Venturi Group, LLC

Patent Trials and Appeals Board

Oct 26, 2021

2021001841 (P.T.A.B. Oct. 26, 2021)

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.
16/286,389 02/26/2019 Mark B. Knudson 0662458021US5 8118
109861 7590 10/26/2021
Perkins Coie - Nevro
1201 Third Avenue, Suite 4900
Seattle, WA 98101
EXAMINER
VOORHEES, CATHERINE M
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
10/26/2021 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):
patentprocurement@perkinscoie.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARK B. KNUDSON, ADRIANUS P. DONDERS, and
TIMOTHY R. CONRAD

Appeal 2021-001841
Application 16/286,389
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, BRADLEY B. BAYAT, and
AMEE A. SHAH, Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 11–21.2 We have jurisdiction under
35 U.S.C. § 6(b). A video hearing was held on September 28, 2021.
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real party in interest as
“Flathead Partners, LLC and Nevro Corp. Flathead Partners, LLC is the
assignee of the instant application, and Nevro Corp. is the exclusive
licensee.” Appeal Br. 1.
2 The Examiner objected to claim 22 “as being dependent upon a rejected
base claim.” Non-Final Act. 10 (“Non-Final Act.” refers to the Non-Final
Office Action mailed on April 24, 2020).
Appeal 2021-001841
Application 16/286,389

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STATEMENT OF THE CASE
Subject Matter on Appeal
Claims 11 and 14 are the independent claims on appeal. Claim 11,
reproduced below, is illustrative of the claimed subject matter.
11. An apparatus for treating pain, comprising:
a) at least two bipolar electrodes adapted to overlie a dorsal
surface of the spinal cord; and
b) an implantable rechargeable controller that is electrically
connected to the at least two bipolar electrodes and
configured to provide electrical signals having a
frequency of at least 3,000 Hz to each of the at least two
bipolar electrodes to form an electric field between the at
least two bipolar electrodes that at least partially blocks
transmission of pain signals along ascending pathways in
the spinal cord.
Appeal Br., Claims App.
References
The prior art relied upon by the Examiner is:
Name Reference Date
Woloszko et al.
(“Woloszko”)
US 5,755,758 May 26, 1998
Feler et al. (“Feler”) US 6,002,964 Dec. 14, 1999
Woods et al. (“Woods”) US 2003/0114899 A1 June 19, 2003
Kim et al. (“Kim”) US 2006/0052836 A1 Mar. 9, 2006
De Ridder US 2006/0095088 A1 May 4, 2006

Appeal 2021-001841
Application 16/286,389

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Rejections
Claims 11–16 are rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Kim, Woods, and Feler.3
Claims 17 and 20 are rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Kim, Woods, Feler, and De Ridder.
Claims 18, 19, and 21 are rejected under pre-AIA 35 U.S.C. § 103(a)
as unpatentable over Kim, Woods, Feler, De Ridder, and Woloszko.

ANALYSIS
Independent claim 11 calls for a pain treating apparatus that includes:
an implantable rechargeable controller that is electrically
connected to the at least two bipolar electrodes and configured
to provide electrical signals having a frequency of at least
3,000 Hz to each of the at least two bipolar electrodes to form
an electric field between the at least two bipolar electrodes that
at least partially blocks transmission of pain signals along
ascending pathways in the spinal cord.
Appeal Br., Claims App. (emphasis added). Independent claim 14 recites a
method of treating pain in the spinal cord that includes a similar requirement
as the above recited limitation of claim 11. Id.
The Examiner finds that Kim teaches:
an implantable controller that is electrically connected to . . . at
least two bipolar electrodes and provides electrical signals to
each of the two electrodes . . . to form an electric field between
the at least two bipolar electrodes that at least partially blocks

3 The Examiner relies on Avery et al. (US 3,724,467, iss. Apr. 3, 1973) as
extrinsic evidence to support this ground of rejection. See Non-Final Act. 3,
10; Ans. 6.
Appeal 2021-001841
Application 16/286,389

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transmission of pain signals along ascending pathways in the
spinal cord.
Non-Final Act. 5 (citing Kim ¶¶ 3, 15, 87–88, 112, 135). The Examiner also
finds that Kim fails to teach that the implantable controller is configured to
provide its electrical signals with a frequency of at least 3,000 Hz. Id. at 6.
To remedy this deficiency, the Examiner relies on Feler’s teachings.4
Id. at 6–7. The Examiner finds that Feler, which according to the Examiner
is a reference in a related art of epidural nerve root stimulation, teaches:
the application of electrical energy to the spinal cord in order to
manage pain has been actively practiced since the 1960s . . .
and that higher frequencies between 10-25,000 Hz can be used
to block signals along sensory nerves of the spinal cord using
bipolar electrodes in order to treat pain in a patient.
Id. at 6–7 (citing Feler col. 1, ll. 4–10, col. 3, ll. 35–55, col. 5, ll. 8–45,
col. 6, ll. 26–44). Thereafter, the Examiner determines that it would have
been obvious to one of ordinary skill in the art to apply Feler’s teaching of
applying electrical signals to sensory nerves of the spinal cord to treat pain
to Kim’s teaching of applying electrical signals to the spinal cord. See id. at
7; see Ans. 6–7 (citing Feler col. 6, ll. 6–18, Fig. 4), 8–9.
The Appellant argues that Feler’s teaching of 10 KHz – 25 KHz does
not apply to Kim’s teachings because Feler teaches applying signals to sacral
nerve roots and is silent to applying signals to the spinal cord. Appeal Br. 12
(citing Feler, col. 2, ll. 25–27). In support of this argument, the Appellant
relies on a Declaration of James Watson, M.D., under 37 C.F.R. § 1.132

4 The Examiner relies on Woods to teach an implantable controller that is
rechargeable. Non-Final Act. 6. The Examiner does not rely on Woods to
teach a controller that applies electrical signals at a particular frequency to a
spinal cord for pain management.
Appeal 2021-001841
Application 16/286,389

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(“Watson Decl.,” filed March 5, 2019). Appeal Br. 12; Reply Br. 4. The
Appellant contends that one of ordinary skill in the art “would not have
reasonably expected Feler’s sacral nerve root stimulation to successfully
block pain signals when applied directly to the spinal cord because the
effects of high frequency stimulation of the spinal cord were unpredictable.”
Appeal Br. 12 (citing Watson Decl. ¶ 10). According to the declarant, the
“unpredictability is based on the known anatomical and physiological
differences between the spinal cord and a peripheral nerve.” Watson
Decl. ¶ 6; see id. ¶ 10. Specifically, the anatomical and physiological
differences are “significant” and include “cell types, neuronal networks, and
the presence of cerebrospinal fluid (CSF) in the spinal cord.” Appeal Br. 12
(citing Watson Decl. ¶¶ 12–14). The Appellant submits, based on the
evidence from the declarant, that “sacral nerve roots are not part of the
spinal cord-instead, they project from the spinal cord and are similar to
peripheral nerves, rather than to the complex tissue of the spinal cord.” Id.
(citing Watson Decl. ¶ 10). The Appellant’s argument is persuasive.
In response, the Examiner only addresses the Appellant’s argument
that there are significant anatomical and physiological differences between
the spinal cord and a peripheral nerve (e.g., a sacral nerve root) by:
(1) stating that “[t]he sacral nerve roots are associated with the spinal cord”;
and (2) reverting to the Appellant’s invention as described in the
Specification. See Ans. 6–7. As for the former, the Examiner’s general
statement that “[t]he sacral nerve roots are associated with the spinal cord”
does not adequately address the declarant’s statement that sacral nerve roots
are not part of the spinal cord and are similar to peripheral nerves. As for
the latter, the Examiner cannot rely on the Appellant’s disclosure of their
Appeal 2021-001841
Application 16/286,389

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invention as evidence to support a determination that one of ordinary skill in
the art would have applied Feler’s teaching of applying a particular
frequency of electrical signals to sacral nerve roots to modify Kim’s
teaching of applying electrical signals to the spinal cord. See Reply Br. 4.
Additionally, the Appellant correctly points out that the Examiner’s response
fails to address or acknowledge the evidence from the declarant. Id.
Thus, we do not sustain the Examiner’s rejection of independent
claims 11 and 14, and dependent claims 12, 13, 15, and 16. Further, the
Examiner fails to rely on the teachings of De Ridder or De Ridder and
Woloszko in any manner that would remedy the deficiency in the
Examiner’s rejection as discussed above. Thus, we likewise do not sustain
the Examiner’s rejections of dependent claims 17–21.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
11–16 103(a) Kim, Woods, Feler

11–16
17, 20 103(a) Kim, Woods, Feler,
De Ridder
17, 20
18, 19, 21 103(a) Kim, Woods, Feler,
De Ridder, Woloszko
18, 19, 21
Overall
Outcome
11–21

REVERSED