Ex Parte Zhu et al

Patent Trial and Appeal Board

Jun 27, 2018

13904940 (P.T.A.B. Jun. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/904,940 05/29/2013
50638 7590 06/27/2018
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
Changfang Zhu
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.
BSNC-1-472.1 1094
EXAMINER
CWERN, JONATHAN
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
06/27/2018 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 CHANGF ANG ZHU and KERRY BRADLEY
Appeal2017-000263
Application 13/904,940 1
Technology Center 3700
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a process of
delivering ultrasound energy to a patient. The Examiner rejected the claims
for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants state that the "real party in interest for this appeal is Boston
Scientific Neuromodulation Corporation. Boston Scientific
Neuromodulation Corporation, the assignee of the present patent application,
is a wholly-owned subsidiary of Boston Scientific Corporation." Appeal Br.
2.
Appeal2017-000263
Application 13/904,940
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 1-3, 5, 6, and 9-15, under 35 U.S.C. § I03(a) as being
obvious over Gertner2 and Kramer3 (Final Act. 2-9); and
(2) Claim 4, under 35 U.S.C. § I03(a) as being obvious over Gertner,
Kramer, and Ferrara 4 (Id. at 9-10).
Claim 1 is representative and reads as follows:
1. A method of treating a patient with an ailment,
compnsmg:
providing an ultrasonic catheter with at least one
ultrasonic transducer disposed along a distal end of the catheter;
inserting the distal end of the ultrasonic catheter into an
epidural space of the patient with the at least one ultrasonic
transducer adjacent to a dorsal root ganglion (DRG);
and delivering ultrasound energy from the at least one
ultrasonic transducer to the DRG thereby modulating the DRG
to treat the ailment.
Appeal Br. 12.
DISCUSSION
The Examiner's Prima Facie Case
In rejecting claims 1-3, 5, 6, and 9-15 over Gertner and Kramer, the
Examiner cited Gertner as describing a method of using a catheter to apply
ultrasound energy to a patient's dorsal root ganglion (DRG), but conceded
that Gertner's method differed from Appellants' claimed method in that
Gertner did not explicitly teach claim 1 's step of "'inserting the distal end of
the ultrasonic catheter into an epidural space of the patient with the at least
2 US 2011/0092781 Al (published Apr. 21, 2011).
3 US 2012/0310140 Al (published Dec. 6, 2012).
4 WO 2011/109334 Al (published Sept. 9, 2011).
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[ one ultrasonic transducer] adjacent to a dorsal root ganglion (DRG). '"
Final Act. 4.
As evidence that the process recited in the rejected claims would
nonetheless have been obvious, the Examiner cited Kramer as disclosing
insertion of an electrode-bearing catheter into the epidural space for the
purpose of neuromodulating the nerves of the DRG. Id.
Based on the references' combined teachings, the Examiner reasoned
that, when using a catheter to apply ultrasound energy to the DRG as taught
in Gertner, it would have been obvious to insert the catheter into the epidural
space as taught by Kramer ( and recited in Appellants' claim 1 ), "because
this allows for more particularly selected neuromodulation of the DRG
([Kramer ,r 165], ln 25-27) and minimizes deleterious side effects, such as
undesired motor responses or undesired stimulation or neuromodulation of
unaffected body regions outside the target area ([id. ,r 168], ln 1, 3-5)."
Final Act. 4.
Analysis
As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present appeal, having carefully considered the arguments and
evidence advanced by Appellants and the Examiner, Appellants do not
persuade us that the preponderance of the evidence fails to support the
Examiner's conclusion obviousness. To the contrary, we adopt as our own
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the Examiner's findings of fact, and conclusion of obviousness based
thereon. We address Appellants' arguments below, providing the following
analysis for emphasis.
Appellants do not dispute, nor do we discern error in, the Examiner's
finding (Final Act. 3) that Gertner teaches or suggests using an ultrasonic
catheter to deliver ultrasound energy to the nerves of the DRG, as required
by Appellants' claim 1. In that regard, we note the following disclosure in
Gertner:
Focused ultrasound to th[e] region [of the facet joint] can
inhibit nerves involved in back pain which originate at the
dorsal root nerve and travel to the facet joint 8645. Ablation or
inhibition of these nerves can limit or even cure back pain due
to facet joint arthropathy. Focused ultrasound can be applied to
the region of the facet joint from a position outside the patient
to the facet joint using powers of between 100 W/cm2 and 2500
W / cm2 at the nerve from times ranging from 1 second to 10
minutes.
Gertner ,r 351.
We also note Gertner' s disclosure that ultrasound energy can be
delivered to nerves from inside the patient, for example, by using an
intravascular catheter disposed within the aorta-renal artery ostium to apply
the ultrasound to the nearby renal nerves, thereby ablating those nerves. Id.
,r 375; see also id. at Fig. 20.
Although Gertner might not meet claim 1 's requirement of inserting
the catheter into the epidural space to deliver the ultrasound energy, Kramer,
as the Examiner found (Final Act. 4), discloses that when using an electrode-
bearing catheter to deliver electrical stimulation to the DRG, inserting the
catheter into the epidural space (Kramer ,r,r 165, 167) allows more accurate
delivery of the stimulation to the target nerves, and avoids stimulation of
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nerves and/or tissues for which treatment is not desired:
Such targeted treatment minimizes deleterious side effects, such
as undesired motor responses or undesired stimulation or
neuromodulation of unaffected body regions. This is achieved
by directly neuromodulating a target anatomy associated with
the condition while minimizing or excluding undesired
neuromodulation of other anatomies. For example, this may
include stimulating the dorsal root ganglia, dorsal roots, dorsal
root entry zones, or portions thereof while minimizing or
excluding undesired stimulation of other tissues, such as
surrounding or nearby tissues, portions of the ventral root and
portions of the anatomy associated with body regions which are
not targeted for treatment.
Kramer ,r 168.
Given this teaching in Kramer that catheter-delivered, nerve-
modulating therapeutic energy can be delivered more accurately to the DRG
by inserting the catheter into the epidural space and delivering the therapy
directly to the DRG, Appellants do not persuade us that the Examiner erred
in finding that, when inhibiting the nerves of the DRG as taught in Gertner,
an ordinary artisan had good reason for, and a reasonable expectation of
success in, inserting Gertner' s ultrasonic catheter into an epidural space
adjacent to the DRG, so as to avoid delivering the ultrasound to undesired
portions of the patient.
It might be true, as Appellants contend (see Appeal Br. 5-7; Reply Br.
2--4 ), that the electrical stimulation disclosed in Kramer and the ultrasound
used in Gertner are distinct therapeutic modalities. As the Supreme Court
has explained, however, "if a technique has been used to improve one
device, and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
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unless its actual application is beyond his or her skill." KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398,417 (2007).
Thus, although electrical stimulation and ultrasound might be distinct
ways of delivering therapy to the DRG, Gertner and Kramer are
substantially similar in that both involve application of therapeutic energy to
the DRG. Appellants, therefore, do not persuade us that the Examiner erred
in finding that an ordinary artisan would have found Kramer's teachings,
regarding the accuracy advantages of using the epidural approach to deliver
such therapy to the DRG, applicable to Gertner's methods.
It might be true, as Appellants contend (Appeal Br. 7-9; Reply Br. 5-
8), that Gertner does not expressly describe using its internally deployed
devices to apply ultrasound to the DRG. Contrary to Appellants'
contentions, however, the fact that Gertner, or Kramer for that matter, might
not describe all of the steps and features of the process of Appellants' claim
1 does not demonstrate that the claimed process is nonobvious. See Dann v.
Johnston, 425 U.S. 219,230 (1976) ("[T]he mere existence of differences
between the prior art and an invention does not establish the invention's
nonobviousness. ").
Appellants do not persuade us, moreover (see Appeal Br. 9; Reply Br.
7), that Gertner teaches away from the process of Appellants' claim 1.
Although, as Appellants contend, Gertner in one embodiment uses an
external rather than internal device to apply its nerve-inhibiting ultrasound to
the dorsal root nerves ( Gertner ,r 3 51 ), Appellants identify no specific
teaching in Gertner criticizing or disparaging processes in which the epidural
space is accessed for the purposes of applying the ultrasound. See In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) ("The prior art's mere
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disclosure of more than one alternative does not constitute a teaching away
from any of these alternatives because such disclosure does not criticize,
discredit, or otherwise discourage the solution claimed .... ").
Indeed, contrary to Appellants' teaching away arguments, Gertner, as
noted above, discloses the use of an internal approach that places an
ultrasound catheter in close proximity to the nerves targeted for ultrasound
application. See Gertner ,r 3 7 5 ( disclosing use of an intra vascular catheter
disposed within the aorta-renal artery ostium to apply the ultrasound to the
nearby renal nerves, thereby ablating those nerves). Given Gertner's
disclosure that it was desirable to internally deploy an ultrasound catheter in
close proximity to the nerves targeted for treatment, we are not persuaded
that Gertner would have taught away from the epidural approach taught in
Kramer, which similarly deploys its therapeutic catheter internally in close
proximity to the targeted nerves.
Moreover, given Gertner's teaching, noted above, that ultrasound
treatment of the dorsal root nerves can either ablate or merely inhibit the
nerves (Gertner ,r 351 ), Appellants do not persuade us that Gertner suggests
only ablating DRG nerves, rather than modulating them as recited in
Appellants' claim 1.
We are also unpersuaded that the Examiner failed to advance evidence
suggesting that applying ultrasound to the DRG from a transducer deployed
in an epidural space as recited in Appellants' claim 1 would be "safe or
effective." See Appeal Br. 6; Reply Br. 4.
It is well-settled that "[ o ]bviousness does not require absolute
predictability of success .... For obviousness under§ 103, all that is
required is a reasonable expectation of success." In re Kubin, 561 F.3d
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Application 13/904,940
1351, 1360 (Fed. Cir. 2009) (quoting In re O'Farrell, 853 F.2d 894, 903---04
(Fed. Cir. 1988) (emphasis removed)).
In the present case, as noted above, Appellants do not dispute the
Examiner's finding that Gertner discloses applying ultrasound to the DRG.
Although Gertner's disclosure might relate only to applying ultrasound from
a location outside the epidural space that is not adjacent to the DRG, we
agree with the Examiner that, based on Gertner' s undisputed disclosure of
applying ultrasound to the DRG, an ordinary artisan had a reasonable
expectation of successfully applying ultrasound from a location inside the
epidural space adjacent to the DRG, using an ultrasonic catheter such as that
described in Gertner.
In that regard, we note, as seen above, Gertner's disclosure regarding
the controllability of ultrasound parameters, including power and duration of
application. See Gertner ,r 351. We also note, as seen above, Kramer's
disclosure that it was known to deploy catheters within the epidural space to
deliver stimulatory energy to the DRG. Kramer ,r,r 165, 167. To the extent
Appellants contend the disclosures of Gertner and Kramer in this regard are
non-enabling, Appellants fail to identify any persuasive evidence in support
of that position.
In sum, for the reasons discussed, Appellants do not persuade us that
the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness as to claim 1. We, therefore, affirm the
Examiner's rejection of claim 1 over Gertner and Kramer, as well as claims
2, 5, 6, and 9-15, which were not argued separately. 37 C.F.R.
§ 4I.37(c)(l)(iv).
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Appellants' claim 3, also rejected over Gertner and Kramer, recites
"[t ]he method of claim 1, wherein the ultrasound energy has a frequency in
the range of 20KHz-lOOKHz, thereby heating the DRG." Appeal Br. 12.
The Examiner cited ,r 3 50 of Gertner as evidence that it was known in
the art to use ultrasound to heat the area adjacent to the vertebral column
when inhibiting nerves in that area, and cited ,r,r 224 and 338 of Gertner as
disclosing suitable ultrasound frequency ranges overlapping the range
recited in Appellants' claim 3. Final Act. 5.
Appellants do not dispute that Gertner discloses suitable ultrasound
frequency ranges overlapping the range recited in Appellants' claim 3.
Rather, Appellants contend that the frequencies disclosed in ,r,r 224 and 338
of Gertner relate only to nerve ablation, whereas the claimed methods are
limited to modulating the DRG. Appeal Br. 10; Reply Br. 9.
We are not persuaded. As discussed above, Gertner discloses that
treatment of the dorsal root nerves can simply involve inhibition, rather than
ablation, and that the power and duration of the applied ultrasound can be
controlled. Gertner ,r 351. Appellants do not persuade us, therefore, that
when delivering ultrasound at the frequencies described as being suitable for
its therapeutic applications, Gertner suggests only ablating nerves.
Accordingly, because Appellants do not persuade us that the preponderance
of the evidence fails to support the Examiner's conclusion of obviousness as
to claim 3, we affirm the Examiner's rejection of that claim over Gertner and
Kramer.
The Examiner also rejected Appellants' claim 4 for obviousness over
Gertner, Kramer, and Ferrara. Final Act. 9-10. The Examiner relied on the
teachings in Gertner and Kramer, discussed above, and cited Ferrara as
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evidence that it would have been obvious to apply ultrasound at a frequency
encompassed by claim 4, to increase blood flow to the DRG, as claim 4
requires. See id.
Appellants contend only that claim 4 is patentable based on the
arguments presented in traversal of the rejection of claim 1. Appeal Br. 1 O;
Reply Br. 10. As discussed above, however, we do not find those arguments
persuasive. Accordingly, as Appellants do not identify, nor do we discern,
error in the Examiner's conclusion of obviousness as to claim 4, we affirm
the Examiner' rejection of claim 4 over Gertner, Kramer, and Ferrara.
SUMMARY
For the reasons discussed, we affirm both of the Examiner's
obviousness rejections.
TIME PERIOD
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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