AEGEA MEDICAL INC.

Patent Trials and Appeals Board

Jun 18, 2021

2020006512 (P.T.A.B. Jun. 18, 2021)

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.
16/224,287 12/18/2018 Hugh R. Sharkey 19671-0555006 1258
26161 7590 06/18/2021
FISH & RICHARDSON P.C. (BO)
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
06/18/2021 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):
PATDOCTC@fr.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
KURT D. SPARKS
Appeal 2020-006512
Application 16/224,287
Technology Center 3700
Before MURRIEL E. CRAWFORD, MICHAEL L. WOODS, and
MATTHEW S. MEYERS, Administrative Patent Judges.
WOODS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s Final rejection of claims 1–14.1 We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 We use the term “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Aegea Medical Inc. as the real party in
interest. Appeal Br. 2.
Appeal 2020-006512
Application 16/224,287

2
CLAIMED SUBJECT MATTER
The claims are directed to a method of providing therapy to a patient’s
uterus. Spec. ¶ 11. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A method of providing heat therapy to a patient’s uterus
comprising:
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 heat therapy through the uterine heat therapy
system into the uterus; and
condensing vapor on tissue within the uterus.
Appeal Br. 6 (Claims App.).
REFERENCES2
The prior art relied upon by the Examiner is:

Name Reference Date
Nobles US 2002/0013601 A1 Jan. 31, 2002
Mulier US 2002/0177846 A1 Nov. 28, 2002
Weng US 6,626,855 B1 Sept. 30, 2003
Hua Xiao US 2004/0002698 A1 Jan. 1, 2004
Barry ’233 US 2006/0161233 A1 July 20, 2006
Barry US 8,585,645 B2 Nov. 19, 2013

2 We refer only to the first named inventor, and as to the two Barry
references, additional identifiers distinguish the two references with the
same inventor.
Appeal 2020-006512
Application 16/224,287

3
REJECTIONS
Claims 1, 3–10, 13, and 14 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Hua Xiao, Barry, and Mulier. Final Act. 3–7.
Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over Hua
Xiao, Barry, Mulier, and Nobles. Final Act. 7.
Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Hua Xiao, Barry, Mulier, and Barry ’233. Final Act. 7–8.
Claim 12 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Hua Xiao, Barry, Mulier, and Weng. Final Act. 8–9.
OPINION
The Examiner finds that Hua Xiao teaches all the limitations of claim
1, except for the final limitation of “condensing vapor on tissue within the
uterus.” Final Act. 3. As to that limitation, the Examiner finds that Barry
teaches heat therapy using vapor, and that Barry “discloses that various other
energy modalities could be used to achieve the end result of tissue ablation,
such as . . . a resistive heating source.” Id. at 3 (citing Barry, 9:25–31). The
Examiner reasons that:
Since Hua Xiao’s device and method is directed to thermal
ablation (Para 1) using a resistive heating source (Para 7), it
would have been obvious to one of ordinary skill in the art at the
time the invention was made to modify Hua Xiao to use vapor as
the heat therapy, as taught by Barry, since the heat ablation
systems of both Hua Xiao and Barry achieve the same result (and
Barry even admits that) and thus were art-recognized equivalents
at the time the invention was made; therefore, it would have been
obvious to one of ordinary skill in the art to substitute Barry’s
vapor heat therapy system in place of Hua Xiao’s resistive heat
therapy system since it has been held that substituting parts of an
invention involves only routine skill in the art.
Appeal 2020-006512
Application 16/224,287

4
Id. at 3–4.
To summarize, the Examiner finds Hua Xiao’s instrument is used for
heat therapy in a uterus using radiant heat, finds Barry’s instrument is used
for heat therapy in the lungs using vapor, contends Barry teaches that radiant
heat and vapor heat are “art-recognized equivalents,” and concludes the
combination would have been obvious, because using Barry’s vapor in place
of Hua Xiao’s radiant heat is a substitution that “involves only routine skill
in the art.” See Final Act. 3–4.
Appellant argues the Examiner relied on impermissible hindsight in
the proposed combination, because “Barry’s use of vapor addresses a
problem in the lung that [heating]3 devices did not have in the uterus. A
skilled artisan would therefore not look to Barry’s lung therapy method to
make any modifications to the [heating] system of Xiao.” Appeal Br. 4; see
also Reply Br. 2.
We agree with Appellant.
A statement that modifications of the prior art to meet the claimed
invention would have been “well within the ordinary skill of the art at the
time the claimed invention was made,” because the references relied upon
teach that all aspects of the claimed invention were individually known in
the art, is not sufficient to establish a prima facie case of obviousness
without some objective reason to combine the teachings of the references.
Ex parte Levengood, 28 USPQ 2d 1300 (Bd. Pat. App. & Inter. 1993).

3 Appellant asserts the Examiner relies on the “RF” energy source of Hua
Xiao. Appeal Br. 4. This is noted by the Examiner as incorrect, because
instead the rejection relies on the “radiant” heat embodiment of Barry. See
Answer 4; see also Final Act. 3.
Appeal 2020-006512
Application 16/224,287

5
Further, the Federal Circuit has stated that “rejections on obviousness
grounds cannot be sustained by mere conclusory statements; instead, there
must be some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006).
We see two errors in the Examiner’s reasoning.
First, the finding that vapor and radiant heating “achieve the same
result” and “were art-recognized equivalents” is not supported by the
evidence of record. For example, no citation to evidence behind the
conclusion appears in the Final Action. See Final Act. 3–4. We assume the
Examiner relies on Barry’s teaching that “other energy modalities could be
used.” Final Act. 3 (citing Barry at 9:25–31). But this does not support a
finding that radiant heat and vapor heat are recognized in the art as
equivalents. Barry’s disclosure lacks sufficient detail about how to
implement the alternative heat sources. See, generally, Barry col. 1–9.
The second problem is that the rejection fails to adequately reason
why the ordinary artisan, reading Hua Xiao and Barry, would have been led
to modify the process of Hua Xiao to use Barry’s lung-treatment vapor as a
heat source in the uterus. For example, no problem with Hua Xiao’s method
appears in the rejection that would have led the artisan to make the proposed
substitution. Although the Examiner states that “Barry[] does not teach
away from using vapor to treat other body tissue,” this reasoning is
insufficient for the artisan to undertake the proposed substitution. Ans. 4.
We also do not discern any discussion in these references, or from the
Examiner, that would indicate doing so would yield predictable results,
given the differing nature of the uterus and lungs.
Appeal 2020-006512
Application 16/224,287

6
The stated motivation to modify Hua Xiao, therefore, lacks sufficient
“rational underpinning to support the legal conclusion of obviousness.”
Kahn, 441 F.3d at 988. For this reason, we do not sustain the rejection of
claim 1, or the dependent claims rejected along with it. Because the
Examiner has not shown that either Nobles, Barry ’233, or Weng remedies
this shortcoming, we also do not sustain the rejections additionally relying
on these references.
CONCLUSION

The Examiner’s rejections are reversed.
DECISION SUMMARY
In summary:

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–10, 13,
14
103(a) Hua Xiao, Barry,
Mulier
1, 3–10, 13,
14
2 103(a) Hua Xiao, Barry,
Mulier, Nobles
2
11 103(a) Hua Xiao, Barry,
Mulier, Barry ’233
11
12 103(a) Hua Xiao, Barry,
Mulier, Weng
12
Overall Outcome 1–14
REVERSED