C.R.BARD, INC., C/o Bard Peripheral Vascular, Inc.

Patent Trials and Appeals Board

Jun 3, 2021

2020005747 (P.T.A.B. Jun. 3, 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.
15/560,660 09/22/2017 Corey ROUSU P-18450.US02 9024
79990 7590 06/03/2021
BECTON DICKINSON AND COMPANY
KING & SCHICKLI, PLLC
800 CORPORATE DRIVE, SUITE 200
LEXINGTON, KY 40503
EXAMINER
YABUT, DIANE D
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/03/2021 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):
ip.docket@bd.com
uspto@iplaw1.net
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

Ex parte COREY ROUSU
_______________

Appeal 2020-005747
Application 15/560,660
Technology Center 3700
_______________

Before JOSIAH C. COCKS, BRETT C. MARTIN, and
BRANDON J. WARNER, Administrative Patent Judges.

COCKS, Administrative Patent Judge.

DECISION ON APPEAL

I. STATEMENT OF THE CASE
This is a decision on appeal by Appellant under 35 U.S.C. § 134(a)
from a final rejection of claims 1–5, 12–17, 30, 34, and 41–45 of
Application 15/560,660 (“the ’660 application”). 1, 2 We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.

1 In this opinion, we make reference to Appellant’s Reply Brief filed August
5, 2020 (“Reply Br.”), the Examiner’s Answer dated June 5, 2020 (“Ans.”),
Appellant’s Appeal Brief filed February 17, 2020 (“Appeal Br.”), and the
Final Rejection dated September 27, 2019 (“Final Rej.”)
2 Appellant identifies the real party-in-interest as C.R. Bard, Inc. Appeal Br.
2.
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A. References Relied on by the Examiner
Adams US 5,556,382 Sept. 17, 1996
Tilson et al. (“Tilson”) WO 2012/099979 A1 July 26, 2012
B. Rejections on Appeal
The Examiner rejected claims 1–5, 12–17, 30, 34 and 42–45 under
35 U.S.C. § 102(a)(1) as anticipated by Tilson. Final Rej. 5.
The Examiner rejected claim 41 under 35 U.S.C. § 103 as being
unpatentable over Tilson in view of Adams. Id. at 8.
C. The Subject Matter of the ’660 Application
The Specification of the ’660 application describes the disclosed
invention as follows:
An apparatus for performing a medical procedure in the
vasculature comprises an inflatable perfusion balloon including
a passage for transmitting fluid in an inflated condition of the
balloon. A metal or wire mesh is positioned along or over at
least a portion of the inflatable balloon. The mesh may allow
fluid to flow through the wire mesh into the passage when the
balloon is inflated. The mesh may comprise a wire sock or
sleeve, and may comprise a shape memory material, such as
Nitinol.
Spec. code [57].
Claims 1, 30, and 34 are independent. Claim 1 is illustrative and is
reproduced below:
1. An apparatus for performing a medical procedure in the
vasculature, comprising:
an inflatable perfusion balloon including a passage for
transmitting fluid flowing through the vasculature in an inflated
condition of the balloon; and
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a wire mesh positioned over at least a portion of the
inflatable perfusion balloon.
Appeal Br. 11 (Claims App’x).

II. ANALYSIS
A. Anticipation Rejection Under 35 U.S.C. § 102
1. Overview of Tilson
Tilson is entitled “INFLATABLE MEDICAL DEVICES.” Tilson
code [54]. Summarily, Tilson teaches a number of embodiments of an
inflatable device that may comprise an inflatable balloon encircled by a shell
having fiber reinforced walls. Id. at code [57].
Figures 1A and 1B and are reproduced below:

Figures 1A and 1B above illustrate shell 678 with shell wall 684. Id. ¶ 100.
Shell wall 684 is described as being “fluid-tight (e.g., non-porous enough to
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prevent water, and/or saline solution and/or air transfer or osmosis through
the shell wall 684).” Id. ¶ 113.
Figure 3A of Tilson is reproduced below:

Figure 3A depicts an embodiment of the inflatable structure with shell 678
having reinforcement fibers 86a, 86b. Tilson ¶ 117. Reinforcement fibers
86a, 86b are configured to “maximiz[e]” strength of the shell.” Id. ¶ 124.
Shell 678 includes apertures 714 that operate to allow fluid flow through and
release internal pressures from the shell. Id. ¶ 115.
Figure 10A, illustrating a cross-sectional view of the shell wall 684, is
reproduced below.

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Figure 10A illustrates an example of a cross-section B-B of Figure 1A. Id.
¶ 44. “[F]iber matrix may have one, two or more reinforcement fibers 86
running substantially parallel to each other and embedded in an adhesive
208” and the fibers “may be positioned such that there is adhesive separating
each fiber along its length. Id. ¶¶ 137–138.
2. Discussion
In rejecting claim 1 as anticipated, the Examiner cites to Tilson as
teaching every element required by the claim. See Final Rej. 5. At issue is
the Examiner’s reliance upon Tilson as anticipating “a wire mesh positioned
over at least a portion of the inflatable perfusion balloon.” Final Rej. 5. In
supporting the rejection, the Examiner states “shell 678 has a wire mesh, or
network made from fibers 86 or crossing reinforcement filaments 86a, 86b
creating an open texture grid layer; see paragraphs [0117]-[0118] and Figure
3A.” Id. Appellant argues that the limitation “mesh” has been defined
within its originally filed disclosure as “a material having open texture with
spaced holes[.]” Appeal Br. 4 citing Spec. ¶ 33. That referenced paragraph
of the Specification expressly sets forth: “[f]or purposes of this disclosure,
the term ‘mesh’ is intended to refer to a material having an open texture with
spaced holes, and ‘wire’ means the mesh comprises one or more filaments or
a similar thin flexible members.” Spec. ¶ 33. The Examiner does not
propose an alternative construction, and we do not discern that the Examiner
disagrees that the Specification provides a defined meaning of “mesh.”
Thus, in the context of the ’660 application, a “mesh” is understood as a
material “having an open texture with spaced holes.”
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The Examiner references reinforcement fibers 86a, 86b and a discussion
of potential arrangements thereof in Tilson. Final Rej. 5 (citing Tilson ¶¶
117–118, Figure 3A). The cited portions of Tilson discuss configurations of
fibers as a part of shell 678. The Examiner “points to fibers 86a, 86b
themselves as defining a ‘wire mesh’,” states that “apertures 714 are formed
through the fibers 86a, 86b to allow for fluid flow,” and concludes that
“fibers 86a, 86b and apertures 714 of Tilson meet the limitations of a ‘wire
mesh’ and ‘openings in the wire mesh’, respectively.” Ans. 3.3 Thus, it is
apparent that the Examiner relies on fibers 86a, 86b, which are components
of shell wall 684, as a material forming a “mesh,” i.e., a material having an
open texture with spaced holes, and the separate apertures 714 as the
structures constituting the additional recited “openings in the wire mesh []
capable of allowing fluid to flow” in claim 3. See also Final Rej. 5
(characterizing “reinforcement filaments 86a, 86b as creating an open
texture grid layer” and “openings 714” as “allowing fluid flow”).
Appellant argues that “there is clearly no open texture with spaced
holes created by [fibers] 86a, 86b” (Reply Br. 3) and that shell wall 684
formed by those fibers is “fluid-tight” (id. at 5) (citing Tilson ¶ 113). It is
Appellant’s position that the shell wall of shell 687 cannot, itself, be
regarded as the claimed “mesh,” as that term is defined in the context of the

3 Claim 3 of the ’660 application depends from claim 2, which depends from
claim 1. Claim 2 adds “wherein the balloon comprises a first cell and a
second cell in a single cross-section of the balloon.” Appeal Br. 11 (Claims
App’x). Claim 3 further adds a requirement of “wherein a space is provided
between the first and the second cell, and openings in the wire mesh allow
fluid to flow from external to the balloon, into the space, and to the
passage.” Id.
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’660 application. That position is supported by, and consistent with, the
’660 application. To that end, the ’660 application distinguishes its
disclosure of a “reinforced perfusion balloon” from other known “[f]iber-
reinforced composite balloons.” Spec. ¶¶ 10–12. One such distinction
relates to manufacturing complexity and expense of known fiber-reinforced
composite balloons. Id. ¶¶ 10–11. Another such distinction seemingly is
that the perfusion balloon of the ’660 application includes description of an
outer mesh that “allows fluid to flow through the mesh into the passage
when the balloon is inflated.” Id. ¶ 12. That description is consistent with
the understanding of the term “mesh” as being a “material having an open
texture with spaced holes.” Id. ¶ 33.
It is difficult to reconcile the Examiner’s view that Tilson’s
disclosure, which appears readily regarded as the type of fiber-reinforced
composite balloon discounted by the ’660 application, nevertheless
anticipates claim 1, among other claims, here. That is primarily so because
Tilson conveys that fibers 86a, 86b are contained with shell wall 684, which
is disclosed as “fluid-tight” and, thus, does not permit the flow of fluid
therethrough. See Tilson ¶ 113. As such, shell wall 684, encompassing
fibers 86a, 86b, cannot reasonably be characterized as a “material having
open texture with spaced holes,” i.e., a “mesh.” See Spec. ¶ 33. Moreover,
to the extent the Examiner is of the view that reinforcement fibers 86a, 86b
may be regarded as a separate structure that is divorced from association
with shell 678 (see, e.g., Ans. 3), that view is ill-explained. Tilson conveys
that its shell 678 includes an outer shell wall 684 which itself is composed of
fibers 86a, 86b. It is not evident that Tilson describes fibers 86a, 86b as
forming a structure recognizable as apart or distinct from shell 678, and
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which would independently form the structure of a “mesh,” as that term is
understood here. Indeed, the Examiner does not direct us to any
embodiment of, or description in, Tilson in which the fibers may reasonably
be regarded in that manner. The Examiner’s view to the contrary simply is
not supported adequately on the record.
To establish anticipation under 35 U.S.C. § 102, each and every
element in a claim, arranged as is recited in the claim, must be found in a
single prior art reference. Karsten Mfg. Corp. v. Cleveland Golf Co., 242
F.3d 1376, 1383 (Fed. Cir. 2001). For the reasons discussed above, we are
not persuaded that the Examiner adequately shows how Tilson accounts for
the “mesh” element as required by claim 1. Therefore, on the record before
us, we do not sustain the Examiner’s anticipation rejection of claim 1.
With regard to independent claims 30 and 34, each of those claims also
requires a similar “mesh” feature as discussed above in connection with
claim 1. Thus, we also do not sustain the anticipation of those claims based
on Tilson for the same reasons.
Claims 2–4 and 12–17 ultimately depend from claim 1, and claims 42–
45 ultimately depend from claim 30. By virtue of their dependency, those
dependent claims also have the noted “mesh” requirement. We do not
sustain the rejection of claims 2–4, 12–17, or 42–45 as anticipated by Tilson.
B. Obviousness Rejection Under 35 U.S.C. § 103
The Examiner rejects claim 41 as unpatentable based on Tilson in
view of Adams. Claim 41 depends from claim 1. The Examiner applies
Adams’s teachings to account for features added by claim 41, but not in any
way that would remedy the deficiency in Tilson as discussed above
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pertaining to the required “mesh” feature. We also do not sustain the
rejection of claim 41.
III. CONCLUSION
We have fully considered the record before us, including Appellant’s
briefing, the Examiner’s Final Rejection, and the Examiner’s Answer. For
the reasons discussed above, we are persuaded on the present record that the
Examiner was incorrect in rejecting claims 1–5, 12–17, 30, 34, and 41–45 as
stated in the Final Rejection. Accordingly, the Examiner’s decision to reject
claims 1–5, 12–17, 30, 34, and 41–45 is reversed.
IV. DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 12–17,
30, 34, 42–45
102(a)(1) Tilson 1–5, 12–17,
30, 34, 42–
45
41 103 Tilson, Adams 41
Overall
Outcome
1, 5, 12–17,
30, 34, 41–
45

REVERSED