DAVIES, WILLIAM F. et al.

Patent Trials and Appeals Board

Aug 2, 2019

14954456 - (D) (P.T.A.B. Aug. 2, 2019)

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.
14/954,456 11/30/2015 WILLIAM F. DAVIES JR. P-20079.US03CON 2947
79990 7590 08/02/2019
BECTON DICKINSON AND COMPANY
KING & SCHICKLI, PLLC
800 CORPORATE DRIVE, SUITE 200
LEXINGTON, KY 40503
EXAMINER
BACHMAN, LINDSEY MICHELE
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
08/02/2019 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):
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laura@iplaw1.net
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WILLIAM F. DAVIES, JR. and LANNY R. PEPPER
____________

Appeal 2019-001688
Application 14/954,4561
Technology Center 3700
____________

Before EDWARD A. BROWN, JEREMY M. PLENZLER, and
BRANDON J. WARNER, Administrative Patent Judges.

BROWN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant seeks review under 35 U.S.C. § 134(a) of the Examiner’s
decision rejecting claims 21–40.2 We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.

1 Bard Peripheral Vascular, Inc. (“Appellant”) is the Applicant and is
identified as the real party in interest. 37 C.F.R. § 1.46; Appeal Br. 3.
2 Claims 1–20 are cancelled. Appeal Br. 17 (Claims App.).
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CLAIMED SUBJECT MATTER
Appellant’s “disclosure relates to medical dilation balloons; and, in
particular, it relates to non-compliant and semi-compliant medical balloons
useful in angioplasty, stent placement and dilation and other medical
applications including cardiology, radiology, urology and orthopedics.”
Spec. ¶ 2.
Claims 21, 32, and 40 are independent claims. Claim 21 illustrates
the claimed subject matter:
21. A fiber-reinforced medical balloon that may be
inflated and deflated, the balloon comprising:
a fiber layer embedded in a continuous matrix of polymer
material defining a generally cylindrical barrel wall;
wherein the fiber of the fiber layer extends
circumferentially around a longitudinal axis of the balloon over
at least a portion of said barrel wall; and
wherein the fiber pitch in a first portion of the barrel wall
is less than the fiber pitch in a second portion of the barrel wall.

Appeal Br. 17 (Claims App.).

REJECTION
Claims 21–40 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Jorgensen (US 5,647,848, issued July 15, 1997) and Hart (US
6,626,861 B1, issued Sept. 30, 2003).

ANALYSIS
Claims 21, 27–32, 34, 35, 39, and 40
Appellant argues claims 21, 27–32, 34, 35, 39, and 40 as a group and
presents substantially the same argument for independent claims 21, 32, and
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40. Appeal Br. 9–13. Accordingly, we select claim 21 as the representative
claim to decide the appeal of this rejection for the group, with claims 27–32,
34, 35, 39, and 40 standing or falling with claim 21. See 37 C.F.R.
§ 41.37(c)(1)(iv).
Claim 21 recites, inter alia, that “the fiber pitch in a first portion of
the barrel wall is less than the fiber pitch in a second portion of the barrel
wall.” Appeal Br. 17 (Claims App.). For claim 21, the Examiner finds that
Jorgensen teaches a fiber layer (constraining structure 26) embedded in a
continuous matrix of polymer material (elastomeric skin 24) to define a
generally cylindrical barrel wall, where the fiber of the fiber layer extends
circumferentially around a longitudinal axis along the barrel wall. Final Act.
4 (citing Jorgensen, col. 3, l. 35, ll. 41–48, Fig. 1). The Examiner finds that
Jorgensen does not disclose “varying the fiber pitch along the barrel wall.”
Id.
The Examiner finds that Hart discloses a balloon catheter including a
mesh (outer mesh sleeve 72) on the outside of the balloon (balloon 62) to
control expansion of the balloon. Id. at 5 (citing Hart, col. 3, ll. 40–58). The
Examiner also finds that the pitch of the helically wound mesh varies along
the length of the generally cylindrical barrel wall of the balloon to control
the balloon’s shape. Id. (citing Hart, col. 9, ll. 1–37, Figs. 6, 8). The
Examiner concludes that it would have been obvious to one of ordinary skill
in the art to modify Jorgensen’s device such that the pitch of the helically
wound mesh varies along the balloon’s length, as taught by Hart, “to provide
the stated advantages.” Id. The Examiner indicates that the “stated
advantages” are “to control the shape of the balloon.” Id. at 3.
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Appellant contends that the Examiner’s combination of Jorgensen and
Hart would not result in the claimed subject matter. Appeal Br. 9.
Appellant points out that claim 21 requires “both a generally cylindrical
barrel wall, and also a fiber pitch that varies in one way or another along the
cylindrical barrel wall.” Id. Appellant contends that the Examiner
acknowledges that varying the pitch of the fibers in Hart results in changing
the shape of the balloon, and, in fact, is specifically for this purpose. Id. at
9–10. Appellant reproduces Figures 6–9 of Hart, which show that the shape
of the balloon changes form the uninflated condition (Figures 6, 8) to the
inflated condition (Figures 7, 9), creating a reduced radius portion 78 and
annular chambers 80 on either side of reduced radius portion 78. Id. at 10
(citing Hart, col. 9, ll. 14–15, 18–21). Appellant contends that “Hart
specifically notes that the mesh of fibers is specifically designed to create
portions of the balloon wall that have smaller, reduced radii,” and this is
“antithetical to any ‘generally cylindrical’ shape of a balloon barrel wall, as
required by the claims.” Id. Appellant contends that if these teachings were
incorporated into Jorgensen’s balloon, the resulting balloon would not have
a “generally cylindrical barrel wall.” Id. Otherwise, Appellant contends, if
the combined teachings “did not alter the shape of the Jorgensen balloon,
then the alleged reason for the combination of references as stated by the
Examiner would be moot and irrational.” Id. at 11–12.
The Examiner responds that Appellant attempts to limit the claimed
balloon shape to be generally cylindrical in both the collapsed and expanded
configurations, but the claims do not recite this limitation. Ans. 2. The
Examiner submits that Jorgensen discloses a generally cylindrical barrel wall
in both the unexpanded and expanded states, as shown in Figures 1–3. Id. at
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3. The Examiner further submits that Hart discloses a generally cylindrical
barrel wall in the unexpanded state, as shown in Figures 3, 6, and 8. Id. The
Examiner states that the claims do not require a balloon that expands to the
claimed shape. Id. Appellant replies that the Examiner’s proposed
combination would not result in a balloon with a generally cylindrical barrel,
whether inflated or deflated. Reply Br. 1. According to Appellant, each of
Figures 3, 6, and 8 of Hart cited by the Examiner shows a balloon with
varying diameter along its length. Id. at 2.
Appellant’s contentions are not persuasive. The preamble of claim 21
recites “[a] fiber-reinforced medical balloon that may be inflated and
deflated.” We agree with the Examiner that claim 21 does not recite that the
“generally cylindrical barrel” shape is necessarily for both inflated and
deflated states of the balloon.
Furthermore, to the extent Appellant is contending that claim 21
requires that the generally cylindrical barrel wall extend along an entire
length of the balloon, or that the balloon must have a constant diameter
along its entire length, we disagree with this construction. Claim 21 recites
“a fiber layer embedded in a continuous matrix of polymer material defining
a generally cylindrical barrel wall,” but does not relate a length of the
generally cylindrical barrel wall to a length of the balloon. Appeal Br. 17
(Claims App.). The broadest reasonable interpretation of claim 21 does not
require that the generally cylindrical barrel wall extend along the entire
length of the balloon. Also, claim 21 recites a “generally cylindrical barrel
wall,” and the term “generally” does not require the barrel wall to have a
constant diameter along its length, but allows for some variation in the
diameter. We note, for example, that Figure 1B of Appellant’s application
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appears to show a non-constant diameter of balloon in the deflated state. See
Spec. ¶ 36. Appellant does not direct us to any disclosure that is inconsistent
with our understanding of “generally cylindrical.” Even if each of Figures 3,
6, and 8 of Hart shows a balloon in a state with a diameter that is not
constant, but varies along its length, the term “generally cylindrical” allows
a variation in diameter. Thus, we are not persuaded that Hart does not
disclose “a generally cylindrical barrel wall” in the states of the balloon
catheter shown in these figures.
Appellant also contends that the Examiner fails to articulate a reason
based on a rational underpinning as to why it would have been obvious to
combine the teachings of Jorgensen and Hart to arrive at the claimed subject
matter. Appeal Br. 12. Appellant contends that the Examiner’s rationale,
“to provide the stated advantages,” amounts to a “mere conclusory
statement.” Id. at 12–13. Appellant notes that the Examiner indicates that
these “advantages” from combining Hart with Jorgensen would be “to
control the shape of the balloon.” Appeal Br. 13 (citing Final Act. 3).
Appellant contends, however, that this is not a reason for the combination,
but is “a stated characteristic of the outer mesh of Hart within the context of
Hart.” Id. According to Appellant, “the Examiner has stated no advantage
of controlling the shape of any balloon, much less any advantage of
controlling the shape of the Jorgensen balloon.” Id.
Appellant further contends that Jorgensen suggests that different
diameters within the expanded balloon would be undesirable. Appeal Br.
13. According to Appellant, “Jorgensen specifically states that the purpose
of the invention is to produce ‘a reinforced elastomeric balloon having a
predefined maximum expanded diameter’ and warns against ‘bulges’ in the
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balloon as being unwanted.” Id. (citing Jorgensen, col. 2, ll. 4–9, col. 5, ll.
14–16).
Although the Examiner refers to “stated advantages” in the Final
Action, the Examiner clarifies that the “stated advantages” (namely, to
control the expansion or shape of the balloon) meant the “reason” for the
modification. See Ans. 3. As the Examiner has articulated a rationale (to
provide the function of control expressly disclosed in Hart to the balloon of
Jorgensen) sufficient to establish a prima facie case of obviousness, we
disagree with Appellant that the Examiner has not provided a reason to
modify Jorgensen. The Examiner submits that Jorgensen’s warning against
bulges in the balloon is directed towards unpredictable weakened portions of
the balloon, not a controlled bulbous shape, as in Hart’s device. We note
that Hart describes that “the elastomeric properties of the balloon may cause
such balloon to ‘bulge’ through the open regions between the reinforcing
fibers.” Hart, col. 2, ll. 4–6 (emphasis added). This description does not
indicate that the balloon should have a constant diameter along its length to
avoid this problem.
Accordingly, we sustain the rejection of claim 21 as unpatentable over
Jorgensen and Hart. Claims 27–32, 34, 35, 39, and 40 fall with claim 21.

Claims 22–26, 33, and 36–38
Claims 22–26 depend from claim 21 and recite limitations as to how
the fiber pitch changes along the barrel wall, and claims 33 and 36–38
depend from claim 32 and recite similar limitations. Appeal Br. 17–19
(Claims App.). For claims 22–26, the Examiner finds that “Hart teaches that
it is known to vary the expansion of the cylindrical barrel portion in a variety
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of ways depending on the intended application of the balloon catheter.”
Final Act. 5 (citing Hart, col. 2, ll. 19–36, Figs. 6–10). The Examiner
determines that it would have been an obvious matter of design choice to a
person of ordinary skill in the art to wrap the fibers of Jorgensen in view of
Hart such that the fiber pitch increases or decreases from the proximal end to
the distal end in a smooth transition or stepwise increments. Id. The
Examiner adds that one of ordinary skill in the art would have expected the
device taught by Jorgensen and Hart, and Appellant’s invention, to perform
equally well. Id. The Examiner’s findings and reasoning for claims 33 and
36–38 are the same as for claims 22–26. Id. at 8.
Appellant contests the Examiner’s “design choice” position. Appeal
Br. 14. Appellant contends the Specification discloses multiple advantages
offered by the claimed configurations. Id. at 14–15 (citing Spec. ¶ 49).
The Examiner responds with findings for each of claims 22–26, 33,
and 36–38 based on disclosures in Hart. Ans. 5. As to the Examiner’s
findings for claims 22 and 33, the Examiner cites to Figure 2 of Hart as
showing “the fiber pitch at 78, on a proximal portion of the barrel, the pitch
is higher than at 72.” Id. The Examiner cites to Figures 9 and 10 of Hart as
to limitations in claims 24 and 36 and claims 25 and 37, respectively. Id.
In reply, Appellant notes correctly that Figure 2 of Hart does not show
references numbers 72 and 78 as indicated by the Examiner. Reply Br. 3.
Appellant recognizes the Figures 6–10 of Hart show these reference
numbers. Id. In view of the Examiner’s citation to Figures 9 and 10 of Hart
as showing these reference numbers, we understand that the Examiner’s
citation to Figure 2 of Hart is a typographical error, and that the Examiner is
relying on a different figure that shows these reference numbers.
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As to claim 22, Appellant contends that “the claims specifically
require that the fiber pitch ‘decreases from a proximal end ... to a distal
end.’ This means that the two points of consideration must be the proximal
and distal ends (i.e. the extremities) of the balloon and not just portions that
may be considered ‘proximal’ or ‘distal’ with respect to some other
unnamed portion.” Reply Br. 3 (emphasis added). However, claim 22
actually recites that “the fiber pitch decreases from a proximal portion of the
barrel wall to a distal portion of the barrel wall.” Appeal Br. 17 (Claims
App.) (emphasis added). In other words, Appellant misstates the actual
language of claim 22. Furthermore, Appellant’s contentions as to why Hart
does not disclose the limitation of claim 22 are premised on this
misstatement. Accordingly, Appellant does not apprise us of any error in the
Examiner’s findings based on a proper construction of the claim language.
We thus sustain the rejection of claim 22.
Claim 23 recites that “the fiber pitch decreases from a proximal
portion of the barrel wall to a distal portion of the barrel wall in stepwise
increments.” Appeal Br. 17 (Claims App.). Appellant contends that claim
23 “specifically requires decreasing of the fiber pitch in stepwise increments
(i.e. decreasing in more than a single increment) from a proximal portion to
a distal portion,” and none of Hart’s figures disclose any such multiple
stepwise increments of decreasing fiber pitch.
Appellant’s contention is not persuasive. For example, Figure 8 of
Hart appears to show that, in moving in the direction from proximal end 54
to distal end 56, the fiber pitch of the mesh increases at left reduced radius
78, then decreases, then increases at right reduced radius 78, then decreases,
and then increases. We are not persuaded that decreasing the fiber pitch of
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the mesh in Hart cannot be considered as being in “stepwise increments,”
plural, as claimed. In this regard, claim 23 does not recite that the fiber pitch
decreases in successive stepwise increments, for example. We thus sustain
the rejection of claim 23.
Appellant does not present separate argument for claims 24–26, 33,
and 36–38, and thus, does not apprise us of error in the Examiner’s
corresponding findings or reasoning. We sustain the rejection of claims 24–
26, 33, and 36–38.

DECISION
We affirm the rejection of claims 21–40.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED