Ex parte Dowdle

Board of Patent Appeals and Interferences

Aug 14, 1998

07890335 (B.P.A.I. Aug. 14, 1998)

Application for patent filed May 26, 1992. According 1
to applicant, this application is a continuation of
Application No. 07/150,475, filed January 28, 1988; which is a
continuation of Application No. 06/843,405, filed March 24,
1986; which is a continuation of Application No. 06/559,569,
filed December 8, 1983; which is a continuation-in-part of
Application No. 06/513,145, filed July 12, 1983, all of which
were abandoned.
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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journal and (2) is not binding precedent of the Board.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. 47
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte EUGENE B. DOWDLE
________________
Appeal No. 95-0155
Application No. 07/890,3351
________________
HEARD: August 5, 1998
________________
Before WINTERS, GRON and OWENS, Administrative Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision
rejecting claims 69, 70, 72 through 78, 80 through 84, 87
Appeal No. 95-0155
Application No. 07/890,335
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through 90, and 92 through 96, which are all of the claims
remaining in the application.
REPRESENTATIVE CLAIMS
Claims 69 and 95, which are illustrative of the subject
matter on appeal, read as follows:
69. A method of treatment or prophylaxis of thrombosis,
embolism or other conditions where it is desired to produce
fibrinolytic or proteolytic activity selectively in the
presence of fibrin via the mechanism of plasminogen activation
which comprises administering by injection or intravenously to
a patient a plasminogen activator composition comprising a
plasminogen activator component, said component being a human
tPA/human pro-tPA couple composed of from 70 to 100% human
pro-tPA and from 0 to 30% human tPA.
95. A pharmaceutical composition suitable for the
treatment or prophylaxis of thrombosis or embolism which
composition acts selectively in the presence of fibrin by
means of local plasminogen activation and which is in dosage
units for injection or intravenous infusion, said composition
comprising:
(a) a human tPA/human pro-tPA couple composed of 70-100%
human pro-tPA and up to 30% human tPA; and
(b) a physiologically compatible medium.
THE REFERENCES
In rejecting all of the appealed claims under 35 U.S.C.
§ 103, the examiner relies on the following reference:
Collen et al. 0 041 766 Dec. 16, 1981
(European Patent Application)
Appeal No. 95-0155
Application No. 07/890,335
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In taking the position that a person having ordinary
skill in this art would have difficulty drawing a correlation
between in vitro test results and utility in vivo, the
examiner relies on the following reference:
Appeal No. 95-0155
Application No. 07/890,335
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D. Collen, "Synergism of Tissue-Type Plasminogen Activator
(t-PA) and Single-Chain Urokinase-Type Plasminogen Activator
(scu-PA) on Clot Lysis In Vitro and a Mechanism for this
Effect," 57 Thrombosis and Haemostasis no. 3, 373 (1987).
THE ISSUE
As stated in the Examiner's Answer, page 2, section (4),
the previously entered rejections under 35 U.S.C. § 112, first
paragraph, and under 35 U.S.C. § 103 over the Reich et al.
reference, have been withdrawn.
The sole issue on appeal is whether the examiner erred in
rejecting claims 69, 70, 72 through 78, 80 through 84, 87
through 90 and 92 through 96 under 35 U.S.C. § 103 as
unpatentable over European Patent Application 0 041 766.
DELIBERATIONS
Our deliberations in this matter have included evaluation
and review of the following materials: (1) the instant speci-
fication, including all of the claims on appeal; (2)
applicant's Appeal Brief, the Reply Brief, and the
Supplemental Reply Brief; (3) the Examiner's Answer; and (4)
the above-cited references relied on by the examiner.
On consideration of the record, including the above-
listed materials, we reverse the examiner's rejection under
35 U.S.C. § 103.
Appeal No. 95-0155
Application No. 07/890,335
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Appeal No. 95-0155
Application No. 07/890,335
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DISCUSSION
Initially, we agree with the examiner's finding that the
claimed pharmaceutical composition and method are not
described by European Patent Application 0 041 766 within the
meaning of 35 U.S.C. § 102.
We have carefully reviewed European Patent Application
0 041 766 in its entirety, including the claims therein. At
best, this reference suggests that pro-tPA has "sufficient
binding capacity to fibrin" and behaves "in the same way" as
tPA when subjected to immunodiffusion analysis and quenching
experiments (European Patent Application 0 041 766, Example 4,
last paragraph). This reference teaches the use of tPA, not
pro-tPA, as a pharmaceutical. See claims 18 and 19 of
European Patent Application 0 041 766, drawn to a
pharmaceutical composition and a method of preparing a
pharmaceutical composition, which depend from claims 1 through
3 but exclude the subject matter of claim 4 drawn to pro-tPA.
Contrary to what a person having ordinary skill would
have expected at the time the invention was made, per the
teachings of European Patent Application 0 041 766,
applicant's specification describes the superiority of pro-tPA
Appeal No. 95-0155
Application No. 07/890,335
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over tPA in treating thrombosis and related diseases. In
showing the characteristics of pro-tPA, and in predicting its
superior performance in vivo, applicant sets forth in vitro
data in the specification (Examples 8 and 10). The 1986 and
1988 publications of Rao and Rijken, respectively, further
support the fact stated in the specifi-cation that pro-tPA is
more advantageous than tPA as a pharma-ceutical for treating
thrombosis and related diseases. The Rao and Rijken
publications (copies attached to the Supplemental Reply Brief)
provide evidence that pro-tPA is clinically superior to tPA
when administered in vivo to human patients.
Having considered all the evidence of record, including
the Rao and Rijken publications, we find that the claimed
subject matter possesses unexpectedly superior properties. On
this basis, the rejection of claims 69, 70, 72 through 78, 80
through 84, 87 through 90 and 92 through 96 under 35 U.S.C.
§ 103 as unpatentable over European Patent Application 0 041
766 is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
Appeal No. 95-0155
Application No. 07/890,335
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)
)
TEDDY S. GRON ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
TERRY J. OWENS )
Administrative Patent Judge )
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