Ex Parte Sharkey et al

Patent Trial and Appeal Board

Jun 19, 2018

13550392 (P.T.A.B. Jun. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/550,392 07/16/2012
66854 7590
SHAY GLENN LLP
2755 CAMPUS DRIVE
SUITE 210
SAN MATEO, CA 94403
06/21/2018
FIRST NAMED INVENTOR
Hugh R. Sharkey
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.
10546-700.303 2222
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
06/21/2018 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):
info@shayglenn.com
shayglenn_pair@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HUGH R. SHARKEY, RAMIRO REYES, and
KURTD. SPARKS 1
Appeal2017-007002
Application 13/550,392
Technology Center 3700
Before: MICHAEL L. HOELTER, MICHELLE R. OSINSKI, and
BRENT M. DOUGAL, Administrative Patent Judges.
DOUGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a final rejection of
claims 1-13. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as Aegea Medical Inc.
Appeal Br. 2.
Appeal2017-007002
Application 13/550,392
CLAIMED SUBJECT MATTER
The claims are directed to a heat therapy method for treatment of a
uterus. Claim 1, reproduced below, is the sole independent claim:
1. A method of providing heat therapy to a patient's uterus
compnsmg:
inserting a uterine heat therapy system through a cervix
and a cervical canal into the uterus;
creating a seal between an exterior surface of the uterine
heat therapy system and the cervical canal;
delivering vapor through the uterine heat therapy system
into the uterus; and
condensing the vapor on tissue within the uterus.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Yoon
Weng
Nobles
Mulier
Childers
Hua Xiao
us 6,159,207
US 6,626,855 B 1
US 2002/0013601 Al
US 2002/0177846 Al
US 2003/0217962 Al
US 2004/0002698 Al
REJECTIONS
Dec. 12, 2000
Sept. 30, 2003
Jan. 31, 2002
Nov. 28, 2002
Nov. 27, 2003
Jan. 1,2004
Claims 1, 3-5, 7-10, and 13 are rejected under 35 U.S.C. §I03(a) as
being unpatentable over Mulier and Hua Xiao.
Claims 2, 6, 11, and 12 are rejected under 35 U.S.C. §I03(a) as being
unpatentable over Mulier and Hua Xiao in view of respectively, Nobles,
Yoon, Childers, or Weng.
2
Appeal2017-007002
Application 13/550,392
OPINION
The Examiner finds that the method of therapy related to Mulier' s
vapor injection needle of Figure 20, as used for treating fibroids within the
wall of the uterus, teaches all of the features of independent claim 1, except
for "creating a seal between an exterior surface of the uterine heat therapy
system and the cervical canal." Final Act. 2-3; see also Ans. 2--4. The
Examiner relies on the teachings of Hua Xiao for the missing method step.
Id. at 3. The Examiner determines that "it would have been obvious ... to
modify Mulier et al. to include the step of creating a seal, as taught by Hua
Xiao et al., for the purpose of thermally insulating the cervix and preventing
material from exiting the uterus." Id.
Appellants contest the Examiner's determination, arguing that it is
based on hindsight and lacks rational underpinnings. Appeal Br. 4--5.
Appellants argue that Mulier teaches "a vapor needle that injects vapor
directly into targeted fibroid tissue," and that therefore "the vapor is injected
into and confined within the targeted tissue." Id. at 4. Appellants further
argue that Mulier is not concerned with "material exiting the uterus." Id.
Appellants then argue that the only apparent motivation to modify Mulier' s
vapor injection needle, as outlined by the Examiner, is Appellants'
Specification. Id.
The Examiner agrees that "Mulier discloses that the vapor is injected
into the tissue" but argues that this does not mean "that the vapor is
'confined within' the tissue." Ans. 3. The Examiner states that Mulier is
silent in this respect. Id. The Examiner further explains that Mulier teaches
"that vapor spray 22 ... condenses at the tissue site and undergoes a phase
change from gas to liquid." Id. (citing Mulier ,r 48). The Examiner reasons
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Appeal2017-007002
Application 13/550,392
that it is possible that an amount of "the resulting liquid" "will exit the
opening of the puncture either when the needle is withdrawn or before the
opening of the puncture is able to fully heal." Id. The Examiner then states
that "material exiting the uterus could be a concern in Mulier" and that
"creat[ing] a seal to prevent material from exiting the uterus ... could be
beneficial to Mulier." Id. at 4.
The Examiner's position appears to be based on supposition and the
mere possibility that an issue "could be a concern" to one of skill of art.
This is insufficient to establish that the reason to combine is supported by
rational underpinnings. In re Warner, 379 F.2d 1011, 1017 (CCPA 1967)
(The Examiner may not "resort to speculation, unfounded assumption or
hindsight reconstruction.").
The Examiner has not provided a rational basis for why one of skill in
the art would have been motivated to modify Mulier's vapor injection
needle2 to "creat[ e] a seal between an exterior surface of the uterine heat
therapy system and the cervical canal" as required by claim 1. The
Examiner has not put forth a rational reason why one of skill in the art would
have been motivated to seal a cavity remote from the treatment area.
Further, Mulier teaches that "Vapor provides a medium for transfer of
thermal energy to a tissue site. The vapor rapidly heats the tissue rapidly
upon release of thermal energy in the phase change of the vapor from gas to
2 We note that the Examiner does mention that Mulier teaches other types of
treatment instruments, however the Examiner does not provide sufficient
analysis on how these instruments relate to the claimed method. See Final
Act. 7. The Examiner also provides no analysis on whether she is modifying
the rejection to combine multiple embodiments of Mulier. Id. Thus, we do
not address other possible combinations of the prior art not clearly set forth
in the rejection.
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Appeal2017-007002
Application 13/550,392
liquid." Mulier, Abstract. Even if liquid exits the tissue site after vapor
injection in Mulier, it is unclear why liquid exiting the tissue would be a
possible area of concern for Mulier as the heating appears to occur during
the phase change within the tissue.
For these reasons we do not sustain the rejection of claim 1, or its
dependents.
DECISION
The Examiner's rejections of claims 1-13 are reversed.
REVERSED
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