Ex Parte Alberts et al

Patent Trial and Appeal Board

Mar 8, 2016

12986735 (P.T.A.B. Mar. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/986,735 01107/2011
50638 7590 03/08/2016
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
Jay L. Alberts
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-1-567.1 7003
EXAMINER
FAIRCHILD, MALLIKA DIPAYAN
ART UNIT PAPER NUMBER
3762
MAILDATE DELIVERY MODE
03/08/2016 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 JAY L. ALBER TS and CAMERON C. MCINTYRE
Appeal2014-001260
Application 12/986,735
Technology Center 3700
Before JOSEPH A. FISCHETTI, BIBHU R. MOHANTY, and
CYNTHIA L. MURPHY, Administrative Patent Judges.
MURPHY, Administrative Patent Judge.
DECISION ON APPEAL
The Appellants 1 appeal under 35 U.S.C. § 134 from the Examiner's
rejection of claims 1 and 3. We have jurisdiction over this appeal under 35
U.S.C. § 6(b).
We AFFIRM.
1 "The real party in interest in the present appeal is The Cleveland Clinic
Foundation." (Appeal Br. 1.)
Appeal2014-001260
Application 12/986,735
STATEMENT OF THE CASE
The Appellants' invention "relates to a system and method for
stimulating anatomic regions" and "for selecting parameters for such
stimulation." (Spec. i-f 3.)
Claims on Appeal2
1. A method, comprising:
using deep brain stimulation, stimulating at least one of the
zona incerta, lenticular fasciculus, and motor region of the globus
pallidus;
wherein:
less than 10% of non-motor regions of the brain is
stimulated as a result of the stimulation; and
less than 10% of non-motor regions of the globus
pallidus is stimulated as a result of the stimulation.
3. A method, comprising:
stimulating an anatomical region in a stimulation
procedure in which at least one of the zona incerta, lenticular
fasciculus, and motor region of the globus pallidus are
stimulated, while current is not spread to, and therefore there is
no stimulation of, any of the corticospinal tract (CS),
corticobulbartract (CB), and the non-motor regions of the globus
pallidus (GP).
Meadows
Lujan
References
US 2009/0118786 Al
US 2009/0118635 Al
Rejection
May 7, 2009
May 7, 2009
The Examiner rejects claims 1 and 3 under 35 U.S.C. § 103(a) as
unpatentable over Meadows and Lujan. (Final Action 8.)
2 These claims are quoted from the Claims Appendix ("Claims App.")
accompanying the Appeal Brief.
2
Appeal2014-001260
Application 12/986,735
ANALYSIS
Independent claim 1 is directed to a method comprising "stimulating
at least one of the zona incerta, lenticular fasciculus, and motor region of the
globus pallidus." (Claims App.) Independent claim 3 is similarly directed
to a method wherein "at least one of the zona incerta, lenticular fasciculus,
and motor region of the globus pallidus are stimulated." (Id.) The Examiner
finds that the prior art discloses such stimulation. (See Final Action 5---6.)
The Appellants argue that Meadows does not mention anything about
the motor region of the globus pallidus, does not indicate that the region of
stimulation is the motor region on the globus pallidus, does not discuss the
placement of electrodes in the globus, and "does not state that the way its
system is used for motor function is by stimulation using implanted
electrodes." (Appeal Br. 3--4; see also Reply Br. 2-3.)
We are not persuaded by these arguments because they address only
what is expressly spelled out in Meadows, rather than what a person of
ordinary skill in the art would envisage from the teachings of this reference. 3
Meadows teaches that its method can be used as a therapy for a
"motor control dysfunction" caused by "Parkinson's Disease." (Meadows
i-f 9.) Meadows also teaches that its method comprises "conveying
stimulation energy" to an "implanted electrode located within a tissue area"
that is "located in the brain where motor dysfunctions often originate." (Id.)
3 See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381
(Fed. Cir. 2015) (quoting In re Petering, 301F.2d676, 681(C.C.P.A.1962)
(A reference can be considered to disclose claimed subject matter even if it
"'d[oes] not expressly spell out' all the limitations arranged or combined as
in the claim, if a person of skill in the art, reading the reference, would 'at
once envisage' the claimed arrangement or combination").
3
Appeal2014-001260
Application 12/986,735
Meadows further teaches that "stimulation energy" is conveyed from the
electrode(s) to the target tissue region to change the status of the
dysfunction. (Id. i-f 64.) A person of ordinary skill in the art would
appreciate that the motor region of the globus pallidus is a location in the
brain "where motor dysfunctions often originate." And, although Meadows
may not expressly spell out that the motor region of the globus pallidus is to
be stimulated when treating a dysfunction caused by Parkinson's Disease, a
person of ordinary skill in the art would at once envisage that such
stimulation occurs. 4
Independent claim 1 recites that, when the above-discussed
stimulation occurs, "less than 10% of non-motor regions of the brain is
stimulated as a result of the stimulation" and "less than 10% of non-motor
regions of the globus pallidus is stimulated as a result of the stimulation."
(Claims App.) Independent claim 3 recites that, during the above-discussed
stimulation, "current is not spread to, and therefore there is no stimulation
of, any of the corticospinal tract (CS), corticobulbar tract (CB), and the non-
motor regions of the globus pallidus (GP)." (Id.) The Examiner finds the
prior art teaches not stimulating non-motor regions of the brain during
stimulation of motor regions of the brain. (See Final Action 8-10.)
The Appellants argue that Meadows does not give any consideration
to limiting the "influence which stimulation might have on the non-motor
regions" (Appeal Br. 5), "the cited references do not suggest that incidental
4 As noted by the Appellants (see Appeal Br. 3; Reply Br. 3), Meadows
teaches that the dysfunction "may also be a non-motor dysfunction."
(Meadows i-f 33.) However, this alternative use for Meadows's method does
not contradict its teachings regarding using the method as a therapy for
motor control dysfunctions caused by Parkinson's Disease.
4
Appeal2014-001260
Application 12/986,735
stimulation of non-motor regions when targeting motor regions, would result
in harmful effects" (Reply Br. 3), and "[t]he Examiner is using what the
inventors of the present application have figured out, and which was not
before recognized, as the basis for asserting Meadows" (id. at 4).
We are not persuaded by these arguments because they are not
commensurate with the scope of the claims. 5
The Appellants' arguments implicate that the prior art must teach that
the optimum selected stimulation parameters (i.e., the stimulation parameters
programmed into a patient's neurostimulator at the completion of a
stimulation parameter selection procedure) possess the recited limitations.
However, independent claims 1 and 3 only require the recited stimulation
conditions to occur once; and they do not require the corresponding
stimulation parameters to be those programmed into a patient's
neurostimulator. In other words, the requirements of independent claims 1
and 3 can be met by a single iteration in a stimulation parameter selection
procedure, regardless of whether this iteration corresponds to optimum
stimulation conditions.
Meadows teaches stimulation parameter selection procedure wherein
"a value of at least one of the stimulation parameters may be incrementally
adjusted in one direction (e.g., increasing the pulse amplitude, pulse width,
or pulse rate) if [a] measured physiological end-function indicates an
improvement in the status of the dysfunction." (Meadows i-f 41.) This
procedure is "repeated until optimized or otherwise effective or improved
5 See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875
(Fed. Cir. 2004) ("[I]t is important not to import into a claim limitations that
are not a part of the claim").
5
Appeal2014-001260
Application 12/986,735
stimulation parameters are determined, which can then be programmed into
[the implantable pulse generator]." (Id. i-f 38.)
As explained by the Examiner, "[t]he globus pallidus is a very small
structure" and stimulation "would necessarily be such that the current is
limited to a region close to the motor region of the globus pallidus."
(Answer 6.)6 This would be especially true during early iterations of
Meadows' s stimulation parameter selection procedure, as the starting point
for optimization would be a relatively small pulse amplitude, a relatively
short pulse width, or a relatively low pulse rate. As such, a person of
ordinary skill in the art would infer that, at least during an early iteration of
Meadows' s stimulation parameter selection procedure, the motor region of
the globus pallidus would be stimulated at low current levels whereat there
would not be stimulation of, or current creep into, surrounding non-motor
regions of the brain. 7
6 The Examiner finds that Meadows does not discloses that "less than 10%
of non-motor regions of the brain are stimulated as a result of the stimulation
and less than 10% of the non-motor region of the globus pallidus is
stimulated as a result of the stimulation." (Final Action 8.) The Examiner
also finds that Meadows does not disclose that "the current is not spread to,
and therefore there is no stimulation of, any of the corticospinal tract (CS),
corticobulbar tract (CB), and the non-motor regions of the globus pallidus
(GP)." (Id. at 9). We agree with the Examiner that Meadows may not
precisely teach these stimulation conditions and we agree that Meadows may
not teach that its neurostimulator should be programmed based upon these
stimulation conditions.
7 See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007) (An
obviousness analysis "need not seek out precise teachings directed to the
specific subject matter of the challenged claim" as "the inferences and
creative steps that a person of ordinary skill in the art would employ" can be
taken into account).
6
Appeal2014-001260
Application 12/986,735
If Meadows' s stimulation parameter selection procedure followed the
conventional approach discussed by the Appellants, the incremental
increases in pulse amplitude, pulse width, and/or pulse rate might indeed
"continue[] without consideration of effect on creep to the non-motor
regions." (See Appeal Br. 5; see also Spec. i-f 6.) And the stimulation
parameters corresponding to such allegedly harmful stimulation conditions
might indeed be programmed into Meadow's implantable pulse generator.
However, as discussed above, independent claims 1 and 3 only require the
recited stimulation conditions to occur once; and they do not require the
corresponding stimulation parameters to be those programmed into a
patient's neurostimulator.
In view of the foregoing, we are not persuaded that the Examiner
erred in rejecting independent claims 1 and 3 as unpatentable over Meadows
and Lujan, and thus we sustain this rejection.
DECISION
We AFFIRM the Examiner's rejection of claims 1 and 3.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
7