Ex Parte Warnking

Patent Trial and Appeal Board

Jan 11, 2018

14731347 (P.T.A.B. Jan. 11, 2018)

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.
14/731,347 06/04/2015 Reinhard J. WARNKING 109317-2703 9614
30542 7590 01/16/2018
FOT FY Rr T ARDNFR T T P
EXAMINER
3000 K STREET N.W. HOFFMAN, JOANNE M
SUITE 600
WASHINGTON, DC 20007-5109 ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
01/16/2018 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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REINHARD J. WARNKING
Appeal 2017-011442
Application 14/731,347
Technology Center 3700
Before JOHN C. KERINS, KEN B. BARRETT, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
Final decision rejecting claims 36—56. An oral hearing pursuant to 37
C.F.R. § 41.47 was held on January 4, 2018. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
1 Appellant is the Applicant, ReCor Medical, Inc, which according to the
Appeal Brief is the real party in interest. Appeal Br. 2.
Appeal 2017-011442
Application 14/731,347
THE CLAIMED SUBJECT MATTER
Appellant’s invention relates to an apparatus for “inactivating
conduction of the renal nerves” to treat hypertension. See Spec. 13. Claim
36, reproduced below with italics added, is illustrative of the claimed subject
matter.
36. Apparatus for inactivating renal nerve conduction in a
mammalian subject comprising:
a catheter configured to be inserted into a renal artery of
the mammalian subject;
an ultrasound transducer positioned along a distal end of
the catheter, the ultrasound transducer configured to be inserted
into the renal artery of the mammalian subject and to emit
unfocused ultrasound energy;
an actuator electrically connected to the ultrasound
transducer, the actuator configured to cause the ultrasound
transducer to emit a therapeutic dose of unfocused ultrasound
energy into an impact volume of at least 0.5 cm3 encompassing
the renal artery to inactivate conduction of renal nerves
throughout the impact volume without causing damage to an
intima layer of the renal artery;
a balloon mounted at the distal end of the catheter, wherein
the balloon is configured to engage a wall of the renal artery
without substantially blocking flow of blood through the renal
artery, wherein the balloon comprises a non-circular shape when
in an inflated condition and a liquid is delivered to the balloon to
cool the intima layer of the renal artery; and
a machine-readable element affixed to the catheter, the
machine-readable element encoding an optimum actuation
frequency of ultrasonic energy to be emitted by the ultrasound
transducer during use.
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Application 14/731,347
REJECTIONS
1) Claims 36—56 are rejected under 35U.S.C. § 112, second
paragraph as being indefinite.
2) Claims 36, 46, 47, and 49 are rejected under 35 U.S.C. § 103(a)
under 35 U.S.C. § 103(a) as unpatentable over Lesh (US
2002/0165535 Al, published Nov. 7, 2002), LauferUS
2007/0255342 Al, published Nov. 1, 2007), Cowan (US
2004/0230116 Al, published Nov. 18, 2004), and Demairais ‘549
(US 2007/0203549 Al, published Aug. 30, 2007).
3) Claims 37, 38, and 48 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Lesh, Laufer, Cowan, Demarais ‘549, and
Hastings (US 5,775,338, issued July 7, 1998).
4) Claims 39, 50, and 54 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Lesh, Laufer, Cowan, Demarais ‘549, and Loeb
(US 2002/0193781 Al, published Dec. 19, 2002).
5) Claims 40, 43—45, and 51 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Lesh, Laufer, Cowan, Demarais ‘549, and
Demarais ‘875 (US 2007/0135875 Al, published June 14, 2007).
6) Claims 41, 42, 52, 53, 55, and 56 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Lesh, Laufer, Cowan, Demarais
‘549, and McGovern (US 6,517,534 Bl, issued Feb. 11, 2003).
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Application 14/731,347
DISCUSSION
Rejection 1
The Examiner determines that the limitation in independent claims 36
and 46, “a transducer is configured for transmitting unfocused ultrasound
energy,” is indefinite because it “does not distinctly point out what the
structure of this transducer is or what makes the transducer special such that
it can transmit unfocused ultrasound energy,” “claims 36 and 46 fail to
positively recite the unfocused ultrasound energy,” and the recitation “to
transmit unfocused ultrasound energy” is functional and does not recite
structure. Final Act. 7. The Examiner also determines that claims 36 and 46
are “geared toward the intended use of the apparatus and not the apparatus
itself, and . . . any device with the same configuration of elements would
therefore be able to perform” the recited functions “of protecting tissue and
deactivating renal nerves.” Id. at 8.
Appellant first contends that the phrase “to transmit unfocused
ultrasound energy” is not recited in claim 36 or claim 46. Appeal Br. 7.
Appellant next contends that the claims are not indefinite and not directed to
the intended use of the apparatus because the claims explicitly recite, inter
alia, “an ultrasound transducer configured to be inserted into a renal artery”
and “an actuator configured to cause the ultrasound transducer to emit a
therapeutic dose of unfocused ultrasound energy.” Id. at 7—8.
The Examiner maintains the rejection stating that any apparatus
“displaying the same parts and features of the apparatus would be able to
deactivate the renal nerves as the claim language is not specific on size and
shape and explicit locations of each element of the apparatus.” Ans. 15. For
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Application 14/731,347
the following reasons, we do not sustain the rejection of claims 36—56 under
35 U.S.C. § 112, second paragraph.
“[W]e apply the approach for assessing indefiniteness approved by the
Federal Circuit in Packard, i.e., ‘[a] claim is indefinite when it contains
words or phrases whose meaning is unclear.”’ Ex parte McAward, No. 2015-
006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential)
(quoting/;? re Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir. 2014)). The
breadth of a claim, however, is not to be equated with indefmiteness. See
e.g., In re Miller, 441 F.2d 689, 693 (CCPA 1971). Appellant’s
Specification describes the details of transducer 30 that emits unfocused
ultrasound energy. Spec. Tflf 29-32. The Specification further describes how
ultrasound system 20 causes transmission of unfocused ultrasound energy to
inactivate conduction of renal nerves. Spec. Tflf 33, 40-44. Reading claims
36 and 46 in light of the Specification would reasonably inform one of
ordinary skill in the art as to the scope of the claim limitations “the
ultrasound transducer configured ... to emit unfocused ultrasound energy”
and “the actuator configured to cause the ultrasound transducer to emit a
therapeutic dose of unfocused ultrasound energy ... to inactivate conduction
of renal nerves.” Claims 36 and 46 recite broad functional language, but are
not indefinite under 35 U.S.C. § 112, second paragraph. We, thus, do not
sustain the rejection of claims 36—56 under 35 U.S.C. § 112, second
paragraph.
Rejection 2
The Examiner finds that Lesh discloses most of the limitations of
claim 36 including an “ultrasonic actuator 840 which controls the power
and current to the ultrasonic transducer within the frequency range of
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5MHz to 20 MHz which would be a therapeutic dose of ultrasound
energy and therefore would be able to impact a volume of tissue.” Final
Act 8—9 (citing Lesh, H 120, 164). The Examiner finds that Lesh does not
disclose “that nerves are deactivated.” Id. at 9. The Examiner finds that
Laufer discloses “the use of ultrasound to inactivate nerves” and reasons
it would have been obvious to modify Lesh to include “the inactivation of
ultrasound of nerves as taught by Laufer” as use of a predictable variation of
known work from the same or different field of endeavor. Id. at 9—10.
Appellant contends that Lesh “is intended for placement into a
pulmonary vein ostium, not for deactivation of renal nerves” and, thus, fails
to disclose an ultrasound transducer for inactivating conduction of renal
nerves as recited in claim 36. Appeal Br. 10; Thomas Deck 117.2 Dr.
Thomas explains that “Lesh describes a deflectable tip catheter used in
combination with a guidewire for delivering an ablation element such as an
ultrasonic transducer to target areas of a patient’s vasculature .... but not
for deactivation of renal nerves.” Thomas Deck 117. Appellant next
contends that Laufer’s device is used for plastic and cosmetic surgery
external to the body by applying ultrasound to a nerve to paralyze muscles
and thus does not disclose “a catheter configured to be inserted into a renal
artery” or an ultrasound transducer “configured to be inserted into the renal
artery,” or to “inactivate conduction of renal nerves.” Appeal Br. 11;
Thomas Deck 119. Dr. Thomas submits the one of ordinary skill in the art
would not have looked to an external plastic surgery device such as Laufer
2 “Thomas Deck” refers to the Declaration of Dr. Lewis Thomas, dated
August 2, 2016 submitted as Appendix B to the Appeal Brief. Appeal Br.
24.
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to modify Lesh because “attempting to insert the device of Laufer
intravascularly would have catastrophic results on the vasculature due to the
size of the device and its lack of biocompatible structure.” Id.
The Examiner responds that
the Lesh reference teaches every aspect of the device that would be
needed to activate renal nerves at it contains the same elements and
structure as described in the claims. . . . Therefore, it would have been
obvious to combine the references to show that the Lesh device would
be capable to achieve the same function as the claimed device.
Ans. 17 (emphasis added).
The Examiner also notes that Laufer was relied on only “to teach:
inactivating nerve conduction in a mammalian subject. . . and the Laufer
reference teaches that ultrasound energy can be used to inactivate or inhibit
nerves; therefore a renal nerve is still a nerve and if ultrasound is applied it
then would be inactivated.” Id. at 18. Lor the following reasons, we do not
sustain the rejection of claim 36.
Claim 36 recites “an actuator . . . configured to cause the ultrasound
transducer to emit a therapeutic dose of unfocused ultrasound energy into an
impact volume of at least 0.5 cm3 encompassing the renal artery to inactivate
conduction of renal nerves throughout the impact volume.” Appeal Br. 19
(Claims App.). The Examiner has not made a finding that Lesh discloses an
actuator “configured to cause the ultrasound transducer to emit a therapeutic
does of unfocused ultrasound energy into an impact volume of at least 0.5
cm3” as required by claim 36. See final Act. 9. Nor has the Examiner
provided adequate technical reasoning that Lesh’s actuator, disclosed as
providing ultrasound energy for use in ablating tissue, “would be capable” of
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achieving this function. Id. The Examiner’s reliance on Laufer for teaching
that “nerves are deactivated” does not cure this deficiency. See id.
We, thus, do not sustain the rejection of claim 36. Claim 46 contains
substantially the same limitation. Appeal Br. 21 (Claims App.). The
Examiner’s rejection of claim 46 is based on substantially the same findings
and reasoning as the rejection of claim 36. Final Act. 11—12. We do not
sustain the rejection of claim 46 for the same reasons as stated above for
claim 36. Claims 47 and 49 depend from claim 46. Appeal Br. 21—22
(Claims App.). We do not sustain the rejection of claims 47 and 49 for the
same reasons.
Rejections 3—6
Claims 37-45, 48, and 50-56 depend directly or indirectly from claim
36 or claim 46. Appeal Br. 19—23 (Claims App.). The Examiner rejects
these claims based on the combination of Lesh, Laufer, Cowan, and
Demarais ‘549 with additional disclosure from Hastings, Loeb, Demarais
‘875, and McGovern. Final Act. 13—18. The Examiner’s reliance on the
additional disclosure from Hastings, Loeb, Demarais ‘875, and McGovern
fails to cure the deficiencies in the rejection of claims 36 and 46 stated
above. We, therefore, do not sustain the rejections of claims 37-45, 48, and
50-56 for the same reasons.
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Appeal 2017-011442
Application 14/731,347
DECISION
The Examiner’s decision rejecting claims 36—56 is reversed.
REVERSED
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