Ex Parte Gunday et al

Patent Trial and Appeal Board

Jan 28, 2019

13480153 (P.T.A.B. Jan. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/480, 153 05/24/2012
151971 7590 01/30/2019
Forge IP, PLLC
1077 Bridgeport Ave
Suite 301
Shelton, CT 06484
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Erhan H. Gunday
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.
04530-POOllB 2049
EXAMINER
TORRESDIAZ,ARNALDO
ART UNIT PAPER NUMBER
3795
NOTIFICATION DATE DELIVERY MODE
01/30/2019 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):
patent@forge-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERHAN H. GUNDA Y, LAWRENCE J. GERRANS, and
ALEX HSIA
Appeal2017-004405
Application 13/480, 153 1
Technology Center 3700
Before JOHN C. KERINS, EDWARD A. BROWN, and
ARTHUR M. PESLAK, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Erhan H. Gunday et al. (Appellants) seek review under 35 U.S.C.
§ 134(a) of the Examiner's decision rejecting claims 1, 3, 4, 9--11, 15, 16,
18-36, and 40-42, which are the pending claims. Appellants' representative
presented oral argument on January 8, 2019. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
1 Sanovas, Inc. is identified as the real party in interest. Appeal Br. 2.
Appeal2017-004405
Application 13/480,153
CLAIMED SUBJECT MATTER
Appellants' disclosure "generally relates to the field of medical
imaging devices. In particular, the present invention relates to a system and
method for cleaning a medical imaging device in situ." Spec. ,r 2.
Claims 1, 10, and 3 0 are independent. Claim 1 illustrates the claimed
subject matter, and reads:
1. An imaging catheter device comprising:
a catheter body having a proximal end, a distal end, and a
lumen;
a cleaning member disposed at the distal end of said
catheter body; and
an imaging device movably disposed in said lumen and
through said cleaning member;
wherein said cleaning member includes a conduit through
which said imaging device moves;
wherein said cleaning member further includes a plurality
of flexing flaps at least partially occluding the conduit such that
said imaging device displaces at least some of the flexing flaps
when moved through the conduit to clean said imaging device;
and
wherein at least one of the flexing flaps is not aligned with
at least one other flexing flap.
Appeal Br. 14 (Claims App.).
REJECTIONS
The Final Office Action includes the following rejections under 35
U.S.C. § I03(a):
Claims 1, 3, 4, 9--11, 15, 16, 18, 20-22, 25, 27-36, and 40-42 are
rejected as unpatentable over Bhatta (US 5,375,589, issued Dec. 27, 1994)
and Brockmeier (US 2008/0290605 Al, published Nov. 27, 2008).
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Application 13/480,153
Claim 19 is rejected as unpatentable over Bhatta, Brockmeier, and
Byers (US 2010/0087705 Al, published Apr. 8, 2010).
Claims 23, 24, and 26 are rejected as unpatentable over Bhatta,
Brockmeier, and Miller (US 2009/0105543 Al, published Apr. 23, 2009).
ANALYSIS
Claims 1, 3, 4, 9-11, 15, 16, 18, 20-22, 25, 27-36, and 40-42
over Bhatta and Brockmeier
As to claim 1, the Examiner finds that Bhatta discloses an imaging
catheter device comprising a catheter body ( casing 1) having a distal end, a
cleaning member ( cleaning means 3) disposed at the distal end and including
a conduit (opening 9), and an imaging device (optical fiber 2) movably
disposed in the cleaning member. Final Act. 7 (citing Bhatta, Figs. 1-3, 9).
The Examiner finds that the cleaning member includes brush-like flexible
surfaces, at least some of which are displaced by the imaging device when
moved through the conduit to clean the imaging device, but finds that Bhatta
does not explicitly disclose that the flexible surfaces are flaps, as claimed.
Id. at 7-8 (citing Bhatta, col. 3, 11. 17-35). The Examiner finds that
Brockmeier teaches a seal member including bristle members extending
radially inwardly to a central longitudinal axis. Final Act. 8. The Examiner
finds that Brockmeier additionally teaches flexing flaps (flat flexible
components 802 of seal member 800) at least partially occluding a conduit
such that an imaging device displaces at least some of the flexing flaps when
moved through the conduit. Id. The Examiner finds that at least one flexing
flap is not aligned with at least one other flexing flap. Id. at 8-9 ( citing
Brockmeier ,r 40).
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Application 13/480,153
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to modify Bhatta's apparatus to include the flap-
shaped bristle arrangement of Brockmeier because "using bristle-like
structures partially occluding a conduit is well known in the art and suitable
for use in the cleaning of surgical instrument/apparatus in the surgical field."
Final Act. 9. The Examiner reasons that one of ordinary skill in the art
would have been motivated to substitute Bhatta's bristles with Brockmeier's
flap-shaped bristles because the combination would yield the same
predictable results. Id.
In the Final Action, the Examiner indicates that Official Notice is
taken that "the flap arrangement that seals" in Brockmeier acts as both a
valve and a cleaning device by occluding the medical device. Final Act. 5.
In support, the Examiner cites Crump. 2 However, in the Examiner's
Answer, the Examiner explains that the Official Notice position based on
Crump is moot because the Examiner was explaining his position in a
previous rejection based on Bhatta, Byers, and Crump, which was
withdrawn in the Final Action. Ans. 10 (citing Final Act. 2).
Appellants contend that the only embodiment described and illustrated
in Bhatta employs a brush. Appeal Br. 6 ( citing Bhatta, col. 3, 11. 31-32,
Fig. 2). Appellants also contend that Brockmeier discloses a sealing
mechanism designed to "'provide a substantial seal between a bodily cavity
o(a patient and the atmosphere outside o(the patient while an instrument is
inserted through the cannula assembly.'" Id. at 6-7 ( citing Brockmeier
,r 27). Appellants acknowledge the prior art use of bristle-like structures to
2 US 6,543,451 Bl, issued April, 8, 2003.
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Application 13/480,153
clean a surgical instrument, but contend "it does not follow that a person of
skill would expect the substitution of flaps for the bristles to yield the same
result of cleaning the instrument, especially in view of prior art that discloses
use of flaps for an entirely different purpose of creating a seal." Id. at 7.
Appellants assert that because Brockmeier's sealing device with flaps is
designed to provide a tight seal between the surgical instrument and the
outside environment, a person of skill would not expect the sealing device to
clean off the surgical device by moving it back and forth through the sealing
mechanism, but, to the contrary, "would expect such device to create a tight
seal once the surgical instrument is inserted therein and not allow for the
instrument to be displaced within the sealing mechanism to clean the
instrument." Id. at 7-8.
To the extent Appellants are contending that Bhatta's disclosure is
limited to using a brush as the cleaning means, we disagree. As noted by the
Examiner, Bhatta discloses, "[a]lthough [] the preferred embodiment
employs a brush, the cleaning means 3 may comprise any flexible swface
capable of removing tissue when in frictional contact with the distal end 8 of
the fiber 2." Ans. 3; see Bhatta, col. 3, 11. 31-35 (emphasis added). Bhatta
does not, however, disclose that the "flexible surface" may be in the form of
the claimed flexing flaps.
The Examiner agrees that Brockmeier's seal assembly is adapted to
provide a substantial seal between a body cavity of a patient and the
atmosphere outside the patient while an instrument is inserted through the
cannula assembly. Ans. 5. However, the Examiner submits that
Brockmeier' s sealing assembly facilitates the removal of irregularly shaped
body tissue. Id. ( citing Brockmeier ,r 27). Appellants contest the
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Application 13/480,153
Examiner's interpretation of paragraph 27 of Brockmeier. Reply Br. 2.
Appellants submit that a person of ordinary skill in the art would understand
that this passage "is referring to the advantages of enabling removal of the
irregularly shaped body tissue through the incision once the seal assembly
300 has been detached from the cannula assembly 200." Id. at 3.
We are persuaded that the Examiner has not established, with
evidence, that there would be a reasonable expectation of success that the
flexible components of Brockmeier would achieve the claimed cleaning
function. Reply Br. 3. The Examiner's position is premised on the finding
that the embodiment shown in Figure 16 of Brockmeier, "besides providing
a sealing configuration, also provides the advantage of facilitating the
removal of irregularly shaped body tissue." Ans. 7. According to the
Examiner, the flexible flat components shown in Figure 16 of Brockmeier
would have rendered the same predictable results of sealing and removing
irregularly shaped body tissue as the bristle-like component shown in
Figures 2 and 3B, as suggested by Brockmeier in paragraph 27. Id. at 9.
However, paragraph 27 discloses that the detachability of seal assembly 300
facilitates the removal of irregularly shaped body tissue in the assembly. See
Brockmeier ,r 27. This paragraph does not disclose that the bristle-like
component shown in Figure 2 or 3B of Brockmeier (or the flexible flat
components shown in Figure 16 of Brockmeier) will also remove irregularly
shaped body tissue when an imaging device displaces at least some of the
flexing flaps when moved through the conduit to clean the imaging device,
as required by claim 1. Accordingly, we agree with Appellants that the
Examiner relies on an incorrect interpretation of paragraph 27 of
Brockmeier. Reply Br. 3.
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As the underlying factual basis for the rejection of claim 1 set forth by
the Examiner is not supported by a preponderance of the evidence, the
Examiner has not established an adequate reason with rational underpinnings
to modify Bhatta in view of Brockmeier to result in the device recited in
claim 1. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (holding that
"[t]he legal conclusion of obviousness must be supported by facts. Where
the legal conclusion is not supported by facts it cannot stand."). Therefore,
we do not sustain the rejection of claim 1, or of claims 3, 4, 9, and 10
depending therefrom, as unpatentable over Bhatta and Brockmeier.
Independent claim 11 is directed to a cleaning system for a medical
imaging device comprising, in pertinent part, a cleaning member comprising
"a conduit through which the imaging device moves" and "a plurality of
flexing flaps at least partially occluding the conduit such that the imaging
device displaces at least some of the flexing flaps when moved through the
conduit." Appeal Br. 15 (Claims App.). The Examiner finds that Bhatta as
modified by Brockmeier discloses these similar limitations as in claim 1.
Final Act. 10. We do not sustain the rejection of claim 11, or of claims 15,
16, 18, 20-22, 25, and 27-29 depending therefrom, for reasons similar to
those discussed for claim 1.
Independent claim 3 0 recites a method of cleaning a medical imaging
device comprising, in pertinent part, the step of "cleaning the imaging device
by moving at least one of the imaging device and the cleaning member
relative to the other to move the imaging device through the conduit in said
cleaning member such that the imaging device displaces at least some of the
flexing flaps." Appeal Br. 16-17 (Claims App.). The Examiner notes that
method claim 30 corresponds to apparatus claim 1 and rejects claim 30 for
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Application 13/480,153
the same reasons as claim 1. Final Act. 14. We do not sustain the rejection
of claim 30, or of claims 31-36 or 40-42 depending therefrom, for reasons
similar to those for claim 1.
Claim 19 over Bhatta, Brockmeier, and Byers
Claims 23, 24, and 26 over Bhatta, Brockmeier, and Miller
The Examiner's reliance on Byers or Miller in rejecting dependent
claims 19, 23, 24, and 26 fails to cure the deficiencies in the rejection of
parent claim 11. Final Act. 14--17. Accordingly, we do not sustain the
rejections of claims 19, 23, 24, and 26.
DECISION
The rejections of claims 1, 3, 4, 9-11, 15, 16, 18-36, and 40-42 are
reversed.
REVERSED
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