561 F.3d 1351 (Fed. Cir. 2009), 2008-1184, In re Kubin
|Citation:||561 F.3d 1351, 90 U.S.P.Q.2d 1417|
|Party Name:||In re Marek Z. KUBIN and Raymond G. Goodwin.|
|Case Date:||April 03, 2009|
|Court:||United States Courts of Appeals, Court of Appeals for the Federal Circuit|
Barbara R. Rudolph, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for appellants. With her on the brief were Herbert H. Mintz and Bart A. Gerstenblith. Of counsel was Stuart L. Watt, Wendy A. Whiteford and Gail A. Katz, Amgen Inc., of Thousand Oaks, CA, and Kathleen Fowler, of Seattle, WA.
Janet A. Gongola, Associate Solicitor, Office of the Solicitor, United States Patent and Trademark Office, of Arlington, VA, argued for the Director of the United States Patent and Trademark Office. With her on the brief were William G. Jenks, Mary L. Kelly, and Stephen Walsh, Associate Solicitors. Of counsel was Raymond T. Chen, Associate Solicitor.
Rouget F. Henschel, Foley & Lardner LLP, of Washington, DC, for amicus curiae Biotechnology Industry Organization. With him on the brief were Stephen B. Maebius and Philip G. Kiko. Of counsel was Hans Sauer, Biotechnology Industry Organization, of Washington, DC, and Brian P. Barrett, Eli Lilly and Company, of Indianapolis, IN.
Matthew I. Kreeger, Morrison & Foerster LLP, of San Francisco, CA, for amicus curiae Novartis Vaccines and Diagnostics, Inc. Of counsel on the brief was Beth S. Brinkmann, of Washington, DC.
Jeffrey P. Kushan, Sidley Austin LLP, of Washington, DC, for amici curiae Glaxosmithkline, et al. With him on the brief were Paul J. Zegger, Jon P. Santamauro, and Eric M. Solovy.
James J. Kelley, Eli Lilly and Company, of Indianapolis, IN, for amicus curiae Eli Lilly and Company. With him on the brief were MaryAnn Wiskerchen, Gregory A. Cox, Steven P. Caltrider and Robert A. Armitage.
Before RADER, FRIEDMAN, and LINN, Circuit Judges.
RADER, Circuit Judge.
Marek Kubin and Raymond Goodwin (" appellants" ) appeal from a decision of the Board of Patent Appeals and Interferences (the " Board" ) rejecting the claims of U.S. Patent Application Serial No. 09/667,859 (" '859 Application" ) as obvious under 35 U.S.C. § 103(a) and invalid under 35 U.S.C. § 112 ¶ 1 for lack of written description. Ex parte Kubin, No. 2007-0819, 83 U.S.P.Q.2d 1410 (B.P.A.I.2007) (" Board Decision " ). Because the Board correctly determined that appellants' claims are unpatentably obvious, this court affirms.
This case presents a claim to a classic biotechnology invention-the isolation and sequencing of a human gene that encodes a particular domain of a protein. This court provided a primer on the basics of this technology in In re O'Farrell, 853 F.2d 894, 895-99 (Fed.Cir.1988). Specifically, appellants claim DNA molecules (" polynucleotides" ) encoding a protein (" polypeptide" ) known as the Natural Killer Cell Activation Inducing Ligand (" NAIL" ).
Natural Killer (" NK" ) cells, thought to originate in the bone marrow, are a class of cytotoxic lymphocytes that play a major role in fighting tumors and viruses. NK cells express a number of surface molecules which, when stimulated, can activate cytotoxic mechanisms. NAIL is a specific receptor protein on the cell surface that plays a role in activating the NK cells.
The specification of the claimed invention recites an amino acid sequence of a NAIL polypeptide. The invention further isolates and sequences a polynucleotide that encodes a NAIL polypeptide. Moreover, the inventors trumpet their alleged discovery of a binding relationship between NAIL and a protein known as CD48. The NAIL-CD48 interaction has
important biological consequences for NK cells, including an increase in cell cytotoxicity and in production of interferon. Representative claim 73 of appellants' application claims the DNA that encodes the CD48-binding region of NAIL proteins:
73. An isolated nucleic acid molecule comprising a polynucleotide encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48.
In other words, appellants claim a genus of isolated polynucleotides encoding a protein that binds CD48 and is at least 80% identical to amino acids 22-221 of SEQ ID NO:2-the disclosed amino acid sequence for the CD48-binding region of NAIL.
Appellants' specification discloses nucleotide sequences for two polynucleotides falling within the scope of the claimed genus, namely SEQ ID NO:1 and SEQ ID NO:3. SEQ ID NO: 1 recites the specific coding sequence of NAIL, whereas SEQ ID NO: 3 recites the full NAIL gene, including upstream and downstream non-coding sequences. The specification also contemplates variants of NAIL that retain the same binding properties:
Variants include polypeptides that are substantially homologous to the native form, but which have an amino acid sequence different from that of the native form because of one or more deletions, insertions or substitutions. Particular embodiments include, but are not limited to, polypeptides that comprise from one to ten deletions, insertions or substitutions of amino acid residues, when compared to a native sequence.
A given amino acid may be replaced, for example, by a residue having similar physiochemical characteristics. Examples of such conservative substitutions include substitution of one aliphatic residue for another, such as Ile, Val, Leu, or Ala for one another; substitutions of one polar residue for another, such as between Lys and Arg, Glu and Asp, or Gln and Asn; or substitutions of one aromatic residue for another, such as Phe, Trp, or Tyr for one another. Other conservative substitutions, e.g., involving substitutions of entire regions having similar hydrophobicity characteristics, are well known.
'859 Application at 26. However, the specification does not indicate any example variants of NAIL that make these conservative amino acid substitutions.
The Board rejected appellants' claims as invalid under both § 103 and § 112. With regard to the § 112 rejection, the Board found the genus of nucleic acids of representative claim 73 unsupported by an adequate written description. First, the Board observed that although appellants had sequenced two nucleic acids falling within the scope of claim 73, they had not disclosed any variant species where amino acids 22-221 were different in any way from the disclosed SEQ ID NO:2 sequence. Thus, the Board concluded that appellants were not entitled to their genus claim of DNA molecules encoding proteins 80% identical to SEQ ID NO:2:
[Appellants] have not described what domains of those sequences are correlated with the required binding to CD48, and thus have not described which of NAIL's amino acids can be varied and still maintain binding. Thus ... their Specification would not have shown possession of a sufficient number of sequences falling within their potentially large genus to establish possession of their claimed genus.
Without a correlation between structure and function, the claim does little more than define the claimed invention by
function. That is not sufficient to satisfy the written description requirement.
Board Decision at 16-17.
Regarding obviousness, the Board rejected appellants' claims over the combined teachings of U.S. Patent No. 5,688,690 (" Valiante" ) and 2 Joseph Sambrook et al., Molecular Cloning: A Laboratory Manual 43-84 (2d ed.1989) (" Sambrook" ). The Board also considered, but found to be cumulative to Valiante and Sambrook, Porunelloor Mathew et al., Cloning and Characterization of the 2B4 Gene Encoding a Molecule Associated with Non-MHC-Restricted Killing Mediated by Activated Natural Killer Cells and T Cells, 151 J. Immunology 5328-37 (1993) ( " Mathew" ).
Valiante discloses a receptor protein called " p38" that is found on the surface of human NK cells. Valiante teaches that the p38 receptor is present on virtually all human NK cells and " can serve as an activation marker for cytotoxic NK cells." '690 Patent col.3 ll.3-4; see also id. at col.5 ll.6-7 (" Stimulation of p38 results in activation of cytotoxicity" ). Valiante also discloses and claims a monoclonal antibody specific for p38 called " mAB C1.7." The Board found (and appellants do not dispute) that Valiante's p38 protein is the same protein as NAIL. Board Decision at 4. A monoclonal antibody is an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are useful as probes for specifically...
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