Ex Parte Fritz et al

Patent Trial and Appeal Board

Feb 26, 2019

14313270 (P.T.A.B. Feb. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/313,270 06/24/2014 Bryan P. Fritz
89554 7590 02/28/2019
Christopher & Weisberg, P.A.
1232 N. University Drive
Plantation, FL 33322
UNITED ST A TES OF AMERICA
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.
21819J-2043U-C00016896.US 2695
EXAMINER
ALTER MORSCHAUSER, ALYSSA MARGO
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
02/28/2019 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):
ptomail@cwiplaw.com
rs.patents.five@medtronic.com
cwdocketing@cardinal-ip. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte BRYANP. FRITZ, ROBERT C. FARNAN,
ANDREW J. DUSBABEK, OLIVER MARSEILLE, MURAT
CAMKIRAN, GRANT THOMPSON, and SCOTT A. OLSON
Appeal2018-003492
Application 14/313,270
Technology Center 3700
Before STEFAN STAICOVICI, EDWARD A. BROWN, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
MARSCHALL, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the
Examiner's rejection of claims 1-14, 16-20, and 22--42. 2 We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant is the Applicant, CircuLite, Inc. The Appeal Brief identifies
Medtronic plc. as the real party in interest and notes that CircuLite, Inc., is
wholly owned by Heartware International, Inc., a wholly owned subsidiary
of Medtronic plc. Appeal Br. 1.
2 Claims 15 and 21 were cancelled. Appeal Br. 16, 18 (Claims App.).
Appeal2018-003492
Application 14/313,270
THE CLAIMED SUBJECT MATTER
The claimed subject matter "relates to blood pumps and ancillary
devices for connecting the blood pump to associated cannulae." Spec. ,r 2.
Claims 1, 17, and 18 are independent. Claim 1 is reproduced below.
1. A system for facilitating fluid connection between a blood
pump and a circulatory system of a patient, comprising:
a cannula having proximal and distal ends, the distal end
of the cannula adapted to be in fluid communication with the
circulatory system, the proximal end of the cannula configured
to couple to an inlet of the blood pump; and
a tunneling device configured to be inserted into a body
of a patient to direct the proximal end of the cannula adjacent to
the inlet for connection thereto;
wherein the cannula further comprises a first connecting
structure; and
the tunneling device further comprises a second
connecting structure, the first and second connecting structures
being selectively engageable to allow in situ connection and
disconnection between the cannula and tunneling device.
Appeal Br. 14 (Claims App.).
THE REJECTIONS
Appellant appeals from the following rejections:
1. Claims 1-14, 16-20, and 22--42 under 35 U.S.C. § 112(b) as
indefinite.
2. Claims 1-9, 16-19, 22-26, 41, and 42 under 35 U.S.C. § I02(a)(l)
as anticipated by Marseille '975. 3
3 U.S. Patent Publication No. 2009/0023975 Al, published January 22, 2009
("Marseille '975").
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Application 14/313,270
3. Claims 27-32 under 35 U.S.C. § 103 as unpatentable over
Marseille '975.
4. Claims 10-14 and 20 under 35 U.S.C. § 103 as unpatentable over
Marseille '97 5 and Marseille ' 18 8. 4
ANALYSIS
Re} ections Under 3 5 US. C. § 112 (b)
The Examiner found the "selectively engaging" language in each of
the independent claims indefinite under 35 U.S.C. § 112(b). Final Act. 3.
The Examiner found that "[i]t is unclear whether the Applicant intends for
the components to be engag[e]able/engaging to allow a connection or not."
Id. In the Answer, the Examiner further found that "it is unclear if once the
connection is broken (i.e. disconnected) if there is intention to be able to
reconnect the components." Ans. 3. As to claim 34, the Examiner found the
language "selectively engaging the connecting structures further includes
removing a detachable tip" indefinite because "[i]t is unclear how removing
an attachment meets the limitation of 'selectively engaging the connection
structures."' Final Act. 4.
Appellant argues that the remainder of the claim language adequately
describes the type of engagement required-"to allow in situ connection and
disconnection between the cannula and tunneling device." Reply Br. 2.
Appellant also argues that the specification adequately describes the
connecting structure allowing for the selective engagement. Id. (citing Spec.
,r,r 43, 51 ). As to claim 34, Appellant argues that the claim clearly specifies
4 U.S. Patent Publication No. 2009/0182188 Al, published July 16, 2009
("Marseille '188").
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Appeal2018-003492
Application 14/313,270
removal of the tip before engaging the connecting structures, and the
specification describes this procedure. Id. at 9.
We agree with Appellant that the claim term "selectively engageable,"
when read in light of the specification, does not render any of the claims
indefinite. As Appellant points out, the claim language itself specifies that
the engagement allows "connection and disconnection between the cannula
and tunneling device," undermining the Examiner's finding that it is unclear
whether the claims allow for connection or not. See Final Act. 3. Similarly,
in light of the "connection and disconnection" claim language and the
structures described in the specification, it is apparent that the claims require
the ability to reconnect the structures after they are disconnected, if desired.
See Ans. 3 (finding lack of clarity regarding the ability to reconnect
components). Finally, we do not view the similar language in claim 34 as
introducing indefiniteness issues because it includes the step of "removing a
detachable tip of the tunneling device" "before selectively engaging the
connecting structures." See Appeal Br. 22 (Claims App.); Final Act. 4. The
order of the steps are made clear by the claim language itself, and, as
discussed above, the "selectively engaging" language alone does not
introduce ambiguity.
Based on the foregoing, we do not sustain the rejection of claims 1-
14, 16-20, and 22--42 under 35 U.S.C. § 112(b) as indefinite.
Rejections Under 35 US.C. §§ 102(a)(l) and 103
Claims 1 and 1 7 require a cannula and tunneling device with
respective connecting structures that are "selectively engageable to allow in
situ connection and disconnection." Appeal Br. 14 (Claims App.).
Similarly, method claim 18 requires the step of "selectively engaging a first
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Application 14/313,270
connecting structure of the cannula in situ with a second connecting
structure of the tunneling device." Id. at 17. Claim 1 also requires a
"proximal end of the cannula configured to couple to an inlet of the blood
pump" and "a tunneling device configured ... to direct the proximal end of
the cannula adjacent to the inlet" of the blood pump. Id. at 14 (Claims
App.). The Examiner found that Marseille '975 discloses a cannula (10)
having a proximal end configured to couple to an inlet of a blood pump ( 15).
Final Act. 4--5. The Examiner also found that Marseille '975 discloses
distal tip portions (92, 122) on one end of the cannula (10), which satisfies
the "tunneling device" limitation. Id. at 5; Ans. 4. As to the connecting
structures, the Examiner referred to Figures 5A, 5B, 6A, and 6B and the
"integral connection" between the cannula and tunneling device in Marseille
'975. Final Act. 5; Ans. 4. As to selective engagement, the Examiner found
the following regarding Marseille '975:
In the exemplary embodiment of FIGS. 5A-5B, the rigid flared
tip portion 92 includes a cylindrical portion 102 embedded
within a segment of the main portion 100 of the elongate body
111 of the cannula 90.
Ans. 4.
Appellant argues that the tips 92, 122 the Examiner relies upon as
tunneling devices are not selectively engageable to allow for in situ
connection and disconnection relative to the respective cannulae 90, 120.
Appeal Br. 1 O; Reply Br 3--4. Appellant also argues, with respect to claim 1,
that even if tip portions 92, 122 constitutes a tunneling device, it is not
"configured to direct the proximal end of the cannula to a pump inlet."
Appeal Br. 10.
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Application 14/313,270
We agree with Appellant that the Examiner has not supported
adequately the finding that Marseille '975 discloses connecting structures on
the cannula and tunneling device that are "selectively engageable to allow in
situ connection and disconnection between the cannula and tunneling
device," or a tunneling device configured to direct the proximal end of the
cannula to the pump inlet. The Examiner does not offer an explicit
construction of the "selectively engageable" limitation, and as discussed
above the Examiner found the limitation indefinite. It appears that the
Examiner reads the limitation broadly enough that it covers "integral
engagement between the walls" of the cannula and tip. Ans. 4. We
disagree. As noted above in the context of our discussion regarding
indefiniteness, the claim language itself requires selective engagement that
allows for connection and disconnection of the cannula and tunneling device
connecting structures in situ. An integral connection between the cannula
and tunneling device does not allow for this selective connection and
disconnection, and the Examiner's findings do not even address the in situ
nature of the required selective engagement. See id.; Marseille '975 ,r 44
( describing coupling of the two components using "adhesives, mechanical
fasteners, fittings, integral formation, and the like," but not suggesting any in
situ connection or disconnection). As to the tunneling device limitation, tip
portions 92, 122 of Marseille '975 (the alleged tunneling devices) are at the
distal end of the cannula that connects to wall 40 of heart 14, and therefore
do not "direct the proximal end of the cannula to a pump inlet" as the claim
requires. See Marseille '975 Fig. 5B (depicting tip portion 92 inserted into
incision into heart chamber 14a); Appeal Br. 10.
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Based on the foregoing, we do not sustain the anticipation rejection of
independent claims 1, 17, and 18, or claims 2-9, 16, 19, 22-26, 41, and 42
that ultimately depend from those claims. The Examiner's obviousness
rejections of dependent claims 10-14, 20, and 27-32 do not remedy the
deficiencies noted above in the anticipation rejections, and we therefore do
not sustain the obviousness rejections for the same reasons discussed above.
See Final Act. 6-7.
DECISION
We reverse the decision of the Examiner to reject claims 1-14, 16-20,
and 22--42.
REVERSED
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