CLEARSTREAM TECHNOLOGIES LIMITED

Patent Trials and Appeals Board

Aug 4, 2020

14383739 - (D) (P.T.A.B. Aug. 4, 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.
14/383,739 09/08/2014 Pat Byrne P-18270.US02 / 1626A-045 8822
138315 7590 08/04/2020
C. R. Bard, Inc./ClearStream/K&S
KING & SCHICKLI, PLLC
800 CORPORATE DRIVE
SUITE 200
LEXINGTON, KY 40503
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
08/04/2020 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):
laura@iplaw1.net
uspto@iplaw1.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAT BYRNE, ANGELA SUSAN CRALL, ROBERT RIGHI,
ALLAN RONAN, PAUL MERTON WALES, and SEAN WALL
Appeal 2020-000243
Application 14/383,739
Technology Center 3700
Before JENNIFER D. BAHR, JILL D. HILL, and LISA M. GUIJT,
Administrative Patent Judges.
BAHR, 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 1–4, 7, 8, 10–15, 21–24, 27, and 28.2
See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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 Clearstream
Technologies Limited. Appeal Br. 2.
2 The Examiner has withdrawn all rejections of claim 26. See Ans. 4.
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CLAIMED SUBJECT MATTER
Appellant’s invention is directed to “balloons for performing medical
procedures, such as angioplasty and, more particularly, to a medical balloon
having a predetermined portion, such as a working surface, that may be
precisely located or identified during use.” Spec. 1. Claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A balloon catheter, comprising:
an elongated, tubular shaft extending in a longitudinal
direction, said shaft having a proximal end and a distal end; and
an inflatable balloon supported along the distal end of the
shaft, the balloon when inflated including first and second
spaced conical end sections and a working surface between the
conical end sections, each of the first and second spaced conical
end sections having a transition to the working surface, the
balloon further including a radiopaque marking identifying the
transition from the first or second conical end section to the
working surface;
wherein the radiopaque marking comprises a first pattern
on the first or second conical end section, the radiopaque
marking further including a second, different pattern on the
working surface.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Dror US 5,102,402 Apr. 7, 1992
Becker US 6,652,568 B1 Nov. 25, 2003
van Sloten US 2008/0228138 A1 Sept. 18, 2008
Schultz US 2008/0274159 A1 Nov. 6, 2008
Allex US 2010/0234875 A1 Sept. 16, 2010
Eli US 2012/0232528 A1 Sept. 13, 2012

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REJECTIONS3
Claims 1–4, 7, 8, and 10–15 stand rejected under 35 U.S.C. § 112,
second paragraph, as indefinite.
Claims 1–4, 7, 8, 10, 22, 24, and 28 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Allex.
Claims 12–14 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Allex and Schultz.
Claims 12 and 15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Allex and Dror.
Claims 1, 2, 4, 8, 10, 21, 23, and 27 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over van Sloten and Becker.
Claim 11 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over van Sloten, Becker, and Eli.
Claims 12–14 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over van Sloten, Becker, and Schultz.
Claims 12 and 15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over van Sloten, Becker, and Dror.
Claims 22, 24, and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over van Sloten and Eli.

3 The Examiner has withdrawn the written description and enablement
rejections of claims 23 and 26 under 35 U.S.C. § 112, first paragraph; the
rejection of claims 3 and 7 under 35 U.S.C. § 103(a) as unpatentable over
van Sloten and Becker; and the rejection of claim 26 under
35 U.S.C. § 103(a) as unpatentable over van Sloten and Eli. Ans. 4.
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OPINION
Indefiniteness
The basis of the Examiner’s rejection is that the term “radiopaque
marking” is used inconsistently in claims 1–4, 7, 8, and 10–15. Final Act. 5;
Ans. 5–8. Specifically, claim 1 recites “a radiopaque marking” as
comprising “a first pattern” and “a second, different pattern.” Appeal Br. 21
(Claims App.). Claim 2, which depends from claim 1, then defines the first
pattern as comprising “a first radiopaque marking” and the second pattern as
comprising “a second radiopaque marking.” Id. Similarly, claim 4, which
also depends from claim 1, recites that “the first or second pattern comprises
a plurality of radiopaque markings.” Id. Claim 7, which depends from
claim 1, recites that “the first pattern comprises at least two spaced
radiopaque markings,” and claim 8, which also depends from claim 1,
recites that “the second pattern comprises a plurality of radiopaque
markings.” Id. at 22. The Examiner determines that it is unclear how “a
radiopaque marking,” which claim 1 recites as comprising “a first pattern”
and “a second pattern,” can comprise multiple radiopaque markings (which
claims 2, 4, 7, and 8 recite the first pattern and/or second pattern as
comprising). Final Act. 5.
Appellant argues that claim 1 “does not require ‘a single marking,’”
as the Examiner states on page 5 of the Final Action, because “‘a’ or ‘an’
can mean ‘one or more.’” Appeal Br. 9.
Appellant is correct that claim 1 is not limited to only a single
radiopaque marking. Rather, the use of the open-ended term “including” in
the phrase “the balloon further including” followed by the recitation of “a
radiopaque marking” only requires one radiopaque marking, but also allows
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for the balloon to include more than one radiopaque marking. See Mars Inc.
v. H.J. Heinz Co., 377 F.3d 1369, 1376 (Fed. Cir. 2004) (pointing out that
the use of the transitional term “including” is inclusive or open-ended and
does not exclude additional, unrecited elements or method steps); KJC Corp.
v. Kinetic Concepts Inc., 223F.3d 1351, 1356 (Fed. Cir. 2000) (stating that
“an indefinite article ‘a’ or ‘an’ in patent parlance carries the meaning of
‘one or more’ in open-ended claims containing the transitional phrase
‘comprising’”). However, claim 1 recites that “the radiopaque marking
comprises a first pattern” and “a second, different pattern.” Thus, although
the balloon of claim 1 may include more than one radiopaque marking,
claim 1 recites that one radiopaque marking (i.e., “the radiopaque marking,”
which refers back to “a radiopaque marking”) comprises “a first pattern” and
“a second, different pattern.” In other words, as recited in claim 1, “a first
pattern” and “a second, different pattern” are components of “a radiopaque
marking.” Claims 2, 4, 7, and 8, which depend from claim 1, cause
confusion as to what is meant by “a radiopaque marking” by then reciting
that the first and/or second pattern comprises two or more “radiopaque
markings,” indicating that “radiopaque markings” are components of the
first and second patterns, rather than the other way around. In other words,
it is unclear whether the term “radiopaque marking” denotes a single,
continuous region of radiopaque material (as suggested by the recitations in
claims 2, 4, 7, and 8 of first and/or second patterns comprising one or more
radiopaque markings), or is to be construed to encompass a plurality of
distinct and discontinuous regions of radiopaque material, which together
might form one or more patterns (as suggested by the recitation in claim 1 of
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a radiopaque marking including a first pattern and a second, different
pattern).
The Examiner states that “Appellant’s [S]pecification disavows that
the singular phrase ‘a radiopaque marking’ encompasses multiple patterns
and multiple radiopaque markings.” Ans. 6. In this regard, Appellant’s
Specification defines “[t]he term ‘marking’” as “a radiopaque material
forming a single layer on the surface of the balloon wall.” Spec. 4. The
radiopaque material forming “a single layer,” as defined in the
Specification, suggests that the “marking” takes the form of a single,
continuous region of radiopaque material, rather than multiple patterns of
discrete regions of radiopaque material. Thus, the recitation in claim 1 of “a
radiopaque marking” comprising “a first pattern” and “a second, different
pattern,” when read in light of Appellant’s Specification, as well as when
considered in light of the dependent claims as discussed above, raises
ambiguity as to the scope of “radiopaque marking” in claim 1, as well as in
the dependent claims.
A claim is properly rejected as indefinite under 35 U.S.C. § 112
second paragraph if, after applying the broadest reasonable interpretation in
light of the specification, the metes and bounds of a claim are not clear
because the claim “contains words or phrases whose meaning is unclear.” In
re Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir. 2014) (per curiam)
(approving, for pre-issuance claims, the standard from MPEP § 2173.05(e));
see also Ex parte McAward, Appeal 2015-006416, 2017 WL 3669566, at *5
(PTAB Aug. 25, 2017) (precedential) (adopting the approach for assessing
indefiniteness approved by the Federal Circuit in Packard). The ambiguity
and lack of consistency in the manner in which “radiopaque marking” or
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“radiopaque markings” is used in the Specification and claims render the
scope of these claims unclear.
For the above reasons, we sustain the rejection of claims 1–4, 7, 8,
and 10–15 as indefinite.
Anticipation—Allex
In reading claim 1 on the balloon catheter of Allex, the Examiner
finds, in pertinent part, that the “fibers of [Allex’s] layer 30 form the
radiopaque marking.” Final Act. 6. In reading claim 22 on the balloon
catheter of Allex, the Examiner finds that “the fibers in [Allex’s] layer 30
are radiopaque” (citing Allex ¶¶ 53–55) and that layer 30 “can comprise a
plurality of ‘non-braided fibers’ as well as a ‘braided fiber sleeve.’” Id. at
8–9 (citing Allex ¶¶ 37, 39). Thus, according to the Examiner, “the non-
braided fibers and the [braided] fibers [of Allex] comprise ‘at least three
radiopaque markings.’” Id. at 8–9.
Appellant argues that the Examiner’s reading of the radiopaque
marking(s) on the fibers in Allex’s layer 30 “ignores the clear express
definition of ‘marking’ provided in Appellant’s [S]pecification” because the
fibers in layer 30 “are clearly not ‘on’ any section or surface of the balloon
wall 28.” Appeal Br. 10. Appellant’s Specification states:
The term ‘marking’ for purposes of this disclosure refers to a
radiopaque material forming a single layer on the surface of the
balloon wall 28, as contrasted with a multi-layered arrangement
(such as one comprising a first layer of a radiopaque material,
such as a film, underlying another electroplated or deposited
layer of a radiopaque material).
Spec. 4.
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In response, the Examiner finds that Allex’s fiber layer 30 is
“‘disposed on’ a balloon wall 20 (referred to as ‘inflation layer 20’ by Allex)
(Para 29)” and that “the radiopaque material is embedded in one or more of
the inelastic fibers composing layer 30 (Para 55).” Ans. 9. The Examiner
emphasizes that Allex discloses layer 30 can comprise “one or more” fibers;
thus, layer 30 “is a single fiber . . . having radiopaque material embedded
therein (Para 55) which forms a single layer on the surface of the balloon
wall 20 (Para 31 and seen in Fig 2).” Id.
Appellant disputes the Examiner’s finding that “an embedded fiber in
an inner layer of a balloon somehow is ‘on’ the surface of the balloon.”
Reply Br. 3. Appellant contends that “construing a fiber sandwiched
between layers in the Allex arrangement to be one that is neither multi-
layered nor ‘on’ a surface cannot meet the claim requirements when
reasonably construed in light of the [S]pecification.” Id. at 4.
Allex discloses balloon 10 including “an inflation layer 20, a fiber
layer 30, and a coating layer 40.” Allex ¶ 29; Fig. 2. “[F]iber layer 30 is
disposed on the inflation layer 20.” Id. ¶ 31. However, inflation layer 20 is
not a balloon wall, as the Examiner represents on page 9 of the Answer.
Rather, inflation layer 20 is the inner layer of a multi-layer wall and “need
only be thick enough to facilitate applying the fiber layer 30 on the inflation
layer 20.” Id. ¶ 30. As Appellant contends (Reply Br. 4), fiber layer 30 is
sandwiched between inflation layer 30 and coating layer 40, and, thus, is not
a radiopaque marking as defined in Appellant’s Specification (i.e., “a
radiopaque material forming a single layer on the surface of the balloon
wall”). See Allex, Fig. 2, ¶ 45 (disclosing that “[i]n various embodiments, a
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coating layer 40 is disposed around the fiber layer 30”)4, ¶¶ 46, 47
(disclosing methods of forming coating layer 40).
Moreover, the Examiner reads the claimed “radiopaque marking” on
the embodiment of Allex’s fiber layer 30 in which “the radiopaque material
is embedded in one or more of the inelastic fibers composing the inelastic
fiber layers of the fiber layer 30” disclosed in paragraph 55 of Allex. Ans. 9.
Even assuming that fiber layer 30 comprises a single layer and a single fiber,
the Examiner does not set forth any evidentiary findings or technical
explanation to establish that the radiopaque material in this embodiment
would necessarily be embedded in the fiber so as to form a single layer on
the surface of the balloon wall. Thus, the Examiner fails to establish by a
preponderance of the evidence that Allex discloses a balloon structure in
which fiber layer 30 with embedded radiopaque material disclosed in
paragraph 55 would constitute a radiopaque “marking” as defined in
Appellant’s Specification, even if coating layer 40 were not present.
For the above reasons, we do not sustain the rejection of claims 1 and
22, or their dependent claims 2–4, 7, 8, 10, 24, and 28, as anticipated by
Allex.
Obviousness—Allex in combination with Schultz or Dror
The Examiner’s application of Schultz or Dror in rejecting claims 12–
15, which depend from claim 1, does not make up for the deficiencies in the

4 In all embodiments discussed by Allex, the balloon wall appears to include
coating layer 40. To the extent that the Examiner may infer that Allex
contemplates other embodiments in which the balloon wall does not include
coating layer 40, the Examiner does not specifically direct our attention to
such an embodiment, much less explain what such an embodiment might
look like.
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Examiner’s findings with regard to Allex.5 Accordingly, we do not sustain
the rejection of claims 12–14 as unpatentable over Allex and Schultz or the
rejection of claims 12 and 15 as unpatentable over Allex and Dror.
Obviousness—van Sloten and Becker
Claims 1, 4, 8, 10, 21, 23, and 27
The Examiner finds that van Sloten discloses a balloon catheter
having most of the features of claim 1, including, in pertinent part, a
radiopaque marking (markers 46, 48) that identify the transitions between
the working surface and the first and second spaced conical end sections, but
that “[v]an Sloten does not explicitly disclose that the first pattern is found
on the first and second conical end sections.” Final Act. 11–12. The
Examiner finds that Becker teaches a balloon catheter with “a radiopaque
marking 26 located on each of the conical end sections identifying the
transitions from the conical end sections to the working surface . . . for the
purpose of identifying the location of the working surface to insure proper
placement.” Id. at 12 (citing Becker, Fig. 4; 2:21–23; 4:56–58, 64–67).

5 It is not clear whether the Examiner proposes to simply replace the
radiopaque material of Allex (embedded in the fiber of fiber layer 30) with
the radiopaque material-containing drug material taught by Dror, or whether
the Examiner proposes to add capsules of such material to the exterior
surface of Allex’s balloon, as shown in Figure 3 of Dror. If the Examiner
proposes a simple replacement, such a modification would not remedy the
Examiner’s failure to establish by a preponderance of the evidence that the
fiber layer 30 with embedded radiopaque material disclosed in paragraph 55
would constitute a radiopaque “marking” as defined in Appellant’s
Specification. If the Examiner proposes adding capsules to the exterior
surface of Allex’s balloon as shown in Figure 3 of Dror, it is not clear how
this would satisfy the other requirements of the radiopaque marking(s) set
forth in the claims.
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The Examiner determines it would have been obvious “to modify
[v]an Sloten to include the first pattern or radiopaque marking 46,48 on the
conical end sections, as taught by Becker, since Becker teaches that locating
these markings on the conical end sections provides the same benefit and
result as having them at the location in [v]an Sloten” and that, “because they
provide the same benefit, these two locations were considered art-recognized
equivalents at the time the invention was made and it has been held that
substituting equivalents would have been obvious to those of ordinary skill
in the art.” Final Act. 12.
Appellant argues that “‘[p]roviding the same benefit’ is simply not a
reason with a rational underpinning for combining the reference teachings”
and that “if the ‘same benefit’ is provided by each reference independently,
then this is actually a reason not to combine their teachings, since a skilled
artisan would have no reason to do so.” Appeal Br. 14. This line of
argument is not consistent with the law on obviousness as reflected in the
decisions of the Supreme Court and the Court of Appeals for the Federal
Circuit, which do not require that the combination lead to an additional
benefit or perform differently than the prior art would perform without the
modification. “[W]hen a patent claims a structure already known in the
prior art that is altered by the mere substitution of one element for another
known in the field, the combination must do more than yield a predictable
result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Appellant also contends that the Examiner’s “alternate ‘art-recognized
equivalents’ rationale appears to be the Examiner attempting to rely on a per
se rule of obviousness.” Appeal Br. 15. This argument is unavailing
because, as discussed above, Supreme Court precedent clearly supports the
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Examiner’s reliance on the substitution of art-recognized equivalents as a
rationale for making the combination. See KSR, 550 U.S. at 416.
The modification at issue here is the placement of van Sloten’s
markers 46 and 48, which mark the proximal and distal ends of the working
portion of the balloon, on the conical end sections. See van Sloten ¶ 40
(disclosing “a pair of markers 46 and 48 which indicate the proximal and
distal extent of a working portion 22 of the balloon”). A person of ordinary
skill in the art would readily appreciate that this could be accomplished by
placing markers 46, 48: (1) at the extreme ends of working portion 22 with
their proximal and distal edges, respectively, at the transitions, (2) on the
conical end sections (proximal and distal tapering portions 24, 26) with their
distal and proximal edges, respectively, at the transitions, or (3) at the
transitions between working portion 22 with markers 46, 48 partially on
working portion 22 and partially on proximal and distal tapering portions 24,
26. Thus, the selection of any of these three locations for markers 46, 48
would have been obvious to a person having ordinary skill in the art. See
KSR, 550 U.S. at 421 (stating that “[w]hen there is a design need or market
pressure to solve a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp” and “[i]f this leads to
the anticipated success, it is likely the product not of innovation but of
ordinary skill and common sense”).
Figure 5 of van Sloten appears to illustrate markers 46, 48 at the
transitions partially on working portion 22 and partially on proximal and
distal tapering portions 24, 26. However, the demarcations between working
portion 22 and tapering portions 24, 26 are not sufficiently clear to convey
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with reasonable certainty whether van Sloten’s markers 46, 48 are on
working portion 22, on tapering portions 24, 26, or partially on both. Thus,
the Examiner relies on Becker for its teaching of having such radiopaque
markers on the conical/tapered end sections. Final Act. 12; see Becker, Fig.
4 (illustrating radiopaque layer 26 extending onto the tapered portion of the
balloon); id. 4:56–57, 64–66 (teaching that the radiopaque “material may be
placed at any location along the balloon” and that “[a] preferred embodiment
would have at least the ends of the working length . . . marked with
radiopaque material”); id. 4:62–63 (distinguishing between the “working
length of the balloon” and “the entire length” of the balloon). Thus, Becker
simply provides evidence that the use of radiopaque markers on the conical
end sections of a balloon to mark the ends of the working length of the
balloon was known in the art at the time of Appellant’s invention.
For the above reasons, the Examiner’s stated reasons for the
determination that it would have been obvious to place van Sloten’s markers
46, 48 on the conical end sections (tapering portions 24, 26) have rational
underpinnings.
Appellant submits that the combination of van Sloten and Becker
“would not result in the claimed invention” because Becker’s “marker
extends over into the portion of the balloon that includes the working
surface” and “would actually render any radiopaque marking located as
shown in [v]an Sloten invisible, thereby foreclosing the ability of the
clinician to detect the transitions between the conical end sections and the
cylindrical or barrel section of the balloon, including the working surface.”
Appeal Br. 15.
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In response, the Examiner explains that the rejection does not rely on
the particular embodiment illustrated in Figure 4, but, rather, on Becker’s
teaching to mark the ends of the working length with radiopaque material.
Ans. 16 (also emphasizing that Becker distinguishes between the “working
length” and the “entire length” of the balloon).
Appellant’s argument improperly presumes a lack of skill on the part
of the person of ordinary skill in the art. “A person of ordinary skill is also a
person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421.
Becker teaches that radiopaque markers can be placed on the tapered ends of
the balloon, beyond the ends of the working surface (“working length”), to
mark operationally significant portions of the balloon, including the ends of
the working length of the balloon. As explained above, a person having
ordinary skill in the art would have readily appreciated how to mark the ends
of working portion 22 as van Sloten discloses in paragraph 40 and, if opting
to place markers 46, 48 on tapered end portions 24, 26, would not have been
prompted to extend markers 46, 48 from the tapered end portions onto
working portion 22 to such a significant extent that they would no longer
serve to mark the ends of working portion 22, much less to such an extent
that they interfere with central marker 44.
For the above reasons, Appellant fails to apprise us of error in the
rejection of claim 1 as unpatentable over van Sloten and Becker.
Accordingly, we sustain the rejection of claim 1, as well as claims 4, 8, 10,
21, 23, and 27, for which Appellant does not present any separate arguments
and which, thus, fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv)
(permitting the Board to select a single claim to decide the appeal as to a
single ground of rejection of a group of claims argued together).
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Claim 2
In addressing the limitation in claim 2 that “the second pattern
comprises a second radiopaque marking extending from the transition
between the first conical end section and the working surface to the
transition between the second conical end section and the working surface,”
the Examiner relies on Becker’s teaching “that the radiopaque material can
be in the form of ‘longitudinal stripes’ and that the material may be placed at
any location along the balloon including along the length of the working
length.” Final Act. 13 (citing Becker 4:56–63).
Appellant argues that Becker’s “working length” refers “to the entire
length of the balloon, not the claimed ‘working surface’” within Appeal Br.
15–16 (citing Becker 4:61–63, Fig. 4). In particular, Appellant asserts that
“[a]s Becker observes, ‘longitudinal stripes of radiopaque material along the
entire length, or the working length of the balloon 14’ is ‘not shown,’ yet
Figure 4 does show ‘at least the ends of the working length and the ends of
the [s]tent marked with radiopaque material.’” Id. at 16. Thus, Appellant
concludes that “there is no teaching of the ‘working surface’ feature required
by claim 2 in either cited reference.” Id.
Appellant’s argument is not persuasive. As the Examiner correctly
states, “Becker explicitly differentiates between the entire length of the
balloon and the working surface of the balloon.” Ans. 16 (citing Becker
4:61–64). We agree with the Examiner that “by listing both ‘the entire
length’ and ‘the working length of the balloon’ as alternative options [for the
portion of the balloon over which the longitudinal stripes of radiopaque
material could extend], Becker sets forth that the working length (i.e.[,] the
claimed ‘working surface’) is not the entire length of the balloon as asserted
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by Appellant.” Ans. 16–17. We also agree with the Examiner that Becker’s
notation “(not shown)” in line 63 of column 4 of Becker indicates that the
embodiment described (i.e., “longitudinal stripes of radiopaque material
along the entire length, or the working length of the balloon”) is an
unillustrated embodiment, not the embodiment of Figure 4. Id. at 17; see
Becker 4:61–63.
For the above reasons, Appellant does not apprise us of error in the
rejection of claim 2 as unpatentable over van Sloten and Becker, which we,
thus, sustain.
Obviousness—van Sloten, Becker, and Eli
In rejecting claim 11, the Examiner determines it would have been
obvious to further modify the balloon of van Sloten/Becker
to include markings in the form of a scale, as taught by Eli, for
the purpose of not only allowing the user to identify the center
of the working surface (which is the purpose of marking 44 in
van Sloten and which could also be achieved with the Eli
markings since the markings are spaced evenly along the extent
of the working surface) but also allowing the user to measure
the length of the obstruction to be treated (Para 22).
Final Act. 16.
Appellant argues that “it is pure speculation that providing the
markings of Eli would allow a user to find the center or measure the length
of anything, since the central portion of the Becker balloon includes a solid
metal stent . . . that would prevent any underlying markings from being
perceived.” Appeal Br. 17. Appellant also asserts that, because Eli
discloses a balloon without a stent, the Examiner is engaging in “hindsight
reconstruction” in combining the references. Id. at 18. These arguments are
unavailing because they are not responsive to the rejection set forth by the
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Examiner, which does not incorporate Becker’s stent into van Sloten. See
Ans. 19 (stating that “the stent of Becker has not been incorporated into the
combination with [v]an Sloten”).
Appellant’s assertion that, by not incorporating Becker’s stent into
van Sloten, the Examiner is “cherry picking” from the reference teachings
(Reply Br. 7) is not persuasive. A person having ordinary skill in the art
would have readily appreciated that Becker’s teachings regarding
radiopaque marking of pertinent portions of the balloon are relevant to
balloon catheters generally, whether used only for dilation or also in a
stenting procedure. See Becker 1:5–7 (stating that the invention “relates
generally to the field of intravascular balloon catheters, and more
particularly to a balloon catheter with a radiopaque balloon”), 2:1–23
(discussing use of balloon catheters for dilation, as well as for stenting
procedures, and the need for “improved radiopaque properties to improve
placement and visibility of the balloon”).
Accordingly, Appellant does not apprise us of error in the rejection of
claim 11 as unpatentable over van Sloten, Becker, and Eli, which we, thus,
sustain.
Obviousness—van Sloten, Becker, and Schultz
Appellant does not present any arguments specifically contesting the
rejection of claims 12–14 as unpatentable over van Sloten, Becker, and
Schultz. Thus, for the reasons set forth above with respect to the rejection of
claim 1, from which claims 12–14 depend, we sustain the rejection of claims
12–14 as unpatentable over van Sloten, Becker, and Schultz.
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Obviousness—van Sloten, Becker, and Dror
Claim 12
Appellant does not present any arguments specifically contesting the
rejection of claim 12 as unpatentable over van Sloten, Becker, and Dror. See
Appeal Br. 18 (addressing only the rejection of claim 15 as unpatentable
over van Sloten, Becker, and Dror). Thus, for the reasons set forth above
with respect to the rejection of claim 1, from which claim 12 depends, we
sustain the rejection of claim 12 as unpatentable over van Sloten, Becker,
and Dror.
Claim 15
The Examiner finds that van Sloten’s balloon, as modified in view of
Becker, lacks a drug formulated to include a radiopacifier as required in
claim 15, but finds that Dror teaches “a balloon . . . having a drug thereon
that is a radiopacifier acting as a radiopaque marking . . . for the purpose of
both treating the body and allowing visualization of the treated body.” Final
Act. 18 (citing Dror, Fig. 3; 3:12–18). The Examiner determines it would
have been obvious to modify the balloon of van Sloten/Becker “to include a
drug in the form of a radiopacifier acting as a radiopaque marking, as taught
by Dror, for the purpose of both treating the body and allowing visualization
of the treated body.” Id. (citing Dror 3:12–18).
Appellant argues that the Examiner’s stated rationale (“both treating
the body and allowing visualization of the treated body”) “is simply an
observation of the teaching of Dror, and not a reason that would motivate a
skilled artisan for combining the reference teachings.” Appeal Br. 18.
Appellant also points out that van Sloten/Becker “would already allow for
‘treating of the body and visualization of the treated body.’” Id.
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Appellant’s argument is not persuasive. Appellant is correct that the
Examiner’s stated reason for the combination (“for the purpose of both
treating the body and allowing visualization of the treated body”) is derived
directly from the teachings of Dror. See Dror 3:15–33 (teaching drugs for
treating blood vessels to prevent restenosis also including radiopaque
compounds that allow the vessel to be visualized by fluoroscopy or similar
methods). This teaching sets forth a benefit of combining the drug and
radiopaque components to allow both treatment and visualization and, thus,
provides a reason for making the combination. Although van Sloten’s
balloon treats the body, by performing angioplasty to open a blood vessel,
for example, Dror teaches use of drugs to help prevent restenosis, which is
an additional benefit not provided by van Sloten’s balloon without such
drugs.
For the above reasons, Appellant does not apprise us of error in the
rejection of claim 15 as unpatentable over van Sloten, Becker, and Dror,
which we, thus, sustain.
Obviousness—van Sloten and Eli
The Examiner finds that “[v]an Sloten does not disclose that the
second radiopaque marking [(central marker 44)] extends from the first
transition to the second transition.” Final Act. 19. However, the Examiner
finds that Eli teaches a balloon “having a radiopaque marking 28 that
extends the entire extent of a working surface (as seen in Fig 3,4) for the
purpose of providing a scale to measure the length of an obstruction to be
treated (Para 22).” Id. The Examiner determines it would have been
obvious
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to modify [v]an Sloten to include the marking on the working
surface as one that extends between the transitions, as taught by
Eli, for the purpose of not only allowing the user to identify the
center of the working surface (which is the purpose of marking
44 in van Sloten and which could also be achieved with the Eli
markings since the markings are spaced evenly along the extent
of the working surface) but also allowing the user to measure
the length of the obstruction to be treated (Para 22).
Final Act. 19.
Appellant argues that the Examiner’s finding that Eli’s radiopaque
marking 28 extends the entire extent of a working surface of the balloon “is
pure speculation.” Appeal Br. 19.
The Examiner provides “zoomed-in views” of Figure 4 of Eli to show
that marking 28, which includes a plurality of transversely-extending lines,
extends from the first transition to the second transition. Ans. 23–24
(explaining that “the two transitions are the points at which the cylindrical
portion of the balloon (‘the working surface’) begins to curve towards the
conical portions (‘conical end sections’)”).
Appellant counters with an even further expanded view of Figure 4 of
Eli, which Appellant asserts shows “a gap between the mark and any actual
transition to the conical end section.” Reply Br. 8. We agree with
Appellant’s insinuation that such a highly magnified view of Eli’s Figure 4
goes far beyond what Eli’s Figure 4 was ever intended to show. See Id.
(alluding to “[e]scalating the ‘arms race’”); In re Wilson, 312 F.2d 449, 454
(1963) (stating that it is improper to rely “on a greatly enlarged section of a
small drawing obviously never intended to show the dimensions of
anything”). Nevertheless, even in such a highly magnified view, we do not
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discern a perceptible gap between the line showing the left-most marker 28
and the beginning of the curve toward the conical end portions.
Although, in the case of patent drawings not indicated as drawn to
scale, it is improper to rely “on ‘a greatly enlarged section of a small
drawing obviously never intended to show the dimensions of anything,’”
that does “not mean that things patent drawings show clearly are to be
disregarded.” In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972) (quoting
Wilson, 312 F.2d at 454 (1963). Eli’s Figure 4 reasonably conveys, without
magnification, that markers 28 extend along the entire length of the working
surface of the balloon, when inflated, as called for in claim 22. The
magnifications provided by the Examiner and Appellant merely confirm that
this is the case.
Appellant reproduces a portion of Eli’s Figure 3, which illustrates the
same embodiment as Figure 4, and asserts that this “plainly shows that the
marks are not at the transition.” Reply Br. 7–8. Notably, claim 22 defines
the first and second conical sections, working surface, and transitions of “the
balloon when inflated.” Appeal Br. 23 (Claims App.). Thus, Appellant’s
reliance on Eli’s Figure 3 is unavailing because Figure 3 shows the balloon
in its uninflated state, in contrast to Figure 4, which shows the balloon of
Figure 3 in its “expanded condition.” Eli ¶¶ 11–12.
For the above reasons, Appellant fails to effectively rebut the
Examiner’s finding that Eli’s radiopaque marking 28 extends the entire
extent of a working surface of the balloon, and, thus, fails to apprise us of
error in the rejection of claim 22 as unpatentable over van Sloten and Eli,
which we, thus sustain. We also sustain the rejection of claims 24 and 28,
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for which Appellant does not present any separate arguments and which thus
fall with claim 22, as unpatentable over van Sloten and Eli.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–4, 7, 8,
10–15
112, second
paragraph
Indefiniteness 1–4, 7, 8,
10–15

1–4, 7, 8,
10, 22, 24,
28
102(b) Allex 1–4, 7, 8,
10, 22, 24,
28
12–14 103(a) Allex, Schultz 12–14
12, 15 103(a) Allex, Dror 12, 15
1, 2, 4, 8,
10, 21, 23,
27
103(a) van Sloten, Becker 1, 2, 4, 8,
10, 21, 23,
27

11 103(a) van Sloten, Becker,
Eli
11
12–14 103(a) van Sloten, Becker,
Schultz
12–14
12, 15 103(a) van Sloten, Becker,
Dror
12, 15
22, 24, 28 103(a) van Sloten, Eli 22, 24, 28
Overall
Outcome
1–4, 7, 8,
10–15, 21–
24, 27, 28

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED