William S. Suhr

Patent Trials and Appeals Board

Mar 30, 2020

13579696 - (D) (P.T.A.B. Mar. 30, 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.
13/579,696 11/02/2012 William S. Suhr SUHR-P008 1768
7590 03/30/2020
Henry C. Query, Jr.
504 S. Pierce Avenue
Wheaton, IL 60187
EXAMINER
KNAUSS, CHRISTIAN D
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
03/30/2020 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 WILLIAM S. SUHR
____________

Appeal 2019-002723
Application 13/579,696
Technology Center 3700
____________

Before JENNIFER D. BAHR, MICHAEL L. HOELTER, and
MICHELLE R. OSINSKI, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1, 6–8, and 13.2 We have jurisdiction over the
appeal under 35 U.S.C. § 6(b).

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Dr. William S. Suhr.
Appeal Br. 2.
2 Claims 2–5, 9–12, and 14–16 are cancelled. Appeal Br. 19–20 (Claims
App.). “Claims 17–24 are objected to as being dependent upon a rejected
base claim, but would be allowable if rewritten in independent form
including all of the limitations of the base claim and any intervening
claims.” Non-Final Act. 13.
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We AFFIRM.

THE CLAIMED SUBJECT MATTER
Claims 1 and 13 are independent. Claim 1 is reproduced below.
1. A balloon catheter for use in treating a condition of a vessel
occurring near a bifurcation defined by the intersection of a main
vessel with a side branch vessel, the balloon catheter comprising:
a shaft which includes a proximal end, a distal end and a
side surface;
a single guide wire lumen which extends longitudinally
through the shaft;
a distal port which extends from the guide wire lumen
through the distal end of the shaft;
a side port which extends transversely from the guide wire
lumen through the side surface of the shaft; and
a balloon which is formed separately from the shaft, the
balloon being mounted on the shaft and comprising a first end
which is sealed to the shaft proximally of the side port, a second
end which is sealed to the shaft distally of the side port, an
aperture which is aligned with the side port, and a longitudinal
segment which extends from the first end to the second end and
is entirely sealed to the shaft, said aperture being located in said
longitudinal segment such that a portion of the balloon
surrounding the aperture is sealed to the shaft around the side
port;
wherein the balloon is configured such that, in an inflated
condition the balloon comprises a longitudinal centerline which
is radially offset from a longitudinal centerline of the shaft; and
wherein in use of the balloon catheter a proximal end of a
first guide wire which is pre-positioned in the main vessel is
inserted into the distal port and threaded through the guide wire
lumen toward the proximal end of the shaft and a proximal end
of a second guide wire which is pre-positioned in the side branch
vessel is inserted into the side port and threaded through the
guide wire lumen toward the proximal end of the shaft;
whereby the balloon is guided to the bifurcation on the
first and second guide wires.
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EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:

Name Reference Date
Cragg US 5,795,331 Aug. 18, 1998
Loaldi US 2003/0187494 A1 Oct. 2, 2003
Suhr US 2004/0015231 A1 Jan. 22, 2004

REJECTIONS
I. Claims 1, 7, 8, and 13 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Suhr. Non-Final Act. 3–6.
II. Claims 1, 7, 8, and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Loaldi and Cragg. Id. at 6–11.
III. Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
Loaldi, Cragg, and Suhr. Id. at 11–13.

OPINION
Rejection I
The Examiner finds that Suhr discloses, among other things,
balloon 20 comprising first end 16 sealed to shaft 34 proximally of side
port 30, second end 18 sealed to shaft 34 distally of side port 30, and a
longitudinal segment which extends from first end 16 to second end 18 and
is entirely sealed to the shaft. Non-Final Act. 3. The Examiner also finds
that Suhr discloses, among other things, that when balloon 20 is in an
inflated condition, it comprises a longitudinal centerline that is radially
offset from a longitudinal centerline of shaft 34. Id. at 4. The Examiner
includes an annotated reproduction of a portion of Figure 2 of Suhr to
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illustrate what the Examiner considers to be first end 16, second end 18, and
the longitudinal segment of the balloon, as set forth in the claims. Id. at 4.
Both Suhr’s Figure 2 and the Examiner’s annotated version of a portion of
Suhr’s Figure 2 are reproduced below.

Figure 2 of Suhr
Suhr’s Figure 2 depicts a longitudinal cross sectional view of balloon
catheter 10' in its inflated condition, with balloon catheter 10' including
balloon head 20 that includes first balloon portion 16, second balloon
portion 18, proximal end 22, distal end 24, and midpoint 26. Suhr ¶¶ 10, 19.

Examiner-annotated version of Figure 2 of Suhr
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The Examiner’s annotated version depicts only a central portion of
Suhr’s Figure 2 and includes annotations indicating what the Examiner
determines to be the “longitudinal segment,” “first end proximal seal,” and
“second end distal seal” of balloon 20. Non-Final Act. 4. The Examiner
takes the position that “the claim does not specify the locations of the first
and second ends of the balloon” and “[t]he claim does not specify that the
first end of the balloon is sealed proximally of the side port at the proximal
end of the shaft and distally of the side port at the distal end of the shaft.”
Id. at 5 (boldface and underlining omitted). The Examiner also takes the
position that “the centerline of portion 26 of the balloon is radially offset
from the centerline of the shaft.” Id. at 4.
Appellant argues that “the Examiner’s interpretations of the terms
‘first end’ and ‘second end’ are unreasonable in light of the specification as
it would be interpreted by one of ordinary skill in the art.” Appeal Br. 10–
11. According to Appellant, “[t]he plain and ordinary meaning of the term
‘end’ is ‘the extreme or last part lengthwise.’” Id. at 11 (citing Merriam-
Webster Dictionary). Appellant also points to Figure 1 of the Specification
in which “the first end 26 of the balloon 12 is located at one extreme of the
balloon and the second end 28 is located at the opposite extreme of the
balloon” in support of its proffered interpretation. Id. (citing Spec. Fig. 1).
Appellant argues that in accordance with the proper interpretation of “end,”
“the ‘first end’ of Suhr’s balloon 20 is not the entire first portion 16 of the
. . . balloon” and “the second portion 18 of Suhr’s balloon 20 is not located
at the other longitudinal extreme of the balloon.” Id. at 12. In sum,
Appellant argues that “[u]sing the proper interpretations of the terms ‘first
end’ and ‘second end’, one can clearly see that Suhr does not disclose a
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balloon having a longitudinal segment which extends from the first end of
the balloon to the second end of the balloon and is entirely sealed to the
shaft.” Id. at 12–13.
The Examiner responds that “[r]eading ‘the opposite longitudinal
extremes of the balloon’ into the claims for the terms ‘the first end’ and ‘the
second end’ is not giving the term ‘end’ its broadest reasonable
interpretation.” Ans. 4. The Examiner counters that “[a] more appropriate
interpretation of the term ‘end’ is ‘a part or place at or adjacent to an
extremity.’” Id. (quoting Dictionary.com). The Examiner takes the position
that “the extreme points on the balloon are depicted at 22 and 24[,] and
portions 16 and 18, interpreted by the Examiner as the first end and the
second end, are parts of the balloon adjacent to those extremities” and
“longitudinal segment (at 26) . . . extends from the first end to the second
end.” Id. at 4–5 (citing Suhr Fig. 2, ¶ 19).
During patent prosecution, the USPTO 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). Even assuming arguendo that the Examiner’s
proffered interpretation is the broadest reasonable interpretation, we disagree
with the Examiner that the entirety of portions 16, 18 can each reasonably be
considered an “end” of balloon 20 by virtue of being adjacent to extremities
22, 24, respectively, of balloon 20. Without ascribing any particular cut off
point for the “part” of balloon 20 that can be considered “adjacent” an
extremity in accordance with the Examiner’s interpretation, in our view it is
unreasonable to consider the Examiner-identified sections of balloon
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portions 16, 18 that are actually farthest from extremities 22, 24 of balloon
20 and instead most near midpoint 26 of balloon 20 to be part of an “end” of
balloon 20.
Because it is unreasonable to consider the Examiner-identified “first
end proximal seal” and “second end distal seal” (Non-Final Act. 4) to be
located at “ends” of the balloon, it is also unreasonable to consider the
segment that extends between them to be the claimed “longitudinal segment
which extends from the first end to the second end and is entirely sealed to
the shaft,” as claimed. We agree with Appellant that “Suhr does not disclose
a balloon having a longitudinal segment which extends from the first end of
the balloon to the second end of the balloon and is entirely sealed to the
shaft.” Appeal Br. 12–13.
For the foregoing reasons, Appellant apprises us of error in the
Examiner’s finding that Suhr discloses all of the limitations of independent
claims 1 and 13. We do not sustain the rejection of claims 1 and 13, nor
claims 7 and 8 which depend therefrom, under 35 U.S.C. § 102(b) as
anticipated by Suhr.
Rejection II
Appellant presents arguments for independent claims 1 and 13
together and relies on the same arguments for dependent claims 7 and 8.
Appeal Br. 13–17. We select claim 1 as representative of the issues that
Appellant presents in the appeal, and claims 7, 8, and 13 stand or fall
therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Loaldi teaches many of the limitations of
independent claim 1, but acknowledges that
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Loaldi fails to disclose that the balloon is formed separately from
the shaft, the first end of the balloon sealed to the shaft
proximally of the side port, the second end sealed to the shaft
distally of the side port, an aperture formed in the balloon is
aligned with the side port, and a longitudinal segment which
extends from the first end to the second end and is entirely sealed
to the shaft, said aperture being located in said longitudinal
segment such that a portion of the balloon surrounding the
aperture is sealed to the shaft around the side port.
Non-Final Act. 6–7 (citing Loaldi Figs. 33, 34, 37–40, 56). The Examiner
turns to Cragg, finding that Cragg teaches a balloon catheter comprising
balloon 52 formed separately of shaft 13, with balloon 52 including first end
54 sealed to shaft 13 proximally of side port 60, second end 55 sealed to
shaft 13 distally of side port 60, an aperture aligned with side port 60, and a
longitudinal segment that extends from first end 54 to second end 55 and is
entirely sealed to shaft 13. Id. at 7–8 (citing Cragg Figs. 7, 8C, 17, 18;
12:25–46). The Examiner concludes that it would have been obvious
to modify the balloon catheter disclosed by Loaldi such that th[e]
balloon is formed separately from the shaft, the first end of the
balloon sealed to the shaft proximally of the side port, the second
end sealed to the shaft distally of the side port, . . . and a
longitudinal segment which extends from the first end to the
second end and is entirely sealed to the shaft . . . as taught by
Cragg . . . because applying a known technique (the
manufacturing process of the balloon catheter taught by Cragg)
to a known device (the balloon catheter disclosed by Loaldi) to
yield predictable results (forming a balloon having a longitudinal
centerline that is offset from the longitudinal centerline of the
catheter shaft, wherein a first end of the balloon is sealed to the
shaft proximally of the side port, a second end is sealed to the
shaft distally of the side port, . . . and a longitudinal segment
which extends from the first end to the second end and is entirely
sealed to the shaft . . . ) would have been recognized by one
having ordinary skill in the art at the time the invention was
made.
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Non-Final Act. 8–9.
Appellant argues that “Cragg does not disclose a balloon catheter in
which the balloon has a longitudinal segment which extends from the first
end of the balloon to the second end of the balloon and is entirely sealed to
the shaft.” Appeal Br. 15. More particularly, Appellant asserts that
“Cragg’s balloon catheter includes a pair of radiopaque markers 15, 17
which are mounted concentrically on the shaft 13 on opposite sides of the
side port 60” and “prevent the longitudinal segment from being entirely
sealed to the shaft between the first and second ends 54, 56.” Id. According
to Appellant, “instead of providing a balloon catheter in which the entire
longitudinal segment of the balloon is sealed to the shaft, Cragg teaches that
only certain portions of the longitudinal segment are sealed to the shaft.”
Reply Br. 5. The Examiner responds that “[t]he Examiner is relying on
Cragg as a teaching reference to teach a sealed attachment configuration
between a balloon and a shaft that was known in the art at the time the
invention was made” and “the Examiner did not propose modifying Loaldi
to include radiopaque markers on the surface of the shaft.” Ans. 7.
Cragg discloses an embodiment in which “a minor circumferential
interior section of the tubular balloon [52'] i[s] adhered along the outer
surface of tube 13 (FIG. 8C) so that the balloon 52' only inflates around the
major circumference of the distal end segment 16” of catheter body 12, and
“[t]he delivery exit ports 60 and 60' . . . are . . made . . . through the adhered
balloon wall 52' and outer tube 13.” Cragg 12:33–42. We agree with the
Examiner that, applying such a teaching to the device of Loaldi (Figs. 33,
34, 37–40, 56) would result in the modified Loaldi device including a
balloon having a longitudinal segment extending from a first end to a second
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end of a balloon that is entirely sealed to the shaft. This is because Loaldi
lacks any such structure, such as radiopaque markers, that would be disposed
between the longitudinal segment of balloon 5 and shaft 2. Moreover,
Appellant does not offer any evidence to support the position that “the
radiopaque markers 15, 17 create weak points in the seal between the
longitudinal segment and the shaft 13” due to radiopaque markers 15, 17
preventing the longitudinal segment from being entirely sealed to the shaft
(Appeal Br. 15). In this regard, Appellant’s assertion amounts to attorney
argument unsupported by evidence, and, thus, is entitled to little, if any,
weight. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); see also In re
Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (An attorney’s arguments in a
brief cannot take the place of evidence.).
Appellant also argues that modifying Loaldi so (i) as to form its
balloon 5 separately from its shaft 2, (ii) that its balloon 5 includes a first
end which is sealed to shaft 2 proximally of side port 15, (iii) that its balloon
5 includes a second end which is sealed to shaft 2 distally of side port 15,
and (iv) that its balloon 5 includes a longitudinal segment which extends
from the first end to the second end and is entirely sealed to shaft 2 “would
render Loaldi inoperable for its intended purpose.” Appeal Br. 16. More
particularly, Appellant argues that “if the balloon [5] were to be formed as a
separate member having first and second ends that are sealed to the shaft 2,
the interior volume of the balloon [5] would be isolated from the inflation
lumen 18 by the shaft 2 itself” and “the balloon could not be inflated, thus
rendering the modified balloon catheter inoperable for its intended purpose.”
Id. at 16–17.
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The Examiner responds that “one having ordinary skill in the art
would recognize that modifying a balloon catheter having a separate balloon
sealed to the catheter shaft would require alternate inflation means than a
balloon that is formed integrally with the shaft.” Ans. 7–8. More
particularly, the Examiner points to Cragg’s teaching “that the balloon
catheter comprises an inflation/deflation lumen (18) with inflation/deflation
holes (58) in fluid communication with the interior of the balloon to
inflate/deflate the balloon.” Id. at 8 (citing Cragg Figs. 7, 8C, 18).
Appellant replies that “the Examiner appears to be relying on hindsight to
rectify the failings of the proposed modification” and that “[i]f one of
ordinary skill in the art had the benefit of the present application, that person
could certainly modify Loaldi’s balloon to make [Appellant’s] claimed
invention[, but] this would be improper.” Reply Br. 6. Appellant’s
argument is unavailing because Appellant does not point to any knowledge
relied on by the Examiner that was gleaned only from Appellant’s disclosure
and that was not otherwise within the level of ordinary skill in the art at the
time of the invention, thereby failing to support Appellant’s hindsight
assertion. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (“Any
judgment on obviousness is in a sense necessarily a reconstruction based
upon hindsight reasoning, but so long as it takes into account only
knowledge which was within the level of ordinary skill at the time the
claimed invention was made and does not include knowledge gleaned only
from applicant’s disclosure, such a reconstruction is proper.”). Here, Cragg
itself provides an example of an alternate inflation means for a balloon
catheter having a separate balloon sealed to the catheter shaft that utilizes
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openings through the outer wall of the catheter body to the interior space of
the balloon. See, e.g., Cragg 9:39–50.
Appellant also argues that “the Examiner has provided no support for
the proposition that the person of ordinary skill in the art would have a valid
reason to first, form Loaldi’s balloon as a separate component and second,
provide the shaft with apertures to connect the inflation lumen with the
interior of the balloon.” Reply Br. 6. According to Appellant, “[f]aced with
such a prospect, the person of ordinary skill in the art would be more
inclined to just leave Loaldi’s balloon the way it is.” Id. The Supreme
Court has rejected a rigid teaching, suggestion, or motivation requirement to
combine known elements in order to show obviousness. See In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006) (cited with approval in KSR Int’l Co. v.
Teleflex, Inc., 550 U.S. 398, 418 (2007) (“[R]ejections on obviousness
grounds . . . [require] some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.”). In this case,
the modification to Loaldi’s balloon catheter proposed by the Examiner is
based on the application of “a known technique (the manufacturing process
of the balloon catheter taught by Cragg) to a known device (the balloon
catheter disclosed by Loaldi) to yield predictable results (forming a balloon
having a longitudinal centerline that is offset from the longitudinal centerline
of the catheter shaft . . .).” Non-Final Act. 8. Thus, the Examiner articulates
reasoning having rational underpinnings, and Appellant does not sufficiently
identify any flaw in the Examiner’s reasoning.
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s conclusion that the combination of Loaldi and Cragg renders
obvious the subject matter of independent claim 1. We sustain the rejection
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of claim 1, and claims 7, 8, and 13 falling therewith, under 35 U.S.C. § 103
as unpatentable over Loaldi and Cragg.
Rejection III
Appellant relies on the same arguments and reasoning we found
unpersuasive in connection with independent claim 1 as the basis for seeking
reversal of the rejection of claim 6. Appeal Br. 17. Accordingly, for the
same reasons discussed above in connection with the rejection of claim 1,
we also sustain the rejection of claim 6 under 35 U.S.C. § 103(a) as
unpatentable over Loaldi, Cragg, and Suhr.

CONCLUSION
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1, 7, 8, 13 102(b) Suhr 1, 7, 8, 13
1, 7, 8, 13 103(a) Loaldi, Cragg 1, 7, 8, 13
6 103(a) Loaldi, Cragg, Suhr 6
Overall
Outcome
1, 6–8, 13

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