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

Filing 502

DECLARATION re #498 MOTION for Summary Judgment of No Obviousness-Type Double Patenting BY HARVEY F. LODISH, Ph.D. by Amgen Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C#4 Exhibit D-1#5 Errata D-2#6 Exhibit D-3#7 Errata D-4#8 Exhibit E-1#9 Exhibit E-2 (part 1)#10 Exhibit E-2 (part 2)#11 Exhibit E-3#12 Exhibit E-4#13 Exhibit E-5 (part 1)#14 Exhibit E-5 (Part 2)#15 Exhibit E-5 (part 3)#16 Exhibit E-6)(Gottfried, Michael)

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

Doc. 502 Att. 4

Case 1:05-cv-12237-WGY

Document 502-5

Filed 06/14/2007

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EXHIBIT D-1

Lodish Decl to Motion for SJ re ODP - Public

Dockets.Justia.com

Case 1:05-cv-12237-WGY

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Table D-1 Representative Original Group I Claims 1. A purified and isolated polypeptide having part or all of the primary structural conformation and one or more of the biological properties of naturally-occurring erythropoietin and characterized by being the product of procaryotic or eucaryotic expression of an exogenous DNA sequence. 40. A glycoprotein product having a primary structural conformation sufficiently duplicative of that of a naturally-occurring erythropoietin to allow possession of one or more of the biological properties thereof and having an average carbohydrate composition which differs from that of naturally-occurring erythropoietin. `933 Polypeptide Claims 1. A non-naturally occurring erythropoietin glycoprotein product having the in vivo biological activity of causing bone marrow cells to increase production of reticulocytes and red blood cells and having glycosylation which differs from that of human urinary erythropoietin. 2. The non-naturally occurring EPO glycoprotein product according to claim 1 wherein said product has a higher molecular weight than human urinary EPO as measured by SDS-PAGE. 3. A non-naturally occurring glycoprotein product of the expression in a mammalian host cell of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin said product possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells. 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. 5. A non-naturally occurring human erythropoietin glycoprotein possessing the in

Case 1:05-cv-12237-WGY

Document 502-5

Filed 06/14/2007

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Representative Original Group I Claims

`933 Polypeptide Claims 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 comprising a sequence encoding the leader sequence of human erythropoietin set out in FIG. 6; and (b) isolating a glycosylated erythropoietin polypeptide therefrom. 6. A non-naturally occurring glycoprotein product of the expression in a non-human eucaryotic host of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin, said product possessing the in vivo biological property of causing human 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 erythropoietin. 7. The glycoprotein product according to claim 3, 4, 5 or 6 wherein the host cell is a non-human mammalian cell. 7. The glycoprotein product according to claim 3, 4, 5 or 6 wherein the host cell is a nonhuman mammalian cell. 8. The glycoprotein product according to claim 7 wherein the non-human mammalian cell is a CHO cell.