Ex Parte Sing et al

Patent Trial and Appeal Board

Jul 20, 2016

12887945 (P.T.A.B. Jul. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/887,945 09/22/2010
11050 7590 07/22/2016
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Eduardo Chi Sing
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.
1001.2218103 3468
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
07/22/2016 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDUARDO CHI SING, MARK ASHBY,
TIN TRAN, and RICHARD GREFF
Appeal2014-000880
Application 12/887 ,945
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, AND
RICHARD J. SMITH, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1-9 (Br. 3). 2
Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as "Boston Scientific Scimed,
Inc." (Br. 3).
2 "[C]laim[s] 10-18 [stand] withdrawn from consideration" (Final Rej. 1).
Appeal2014-000880
Application 12/887 ,945
STATEMENT OF THE CASE
Appellants' claim 1 is representative and reproduced below:
1. A method of forming a clot formation accelerator loaded
hemostasis material, comprising:
dissolving gelatin granules in water to form a gelatin solution;
heating the gelatin solution;
cooling the gelatin solution;
adding a cross-linking agent to the cooled gelatin solution;
mixing a clot formation accelerator into the cross-linking agent and
gelatin solution to form a mixture;
adding air to the mixture to form a foam hemostasis material matrix;
drying the foam hemostasis material matrix at a temperature above
freezing to form the hemostasis material.
Claim 1, 2, 5-7, and 9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Correll, 3 Damschroder, 4 and Studer. 5
Claims 3, 4, and 8 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Correll, Damschroder, Studer,
Maoyuan, 6 and Amiji. 7
3 John T. Correll, US 2,465,357, issued Mar. 29, 1949.
4 Damschroder et al., US 2,460,809, issued Feb. 8, 1949.
5 Andre Studer, US 2,558,395, issued June 26, 1951.
6 Huang Maoyuan, CN 93108804, filed July 28, 1993. Examiner relied upon
the English language Abstract and refers to this document as Zhanjiang.
7 Mansoor M. Amiji, US 5,885,609, issued Mar. 23, 1999.
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Application 12/887 ,945
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants disclose that their "manufacturing process of the gelatin
is similar to the process described in ... Correll" (Spec. 6: 5-7).
FF 2. Appellants disclose the use of "[a] cross-linking agent, such as
formaldehyde" and a "clot formation accelerator[]", such as "Thrombin"
(Spec. 6: 10 and 21-25; see also id. at 8: 11-12 and Table 1).
FF 3. Correll "relates to a liquid-permeable, water-insoluble, gelatin
sponge having the general physical characteristics of a sponge but being
absorbable by animal bodies" (Correll 1: 1--4).
FF 4. Correll discloses the following method of forming a gelatin sponge:
[F]irst prepare an aqueous solution containing 3-10% by
weight of gelatin, preferably a skin gelatin, although other
types, such as bone gelatin, may be employed, ... at a
relatively warm temperature, such as 80° centigrade, allowed to
cool to 35°--40° centigrade. Then [] add a small amount of
formalin ( 40% aqueous solution of formaldehyde) ... an
incubate the resulting solution at slightly above room
temperature (30°-37° centigrade) for approximately two hours.
The material is then beaten vigorously for about 5-15 minutes
to produce a firm foam of from 4 to 8 times the volume of the
original solution. This is placed on a monel wire screen in a
drying oven and large quantities of air at about 30 to 33°
centigrade and 10% humidity are circulated through it. This is
continued until the foam is dry.
(Correll 2: 37 - 3: 2; Ans. 3--4.)
FF 5. Examiner finds that "Correll does not expressly state that the bone
gelatins are granules (particles)" and relies upon Damschroder to make up
for the foregoing deficiency in Correll (Fin. Rej. 4).
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Application 12/887 ,945
FF 6. Damschroder discloses that the dissolving action of "50 mesh or
finer" gelatin particles dissolve faster than larger gelatin particles; therefore,
"it is desirable that the gelatin-containing materials be first divided into
small units so that the dissolving action may readily take place"
(Damschroder 1: 44--49; Ans. 4).
FF 7. Examiner finds that the combination of Correll and Damschroder
fails to suggest the "addition of a clot formation accelerator such as
thrombin into the gelatin and formaldehyde solution (e.g. prior to sponge
formation[)]" and relies on Studer to make up for this deficiency in the
combination of Correll and Damschroder (Ans. 7).
FF 8. Studer "relates to a process for the manufacture of hemostatic
tampons and bandages" (Studer 1: 1-3).
FF 9. Studer discloses "that hemostatic tampons and bandages may be
prepared from undenatured water soluble gelatin by adding thrombin to an
aqueous gelatin solution, transforming the solution obtained into foam and
drying the foam obtained" (Studer 1: 31-36; Ans. 5).
FF 10. Studer's "tampons and bandages need not be dipped into a thrombin
solution but may be placed on any wound without prior treatment" (Studer
1: 41--44; Ans. 5).
FF 11. Examiner finds that that combination of Correll, Damschroder, and
Studer fails to suggest "adding a polysaccharide such as chitosan to the
gelatin mixture" and relies upon Maoyuan to suggest "the preparation of a
chitosan-gelatin sponge" (Fin. Rej. 7).
FF 12. Examiner relies on Amiji to suggest "that Chitosan is favorably used
as a hemostatic material for sponges as it provides thrombogenic properties"
(Fin. Rej. 7).
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Application 12/887 ,945
ANALYSIS
The combination of Correll, Damschroder, and Studer:
Based on the combination of Correll, Damschroder, and Studer,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious to have a method, wherein thrombin is
incorporated into the method disclosed by the combination of Correll and
Damschroder, such that the resulting device, i.e. sponge, would not require
"dipping the sponge in thrombin solution after formation of the sponge"
(Fin. Rej. 5).
We recognize, but are not persuaded by, Appellants' contention that
the combination of Correll, Damschroder, and Studer fails to suggest the:
dissolving of gelatin granules in water to form a gelatin solution and
subsequent heating of the gelatin solution, which, as Appellants' contend, is
required by Appellants' claimed invention (App. Br. 5-9; Reply Br. 1-6).
Notwithstanding Appellants' contention to the contrary, Correll discloses the
concurrent or simultaneous dissolving of gelatin granules in water and
heating the gelatin solution as it forms (FF 1 and 4 ). "Where the result
accomplished is substantially the same, steps taken concurrently or
simultaneously are the equivalent of and not patentable over steps taken
successively" New Wrinkle, Inc. v. Watson, Comr. Pats., 96 USPQ 436, 437
(D.C. Cir. 1953).
We recognize, but are not persuaded by, Appellants' contention that
Damschroder discloses a disadvantage associated with a long dissolution
time, wherein "material which dissolves first is being subject to hydrolysis
during the dissolving of the remainder of the material and, therefore, the
gelatin is hydrolyzed more than is desired for a uniform product" (Reply Br.
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4, citing Damschroder 1: 5 5 - 2: 1; cf Damschroder 2: 1-5 ("If the presence
of some excessively hydrolyzed gelatin is not objectionable in the final
product, the use of small particles of hide or bone as the starting material is
not so important") (emphasis added)). Notwithstanding Appellants'
contention to the contrary, Damschroder suggests the solution to the
foregoing concern; specifically, the use of small "gelatin particles [that]
dissolve faster than larger gelatin particles (FF 6). In this regard, we find no:
(a) requirement in Appellants' claim 1 that requires a uniform gelatin
solution, (b) evidence that supports a conclusion that any potential
hydrolysis of gelatin during the heating step suggested by the combination of
references relied upon by Examiner results in a product that is unsatisfactory
for its intended use, and/ or ( c) evidence that supports a conclusion that all
gelatin that is dissolved in water to form a gelatin solution, in the absence of
heat, will be subject to hydrolysis during dissolution or subsequent heating
at the exact same rate, thus necessarily producing a uniform gelatin product.
In addition, Appellants claimed invention does not require a particular
pH or time at a specified temperature (see Appellants' Claim 1). Therefore,
we are not persuaded by Appellants' contention that "in the absence of
further disclosure within Correll of pH and times at temperature, it is not
inherently the case that the operations recited by Correll result in the same
gelatin solution at elevated temperature as obtained by the instant process"
(Reply Br. 5---6). Appellants' contention is not commensurate in scope with
Appellants' claimed invention (see Reply Br. 5---6; cf Appellants' Claim 1;
FF 1).
We recognize, but are not persuaded by, Appellants' contentions
regarding Damschroder (App. Br. 10-11; Reply Br. 6-8). Notwithstanding
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Application 12/887 ,945
Appellants' contention to the contrary, Damschroder suggests that, at the
time of Appellants' claimed invention, a person of ordinary skill in this art
would have recognized smaller particles dissolve more quickly in solution
that larger particles (FF 6). Appellants' fail to provide persuasive argument
or evidence to rebut Examiner's finding.
We recognize, but are not persuaded by, Appellants' contention that a
person of ordinary skill in this art would not add Studer's thrombin to a
device comprising cross-linked gelatin (App. Br. 11-14; see Reply Br. 8
("[t]he thrombin delivery method of Studer, which relies upon dissolution of
a noncross-linked sponge is fundamentally incompatible with the cross-
linked sponges of Correll")). According to Appellants "[ o ]ne of ordinary
skill in the art in view of the disclosure of Studer would not attempt to
deliver thrombin from a sponge which is not easily soluble and thus not
amenable to releasing thrombin, in the manner upon which the Examiner
relies, with a reasonable expectation of success" (App. Br. 11 ). Appellants,
however, fail to establish an evidentiary basis on this record to support a
conclusion that thrombin would be incapable of being freely released from a
cross-linked gelatin device as suggested by the combination of Correll,
Damschroder, and Studer. "Attorney's argument in a brief cannot take the
place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
We recognize, but are not persuaded by, Appellants' reliance on
Waugh8 and contention that "formaldehyde is an inhibitor of clotting by
thrombin" (App. Br. 12-13; Reply Br. 8-10). In this regard, we note that
8 David F. Waugh and Betty J. Livingstone, FORMALDEHYDE AS AN
INHIBITOR OF CLOTTING OF FIBRINOGEN BY THROMBIN, 55 J. Phys.
Colloid Chem. 464--7 6 ( 1951 ).
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Application 12/887 ,945
Appellants disclose a method of preparing a device that comprises both
formaldehyde and thrombin (FF 2). Nevertheless, Waugh discloses that
"[ fJormaldehyde [] combines with a number of the reactive groups of
proteins and may form bridges between two such groups" (Waugh,
Abstract). The combination of prior art relied upon by Examiner suggests
the combination of a gelatin solution and formaldehyde and then the
subsequent addition of thrombin to the cross-linked gelatin (Ans. 10; see FF
3-10). To the extent that Appellants would contend that this is not explicitly
disclosed by the combination of prior art relied upon by Examiner, we note
that an obviousness analysis "may include recourse to logic, judgment, and
common sense available to the person of ordinary skill that do not
necessarily require explication in any reference or expert opinion." Perfect
Web Techs., Inc. v. Info USA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009).
See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962) (obviousness question
cannot be approached on basis that skilled artisans would only know what
they read in references; such artisans must be presumed to know something
about the art apart from what the references disclose).
On this record, Appellants failed to establish an evidentiary basis to
support a conclusion that the cross-linked gelatin suggested by the
combination of Correll and Damschroder would possess non-reacted
formaldehyde groups that would be capable of acting on thrombin. For the
foregoing reasons, we find no evidentiary basis on this record to support
Appellants' contention that "under the conditions of the proposed
combination [thrombin] would be expected to be at least somewhat inhibited
by the other components of the combination and would, in itself, be
expected to have adverse effects upon the resulting combination" (App. Br.
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13). Further, to the extent that the method suggested by the combination of
references relied upon by Examiner does result in thrombin being "at least
somewhat inhibited," Appellants fail to establish an evidentiary basis on this
record to support a conclusion that the thrombin in their composition, which
comprises thrombin and formaldehyde is not "at least somewhat inhibited"
to the same degree as the thrombin present in method suggested by
Examiner's combination of references (see App. Br. 13; cf FF 3-10).
For the foregoing reasons, we are not persuaded by Appellants'
contention that the addition of thrombin to cross-linked gelatin, as suggested
by the combination of prior art relied upon by Examiner, would "inhibit[]
the formation and stability of foam, requiring lyophilization (freezing during
drying) and the inhibition of gelatin cross-linking by thrombin" (App. Br. 9;
Reply Br. 9-10).
Appellants' claim 1 does not require the presence of a polysaccharide
(see Appellants' Claim 1). Therefore, we recognize, but are not persuaded
by, Appellants' contention that they overcome their alleged problem with a
formaldehyde and thrombin combination "by the addition of
polysaccharides, thus providing solutions to problems not disclosed in the
cited art" (App. Br. 12-13). Appellants' contention is not commensurate in
scope with Appellants' claimed invention.
The combination of Correll, Damschroder, Studer, Maoyuan, and Amiji:
Based on the combination of Correll, Damschroder, Studer, Maoyuan,
and Amiji, Examiner concludes that, at the time Appellants' invention was
made, it would have been prima facie obvious "to combine the chitosan[,
suggested by the combination of Maoyuan and Amiji,] with gelatin in the
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aqueous mixture as described by" the combination of Correll, Damschroder,
and Studer (Fin. Rej. 7).
Having found no deficiency in the combination of Correll,
Damschroder, and Studer, we are not persuaded by Appellants' contention
that the combination of Maoyuan and Amiji fails to make up for Appellants'
alleged deficiency in Correll, Damschroder, and Studer (App. Br. 14).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Correll, Damschroder, and Studer is affirmed.
Claims 2, 5-7, and 9 are not separately argued and fall with claim 1.
The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Correll, Damschroder, Studer, Maoyuan, and Amiji
is affirmed. Claims 4 and 8 are not separately argued and fall with claim 3.
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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