Tufts Medical Center, Inc.

Patent Trials and Appeals Board

Oct 29, 2021

2021004003 (P.T.A.B. Oct. 29, 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.
16/840,284 04/03/2020 Navin K. KAPUR 93469-0006-0501 7198
29052 7590 10/29/2021
EVERSHEDS SUTHERLAND (US) LLP
999 PEACHTREE STREET, N.E.
SUITE 2300
ATLANTA, GA 30309
EXAMINER
SCHMIDT, EMILY LOUISE
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
10/29/2021 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte NAVIN K. KAPUR

Appeal 2021-004003
Application 16/840,284
Technology Center 3700
____________

Before JOHN C. KERINS, JILL D. HILL, and CYNTHIA L. MURPHY,
Administrative Patent Judges.

MURPHY, Administrative Patent Judge.

DECISION ON APPEAL
The Appellant1 appeals from the Examiner’s rejections of claims 1–12
and 27–40. We REVERSE.2

1 The Appellant is the “applicant” (e.g., “the inventor” as defined in 37
C.F.R. § 1.42. “The real party in interest for this appeal is Tufts Medical
Center, Inc.” (Appeal Br. 2.)
2 We have jurisdiction over this appeal under 35 U.S.C. § 134 and
35 U.S.C. § 6(b). An oral hearing was held on October 25, 2021.
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Application 16/840,284

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THE APPELLANT’S INVENTION
According to the Appellant, their invention “is directed to an
extension cannula configured for use with an extracorporeal membrane
oxygenation (‘ECMO’) system so that oxygenated blood returned to the
patient’s body is delivered into the aorta at a location removed from a
patient’s renal arteries.” (Appeal Br. 3.) “The extension cannula of [the]
present invention is expected to provide improved delivery of oxygenated
blood from the ECMO machine.” (Spec. ¶ 19.)
ECMO “is an established strategy for cardiopulmonary support.”
(Spec. ¶ 2.) ECMO “drains blood from the venous system, oxygenates this
blood outside of the patient, and then delivers oxygenated blood back to the
arterial system.” (Id.) With “peripheral” ECMO, “large bore cannulas” are
placed in the femoral vein and femoral artery. (Id.)
The Appellant’s extension cannula is “for use with a conventional
ECMO return cannula.” (Spec. ¶ 17.) The described and depicted
conventional ECMO cannula 60 is shown “coupled to an ECMO machine 61
via outlet 24 and first inlet 22 of [an] in-line connector 20.” (Id. ¶ 68, see
also Fig. 6A.) The conventional ECMO cannula 60 is “inserted through the
patient’s femoral artery FA.” (Id.) Thus, the conventional ECMO cannula
has “a lumen that defines a blood flow path extending from an ECMO
machine to a location within a patient’s vasculature proximal of a patient’s
renal vessels.” (Appeal Br. 3.)
The Appellant’s described and depicted extension cannula 10 includes
a shaft 17 and a conduit 12 which is “self-expanding.” (See Spec. ¶ 46.)
“Self-expanding conduit 12 has inlet 16 at its proximal end and outlet 14 at
its distal end, and a lumen extending therethrough for permitting blood
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flow.” (Id. ¶ 47.) Self-expanding conduit 12 also “has a length sufficient to
extend from the outlet the conventional VA-ECMO cannula to a position
above the patient’s renal arteries.” (Id.)
In operation, the conduit 12 is disposed in a “collapsed insertion state”
within a delivery sheath 40. (Spec. ¶ 69, see also Fig. 6C.) The delivery
sheath 40 is positioned so that the conduit’s proximal end “lies near the
distal outlet” of the conventional ECMO return cannula 60, and the
conduit’s distal end is disposed “in the desired location,” for example, within
the thoracic aorta TA. (Id. ¶ 60; see also Fig. 6C.) The sheath 40 is then
retracted and the conduit 12 “transition[s] from the collapsed insertion state
to an expanded deployed state.” (Id. ¶ 69, see also Fig. 6E.) Accordingly,
“oxygenated blood may be perfused from ECMO cannula 60 to the central
location within the patient’s vasculature.” (Id.) Thus, the conduit 12 is
“biased to transition to the expanded deployed state to thereby form a
continuation of the blood flow path through the lumen of the ECMO return
cannula.” (Appeal Br. 3.)
ILLUSTRATIVE CLAIM
1. An extension cannula for use with an ECMO return cannula
having an inlet, an outlet and an internal diameter, a lumen of
the ECMO return cannula configured to define a blood flow
path extending from an ECMO machine to a location within a
patient’s vasculature proximal of a patient’s renal vessels, the
extension cannula comprising:
an elongated shaft having a proximal end and a distal
region, the elongated shaft comprising a hypotube;
a conduit coupled to the distal region of the elongated
shaft, the conduit having an inlet disposed in the distal region,
an outlet and an internal lumen, the conduit configured to be
inserted through the lumen of the ECMO return cannula in a
collapsed insertion state and to transition between the collapsed
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insertion state and an expanded deployed state, the conduit
biased to transition to the expanded deployed state to thereby
form a continuation of the blood flow path through the lumen of
the ECMO return cannula, the conduit in the expanded
deployed state having a diameter equal to or greater than the
internal diameter,
wherein the elongated shaft is configured to permit the
conduit to be advanced through the lumen of the ECMO return
cannula to position the inlet of the conduit at a location within
the outlet of the ECMO return cannula, and further configured
so that the blood flow path does not pass through the elongated
shaft, and
wherein the conduit has a length selected so that when
the extension cannula is inserted through the lumen of the
ECMO return cannula, and transitioned to the expanded
deployed state, the inlet of the conduit is positioned at the
location within the outlet of the ECMO return cannula,
proximal of the patient’s renal vessels, and the outlet of the
conduit extends beyond the outlet of the ECMO return cannula
and the patient’s renal vessels.
REJECTIONS
The Examiner rejects claims 1–11 and 27–39 under 35 U.S.C. § 103
as unpatentable over Cottone (US 2019/0160259 A1, May 30, 2019) and
Wang (US 2014/0012281 A1, Jan. 9, 2014). (Final Act. 2.)
The Examiner rejects claims 12 and 40 under 35 U.S.C. § 103 as
unpatentable over Cottone, Wang, and Wu (US 2016/0158489, June 9,
2016). (Final Act. 6.)
ANALYSIS
Claims 1 and 27 are the independent claims on appeal, with the rest of
the claims on appeal depending from or otherwise incorporating the subject
matter thereof. (See Appeal Br., Claims App.)
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Independent claim 1 sets forth an “extension cannula” comprising an
“elongated shaft” and a “conduit coupled to the distal region of the
elongated shaft.” (Appeal Br., Claims App.) Independent claim 27 similarly
sets forth an “extension cannula” comprising a “conduit” and “an elongated
shaft having a distal region coupled to the conduit.” (Id.) The Examiner
finds that Cottone discloses such an extension cannula. (See Final Act. 2.)
Cottone discloses a “guide catheter extension 1000” that is “sized and
configured to pass through and extend distally from a guide catheter.”
(Cottone ¶ 80.) Cottone’s guide catheter extension 1000 comprises “a push
member 1001 coupled to a distal tube frame 1005.” (Id.) Cottone discloses
that “[t]he ability to maintain a concentric lumen of the tube frame 1005
enables smooth wire movement, in either direction within the tubular lumen,
without resulting in deformation of the lumen.” (Id. ¶ 98.)
Independent claim 1 sets forth that the conduit is configured to
“transition between [a] collapsed insertion state and an expanded deployed
state.” (Appeal Br., Claims App.) Independent claim 27 similarly sets forth
that the conduit “transition[s] from [a] collapsed insertion state to [an]
expanded deployed state.” (Id.) The Examiner finds that Wang teaches “an
extension member which can move between [a] first configuration
(collapsed) and an expanded configuration which allows for the members to
have a close fit with the sheath it is inserted through while still allowing a
device to be inserted therethrough.” (Final Act. 3.)
Wang discloses that, “[w]hen designing guide extension catheters,” it
may be desirable for the distal sheath (i.e., conduit) “to have an inner
diameter sufficiently large for a therapeutic medical device to extend
therethrough.” (Wang ¶ 43.) Wang teaches that an “expandable member”
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may be attached to the sheath body, this expandable member being
“configured to shift” between a first configuration and a second “expanded”
configuration. (Id. ¶ 46.) The expandable member is “expanded by
advancing a therapeutic medical device through [the] distal sheath.” (Id.
¶ 48.) Specifically, passing a therapeutic medical device through the distal
sheath will “exert a radially outward force onto the distal sheath,” causing
the expandable member to expand. (Id.)
The Examiner determines that it would have been obvious to modify
Cottone’s distal tube frame 1006 “to transition from a collapsed state to an
expanded state” as taught by Wang. (Final Act. 3.)
Independent claim 1 sets forth that the conduit is “biased to transition
to the expanded deployed state.” (Appeal Br., Claims App.) Independent
claim 27 similarly sets forth that the conduit is “biased to transition from the
collapsed insertion state to the expanded deployed state.” (Id.)
The Examiner maintains that because Cottone discloses that its
conduit may be “made of [N]itonol,” Cottone discloses that its conduit may
be made of a “shape memory material” that “expands when deployed.”
(Final Act. 3; see also Answer 5.) However, Cottone’s discussion of Nitinol
is in the context of a segment that can “bend in tight curves through various
vascular passageways without permanent lumen deformation.” (Cottone
¶ 98.) This in no way discloses or suggests that the Cottone conduit has the
capability of self-expansion; instead it is indicative that the material may
allow for bending without kinking (permanent deformation), and for elastic
shape recovery. As noted by Appellant, “Nitinol is capable of exhibiting
myriad different behaviors,” based on how a particular object is fabricated.
(Appeal Br. 11.) Thus, we agree with the Appellant that the record provides
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no basis “to assume that a Nitinol device,” in particular a device of the
Cottone construction, “should be self-expanding.” (Id.)
The Examiner maintains that Wang discloses an “embodiment” which
is “self-expanding.” (Answer 5.) Wang discloses a sheath 526 in which the
sheath body 554 includes a longitudinal slit 546 and a flared distal end. (See
Wang ¶ 58, Fig. 16.) The distal sheath 526 can be expanded from a
configuration where the slit is closed to a configuration where the slit opens
“when a therapeutic medical device is passed therethrough.” (Id. ¶ 58.) And
Wang does say that the flared distal end “may include expandable or shape
memory material such that the distal end 554 may be self-expanding.” (Id.)
However, although Wang teaches use of self-expanding material to flare a
largely unconstrained material at a distal end of a sheath, it does not disclose
or suggest the use of self-expanding shape memory or expandable material
for a sheath that is initially tubular and is to remain tubular after expansion,
as the Examiner’s proposed modification appears to require. Instead, this
type of expansion in Wang is achieved by the aforenoted insertion of a
therapeutic medical device. The Examiner’s rejection does not adequately
account for this.
Thus, we do not sustain the Examiner’s rejection of independent
claims 1 and 27 as obvious over Cottone and Wang. The Examiner’s further
findings with respect to the remaining claims and Wu do not compensate for
the above-discussion shortcomings in the rejection of claims 1 and 27. (See
Final Act. 4–7.) Thus, we also do not sustain the Examiner’s rejections of
claims 2–12 and 28–40.
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CONCLUSION
Rejected 35 U.S.C. References/
Basis
Affirmed Reversed
1–11, 27–39 103 Cottone, Wang 1–11, 27–39
12, 40 103 Cottone, Wang, Wu 12, 40
Overall
Outcome
1–12, 27–40

REVERSED