Ex Parte Molnar et al

Patent Trial and Appeal Board

Feb 28, 2017

12768403 (P.T.A.B. Feb. 28, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/768,403 04/27/2010 Gabriela C. Molnar 1023-937US01/P0037079.00 5541
71996 7590 03/02/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
BAYS, PAMELA M
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
03/02/2017 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 GABRIELA C. MOLNAR, STEVEN M. GOETZ, and
ANDREW N. CSAVOY
Appeal 2015-004401
Application 12/768,4031
Technology Center 3700
Before: CHARLES N. GREENHUT, ANNETTE R. REIMERS, and
THOMAS F. SMEGAL, Administrative Patent Judges.
GREENHUT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1—
6, 10-23, and 27—36. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part and enter new grounds of rejection.
1 According to Appellants, the real party in interest is Medtronic, Inc.
Appeal Br. 3.
Appeal 2015-004401
Application 12/768,403
CLAIMED SUBJECT MATTER
The claims are directed to stimulation electrode systems and methods.
Claim 1, reproduced below, with emphasis added is illustrative of the
claimed subject matter:
Claiml: A method comprising:
sensing a bioelectrical signal in a brain of a patient with a
sense electrode combination that comprises at least one
electrode;
accessing a physiological model that indicates one or more
characteristics of tissue proximate the at least one electrode
within the brain of the patient; and
selecting a stimulation electrode combination for
delivering electrical stimulation to the brain of the patient based
on a signal characteristic of the bioelectrical signal and the
physiological model, the signal characteristic indicating a
location of the at least one electrode relative to a target tissue site.
REJECTION
Claims 1—6, 10-23, and 27—36 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Rondoni (WO 2009/134475 Al; published Nov.
5, 2009) and Pless (US 2009/0276005 Al; published Nov. 5, 2009).
OPINION
Claims 1—6, 10—23, and 27—36 are rejected under § 112, second paragraph.
At the outset, we must acknowledge that the Examiner and Appellants
consider the scope of the subject matter defined by the claims before us to be
two very different things. This is because independent claims 1,18, 33. and
36 are ambiguous. Appellants repeatedly argue that, contrary to the
Examiner’s understanding, the claims do “not recite that ‘stimulation is
based on a signal characteristic . . App. Br. 10; Reply Br. 3. However,
this is literally what each independent claim recites: “delivering electrical
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stimulation to the brain of the patient based on a signal characteristic . . .
Appellants presume the phrase emphasized above should be parsed:
“selecting a stimulation electrode combination ... based on a signal
characteristic.” Reply Br. 3—A. However, claims before the PTO are given
their broadest reasonable interpretation and Appellants’ proposed
interpretation is not necessarily the only reasonable one. It is not clear what
action “based on” refers back to, “selecting,” “delivering,” or both.
Although the Specification does discuss using the location-indicative signal
as a basis for electrode selection, there also appears to be an implication that
such location information may also be used to determine the desired or
anticipated therapy field resulting from delivered stimulation. See, e.g.,
Spec, paras. 3, 37, 59, 63-64, 73, 76. If Appellants wish to claim subject
matter directed only to the former, the claims should be amended to clearly
define that subject matter while Appellants have an opportunity to do so.
See Ex Parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) accord In re
Packard, 751 F.3d 1307, (Fed. Cir. 2014). Accordingly, pursuant to 37
C.F.R. § 41.50(b) we reject claims 1—6, 10-23, and 27—36 under 35 U.S.C. §
112, second paragraph, as being indefinite.
Regardless of how the ambiguity above is resolved claims 1, 18, 33, and 36
are properly rejected under § 103(a) over Rondoni and Pless.
Although claims 18, 33, and 36 are argued under separate
subheadings, the arguments are premised upon the same language and refer
back to the arguments set forth regrading claim 1. App. Br. 18, 20-22.
Thus, the same issues are raised regarding the § 103(a) rejection of each of
the independent claims before us.
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The Examiner’s rejection is not articulated with a high level of
particularity. See, e.g., Final Act. 3 (citing various paragraphs of Rondoni
without any explanation of what steps or structure in the cited paragraphs
satisfies the precise limitations recited in the claims). Nevertheless, from
inspection of the cited paragraphs of Rondoni, it is apparent that Appellants’
assertion that Rondoni does not disclose determining a location of an
electrode (App. Br. 11) is inaccurate. Although Rondoni does not contain an
express statement that location is determined, in order for Rondoni to “target
particular anatomic structures” (para. 47), use “patient anatomy data” to
generate an electrical field therapy model (para. 61), and/or use patient
anatomy data to indicate “characteristics of patient tissue (e.g., impedance)
proximate to implanted leads 34, 36” (paras. 61—62), Rondoni must account
for at least the general location of the electrodes. See Ans. 13—14 (quoting
from Rondoni paras. 47 and 60-62). The patient anatomy data, which “may
be specific to patient 12 or may represent data for more than one patient,
e.g., model or averaged data of the anatomical structure and tissue
conductivity of multiple patients” (para. 61) is reasonably regarded as the
recited “physiological model.” Ans. 14. It does not appear to be disputed
that this patient anatomy data is used to “select[] a stimulation field and . . .
generate] the stimulation parameter values” (para. 61), or that “the therapy
parameters may include an electrode combination”2 (para. 47). See Ans. 13—
14.
Appellants go on to argue, “[mjoreover, even if the physiological
parameters disclosed by Rondoni could give an indication of an electrode
2 “An electrode combination may include a selected subset of one or more
electrodes 17 located on one or more implantable lead 16 coupled to IMD
14.” Para. 47.
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Application 12/768,403
location, the Examiner failed to establish that Rondoni does disclose a
method that includes sensing physiological parameters ‘to determine a
location of the electrode,,[] as the Examiner asserted Rondoni discloses.”
App. Br. 12. A careful review of the paragraphs 56, 61, 62, 86, and 104
cited by the Examiner to meet this limitation (Final Act. 3, Ans. 13—15)
reveals that Appellants are correct. Although Rondoni uses sense electrodes
to “sense[] a physiological parameter of a patient 12, such as, but not limited
to, a heart rate, respiration rate, respiratory volume, core temperature,
muscular activity, electromyogram (EMG), an electroencephalogram (EEG),
an electrocardiogram (ECG) or galvanic skin response” (para. 56) there does
not appear to be any support for the Examiner’s finding that Rondoni uses
any of these sensed signals to determine the location of the electrodes. See
Ans. 14—15. Nonetheless, Pless clearly accounts for this deficiency by
demonstrating that the technique of determining electrode placement based
on sensed electroneurogram (ENG) signals was known in the art: “a
physician or surgeon can observe measured ENG characteristics to
determine which neural structure the probe assembly is touching.” See Final
Act. 3^4 (citing Pless paras. 21 and 33; Ans. 15—16 (citing paras. 9-11)). As
discussed above, because Rondoni relies at least in part on location
information, there is a rational basis for the Examiner’s stated motivation to
employ Pless’s location-determining technique: “in order to more accurately
locate the stimulation electrode within the brain and brain regions to provide
more effective stimulation therapy for the patient.” Final Act. 4; see App.
Br. 13.
Appellants do not appear to dispute that the portion of Pless cited by
the Examiner (para. 33) satisfies the Examiner’s interpretation of the phrase
discussed above with respect to our rejection under § 112, second paragraph.
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App. Br. 12—14 (“in the method disclosed by Pless, no selection of a
stimulation electrode combination is made based on the characteristic
ENG.”). Appellants’ argument that “in the method disclosed by Pless, no
selection of a stimulation electrode combination is made based on the
characteristic ENG” is an attack on Pless individually without consideration
of the combined teachings of Pless and Rondoni. “Non-obviousness cannot
be established by attacking references individually when the rejection is
based upon the teachings of a combination of references.” See In re Merck
& Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986)(citation omitted). As
discussed above, Rondoni already teaches using anatomy data, which is
indicative of, or based on, electrode location, for selecting stimulation
parameters, which include electrode combinations. Modifying Rondoni to
include Pless’s electrode locating technique would yield the claimed subject
matter even under the interpretation of claims 1, 18, 33, and 36 advanced by
Appellants.
Accordingly, we sustain the Examiner’s rejection of claims 1—4, 13—
21, 29, and 30-36. As we have departed from the thrust of the Examiner’s
rejection, we designate this affirmance as including a new ground of
rejection pursuant to 37 C.F.R. § 41.50(b).
The Examiner’s rejection of claims 5, 6, 10—12, 22, 23, 27, and 28 is
reversed.
Our reviewing court’s predecessor guides:
[T]he precise language of 35 U.S.C. § 102 that ‘(a) person shall
be entitled to a patent unless,’ concerning novelty and
unobviousness, clearly places a burden of proof on the Patent
Office which requires it to produce the factual basis for its
rejection of an application under sections 102 and 103.
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In re Warner 379 F.2d 1011, 1016 (CCPA 1967). The Patent Trial and
Appeal Board is primarily a tribunal of review. See Ex parte Frye, 94
USPQ2d 1072, 1075-1077 (BPAI 2010)(precedential). For that review to be
meaningful it must be based on some concrete evidence in the record to
support the Examiner’s factual findings and legal conclusions. In re Zurko,
258 F.3d 1379, 1386 (Fed. Cir. 2001). A rejection must be set forth in
sufficiently articulate and informative manner as to meet the notice
requirement of § 132, such as by identifying where or how each limitation of
the rejected claims is met by the prior art references. In re Jung, 637 F. 3d
1356, 1363 (Fed. Cir. 20U); see also 37 C.F.R. § 1.104(c)(2) (“When a
reference is complex or shows or describes inventions other than that
claimed by the applicant, the particular part relied on must be designated as
nearly as practicable. The pertinence of each reference, if not apparent, must
be clearly explained and each rejected claim specified.”); Gechter v.
Davidson 116 F.3d 1454, 1460 (Fed. Cir. 1997)(PTO must create a record
that includes “specific fact findings for each contested limitation and
satisfactory explanations for such findings.”).
As discussed above, Rondoni discloses selecting stimulation electrode
combinations based on electrode location and a physiological model, while
Pless teaches using sense electrodes for determining electrode locations. In
rejecting claims 5, 10, 22, and 27, the Examiner cites the same paragraphs
discussed above without specifically explaining how the disputed limitations
are met by the cited prior art. See Final Act. 5; Ans. 18. Accordingly, the
Examiner has not established that it would have been obvious to “select[]
one of the sense electrode combinations based on the [sensed] signal
characteristics” (claims 5 and 22; App. Br. 16, 19) or to “confirm[] the
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[selected] stimulation electrode combination based on the physiological
model” (claims 10 and 27; App. Br. 17, 20).
Accordingly, we do not sustain the Examiner’s rejection of claims 5,
6, 10-12,22, 23,27, and 28.
Claims 10—12, 14, 15, 27, 28, 30, 31, 34, and 35 are rejected under 35
U.S.C. § 112, first and second paragraphs.
If claims 1, 18, 33, and 36 are afforded the interpretation advanced by
Appellants and discussed above in relation to 35 U.S.C. § 112, second
paragraph, they would require selecting a stimulation electrode combination
based on both 1) a signal characteristic of the biological signal and 2) the
physiological model. Under this interpretation, the disclosed embodiment
covered by the independent claims, is limited to that illustrated in Figure 5,
wherein stimulation is selected based on both the sensed signals and
physiological model (step 104). Dependent claims 10, 14, and 27, on the
other hand, aim to limit the claimed subject matter to the embodiment
depicted in Figure 8, and dependent claims 30 and 35 aim to limit the
claimed subject matter to the embodiment disclosed in Figure 9. The
problem with these dependent claims is that each of the embodiments
depicted in Figures 8 and 9 is mutually exclusive with the embodiment
depicted in Figure 5. The selection step 104 in Figure 5, which calls for
selection based on both sensed signals and the physiological model, and
which is recited in each of the independent claims, is replaced by the
selection steps 120, 126 in Figures 8 and 9, respectively. Both steps 120 and
126 omit elements of step 104. However, dependent claims 10, 14, 27, 30
and 35 cannot similarly omit those elements because dependent claims must
further limit the claims from which they depend. See 35 U.S.C. § 112, fourth
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paragraph. Giving effect to all the limitations of claims 10, 14, 27, 30, and
35, including those of the respective independent claims from which they
depend, means claims 10, 14, 27, 30, and 35 each include elements of two
different and mutually exclusive embodiments, i.e., the physiological model
(claims 10, 14, and 27) or the sensed signal (claims 30 and 35) is used for
both selection and confirmation. Such combinations are neither described
in, nor enabled by, Appellants’ disclosure in the manner required by 35
U.S.C. § 112, first paragraph. SeeMPEP § 2163 (including 2163.03(V)
regarding original claims), and 2164. Additionally, the inability to reconcile
the subject matter disclosed with that claimed renders the scope of the
claims uncertain in violation of 35 U.S.C. § 112, second paragraph, as well.
See MPEP § 2173.03 (citing In re Cohn, 438 F.2d 989, 993 (CCPA 1971)).
We acknowledge that Appellants may have simply intended to recite
independent claims generic to each of the embodiments depicted in Figures
5, 8, and 9. Nevertheless, “[i]t is the applicants’ burden to precisely define
the invention, not the PTO’s.” In re Morris, 111 F. 3d 1048, 1056 (Fed. Cir.
1997).
Pursuant to our authority under 37 C.F.R. § 41.50(b), and for the
foregoing reasons, we reject claims 10, 14, 27, 30, and 35 and their
respective dependent claims under 35 U.S.C. § 112, first paragraph as failing
to comply with the written description and enablement requirements and
under 35 U.S.C. § 112, second paragraph as being indefinite.
DECISION
Pursuant to 37 C.F.R. § 41.50(b), claims 1—6, 10-23, and 27—36 are
rejected under § 112, second paragraph.
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The Examiner’s rejection of claims 1—4, 13—21, 29, and 30-36 under
35 U.S.C. § 103(a) as unpatentable over Rondoni and Pless is affirmed, but
that affirmance is designated as including a new ground of rejection pursuant
to 37 C.F.R. § 41.50(b).
The Examiner’s rejection of claims 5, 6, 10—12, 22, 23, 27, and 28
under 35 U.S.C. § 103(a) as unpatentable over Rondoni and Pless is
reversed.
Pursuant to 37 C.F.R. § 41.50(b), claims 10-12, 14, 15, 27, 28, 30, 31,
34, and 35 are rejected under 35 U.S.C. § 112, first and second paragraphs.
RESPONSE TO NEW GROUNDS
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). Section 41.50(b) provides “ new ground[s] 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
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request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
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-IN-PART; 37 C.F.R, $ 41.50(b)
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