Paper No. 15
`Filed: January 3, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner.
`
`
`
`
`
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`
`
`
`Patent No. 8,603,514
`Issue Date: December 10, 2013
`Title: UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
`INCORPORATING TASTE-MASKING COMPOSITIONS
`Inter Partes Review No. IPR2016-01111
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Filed: January 3, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner.
`
`
`
`
`
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`
`
`
`Patent No. 8,603,514
`Issue Date: December 10, 2013
`Title: UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
`INCORPORATING TASTE-MASKING COMPOSITIONS
`Inter Partes Review No. IPR2016-01111
`
`
`
`
`
`
`
`
`
`
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`
`
`
`
`TABLE OF CONTENTS
`
`
`I.
`II.
`
`Page
`INTRODUCTION ........................................................................................... 1
`LEGAL STANDARDS ................................................................................... 1
`A.
`Request for Rehearing ........................................................................... 1
`B.
`Collateral Estoppel ................................................................................ 2
`III. BACKGROUND ............................................................................................. 2
`IV. THE BOARD MISAPPREHENDED PETITIONER’S ARGUMENT
`REGARDING COLLATERAL ESTOPPEL AND OVERLOOKED
`SPECIFIC EVIDENCE ................................................................................... 3
`A.
`The Board Overlooked Specific Evidence in the ‘588 Patent
`Decision Finding that Dependent Claim 3 in the ‘588 patent
`was Found Separately Unpatentable over Chen.................................... 4
`The Board overlooked specific evidence in the ‘588 patent
`decision finding that Chen teaches a substantially identical
`process and inherently teaches the same product. ................................. 8
`THE BOARD MISAPPREHENDED THE EVIDENCE PROVIDED
`IN PATENT OWNER’S PRELIMINARY RESPONSE ..............................11
`VI. CONCLUSION ..............................................................................................14
`
`B.
`
`V.
`
`ii
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`
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`
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`
`
`TABLE OF AUTHORITIES
`
`
`Page(s)
`
`Cases
`Ex parte Smith,
`No. 2009-014595 (B.P.A.I. August 17, 2010) ...................................... 2
`Innolux Corp. v. Semiconductor Energy Lab. Co.,
`IPR2013-00064, Paper 11 (PTAB April 30, 2013) ............................... 2
`Interthinx, Inc. v. Corelogic Solutions, LLC,
`CBM2012-00007, Paper 15 (PTAB January 31, 2013) ......................14
`
`S.A.P. Am., Inc. v. Versata Dev. Grp., Inc.,
`CBM2012-00001, Paper 36 (PTAB January 9, 2013) ........................14
`
`Statutes
`35 U.S.C. § 102 ....................................................................................... 4, 6, 7
`35 U.S.C. § 103 ....................................................................................... 4, 6, 7
`35 U.S.C. § 112 ............................................................................................5, 6
`Other Authorities
`MPEP § 2286 .................................................................................................14
`MPEP § 2659 .................................................................................................14
`
`37 C.F.R. § 42.63 .......................................................................................1, 12
`37 C.F.R. § 42.71 ............................................................................................. 1
`
`
`
`iii
`
`Rules
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`
`
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.71(c) and (d), Petitioners, Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Petitioners”),
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`hereby submit this Request for Rehearing on the Decision Denying Institution of
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`Inter Partes Review in the above-captioned matter. Paper No. 14, “Inst. Dec.” In
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`the Institution Decision, all of Petitioner’s grounds for obviousness of claims 1-3,
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`9, 15, 62-65, 69-73 and 75 of U.S. Patent No. 8,603,514 (“the ‘514 patent”) were
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`denied.
`
`II. LEGAL STANDARDS
`A. Request for Rehearing
`A request for rehearing is appropriate when the requesting party believes
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`“the Board misapprehended or overlooked” a matter that was previously addressed
`
`in the record. See 37 C.F.R. § 42.71(d). The request “must specifically identify all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, an opposition, or a
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`reply.” Id. In reviewing such a request, the “panel will review the decision for an
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`abuse of discretion.” 37 C.F.R. § 42.71(c). Moreover, for evidence to be
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`considered by the Board, “all evidence must be filed in the form of an exhibit.” 37
`
`C.F.R. § 42.63(a).
`
`
`
`1
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`
`
`B. Collateral Estoppel
`The PTO affords preclusive effect to its own findings in subsequent PTO
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`proceedings under certain circumstances. For example, “administrative estoppel”
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`may be used to give preclusive effect to an examiner’s findings in subsequent
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`reexamination proceedings if the patent owner did not traverse those findings
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`during prosecution.1
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`III. BACKGROUND
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`On December 5, 2016, the Board (“Instant Board”) denied institution of
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`Petitioner’s Petition on the grounds that the “Petition has not demonstrated a
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`reasonable likelihood of establishing that it would prevail in showing
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`unpatentability of independent claims 1 and 62 or their respective dependent
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`claims, 2-3, 9, 15, 63-65, 69-73 and 75 over Bess and Chen” and that the “Petition
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`has not demonstrated a reasonable likelihood of establishing that it would prevail
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`in showing unpatentability of claims 1-3, 9, 15, 62-65, 69-73 and 75 over the
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`combination of Chen and Cremer.” Inst. Dec. 14 at 17, 19.
`
`1 See Ex parte Smith, No. 2009-014595 (B.P.A.I. Aug. 17, 2010); see also Innolux
`
`Corp. v. Semiconductor Energy Lab. Co., IPR2013-00064, Paper No. 11 (PTAB
`
`April 30, 2013) (rejecting petitioner’s administrative estoppel argument because
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`claims challenged in the petition were not “patentably indistinct” from claims
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`cancelled in prior reexamination proceeding).
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`
`
`2
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`
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`IV. THE BOARD MISAPPREHENDED PETITIONER’S ARGUMENT
`REGARDING COLLATERAL ESTOPPEL AND OVERLOOKED
`SPECIFIC EVIDENCE
`Petitioner’s argument that collateral estoppel will preclude re-argument is
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`not misplaced. Petitioner hereby submits that the Instant Board overlooked very
`
`specific evidence provided in the ‘588 patent decision, which resulted in
`
`misapprehending the applicability of the collateral estoppel issue. The dispositive
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`limitation identified by the Instant Board in the challenged ‘514 patent is that the
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`individual unit dose does “not vary by more than 10% of said desired amount of
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`said at least one active.” Inst. Dec. at 4. That is identical to the issue decided in
`
`the ‘588 patent decision as it relates to dependent claim 3, which is also consistent
`
`with Patent Owner’s previous arguments that the phrase “substantially uniform”
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`meant “a film having a degree of uniformity of 10 % from the FDA label amount
`
`for the active per dosage unit.” Ex.1038 at 10. Moreover, given the ‘588 Board’s
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`previous finding of inherency as it relates to Chen for the same issue and the
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`evidence relied upon by the Petitioner’s Expert, a person of ordinary skill in the art
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`(POSA) would conclude that Chen’s substantially identical process would result in
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`substantially equally sized individual unit doses that do not vary by more than 10%
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`of the desired amount of the active.
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`
`
`3
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`
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`A. The Board Overlooked Specific Evidence in the ‘588 Patent
`Decision Finding that Dependent Claim 3 in the ‘588 patent was
`Found Separately Unpatentable over Chen.
`In its Decision (Paper 14), the Instant Board found that collateral estoppel
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`did not apply because the issue presented in Appeal No. 2014-000547, an inter
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`partes reexamination of US Patent No. 7,824,588 B2 (“the ‘588 patent decision”)2
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`(Ex. 1038,) was not identical to the issue presented in the instant case. Inst. Dec. at
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`16. According to the Instant Board, the Patent Owner in the ‘588 patent decision
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`did not argue the claims separately, and as a result, the ‘588 patent decision
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`resolved only the issue of whether the relevant prior art reference, Chen, met the
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`uniformity requirement based on features provided in the independent claims. Inst.
`
`Dec. at 16. Thus, according to the Instant Board, the ‘588 Board’s finding that
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`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 were anticipated under 35 U.S.C. §
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`102(b) by, or in the alternative, obvious under 35 U.S.C. § 103(a) over Chen
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`allegedly resolved only those issues as it relates to the “substantial uniformity”
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`limitation as provided in the independent claims. According to the Instant Board,
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`the ‘588 patent decision did not address the issues as presented in any of the
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`dependent claims including, inter alia, dependent claim 3 of the ‘588 patent, which
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`2 US Pat. No. 8,603,514 is a continuation-in-part of application No. 10/768,809,
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`now US Pat. No. 7,824,588.
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`
`
`4
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`
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`recited “[t]he method of claim 1, wherein the self-supporting therapeutic active-
`
`containing film has a variation of active content of less than 10% per film unit.”
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`Inst. Dec. at 17. This decision overlooks express contradictory findings in the
`
`prior decision.
`
`As set forth more fully below, the Instant Board erred in concluding that the
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`issue decided before the ‘588 Board was not identical to the issue presented in the
`
`instant case. In particular, the ‘588 Board explicitly and expressly concluded that
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`Chen met the 10% variation of active content per film unit requirement of
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`dependent claim 3 of the ‘588 patent. Accordingly, the issues resolved in the ‘588
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`patent decision are indeed identical to the issues presented in the challenged ‘514
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`patent and collateral estoppel should apply for at least this reason.
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`The ‘588 Board in its decision noted that the Examiner in a prior
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`reexamination proceeding had rejected the claims under 35 U.S.C. § 112, first and
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`second paragraphs, because “[i]t is not clear exactly what is encompassed by a
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`substantially uniform content of therapeutic active composition, and the ‘588
`
`patent does not provide a definition for a substantially uniform content of
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`therapeutic active composition.” Ex. 1038 at 5. In an effort to overcome the
`
`rejections under 35 U.S.C. § 112, the ‘588 Board noted that the Patent Owner had
`
`argued that the phrase “substantially uniform content of therapeutic active
`
`composition” meant “a film having a degree of uniformity of 10 % from the FDA
`
`
`
`5
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`
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`label amount for the active per dosage unit.” Ex. 1038 at 6. The ‘588 Board
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`ultimately was unpersuaded by Patent Owner’s narrower interpretation and found
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`the use of “substantially” in the claims to be indefinite. Exhibit 1038 at 10.
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`Despite the Patent Owner’s previous argument that the phrase “substantially
`
`uniform content of therapeutic active composition” meant “a film having a degree
`
`of uniformity of 10 % from the FDA label amount for the active per dosage unit,”
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`the Patent Owners (as well the Instant Board) now consider the phrases to relate to
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`different issues. See PO Prelim. Resp. at 30.
`
`After affirming the rejections under 35 U.S.C. § 112,3 the ‘588 Board then
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`addressed the issue of applying prior art to the claims for its analysis under 35
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`U.S.C. §§ 102 and 103 with the understanding that “uniform content of therapeutic
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`active composition” meant “non-agglomerated and evenly dispersed active content
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`for any area of a given film, with the qualifier ‘substantially’ expanding the scope
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`to encompass some undefined agglomeration or some undefined degree of
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`unevenly dispersed active material to also be acceptable.” Ex. 1038 at 14. As
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`justification for providing an analysis of the claims in view of the prior art, the
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`‘588 Board commented that it “will address the propriety of the certain prior art
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`3 Ex. 1038 at 20. “[w]e affirm the Examiner’s rejections of : 1. Claims 1-24, 75,
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`78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 106, 111-132, 177, 178, 183, 186. 189,
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`192, and 193 under 35 U.S.C. § 112, as being indefinite.”
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`
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`6
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`
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`rejections maintained by the Examiner for the sake of administrative and judicial
`
`efficiency because we need not understand the exact scope of ‘substantially
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`uniform’ to resolve certain prior art rejections and/or can give a certain conditional
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`interpretation of ‘substantially uniform’ to resolve certain prior art rejections as is
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`readily apparent for the discussions below.” Ex. 1038 at 11.
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`To this end, the ‘588 Board found, inter alia, that claims 1-3, 5-8, 10, 11, 15,
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`17-24, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 106, 111-117, 119-121, 177,
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`178, 183, 186, and 189 were anticipated under 35 U.S.C. § 102(b) by, or in the
`
`alternative, obvious under 35 U.S.C. § 103(a) over Chen. Ex. 1038 at 20. In
`
`making this finding, the ‘588 Board concluded: “[W]e find that a weight deviation
`
`of ±0.001 [as disclosed by Chen] satisfies the limitation of ‘substantially uniform’
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`active content.” Ex. 1038 at 19. The ‘588 Board further found that “[t]his
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`amount is well within the less than 10% variation of active content per film
`
`unit requirement of claim 3.” Ex. 1038 at 19, emphasis added. In an
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`accompanying footnote in the ‘588 patent decision, the ‘588 Board expressly noted
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`that “[w]hile Patent Owner does not clearly argue the limitation of claim 3
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`separately from independent claims 1, 192, and 193, we note that Patent Owner
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`refers to claim 3 in distinguishing the scope over that of claim 1. App. Br. 23; Reb.
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`Br. 3.” Ex. 1038 at 19. Thus, there can be no dispute that the Patent Owner argued
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`
`
`7
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`
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`dependent claim 3 separately from the other claims and the ‘588 Board ruled on
`
`that separate argument. The Patent Owner did not appeal these findings.
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`B.
`
`The Board overlooked specific evidence in the ‘588 patent
`decision finding that Chen teaches a substantially identical
`process and inherently teaches the same product.
`The ‘588 Board also found that Chen inherently disclosed a film with a
`
`substantially uniform content of therapeutic active composition per unit of film
`
`reasoning that “Chen describes a substantially identical process to that described in
`
`the ‘588 patent.” Ex. 1038 at 15-16. The evidence relied upon by the ‘588 Board
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`was within the ‘588 patent specification itself. According to the ‘588 Board, the
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`“only process clearly distinguished by the ‘588 patent is ‘uncontrolled air currents,
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`either above or below the film’” which “‘can create non-uniformity in the final
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`film products.’” Ex. 1038 at 16.
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`The ‘588 Board found Chen to describe “a process in which a film is dried in
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`a ‘drying oven with aeration controller’ as illustrated in Figure 2.” Ex. 1038 at 17.
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`From the accompanying disclosure, the ‘588 Board there found that Chen taught
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`controlled drying and avoided air currents directed onto the top surface of a film.
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`Ex. 1038 at 17. Given the above, the ‘588 Board found that the drying process of
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`Chen was not sufficiently distinguished from the drying method of the ‘588 patent.
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`Ex. 1038 at 17. This finding is equally applicable to the challenged ‘514 patent
`
`
`
`8
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`
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`because the processes in the ‘588 patent and the ‘514 patent are substantially
`
`identical, and it was error to overlook this finding.
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`The ‘588 Board further found that Chen’s Table 4 described weight per
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`dosage film, thickness, density and water measurements with minimal deviation as
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`evidence that substantially uniform content of therapeutic active was inherent in
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`the films produced by the substantially identical methods described by Chen,
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`which was also found to be consistent with the additive test described in the ‘588
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`patent for determining uniformity. Ex. 1038 at 18. The ‘588 Board specifically
`
`referenced the following disclosure in the ‘588 patent: “when the components of
`
`different densities are combined in a uniform manner in a film, as in the present
`
`invention, individual dosages forms from the same film of substantially equal
`
`dimensions, will contain the same mass.” Ex. 1038 at 18. From this disclosure,
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`the ‘588 Board found that the “weight deviation of ±0.001 satisfies the limitation
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`of ‘substantially uniform’ active content.” Ex. 1038 at 19. However, as noted
`
`above, the ‘588 Board went even further and found that “[t]his amount is well
`
`within the less than 10% variation of active content per film unit requirement of
`
`claim 3.” Ex. 1038 at 19.
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`The disclosure in the ‘588 patent discussed above applies equally to the
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`challenged ‘514 patent. See Ex. 1001 at 42: 29-33. As a result, the Instant Board
`
`should have provided a similar finding in the challenged ‘514 patent as to
`
`
`
`9
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`
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`inherency because Chen’s process is substantially identical to the ‘588 patent as
`
`well as to the ‘514 challenged patent and a POSA can expect the same results, i.e.,
`
`a film including an active and meeting the 10% variation limitation. As for Patent
`
`Owner’s arguments that the claimed uniformity is not inherent (see PO Prelim.
`
`Resp. at 25-26), the Patent Owner relies entirely on various non-evidentiary IPR
`
`decisions that carry no evidentiary weight. See infra. Section V at 11-13.
`
`The Instant Board is further reminded that Chen also provided disclosure of
`
`a pharmaceutical film containing the active ingredient sildenafil. The thickness of
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`the individual dosages Chen made was 3.2 ±0.1, which is well within the claimed
`
`10% uniformity limitation. The density property (i.e., mass per unit volume) was
`
`also provided and did not include a standard deviation. Petition at 33-34.
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`Likewise, Bess (Ex. 1004) which was used in combination with Chen, also
`
`disclosed uniform films containing the active ingredient dextromethorphan. The
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`films were of similar dosage units having a thickness of 0.009 ±0002 inches and a
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`weight variance of 70 ±3 mg. Ex. 1004 at 12:64-13-9. As a percentage, the
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`disclosed weight variance translates to about 4%, which is markedly less than the
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`10% claimed uniformity limitation in the challenged ‘514 patent. Petition at 34.
`
`Petitioner’s expert, Dr. Celik, like the Board in the ‘588 patent decision,
`
`opined that the prior art process described in Chen was substantially identical to
`
`that described in the challenged ‘514 patent for a variety of reasons, e.g., Ex. 1003
`
`
`
`10
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`
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`at 35-36. From this, as well as a POSA’s understanding of the applicability of
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`Stoke’s Law, and Chen’s repeated emphasis on making sure that his formulations
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`were “uniform” and “homogenous” at every step of his manufacturing process, a
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`POSA would have understood that the entire point of Chen’s process was to make
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`films that were at least as uniform as the 10% limit. Ex. 1003 at 37.
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`Based on the foregoing, Petitioner’s argument that collateral estoppel will
`
`preclude re-argument is not misplaced. The Instant Board overlooked very
`
`specific evidence provided in the ‘588 patent decision, which resulted in
`
`misapprehending the applicability of the collateral estoppel issue. The same
`
`dispositive limitation identified by the Instant Board was decided in the ‘588
`
`patent decision as it relates to dependent claim 3 of the ‘588 patent, which, as
`
`noted above, is entirely consistent with Patent Owner’s previous arguments that
`
`the phrase “substantially uniform” meant “a film having a degree of uniformity of
`
`10 % from the FDA label amount for the active per dosage unit.” Moreover, the
`
`Instant Board has overlooked the ‘588 Board’s previous finding of inherency as it
`
`relates to Chen for the very same issue.
`
`V. THE BOARD MISAPPREHENDED THE EVIDENCE PROVIDED IN
`PATENT OWNER’S PRELIMINARY RESPONSE
`In its Decision, the Instant Board found that “Patent Owner asserts a number
`
`
`
`of reasons why Petitioner has not demonstrated a reasonable likelihood of
`
`establishing that a POSA would have found it obvious to combine the teachings of
`
`
`
`11
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`
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`Bess and Chen in a manner that yields the claimed invention” and that “[h]aving
`
`considered the arguments and the evidence, we agree with the Patent Owner.”
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`Inst. Dec. at 10.
`
`The arguments provided in Patent Owner’s Preliminary Response relied to a
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`great extent on findings provided in IPR2015-00165, IPR2015-00167, IPR2015-
`
`00168, and IPR2015-001694; none of which were formally entered as exhibits by
`
`the Petitioner or the Patent Owner. Thus, all arguments in reliance on these prior
`
`IPR proceedings should have carried no evidentiary weight in deciding this
`
`Petition (See 37 C.F.R. § 42.63(a)).
`
`For example, with regard to Patent Owner’s argument that Petitioner’s
`
`reliance on the weight data in Bess to demonstrate uniformity is misplaced, Patent
`
`Owner’s argued that “[a]s the Board already held in the ‘167 IPRs,5 the total
`
`weight of the entire composition cannot be used as a proxy for measuring the
`
`amount of active as required by the claims.” See, e.g., IPR2015-00165 Final
`
`Written Decision at 21 (“Consistent dosage unit weight of films is not the
`
`uniformity standard recited in claim 1 of the ‘167 patent. Rather claim 1 expressly
`
`requires a determination of the amount of active component.”); see also IPR2015-
`
`4 PO Prelim. Resp. at 2, 3, 11, 12, 15, 19, 25, 26, 28, 30, and 31.
`
`5 IPR 2015-00165, IPR2015-00168 and IPR2015-00169 are collectively referred to
`
`as “the ‘167 IPRs); PO Prelim. Resp. at 2.
`
`
`
`12
`
`
`
`0168 Final Written Decision at 17-18; IPR2015-00169 Final Written Decision at
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`23-24.” PO Prelim. Resp. at 12.
`
`With regard to the claimed uniformity being inherent in Chen, the Patent
`
`Owner’s argument relied entirely on the IPR proceedings not entered into
`
`evidence. See PO Prelim. Resp. at 25-26. Patent Owner prefaces its arguments by
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`first commenting that the ‘588 decision is immaterial on the basis that “the claims
`
`at issue in the reexamination do not include that the uniformity of an active “not
`
`vary by more than 10%.” PO Prelim. Resp. at 25-26. For reasons discussed
`
`above, the identical issue was decided in the ‘588 patent decision as it relates to
`
`prior art Chen’s dependent claim 3, which was also consistent with Patent Owner’s
`
`previous arguments that the phrase “substantially uniform” meant “a film having a
`
`degree of uniformity of 10 % from the FDA label amount for the active per dosage
`
`unit.” Ex.1038 at 10. (see infra. Section IV).
`
`Petitioner is also troubled by the Instant Board’s improper commentary that
`
`the findings in its Decision are consistent with the findings set forth in the district
`
`court decision (referring to Ex. 2009) addressing the disclosures of Chen and Bess
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`with respect to the ‘514 patent. See Inst. Dec. at 17; footnote 3. The district court
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`decision is not final until all pending appeals have been resolved and, as such,
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`provides no preclusive effect in these proceedings as to whether the Petitioner has
`
`
`
`13
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`
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`demonstrated a reasonable likelihood that it would prevail or not in showing
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`unpatentability of at least one of the challenged claims.6
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`VI. CONCLUSION
`
`The Instant Board has misapprehended the collateral estoppel issue and
`
`overlooked specific evidence in support thereof provided by the Petitioner and its
`
`expert. Moreover, the Instant Board misapprehended Patent Owner’s arguments
`
`and its extensive reliance on improper evidence to deny trial institution. Petitioner
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`respectfully requests that the Instant Board grant this request for rehearing and
`
`institute trial on Petitioner’s Petition.
`
`
`
`
`6 See S.A.P. Am., Inc. v. Versata Dev. Grp., Inc., CBM2012-00001, Paper No. 36 at
`
`19-20 (PTAB January 9, 2013) (rejecting collateral estoppel argument raised by
`
`patent owner based on district court’s finding of validity that was pending on
`
`appeal); Interthinx, Inc. v. Corelogic Solutions, LLC, CBM2012-00007, Paper No.
`
`15 at 10 (PTAB January 31, 2013) (same but no appeal taken yet). MPEP § 2659
`
`(“Claims finally held invalid by a Federal Court, after all appeals, will be
`
`withdrawn from consideration and not reexamined during a reexamination
`
`proceeding.” (emphasis added)); id. § 2286 (“A final holding of claim invalidity or
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`unenforceability (after all appeals)[] . . . is controlling on the Office.” (emphasis
`
`added)).
`
`
`
`14
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`
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`Respectfully submitted,
`
`
`
`
`
`/s/ Jeffery B. Arnold
`Jeffery B. Arnold
`USPTO Reg. No. 39,540
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607 9981
`jarnold@cantorcolburn.com
`
`Lead Counsel for Petitioners
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
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`Dated: January 3, 2017
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`15
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that on January 3, 2017, a true and correct copy of
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`the foregoing REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d) was
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`served pursuant to 37 C.F.R. § 42.6(e) on attorneys of record for the Patent Owner
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`by filing this document through the Patent Trial and Appeal Board End to End
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`(PTAB E2E) system and delivering a copy via electronic mail as follows:
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`Harold H. Fox
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036-1795
`hfox@steptoe.com
`150IPR@steptoe.com
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`John L. Abramic
`STEPTOE & JOHNSON LLP
`115 South LaSalle Street, Suite 3100
`Chicago, IL 60603
`jabramic@steptoe.com
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`Counsel for MonoSol Rx, LLC
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`Dated: January 3, 2017
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`/s/ Jeffery B. Arnold
`Jeffery B. Arnold
`USPTO Reg. No. 39,540
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`Lead Counsel for Petitioners
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
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