Paper No. ___
`Filed: October 28, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`Patent Owner
`_____________________________
`
`Case IPR2016-00712
`Patent No. 8,927,592
`_____________________________
`
`
`
`
`
`
`
`PETITIONER’S MOTION TO FILE SUPPLEMENTAL INFORMATION
`PURSUANT TO 37. C.F.R. § 42.123(a)
`
`
`Filed: October 28, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`Patent Owner
`_____________________________
`
`Case IPR2016-00712
`Patent No. 8,927,592
`_____________________________
`
`
`
`
`
`
`
`PETITIONER’S MOTION TO FILE SUPPLEMENTAL INFORMATION
`PURSUANT TO 37. C.F.R. § 42.123(a)
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.123(a), Petitioner Mylan Laboratories Limited
`
`(“Petitioner”) moves to submit as supplemental information:
`
`1. An October 7, 2016, district court claim construction memorandum
`
`opinion (“Claim Construction Order,” Ex. 1039) that construes the
`
`very same claims for which inter partes review has been instituted in
`
`this proceeding (“the instituted claims”) and that supports and
`
`confirms the Board’s claim constructions from the institution decision
`
`(Paper 9).
`
`2. A June 9, 2016, Final Office Action (Ex. 1040) for a continuation
`
`application of the ’592 patent in which the same Examiner who
`
`originally allowed the instituted claims has finally rejected claims that
`
`are even narrower than the instituted claims.
`
`Petitioner respectfully requests permission to file these documents as
`
`supplemental information under 37 C.F.R. § 42.123(a) because each of these
`
`documents is “relevant to a claim for which the trial has been instituted” and
`
`because the request for authorization to file the motion was made on October 21,
`
`2016, “within one month after the date the trial [was] instituted” on September 22,
`
`2016.
`
`
`
`
`
`
`
`II. STATEMENT OF MATERIAL FACTS
`
`On March 15, 2016, Mylan filed a petition for inter partes review (paper 3)
`
`of claims 1-5 and 7-30 of U.S. Patent No. 8,927,592 (“the ’592 patent”, Ex. 1001).
`
`Petitioner also submitted an expert declaration (Ex. 1002) by Dr. Rahul Seth.
`
`On June 9, 2016, the same Examiner who allowed the instituted claims of
`
`the ’592 patent issued a Final Office Action rejecting all pending claims in U.S.
`
`Patent Application No. 14/575,566 (the ’566 application). The ’566 application is
`
`a continuation of the application that led to the ’592 patent. The Office Action
`
`referredthe Petition in this IPR and stated that the “Seth Declaration is directly
`
`applicable to the instant claims and refutes points raised in the Sartor Declaration.”
`
`Ex. 1040 at 3. The Office Action also characterized the claims undergoing
`
`examination as follows:
`
`The instant claims recite methods for treating a patient with castration
`
`resistant or hormone refractory, metastatic prostate cancer that has
`
`progressed during or after treatment with docetaxel, comprising
`
`administering to said patient a dose of 20 to 25 mg/m2 of cabazitaxel,
`
`or a hydrate or solvate thereof, as a one-hour infusion, in combination
`
`with 10 mg/day of prednisone or prednisolone, wherein the
`
`administration of cabazitaxel, or hydrate or solvate thereof, is repeated
`
`as a new cycle every 3 weeks.
`
`
`
`-2-
`
`
`
`Id. at 5. The Examiner determined that the claims were unpatentable in view of
`
`prior art references asserted in this IPR proceeding, including Beardsley, Mita, and
`
`Pivot. For example, the Office Action states:
`
`The indicia of obviousness in the instant case are many and strong, as
`
`the prior art teaches all of the limitations of the instant claims.
`
`Cabazitaxel was known in the art and taught to be useful in treating
`
`cancer, particularly docetaxel-resistant cancer. Clinically effective
`
`doses of cabazitaxel were known in the art and are the same doses
`
`presently claimed. Taxanes, including cabazitaxel, were known in the
`
`art to be administered in combination with prednisone in the dose
`
`presently claimed.
`
`Id. at 16-18. The Examiner also concluded that the skilled artisan would have had
`
`a reasonable expectation of success, stating:
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`The skilled artisan would have been imbued with more than a
`
`reasonable expectation that cabazitaxel, in the dosing regimen
`
`presently claimed, administered in combination with 10mg/day
`
`prednisone, would be effective in treating castration resistant or
`
`hormone refractory metastatic prostate cancer that has progressed
`
`during or after treatment with docetaxel. This is particularly true
`
`because the cited prior art teaches that in a Phase II trial, cabazitaxel is
`
`clinically effective in treating docetaxel-resistant metastatic breast
`
`cancer (Beardsley et al. and Pivot et al.), which led to cabazitaxel
`
`being investigated in a phase III multi-center, randomized superiority
`
`trial comparing 3-weekly XRP6258 with prednisone to mitoxantrone
`
`with prednisone in patients with castrate resistant metastatic prostate
`
`
`
`-3-
`
`
`
`cancer previously treated with docetaxel-containing treatment
`
`(Beardsley et al., Rodrigues et al., and NHSC). Those skilled in the
`
`art would not administer a drug in a Phase III clinical trial if they did
`
`not have at least a reasonable expectation that treatment would be
`
`successful.
`
`Id. at 20 (all emphasis in original). The Examiner also rejected Dr. Sartor’s
`
`arguments regarding likelihood of success of the Phase III trial:
`
`It is the position of the Examiner that the Sartor declaration
`
`incorrectly assumes that positive results of Phase III clinical trials
`
`were necessary to demonstrate a reasonable likelihood of success for
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`administering 20-25 mg/m2 of cabazitaxel with prednisone to patients
`
`with mCRPC that had progressed during or after treatment docetaxel
`
`Id. at 28-29. The Examiner similarly rejected Dr. Sartor’s testimony that there was
`
`no reasonable likelihood of success in obtaining statistically significant results:
`
`The Examiner is thus not persuaded by Applicants’ argument that a
`
`person of ordinary skill in the art would not have had a reasonable
`
`expectation that the Phase III study of cabazitaxel for treating prostate
`
`cancer referred to in Beardsley et al., Rodriguez [sic] et al., and NHSC
`
`would succeed in returning statistically significant results over the
`
`reference treatment.
`
`Id. at 30-31.
`
`On June 24, 2016, Patent Owner filed a preliminary response along with
`
`another declaration from Dr. Sartor (Ex. 2001). In its preliminary response, Patent
`
`Owner asked the Board to defer to the Examiner’s original decision to allow the
`
`
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`-4-
`
`
`
`claims of the ’592 patent. See, e.g., Preliminary Response (Paper 7) at See Paper 7
`
`at 3, 7, 8-11, 14-15, 17, 22-23, 28-33, 36, 38, 40, 44, 52-53, 56-57, 59.
`
`On August 2, 2016, Petitioner requested authorization to file a motion to
`
`submit the Final Office Action from the ’566 application as supplemental
`
`information. On August 3, the Board stated that Petitioner’s request was
`
`premature and that Petitioner could renew its request after a decision was reached
`
`regarding institution. On September 22, 2016, the Board instituted inter partes
`
`review of claims 1-5 and 7-30 of the ’592 patent on grounds 1-6. Paper 9 at 22-23.
`
`The Board exercised its discretion to include Attard (Ex. 1021) and Beardsley (Ex.
`
`1022) as references in Ground 1 together with Winquist (Ex. 1009) and the
`
`TROPIC Listing (Ex. 1008). Id. at 16.
`
`On October 7, 2016, Judge Shipp issued a claim construction memorandum
`
`and order in the related case captioned as Sanofi-Aventis v. Fresenius Kabi USA et
`
`al., Lead Coordinated Case No. 14-7869 (D.N.J.) (the text of which is available at
`
`https://casetext.com/case/sanofi-aventis-us-llc-v-fresenius-kabi-united-states-llc-1)
`
`(“Claim Construction Order,” Ex. 1039).
`
`On October 21, 2016, Petitioner renewed its request to file a motion to
`
`submit supplemental information the Final Office Action and also requested
`
`authorization to file as supplemental information the claim construction order.
`
`Patent Owned indicated it intended to oppose the motion. On October 24, the
`
`
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`-5-
`
`
`
`Board authorized the filing of this motion at a date no later than Friday, October 28,
`
`2016. The Claim Construction Order and Final Office Action (Exs. 1039 and 1040,
`
`respectively) are provided herewith, consistent with prior Board decisions stating
`
`that such provision is not problematic and facilitates the Board’s review of the
`
`motion. See IPR2014-0124, paper 26 at 5 (“Such submittal is not problematic in
`
`that it facilitated our review, and we can expunge exhibits that are not submitted
`
`appropriately”).
`
`III. LEGAL STANDARD
`
`Under 37 C.F.R. § 42.123(a), there are only two requirements for
`
`submission of supplemental information: (1) A request for the authorization to file
`
`a motion to submit supplemental information is made within one month of the date
`
`the trial is instituted; and (2) The supplemental information must be relevant to a
`
`claim for which the trial has been instituted. Under subsection (a), there need be no
`
`justification for why the information could not have been obtained earlier. Id.
`
`IV. ARGUMENT
`
`A. The Board Should Authorize Submission of the Claim
`Construction Order under 37 C.F.R. § 42.123(a).
`
`1.
`
`Petitioner Timely Requested Authorization.
`
`Petitioner requested authorization to file this motion on October 21, 2016,
`
`“within one month after the date the trial [was] instituted” on September 22, 2016.
`
`37 C.F.R. § 42.123(a); Paper 9.
`
`
`
`-6-
`
`
`
`2.
`
`The Claim Construction Order is Relevant.
`
`The Claim Construction Order is relevant to at least one instituted claim
`
`because it actually construes the instituted claims and construes them consistently
`
`with the Board’s construction of these same terms. Petitioner asserted in the
`
`Petition that the preamble phrases of claims 1 and 27 are non-limiting statements
`
`of the purpose of the claimed methods or, at most, should be construed as a method
`
`intended to either benefit a patient or increase the survival of a patient. Paper 3 at
`
`17-20; Paper 9 at 7, 10. Patent Owner argued that claim 1 requires a method that
`
`produces a therapeutic effect in a patient and that claim 27 requires a method that
`
`prolongs the life of a patient as compared to no treatment or palliative treatment,
`
`where that method has been demonstrated to provide a statistically significant
`
`increase in overall survival. Paper 7 at 12-20; Paper 9 at 7, 10. In the institution
`
`decision, the Board correctly adopted Petitioner’s position. See Paper 9 at 7, 10.
`
`Sanofi v. Fresenius, in which Petitioner is a co-defendant and Patent Owner
`
`is the Plaintiff, involves the ’592 patent. On October 7, 2016, the district court
`
`issued the Claim Construction Order. The Claim Construction Order includes,
`
`inter alia, constructions of the preambles of claims 1 and 27 of the ’592 patent that
`
`confirm and support the constructions proposed by Petitioner and adopted by the
`
`Board. See, e.g. Ex. 1039 at 0008-0014 (“Having considered the parties’ arguments
`
`and reviewed the intrinsic evidence discussed above, the Court finds that the
`
`
`
`-7-
`
`
`
`phrases ‘a method for treating’ and a ‘method of increasing the survival of,’ which
`
`state the purpose of the claim invention and was not added during patent
`
`prosecution, are not limiting.”). Other terms of the ’592 claims are also construed.
`
`Although a district court does not employ the broadest reasonable interpretation
`
`standard for claim construction that is employed in this IPR proceeding, the
`
`constructions and reasoning of the district court are relevant to the claims at issue
`
`because the broadest reasonable interpretation would include the district court’s
`
`construction of the preambles of claims 1 and 27 under the Phillips standard.
`
`Because Petitioner sought authorization to file the instant motion within one
`
`month of institution of trial, and because the Claim Construction Order is relevant
`
`to at least one instituted claim, Petitioner should be permitted to submit the Claim
`
`Construction Order as supplemental information.
`
`B.
`
`The Board Should Authorize Submission of the Final Office
`Action under 37 C.F.R. § 42.123(a).
`
`1.
`
`Petitioner Timely Requested Authorization.
`
`Petitioner requested authorization to file this motion on October 21, 2016,
`
`“within one month after the date the trial [was] instituted” on September 22, 2016.
`
`37 C.F.R. § 42.123(a); Paper 9.
`
`2.
`
`The Final Office Action Is Relevant.
`
`As set forth above, the Board instituted review of claims 1-5 and 7-30 of
`
`the ’592 Patent on six grounds. The references applied in the instituted grounds
`
`
`
`-8-
`
`
`
`include Winquist (Ex. 1009), the TROPIC Listing (Ex. 1008), Attard, Beardsley,
`
`Didier (Ex. 1011), Mita (Ex. 1012), Tannock (Ex. 1013) and Pivot (Ex. 1010).
`
`In its preliminary response, Patent Owner repeatedly relied on the
`
`acquiescence of the Office to Patent Owner’s and Dr. Sartor’s arguments during
`
`prosecution of the’592 patent as support for its claim construction arguments and
`
`as reason not to find that the instituted claims of the ’592 patent are obvious. See,
`
`e.g., Preliminary Response (Paper 7) at 8-9 (stating that the claims of the ‘592
`
`patent “were extensively reviewed” and that the prior art asserted in the Petition as
`
`well as other references such as NHSC were considered by the Examiner); id. at
`
`10-11 (citing the Examiner’s reasons for allowance and statements regarding the
`
`Sartor declaration); id. at 14 (“Both the Examiner and Applicants recognized that
`
`the preamble language limited the claimed invention over the prior art.”); id. at 17
`
`(“Indeed, the Examiner allowed the claims based on the clinical efficacy of
`
`cabazitaxel”); id. at 52 (“The Board should exercise its discretion to deny the
`
`instant Petition because the same or substantially the same arguments were
`
`overcome during prosecution.”); id. at 53 (“Thus, the Petition merely asks the
`
`Board to second-guess the Office’s previous decision on substantially the same
`
`issue and to reconsider evidence of objective indicia of nonobviousness that the
`
`Office expressly determined was sufficient to overcome obviousness rejections
`
`based on the same information.”).
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`
`
`-9-
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`
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`Even more recently, Patent Owner has objected to ten exhibits submitted by
`
`Petitioner with the Petition on the basis that the references, including both art
`
`found in the grounds and background art, were “previously considered by the
`
`examiner” and presented “cumulative evidence of the materials that were
`
`previously considered by the patent examiner.” Paper 11 at, e.g., 4-5; see also id. at
`
`6, 8, 10.
`
`Because Patent Owner contends that the Examiner’s prior conduct,
`
`statements, and decisions during the prosecution of the ’592 patent dictate the
`
`outcome of this IPR proceeding with respect to the instituted claims, alters the
`
`meaning of those claims, and even governs which prior art references are
`
`admissible in this IPR proceeding, it is relevant to those instituted claims how that
`
`same Examiner’s conduct, statements and decisions changed when the Examiner
`
`was permitted to evaluate Patent Owner’s and Dr. Sartor’s arguments against the
`
`testimony of Dr. Seth and against the Petition in this IPR proceeding. The Final
`
`Office Action demonstrates that the same Examiner who originally allowed the
`
`instituted claims concluded that Dr. Seth’s declaration rebutted Dr. Sartor’s
`
`declaration. Ex. 1040 at 3 (“the Seth Declaration is directly applicable to the
`
`instant claims and refutes points raised in the Sartor Declaration, the Sartor
`
`Declaration will be considered in light of the Seth Declaration....”).
`
`
`
`-10-
`
`
`
`In analyzing the claims of the ’566 application, the Examiner identified the
`
`reference known as “NHSC” as teaching all of the elements of claims 1 and 24 of
`
`the 566 application except the amount of prednisone. Ex. 1040 at 17 (“Indeed,
`
`NHSC differs from independent Claims 1 and 24 only in that it does not disclose
`
`the dose of prednisone administered”). As described by the Examiner himself,
`
`these claims require each of the elements of claims 1 and 27 of the ’592 patent,
`
`with some added limitations:
`
`The instant claims recite methods for treating a patient with castration
`
`resistant or hormone refractory, metastatic prostate cancer that has
`
`progressed during or after treatment with docetaxel, comprising
`
`administering to said patient a dose of 20 to 25 mg/m2 of cabazitaxel,
`
`or a hydrate or solvate thereof, as a one-hour infusion, in combination
`
`with 10 mg/day of prednisone or prednisolone, wherein the
`
`administration of cabazitaxel, or hydrate or solvate thereof, is repeated
`
`as a new cycle every 3 weeks.
`
`Id. at 5. In this IPR, Patent Owner has conceded that NHSC “contains
`
`substantially the same disclosure” as Winquist. Paper 11 at 4. Notably, claims 1
`
`and 27 of the ’592 patent do not recite a specific dose of prednisone. EX1001 at
`
`claims 1 and 27. Because the claims of the ’566 application are narrower than the
`
`instituted claims, the Examiner’s obviousness conclusions necessarily apply to the
`
`instituted claims as well. See, e.g., Ormco Corp. v. Align Tech., Inc., 498 F.3d
`
`
`
`-11-
`
`
`
`1307, 1319 (Fed. Cir. 2007) (when a narrow claim is obvious, a broader claim is
`
`likewise obvious).
`
`The Examiner of the ’566 application also specifically rejected Patent
`
`Owner’s and Dr. Sartor’s arguments that there was no reasonable expectation of
`
`success. See, e.g., Ex. 1040 at 20 (concluding that the skilled artisan would have
`
`had a reasonable expectation of success that the claimed methods would be
`
`clinically efficacious); id. at 28-29 (rejecting Dr. Sartor’s testimony that there was
`
`no reasonable likelihood of success for the clinical trial and concluding that “the
`
`TROPIC study was designed and conducted because it was expected to succeed”
`
`(emphasis in original)); id. at 30-31 (rejecting Dr. Sartor’s testimony that there was
`
`no reasonable likelihood of success in obtaining statistically significant results); id.
`
`at 32 (“In addition, whether or not the clinical study described in Beardsley et al.,
`
`Rodriguez [sic] et al., and NHSC would ultimately yield statistically significant
`
`Phase III human clinical results does not bear on patentability.”); id. at 35-36
`
`(rejecting Dr. Sartor’s testimony “that the results in Mita et al. might not repeat”
`
`and finding that “the reasonable expectation for one o[f] ordinary skill in the art is
`
`that they would repeat” as proven by Pivot, Beardsley, and Rodrigues).
`
`In the institution decision in this IPR proceeding, the Board noted that “[t]he
`
`parties present sharply divergent testimonial and documentary evidence of whether
`
`a POSA would have had a reasonable expectation of successfully treating prostate
`
`
`
`-12-
`
`
`
`cancer patients.” Paper 9 at 13. Accordingly, the Examiner’s discussion and
`
`conclusions regarding the obviousness of the narrower claims of the ’566
`
`application and the reasonable likelihood of success are relevant to the
`
`patentability of the instituted claims at issue. Moreover, the Examiner’s analysis
`
`applying Petitioner’s arguments to find unpatentable the claims of the ’566
`
`application as obvious is relevant to the factual issues that underlie the conclusion
`
`of obviousness, including the scope and content of the prior art, the differences
`
`between the claimed invention and the prior art, and the level of ordinary skill in
`
`the art. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
`
`Because Petitioner sought authorization to file the instant motion within one
`
`month of institution of trial, and because the Final Office Action is relevant to at
`
`least one instituted claim, Petitioner should be permitted to submit the Final Office
`
`Action as supplemental information. Furthermore, Exhibits 1039 and 1040 do not
`
`change the grounds of unpatentability as originally presented in the petition or the
`
`scope of the proceeding as initially instituted. Moreover, as discussed above in
`
`Section II, Exhibits 1039 and 1040 were not withheld intentionally, and
`
`consideration of this information will not frustrate the Board’s ability to complete
`
`this proceeding in a timely manner.
`
`
`
`-13-
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`
`
`V. CONCLUSION
`
`For the reasons discussed above, Petitioner respectfully requests that the
`
`Board grant its motion to submit the Final Office Action and Claim Construction
`
`Order as supplemental information pursuant to 37 C.F.R. § 42.123(a).
`
`
`
`
`
`
`Dated: October 28, 2016
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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`-14-
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`
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`Updated List of Exhibits
`
`Exhibit No.
`
`Description
`
`1001
`
`U.S. Patent No. 8,927,592 to Gupta
`
`1002
`
`Declaration of Dr. Rahul Seth
`
`1003
`
`Curriculum Vitae of Dr. Rahul Seth
`
`1004
`
`File History of 8,927,592 to Gupta
`
`1005
`
`U.S. Provisional Patent Application No. 61/256,160
`
`1006
`
`U.S. Provisional Patent Application No. 61/293,903
`
`1007
`
`U.S. Provisional Patent Application No. 61/355,834
`
`1008
`
`Sanofi-Aventis; XRP6258 Plus Prednisone Compared to
`Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic
`Prostate Cancer (TROPIC). Archived Oct. 23, 2008.
`https://web.archive.org/web/20081023121613/http://clinicaltrials.g
`ov/ct2/show/NCT00417079 (“the TROPIC Listing”).
`
`1009
`
`Winquist et al., Canadian Journal of Urology, 15(1), 2008
`
`1010
`
`Pivot et al., Annals of Oncology 19:1547-1552, 2008
`
`1011
`
`U.S. Patent No. 7,241,907 to Didier et al.
`
`1012
`
`Mita et al., Clin Cancer Res, 15(2), 2009
`
`1013
`
`Tannock et al., N. Engl. J. Med. 351, 2004, 1502-1512
`
`1014
`
`3:15-cv-03392 Complaint (D.N.J.)
`
`1015
`
`Booth et al., Nature Reviews Drug Discovery 3, 609-610, 2003
`
`1016
`
`Stedman’s Medical Dictionary, 27th Edition (excerpts), 2000
`
`1017
`
`J. S. Abrams et al., 74 Cancer Supp. 1164-1176 (1994)
`
`1018
`
`Kelland et al., Cancer Chemother. Pharmacol. 30, 1992, 444-450
`
`
`
`
`
`
`
`1019
`
`Verweij et al., Annals of Oncology 5, 1994, 495-505
`
`1020
`
`Galletti, et al., CHEMMEDCHEM, 2, 2007, 920-942
`
`1021
`
`Attard, et al., Pathologie Biologie, 54, 2006, 72-84
`
`1022
`
`Beardsley, et al., Curr Opin Support Palliat Care, 2, 2008 161-166
`
`1023
`
`El-Maraghi and Eisenhauer, Journal of Clinical Oncology 26, 1346-
`1354, 2008
`
`1024
`
`The Taxotere® Label
`
`1025
`
`Liu, Water Insoluble Drug Formulation, First Edition, 525-568,
`2000
`
`1026
`
`Affidavit of C. Butler, The Internet Archive
`
`1027
`
`Rosenberg et al., Cancer 110, 556-563, 2007
`
`1028
`
`Gayther et al., Cancer Research 60, 4513-4518, 2000
`
`1029
`
`Ratain and Sargent, European Journal of Cancer 45, 257-280, 2009
`
`1030
`
`Moul, Reviews in Urology 6, S10-S17, 2004
`
`1031
`
`Joint Statement on Claim Construction, 3:15-cv-03392 (D.N.J.)
`
`1032
`
`J. B. Brady Urological Institute Johns Hopkins Medical Institutions,
`New Drugs for Prostate Cancer: Chemotherapy Transformed, 2003
`
`1033
`
`Hospers et al., 14 Current Pharmaceutical Design 3020-3032, 2008
`
`1034
`
`Zhu et al., Cancer Epidemiol. Biomarkers Prev. 15, 3-5, 2006
`
`1035
`
`Markman Hearing Transcript (excerpted), 3:15-cv-03392 (D.N.J.)
`
`1036 (served
`but not filed)
`
`Liu, Water Insoluble Drug Formulation, First Edition, 2000
`(Excerpts)
`
`1037 (served
`but not filed)
`
`J. B. Brady Urological Institute Johns Hopkins Medical Institutions,
`New Drugs for Prostate Cancer: Chemotherapy Transformed, 2003
`
`
`
`
`
`
`
`1038 (served
`but not filed)
`
`Declaration of Patrick M. Medley
`
`1039
`
`1040
`
`Amended claim construction memorandum and order, Sanofi-
`Aventis v. Fresenius Kabi USA et al., Lead Coordinated Case No.
`14-7869 (D.N.J.)
`
`Final office action of June 9, 2016, U.S. Patent Application No.
`14/575,566
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that the foregoing Petitioner’s Motion to File
`
`Supplemental Information and Exhibits 1039 and 1040 were served on October 28,
`
`2016, on the Patent Owner at the correspondence address of the Patent Owner as
`
`follows:
`
`Dominick A. Conde
`William E. Solander
`Jason A. Leonard
`Whitney L. Meier
`Daniel J. Minion
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 1014-3800
`Email: dconde@fchs.com
`Email: wsolander@fchs.com
`Email: jleonard@fchs.com
`Email: wmeier@fchs.com
`Email: dminion@fchs.com
`
`
`
`Dated: October 28, 2016
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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