Ex Parte Clower et al

Patent Trial and Appeal Board

Jan 3, 2018

13693218 (P.T.A.B. Jan. 3, 2018)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/693,218 12/04/2012 Dottie Clower 20437-0026001 9308
26191 7590 01/05/2018
FISH & RICHARDSON P.C. (TC)
PO BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
ROGERS, JAMES WILLIAM
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
01/05/2018 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DOTTIE CLOWER,
DESPINA DOBBINS, and STEPHANIE KLADAKIS
Appeal 2017-001367
Application 13/693,218
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a tissue
sealant. The Examiner rejected the claims as anticipated and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
Statement of the Case
Background
“Tissue sealants are typically used to stop bleeding during vascular or
liver surgery, eliminate air leaks in the lungs, and to prevent adhesions”
(Spec. 1:6-7). The “tissue sealant consists of two distinct components that
1 Appellants identify the Real Party in Interest as Cohera Medical, Inc. (see
App. Br. 1).
Appeal 2017-001367
Application 13/693,218
are mixed together just prior to application to tissue to cause a rapid,
irreversible chemical reaction” {id. at 1:9-11). “One problem with such
two-part sealants, however, is that the rapid cure times can cause the sealant
applicator to clog” {id. at 1:13-15).
The Claims
Claims 1-13, 15-18, and 20 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A tissue sealant comprising the reaction product of:
(a) a polyol;
(b) a polyisocyanate selected from the group consisting of
lysine diisocyanate and derivatives thereof, lysine triisocyanate and
derivatives thereof, and combinations thereof; and
(c) an alkoxy silane having the formula: (R1R2R3)-Si-CH2-Z
where:
(i) Z is an -OH, -SH, -NCO, or-NHR4 group, where R4 is
hydrogen, an alkyl group, or an aryl group; and
(ii) each R1, R2, and R3, independently, is H, an alkoxy group,
an alkyl group, a heteroalkyl group other than an alkoxy group, an
aryl group, or a heteroaryl group, with the proviso that at least two of
R1, R2, and R3 are alkoxy groups,
wherein the relative amounts of the polyol, polyisocyanate, and
alkoxy silane are selected such that the number of isocyanate groups
available for reaction is greater than the number of isocyanate-reactive
groups available for reaction selected from the group consisting of -
OH groups, -SH groups, -NHR4 groups, and combinations thereof,
and produces a reaction product that comprises free isocyanate
groups,
wherein the tissue sealant is moisture-curable and
biodegradable in a physiological environment.
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Application 13/693,218
The Issues
A. The Examiner rejected claims 1, 6-8, 13, 16, and 20 under 35 U.S.C.
§ 102(b) as anticipated by Beckman2 (Non-Final Act.3 3—4).
B. The Examiner rejected claims 1-7, 9-13, 15, 16, and 20 under 35
U.S.C. § 103(a) as obvious over Beckman (Non-Final Act. 6-8).
C. The Examiner rejected claims 1-7, 9-13, 15-18, and 20 under 35
U.S.C. § 103(a) as obvious over Beckman and Gravett4 (Non-Final Act. 8).
D. The Examiner rejected claims 1-13, 15-18, and 20 under 35 U.S.C.
§ 103(a) as obvious over Beckman, Gravett, and Stanjek5 (Non-Final Act.
9).
Because these rejections turn on the same issues, we will consider
these rejections together.
The Examiner finds
Beckman discloses biodegradable and moisture-curable tissue
sealants that include the reaction product of a polyol (including
polyethylene glycol) activated with polyfunctional linkers
including polyisocyanates such as lysine diisocyanate and
lysine triisocyanate and an alkoxysilane having the formula:
(R1R2R3)-Si-CH2-Z where (i) Z is an -OH, -SH,-NCO, or -
NHR4 group, where R4 is hydrogen or an alkyl group; and (ii)
each R1, R2, and R3, independently, is H, an alkoxy group, an
alkyl group, a heteroalkyl group other than an alkoxy group, an
aryl group, or a heteroaryl group, with the proviso that at least
two of R1, R2, and R3 are C1-C6 alkoxy groups. See entire
2 Beckman et al., WO 2011/150199 A2, published Dec. 1, 2011.
3 We refer to the Non-Final Action mailed Dec. 12, 2014 because
this was the most recent action that actually included the details of
the Examiner’s rejections.
4 Gravett et al., US 2004/0225077 Al, published Nov. 11, 2004.
5 Stanjek et al., US 2007/0167598 Al, published July 19, 2007.
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Application 13/693,218
disclosure especially abstract, page 1 lines 20-26, page 3 lines
4-7, page 4 lines 13-page 5 line 2 and claims
(Non-Final Act. 3). In particular, the Examiner finds: “[sjince the
composition is moisture curable it follows that there must be some reactive
functional groups remaining to react with water, this would include free
isocyanate groups” (Non-Final Act. 3—4).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Beckman either anticipates
claim 1 or renders claim 1 obvious?
Findings of Fact
1. Beckman teaches:
A tissue sealant is described that includes the reaction product
of (a) a polyol having at least two groups capable of reacting
with an alkoxy silane; and (b) an alkoxy silane having the
formula: (R1R2R3)-Si-CH2-Z where (i) Z is an -OH, -SH, -NCO,
or -NHR4 group, where R4 is hydrogen or an alkyl group; and
(ii) each R1, R2, and R3, independently, is H, an alkoxy group,
an alkyl group, a heteroalkyl group other than an alkoxy group,
an aryl group, or a heteroaryl group, with the proviso that at
least two of R1, R2, and R3 are alkoxy groups
(Beckman 1:21-26).
2. Beckman teaches in “some embodiments, the activated polyol
is the reaction product of a polyol and a polyfunctional linker molecule
having at least one functional group capable of reacting with a hydroxyl
group of the polyol, and at least one functional group capable of reacting 1 o
with the Z group of the alkoxy silane” (Beckman 2:7-10).
3. Beckman teaches “the polyfunctional linker molecule is a
poly isocyanate. Examples of suitable polyisocyanates include . . . lysine
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Appeal 2017-001367
Application 13/693,218
diisocyanate and derivatives thereof, lysine triisocyanate and derivatives
thereof, and combinations thereof’ (Beckman 2:14-17).
4. Beckman teaches:
In one embodiment, the polyol is a polyalkylene glycol such as
polyethylene glycol; the alkoxy silane is a trialkoxy silane such
as a triethoxy silane in which the Z group is an alkylamino
group such as a cyclohexylamino group (where R4 is a
cyclohexyl group); and the polyfunctional linker molecule is a
multi-functional isocyanate such as lysine diisocyanate (“LDI”)
or a derivative thereof (e.g., alkyl esters such as methyl or ethyl
esters), or lysine triisocyanate (“LTI”) or a derivative thereof
(e.g., alkyl esters such as methyl or ethyl esters). The linker
molecule reacts with the hydroxyl groups of the polyol to create
an activated polyol
(Beckman 4:26 to 5:2).
5. Beckman teaches the “tissue sealant is moisture-curable and
biodegradable in a physiological environment” (Beckman 1:26-27).
Principles of Law
A prior art reference can only anticipate a claim if it discloses all the
claimed limitations “arranged or combined in the same way as in the claim.”
Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361
(Fed. Cir. 2012).
A prima facie case for obviousness “requires a suggestion of
all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349
F.3d 1333, 1342 (Fed. Cir. 2003) and “a reason that would have
prompted a person of ordinary skill in the relevant field to combine
the elements in the way the claimed new invention does.” KSR
Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
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Application 13/693,218
Analysis
Appellants contend the “only tissue sealants taught in Beckman lack
free (i.e. unreacted) isocyanate groups” (App. Br. 4). Appellants contend
“Beckman provides no reason to have excess isocyanate groups. In fact,
excess isocyanate groups would be superfluous given Beckman’s reason for
including the polyisocyanate in the first place, which is to react with the
polyol and alkoxy silane” {id. at 5). Appellants analyze Example 1 of
Beckman and contend: “The total number of isocyanate groups is equal to
total number of isocyanate-reactive groups. . . . The resulting product lacks
free (i.e. unreacted) isocyanate groups.” {Id. at 5-6).
The Examiner responds the “mental selection step purportedly
produces a reaction product comprising free isocyanate groups. The claims
are drawn to the product itself and not the method of manufacture, even
though [Appellants] arguments revolve significantly around the process of
making” (Ans. 3). The Examiner finds “it would be evident to one of
ordinary skill that the reactants could be selected in which an excess of
isocyanate groups are present in the reaction step, thereby producing a
product with free isocyanate groups” {id.).
We find that Appellants have the better position. We interpret the
requirement that the final tissue sealant comprises a reaction product that
“produces a reaction product that comprises free isocyanate groups” as
imposing a structural limitation on claim 1 that excludes tissue sealants
without free isocyanate groups {id.). The Beckman Declaration6 evidences
that Beckman lacks free isocyanate groups {see Beckman Decl. ^ 6). We
6 Declaration of Prof. Eric J. Beckman, dated Sept. 22, 2015.
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Application 13/693,218
credit this Declaration and find the Examiner has provided no evidence
rebutting the conclusion of the Beckman Declaration. In particular, we are
not persuaded by the Examiner’s finding of “clear embodiments where more
isocyanate groups are present than would be consumed in a reaction between
the three components” (Ans. 4). Therefore, Beckman does not teach or
anticipate a sealant with “free isocyanate groups” as required by claim 1.
We also agree with Appellants that the Examiner has provided no
reason, whether based on a prior art suggestion in Beckman, the knowledge
of the ordinary artisan, or common sense, for modifying the tissue sealant
disclosed by Beckman to obtain a composition with “free isocyanate groups”
as required by claim 1 (see App. Br. 4). As stated in Antonie, while
discovery of an optimum value of a variable is normally obvious, one
exception to this rule is the situation where the parameter optimized was not
recognized to be a result-effective variable. See In re Antonie, 559 F.2d 618,
620 (CCPA 1977). Therefore, to the extent that the Examiner contends “it
would be evident to one of ordinary skill that the reactants could be selected
in which an excess of isocyanate groups are present in the reaction step,” we
find the Examiner has not established that selection of “free isocyanate
groups” represents an optimizable variable based on teachings in Beckman
(Ans. 3). We therefore also find Beckman does not render claim 1 obvious.
The Examiner does not identify teachings in Gravett or Stanjek that cure the
deficiencies in Beckman (see Non-Final Act. 8-9).
Conclusions of Law
The evidence of record does not support the Examiner’s conclusion
that Beckman either anticipates claim 1 or renders claim 1 obvious.
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SUMMARY
In summary, we reverse the rejection of claims 1, 6-8, 13, 16, and 20
under 35 U.S.C. § 102(b) as anticipated by Beckman.
We reverse the rejection of claims 1-7, 9-13, 15, 16, and 20 under 35
U.S.C. § 103(a) as obvious over Beckman.
We reverse the rejection of claims 1-7, 9-13, 15-18, and 20 under 35
U.S.C. § 103(a) as obvious over Beckman and Gravett.
We reverse the rejection of claims 1-13, 15-18, and 20 under 35
U.S.C. § 103(a) as obvious over Beckman, Gravett, and Stanjek.
REVERSED
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