Ex Parte Gerber et al

Patent Trial and Appeal Board

Jun 2, 2017

13456969 (P.T.A.B. Jun. 2, 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.
13/456,969 04/26/2012 Martin T. Gerber 1123-051US01/P41718.USU1 1853
71996 7590 06/06/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
PLATES KI, ERIN M
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
06/06/2017 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 MARTIN T. GERBER,
STEVEN M. GOETZ,
CHRISTOPHER POLETTO
Appeal 2015-007532
Application 13/456,969
Technology Center 3700
Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
GORDON D. KINDER, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s
decision, as set forth in the Final Office Action dated October 22, 2014
(“Final Act.”), rejecting claims 11, 13, 15—22, 24, 26, 28, and 30. App. Br.
4. Claims 1, 3, 5—10, 23, 25, 27, 29, and 31 have been withdrawn from
consideration while claims 2, 4, 12, and 14 have been canceled.
Amendment dated August 4, 2014. We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.
Appeal 2015-007532
Application 13/456,969
THE CLAIMED SUBJECT MATTER
The claimed subject matter “relates to implantable medical devices.”
Spec. 12. Claim 11 is the sole independent claim, is illustrative of the
subject matter on appeal, and is reproduced below.
11. A system comprising:
an implantable electrical stimulation generator; and
a processor configured to control the stimulation generator
to deliver prophylactic electrical stimulation to a cranial nerve at
a first stimulation intensity within a first range of stimulation
intensity thresholds determined based on patient perception in
the absence of any symptoms of a chronic condition, and to
deliver abortive electrical stimulation to the cranial nerve at a
second stimulation intensity within a second range of stimulation
intensity thresholds based on patient perception while a symptom
of the chronic condition is occurring,
wherein the prophylactic stimulation is configured to
inhibit onset of a symptom of the chronic condition, and
wherein the abortive stimulation is configured to reduce
an effect of a symptom of the chronic condition.
REFERENCES RELIED ON BY THE EXAMINER
Pless
Besio
Craig
Covalin
US 2002/0072770 A1
US 2006/0173510 A1
US 2007/0233194 A1
US 2010/0030299 A1
June 13, 2002
Aug. 3, 2006
Oct. 4, 2007
Feb. 4, 2010
Schachter et al. “Warning Signs of Seizures,” Epilepsy Foundation
THE REJECTIONS ON APPEAL
Claims 11, 17—22, and 30 are rejected under 35 U.S.C. § 102(b) as
anticipated by Pless.
Claims 13 and 15 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Pless, Craig, and Schachter.
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Appeal 2015-007532
Application 13/456,969
Claims 16, 24, and 26 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Pless.
Claim 28 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Pless, Besio, and Covalin.
ANALYSIS
The rejection of claims 11, 17—22, and 30
as anticipated by Pless
Sole independent claim 11 includes (twice) the recitation of a range of
thresholds “based on patient perception.” The Examiner states, “since
patient perception is not always an easily measured criterion . . .
measurement of brain waves is a good way of approximating patent
perception.” Final Act. 3—A. The Examiner explains, “if the patient’s brain
is reacting to a stimulus, therefore, this qualifies as patient perception.” Ans.
13. Appellants disagree stating that the Examiner’s assertion “is
unsubstantiated and insufficient to support a prima facie case of
anticipation.” App. Br. 7; see also App. Br. 6.
Appellants’ Specification provides limited guidance as to the meaning
of “patient perception” stating, “[a] stimulation threshold may refer to a
level of stimulation intensity at which a patient experiences a perceivable
sensation as a result of stimulation delivered at that intensity level.” Spec.
115. Appellants also state, “[t]o the extent the Examiner is relying on
Official Notice as support for the assertion that ‘measurement of brain waves
is a good way of approximating patient perception,” Appellants contend that
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Application 13/456,969
they have “previously traversed this reliance on Official Notice.”1 App. Br.
7.
In the absence of an express definition of the claim phrase “patient
perception,” “it is appropriate to consult a general dictionary definition of
the word for guidance.” Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348
(Fed. Cir. 2010) (citing Phillips v. AWHCorp., 415 F.3d 1303, 1322—23
(Fed. Cir. 2005) (en banc). The term “perception” is defined as
“consciousness,” “observation,” “awareness of the elements of environment
through physical sensation,” and “appreciation.”2 Webster’s New
Collegiate Dictionary 843 (1979). See also https://www.merriam-
webster.com/dictionary/perception.
Hence, as understood, the claim term “perception” is interpreted to
mean consciousness or awareness of something through the senses. Thus,
not only must the perception be one involving awareness or appreciation
through physical sensation, but such perception must also be that of the
patient, and not that of another individual who may be monitoring the
patient.3
1 We note that the present rejection stated by the Examiner does not assert
any reliance on Official Notice. Final Act. 2-4.
2 Another source defines “perception” as “the ability to see, hear, or become
aware of something through the senses” and “awareness of something
through the senses.” https://en.oxforddictionaries.com/defmition/perception.
3 Appellants’ Briefs state that in Pless, the level of stimulation therapy is
ascertained “based on when the physician determines there is satisfactory
cession of the epileptiform activity, not when the patient perceives a
cessation in activity.” App. Br. 6; Reply Br. 3 (both referencing Pless
1117).
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Application 13/456,969
Pless teaches that a “neurostimulator may be used by a physician to
induce epileptiform activity and then verily the effectiveness of the
parameters of the neurostimulation signals.” Pless |13. If the detected
signal (i.e., “brain electrical activity”) shows the existence or the imminent
onset of a neurological disorder (i.e., epilepsy), then a second signal is
applied to the brain in an effort to terminate such activity. Pless 10—14.
Thus, Pless is concerned with a physician detecting a patient’s brain waves
“to determine various stimulation parameters for responsive and non-
responsive stimulation” in an effort to prevent and/or control a patient’s
neurological disorder. Pless Tflf 114—117; see also Pless 46, 47.
In view of the above, the Examiner’s reliance on the teachings of
Pless coupled with the statement, “measurement of brain waves is a good
way of approximating patient perception” (Final Act. 4), does not fall
properly within the claim term “patient perception” as that term has been
defined above. This would be the case whether the patient is conscious or
not. Pless 13. Missing is a teaching of “consciousness” or “awareness,” via
the senses, regarding “stimulation intensity thresholds determined based on
patient perception” as recited. (Emphasis added.)
Furthermore, regarding the Examiner’s selection of brain wave
activity as “a good way of approximating patient perception” “since patient
perception is not always an easily measured criterion” (Final Act. 3—4), this
statement is seen to be one involving guesswork, supposition, or theory. We
are instructed that the Examiner may not “resort to speculation, unfounded
assumptions or hindsight reconstruction to supply deficiencies in its factual
basis.” In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). While the above
guidance from our reviewing court was made with respect to an obviousness
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rejection, we see no reason why such guidance is not equally applicable to
the present anticipation rejection.
We also note that the Examiner alternatively addresses Pless stating, a
“responsive stimulation may be provided as a result of the detection of
motion (Pless 1 [0047]).” Ans. 13; see also Final Act. 3. However, Pless is
silent regarding non-responsive/prophylactic stimulation detected in a like
manner. Further, there is no indication in Pless that such motion was made
consciously as per the understanding of the claim phrase “patient
perception.” In such situations, we are instructed, “[a] claim is anticipated
only if each and every element as set forth in the claim is found, either
expressly or inherently described, in a single prior art reference.” Verdegaal
Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987).
Thus, in the matter before us, Pless’ silence fails to satisfy this “each and
every” requirement for an anticipation rejection.
Accordingly, and based on the record presented, we reverse the
Examiner’s rejection of claims 11, 17—22, and 30 as being anticipated by
Pless. Furthermore, the Examiner’s additional reliance on Pless alone, or
Pless combined with either (a) Craig and Schachter or (b) Besio and Covalin
(all under an obviousness analysis), are not relied upon in such a manner as
would cure the above deficiencies. Thus, we likewise reverse the
Examiner’s rejection of (a) claims 13 and 15 as unpatentable over Pless,
Craig, and Schachter; (b) claims 16, 24, and 26 as unpatentable over Pless;
and, (c) claim 28 as unpatentable over Pless, Besio, and Covalin.
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DECISION
The Examiner’s rejections of claims 11, 13, 15—22, 24, 26, 28, and 30
are REVERSED.
REVERSED
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