Ex parte SHAPIRODownload PDFBoard of Patent Appeals and InterferencesJan 27, 200008396988 (B.P.A.I. Jan. 27, 2000) Copy Citation Application for patent filed March 1, 1995. According to appellant, this application1 is a divisional of Application 08/068,392, filed May 28, 1993, which is currently the subject of an appeal (Appeal No. 1995-2464) pending before this Board. We have considered the two appeals together. 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opinion in support of the decision being entered today (1) was not written for publication in a law journal and (2) is not binding precedent of the Board.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. 15 UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte STEVEN D. SHAPIRO ____________ Appeal No. 1997-3329 Application No. 08/396,9881 ____________ ON BRIEF ____________ Before WILLIAM F. SMITH, ELLIS, 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 claim 3, the only remaining pending claim. Appeal No. 1997-3329 Application No. 08/396,988 2 Claim 3 is reproduced below: 3. Human macrophage metalloelastase in essentially pure form and having the 470 amino acid sequence shown in SEQ ID NO:2. The references relied upon by the examiner are: Flier et al. (Flier) 5,223,425 June 29, 1993 (filed November 30, 1988) Docherty et al. (Docherty) WO87/07907 Dec. 30, 1987 Shapiro et al. (Shapiro), "Molecular Cloning, Chromosomal Localization, and Bacterial Expression of a Murine Macrophage Metalloelastase," J. Biol. Chem., vol. 267, no. 7, pp. 4664-4671 (1992). Gray et al. (Gray), "Two Interleukin 1 Genes in the Mouse: Cloning and Expression of the cDNA for Murine Interleukin 1$," The J. of Immunology, vol. 137, no. 11, pp 3644-3648 (1986). Ground of Rejection Claim 3 stands rejected under 35 U.S.C. § 103. As evidence of obviousness, the examiner relies upon Shapiro, Flier, Docherty and Gray. We reverse. BACKGROUND The applicant's invention, as described at page 3 of the specification, is directed to a human macrophage metalloelastase (HME), which is a proenzyme having a molecule mass of 54 kDa and the amino acid sequence containing 470 amino acids (SEQ ID NO: 2). Metalloproteinases are said to comprise a family of structurally related matrix Appeal No. 1997-3329 Application No. 08/396,988 3 degrading enzymes involved in normal embryonic development, growth, tissue remodeling, and tissue repair and the claimed proteinase is described as useful in a manner similar to other known matrix metalloproteinases that have elastolytic activity. DISCUSSION: The rejection 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 dispositive question is whether those of ordinary skill in this art at the time of the invention would have found the claimed human macrophage metalloelastase obvious from the disclosure of a murine macrophage metalloelastase and the disclosure of Shapiro that a homologous metalloelastase, not specifically described, could exist and would be desirable to isolate. We agree with the examiner that one skilled in the art could reasonably read the statement in Shapiro that: . . . we demonstrated that Mme is located on mouse chromosome 9, suggesting that the human homolog of Mme may map to human chromosome 19 . . . . as indicating the existence of the human macrophage metalloelastase. However, this interpretation is in contrast with the statement at page 3 of the specification that: despite the efforts of many investigators, human macrophage elastase activity could not be documented and many doubted its existence. Appeal No. 1997-3329 Application No. 08/396,988 4 The examiner has offered no other evidence in support of the proposition that the human macrophage elastase was known in the prior art at the time of applicant's invention. Absent evidence establishing that the protein was known, it would not have been obvious to use the methodology of Shapiro, Flier or Docherty in combination with the cDNA library of Gray to isolate and characterize an unknown protein. When we weigh all of the evidence, it is not clear what the situation was at the time of the invention. However, 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 these circumstances, we are constrained to reach the conclusion that the examiner has failed to provide the evidence necessary to support a prima facie case of obviousness as to the claimed human macrophage metalloelastase having the amino acid sequence of SEQ ID NO:2. 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 3 under 35 U.S.C. § 103 is reversed. Appeal No. 1997-3329 Application No. 08/396,988 5 SUMMARY To summarize, the decision of the examiner to reject claim 3 under 35 U.S.C. § 103 is reversed. REVERSED WILLIAM F. SMITH ) Administrative Patent Judge ) ) ) ) JOAN ELLIS ) BOARD OF PATENT Administrative Patent Judge ) APPEALS AND ) INTERFERENCES ) ) DOUGLAS W. ROBINSON ) Administrative Patent Judge ) Appeal No. 1997-3329 Application No. 08/396,988 6 Roger A. Williams G D Searle & Co. 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