Ex Parte Fager

Board of Patent Appeals and Interferences

Jun 17, 2008

11074893 (B.P.A.I. Jun. 17, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte GUNNAR FAGER
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Appeal 2008-1956
Application 11/074,893
Technology Center 1700
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Decided: June 17, 2008
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Before EDWARD C. KIMLIN, CATHERINE Q. TIMM, and
KAREN M. HASTINGS, Administrative Patent Judges.

KIMLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal from the final rejection of claims 12-41. Claims 12
and 17 are illustrative:
12. A method of treatment of dialysis of a patient in need of such
treatment which comprises subjecting said patient to dialysis using a
dialyzing solution including a low molecular weight thrombin inhibitor
having a molecular weight of below 2,000.

Appeal 2008-1956
Application 11/074,893

17. A dialyzing solution including a low molecular weight thrombin
inhibitor.

The Examiner relies upon the following references in the rejection of
the appealed claims:
Fourneir FR 2,687,070 Aug. 13, 1993
Lundgren WO 97/397770 Oct. 30, 1997
Grootenhuis WO 97/30073 Aug. 21, 1997

Appellant’s claimed invention is directed to a dialyzing solution and a
method of treatment by dialysis wherein the solution comprises a low
molecular weight thrombin inhibitor (claim 17), having a molecular weight
of below 2,000 (claim 12).
Appealed claims 17, 18, 22, and 23 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by FR ‘070. Claims 12-16, 19-21, and 24-41
stand rejected under 35 U.S.C. § 103(a) as being unpatentable over FR ‘070
in view of WO ‘073 and WO ‘770.
Appellant has not separately argued any particular claim on appeal.
Accordingly, the groups of claims separately rejected by the Examiner stand
or fall together.
We have thoroughly reviewed each of Appellant’s arguments for
patentability, as well as the declaration evidence relied upon in support
thereof. However, we find that the Examiner’s rejections are well founded
and supported by the prior art evidence relied upon. Accordingly, we will
sustain the Examiner’s rejections for the reasons set forth in the Answer, and
we add the following primarily for emphasis.
We consider first the Examiner’s § 102 rejection of claims 17, 18, 22,
and 23 over FR ‘070. There is no dispute that the reference specifically
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Application 11/074,893

discloses a dialyzing solution comprising low molecular weight fragments of
heparin, a thrombin inhibitor. The dispute arises over whether the low
molecular weight fragments disclosed by the reference meet the presently
claimed “low molecular weight thrombin inhibitor.”
It is Appellant’s position that the low molecular weight heparins
disclosed by FR ‘070, having a molecular weight between 2,500 and 8,000,
are not encompassed by claim 17 since the Specification assertedly defines a
low molecular weight thrombin inhibitor as one having a molecular weight
below 2,000. However, we agree with the Examiner that the relevant
disclosure at page 7 of Appellant’s Specification fails to define the claimed
low molecular weight thrombin inhibitor as including only compounds
having a molecular weight below 2,000. The cited paragraph of Appellant’s
Specification appearing at page 7 reads “[t]he term “low molecular weight
thrombin inhibitor” will be understood by those skilled in the art. The term
may also be understood to include any composition of matter . . . which
possesses a molecular weight of below 2,000 . . . ” (emphasis added).
Hence, while the claim language may also include compounds having a
molecular weight below 2,000, it also embraces compounds having a
molecular weight above 2,000 that would be considered low molecular
weight by one of ordinary skill in the art. As explained by the Examiner, FR
‘070 provides substantial evidence that one of ordinary skill in the art would
consider low molecular weight thrombin inhibitors to include compounds
having molecular weights varying from 2,500 to 8,000. The opinion of the
present inventor in the Declaration of record does not refute this clear,
explicit teaching in FR ‘070.
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Application 11/074,893

Furthermore, FR ‘070 expressly discloses that “[o]ther
anticoagulatory agents can be used in the dialysis bath if their molecular
weights enable them to cross the membrane employed in haemodialysis
sessions” (Translation 3, third para.). Accordingly, we find that FR ‘070
provides a clear description within the meaning of § 102 of other known low
molecular weight thrombin inhibitors that fall within the scope of claim 17
which were known in the art, such as those disclosed in WO ‘073 and WO
‘770.
Concerning the Examiner’s § 103 rejection, we are in full agreement
with the Examiner that WO ‘073 and WO ‘770 provide substantial evidence
that it would have been obvious for one of ordinary skill in the art to employ
thrombin inhibitors having a molecular weight below 2,000, including the
presently claimed melagatran, in the dialyzing solution of FR ‘070. As set
forth by the Examiner, WO ‘373 expressly teaches that the low molecular
weight thrombin inhibitors “are more effective with lower dosages and
having [sic, have] fewer and less severe side effects, with use in
extracorporeal circuit, dialysis or parenteral applications” (Ans. 6).
Furthermore, as noted by the Examiner, FR ‘070 provides ample motivation
for using the low molecular weight thrombin inhibitors of WO ‘073 and
WO ‘770 by expressly disclosing that “[t]he lighter molecular weights of
these fragments therefore enable them to cross the membranes which are
currently employed in haemodialysis” (Translation 3, second para.).
The Declarant’s statement that “there is no motivation provided by
any of the three cited WO documents to substitute a low molecular weight
thrombin inhibitor for sodium heparinate as taught by FR ‘070” (para. 7) is a
bald assertion without the requisite explanatory analysis. Also, the
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Application 11/074,893

Declarant’s statement is a legal conclusion which is outside the scope of the
Declarant’s expertise. See Cable Electronic Products Inc. v. Genmark, 770
F.2d 1015 (Fed. Cir. 1985); and In re Grunwell, 609 F.2d 486 (CCPA 1979).
Appellant contends that “[t]he Fager declaration describes
experiments which demonstrate unequivocally that, by providing low a
molecular weight thrombin inhibitor, such as melagatran, to the dialysing
solution prior to and/or during dialysis, in accordance with the presently
claimed method, not only can problems associated with standard prior art
methodology . . . be solved, but also distinct and unexpected advantages are
observed for such inhibitors when compared to the compounds and
methodology described in the French ‘070 patent” (Principal Brief 11,
second para.). However, we agree with the Examiner that Appellant has not
established that the superior delivery of the low molecular weight thrombin
inhibitor, melagatran, relative to inhibitors, such as unfractionated standard
sodium heparinate and Fragmin, having higher molecular weights would be
considered truly unexpected by one of ordinary skill in the art. In re Merck
& Co., 800 F.2d 1091, 1099 (Fed. Cir. 1986). The Declarant fails to set
forth any reason why one of ordinary skill in the art would not have
expected a lower molecular weight compound to permeate a dialysis
membrane more readily than a higher molecular weight compound,
especially in light of the cited prior art which teaches that low molecular
weight fragments cross the membrane more efficiently. Also, the Declarant
gives no reason why one of ordinary skill in the art would not have
considered it obvious to use the lower molecular weight inhibitors of WO
‘073 and WO ‘770 in a conventional dialysis method of the type disclosed
by FR ‘070.
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Application 11/074,893

Accordingly, based on the foregoing and the reasons well stated by
the Examiner, the Examiner’s decision rejecting the appealed claims is
affirmed.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

LS/cam

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