Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 642

NOTICE by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc. of Filing with Clerk's Office of Exhibits to Declaration of Krista M. Rycroft in Support of Roche's Opposition to Plaintiff Amgen Inc.'s Motion for Summary Judgment of No Inequitable Conduct (Toms, Keith)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 642

Case 1:05-cv-12237-WGY

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., Plaintiff, vs. F. HOFFMANN-LA ROCHE LTD; ROCHE DIAGNOSTICS GmbH; and HOFFMANN-LA ROCHE INC. Defendants. ) ) ) ) ) ) ) ) ) ) ) ) )

CIVIL ACTION No.: 05-CV-12237WGY

NOTICE OF FILING WITH CLERK'S OFFICE OF EXHIBITS TO DECLARATION OF KRISTA M. RYCROFT IN SUPPORT OF ROCHE'S OPPOSITION TO PLAINTIFF AMGEN INC.'S MOTION FOR SUMMARY JUDGMENT OF NO INEQUITABLE CONDUCT Pursuant to CMF/ECF Administrative Procedures Rule M(6) notice is hereby given that the exhibits listed below have been manually filed with the Court and are available in paper form only. The original documents are maintained in the case file in the Clerk's Office. Exhibit 1 Exhibit 2 Exhibit 3 Exhibit 4 Exhibit 5 Exhibit 6 Exhibit 7 Exhibit 8 [submitted for in camera review] U.S. Patent No. 5,441,868. Protest by Dr. Lai in the `178 File History (Paper 31), dated July 23, 1993. (AMITC 00941255-61 (attachments excluded)). Office Action in the `178 File History (Paper 34), mailed on December 29, 1993. (AM-ITC 00941410-15). U.S. Patent No. 5,547,933. Miyake et al., "Purification of Human Erythropoietin," J. Biol. Chem., Vol. 252, No. 15, pp. 5558-64 (Aug. 1977). (AM-ITC 00987639-49). Rebuttal Expert Report of Stephen Kunin, dated May 11, 2007. Declaration of Michael Borun Accompanying a Petition to Make Special in the `179 File History (Paper 3), dated February 9, 1988. (AM-ITC 00953134-41).

Dockets.Justia.com

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Exhibit 9 Exhibit 10 Exhibit 11 Exhibit 12 Exhibit 13 Exhibit 14 Exhibit 15 Exhibit 16 Exhibit 17 Exhibit 18 Exhibit 19 Exhibit 20 Exhibit 21 Exhibit 22 Exhibit 23 Exhibit 24

Preliminary Amendment in the `179 File History (Paper 7), dated October 23, 1987. (AM-ITC 00953195-203). Applicant's Second Preliminary Amendment in the `179 File History (Paper 8), dated May 24, 1988. (AM-ITC 00953204-25). Examiner Interview Summary Record in the `179 File History (Paper 30) dated November 13, 1993. (AM-ITC 00953602-03). Applicant's Amendment and Remarks Under 37 C.F.R. §§ 1.111 and 1.115 in the `179 File History (Paper 33), dated January 3, 1994. (AM-ITC 00953636-48). Information Disclosure Statement in the `179 File History (Paper 44). (AM-ITC 00953710-11). Preliminary Amendment in the `381 File History (Paper 4), dated June 6, 1995. (AM-ITC 00898298-301). IDS filed in the `381 File History (Paper 6), dated January 3, 1996. (AM-ITC 00898307-33). Interview Summary in the `381 File History (Paper 7), dated December 11, 1996. (AM-ITC 00898334-37). Preliminary Amendment in the `369 File History (Paper 5), dated June 6, 1995. (AM-ITC 00898621-24). Second Preliminary Amendment in the `369 File History (Paper 8), dated December 20, 1996. (AM-ITC 00898654-63). Disclosure Statement and accompanying PTO-1449 in the `369 File History (Paper 6), dated January 3, 1996. (AM-ITC 00898625-51). Information Disclosure Statement in the `369 File History (Paper 9), dated December 20, 1996. (AM-ITC 00898691-92). Associate Power of Attorney in the `073 File History (Paper 11), dated December 30, 1992. (AM-ITC 00899119-21). Examiner Interview Summary Record in the `369 File History (Paper 7), dated December 11, 1996. (AM-ITC 00898652-53). Preliminary Amendment in the `178 File History (Paper 3), dated October 23, 1987. (AM-ITC 00941081-88). Applicant's Amendment and Request for Reconsideration Under 37 C.F.R. §§ 1.111 and 1.115 in the `874 File History (Paper 42), dated February 16, 1995. (AM-ITC 00941507-21). 2

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Exhibit 25 Exhibit 26 Exhibit 27 Exhibit 28 Exhibit 29

communication from Examiner Schain to Mr. Borun in the `178 File History (Paper 21). (AM-ITC 00941224-27). Examiner Interview Summary Record in the `178 File History (Paper 32), dated November 18, 1993. (AM-ITC 00941406-07). Examiner Interview Summary Record in the `178 File History (Paper 33), dated November 22, 1993. (AM-ITC 00941408-409). Notice of Change of Address in the `178 File History (Paper 30). (AM-ITC 00941253-54). Third Preliminary Amendment and Terminal Disclaimer Pursuant to 37 C.F.R. §1.321 in the `556 File History (Paper 6), dated December 20, 1996. (AM-ITC 00868077-88). Interview Summary from the `556 File History (Paper 4), dated December 11, 1996. (AM-ITC 00868071-73). Information Disclosure Statement and accompanying PTO-1449 in the `556 File History (Paper 7), dated December 20, 1996. (AM-ITC 00868126-55). [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] Associate Power of Attorney in the `179 File History (Paper 2), dated February 9, 1988. (AM-ITC 00953131-33). Examiner Interview Summary Record in the `179 File History (Paper 10) dated September 14, 1988. (AM-ITC 00953232-34). Applicant's Reply Under 37 C.F.R. § 1.111 in the `179 File History (Paper 14), dated September 27, 1988. (AM-ITC 00953272-78). Petition for Access filed in the `179 File History (Paper 12), dated September 27, 1988. (AM-ITC 00953250-56). Request for Withdrawal of Suspension in the `179 File History (Paper 20), dated May 1, 1989. (AM-ITC 00953313-17). Examiner Interview Summary Record in the `178 File History (attached to Paper 4), dated July 20, 1988. (AM-ITC 00941101).

Exhibit 30 Exhibit 31 Exhibit 32 Exhibit 33 Exhibit 34 Exhibit 35 Exhibit 36 Exhibit 37 Exhibit 38 Exhibit 39 Exhibit 40 Exhibit 41

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Exhibit 42 Exhibit 43 Exhibit 44 Exhibit 45 Exhibit 46 Exhibit 47 Exhibit 48

Examiner Interview Summary Record in the `178 File History (Paper 8) dated January 26, 1989. (AM-ITC 00941145-46). Examiner Interview Summary Record in the `178 File History (Paper 14) dated June 22, 1989. (AM-ITC 00941184-85). Examiner Interview Summary Record in the `178 File History (Paper 17), dated December 20, 1989. (AM-ITC 00941204-05). Power of Attorney in the `178 File History (Paper 24), dated February 22, 1990. (AM-ITC 00941241-42). March 29, 2007 deposition transcript of Stuart Watt. September 7, 2000 trial testimony of Stuart Watt. Second Preliminary Amendment and Terminal Disclaimer Pursuant to 37 C.F.R. § 1.321 in the `381 File History (Paper 9), dated December 20, 1996. (AM-ITC 00898342-53). Examiner Interview Summary Record in the `369 File History (Paper 11), dated May 6, 1997. (AM-ITC 00898727-28). Examiner Interview Summary Record in the `197 File History (Paper 24), dated March 1, 1995. (AM-ITC 00899176-77). Examiner Interview Summary Record in the `197 File History (Paper 32), dated April 21, 1999. (AM-ITC 00899440-41). Terminal Disclaimer in the `197 File History (Paper 35), dated April 26, 1999. (AM-ITC 00899686-88). Examiner Interview Summary Record in the `774 File History (Paper 46), dated October 18, 1995. (AM-ITC 00941538-39). [submitted for in camera review] [submitted for in camera review] Declaration of Fu-Kuen Lin, submitted in Interference No. 102,334, dated March 18, 1991. (AM-ITC 00295809-16). [submitted for in camera review] [submitted for in camera review] [submitted for in camera review]

Exhibit 49 Exhibit 50 Exhibit 51 Exhibit 52 Exhibit 53 Exhibit 54 Exhibit 55 Exhibit 56 Exhibit 57 Exhibit 58 Exhibit 59

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Exhibit 60 Exhibit 61 Exhibit 62 Exhibit 63 Exhibit 64

Declaration of Thomas Strickland Pursuant to 37 C.F.R. §1.132, dated November 30, 1988. (AM-ITC 00941119-44). U.S. Patent No. 4,667,016 (Lai et al.). U.S. Patent No. 4,703,008. Amgen v. ITC, 902 F.3d 1532 (Fed. Cir. 1990). Applicant's Amendment and Remarks Under 37 C.F.R. §§ 1.111 and 1.115 in the `298 File History (Paper 15), dated March 11, 1987 (without exhibits). (AM-ITC 00873616-43). CHARLES W. RIVISE & A.D. CAESAR, INTERFERENCE LAW AND PRACTICE, Vol. I § 6 (Michie Co., 1940). [submitted for in camera review] Associate Power of Attorney filed in the `179 File History (Paper 2) on February 9, 1988. (AM-ITC 00953131-33). [submitted for in camera review] MPEP § 2002.03(b) (5th ed. Rev. 3, May 1986). Fritsch v. Lin, 21 U.S.P.Q.2d 1737 (Bd. Pat. App. & Interf. 1992). MPEP § 2001.05 (5th ed. Rev. 3, May 1986). Statement of Grounds submitted on October 8, 1992 by Amgen in the EP 411 678 Opposition Proceedings. MPEP § 804 (8th ed., Rev. 5, Aug. 2006). Notice of Allowability in the `179 File History (Paper 46), mailed on February 6, 1995. (AM-ITC 00953708). Amendment Under Rule 116 in the `178 File History (Paper 19), dated January 10, 1990. (AM-ITC 00941211-20). Office Action in the `179 File History (Paper 29), mailed on September 1, 1993. (AM-ITC 00953590-601). Office Action in the `179 File History (Paper 34), mailed on February 15, 1994. (AM-ITC 00953649-56). Miyake et al, "Purification of Human Erythropoietin" (1977). 00941138-44). (AM-ITC

Exhibit 65 Exhibit 66 Exhibit 67 Exhibit 68 Exhibit 69 Exhibit 70 Exhibit 71 Exhibit 72 Exhibit 73 Exhibit 74 Exhibit 75 Exhibit 76 Exhibit 77 Exhibit 78

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Exhibit 79 Exhibit 80 Exhibit 81 Exhibit 82 Exhibit 83 Exhibit 84 Exhibit 85 Exhibit 86 Exhibit 87 Exhibit 88 Exhibit 89 Exhibit 90 Exhibit 91 Exhibit 92 Exhibit 93 Exhibit 94 Exhibit 95 Exhibit 96 Exhibit 97

Belalcazar, V. et al. Electrophoresis 27:4387-4395 (2006). U.S. Patent No. 5,621,080. Preliminary Amendment in the `874 File History (Paper 37), dated June 13, 1994. (AM-ITC 00941451-54). [submitted for in camera review] [submitted for in camera review] Request for Withdrawal of Suspension in the `179 File History, dated May 1, 1989. (AM-ITC 00900823-26). Amendment Under Rule 116 in the `178 File History (Paper 11), dated June 2, 1989. (AM-ITC 00997385-92). Amendment Under Rule 116 in the `178 File History (Paper 11), dated June 2, 1989. (AM-ITC 00941164-72). "Lin EPO Patents." (AM-ITC 00906488). MPEP § 609.02 (8th ed. Rev. 5, Aug. 2006). communication from the Examiner in the `179 File History (Paper 16), dated December 2, 1988. (AM-ITC 00953282-83). Request for Withdrawal of Suspension in the `179 File History (Paper 20), dated May 1, 1989. (AM-ITC 00953314-524). Declaration of Interference in the `179 File History (Paper 21), mailed on May 8, 1989. (AM-ITC 00953525-28). Interference Digest in the `179 File History (Paper 22). (AM-ITC 00953529-30). Search Notes from the `422 Patent File History. (AM-ITC 00899764). Second Preliminary Amendment and Remarks in the `774 File History (Paper 50), dated December 20, 1995. (AM-ITC 00941543-51). `178 application. (AM-ITC 00940939-1074). Applicant's Amendment and Reply Under 37 C.F.R. §§ 1.111 and 1.115 in the `178 File History (Paper 6), dated December 1, 1988. (AM-ITC 00941105-18). Amendment in the `178 File History (Paper 15), dated July 11, 1989. (AM-ITC 00941187-97).

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Exhibit 98 Exhibit 99 Exhibit 100 Exhibit 101 Exhibit 102

Examiner Interview Summary Record in the `178 File History (Paper 18), dated December 20, 1989. (AM-ITC 00941206-10). Office Action in the `178 File History (Paper 4), mailed on June 2, 1988. (AMITC 00941089-100). Egrie et al., Characterization of Recombinant Monkey and Human Erythropoietin, Proc. Clin. Biol. Res. 1985, 191:339-50. [submitted for in camera review] Egrie et al., Presentation (1984) from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA, October 2, 1984. (AM-ITC 01073032-42). [submitted for in camera review] [submitted for in camera review] Trial testimony of Michael Borun from September 6, 2000. Trial testimony of Michael Borun from February 5, 2002. Justice Neuberger's March 21, 2002 opinion in HMR v. Kirin-Amgen, Inc. in the High Court of Justice (Chancery Division) (UK). (AM-ITC 10166841-925). Trial transcript from Amgen v. TKT Office Action in the `178 File History (Paper 9), mailed on February 10, 1989. (AM-ITC 00941147-60). Office Action in the `178 File History (Paper 13), mailed on June 20, 1989. (AMITC 00941175-83). WO 86/03520. Preliminary Amendment in the `874 File History (Paper 45), dated June 7, 1995. (AM-ITC 00941535-57) MPEP § 704.01 (5th ed., Rev. 6, Oct. 1987). Notice of Allowability in the `774 File History (Paper 52). (AM-ITC 0094156166). June 6, 1997 Notice of Allowability in the `556 File History (Paper 9). (AM-ITC 00868157-61). Declaration of Interference in the `178 File History (Paper 22). 00941228-35). 7 (AM-ITC

Exhibit 103 Exhibit 104 Exhibit 105 Exhibit 106 Exhibit 107 Exhibit 108 Exhibit 109 Exhibit 110 Exhibit 111 Exhibit 105 Exhibit 113 Exhibit 114 Exhibit 115 Exhibit 116

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Exhibit 117 Exhibit 118 Exhibit 119 Exhibit 120 Exhibit 121 Exhibit 122 Exhibit 123

Interference Digest in the `178 File History (Paper 23). (AM-ITC 00941236-37). [submitted for in camera review] [submitted for in camera review] October 5, 1998 PTO Initiative, "Changes to Implement the Patent Business Goals," Vol. 63, No. 192, pp. 53498-530. June 27, 2007 deposition transcript of Stephen Kunin. Eschbach et al., Correction of the Anemia of End-Stage Renal Disease with Recombinant Human Erythropoietin, NEJM 316:73-78 (1987) (Egrie, co-author). Vapnek et al., "Comparative Studies of Natural and Recombinant Erythropoietin," Banbury Reports 29:Therapeutic Peptides and Proteins, 241-56 (1988). (AM-ITC 00580141-56). April 15, 1991 deposition transcript of Joan Egrie. Reply Of Opponent II, Kirin-Amgen, Inc., To The Response Of the Patentee, Genetics Institute, Inc., In the Opposition To EP 209 539. (AM-ITC 0031241172). Declaration of Thomas Heckler, dated May 19, 1992. (AM-ITC 00311601-18). Declaration of Eugene Goldwasser, dated January 23, 1993. (AM-ITC 01009089129). [submitted for in camera review] Terminal Disclaimer in the `381 File History (Paper 8), dated December 20, 1996. (AM-ITC 00898338-41). February 20, 2007 Third Party Marshall, Gerstein & Borun LLP's Objections and Responses to Subpoena Ad Testificandum and Duces Tecum, Objections and Response to Request No. 1. March 27, 2007 Letter from Ross to Rycroft. [submitted for in camera review] Physician's Desk Reference (44th ed. 1990) at 616. Amgen's June 1994 Product Label for Epogen®. (AM-ITC 00601553-60). March 9, 2007 Product Labels for Epogen® and Procrit® available at http://www.accessdata.fda.gov.

Exhibit 124 Exhibit 125

Exhibit 126 Exhibit 127 Exhibit 128 Exhibit 129 Exhibit 130

Exhibit 131 Exhibit 132 Exhibit 133 Exhibit 134 Exhibit 135

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Exhibit 136 Exhibit 137 Exhibit 138 Exhibit 139 Exhibit 140 Exhibit 141 Exhibit 142 Exhibit 143 Exhibit 144 Exhibit 145 Exhibit 146 Exhibit 147 Exhibit 148 Exhibit 149 Exhibit 150

[submitted for in camera review] Office Action in the `298 File History (Paper 17), dated June 18, 1987. (R008892042-48). Applicant's Amendment and Reply Under 37 C.F.R. §§ 1.111 and 1.115 in the `298 File History (Paper 20), dated July 8, 1987. (R008892053-75). Examiner Interview Summary Record in the `298 File History (Paper 21), dated July 30, 1987. (R008892076). [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] Gaylis et al., "In Vitro Models of Human Testicular Germ-Cell Tumors", World J. Urol., 2:2-5 (1984). Drs. Ascensao, Gaylis, Fraley, Bronson and Zanjani, entitled "Inducible Production of Erythropoietin By A Human Yolk Sac Tumor Line." (AM-ITC 00057739). [submitted for in camera review] Intentionally left blank. Ascensao et al., "Erythropoietin Production by a Human Testicular Germ Cell Line", Blood 62(5):1132-34 (1983). [submitted for in camera review] U.S. Patent No. 5,441,868. EP 0 093 619.

Exhibit 151 Exhibit 152 Exhibit 153 Exhibit 154 Exhibit 155 Exhibit 156

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Exhibit 157 Exhibit 158 Exhibit 159 Exhibit 160 Exhibit 161 Exhibit 162 Exhibit 163 Exhibit 164 Exhibit 165 Exhibit 166 Exhibit 167 Exhibit 168 Exhibit 169 Exhibit 170 Exhibit 171 Exhibit 172 Exhibit 173 Exhibit 174 Exhibit 175 Exhibit 176 Exhibit 177 Exhibit 178

February 21, 1984 Genentech Press http://www.gene.com/gene/news/press-releases.

Release,

accessible accessible

at at

November 13, 1987 FDA Press Release, http://www.fda.gov/bbs/topics/NEWS/NEW00191.html.

Office Action in the `179 File History (Paper 9), mailed on August 3, 1988. (AMITC 00953226-31) U.S. Patent No. 4,766,075. Information Disclosure Statement in the `179 File History (Paper 15), dated September 26, 1988. (AM-ITC 00953279-81). Notice of Allowability in the `179 File History. (AM-ITC 00953308). Notice of Allowability with an illegible date in the `381 File History (Paper 12). (AM-ITC 00898389-90). U.S. Patent No. 4,966,843 (McCormick et al.). U.S. Serial No. 438,991. September 6, 1984 Declaration Under 37 C.F.R. § 1.131 in the `843 File History. MPEP § 706.02 (5th ed., Rev. 6, Oct. 1987). [submitted for in camera review] [submitted for in camera review] U.S. Patent No. 5,756,349. [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] MPEP § 2004 (5th ed. Rev. 3, May 1986). MPEP § 2004 (8th ed. Rev. 5, Aug. 2006). [submitted for in camera review] [submitted for in camera review]

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Exhibit 179 Exhibit 180 Exhibit 181 Exhibit 182 Exhibit 183 Exhibit 184 Exhibit 185 Exhibit 186 Exhibit 187 Exhibit 188 Exhibit 189

Amgen's Amended Complaint against Hoechst Marion Roussel, Inc., dated October 7, 1999. (AM-ITC 00823572-90). MPEP § 2001.06(b) (5th ed. Rev. 3, May 1986). MPEP § 2001.01 (8th ed. Rev. 5, Aug. 2006). U.S. Gen. Accounting Office, GAO-RCED-89-120BR, Biotechnology, Backlog of Patent Applications, at 20 (1989). Examiner Interview Summary Record in the `178 File History (Paper 51), dated March 14, 1996. (AM-ITC 00941552-53). U.S. Patent No. 5,955,422. Preliminary Amendment in the `741 File History (Paper 2), dated November 6, 1990. (AM-ITC 00899075-87). [submitted for in camera review] Amendment Under Rule 1.116 in the `197 File History (Paper 18), dated December 20, 1993. (AM-ITC 00899150-54). Examiner Interview Summary Record in the `197 File History (Paper 17), dated November 23, 1993. (AM-ITC 00899148-49). Garcia, JF, and JC Schooley, "Disassociation of Erythropoietin from Erythropoietin-Antierythropoietin Complex," Proc. Soc. Biol. Med. 138:213-215 (1971). [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] Information Disclosure Statement and accompanying PTO-1449 in the `197 File History (Paper 34), dated April 28, 1999. (AM-ITC 00899477-515). Office Action in the `197 File History (Paper 20), mailed on June 1, 1994. (AMITC 00899157-61). Request for Reconsideration in the `197 File History (Paper 23), dated December 1, 1994. (AM-ITC 00899169-75).

Exhibit 190 Exhibit 191 Exhibit 192 Exhibit 193 Exhibit 194 Exhibit 195 Exhibit 196 Exhibit 197

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Exhibit 198 Exhibit 199 Exhibit 200 Exhibit 201 Exhibit 202

[submitted for in camera review] [submitted for in camera review] Amendment in the `197 File History (Paper 33), dated April 28, 1999. (AM-ITC 00899469-75). [submitted for in camera review] Garcia, "Radioimmunoassay of erythropoietin: circulating levels in normal and polycythemic human beings", J. Lab. Clin. Med., 99:5 624-635 Apr. (1982). (AM-ITC 00478389-400). Yalow, R.S. and Berson, S.A., "Immunoassay of Endogenous Plamsa Insulin in Man," J. Clin. Invest. 39, 1157-75. (1960). Yalow, R."Radioimmunoassay: A Probe for Fine Structure of Biological Systems", Nobel Lecture, pp. 447-68 (12/8/77). Exhibit 205 is intentionally left blank. Garcia, J. F. "Assays for Erythropoietin" in Kidney Hormones (1977) vol. 2, pp. 7-35. Clemons, G.K. (1988) Comparison of Radioimmunoassay and Bioassays of Erythropoietin, in REGULATION OF ERYTHROPOIESIS: SYMPOSIUM ON ERYTHROPOIESIS 363-374. Garcia, J.F. "Radioimmunoassay of Human Plasma Erythropoietin" in: Regulation of Erythropoiesis: 1st International Conference on Hematopoiesis (1971), pp. 132-153. U.S. Patent No. 4,254,095. Sherwood and Goldwasser, "A radioimmunoassay for erythropoietin," Blood (1979) 54(4), pp. 885-893 (1979). Garcia et al, "Radioimmunoassay of erythropoietin," Blood Cells (1979) 5(3), PP. 405-419. Zaroulis et al., "A microimunnoflourescent assay to detect human granulocyte antigens & antibodies." Am. J. Hematol. (1981) 10, pp. 65-73. Rege et al., "A radioimmunoassay for erythropoietin: serum levels in normal human subjects and patients with hematopoietic disorders," J. Lab. Clin. Med. (1982) 100(6), pp. 829-843.

Exhibit 203 Exhibit 204 Exhibit 205 Exhibit 206 Exhibit 207

Exhibit 208

Exhibit 209 Exhibit 210 Exhibit 211 Exhibit 212 Exhibit 213

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Exhibit 214

Sytkowski and Sue, "A novel radioimmunoassay for human erythropoietin using a synthetic NH2 terminal peptide and antipeptide antibodies," J. Immunol. Methods (1983) 69(2), pp. 181-186. Egrie et al., "Development of radioimmunoassays for human erythropoietin using recombinant erythropoietin as tracer and immunogen," J. Immunol. Methods (1987) 99(2), pp. 235-241. Goldwasser, J. Biol. Chem., vol. 249, pp. 4202-06 (1974). White et al., "Studies in erythropoietin" Recent Prog. Horm. Res., 16:219, 1960. Goldwasser, "Studies on Erythropoiesis," J. Lab. Clin. Med. 50(4):534-42 (1958). Cotes and Bangham, "The international reference preparation of erythropoietin," (1966) Bull. World Health Org 35(5), 751-760. Annable et al., "The Second International Reference Preparation of Erythropoietin, Human, Urinary, For Bioassay." Bull. World Health Org. (1972), 47(1), pp. 99-112 [submitted for in camera review] Storring and Gaines Das, "The International standard for recombinant DNAderived erythropoietin," J. of Endocrinology, Vol. 134, pp. 459-84 (1992). June 21-22, 1982 (UCH00002512-17). Report of the Erythropoietin Assay Workshop.

Exhibit 215

Exhibit 216 Exhibit 217 Exhibit 218 Exhibit 219 Exhibit 220

Exhibit 221 Exhibit 222 Exhibit 223 Exhibit 224 Exhibit 225 Exhibit 226 Exhibit 227 Exhibit 228 Exhibit 229 Exhibit 230 Exhibit 231 Exhibit 232 Exhibit 233

[submitted for in camera review] [submitted for in camera review] [submitted for in camera review] MPEP § 2001.04 (5th ed. Rev. 14, 1992). MPEP § 2363.02 (5th ed. Rev. 13, Nov. 1989). MPEP § 2363.02 (8th ed., Aug. 2001). MPEP § 2301 (8th ed. Rev. 5, Aug. 2006). MPEP § 706 (5th ed. Rev. 6, Oct. 1987). MPEP § 706 (8th ed. Rev. 5, Aug. 2006). MPEP § 708.02 (5th ed. Rev 6, Oct. 1987).

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Exhibit 234 Exhibit 235 Exhibit 236 Exhibit 237 Exhibit 238 Exhibit 239 Exhibit 240 Exhibit 241 Exhibit 242 Exhibit 243 Exhibit 244 Exhibit 245 Exhibit 246 Exhibit 247 Exhibit 248 Exhibit 249

MPEP § 708.02 (8th ed. Rev. 5, Aug. 2006). U.S. Patent No. 4,879,272. "Guidelines for Reexamination Of Cases In View of In Re Portola Packaging, Inc." 1223 OG 124. Office Action in the `874 File History (Paper 38), mailed on August 16, 1994 (AM-ITC 00941455-66). Office Action in the `874 File History (Paper 43), mailed on May 17, 1995 (AMITC 00941522-29). Declaration of interference in the `741 File History (Paper 8), mailed on November 20, 1992 (AM-ITC 00899104-07). Interference Digest in the `741 File History (Paper 9) (AM-ITC 00899108-09). Declaration of interference in the `741 File History (Paper 8), mailed on November 20, 1992. (AM-ITC 00899104-07). Portions of U.S. Patent No. 5,618,698. [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] [submitted for in camera review] Office Action in the `178 File History (Paper 16), mailed on September 18, 1989. (AM-ITC 00941198-203). Decision on Petition to Make Special in the `179 File History (Paper 5). (AMITC 00953191-92). Communication from Examiner Schain in the `178 File History (Paper 21). (AMITC 00941224-27).

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Dated: July 5, 2007 Boston, Massachusetts

Respectfully submitted, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By their attorneys, /s/ Keith E. Toms Lee Carl Bromberg (BBO# 058480) Timothy M. Murphy (BBO# 551926) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel. [phone] [e-mail] Leora Ben-Ami (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Christopher T. Jagoe (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. [phone]

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CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies will be sent to those indicated as non registered participants on the above date. /s/ Keith E. Toms Keith E. Toms
03099/00501 698599.1

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