Velander v. Garner
| Decision Date | 05 November 2003 |
| Docket Number | No. 02-1366.,(Interference No. 104,242),02-1366. |
| Citation | 348 F.3d 1359 |
| Parties | William H. VELANDER, William N. Drohan, Henryk Lubon (Deceased) and John L. Johnson (Deceased), Appellants, v. Ian GARNER, Michael L. Dalrymple, Donna E. Prunkard, and Donald C. Foster, Appellees. |
| Court | U.S. Court of Appeals — Federal Circuit |
R. Elizabeth Brenner, Foley & Lardner, of Washington, DC, argued for appellants. With her on the brief were Stephen A. Bent and Jack L. Lahr.
James F. Haley, Jr., Fish & Neave, of New York, NY, argued for appellees. With him on the brief was Karen Mangasarian.
Before SCHALL, GAJARSA, and PROST, Circuit Judges.
Opinion for the court filed by Circuit Judge SCHALL, in which Circuit Judge PROST joins. Dissenting opinion filed by Circuit Judge GAJARSA.
This appeal stems from an interference proceeding involving the claims of United States Patent Application Serial No. 08/443,184 (the "'184 application") and United States Patent No. 5,639,940 (the "'940 patent"). William H. Velander, William N. Drohan, Henryk Lubon (deceased), and John L. Johnson (deceased) (collectively "Velander") are the inventors named on the '184 application. Ian Garner, Donna E. Prunkard, and Donald C. Foster (collectively "Garner") are the inventors named on the '940 patent. Velander appeals the decision of the United States Patent and Trademark Office, Board of Patent Appeals and Interferences ("Board"), that granted Garner's preliminary motion to have all of the allowed claims of the '184 application held unpatentable as obvious over the prior art. Garner v. Velander, Interference No. 104,242 (B.P.A.I. Aug. 16, 2001) ("Velander"). Because the decision of the Board is supported by substantial evidence and is not contrary to law, we affirm.
This case relates to the production of non-human mammals that have been genetically altered ("transgenic animals") so that they produce the enzyme fibrinogen in its biologically active state. After the enzyme is produced, it is recovered from the milk of the mammal. The fibrinogen enzyme consists of two copies of three separate peptides: the Aα chain, the Bβ chain, and the γ chain.
Fibrinogen is normally synthesized by the liver and plays a key role in blood clotting. An absence of fibrinogen in a human can lead to a malfunction in the blood clotting process. The production and isolation of biologically active fibrinogen can provide a source of fibrinogen to treat individuals suffering from a deficiency of the enzyme. The present interference involves competing claims to a transgenic animal (and methods to make such an animal) that produces fibrinogen and secretes it into its milk.
The '184 application (also referred to as the "Velander application") was filed on May 17, 1995. The application was afforded the benefit of the February 18, 1994 filing date of its parent application, United States Patent Application Serial No. 08/198,068. The claims of the Velander application are directed to (i) the production of a transgenic animal that expresses a foreign (or heterologous) biocompetent fibrinogen protein and (ii) a method of producing biocompetent fibrinogen using such an animal.
On March 3, 1994, Garner filed United States Patent Application Serial No. 08/206,176. The '940 patent (also referred to as the "Garner patent") issued from that application. Upon issuance, the '940 patent was assigned to Pharmaceutical Proteins Ltd. and ZymoGenetics, Inc. The claims of the Garner patent, like those of the Velander application, are directed to both the production of a transgenic animal that expresses a foreign (or heterologous) biocompetent fibrinogen protein and a method of producing biocompetent fibrinogen using such an animal.1
On June 30, 1998, the Examiner allowed claims 64-73 of the Velander application, but declared an interference between those claims and the issued Garner patent. The interference was declared on the ground that claims 64-73 of the '184 application and claims 1-33 of the '940 patent either corresponded to the proposed interference counts or would require performance of the method in the counts in order to produce the claimed transgenic animals. The interference counts, which corresponded to all of Velander's allowed claims (64-73) and all of Garner's patented claims (1-33), were as follows:
A method for producing biocompetent fibrinogen comprising:
providing a transgenic female non-human mammal carrying in its germline heterologous DNA segments Aα, Bβ, and γ chains of fibrinogen, wherein said segments are expressed in a mammary gland of said mammal and biocompetent fibrinogen encoded by said segments is secreted into milk of said mammal;
collecting milk from said mammal; and recovering said biocompetent fibrinogen from said milk.
A transgenic non-human female mammal that produces recoverable amounts of biocompetent human fibrinogen in its milk, wherein said mammal comprises:
a first DNA segment encoding a secretion signal operably linked to a heterologous fibrinogen Aα chain,
a second DNA segment encoding a secretion signal operably linked to a heterologous fibrinogen Bβ chain, and
a third DNA segment encoding a secretion signal operably linked to a heterologous fibrinogen γ chain, and
further wherein each chain is derived from the same species and is operably linked to additional DNA segments required for its expression in the mammary gland of a host female mammal.
A non-human mammal carrying in its germline DNA segments encoding Aα, Bβ, and γ chains of fibrinogen, wherein female progeny of said mammal express said DNA segments in a mammary gland to produce biocompetent fibrinogen.
In due course, after the interference was declared, Garner moved to have Velander's claims 64-73 held unpatentable under 35 U.S.C. §§ 102(b) and 103 (2000).2 In its motion, Garner conceded that if it succeeded in having the claims of the Velander application held unpatentable, the claims of the '940 patent, all of which included the use of cDNA for the production of fibrinogen, would also be unpatentable. Garner did, however, maintain that the use of genomic DNA for the production of fibrinogen, as described in Garner's Reissue Application No. 09/232,488, filed January 15, 1999, was still patentable.3 Because Garner did not identify a single reference that anticipated all of the limitations of any of the claims at issue, the Board stated that it understood Garner's argument to be that the subject matter of Velander's claims was unpatentable under section 103 in view of section 102(b) prior art. Since Velander did not argue that its claims were separately patentable and did not dispute Garner's assertion that either claim 64 or 65 of the '184 application would be a representative claim upon which an obviousness analysis could be based, the Board determined patentability on the basis of claim 65. Claim 65 of the Velander application is as follows:
A transgenic non-human female mammal that produces recoverable amounts of biologically active human fibrinogen that is converted to fibrin upon reaction with human thrombin in its milk, wherein said mammal comprises:
a first DNA segment encoding a secretion signal operably linked to a heterologous fibrinogen Aα chain,
a second DNA segment encoding a secretion signal operably linked to a heterologous fibrinogen Bβ chain, and
a third DNA segment encoding a secretion signal operably linked to a heterologous fibrinogen γ chain, and
further wherein each chain is derived from the same species and is operably linked to additional DNA segments required for its expression in the mammary gland of a host female mammal.
Velander, slip op. at 6.
Pursuant to 35 U.S.C. § 103(a),
[a] patent may not be obtained ... if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.
The ultimate determination of whether an invention would have been obvious under section 103(a) is a legal conclusion based on underlying findings of fact. In re Kotzab, 217 F.3d 1365, 1369 (Fed.Cir.2000). The underlying factual inquiries include (1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; and (3) the differences between the claimed invention and the prior art. Graham v. John Deere Co., 383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). If all the elements of an invention are found in a combination of prior art references,
a proper analysis under § 103 requires, inter alia, consideration of two factors: (1) whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process; and (2) whether the prior art would also have revealed that in so making or carrying out, those of ordinary skill would have a reasonable expectation of success.
In re Vaeck, 947 F.2d 488, 493 (Fed.Cir.1991) (citing In re Dow Chem. Co., 837 F.2d 469, 473 (Fed.Cir.1988)). Both the suggestion and the reasonable expectation of success "must be founded in the prior art, not in the applicant's disclosure." Id. Before the Board, as the moving party, Garner had the burden of establishing by a preponderance of the evidence that the invention of claim 65 of the Velander application would have been obvious as of February 18, 1993, one year before the filing of Velander's 08/198,068 application (the "critical date"). Bruning v. Hirose, 161 F.3d 681, 685-86 (Fed.Cir.1998) (); Velander, slip op. at 4, 6.
In support of its motion, Garner argued to the Board that all the elements of the '184...
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