2016, Patent
`
`Owner canceled the pending claims and sought issuance of the claims largely in
`
`their present form. (Ex. 1002, 615-19.) New independent claim 11 was directed
`
`toward a mucoadhesive film comprising, among other things: “(a) about 40 wt%
`
`to about 60 wt% of a water-soluble polymeric matrix.” Some of the dependent
`
`claims further narrowed that range (e.g., claims 18, 19, 23); other dependent
`
`claims called for the ratio of buprenorphine-to-polymer to be present in certain
`
`ranges (e.g., claims 16, 17, 23). (Id., 616-617.) Patent Owner submitted the
`
`following table that contained “[e]xemplary support for the new claims”:
`
`
`
`13
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`

`

`
`
`
`(Id., 619.) Along with the new claims, Patent Owner submitted an eleven-page
`
`information disclosure statement that identified 323 prior art references. (Id.,
`
`596-606.)
`
`Two weeks after the amendment, on September 23, 2016, the Examiner
`
`issued the Final Rejection rejecting the new claims as obvious in view of Oksche.
`
`(Id., 173-180.) The Office Action contains no discussion of the § 112 support for
`
`the new claims, nor does it analyze whether those claims are entitled to the
`
`claimed priority date. (Id.) Patent Owner responded to the rejection on
`
`December 13, 2016. (Id., 163-171.) In the Response, Patent Owner further
`
`amended the claims and provided argument. (Id.) The Examiner issued another
`
`
`
`14
`
`

`

`
`
`Office Action rejecting all claims on January 3, 2017, as obvious in view of
`
`Oksche. (Id., 77-83.) After an interview concerning a proposed amendment by
`
`the Examiner and certain non-substantive changes to the claims, the Examiner
`
`issued a Notice of Allowance and Fees Due. (Id., 8-10.) No reasons for
`
`allowance were given.
`
`V. THE ASSERTED PRIOR ART PUBLICATION: MYERS (EX. 1010)
`U.S. Patent Publication No. 2011/0033541 (“Myers”) was filed on August
`
`7, 2009 and published on February 10, 2011. (Ex. 1010, 1.) If the challenged
`
`claims of the ’454 patent are not entitled to an effective filing date of August 7,
`
`2009, then Myers is prior art to those claims under post-AIA 35 U.S.C.
`
`§ 102(a)(1). See, e.g., Reckitt Benckiser LLC v. Ansell Healthcare Prods. LLC,
`
`IPR2017-00063, Paper 38 at 6, 12-15 (P.T.A.B. Jan. 30, 2018) (finding
`
`publication of parent application to be anticipating prior art under 35 U.S.C.
`
`§ 102(a)(1)). The challenged claims are subject to the first-to-file provision of
`
`the AIA because, if they are not entitled to an effective filing date of August 7,
`
`2009, then the effective filing date must fall after March 16, 2013. See America
`
`Invents Act, Pub. L. 112-29, 125 Stat. 284, Sec. 3(n)(1) (2011). The next
`
`application in the priority chain was filed on June 21, 2013. (See Ex. 1001, 1.)
`
`Therefore, the challenged claims cannot have an effective filing date prior to June
`
`21, 2013. In addition, as set forth above in Section IV.B, Patent Owner
`
`introduced the claims by way of amendment that was submitted on September 9,
`15
`
`
`

`

`
`
`2016, in an application that was filed on January 6, 2016. Because all potential
`
`dates are after March 16, 2013, the post-AIA provisions of § 102 apply and
`
`Myers constitutes prior art under post-AIA 35 U.S.C. § 102(a)(1).3 Myers is the
`
`publication of the ’571 application and has an identical specification to the ’454
`
`patent. (Ex. 1003, ¶ 39; compare Ex. 1001 with Ex. 1010.) None of the
`
`exceptions of 35 U.S.C. § 102(b)(1) apply, as Myers was published more than
`
`one year prior to the effective filing date of the challenged claims of the ’454
`
`patent.
`
`VI. PERSON OF ORDINARY SKILL IN THE ART
`For the purposes of this proceeding, a POSA with respect to the technology
`
`disclosed in the ’454 patent would include a person who possessed a Master’s or
`
`Ph.D. in pharmaceutical sciences, formulation chemistry, or a related field, plus a
`
`number of years of relevant experience in developing drug formulations. (Ex.
`
`1003, ¶ 42.) As part of a collaborative team working to develop a new drug
`
`
`3For this reason, the Board need not review any of the interim applications filed
`
`after the ’571 application but before the ’669 application. Even if the challenged
`
`claims are entitled to a priority date as early as June 21, 2013—the filing of U.S.
`
`App. No. 13/923,749—the effective date of the ’454 patent claims is still post-
`
`AIA and Myers remains prior art under 35 U.S.C. § 102(a)(1).
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`16
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`product, the POSA would have consulted as needed with others possessing the
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`skills that are typically employed in drug development and manufacturing. (Id.)
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`VII. CLAIM CONSTRUCTION
`For any IPR petition filed on or after November 13, 2018, such as the
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`instant petition, the Board “will apply the standard used in federal courts, in other
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`words, the claim construction standard that would be used to construe the claim
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`in a civil action under 35 U.S.C. § 282(b), which is articulated in Phillips.”
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`Patent and Trademark Office, Changes to the Claim Construction Standard for
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`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
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`Board, Final Rule 83 Fed. Reg. 51340, 51343 (Oct. 11, 2018). Under a proper
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`construction, a POSA would understand the term “acidic buffer” to mean “a
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`weak acid [citric acid], its conjugate base [sodium citrate] or combinations of
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`both that operate in the acidic pH range (i.e. less than pH 7.0).” (Ex. 1003,
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`¶ 51; Ex. 1001, 1:33-51.) As explained above, a POSA would understand that a
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`buffer functions to resist change in pH when an acid or base is added to the
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`composition. (Ex. 1003, ¶ 51; accord Ex. 1023, 4.) The specification explains
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`that “[i]n some embodiments, the buffer may include sodium citrate, citric acid
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`and combinations thereof.” (Ex. 1001, 13:39-41.) The proposed construction of
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`“acidic buffer” is consistent with the Delaware court’s construction of “buffer,”
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`which was “a component in the composition that functions to resist changes to
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`pH when an acid or base is added to the composition.” (Ex. 1023, 4.) The Court
`17
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`found, “[a] combination of acid and base counts as a buffer, but that does not
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`foreclose an individual component, such as citric acid or sodium citrate, also
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`being a buffer.” (Id., 8.)
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`VIII. THE CHALLENGED CLAIMS ARE NOT ENTITLED TO CLAIM
`PRIORITY TO AUGUST 7, 2009
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` Legal Standard for Priority A.
`The challenged claims are not “original claims”—Patent Owner first
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`introduced the challenged claims in a wholesale revision of the then-pending
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`claims of the ’669 application on September 9, 2016. (Ex. 1003, ¶ 57; Ex. 1002,
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`616-617; Ex. 1009, 1459-1462.)
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`In order to rely on the filing date of an earlier application, 35 U.S.C. § 120
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`requires that the earlier application include a disclosure that complies with the
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`written description requirement of 35 U.S.C. § 112. Lockwood v. Am. Airlines,
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`Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997).4 To comply with the written
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`description requirement,
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`the specification “must describe
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`the
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`invention
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`sufficiently to convey to a person of skill in the art that the patentee had
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`possession of the claimed invention at the time of the application, i.e., that the
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`patentee invented what is claimed.” Lizardtech, Inc. v. Earth Res. Mapping, Inc.,
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`4 See SAP Am., Inc. v. Pi-Net Int’l, Inc., IPR No. 2014-00414, Paper No. 11, 11-
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`14 (P.T.A.B. Aug. 18, 2014) (relying on § 112 case law is proper in an inter
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`partes review to establish effective filing date).
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`18
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`424 F.3d 1336, 1345 (Fed. Cir. 2005). The written description requirement
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`“guards against the inventor’s overreaching by insisting that he recount his
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`invention in such detail that his future claims can be determined to be
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`encompassed within his original creation” Vas-Cath Inc. v. Mahurkar, 935 F.2d
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`1555, 1561 (Fed. Cir. 1991). “In order to satisfy the written description
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`requirement, the disclosure as originally filed does not have to provide in haec
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`verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v.
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`Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nevertheless, “one skilled
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`in the art, reading the original disclosure, must immediately discern the
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`limitation at issue in the claims.” Id. (emphasis added). “Entitlement to a filing
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`date extends only to the subject matter that is disclosed; not to that which is
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`obvious…. Therefore the parent application must actually or inherently disclose
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`the elements of the later-filed claims.” Research Corp. Techs., Inc. v. Microsoft
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`Corp., 627 F.3d 859, 870 (Fed. Cir. 2010) (internal citations omitted).
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`In evaluating whether a disclosure provides a sufficient written description,
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`the Federal Circuit has held that “one cannot disclose a forest in the original
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`application, and then later pick a tree out of the forest and say here is my
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`invention. In order to satisfy the written description requirement, the blaze
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`marks directing the skilled artisan to that tree must be in the originally filed
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`disclosure.” Purdue Pharma, 230 F.3d at 1326-1327 (emphasis added).
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`B.
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`
`The ’571 Application Does Not Contain Written Description
`Support for the Polymer Weight Ranges and Ratios of Polymer
`in the Challenged Claims
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`The ’571 application lacks written description support for the limitations
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`that are directed toward the amount of polymer in the claimed films.5 These
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`limitations take two forms. First, in claims 1, 7, 8, and 12, the amount of
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`polymer is expressed as a percentage of the overall weight of the film. In
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`particular, claim 1 requires that the oral film comprise “about 40 wt % to about
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`60 wt % of a water-soluble polymer matrix.” (Ex. 1001, 24:27-28.) Dependent
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`claims 7, 8, and 12 further narrow these ranges. (Ex. 1003, ¶ 57.) Second,
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`dependent claims 5 and 12 limit the amount of water-soluble polymer in the film,
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`by requiring the film to have a ratio of buprenorphine-to-polymer that falls within
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`specified ranges. For example, claim 5 specifies “the weight ratio of (b):(a) is
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`from about 1:3 to about 1:11.5.” (Ex. 1001, 24:3-4.) The ’571 application does
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`not contain written description support for either set of limitations.
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`5 See Celltrion, Inc. v. Biogen, Inc., IPR2017-01095, Paper No. 60, 16 (P.T.A.B.
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`Oct. 4, 2018) (“To receive the benefit of a previous application, every feature
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`recited in a particular claim at issue must be described in the prior application.”)
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`(citing In re Van Langenhoven, 458 F.2d 132, 137 (C.C.P.A. 1972)) (emphasis
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`original).
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`20
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`1.
`
`The Text of the ’571 Application Does Not Contain Any
`Blaze Marks Directing a POSA to the Polymer Weight
`Percentages or (b):(a) Ratios.
`
`There is nothing in the text of the ’571 application that demonstrates the
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`inventors believed that the polymer weight percentages and (b):(a) ratios later
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`added to the challenged claims were part of their invention. To the contrary, the
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`only discussion in the ’571 application concerning the amount of polymers that
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`should be in the films is reproduced in its entirety below:
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`The film may contain any desired level of self-supporting film
`forming polymer, such that a self-supporting film composition is
`provided. In one embodiment, the film composition contains a film
`forming polymer in an amount of at least 25% by weight of the
`composition. The film forming polymer may alternatively be
`present in an amount of least 50% by weight of the composition.
`
`(Ex. 1011, 1444 ([0065]) (emphasis added).) As this passage makes clear, the
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`’571 application does not limit the amount of polymer to a closed range or
`
`express it as a (b):(a) ratio, but instead instructs that “any desired level of …
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`polymer” can be used in the films. (Id.) This short description of open-ended
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`ranges does not provide a POSA any guidance to—and in fact directs a POSA
`
`away from—the polymer weight ranges later claimed in claims 1, 5, 7, 8, or 12.
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`(Ex. 1003, ¶ 61.) For example, there is nothing in the ’571 application that
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`suggests that the bottom end of the range should be “40 wt %” (claim 1) or “48.2
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`wt %” (claims 7 and 12). (Ex. 1003, ¶ 61.) Nor is there a disclosure of the top-
`21
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`end range, whether it is “60 wt %” (claim 1) or “58.6 wt %” (claims 7 and 12).
`
`(See id.)
`
`It is well established that “[t]he disclosure of a broad range of values does
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`not by itself provide a written description support for a particular value within
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`that range.” See Gen. Hosp. Corp. v. Sienna Biopharm., Inc., 888 F.3d 1368,
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`1372 (Fed. Cir. 2018). In this case,