Ethicon LLC

Patent Trials and Appeals Board

May 26, 2020

15899720 - (D) (P.T.A.B. May. 26, 2020)

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.
15/899,720 02/20/2018 Amy L. Marcotte END7055USCNT1.0658018 1013
135715 7590 05/26/2020
Ethicon LLC
c/o Frost Brown Todd LLC
3300 Great American Tower
301 East Fourth Street
Cincinnati, OH 45202
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
05/26/2020 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):
jdewar@fbtlaw.com
patents@fbtlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AMY L. MARCOTTE, TIMOTHY G. DIETZ,
DONNA L. KORVICK, ASHVANI K. MADAN,
and WILLIAM D. DANNAHER
Appeal 2019-006431
Application 15/899,720
Technology Center 3700
Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK,
Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 21–40. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Ethicon LLC, a
wholly owned subsidiary of Johnson & Johnson. Appeal Br. 3.
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Application 15/899,720

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CLAIMED SUBJECT MATTER
Appellant’s invention relates to an endoscopic surgical instrument
having an end effector with a nerve detection feature. Claims 21, 34, and 40
are independent. Claim 21, reproduced below with certain limitations
italicized, is illustrative of the claimed subject matter:
21. A surgical instrument, comprising:
(a) an end effector including an ultrasonic blade
configured to deliver an ultrasonic energy to a surgical site,
wherein the ultrasonic blade is further configured to deliver a
nerve excitation energy to a nerve tissue at the surgical site; and
(b) a control module operatively connected to the
ultrasonic blade and configured to selectively activate the
ultrasonic blade to deliver the ultrasonic energy to the surgical
site, wherein the control module is configured to further activate
the ultrasonic blade to deliver the nerve excitation energy to the
nerve tissue thereby generating a biological response in the nerve
tissue to the nerve excitation energy, and
wherein the control module is further configured to
receive the biological response from the nerve tissue and modify
the delivery of ultrasonic energy to the surgical site based on the
biological response.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Brock US 2002/0120188 A1 Aug. 29, 2002
Costantino US 2009/0033486 A1 Feb. 5, 2009
Wiener US 2011/0015660 A1 Jan. 20, 2011
Ross US 2012/0253372 A1 Oct. 4, 2012

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REJECTIONS
I. Claims 28, 29, and 38–40 are rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement.2
II. Claims 21–25, 27, and 30–36 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Wiener, Costantino, and Brock.
III. Claims 26 and 37 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Wiener, Costantino, Brock, and Ross.
OPINION
Rejection I; Written Description
The Examiner finds that claims 28, 29, and 38–40 fail to comply with
the written description requirement because the recitation of a configuration
to “distinguish the biological response in the nerve tissue to the nerve
excitation energy from another biological response in the nerve tissue to the
ultrasonic energy,” as recited in claims 28, 29, 38, and 39, and a similar
limitation in claim 40, are not supported by the Specification. Final Act. 2–
3. The Examiner also finds that the Specification does not disclose how
distinguishing is performed. Id. at 3.
Appellant argues that the Specification discloses that different types
of energies are distinguished and provides examples of how they may be
distinguished. Appeal Br. 10–11 (citing ¶¶ 44–46). Appellant asserts that
because the Specification provides sufficient disclosure, one of ordinary skill
would appreciate that the inventors possessed the claimed invention. Id. at

2 The Examiner indicates that claims 28, 29, and 38–40 would be allowable
but for the 35 U.S.C. § 112, first paragraph rejection. Final Act. 7.
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11. According to Appellant, the Specification provides sufficient examples
of how to monitor nerve tissue and any comparison or measurement would
be routine and within the capabilities of one of ordinary skill in the art. Id.
The Examiner responds that it is unclear how the signals are
distinguished because the signals go through a “black box” and then produce
an output. Ans. 8. The Examiner concludes that the claims do not comply
with the written description requirement because the Specification does not
disclose a specific control logic or algorithm that performs the claimed
distinguishing function. Id. at 9.
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
“must ‘clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.’ In other words, the test for sufficiency
is whether the disclosure of the application relied upon reasonably conveys
to those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation omitted, alteration
in original).
Claim 28 recites, “wherein the sensor is configured to distinguish the
biological response in the nerve tissue to the nerve excitation energy from
another biological response in the nerve tissue to the ultrasonic energy.”
Appeal Br. 19 (Claims App.). Paragraph 44 of the Specification discloses
that blade 579 is operable to “deliver RF energy, ultrasonic vibration energy,
or any other suitable type of surgical/therapeutic energy . . . in addition to
surgical/therapeutic energy used for cutting, cauterizing, etc., blade (579) is
operable to deliver electrical energy (e.g., DC/AC/pulsatile current) capable
of stimulating nerve cells, fibers, and/or tissue.” Spec. ¶ 44. “By delivering
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such energy, nervous tissue near end effector (512) may become excited,
resulting in a variety of actions as described above. For example, nervous
tissue may twitch, experience a change in impedance, may experience a
change in electrical activity, exhibit an evoked potential or other response,
etc.” Id. We understand the disclosed changes and responses of the nervous
tissue being excited to be biological responses.
The Specification also discloses that “[t]here are numerous ways to
monitor responses to nervous tissue stimuli. For instance, a sensor may be
used to detect evoked potentials generated by stimulated nerves, including
spontaneous nerve activity by sensory and somatic nerves.” Spec. ¶ 38. For
example, “nerve stimulation may be monitored through electromyography
(EMG).” Id. The Specification further discloses that “sensor (520) may be
tuned or configured to avoid false positives in response to surgical and/or
therapeutic activations of blade (579).” Id. ¶ 46. “In addition or in the
alternative, a control logic/algorithm in communication with sensor (520)
may be configured to distinguish between excitations caused by
surgical/therapeutic activations of blade (579) and excitations caused by a
nerve stimulus current.” Id. (emphasis added). Although we appreciate that
no particular algorithm is disclosed, there is sufficient disclosure that sensors
detect excitations, and distinguish between responses in the nerve tissue due
to nerve excitation energy and ultrasonic energy.
We agree with Appellant that claims 28, 29, and 38–40 are adequately
supported, and, therefore, we do not sustain the rejection of these claims as
failing to comply with the written description requirement.

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Rejection II; Obviousness – Claims 21–25, 27, and 30–36
The Examiner finds that Wiener discloses many of the limitations of
claim 21, including a control module and the use of an end effector having a
blade to deliver ultrasonic energy, but that the ultrasonic energy in Wiener is
for cutting, not nerve excitation. Final Act. 3. To address this deficiency in
Wiener, the Examiner finds that Costantino discloses an end effector that
delivers nerve excitation energy to a surgical site. Id. at 4. The Examiner
also finds that Wiener’s control module does not modify the delivery of
ultrasonic energy to the surgical site based on a biological response. Id. To
address this deficiency in Wiener, the Examiner finds that Brock’s control
module modifies the delivery of ultrasonic energy to the surgical site based
on the biological response. Id. (citing Brock ¶¶ 40, 41, 90). The Examiner
reasons that it would have been obvious to modify Wiener’s blade to deliver
nerve excitation energy to the surgical site and to modify Wiener’s control
module to modify the delivery of ultrasonic energy to the surgical site based
on the biological response as taught by Costantino and Brock to improve
surgery and prevent nerve damage. Id. The Examiner rejects independent
claim 34 based on similar findings and reasoning. See id. at 3–4.
Appellant argues that independent claims 21 and 34 require that “the
control module is configured to modify the delivery of one type of energy
(ultrasonic energy) based on a biological response to another type of energy
(nerve excitation energy).” Appeal Br. 14. According to Appellant, this
limitation is not suggested by the combination of art relied upon by the
Examiner. Specifically, Appellant asserts that Brock, upon which the
Examiner relies for this limitation, discloses sensing a non-visible field and
generating a tactile feedback signal or a map based on the sensed field. Id.
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at 15. Based on this disclosure of Brock, Appellant contends that “the art
discloses a system in which a surgeon may manually modify a first type of
energy (nerve excitation energy) based on a response to that same first type
of energy (nerve excitation energy).” Id.
The Examiner responds that Brock’s disclosure of inhibiting or
lessening further action at the end effector in paragraph 90 meets the
limitation at issue. Ans. 9. Specifically, the Examiner states that Brock
“discloses that based on the biological response (the feedback by the sensing
system 8 is the biological response), the delivery of energy is modified
(inhibit or lessen further action at the end effector; impede or lessen further
action).” Id. According to the Examiner, one of ordinary skill in the art
would “consider the end effector energy delivery is modified when its
actions is inhibited, impeded or lessened.” Id. The Examiner notes that
Brock’s force feedback is automatically performed, not manually, and that
Brock “discloses sensing nerves with nerve excitation energy (first energy
type) then modify the end effector to prevent dissection of nerve (modify
dissection energy (second type of energy)).” Id. at 10 (citing Brock ¶ 90).
Appellant has the better position. Claim 21 recites, inter alia,
“wherein the control module is further configured to receive the biological
response from the nerve tissue and modify the delivery of ultrasonic energy
to the surgical site based on the biological response.” Appeal Br. 18 (Claims
App.). The Specification discloses that “sensor (520) may affect delivery of
ultrasonic energy to blade (579) when sensor (520) detects excitation of
nervous tissue (592).” Spec. ¶ 51. In one embodiment, “sensor (520) may
be coupled with a logic in communication with the transducer activation
circuit, and may at least temporarily cut electrical power to the transducer
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when sensor (520) detects excitation of nervous tissue (592), thereby
rendering blade (579) inactive before blade (579) cuts the nervous tissue
(592).” Id. Thus, consistent with the Specification, data from the sensor is
processed by the control module to effect or modify the delivery of power to
the blade, and the control module modifies the delivery of ultrasonic energy
to the surgical site, by cutting electrical power to the transducer, based on
the biological response. See id. ¶ 18.
Brock discloses that, when the instrument nears a nerve, there is “a
feedback by way of the sensing system 8 so as to provide one or more of a
vibration to the handle 12 and a force feedback to the handle 12 in order to
inhibit or lessen further action at the end effector.” Brock ¶ 90. Although
the Examiner posits that Brock’s paragraph 90 provides that the force
feedback causes the control module to automatically inhibit end effector
energy delivery, “the feedback signal is a signal that the surgeon ‘feels’
(tactile) at the haptic interface essentially signaling to the surgeon that the
instrument is at an area that is to be avoided.” Id. ¶ 108. Specifically, Brock
discloses that the system includes “a haptic interface which has the ability of
receiving tactile (force or vibration) feedback signals indicative of the
sensing of certain fields.” Id. ¶ 100. Brock defines “a tactile feedback” as a
“(palpable hardness [(force)] or vibration sense) provided at a surgeon’s
tactile (haptic) interface.” Id. ¶ 67. Brock uses the feedback so that “the
system operates so as to essentially ‘warn’ a surgeon (provide an alarm) of
proximity to a nerve or other critical anatomic structure (an avoidance
area).” Id. ¶ 91. Based on this disclosure of Brock, we agree with Appellant
that the surgeon may manually modify application of the ultrasonic energy
in response to the force feedback signal. Appeal Br. 15. The Examiner has
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not adequately established that the control module of Brock modifies the
delivery of ultrasonic energy to the surgical site based on the biological
response, as required by claim 21. Accordingly, we do not sustain the
Examiner’s rejection of independent claims 21 and 34, and claims 22–25,
27, 30–33, 35, and 36 depending therefrom, as unpatentable over Wiener,
Costantino, and Brock.

Rejection III; Wiener, Costantino, Brock, and Ross
Claims 26 and 37 depend from claims 21 and 34, respectively.
Appeal Br. 19, 22 (Claims App.). The Examiner’s use of Ross does not
remedy the deficiency discussed above regarding Rejection II. See Final
Act. 6. Accordingly, for the same reasons, we do not sustain Rejection III.
CONCLUSION
The Examiner’s rejections are reversed.
More specifically,
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
28, 29, 38–
40
112, first
paragraph
Written Description 28, 29, 38–
40
21–25, 27,
30–36
103(a) Wiener, Costantino,
Brock
21–25, 27,
30–36
26, 37 103(a) Wiener, Costantino,
Brock, Ross
26, 37
Overall
Outcome
21–40

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REVERSED