Ex Parte VOLZ

Patent Trial and Appeal Board

Nov 5, 2018

13168032 (P.T.A.B. Nov. 5, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/168,032 06/24/2011
20995 7590 11/07/2018
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
KIM VOLZ
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.
EKOS.243A 9261
EXAMINER
CWERN, JONATHAN
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
11/07/2018 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KIM VOLZ
Appeal2017-009203
Application 13/168,032
Technology Center 3700
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to an
ultrasound catheter system. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"[U]ltrasonic energy is delivered to the treatment site to enhance the
effect and/or delivery of [a] therapeutic compound" (Spec. ,r 2). The
1 Appellant identifies the Real Party in Interest as EKOS CORPORATION
(see App. Br. 3).
2 We have considered and herein refer to the Specification of June 24, 2011
("Spec."); Final Office Action of Oct. 12, 2016 ("Final Act."); Appeal Brief
of Feb. 9, 2017 ("App. Br."); and Examiner's Answer of Mar. 30, 2017
("Ans.").
Appeal2017-009203
Application 13/168,032
Specification teaches "[ w ]hile such ultrasound catheter[] systems have been
proven to be successful, there is a general need to improve the effectiveness
and speed of such systems" (Spec. ,r 4).
The Claims
Claims 1-8 are on appeal. Independent claim 1 is representative and
reads as follows:
1. An ultrasound catheter system comprising:
a catheter having at least one ultrasonic element; and
a control system configured to provide an oscillating
electrical signal pattern that drives the at least one ultrasonic
element to generate ultrasonic energy, the oscillating electrical
signal pattern having only one of a rise or a fall rate greater than
a sinusoidal waveform of the same amplitude and fundamental
frequency as the oscillating electrical signal pattern.
The Issue
The Examiner rejected claims 1-8 under 35 U.S.C. § I03(a) as
obvious over Wilson, 3 Fujimoto, 4 Mattiuzzi, 5 Schleuniger, 6 Shields, Jr., 7
Tepper, 8 Tsaliovich, 9 Tuszynski, 10 and Umemura 11 (Final Act. 2-5).
3 Wilson, US 2004/0199228 Al, published Oct. 7, 2004.
4 Fujimoto et al., US 5,694,936, issued Dec. 9, 1997.
5 Mattiuzzi et al., US 2010/0280505 Al, published Nov. 4, 2010.
6 Schleuniger et al., US 2004/0171970 Al, published Sept. 2, 2004.
7 Shields, Jr., US 2007/0249969 Al, published Oct. 25, 2007.
8 Tepper et al., US 5,524,624, issued June 11, 1996.
9 Tsaliovich, US 6,544,259 B 1, issued Apr. 8, 2003.
10 Tuszynski et al., US 2005/0249667 Al, published Nov. 10, 2005.
11 Umemura et al., US 5,523,058, issued June 4, 1996.
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Application 13/168,032
The issue with respect to this rejection is:
(i) Does the evidence of record support the Examiner's conclusion
that the prior art suggests a control system configured to provide an
"oscillating electrical signal pattern having only one of a rise or a fall rate
greater than a sinusoidal waveform" as required by claim 1?
(ii) If so, has Appellant presented evidence of secondary
considerations that, when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
Findings of Fact
1. The Specification teaches "[i]n some embodiments, the leading
edge of the electrical drive has a decreased rise rate compared to a sinusoidal
wave, and the trailing edge of the electrical drive has an increased fall rate
compared to that of a sinusoidal wave. A sawtooth waveform is this type of
drive signal" (Spec. ,r 119).
2. Claim 4, which depends from claim 1, states "the oscillating
electrical signal pattern comprises a sawtooth waveform" (App. Br. 14).
3. Wilson teaches "ultrasonic catheters configured to deliver
ultrasonic energy and a therapeutic compound to a treatment site" (Wilson
4. Wilson teaches
the ultrasonic catheter 10 generally comprises a multi-
component, elongate flexible tubular body 12 ... [that]
includes a flexible energy delivery section 18 . .. A backend
hub 33 is attached ... comprising a proximal access port 31 ...
The proximal access port 31 can be connected to control
circuitry 100 via cable 45.
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(Wilson ,r 54). Wilson teaches: "In certain embodiments, a cooling fluid is
introduced ... the flow rate of the cooling fluid and the power to the
ultrasound assembly 42 can be adjusted to maintain the temperature of the
inner core energy delivery section 41 within a desired range" (Wilson ,r 84).
5. Wilson teaches "ultrasonic energy can be emitted in waveforms
having various shapes, such as sinusoidal waves, triangle waves, square
waves, or other wave forms" (Wilson ,r 67).
6. Fujimoto teaches "an ultrasonic treatment apparatus
comprising: an ultrasonic source for generating an ultrasonic treatment
wave; and driving means for driving the ultrasonic source" (Fujimoto 2:34--
37).
7. Figure 4B of Fujimoto is reproduced below:
•t; to+ t12l
tj t => fO ~ fo- f12
48
--TIME
FIG.
Fujimoto teaches that changes in Figure "4B may be used as a change in
frequency along the time axis ... the driving signal changes in the form of a
saw-tooth wave" (Fujimoto 7:52-57).
8. Mattiuzzi teaches a "mechanical pressure wave generated by a
source of acoustic waves particularly ultrasound ones. In this case low
frequency ultrasound waves and with triangular or sawtooth pulse
arrangement are advantageous" (Mattiuzzi ,r 31 ).
9. Schleuniger teaches "replaceable emitting head 1 of a hand-held
device for emission of ultrasonic therapeutic signals" (Schleuniger ,r 18).
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10. Schleuniger teaches the "ultrasonic power emitted is
advantageously modulated. The modulation may be saw-tooth, square-wave
or sinusoidal" (Schleuniger ,r 47).
11. Shields, Jr. teaches "an ultrasound therapy device for delivering
ultrasonic treatment to a biological entity. The ultrasound therapy device
includes a waveform generator, one or more transducers, one or more
sensors, and a controller" (Shields, Jr. ,r 11 ).
12. Shields, Jr. teaches "the waveform generator 26 may generate a
first signal having varying characteristics including, for example ... single-
sine waveforms, multi-sine waveforms, frequency-swept sine waveforms,
step waveforms, pulse waveforms, square waveforms, triangular waveforms,
saw-tooth waveforms" (Shields, Jr. ,r 53).
13. Tepper teaches "an apparatus ... for both stimulating and
imaging with ultrasound a tissue at a selected site within a patient" (Tepper
3:46-47).
14. Tepper teaches "[s]ignal generator 52 includes an oscillator 62
for generating, in response to controller 58, a desired waveform. Oscillator
62 can produce the waveform to have a desired waveshape, such as a sine
wave, square wave, sawtooth wave" (Tepper 6:65 to 7:2).
15. Tsaliovich teaches:
A source of sonic waves can be additionally provided to
advantageously contribute to the effectiveness of the device.
The sonic source can be designed as a separate audio oscillator
with a range, for example, from about 5 kHz to about 15 kHz,
or combined with the oscillator of ultrasound waves. In the
latter case, a traditional waveform generator (square-wave,
sawtooth, triangle, etc.) can be conveniently used that is capable
of producing a signal.
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(Tsaliovich 4:50-57).
16. Tuszynski teaches a "process for synergistically combining
sonic energy and other forms of energy, or other therapeutic agents, in the
treatment of cells in living organisms" (Tuszynski ,r 8).
1 7. Tuszynski teaches
One skilled in the art can determine the proper cycle of
the ultrasound, proper intensity of the ultrasound, and time to
be applied in each specific case based on experiments using an
animal as a model. ...
In addition, one skilled in the art can determine the
excitation source frequency of the mechanical vibrational
energy source .... the shape of the frequency can be of
different types. For example, the frequency can be in the form
of a square pulse, ramp, sawtooth, sine, triangle, or complex.
(Tuszynski ,r,r 746-747).
18. Umemura teaches "an ultrasonic therapeutic apparatus suitable
for medical treatment of malignant tumors and medical treatment of thrombi
and calculi, an ultrasonic diagnostic apparatus" (Umemura 1:8-11).
19. U memura teaches:
a drive circuit operated as usual with a drive waveform
in the form of a sine wave or a rectangular wave having good
symmetry is unsuitable for generating ultrasonic waves of
frequencies of even multiples from the piezoelectric vibrator
element because the drive waveform does not contain
frequencies of even multiples of the fundamental frequency
and therefore it is necessary to contrive a drive circuit which is
operated with a drive waveform in the form of a waveform
containing intended frequency components ....
A second expedient concerning the drive circuit is that
in place of a rectangular wave, a sawtooth wave or a stepped
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Application 13/168,032
wave simulating the sawtooth wave is used as the drive
waveform.
(U memura 14: 3-18).
20. Umemura teaches
the case where a sawtooth wave or a stepped wave simulating
the sawtooth wave is used as the drive waveform will be
described. Since it is well known that the sawtooth wave has
frequency components of even multiples of the fundamental
frequency, the stepped wave simulating the sawtooth wave will
be described herein.
(Umemura 15 :20-25).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417. "A person of ordinary skill is also a person of
ordinary creativity, not an automaton." Id. at 421.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2-5; FF 1-20) and agree that
the claims are rendered obvious by the prior art. We address Appellant's
arguments below.
Prima facie obviousness
Appellant contends "a sawtooth waveform would not have been an
obvious design choice to one of ordinary skill in the art" (App. Br. 6).
Appellant specifically contends that
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(Id.).
To produce a non-symmetrical sawtooth waveform would
require an input of energy at both odd AND even harmonics.
This would generally reduce the efficiency of the transducers
and would potentially require added complexity in the drive
system. Therefore, the use of a non-symmetrical sawtooth
waveform would not be viewed as an obvious design goal by
one of ordinary skill in the art.
We find this argument unpersuasive because Wilson broadly teaches
that "ultrasonic energy can be emitted in waveforms having various shapes"
(FF 5) and each of the other eight cited references teaches the use of
sawtooth waveforms for ultrasonic treatment (FF 7, 8, 10, 12, 14, 15, 17, 19,
20). Moreover, Tuszynski specifically teaches that "one skilled in the art
can determine the excitation source frequency of the mechanical vibrational
energy source .... For example, the frequency can be in the form of a ...
sawtooth" (FF 17). Tuszynski evidences that the ordinary artisan can select
known equivalent frequencies for ultrasound including sawtooth waves,
along with choosing other parameters including intensity, cycle and
application time (FF 17). Umemura evidences that the ordinary artisan
knew how to generate sawtooth waves (FF 20). To the extent that sawtooth
waves would require adjustments relative to sinusoidal waves due to
complexity or efficiency requirements does not diminish the obviousness of
using a waveform recognized by eight references as suitable for ultrasonic
treatment (FF 7, 8, 10, 12, 14, 15, 17, 19, 20). Thus, the overwhelming
weight of evidence supports the Examiner's position that "Wilson
recognizes that it would be acceptable to modify the invention in such a
fashion with different waveforms already. The changes to the system would
be within the level of one of ordinary skill in the art to account for" (Ans. 3).
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Appellant contends "the reduction of efficiency of an ultrasound
transducer would result in the generation of undesirable heat within the body
that can damage internal tissue. Wilson discloses that the generation of heat
in the body from the ultrasound elements is undesirable" (App. Br. 7).
Appellant contends, "[i]ndeed, Wilson discloses at paragraphs [0084] and
[0129] that the catheter has a cooling systems to maintain the temperature of
the catheter within a desired range" (id.).
We find this argument unpersuasive for several reasons. First, the
Genstler Declaration 12 does not state that undesirable heat would be formed
using a sawtooth wave or that reduced efficiency would necessarily result in
increased heat (see Genstler Deel. ,r 6). Thus, the idea that reduced
efficiency would result in increased heat is solely attorney argument without
evidentiary support. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)
("Attorney's argument in a brief cannot take the place of evidence.").
Second, we agree with the Examiner that:
It is clear from Wilson that the problem relating to excess heat
caused by ultrasound transducers was known in the art, and that
a solution is provided for this problem in the form of the
cooling system. Any additional heat generated by the use of a
sawtooth waveform would thus be accounted for by the cooling
system of Wilson.
(Ans. 4). Third, Wilson expressly recognizes that cooling is optimizable,
teaching "the flow rate of the cooling fluid and the power to the ultrasound
assembly 42 can be adjusted to maintain the temperature of the inner core
energy delivery section 41 within a desired range" (FF 4). Therefore, to the
12 Declaration of Curtis Genstler, dated Sept. 15, 2015.
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extent that sawtooth waveforms resulted in heating, Wilson teaches how to
control temperature (FF 4).
Appellant contends
[a]s there is no indication in Wilson, or any of the other
references cited by the Final Office Action, that there would be
a benefit to using a waveform "wherein one of the rise or fall
rate is greater than the corresponding rate in a sinusoidal
waveform of the same amplitude and fundamental frequency,"
Applicant respectfully submits that one of ordinary skill in the
art would not be motivated to use a sawtooth waveform.
(App. Br. 7).
We are not persuaded. In KSR, the Supreme Court rejected the rigid
application of the teaching, suggestion, and motivation test by the Federal
Circuit, stating that
The principles underlying [earlier] cases are instructive
when the question is whether a patent claiming the
combination of elements of prior art is obvious. When a
work is available in one field of endeavor, design incentives
and other market forces can prompt variations of it, either in
the same field or a different one. If a person of ordinary
skill can implement a predictable variation, § 103 likely bars
its patentability.
KSR, 550 U.S. at 417. We agree with the Examiner that the ordinary artisan,
informed by Wilson that different shape waveforms could be utilized (FF 5),
would have selected predictable variations which include sawtooth
waveforms that were known to be equivalent to sinusoidal waves as
evidenced by the cited prior art. Specifically, Fujimoto teaches "a saw-tooth
wave" (FF 7); Mattiuzzi teaches "ultrasound waves ... with triangular or
sawtooth pulse arrangement are advantageous" (FF 8); Schleuniger teaches
the "ultrasonic power emitted is advantageously modulated. The modulation
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may be saw-tooth, square-wave or sinusoidal" (FF 1 O); Shields, Jr. teaches
"square waveforms, triangular waveforms, saw-tooth waveforms" (FF 12);
Tepper teaches "the waveform to have a desired waveshape, such as a sine
wave, square wave, sawtooth wave" (FF 14); Tsaliovich teaches "a
traditional waveform generator (square-wave, sawtooth, triangle, etc.) can be
conveniently used" (FF 15); Tuszynski teaches "the frequency can be in the
form of a square pulse, ramp, sawtooth, sine, triangle, or complex" (FF 1 7);
and Umemura suggests a sawtooth wave (FF 19). Thus, the evidence
demonstrates that a sawtooth wave was a predictable variation of the various
waveforms disclosed by Wilson (FF 7).
Secondary considerations
Appellant contends the "present application discloses [an] unexpected
result in paragraphs [0141] to [0146]. ... A Neurowave (sine wave) and a
'sawtooth' wave ... were both tested for efficacy" (App. Br. 8). Appellant
argues that the Specification provided data which looked at the bioefficiency
of ultrasound protocols on enzyme mediated thrombolysis and quantified it
in terms of the lysis enhancement factor ("LEF"). Id.
(Id.).
Appellant contends
The sine wave showed a 25.81 LEF% at 1.0 Vpp and a 26.10
LEF% at 2.5 Vpp. By contrast, the "sawtooth" wave showed a
44.27 LEF% at 1.0 Vpp and a 38.25 LEF% at 2.5 Vpp.
Compared to the sine wave, the "sawtooth" wave showed a
170% increase in LEF% at 1.0 Vpp and a 150% increase in
LEF% at 2.5 Vpp.
We have considered the asserted evidence but find it unpersuasive of
unexpected results. The "LEF%" with the 150% and 170% increases does
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not directly compare the results of the neurowave and sawtooth wave (see
Spec. ,r 146), but rather compares both to a drug control, thereby using math
to amplify apparent differences based on the raw data of L%[lytic agent
only]/LUS% [Lytic agent with ultrasound protocol]. Id. ,r 144. Indeed, the
error ranges of the L%/LUS% data in Table 4 overlap between the
sinusoidal Neurowave values of 12.68±0.62 and the Sawtooth values of
13.90±0.98 with both of the methods providing overlapping values in the
range between 12.92-13.3 (see Spec. ,r 146, Table 4). Appellant did not
provide an analysis to show that these values are significantly different from
each other.
While the raw data in Table 3, the other table relied upon for
unexpected results, does not show overlap between the raw L%/LUS% data
for the Neurowave and Sawtooth protocols, the upper value of the
Neurowave of 11.99±0.72 is 12.71 and the lower value of the Sawtooth of
13.75±0.8 is 12.95 (see Spec. ,r 146, Table 3). The percent difference
between the raw data values for Table 3 is 100% - (11.99/13.75 *100) or
about a 13% difference. The percent difference between the raw data values
for Table 4 is 100% - (12.68/13.90 *100) or about a 9% difference (see
Spec. ,r 146, Tables 3 and 4). Appellant provides no statistical analysis
showing that these differences in results were statistically significant.
Thus, without performing mathematical manipulations that enhance
the apparent differences between the data values, the raw data shows small
percentage differences between the sawtooth and sinusoidal waveforms.
This data is not persuasive of unexpected results because, absent statistical
analysis, the evidence does not persuasively demonstrate that the differences
between the protocols is a difference in kind necessary to show an
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unexpected result. The Federal Circuit found that a "32-43% increase in
stress-rupture life ... does not represent a 'difference in kind' that is
required to show unexpected results." In re Harris, 409 F.3d 1339, 1344
(Fed. Cir. 2005). The differences between the Neurowave and Sawtooth
protocols here are significantly less than the 32% value that was insufficient
in Harris.
Analogous Art
Appellant contends the "Final Office Action cites a number of
references that have, as their goal, heat generation. For the reasons stated
above, one of ordinary skill in the art would not be motivated to combine
Wilson with references that are configured to generate heat" (App. Br. 9).
Appellant contends
(Id.).
In contrast, as noted above, in Wilson the device is configured
to enhance the therapeutic effects of a therapeutic compound
while maintaining the device within a desired temperature
range. Accordingly, there is no motivation to use a wave form
as taught by Fujimoto or Mattiuzzi that is used to generate heat
within the device disclosed by Wilson.
We find this argument unpersuasive because Appellant
mischaracterizes Wilson's device which is designed and "configured to
deliver ultrasonic energy" (FF 3). Any energy delivery, "emitted in
waveforms having various shapes" (FF 5), necessarily generates some
amount of heat (see Ans. 4; "the use of an ultrasound transducer will
necessarily generate a certain amount of heat"). Appellant provides no
evidence that the use of a sawtooth wave form generates more or less heat
than the sinusoidal, triangle, square or "other wave forms" expressly
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disclosed by Wilson (FF 5), or that the amount of heat energy delivered by
whichever waveform is chosen would not be optimizable as desired by the
ordinary artisan.
Appellant specifically contends that "[ w ]ith regard to the remaining
references, they are nonanalogous art and are therefore not prior art that is
available for use in an obviousness rejection under 35 U.S.C. § 103" (App.
Br. 9). Appellant contends that the devices of Schleuniger, Tsaliovich,
Umemura, Shields, Jr., Tepper, and Tuszynski are nonanalogous because
their devices are "entirely unrelated to the same field of endeavor as the
present application - an ultrasound catheter configured to deliver a
therapeutic compound to the treatment site so as to treat vascular occlusions"
(App. Br. 10-11). Appellant also contends that these references are "not
reasonably pertinent to the problem faced by the inventor of the present
application - to enhance the delivery of a therapeutic compound to a
treatment site" (App. Br. 10-11).
We are not persuaded. "Prior art is analogous if it is from the same
field of endeavor or if it is reasonably pertinent to the particular problem the
inventor is trying to solve." Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331,
1335 (Fed. Cir. 2015). Here, Schleuniger, Tsaliovich, Umemura, Shields,
Jr., Tepper, and Tuszynski all teach ultrasound devices for treatment of
patients by applying ultrasound energy to patients (FF 6-20). This comports
with the teaching in the Specification that the "present invention relates
generally to ultrasound systems" (Spec. ,r 1 ). Therefore, the cited references
are all in the same field of endeavor as Wilson and the Specification,
ultrasound therapy systems.
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In addition, the references relied upon by the Examiner are reasonably
pertinent to the problem of "provid[ing] a large pressure gradient (with
respect to time and/ or distance) at the leading and/ or trailing edge of each
ultrasound wave" (Spec. ,r 116; cf claim 1 ). That is, each of the cited
references discusses design of devices to generate desired waveforms,
including sawtooth waveforms (FF 7, 8, 10, 12, 14, 15, 17, 19, 20). For
example, Mattiuzzi teaches that sawtooth waveforms are advantageous in
generating mechanical pressure, teaching a "mechanical pressure wave
generated by a source of acoustic waves particularly ultrasound ones. In this
case low frequency ultrasound waves and with triangular or sawtooth pulse
arrangement are advantageous" in the context of treating biological tissue
(FF 8). Tepper teaches designing a device to produce desired waveforms,
specifically, teaching that"[ o ]scillator 62 can produce the waveform to have
a desired waveshape, such as a sine wave, square wave, sawtooth wave" for
stimulating tissue growth (FF 14). Thus, contrary to Appellant's position,
the cited prior art discusses generation of sawtooth waveforms for
ultrasound treatment of patients and are therefore pertinent to the desire of
the Specification to generate such waveforms (FF 1 ).
We also agree with the Examiner's findings that:
All of the references are directed to driving an ultrasound
transducer with a specific waveform, as in Wilson .... the
principles of driving the ultrasound transducer remain the same
regardless of the location of the transducer, or indeed the
desired use of the transducer.
Indeed, appellant's own specification also discloses in
[0175] of the published specification: "Although many
embodiments have been described in the context of an
intravascular catheter it should be appreciated that the non-
linear application of one or more power parameters and
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ultrasound pulse shaping can also be applied to
nonintravascular catheters or devices and/ or non catheter
applications."
(Ans. 7-8).
Conclusion of Law
(i) The evidence of record supports the Examiner's conclusion that the
prior art suggests a control system configured to provide an "oscillating
electrical signal pattern having only one of a rise or a fall rate greater than a
sinusoidal waveform" as required by claim 1.
(ii) Appellant has not presented evidence of secondary considerations,
that when weighed with the evidence of obviousness, is sufficient to support
a conclusion of non-obviousness.
SUMMARY
In summary, we affirm the rejection of claims 1-8 under 35 U.S.C.
§ 103(a) as obvious over Wilson, Fujimoto, Mattiuzzi, Schleuniger, Shields,
Jr., Tepper, Tsaliovich, Tuszynski, and Umemura. 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
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