Ex Parte Elton et al

Patent Trial and Appeal Board

Mar 12, 2018

14123596 (P.T.A.B. Mar. 12, 2018)

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.
14/123,596 12/03/2013 Richard K. Elton 289-PDD-11-041 US 5498
79990 7590
C. R. Bard, Inc.
Bard Peripheral Vascular, Inc.
1415 W. 3rd Street
P.O. Box 1740
Tempe, AZ 85280-1740
EXAMINER
MANNAN, MIKAIL A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/14/2018 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):
BPVIP.Docket@crbard.com
Charles .Runyan @ crbard. com
raust@ austiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD K. ELTON and COREY E. STAPLETON
Appeal 2017-001863
Application 14/123,596
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a non-
compliant medical balloon for performing an angioplasty. The Examiner
rejected the claims as anticipated and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm-in-part.
Statement of the Case
Background
“Balloon angioplasty is routinely used to remove blockages in the
tubular organs such as arteries or veins. . . . Besides high pressure
requirements, the angioplasty balloons also must be resistant to puncture and
scratch, easy to track and push, and present a low profile” (Spec. 1).
1 Appellants identify the Real Party in Interest as C.R. Bard, Inc. (see App.
Br. 2).
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Application 14/123,596
“Because of its relatively high viscosity, there is also a need to eliminate or
reduce the use of contrast agent used in inflation/deflation of the balloons”
(Spec. 1). “Furthermore, the physician performing the angioplasty
procedure should be able to locate the position of the uninflated balloon with
accuracy, so that the balloon will be properly positioned during and after
inflation” (Spec. 2).
The Claims
Claims 1, 2, 5-21, 27-29, 31, and 53 are on appeal. Claims 1 and 27
are representative and read as follows:
1. A non-compliant medical balloon for performing an
angioplasty, comprising:
a body including a non-compliant wall having an inner
layer, an outer layer, and a discrete, intermediate layer at least
partially between the inner and outer layer, at least the
intermediate layer comprising a film including a radiopaque
material.
27. A medical balloon for performing an angioplasty,
comprising:
a barrel portion including a first radiopaque foil or
film; and
a first cone portion including a second radiopaque foil
or film.
The Issues
A. The Examiner rejected claims 1, 2, 5-12, 27, 31, and 53 under 35
U.S.C. § 102(b) as anticipated by Tilson2 (Final Act. 5-6).
2 Tilson et al., US 2009/0299327 Al, published Dec. 3, 2009.
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B. The Examiner rejected claims 13-15 under 35 U.S.C. § 103(a) as
obvious over Tilson and Allex3 (Final Act. 6-7).
C. The Examiner rejected claims 20 and 21 under 35 U.S.C. § 103(a) as
obvious over Tilson, Allex, and Pepin4 (Final Act. 7).
D. The Examiner rejected claims 28 and 29 under 35 U.S.C. § 103(a) as
obvious over Tilson and Pepin (Final Act. 8).
E. The Examiner rejected claims 16-19 under 35 U.S.C. § 103(a) as
obvious over Tilson, Allex, and Bartholf5 (Final Act. 8-10).
A. 35 U.S.C. § 102(b) over Tilson
The Examiner finds
Tilson discloses a non-compliant medical balloon (20) for
performing an angioplasty, comprising: a body (surface of
balloon) including a non-compliant wall (balloon can be
noncompliant, Paragraph [0092]; balloon wall 22) having an
inner layer (inner layer 72b), an outer layer (outer layer 72a),
and a discrete, intermediate layer (middle layer 72c) at least
partially between the inner and outer layer, at least the
intermediate layer comprising a film including a radiopaque
material (middle layer may comprise several layers, at least one
may have a radiopaque material, Paragraph [0061]—[0063]; the
film may be a polymer with radiopaque particulates, Para
[0061], [0370]—[0374]).
(Final Act. 5).
Appellants contend claim 1 requires “the intermediate layer
comprising a film including a radiopaque material” and that as “noted
3 Allex et al., US 2010/0234875 Al, published Sept. 16, 2010.
4 Pepin et al., US 5,531,721, issued July 2, 1996.
5 Bartholf et al., US 6,942,688 B2, issued Sept. 13, 2005.
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in Appellant’s specification, such a film ‘refer[s] to preformed films
of polymeric materials incorporating a radiopaque material or blend of
materials.’ Specification, para. [0037]” {App.Br. 6). Appellants
contend the “rejection does not explain how the claimed film is
disclosed in the Tilson reference, but simply contends a ‘radiopaque
film’ is ‘a layer having a radiopaque material’” {id. at 7). Appellants
contend that “[mjerely because Tilson has layers does not establish
that one of these layers is a film including a radiopaque material - the
middle layer could be fibers, unbound particulate materials, or any
number of things” {id. at 7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Tilson anticipates claims 1, 27, and
31?
Findings of Fact
1. The Specification teaches
radiopacity may be provided to the balloon 10 by the presence
of a radiopaque film 35 or foil 36 as an intermediate layer 34 of
the balloon wall 28. Radiopaque foils refer to metal foils
produced from metals which exhibit a sufficiently high
absorption of X-rays . . . Examples of such metal foils include,
but are not limited to, thin foils made from, platinum, gold,
silver, tin, copper, iridium, palladium, lead, and many other
similar metals.
(Spec. 7).
2. The Specification teaches: “Radiopaque films refer to
preformed films of polymeric materials incorporating a radiopaque material
or blend of materials” (Spec. 8).
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3. The Specification teaches:
Examples of film polymers include thermoplastic and thermoset
polymers. Some examples of thermoplastic polymers include,
but are not limited to, polyurethanes, polyamides, polyether-
polyamide copolymers such as PEBAX, polyethylene
terephthalate or other polyesters, polyvinyl acetate, polyvinyl
chloride, and many other thermoplastic materials useful for
making films. Some examples of thermoset polymers include,
but are not limited to, crosslinked polyurethanes, polyureas,
epoxies, acrylics, silicones, and many other thermoset materials
that can be formed into thin films.
(Spec. 8).
4. The Specification teaches “providing the balloon with a
radiopacity substantially from a first end to a second end, the radiopacity
provided at least in part by a foil or film” (Spec. 4).
5. The Specification teaches “the film 35 may be provided on both
the intermediate section 16 and the end sections 18, 20, or one or both of
these sections may instead be covered by a foil 36” (Spec. 6).
6. Tilson teaches:
The panel or radiopaque foil pattern can have panel arms that
can be folded over a balloon 20 during manufacture such that
radiopaque foil panel can be embedded within the balloon wall
22. The radiopaque foil and any other radiopaque or metal
element herein can be made from gold, platinum, platinum-
iridium alloy, tantalum, palladium, bismuth, barium, tungsten,
or combinations thereof. Any of the layers can have particles of
gold, platinum, platinum-iridium alloy, tantalum, palladium,
bismuth, barium, tungsten or combinations thereof. Any of the
layers can have radiopaque dyes.
(Tilson T| 356).
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7. Figure 460 of Tilson is reproduced below:
BB-S8
Figure 460 (labeled 46P in the Tilson text)
illustrates that the outer layer 12a can be an MMA-resistant and
MMA-releasing polymer film. The inner layer 12b can be a
leak proof bladder made from a polymer film. The first middle
layer 12c can be a fiber tape, for example with the fibers
oriented as longitudinal fibers. The second middle layer 12d
can be a resin or adhesive. The third middle layer 12e can be a
fiber tape, for example with the fibers oriented as latitudinal or
hoop fibers. The fourth middle layer 72/can be a resin or
adhesive. The fifth middle layer 72s can be a radiopaque
layer, such as a metal foil. The sixth middle layer 12h can be a
resin or adhesive.
(Tilson 384; emphasis added).
8. Tilson teaches:
The first middle layer can have a radiopaque material and be
substantially contiguous throughout the wall. For example, the
first middle layer can have a metal foil. The first middle layer
can have a radiopaque material in non-powder form. The first
middle layer can have less than about 100 pieces of radiopaque
material. The radiopaque material can covers (not necessarily
on the top surface) at least about 30% of the area of the wall of
the balloon. The first middle layer can have a first elongated
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Application 14/123,596
member that can have a radiopaque material. For example, the
elongate member can be a strip, such as the strip described
herein.
(Tilson lj 61).
9. Tilson teaches the “first middle layer can have a fiber. The
second middle layer can have a radiopaque material. The first middle layer
can be between the inner layer and the second middle layer” (Tilson 62).
10. Tilson teaches “balloon 20 . . . can be used for Kyphoplasty,
angioplasty” (Tilson 531).
11. Tilson teaches a “polymer film may be coated with a material.
The coating may be applied by, for instance, sputter coating. The material
that is coated on the polymer film may provide substantial radiopacity”
(Tilson If 451).
Principles of Law
“The protocol of giving claims their broadest reasonable interpretation
during examination does not include giving claims a legally incorrect
interpretation. This protocol is solely an examination expedient, not a rule
of claim construction.” In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir.
2009).
Anticipation under 35 U.S.C. § 102 requires that “‘each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference.”’ In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999).
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Analysis
Claim 1
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. For claim 1, the
dispute centers over the phrase “a film including a radiopaque material.”
We first turn to the Specification to interpret this phrase. The
Specification states: “Radiopaque films refer to preformed films of
polymeric materials incorporating a radiopaque material or blend of
materials” (FF 2). The Specification explains that examples of such film
polymers “include thermoplastic and thermoset polymers” (FF 3). The
Specification contrasts such films with radiopaque foils made from thin foils
of metals (FF 1).
We agree with Appellants that the claim phrase “a film including a
radiopaque material” is reasonably interpreted in light of the Specification as
limited to polymeric films with a radiopaque material incorporated into the
polymer itself, not layered, coated, or sputtered onto a polymer.
We are not persuaded by the Examiner’s contention that “any of the
layers may further comprise a film, and that film may be interpreted as the
intermediate layer film as in Paragraph [0449]” (Ans. 3). This interpretation
is inconsistent with the express definition of film in the Specification as
requiring polymeric materials.
The correct inquiry in giving a claim term its broadest
reasonable interpretation in light of the specification is not
whether the specification proscribes or precludes some broad
reading of the claim term adopted by the examiner. And it is
not simply an interpretation that is not inconsistent with the
specification. It is an interpretation that corresponds with what
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and how the inventor describes his invention in the
specification, i.e., an interpretation that is “consistent with the
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
In re Smith International, Inc., 871 F.3d 1375, 1382-83 (Fed. Cir. 2017).
Turning to the anticipation rejection, Tilson teaches radiopaque foils
(FF 6) that may be placed in intermediate layers in angioplasty balloons (FF
8). The Examiner does not identify, and we do not find, any teaching in
Tilson suggesting a polymeric film that incorporates radiopaque materials
consistent with our interpretation of claim 1 in light of the Specification {see,
e.g., Ans. 3). While the Examiner contends that the term “a polymer film” is
not a limitation of claim 1, we disagree, and conclude that the phrase “a film
including a radiopaque material” is limited to polymeric films with a
radiopaque material incorporated into the polymer itself as discussed above.
Therefore, we agree with Appellants that Tilson does not anticipate claim 1.
Claim 27
We again begin with claim interpretation and for claim 27, the dispute
centers over the phrases “a first radiopaque foil or film; and ... a second
radiopaque foil or film.”
We turn to the Specification to interpret whether barrel and cone
portions of the balloon have the same or different foil materials. The
Specification teaches “the film 35 may be provided on both the intermediate
section 16 and the end sections 18, 20, or one or both of these sections may
instead be covered by a foil 36” (FF 5). Thus, while the Specification does
contemplate foils with different radiopacities, the Specification also
contemplates the situation where radiopaque components cover both the
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intermediate and end sections, resulting in a first and second regions with the
same radiopacity (FF 5).
Claim 27 does not require that the first and second radiopaque foils
differ in their radiopacity or in any other way.
We therefore agree with the Examiner that, consistent with the
Specification and claim language, the first and second radiopaque foils in
claim 27 may have the same radiopacity. Cf. Linear Technology Corp. v.
International Trade Commission, 566 F.3d 1049, 1055 (Fed.Cir. 2009) (“We
agree with the Commission’s construction of ‘second circuit’ and ‘third
circuit,’ defining the terms broadly to not require entirely separate and
distinct circuits. Indeed, there is nothing in the claim language or
specification that supports narrowly construing the terms to require a
specific structural requirement or entirely distinct ‘second’ and ‘third’
circuits.”)
Tilson teaches a medical balloon for performing angioplasty (FF 10)
that may comprise a radiopaque foil (FF 6-7) composed of multiple portions
such as strips (FF 8).
We are not persuaded by Appellants’ contention that “[e]ven if
correct, this does not establish the presence of different foils or films on the
cone and barrel portions of Tilson, as the instant claim requires” (App. Br.
8), because claim 27 does not include any requirement that the first and
second foil portions differ in any way, nor does the Specification impose
such a requirement (see Claim 27, FF 5).
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Claim 31
We begin with claim interpretation. Claim 31 requires: “A balloon for
performing an angioplasty comprising a body having a radiopaque decal
comprising a polymer film applied thereto.” The Specification teaches
“outer layer 32 may also comprise a radiopaque film, such as for example a
radiopaque applique or decal 44 attached to the balloon 10, which may
otherwise be formed of non-radiopaque materials” (Spec. 10).
We interpret the decal as requiring at least a polymeric film and a
radiopaque element that is attached to that film. Claim 31 does not clearly
require the decal to be composed of a polymer film that incorporates a
radiopaque material nor does the Specification expressly require the decal to
be formed with a polymer film incorporating a radiopaque material.
Tilson teaches an embodiment where a “polymer film may be coated
with a material. The coating may be applied by, for instance, sputter
coating. The material that is coated on the polymer film may provide
substantial radiopacity” (FF 11).
Appellants contend the Examiner “does not establish that Tilson
describes a radiopaque decal comprising a polymer film. The rejection
does not even address the word ‘decaf in the claim, which is simply
ignored” (App. Br. 8).
We find this argument unpersuasive because “the reference need not
satisfy an ipsissimis verbis test.” In re Cleave, 560 F.3d 1331, 1334 (Fed.
Cir. 2009). There is no requirement that Tilson use the term “decal” to
anticipate the claimed structure. Tilson must simply teach a structure that
falls within the scope of the claim as reasonably interpreted. “[Ajpparatus
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claims cover what a device is, not what a device does.'1'’ Hewlett-Packard
Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990).
Here, the apparatus of claim 31 is a balloon with a polymer film that
has some type of radiopaque material applied thereto. Tilson teaches a
balloon with a polymer film that may have a radiopaque material sputtered
onto the polymer film (FF 11). Unlike claim 1, which reasonably requires
the film to incorporate the radiopaque material, claim 31 expressly
encompasses a radiopaque material that is applied to a polymer film as in the
sputtering process of Tilson (FF 11).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Tilson anticipates claim 1.
The evidence of record supports the Examiner’s conclusion that
Tilson anticipates claims 27 and 31. Claim 53 falls with claim 31.
B., C., E. 35 U.S.C. § 103(a) over claims dependent on claim 1
The Examiner relies upon Tilson for each of these rejections to teach a
“film including a radiopaque material” (see Final Act. 6-10). Having
reversed the anticipation rejection of claim 1 over Tilson because Tilson
does not teach a “film including a radiopaque material” for the reasons given
above, we also find that the further combinations with Allex, Pepin, and
Bartholf do not render the rejected claims obvious for the same reason.
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D. 35 U.S.C. § 103(a) over claims dependent on claim 27
Appellants contend: “Regarding claim 28, it requires: (1) a first cone
portion including a second radiopaque foil or film; and (2) a second cone
portion having a third radiopaque foil or film. The rejection does not
contend that Tilson or Pepin disclose the claimed two cone portions of a
balloon with the foils or films” (App. Br. 12). Appellants also contend the
“further requirement of claim 29 that the RO materials applied to the cones
is the same has also not been shown to be present in the references” {id.).
The Examiner contends
the third radiopaque material may be the same as the first and
the second radiopaque material, which is applied to the entirety
of the balloon as in Paragraph [0346] of Tilson. Further,
multiple layers can have a radiopaque foil or film and each can
be on the entire of the balloon; where the layers would
encompass the cone portions as in Paragraphs [0356] and
[0053], see Fig. 5A.
(Ans. 7).
Appellants respond
paragraph 356 of Tilson fails to describe that “multiple layers
can have a radiopaque foil or film and each can be on the entire
of the balloon,” as alleged. The same is true for paragraph 53,
which as noted above does not afford a factual predicate for the
Examiner’s contentions. Neither does Figure 5A, which does
not disclose any “cone portion” at all.
(Reply Br. 8).
We find the Examiner has the better position. Tilson teaches a “single
radiopaque layer can encompass substantially the entire area of the balloon”
(Tilson 346), reasonably supporting the Examiner’s position that every
portion of the balloon may be coated with radiopaque material. Figure 29A
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reasonably depicts two tapers from a broader to narrower element
comprising a “cone” shape near element 56a and 56b (see Fig. 29A),
reasonably satisfying the requirement for a first and second cone portion
even if they must be different. Appellants provide no evidence to the
contrary. Therefore, Tilson teaches a balloon satisfying the requirement of
claims 28 and 29.
SUMMARY
In summary, we reverse the rejection of claims 1, 2, and 5-12 under
35 U.S.C. § 102(b) as anticipated by Tilson.
We affirm the rejection of claims 27, 31, and 53 under 35 U.S.C. §
102(b) as anticipated by Tilson.
We reverse the rejection of claims 13-15 under 35 U.S.C. § 103(a) as
obvious over Tilson and Allex.
We reverse the rejection of claims 20 and 21 under 35 U.S.C. § 103(a)
as obvious over Tilson, Allex, and Pepin.
We affirm the rejection of claims 28 and 29 under 35 U.S.C. § 103(a)
as obvious over Tilson and Pepin.
We reverse the rejection of claims 16-19 under 35 U.S.C. § 103(a) as
obvious over Tilson, Allex, and Bartholf.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFlRMED-fN-PART
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