UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS; and ERICH SPANGENBERG,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`____________________________________________
`
`Case: IPR2015-01993
`U.S. Patent No. 8,399,514
`____________________________________________
`
`BIOGEN’S REPLY IN SUPPORT OF ITS MOTION TO ANTEDATE
`
`
`
`
`
`
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS; and ERICH SPANGENBERG,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`____________________________________________
`
`Case: IPR2015-01993
`U.S. Patent No. 8,399,514
`____________________________________________
`
`BIOGEN’S REPLY IN SUPPORT OF ITS MOTION TO ANTEDATE
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Case: IPR2015-01993
`Patent No. 8,399,514
`
`
`I.
`
`II.
`
`
`Introduction ...................................................................................................... 1
`
`The Provisional Application Provides Written-Description Support for
`the ’514 Patent Claims ..................................................................................... 1
`
`III. The Provisional Application Enables the ’514 Patent Claims ........................ 5
`
`IV. Petitioner Does Not Challenge Biogen’s Evidence of Conception ................. 7
`
`V.
`
`Biogen Was Diligent Throughout the Critical Period ..................................... 7
`
`A.
`
`B.
`
`C.
`
`There Was No Gap in Biogen’s Diligence ............................................ 8
`
`Biogen’s Evidence of Diligence Is Specific and Thorough ................10
`
`Biogen’s Animal Studies Constitute Diligence ..................................11
`
`VI. Conclusion .....................................................................................................12
`
`
`
`
`
`i
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`
`
`
`TABLE OF AUTHORITIES
`
`Case: IPR2015-01993
`Patent No. 8,399,514
`
`
` Page(s)
`
`Cases
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ............................................................ 3
`
`In re Brana,
`51 F.3d 1560 (Fed. Cir. 1995) ............................................................................ 11
`
`Brown v. Barbacid,
`436 F.3d 1376 (Fed. Cir. 2006) .......................................................................... 12
`
`Cottrell v. Shafer,
`97 F.2d 121 (C.C.P.A. 1938) ............................................................................... 9
`
`In re Hartop,
`311 F.2d 249 (C.C.P.A. 1962) ............................................................................ 12
`
`Hunter v. Beissbarth,
`230 U.S.P.Q. 365 (B.P.A.I. 1986) ................................................................ 10, 11
`
`Hybritech Inc. v. Monoclonal Antibodies, Inc.,
`802 F.2d 1367 (Fed. Cir. 1986) ............................................................................ 6
`
`In re Jolley,
`308 F.3d 1317 (Fed. Cir. 2002) .......................................................................... 12
`
`In re Krimmel,
`292 F.2d 948 (C.C.P.A. 1961) ............................................................................ 12
`
`Moore v. Harris,
`92 U.S.P.Q. 187 (Bd. Pat. Int. 1951) .................................................................... 9
`
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) .............................................................................. 4
`
`Scott v. Koyama,
`281 F.3d 1243 (Fed. Cir. 2002) .................................................................. 8-9, 12
`
`ii
`
`
`
`
`Streck, Inc. v. Research & Diagnostic Sys., Inc.,
`665 F.3d 1269 (Fed. Cir. 2012) ........................................................................ 2-3
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`Case: IPR2015-01993
`Patent No. 8,399,514
`
`
`TRW Auto. US LLC v. Magna Elecs., Inc.,
`IPR2014-00258, Paper 18 (PTAB Aug. 27, 2014) ............................................... 2
`
`Vogt v. Neuschotz,
`154 U.S.P.Q. 376 (B.P.A.I. 1966) .................................................................. 8, 11
`
`Regulations
`
`37 C.F.R. § 42.65(a) ................................................................................................... 2
`
`
`
`
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`iii
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`Case No. IPR2015-01993
`Patent 8,399,514
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`I.
`
`Introduction
`
`Petitioner’s reply to Biogen’s Motion to Antedate rests on incorrect legal
`
`standards and thinly supported rebuttal testimony. The Board should conclude that
`
`Biogen is entitled to its priority date and has antedated Kappos 2006.
`
`II. The Provisional Application Provides Written-Description Support for
`the ’514 Patent Claims
`
`Beginning in its first paragraph, the ’921 provisional application states
`
`unequivocally that the invention relates in part to the “use of therapeutic
`
`compounds . . . for treating neurological diseases, including . . . multiple sclerosis.”
`
`(Ex. 1012 at ¶ [0001]; Ex. 2046 ¶ 29; Ex. 2384 at 103:25-104:16, 105:2-5.) The
`
`application further states that fumaric acid derivatives have been proposed for the
`
`treatment of MS and that, in some embodiments, the inventive treatment method
`
`involves administering a therapeutically effective amount of “a fumaric acid
`
`derivative (e.g., DMF or MMF).” (Ex. 1012 at ¶¶ [0020], [0031], [0066].) The
`
`application then discloses that “an effective dose of DMF or MMR [sic, MMF] to
`
`be administered to a subject orally can be . . . from about 480 mg to about 720 mg
`
`per day.” (Id. at ¶ [0116].) Dr. Wynn, an MS clinician with decades of experience,
`
`explains in his declaration why these and other disclosures in the provisional
`
`application provide written-description support for the claimed subject matter
`
`relating to a method of treating MS with a dose of about 480 mg/day of DMF,
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`Patent 8,399,514
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`MMF, or a combination thereof. (Ex. 2046 ¶¶ 27-45.)
`
`In response to this evidence, Petitioner submits a declaration of Dr. Samuel
`
`Pleasure, a clinician who sees MS patients only on a part-time basis (five to six
`
`hours per week). (Ex. 2384 at 36:14-18.) After acknowledging that the ’514 patent
`
`focuses on MS, Dr. Pleasure cursorily concludes that paragraph [0116] of the ’921
`
`provisional application does not provide written-description support for the claims.
`
`(Ex. 1045 ¶ 57.) He states that, if anything, a dose of 720 mg/day is called out, but
`
`he never addresses why 480 mg/day is also not called out. (Id.)
`
`The Board should give no weight to Dr. Pleasure’s testimony for at least
`
`three reasons. First, his analysis is wholly conclusory and unsupported. (Ex. 1045
`
`¶¶ 57-58); TRW Auto. US LLC v. Magna Elecs., Inc., IPR2014-00258, Paper 18 at
`
`10-11 (PTAB Aug. 27, 2014) (giving little weight to expert declaration that simply
`
`repeated petitioner’s conclusory statements); 37 C.F.R. § 42.65(a). Second, Dr.
`
`Pleasure does not address (or even mention) Dr. Wynn’s expert testimony,
`
`undercutting the value of Dr. Pleasure’s opinions as purported “rebuttal”
`
`testimony. Third, Dr. Pleasure bases his opinions on his incorrect assumption that
`
`written description requires that an inventor “had made” (i.e., reduced to practice)
`
`the claimed invention. (Ex. 1045 ¶¶ 44, 49 (twice referring to purported “had
`
`made” standard for written description); Ex. 2384 at 102:8-103:7.) His analysis is
`
`therefore flawed as a matter of law. See, e.g., Streck, Inc. v. Research & Diagnostic
`
`2
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`Patent 8,399,514
`Sys., Inc., 665 F.3d 1269, 1285-86 (Fed. Cir. 2012); Ariad Pharm., Inc. v. Eli Lilly
`
`& Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc) (written description does
`
`not require either examples or an actual reduction to practice).
`
`In Streck, for example, the claims encompassed an integrated reticulocyte
`
`control using either true (natural) reticulocytes or reticulocyte analogs. 665 F.3d at
`
`1275. The patent challenger alleged that an integrated control using true
`
`reticulocytes was not supported because, inter alia, the patent owner had never
`
`attempted to make such a control. Id. at 1286. The district court rejected this
`
`argument on summary judgment, and the Federal Circuit affirmed. Id. at 1287.
`
`Pointing to disclosures in the specification, the Court held that the claims had
`
`adequate written-description support, rejecting the assertion that the patentee had
`
`to show an actual reduction to practice. Id. at 1286. Dr. Pleasure’s similar assertion
`
`here that the provisional application fails to show that the inventors “had made” the
`
`claimed invention is legally irrelevant. See id. The Board should therefore
`
`disregard his testimony and reject Petitioner’s arguments as unsupported. (Paper 45
`
`at 2.)
`
`Petitioner’s remaining written-description arguments are also irrelevant and
`
`unsupported. Petitioner asserts, for example, that a dose of about 480 mg/day “is
`
`only mentioned once, never by itself.” (Paper 45 at 2.) But § 112 does not require
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`that the specification describe a claim limitation more than once or by itself.
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`Once again relying on Dr. Pleasure’s conclusory analysis, Petitioner also
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`contends that the provisional application “blazes a trail” to a dose of about 720
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`mg/day, not to about 480 mg/day. (Paper 45 at 2.) However, this ignores that the
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`‘921 provisional application discloses about 480 mg/day as the lowest endpoint of
`
`the narrowest range. (Ex. 1012 at ¶ [0116]; Ex. 2046 ¶ 37.) But even if, assuming
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`arguendo, the application suggests that a dose of about 720 mg/day is most
`
`preferred, that fact does not detract from the legally adequate disclosure of a dose
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`of about 480 mg/day of DMF or MMF. Biogen was not required to disclose only
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`one effective dose. Indeed, Biogen’s Phase 3 studies subsequently proved that both
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`480 mg/day and 720 mg/day of DMF are therapeutically effective in treating MS.
`
`(Ex. 2044 at ¶¶ 43-48.)
`
`Petitioner’s “blaze marks” position derives from In re Ruschig, 379 F.2d
`
`990, 995 (C.C.P.A. 1967), which is easily distinguished. There, the applicant
`
`claimed a compound “never named or otherwise exemplified in the specification”
`
`that could be produced only if choices were made among several variables. 379
`
`F.2d at 992-93. Although recognizing that one could “imagine” the claimed
`
`compound among the half-million members of the genus, the Court concluded that
`
`too many variables would have to be combined without any guiding “blaze marks”
`
`to establish that the applicant possessed it. Id. at 995. That is not true here. One of
`
`ordinary skill reading the provisional application need not “imagine” an effective
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`dose of about 480 mg/day of DMF or MMF (or sort through a half-million possible
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`doses), as a dose of about 480 mg/day of DMF or MMF is expressly disclosed.
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`(Ex. 1011 ¶ [0116]; Ex. 1012 ¶ [0116]; Ex. 2382 ¶ [0116]; Ex. 2383 ¶ [0116]; Ex.
`
`2046 ¶¶ 35-38; Ex. 1050 at 80:22-83:7; Ex. 2384 at 119:15-18.)
`
`Concerning the dependent claims directed to divided doses, Petitioner states
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`that entitlement to a filing date does not extend to subject matter that would be
`
`obvious from the disclosure. (Paper 45 at 3.) This argument fails to address Dr.
`
`Wynn’s opinion that the provisional application discloses administering about 480
`
`mg/day in 2, 3, 4, or 6 equal doses. (Ex. 2046 ¶ 42.) As Dr. Wynn testified during
`
`his deposition, one of ordinary skill would “readily understand” that the
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`application’s disclosure concerning divided doses applies equally “regardless of
`
`what the total daily dose was.” (Ex. 1050 at 100:7-101:15.) Thus, he explained
`
`how one skilled in the art would interpret the specification, without resorting to an
`
`obviousness standard.
`
`III. The Provisional Application Enables the ’514 Patent Claims
`Petitioner argues that undue experimentation would have been required to
`
`practice the claimed invention. (Paper 45 at 3-4.) That is incorrect. The provisional
`
`application instructs one to treat an MS patient with a dose of about 480 mg/day of
`
`DMF, MMF, or a combination thereof. Petitioner does not dispute that
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`administering a dose of about 480 mg/day of DMF to an MS patient would in fact
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`effectively treat the patient without any experimentation or modification to that
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`treatment protocol. Nothing more is required for enablement. Tellingly, Petitioner
`
`fails to identify what “experimentation” allegedly would have been required.
`
`Petitioner asserts that the provisional application’s working examples show
`
`only that DMF and MMF activate the Nrf2 pathway in vitro in human cancer cells.
`
`(Paper 45 at 3-4.) Petitioner points out that the application does not include an
`
`example of any testing “in any MS model system, let alone in an MS patient.” (Id.
`
`at 4.) But Petitioner’s reliance on the absence of in vivo testing ignores the state of
`
`the art. Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed.
`
`Cir. 1986) (a patent preferably omits what is well known). When the ’921
`
`provisional application was filed, Biogen had already carried out a Phase 2 study in
`
`patients with RRMS, demonstrating proof of concept. (Ex. 2046 ¶ 51.) Thus,
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`DMF’s potential utility in human MS patients had been established, albeit not with
`
`a daily dose of 480 mg/day.
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`Petitioner asserts that Dr. Wynn’s testimony regarding the complexity of the
`
`field supports non-enablement. (See Paper 45 at 3.) It does not. Dr. Wynn was not
`
`addressing the use of DMF to treat MS; he was discussing the applicability of a
`
`particular mouse model used for developing MS drugs generally. (Ex. 1050 at
`
`66:6-24.) Again, because the relevant art had progressed beyond in vitro—and
`
`even MS mouse model—testing, the fact that the ’921 provisional application does
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`not include such data is irrelevant.
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`Petitioner also claims that Dr. Wynn “admitted” that it is unpredictable
`
`whether a therapeutically effective treatment for one type of MS would also
`
`effectively treat another type of MS, such as PPMS. (Paper 45 at 4.) But he made
`
`no such admission. (Ex. 1050 at 63:14-64:1.) Moreover, Petitioner cites no
`
`testimony from Dr. Pleasure (or any other evidence) that administering about 480
`
`mg/day of DMF would not effectively treat all relapsing forms of MS. (See also
`
`Ex. 1066 at 2 (Tecfidera® is approved to treat relapsing forms of MS).) Thus, the
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`Board should reject Petitioner’s unsupported non-enablement argument.
`
`IV. Petitioner Does Not Challenge Biogen’s Evidence of Conception
`Petitioner does not dispute that Dr. O’Neill conceived the claimed invention
`
`by February 2004. (Paper 45 at 6; Paper 40 at 2-6.) Notably, Petitioner chose not to
`
`cross-examine Drs. Dawson or Bozic, who corroborated Dr. O’Neill’s conception.
`
`V. Biogen Was Diligent Throughout the Critical Period
`Petitioner now asserts that the critical period runs from just before May 30,
`
`2006, to February 8, 2007. (Paper 45 at 6.) But Petitioner previously asserted that
`
`Kappos 2006 was publicly available no later than July 1, 2006. (Ex. 1020 at 3.)
`
`Petitioner offers no evidence that Kappos 2006 was publicly available before then.
`
`Biogen was nonetheless diligent from May 2006.
`
`Petitioner does not dispute that on each day of the critical period, Biogen
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`engaged in two categories of overlapping activities: (1) nonclinical animal studies,
`
`and (2) advancing clinical development toward Phase 3 trials. (Paper 45 at 5-12.)
`
`Instead, Petitioner incorrectly asserts that these activities should not be credited
`
`toward diligence. (Id.)
`
`A. There Was No Gap in Biogen’s Diligence
`Despite conceding that documentary evidence shows that Biogen was taking
`
`steps to include a 480 mg/day dosing arm in Phase 3 studies, Petitioner asserts a
`
`four-month gap in diligence between May and September 2006. (Paper 45 at 6-10.)
`
`That is simply incorrect.
`
`Petitioner does not dispute that every day between early May 2006 and
`
`September 2006, Biogen carried out tasks to advance toward Phase 3 trials. (Paper
`
`40 at 12-25.) Petitioner asserts, however, that Biogen’s efforts were preliminary,
`
`regulatory in nature, and had no bearing on reducing Dr. O’Neill’s invention to
`
`practice. (Paper 45 at 6-10.) Yet Biogen’s regulatory efforts and reduction to
`
`practice went hand-in-hand. Before administering the inventive 480 mg/day dose
`
`to MS patients in Phase 3 trials, Biogen had to comply with all regulatory
`
`prerequisites. (Paper 40 at 12-13); see Vogt v. Neuschotz, 154 U.S.P.Q. 376, 378
`
`(B.P.A.I. 1966) (working to comply with governmental agencies’ rules and
`
`demands qualifies as diligence toward reduction to practice); Scott v. Koyama, 281
`
`F.3d 1243, 1248 (Fed. Cir. 2002) (“[E]fforts toward actual reduction to practice are
`
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`relevant to diligence until constructive reduction to practice.”).
`
`Petitioner quotes from Moore v. Harris, 92 U.S.P.Q. 187 (Bd. Pat. Int. 1951)
`
`and Cottrell v. Shafer, 97 F.2d 121 (C.C.P.A. 1938), but the facts of those cases are
`
`readily distinguished. In Moore, the senior party to the interference was unable to
`
`prove diligence because he was only preparing a cost estimate during the relevant
`
`time. 92 U.S.P.Q. at 189. In Cottrell, simply keeping a sketch of the patented
`
`features of trucks used on railway cars under consideration while testing different
`
`devices in different trucks was insufficient to show diligence. 97 F.2d at 121.
`
`Unlike those cases, Biogen carried out extensive daily tasks that were prerequisites
`
`to conducting Phase 3 clinical trials.
`
`From May 2006 through the start of its Phase 3 trials in March 2007, Biogen
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`worked with the FDA and foreign agencies on the most critical issues for Phase 3
`
`design, including the proposed maximum dose to be tested. (See, e.g., Paper 40 at
`
`15-25; Ex. 1052 at 141:1-16; Ex. 1055 at 75:22-76:2.)1 Because the team
`
`determined that 720 mg/day was the highest dose that it wanted to test, the early
`
`draft Phase 3 protocol concepts mentioned only that maximum dose. (See, e.g.,
`
`Paper 40 at 18-19; Ex. 1052 at 141:1-16.)
`
`Nevertheless, months before formally including the 480 mg/day dose in its
`
`1 Biogen withdraws any reliance on Ex. 2339.
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`Phase 3 clinical trial design, Biogen performed design calculations to include 480
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`mg/day in Phase 3. (See, e.g., Paper 40 at 18-19; Ex. 1052 at 73:5-74:6, 107:21-12,
`
`118:7-24.) Soon after Biogen and the FDA agreed at the EOP2 meeting on, among
`
`other critical issues, Biogen’s proposed maximum dose of 720 mg/day, Biogen
`
`formally included the 480 mg/day dose in the Phase 3 design. (See, e.g., Paper 40
`
`at 20-21.) Indeed, Petitioner concedes that as of September 6, 2006, a few weeks
`
`after the EOP2 meeting, Biogen had added 480 mg/day to its Phase 3 design.
`
`(Paper 45 at 7-8; Paper 40 at 21.)
`
`If Petitioner is suggesting that Biogen should have tested 480 mg/day in
`
`Phase 2 (Paper 45 at 8), that argument is misplaced. The relevant diligence period
`
`runs from just before May 30, 2006, until February 8, 2007. Biogen concluded its
`
`Phase 2 trials well before that diligence period; thus, its earlier decisions regarding
`
`Phase 2 studies have no bearing on diligence.
`
`Biogen’s Evidence of Diligence Is Specific and Thorough
`B.
`Relying on Hunter v. Beissbarth, 230 U.S.P.Q. 365, 368 (B.P.A.I. 1986),
`
`Petitioner asserts that Biogen provides little specificity as to dates and facts
`
`regarding its Phase 3 development efforts. (Paper 45 at 9.) This is not so, and
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`Hunter is inapposite. In that case, only two days of activity were corroborated
`
`during the two-month diligence period, and the proffering party failed to submit
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`relevant testimony, raising an inference that the testimony would be unfavorable.
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`10
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`Hunter, 230 U.S.P.Q. at 368. In contrast, Biogen submitted over 120 exhibits from
`
`the relevant period. (See, e.g., Exs. 2076-2080, 2082-2083, 2085-2087, 2090,
`
`2092, 2096-2381.) Biogen also submitted the testimony of five witnesses to prove
`
`diligence, two of whom Petitioner did not depose. (Exs. 2077-2078.) And Biogen’s
`
`daily diligence chart included over 250 daily entries. (Ex. 2051.) Petitioner fails to
`
`address that evidence.
`
`C. Biogen’s Animal Studies Constitute Diligence
`Despite admitting that preclinical animal studies are the “rate-limiting” step
`
`in the FDA-approval process and that Biogen’s animal studies were required by the
`
`FDA, Petitioner asserts that those studies cannot support diligence. (Paper 45 at 10;
`
`Paper 40 at 13-15.) Petitioner is wrong.
`
`In Vogt, the Board found that meeting a government sponsor’s needs was
`
`necessary because the invention could not have been reduced to practice without
`
`the sponsor’s facilities. 154 U.S.P.Q at 378. Similarly, Biogen could not reduce Dr.
`
`O’Neill’s invention to practice without human testing. The FDA regulates that
`
`testing and requires animal testing, as Petitioner admits. (Paper 45 at 10.) Thus,
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`under Vogt, Biogen’s animal studies—which allowed Biogen to reduce the
`
`invention to practice in Phase 3 trials—qualify as reasonable diligence.
`
`Petitioner’s cited cases are inapplicable as they concern utility, not diligence.
`
`In re Brana, 51 F.3d 1560, 1568 (Fed. Cir. 1995) (utility of antitumor compound);
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`11
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`In re Krimmel, 292 F.2d 948, 954 (C.C.P.A. 1961) (utility of compound for
`
`treating iris inflammation); In re Hartop, 311 F.2d 249, 257 (C.C.P.A. 1962)
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`(utility of solution having anesthetic or hypnotic properties).
`
`Petitioner also asserts that the animal studies did not test the effectiveness of
`
`480 mg/day of DMF for treating MS. (Paper 45 at 10-11.) Those FDA-required
`
`studies, however, were “a reasonable course” within an overall drug-development
`
`program that permitted Biogen to practice the invention in Phase 3 trials. Activities
`
`demonstrating reasonable diligence may take a “diversity of forms” and include
`
`efforts toward actual reduction to practice until constructive reduction to practice.
`
`Scott, 281 F.3d at 1248; In re Jolley, 308 F.3d 1317, 1327 (Fed. Cir. 2002); see
`
`also Brown v. Barbacid, 436 F.3d 1376, 1380 (Fed. Cir. 2006) (no rule requires a
`
`specific kind of activity in determining reasonable diligence).
`
`VI. Conclusion
`Biogen respectfully requests that the Board grant its Motion to Antedate.
`
`Dated: October 21, 2016
`
`Respectfully submitted,
`
`By: /Michael J. Flibbert/
`
`
`Michael J. Flibbert, Reg. No. 33,234
`Maureen D. Queler, Reg. No. 61,879
`Erin M. Sommers, Reg. No. 60,974
`
`Counsel for Patent Owner in
`IPR2015-01993
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing BIOGEN’S REPLY
`
`IN SUPPORT OF ITS MOTION TO ANTEDATE was served electronically via
`
`e-mail on October 21, 2016, in its entirety on the following:
`
`James T. Carmichael
`Carol A. Spiegel
`Carmichael IP, PLLC
`8000 Towers Crescent Drive, 13th Floor
`Tysons Corner, VA 22182
`jim@carmichaelip.com
`carol@carmichaelip.com
`
`Petitioner has agreed to electronic service.
`
`By: / Maureen D. Queler /
`Maureen D. Queler
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`Dated: October 21, 2016
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