Ex Parte Gerber et al

Patent Trial and Appeal Board

Nov 10, 2016

12989754 (P.T.A.B. Nov. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/989,754 10/26/2010
71996 7590 11/15/2016
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Martin T. Gerber
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.
P0028122.0l 1852
EXAMINER
MALAMUD, DEBORAH LESLIE
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
11/15/2016 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
Ex parte MARTIN T. GERBER and JOHN C. RONDONI 1
Appeal2014-005466
Application 12/989,754
Technology Center 3700
Before JENNIFER D. BAHR, JAMES P. CALVE, and
AMANDA F. WIEKER, Administrative Patent Judges.
WIEKER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Martin T. Gerber and John C. Rondoni ("Appellants") appeal under
35 U.S.C. § 134(a) from the Examiner's final rejection of claims 16-45. We
have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, the Real Party in Interest is Medtronic Inc.
Appeal Br. 3.
Appeal2014-005466
Application 12/989,754
CLAIMED SUBJECT MATTER
The invention concerns "determin[ing] therapy parameter values for
therapy delivered by medical devices." Spec. i-f 1. Claim 16 is illustrative of
the subject matter on appeal, and recites:
16. A method comprising:
determining a first therapy program that comprises a set of
therapy parameters values;
generating an algorithmic model of a therapy field based
on the first therapy program, the algorithmic model representing
where therapy will propagate from a therapy system delivering
therapy according to the first therapy program; and
automatically determining a second therapy program that
increases an operating efficiency of the therapy system while
substantially maintaining the therapy field.
Appeal Br. 16 (Claims App.) (emphasis added). Independent claims 30 and
44 contain similar language to that emphasized above in claim 16. Id. at 19,
21 (Claims App.).
REJECTION
Claims 16-45 stand rejected under 35 U.S.C. § 102(b) as anticipated
by Mcintyre.
ANALYSIS
Regarding claim 16, the Examiner finds that Mcintyre discloses a
FEM model that estimates a volume of activation.2 Final Act. 4. The
Examiner finds this "model is used in a system for optimizing stimulation
parameters (operating efficiency)." Id.; see also id. at 3. Also, in the
2 Mcintyre describes "volume of activation" as the "volume of tissue likely
to be affected by typical stimulation parameters." Mcintyre i-f 25.
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Examiner's Answer to the Appeal Brief, the Examiner finds that the "score"
created by Mcintyre' s algorithm, which evaluates how a modeled volume of
activation "map[s] against desired and undesired [brain] regions," is the
claimed "operating efficiency." Ans. 6.
Appellants contend that the Examiner makes inconsistent findings,
between the Final Office Action and the Answer, as to what corresponds to
the claimed step of "increases an operating efficiency." Reply Br. 5-7.
Regarding the Examiner's findings in the Final Office Action, Appellants
contend, inter alia, that neither Mcintyre' s disclosure of" optimizing
stimulation parameters" nor Mcintyre's ability to "optimize efficacy of
treatment" increases an operating efficiency of the therapy system, as
claimed. Appeal Br. 9-10 (citing Final Act. 3--4); Reply Br. 5---6. Regarding
the Examiner's findings in the Answer, Appellants contend, inter alia, that
Mcintyre' s "score" is unrelated to operating efficiency of a therapy system,
under a broadest reasonable interpretation of that phrase. Reply Br. 8.
We agree with Appellants that the Examiner made inconsistent
findings. Reply Br. 6-7. In the Final Office Action, the Examiner finds that
Mcintyre's stimulation parameters correspond to "operating efficiency." See
Final Act. 4. In the Answer, the Examiner finds that Mcintyre's score
corresponds to "operating efficiency." Ans. 6. Appellants did not, however,
file a Petition requesting the Examiner's Answer be designated a new
ground of rejection, in light of this inconsistency. See MPEP § 1207.03(b);
37 C.F.R. §§ 1.181, 41.40. Instead, Appellants filed a Reply Brief disputing
the Examiner's findings. See Reply Br. 5-8. Accordingly, we consider the
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Application 12/989,754
Examiner's findings as made in both the Final Office Action and the
Examiner's Answer, and Appellants' arguments in response.
As a threshold matter, we must ascertain the meaning of the claim
language "increases an operating efficiency." During patent examination
proceedings, "claims are given their broadest reasonable interpretation
consistent with the specification." In re Hyatt, 211F.3d1367, 1372 (Fed.
Cir. 2000). Here, Appellants' Specification does not define this phrase
expressly. The Specification does, however, provide examples of what is
encompassed by this language. For example, the Specification explains that
operating efficiency may be increased by "decreasing power consumption or
operating at efficient amplitudes based on voltage multiplier levels." Spec.
i1i19, 127, 132; see also Appeal Br. 17 (Claims App.) (claim 22). The
Specification also explains that "operating efficiency data" may be utilized
to "improve the energy efficiency of the [implantable medical device]."
Spec. i-fi-f 121, 128, 131. Indeed, "small change[s] in therapy parameter
values," such as, for example, "identify[ing] the position on the amplitude-
duration curve that is most efficient," "may result in significant changes in
battery recharge frequency and/or longevity." Id. i-f 132. Therefore, a person
of ordinary skill in the art, reading claim 16 in light of the Specification,
would understand "increases an operating efficiency" to relate to increases
in the functional efficiency of the therapy system in terms of, for example,
energy usage or battery life, rather than efficacy of the therapy delivered.
In the Final Office Action, the Examiner finds that Mcintyre' s FEM
model "is used in a system for optimizing stimulation parameters (operating
efficiency)." Final Act. 4. However, the Examiner does not explain
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Application 12/989,754
persuasively how "optimizing stimulation parameters" relates to improving
the functional efficiency of the system. Mcintyre describes that stimulation
parameters include, e.g., pulse amplitude, pulse bandwidth, frequency, the
particular electrode contacts stimulated (when plural contacts are disposed
on the same lead), and polarity. Mcintyre i-fi-125, 72. The portions of
Mcintyre cited by the Examiner describe that Mcintyre' s modeling system
can be used to "optimize or otherwise adjust neural stimulation treatment by
varying electrode position, stimulation protocol, or electrode design." Id.
i176. In other words, the cited portions explain that stimulation treatment is
optimized by modifying stimulation parameters. Id.; see also Final Act. 3
(finding that Mcintyre's system "adjusts stimulation parameters to optimize
efficacy of treatment"). The cited portions do not describe, however,
whether these modifications in stimulation parameters also "increas[ e] an
operating efficiency," i.e., increase the functional efficiency of the therapy
system. See, e.g., Mcintyre i-fi-125, 76-77 (cited by Final Act. 4).
With respect to dependent claim 22, the Examiner cites paragraph 102
of Mcintyre, which explains that "engineering optimization is used to assist
the [stimulation parameter] selection process" and "limits on the stimulation
parameters are determined by the output of the current clinical stimulator."
Mcintyre i-f 102; Final Act. 5. This disclosure, however, appears to relate to
the technical operating limitations of the stimulator, e.g., the range of
amplitude it is capable of generating, not the "operating efficiency" of the
system. Mcintyre i-f 102. Neither Mcintyre nor the Examiner explains
whether those technical operating limitations impact how efficiently the
system operates, e.g., in terms of its energy usage or battery life. Further,
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even if "engineering optimization" were understood to correspond to the
claimed "operating efficiency," the Final Office Action fails to explain how
a therapy field generated by Mcintyre's FEM model is "maintain[ ed]" while
the "engineering optimization" is increased, as claimed. See Final Act. 4--5.
Accordingly, the Examiner's findings as made in the Final Office
Action are not supported by a preponderance of evidence.
In the Examiner's Answer, the Examiner finds that Mcintyre's "score
is understood to be the 'operating efficiency of the therapy system' as
claimed." Ans. 6. The Examiner does not explain persuasively how
Mcintyre's score, which maps a modelled volume of activation against
regions of the brain in which activation is desired or undesired to predict the
treatment efficacy of different electrode locations and parameter settings
(see Mcintyre i-fi-1 67-69), relates in any manner to "increasing an operating
efficiency" of the therapy system, as that phrase has been construed.
Accordingly, the Examiner's findings as made in the Examiner's Answer are
not supported by a preponderance of evidence.
Therefore, we reverse the Examiner's rejection of independent claim
16, and claims 17-29, which depend from claim 16.
Independent claims 30 and 44 recite systems that "automatically
determin[ e] a second therapy program that increases an operating efficiency
of the therapy system." Appeal Br. 19, 21 (Claims App.). For the reasons
discussed above with respect to similar language in independent claim 16,
we do not sustain the Examiner's rejection of claims 30 or 44, or dependent
claims 31--43 and 45, as anticipated by Mcintyre.
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DECISION
The rejection of claims 16-45 is REVERSED.
REVERSED
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