Ex Parte Pike

Patent Trial and Appeal Board

Aug 2, 2017

13304933 (P.T.A.B. Aug. 2, 2017)

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.
13/304,933 11/28/2011 Robert W. Pike JR. 400528-20033 2619
144837 7590 08/04/2017
Roberts Mlotkowski Safran Cole & Calderon, P.C.
7918 Jones Branch Drive
Suite 500
Mclean, VA 22102
EXAMINER
IP, JASON M
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
08/04/2017 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):
kpredmore @rmsc2.com
docketing@rmsc2.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT W. PIKE JR.
Appeal 2016-004893
Application 13/304,9331
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
DAVID COTTA, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1—7, 9-22, and
24—29 (App. Br. 1). Examiner entered rejections under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellant’s disclosure “relates to a method of using ablation catheters
for the treatment of cardiac arrhythmias, including atrial fibrillation, using a
denervation of the renal nerve alone or in combination with ablation of
1 Appellant identifies the real party in interest as “Biosense Webster (Israel)
Ltd.” (App. Br. 1.)
Appeal 2016-004893
Application 13/304,933
cardiac tissue” (Spec. 11). Independent claims 1, 22, and 29 are
representative and reproduced below:
1. A method for the treatment of a patient having a blood
pressure comprising the steps of:
inserting an ablation catheter having an electrode mounted
thereon into a renal artery of a patient wherein the renal artery
has a wall defining a lumen;
stimulating a portion of the wall of the lumen of the renal
artery using high-frequency pulses;
monitoring the blood pressure of the patient at least before
and during, or at least before and after, stimulating a portion of
the wall;
identifying a location on the wall of the lumen of the renal
artery where the stimulation causes a decrease in the blood
pressure of the patient thereby indicating the presence of a renal
nerve near the location; and,
ablating the renal nerve near the identified location.
(App. Br. 12.)
22. A method for the treatment of a patient comprising the
steps of:
inserting an irrigated ablation catheter having an
electrode mounted thereon into a renal artery of a patient
wherein the renal artery has a wall defining a lumen;
stimulating a portion of the wall of the lumen of the renal
artery through the electrode using high-frequency pulses;
monitoring the blood pressure of the patient at least
before and during, or at least before and after, stimulating a
portion of the wall;
identifying a location on the wall of the lumen of the
renal artery where the stimulation causes a decrease in the
blood pressure of the patient thereby indicating the presence of
a renal nerve near the location;
ablating the renal nerve near the identified location.
(Id. at 15.)
29. A method for locating a renal nerve in a renal artery of a
patient having a blood pressure comprising the steps of:
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Application 13/304,933
inserting a catheter into the renal artery of the patient,
wherein the renal artery has a wall defining a lumen, and the
catheter had a stimulation element configured for stimulating a
portion of the wall;
stimulating a portion of the wall of the lumen of the renal
artery;
monitoring the blood pressure of the patient at least
before and during, or at least before and after, stimulating a
portion of the wall;
identifying a location on the wall of the lumen of the
renal artery where the stimulation causes a decrease in the
blood pressure of the patient thereby indicating the presence of
a renal nerve near the location.
(Id. at 16.)
The claims stand rejected as follows:
Claims 1—3, 5—7, 9, 12, and 19 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Deem.2
Claims 4, 10, and 11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Deem and Tu.3
Claims 22, 24—26, and 29 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Deem and Tu.
Claims 13—15 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Deem, Tu, and Imran.4
Claims 27 and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Deem, Tu, and Imran.
Claims 16 and 17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Deem and Webster.5
2 Deem et al., US 2005/0288730 Al, published Dec. 29, 2005.
3 Tu et al., US 6,217,576 Bl, issued Apr. 17, 2001.
4 Imran, US 5,545,161, issued Aug. 13, 1996.
5 Webster, Jr. et al., US 6,292,695 Bl, issue Sept. 18, 2001.
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Application 13/304,933
Claim 18 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Deem, Webster, and Schwartz.6
Claims 20 and 21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Deem and Schwartz.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Deem “provides methods and apparatus for renal neuromodulation
(e.g., denervation) using a pulsed electric field (PEF)” (Deem 133; see Ans.
3).
FF 2. Deem’s “PEF systems may be utilized, for example, within the renal
artery, within the renal vein or within both the renal artery and the renal vein
to facilitate more complete denervation” (Deem 139; see Ans. 3).
FF 3. Deem discloses that
After the PEF catheter is positioned within the vessel at a
desired location with respect to the target neurons, it is
stabilized within the vessel (e.g., braced against the vessel wall)
and energy is delivered to the target nerve or neurons. In one
variation, pulsed RF [(radiofrequency)] energy is delivered to
the target to create a non-thermal nerve block, reduce neural
signaling, or otherwise modulate neural activity.
(Deem 140; see Ans. 3.)
FF 4. Deem discloses that PEF systems “[ijnclude electrodes that do not
physically contact the vessel wall. RF energy, both traditional thermal
6 Schwartz, US 2007/0032826 Al, published Feb. 8, 2007.
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Application 13/304,933
energy and relatively non-thermal pulsed RF, are examples of pulsed electric
fields that can be conducted into tissue to be treated from a short distance
away from the tissue itself’ (Deem 144; see Ans. 3).
FF 5. Deem discloses the use of
detectors or other elements that facilitate identification of
locations for treatment and/or that measure or confirm the
success of treatment. For example, [in addition to delivering
treatment energy, Deem’s] system can be configured to . . .
deliver stimulation waveforms and monitor physiological
parameters known to respond to stimulation of the renal nerves.
Based on the results of the monitored parameters, the system
can determine the location of renal nerves and/or whether
denervation has occurred.
(Deem 149; see id. 1132 (“With the electrodes deployed, stimulation and/or
PEF electroporation waveforms may be applied to denervate or modulate the
renal nerves”); id. 1135; see also Ans. 4.)
FF 6. Deem discloses that
stimulation fields may be utilized to properly position the
apparatus for treatment and/or to monitor the effectiveness of
treatment in modulating neural activity. This may be achieved
by monitoring the responses of physiologic parameters known
to be affected by stimulation of the renal nerves. Such
parameters comprise, for example, . . . renal. . . blood pressure.
Stimulation also may be used to challenge the denervation for
monitoring of treatment efficacy: upon denervation of the renal
nerves, the known physiologic responses to stimulation should
no longer occur in response to such stimulation.
(Deem 1135.)
FF 7. Deem discloses that “[ejfferent nerve stimulation waveforms may,
for example, comprise frequencies of about 1-10 Hz, while afferent nerve
stimulation waveforms may, for example, comprise frequencies of up to
about 50 Hz” {Id. 1136).
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FF 8. Examiner finds that Deem fails to “explicitly disclose”: (a) “the use
of high-frequency pulses;” and (b) “identifying a location on the wall of the
lumen of the renal artery where the stimulation causes a before/after
decrease in the blood pressure of the patient thereby indicating the presence
of a renal nerve near the location; and directing the ablation at the identified
location” (Ans. 3—4).
FF 9. Examiner finds that Deem fails to disclose “that the ablation catheter
has an irrigated electrode used to decrease damage of endothelial cells lining
the lumen of the renal artery” or “that the irrigated electrode has a plurality
of holes through which a cooling fluid is capable of flowing” and relies on
Tu to make up for this deficiency in Deem (Ans. 5 and 9—10).
FF 10. Examiner finds that the combination of Deem and Tu fails to
disclose the use of saline as a cooling fluid or “that the cooling fluid is below
body temperature or .. . below 20 degrees centigrade” and relies on Imran to
make up for this deficiency in the combination of Deem and Tu (Ans. 6).
FF 11. Examiner finds that Deem fails to disclose the treatment of “a
cardiac arrhythmia by inserting a second ablation catheter into the heart of a
patient” or “ablating cardiac tissue using the ablation catheter in order to
correct the cardiac arrhythmia” and relies on Webster to make up for this
deficiency in Deem (Ans. 7).
FF 12. Examiner finds that the combination of Deem and Webster fails to
disclose a “cardiac arrhythmia [that] is atrial fibrillation” or that the “step of
ablating cardiac tissue results in the isolation of one or more pulmonary
veins” and relies on Schwartz to make up for this deficiency in the
combination of Deem and Webster (Ans. 7).
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FF 13. Examiner finds that Deem fails to disclose “that the ablation catheter
includes a location sensor” or that the location sensor “is a magnetic location
sensor capable of providing information with regard to the location of the tip
of the ablation catheter” and relies on Schwartz to make up for this
deficiency in Deem (Ans. 8).
ANALYSIS
The rejection over Deem:
Based on Deem, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious “to apply the
frequencies of Deem . . ., as to provide a commonly-used frequency range”
(Ans. 3). In this regard, Examiner reasons that Deem’s disclosure of pulsed
RF energy, necessarily, suggests the use of high-frequency pulses, because
“the RF spectrum . . . include[s] what is considered to be a ‘high frequency’
range” (Ans. 3; see also id. at 13 (Examiner “stands by the position that
‘high-frequency’ vaguely alludes to the type of electromagnetic radiation
being used. Additionally, [Appellant recognizes that] high-frequency
generators [were] known in the art”); cf FF 8). Examiner further concludes
that, at the time of Appellant’s invention was made, it would have been
prima facie obvious to monitor, inter alia, blood pressure to properly
position Deem’s PEF system (see Ans. 3^4; see id. at 4 (Deem discloses “the
use of detectors or elements that facilitate identification of locations for
treatment and/or that measure or confirm the success of treatment, and,
based on the results of the monitored parameters, the system can determine
the location of renal nerves and/or whether denervation has occurred
([0049])”) (alteration original); FF 5—6; cf. FF 8). We are not persuaded.
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Although high-frequency generators may have been known in the art
at the time of Appellant’s claimed invention, and RF energy may encompass
high-frequency energy, Examiner failed to provide an evidentiary basis to
support a conclusion that, at the time of Appellant’s claimed invention, a
person of ordinary skill in this art would have utilized high-frequency pulses
to stimulate a portion of the wall of a lumen of the renal artery to identify a
location where the stimulation causes a decrease in the blood pressure of the
patient, thereby indicating the presence of a renal nerve near the location, as
required by Appellant’s claimed invention (see App. Br. 12, 15, and 16; see
generally Ans. 3 and 13; cf FF 7).
Deem provides evidence that nerve stimulation steps make use of
“frequencies of about 1-10 Hz” or “up to about 50 Hz” (see FF 7).
Examiner fails to establish that, at the time of Appellant’s claimed invention,
a person of ordinary skill in this art would have considered “frequencies of
about 1-10 Hz” or “up to about 50 Hz” as correlating with the high-
frequency pulses required by Appellant’s claimed invention (see FF 7; cf
App. Br. 12, 15, and 16). Thus, while RF may encompass high-frequency
pulses, Examiner failed to establish an evidentiary basis on this record to
support a conclusion that a person of ordinary skill in this art, at the time of
Appellant’s claimed invention, would have found it prima facie obvious to
utilize high-frequency pulses to locate the appropriate position of an ablation
catheter in a renal artery of a patient as is required by Appellant’s claimed
invention (see App. Br. 12, 15, and 16).
To be complete, we note that although Appellant’s claim 29 does not
require stimulation with high-frequency pulses, Examiner relies on Deem to
“teach the use of RF (radio frequency) energy and the RF spectrum does
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Application 13/304,933
include what is considered to be a ‘high frequency’ range []” and support a
conclusion that “it would have been obvious to one of ordinary skill at the
time the invention was made to apply high frequency energy, as to provide a
commonly-used range of frequencies” (Ans. 9). Thus, Examiner’s rationale
for rejecting claim 29 relies upon the conclusion that it would have been
obvious to stimulate the wall of the lumen of the renal artery with high
frequency energy. As discussed above, however, Examiner failed to
establish an evidentiary basis on this record to support this conclusion.
Accordingly, Examiner’s rejection of claim 29 suffers from the same
deficiency discussed above.
Examiner further failed to establish that any of Tu, Imran, Webster, or
Schwartz, alone or in combination, make up for the foregoing deficiency in
Deem.
For the foregoing reasons, we agree with Appellant’s contention that
Deem, as relied upon by Examiner, fails to disclose or suggest the
stimulation step of Appellant’s claimed invention, and none of Tu, Imran,
Webster, or Schwartz, alone or in combination, make up for this deficiency
in Deem (see App. Br. 6; see generally id. at 7—10). In re Kahn, 441 F.3d
977, 988 (Fed. Cir. 2006) (“rejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness”).
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CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
All rejections on this record are reversed.
REVERSED
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