Ex Parte Ridgway

Board of Patent Appeals and Interferences

Sep 11, 2007

10854708 (B.P.A.I. Sep. 11, 2007)

The opinion in support of the decision being entered today
is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte HELEN JANE RIDGWAY
____________

Appeal 2006-2372
Application 10/854,708
Technology Center 1700
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Decided: September 11, 2007
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Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 1-3 and 6-21, the
only claims pending in this application. We have jurisdiction under 35
U.S.C. § 6(b).
INTRODUCTION
The claims are directed to a method for measuring platelet function.
Claims 1 and 6 are illustrative:
Appeal 2006-2372
Application 10/854,708

1. A method for measuring platelet function comprising:
obtaining a baseline count of platelets in a sample comprising platelets
in a liquid medium obtained from a physiological source of the platelets,
wherein the sample is devoid of an effective amount of an agent which
interferes with platelet function;
subsequently adding an activation agonist to the sample;
allowing activatable platelets in the sample to activate;
obtaining a count of the unactivated platelets in the sample after
activation of the activatable platelets;
determining the difference between the baseline count of platelets in
the sample before adding the activation agonist and the count of unactivated
platelets in the sample;
wherein the difference is a measure of the activity of the platelets in
the original sample; and
wherein the sample prior to the addition of the activation agonist
includes D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone (PPCAK
[sic, PPACK]) as an anti-coagulant.
6. The method of claim 1, wherein the activation-agonist is in solid
form and wherein the activation agonist is added in solid form to the sample.

The Examiner relies on the following prior art references to show
unpatentability:
Brady US 6,410,337 B1 Jun. 25, 2002
Jennings WO 2004/036226 A1 Apr. 29, 2004

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Application 10/854,708

The rejections as presented by the Examiner are as follows:
1. Claims 1-3, 8-11, 14, 18, 20, and 21 stand rejected under 35 U.S.C. § 35
U.S.C § 103(a) as unpatentable over Jennings.
2. Claims 6, 7, 12, 13, 15-17, and 19 stand rejected under 35 U.S.C. § 35
U.S.C § 103(a) as unpatentable over the combination of Jennings and Brady.
We affirm.

DISCUSSION
The claims have not been argued separately and therefore, for each
ground of rejection, the claims will stand or fall together. 37 C.F.R. §
41.37(c)(1)(vii). Therefore, we limit our discussion to representative claims
1 and 6.

Claim 1:
Claim 1 is drawn to a method for measuring platelet function. The
method comprises five steps:
i. obtaining a baseline count of platelets in a sample. Claim 1
defines the sample as one that comprises platelets in a liquid
medium obtained from a physiological source of the
platelets, which is devoid of an effective amount of an agent
which interferes with platelet function;
ii. adding an activation agonist to the sample after the baseline
count is performed;
iii. allowing activatable platelets in the sample to activate;
iv. obtaining a count of the unactivated platelets in the sample
from step iii; and
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Application 10/854,708

v. determining the difference between the baseline count of
platelets in the sample before and after the addition of the
activation agonist, which represents a measure of the activity
of the platelets in the original sample
In addition, claim 1 requires that the sample include D-phenylalanyl-
L-prolyl-L-arginine chloromethyl ketone (PPACK) as an anti-coagulant,
prior to the addition of the activation agonist.
The Examiner finds that Jennings teaches a method for assessing
platelet aggregation that comprising the steps of:
(a) obtaining a blood sample from an individual;
(b) combining the blood sample with an anticoagulant;
(c) separating the blood sample into two tubes (a baseline tube and a
second tube);
(d) counting platelets in the baseline tube;
(e) adding a platelet agonist to the sample in the second tube to
activate the activatable platelets;
(f) counting unactivated platelets in the second tube; and
(g) determining the difference between the platelet count in the
baseline tube with the platelet count in the second tube to obtain a
measure of the percent aggregation of platelets in the blood
sample.
(Answer 3-4.) In addition, the Examiner finds that Jennings teaches that the
preferred anticoagulant for use in the method is PPACK.
The Examiner recognizes that Jennings fails “to teach the use of the
same sample to obtain both the baseline count and the count of unactivated
platelets after combination with the agonist” (Answer 4). However, based
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Application 10/854,708

on the teachings of Jennings, the Examiner concludes that it would have
been obvious to one of ordinary skill in the art at the time of the instant
invention to perform the method of measuring platelet aggregation taught by
Jennings in a single tube to avoid the possibility of contaminating the sample
(id.).
In response, Appellant asserts that “Jennings fails to teach using the
same sample to obtain both the baseline count and the count of unactivated
platelets after combination with the agonist in a single-tube method, as
taught by the present application” (Br. 6). According to Appellant,
“Jennings states that the two-tube, separate-sample method ‘allowed the
flexibility of analysis time without the risk of inaccurate results’ and
‘allowed for duplicate runs of a specimen if questionable results were
initially obtained’” (Br. 6-7). Lastly, Appellant asserts that Jennings uses
the ICHOR hematology analyzer which requires a two-tube, separate-sample
method. (Br. 7.)
Based on the contentions of the Examiner and Appellant, the issue
distills down to whether it would have been prima facie obvious to a person
of ordinary skill in the art at the time the invention was made to perform the
method taught by Jennings in a single tube.
For the reasons set forth above, it is our opinion that the Examiner has
the better argument. But for the use of two separate samples, the method
taught by Jennings is the same as Appellant’s claimed method. There is no
doubt that Jennings does not expressly teach this variation in the
methodology disclosed therein. However, we find that it is proper to “take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” See KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727,
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1741, 82 USPQ2d 1385, 1396 (2007). See also id. at 1742, 82 USPQ2d at
1397 (“A person of ordinary skill is also a person of ordinary creativity, not
an automaton.”). In this regard, we note that “[w]hen a work is available in
one field of endeavor, design incentives and other market forces can prompt
variations of it, either in the same field or a different one. If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 1740, 82 USPQ2d at 1396.
In our opinion, a person of ordinary skill in the art at the time the
invention was made would have readily understood that Jennings’ method
could have been predictably improved by performing all of the method steps
in a single tube. We find no evidence on this record that this modification or
variation in Jennings’ method would have been unpredictable or produced
an unexpected result. Instead, as the Examiner explains, a person of
ordinary skill in the art would have realized that maintaining the sample in a
single tube reduces the risk of contaminating not only the sample but those
involved in performing the method (Answer 5 - 8).
Further, we are not persuaded by Appellant’s argument based on
Jennings’ teaching that the use of two tubes provides an opportunity to
perform “duplicate runs of a specimen if questionable results were initially
obtained” (Jennings 15: 32-33). We find that the Examiner has provided a
plausible rationale as to why a person of ordinary skill in the art would
perform the method in a single tube, specifically to limit the possibility of
contamination of both the sample and personnel performing the method. It
is well settled that obviousness analyses involving potential modifications of
the prior art entail weighing the relative trade-offs of the various
alternatives. See Medichem S.A. v. Rolabo S.L., 437 F.3d 1157, 1165, 77
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USPQ2d 1865, 1870 (Fed. Cir. 2006) (“The fact that the motivating benefit
comes at the expense of another benefit, however, should not nullify its use
as a basis to modify the disclosure of one reference with the teachings of
another. Instead, the benefits, both lost and gained, should be weighed
against one another.”) (quoting Winner Int’l Royalty Corp. v. Wang, 202
F.3d 1340, 1349 n.8, 53 USPQ2d 1580, 1587 n.8 (Fed. Cir. 2000)).
Lastly, while Appellant asserts that Jennings utilizes an ICHOR
hematology analyzer which requires the use of two separate samples, we
find that Jennings simply identifies the ICHOR hematology analyzer as a
preferred device, and expressly states that the “[a]nalysis of blood samples
can be carried out using any hematology analyzer, preferably an automated
hematology analyzer” (Jennings 10: 1-2). Accordingly, we are not
persuaded by Appellant’s argument based on Jennings’ preference for the
use of the ICHOR hematology analyzer.
On reflection, we find no error in the Examiner’s prima facie case of
obviousness. Accordingly, we affirm the rejection of claim 1 under 35
U.S.C. § 35 U.S.C § 103(a) as unpatentable over Jennings. Since they were
not separately argued claims 2, 3, 8-11, 14, 18, 20, and 21 fall together with
claim 1.

Claim 6:
Claim 6 depends from and further limits the activation agonist of
claim 1 to one that is in solid form and is added to the sample in solid form.
The Examiner relies on Jennings as set forth above (Answer 5). The
Examiner finds, however, that Jennings fails “to teach the activation agonist
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can be in solid form . . .” (id.). The Examiner relies on Brady to make up for
this deficiency in Jennings.
According to the Examiner Brady teaches “a method and kit for
measuring platelet function” (id.). In this regard, the Examiner finds that
Brady teaches “that the components in the kit, including the platelet agonist,
can be present in a solid, lyophilized form” (id.).
Based on this evidence the Examiner concludes that
it would have been obvious to one of ordinary skill in the art at
the time of the instant invention to provide the platelet
activation agonist in the platelet aggregation assay taught by
Jennings . . . in a solid form since Brady . . . teach that it is
advantageous to provide the reagents used in a platelet assay in
a solid, lyophilized form so as to preserve the reagents for a
long period of time until use, and thus extend the shelf life of
the reagents.

(Answer 6.)
We find no error in the Examiner’s prima facie case of obviousness.
In response, Appellant’s only argument is that like Jennings, Brady
also teaches a two tube method and therefore does not make up for
Appellant’s perceived deficiency in Jennings (Br. 7). However, for the
reason discussed above, we are not persuaded by Appellant’s argument, and
instead find that Jennings would have suggested a “single tube” method to a
person of ordinary skill in the art at the time the invention was made.
Accordingly, we affirm the rejection of claim 6 under 35 U.S.C. § 35
U.S.C. § 103(a) as unpatentable over the combination of Jennings and
Brady. Since they are not separately argued, claims 7, 12, 13, 15-17, and 19
fall together with claim 6.

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Application 10/854,708

CONCLUSION
In summary, we affirm the rejections of record.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

Ssc

AKERMAN SENTERFITT
P.O. BOX 3188
WEST PALM BEACH, FL 33402-3188
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