Ex Parte LEE

Patent Trial and Appeal Board

Aug 27, 2018

14070211 (P.T.A.B. Aug. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/070,211 11/01/2013
121974 7590 08/29/2018
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
HENRYH.LEE
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.
8150BSC0260 8725
EXAMINER
OUYANG,BO
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
08/29/2018 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
following e-mail address(es):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HENRY H. LEE 1
Appeal2017-008159
Application 14/070,211
Technology Center 3700
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
DAVID COTTA, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the Examiner's rejection under 35 U.S.C. § 103
of claims directed to a balloon assembly comprising an outer texture surface.
We have jurisdiction for this appeal under 35 U.S.C. § 6(b ).
The rejections are reversed, but new grounds of rejection are set forth
pursuant to 37 C.F.R. § 41.50(b).
1 The Appeal Brief ("Appeal Br.") 3 lists Vessix Vascular, Inc. as the real
party in interest.
Appeal2017-008159
Application 14/070,211
STATEMENT OF CASE
Appellant appeals from the Examiner's determination that claims 1-
19 are unpatentable. The claims stand finally rejected by the Examiner as
follows:
1. Claims 1, 5, and 8-16 is under pre-AIA 35 U.S.C. § I03(a) as
obvious in view of Salahieh et al. (U.S. Pat. Application Pub. No.
2010/0204560 Al, pub. Aug. 12, 2010) ("Salahieh"), Burton et al. (U.S. Pat.
Application Pub. No. 2010/0036314 Al, pub. Feb. 11, 2010) ("Burton"),
and Aitchison et al. (U.S. Pat. Application Pub. No. 2011/0157774 Al, pub.
June 30, 2011) ("Aitchison").
2. Claims 2--4, 6, 7, 17, and 19 under pre-AIA 35 U.S.C. § I03(a) as
obvious in view of Salahieh, Burton, Aitchison, and Chung et al. (U.S. Pat.
Application Pub. No. 2010/0119755 Al, pub. May 13, 2010) ("Chung").
3. Claim 18 underpre-AIA 35 U.S.C. § I03(a) as obvious in view of
Salahieh, Burton, Aitchison, Chung, and Glassenberg et al. (U.S. Pat.
Application Pub. No. 2008/0029100 Al, pub. Feb. 7, 2008) ("Glassenberg").
There are two independent claims on appeal, claims 1 and 1 7. These
claims are reproduced below:
1. A balloon assembly, comprising:
a radially-expandable balloon comprising an outer
textured surface;
a plurality of flexible circuits attached to the radially-
expandable balloon, the plurality of flexible circuits including a
surface that faces the outer textured surface of the radially-
expandable balloon;
wherein the surface of at least some of the flexible
circuits is textured; and
one or more electrodes coupled to at least some of the
plurality of flexible circuits.
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Application 14/070,211
17. A balloon assembly, comprising:
(a) a radially-expandable balloon comprising an outer
textured surface defining a textured surface area comprising a
plurality of randomly distributed sub-micron nodules; and
(b) a plurality of flexible circuits attached to the radially-
expandable balloon, wherein at least some of the flexible
circuits include a textured surface that faces the outer textured
surface of the balloon.
CLAIM INTERPRETATION
Claims 1 and 17 both require "a radially-expandable balloon
comprising an outer textured surface." Claim 17 further requires that the
texture comprises "a plurality of randomly distributed sub-micron nodules."
While both claims require the surface of the balloon to be textured,
the claims do not require a texture, or degree of texture, when the balloon is
expanded. Thus, as long as the balloon has an outer textured surface prior to
being radially expanded, the claim limitations are met.
The claimed balloon assembly also comprises flexible circuits
attached to the balloon. In claims 1 and 17, the surface of at least some of
the flexible circuits that face the textured surface of the balloon "is
textured." Claims 1 and 1 7 do not require any degree or type of texture on
the surface of the circuit.
Claim 1 7 further requires that the "textured surface area" comprise "a
plurality of randomly distributed sub-micron nodules." A nodule is small
lump of rounded or irregular shape. 2 Figures 52 and 53 of the Specification
show examples of a surface with such nodules. Spec. 26:6-9.
2 MERRIAM-WEBSTER, https://www.merriam-webster.com/dictionary/nodule
(last visited Aug. 9, 2018).
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Application 14/070,211
REJECTIONS
1. Rejection based on Salahieh, Burton, and Aitchison
The Examiner found that Salahieh describes a radially expandable
balloon with attached circuits as required by claim 1. Final Act. 3. The
Examiner acknowledged that Salahieh is silent with regard to the texturing
of the surface as required by all the rejected claims. Id. To meet the
requirement of the claims of "an outer textured surface," the Examiner cited
the teaching in Burton of a radially-expandable balloon comprising an outer
textured surface which may be textured at the micron level. Id. at 4. With
respect to the claimed requirement that the surface at least some of the
flexible circuits that face the textured surface of the balloon "is textured,"
the Examiner found that Aitchison teaches electrical leads that are textured
to improve adhesion to a surface. Id.
The Examiner concluded that it would have been obvious to one of
ordinary skill in the art to modify the balloon of Salahieh with an outer
textured surface, as taught by Burton, to "allow for the balloon to be rough
to better grip tissue when expanded." Final Act. 8. The Examiner also
concluded it would have been obvious to have textured circuits, as taught by
Aitchison, to allow the circuit to better adhere to the balloon. Id.
Burton
Appellant contends that Burton teaches that surface roughness is
reduced upon inflation and, thus, "one would not be motivated to use the
balloon of Burton to increase friction with tissue." Appeal Br. 7. Appellant
also argues that one of ordinary skill in the art "would not have been
motivated to use such an unstable balloon surface for purposes of gripping
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Application 14/070,211
tissue when expanded and "to improve adhesion to another surface." Id. at
10. Appellant also states, "there does [not] appear to be any disclosure or
suggestion that that it is desirable to grip tissue upon balloon inflation; in
fact, vascular balloons are commonly provided with a lubricious coating in
order to ease movement through the vasculature." Reply Br. 9.
We agree with Appellant that the Examiner did not provide sufficient
evidence to establish that one of ordinary skill in the art would have had
reason to texture the surface of Salahieh's expandable balloon for the
purpose of gripping tissue. The Examiner did not provide adequate evidence
that texturing a balloon surface would be desirable when in contact with
tissue to increase friction nor that the surface described by Burton would
"allow for the balloon to be rough to better grip tissue when expanded."
Appeal Br. 7.
Aitchison
Appellant contends that Aitchison "teaches that leads may be textured
to improve adhesion to the liquid crystal polymer (LCP)," but "does not
describe adhesion to balloons or to solid polymers like those used in catheter
balloons." Id.
While it is correct that Aitchison describes texturing electrical leads
"to improve adhesion to the LCP" (Aitchison ,r 294), the Examiner
reasonably found that one of ordinary skill in the art would have understood
from this teaching that a textured surface improves adhesion between
polymer surfaces. Ans. 3. Appellant did not provide adequate arguments or
evidence that texturing the flexible circuits of Salahieh would not have been
reasonably expected to improve their adhesion to the balloon surface.
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Appeal2017-008159
Application 14/070,211
Summary
The Examiner provided adequate evidence to modify Salahieh with
the teachings of Aitchison. However, the Examiner did not establish by a
preponderance of the evidence a reason based on Burton's disclosure to have
textured the surface of Salahieh's catheter balloon. Consequently, the
rejection of claim 1, and dependent claims 5 and 8-16, is reversed.
2. Rejection based on Salahieh, Burton, Aitchison, and Chung
The Examiner further cited Chung to meet the limitation of claim 17
of a balloon assembly having "an outer textured surface defining a textured
surface area comprising a plurality of randomly distributed sub-micron
nodules." The Examiner found Chung teaches modifying the surface of
polymers on a sub-micron scale. Final Act. 6. The Examiner concluded it
would have been obvious to one of ordinary skill in the art "to make the
texture of the Salahieh and Burton balloon at a sub-micron level, causing
sub-micron nodules, to have a smaller texture on the balloon prevent adverse
interaction with tissue." Id.
Appellant contends that the Examiner did not provide evidence that
sub-micron nodules on a balloon prevent adverse interactions with tissue.
Appeal Br. 9.
We agree with Appellant and reverse the obviousness rejection of
claim 17 and dependent claims 2--4, 6, 7, and 19.
3. Rejection based on Salahieh, Burton, Aitchison, Chung, and Glassenberg
Claim 18 depends from claim 1 7 and further recites that "the radially-
expandable balloon further comprises an area of the outer textured surface
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Application 14/070,211
that is non-textured." The Examiner found that Glassenberg "teaches a
radially-expandable balloon with a textured surface and a non-textured
surface." Final Act. 8. The Examiner concluded it would have been
obvious to one of ordinary skill in the art to have modified Salahieh in view
Burton to have a non-textured area to save production costs compared to
texturing the entire surface. Id. at 9. Appellant made the same argument as
for claim 17, and did not dispute the Examiner's reasoning as to why the
claim would have been obvious. Appeal Br. 10. However, we are
compelled to reverse the rejection because the rejection of claim 17 is
deficient.
NEW GROUNDS OF REJECTION
Claim 1
As found by the Examiner, Salahieh describes a balloon catheter with
circuits as required by claim 1, but not having an "outer textured surface."
Final Act. 3--4. However, Burton describes a balloon catheter with a
textured outer surface (Burton ,r 8) as required by the claim 1.
Burton provides at least two reasons for making the outer catheter
wall of Salahieh textured. First, Burton teaches that the "texture of the
balloon wall reduces force for collapsing the balloon to facilitate the
retraction of the balloon into the sheath lumen for retrieval of the balloon
catheter from the body vessel." Id. ,r 10. Second, Burton teaches that the
rough texture can be used to deliver drugs ("medicants") to a patient, where
the drug is coated on the balloon surface in the deflated state, and upon
inflation, the surface is smoothed, "so that the valleys 5 6 and the peaks 54
[ of the outer textured surface] diminish, thereby forcefully implanting the
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medicants 60 into the treatment area, e.g., stenosis, of the body vessel." Id.
,r 53. Thus, one of ordinary skill in the art would have had reason to provide
a textured surface on Salahieh's balloon catheter to facilitate its removal
from the body vessel and/or to deliver drugs. While Burton teaches that the
"balloon in the inflated state is tensioned to have a surface roughness
substantially less than a surface roughness of the balloon in the deflated
state" (id. ,r 8), the claim does not require the balloon in the inflated state to
have a specific degree of texturing nor for it be textured at all. See Claim
Interpretation supra.
In addition to the two reasons provided by Burton for making the
outer surface of the balloon textured, Aitchison provides a third rationale by
teaching that adhesion between surfaces is facilitated by texture. While the
teaching in Aitchison is to improve the adhesion of an electrical lead to a
LCP, the skilled artisan would have reasonably expected that a rough
textured on one or both surfaces would improve adhesion between the
circuits and the balloon catheter of Salahieh.
Aitchison is applied as discussed above for making the circuit surfaces
textured to improve adhesion.
For the foregoing reasons, a new ground of rejection of claim 1 is set
forth pursuant to 37 C.F.R. § 4I.50(b) as obvious in view of Salahieh,
Burton, and Aitchison. We leave it to the Examiner to determine the
obviousness of dependent claims 5 and 8-16.
Claim 17
Claim 17 is rejected as obvious in view of Salahieh, Burton, and
Aitchison for the same reasons as claim 1. However, claim 17 further
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Application 14/070,211
requires the balloon assembly to have "an outer textured surface defining a
textured surface area comprising a plurality of randomly distributed sub-
micron nodules." Burton teaches that its surface can have "micron level
texture." Burton ,r 60. Although Burton does not describe a sub-micron
textured surface, we found that Aitchison provides a reason to texture the
surface to improve adhesion between the circuits and catheter surface. Thus,
the degree of texturing is a result effective variable that would have been
obvious to optimize to achieve a satisfactory degree of adhesion. See MPEP
§ 2144.05(II) summarizing case law on the obviousness of routine
optimization when the general working conditions are described in the prior
art.
The law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims. . . . These cases have consistently
held that in such a situation, the applicant must show that the
particular range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior
art range.
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (internal citations
omitted). Appellant has not established the criticality of the claimed degree
of texture.
For these reasons, we conclude that, absent unexpected results, it
would have been obvious to have arrived at the claimed distribution of sub-
micron nodules.
Accordingly, claim 17 is rejected as obvious in view of Salahieh,
Burton, and Aitchison. This is a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). We leave it to the Examiner to determine the
obviousness of dependent claims 2--4, 6, 7, and 19.
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Application 14/070,211
Claim 18
Claim 18 is rejected as obvious in view of Salahieh, Burton,
Aitchison, and Glassenberg. Claim 18 is rejected as obvious in view of
Salahieh, Burton, and Aitchison for the same reasons as claims 1 and 1 7.
The additional limitation of claim 18, found in the teaching of Glassenberg,
is obvious for the reasons set forth by the Examiner which Appellant did not
dispute in the appeal. The rejection is designated as a new ground of
rejection pursuant to 37 C.F.R. § 4I.50(b) because the underlying rejection
based on the teachings of Burton and Aitchison is applied differently than in
the rejection set forth by the Examiner.
TIME PERIOD FOR RESPONSE
This Decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 4I.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. The new ground of rejection
is binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
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Application 14/070,211
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MPEP § 1214.01.
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). See 37 C.F.R.
§§ 41.50(±), 4I.52(b).
REVERSED
37 C.F.R. § 4I.50(b)
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