Paper No. ________
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`MYLAN TECHNOLOGIES, INC.
`Petitioner,
`
`v.
`
`NOVEN PHARMACEUTICALS, INC.
`Patent Owner.
`
`
`U.S. Patent No. 9,730,900
`
`Title: TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`_______________
`
`Inter Partes Review No. IPR2018-00174
`____________________________________________________________
`
`
`PATENT OWNER OPPOSITION TO REQUEST FOR REHEARING
`
`

`

`IPR2018-00174
`Patent Owner Opposition to Request for Rehearing
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`
`Legal Standards ............................................................................................... 2
`
`
`
`I.
`
`II.
`
`III.
`
`Petitioner Impermissibly Introduces New Evidence Not of Record ............... 4
`
`IV. Petitioner Impermissibly Relies On New Arguments Not In The Petition ..... 5
`A.
`Petitioner’s New Arguments Regarding Mueller Figure 3
`Should Not Be Considered .................................................................... 5
`Petitioner’s New Arguments Regarding Chien Figure 5 Should Not
`Be Considered ....................................................................................... 7
`
`B.
`
`V.
`
`Petitioner’s Unsupported Assertions Regarding Chien Do Not Create
`A Genuine Issue Of Material Fact ................................................................... 8
`
`VI. Petitioner Has Not Shown Any Abuse Of Discretion In The Board’s
`Treatment Of Mueller or Chien ..................................................................... 11
`
`VII. Petitioner Attempts An Unauthorized Reply ................................................. 13
`
`VIII. Conclusion ..................................................................................................... 14
`
`
`
`
`
`
`i
`
`

`

`
`
`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375
`(Fed. Cir. 2015) ..................................................................................................6, 9
`
`PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840 F.2d 1565
`(Fed. Cir. 1988) ...................................................................................................... 2
`
`Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089 (Fed. Cir. 1997) ...................... 9
`
`Statutes
`35 U.S.C. § 314(a) ...............................................................................................6, 9
`
`Rules and Regulations
`37 C.F.R. § 42.71 (d) ...................................................................................... 2, 6, 7
`
`37 C.F.R. § 42.108(c) ............................................................................................ 10
`
`37 C.F.R. § 42.61(c) ......................................................................................... 8, 10
`
`37 C.F.R. § 42.65(a) ................................................................................................ 9
`
`37 C.F.R. § 42.71(c) ................................................................................................ 2
`
`Office Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012) ................ 3, 4, 9
`
`Inter Partes Reviews
`
`Apple, Inc., v. Contentguard Holdings, Inc., IPR2015-00358, Paper 9
`(PTAB, July 2, 2015) ................................................................................................. 8
`
`Captioncall, LLC v. Ultratec, Inc., IPR2014-00780, Paper 40
`(PTAB, May 19, 2016) .......................................................................................3, 7
`
`Int’l Bus. Machines Corp. v. Electronics and Telecomm. Research Inst.,
`IPR2014-00976, Paper 16 (PTAB, Feb. 24, 2016) ................................................ 3
`
`MasterCard Int’l Inc. v. Grecia, IPR2017-00793, Paper 7 (PTAB, July 3, 2017) ... 8
`
`ii
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`Nestlé Purina Petcare Co. v. Oil-Dri Corp. of Amer., IPR2015-00737,
`Paper 39 (PTAB, Feb. 9, 2017) ............................................................................ 14
`
`Power Integrations, Inc., v. Semiconductor Components Indus, LLC,
`IPR2017-01975, Paper 11 (PTAB, April 30, 2018) ...................................... 2, 4, 5
`
`Sandoz, Inc., v. Abbvie Biotech. Ltd., IPR2017-01824, Paper 16
`(PTAB, May 3, 2018) ........................................................................................... 17
`
`Subaru of Am., Inc. v. Blitzsafe Texas LLC, IPR2018-00090, Paper 15
`(PTAB, April 20, 2018) ........................................................................................ 12
`
`Telit Wireless Solutions Inc. v. M2M Solutions LLC, IPR2016-00055, Paper 13
`(PTAB, May 24, 2016) ........................................................................................... 9
`
`United Microelectronics Corp., v. Lone Star Silicon Innovations LLC.,
`IPR2017-01513, Paper 10 (PTAB, May 22, 2018) ..................................... 4, 6, 10
`
`Wright Med. Tech., Inc. v. Biomed. Enter., Inc., IPR2015-00786, Paper 40
`(PTAB, May 26, 2016) .................................................................................... 4, 16
`
`
`
`
`iii
`
`

`

`IPR2018-00174
`Patent Owner Opposition to Request for Rehearing
`
`
`I.
`
`Introduction
`
`Patent Owner opposes the Request for Rehearing (“Request”) filed July 12,
`
`2018, by Petitioner, Mylan Technologies, Inc., as improperly presenting new
`
`evidence, raising new arguments, and failing to establish that the Board abused its
`
`discretion in denying institution of Inter Partes Review. This Opposition was
`
`authorized in the Board’s July 16, 2018, email and is timely filed by July 23, 2018.
`
`For the reasons set forth herein, Petitioner’s Request should be denied.
`
`Petitioner mischaracterizes the Decision Denying Institution (Paper 8;
`
`hereafter “Decision”) as resting on a few findings Petitioner disagrees with, and
`
`attempts to use the Request as a vehicle to introduce new evidence and raise new
`
`arguments. For example, Petitioner now argues that the deficiencies in Figure 3 of
`
`Mueller (EX1005) are “immaterial.” Request at 1, 6-11. Yet, the Petition did not
`
`even acknowledge the deficiencies existed, let alone present evidence and
`
`arguments that they somehow are “immaterial.” Nor did Petitioner seek permission
`
`to address the deficiencies of Mueller Figure 3 in a Reply. Cf. Request at 5. Even
`
`more egregious is Petitioner’s presentation of new purported evidence in the
`
`Request, including (i) a new marked-up version of Mueller Figure 3 (Request at 7),
`
`(ii) an image of what is alleged to be the corresponding figure of the German
`
`application from which Mueller claims priority (Request at 9), and (iii) Dr. Brain’s
`
`testimony submitted in later-filed IPR2018-01119 (Request at 8-9). Petitioner’s
`
`1
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`arguments regarding Chien (EX1009) amount to no more than a disagreement with
`
`the Board’s refusal to credit unsupported assertions as to the subject matter of
`
`Chien Figure 5 (Request at 2-3, 11-15). Petitioner erroneously asserts that the
`
`absence of evidence on a point on which it bears the burden of proof creates a
`
`genuine issue of material fact to be resolved in its favor (id.).
`
`Since the Request does not show that the Board abused its discretion in
`
`denying institution, it should be denied.
`
`II. Legal Standards
`
`Petitioner bears the heavy burden of showing that the Board abused its
`
`discretion in denying institution. See 37 C.F.R. § 42.71(c), (d). “An abuse of
`
`discretion occurs when a ‘decision was based on an erroneous conclusion of law or
`
`clearly erroneous factual findings, or . . . a clear error of judgment.’” Power
`
`Integrations, Inc., v. Semiconductor Components Indus., LLC, IPR2017-01975,
`
`Paper 11 at 3 (PTAB, April 30, 2018) (quoting PPG Indus. Inc. v. Celanese
`
`Polymer Specialties Co. Inc., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations
`
`omitted)).
`
`A proper request for rehearing must “specifically identify all matters
`
`Petitioner believes the Board misapprehended or overlooked, and the place where
`
`each matter was previously addressed in the Petition.” 37 C.F.R. § 42.71(d). Rather
`
`than merely disputing findings Petitioner disagrees with, Petitioner “must cite
`
`2
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`where the argument or evidence allegedly overlooked or misapprehended was
`
`previously discussed in one of the parties’ papers.” Captioncall, LLC v. Ultratec,
`
`Inc., IPR2014-00780, Paper 40 at 2-3 (PTAB, May 19, 2016) (emphasis in
`
`original). The Board’s rules and decisions hold that “disagreements with the
`
`Board’s conclusions are not a basis for alleging that the Board misapprehended or
`
`overlooked the arguments and evidence presented.” Int’l Bus. Machines Corp. v.
`
`Electronics and Telecomm. Research Inst., IPR2014-00976, Paper 16 at 4 (PTAB,
`
`Feb. 24, 2016); see also Wright Med. Tech., Inc. v. Biomed. Enter., Inc., IPR2015-
`
`00786, Paper 40 at 4 (PTAB, May 26, 2016).
`
` “Evidence not already of record at the time of the decision will not be
`
`admitted absent a showing of good cause.” Office Trial Practice Guide, 77 Fed.
`
`Reg. 48756, 48768 (Aug. 14, 2012). Indeed, “[a] request for rehearing is not an
`
`opportunity for the requestor to present new arguments or evidence.” Power
`
`Integrations, Paper 11 at 5; see also United Microelectronics Corp., v. Lone Star
`
`Silicon Innovations LLC., IPR2017-01513, Paper 10 at 11–12 (PTAB, May 22,
`
`2018). This is important because “it goes without saying that [the Board] could not
`
`have misapprehended or overlooked new evidence that was not of record … or
`
`new arguments that were not previously presented regarding that new evidence.”
`
`Power Integrations, Paper 11 at 5.
`
`3
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`III. Petitioner Impermissibly Introduces New Evidence Not of Record
`
`Petitioner’s Request impermissibly introduces, cites to, and relies on new
`
`purported evidence that is not of record in this proceeding. Citing new evidence
`
`that is not of record in a request for rehearing is unequivocally improper because
`
`the Board “could not have misapprehended or overlooked new evidence that was
`
`not of record.” Power Integrations, Paper 11 at 5; see also Office Trial Practice
`
`Guide, 77 Fed. Reg. at 48768.
`
`Petitioner’s Request presents at least three new items of purported evidence,
`
`including:
`
`(i) a new marked-up version of Mueller Figure 3 (Request at 7);
`
`(ii) an image of what is alleged to be the corresponding figure
`
`of the German application from which Mueller claims priority
`
`(Request at 9); and
`
`(iii) Dr. Brain’s testimony submitted in later-filed
`
`IPR2018-01119 (Request at 8-9).
`
`Petitioner did not alert the Board that this purported evidence is not of record. Nor
`
`did Petitioner make any attempt to seek admission of this new evidence, let alone
`
`show good cause why it should be admitted at this stage of the proceedings. Cf.
`
`Office Trial Practice Guide, 77 Fed. Reg. at 48768 (“Evidence not already of
`
`record at the time of the decision will not be admitted absent a showing of good
`
`4
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`cause.”). Thus, the purported new evidence and arguments citing to it (appearing at
`
`least at pages 7-9 of the Request) should not be considered. Moreover, Petitioner’s
`
`arguments citing to and relying on the purported new evidence cannot be proper
`
`grounds for granting rehearing because they do not relate to evidence or arguments
`
`the Board could have overlooked or misapprehended.
`
`IV. Petitioner Impermissibly Relies On New Arguments Not In The Petition
`
`The Board has repeatedly held that “[a] request for rehearing is not an
`
`opportunity to present new arguments,” and “[i]t would be manifestly unfair to
`
`Patent Owner for [the Board] to entertain those new arguments at this late
`
`juncture.” United Microelectronics Corp., Paper 10 at 11–12. Accordingly,
`
`Petitioner’s new arguments, which pervade its Request, should not be considered.
`
`A.
`
`Petitioner’s New Arguments Regarding Mueller Figure 3
`Should Not Be Considered
`
`In the Request, Petitioner argues for the first time that the “identified image
`
`distortion” in Mueller Figure 3 is “immaterial.” Request at 1-2, 6-11. These new
`
`arguments were not misapprehended or overlooked by the Board. Indeed,
`
`Petitioner did not even acknowledge the distortions in Mueller’s Figure 3 in its
`
`Petition, let alone present evidence and arguments that the distortions somehow are
`
`“immaterial” to its asserted grounds of invalidity.
`
`5
`
`

`

`
`
`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`Petitioner blatantly ignored the requirements of 37 C.F.R. § 42.71(d), as
`
`nowhere in the Request does Petitioner identify where these arguments were made
`
`in the Petition. Cf. Captioncall, Paper 40 at 2-3 (Petitioner “must cite where the
`
`argument or evidence allegedly overlooked or misapprehended was previously
`
`discussed in one of the parties’ papers.”) (emphasis in original). Instead, Petitioner
`
`criticizes the Board for not having “evaluated the materiality of this distortion [in
`
`Mueller Figure 3]” on its own initiative. Request at 6. Yet, it is Petitioner who
`
`bears the burden of proving its case; that burden never shifts to Patent Owner or
`
`the Board. See 35 U.S.C. § 314(a); Dynamic Drinkware, LLC v. Nat’l Graphics,
`
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (“In an inter partes review, the burden
`
`of persuasion is on the petitioner to prove ‘unpatentability by a preponderance of
`
`the evidence,’ 35 U.S.C. § 316(e), and that burden never shifts to the patentee”);
`
`MasterCard Int’l Inc. v. Grecia, IPR2017-00793, Paper 7 at 15 (PTAB, July 3,
`
`2017) (“It is Petitioner who must make out its own case. The Board is not a party
`
`in this proceeding and must remain neutral and unbiased.”). The Board properly
`
`denies institution when “Petitioner leaves it to the Board to ascertain what gaps to
`
`fill.” Apple, Inc., v. Contentguard Holdings, Inc., IPR2015-00358, Paper 9 at 9
`
`(PTAB, July 2, 2015).
`
`Neither the Petition nor Dr. Brain identified or discussed the just-now-
`
`acknowledged distortions in Mueller Figure 3. Thus, the Board correctly found that
`
`6
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`“[n]either Petitioner nor Dr. Brain address how an ordinarily skilled artisan would
`
`interpret Figure 3, given these deficiencies of the graph.” Decision at 21. A request
`
`for rehearing is not an opportunity for Petitioner to attempt to remedy the
`
`inadequacies of its Petition with new arguments and evidence. E.g., Telit Wireless
`
`Solutions Inc. v. M2M Solutions LLC, IPR2016-00055, Paper 13 at 3, 5 (PTAB,
`
`May 24, 2016) (rejecting petitioner’s “belated[]” attempt to use rehearing “to
`
`provide explanation [the Board] found lacking in the original Petition”). Thus,
`
`Petitioner’s new arguments regarding the alleged “immateriality” of the distortions
`
`in Mueller Figure 3 at pages 1-2 and 6-11 of the Request are not proper grounds
`
`for granting rehearing because they do not relate to arguments the Board
`
`overlooked or misapprehended.
`
`B.
`
`Petitioner’s New Arguments Regarding Chien Figure 5
`Should Not Be Considered
`
`In the Request, Petitioner argues for the first time that because Chien does
`
`not explicitly specify that Figure 5 pertains to a multi-layer system, it follows that
`
`Figure 5 pertains to a monolithic system. See, e.g., Request at 13-14. Petitioner
`
`also argues for the first time in the Request that other figures of Chien support its
`
`conjecture as to the subject matter of Chien Figure 5. Request at 14-15. In addition
`
`to being wholly unsupported by any evidence, these arguments were not presented
`
`in the Petition or the Brain Declaration. Indeed, contrary to 37 C.F.R. § 42.71(d),
`
`7
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`nowhere does the Request identify where such arguments were made in the
`
`Petition. Thus, Petitioner’s new arguments regarding Chien Figure 5 at pages 13-
`
`14 and 14-15 of the Request are not proper grounds for granting rehearing because
`
`they do not relate to arguments the Board overlooked or misapprehended. See, e.g.,
`
`United Microelectronics Corp., Paper 10 at 11 (“A request for rehearing is not an
`
`opportunity to present new arguments.”).
`
`V.
`
`Petitioner’s Unsupported Assertions Regarding Chien Do Not Create
`A Genuine Issue Of Material Fact
`
`Petitioner wrongly argues that the Board “erroneously resolved a fact
`
`question [surrounding the subject matter of Chien Figure 5] raised by Patent
`
`Owner’s declarant without taking the evidence ‘in the light most favorable to the
`
`petitioner.’” Request at 11. In raising this issue, Petitioner fails to acknowledge
`
`that it presented no evidence that Chien Figure 5 relates to a monolithic patch, nor
`
`could it.
`
`Contrary to Petitioner’s unsupported mischaracterizations, Chien does not
`
`describe the subject matter of Figure 5 as pertaining to a monolithic patch. Indeed,
`
`Petitioner has not pointed to any evidence of record that the Board misapprehended
`
`or overlooked in concluding that (i) Chien “fails to identify the layer to which the
`
`‘coating’ data in Figure 5 refers” (Decision at 23), (ii) “Chien states only that ‘FIG.
`
`5 is a graph showing the effect of thickness of coating in a dosage unit on the
`
`8
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`human cadaver skin permeation rate of estradiol” (id. at 23), and (iii) “Chien
`
`describes each layer of the multi-layer dosage form as having a ‘coating’” (id. at
`
`24). As set forth in 37 C.F.R. § 42.61(c), “[a] specification or drawing of a United
`
`States patent application or patent is admissible as evidence only to prove what the
`
`specification or drawing describes.” By relying on a reference that does not
`
`describe the subject matter at issue, Petitioner put itself in the position it now finds
`
`itself in―having no evidence of the subject matter of Chien Figure 5 to meet its
`
`burdens of production and persuasion. See 35 U.S.C. § 314(a); Dynamic
`
`Drinkware, 800 F.3d at 1378. Petitioner cannot remedy this deficiency in its
`
`Petition via a request for rehearing.
`
`The Request admits that the Petition solely “relied on Dr. Brain’s testimony”
`
`on the subject matter of Chien Figure 5. Request at 11. But Dr. Brain did not―and
`
`could not―point to any portion of Chien describing the subject matter of Figure 5.
`
`Petitioner and Dr. Brain add words to Chien that are not there when they allege
`
`that Chien Figure 5 pertains to a monolithic patch. See, e.g., Request at 11.
`
`Contrary to Petitioner’s assertions, the Board is not required to credit Dr. Brain’s
`
`unsupported testimony as “establishing” the subject matter of Chien Figure 5. See
`
`37 C.F.R. § 42.65(a). As set forth in the Office Trial Practice Guide, “nothing in
`
`the Federal Rules of Evidence or Federal Circuit jurisprudence requires the fact
`
`finder to credit unsupported assertions of an expert witness.” 77 Fed. Reg. at 48763
`
`9
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`(citing Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997));
`
`see also Subaru of Am., Inc. v. Blitzsafe Texas LLC, IPR2018-00090, Paper 15 at
`
`n.5 (PTAB, April 20, 2018) (“There is no genuine issue of material fact here
`
`because the Petition and the Matheson Declaration are conclusory with regard to
`
`the ‘streaming audio’ limitation.”).
`
`The Board did not “overlook” Petitioner’s arguments or Dr. Brain’s
`
`assertions regarding Chien, but rather correctly found that Chien does not disclose
`
`that Figure 5 relates to a monolithic patch. See, e.g., Decision at 23-24. That is, the
`
`Board did not credit Dr. William’s testimony over Dr. Brain’s as Petitioner asserts,
`
`but rather the Board saw that Chien “fails to identify the layer to which the
`
`‘coating’ data in Figure 5 refers.” Decision at 23. Contrary to Petitioner’s
`
`mischaracterizations, Patent Owner did not argue―nor did the Board decide―that
`
`Chien Figure 5 relates to a multi-layer patch. Rather, the Board reviewed Chien
`
`and found that it does not identify the subject matter of Figure 5. Id. The Board’s
`
`finding on this issue based on the four corners of Chien is supported by 37 C.F.R.
`
`§ 42.61(c) (“A specification or drawing of a United States patent application or
`
`patent is admissible as evidence only to prove what the specification or drawing
`
`describes.”), and does not run afoul of 37 C.F.R. § 42.108(c).
`
`Petitioner’s request for rehearing as to Chien also is based on the erroneous
`
`position that Petitioner’s failure to present admissible evidence on a point on which
`
`10
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`it bears the burden of proof creates a genuine issue of material fact to be resolved
`
`in its favor. Request at 11-12. When the erroneous legal argument is stripped away,
`
`Petitioner presents no more than a disagreement with the Board’s analysis of Chien
`
`based on new arguments, which is not a proper basis for granting rehearing. See
`
`Nestlé Purina Petcare Co. v. Oil-Dri Corp. of Amer., IPR2015-00737, Paper 39 at
`
`8 (PTAB, Feb. 9, 2017) (“Merely disagreeing with our analysis or conclusions
`
`does not serve as a proper basis for a request for rehearing.”). The Board’s finding
`
`that Petitioner failed to establish a reasonable likelihood of success as to the
`
`asserted ground relying on Chien did not amount to an abuse of discretion, but
`
`rather complied with the statutory allocation of the burden of proof to Petitioner by
`
`35 U.S.C. § 314(a).
`
`VI. Petitioner Has Not Shown Any Abuse Of Discretion In The Board’s
`Treatment Of Mueller or Chien
`
`Petitioner has not shown any abuse of discretion in the Board’s treatment or
`
`Mueller or Chien.
`
`With respect to Mueller, Petitioner has not identified any specific arguments
`
`in the Petition or evidence of record that the Board misapprehended or overlooked
`
`in concluding that “estradiol permeation values cannot be reasonably ascertained
`
`from [Mueller] Figure 3.” Decision at 20. Nor has Petitioner identified any specific
`
`arguments in the Petition or evidence of record that the Board misapprehended or
`
`11
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`overlooked in reaching its findings that (i) “Mueller does not disclose any
`
`numerical data” (id.), (ii) “Petitioner does not establish … that Figure 3 provides
`
`an accurate scale for estradiol permeation” (id.), (iii) “[n]either Petitioner nor Dr.
`
`Brain address how an ordinarily skilled artisan would interpret Figure 3, given
`
`these deficiencies of the graph” (id. at 21), and (iv) “Petitioner and Dr. Brain set
`
`forth estradiol permeation values in a table without explaining why or how an
`
`ordinarily skilled artisan would ignore or adjust for the imprecisions of Figure 3”
`
`(id. at 21). Petitioner likewise has not shown that the Board’s decision as to
`
`Mueller rests on clearly erroneous factual findings or a clear error of judgment, and
`
`Petitioner has not alleged that the Board’s decision as to Mueller was based on an
`
`erroneous conclusion of law.
`
`Similarly, Petitioner has not shown any abuse of discretion in the Board’s
`
`findings as to Chien. As noted above, Petitioner has not pointed to any arguments
`
`in the Petition or evidence of record that the Board misapprehended or overlooked
`
`in concluding that Chien “fails to identify the layer to which the ‘coating’ data in
`
`Figure 5 refers” (Decision at 23), or in finding that “Chien states only that ‘FIG. 5
`
`is a graph showing the effect of thickness of coating in a dosage unit on the human
`
`cadaver skin permeation rate of estradiol” (id.) and “Chien describes each layer of
`
`the multi-layer dosage form as having a ‘coating’” (id. at 24). Nor has Petitioner
`
`12
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`otherwise shown that the Board’s decision as to Chien was based on an erroneous
`
`conclusion of law, clearly erroneous factual findings, or a clear error of judgment.
`
`Petitioner’s Request does little more than disagree with the Board on issues
`
`that were already considered, relying on new arguments and new purported
`
`evidence improperly introduced for the first time in the Request, but mere
`
`disagreements do not amount to an abuse of discretion. See, e.g., Wright Med.
`
`Tech., Paper 40 at 4 (“Petitioner’s disagreement with our interpretation of the
`
`claims, without more, does not provide sufficient basis to modify our Final
`
`Decision.”). Thus, the Request does not present a proper basis for granting
`
`rehearing.
`
`VII. Petitioner Attempts An Unauthorized Reply
`
`As shown above, Petitioner’s Request is replete with new arguments and
`
`introduces, cites to, and relies on new evidence in contravention of the Board’s
`
`rules and decisions. As such, the Request amounts to an attempt to submit an
`
`unauthorized reply to Patent Owner’s Preliminary Response. While the Request
`
`notes that the Board denied Petitioner’s request to submit a reply (Request at 5),
`
`Petitioner omits that the Board did so because Petitioner failed to follow the proper
`
`procedures when requesting a conference call with the Board to request
`
`authorization for a reply. Petitioner’s improper use of a request for rehearing to
`
`submit what is, in effect, a reply to supplement its Petition should be denied. See,
`
`13
`
`

`

`
`
`IPR2018-00174
`
`Patent Owner Opposition to Request for Rehearing
`
`
`e.g., Sandoz, Inc., v. Abbvie Biotech. Ltd., IPR2017-01824, Paper 16 at 7 (PTAB,
`
`May 3, 2018) (“Petitioner’s attempt in the Rehearing Request to point us to
`
`additional evidence it contends is sufficient to make a threshold showing … is not
`
`only untimely, but also appears to circumvent our Order (Paper 13) denying
`
`Petitioner’s request to file a reply on that very issue.”).
`
`VIII. Conclusion
`
`For at least the foregoing reasons, Petitioner has not carried its heavy burden
`
`of establishing that the Board abused its discretion in denying institution of Inter
`
`Partes Review. Thus, the Request for Rehearing should be denied.
`
`
`
`
`
`
`
`Dated: July 20, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /Courtenay C. Brinckerhoff /
`Courtenay C. Brinckerhoff
`Registration No. 37,288
`
`Jason N. Mock
`Registration No. 69,186
`
`Foley & Lardner LLP
`Counsel for Petitioner
`
`14
`
`

`

`
`
`IPR2018-00174
`Patent Owner Opposition to Request for Rehearing
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner
`
`Opposition to Request for Rehearing is being served on July 20, 2018, by email
`
`directed to the attorneys of record for the Petitioner at the following addresses:
`
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` /Courtenay C. Brinckerhoff/
`Courtenay C. Brinckerhoff
`Registration No. 37,288
`
`
`
`Jason N. Mock
`Registration No. 69,186
`
`Foley & Lardner LLP
`Counsel for Petitioner
`
`
`
`
`
`
`
`
`
`
`
`
`