BIOINDUCTION LIMITED

Patent Trials and Appeals Board

Oct 22, 2020

15040563 - (D) (P.T.A.B. Oct. 22, 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.
15/040,563 02/10/2016 NIKUNJ PATEL 72095-0009 3940
20915 7590 10/22/2020
MCGARRY BAIR PC
7412 Panners Lane NE
Rockford, MI 49341
EXAMINER
EVANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
10/22/2020 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):
patents@mcgarrybair.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NIKUNJ PATEL and IVOR STEPHEN GILLBE
Appeal 2019-006287
Application 15/040,563
Technology Center 3700

Before MICHAEL C. ASTORINO, PHILIP J. HOFFMANN, and
KENNETH G. SCHOPFER, Administrative Patent Judges.

HOFFMANN, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s rejection of claims 2, 4–7, 11, 13–17, 26, and 27. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appellant’s invention is directed to treating diseases through deep
brain stimulation. See Spec., Title, Abstract. Independent claims 2 and 26

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies “Bioinduction Limited” as the real
party in interest. Appeal Br. 2.
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are the independent claims on appeal. Below, we reproduce claim 2, with
additional formatting, as illustrative of the appealed claims.
2. A method of treating Alzheimer’s Disease and/or
Multiple Sclerosis and/or Minimally Conscious State and/or
Mood Disorders and/or vascular brain disorders where there is
small vessel compromise in a subject in need thereof,
said subject having previously been diagnosed as
suffering from Alzheimer’s Disease and/or Multiple Sclerosis
and/or Minimally Conscious State and/or Mood Disorders
and/or vascular brain disorders where there is small vessel
compromise,
the method comprising
applying a neuromodulation signal to the lPAG or vlPAG
of the subject having Alzheimer’s Disease and/or Multiple
Sclerosis and/or Minimally Conscious State and/or Mood
Disorders and/or vascular brain disorders where there is small
vessel compromise,
wherein the neuromodulation signal has a frequency
within the range of 5 to 50 Hz.
REJECTIONS AND PRIOR ART
The Examiner rejects the claims as follows:
I. Claims 2, 4–7, 11, 13–17, 26, and 27 under 35 U.S.C. § 112(a)
as unsupported by an enabling disclosure;
II. Claims 2, 4–7, 11, 13–17, 26, and 27 under 35 U.S.C. § 112(b)
as indefinite; and
III. Claims 2, 4–7, 11, 13–17, 26, and 27 under 35 U.S.C. § 103 as
unpatentable based on Jaax et al. (US 8,515,541 B1, issued
Aug. 20, 2013) (“Jaax”).2

2 We combine the obviousness rejections relative to the Non-Final Office
Action. Also, throughout prosecution, the Examiner repeatedly refers to this
reference as “Jaxx.”
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ANALYSIS
Rejections I and II—Rejections under 35 U.S.C. §§ 112(a) and 112(b)
Initially, we note that the Examiner rejects all of the claims under
§§ 112(a) and 112(b), based on the Examiner’s determination that
Appellant’s claims, not Specification, lack something critical or essential.
Non-Final Action mailed Oct. 19, 2018 (“Non-Final Action”), at 2–4. Thus,
we may fully agree, for example, with Professor Julian F.R. Patton that
“[d]efining the precise stimulation variables is critical and varies depending
on the brain region and the type of structure being stimulated[,] . . . [ and
that Appellant’s] application does this,” and yet still sustain both rejections
because Appellant’s claims do not recite at least one such critical variable.
Declaration of Professor Julian F.R. Patton dated Oct. 1, 2018, ¶ (6)(ii). We
may sustain the rejections even if Appellant’s Specification describes the
unclaimed critical variable.3
In this case, the evidence that adequately supports the Examiner’s
rejections under §§ 112(a) and 112(b) is Professor Patton’s explanation:
Defining the precise stimulation variables is critical and varies
depending on the brain region and the type of structure being
stimulated . . . . [Appellant’s] application [defines these
variables] . . . .
For example, optimal stimulation parameters to excite
grey matter may differ from white matter. Electrical polarity
must also be considered and may preferentially activate one
pathway but not another. The incorrect stimulation frequency
and/or stimulation intensity can cause damage. All told, the
selection of specified stimulation parameters is brain region

3 The Examiner finds that at least paragraph 90 of Appellant’s Specification
describes treatment polarity, which the Examiner determines is a critical
variable missing from Appellant’s claims, as discussed in further detail
below. See Non-Final Action 5.
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specific and may even be brain sub-region specific and will be
critical for effective long-term activation of a central neural
structure. Patel’s application is unequivocal about this.
Id. (emphases added).
Based on the professor’s explanation, at least the electric polarity is
critical to claim 2’s method of treating disease. Notwithstanding Appellant’s
arguments (see Appeal Br. 6–9), because claim 2 itself does not recite a
critical feature, the Examiner may reject the claim as unsupported by an
enabling disclosure under 35 U.S.C. § 112(a) (see In re Mayhew, 527 F.2d
1229, 1233 (CCPA 1976)). Also despite Appellant’s arguments to the
contrary (see Appeal Br. 9–11), because claim 2 does not recite a critical
feature, the Examiner may reject the claim as incomplete, and, therefore,
indefinite under 35 U.S.C. § 112(b) (see In re Collier, 397 F.2d 1003, 1006
(CCPA 1968)). Accordingly, we sustain the § 112 rejections of claim 2.
Appellant does not argue separately any of claims 4–7, 11, 13–17,
and 27 that depend from independent claim 2.4 Appellant’s arguments
regarding claim 26 are the same in substance as Appellant’s arguments for
claim 2, and claim 26 does not recite the critical feature of electric polarity.
Consequently, because we sustain the § 112 rejections of claim 2, we also
sustain the § 112 rejections of claims 4–7, 11, 13–17, 26, and 27.

4 Although Appellant states that “[c]laim 27 depends from claim 26”
(Appeal Br. 10), based on our review of the record, it appears that claim 27
depends from claim 2 (see, e.g., id. at Claims App.; see also Submission
filed Oct. 1, 2018, at 4 (“27. (New) The method according to
claim 2 . . . .”)).
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Rejection III—Rejection under 35 U.S.C. § 103
The Examiner purports to reject each of the claims as “unpatentable
over Ja[a]x.” Non-Final Action 5; see also id. at 5–9. Over these pages in
the Non-Final Office Action, the only reference that the Examiner discusses
is Jaax. Id. In the Response to Arguments section, as well as a Response to
Amendment section, of the Office Action, however, the Examiner appears to
rely on at least four other references—“WO 2007/007058 to Green,” “Green
[US] 2014/0039450,” “Bruinstroop [US] 2007/0191903,” and “De Ridder,”
which is US Publication no. US 2006/0004422 A1. Non-Final Action 10–
11; see also Answer 7–8. Thus, it is not clear to us on what basis the
Examiner actually rejects the claims.
Regardless, the Examiner does not support adequately in the Non-
Final Office Action, and the Answer, that it would have been obvious to
modify Jaax, based on these other references, to provide a method of treating
disease comprising applying a neuromodulation signal to the lateral
periaqueductal gray (“lPAG”) or ventrolateral periaqueductal gray
(“vlPAG”) of a subject having Alzheimer’s Disease and/or Multiple
Sclerosis and/or Minimally Conscious State and/or Mood Disorders and/or
vascular brain disorders where there is small vessel compromise, wherein
the neuromodulation signal has a frequency within the range of 5 to 50 Hz,
as claimed. In the Answer, for example, the Examiner explains what each of
the five above-identified references discloses, and then determines that “[i]t
would [have] be[en] ‘obvious to try’ the finite number of identified areas of
the PAG to find the right location and obvious to try a limited number of
stimulation frequencies under 100 Hz.” Answer 8. As we state above, the
Examiner does not support adequately this determination. There are too
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many differences between Jaax and claim 2’s method, and among the
references themselves, for us to agree with the Examiner’s determination.
For example, although the Examiner states that “[i]t is well known
and common knowledge in the art to apply stimulation to the vlPAG or
IPAG and use a frequency within the range of 5–50 Hz,” the Examiner does
not rely on Jaax to disclose either of the claimed specific area of stimulation
or the claimed frequency. Id. at 7. Instead, the Examiner appears to rely on
the other references to disclose stimulation of various areas of the brain, and
various stimulation frequencies, and determines that because Jaax shows
some kind of brain stimulation and some frequency, “[i]t would [have]
be[en] ‘obvious to try’ the finite number of identified areas of the PAG to
find the right location and obvious to try a limited number of stimulation
frequencies under 100 Hz” to thereby arrive at the claimed invention. Id.
at 8. Without further explanation from the Examiner, however, this is
inadequate to support the rejection.
CONCLUSION
We AFFIRM the Examiner’s §§ 112(a) and 112(b) rejections.
We REVERSE the Examiner’s § 103 rejection.
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In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
2, 4–7, 11,
13–17, 26,
27
112(a) Enablement 2, 4–7, 11,
13–17, 26,
27

2, 4–7, 11,
13–17, 26,
27
112(b) Indefiniteness 2, 4–7, 11,
13–17, 26,
27

2, 4–7, 11,
13–17, 26,
27
103 Jaax 2, 4–7, 11,
13–17, 26,
27
Overall
Outcome
2, 4–7, 11,
13–17, 26,
27

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2018).
AFFIRMED