Ex Parte Giftakis et al

Patent Trial and Appeal Board

Nov 17, 2016

12432268 (P.T.A.B. Nov. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/432,268 0412912009
71996 7590 11/21/2016
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.
1023-829US01/P0033947.00 6759
EXAMINER
CATINA, MICHAEL ANTHONY
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
11/21/2016 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
ExparteJONATHONE. GIFTAKIS andNATHAN A. TORGERSON
Appeal2014-008524
Application 12/432,268
Technology Center 3700
Before JENNIFER D. BAHR, GEORGE R. HOSKINS, and
LEE L. STEPINA, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jonathon E. Giftakis and Nathan A. Torgerson ("Appellants") 1 appeal
under 35 U.S.C. § 134 from the Examiner's decision rejecting claims 12-14,
17-21, 32-34, 37-39, 42, 44--49, 52-58, 61-66, and 69-71 in this
application. The Board has jurisdiction over the appeal under 35 U.S.C.
§ 6(b ).
We REVERSE.
1 The Appeal Brief identifies Medtronic, Inc. as the real party in interest.
Appeal Br. 3.
Appeal2014-008524
Application 12/432,268
CLAIMED SUBJECT MATTER
Claims 12, 32, and 42 are independent. Claim 12 illustrates the
claimed subject matter on appeal, and it recites:
12. A method comprising:
receiving, with a processor, a first signal indicative of a
physiological parameter of a patient;
receiving, with the processor, a second signal indicative of
a patient parameter of the patient; and
adjusting, with the processor, a seizure detection algorithm
of a medical device based on the first and second signals, wherein
adjusting the seizure detection algorithm comprises:
identifying, with the processor, a target seizure
based on the second signal;
determining, with the processor, whether the
medical device, while implementing the seizure detection
algorithm, identified the target seizure based on the first
signal;
in response to determining that the medical device
did not identify the target seizure based on the first signal,
determining \~1hether a portion of the first signal associated
with the target seizure is indicative of a baseline non-
seizure state of the patient; and
adjusting the seizure detection algorithm if the
portion of the first signal associated with the target seizure
is not indicative of the baseline non-seizure state of the
patient.
REJECTIONS ON APPEAL
Claims 12-14, 17, 32-34, 42, 44--46, 52, 56, 57, 64, 65, and 69 stand
rejected under 35 U.S.C. § 102(e) as anticipated by Leyde
(US 2009/0171168 Al, pub. July 2, 2009).
Claims 18, 19, 37, 53, 61, and 71 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Leyde and Donoghue (US 2005/0203366 Al,
pub. Sept. 15, 2005).
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Appeal2014-008524
Application 12/432,268
Claims 20, 38, and 47 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Leyde and Giftakis (US 2006/0135877 Al, pub. June 22,
2006).
Claims 21, 39, and 48 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Leyde, Giftakis, and Donoghue.
Claims 49, 58, and 66 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Leyde and Nathan (US 2012/0053491 Al, pub. Mar. 1,
2012).
Claims 54, 62, and 70 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Leyde and Greene (US 2008/0319335 Al, pub. Dec. 25,
2008).
Claims 55 and 63 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Leyde and Osorio (US 6,560,486 B 1, iss. May 6, 2003).
ANALYSIS
A. Anticipation by Leyde
Claims 12-14, 17, 56, and 57
In rejecting claim 12, the Examiner finds Leyde discloses the claimed
"first signal" as monitored neurological EEG data. Final Act. 3 (citing
Leyde i-fi-128, 31 ). The Examiner finds Leyde discloses the claimed "second
signal" as monitored clinical manifestation data, for example convulsions or
ictal moans, which "identify[] ... a target seizure" occurrence as claimed.
Id. (citing Leyde i-fi-128, 33, 40, 97-98); see also Leyde i130 ("ictal state" is
"a state in which a neurological event, such as a seizure, is occurring"). The
Examiner finds Leyde discloses the claimed "determining ... whether the
medical device ... identified the target seizure based on the first signal"
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Application 12/432,268
when Leyde compares the clinical manifestation data with the EEG data to
determine if the device correctly predicted or determined a seizure state
based on the EEG data. Final Act. 3 (citing Leyde i-fi-197-98).
The Examiner finds Leyde discloses the claimed "in response to
determining that the medical device did not identify the target seizure based
on the first signal [i.e. EEG data], determining whether a portion of the first
signal [i.e. EEG data] associated with the target seizure is indicative of a
baseline non-seizure state of the patient" (with emphasis added to claim
language). Id. at 3--4 (citing Leyde i-fi-1 30, 97-98). In particular, the
Examiner determines Leyde' s analysis of the EEG data to see if the EEG
seizure detection algorithm should be corrected "is equivalent to determining
if the [EEG] signal is indicative of a non-seizure state, i.e.[,] the EEG is
normal," and "[t]hen the algorithm is corrected, if necessary, for example if
the device did not accurately predict or a detect a seizure state" based on the
EEG data. Id. at 4 (citing Leyde i198). The Examiner further states the
claimed "baseline" state "is arbitrary and does not differentiate ... from a
non-seizure state," and "[a]ny non-seizure state or activity would generally
be considered a baseline state as normal EEG activity is not ictal or
epileptiform activity." Id. at 16.
Appellants argue the Examiner errs in finding Leyde discloses both of
the determining steps recited in claim 12. Appeal Br. 8-9; Reply Br. 7-8.
Appellants also argue the Examiner errs in interpreting "the claimed
'baseline non-seizure state' as equivalent to any non-seizure state." Appeal
Br. 11. We agree with these arguments.
First, as a matter of claim construction, claim 12 recites
"determining .... whether the medical device, while implementing the
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Application 12/432,268
seizure detection algorithm, identified the target seizure based on the first
signal" (hereafter "first determination"). Appeal Br. 27 (Claims App.).
Claim 12 then recites, "in response to" the first determination indicating the
device did not identify the target seizure based on the first signal,
"determining whether a portion of the first signal associated with the target
seizure is indicative of a baseline non-seizure state of the patient" (hereafter
"second determination"). Id. (emphasis added). The separateness of these
first and second determinations is established by the second determination
being made "in response to" a specified result of the first determination.
Further, both of the first and second determinations are made with
respect to the claimed "first signal," which the Examiner finds to be Leyde's
neurological EEG data. Final Act. 3. Thus, to anticipate claim 12, Leyde
must disclose firstly determining whether its seizure detection algorithm
identified a target seizure based on the EEG neurological data, and then
secondly (i.e., in response to determining that the algorithm did not identify
the target seizure) determining whether a portion of the EEG neurological
data is indicative of a baseline non-seizure state.
The Examiner's rejection conflates these two steps in finding both
steps are met by the one action of determining whether Ley de' s seizure
detection algorithm reports a seizure state or a non-seizure (i.e. normal) state
based on the neurological EEG data. See Final Act. 3--4, 16-17; Ans. 16-
17.
Further, the Examiner's construction of the claimed "baseline non-
seizure state" as encompassing "[a]ny non-seizure state or activity" (Final
Act. 16) is unreasonably broad, in light of the language of claim 12 and
Appellants' supporting Specification. As to the claim language, claim 12
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Application 12/432,268
recites the second determination-that is, the baseline non-seizure state
determination-is made "in response to determining that the medical device
did not identifj; the target seizure." Appeal Br. 27 (emphases added). Thus,
as recited in the claim, the baseline non-seizure state determination is made
based on the EEG data only after it has already been determined that the
EEG data algorithm did not identify a target seizure state. As claimed, the
baseline non-seizure state must be different from another non-seizure state
or activity. That is, the word "baseline" specifies a type of non-seizure state.
That understanding is consistent with Appellants' Specification,
which differentiates the "baseline state" from an "abnormal" state, where
both of those states are non-seizure states. Spec. i-fi-f 108-111, 141. The
Specification indicates differentiating between those two types of non-
seizure states is useful to "confirm" that the identification of a target seizure
based on the second signal (e.g., the convulsion I ictal moan activity signal)
was not a false positive. Id. A baseline non-seizure state suggests the
claimed "identifying ... a target seizure state based on the second signal"
may be a false positive, whereas an abnormal non-seizure state suggests the
claimed "not identify[ing] the target seizure based on the first signal" may
be a false negative. 2 Id.
For the foregoing reasons, we do not sustain the rejection of claim 12,
and of claims 13, 14, 17, 56, and 57 depending from claim 12, as anticipated
byLeyde.
2 The Examiner states "[i]fthe baseline non-seizure state is [considered to
be] different than [a] normal brain state without a seizure, ... this ... would
raise a 112 issue as the specifics of establishing this baseline state is not
recited in the method claim language." Final Act. 16. However, there is no
rejection of claim 12 under 35 U.S.C. § 112 for us to review.
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Application 12/432,268
Claims 32-34, 42, 44-46, 52, 64, 65, and 69
Independent claim 32 recites a system comprising a processor that
adjusts a seizure detection algorithm by, in part, performing the same steps
recited in method claim 12 that are discussed above. Appeal Br. 30 (Claims
App.). For the reasons provided in connection with claim 12, we do not
sustain the rejection of claim 32, and of claims 33, 34, 64, 65, and 69
depending from claim 32, as anticipated by Leyde.
Independent claim 42 recites a system comprising means for adjusting
a seizure detection algorithm by, in part, performing the same steps recited
in method claim 12 that are discussed above. Appeal Br. 32 (Claims App.).
For the reasons provided in connection with claim 12, we do not sustain the
rejection of claim 42, and of claims 44--46 and 52 depending from claim 42,
as anticipated by Leyde.
B. Obviousness based on Leyde and one or more of Donoghue, Giftakis,
Nathan, Greene, and Osorio
The Examiner's additional consideration of dependent claims 18-21,
37-39, 47--49, 53-55, 58, 61-63, 66, 70, and 71 in light of Leyde in
combination with one or more of Donoghue, Giftakis, Nathan, Greene, and
Osorio, does not cure the deficiency of Leyde in connection with
independent claims 12, 32, and 42 noted above. See Final Act. 10-16.
Therefore, we do not sustain the various obviousness rejections of these
dependent claims.
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Application 12/432,268
DECISION
The Examiner's decision to reject claims 12-14, 17-21, 32-34, 37-
39, 42, 44--49, 52-58, 61---66, and 69-71 is reversed.
REVERSED
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