Ex Parte Okuda

Board of Patent Appeals and Interferences

May 10, 2011

11050766 (B.P.A.I. May. 10, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MASAHIRO OKUDA
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Appeal 2010-004059
Application 11/050,766
Technology Center 1700
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Before BRADLEY R. GARRIS, ADRIENE LEPIANE HANLON, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

GARRIS, Administrative Patent Judge.

DECISION ON APPEAL

Appellant appeals under 35 U.S.C. § 134 from the Examiner's decision
rejecting claims 1-19, 21, and 22 under 35 U.S.C. § 103(a) as unpatentable over
Okuda (EP 1 385 003 A1, pub. Jan. 28, 2004) in view of Jacobsen (Eva M.
Jacobsen et al., The Evaluation of Clotting Times in the Laboratory Detection of
Lupus Anticoagulants, 104 Thrombosis Research 275-282 (2001)). We have
jurisdiction under 35 U.S.C. § 6.
We AFFIRM.
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Appellant claims a reagent kit for detecting lupus anticoagulant comprising a
first coagulation time measurement reagent comprising synthetic
phosphatidylserine and synthetic phosphatidylethanolamine having a concentration
in the range from 40 to 280 µM and a second coagulation time measurement
reagent comprising synthetic phosphatidylserine and synthetic
phosphatidylethanolamine having a concentration in the range from 1 to 30 µM
(claim 1).
Representative claim 1 reads as follows:
1. A reagent kit for detecting lupus anticoagulant comprising:

a first coagulation time measurement reagent containing synthetic
phosphatidylserine and synthetic phosphatidylethanolamine; and

a second coagulation time measurement reagent containing synthetic
phosphatidylserine and synthetic phosphatidylethanolamine;

wherein the concentration of the synthetic phosphatidylethanolamine of said
first coagulation time measurement reagent is in the range from 40 to 280 µM, and
the concentration of the synthetic phosphatidylethanolamine contained in said
second coagulation time measurement reagent is in the range from 1 to 30 µM.

Appellant does not argue the rejected claims separately. Accordingly, we
select independent claim 1 to represent the rejected claims, and all claims will
stand or fall with this representative claim.
The Examiner makes the following undisputed findings regarding Okuda.
Okuda discloses a reagent kit for detecting lupus anticoagulant having first and
second coagulation time measurement reagents containing phosphatidylserine and
phosphatidylethanolamine as required by claim 1. In Okuda, the concentration of
phosphatidylserine is higher in the first reagent than in the second reagent, which is
an embodiment encompassed by claim 1 and disclosed in the Specification (Spec.
6). However, Okuda fails to disclose the claim 1 requirement that the
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concentration of phosphatidylethanolamine is higher in the first than the second
reagent.
In addition, the Examiner finds that Jacobsen discloses methods for
detecting lupus anticoagulant using two reagents containing high and low amounts
of active ingredients. In a first method, the reagents contain high and low amounts
of phospholipids (Jacobsen 277, 1.2.2 at 1.), and in a second method, the reagents
contain high and low amounts of cephalin (id. at 2.). It is undisputed on this record
that the phosphatidylserine and phosphatidylethanolamine claimed by Appellant
and disclosed by Okuda are phospholipids and that cephalin comprises a mixture
of phospholipids including phosphatidylserine and phosphatidylethanolamine.
The Examiner concludes that it would have been obvious for one with
ordinary skill in the art to modify the reagent kit of Okuda such that the
concentration of phosphatidylethanolamine is higher in the first reagent than in the
second reagent as required by claim 1 in view of Jacobsen (Ans. 6).
Appellant argues that "Jacobsen does not remedy the deficiency in Okuda
because it would not teach a person having ordinary skill in the art to alter the
amount of PE [i.e., phosphatidylethanolamine] in the test reagents in Okuda" (App.
Br. para. bridging unnumbered pp. 13-14). According to Appellant, "[a] person
having ordinary skill in the art would understand that the cephalin disclosed in
Jacobsen comprises phospholipids and that the teachings in Jacobsen related to
phospholipids and were not specific to PE [i.e., phosphatidylethanolamine]" (id.).
Appellant's argument is unpersuasive for the reasons given by the Examiner
(Ans. para. bridging 7-8). As correctly indicated by the Examiner, Jacobsen's
teaching of high and low cephalin concentrations in the two reagents would have
been understood by an artisan as teaching high and low concentrations of the
respective phospholipids in cephalin including phosphatidylethanolamine (id.).
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For this reason, Jacobsen's teaching would have suggested to the artisan providing
the phosphatidylethanolamine of Okuda at a higher concentration in the first
reagent than in the second reagent.
Appellant disagrees with the Examiner's position that the high and low
cephalin concentrations taught by Jacobsen would necessarily result in high and
low phosphatidylethanolamine concentrations and that such would be understood
by a person having ordinary skill in the art (App. Br. unnumbered p. 13, last full
para.). However, we perceive no rational foundation for Appellant's disagreement.
Appellant acknowledges and indeed has submitted evidence to establish that
cephalin was known in the prior art to comprise a mixture of phospholipids
including phosphatidylethanolamine (id. at 1st full para.). Particularly in light of
this acknowledgment, we agree with the Examiner that common sense supports the
Examiner's position (Ans. para. bridging 7-8).
Finally, we observe that Appellant characterizes the claimed invention as
solving the problem exhibited by conventional reagent kits for detecting lupus
anticoagulant wherein samples containing heparin or warfarin may create false
positives (App. Br. unnumbered p. 14). For completeness, it is appropriate to
clarify that the reagent kit of Okuda is disclosed as solving this very same problem
(see paras. [0035]-[0038]).
For the reasons stated above and in the Answer, the Examiner has
established a prima facie case of obviousness which Appellant has failed to
successfully refute with argument and evidence in the record of this appeal. It
follows that we sustain the § 103 rejection of all claims as unpatentable over
Okuda in view of Jacobsen.

The decision of the Examiner is affirmed.
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No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a) (2008).

AFFIRMED

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