CLEARSTREAM TECHNOLOGIES LIMITED

Patent Trials and Appeals Board

Feb 14, 2020

14383754 - (D) (P.T.A.B. Feb. 14, 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.
14/383,754 09/08/2014 Sean Wall P-18266.US02 / 1626A-048 7367
138315 7590 02/14/2020
C. R. Bard, Inc./ClearStream/K&S
KING & SCHICKLI, PLLC
800 CORPORATE DRIVE
SUITE 200
LEXINGTON, KY 40503
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
02/14/2020 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 SEAN WALL
__________

Appeal 2019-004449
Application 14/383,754
Technology Center 3700
__________

Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
LISA M. GUIJT, Administrative Patent Judges.

HOELTER, 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, 2, 4–9, 11, 12, 14–16, 19, 20, 24–27,
and 29–32. Final Act. 1 (Office Action Summary).2 We have jurisdiction
under 35 U.S.C. § 6(b). For the reasons explained below, we do not find

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 lists claim 10 as being rejected. Final Act. 1. However,
claims 3, 10, 13, 17, 18, 21–23, and 28 are canceled. See Appeal Br. 8–10
(Claims App.).
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error in the Examiner’s rejections of these claims. Accordingly, we
AFFIRM the Examiner’s rejections.

CLAIMED SUBJECT MATTER
The disclosed subject matter “relates generally 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. 1:8–
12. Apparatus claims 1, 29, and 30 are independent. Claim 1 is illustrative
of the claims on appeal and is reproduced below.
1. A balloon catheter for use in connection with a
guidewire, comprising:
an elongated, tubular shaft extending in a longitudinal
direction, said shaft having a proximal end and a distal end;
an inflatable balloon, including first and second ends and
a cylindrical portion between the first and second ends that, when
inflated, provides a working surface on the cylindrical portion,
the second end being a distal end of the balloon along the distal
end of the shaft; and
at least one wire extending longitudinally from the first
end to the second end of the balloon, the wire including a first
portion with a different radiopacity from a second portion of the
wire for identifying an end of the working surface of the balloon.

REFERENCES RELIED ON BY THE EXAMINER
Dror et al. US 5,102,402 Apr. 7, 1992
Tu et al. US 6,123,718 Sept. 26, 2000
Aita et al. US 6,884,234 B2 Apr. 26, 2005
Burgmeier et al. US 2005/0215950 A1 Sept. 29, 2005
Spencer et al. US 2008/0249464 A1 Oct. 9, 2008
Solar et al. US 2009/0275920 A1 Nov. 5, 2009

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THE REJECTIONS ON APPEAL
Claims 1, 2, 4, 6–8, 11, 12, 14, 15, 24–27, and 293 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Tu and Solar. Final Act. 5.
Claim 16 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Tu, Solar, and Dror. Final Act. 8.
Claims 1, 2, 5, 6, 9, and 14 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Spencer and Solar. Final Act. 8.
Claims 19 and 30–32 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Spencer, Solar, and Burgmeier. Final Act. 10.
Claim 20 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Spencer, Solar, Burgmeier, and Aita. Final Act. 10.

ANALYSIS
The rejection of claims 1, 2, 4, 6–8, 11, 12, 14, 15, 24–27, and 29
as obvious over Tu and Solar
The rejection of claims 1, 2, 5, 6, 9, and 14
as obvious over Spencer and Solar
With respect to each rejection, Appellant focuses solely on claim 1.
See Appeal Br. 4–5. We, thus, select claim 1 for review, and note those
instances where a difference exists between the two.4 Accordingly, the

3 The Examiner lists claim 16 in the header of the rejection but claim 16 is
not discussed in the body of the rejection. Final Act. 5–8. Because claim 16
is rejected as being obvious over Tu, Solar, and Dror (see Final Act. 8), we
determine that the inclusion of claim 16 in the header of this rejection is a
typographical error.
4 Appellant states, “[r]egarding the combination of Solar with Spencer, the
same analysis essentially applies.” Appeal Br. 4.
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remaining claims (i.e., claims 2, 4–9, 11, 12, 14, 15, 24–27, and 29) stand or
fall with their respective claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
Claim 1 recites an inflatable balloon having first and second ends, a
working surface located there between, and a wire extending from the first
end to the second end with “the wire including a first portion with a different
radiopacity from a second portion of the wire for identifying an end of the
working surface of the balloon.” Appeal Br. 8 (Claims App.). The
Examiner primarily relies on the teachings of Tu and Spencer (in their
respective rejections), but acknowledges that neither discloses a wire having
a first portion with a different radiopacity from a second portion. See Final
Act. 5, 9.5 With respect to each rejection, the Examiner relies on Solar for
such disclosure. See Final Act. 5, 9 (citing Solar ¶¶ 45–47; Figs. 1–5). In
both cases, the Examiner concludes that it would have been obvious to
modify the balloon catheter of Tu or Spencer to have a first portion with a
different radiopacity from a second portion, as disclosed by Solar, and
provides a reason for Solar’s combination therewith. See Final Act. 5–6, 9.
Additionally (for each rejection), the Examiner discusses Solar’s radiopaque
coil 34 (“serving as a marker for locating the wire”) and, alternatively,
Solar’s radiopaque markers 36 (which “may be placed at optimal
locations”). Final Act. 5; see also Final Act. 9. The Examiner states that,
for each combination, Solar’s coil 34 or marker 36 “would allow for
identifying an end of the working surface of the balloon.” Final Act. 5, 9.

5 Although the Examiner finds that Tu does not disclose a difference in
radiopacity, we note that Tu discloses radiopaque marker band 33 on
stiffening wire 31. See Tu Fig. 3. Thus, Tu would appear to disclose a
“different radiopacity” along Tu’s wire.
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Appellant contends, “nothing establishes that the coil 34 in Solar or
the markers 36 identify an end of the balloon working surface” as
contrasted with that of the balloon itself. Appeal Br. 4. Appellant
acknowledges that in Solar, “the markers ‘may be spaced at optimal
locations such as at a proximal end and a distal end of balloon 24, for
example.’” Appeal Br. 4 (referencing Solar ¶ 46). However, Appellant
contends that Solar “fails to describe identifying the ends of the balloon
working surface,” and the Examiner’s finding to the contrary “is pure
speculation, which lacks the support of substantial evidence, and thus cannot
sustain the rejection.”6 Appeal Br. 4 (referencing In re Warner, 379 F.2d
1011, 1017 (CCPA 1967)).
As noted above, Solar teaches that both coil 34 and markers 36 can be
employed with the balloon for positioning or locating purposes. See Solar
¶¶ 45, 46. Solar specifically describes locating the markers at proximal and
distal ends of the balloon “for example.” Solar ¶ 46. One skilled in the art,
guided by Solar’s description of this location as being only an “example,”
would reasonably understand that other locations are also possible.7 Thus,
we disagree with Appellant’s contention that because Solar “fails to describe

6 We are reminded of instructions from our reviewing court that “apparatus
claims cover what a device is, not what a device does.” Hewlett-Packard
Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468, (Fed. Cir. 1990). And
further, that claims directed to an apparatus, as here, must be distinguished
from the prior art in terms of structure rather than function. See In re
Schreiber, 128 F.3d 1473, 1477–78, (Fed. Cir. 1997).
7 “A person of ordinary skill is also a person of ordinary creativity, not an
automaton.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
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identifying the ends of the balloon working surface,” this renders such a
location non-obvious to one skilled in the art. Appeal Br. 4.
For example, Tu clearly discloses a working surface on a cylindrical
portion of an inflated balloon. See Tu Figs. 3, 6. Tu also discloses that
“[t]he location of the at least one radiopaque marker band 33 allows the
position of the inflatable balloon 10 to be accurately determined by
fluoroscopy in order to ensure proper positioning of the inflatable balloon
prior to inflation.” Tu 8:40–44. Solar discloses “coil 34 is comprised of
radiopaque material, and thus acts as a marker for positioning of system 10,
100 or 200” (Solar ¶ 45) and proffers similar language regarding markers 36
(see Solar ¶ 46). One of the reasons the Examiner provided for combining
Tu and Spencer with Solar is “in order to allow for locating . . . different
regions of the balloon.” Final Act. 6, 9. Because the working region of the
balloon differs from the region of the balloon as a whole, Appellant does not
explain why one skilled in the art would not desire a precise or optimal
balloon (and hence its working surface) location. See Solar ¶¶ 45, 46. This
is especially the case when Solar is specifically concerned with proper
placement so as to “provide[] an area of focused force for cracking or
breaking up hard or difficult lesions.” Solar ¶ 47. In view of the foregoing,
we agree with the Examiner that the combined teachings of Tu or Spencer
with Solar would result in a balloon catheter that is capable of identifying an
end of the working surface as recited. See Final Act. 5, 9.
Appellant further contends that “[t]he proposed combination of the Tu
or Spencer and Solar teachings ‘in order to allow for locating the wire itself
and different regions of the wire as well as different regions of the balloon
such as proximal or distal ends’ is not a reason for combining the reference
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teachings.” Appeal Br. 5; see also Reply Br. 4, 5. This is because
“[a]ccording to the Examiner, the shaft or wire of Tu/Spencer is metal, and
thus is already locatable,” and further, “[t]here is no identification of any
reason with a rational underpinning of a desire to locate ‘different regions of
the wire.’” Appeal Br. 5.
These contentions are unpersuasive. First, as noted above, Solar
discloses alternative methods for disclosing a balloon location, i.e., use of
coil 34 or markers 36. As also noted above, the Examiner states that in
either case, Solar’s teachings “would allow for identifying an end of the
working surface of the balloon.” Final Act. 5, 9. The Examiner’s reasoning
addresses both the use of a coil and the use of markers for the express
purpose of providing “areas of focused force” against lesions. Solar ¶ 47.
Thus, Appellant’s above focus on the proximal or distal ends of the balloon,
when such locations were only exemplary (see Solar ¶ 46), is not persuasive
of Examiner error, or that the Examiner lacked articulated reasoning with
rational underpinning to support the legal conclusion of obviousness. See
KSR, 550 U.S. at 418.
In the Reply Brief, Appellant argues that although the Examiner
identifies a working surface in Tu’s Figure 3, “Tu never describes a
‘working surface’ as that term is defined by Applicant’s [S]pecification.”
Reply Br. 1–2. This argument is likewise unpersuasive. Claim 1 recites “a
working surface on the cylindrical portion” of the balloon and Tu’s Figure 3
shows a cylindrical surface similar to that depicted in, for example,
Appellant’s Figures 2, 4, 6, 10, and 11. Appellant does not explain how the
Specification defines “working surface” such that it encompasses
Appellant’s disclosed surfaces but excludes Tu’s. Further, we have been
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instructed that our reviewing court “did not mean that things patent drawings
show clearly are to be disregarded.” In re Mraz, 455 F.2d 1069, 1072
(CCPA 1972).
Appellant also challenges the Examiner’s reliance on Figure 4 of
Appellant’s Specification, stating that this Figure “shows the problem solved
by the present invention,” i.e., “[m]isalignment of the marker bands.” Reply
Br. 2–3. However, the Examiner did not rely on this Figure for the purpose
of identifying the problem. Instead, the Examiner relied on this Figure as an
illustration of the ends of the working surface of the balloon, which this
Figure so readily depicts. See Ans. 10, 11.
Appellant also intimates that the Examiner’s treatment of the claim 1
limitation “for identifying an end of the working surface of the balloon”
as “intended use” (see Ans. 10) is incorrect because “[e]xpress language of
the claim cannot simply be disregarded based on the legally unsupported
proposition that it is entitled to ‘limited’ weight.” Reply Br. 3–4. This
argument is not persuasive because the Examiner did not disregard this
limitation. Instead, the Examiner stated that “Tu and Solar disclose wire and
radiopaque markers that could be put in any location as pointed out by
Solar.” Ans. 10 (referencing Solar ¶¶ 45, 46); see also id. at 12 (regarding
the combination of Spencer and Solar). Further, once the Examiner finds
that the prior art structure would be capable of performing all of the
functions claimed, the burden shifts to the applicant to show that this is not
the case. See In re Schreiber, 128 F.3d 1474, 1478 (Fed. Cir. 1997).
Appellant is not persuasive that the cited combination is unable to function
as claimed. Appellant also understands that “[t]he same argument is made in
relation to the Spencer reference.” Reply Br. 4.
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In summation, and based on the record presented, Appellant does not
apprise us of Examiner error. Accordingly, the rejection of claims 1, 2, 4, 6–
8, 11, 12, 14, 15, 24–27, and 29 as being obvious over Tu and Solar, and the
rejection of claims 1, 2, 5, 6, 9, and 14 as being obvious over Spencer and
Solar, are sustained.

The rejection of claim 16
as obvious over Tu, Solar, and Dror
Appellant does not provide substantive arguments concerning the
rejection of claim 16, and appears to rely on arguments provided for parent
claim 1. See Appeal Br. 4–7. As we are not aware of any deficiencies in the
Examiner’s rejection of independent claim 1 as being obvious over Tu and
Solar, we likewise sustain the Examiner’s rejection of claim 16 as being
obvious over Tu, Solar, and Dror.

The rejection of claims 19 and 30–32
as obvious over Spencer, Solar, and Burgmeier
Appellant does not present arguments regarding claim 19 (which
ultimately depends from claim 1). See Briefs generally. We summarily
sustain its rejection. Appellant argues independent claim 30 and dependent
claims 31 and 32 together. See Appeal Br. 5–7. We select claim 30 for
review, with claims 31 and 32 standing or falling therewith.
Claim 30 requires “means for identifying an end of the working
surface of the balloon.” Appeal Br. 11 (Claims App.). Appellant points out
that claim 30 has a means plus function limitation and states that, according
to examination guidelines, “the application of a prior art reference to a
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means or step plus function limitation requires that the prior art element
perform the identical function specified in the claim.” Appeal Br. 5
(citation omitted). The Examiner relies on Burgmeier for performing the
identical function specified. See Final Act. 20 (referencing Burgmeier “Fig.
2, the radiopaque 40/41 identify the length and two ends of the cylindrical
portion”); see also Ans. 13–16. To be clear, Burgmeier teaches that, as
regarding Figure 2, “radiopaque portion 40 extends within the expandable
balloon portion 28 from adjacent the proximal balloon cone X to adjacent
the distal balloon con[e] Y.” Burgmeier ¶ 45. Appellant does not explain
how this disclosure in Burgmeier, which identifies the ends of the working
surface, differs from the manner recited, i.e., at the ends of the cylindrical
portion of the balloon. See also Ans. 13–16. Additionally, compare, e.g.,
Burgmeier’s Figure 2 with Appellant’s Figures 2, 4, 6, 10, and 11. Hence,
this contention by Appellant is not persuasive.
Appellant also argues that “the present rejection lacks any explanation
as to why a sheath or coating 41 [of Burgmeier] on a catheter shaft is the
equivalent of a wire extending longitudinally along the balloon and attached
to the shaft at the balloon distal end and including a radiopaque portion for
identifying an end of the working surface of the balloon.” Appeal Br. 6.
This argument is not persuasive because Appellant is not arguing the
rejection, i.e., the Examiner only relied on Burgmeier for its explicit manner
of “identifying an end of the working surface of the balloon.” Final Act. 10;
see also Ans. 13. The Examiner relied on the combination of Spencer and
Solar for the other limitations. See Final Act. 10 (“Spencer and Solar
disclose[] essentially every limitation[]”). Thus, this argument by Appellant,
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essentially arguing Burgmeier individually, is not persuasive of Examiner
error.
Appellant further states, “[t]he proposed rejection also lacks a rational
underpinning.” Appeal Br. 6; see also Reply Br. 5. However, Appellant
appears to disregard the reason the Examiner provided for combining
Spencer, Solar and Burgmeier. See Final Act. 10. This contention by
Appellant is not persuasive.
Appellant also argues that “the sheath or coating 41 of Burgmeier
would be provided on the shaft of Solar or Spencer” and “[t]heir wires
would still not identify any end of the working surface.” Appeal Br. 7.
Again, as noted above, Appellant is not responding to the Examiner’s
rejection, which modified “Spencer to identify[] an end of the working
surface of the balloon as taught by Burgmeier.” Final Act. 10.
According, and based on the record presented, the Examiner’s
rejection of claims 19 and 30–32 as being obvious over Spencer, Solar, and
Burgmeier is sustained.

The rejection of claim 20
as obvious over Spencer, Solar, Burgmeier, and Aita
Claim 20 depends, ultimately, from claim 1. Appellant does not
provide substantive arguments concerning this rejection of claim 20. See
Briefs generally. Instead, Appellant appears to rely on arguments provided
with respect to claim 1 above. See Appeal Br. 4–5. As we not aware of any
deficiencies in the Examiner’s rejection above, we likewise sustain the
Examiner’s rejection of claim 20 as being obvious over Spencer, Solar,
Burgmeier, and Aita.
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CONCLUSION
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1, 2, 4, 6–8,
11, 12, 14, 15,
24–27, 29
103(a) Tu, Solar 1, 2, 4, 6–8,
11, 12, 14,
15, 24–27, 29

16 103(a) Tu, Solar, Dror 16
1, 2, 5, 6, 9,
14
103(a) Spencer, Solar 1, 2, 5, 6, 9,
14

19, 30–32 103(a) Spencer, Solar,
Burgmeier
19, 30–32
20 103(a) Spencer, Solar,
Burgmeier, Aita
20
Overall
Outcome
1, 2, 4–9, 11,
12, 14–16,
19, 20, 24–
27, 29–32

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED