Ex Parte Sowinski et al

Patent Trial and Appeal Board

Feb 15, 2017

13706277 (P.T.A.B. Feb. 15, 2017)

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.
13/706,277 12/05/2012 Krzysztof Sowinski 06-01260US03 9327
99185 7590 02/17/2017
(Retinae TTS» T eaal Shared .Services;
EXAMINER
1300 MacArthur Boulevard
Mahwah, NJ 07430
FISCHER, JUSTIN R
ART UNIT PAPER NUMBER
1747
NOTIFICATION DATE DELIVERY MODE
02/17/2017 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):
patents @ getinge. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KRZYSZTOF SOWINSKI, RONALD RAKOS, JERRY DONG,
DENNIS KUJAWSKI, PATRICK A. HAVERKOST,
and PAUL F. CHOUINARD
Appeal 2016-003582
Application 13/706,277
Technology Center 1700
Before CHUNG K. PAK, JULIA HEANEY, and JANE E. INGLESE,
Administrative Patent Judges.
INGLESE, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1, 4, 5, 7, 10, 12—15, 20, 22, 23, 25, 32, 33, 42, 44,
45, and 47^49.2 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Maquet Cardiovascular
LLC. (Appeal Brief filed September 23, 2015 (“App. Br.”), 11.)
2 Non-Final Office Action entered March 23, 2015 (“Office Act.”).
Appeal 2016-003582
Application 13/706,277
STATEMENT OF THE CASE
The subject matter on appeal is generally directed to a composite
multilayer implantable structure, a method of forming an implantable
prosthesis, and a vascular graft. App. Br. 11—14.
Details of the appealed subject matter are recited in representative
claims 1,33, and 47, which are reproduced below from the Claims Appendix
to the Appeal Brief:
1. A composite multilayer implantable structure
comprising:
a first layer formed from a thermoplastic textile material;
a second layer formed of expanded
polytetrafluoroethylene having a porous microstructure defined
by nodes interconnected by fibrils; and
an elastomeric bonding agent formed from an aromatic
polycarbonate urethane and securing said first layer to said
second layer such that said elastomeric bonding agent is
disposed within pores of said microstructure to bond the first
layer to the second layer, wherein the aromatic polycarbonate
urethane is a reaction product of polyhexamethylenecarbonate
diol with methylene bisphenyl diisocyanate and a chain
extender 1,4-butanediol.
33. A method of forming an implantable prosthesis comprising
the steps of:
applying an elastomeric bonding agent comprising an
aromatic polycarbonate urethane to a first layer comprising
expanded polytetrafluoroethylene and having a microporous
structure of nodes interconnected by fibrils, wherein the
aromatic polycarbonate urethane is a reaction product of
polyhexamethylenecarbonate diol with methylene bisphenyl
diisocyanate and a chain extender 1,4-butanediol;
disposing said elastomeric bonding agent within pores of
said microporous structure; and
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securing said first layer to a textile layer comprising a
thermoplastic material with said elastomeric bonding agent via
application of external compression and heat.
47. A composite multilayer implantable structure comprising:
a first layer formed from a thermoplastic textile material;
a second layer formed of expanded
polytetrafluoroethylene having a porous micro structure defined
by nodes interconnected by fibrils; and
a sprayed adhesive layer positioned on the second layer,
wherein the sprayed adhesive layer comprises an elastomeric
bonding agent formed from a polycarbonate urethane that
secures the first layer to the second layer so that the elastomeric
bonding agent is disposed within pores of the porous
microstructure to bond the first layer to the second layer,
wherein the polycarbonate urethane is a reaction product of a
macro glycol, a diisocyanate and a chain extender.
(App. Br. 108, 110-111, 112, Claims Appendix.)
Appellants seek review of the following grounds of rejection
maintained by the Examiner in the Answer entered December 23, 2015
(“Ans.”):
I. Claims 47 and 49 under 35 U.S.C. § 103(a) as unpatentable
over Schmitt (US 5,527,353, issued June 18, 1996) and Du (EP 0 855 170
A2, published July 29, 1998).
II. Claims 1, 4, 5, 7, 10, 12, 22, 42, 43, 45, and 48 under 35 U.S.C.
§ 103(a) as unpatentable over Schmitt, Du, and Richter et al. (US 4,656,228,
issued April 7, 1987).
III. Claim 13 under 35 U.S.C. § 103(a) as unpatentable over
Schmitt, Du, Richter, and Trescony et al. (US 5,607,464, issued March 4,
1997).
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IV. Claims 14, 15, and 23 under 35 U.S.C. § 103(a) as unpatentable
over Schmitt, Du, Richter, and Medell (US 3,479,670, issued November 25,
1969) and/or McIntyre et al. (US 5,976,192, issued November 2, 1999).
V. Claim 20 under 35 U.S.C. § 103(a) as unpatentable over
Schmitt, Du, Richter, and Della Coma et al. (US 4,955,899, issued
September 11, 1990).
VI. Claims 32, 33, and 44 under 35 U.S.C. § 103(a) as unpatentable
over Schmitt, Du, Richter, and Burnside et al. (US 6,626,939 Bl, issued
September 30, 2003).
VII. Claims 47 and 49 under 35 U.S.C. § 103(a) as unpatentable
over Chouinard (US 6,156,064, issued December 5, 2000) and Du.
VIII. Claims 1, 4, 5, 7, 10, 12, 22, 23, 25, 32, 33, 45, and 48 under 35
U.S.C. § 103(a) as unpatentable over Chouinard, Du, and Richter.
DISCUSSION
Upon consideration of the evidence on this appeal record and each of
Appellants’ contentions, we affirm the Examiner’s rejections of claims 1, 4,
5, 7, 10, 12-15, 20, 22, 23, 25, 32, 33, 42, 44, 45, and 47-A9 under 35
U.S.C. § 103(a) for the reasons set forth in the Office Action and the
Answer. We add the discussion below primarily for emphasis.
Rejection I3
3 We limit our discussion to those claims separately argued, and claims not
separately argued stand or fall with the argued claims. 37 C.F.R.
§ 41.37(c)(l)(iv). Appellants argue claims 47 and 49 as a group. (See
generally App. Br. 15—37.) Therefore, for the purposes of this appeal, we
select claim 47 as representative, and decide the propriety of Rejection I
based on claim 47 alone.
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Consistent with the Examiner’s undisputed findings, Schmitt discloses
a soft-tissue prosthesis comprising a knitted textile supporting sleeve formed
from polyester or polypropylene (first thermoplastic textile layer) adhesively
laminated to a polymer lining formed from expanded
polytetrafluoroethylene (ePTFE) (second layer). Office Act. 2—3; Schmitt
col. 4,11. 52—59; col. 5,11. 2—3, 14—16, 51—67. Appellants also do not
dispute the Examiner’s finding that ePTFE inherently has a porous
microstructure defined by nodes interconnected by fibrils, and the Examiner
determines that the adhesive disclosed in Schmitt would be disposed within
the pores of Schmitt’s ePTFE polymer lining. Compare Office Act. 2—3,
with App. Br. 15—37.
The Examiner acknowledges that Schmitt does not disclose the
adhesive used to bond the supporting sleeve to the polymer lining, and the
Examiner relies on Du’s disclosure of adhesives suitable for use in stent
graft prostheses to bond a PTFE structural component to a polypropylene
textile component. Office Act. 3; Du 4,11. 31—39; 6,11. 6—6, 15—20; 8,11. 1—
5. Specifically, Du discloses that suitable adhesives for bonding a stent
formed from a latticework of interconnected PTFE filaments to a graft
formed from interwoven polypropoylene textile strands include
“polycarbonate urethanes such as disclosed in U.S. Patent No. 5,229,431
(Pinchuk),” which are a reaction product of a macroglycol, a diisocyanate,
and a chain extender. Du 8,11. 1—5; Pinchuk col. 4,11. 16—20. Du discloses
that the adhesive can be applied by spraying a solution formed from the
adhesive and a solvent onto the graft latticework. Du 8,11. 6—10. The
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Examiner notes that Appellants’ Specification indicates that the
polycarbonate urethanes described in Pinchuk are particularly suitable for
use as adhesives in Appellants’ composite multilayer implantable structure.
Office Act. 3; Spec. 134.
Based on these factual findings, the Examiner concludes that it would
have been obvious to one of ordinary skill in the art at the time of
Appellants’ invention to use the polycarbonate urethane adhesive disclosed
in Du as the adhesive for the soft-tissue prosthesis disclosed in Schmitt.
Office Act. 3.
Appellants argue, citing to In re Saunders, 444 F.2d 599, 602—603
(CCPA 1971), that the Examiner improperly relies on the disclosure of
Pinchuk because Du does not incorporate Pinchuk by reference. App. Br.
22-24.
However, Saunders does not support, and actually undermines,
Appellants’ argument. In Saunders the Court held that a statement in a prior
art patent to Hostettler that “[t]he above-described siloxane-oxyalkylene
block copolymers can be prepared in accordance with the procedures
described and claimed in the copending application of D. L. Bailey and F.
M. O’Conner, Serial No. 417,935, filed December 14, 1953,” referred to
particular “above-described” siloxane-oxyalkylene block copolymers
disclosed in Hostettler that did not anticipate the claimed subject matter.
Saunders 444 F.2d at 603. However, the Court held that other siloxane-
oxyalkylene block copolymers disclosed in Bailey did render the claimed
subject matter obvious, and thus relied on the disclosure of Bailey as
referenced by Hostettler to affirm the Patent Office’s “strong showing of
prima facie obviousness.” Id. at 603—604. Contrary to Appellants’
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arguments, the Court in Saunders thus did not consider the reference in
Hostettler to Bailey inadequate to incorporate Bailey by reference. Id.
In addition, In re Voss, 557 F.2d 812 (CCPA 1977) and In re Hughes,
550 F.2d 1273, 1275 (CCPA 1977) also provide guidance relevant to the
particular facts of the present case. In Foss the court determined that a
statement in a parent patent application indicating that “[reference is made
to United States Patent No. 2,920,971, granted to S. D. Stookey, for a
general discussion of glass-ceramic materials and their production” showed
a clear intention to make the “discussion of glass-ceramic materials and their
production” in Stookey become part of the parent patent application. Foss
577 F.2d at 816—817. The Court determined that the Board therefore erred
in finding otherwise because this was not a situation where Appellants were
relying on the parent application’s reference to Stookey to provide an earlier
filing date. Id. at. 817. Similarly, in In re Hughes, 550 F.2d 1273 (CCPA
1977) the Court held that a statement that “[reference is made to application
Ser. No. 131,108 for complete descriptions of methods of preparing aqueous
polymeric dispersions applicable in the hereinafter described invention”
incorporated the disclosure of such methods into the patent in question.
Hughes 550 F.2d at 1275. Consistent with Foss and Hughes, Du discloses
that the “[alternative adhesives [used in its invention] include polycarbonate
urethane such as disclosed in U.S. Patent No. 5,229,431 (Pinchuk).” Du,
p.8,1. 5. Du clearly shows its intention to use the polycarbonate urethane
disclosed in U.S. Patent No. 5,229,431 (Pinchuk) as its adhesives. Id.
Moreover, Appellants have had ample opportunity to argue the applicability
of the content of Pinchuk in the Examiner’s obviousness rejections during
prosecution and in the appeal to the Board because the Examiner has relied
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upon its teaching since the March 23, 2015 Non-Final Office Action.
Indeed, Appellants argue that Schmitt, Due, and Pinchuk would not have
suggested the claimed invention as indicated infra. Appellants’ arguments
are therefore unpersuasive of reversible error.
Appellants further argue that the combined disclosure of Schmitt, Du,
and Pinchuk do not disclose or suggest a sprayed polycarbonate urethane
adhesive layer and its penetration into pores of ePTFE as recited in claim 47.
App. Br. 30—32. In support of this argument, Appellants assert that Exhibits
A, G4, and Pinchuk et al. (US 5,163,951, “Pinchuk ‘951”) demonstrate that
polycarbonate urethanes are repelled from the surface of PTFE and ePTFE,
and thus would not fill its pores. Id.
However, as discussed above, it is undisputed that the ePTFE polymer
lining disclosed in Schmitt inherently has a porous microstructure defined by
nodes and interconnected by fibrils. Schmitt’s silence regarding suitable
adhesives for laminating the ePTFE polymer lining to a knitted
polypropylene textile sleeve would have left it to one of ordinary skill in the
art to select an appropriate adhesive for this purpose. Du’s disclosure of
conventional adhesives used in the stent art, such as polycarbonate urethanes
as described in Pinchuk, which are suitable for binding a PTFE stent
component to a polypropoylene textile, would have led one of ordinary skill
in the art to use such a polycarbonate urethane adhesive to laminate the
ePTFE polymer lining to the knitted polypropylene textile disclosed in
Schmitt.
4 The Exhibits discussed in this Decision were submitted by Appellants in
prosecution and are thus all of record.
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Du’s disclosure of combining the adhesive with a solvent and
spraying the solution onto the stent component would have led one of
ordinary skill in the art to use such a process to apply the polycarbonate
urethane adhesive to the ePTFE polymer lining disclosed in Schmitt. As is
evident from Du’s disclosure, one of ordinary skill in the art would have had
sufficient skill to select a suitable solvent to combine with the polycarbonate
urethane, and also would have had sufficient skill to use an appropriate
technique for spraying the adhesive onto the ePTFE polymer lining. In so
doing, by virtue of ePTFE’s porous microstructure, the polycarbonate
urethane would have penetrated into pores of the ePTFE as recited in claim
47.
Appellants’ reliance on Exhibits A, G, and Pinchuk ‘951 ignores the
express disclosure in Du that polycarbonate urethanes are suitable adhesives
for use in stents to bond woven textiles to PTFE, and Appellants’ arguments
thus fail to take into consideration the level of ordinary skill in the art and
the state of the art, such as Du, at the time of Appellants’ invention. In this
regard, we note that another Exhibit submitted by Appellants explicitly
describes coating ePTFE using solvents that penetrate into its porous
regions. US 6,833,153 (“Exhibit H”), col. 5,11. 14—33. Appellants’
arguments are therefore unpersuasive of reversible error.
Relying on Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc.,
545 F.3d 1312 (Fed. Cir. 2008), Appellants further argue that Schmitt and
Du, individually and in combination, do not enable use of a polycarbonate
urethane adhesive to bond ePTFE to a thermoplastic textile material as
recited in claim 47. App. Br. 16—22, 24—29. Appellants contend that one of
ordinary skill in the art therefore would not have had a reasonable
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expectation of successfully bonding ePTFE to a thermoplastic textile
material using a polycarbonate urethane adhesive in view of the combined
disclosures of Schmitt and Du. App. Br. 32—37. In support of these
arguments, Appellants rely on numerous Exhibits (A, B, C, D, E, H, I, K,
and L) and two Declaration of Jerry Dong, an inventor of the present
application, submitted to the Patent Office on June 27, 2014 and January 21,
2015. Id.
We note initially that “a non-enabling reference may quality as prior
art for the purpose of determining obviousness under § 103.” Symbol
Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991).
Appellants’ reliance on Imp ax Laboratories is misplaced because Impax
held that a prior art reference must enable claimed subject matter to
anticipate a claimed invention rather than render it obvious. Impax 545
F.3d at 1315—1316. Nevertheless, a prior art reference is presumptively
enabling, and Appellants bear the burden of demonstrating otherwise. In re
Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (A prior art
printed publication, like a prior art patent, “is presumptively enabling
barring any showing to the contrary by a patent applicant or patentee.”).
Many of the Exhibits submitted by Appellants discuss the difficulty of
bonding substances such as silicon to the surface of Teflon (PTFE) and
ePTFE. See, e.g., Ex. A, B, D, E. However, Appellants’ and the Declarant’s
reliance on the Exhibits ignores the express disclosure in Du that
polycarbonate urethanes are suitable adhesives for use in stents to bond
woven textiles to Teflon (PTFE). Thus, although the difficulty of bonding
substances to PTFE may have been known, Du provides a solution to this
known problem by indicating that polycarbonate adhesives are suitable for
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bonding woven textiles to PTFE in stents. By ignoring this disclosure in Du,
Appellants’ arguments and the Declarations only partially consider the state
of the art, rather than the art as a whole at the time of Appellants’ invention.
In fact, Exhibit A5 at pages 622—623 indicates that ePTFE membranes can
be laminated to woven materials made from polyester, and Exhibit H
describes solvents used to coat ePTFE by penetrating into its porous regions
(discussed above).
Accordingly, on this record, Appellants do not proffer sufficient
reasoning and/or evidence to demonstrate that one of ordinary skill in the art
would not have reasonably expected that the polycarbonate urethane
adhesive disclosed in Du could be used to successfully bond the ePTFE
polymer lining to the knitted polypropylene textile sleeve per the collective
teachings of Schmitt and Du. In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir.
2009) (“Obviousness does not require absolute predictability of success . . .
all that is required is a reasonable expectation of success.”) (emphasis
omitted, citing In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988));
Velanderv. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (“In giving more
weight to prior publications than to subsequent conclusory statements by
experts, the Board acted well within [its] discretion.”); Yorkey v. Diab, 601
F.3d 1279, 1284 (Fed. Cir. 2010) (The Board has discretion to give more
5 Wikol et al., Expanded Polytetrafluoroethylene Membranes and Their
Applications, extracted from Filtration and Purification in the
Biopharmaceutical Industry, 2nd ed., https://www.gore.com/
DMungoBlobs/827 /932/ExpandedPTFEandTheirMembranes_ Gore_
Chapter23_Feb2008.pdf. (“Exhibit A”).
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weight to one item of evidence over another “unless no reasonable trier of
fact could have done so”).
Appellants’ arguments and the Declarations are therefore
unpersuasive of reversible error, and we accordingly sustain the Examiner’s
rejection of claims 47 and 49 under 35 U.S.C. § 103(a) as unpatentable over
Schmitt and Du.
Rejection II6
Appellants do not dispute the Examiner’s finding that Du discloses
that polycarbonate urethanes as disclosed in Pinchuk are suitable adhesives
for use in stents to bond PTFE filaments to an interwoven polypropoylene
textile. Compare Office Act. 3—4, with App. Br. 37—54; Du 4,11. 31—39; 6,
11. 6—6, 15—20; 8,11. 1—5. Appellants also do not dispute the Examiner’s
finding that Pinchuk discloses polycarbonate urethanes that are a reaction
product of an aromatic polycarbonate macroglycol derived from phosgene, a
diisocyanate such as methylene bisphenyl diisocyanate, and a chain extender
such as 1,4-butanediol. Compare Office Act. 3—4, with App. Br. 37—54;
Pinchuk col. 4,11. 16—20; col. 5,11. 32—34; col. 6,11. 4—10, 27—31. Nor do
Appellants dispute the Examiner’s finding that Richter discloses that
polyhexamethylene carbonate diols are derived from phosgene. Compare
Office Act. 4, with App. Br. 37—54; Richter col. 3,11. 1—3. The Examiner
concludes that it would have been obvious to one of ordinary skill in the art
at the time of Appellants’ invention, in view of Richter’s disclosure that
6 Appellants argue claims 1, 4, 5, 7, 10, 12, 22, 42, 43, 45, and 48 as a group.
(See generally App. Br. 37—54.) Therefore, for the purposes of this appeal,
we select claim 1 as representative, and decide the propriety of Rejection II
based on claim 1 alone.
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polyhexamethylene carbonate diols are derived from phosgene, to utilize a
polyhexamethylene carbonate diol as the macroglycol derived from
phosgene disclosed in Pinchuk to produce a polycarbonate urethane by
reacting the polyhexamethylene carbonate diol with methylene bisphenyl
diisocyanate and 1,4-butanediol as disclosed in Pinchuk. Office Act. 4.
Appellants argue that Richter is non-analogous art because Richter is
directed to polyamide compounds containing aliphatic polycarbonate
urethanes having high rigidity and notched impact strength that are used for
injection molding protective helmets, which have “absolutely nothing to do
with composite multilayer implantable structures.” App. Br. 39-40.
For a prior art reference to be analogous art, the reference must either
be in the field of the inventors’ endeavor, or must be reasonably pertinent to
the particular problem with which the inventors were concerned from the
viewpoint of one of ordinary skill in the art. See, e.g., In re Kahn, 441 F.3d
977, 986—87 (Fed. Cir. 2006) (stating that the analogous art test requires that
“a reference is either in the field of the applicant’s endeavor or is reasonably
pertinent to the problem with which the inventor was concerned . . . based on
the judgment of a person having ordinary skill in the art.”); In re Antle, 444
F.2d 1168, 1171—1172 (CCPA 1971) (indicating that section 103 requires a
presumption of full knowledge by the inventor of the prior art in the field of
his endeavor, but does not require a presumption of full knowledge by the
inventor of prior art outside the field of his endeavor, i.e., of non-analogous
art. “In that respect, it only requires us to presume that the inventor would
have the ability to select and utilize knowledge from other arts reasonably
pertinent to his particular problem which would be expected of a man of
ordinary skill in the art to which the subject matter pertains.”)
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Applying the above principles of law to the facts of this case, we find
Appellants’ argument that Richter is non-analogous art to be without
persuasive merit. As correctly found by the Examiner, Du and Pinchuk
evidence that Richter is reasonably pertinent to the particular problem with
which the inventors were concerned, as determined from the viewpoint of
one of ordinary skill in the art. As discussed above, it is undisputed that
Pinchuk indicates that the polycarbonate urethanes disclosed in Du as
suitable adhesives for use in stents to bond PTFE to a polypropylene textile
are a reaction product of an aromatic polycarbonate macroglycol derived
from phosgene, a diisocyanate such as methylene bisphenyl diisocyanate,
and a chain extender such as 1,4-butanediol. Accordingly, one of ordinary
skill in the art seeking to use a polycarbonate urethane disclosed in Pinchuk
as an adhesive as disclosed in Du to bond ePTFE to a polypropoylene textile
as disclosed in Schmitt would have looked to Richter for disclosure of
suitable polycarbonate macroglycols derived from phosgene, such as
polyhexamethylene carbonate diols. Therefore, Appellants’ arguments are
unpersuasive of reversible error in the Examiner’s finding that Richter is
reasonably pertinent to the particular problem with which the inventors were
concerned, as determined by one of ordinary skill in the art.
Although Appellants also argue that Richter does not disclose an
adhesive material and thus does not provide an enabling disclosure of a
polycarbonate urethane adhesive used to bond a woven textile to ePTFE, and
although Appellants further contend that one of ordinary skill in the art
therefore would not have had a reasonable expectation of successfully
bonding ePTFE to a thermoplastic textile material using a polycarbonate
urethane adhesive in view of the combined disclosures of Schmitt, Du, and
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Richter, Appellants’ arguments do not address the basis for the Examiner’s
reliance on the collective teachings of Schmitt, Du, and Richter, and are thus
unpersuasive of reversible error. App. Br. 37—39, 41—54. As discussed
above, the Examiner relies on Richter for the disclosure of suitable
polycarbonate macroglycols derived from phosgene, such as
polyhexamethylene carbonate diols, that can be used to prepare Du’s
polycarbonate urethanes by reacting the polyhexamethylene carbonate diol
with a diisocyanate such as methylene bisphenyl diisocyanate, and a chain
extender such as 1,4-butanediol, as disclosed in Pinchuk referred by Du.
Moreover, as indicated supra, based on the disclosures of Schmitt and Du,
one of ordinary skill in the art would have had a reasonable expectation of
success in bonding ePTFE to a thermoplastic textile material using Du’s
polycarbonate urethane adhesive made with Richter’s polycarbonate
macroglycols derived from phosgene.
Accordingly, Appellants’ arguments are unpersuasive of reversible
error in the Examiner’s conclusion that the combined disclosures of Schmitt,
Du, and Richter would have suggested a composite multilayer implantable
structure as recited in claim 1. We accordingly sustain the Examiner’s
rejection of claims 1, 4, 5, 7, 10, 12, 22, 42, 43, 45, and 48 under 35 U.S.C.
§ 103(a) as unpatentable over Schmitt, Du, and Richter.
Rejections III—V
Appellants rely on their contentions that the Examiner erred in
rejecting the base claim, independent claim 1, from which claims 13—15, 20,
and 23 depend, and argue that the additional references cited in these
rejections fail to remedy the deficiencies of Schmitt, Du, and Richter. App.
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Br. 54—56. Because we are unpersuaded of reversible error in the
Examiner’s rejection of claim 1, Appellants’ position as to these grounds of
rejection is also without merit. Accordingly, we sustain the rejections of
claims 13—15, 20, and 23 under 35 U.S.C. § 103(a).
Rejection VI7
The Examiner relies on Burnside for disclosing that heat and pressure
were conventionally used in the art to form medical assemblies, and the
Examiner concludes that it would have been obvious to apply heat and
pressure to secure the polycarbonate urethane adhesive suggested by Du in
Schmitt’s soft-tissue prosthesis. Office Act. 7.
In essence, Appellants repeat the arguments made in connection with
rejections I and II and assert that Burnside fails to remedy the asserted
deficiencies of Schmitt, Du, and Richter because although Burnside
discloses the use of polycarbonate urethane as a sprayed adhesive to bond a
braided PLLA stent to a braided PET (Dacron) graft, Burnside does not
disclose or suggest that polycarbonate urethane suitably binds to ePTFE and
penetrates the pores of ePTFE. App. Br. 56—74. However, we find
Appellants’ arguments unpersuasive of reversible error because they do not
address the basis for the Examiner’s reliance on Burnside. Specifically, the
Examiner relies on Burnside’s disclosure that heat and pressure are
conventionally used to form medical assemblies, thus suggesting the use of
heat and pressure to secure the ePTFE polymer lining to the knitted
7 Appellants argue claims 32, 33, and 44 as a group. (See generally App. Br.
56—74.) Therefore, for the purposes of this appeal, we select claim 33 as
representative, and decide the propriety of Rejection VI based on claim 33
alone.
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polypropylene textile disclosed in Schmitt with the polycarbonate urethane
adhesive suggested by Du. We accordingly sustain the Examiner’s rejection
of claims 32, 33, and 44 under 35 U.S.C. § 103(a) as unpatentable over
Schmitt, Du, Richter, and Burnside.
Rejection VII8
Appellants do not dispute the Examiner’s finding that Chouinard
discloses a medical assembly comprising a stent formed of interbraided
polyethylene terephthalate (PET) filaments (corresponding to the recited
first layer formed from a thermoplastic textile material) and a membrane
formed from ePTFE (corresponding to the second layer formed of ePTFE)
adhesively attached to the stent. Compare Office Act. 7, with App. Br. 74—
90; Chouinard col. 2,11. 18—23; col. 3,11. 53—56; col. 8,11. 9-10, 28—29; col.
9,11. 17—19. The Examiner acknowledges that Chouinard does not disclose
the adhesive used to bond the stent and ePTFE membrane, and the Examiner
relies on Du’s disclosure of adhesives suitable for use in stent graft
prostheses to bond a PTFE structural component to a polypropylene textile
component, as discussed above for Rejection I. Office Act. 7—8; Du 4,11.
31—39; 6,11. 6—6, 15—20; 8,11. 1—5. Based on these findings, the Examiner
concludes that it would have been obvious to one of ordinary skill in the art
at the time of Appellants’ invention to use the polycarbonate urethane
8 Appellants argue claims 47 and 49 as a group. (See generally App. Br. 74—
90.) Therefore, for the purposes of this appeal, we select claim 47 as
representative, and decide the propriety of Rejection VII based on claim 47
alone.
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Application 13/706,277
adhesive disclosed in Du as the adhesive for the medical assembly disclosed
in Chouinard. Office Act. 7—8.
In essence, Appellants repeat the same arguments that they provided
for Rejection I, but address Chouinard rather than Schmitt. App. Br. 74—90.
We therefore only address arguments that are specifically directed to
Chouinard, and Appellants’ remaining arguments are addressed above.
Appellants argue that Chouinard, individually and in combination
with Du, does not enable use of a polycarbonate urethane adhesive to bond
ePTFE to a thermoplastic textile material as recited in claim 47, and
Appellants contend that one of ordinary skill in the art therefore would not
have had a reasonable expectation of successfully doing so in view of the
combined disclosures of Chouinard and Du. App. Br. 75—84, 86—90.
Appellants rely on the same Exhibits and Declarations in support of these
arguments that Appellants relied on in their arguments for Rejection I. Id.
However, Appellants’ arguments regarding Chouinard and Du suffer
from the same shortcomings as discussed above for Rejection I, and are thus
unpersuasive of reversible error. Specifically, Appellants’ arguments and
the Declarations do not consider the state of the art in its entirety, e.g., Du, at
the time of Appellants’ invention, and thus fail to demonstrate that one of
ordinary skill in the art would not have reasonably expected that the
polycarbonate urethane adhesive disclosed in Du could be used to
successfully bond the ePTFE membrane to the interbraided PET stent
disclosed in Chouinard.
Appellants further argue that the combined disclosure of Chouinard,
Du, and Pinchuk do not disclose or suggest a sprayed polycarbonate
urethane adhesive layer and its penetration into pores of ePTFE as recited in
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claim 47, and Appellants again rely on Exhibits A, G, and Pinchuk ‘951 in
support of these arguments. App. Br. 84—86.
However, as discussed above, it is undisputed that ePTFE inherently
has a porous microstructure defined by nodes interconnected by fibrils.
Chouinard’s silence regarding suitable adhesives for bonding the ePTFE
membrane to the interbraided PET stent would have left it to one of ordinary
skill in the art to select an appropriate adhesive for this purpose. Du’s
disclosure of conventional adhesives used in the stent art, such as
polycarbonate urethanes as described in Pinchuk, which are suitable for
binding a PTFE stent component to a polypropylene textile would have led
one of ordinary skill in the art to use such a polycarbonate urethane adhesive
to bond the ePTFE membrane and interbraided PET disclosed in Chouinard.
As is evident from the teachings of Chouinard and Du, one of ordinary skill
in the art would have had sufficient skill to select a suitable solvent to
combine with the polycarbonate urethane, and also would have had
sufficient skill to use an appropriate technique for spraying the adhesive onto
the ePTFE polymer lining, as taught by Du. In so doing, by virtue of
ePTFE’s porous microstructure, the polycarbonate urethane would have
penetrated into pores of ePTFE as recited in claim 47.
We accordingly sustain the Examiner’s rejection of claims 46 and 47
under 35 U.S.C. § 103(a) as unpatentable over Chouinard and Du.
Rejection VIII
Appellants’ arguments against Rejection VIII essentially repeat
arguments that they presented earlier in connection with the previous
rejections (discussed above). App. Br. 90-106. Because Appellants’
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arguments discussed above are unpersuasive of reversible error, we also
sustain the Examiner’s rejection of claims 1, 4, 5, 7, 10, 12, 22, 23, 25, 32,
33, 45, and 48 under 35 U.S.C. § 103(a) as unpatentable over Chouinard,
Du, and Richter.
Reply Brief
Appellants argue in the Reply Brief that the Examiner’s Answer adds
new grounds of rejection and new “multiple official notices.” Reply Br. 43.
We do not address this argument because such issues are reviewable by
petition under 37 C.F.R. § 1.181, and are therefore not within the jurisdiction
of the Board. Ex parte Frye, 94 USPQ2d 1072, 1078 (BPAI 2010)
(precedential); MPEP § 1201 (8th Ed., Rev. 8, Jul. 2010) (the Board will not
ordinarily hear a question that is reviewable by petition).
ORDER
In view of the reasons set forth above and in the Office Action and the
Answer, we affirm the Examiner’s rejections of claims 1, 4, 5, 7, 10, 12—15,
20, 22, 23, 25, 32, 33, 42, 44, 45, and 47-A9 under § 103(a).
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
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