Ex Parte Giftakis et al

Patent Trial and Appeal Board

Jun 23, 2016

12236316 (P.T.A.B. Jun. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/236,316 09/23/2008
71996 7590 06/27/2016
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Jonathon E. Giftakis
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.
1023-738US01/P0030295.0l 7673
EXAMINER
NG, JONATHAN K
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
06/27/2016 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):
pairdocketing@ssiplaw.com
medtronic _neuro _ docketing@cardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte JONATHON E. GIFTAKIS, JONATHAN C. WERDER,
DAVID C. ULLESTAD, and NINA M. GRAVES
Appeal2014-001251 1
Application 12/236,3162
Technology Center 3600
Before BIBHU R. MOHANTY, KENNETH G. SCHOPPER, and
MATTHEWS. MEYERS, Administrative Patent Judges.
MEYERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final
rejection of claims 1-5, 8, 10-17, 19-32, 37--45, and 52---63. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1. Our decision references Appellants' Appeal Brief ("Appeal Br.," filed
July 30, 2013) and Reply Brief ("Reply Br.," filed October 29, 2013), the
Examiner's Answer ("Ans.," mailed August 29, 2013), and Final Office
Action ("Final Act.," mailed March 1, 2013).
2. Appellants identify Medtronic, Inc. as the real party in interest
(Appeal Br. 3).
Appeal2014-001251
Application 12/236,316
CLAIMED INVENTION
Appellants' claimed invention relates generally "to evaluating one or
more therapy programs or groups of programs or adjusting therapy delivered
by a medical device based on an indication that a patient event occurred"
(Spec. ii 6).
Claim 1, reproduced below with added bracketed notations, is
illustrative of the subject matter on appeal:
1. A method comprising:
[a] receiving, with at least one of a medical device
programmer or a medical device, a plurality of indications, each
indication of the plurality of indications indicating an occurrence
of a patient event, wherein the patient event is related to a
condition of the patient;
[b] for each indication of the plurality of indications,
generating, with at least one of the medical device programmer
or the medical device, an event marker based on the respective
indication of the occurrence of the patient event;
[ c] with at least one of the medical device programmer or
the medical device, associating each event marker \'l1ith at least
one therapy program of a plurality of stored therapy programs,
wherein the medical device is configured to deliver therapy to
the patient according to the plurality of therapy programs, and
wherein each therapy program of the plurality of stored therapy
programs is associated with a respective threshold value, and at
least two therapy programs are associated with different
threshold values;
[ d] determining, with at least one of the medical device
programmer or the medical device, an event metric for a therapy
program of the plurality of stored therapy programs based on a
number of event markers associated with the therapy program;
[ e] determining, with at least one of the medical device
programmer or the medical device, whether the event metric
indicates the therapy program is ineffective for the patient
condition, and wherein determining whether the event metric
indicates the therapy program is ineffective for the patient
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Application 12/236,316
condition comprises comparing the event metric to the threshold
value associated with the therapy program; and
[ f] with at least one of the medical device programmer or
the medical device, adjusting therapy delivered to the patient by
the medical device in response to determining the event metric
indicates the therapy program is ineffective for the patient
condition.
REJECTIONS
Claims 1-5, 8, 10-17, 19, 20, 22, 24--32, 37-39, 41--45, and 52---63 are
rejected under 35 U.S.C. § 103(a) as unpatentable over Snell (US 5,518,001,
iss. May 21, 1996), Osorio (US 2004/0158119 Al, pub. Aug. 12, 2004), and
Goetz (US 2005/0060007 Al, pub. Mar. 17, 2005).
Claims 21and40 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Snell, Osorio, Goetz, and Smith (US 200710040692 Al,
pub. Feb. 22, 2007).
Claim 23 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Snell, Osorio, Goetz, and Eiffert (US 2002/0120187 Al, pub. Aug.
29, 2002).
ANALYSIS
We are persuaded by Appellants' argument that the Examiner erred in
rejecting independent claim 1under35 U.S.C. § 103(a) because the
combination of Snell, Osorio, and Goetz fails to disclose or suggest "a
plurality of stored therapy programs ... , wherein each therapy program of
the plurality of stored therapy programs is associated with a respective
threshold value, and at least two therapy programs are associated with
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Application 12/236,316
different threshold values," as recited by limitation [ c] of independent claim
1 (see Appeal Br. 10-12; see also Reply Br. 7-10).
The Examiner maintains that the rejection is proper, and cites
paragraphs 48 and 56, as well as Figure 5, of Goetz as disclosing the argued
limitations (see Final Act. 2---6; see also Ans. 28-30). More particularly, the
Examiner finds that "each therapy program has multiple threshold values
and they are different than each other in value" (Ans. 29) and asserts that
"under the broadest reasonable interpretation, one can interpret claim 1 to
encompass where each therapy program is each associated with different
threshold values" (id. at 30).
Goetz "is directed to a technique for selection of parameter
configurations for a neurostimulatar using decision trees" (Goetz i-f 6). More
particularly, Goetz discloses that its "technique may be employed by a
programming device to allow a clinician to select parameter configurations,
and then program an implantable neurostimulator to deliver therapy using
the selected parameter configurations" (id.). Goetz discloses that its
programming device utilizes "a parameter configuration search algorithm"
which "relies on a decision tree to identify potential optimum parameter
configurations" (id. i-f 8). Goetz discloses that the "decision tree is useful in
classifying observations in a data set based upon one or more attributes or
fields within the data" (id. i-f 9) and "[t]he data set includes parameter
configurations matched with observed ratings of efficacy on patients of a
similar symptomatic indication" (id. i-f 1 O; see also id. i-f 11 ). In this regard,
Goetz discloses
partial decision trees of FIGS. 4 and 5 address the problem of
selecting the optimum electrode configuration. The partial
decision tree of FIG. 4 represents a first level of the decision tree
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Application 12/236,316
hierarchy, and is directed to identification of therapy, device,
lead and symptomatic indication. Specifically, the decision tree
of FIG. 4 is design to identify the type of neurostimulation
therapy ( 44) to be applied to the patient, e.g., therapy directed to
pain relief (46), gastro disorders (48), movement disorders (50),
or other disorders (52), such as sexual dysfunction.
(Id. i-f 49). Goetz further discloses "the decision tree of FIG. 5 may start
with a root node such as electrode combination LE23 (90), i.e., a
combination of second and third electrodes on a left" and "[i]f the
combination produces a satisfactory efficacy rating, the process terminates
(92)" (id. i-f 56). Goetz also discloses
(Id.).
FIG. 5 uses a rating scale of 1 to 5, with 5 being best and 1 being
worst. In some embodiments, nodes with ratings of less than 3
may be discarded, rather than expanded. If a rating of 5 is not
achieved, then the root node 90 may be expanded to explore other
combinations.
We are not persuaded by the Examiner's analysis because, although
Goetz discloses that different electrode combinations may be associated with
different thresholds reflecting efficacy and side effects (see e.g., Goetz
i-fi-155-58; see also id. at Fig. 5), as Appellants point out
[c]laim 1 does not recite that at least two therapy programs are
associated with multiple threshold values, as asserted by the
Examiner. Rather, claim 1 specifies that each therapy program
of the plurality of stored therapy programs is associated with a
respective threshold value, and at least two therapy programs are
associated with different threshold values.
(Reply Br. 8).
We also agree with Appellants that "paragraph [0056] of Goetz does
not disclose that at least two electrode combinations are associated with
different efficacy rating thresholds" (id. at 7); but rather, "Goetz describes
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application of the same efficacy rating threshold to expand the nodes of the
decision tree, and thereby test additional electrode combinations" (id.). In
this regard, we note that Goetz discloses that "ratings of 4 and 3 yield
evaluation of additional next-level nodes 94, 96 directed to electrode
combinations LE34 and RE34" (Goetz i-f 56; see also id. at Fig. 5). Thus,
Goetz presents various treatment options using a sliding scale of likelihood
of efficacy, but Goetz does not disclose or suggest "a plurality of stored
therapy programs ... , wherein each therapy program of the plurality of
stored therapy programs is associated with a respective threshold value, and
at least two therapy programs are associated with different threshold values,"
as recited by limitation [ c] of independent claim 1. The Examiner does not
rely on either of Snell or Osorio to address this limitation (see Final Act. 5-
6; see also Ans. 5---6).
In view of the foregoing, we reverse the Examiner's rejection of
independent claim 1. For the same reasons; we also do not sustain the
Examiner's rejection of dependent claims 2-5, 8, 10-17, 19, 20, 22, and 24--
26. Cf In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) ("dependent
claims are nonobvious if the independent claims from which they depend are
nonobvious").
Independent claims 27 and 45, and dependent claims 28-32, 37-39, 41--45,
and 52-63
Independent claims 27 and 45 include limitations substantially similar
to independent claim 1 's limitations discussed above. Therefore, we do not
sustain the Examiner's rejection under 35 U.S.C. § 103(a) of independent
claims 27 and 45, and claims 28-32, 37-39, 41--45, and 52---63 that depend
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therefrom, for the same reasons set forth above with respect to independent
claim 1.
Dependent claims 21and40
Claims 21 and 40 depend from independent claims 1 and 27,
respectively. The Examiner's rejection of claims 21 and 40 under 35 U.S.C.
§ 103(a) based on Smith, in combination with Snell, Osorio, and Goetz, does
not cure the deficiency in the Examiner's rejection of independent claim 1.
Therefore, we do not sustain the Examiner's rejection of claims 21 and 40
under 35 U.S.C. § 103(a) for the same reasons set forth above with respect to
the independent claims.
Dependent claim 23
Claim 23 depends from independent claim 1. The Examiner's
rejection of claim 23 under 35 U.S.C. § 103(a) based on Eiffert, in
combination with Snell, Osorio, and Goetz, does not cure the deficiency in
the Examiner's rejection of independent claim 1. Therefore, we do not
sustain the Examiner's rejection of claim 23 under 35 U.S.C. § 103(a) for
the same reasons set forth above with respect to the independent claims.
DECISION
The Examiner's rejections of claims 1-5, 8, 10-17, 19-32, 37--45, and
52---63 under 35 U.S.C. § 103(a) are reversed.
REVERSED
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