Steven J. Allex et al.

Patent Trials and Appeals Board

Jan 2, 2020

14340407 - (D) (P.T.A.B. Jan. 2, 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.
14/340,407 07/24/2014 Steven J. Allex R41110-2 5309
28213 7590 01/02/2020
DLA PIPER LLP (US)
4365 EXECUTIVE DRIVE
SUITE 1100
SAN DIEGO, CA 92121-2133
EXAMINER
ALEMAN, SARAH WEBB
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
01/02/2020 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):
gtdocket@dlapiper.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte STEVEN J. ALLEX, DONALD GEER,
BRETT ALLYN WILLIAMS, BRADY JON HATCHER,
and TRISTAN LYNN TIESO

____________

Appeal 2018-001068
Application 14/340,407
Technology Center 3700
____________

Before LISA M. GUIJT, BRADLEY B. BAYAT, and
FREDERICK C. LANEY, Administrative Patent Judges.

LANEY, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision (filed Feb. 4, 2016 hereinafter “Final Act.”) rejecting claims 1–13.2
We have jurisdiction over this appeal 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 Vector Corp., LLC, as the real party
in interest. Appeal Br. 3. (filed Mar. 7, 2017).
2 Claim 14 has been canceled. Appeal Br. 12.
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INVENTION
Appellant’s invention “relates generally to medical devices and more
specifically to radiopaque catheter balloons for use with balloon catheters.”
Spec. ¶ 2.
Claim 1, reproduced below, is the sole independent claim and is
representative of the invention.
1. A balloon for use with an intraluminal catheter,
comprising:
(a) an inflation layer, consisting of a compliant polymeric
cylinder having a central region ending in opposing conical
regions, said cylinder defining an outer surface and an inner
lumen for retention of inflation fluid;
(b) a fiber layer, consisting of at least two layers of
inelastic, braided fibers disposed around the length of the
inflation layer; and
(c) at least one coating layer, consisting of at least one
adhesive disposed to affix the fiber layer to the inflation layer,
wherein at least one adhesive penetrates the fiber layer to form
the at least one coating layer,
wherein the braided fibers have a pitch with respect to one
another between 65° and 75° along the central region of the
balloon and a pitch with respect to one another between 35° and
45° at both conical regions of the balloon when inflated to
provide the balloon with a burst pressure of 16 atmospheres or
greater.
Appeal Br. 11 (Claims App.).
REJECTIONS
I. The Examiner rejected claims 1–5 and 9–13 under 35 U.S.C.
§ 103(a) as unpatentable over Elton (WO 2010/027998 A1;
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pub. Mar. 11, 2010) and Davies, Jr. et al. (US 7,914,487 B2;
iss. Mar. 29, 2011, hereinafter “Davies”).3
II. The Examiner rejected claims 6–8 under 35 U.S.C. § 103(a) as
unpatentable over Elton, Davies, and van Sloten et al. (US
2008/0228138 A1; pub. Sept. 18, 2008, hereinafter “van
Sloten”).

ANALYSIS
Before we reach the Examiner’s obviousness rejections of claims 1–
13, we first turn to Appellant’s argument that the Examiner’s objection to
marked up Figure 5, which includes a legend showing a range of pitch
angles for different portions of the balloon device shown. “[T]he kind of
adverse decisions of [E]xaminers which are reviewable by the [B]oard must
be those which relate, at least indirectly, to matters involving the rejection of
claims.” In re Hengehold, 440 F.2d 1395, 1403-04 (CCPA 1971). Because
the Examiner finds marked up Figure 5 introduces new matter, which is
matter that is also found in the claims rejected in this appeal, we determine
that it is within our purview to address the Examiner’s objection to marked
up Figure 5.
The Examiner finds the Specification fails to convey to a skilled
artisan that Appellant had possession of braided fibers having a pitch with
respect to one another between 65° and 75° along the central region of the
balloon and a pitch with respect to one another between 35° and 45° at both

3 We note that the Examiner provides a heading for this rejection that
identifies 35 U.S.C. § 103, but states claims 1–5 and 9–13 are anticipated by
Elton and Davies. Final Act. 4. We understand the Examiner’s reference to
anticipation to be a typographical error.
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conical regions of the balloon, as claim 1 recites. Final Act. 3. The
Examiner asserts the written description is silent regarding the braid pitches
in the central and conical regions of the claimed radiopaque balloon. Id.
The Examiner also finds the Figures do not support a finding that Appellant
was in possession of this recited limitation. Id. In particular, the Examiner
finds that neither the originally filed Figure 5, which is a copy of a
photograph of a braided fiber sheath (hereinafter “original Figure 5”), nor
the subsequently submitted (filed Oct. 30, 2013) replacement Figure 5,
which is a drawing of the photographed braided fiber sheath (hereinafter
“replacement Figure 5”), are sufficient to evidence the braided fibers with
the recited range of pitches at the central and conical regions. Id.
Appellant does not dispute the fact that the written description lacks
any reference to using a specific range of pitches for the braided fibers at the
central and conical regions of the disclosed radiopaque balloon. See Appeal
Br. 5–6. Appellant instead relies solely on Figure 5, in either its
photographic or drawing form, as evidence that the applicants possessed the
claim ranges of pitch for the braided fibers. Offering the Declaration of
Steven J. Allex (Appellant’s App’x D), Appellant argues both forms of
Figure 5 show the recited pitch ranges for the braided fibers in the central
and conical regions. Id.
Appellant’s expert, Mr. Allex, declares, “a skilled artisan . . . would
have been able to determine the braided orientation including pitch angles
from [the] originally filed Figure 5 . . . by conventional methods which were
known and customary in the art at the time of filing.” Appeal Br. (Evidence
App’x D ¶ 4) (emphasis added). Although Mr. Allex declares the pitch of
the braids at central and conical regions of the balloon “could have been
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routinely determined from originally filed Figure 5,” he does not represent
that he actually took any steps to determine the pitch of the braids from the
original Figure 5. Id. (Evidence App’x D, ¶ 5) (emphasis added). Mr.
Allex’s conclusory remarks about what a skilled artisan “could have” done
or “would have been able” to do has little, if any, evidentiary value.
Therefore, Appellant has not persuasively rebutted the Examiner’s
determination that original Figure 5 lacks the clarity necessary to the satisfy
the written description requirement for the specific range of pitch angles
shown in marked up Figure 5, which a preponderance of the evidence
supports.
Turning to replacement Figure 5, this illustration cannot be relied
upon because there is no indication within the Specification that it was
drawn to scale. Ans. 2; see Hockerson-Halberstadt, Inc. v. Avia Group lnt’l,
222 F.3d 951, 956 (Fed. Cir. 2000). Although, under proper circumstances,
drawings alone may provide a “written description” of an invention as
required by the first paragraph of 35 U.S.C. § 112, we do not agree this case
presents the proper circumstances. These are not the proper circumstances
because it would require evaluating replacement Figure 5 for precise
dimensional attributes, rather than approximations, and there is no dispute
the written specification is devoid of any indication replacement Figure 5 is
drawn to scale.4 Thus, relying on replacement Figure 5 on this record would
be contrary to Federal Circuit precedent that “arguments based on drawings

4 Appellant contends that replacement Figure 5 is a “computer drawn
replica” of the actual device photographed in original Figure 5. Appeal Br.
6. Even accepting this as true, it does not change the fact that Appellant
does not provide any indication that the replacement Figure 5 was drawn to
scale in the written description.
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not explicitly made to scale . . . are unavailing.” Nystrom v. Trex Co., 424
F.3d 1136, 1149 (Fed. Cir. 2005) (citing Hockerson-Halberstadt, Inc., 222
F.3d at 956; In re Wright, 569 F.2d 1124, 1127 (CCPA 1977)).
However, even if the proper circumstances were present in this case
and replacement Figure 5 could be relied upon, Appellant still has not shown
persuasively that replacement Figure 5 shows the claimed ranges of angles
for the braided fibers in the central and conical regions. Having considered
the Allex Declaration ourselves (Evidence App’x D), marked up Figure 5
shows a range for the braid pitch in a central region and a second range for
the braid pitch of the conical regions. A measurement of a braid angle at a
specific point, as shown in Appendix C of the Allex Declaration, would
result in a single angle, such as 67°. A measurement at a specific point of
the replacement drawing cannot be relied upon for the claimed ranges of
angles. Therefore, we are not persuaded the Examiner’s objection to marked
up Figure 5 as introducing new matter was in error.
As a result, for all of the foregoing reasons, we sustain the Examiner’s
objection to marked up Figure 5.
Rejections I and II – Obviousness
In contesting obviousness Rejections I and II, Appellant groups all of
the claims together. Appeal Br. 4. Like the Appellant, we select claim 1 to
decide the appeal of these rejections, with claims 2–13 standing or falling
with claim 66. 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).
The Examiner determines that the combined teachings of Elton and
Davies discloses the combination of elements claim 1 recites, except the
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specific pitch of the braided fibers in the central region to be in the range of
65–75° and the pitch in the conical regions to be in the range of 34–45°.
Final Act. 4–5. The Examiner, however, finds that “Davies teaches that the
pitch (braid angle A) may vary over the surface of the balloon to provide the
best fit for the braided layer (column 8, lines 1-17).” Id. at 5. The Examiner
determines the claimed ranges are not an inventive distinction over the prior
art because, at most, they are the discovery of optimum or workable ranges
that are within the capabilities of a skilled artisan and involve only routine
skill. Id. at 5 (citing In re Aller, 220 F.2d 454, 456 (CCPA 1955)).
Appellant asserts that the Examiner is mistaken because Davies gives
no direction “as to where along the balloon variations should be made” or
“as to what kind of variations should be made.” Appeal Br. 8. According to
Appellant, “no one reading Davies would recognize that specific pitch
parameter on the conical regions as compared to the central region of the
balloon should be varied.” Id. Appellant contends, “even if one were to
experiment with variations to pitch, nothing but serendipity would produce
the pitches producing the claimed burst pressures as unexpectedly
discovered and claimed by Appellant.” Id. at 9.
Appellant’s argument is unpersuasive because it fails to undermine
the Examiner’s determination that selecting “the specific pitch of the braided
fibers in the central region to be in the range of 65–75° and the pitch in the
conical regions to be in the range of 34–45°” is nothing more than an
application of the ordinary skill possessed by an artisan. Ans. 4. Appellant
does not dispute the Examiner’s finding that the combination of Elton and
Davies discloses the general conditions of the device claim 1 recites. Nor
does Appellant dispute that Davies evidences (see Davies col. 8, ll. 11–14) a
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skilled artisan knew varying the pitch angles of the braided fibers “from
location to location over the surface of the balloon” could enhance the fit of
the braided layer over the length of the balloon. Ans. 4. Thus, the Examiner
has established the pitch angles of the braided fibers at different locations of
the balloon were known to be “result-effective variables.” “[W]here the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation.” In
re Applied Materials Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (quoting In
re Aller, 220 F.2d at 456).
Although Appellant offers attorney argument that the claimed
configuration of pitch angles for the braided fibers at the central and conical
regions provides “unexpected results,” such conclusory remarks without any
evidentiary support have little, if any, probative value. Furthermore, the
Specification does not support Appellant’s contention the claimed range of
pitch angles enable the claimed burst. The Specification states, “the braided
sleeve may be formed from inelastic fibers of any configuration, e.g., fibers
of single or multiple threads, so long as the formed braided sheath prevents
radial distortion of the [inflated] balloon.” Spec. ¶ 33. Therefore, we
sustain the Examiner’s obviousness rejection of claim 1, as well as claims 2–
13, which fall with therewith.
CONCLUSION
The rejections of claims 1–13 under 35 U.S.C. § 103(a) are affirmed.
In addition, we sustain the Examiner’s objection to marked up Figure 5 that
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includes legends to identify specific ranges of variance in the braid angles at
different locations of the balloon device shown.

DECISION SUMMARY

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

Claims
Rejected
Basis Affirmed Reversed
1–5, 9–13 § 103 Elton, Davies 1–5, 9–13
6–8 § 103 Elton, Davies,
van Sloten
6–8
Overall Outcome 1–13