Ex Parte Nicolas et al

Patent Trial and Appeal Board

May 23, 2016

12729802 (P.T.A.B. May. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121729,802 03/23/2010 Patrick Nicolas
30636 7590 05/24/2016
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
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.
10124/08102 7888
EXAMINER
GIULIANI, THOMAS ANTHONY
ART UNIT PAPER NUMBER
3739
MAIL DATE DELIVERY MODE
05/24/2016 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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PATRICK NICOLAS, DOREEN RAO,
MICHAEL S.H. CHU, and JOHN PETRICCA1
Appeal2014-005749
Application 12/729,802
Technology Center 3700
Before ANTON W. PETTING, ROBERT L. KINDER, and
ROBERT J. SILVERMAN, Administrative Patent Judges.
KINDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134(a) of the
Examiner's Final Rejection of claims 1, 2, 6, 7, 10-13, 16-23, and 25-27.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is Boston Scientific
Scimed, Inc. App. Br. 2.
Appeal2014-005749
Application 12/729,802
Appellants' Invention
Appellants' invention relates to "a thermal ablation device" used in
hydro-thermal ablation ("HTA"). Spec. i-fi-12, 3. In HTA procedures, "heated
saline solution is applied to targeted portions of the endometrial lining via a
hysteroscope inserted into the uterus through the cervical canal." Id. at i12.
Appellants' design addresses problems related to leakage of the heated fluid
from the uterus that can damage non-targeted tissue. Id.
Independent Claims on Appeal
Claims 1 and 16 are the independent claims on appeal. Claim 1 is
illustrative of the claimed subject matter and reads:
1. A thermal ablation device, comprising:
an elongated member sized and shaped for insertion into a
uterus via a cervical opening, the elongated member defining a
first lumen extending therethrough to a first distal opening
which, when the apparatus is in an operative position, opens into
the uterus and a second lumen extending therethrough to a
second distal opening which, when the apparatus is in the
operative position, opens into the uterus, the first and second
lumens having a D-shaped cross-section;
a base member positioned over a portion of the elongated
member so that, when a distal end of the elongated member is
open to the uterus, the base member is received within the
cervical canal; and
a seal positioned on the base member so that, when the
elongated member is in the operative position, the seal is adapted
to engage cervical tissue around a circumference of the base
member and prevent fluid introduced into the uterus via the first
lumen from flowing therepast into the cervix, the seal including
a plurality of deflectable flexible members separated from one
another along a length of the base member and projecting radially
outward from an outer surface of the base member.
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Appeal2014-005749
Application 12/729,802
App. Br. 10 (Claims App'x).
Examiner's Rejection
The Examiner rejected claims 1, 2, 6, 7, 10-13, 16-23, and 25-27
under 35 U.S.C. § 103(a) over Petrie (US 2008/0097563 Al, pub. Apr. 24,
2008) and Hibler (US 2007/0032814 Al, pub. Feb. 8, 2007). Final Act. 2
(mailed Sept. 3, 2013).
ANALYSIS
Appellants first contend "that Petrie and Hibler, taken alone or in
combination, fail to teach or suggest a seal including a plurality of
deflectable [flexible] members as recited in claim 1." App. Br. 5. Claim 16
has the same claim limitation as claim 1. See App. Br. 16 ("a plurality of
deflectable flexible members"). Appellants argue "that the seals formed by
balloons [of Hibler] 'are rigid walled balloons formed from polyethylene
terphthalate (PET).'" Reply Br. 3 (quoting Hibler if 44). Likewise,
according to Appellants "the pressure points 700 of Hibler are not
deflectable nor flexible." Id. Instead, the balloons and pressure points "are
rigid when fully inflated and that they are fully inflated to achieve the seal
and anchoring functions." Id. at 6.
We have considered Appellants contentions but find them
unpersuasive. The Examiner finds, and we agree, that because Hibler
discloses an inflatable and deflatable balloon, it would necessarily teach the
deflectable and flexible limitations of claims 1 and 16. Ans. 2. The simple
fact that the seal and pressure points of Hibler are described as a balloon
capable of increased and decreased expansion indicates that the material
must be both deflectable and flexible to some degree. See Hibler ii 54 ("The
seal assembly of the illustrated embodiment, shown in FIGS. 3A and 3B, is a
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Appeal2014-005749
Application 12/729,802
corrugated inflatable balloon, which provides for regions of increased
expansion, separated by regions of relatively decreased expansion when
inflated."). Thus, we disagree with Appellants' contentions that Hibler does
not teach or suggest "a plurality of deflectable flexible members."
Further, Hibler discloses that its balloons may be comprised of the
same deflectable and flexible silicone material as used, and claimed, by
Appellants. For example, Appellants quote paragraph 44 of Hibler, which
also explains how "silicon[ e ]" may be used:
Those skilled in the art will appreciate that various expandable
materials may be used to form the balloons 20, 30 and other
structural components of the device 1. Preferably, the balloons
20, 30 are rigid-walled balloons formed from polyethylene
terephthalate (PET). A skilled artisan will appreciate that other
materials, including but not limited to nylon or silicon2, may be
used for the balloons 20, 30 as well.
Although PET is described for use in one embodiment, Hibler also states
that "silicon[ e ]" could be used, 3 which is a known deflectable and flexible
2 Although Hibler states "silcon" we believe this to be a typographical error
and "silicone" was intended to be used in this paragraph. We base this
finding on the surrounding context of this paragraph, silicon is a metalloid
element, and silicone is known for use in similar medical devices. Further,
Appellants also make the same typographical error - the Specification states
"flap 63 0 may be formed of the same substantially flexible silicon material
as ribs 622" - which suggests this misspelling may be common. Spec. i-f 23;
see also id. i-f 20 ("formed of a substantially flexible silicon material").
3 We are aware of the Examiner's findings with respect to claims 10 and 25,
which were not separately challenged by Appellants on appeal. See Final
Act. 5 ("Petrie in view of Hibler does not expressly teach a seal formed of
silicone."). Based on Hibler's disclosure that the balloons may be comprised
of "silicon[ e]," we disagree that the combination of Hibler and Petrie does
not expressly teach the elements of claims 10 and 25.
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Appeal2014-005749
Application 12/729,802
material. Appellants' dependent claims similarly recite "wherein the seal is
formed of silicone." App Br. 15, 25 (claims 10, 25).
Appellants also contend "Petrie and Hibler, taken alone or in
combination, also fail to teach or suggest 'the first and second lumens
having a D-shaped cross-section,' as recited in claim 1." App. Br. 9.
The Examiner finds that there is "no criticality or evidence of
unexpected results" from using the D-shaped cross-section. Ans. 3. The
Examiner finds that the design of Petrie, as modified by Hibler, is similar
and "would perform the same function of circulating fluid equally well." Id.
The Examiner takes official notice that the proposed "modification would
have merely comprised an obvious design choice with a design that is well
known in the art to be interchangeable therewith." Id. Finally, the Examiner
notes that "a change in form or shape is generally recognized as being within
the level of ordinary skill in the art, absent any showing of unexpected
results." Id. at 4. The Examiner's findings are persuasive.
Appellants' Specification supports the Examiner's finding that the D-
shaped cross section is merely a matter of design choice. After noting that
the delivery and return lumen may be formed of substantially equal sizes to
permit even circulation, the Specification explains "that lumens of any
suitable shape may be employed without deviating from the spirit and scope
of the present invention such as, for example, circular lumens, elliptical
lumens, etc." Spec. i-f 8. Appellants' contention that the diameters and
geometry of the first and second lumens are selected to maximize use of the
circular conduit provided within the sheath is not fully supported by
Appellants' Specification. See Reply Br. 9. For example, Appellants'
Specification explains that the invention would work with circular or
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Appeal2014-005749
Application 12/729,802
elliptical lumens, which are not capable of maximizing the use of space
within the circular conduit. Spec. i-f 8.
We agree with the Examiner's finding that use of a D-shaped cross
section within a circular conduit is a predictable design choice and also well
known in the art. See Ans. 3. The Examiner takes official notice in support
of this finding and cites US 2004/0230188 Al, pub. Nov. 18, 2004, which
depicts numerous cross sectional designs of lumens for fluid flow, including
use of a D-shape (Fig. 3I). Id. Appellants do not persuasively rebut the
Examiner's findings.
Based upon the record before us, we sustain the Examiner's rejection
of claims 1 and 16 over Petrie and Hibler. Because the remaining claims
depend either directly or indirectly from one of these claims, and because
Appellants do not separately argue these remaining claims, we likewise
sustain the Examiner's rejection of claims 2, 6, 7, 10-13, 17-23, and 25-27
under 35 U.S.C. § 103(a). See App. Br. 10-11.
DECISION
We AFFIRM the Examiner's rejection of claims 1, 2, 6, 7, 10-13, 16-
23, and 25-27.
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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