Ex Parte Allex et al

Patent Trial and Appeal Board

Sep 17, 2018

12610102 (P.T.A.B. Sep. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/610,102 10/30/2009
28213 7590 09/19/2018
DLA PIPER LLP (US)
4365 EXECUTIVE DRIVE
SUITE 1100
SAN DIEGO, CA 92121-2133
FIRST NAMED INVENTOR
Steven J. Allex
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
R41110-l 9735
EXAMINER
ALEMAN, SARAH WEBB
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/19/2018 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 TRI ST AN LYNN TIE SO
Appeal2016-007940
Application 12/610, 102 1
Technology Center 3700
Before LISA M. GUIJT, BRADLEY B. BAY AT, and
FREDERICK C. LANEY, Administrative Patent Judges.
LANEY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Steven J. Allex et al. (Appellants) appeals under 35 U.S.C. § 134(a)
from the Examiner's decision (filed Jan. 24, 2014 hereinafter "Non-Final
Act.") rejecting claims 66-78. 2 We have jurisdiction over this appeal under
35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is R4 Vascular,
Incorporated. Br. 3. (filed Mar. 2, 2015).
2 Claims 1---65 are canceled. Br. 3.
Appeal2016-007940
Application 12/ 610,102
INVENTION
Appellants' invention "relates generally to medical devices and more
specifically to radiopaque catheter balloons for use with balloon catheters."
Spec. ,r 2.
Claim 66, reproduced below, is independent and representative of the
invention.
66. A radiopaque 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 or non-braided fibers disposed around the
length of the inflation layer;
( 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; and,
( d) a radiopaque material disposed over substantially the
entire length of the outer surface of the inflation 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 to provide the balloon
with a burst pressure of 16 atmospheres or greater.
Br. 13 (Claims App.).
REJECTIONS
I. The Examiner rejected claims 66-78 under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement.
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Application 12/ 610,102
II. The Examiner rejected claims 66-78 under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly
point out and distinctly claim the subject matter which the
inventor regards as the invention.
III. The Examiner rejected claims 66-70 and 74--78 under 35
U.S.C. § I03(a) as unpatentable over Elton (WO 2010/027998
Al; pub. Mar. 11, 2010) and Davies, Jr. et al. (US 7,914,487
B2; iss. Mar. 29, 2011, hereinafter "Davies").
IV. The Examiner rejected claims 71-73 under 35 U.S.C. § I03(a)
as unpatentable over Elton, Davies, and van Sloten et al. (US
2008/0228138 Al; pub. Sept. 18, 2008, hereinafter "van
Sloten").
ANALYSIS
Rejection I - Written Description
The Examiner finds the Specification fails to convey to a skilled
artisan that the applicants had possession of "braided fibers hav[ing] 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," as claim 66 recites. Non-Final Act. 2-
4; Ans. 6-9. The Examiner asserts the written description is silent regarding
the braid pitches in the central and conical regions of the claimed radiopaque
balloon. Non-Final Act. 4. The Examiner also finds the Figures do not
support a finding that the applicants were in possession of this recited
limitation. Id. at 2--4. In particular, the Examiner finds that neither the
originally filed Figure 5, which is a copy of a photograph of a braided fiber
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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. 3 Id. at 2--4; Ans. 6-9. 4
Appellants do 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 Br. 7-8.
Appellants instead rely 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
(Appellants' Exhibit B), Appellants argue both forms of Figure 5 show the
recited pitch ranges for the braided fibers in the central and conical regions.
Id. at 8. We address each form of Figure 5 in tum.
Regarding original Figure 5, the Examiner finds the photo is "unclear"
and lacks the clarity necessary to support a finding the applicants had
3 We note that the clearest copy of the photographic version of Figure 5 is at
Appendix A to the Declaration of Steven J. Allex, which is Appellants'
Exhibit B in the Evidence Appendix.
4 The Examiner did not enter the subsequently submitted replacement
drawing of Figure 5 because it introduced new matter. Non-Final Act. 3.
The Examiner finds that the replacement drawing shows variations in the
pitch of the braided fibers along the length of the balloon, which the original
application does not disclose. Id. Because we determine that the
Examiner's findings that neither the original Figure 5 photograph or the
replacement Figure 5 drawing do not evidence applicants' had possession of
the specifically claimed ranges of pitch angles that claim 66 recites, see
infra, we deem the issue of whether replacement Figure 5 should, or should
not, have been entered to be moot.
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Application 12/ 610,102
possession of specific pitch ranges recited for the braided fibers in the
central and conical regions because "the structure of the braid is distorted by
glare, fading, etc." Non-Final Act. 2. Appellants do not dispute the
Examiner's characterization of the quality of original Figure 5 and, having
considered it ourselves, we agree with the Examiner's characterization.
Appellants' 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." Br. (Evidence App.,
Ex. B, ,r 4) (emphasis added). Although Mr. Allex declares the pitch of the
braids at central and conical regions of the balloon "could have been
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., Ex. B, ,r 5) (emphasis added). Nor
does Mr. Allex explain why the Examiner is mistaken about the quality of
original Figure 5 being too unclear and inadequate to show the specific pitch
angle ranges recited. 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, Appellants have 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 claim 66 recites, which a preponderance of the evidence
supports.
Turning to replacement Figure 5, the Examiner determines this
illustration cannot be relied upon because there is no indication within the
Specification that it was drawn to scale. Non-Final Act. 4; Ans. 7-8 (citing
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Application 12/ 610,102
Hockerson-Halberstadt, Inc. v. Avia Group lnt'l, 222 F.3d 951, 956 (Fed.
Cir. 2000)). Appellants argue the Examiner erred because "[a]n applicant
may show possession of an invention by disclosure of drawings ... that are
sufficiently detailed to show that applicant was in possession of the claimed
invention as a whole." Br. 7 (citing Vas-Cath, Inc. v. Mahurkar, 935 F2d
1555, 1565 (Fed. Cir. 1991)).
Although, under proper circumstances, we agree with Appellants that
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. 5 Thus, relying on replacement Figure 5 on this record would
be contrary to Federal Circuit precedent that "arguments based on drawings
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, Appellants still have not
shown persuasively that replacement Figure 5 shows the claimed ranges of
angles for the braided fibers in the central and conical regions. Having
5 Appellants contend that replacement Figure 5 is a "computer drawn
replica" of the actual device photographed in original Figure 5. Br. 6. Even
accepting this as true, it does not change the fact that Appellants do not
provide any indication that the replacement Figure 5 was drawn to scale in
the written description.
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considered the Allex Declaration ourselves (see Br. 16 (Evidence App., Ex.
B)), we agree with the Examiner's following rationale for why it is
unpersuasive:
Claim 66 recites 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.
Ans. 8. Therefore, we are not persuaded the Examiner's finding that
replacement Figure 5 does not satisfy the written description requirements
for claim 66 was in error.
As a result, for all of the foregoing reasons, we sustain the Examiner's
rejection of claim 66, as well as claims 67-78 depending therefrom, under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
Rejection II-Indefiniteness
Appellants do not present any arguments contesting this rejection in
the Appeal Brief. Thus, Appellants have waived any argument of error. See
37 C.F.R. § 4I.37((c)(iv) ("Except as provided for in§§ 41.41, 41.47 and
41.52, any arguments ... not included in the appeal brief will be refused
consideration by the Board for purposes of the present appeal.").
Accordingly, we summarily sustain the rejection of claims 66-78 under
35 U.S.C. § 112, second paragraph. See In re Berger, 279 F.3d 975, 984,
985 (Fed. Cir. 2002) (holding that the Board did not err in sustaining a
rejection under 35 U.S.C. § 112 when the applicant failed to contest the
rejection on appeal); MPEP § 1205.02, 8th ed., Rev. 8, August 2012 ("[I]f a
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ground of rejection stated by the examiner is not addressed in the appellant's
brief, that ground of rejection will be summarily sustained by the Board.").
Rejections III and IV- Obviousness
In contesting obviousness Rejections III and IV, Appellants group all
of the claims together. Br. 5, 9--11. Like the Appellants, we select claim 66
to decide the appeal of these rejections, with claims 67-78 standing or
falling with claim 66. See 37 C.F.R. § 4I.37(c)(l)(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 66 recites, except "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°."
Non-Final Act. 7; see also Ans. 4--5. The Examiner, however, finds that
"Davies teaches that th[ e] variation in pitch [ of the braided fibers] enhances
the fit of the braided layer over the length of the balloon." Non-Final Act. 6
( citing Davies col. 8, 11. 1-1 7). 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 7 (citing In re Aller,
220 F.2d 454,456 (CCPA 1955)).
Appellants assert 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." Br. 10. According to
Appellants, "no one reading Davies would recognize that specific pitch
parameter on the conical regions as compared to the central region of the
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balloon should be varied." Id. at 10-11. Appellants contend, "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 Appellants." Id. at 11.
Appellants' 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. Appellants
do not dispute the Examiner's finding that the combination of Elton and
Davies disclose the general conditions of the device claim 66 recites. Nor
do Appellants dispute that Davies evidences (see Davies col. 8, 11. 11-14) a
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. 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 Appellants offer attorney argument that 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 Appellants' contention the claimed range of
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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. ,r 33. Therefore, we
sustain the Examiner's obviousness rejection of claim 66, as well as claims
67-78, which fall with therewith.
DECISION
The Examiner's rejections of claims 66-78 are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv).
AFFIRMED
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