IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Inter Prrrtes Reexamination of
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`Examiner:
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`Alan D. Diamond
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`Yang et al.
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`U.S. Patent No. 7,824,588
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`Reexamination Control No: 95/001,753
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`Group Art Unit:
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`3991
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`Confirmation N0.
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`6620
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`H&B Docket: 1199-4B DIV/RCEfREX
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`Filed: September 12, 2011
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`M&E Docket: 117744-00016
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`For: METHOD OF MAKING SELF-SUPPORTING
`THERAPEUTIC ACTIVPLCONTAINENG FILM
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`APPELLANT’S APPEAL BRIEF '
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`Mail Stop Inter Pm-res Reexam
`Central Reexamination Unit
`Commissioner for Patents
`U.S. Patent and Traclemartvc Office
`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Certificate of1C‘FS- Web It"r(msmz‘ssion
`I hereby certify that this correspondence is being transmitted
`via the U.S. Patent and Trademark Office electronic filing
`system (BPS-Web) to the USPTO on June 24, 2013.
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`Signed: Michael I. Chakansky /Michael I Chakansky/Reg. No. 31,600
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`I hereby certify that, pursuant to 37 CFR § 1.943(0), based on the WordPert‘cct word count of
`13,047 words, Appel|a11t’s brief does not exceed l4,000 words in length, excluding appendices of
`claims and reference materials such as prior art references.
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`Signed: Michael I. Citakansky /Michael I Chalcansky/Reg. No. 31,600
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`Dear Madame:
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`On Februaty 22, 2013, patent owner Mo11oSol Rx, LLC (“Appellant”) filed its Notice of
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`Appeal to the Patent Trial and Appeal Board (PTAB), appealing all of the Examiner's rejections
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`of all claims delineated as rejected in the Right of Appeal Notice mailed January 23, 2013
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`("RAN"), in the above-identified inter partes reexamination. On February 22, 2013, Appellant
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`also filed, inter alia, petitions for continued reexamination and entry of declarations and
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`DRL - EXHIBIT 1030
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`DRL001
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`DRL - EXHIBIT 1030
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`

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`Inter-Pm'tes Rcexantination Control No. 95/001,753
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`US Patent No. 7,824,588
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`amendments not admitted in the RAN, and for more time to file Appelianfs Appeal Brief herein.
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`In a decision mailed to Appellant on April 22, 2013, Appellant was afforded an extension of
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`time up to and including June 22, 2013 to file Appcllant’s AppeaE'Brief herein. As June 22,
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`2013 is a Saturday, this Appeal Brief, filed Monday June 24, 2(}l3 is timely.
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`Appellant submits this Appeal Brief in support of it appeal, and authorizes the
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`Commissioner to charge ail fees associated therewith, including, without limitatioii, the
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`$2,000.00 fee for filing this brief in support of an appeal in an r'nrez'parte.s' reexamination
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`proceeding, pursuant to 37 C.F.R. § 4I.20(b)(2)(i), to Deposit Account No. 08-2461.
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`DRL - EXHIBIT 1030
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`DRL - EXHIBIT 1030
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`

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`Inter Paries Reexamination Control No. 95/001,753
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`US Patent No. 7,824,588
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`TABLE OF CONTENTS
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`APPELLANTS APPEAL BRIEF .
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`-_i_;
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`Statement of‘ the Real Party in Interest
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`. :2;
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`II.
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`Reiated Appeais and interferences
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`111.
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`Status of Claims .
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`_—:i,;
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`_-__§_-_
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`IV.
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`Status of Amendments .
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`V.
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`Summary of Claimed Subject Matter
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`;_1,,l,,-_
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`V1.
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`Issues to be Reviewed on Appeal
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`ARGUMENT .
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`Preliminary Statement.
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`. :13;
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`_~,1,fi;
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`The Examiner’s rejections fall into two broad categories.
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`Argument Addressing Specific Rejections.
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`_-j2._0_-
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`A.
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`B.
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`C.
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`The Examiner’s construction of the claim phrase “substantially uniform content
`of therapeutic active composition” as “a film that has been prepared according to
`the processing steps of claims 1, 192 or 193, i.e., mixing, forming and removing,
`or mixing, forming and using” was improper; this term should be construed, as
`per the specification mandate, as requiring a degree of uniformity such that the
`amount of active in a dosage unit does not vary more than 10% in the amount of
`active required by the FDA .
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`The 35 U.S.C. 112 rejections of Claims 1-24, 75, 78, 81, 84, 87, 90, 93, 96, 99,
`102, 105, 106, 111-132, 177, 178, 183, 186, 189, 192 and 193, as being indefinite,
`as failing to comply with the written description requirement, as failing to comply
`with the enablement requirement, are all improper.
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`The rejections ofClaims _I_, {25-28, 30-33, 35, 36, 40, 42-53, 55-58, 60, 61, 65,
`67-74, 76, 77, 79, 80, 82, 83, 85, 86, 88, 89, 91, 92, 94, 95, 97, 98, 100, 101, 103,
`104,107-110, 133-139, 141-143,155-161,163-165, 179-182,184, 185,187,188
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`DRL - EXHIBIT 1030
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`

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`Imez-Partes Reexamination Contro1No. 95/001,753
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`US Patent No. 7,824,588
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`and 190,] 192 and 193 under 35 U.S.C. 102(b) as being anticipated by Chen are
`improper.
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`1.
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`2.
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`Removing said polar solvent from said matrix with heat and/or radiation
`energy by exposing said matrix to a temperature greater than the
`degradation temperature of said therapeutic active composition is neither
`anticipated nor made obvious by Chen.
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`:25;
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`Wherein the resulting film maintains the substantially uniform content of
`therapeutic active composition per unit of film, wherein the degree of
`uniformity is such that the amount of active present may 11ot vary more
`than 10% from the FDA label amount is neither anticipated nor made
`obvious by Chen.
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`;2__'_Z;
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`The rejections of Claims 1-3, 5-8, i0, 11, 15, 17-24, 75, 78, 81, 84, 87, 90, 93, 96,
`99,102, 105, 106,11]-117,119-121,177,178, 183, 186 and 189 under35 U.S.C.
`102(b) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious
`over Chen are improper.
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`The rejections of Claims 4, 14, [29, 39, 54, 64,] l 18[, 140 and 162] under 35
`U.S.C. 103(a) as being unpatentable over Chen are improper.
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`;3_2;
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`The rejections of Claims 1, 122-132, [ 144-154 and 166-176 ] under 35 U.S.C.
`103(a) as being unpatentable over the combination of Chen and Le Person are
`improper.
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`;3_,’§;
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`The rejections ofCiaims 2, 5, 8, 9, 12, 15, 16, 18, [34, 37, 41, 59, 62, 66,] 84, 99,
`£13 and 121 under 35 U.S.C. 103(a) as being unpatentable over the combination
`of Chen and Bernstein are improper.
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`The rejections of Claims 13, 14 and 17 [, 38, 39, 42, 63, 64 and 67 ] under 35
`U.S.C. 103(a) as being unpatentable over Chen in combination with Staab or
`1-Iijiya are improper.
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`The rejections of Claims 2, 5, 8, 15, 84, 99 and 113 under 35 U.S.C. l(13(a) as
`being unpatentable over the combination of Chen and Hijiya are improper.
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`:35};
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`The rejections of Claims [25, 26, 30, 31, 46, 47, 58, S1, 55, 56, 71 , 72, 76, 77, 79,
`80, 82, 83, 85, 86, 97, 98, 133, 134, I36, 137, I55, 156, 158, 159, 184, 185, 187,
`188, ] 192 and 193 under 35 U.S.C. l02(b) as anticipated by Pelt are improper.
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`D.
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`DRL — EXHIBIT 1030
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`

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`[m‘erPartes Reexaminaiion Control No. 95/001,753
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`US Patent No. 7,824,588
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`K.
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`The rejections of Claims [27, 52, 134, 135, 144-148, 156-159 and 166-170]
`under 35 U.S.C. 103(a) as being unpatentable over Peh as applied to claims [25,
`26, 30, 31, 46, 47, 50, 51, 55, 56, 71, 72,76, 77,79, 80, 82,83, 85,86, 97,98,
`133,134, 136,137, 155, 156, 158, 159,184,185, 187,188,] 192 and193 above,
`and further in combination with Le Person, are improper.
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`_-_3__5_;
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`The rejections of Claims [28, 36, 38, 42, 43, 45,47, 48, 53, 61, 63, 67, 68,70, 72,
`73, 94, 95, 103,104, 107-110, l38,139,160,161,] 192 and 193 under35 U.S.C.
`103(3) as being unpatentabie over Peh as applied to claims [25, 26, 30, 31, 46, 47,
`50, 51,55, 56, 71, 72,76, 77,79, 80, 82,83, 85, 86, 97, 98, 133, 134, 136, 137,
`155, 156, 158, 159, 184, 185, 187, 188,] 192 and 193 above, and further in
`combination with Staab, are improper.
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`The rqiectioirs of Claims [27, 30, 33, 40, 43, 52, 55, 58, 65, 68, 85, 86, 100, 101,
`134, 143, 156, 165,] 192 and 193 unde1'35 U.S.C. 103(a) as being unpatentablc
`over Peh as applied to claims [25, 26, 30, 31, 46, 47, 50, 51, 55, 56, 71, 72, 76,
`77, 79, 80, 82, 83, 85, 86, 97,98, 133,134, 136, 137, 155, 156, 158, I59, 184,
`185, 187, 188, ] I92 and 193 above, and further in combination with Chen, are
`improper.
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`_-_3j_—_
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`The rejections of Claims [49 and 74 ] under 35 U.S.C. 103(a) as being
`unpatentable over Peh as applied to claims [25, 26, 30, 31, 46, 47, 50, 51, 55, 56,
`71, 72, 76, 77, 79, 80, 82, 83, 85,86, 97,98, 133, 134, 136, I37, 155, 156, I58,
`159, 184, 185, 187, 188, ] 192 and 193 above, and further in combination with
`Strobush, are improper.
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`_-,3_,8_;
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`The rejections of Claims [29, 32, 34-37, 40-42, 44, 54, 57, 59-62, 65-67, 69, 88,
`89, 91, 92, 140-142, 162-164, 179-182, 190 and 191] under 35 U.S.C. 103(a) as
`being unpatentabie over Peh as appiied to claims [25, 26, 30, 31, 46, 47, 50, 51,
`55, 56, 71, 72, 76, 77,79, 80,82, 83, 85,86, 97, 98, 133,134, 136, 137, 155, 156,
`158, 159, 184, 185, 187, 188,] I92 and 193 above, and further in combination
`with Bernstein, are improper.
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`The rejections of Claims [39 and 64 ] under 35 U.S.C. 103(a) as being
`unpatentable over Peh as applied to claims [25, 26, 30, 31, 46, 47, 50, 51, 55, 56,
`71, 72, 76, 77, 79, 80,82, 83,85, 86, 97,98, 133, 134, 136, 137, 155, 156, 158,
`159, 184, 185, 187, 188,] 192 and 193 above, and further i11 combination with
`Hijiya, are improper.
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`-39-
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`The rejections of Claims [149-154 and 171-176] under 35 U.S.C. 103(a) as being
`unpatentable over Peh in combination with Le 1’erson as applied to claims [27, 52,
`134, 135, 144-148, 156-159 and 166-170 3 above, and further in combination with
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`DRL - EXHIBIT 1030
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`

`
`InterParIes Rccxaminalion Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`Staab or Bernstein, are improper.
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`;{1€_}_;
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`R.
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`The failure to enter the amendment, and the failure to formally enter the
`declarations proper afier the Examiner reviewed same to conclude that the
`“declarations would not overcome the art of record,” and the failure to consider
`Appellant’s remarks in its post ACP reply were improper.
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`;§l_§_~_
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`VII.
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`CONCLUSION .
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`CLAEMS APPENDIX .
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`CLAiM AMENDMENTS AFTER ACP - NOT ENTERED .
`EVIDENCE APPENDIX .
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`RELATED PROCEEDINGS APPENDIX .
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`CERTIFICATE OF FIRST CLASS SERVICE .
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`- iv-
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`DRL - EXHIBIT 1030
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`

`
`Inter-Partes Reexamination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`APPELLANT’S APPEAL BRIEF
`
`1.
`
`Statement of the Real Party in Interest
`
`MonoSol Rx, LLC owner of U.S. Patent No. 7,824,588 ("the ‘S88 Patent"), in
`
`reexamination herein,
`
`is the real party in interest for Appellant.
`
`DRL - EXHIBIT 1030
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`DRL007
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`

`
`InterPar!es Reexamination Control No. 95i’00i,753
`
`US Patent No. 7,824,588
`
`11.
`
`Related Appeals and Interferences
`
`Other than as noted below, Appellant is not aware of any reiated appeals, interferences or
`
`judicial proceedings which will directly affect or be directly affected by or have a bearing on the
`
`Board’s decision in the pending appeal.
`
`On November 2, 2010, Appellant commenced an action for patent infringement against
`
`BioDeiivery Sciences International, Inc. ("Third Party Requester" or “Respondent”), inter aim,
`
`in the United States District Court for the District of New Jersey, captioned MonoSol Rx, LLC V.
`
`BioDelivery Sciences international, Inc., MEDA Pharmaceuticals, Inc. and Aveva Drug
`
`Delivery Systems, Inc., I0-cv-5695 ("the Litigation"). In the Litigation, Appellant charged the
`
`defendants, including Third Party Requester, with infringement of several patents it owns,
`
`namely, the ‘S88 Patent, US. 7,357,891 ("the ‘891 Patent") and U.S. 7,425,292 ("the ‘292
`
`Patent").
`
`While the Litigation was ongoing, Third Party Requester fi1‘Sl: requested z'm‘erpa:'tes
`
`reexamination of the ‘S88 Patent (95/001,753, filed September l2,20i1); and then requested ex
`
`parre reexamination of the remaining patents in the Litigation, the ‘E391 Patent (90/012,098, filed
`
`January 20, 2012) and the '292 Patent (90/012,097, filed January 20, 2012). After filing all of its
`
`reexamination requests, Third Party Requester, inter alia, moved the District Court to stay the
`
`Litigation pending resolution of all three reexaminations. On March 7‘, 2012, the District Court
`
`stayed the Litigation. The'891 Patent and the ‘292 Patent successfully exited reexamination with
`
`reexamination certificates issued on August 21, 2012 and July 3, 2012, respectively, leaving the
`
`'588 Patent Reexamination pending and the Litigation stayed.
`
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`

`
`InferPar(eS Reexamination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`On June 12, 2013, Third-Party Requestor, improperly, more than one year after Appellant
`
`had brought its District Court action, petitioned for Inter Parres Review of the ‘E391 Patent
`
`(IPR2013-00316) and the ‘Z92 Patent (IPR20l3—00315) which had recently successfully exited
`
`reexamination. The petitions are outstanding.
`
`in addition to the patents in the Litigation, Tliird-Party Requester also requested inter
`
`partes reexamination of two additional patents of Appellant, namely, U.S. 7,666,337 (“the ‘337
`
`Patent”) (Control No. 95/002,171) and U.S. Patent 7,897,080 ("the ‘O80 Patent") (Control No.
`
`95l0G2,l70). These reexaminations are pending as well. Ail five (5) reexaminations were
`
`assigned to the same examiner, Alan D. Diamond.
`
`Please note, as discussed below, that Appellant has petitioned the Director under 37
`
`C.F.R. § 1.182 to re—open prosecution of the t'nrerparte.s' reexamination herein and enter
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`Appellant's reply to ACP in its entirety, including remarks, amendment and declarations. This
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`petition is pending.
`
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`

`
`Inter-Parfes Reexaniination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`HI.
`
`Status of Claims
`
`Claims I - 191 were in the ‘588 Patent as issued. Claim 1 was amended, and Ctaims 192
`
`and 193 were added by Amendment in connection with Appe1lant’s Januaiy 10, 2012 Repiy to
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`the Exarniner’s November 10,2011 Office Action.
`
`In the RAN, the Examiner rejected all of the
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`claims (1-193) pending in the instant ‘588 Reexamination, and Appellant is appealing each and
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`every rejection not cancelled hereby.
`
`Independent claim 25 and all those depending therefrom, nameiy, claims 26-49, 76, 79,
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`82, 85, 88, 91, 94, 97, 100, 103, 106-108, 133-154, 179-180, 184, 187, and 190; and independent
`
`claim 50, and all those depending therefrom, namely, claims 51-74, 77, 80, 83, 86, 89, 92, 95,
`
`98, 101, 104, 109, 110, 155-176, 181, 182, 185, 188, 191, are not being addressed herein in light
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`of the denial to enter amendments thereto after the ACP, see discussion below.
`
`Independent ciaim 1, and its depending claims namely, claims 2-24, 75, 78, 81, 84, 87,
`
`90, 93, 96, 99, 102, 105, 106, 111-132, 177, 178, 183, 186, 189, and independent claims 192 and
`
`193 stand rejected and are addressed in this appeal.
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`
`InterPm-res Reexamination Control No.‘ 95/001,753
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`US PatentNo. 7,824,588
`
`IV.
`
`Status of Amendments
`
`In the RAN, the Examiner, in connection with Appe11a.nt’s August 17, 2012 Reply to the
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`July 20, 2012 Action Closing Prosecution ("ACP"), refused entry of (i) Appeliant’s amendment
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`to claims 1, 3, 25, 28, 50, 53, 192 and 193 (see attached CA—Not Entered Pages 1-4), and (ii) two
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`declarations:
`
`the Rule 1.132 Declaration by Gregory J . Slominski, dated August 15, 2012
`
`("Slominski Declaration") and the Rule 1.132 Declaration by Garry Myers, dated August 17,
`
`2012 ("Myers Declaration"). The Examiner also refused to consider Appc1lant’s remarks
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`therein. Appellant, by way of petition filed concurrently with its Notice of Appeal requested the
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`Director under 37 C.F.R. § 1.182 to re-open prosecution and enter Appe1iant‘s Reply to ACP in
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`its entirety, including remarks, amendment and declarations. That petition is currently pending.
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`
`Im‘erPar!es Reexamination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`V.
`
`Summary of Claimed Subject Matter
`
`Appeilant’s ciaimed subject matter is directed to methods for making self-supporting
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`therapeutic active—containing films by mixing an edible polymer, a therapeutic active
`
`composition and a polar solvent to form a matrix, forming a wet film fi'om the matrix, the wet
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`film having a substantially uniform content of the therapeutic active composition throughout,
`
`and removing the solvent by heating and/or with radiation energy, wherein the self-supporting
`
`film maintains the substantially uniform content of therapeutic active composition per unit of
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`film, where a unit of film is defined broadly to include a roli of finished film, a standard area of
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`dried film before being cut, or a dosage unit (see, e.g., col. 2, lines 31-44, col. 4, l. 25 to col. 5, i.
`
`14, col. 6, II. 47-48, col. 6, ll. 56-61, col. 7, l. 59 to col. 8, l. 2, col. 8, 1. 65 to col. 9, l. 12, col. E2,
`
`1. 44 to coi. 13, l. 3, col. 14, 11. 47-52, col. 14,1. 54to col. 15,1. 10, col. 17,1. 6] to col. 18, 1. 4,
`
`coi. 21, it. 5-9, col. 26, 11. 21-23, coi. 39, I. 57 to cot. 40, i. 3, col. 25, l. 63 to col. 41, i. 7, col. 42,
`
`ll. 1-31).‘ This degree of uniformity across finished rolls of film, separates and distinguishes
`
`Appellant’s invention from the prior art processes performed in the lab or in other
`
`non-comrnercial settings. For therapeutic actives the degree of uniformity of content of active in
`
`‘ The support provided herein for the claimed subject matter is by way of example only.
`Additional support for the claimed subject matter may be found throughout the issued ‘S88
`Patent, including in the Tables, Figures, Examples, and claims of the issued ‘S88 Patent.
`. be
`.
`Moreover, as stated in MPEP 2258.11, “[c]onsideration of 35 U.S.C. 112 issues should .
`limited to the amendatory (e.g., new language) matter.” As further stated in MPEP §22S8.II, to
`go further, “would be inconsistent with the statute [35 U.S.C. § 112] to the extent that 35 U.S.C.
`112 issues would be raised as to matter in the original patent claim.” MPEP §2258.II.
`Accordingly, claimed subject matter which appeared in the issued ‘S88 Patent cannot be
`examined for compliance with 35 U.S.C. §1l2. Thus, for example, as acknowledged by the
`Examiner (see RAN, p. 11), “{i]f a limitation that appears in an existing patent claim also
`appears in a claim newly presented in a reexamination proceeding, that limitation cannot be
`examined as to 35 U.S.C. I12.” MPEP §2258.II.
`
`-5-
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`
`InlerPa1'!es Reexamination Control No. 95/001,753
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`US Patent No. 7,824,588
`
`connection with unit dosages is +/— 10% of the FDA label amount for the active (see, e.g., col. 2,
`
`lines 31-44).
`
`There are three independent claims on appeal, i.e., claims 1, 192, and 193.
`
`Independent claim 1 is directed to method of making a self-supporting therapeutic
`
`active-containing film comprising:
`
`(a)
`
`Mixing at least one edible polymer component, a therapeutic active
`
`composition, and at least one polar solvent to form a matrix (see, e.g., col.
`
`4, 1. 25 to col. 5, l. 14, col. l4, 11.47-51);
`
`(b)
`
`Forming a wet film from said matrix, said wet film having a substantially
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`unifoim content of therapeutic active composition throughout said wet
`
`film (see, e.g, C01. 7, l. 59 to col. 8, 1. 2, col. 8,1. 65 to cot. 9, 1. 12, col. 12,
`
`1. 44 to eoi. 13, l. 3, col. 14,1. 63 to col. 15, l. 10);
`
`(C)
`
`Removing said polar solvent from said matrix with heat andfer radiation energy
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`by exposing said matrix to a temperature greater than the degradation temperature
`
`of said therapeutic active composition to form a selflsupporting film (see, e.g.,
`
`col. 4, it. 40-42, col. 4, 1. 66 to col. 5, I. 2, col. 6, ll. 56-61, col. I2, li. 33-40; see
`
`also col. 39, 1. 1 to col. 40, I. 3).
`
`As recited in claim I, the temperature of the matrix is 100° C. or less during said
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`step of removing said polar solvent from said matrix (see, e.g., original claim 1 at eel. 40, ii.
`
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`
`IaterParfes Reexamination Control No. 95f00l,753
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`US PatenlNo. 7,824,588
`
`1-3). As further recited in claim 1, the resulting self-supporting film maintains the substantially
`
`uniform content of therapeutic active composition per unit of film (see, c.g., col. 7, 1. 59 to col. 8,
`
`l. 2, col. 8,1. 65 to col. 9, l. 12, col. 12, 1. 44 to col. 13, 1. 3, col. 14, l. 63 to col. 15,1. 10).
`
`Independent claim 192 is directed to a method of making a self—supporting therapeutic
`
`active-containing film comprising:
`
`(a)
`
`Mixing at least one edible polymer component, a therapeutic active
`
`composition and at least one polar solvent to form a matrix (see, e.g., col.
`
`4,1. 25 to col. 5,1. 14, col. 14, ll. 4761);
`
`(b)
`
`Forming a wet film from said matrix, said wet film having a substantially uniform
`
`content of therapeutic active composition tltroughout said wet film (see, e.g, col.
`
`7, l. 59 to col. 8, I. 2, col. 8, l. 65 to col. 9, l. E2, col. I2, 1. 44 to col. 13, l. 3, col.
`
`14, E. 63 to col. E5, l. l0);
`
`(0)
`
`Removing said polar solvent from said matrix with heat and/or radiation
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`energy by heating said matrix to a temperature that is less than the boiling
`
`point of said at least one polar solvent so as to form a viscoelastic film
`
`(see, e.g., col. 4, ll. 40-42, col. 4, l. 66 to col. 5,1. 2, col. 6, ll. 56-61, col.
`
`12, 11. 33-40, col. 40, l. 63 to col. 41, l. 5).
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`
`1n(erPa1'les Reexamination Control No. 95/001,753
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`US Patent No. 7,824,588
`
`As recited in claim 192, the resulting viscoelastic film maintains the substantially
`
`uniform content of therapeutic active composition per unit of film (see, e.g, col. 7, l. 59 to col. 8,
`
`L 2, coi. 8, l. 65 to col. 9, E. E2, col. 12, l. 44 to col. 13, l. 3, col. 14, l. 63 to col. 15,1. 10).
`
`Independent claim 193 is directed to a method of making a selfisupporting therapeutic
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`active-containing film comprising:
`
`(a)
`
`Mixing at least one edible polymer component, a therapeutic active
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`composition, and at least one polar solvent to form a matrix (see, e.g., col.
`
`4, 1. 25 to col. 5, i. 14, Col. 14, ll. 47-51);
`
`(1))
`
`Forming a wet film from said matrix, said wet film having a substantiaiiy
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`uniform content of therapeutic active composition tlnougliout said wet
`
`fihn (see, e.g, col. 7, l. 59 to col. 8, 1. 2, col. 8, l. 65 to col. 9,1. 12, col. I2,
`
`1. 44 to col. 13,1. 3, col. I4, 1. 63 to col. 15,1. 10);
`
`(0)
`
`Using heat and/or radiation energy to remove said polar solvent from said matrix
`
`to form a selflsupporting therapeutic active-containing film without forming
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`bubbles (see, c.g., col. 4, ll. 40-42, col. 4, 1. 67 to col. 5, 1. 2, col. 6, ll. 56-61, col.
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`7, ll. 56-66, col. I2, ll. 33-40; see also (:01. 42, 11. 1-11).
`
`As recited in claim 193, the resulting self-supporting film maintains the substantially
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`uniform content of therapeutic active composition per unit of film (see, e.g, col. 7, 59 to col. 8, l.
`
`2, col. 8, 1. 65 to col. 9, l. 12, col. 12, l. 44 to col. 13, E. 3, col. 14, l. 63 t.o col. 15,1. 10).
`
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`
`Inter Parres Reexamination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`Dependent claim 3 is directed to the method of claim I, wherein the seif-supporting
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`therapeutic active—con£aining film has a variation of active content of iess than 10% per film unit
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`(see,c.g., col. 15,11. 1-10).
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`

`
`InterPm-Ies Reexamination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`V1.
`
`Issues to be Reviewed on Appeai
`
`A.
`
`Is the definition of a film having a “substantially uniform content of therapeutic
`active composition” as “a film that has been prepared according to the processing
`steps of claims 1, 192 or 193, i.e., mixing, forming and removing, or mixing,
`forming a11d using, is taken to be a film having ‘substantially uniform content of
`therapeutic active composition’ ” as proposed by the Examiner, and used in
`rejecting the claims, proper‘?
`
`Are the rejections of Claims E-24, 75,78, 81, 84, 87, 90, 93, 96, 99, 102, 105,
`106,111-132, 177, 178,183,186, 189, 192 and 193, under35 U.S.C. 112, as
`being indefinite, as failing to comply with the written description requirement,
`and as failing to comply with the enabiement requirement, proper?
`
`Are the rejections of Claims [25-28, 30-33, 35, 36, 40, 42-53, 55-58, 60, 61, 65,
`67-74, 76, 77, 79, 80, 82, 83, 85, 86, 88, 89, 91, 92, 94, 95, 97, 98, 100, 101, 103,
`104,107-110,133-139,141-143,155-161,163-165,l79—182,l84,185,l87,188
`and 190], 192 and 193 under 35 U.S.C. 102(b) as being anticipated by Chen
`proper?
`
`Are the rejections of Claims 1-3, 5-8, 10, 11, 15, 17-24, 75, 78, 81, 84, 87, 90, 93,
`96, 99,102,105,106,111-117,119-121,177,178,183,186 and 189 under 35
`U.S.C. 102(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as
`obvious over Chen proper?
`
`Are the rejections of Claims 4, 14, 29, 39, 54, 64, 1 18, 140 and 162 under 35
`U.S.C. 103(a) as being unpatentable over Chen proper‘?
`
`Are the rejections of Claims 1, 122-132[, 144-154 and 166-176] under 35 U.S.C.
`103(a) as being unpatentabie over the combination of Chen and Le Person
`proper?
`
`Are the rejections of Claims 2, 5, 8, 9, 12, 15, 16, 18, [34, 37, 41, 59, 62, 66, 84,
`99,} 113 and 121 under 35 U.S.C. 103(a) as being unpatentable over the
`combination of Chen and Bernstein proper?
`
`Are the rejections of Claims 13, 14, 17{, 38, 39, 42, 63, 64 and 67} under 35
`U.S.C. 103(a) as being unpatentabie over Chen in combination with Staab or
`Hijiya proper?
`
`Are the rejections of Claims 2, 5, 8, 15, 84, 99 and 113 under 35 U.S.C. 103(a) as
`being unpatcntable over the combination of Chen and Hijiya proper‘?
`
`41-
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`

`
`Inter Panes Reexamination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`J.
`
`K.
`
`L.
`
`M.
`
`N.
`
`0.
`
`P.
`
`Are the rejections of Claims [25, 26, 30, 31, 46, 47, 50, 51, 55, 56, 71, 72, 76,77,
`79,80, 82,83, 85,86, 97, 98, 133, 134, 136, 137, 155, 156, 158, 159, 184,185,
`187, 188,] 192 and 193 under 35 U.S.C. 102(b) as anticipated by Pelt proper?
`
`Are the rejections of Claims [27, 52, 134, 135, 144-148, 156-159 and 166-170]
`under 35 U.S.C. 103(a) as being unpatentable over Peh as applied to claims [25,
`26,30, 31, 46,47, 50,51, 55,56, 71, 72,76, 77, 79, 80, 82, 83, 85,86, 97,98,
`133, 134,136, 137, 155, 156, 158,159, 184, 185, 187, 188,] 192 and 193 above,
`and further in combination with Le Person, proper?
`
`Are the rejections of Claims [28, 36, 38, 42, 43, 45, 47, 48, 53,61, 63, 67, 68, 70,
`72,73, 94, 95, 103, 104, 107-110, 138, 139, 160, 161,] 192 and 193 under35
`U.S.C. 103(a) as being unpatentable over Pch as applied to claims [25, 26, 30, 31,
`46,47, 50, 51, 55, 56, 71, 72, 76, 77,79, 80, 82,83, 85,86, 97,98, 133, 134, 136,
`137, 155, 156, 158, 159, 184, 185, 187, 188,] 192 and 193 above, and further in
`combination with Staab, proper?
`
`Are the rejections of Ciaims [27, 30, 33, 40, 43, 52, 55, 58, 65, 68, 85, 86, 100,
`101, 134, 143, 156, 165,] 192 and 193 undcr35 U.S.C. 103(3) as being
`unpatentable over Peh as applied to claims [25, 26, 30, 31, 46, 47, 50, 51, 55, 56,
`71, 72, 76, 77, 79, 80, 82, 83, 85, 86, 97, 98, 133,134, 136,137, 155, 156, 158,
`159, 184, 185, 187, 188,] 192 and 193 above, and further in combination with
`Chen, proper?
`
`Are the rejections of Claims [49 and 74] under 35 U.S.C. l03(a) as being
`unpatentable over Peh as appiied to claims [25, 26, 30, 31,46, 47, 50, 51, 55, 56,
`71, 72,76, 77, 79,80, 82,83, 85,86, 97, 98, 133, 134, 136,137, 155, 156, 158,
`159, 184, 185, 187, 188,] 192 and 193 above, and further in combination with
`Strobush, proper‘?
`
`Are the rejections of Claims [29, 32, 34-37, 40-42, 44, 54, 57, 59-62, 65-67, 69,
`88, 89, 91, 92, 140-142, 162-164, 179-182, 190 and 191] under35 U.S.C. 103(3)
`as being unpatentable over Peh as applied to claims [25, 26, 30, 31, 46, 47, 50, 51,
`55,56, 71, 72, 76, 77,79, 80, 82, 83, 85,86, 97, 98, 133,134, 136, 137, 155, 156,
`158, 159, 184, 185, 187, 188,] 192 and 193 above, and further in combination
`with Bernstein, proper?
`
`Are the rejections of Claims [39 and 64] under 35 U.S.C. 103(a) as being
`unpatentable over Peh as applied to claims [25, 26, 30, 31, 46, 47, 50, 51, 55, 56,
`71,72, 76, 77,79, 80, 82, 83,85, 86,97, 98, 133,134, 136, 137,155, 156, 158,
`
`.12-
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`Im*e.r-Pcrrtes Reexamination Control No. 95/001,753
`
`US Patent No. 7,824,588
`
`Q.
`
`R.
`
`159, l84, 185, I87, 188,] 192 and 193 above, and further in combination with
`Hijiya, proper?
`
`Are the rejections of Claims {l49—l54 and 171-176} under 35 U.S.C. l03(a) as
`being unpatentable over Pei: in combination with Le Person as applied to claims
`[27, 52, 134, 135, E44448, 156-159 and 166470] above, and further in
`combination with Staab or Bernstein, proper?
`
`Was the failure to enter the amendment, and the failure to formally enter the
`declarations proper after the Examiner reviewed same to conclude that the
`“declarations would not overcome the art of record,” and the failure to consider
`Appellant’s remarks in its post ACP reply proper?
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`InferParles Reexamination Control No. 951001353
`
`US Patent No. 7,824,588
`
`ARGUMENT
`
`Preliminary Statement.
`
`Prior to the present invention, commercial pharmaceutical (FDA Approved) oral films for
`
`s