Applied Cardiovascular Solutions, LLC et al.

Patent Trials and Appeals Board

Jun 1, 2020

14208338 - (D) (P.T.A.B. Jun. 1, 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.
14/208,338 03/13/2014 F. Javier Otero 10046-040US1 5369
96039 7590 06/01/2020
Meunier Carlin & Curfman LLC
999 Peachtree Street NE
Suite 1300
Atlanta, GA 30309
EXAMINER
TEMPLETON, CHRISTOPHER L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/01/2020 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):
docketing@mcciplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte F. JAVIER OTERO, JOSEPH J. BEAMAN, KRISHNENDU
ROY, and ANDREW ZIMBROFF
Appeal 2019-006188
Application 14/208,338
Technology Center 3700
Before BRETT C. MARTIN, MICHAEL J. FITZPATRICK, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, 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 1–10, 12–14, 16, 18, 19, and 24–27.2
We have jurisdiction under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Applied
Cardiovascular Solutions, Inc. and the Board of Regents, the University of
Texas System. Appeal Br. 3.
2 Claims 11, 15, 17, 20–23, 28, and 29 have been cancelled. Appeal Br. 30–
33 (Claims App.).
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We reverse.
CLAIMED SUBJECT MATTER
The claims are directed to methods of occluding a left atrial
appendage (LAA) of a patient by injecting an amount of crosslinkable
biomaterial to decrease a rate of thromboembolic events associated with
atrial fibrillation (AF). Spec. 2:14–25.
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A method of occluding a left atrial appendage (LAA) of a
patient comprising:
(a) providing a delivery catheter comprising:
a proximal region;
a distal region comprising a distal tip;
a first lumen extending from the proximal region to
the distal region; and
an occluding element positioned in proximity to the
distal tip;
(b) advancing the delivery catheter percutaneously
through vasculature of the patient such that the distal tip of the
delivery catheter reaches a left atrium of the patient;
(c) advancing the distal tip of the delivery catheter into the
LAA of the patient, such that the occluding element transitorily
occludes the LAA;
(d) withdrawing blood from the patient’s LAA;
(e) measuring a volume of the blood withdrawn from the
patient’s LAA to determine an amount of a crosslinkable
biomaterial to be injected into the LAA of the patient; and
(f) injecting the amount of the crosslinkable biomaterial
into the LAA of the patient, wherein the crosslinkable
biomaterial comprises a first precursor molecule and a second
precursor molecule; and
wherein the first precursor molecule and the second
precursor molecule crosslink in situ in the LAA to form a
biocompatible polymeric matrix that occupies a cavity in the
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LAA of the patient, thereby preventing stagnation of blood
within the cavity in the LAA of the patient.
Appeal Br. 30 (Claims App.).
REFERENCES3
The prior art relied upon by the Examiner is:
Name Reference Date
Gnanou US 4,644,033 Feb. 17, 1987
McCormick US 2005/0245891 A1 Nov. 3, 2005
Beckman US 2007/0014755 A1 Jan. 18, 2007
Rehor US 2008/0253987 A1 Oct. 16, 2008
Shalaby US 2009/0264555 A1 Oct. 22, 2009
Gemeinhart US 2009/0291115 A1 Nov. 26, 2009
Dye US 2009/0324719 A1 Dec. 31, 2009
Kassab US 2010/0191279 A1 July 29, 2010
Sheardown US 2010/0303911 A1 Dec. 2, 2010
West US 2012/0255124 A1 Oct. 11, 2012
Chau US 2014/0212373 A1 July 31, 2014
Jose R. Lopez-Minguez et al., Immediate and One-year Results in 35
Consecutive Patients After Closure of Left Atrial Appendage With the
Amplatzer Cardiac Plug, Rev Esp Cardiol. 66(2):90–97 (2013) (“Lopez
Minguez”).

REJECTIONS
I. Claims 1–5, 8, 12, 16, 18, and 26 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kassab, Rehor, and McCormick.
II. Claim 9 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Kassab, Rehor, McCormick, and Dye or Gnanou.

3 The evidence submitted by Appellant is a declaration under 37 CFR 1.132
executed by Joeseph J Beaman, one of the inventors named in the present
Application, made of record on March 28, 2018.
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III. Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Kassab, Rehor, McCormick, and Chau.
IV. Claims 7 and 25 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kassab, Rehor, McCormick, and Beckman.
V. Claim 10 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Kassab, Rehor, McCormick, and Sheardown.
VI. Claims 13 and 14 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kassab, Rehor, McCormick, and Lopez-Minguez.
VII. Claim 19 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Kassab, Rehor, McCormick, and West.
VIII. Claim 24 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Kassab, Rehor, McCormick, and Gemeinhart.
IX. Claims 1 and 27 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kassab, Shalaby, and McCormick.

OPINION
Rejection I (Kassab, Rehor, and McCormick)
The Examiner finds that Kassab discloses all of the elements recited
in claim 1, except for the use of a cross-linkable biomaterial and the step of
measuring the volume of blood withdrawn to determine an amount of
biomaterial to be injected. Non-Final Act. 2–3. The Examiner finds that
McCormick teaches the step of withdrawing blood from a patient, measuring
the volume of the blood withdrawn to determine an amount of biomaterial to
be injected, and injecting the amount of the biomaterial. Id. at 4 (citing
McCormick ¶ 68). The Examiner finds McCormick teaches this step is “for
the purpose of determining the volume of the void to be filled, estimating the
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amount of agent required to fill the void, not overfilling or under filling the
void, and reducing the risk of rupturing the void.” Id. (citing McCormick
¶ 68). The Examiner determines that a person of ordinary skill in the art
would have found it obvious to implement this step in the method disclosed
by Kassab to achieve the same benefits this step provides in McCormick. Id.
at 4–5.
Appellant argues that, although Kassab teaches injecting an adhesive
or biological glue into the LAA of a patient in order to occlude it, Kassab
performs this step only after causing the LAA to completely collapse. See
Appeal Br. 9–12. According to Appellant, if a surgeon were to measure the
volume of blood withdrawn before injection of biological glue, as suggested
by the Examiner, one would necessarily obtain a measurement of the
internal volume of the patient’s unmanipulated LAA. Id. at 11. Thus,
Appellant contends, the Examiner’s proposed modification would offer no
benefit to a surgeon practicing Kassab’s method. Id. In other words,
Appellant contends that the measurement disclosed by McCormick provides
information that is not pertinent to the method disclosed by Kassab.
In response, the Examiner contends, “[t]he amount of blood
withdrawn in McCormick is used to determine an amount of agent to be
injected (see para. 68 of McCormick)[, and t]he amount injected correlates
to the determined amount.” Ans. 3. The Examiner finds that Appellant’s
argument rests on an unrecited requirement in claim 1 for the volume
measured and the amount of biomaterial injected to be equal, i.e., for there to
be a 1 to 1 ratio of measured blood to injected biomaterial. Id. As claim 1
has no such requirement, the Examiner concludes Appellant’s argument is
unpersuasive. Id. The Examiner also reiterates the finding that the proposed
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modification to Kassab’s method would provide the benefit of the
measurement disclosed in McCormick, e.g., prevention of
overfilling/underfilling. Id. at 3–4 (citing McCormick ¶ 68).
Although we agree with the Examiner that (i) claim 1 does not require
a 1 to 1 ratio of measured volume to injected biomaterial, and (ii)
McCormick discloses a benefit of measuring an amount of blood withdrawn
before injecting an amount of biomaterial based on the measured amount,
for the following reasons, we do not agree that McCormick’s disclosed
benefit would apply in the context of Kassab’s method. As Appellant asserts
(Appeal Br. 11), Kassab’s method requires collapsing the LAA before
injecting biomaterial (adhesive 47). See McCormick ¶¶ 34–36. Despite the
fact that claim 1 does not require a 1 to 1 ratio of the measured volume to the
injected biomaterial, claim 1 requires a relationship between these two
quantities. Specifically, claim 1 recites “measuring a volume of the blood
withdrawn from the patient's LAA to determine an amount of a crosslinkable
biomaterial to be injected into the LAA of the patient.” Appeal Br. 30
(Claims App.). In light of this fact, the Examiner does not adequately
explain how a measurement of the volume of blood or other material
removed from the unaltered LAA bears any relationship to (and, therefore
would assist in determining) the amount of adhesive 47 required to attach
the walls of the collapsed LAA. In other words, the rejection of claim 1
leaves unaddressed how the volume of a fully inflated LAA informs the
amount of adhesive required to seal a collapsed LAA. Accordingly, we
agree with Appellant that the Examiner relied on impermissible hindsight in
rejecting claim 1, and claims 2–5, 8, 12, 16, 18, and 26 depending therefrom,
as unpatentable over Kassab, Rehor, and McCormick.
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Rejections II–VIII (Kassab, Rehor, McCormick, Dye, Gnanou, Chau,
Beckman, Sheardown, Lopez-Minguez, West, and Gemeinhart)
The Examiner does not use the teachings of Dye, Gnanou, Chau,
Beckman, Sheardown, Lopez-Minguez, West, and Gemeinhart in any
manner that would remedy the deficiency discussed above regarding
Rejection I and the combination of the teachings of Kassab, Rehor, and
McCormick. See Non-Final Act. 5–9. Accordingly, for the same reasons,
we do not sustain Rejections II–VIII.
Rejection IX (Kassab, Shalaby, McCormick)
In Rejection IX, the Examiner rejects claim 1 based on the same
findings of fact regarding Kassab and McCormick, but replaces Rehor with
Shalaby to address the recited characteristics of the biomaterial. Non-Final
Act. 10–11. For the same reasons discussed above regarding Rejection I, we
do not sustain the rejection of claim 1, and claim 27 depending therefrom, as
unpatentable over Kassab, Shalaby, and McCormick.

CONCLUSION
The Examiner’s rejections are reversed.

DECISION SUMMARY

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 8, 12,
16, 18, 26
103(a) Kassab, Rehor,
McCormick
1–5, 8, 12,
16, 18, 26
9 103(a) Kassab, Rehor,
McCormick, (Dye or
Gnanou)
9
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
6 103(a) Kassab, Rehor,
McCormick, Chau
6
7, 25 103(a) Kassab, Rehor,
McCormick, Beckman
7, 25
10 103(a) Kassab, Rehor,
McCormick,
Sheardown
10
13, 14 103(a) Kassab, Rehor,
McCormick, Lopez-
Minguez
13, 14
19 103(a) Kassab, Rehor,
McCormick, West
19
24 103(a) Kassab, Rehor,
McCormick,
Gemeinhart
24
1, 27 103(a) Kassab, Shalaby,
McCormick
1, 27
Overall
Outcome
1–10, 12–
14, 16, 18,
19, 24–27

REVERSED