Ex parte Fong et al.Download PDFBoard of Patent Appeals and InterferencesFeb 11, 200008090369 (B.P.A.I. Feb. 11, 2000) Copy Citation THIS OPINION WAS NOT WRITTEN FOR PUBLICATION The opinion in support of the decision being entered today (1) was not written for publication in a law journal and (2) is not binding precedent of the Board. Paper No. 34 UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte TUNG M. FONG, RUEY-RUEY C. HUANG, and CATHERINE D. STRADER ____________ Appeal No. 1996-1204 Application No. 08/090,369 ____________ HEARD: January 13, 2000 ____________ Before WINTERS, GRON, and ROBINSON, Administrative Patent Judges. ROBINSON, Administrative Patent Judge. DECISION ON APPEAL This is a decision on the appeal under 35 U.S.C. § 134 from the examiner's final rejection of claims 25-30, which are all of the claims pending in the case. Claims 25, 26, and 27 are representative of the claims on appeal, a copy of which are attached as an appendix to this decision. Appeal No. 1996-1204 Application No. 08/090,369 2 The references relied upon by the examiner are: Shigemoto et al. (Shigemoto), “Cloning and Expression of a Rat Neuromedin K Receptor cDNA,” Journal of Biological Chemistry, Vol. 265(2), pp. 623-628 (1990). Hopkins et al. (Hopkins), “Isolation and Characterization of the Human Lung NK-1 Receptor cDNA,” Biochemical and Biophysical Research Communications, Vol. 180(2), pp. 1110-1117 (1991). Gerard et al. (Gerard), “The Human Neurokinin A (Substance K) Receptor,” Journal of Biological Chemistry, Vol. 265(33), pp. 20455-20462 (1990). Fraser et al. (Fraser), “Cloning, Sequence Analysis, and Permanent Expression of a Human " -Adrenergic Receptor in Chinese Hamster Ovary Cells,” Journal of Biological2 Chemistry, vol. 264(20), pp. 11754-11761 (1989). A reference relied upon by appellants: Dietl et al. (Dietl), “Phylogeny of Tachykinin Receptor Localization in the Vertebrate Central Nervous System: Apparent Absence of Neurokinin-2 and Neurokinin-3 Binding Sites in the Human Brain,” Brain Research, Vol. 539, pp. 211-222 (1991). Grounds of Rejection Claims 25-28 and 30 stand rejected under 35 U.S.C. § 103. As evidence of obviousness, the examiner relies upon Shigemoto, Hopkins, and Gerard. Claim 29 stands rejected under 35 U.S.C. § 103. As evidence of obviousness, the examiner relies upon Shigemoto, Hopkins, Gerard, and Fraser. We reverse. Appeal No. 1996-1204 Application No. 08/090,369 3 BACKGROUND The applicants’ invention, as described at pages 1-4 of the specification, is directed to a cloned human neurokinin-3 receptor (NK-3) peptide and a recombinant DNA molecule which encodes the receptor. The human NK-3 is described as useful in an assay for the presence of neurokinin B, which binds preferentially to NK-3, as well as in conjunction with diagnosis to determine the body fluid concentration of neurokinin-B related substances in patients. Neurokinin B is a naturally occurring peptide belonging to the neurokinin family of peptides, is known in the art, and has been implicated in the pathophysiology of numerous diseases. DISCUSSION The rejections under 35 U.S.C. § 103 Obviousness is a legal conclusion based on the underlying facts. Graham v. John Deere Co., 383 U.S. 1, 17-18, 148 USPQ 459, 467 (1966); Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1270, 20 USPQ2d 1746, 1750 (Fed. Cir. 1991); Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1566-68, 1 USPQ2d 1593, 1595-97 (Fed. Cir. 1987). Here, the examiner has cited Shigemoto as describing (Answer, page 4-5): an isolated cDNA encoding the rat homologue of the encoded human NK-3 (neuromedin K) receptor (Figure 1, page 625) of the instant invention. Further disclosed by this reference was a plasmid containing that DNA and a COS cell transformed with that plasmid (first full paragraph in the left column on page 624). Figure 2 of this reference disclosed that the rat NK-3 (neuromedin K), NK-2 (substance K) and NK-1 (substance P) receptors, all of which are G protein-coupled receptors for tachykinins, have substantial sequence similarity which is greatest in the transmembrane domains. The examiner acknowledges that (Answer, page 5): Appeal No. 1996-1204 Application No. 08/090,369 4 [t]his reference did not describe an isolated DNA encoding a human NK-3 receptor or the protein encoded thereby. Hopkins is cited (Answer, page 5) as describing “the isolation of a DNA encoding a human NK-1 receptor by screening a human DNA library with a DNA encoding a rat NK-1 receptor” and disclosing that “the open reading frame from this human cDNA shared 89% sequence homology with a cDNA encoding a rat NK-1 receptor with the two sequences being most divergent at the two ends.” Similarly, Gerard is cited (Answer, page 6) as describing "the isolation of a DNA encoding a human NK-2 (substance K) receptor based upon its anticipated sequence similarity to a DNA encoding a bovine NK-2 receptor” and additionally disclosing “the substantial sequence similarity between the human, bovine and rat NK-2 receptors with the three sequences being most divergent at the two ends.” The examiner concludes (Answer, page 5): An artisan of ordinary skill, . . . would have found the isolation of a DNA encoding the human homologue of the rat NK-3 receptor described in the Shigemoto et. al. reference by screening a human DNA library with a DNA encoding that rat receptor in a manner directly analogous to the one described for the isolation of the DNA encoding the human NK-1 receptor in the Hopkins et. al. reference, to have been prima facie obvious at the time of the instant invention. The initial burden of presenting a prima facie case of obviousness rests on the examiner. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). On this record, the examiner has pointed to no evidence or facts which would reasonably establish that the presently claimed human NK-3, or the DNA which encodes it, were Appeal No. 1996-1204 Application No. 08/090,369 5 known at the time of the invention. We find no mention in Shigemoto of the human counterpart to the rat NK-3. Hopkins, at page 1111, makes a general reference to NK-1, NK-2, and NK-3, but does not state the source of the listed receptors. Similarly, Gerard only mentions NK3 at page 20455, column 2, second paragraph, and does not specify the source of the NK-3 receptor described. In rebuttal to the examiner's position, appellants cite Dietl (Principal Brief, page 15) as providing information regarding the level of knowledge in the art regarding human NK-3 receptors. In describing Dietl, appellants urge that (Principal Brief, page 16): because Dietl et al. suggest that the NK-3 receptor is not present in human brain tissue, there would not have been a reasonable likelihood of success that one of ordinary skill in the art would have been able to isolate the gene encoding the human NK-3 receptor, even if they employed the cDNA encoding the rat NK-3 receptor. Moreover, Dietl et al. actually teach away from the successful isolation of the human NK-3 receptor by suggesting that such an attempt would have been futile. The examiner criticizes the Dietl disclosure (Answer, pages 13-14) urging that in assaying for “eledoisin”, a mollusk neuropeptide, it was unlikely that a mammalian NK receptor would have been expected to bind and “an artisan would have had no expectations regarding the ability of the human homologue of the NK-3 receptor of Shigemoto et al. to bind any non-native ligand." Yet, this is the only evidence, before us, which speaks to the question of whether the human NK-3 receptor or the DNA which encodes it, was known at the time of the invention. We do not agree that it would have Appeal No. 1996-1204 Application No. 08/090,369 6 been obvious to use the methodology of Hopkins and Gerard to isolate, identify and characterize a protein not demonstrated to be known at the time of the invention. The examiner's reliance (Answer, page 14) on the concluding statements of both Hopkins and Gerard concerning further studies relating to the neurokinin receptor genes is too general in nature reasonably to point those of ordinary skill in this art toward the isolation and characterization of the claimed human NK-3 receptor and DNA encoding the receptor, when read in context of the teaching of the articles as a whole. On these facts, the examiner has failed to establish a prima facie case of unpatentability as to the claimed subject matter. Where the examiner fails to establish a prima facie case, the rejection is improper and will be overturned. In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir.1988). Therefore the rejection of claim 25-28 and 30 under 35 U.S.C. § 103 is reversed. In separately rejecting claim 29 under 35 U.S.C. § 103 the examiner has relied on Fraser in addition to Shigemoto, Hopkins and Gerard. However, Fraser does not provide that which we have determined to be missing in the previously discussed rejection. Therefore, this rejection is also reversed. Appeal No. 1996-1204 Application No. 08/090,369 7 SUMMARY To summarize, the decision of the examiner to reject claims 25-30 under 35 U.S.C. § 103 is reversed. REVERSED SHERMAN D. WINTERS ) Administrative Patent Judge ) ) ) ) TEDDY S. GRON ) BOARD OF PATENT Administrative Patent Judge ) APPEALS AND ) INTERFERENCES ) ) DOUGLAS W. ROBINSON ) Administrative Patent Judge ) Appeal No. 1996-1204 Application No. 08/090,369 8 J. Eric Thies Merck & Company, Inc. Patent Department P. O. Box 2000-RY60-30 Rahway, NJ 07065-0907 dwr/ki Appeal No. 1996-1204 Application No. 08/090,369 1 APPENDIX Appeal No. 1996-1204 Application No. 08/090,369 2 Appeal No. 1996-1204 Application No. 08/090,369 3 Appeal No. 1996-1204 Application No. 08/090,369 4 Copy with citationCopy as parenthetical citation