Ex parte SHAPIRO

Board of Patent Appeals and Interferences

Jan 27, 2000

08396988 (B.P.A.I. Jan. 27, 2000)

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publication in a law journal and (2) is not binding precedent of the Board.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
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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
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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.
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Application No. 08/396,988
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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
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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
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Roger A. Williams
G D Searle & Co.
Corporate Patent Law Department
P. O. Box 5110
Chicago, IL 60680
DWR/ki