Ex Parte Patzke

Patent Trials and Appeals Board

Feb 15, 2019

13776758 - (D) (P.T.A.B. Feb. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/776,758 02/26/2013 Juergen Patzke
86528 7590 02/20/2019
Slayden Grubert Beard PLLC
401 Congress Avenue
Suite 1650
Austin, TX 78701
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
18202.105024 1265
EXAMINER
FAN,LYNNY
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
02/20/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
trosson@sgbfirm.com
patent@sgbfirm.com
dallen@sgbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUERGEN PATZKE 1
Appeal2018-000149
Application 13/776,758
Technology Center 1600
Before RICHARD M. LEBOVITZ, GEORGIANNA W. BRADEN, and
DAVID COTTA, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a screening process for
identifying a sample which has a high probability of containing
prothrombotic antiphospholipid antibodies. The Examiner rejected the
claims as obvious under 35 U.S.C. § 103. Pursuant to 35 U.S.C. § 134,
Appellant appeals the Examiner's determination that the claims are
unpatentable. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm the
Examiner's decision.
1 The Appeal Brief ("Br."; entered Apr. 11, 2017) lists Siemens Healthcare
Diagnostics Products GmbH as the real party in interest.
Appeal2018-000149
Application 13/776,758
STATEMENT OF THE CASE
The Examiner finally rejected claims 1-11 as follows:
Claims 1---6 and 8-11 under pre-AIA 35 U.S.C. § I03(a) as obvious in
view of Out et al. (Blood, 1991, 77(12):2655-2659) ("Out") and Patzke (US
2001/0024803 Al, issued Sept. 27, 2001). Ans. 3.
Claim 7 under pre-AIA 35 U.S.C. § I03(a) as obvious in view of Out,
Patzke, and Rechner (US 2007/0254325 Al, issued Nov. 1, 2007). Ans. 5.
Claim 1, the only independent claim on appeal, is reproduced below
( numbering [ 1 ]-[ 4] has been added for reference):
1. A screening process for identifying a sample which has a
high probability of containing prothrombotic antiphospholipid
antibodies, said method comprising the following steps:
[ 1] forming an assay mix by mixing a body fluid sample
from a patient with a platelet-containing reagent containing
platelets from at least one donor other than the patient,
[2] aggregating platelets in the assay mix by adding a
platelet activator to the assay mix,
[3] measuring, by a measuring device, the platelet
aggregation in the assay mix, and
[ 4] identifying the presence of prothrombotic
antiphospholipid antibodies in the patient's sample if the
measured platelet aggregation in the assay mix exceeds a
measured normal reference value of a sample not containing
any antiphospholipid antibodies.
DISCUSSION
The claimed method is a "screening process for identifying a sample
which has a high probability of containing prothrombotic antiphospholipid
antibodies." The method comprises four steps, numbered herein [ 1 ]-[ 4].
2
Appeal2018-000149
Application 13/776,758
Steps [1]-[3] comprise [1] forming a mix of (a) a body fluid from a
patient and (b) platelets from a donor different than the patient, [2]
aggregating the platelets, and [3] measuring the platelet aggregation.
The last step [ 4] of the method is identifying the presence of
prothrombotic antiphospholipid antibodies "if the measured platelet
aggregation in the assay mix exceeds a measured normal reference value of
a sample not containing any antiphospholipid antibodies." (Emphasis
added.) Thus, if the reference value is not exceeded, the presence of
prothrombotic antiphospholipid antibodies are not identified. In other
words, the claim does not require prothrombotic antiphospholipid antibodies
to be identified.
The Examiner cited Out as describing a platelet aggregation assay
with the same steps as claimed, but not using platelets from at least one
donor other than the patient as required by step [ 1] of the claim. Final Act.
3--4. To meet this claim limitation, the Examiner found that "the step of
mixing a sample with a platelet-containing reagent containing platelets from
at least one donor other than the patient was well-known and routinely
practiced in the art of platelet aggregation." Id. 4. To support this finding,
the Examiner cited Patzke as performing a platelet aggregation assay
utilizing formalin-fixed platelets from a donor other than the patient. Id.
The Examiner concluded it would have been obvious to one of ordinary skill
in the art to have used platelets from a donor other than the patient in Out's
aggregation assay because it was routine in the art to utilize donor platelets
in such a way. Id. 4--5.
3
Appeal2018-000149
Application 13/776,758
Does preamble of claim 1 exclude screening samples "already known" to
have anti-phospholipid antibodies?
Appellant contends that Out's method "is performed to study platelet
function in samples already known to have anti-phospholipid antibodies."
Br. 4.
This argument does not persuade us that the Examiner erred in
rejecting the claims as obvious. The preamble of claim 1 recites that the
method is a "screening process for identifying a sample which has a high
probability of containingprothrombotic antiphospholipid antibodies." As
explained in the Specification, antiphospholipid antibodies cause
"antiphospholipid syndrome" ("APS") one of the most common
autoimmune disorders. Spec. ,r 3. The Specification teaches that some
antiphospholipid antibodies have prothrombotic activity. Id. ,r,r 4--5.
Antiphospholipid antibodies with prothrombotic activity activate platelets
and cause platelet aggregation. Id. ,r,r 5, 11, 12.
The Specification explains that the platelet aggregation assay "enables
samples to be identified that have a high probability of containing
antiphospholipid antibodies with prothrombotic action." Spec. ,r 7. In other
words, not all antiphospholipid antibodies are prothrombotic. According to
the Specification, prothrombotic antiphospholipid antibodies can be
identified by the claimed method, namely, taking a blood sample from a
patient and determining whether the sample contains a factor which
increases platelet aggregation as compared to the control. Id. ,r,r 9-10. This
method is not specific for prothrombotic antiphospholipid antibodies
because other factors present in blood may enhance platelet aggregation. Id.
,r 11. The assay does not distinguish between prothrombotic
4
Appeal2018-000149
Application 13/776,758
antiphospholipid antibodies and other factors which cause platelet
aggregation. The Specification teaches, however, that the platelet
aggregation assay eliminates the need for further testing of samples that do
not enhance platelet aggregation and thus are ruled out as having
prothrombotic antiphospholipid antibodies. Id. The samples, which
enhance aggregation, are tested further for the presence of prothrombotic
antibodies using more specific tests. Id. ,r 7. Thus, the claimed method does
not identify with 100% certainty that prothrombotic antiphospholipid
antibodies; rather, only that there is a high probability they are present
because the platelet aggregation assay is positive.
Accordingly, the claimed "screening process for identifying a sample
which has a high probability of containing prothrombotic antiphospholipid
antibodies" does not exclude testing samples which are known to contain
antiphospholipid antibodies as asserted by Appellant. Rather, the samples
could be known to contain antiphospholipid antibodies, for example, when
the sample are obtained from patients diagnosed with APS, but are further
subjected to platelet aggregation screening to determine whether there is a
probability that such antibodies are also prothrombotic. Some of these test
samples will induce platelet aggregation and others will not - in either case,
a "screening process for identifying a sample which has a high probability of
containing prothrombotic antiphospholipid antibodies" will have been
carried out. For these reasons, we are not persuaded that the claim preamble
excludes samples already known to have antiphospholipid antibodies.
5
Appeal2018-000149
Application 13/776,758
Is there evidence that Out's method might be used to identify samples having
anti-phospholipid prothrombotic antibodies?
Appellant contends that there is "no evidence or suggestion in Out
that measuring platelet aggregation might be used to identify samples having
anti-phospholipid antibodies, i.e., to detect the presence of antiphospholipid
antibodies in an unknown sample by comparing an enhanced platelet
aggregation to a normal sample." Br. 5. Appellant states that Out teaches
that there is no difference in platelet aggregation in the samples tested. Id.
Consequently, Appellant argues there is no motivation to apply the methods
steps of Patzke "because there was no reasonable expectation that measuring
platelet aggregation in such assay mix could be applied successfully for the
purpose of detecting the presence of antiphospholipid antibodies." Id.
We are not persuaded by this argument that the Examiner erred in
rejecting the claims. There is no dispute that the platelet aggregation assay
in Out did not detect a significant difference in platelet aggregation between
patient and control samples. Out 2658. We have, however, interpreted the
claims, as the Examiner did, not to require a difference in platelet
aggregation between the "normal reference" and "body fluid sample from a
patient." See Ans. 7. Thus, the disclosure in Out of a platelet aggregation
assay to determine whether samples comprising antiphospholipid antibodies
induce platelet aggregation meets the "identifying" requirement of the
claim. 2 The rejected claim does not require prothrombotic antibodies to
have been identified.
2 Nonetheless, the appreciation of the result of carrying out the same process
step suggested in the prior art, namely, "identifying the presence of
prothrombotic antiphospholipid antibodies," does not distinguish the
6
Appeal2018-000149
Application 13/776,758
Appellant has not provided evidence or scientific reasoning as to why
the platelet aggregation assay utilized in Out, which meets all the steps of
claim 1 except for the source of platelets, would not have been expected by
one of ordinary skill in the art to detect the presence of prothrombotic
antibodies. Because all the steps of Out's assay are the same as the claimed
steps, the Examiner had reasonable basis to find that the results of the assay
would also be the same for both assays, and thus that Out's assay would
have been capable of detecting prothrombotic antibodies when present in a
sample.
As held in In re Best, 562 F.2d 1252 (CCPA 1977):
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
Whether the rejection is based on "inherency" under 35 U.S.C.
§ 102, on "prima facie obviousness" under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO' s inability to manufacture
products or to obtain and compare prior art products.
Id. at 1255 (footnote omitted) (citation omitted).
claimed process from the prior art process described in Out. The claimed
steps are substantially the same as described in Out. There is no
manipulative difference in how the claimed process is carried out. A mental
step of appreciation, i.e., "identifying the presence" of antibodies, does not
make an otherwise obvious claim patentable. See In re Woodruff, 919 F.2d
1575, 1578 (Fed. Cir. 1990); In re Cruciferous Sprout Litig., 301 F.3d 1343,
1351 (Fed. Cir. 2002); Perricone v. Medicis Pharm. Corp., 432 F.3d 1368,
1377-79 (Fed. Cir. 2005); In re Omeprazole Patent Litig., 483 F.3d 1364,
1373 (Fed. Cir. 2007).
7
Appeal2018-000149
Application 13/776,758
Because the Examiner established that the steps carried out by Out are
substantially the same as those claimed, the Examiner had a reasonable basis
to shift the burden to Appellant to show that Out's process would not
identify prothrombotic antibodies. Appellant did not meet the burden.
Thus, for the reasons discussed above, the obviousness rejection of claim 1
based on Out and Patzke is affirmed.
Claims 2---6 and 8-11 were not argued separately and thus fall with
claim 1. 37 C.F.R. § 4I.37(c)(l)(iv). Appellant also did not argue the
rejection of dependent claim 7 separately. Br. 6. The obviousness rejection
of claim 7 is affirmed for the same reasons and those further provided by the
Examiner. Final Act. 5.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
8