Ex Parte Jaax et al

Patent Trial and Appeal Board

Dec 28, 2015

13050836 (P.T.A.B. Dec. 28, 2015)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/050,836 03/17/2011
50638 7590 12/28/2015
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
Kristen N. Jaax
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
BSNC-1-425.2 3364
EXAMINER
FAIRCHILD, MALLIKA DIPAYAN
ART UNIT PAPER NUMBER
3762
MAILDATE DELIVERY MODE
12/28/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KRISTEN N. JAAX, TODD K. WHITEHURST, and
RAFAELCARBUNARU 1
Appeal2014-000098
Application 13/050,836
Technology Center 3700
Before JAMES P. CAL VE, GEORGE R. HOSKINS, and
AMANDA F. WIEKER, Administrative Patent Judges.
WIEKER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Kristen N. Jaax et al. ("Appellants") appeal under 35 U.S.C. § 134(a)
from the Examiner's decision finally rejecting claims 23-34. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Boston Scientific
Neuromodulation Corporation. App. Br. 2.
Appeal2014-000098
Application 13/050,836
CLAIMED SUBJECT MATTER
The invention concerns a method for treating a medical condition by
applying a stimulus to the motor cortex of a patient's brain. Spec., Abstract.
Claim 23, the only pending independent claim, is illustrative of the subject
matter on appeal, and recites:
23. A method of treating a patient with a medical
condition, comprising:
implanting a microstimulator within an opening
extending completely through a skull of said patient, wherein
the microstimulator resides within the opening;
generating a stimulus in accordance with one or more
stimulation parameters using said microstimulator; and
applying said stimulus to a portion of a motor cortex of
said patient adjacent said opening, thereby treating said
medical condition.
App. Br. 9 (emphasis added).
REJECTIONS
The claims stand rejected as follows:
I. Claims 23-34 on the ground of nonstatutory obviousness-type
double patenting, as unpatentable over claims 1-11 of U.S.
Patent No. 7,962,219. Final Act. 2, 5; Ans. 3.
II. Claims 23-34 under 35 U.S.C. § 102(e) as anticipated by
Whitehurst (US 7,013,177 Bl, iss. Mar. 14, 2006). Final Act.
6-9; Ans. 3.
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Application 13/050,836
OPINION
I. Obviousness-Type Double Patenting
Appellants do not argue against the Examiner's rejection of claims
23-34 on the ground of nonstatutory obviousness-type double patenting, as
unpatentable over claims 1-11 of U.S. Patent No. 7,962,219. See generally
App. Br.; Reply Br.; see also Final Act. 2, 4--5 (noting Appellants' request to
hold double patenting rejection in abeyance until no other rejections are
pending when Appellants will submit a Terminal Disclaimer, and
maintaining the double patenting rejection); Response After Final, Jan. 23,
2013, 2. In the absence of allegations of Examiner error by Appellants, we
sustain the Examiner's rejection. See In re Jung, 637 F.3d 1356, 1365 (Fed.
Cir. 2011) (citing Ex parte Frye, 94 USPQ2d 1072 (BP AI 2010)
(precedential)) (panel reviews rejection for error based on the issues
identified by appellant and in light of the arguments and evidence produced
thereon); MANUAL OF PATENT EXAMINING PROCEDURE § 1205.02 (9th ed.
Rev. 7, Nov. 2015).
II. Anticipation by Whitehurst
Regarding sole independent claim 23, the Examiner finds that
Whitehurst discloses implanting a microstimulator within an opening in a
patient's skull such that the microstimulator resides within the opening.
Final Act. 6. Specifically, the Examiner finds that the microstimulator
(SCU 130) "may be implanted under the scalp in a shallow depression or
opening created in the skull." See id. (citing Whitehurst, 8:26-48). The
Examiner also finds that Whitehurst discloses applying a stimulus to a
portion of the motor cortex that is adjacent the opening. Id. at 6-7 (citing
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Application 13/050,836
Whitehurst, 18: 17-19). Specifically, the Examiner finds that when the
micro stimulator is implanted in the parietal, temporal, or frontal bone of the
skull, as taught by Whitehurst, "the electrodes 152 on the lead 150 ... are
used to stimulate the portion of the motor cortex adjacent the opening in
which the [microstimulator] is implanted." Ans. 4--5. Furthermore, the
Examiner finds that, under the broadest reasonable interpretation, the claim
language requiring stimulation of a portion of the motor cortex "adjacent"
the opening includes stimulation at "any part of the motor cortex," whether
"directly below or next to the opening or in the motor cortex in the opposite
hemisphere of the brain." Final Act. 3.
Appellants contend that Whitehurst "is silent as to the location of the
stimulation site relative to the opening in which the microstimulator (SCU
130) resides." App. Br. 4. Specifically, Appellants argue that the
Examiner's interpretation of "adjacent" to include any part of the motor
cortex is overly broad and "renders this term meaningless." Id. at 5 (citing
Spec., Figs. 6-7). Furthermore, Appellants argue that even ifWhitehurst's
microstimulator is placed in an opening in the skull, "this does not mean that
for any particular location of the skull that is selected ... the portion of the
motor cortex to which the stimulus is applied will be adjacent this particular
skull location." Id. at 6; see also Reply Br. 2.
We are not persuaded by Appellants' arguments. During examination
proceedings, claims are given their broadest reasonable interpretation
consistent with the specification. Therefore, claim terms are given their
ordinary and customary meaning, as would be understood by one of ordinary
skill in the art in the context of the entire disclosure. In re Trans logic Tech.,
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Appeal2014-000098
Application 13/050,836
Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a
claim term must be set forth with reasonable clarity, deliberateness, and
precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
Here, Appellants have not directed our attention to any special
definition for the term "adjacent." Id.; see App. Br. 5 (citing Spec., Figs. 6-
7). Rather, the cited portion of the Specification describing Appellants'
Figure 6 states only that "SCU (140) [is] implanted in the skull (160)
adjacent to the motor cortex (104) .... [A] lead (141) may be coupled to the
SCU (140) with the distal end of the lead (141) being routed to a particular
location within the motor cortex (104)." Spec. i-fi-f 103-104. With respect to
cited Figures 7 A-7C, the Specification states that a stimulating electrode
"may be coupled to the outer surface of the motor cortex (104)." Id. i-fi-f 106-
108. Neither description places any restriction on the meaning of the term
"adjacent" or provides any guidance for determining how close a stimulus
must be to be considered "adjacent" to an opening in the skull. Rather,
Appellants' arguments and Appellants' Figure 6 merely establish that a
stimulus provided by lead 141, which lead 141 extends into motor cortex
160 and includes one or more electrodes 142, is "adjacent" to opening 161.
App. Br. 5. 2 Therefore, Appellants have not demonstrated that the Examiner
2 Furthermore, Appellant's claim 29 depends from claim 23 and recites that
the microstimulator "comprises a capsule." The doctrine of claim
differentiation, therefore, presumes that independent claim 23 encompasses
more than a capsule, including, for example, Appellants' Figure 2, in which
SCU 140 includes lead 141 and catheter 143 extending into the brain to
stimulate an internal portion. See Kraft Foods Inc. v. Int 'l Trading Co., 203
F.3d 1362, 1368 (Fed. Cir. 2000). This is consistent with Appellant's
citation to Figure 6. See App. Br. 5.
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Appeal2014-000098
Application 13/050,836
erred in interpreting "adjacent" to include a stimulation applied to portions
of the motor cortex underlying the opening. See Final Act. 3, 6-7; Ans. 4--5.
Given this understanding, Appellants have not demonstrated that the
Examiner erred in finding that Whitehurst discloses stimulating a portion of
the motor cortex that is "adjacent" the opening in the skull in which the
microstimulator resides. Specifically, the Examiner finds that Whitehurst
discloses implanting a microstimulator within an opening in a patient's skull,
such that the microstimulator resides within the opening. Final Act. 6-7
(citing Whitehurst, 8:26-48). This is supported by Whitehurst's disclosure
that the system control unit (SCU 130) of Figure 5 may be implanted in an
"opening in the skull of [the] patient 200, for instance, in parietal bone 141,
temporal bone 142, or frontal bone 143." Whitehurst, 8:26-31.
The Examiner also finds that Whitehurst discloses applying a stimulus
to a portion of a motor cortex adjacent said opening, noting that when
Whitehurst's SCU is implanted in the parietal, temporal, or frontal bones,
"the electrodes 152 on the lead 150 . . . are used to stimulate the portion of
the motor cortex adjacent the opening in which the SCU 130 is implanted."
Ans. 5; Final Act. 6-7 (citing Whitehurst, 18:17-19). This finding is also
supported by the Examiner's citations to the record. Indeed, Whitehurst
explicitly states that "stimulation may also/instead be applied to ... the
motor cortex 116." Whitehurst, 18:17-19. Furthermore, as identified by the
Examiner, Whitehurst's leads 150 extending from the SCU appear
substantially similar to the leads extending from Appellants' SCU 140, as
shown in Appellants' Figures 2 and 6. See Whitehurst Figs. 5---6. Therefore,
Appellants have not articulated persuasively how, when Whitehurst's SCU
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Application 13/050,836
130 is implanted in an opening of the skull that overlies the motor cortex (as
taught by Whitehurst, 8 :26-31 ), the stimulus provided by lead 150 is not
"adjacent said opening," as claimed. This is especially so in light of
Appellants' admission that similar structure depicted in Appellants' Figure 6
satisfies the claim language. See App. Br. 5 ("[T]he specification clearly
illustrates and describes examples of stimulation sites that are adjacent to the
opening in which the microstimulator is implanted. For example, Fig. 6
illustrates the stimulation site as being in the motor cortex just below the
opening (161) in which the SCU (140) is implanted, while Figs. 7A-7C
illustrate the stimulation site as being on the outer surface of the motor
cortex just below the opening (161) in which the SCU (140) is implanted.");
cf Reply Br. 2. Appellants' Figure 6 illustrates SCU 140 implanted in skull
160 adjacent to motor cortex 104. Spec. i-fi-f l 02-103.
Therefore, for the reasons discussed above, we are not persuaded that
the Examiner erred in rejecting claim 23, and we affirm the Examiner's
rejection of that claim. Furthermore, Appellants do not provide specific
argument regarding the rejection of dependent claims 24--31 or 34. App. Br.
6. Accordingly, we also affirm the rejection as to those claims.
Regarding dependent claims 32 and 33, Appellants argue that the
portions of Whitehurst cited by the Examiner, including Figures 7 A-7 C, do
not disclose a capsule having external stimulation and indifferent electrodes,
and which is implanted and resides within an opening of the skull, as
claimed. App. Br. 6-7; Reply Br. 3--4; see also Final Act. 3--4, 8 (citing
Figs. 7 A-7C, 8:26--48; 9:50-54; 966-10:4); Ans. 6-8.
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Application 13/050,836
We agree with Appellants. The Examiner has not identified any
single embodiment in Whitehurst that includes a microstimulator that resides
within an opening of the skull, and which includes the claimed capsule with
external stimulation and indifferent electrodes. See In re Arkley, 455 F.2d
586, 587-88 (CCPA 1972) (noting that the reference "must clearly and
unequivocally disclose the claimed [invention] or direct those skilled in the
art to the [invention] without any need for picking, choosing, and combining
various disclosures not directly related to each other by the teachings of the
cited reference" and stating that although "[ s ]uch picking and choosing may
be entirely proper in the making of a [35 U.S.C. §] 103, obviousness
rejection ... it has no place in the making of a [35 U.S.C. §] 102,
anticipation rejection").
DECISION
We AFFIRM the Examiner's rejection of claims 23-34 on the ground
of nonstatutory obviousness-type double patenting, as unpatentable over
claims 1-11 of U.S. Patent No. 7,962,219;
we AFFIRM the Examiner's rejection of claims 23-31 and 34 under
35 U.S.C. § 102(e) as anticipated by Whitehurst; and
we REVERSE the Examiner's rejection of claims 32-33 under 35
U.S.C. § 102( e) as anticipated by Whitehurst.
AFFIRMED
JNS
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