Covidien LP

Patent Trials and Appeals Board

Sep 2, 2020

14829771 - (D) (P.T.A.B. Sep. 2, 2020)

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.
14/829,771 08/19/2015 Jonathan W. Sapienza H-US-04186 (203-10360) 5834
50855 7590 09/02/2020
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
EXAMINER
IMAM, TANZIM
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/02/2020 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):
docket@carterdeluca.com
rs.patents.two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHAN W. SAPIENZA, PAUL D. RICHARD,
RAMIRO CABRERA, and STEPHEN R. PAUL
Appeal 2019-003867
Application 14/829,771
Technology Center 3700
Before EDWARD A. BROWN, BENJAMIN D. M. WOOD, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
WOOD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1 and 3–13, 15, and 17. See Final
Act. 1. Claims 2, 14, 16, and 18–20 are canceled. Appeal Br. 16–20
(Claims App.). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” refers to the applicant as defined by 37 C.F.R. § 1.42.
Appellant identifies the real party in interest as Covidien LP. Appeal Br. 1.
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CLAIMED SUBJECT MATTER
The claims are directed to a cleaning apparatus for surgical
instruments. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. An apparatus for cleaning a surgical instrument,
comprising:
an elongate member having a first end and a second end,
the second end being configured for disposal within a cavity
of the surgical instrument, the elongate member defining: a
longitudinal channel;
and a plurality of apertures extending transversely
through the elongate member and communicating with the
longitudinal channel, the plurality of apertures being
configured to direct fluid toward the first end of the elongate
member;
wherein the first end of the elongate member is
configured to be coupled to a source of fluid, wherein the
longitudinal channel is configured to allow passage of fluid
to the plurality of apertures.
REFERENCES
Name Reference Date
Milliman US 7,364,060 B2 Apr. 29, 2008
Savage US 7,686,800 B2 Mar. 30, 2010
Miller US 2008/0221580 A1 Sep. 11, 2008
Simmoteit DE 102010008745 A1 Aug. 25, 2011
REJECTIONS
Claims Rejected 35 U.S.C. § Reference(s)/Basis
1, 3–7 103 Simmoteit and Savage
1, 3–7 103 Simmoteit, Savage, and Milliman
8 103 Simmoteit, Savage, Milliman, and
Miller
9, 15, 17 103 Simmoteit, Milliman, and Miller
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Claims Rejected 35 U.S.C. § Reference(s)/Basis
10–13 103 Simmoteit, Milliman, Miller, and
Savage
OPINION
A. Claims 1 and 3–7—Rejected as Unpatentable over Simmoteit
and Savage, or Alternatively, as Unpatentable over Simmoteit,
Savage, and Milliman
For independent claim 1, the Examiner finds that Simmoteit teaches
the apparatus substantially as claimed, including the claimed elongate
member having a longitudinal channel with a plurality of apertures
extending transversely through the elongate member and communicating
with the channel, except that Simmoteit does not disclose that “the plurality
of apertures are configured to direct fluid toward the first end of the elongate
member.” Final Act. 2–3 (citing Simmoteit, Fig. 1a). The Examiner further
finds that Savage teaches that it was known to provide an elongate member
of an analogous apparatus with a plurality of apertures extending
transversely through the elongate member such that the apertures are
configured to direct fluid to the first end of the elongate member. Id. at 3
(citing Savage, 7:22–37, Figs. 1–3). The Examiner determines that it would
have been obvious to one of ordinary skill in the art to angle Simmoteit’s
apertures and properly space them along Simmoteit’s elongate member, as
taught by Savage, “because doing so would substantially reduce or all-
together prevent a recoil, whipping motion or excessive movement of the
second end (right end of 2 in Figure 1a of Simmoteit) of the elongate
member during cleaning of the surgical instrument.” Id. at 3–4.
Among other arguments, Appellant challenges the Examiner’s reason
to combine Simmoteit and Savage. According to Appellant, “‘recoil,
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whipping motion or excessive movement of the second end . . . of the
elongate member during cleaning’ is not a problem sought to be addressed
by the present application or Simmoteit, nor is it a problem known to present
itself during cleaning of surgical instruments.” Appeal Br. 9.
The Examiner responds that “the fluid flow out of apertures 24 and
opening 23 of Simmoteit have a tendency to cause apparatus 10 to move,”
and thus modifying Simmoteit’s device as proposed “will provide the benefit
of substantially reducing or all-together preventing a recoil, whipping
motion or excessive movement of the second end (right end of 2 in Figures
1a of Simmoteit) of the elongate member 2 during cleaning of the surgical
instrument.” Ans. 4–5.
“[R]ejections 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.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). We agree with
Appellant that the Examiner has failed to articulate reasoning with a rational
underpinning sufficient to support the conclusion of obviousness. The
Examiner has not provided any evidence or persuasive argument that recoil,
whipping motion, or excessive movement was a known problem with
medical-instrument cleaning devices. Nor did the Examiner explain why
one of ordinary skill in the art would have considered the problem addressed
by Savage—the management of fluid forces resulting from using small
diameter catheters to inject high volumes of fluid associated with ventricular
angiography (Savage, 3:3–9)—relevant to Simmoteit’s medical-instrument
cleaning device. The premise on which the Examiner’s reason to combine is
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based, that fluid flow out of apertures 24 and opening 23 of Simmoteit “have
a tendency to cause apparatus 10 to move,” is not supported by evidence,
and, in any event, the Examiner has not established that one of ordinary skill
in the art would have appreciated that the proposed modification would have
had any effect on that movement in Simmoteit’s device. Because we are not
persuaded that one of ordinary skill in the art would have had a reason to
combine Simmoteit and Savage in the proposed manner, we decline to
sustain the Examiner’s rejection of claim 1, and its dependent claims 3–7, as
unpatentable over Simmoteit and Savage.
The Examiner alternatively relies on Milliman to teach a surgical
instrument to the extent that “it can be argued that the instrument (12) of
Simmoteit is not a surgical instrument.” Final Act. 4 (citing Milliman, Figs.
1, 6, 34–38; Simmoteit, Fig. 1a). Milliman is not relied on to cure the
deficiency noted above with respect to the combination of Simmoteit and
Savage. Accordingly we also do not sustain the Examiner’s rejection of
claims 1 and 3–7 as unpatentable over Simmoteit, Savage, and Milliman.
B. Claim 8—Rejected as Unpatentable over
Simmoteit, Savage, Milliman, and Miller
Claim 8 indirectly depends from claim 1. Appeal Br. 17 (claims
app.). The Examiner relies on the combination of Simmoteit and Savage to
teach claim 1’s limitations. Final Act. 5. Because we are not persuaded that
one of ordinary skill in the art would have combined Simmoteit and Savage
as the Examiner contends, we likewise are not persuaded that claim 8 is
unpatentable over Simmoteit, Savage, Milliman, and Miller.
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C. Claims 9, 15, and 17—Rejected as Unpatentable
over Simmoteit, Milliman, and Miller
Independent claim 9 differs from independent claim 1 primarily in
that it requires the cleaning device to be configured such that the distal end
of the elongate member is oriented away from, rather than disposed within,
the longitudinal cavity of the surgical instrument, so that the elongate
member can protect a trocar mounted to the distal end of the surgical
instrument. See Appeal Br. 16–18. The Examiner finds that one of ordinary
skill in the art would have substituted Simmoteit’s instrument 12 for
Milliman’s instrument “to achieve the predictable result of cleaning
[Milliman’s] surgical instrument using the apparatus (10) of Simmoteit.”
Final Act. 8 (citing Milliman, Figs. 6, 34–38; Simmoteit ¶¶ 1, 7, 18, 35, Fig.
1a). The Examiner acknowledges, however, that the combination of
Simmoteit and Milliman does not teach, inter alia,
[T]he cap has a mating part configured to be coupled to the
distal end of the surgical instrument such that upon coupling the
mating part to the distal end of the surgical instrument, the
second end of the elongate member is disposed distally of the
distal end of the surgical instrument and encloses a trocar
extending distally from the distal end of the surgical instrument.
Id. The Examiner therefore relies on Miller to teach the above limitation.
According to the Examiner:
Miller teaches an analogous apparatus . . . comprising: an
elongate member (210) having a first end (left end of 210 in
Figure 4A) and a second end (right end of 210 in Figure 4A),
and a cap (200 in Figure 4A) supported on the first end . . .
configured to be coupled to a distal end (right end of 180 in
Figure 4A) of a surgical instrument (180 in Figure 4A) such
that upon coupling the mating part (208) to the distal end (right
end of 180 in Figure 4A) of the surgical instrument (180), the
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second end (right end of 210 in Figure 4A) of the elongate
member (210) is disposed distally of the distal end (right end of
180 in Figure 4A) of the surgical instrument (180) and encloses
a trocar (220) extending distally from the distal end (right end
of 180 in Figure 4A) of the surgical instrument (180).
Id. at 9 (citing Miller ¶ 69, Fig. 4A). The Examiner determines that it would
have been obvious to one of ordinary skill in the art to configure
Simmoteit’s cleaning instrument so that it can be coupled to the distal end of
Milliman’s surgical instrument such that the second end of the elongate
member is disposed distally of the distal end of the surgical instrument to
encloses Milliman’s trocar to “protect[] the trocar extending from the
surgical instrument.” Id. at 9–10.
Appellant responds that “one of ordinary skill in the art would have no
reason to combine Miller with Simmoteit and Milliman in the manner
suggested” by the Examiner. Appeal Br. 13. According to Appellant,
there is no teaching, motivation, or suggestion in Miller or
Simmoteit to make the rinsing device 10 of Simmoteit
reversible so that it is both “configured for disposal within the
longitudinal cavity of the surgical instrument” and “configured
to be coupled to the distal end of the surgical instrument” as
recited in claim 9.
The Examiner responds that the motivation to combine the teachings of
Simmoteit, Milliman, and Miller as proposed “is derived from the general
knowledge of one of ordinary skill in the art.” Ans. 7.
We do not sustain this rejection. We agree with Appellant that the
Examiner’s stated reason for combining the teachings of Simmoteit,
Milliman, and Miller is not supported by a rational underpinning. Although
the Examiner reasonably determined that one of ordinary skill in the art
would have used Simmoteit’s cleaning apparatus to clean Milliman’s
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surgical instrument, Miller would not have motivated one of ordinary skill in
the art to dispose Simmoteit’s device on Milliman’s instrument in a way that
renders it unable to do so.
To use Simmoteit’s device to clean Milliman’s surgical instrument, as
the Examiner proposes, the asserted second end of the device’s elongate
member is disposed within the surgical instrument’s longitudinal cavity.
Simmoteit ¶ 35, Fig. 1a. Claim 9, however, requires the cleaning device to
be mounted on the surgical instrument such that the second end of the
elongate member is disposed distally of the distal end of the surgical
instrument, i.e., the elongate member is facing away from, rather than
inserted into, the instrument’s longitudinal cavity, rendering Simmoteit’s
device unable to fulfill its cleaning function (but instead fulfilling a different
function: protecting a trocar). While the structure in Miller that the
Examiner contends corresponds to the claimed elongate member is arguably
oriented as the claim requires—i.e., hub 200 and outer penetrator 210 are
disposed over inner penetrator 220 (Miller, Fig. 4A)—that structure is an
intraosseous needle set designed to penetrate bone marrow; there is no
teaching in Miller that outer penetrator 210 is designed to protect inner
penetrator 220. In short, the only teaching to use a cleaning device as a
device to protect a trocar is found in the Specification, not the prior art. See
Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1320 (Fed. Cir.
2004) (holding that using an inventor’s disclosure to defeat the patentability
of the inventor’s claims is “the essence of hindsight”) (internal quotation
marks and citations omitted).
Because we are not persuaded that one of ordinary skill in the art
would have combined Simmoteit, Milliman, and Miller to achieve all of the
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limitations of claim 9, we do not sustain the Examiner’s rejection of claim 9,
and its dependent claims 15 and 17, as unpatentable over Simmoteit,
Milliman, and Miller.
D. Claims 10–13—Rejected as Unpatentable
over Simmoteit, Milliman, Miller, and Savage
Claims 10–13 ultimately depend from claim 9. Appeal Br. 18–19
(Claims App.). The Examiner relies on the combination of Simmoteit,
Milliman, and Miller to teach the limitations of claim 9. Final Act. 11.
Because we are not persuaded that one of ordinary skill in the art would
have combined Simmoteit, Milliman, and Miller in the manner that the
Examiner proposes, we likewise are not persuaded that claims 10–13 are
unpatentable over Simmoteit, Milliman, Miller, and Savage.
CONCLUSION
The Examiner’s rejections are reversed.
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DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–7 103 Simmoteit, Savage 1, 3–7
1, 3–7 103 Simmoteit, Savage,
Milliman
1, 3–7
8 103 Simmoteit, Savage,
Milliman, Miller
8
9, 15, 17 103 Simmoteit,
Milliman, Miller
9, 15, 17
10–13 103 Simmoteit,
Milliman, Miller,
Savage
10–13
Overall
Outcome
1, 3–13, 15,
17

REVERSED