Ex Parte King et al

Patent Trial and Appeal Board

Jul 29, 2013

11810941 (P.T.A.B. Jul. 29, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte GARY W. KING, STEVEN M. GOETZ,
KEVIN K. TIDEMAND, WILBERT A. WESSELINK,
GABRIELA C. MIYAZAWA, and JORDAN J. GREENBERG
____________

Appeal 2011-002539
Application 11/810,941
Technology Center 3700
____________

Before GAY ANN SPAHN, MICHAEL C. ASTORINO, and
HYUN J. JUNG, Administrative Patent Judges.

SPAHN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s
rejection of claims 17-32 and 35-42. We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.
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Claimed Subject Matter
The claimed subject matter relates to “electrical stimulation therapy,”
and “[m]ore particularly, . . . to techniques for selecting combinations of
implanted electrodes for delivery of stimulation to a patient.” Spec. 1, para.
[0002]. Claim 17, reproduced below, is illustrative of the appealed subject
matter.
17. A computing device comprising:
a memory comprising a plurality of electrode
combinations and, for each of the electrode combinations,
associated numerical values for at least two different types of
therapy metrics, the therapy metrics each comprising a
quantifiable result of delivery of stimulation, wherein the
numerical values for the therapy metrics are generated with
experimental computer modeling of delivery of stimulation via
the electrode combinations;
a user interface comprising a display and configured to
receive input from a user indicating a selected type of therapy
metric; and
a processor that selects an electrode combination from
among the plurality of electrode combinations stored within the
memory based on the selected type of therapy metric, and
presents the selected electrode combination to the user via the
display.
App. Br., Clms. App’x.

Evidence Relied Upon
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Barreras 5,895,416 Apr. 20, 1999
King 6,714,822 B2 Mar. 30, 2004
Goetz 2005/0060009 A1 Mar. 17, 2005
Whitehurst 6,871,099 B1 Mar. 22, 2005

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Jan Holsheimer, et al., How Do Geometric Factors Influence Epidural
Spinal Cord Stimulation? A Quantitative Analysis by Computer
Modeling, Stereotact. Funct. Neurosurg., 56: 234-249 (1991)
(hereafter “Holsheimer”).

Rejections
The following Examiner’s rejections, under 35 U.S.C. § 103(a), are
before us for review:
I. claims 17-19, 23-32, 35, 38, and 40-42 as unpatentable over
Goetz and Holsheimer;
II. claims 20-22 and 36 as unpatentable over Goetz, Holsheimer,
and Barreras; and
III. claims 37 and 39 as unpatentable over Goetz, Holsheimer,
Whitehurst, and King.

OPINION
Rejection I – Obviousness based on Goetz and Holsheimer
Claims 17, 19, 23-29, 35, and 40-42
Appellants argue that “the stimulation parameters . . . disclosed by
Goetz cannot reasonably be characterized as the therapy metrics of
Appellant[s’] claim 17,” because “the stimulation parameters described by
Goetz merely define the stimulation that is delivered to the patient, and do
not in any way quantify a result of the stimulation.” App. Br. 9. In other
words, Appellants argue that “[a]lthough the stimulation parameters of
Goetz define the stimulation that is delivered to the patient, which may
achieve some result, the stimulation parameters themselves do not quantify
the results of delivery of stimulation,” because “[s]uch results are not known
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until a patient assigns an efficacy rating to a tested electrode combination.”
Id.
The Examiner responds that “the actual phrasing of claim 17 is
worded as, ‘the therapy metrics each comprising a quantifiable result of
delivery of stimulation[,]’ which within the broadest reasonable
interpretation of the phrase, is interpreted as the therapy metric being one
value comprising another value that is a quantifiable result of delivery of
stimulation.” Ans. 16. See Ans. 4. Based on the Examiner’s interpretation,
the Examiner finds that “Goetz et al. teach[] therapy metrics (“stimulation
parameters” [0038]) such as voltage, amplitude, frequency and pulse width,
each comprising a quantifiable result of delivery of stimulation (“efficacy
rating information” [0059]-[0061]).” Ans. 16.
Appellants reply that “even if [the Examiner’s] interpretation of
‘therapy metric’ is reasonable, an assertion with which Appellant[s] do[] not
necessarily agree, the stimulation parameters disclosed by Goetz fail to
amount to ‘therapy metrics’ under the Examiner’s definition,” because “the
stimulation parameters disclosed by Goetz do not comprise a quantifiable
result of stimulation.” Reply Br. 6. In other words and as argued in the
Appeal Brief, “the stimulation parameters described in Goetz merely define
the stimulation that is delivered to the patient, which may achieve some
result,” but “[t]he stimulation parameters themselves do not quantify the
results of delivery of stimulation,” because “[s]uch results of delivery of
stimulation are not known” until an efficacy rating is assigned to a tested
electrode combination. Id.
We are persuaded by Appellants’ arguments. While the Examiner has
correctly pointed to Goetz’s “‘efficacy rating information’ [0061], lines 3-8;
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[0062], lines 1-6” as one of the two different types of therapy metrics
required to satisfy the language of independent claim 17, we agree with
Appellants that Goetz’s “‘stimulation parameters’ [0038], lines 4-5,” as
referenced by the Examiner (Ans. 4), is not a “therapy metric[] . . .
comprising a quantifiable result of delivery of stimulation.” App Br., Clms.
App’x.; see also App. Br. 9. Appellants are correct that the stimulation
parameters themselves do not quantify the results of delivery of stimulation,
and that the results of delivery of stimulation are not known until an efficacy
rating is established for a tested electrode combination. Thus, the
Examiner’s rejection does not satisfy claim 17’s language of “at least two
different types of therapy metrics,” because Goetz’s “stimulation
parameters” do not constitute a “therapy metric[] . . . comprising a
quantifiable result of delivery of stimulation.”
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 17, and its dependent claims, under 35 U.S.C. § 103(a) as
unpatentable over Goetz and Holsheimer. Additionally, independent claim
40 is similar to claim 17. For the same reasons, claim 17 is not sustained,
we likewise do not sustain the rejection of claim 40, and its dependent
claims, under 35 U.S.C. § 103(a) as unpatentable over Goetz and
Holsheimer.
Claims 30-32
Independent claim 30 is directed to a computing device including,
inter alia, “a processor configured to control a medical device to deliver
electrical stimulation therapy to a patient via a baseline electrode
combination, receive user input including patient feedback relating to the
delivery of electrical stimulation via the baseline electrode combination via
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the user interface, compare a baseline numerical value associated with the
baseline electrode combination to respective numerical therapy metric
values of the plurality of electrode combinations, and select an additional
electrode combination from within the plurality of electrode combinations
based on the patient feedback and the comparison between the baseline
numerical value and the respective numerical therapy metric values of the
plurality of electrode combinations.” App. Br., Clms. App’x. Emphasis
added.
Appellants argue that the Examiner’s combination of Goetz and
Holsheimer “fails to disclose or suggest a processor that compares a baseline
numerical value and respective numerical therapy metric values of a
plurality of electrode combinations, as recited in claim 30.” App. Br. 22.
Appellants also argue that:
[E]ven if Goetz discloses numerical therapy metrics values, . . .
Goetz fails to disclose or suggest that a processor selects an
additional electrode combination from within a plurality of
stored electrode combinations based on patient feedback and a
comparison between a baseline numerical therapy metric value
and the respective numerical therapy metric values of the
plurality of electrode combinations, as required by claim 30.
Id.
Appellants note the Examiner finds that Goetz discloses the processor
of claim 30 in its discussion of a genetic algorithm technique for selecting
additional electrode configurations from within a plurality of electrode
configurations based on patient feedback and a baseline numerical value. Id.
(citing Final Rej. 6-7). However, Appellants view Goetz as disclosing “that
the genetic algorithm can be used to generate solutions that are possible
configurations of electrodes on a lead,” and “[t]he process of generating new
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solutions, e.g., by cross-over, mutation, or a combination of both, repeats
until a satisfactory solution is reached, e.g., until an efficacy threshold is
satisfied.” App. Br. 23. Thus, Appellants also argue that “Goetz fails to
disclose that the genetic algorithm functions by selecting electrode
combinations that are already stored, much less based on the therapy metric
values of Appellant[s’] claim 30,” but rather, “the genetic algorithm
disclosed by Goetz generates new solutions for a clinician to test on a
patient.” Id. (citing Goetz, paras. [0045] and [0050]).
We are persuaded by Appellants’ arguments. The Examiner’s
rejection of claim 30 merely indicates that Goetz discloses a processor 30 in
figure 3 which is configured to compare a baseline numerical value
associated with the baseline electrode combination to respective numerical
therapy metric values of the plurality of electrode combinations to order the
electrode combinations based on efficacy information. Ans. 7-8. However,
the Examiner does not point to anything in Goetz to support that Goetz’s
processor 30 is actually configured to do the recited comparison. Ans. 8 and
20-22. Accordingly, the Examiner’s legal conclusion of obviousness is not
supported by factual evidence and therefore, cannot stand. See In re
Warner, 379 F.2d 1011, 1017 (CCPA 1967) (holding that “[t]he legal
conclusion of obviousness must be supported by facts. Where the legal
conclusion is not supported by facts it cannot stand.”).
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 30, and claims 31, 32, and 38 dependent thereon, under
35 U.S.C. § 103(a) as unpatentable over Goetz and Holsheimer.

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Rejection II – Obviousness based on Goetz, Holsheimer, and Barreras
Claims 20-22 and 36 all depend, either directly or indirectly, from
independent claim 17. App. Br., Clms. App’x. The Examiner’s rejection of
claims 20-22 and 36 relies on the erroneous finding that Goetz discloses at
least two different types of therapy metrics wherein the therapy metrics each
comprise a quantifiable result of delivery of stimulation. Ans. 11-14. The
Examiner’s rejection did not rely upon either Holsheimer or Barreras to cure
the deficiency of Goetz. Id. Accordingly, for the same reasons as discussed
supra with respect to the rejection of claim 17, we do not sustain the
Examiner’s rejection of claims 20-22 and 36 under 35 U.S.C. § 103(a) as
unpatentable over Goetz, Holsheimer, and Barreras.

Rejection III – Obviousness based on
Goetz, Holsheimer, Whitehurst, and King
Claim 37
Claim 37 depends from independent claim 17. App. Br., Clms.
App’x. The Examiner’s rejection of claim 37 relies on the erroneous finding
that Goetz discloses at least two different types of therapy metrics wherein
the therapy metrics each comprise a quantifiable result of delivery of
stimulation. Ans. 14-15. The Examiner’s rejection did not rely upon any of
Holsheimer, Whitehurst or King to cure the deficiency of Goetz. Id.
Accordingly, for the same reasons as discussed supra with respect to the
rejection of claim 17, we do not sustain the Examiner’s rejection of claim 37
under 35 U.S.C. § 103(a) as unpatentable over Goetz, Holsheimer,
Whitehurst, and King.

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Claim 39
Claim 39 depends from independent claim 30. App. Br., Clms.
App’x. The Examiner’s rejection of claim 39 relies on the erroneous finding
that Goetz discloses a processor configured to compare a baseline numerical
value associated with the baseline electrode combination to respective
numerical therapy metric values of the plurality of electrode combinations.
Ans. 14-15. The Examiner’s rejection did not rely upon any of Holsheimer,
Whitehurst or King to cure the deficiency of Goetz. Id. Accordingly, for the
same reasons as discussed supra with respect to the rejection of claim 30, we
do not sustain the Examiner’s rejection of claim 39 under 35 U.S.C. § 103(a)
as unpatentable over Goetz, Holsheimer, Whitehurst, and King.

DECISION
We reverse the Examiner’s decision to reject claims 17-19, 20-32, and
35-42.

REVERSED

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