Ex Parte Grayzel et al

Patent Trial and Appeal Board

Dec 30, 2015

13022503 (P.T.A.B. Dec. 30, 2015)

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.
13/022,503 02/07/2011 Jeffrey Grayzel SBC-RO-1 6817
56514 7590 12/30/2015
JEFFREY GRAYZEL
262 FOUNTAIN ROAD
ENGLEWOOD, NJ 07631
EXAMINER
BUI, VY Q
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
12/30/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte JEFFREY GRAYZEL and JOSEPH GRAYZEL
________________

Appeal 2015-0042991
Application 13/022,503
Technology Center 3700
________________

Before EDWARD A. BROWN, JILL D. HILL, and
LEE L. STEPINA, Administrative Patent Judges.

STEPINA, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Jeffrey Grayzel and Joseph Grayzel (Appellants) seek our review
under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 67–
88.2 Oral hearings were conducted on October 29, 2015, and December 7,
2015. We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION pursuant to 37 C.F.R. § 41.50(b).

2 Claims 1–66 are cancelled. Final Act. 2.
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THE CLAIMED SUBJECT MATTER
The disclosed subject matter is directed to a stiffened balloon catheter
for dilation and stenting. Spec. 1 (Title). Claims 67 and 82 are independent.
Claim 67 is illustrative of the claims on appeal and is reproduced below.
67. A stiffened balloon apparatus for use within an anatomic
passage comprising:
an expandable balloon comprised of a flexible material
having one or more longitudinal stiffening members
permanently attached to said balloon, said stiffening members
being comprised of a material stiffer than the material of said
balloon and disposed along longitudinal perimeters of said
balloon, wherein at least a portion of at least one of said one or
more longitudinal stiffening members is radio-opaque to
facilitate determination of the position of said stiffening
member.
Appeal Br. 23.

REFERENCE RELIED ON BY THE EXAMINER
Becker US 6,652,568 B1 Nov. 25, 2003

THE REJECTIONS ON APPEAL
(I) Claims 67–77 and 79–883 are rejected under 35 U.S.C.
§ 102(e) as anticipated by, or, in the alternative, under 35 U.S.C. § 103(a) as
unpatentable over Becker.4,5

3 The Specification is objected to under 35 U.S.C. § 132(a) as introducing
new matter. Final Act. 2. As this matter is an objection, not a rejection, we
do not address this issue in this appeal. See MPEP § 1201. However, we
note that, although the Examiner treats this issue as an objection, the
Examiner refers specifically only to dependent claims 87 and 88. See Final
Act. 2. Accordingly, in substance, this issue should have instead been
treated as a rejection under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement. See MPEP § 2163.06(II).
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(II) Claim 78 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Becker.
ANALYSIS
Rejection (I)
Appellants argue claims 67 and 82 together (see Appeal Br. 5–15),
and we take claim 67 as representative.
The Examiner finds that Becker discloses an “expandable balloon 14
of a flexible polymeric material . . . having one or more longitudinal
stiffening members / radiopaque markers / radiopaque layers 26 /

4 The heading of this rejection in both the Final Office action (see Final Act.
3) and the Examiner’s Answer (see Ans. 3) does not list claims 87 and 88,
but the discussion on page 5 of the Final Action explains the rejection of
claims 87 and 88 as anticipated by Becker and the rejection of claim 88 as
unpatentable over Becker. Accordingly, we treat the omission of claims 87
and 88 from the heading of this rejection as a clerical error not affecting the
disposition of these claims. Appellants state, “[t]he Applicant is
withdrawing claim 87 from the present prosecution.” Id. As stated in MPEP
§ 1205.02, “[a]n appellant’s brief must present arguments responsive to
every ground of rejection stated by the examiner in the Office action from
which the appeal has been taken (as modified by any advisory action and/or
pre-appeal brief conference decision). See 37 CFR 41.31(c) and 37 CFR
41.37(c)(1)(iv). If a ground of rejection stated by the examiner is not
addressed in the appellant’s brief, appellant has waived any challenge to that
ground of rejection and the Board may summarily sustain it, unless the
examiner subsequently withdrew the rejection in the examiner’s answer. See
37 CFR 41.39(a)(1).” Accordingly, we summarily sustain the rejection of
claim 87.
5 We do not address Appellants’ assertion that the Examiner raised a new
ground of rejection in the Final Office action (Appeal Br. 11–13; Reply Br.
2–3, 9, 13), because whether an Examiner’s rejection would or would not
properly be regarded as a new ground of rejection is a petitionable matter,
not an appealable matter, and Appellants had the opportunity to raise this
issue by filing a timely Petition to the Director under 37 C.F.R. § 1.181, but
did not do so.
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radiopaque stripes (not shown) . . . permanently attached along longitudinal
perimeters of said balloon” Final Act. 3 (citing Becker, col. 4, ll. 21–25; ll.
52–55)(emphasis omitted). The Examiner further finds that the
stiffening members / radiopaque markers 26 / radiopaque
stripes (C 4, L 61-63; claim 13) can be [] disposed along the
entire length of the balloon or the working length of the
balloon. The radiopaque material of Becker is comprised of a
radiopaque material, such as a tungsten, or a platinum, or a
barium or a bismuth [Becker, col. 4, ll. 48–55)], which
tungsten, or platinum is much stiffer than the polymeric
material of said balloon.
Id. (emphasis omitted).
Appellants argue that Becker does not disclose a longitudinal
stiffening member as required by claim 67. Appeal Br. 12. Regarding the
embodiment taught by Figures 4–6 of Becker, Appellants argue that the
radiopaque layer “encompasses the entire circumferential area of the
transition regions at either end of the balloon.” Id. at 12. According to
Appellants, “[t]his [arrangement in Becker] contrasts with the instant claims
which call for ‘longitudinal stiffening members ... disposed along
longitudinal perimeters of said balloon’.” Id. at 13.
Regarding the balloon disclosed in Figure 4 of Becker, Appellants
contend that Becker teaches that the radiopaque layer depicted in Figure 4
“may” increase stiffness, but not that the radiopaque layer does increase
stiffness. See id. at 12–13. According to Appellants, when Becker states
“this embodiment may increase stiffness in the transition regions” (col. 4, ll.
36–37), Becker is merely speculating. Id. Additionally, citing column 2,
lines 42–43 of Becker, Appellants contend, “Becker himself admits that the
radiopaque material (stripe [or] otherwise) he applies to his balloon does not
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change the properties of the balloon. Thus, it is clear that the Becker stripe
does not provide any stiffness whatsoever.” Id. at 13.
In response, the Examiner states, “Becker’s member 26/ 30 (F 4-8)
extending along the longitudinal axis of Becker’s device qualifies as [a]
longitudinal stiffening member as recited in independent claims 67 and 82.”
Ans. 16 (emphasis omitted). The Examiner further states, “Becker’s
radiopaque material (tungsten, or platinum) is indeed much stiffer than the
polymeric material of the balloon.” Id. at 17. The Examiner finds, “at least
the stiffening member 26 as shown in F 4, and stiffening member 30 as
shown in F 8 will provide additional stiffness to the transition areas (cone
areas) of the balloon. Id. (citing Becker, col. 2, ll. 21–26) (emphasis
omitted).
In reply, Appellants state, “[Appellants agree] with the Examiner that
it is the added thickness of Becker’s radiopaque layer that ‘may’ provide
added stiffness in the certain areas of the balloon where it is present. And,
again, this does not read on the key claim term of the instant independent
claims.” Reply Br. 14 (emphasis added).
We agree with the Examiner’s finding that Becker discloses a
stiffening member. First, as to whether Becker teaches a “longitudinal”
member, the Examiner finds that both radiopaque layer 26 and radiopaque
material 30 disclosed in Becker qualify as longitudinal members. The Patent
and Trademark Office gives claims their broadest reasonable interpretation
consistent with the specification, reading claim language in light of the
specification as it would be interpreted by one of ordinary skill in the art. In
re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In
describing a problem with providing a uniform diameter and cross-sectional
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area along the length of a stent, Appellants’ Specification states, “[t]his
[problem] results from the very nature of such a cylindrical balloon which is
made of a thin, flexible membrane and hence can expand radially to different
diameters along its longitudinal dimension.” Spec. 1 (emphasis added).
Thus, the term “longitudinal” is used in Appellants’ Specification as relating
to the length dimension of an object. Neither Appellants’ claims nor
Specification set forth a special or alternative definition of the term
“longitudinal.” As such, we give the term “longitudinal” its broadest
reasonable interpretation in light of the common meaning as understood by
one skilled in the art, and in light of the Specification, to mean “placed or
running lengthwise.”6
We reproduce a portion of Figure 4 of Becker below.

6 A general dictionary definition of “longitudinal” is “placed or running
lengthwise.” MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY (11th ed.
2004).
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Figure 4 of Becker is a cross-sectional view of the balloon 14,
including radiopaque layer 26 between two layers 27 and 28 of the balloon.
“The radiopaque layer 26 may be deposited either on the outer wall of the
bottom layer 27, or on the inner wall of the upper layer 28.” Becker, col. 4,
ll. 28–31 (emphasis omitted); see also col. 3, ll. 46–47.
Figure 4 of Becker depicts radiopaque layer 26 extending in the
lengthwise direction of the balloon. As noted by Appellants and shown in
Figure 6 of Becker, radiopaque layer 26 encircles the transition region of the
balloon. Appeal Br. 11. However, the term “longitudinal” in claim 67 does
not preclude a member extending lengthwise and also encircling a portion of
the balloon as radiopaque layer 26 does.
Moreover, as the Examiner finds (Final Act. 3), Becker also discloses
use of radiopaque stripes, which the Examiner equates to stiffening
members, along the entire length of the balloon, or along the working length
of the balloon. Specifically, Becker states, “[t]he balloon could also have
longitudinal stripes of radiopaque material along the entire length, or the
working length of the balloon 14 (not shown). Becker, col. 4, ll. 61–63
(emphasis omitted). Accordingly, the Examiner’s finding that Becker
discloses longitudinal members is supported by the preponderance of the
evidence.
As for whether radiopaque layer 26 or radiopaque material 30
qualifies as a stiffening member, we are not apprised of Examiner error. In
reference to Figure 4, Becker states:
In the embodiment illustrated in FIG. 4, the radiopaque
layer 26 extends from the proximal end of the balloon 14 to the
proximal end of the stent 16, and then from the distal end of the
stent 16 to the distal end of the balloon 14. This embodiment
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would show the exact location of the stent during placement.
Additionally, this embodiment may increase stiffness in the
transition regions.
Becker, col. 4, ll. 31–37 (emphasis added, bolding omitted). Although, as
Appellants note (see Appeal Br. 13; Reply Br. 13), Becker uses the word
“may” in describing an increase in stiffness, this disclosure in Becker is
supportive of the Examiner’s finding that radiopaque layer 26 increases
stiffness. Further, as noted by the Examiner (see Final Act. 5; Ans. 17, 19),
Becker also states:
what has been needed is a balloon catheter with improved
radiopaque properties to improve placement and visibility of
the balloon. Additionally, a balloon catheter with improved
stiffness, especially in the transition areas, has also been
needed to improve cross ability. The present invention satisfies
these and other needs.
Becker, col. 2, ll. 21–26 (emphasis added). Thus, Becker indicates a need
to improve stiffness, especially in the transition areas, and discloses the
present invention does provide the improved stiffness. This statement in
Becker regarding “improved stiffness” further supports the Examiner’s
finding that radiopaque layer 26 increases stiffness.
Appellants contend that a sentence in column 2 of Becker “indicates
that none of the radiopaque material applied to Becker’s balloon changes the
flexural properties of the balloon.” Appeal Br. 7. We reproduce the entire
paragraph of Becker containing the sentence (italicized) at issue below.
The thickness of the balloon wall allows for a substantial
amount of radiopaque material to be doped into the walls,
creating a truly radiopaque balloon. In thinner wall balloons,
adding enough radiopaque material to make the balloon easily
visible will change the properties of the balloon. The
radiopaque layer is about 0.00025 inches to about 0.012 inches
for sufficient radiopacity without changing the properties of the
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balloon. Specifically, the radiopaque layer is about 0.002 inches
to about 0.003 inches. The thick walls additionally allow for
addition of other materials to enhance any properties of the
balloon.
Becker, col. 2, ll. 36–46 (emphasis added).
Weighing the above-noted statements in Becker describing the effects
of incorporating the radiopaque layer in Becker’s balloon, we are not
persuaded that Becker does not teach that the radiopaque layer increases
stiffness of the balloon and is therefore not a stiffening member as recited in
claim 67. Becker indicates that its invention satisfies the need to increase
stiffness in the transition regions. Becker, col. 2, ll. 21–26. Becker explains
this achievement in the context of providing radiopacity to a balloon. Id.;
see also Abstract. The specific references to increasing stiffness in the
portions of Becker quoted above teach that the radiopaque layer increases
stiffness. Accordingly, Becker discloses embodiments of the balloon in
which stiffness is increased. That another portion of Becker teaches that
“the properties” of the balloon are not changed provides, at most, another
embodiment in which some unspecified properties of the balloon are not
changed.
Furthermore, the statement in column 2 of Becker quoted by
Appellants and discussing providing a layer “without changing properties”
relates to “radiopaque material to be doped into the walls.” Becker, col. 2,
ll. 36–38 (emphasis added). In contrast, the paragraph in Becker (supporting
the Examiner’s finding) at column 2, lines 26–37, relates to a radiopaque
layer that may be deposited on the outer wall of bottom layer 27 or the inner
wall of layer 28. Appellants do not direct us to any disclosure in Becker that
shows persuasively that the above-noted statement regarding material doped
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into walls of a balloon also applies to a radiopaque layer that is deposited on
the wall of a balloon.
Appellants also contend “if the Examiner’s theory were held to be true
(that the stripe itself is stiff) then certain embodiments of the Becker
apparatus would be functionally defective.” Appeal Br. 13. Appellants
argue, “if the region comprising Becker’s radiopaque ring was indeed stiffer
than the balloon material itself, as the Examiner argues, then this
circumferential ring would impart increased circumferential stiffness, and
significantly inhibit both the expansion and deflation of the balloon.” Id. at
14. According to Appellants, that the radiopaque material in Becker may
take the shape of a ring supports a conclusion that the radiopaque material
does not impart stiffness to the balloon itself. In this regard, Appellants
state, “the Becker ring - and in turn, the stripe - must either have the same
stiffness or be less stiff than the Becker balloon material itself in order to
allow Becker's balloon to properly inflate and deflate uniformly.” Id.
We do not agree with Appellants on this point. First, Appellants do
not explain persuasively why a radiopaque layer adding some amount of
stiffness to the balloon would necessarily add so much stiffness as to prevent
proper functioning of the balloon. Becker discloses stiffness is increased,
and does not disclose or suggest the resulting balloon would be unable to
inflate and deflate properly—that is, it would be inoperative in any way.
Rather, Becker describes the increased stiffening as an improvement.
Accordingly, Appellants’ contention is contrary to Becker’s disclosure.
Second, as to Appellants’ comments on the stiffness of the stripe
relative to the stiffness of the balloon material, Appellants make a
comparison not required by claim 67. Specifically, claim 67 recites, in part,
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“an expandable balloon comprised of a flexible material having one or more
longitudinal stiffening members permanently attached to said balloon, said
stiffening members being comprised of a material stiffer than the material of
said balloon.” Appeal Br. 23 (emphasis added). The term “comprised of”
means “including but not limited to.” See CIAS, Inc. v. Alliance Gaming
Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (“Although ‘comprised of’ is
not used as regularly as ‘comprising,’ and ‘comprised of’ is sometimes used
other than as a ‘transition phrase,’ nonetheless it partakes of long-standing
recognition as an open-ended term.”). Appellants’ Specification provides no
alternative definition of the term “comprised of.” Thus, the phrase
“stiffening members being comprised of a material stiffer than the material
of said balloon” requires a stiffening member including, but not limited to,
material stiffer than the material of the balloon. In this regard, the term
“comprised of” is typically construed differently from “consisting of” and
“consisting essentially of.” For example, the phrase “consisting of”
excludes any element, step, or ingredient not specified in the claim. In re
Gray, 53 F.2d 520 (CCPA 1931). Even if Appellants’ contention that “the
Becker ring - and in turn, the stripe - must either have the same stiffness or
be less stiff than the Becker balloon material itself” (Appeal Br. 14) is
correct, this would not disqualify the stripe from corresponding to a
longitudinal stiffening member “comprised of a material stiffer than the
material of the balloon,” as claimed. In other words, Appellants’ argument
is not commensurate with the scope of claim 67 because it is not the stiffness
of the stiffening member that is required to be compared to the material of
the balloon in claim 67, but rather, it is stiffness of the material included in
the stiffening member that is compared.
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Appellants also refer to an Affidavit by Dr. Joseph Grayzel
(“Affidavit”), one of the inventors of the present Application.7,8 Appeal Br.
14–15. Appellants argue, “[t]he affidavit states that Becker’s formulated
slurry consists of a mixture of organic polymer and radiopaque materials in
powdered form. This particulate dispersion is devoid of the physical
properties characteristic of solid metal, or metal in crystalline form.” Appeal
Br. 14. Appellants further contend, “[t]he powdered metals are not reacted
with the polymer, nor otherwise chemically bound to the polymer's
molecules. Thus, the powdered metals behave as inert fillers which degrade
the physical properties of the polymer.” Id. In further reference to the
Affidavit, Appellants assert, “[t]his expert opinion states that that the
radiopaque ‘stripe’ or ‘layer’ which Becker employs is less stiff than the
material of Becker’s balloon made of 100% polymer.” Id. at 15. Citing the
Affidavit as support, Appellants contend, “[i]t is not appropriate for the
Examiner to compare a single particle of tungsten with a single particle of
polymer. He has erred by not viewing the stiffening member as the discreet
structure that it is to compare it to the stiffness of the balloon material itself.”
Id. During the first oral hearing, Appellants argued the stiffness of the
stiffening member, as a whole, should be considered, not the stiffness of a

7 Filed on October 6, 2014.
8 Although this document bears the title “AFFIDAVIT” and uses this word
multiple times, this document does not bear any indication of a sworn
statement other than the words “Sworn to by” in the signature block.
Because the Examiner and Appellants use the term “Affidavit” in the
Examiner’s Answer and Appeal and Reply Briefs, respectively, we use this
term in our discussion.
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subcomponent material.9 Appellants also make extensive arguments in the
Reply Brief directed to whether the radiopaque layer of Becker increases
stiffness of the radiopaque layer in Becker and if so, whether the amount of
increase is trivial. See Reply Br. 5–14.
The Examiner replies that claim 67 requires that “said stiffening
member [is] comprised of a material stiffer than the material of said
balloon.” Ans. 21 (emphasis omitted). In other words, the correct
comparison at issue is the stiffness of material included in the stiffening
member(s) relative to the stiffness of the material of the balloon.

9 JUDGE BROWN: Okay. So, in other words, your stiffening
member doesn’t have to be 100 percent of this material that’s stiffer than the
material (indiscernible)?
MR. GRAYZEL: No. I would say that our stiffener as a whole -- I
mean we're talking about a unitary stiffener so every portion of that stiffener
would be stiffer than the balloon material itself because in order for it to act,
if you look in the context of what we’re trying to do there and have a -- have
a stiffened portion that pushes up against the lesion within a blood vessel,
you’re not sure what portion of that stiffener is going to be pushing up
against that lesion, so the entire stiffener has to have this -- almost the entire
stiffener -- because we have -- I was going to say the entire stiffener has to
have the same properties. But we have certain embodiments there where
they show -- where we show cutouts where there are certain portions there
that are less stiff, because that we won’t have that flexibility there but every
single point along our stiffener is stiffer than the balloon material itself. Tr.
12 (Oct. 29, 2015).

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Accordingly, the conclusion in the Affidavit, that the radiopaque stripe is
less stiff than the material of the balloon in Becker, does not address the
relevant question before us. Rather, the question at hand is whether the
radiopaque layer of Becker includes a material stiffer than the material of the
balloon.
Nor are we apprised of error in the Examiner’s finding that
Becker fully meets this limitation [regarding the stiffness of
material included in the stiffening member] because the
stiffening member[] 26 of Becker is indeed comprised of 70-
90% of tungsten, or platinum particulates dispersed in solid 10-
30% polymer (Becker: C 3, L 10-21; F 7), and tungsten, or
platinum is much stiffer than the polymer of said balloon.
Ans. 21 (emphasis omitted).
The Affidavit states that the radiopaque layer “regions” in Becker “are
very thin layers of a slurry” and “[t]he nature of the radio-opaque slurry is
central to the relevance of Becker ’568 to the present application
#13/022,503 for US letters patent.” Affidavit 3. Further, the Affidavit
states, “Becker’s formulated slurry consists of a mixture of organic polymer
and radio-opaque materials in powdered form, such materials being
powdered radio-opaque metals. Hence, they are devoid of the physical
properties characteristic of solid metal, or metal in crystalline form.” Id.
(emphasis added).
The Affidavit does not explain how the conclusions noted above
regarding Becker were reached. Becker does not mention a “slurry,” and
Appellants do not identify any disclosure in Becker, or provide any other
persuasive evidence, that shows such a slurry is necessarily used in Becker.
In other words, the conclusion in the Affidavit that Becker uses a slurry is
not supported by persuasive evidence. Moreover, Becker does not teach that
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its radiopaque layer, which may be deposited on the wall of the balloon (col.
4, ll. 28–31), is in the form of a powder on the balloon wall, much less only
a powder. Affidavits/declarations are entitled to little, if any, weight if the
opinion is considered by the panel to be unsupported and lacking the
underlying facts to support the conclusions. See, e.g., In re Am. Acad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to
weigh the declarations and conclude that the lack of factual corroboration
warrants discounting the opinions expressed in the declarations”); In re
Brandstadter, 484 F.2d 1395, 1406 (CCPA 1973) (holding that affidavits
fail in their purpose when they recite conclusions and few facts to buttress
the conclusions). In full consideration of the Affidavit, the preponderance of
the evidence supports the Examiner’s finding that tungsten and platinum
included in the radiopaque layer are stiffer than the material of the balloon.
Thus, we are not persuaded by Appellants’ argument that the stiffening
member taught by Becker is not comprised of a material stiffer than the
material of the balloon.
Appellants also contend that Becker’s stripe is entirely radiopaque and
“cannot have the property of having only ‘a portion of’ it be radiopaque as
stated in the instant claims.” Appeal Br. 15 (emphasis omitted).
In response, the Examiner states, “only the portion tungsten, or
platinum in Becker’s stiffening member 30 (F 8) is radiopaque while the
polymer portion in Becker's stiffening member 30 is not.” Ans. 22.
Claim 67 recites, in part, “wherein at least a portion of at least one of
said one or more longitudinal stiffening members is radio-opaque to
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facilitate determination of the position of said stiffening member.”10
Emphasis added. Further, Appellants’ Specification does not disclaim
stiffening members that are entirely radiopaque. For example, the
Specification states, “[t]he stiffening members and the projections may be
made radio-opaque so that the balloon or the stent may be precisely located
by x-ray imaging.” Spec. 6. Under the broadest reasonable interpretation of
claim 67 consistent with the standard set forth in In re American Academy of
Science Tech Center, we interpret the term “at least a portion of at least one
of said one or more longitudinal stiffening members is radio-opaque to
facilitate determination of the position of said stiffening member” to require
no less than a portion of the one or more longitudinal stiffening members to
be radiopaque. We thus do not agree with Appellants’ interpretation that
claim 67 requires less than the entire stiffening member to be radiopaque.
Rather, claim 67 does not preclude the entire stiffening member being
radiopaque. Accordingly, Appellants’ arguments on this point are not
commensurate with the scope of claim 67.
Based on the discussion above, we sustain the Examiner’s rejection of
claim 67 under 35 U.S.C. § 102(e) as anticipated by Becker. Claim 82 falls
with claim 67. As our claim construction of claims 67 and 82 with respect
to the term “at least a portion” appears to differ pertinently from that relied
on by the Examiner (by allowing for the entire stiffening member to be
radiopaque), we designate our affirmance of the rejection of claims 67 and
82 a NEW GROUND of rejection in accordance with 37 C.F.R. § 41.50(b).

10 Claim 72 depends from claim 67 and recites, “[t]he stiffened balloon
apparatus of claim 67 wherein said stiffening member is radio-opaque along
its entire length.” Emphasis added.
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Claim 68
The Examiner finds, “stiffening members / radiopaque markers 26 /
radiopaque stripes of the stiffened balloon 14 of claim 67 permit a precise
determination of an orientation of said expandable balloon.” Final Act. 3.
Appellants contend that claim 68 calls for a radiopaque portion, and
“the Becker stripe is completely radiopaque and cannot have just a small
portion that is radiopaque.” Appeal Br. 16.
As we noted above, independent claim 67 recites, in part, “at least a
portion of at least one of said one or more longitudinal stiffening members is
radio-opaque.” Emphasis added. By placing the words “at least” before “a
portion,” claim 67 indicates that a portion of the stiffening member is less
than the entire stiffening member. Furthermore, the ordinary meaning of the
term “portion” is “a section or quantity within a larger thing; a part of a
whole.”11 Accordingly, in accordance with the ordinary meaning of the
word “portion” and because dependent claim does 68 not recite “at least”
before the recited portion, we interpret claim 68 to require a portion of the
stiffening member, but less than the whole stiffening member, to be
radiopaque.
The Examiner replies that, in Becker, the individual particulates of
tungsten or platinum dispersed in solid polymer qualify as radiopaque
portions, and the polymer disposed around the particulates is not radiopaque.
Ans. 22. We disagree with the Examiner on this point. Claim 68 requires a
portion of the stiffening member to be radiopaque. It is not sufficient that the

11 THE AMERICAN HERITAGE® DICTIONARY OF THE ENGLISH LANGUAGE
(2007), https://www.ahdictionary.com/word/search.html?q=portion (last
visited November 5, 2015).
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stiffening member include both radiopaque and non-radiopaque materials.12
Rather, the stiffening member must include a portion (less than the whole)
that is radiopaque. In other words, the Examiner does not show by a
preponderance of the evidence that it is not the entire radiopaque layer 26 of
Becker that is radiopaque. Accordingly, we do not sustain the Examiner’s
decision to reject claim 68 as anticipated by Becker.
Claims 69–71
Appellants make similar arguments for claims 69–71 as those made
for claim 68, and we likewise do not sustain the Examiner’s decision to
reject claims 69–71 as anticipated by Becker.
Claims 73 and 74
Dependent claim 73 recites, “[t]he stiffened balloon apparatus of
claim 67 wherein said stiffening member includes a projection.”
Citing Becker, column 3, lines 10–21, the Examiner finds that Becker
discloses “radiopaque stiffening member / radiopaque layer 30 / radiopaque
stripe deposited on the outside of balloon 14 as an outwardly radial
projection, or the radiopaque stripe deposited on inside of balloon 14 as an
inwardly radial projection.” Final Act. 4.
Appellants argue that the Examiner errs in finding that the radiopaque
layer itself qualifies as the recited projection. Appeal Br. 18.
We agree with Appellants on this issue in that claim 73 requires the
stiffening member to include a projection, which indicates that the projection
is a sub-part of the stiffening member and not the entire stiffening member

12 For example, a mud puddle may include both transparent water and opaque
soil. Yet, the mud puddle, taken as a whole, may still be opaque, i.e., “clear
as mud.”
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itself. Accordingly, we do not sustain the Examiner’s rejection of claim 73
and claim 74, which depends from claim 73.
Claim 75
Dependent claim 75 recites, “[t]he stiffened balloon apparatus of
claim 67 wherein at least one stiffening member comprises a plurality of
discontinuous stiffening pieces aligned in a longitudinal row and at least a
portion of at least one of said pieces is radio-opaque.” Emphasis added.
The Examiner finds, “the balloon 14 (F 4) has at least one stiffening
member compris[ing] two radiopaque stiffening pieces / layers 26 one at
proximal end and one at distal end aligned in a longitudinal row.” Final Act.
4.
Appellants argue that “the Becker stripe is completely radiopaque and
cannot have just a portion that is radiopaque.” Appeal Br. 18.
We do not agree with Appellants’ argument. We interpret the term
“at least a portion” to require no less than a portion, and being sufficiently
broad to not preclude the entire stiffening member being radiopaque.
Accordingly, Appellants’ contention that a completely radiopaque stiffening
member does not have at least a radiopaque portion is not commensurate
with the scope of claim 75. Thus, we sustain the Examiner’s rejection of
claim 75.
Claim 83
Appellants make the same arguments for claim 83 as those made for
claim 68. Appeal Br. 18. For the reasons discussed above regarding the
rejection of claim 68, we do not sustain the Examiner’s rejection of claim
83.
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Claim 86
Claim 86 recites, “said stiffening members are comprised of metal,
plastic, composite or fiber material” (emphasis added). The Examiner finds,
“radiopaque marker 26, or 30, or stripe (not shown) [is] comprised of at least
radiopaque metal such as tungsten, platinum (C 4, L 48-55).” Final Act. 5.
Appellants argue, “[c]laim 86 calls for the stiffening member to be
‘comprised of metal, plastic, composite or fiber material.’ Nowhere in the
Becker ‘568 specification does he show his stripes comprised of a metal,
plastic, composite or fiber material.” Appeal Br. 18.
We do not agree with Appellants on this point. Appellants do not
explain persuasively how the Examiner’s finding is incorrect. As discussed
above, the phrase “comprised of” means including, but not limited to.
Becker discloses that the radiopaque material “suitable for this invention”
may be any of various metals, including tungsten and platinum. Becker, col.
4, ll. 48–52. These metals are also included in Becker’s stripes.
Accordingly, the Examiner’s finding is supported by a preponderance of the
evidence. We sustain the rejection of claim 86.
Claim 87
Appellants present arguments contesting the rejection of claim 87 in
the Reply Brief. Reply Br. 15–16. However, these arguments were not
earlier presented in the Appeal Brief. See Appeal Br. 18–19. In fact, as
noted above, Appellants indicate in the Appeal Brief that claim 87 is
withdrawn. Moreover, the rules applicable to the present appeal provide:
Any argument raised in the reply brief which was not
raised in the appeal brief, or is not responsive to an argument
raised in the examiner's answer, including any designated new
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ground of rejection, will not be considered by the Board for
purposes of the present appeal, unless good cause is shown.
37 C.F.R. § 41.41(b)(2) (2014). Appellants do not provide any explanation
for the failure to present arguments in the Appeal Brief contesting the
rejection of claim 87. The arguments contesting this rejection, raised for the
first time in the Reply Brief, are also not responsive to an argument raised in
the Examiner’s Answer. As such, Appellants do not show good cause for
the Board to consider these new arguments presented for the first time in the
Reply Brief. Accordingly, we sustain the Examiner’s rejection of claim 87
as anticipated by Becker.
Claim 88
The Examiner finds,
Becker’s F 4 shows two separate radiopaque layers 26, one at
the proximal cone and one at the distal cone of balloon 14.
Becker does not explicitly disclose[] different rigidity of the
two layers 26. Inherently, these two separate radiopaque layers
26 must have some degree of difference in rigidity as they are
different elements.
Final Act. 5; see also Reply Br. 3.
Appellants contend, “Becker’s stripes are shown to be uniform and he
does not teach any variations in the stripe within a single balloon.” Appeal
Br. 19.
We agree with Appellants on this issue, the Examiner’s finding that
radiopaque layers 26 must have some degree of difference in stiffness is not
supported by the preponderance of the evidence. Accordingly, we do not
sustain the Examiner’s rejection of claim 88 as anticipated by Becker under
35 U.S.C. § 102(e).

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Claims 72, 76, 77, 79–81, 84, and 85
Appellants do not make separate arguments for dependent claims 72,
76, 77, 79–81, 84, and 85. Accordingly, these claims fall with independent
claim 67 or 82.

Rejection (I); unpatentability of claim 88 under 35 U.S.C. § 103(a)
As an alternative ground of rejection for claim 88, the Examiner
reasons, “[i]t would have been obvious to one of ordinary skill in the art at
the time of the invention to make one layer 26 more rigid than the other
balloon layers 27 & 28, for example, to make the proximal end and the distal
end of balloon 14 with layers 26 [] stiffer than the body of balloon 14 for
more cross ability of catheter 13 in a blood vessel.” Final Act. 5.
In Appellants’ Summary in the Appeal Brief, apparently related to
Becker in general, Appellants state, “Becker ’568 contains only three
relevant statements in the entire reference that are pertinent in showing that
this prior art reference is non-analogous art.” Appeal Br. 19.
To the extent this contention may pertain to this rejection, we do not
agree with Appellants on this issue inasmuch as both Becker and Appellants’
claimed invention relate to balloon catheters, and especially, radiopaque
components of balloon catheters.13 Thus, Becker is in the same field as
Appellants’ invention. We are not persuaded Becker is non-analogous art.

13 Our reviewing court has set forth a two-prong test for determining whether
a prior art reference is analogous: (1) whether the reference is from the
same field of endeavor as the claimed invention, and (2) if the reference is
not within the same field of endeavor, whether the reference is reasonably
pertinent to the particular problem with which the inventor is involved. In re
Klein, 647 F.3d 1343 (Fed. Cir. 2011).

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Appellants do not make separate arguments for patentability against
the alternative rejection of claim 88 as unpatentable over Becker under 35
U.S.C. § 103(a). See Appeal Br. 19; Final Act. 5. Accordingly, we sustain
the Examiner’s decision to reject claim 88 as unpatentable over Becker.

Rejection (II); unpatentability of claim 78 under 35 U.S.C. § 103(a)
Appellants do not make separate arguments for patentability against
the obviousness rejection of claim 78 as unpatentable over Becker. See
Appeal Br. 18; Final Act. 5–6. Accordingly, we sustain the Examiner’s
decision to reject claim 78 as unpatentable over Becker.

DECISION
We affirm the rejection of claims 67, 72, 75–82, and 84–87 as
anticipated by Becker.
We reverse the rejection of claims 68–71, 73, 74, 83, and 88 as
anticipated by Becker.
We affirm the rejection of claims 78 and 88 as unpatentable over
Becker.
Because in some instances the reasoning relied on by the Board to
sustain the rejections of claims 67, 72, 75–82, and 84–88 differs from the
facts and reasoning relied on by the Examiner, we designate our affirmance
of the rejections of these claims as a NEW GROUND OF REJECTION so as
to provide Appellants with a full and fair opportunity to respond to the thrust
of the rejections.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
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rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the Examiner, in which event the
proceeding will be remanded to the Examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record. . . .
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-IN-PART; 37 C.F.R. § 41.50(b)

mls