Ex Parte Kevy et al

Patent Trial and Appeal Board

Oct 30, 2013

10765694 (P.T.A.B. Oct. 30, 2013)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO./
CONTROL NO.
FILING DATE FIRST NAMED INVENTOR /
PATENT IN REEXAMINATION
ATTORNEY DOCKET NO.
10/765,694 01/27/2004 Sherwin V. Kevy et al.

EXAMINER
HESLIN ROTHENBERG FARLEY & MESITI PC
5 COLUMBIA CIRCLE
ALBANY, NY 12203
SCHUBERG, LAURA
ART UNIT PAPER NUMBER
1657
MAIL DATE DELIVERY MODE

10/31/2013 PAPER

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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SHERWIN V. KEVY, SHERYL SULLIVAN,
MAY JACOBSON, and LOU BLASETTI
__________

Appeal 2012-000066
Application 10/765,694
Technology Center 1600
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 from the final rejection of
claims 1-18, 21, and 22, directed to a method for the production of thrombin
from anticoagulated whole blood. The claims have been rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).

1 Appellants identify the Real Party-In-Interest as Harvest Technologies
Corp. (App. Br. 3.)

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STATEMENT OF THE CASE
Claims 1-18, 21, and 22 are pending and on appeal. Appellants do not
provide separate arguments for the claims. Therefore, we select claim 1 as
representative for purposes of deciding this appeal, and the remaining claims
will stand or fall accordingly. 37 C.F.R. § 41.37 (c)(1)(vii). Claim 1 is as
follows:
1. A method for the production of thrombin from anticoagulated whole
blood, comprising:
a) obtaining a volume of anticoagulated whole blood from a
subject;
b) mixing said anticoagulated whole blood with ethanol at room
temperature;
c) incubating the mixture of b) at room temperature for a time
sufficient to produce a cellular and specific plasma component precipitate
and a supernatant;
d) separating the precipitate from the supernatant; and
e) recovering the supernatant wherein said supernatant contains a
thrombin preparation comprising 80-90% of prothrombin-thrombin proteins,
no detectable fibrinogen and 20-30% of baseline levels of anti-thrombin III
(ATIII).
The Examiner relies on the following evidence:
Rock US 4,359,463 Nov. 16, 1982
Gray et al. US 4,680,177 Jul. 14, 1987
Sato et al. US 4,812,310 Mar. 14, 1989
Meucci et al. US 5,135,875 Aug. 4, 1992
Cochrum et al. US 5,773,033 Jun. 30, 1998
Coelho et al. US 6,472,162 B1 Oct. 29, 2002
Appellants rely, in relevant part, on the following additional evidence:
Vijay Kumar & John R. Chapman, Whole Blood Thrombin: Development of
a Process for Intra-Operative Production of Human Thrombin, 39 JECT 18-
23 (2007).
Declaration of Dr. Sherwin V. Kevy, submitted under the provisions of
37 C.F.R. § 1.132, dated June 13, 2007.
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Declaration of Dr. Robert J. Mandle, submitted under the provisions of
37 C.F.R. § 1.132, dated January 25, 2010.
The Examiner rejected the claims as unpatentable under 35 U.S.C.
§ 103(a) as follows:
Claims 1-4, 7-18, 21, and 22 over Coelho and Rock (Ans. 8-10).
Claims 5 and 6 over Coelho, Rock, and Sato (Ans. 11-12).
Claims 1-3 and 7-15 over Gray and Cochrum (Ans. 5-8).
We affirm the rejections over Coelho and Rock, and reverse the
rejection of the claims over Gray and Cochrum.
COELHO & ROCK
Claims 1-4, 7-18, 21, and 22 stand rejected over Coelho and Rock,
while claims 5 and 6 stand rejected over Coelho, Rock, and Sato. Both
rejections rest on the Examiner’s finding that Coelho discloses adding
ethanol to whole blood to sequester thrombin, so we will discuss the
rejections together.
Findings of Fact
The following findings of fact (FF) are supported by a preponderance
of the evidence of record.
1. Coelho discloses a “simple, practical, fast method of preparing
stable human thrombin from a donor’s blood” (Coelho, col. 5, ll. 59-60),
which “allows it to be prepared just prior to or during operative procedures
and it will provide fast clotting throughout even the longest surgeries” (id. at
col. 6, ll. 17-19). Coelho teaches that “thrombin produced by this [method]
can be diluted in saline, water and a dilute CaCl2 solution . . . to provide
precise, slower clotting times thereby allowing any preferred time from less
than five seconds to longer than 2 minutes” (id. at col. 6, ll. 19-23).
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2. Coelho also discloses an apparatus for sequestering
prothrombin from plasma , and teaches “[s]ince it is preferred that the blood
product admitted to the inlet 2 [of the apparatus] be plasma, the whole blood
is first processed . . . to remove the heavier red blood cells from the blood
products, leaving plasma . . . for use in the FIG. 1 device” (Coelho, col. 9, ll.
13-17).
3. Claim 17 of Coelho is reproduced below:
A method for extracting and then dispensing thrombin, the steps
consisting of:
taking whole blood from a person,
sequestering prothrombin from the whole blood by addition of
ethanol, wherein ethanol is present at a concentration between about 8% and
about 20% volume per unit volume,
converting the prothrombin to thrombin,
loading the thrombin into a syringe, and
using the syringe to dispense the thrombin to stem blood flow.
4. The present Specification teaches:
In one embodiment, ethanol is used as a precipitating
agent. The final concentration of ethanol will preferably be
between 10% and 25%. For an 8 to 10 ml starting whole blood
volume, therefore, 1 to 2 ml of 100% or 95% ethanol is added
to the whole blood.
(Spec. ¶ 30.)
Discussion
The Examiner finds that Coelho (in claims 17, 55, 97, 99, 107, and
112) discloses a method of producing thrombin from whole blood that meets
all the limitations of claim 1, except that Coelho does not explicitly disclose
that the blood is anticoagulated (Ans. 8-9, 18). However, the Examiner cites
Rock as evidence that “whole blood that is withdrawn from a patient is
generally collected with an anticoagulant” (id. at 9), and concludes that it
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would have been obvious for one of ordinary skill in the art to use
anticoagulated blood in Coelho’s method because “it was common practice
to add anticoagulants to blood collected for the purpose of obtaining blood
products as taught by Rock” (id.). “As far as the . . . limitations regarding
the purity of the final thrombin product,” the Examiner finds that “these
claim limitations are descriptions of the final product achieved using the
obvious method steps of the claimed invention and are therefore . . . the
inherent result of following those steps” (id. at 10).
Appellants contend that the claims relied on by the Examiner “do not
explicitly state adding ethanol to whole blood” (App. Br. 20). Appellants
contend the claims “recite in one form or another a method for extracting
autologous thrombin from a patient by obtaining whole blood from a person;
sequestering plasma from whole blood; converting the prothrombin to
thrombin; loading the thrombin into a syringe and . . . dispens[ing] the
thrombin to stem blood flow” (id. at 16). Appellants contend “[n]owhere,
however, do any of these claims recite mixing whole blood with ethanol.
Rather, Coelho clearly discloses that ethanol is added to plasma, not to
whole blood” (id.). Appellants contend “when looking at the specification,
which one must do in order to determine if the claim is enabled, . . . Coelho
clearly discloses that ethanol is added to plasma, not whole blood” (id. at
19), and “one of ordinary skill in the art . . . would have been taught away
from the claimed invention” (id. at 25).
Appellants further contend that the Kevy and Mandle Declarations
establish that “the standard of practice in the art for production of thrombin
from whole blood included a plasma isolation step for the removal of
cells/cell debris prior to the precipitation of protein components, leaving
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soluble thrombin in the supernatant” (id. at 24). In addition, Appellants
argue that the Kumar reference, “an article by ThermoGenesis (owner of the
Coelho patent) scientists,” (id. at 25) which was “published well after the
present application was filed,” (id.) “reports generating autologous human
thrombin from whole blood as the starting material” (id.), and “represents
the first disclosure of that which Applicants had already invented” (id.).
Finally, Appellants contend that Rock does not cure Coelho’s failure
to disclose sequestering thrombin from whole blood, rather than plasma,
because Rock “does not relate to the precipitation of either whole blood or
plasma for the recovery of a coagulant material like thrombin” (id. at 28).
These arguments are not persuasive. While Coelho does disclose
sequestering thrombin from plasma, and many of Coelho’s claims are
directed to sequestering thrombin from plasma, many other claims, e.g.,
claim 17, plainly recite sequential steps consisting of “taking whole blood
from a person,” and “sequestering prothrombin from the whole blood by
addition of ethanol” (FF3). We agree with the Examiner’s finding that claim
17, which uses the closed transitional phrase “consisting of,” teaches adding
ethanol to whole blood. While we agree with Appellants that the Kevy and
Mandle Declarations establish that it was standard practice in the art to
isolate plasma from whole blood, prior to sequestering thrombin, that fact
does not nullify the simple fact that Coelho constructively discloses
sequestering prothrombin from whole blood by adding ethanol. That is, the
mere fact that a practice was not standard in the art does not mean that the
practice was not disclosed in the art. “The principle is well established that
the claims of a patent cited as a reference are part of the disclosure of that
reference and may properly be considered in determining the question of
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anticipation.” In re Schaumann, 572 F.2d 312, 317 n. 11 (CCPA 1978).
Similarly, the mere fact that Kumar reports “a reliable technique to generate
autologous human thrombin in the intra-operative setting from whole blood”
(Kumar 19, col. 1), as opposed to an earlier “method for development of
autologous thrombin from single donor plasma” (id.), does not change the
fact that Coehlo discloses sequestering prothrombin from whole blood by
adding ethanol.
Moreover, to the extent Appellants argue that Coelho would not have
enabled one of ordinary skill in the art to sequester thrombin from whole
blood without explicit instructions regarding removal of undesirable cell
debris (App. Br. 22, 23), we note that “a presumption arises that both the
claimed and unclaimed disclosures in a prior art patent are enabled.”
Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir.
2003). Appellants “can then overcome that rejection by proving that the
relevant disclosures of the prior art patent are not enabled” (id.), but we find
that lack of enablement has not been proven on this record.
Finally, Appellants contend that “claim 1 requires that the resulting
autologous thrombin contain 80-90% of prothrombin-thrombin proteins, no
detectable fibrinogen and 20-30% of baseline levels of anti-thrombin III”
(App. Br. 30), but neither Coelho nor Rock teaches such a product, “nor can
one claim that the autologous thrombin of the prior art inherently meets
these criteria given the lack of specifics provided by the cited prior art” (id.).
Appellants contend that “the principle of inherency has no place in the
determination of obviousness” (id.).
This argument is not persuasive. This is not a case where the
Examiner has relied on an unknown inherent property of the prior art for a
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teaching in support of a conclusion of obviousness, i.e., for a reason to
combine the teachings of the reference. Rather, the Examiner has
established a correspondence between the claimed invention and the prior art
(compare, e.g., claim 1 and FFs 3 and 4), as well a reason one of ordinary
skill in the art would have used anticoagulated blood in Coelho’s method.
Thus, the Examiner has established a reasonable basis for finding that the
product of Coelho’s method, modified by Rock, would result in a product
with the claimed properties. That which “flow[s] naturally from following
the suggestion of the prior art cannot be the basis for patentability when the
difference would otherwise have been obvious.” Ex parte Obiaya, 227
USPQ 58, 60 (BPAI 1985).
Moreover, as explained in In re Best, 562 F.2d 1252, 1254-1255
(CCPA 1977):
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to
require the applicant to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.

“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.
Accordingly, the rejection of claims 1-4, 7-18, 21, and 22 as
unpatentable over Coelho and Rock is affirmed, as is the rejection of claims
5 and 6 as unpatentable over Coelho, Rock, and Sato.
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GRAY & COCHRUM
Claims 1-3 and 7-15 stand rejected as unpatentable over Gray and
Cochrum. In a nutshell, we agree with Appellants that the Examiner has not
established that one of ordinary skill in the art would have had a reason to
combine the teachings of Gray and Cochrum, and even if combined, the
result would not have been the claimed invention.
The rejection of the claims over Gray and Cochrum is reversed.
SUMMARY
The rejection of claims 1-4, 7-18, 21, and 22 as unpatentable over
Coelho and Rock is affirmed.
The rejection of claims 5 and 6 as unpatentable over Coelho, Rock,
and Sato is affirmed.
The rejection of claims 1-3 and 7-15 as unpatentable over Gray and
Cochrum is reversed.
TIME PERIOD FOR RESPONSE
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

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