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

Filing 633

Opposition re #544 MOTION for Summary Judgment of No Inequitable Conduct filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Appendix A#2 Appendix B)(Toms, Keith) Additional attachment(s) added on 7/6/2007 (Paine, Matthew).

D

Appendix A. Rejections in the `178 Amgen Did Not Disclose in the `179
Date 10/23/87 `178 Line of Prosecution Application filed Ex. Kushan rejected all claims pending in the `178, including claim 55, which was directed to a pharmaceutical composition comprising an effective amount of polypeptide. The rejection was under §103, as obvious over Miyake, Takezawa, Chiba or Sugimoto in view of Papayannopoulo (all disclosing uEPO). (R. Ex. 99 (AM-ITC 00941089-100). 6/2/1988
Claim 1: A purified and isolated polypeptide having all or part of the structural conformation and one or more of the biological properties of a naturally-occurring erythropoietin and characterized by being the product of an exogenous DNA sequence." Claim 55: "A pharmaceutical composition of an effective amount of a polypeptide according to claims 1, 16, 39, 40 or 41 and a pharmaceutically acceptable diluent, adjuvant or carrier."

Examiner in the `178 Line

`179 Line of Prosecution Application filed

Examiner in the `179 Line

Ex. Kushan

Ex. Tanenholtz

2/10/1989

Ex. Kushan rejected all pending claims of the `178 application, including claims 55 and 6166 over Miyake, Chiba, Takezawa or Sugimoto in view of Papayannopoulo. (all disclosing uEPO). (R. Ex. 109 (AM-ITC 00941147-60)).
Claim 41: "A glycoprotein product having a primary structural conformation and glycosylation sufficiently duplicative of that of a naturally occurring human erythropoietin to allow possession of the in vivo biological property of causing bone marrow cells to

Ex. Kushan

Ex. Tanenholtz

Appendix A-1
ockets.Justia.com

Date

`178 Line of Prosecution
increase production of reticulocytes and red blood cells and having an average carbohydrate composition which differs from that of naturally occurring human erythropoietin. Claim 55: "A pharmaceutical composition comprising an effective amount of a glycoprotein product according to claim 41 and a pharmaceutically acceptable diluent, adjuvant or carrier."

Examiner in the `178 Line

`179 Line of Prosecution

Examiner in the `179 Line

Ex. Kushan rejected pending claims 67-73 due to double patenting over Lai, §102(b) over Sugimoto, and §103 over Sugimoto in view of Papayannopoulo (all disclosing uEPO). (R. Ex. 247 (AM-ITC 00941198-203)).
67. A glycoprotein product of the expression of an exogenous DNA sequence in a eucaryotic host cell, said product having a primary structural conformation and glycosylation sufficiently duplicative of that of a naturally occurring human erythropoietin to allow possession of the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells and having an average carbohydrate composition which differs from that of naturally occurring human erythropoietin. Claim 73: "A pharmaceutical composition comprising an effective amount of a glycoprotein product according to Claim 67 and a pharmaceutically acceptable diluent, adjuvant or carrier." "These product-by-process claims are presented in an effort to positively recite the physical properties of recombinant erythropoietin, and to further define the product of the invention since the recombinant erythropoietin claimed can not be precisely defined except by the process by which it is produced." (R. Ex.

Ex. Kushan

Ex. Tanenholtx

9/18/1989

Appendix A-2

Date
86).

`178 Line of Prosecution

Examiner in the `178 Line

`179 Line of Prosecution

Examiner in the `179 Line

9/18/1989

In a Final Office Action, Ex. Kushan once again rejected claims 67-75 due to double patenting over Lai.

Ex. Kushan

Ex. Tanenholtz

Ex. Schain

11/6/1990

Applicant sought to prosecute claims in the `741 application substantially similar to the pharmaceutical composition claims rejected on June 2, 1988, February 10, 1989, June 20, 1989 and September 18, 1989 in the `178 prosecution. Applicant did not inform Ex. Nolan of the prior rejection.
Claim 61: An erythropoietin-containing, pharmaceutically acceptable composition wherein human serum albumin is mixed with erythropoietin. Claim 63: A composition according to claim 61 containing a therapeutically effective amount of recombinant erythropoietin.

Ex. Nolan (`741 application)

Ex. Fitzgerald

08/02/1993

Applicant continued to prosecute claims in the `197 application that were substantially similar to pharmaceutical composition claims rejected on June 2, 1988, February 10, 1989, June 20, 1989 and September 18, 1989 without informing Exr. Stanton of those rejections.
See claims 61, 63 above.

Ex. Stanton (`197 application)

1/3/1994

Ex. Fitzgerald

Applicant added new claims 72-75 to the `179 application that were substantially

Examiner Hodges

Appendix A-3

Date

`178 Line of Prosecution

Examiner in the `178 Line

`179 Line of Prosecution similar to claims 62-66 and 68-72 in the `178 prosecution, which were rejected on February 10, 1989, June 20, 1989 and September 18, 1989. Applicant did not inform Exr. Hodges of that prior rejection.
Claim 72: A process for the preparation of an in vivo biologically active glycosylated erythropoietin polypeptide comprising the steps of: (a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and (b) isolating said glycosylated erythropoietin polypeptide therefrom.

Examiner in the `179 Line (`179 application)

Mr. Borun files IDS with 375 references, including Miyake, Takezawa, Chiba, Sugimoto and Papayannopoulo which were also disclosed in `178 application. 8/1994 Martinell takes over prosecution of `933 Ex. Martinell Ex Martinell Martinell takes over prosecution of `868 Notice of Allowability for `868 patent
Claim 1. A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of: (a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and

Ex. Martinell Ex. Martinell (`179 application)

2/6/1995

Appendix A-4

Date

`178 Line of Prosecution

Examiner in the `178 Line

`179 Line of Prosecution
(b) isolating said glycosylated erythropoietin polypeptide therefrom.

Examiner in the `179 Line

Notice of Allowability in `933
Claim 4. A non-naturally occurring human erythropoietin glycoprotein possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells which is the product of the process comprising the steps of: (a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding the human erythropoietin amino acid sequence set out in FIG. 6 or a fragment thereof; and (b) isolating a glycosylated erythropoietin polypeptide therefrom.

Ex. Martinell

Ex. Martinell

3/15/1996

4/21/99

Ex. Martinell takes over prosecution of `422 Applicant adds claim which issue as `422 patent that were substantially similar to pharmaceutical composition claims rejected on June 2, 1988, February 10, 1989, June 20, 1989 and September 18, 1989 without Ex. Martinell (`197 application)

4/28/99

64. A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture. 65. A pharmaceutically-acceptable preparation containing a therapeutically effective amount of

Appendix A-5

Date

`178 Line of Prosecution

Examiner in the `178 Line

`179 Line of Prosecution
erythropoietin wherein human serum albumin is mixed with said erythropoietin. "The application further discloses that the glycosylation of human erythropoietin may differ depending upon the host cell used for production. Claim 64, however, excludes EPO that is isolated from human urine by the phrase "purified from mammalian cells grown in culture." This phrase is intended to include any EPO produced by mammalian cells (human, CHO, COS, etc.) that are grown in culture, which means in vitro, In contrast to Claim 64, newly added Claim 65 does not limit the source of the EPO but does specify that the EPO is mixed with human serum albumin in the preparation." (R. Ex. 200 AM-ITC 00899474).

Examiner in the `179 Line

4/28/99

Amgen submits IDS with 392 references, including Miyake, Takezawa, Chiba, Sugimoto and Papayannopoulo,which were also disclosed in `178 application. Ex. Martinell allows `422

Ex. Martinell

5/28/99
03099/00501 699171.1

Appendix A-6