Ex Parte McIntyre et al

Patent Trial and Appeal Board

Sep 26, 2016

13288684 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/288,684 11/03/2011
50638 7590 09/27/2016
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
Cameron C. McINTYRE
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-1-567.2 2146
EXAMINER
FAIRCHILD, MALLIKA DIPAYAN
ART UNIT PAPER NUMBER
3762
MAILDATE DELIVERY MODE
09/27/2016 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)
L11'-~ITED ST ATES PATENT AND TRADE~'v1ARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CAMERON C. MCINTYRE and JAY L. ALBER TS
Appeal2014-006814
Application 13/288,684
Technology Center 3700
Before MICHAEL L. HOELTER, THOMAS F. SMEGAL, and LISA M.
GUIJT, Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 seek our review under 35 U.S.C. § 134 of the Examiner's
decision2 rejecting claims 1-17, 19, and 20.3 We have jurisdiction under
35 U.S.C. § 6(b).
1 Appellants identify the real party in interest as The Cleveland Clinic
Foundation. App. Br. 1.
2 Appeal is taken from the Final Office Action dated October 9, 2013
("Final Act.").
3 Claim 18 is cancelled. See Amendment dated July 9, 2013.
Appeal2014-006814
Application 13/288,684
\Ve AFFIR~vf and enter NEvV GROlJt-JDS OF REJECTION pursuant
to 37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Claims 1, 19, and 20, reproduced below, are the independent claims
on appeal. See Appeal Br. (Claims App.).
1. A computer-implemented method, comprising:
obtaining postural stability results of at least one
administered dual task test, the dual task test requiring
simultaneous performance of a motor function task and a
cognitive function task; and
selecting, by a computer processor, stimulation parameters
for stimulating an anatomical region of a patient, the selection
being based on the results.
19. A non-transitory computer-readable [medium] having
stored thereon instructions executable by a processor, the
instructions which, when executed by the processor, cause the
processor to perform a method, the method comprising:
obtaining postural stability results of at least one
administered dual task test, the dual task test requiring
simultaneous performance of a motor function task and a
cognitive function task; and
selecting stimulation parameters for stimulating an
anatomical region of a patient, the selection being based on the
results.
20. A system, comprising:
a computer processor configured to:
obtain postural stability results of at least one administered
dual task test, the dual task test requiring simultaneous
performance of a motor function task and a cognitive function
task; and
select stimulation parameters for stimulating an
anatomical region of a patient, the selection being based on the
results.
2
Appeal2014-006814
Application 13/288,684
REJECTIONS
I. Claims 1-3, 8, 13-17, 19, and 20 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Meadows (US 2009/0118786 Al; pub.
May 7, 2009) and "Bilateral subthalamic stimulation impairs cognitive -
motor performance in Parkinson's disease patients," Alberts et al, Brain
(2008), vol. 131, p. 3348-3360 (hereinafter "Alberts").
II. Claims 6, 7, and 12 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Meadows, Alberts, and "Effects of deep brain stimulation
and levodopa on postural sway in Parkinson's disease," Rocchi et al., J.
Neurol Neurosurg Psychiatry (2002), vol. 73, p. 267-274.
III. Claims 4, 5, and 9-11 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Meadows, Alberts, and Stone (US 2007 /0203546 Al;
Aug. 30, 2007).
ANALYSIS
Rejection 1
The Examiner found, inter alia, that Meadows teaches a computer-
implemented method (claim 1 ), computer readable medium (claim 19), and
system (claim 20) comprising obtaining postural stability results of at least
one administered test, and selecting, by a computer processor, stimulation
parameters based on the test results for stimulating an anatomical region of
the patient. Final Act. 6-7 (citing Meadows i-fi-12, 9, 33, 53, 54). In
particular, the Examiner found that Meadows discloses therapeutic
application of deep brain simulations (DBS4) for treating Parkinson's
Disease, which causes a motor dysfunction such as posture dysfunction, by
4 Spec., p. 2, 1. 1.
3
Appeal2014-006814
Application 13/288,684
measuring a physiological end-function (e.g., a kinematic function) and
using such measurement to adjust the DBS stimulation parameters. Id.
Determining that Meadows "do[ es] not specifically teach [obtaining]
results of a test that is a dual task test requiring simultaneous performance of
a motor function task and a cognitive function task," the Examiner relied on
Alberts for teaching that "it is well known to have patients perform dual task
tests as claimed (i.e. tests comprising a cognitive function task and a motor
function task) and [to] obtain the results of the dual task tests." Id. at 6-7
(citing Alberts, Abstract, p. 3351, cols. 1, 2, p. 3352, col. 1, 11. 1-17)
(emphasis added). The Examiner explained that "Alberts['] teachings
show[] that patients with Parkinson's [D]isease perform ... dual task tests ..
. simultaneously such as a force maintenance test for motor function ... and
an N-Back test to test cognitive dysfunction to evaluate therapy parameters
in Parkinson's disease patients." Id. at 7-8 (citing Alberts, p. 3351, col. 1, 1.
4---col. 2, 1. 20).
The Examiner reasoned that it would have been obvious to "modify
the teachings of Meadows with the teachings of Alberts in order to provide
the predictable results of treating motor as well as cognitive dysfunction in
Parkinson's disease patients" (id. at 8) and also "to provide the predictable
results [of] improving the DBS programming as these conditions better
reflect the context in which daily activities are performed" (Ans. 9; see
Alberts p. 3348, Abstract ("[there is a] need to assess cognitive and motor
function simultaneously during DBS programming as these conditions may
better reflect the context in which daily activities are performed.").
First, Appellants point out that Meadows does not disclose the use of
a dual task test, and also argue that "the cited section of Alberts merely
4
Appeal2014-006814
Application 13/288,684
discusses evaluations for comparing previouslv performed unilateral and
bilateral [(DBS)] with respect to their effect to motor and non-motor task
functions." App. Br. 3--4 (citing Alberts, 3350 col. 2, p. 3355, col. 1); Reply
Br. 2. Appellants submit that "Alberts does not suggest that the results of a
dual task test are used for selecting stimulation parameters to be used for a
later performed stimulation," and that Alberts "does not enable one of
ordinary skill in the art to use the dual task test to develop stimulation
parameters for DBS." App. Br. 4; Reply Br. 2-3. Appellants explain that
"[b ]y using stimulation parameters determined by a computer from results of
dual task test(s) in which postural stability assessment is a necessary
limitation, Appellants' invention effectively makes use of the dual task
results to limit diminished cognitive performance and increase[] motor
scores." App. Br. 4.
Appellants' argument, however, does not address the Examiner's
findings stated supra. The Examiner relies on Alberts, not Meadows, for
disclosing a dual task test, and indeed, Alberts teaches a dual task test
involving an n-back task and a force-maintenance task. See Alberts, p.
3351, col. 2, paragraph titled, "Dual task: n-back and force maintenance
simultaneously"; cf Spec. i-f 23 ("During the dual-task, participants
performed then-back and force-tracking tasks simultaneously."). The
Examiner also relies on Meadows, not Alberts, for disclosing use of the test
results for selecting stimulation parameters for future (or later performed)
DBS therapeutic application. See Meadows i-f 33 ("the measured
physiological end-function ... can be used to adjust the stimulation
parameters.").
5
Appeal2014-006814
Application 13/288,684
Thus, Appellants' argument that Albert fails to enable the use of a
dual task test to develop stimulation parameters for DBS is misplaced.
Notably, as an example of a measured physiological end-function (or test),
Meadows discloses "a positioning chair in which the patient can be
positioned to perform a variety of physical exercises involving movement of
the patient's limbs, and a computer system for controlling and implementing
the physical exercise, and quantitatively measuring the patient's
neuromuscular ability." Meadows i-f 55. Appellants do not argue that
Meadows' measurement of a physiological end-function is not at least a
single task test. Thus, Appellants' argument does not apprise us of error in
the Examiner's findings with respect to Meadows and Alberts.
Second, Appellants conclude that "Meadows and Alberts did not
suggest any system that could include these features." App. Br. 4. More
particularly, Appellants argue that "the mere knowledge of existence of a
dual task test in no way suggests its use to select stimulation parameters."
Reply Br. 3. Appellants submit that "Alberts explicitly suggests that there
was no reasonable expectation of success at that time, [of a using dual task
test] but rather further investigation was still required." App. Br. 5; Reply
Br. 3. Appellants also submit that the Examiner's proposed combination
impermissibly relies on hindsight reasoning, "because only [Appellants'
Specification] indicates how these features may be realized." App. Br. 5;
Reply Br. 3.
Regarding Appellants' argument that neither Meadows nor Alberts
suggests the Examiner's proposed combination, such an argument appears to
be holding the Examiner to the old TSM (teaching, suggestion, or
motivation) standard; such a standard is not required. KSR Int 'l Co. v.
6
Appeal2014-006814
Application 13/288,684
Teleflex Inc., 550 U.S. 398, 415 (2007). ~vforeover, as stated supra, the
Examiner's rationale is expressly supported by Alberts. Ans. 9 (citing
Alberts, p. 3348, Abstract). In addition, although Alberts discusses the use
of a dual task test to determine the effects of DBS therapy rather than for
selecting stimulation parameters (see, e.g., Alberts, Abstract), we do not
agree with Appellants that because Alberts discloses that there is an
investigation into the effectiveness of using "an abridged version of dual-
task paradigm in the selection of DBS parameters" (Alberts, p. 3358, col. 2,
11. 10-12; App. Br. 4), there was no reasonable expectation of success that a
dual task test would work in the system disclosed by Meadows. To the
contrary, Albert's disclosure provides motivation to modify Meadows to use
a dual task test. Appellants also do not identify any knowledge that the
Examiner relied upon that was gleaned only from Appellants' disclosure and
that was not otherwise disclosed in either Meadows or Alberts, or within the
level of ordinary skill at the time of the invention. See In re McLaughlin,
443 F.2d 1392 (CCPA 1971).
Accordingly, we sustain the Examiner's rejection of independent
claims 1, and claims 2, 3, 8, and 13-17 depending therefrom, and
independent claims 19 and 20.
Rejection II
Appellants submit that claims 6, 7, and 12 are allowable "for at least
the same reasons as claim 1." App. Br. 5. Because we sustain the
Examiner's rejection of independent claim 1, we also sustain the Examiner's
rejection of claims 6, 7, and 12 depending therefrom.
7
Appeal2014-006814
Application 13/288,684
Rejection III
Appellants submit that claims 4 and 5 are allowable "for at least the
same reasons as claim 1." App. Br. 6. Because we sustain the Examiner's
rejection of independent claim 1, we also sustain the Examiner's rejection of
claims 4 and 5 depending therefrom.
Regarding claims 9-11, in addition to the arguments presented supra,
Appellants argue that the Examiner fails to show how Stone discloses the
limitations of claims 9-11 and also that the Examiner relies on Appellants'
Specification, which is improper hindsight reasoning. App. Br. 6-7.
Claim 9 depends from claim 1 and recites "wherein the selecting is
performed to maximize stimulation of a target motor anatomical region and
minimize current creep to non-motor anatomical regions." App. Br. (Claims
App.). The Examiner found that Stone teaches that
it is well known to have software that provides a 3D view of the
patient's images, DBS electrodes and/or calculate volumes of
activation for specified stimulation parameters based on which
the clinician can modify the volume of tissue activation so that
there is maximum stimulation of the target motor area and
minimal spread to the non-motor areas of the brain.
Final Act. 11. The Examiner reasons that it would have been obvious
to modify the teachings of Meadows in view of Alberts to include
calculating a computational model of estimated activated tissue
and providing a visualization as taught by Stone in order to
provide the predictable results of giving the user/clinician a user-
friendly visual image of the active regions of the brain to make
more targeted and accurate determination of the stimulation
therapy parameters.
Id.
Although Stone generally discloses that "[t]he 'best' program may be
a program that best balances greater clinical efficacy and minimal side
8
Appeal2014-006814
Application 13/288,684
effects experienced by the patient" (Stone 11 5), we agree with Appellants
that Stone does not expressly disclose selecting parameters that maximize
stimulation of a target motor anatomical region and minimize current creep
to non-motor anatomical region, as required by claim 9. However,
Meadows more specifically states that "[t]he best stimulus parameter set will
typically be one that delivers stimulation energy to the volume of tissue that
must be stimulated in order to provide the therapeutic benefit (e.g., treatment
of movement disorders), while minimizing the volume of non-target tissue
that is stimulated" (Meadows i-f 4), and describes applying DBS therapy to a
patient having motor dysfunction (id. i-f 14). Thus, we determine that
Meadows discloses the limitations recited in claim 9 and sustain the
Examiner's rejection. Because we rely on Meadows, rather than Stone, we
designate our affirmance as a new ground of rejection under 37 C.F.R. §
41.50(b) to provide Appellants with a full and fair opportunity to respond to
the rejection.
Claim 10 depends from claim 9 and recites "wherein the anatomical
regions are part of the subthalamic nucleus (STN)" (App. Br. (Claims
App.)), and the Examiner relies on Meadows, not Stone, for teaching this
limitation. Final Act. 12 (citing Meadows i-f 64 ("electrodes 26 are adjacent
a target tissue region whose electrical activity is the source of the
dysfunction (e.g., ... [the] subthalamic nucleus).") Thus, we are not
apprised of error in the Examiner's finding. Because claim 10 depends from
claim 9, and because we sustain the rejection of claim 9 pursuant to a new
ground of rejection, we also designate our affirmance of claim 10 as a new
ground of rejection under 37 C.F.R. § 41.50(b).
9
Appeal2014-006814
Application 13/288,684
Claim 11 depends from claim 1 and recites "wherein the stimulation
parameters are selected to minimize stimulation-related cognitive declines"
(App. Br. (Claims App.)) and similar to claim 9 supra, we agree with
Appellants that Stone does not expressly disclose this limitation. However,
as discussed supra with respect to claim 9, Meadows discloses that "[t]he
best stimulus parameter set will typically be one that delivers stimulation
energy to the volume of tissue that must be stimulated in order to provide the
therapeutic benefit (e.g., treatment of movement disorders), while
minimizing the volume of non-target tissue that is stimulated" (Meadows i-f
4), and describes applying DBS therapy to a patient having motor
dysfunction (id. i-f 14). Further, Alberts discloses that "data support[s] ...
the hypothesis that non-motor pathways are likely activated during STN
DBS and may contribute to the present observation," namely, "cognitive and
motor performance decline." Alberts, p. 3356, col. 1, 1. 1, col, 2, 11. 48-54.
Thus, in view of Albert's suggestion of a decline in cognitive
performance that results from stimulation of non-motor pathways, and
Meadows' disclosure to minimize stimulation of non-target tissue (e.g., non-
motor pathways), we find that one skilled in the art would understand the
combined disclosures of Alberts and Meadows to teach the limitation of
claim 11, namely, the selection of parameters to minimize stimulation-
related cognitive declines, and we sustain the Examiner's rejection. Because
we rely on Meadows and Alberts, rather than Stone, we designate our
affirmance as a new ground of rejection under 37 C.F.R. § 41.50(b) to
provide Appellant with a full and fair opportunity to respond to the rejection.
10
Appeal2014-006814
Application 13/288,684
NE\tV GROlJt-JD OF REJECTION
Section 101 of the Patent Act defines the subject matter eligible for
patent protection: "Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent therefor, subject to the
conditions and requirements of this title." 35 U.S.C. § 101. The Supreme
Court has explained that laws of nature, natural phenomena, and abstract
ideas fall outside the scope of this provision and are not patentable subject
matter. Alice Corp. Pty. Ltd. v. CLS Bank Int'!, 134 S. Ct. 2347, 2354
(2014). For example, abstract ideas include, but are not limited to,
fundamental economic practices, methods of organizing human activities, an
idea of itself, and mathematical formulas or relationships. Id. at 2355-57.
The Court in Alice emphasized the use of the two-step framework for
analysis of patentability set forth in Mayo Collaborative Services v.
Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1297 (2012):
First, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts. If so, we then ask,
"[ w ]hat else is there in the claims before us?" To answer that
question, we consider the elements of each claim both
individually and 'as an ordered combination' to determine
whether the additional elements 'transform the nature of the
claim' into a patent-eligible application.
Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1298, 1297). In other
words, the second step is to "search for an 'inventive concept' -- i.e., an
element or combination of elements that is 'sufficient to ensure that the
patent in practice amounts to significantly more than a patent upon the
[ineligible concept] itself."' Id. The prohibition against patenting an
abstract idea "cannot be circumvented by attempting to limit the use of the
11
Appeal2014-006814
Application 13/288,684
formula to a particular technological environment or adding insignificant
post-solution activity." Bilski v. Kappas, 561 U.S. 593, 610-11 (2010)
(citation and internal quotation marks omitted). The Court in Alice noted
that "' [ s ]imply appending conventional steps, specified at a high level of
generality,' was not 'enough' [in Mayo] to supply an 'inventive concept."'
Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at 1300, 1297, 1294).
We begin our analysis by applying the first step of the Mayo test. As
stated supra, the independent claims recite, in relevant part, (i) a computer
implemented method comprising the steps of obtaining test results (from a
known, conventional test5) and selecting (by a computer processor)
stimulation parameters based on the results (claim 1 ); (ii) a non-transitory
computer-readable medium with stored instructions executable by a
processor to perform a method comprising the steps of obtaining such test
results, and selecting stimulation parameters based on the test results (claim
19); and (iii) a system comprising a computer processor configured to obtain
such test results and to select stimulation parameters based on the test results
(claim 20).
We conclude that the claims are directed to an abstract idea under step
one of the Alice analysis because obtaining test results from a known,
conventional test is a data gathering step and selecting stimulation parameters
based on the test results is a mental step that may be performed in the mind
of a physician. Data gathering steps are not sufficient to render the subject
matter statutory under§ 101 (see CyberSource Corp. v. Retail Decision Inc.,
654 F.3d 1366, 1371-72 (Fed. Cr. 2016)) and "mental processes - or
5 See Alberts, p. 3351, col. 2, paragraph titled, "Dual task: n-back and force
maintenance simultaneously."
12
Appeal2014-006814
Application 13/288,684
processes of human thinking - standing alone are not patentable even if they
have practical application." Jn re Comiskey, 499 F.3d 1365, 1377 (Fed. Cir.
2007).
Applying the second step of the Mayo test to independent claim 1, we
determine that the claim limitations of requiring the method to be computer-
implemented wherein a computer processors selects the stimulation
parameters, when considered individually and as an ordered combination, do
not add anything that would transform the nature of the claims from the
abstract idea into a patent-eligible application. As the Court explained in
Alice, implementation of an abstract idea by a computer does not transform
the abstract idea into a patent-eligible application. Alice, 134 S.Ct. at 2358
("stating an abstract idea 'while adding the words "apply it" is not enough
for patent eligibility.'") (citations omitted).
We further determine that claims 2 and 4--1 7, which depend from
claim 1, and which further qualify the test for generating results and/or the
selection of the stimulation parameters, also fail to transform the nature of
the claim into a patent-eligible application when considered individually and
as an ordered combination.
Applying the second step of the Mayo test to independent claim 19,
we determine that the claim limitations of requiring a non-transitory
computer-readable medium having stored instructions executable by a
processor to perform the method of obtaining the test results and selecting
stimulation parameters based on the results, when considered individually
and as an ordered combination, do not add anything that would transform the
nature of the claims from the abstract idea into a patent-eligible application.
Again, as the Court explained in Alice, implementation of an abstract idea by
13
Appeal2014-006814
Application 13/288,684
a computer does not transform the abstract idea into a patent-eligible
application. Alice, 134 S.Ct. at 2358.
Applying the second step of the Mayo test to independent claim 20,
we determine that the claim limitation of requiring a computer processor
configured to obtain the test results and select stimulation parameters, when
considered individually and as an ordered combination, does not add
anything that would transform the nature of the claims from the abstract idea
into a patent-eligible application. As discussed supra, implementation of an
abstract idea by a computer does not transform the abstract idea into a
patent-eligible application. Alice, 134 S.Ct. at 2358.
Claim 3 depends from claim 2 and recites "wherein the stimulation is
performed using implanted electrodes of a deep brain stimulation (DBS)
device." App. Br. (Claims App.). We determine that such stimulation is
conventional post-solution activity that is not sufficient to transform the
abstract idea into patent-eligible subject matter. See Parker v. Flook, 437
U.S. 584, 590-92, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978); see, e.g., Meadows
i-fi-12, 3 ("[DBS] has been applied therapeutically for well over a decade for
the treatment of neurological disorders, including Parkinson's Disease"
wherein "[e]ach of these implantable neurostimulation systems typically
includes one or more electrode carrying stimulation leads, which are
implanted at the desired stimulation site.").
Accordingly, we enter a new ground of rejection of claims 1-17, 19,
and 20 under 35 U.S.C. § 101 as being directed to non-statutory subject
matter.
14
Appeal2014-006814
Application 13/288,684
DECISION
The Examiner's decisions to reject claims 1-17, 19, and 20 under 35
U.S.C. § 103(a) are AFFIRMED, and we designate our affirmance of the
Examiner's decision to reject claims 9-11 as a NEW GROUND OF
REJECTION.
Pursuant to 37 C.F.R. § 41.50(b), we enter a NEW GROUND OF
REJECTION of claims 1-17, 19, and 20 under 35 U.S.C. § 101 as being
directed to non-statutory subject matter.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision, must
exercise one of the following two options with respect to the new
ground of rejection to avoid termination of the appeal as to the
rejected claims:
( 1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
15
Appeal2014-006814
Application 13/288,684
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
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)(l )(iv).
AFFIRMED; 37 C.F.R. § 41.50(b)
16