Ex Parte Min

Patent Trial and Appeal Board

Apr 28, 2016

12333176 (P.T.A.B. Apr. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/333, 176 12/11/2008
36802 7590 05/02/2016
PACESETTER, INC
15900 VALLEY VIEW COURT
SYLMAR, CA 91392-9221
FIRST NAMED INVENTOR
XiaoyiMin
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.
A08Pl069 5874
EXAMINER
MAHMOOD, NADIA AHMAD
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/02/2016 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):
Patent.CRMDSylmar@sjm.com
lcancino-zepeda@sjm.com
epineiro@sjm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte XIAOYI MIN
Appeal2014-004484
Application 12/333, 176
Technology Center 3700
Before EDWARD A. BROWN, AMANDA F. WIEKER, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting the pending claims 1-7 and 10-16. We have jurisdiction
under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 Appellant submits the real party in interest is Pacesetter, Inc., dba St. Jude
Medical, Cardiac Rhythm Management Division. Br. 3.
Appeal2014-004484
Application 12/333, 176
THE CLAIMED SUBJECT MATTER
Claims 1 reproduced below, is illustrative of the claimed subject
matter.
1. A method of evaluating a patient's condition via use of
an implantable cardiac therapy device, the method comprising:
sensing a patient's cardiac activity, including activity of
the atria, via the therapy device;
determining an interatrial conduction delay via the
device;
storing the interatrial conduction delay in memory of the
device;
comparing a record of the interatrial conduction delay
over time with a corresponding threshold as a surrogate
indicator of atrial fibrillation;
determining whether any change indicated warrants
active notification of the change, and
delivering a notification signal to alert at least one of the
patient and attending clinical personnel of the indicated change
when active notification is warranted.
REJECTIONS
1) Claims 1-7, 10, 11, and 13-16 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Nappholz (US 5,184,615, iss.
Feb. 9, 1993) in view ofBardy (US 2002/0099303 Al, pub. July
25, 2002). Final Act. 2.
2) Claim 12 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Nappholz in view ofBardy and Chirife (US
5, 179,949, iss. Jan. 19, 1993). Final Act. 7.
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Appeal2014-004484
Application 12/333, 176
DISCUSSION
Claims 1-7, 10, 11, and 13-16-0bviousness-Nappholz and Bardy
The Examiner found that Nappholz discloses all the limitations of
independent method claim 1 other than "storing the atrial timing
characteristic and comparing the atrial timing characteristic over time."
Final Act. 3. Among the Examiner's specific findings is that Nappholz
discloses "determining at least one timing characteristic." Id. The Examiner
found that Bardy discloses "monitoring the outcomes of atrial fibrillation ...
'on a regular, periodic basis for storage in a database."' Id. (quoting Bardy i-f
12). The Examiner concluded it would have been obvious to modify
the method ofNappholz with the storing and measuring of atrial
characteristics over time as taught by Bardy since such a
modification would provide the predictable results of monitoring
atrial intervals over time to determine if they are indicative of
any change occurring in the status of the patient's condition.
Id. at 4.
The Examiner also found that N appholz discloses all of the limitations
of apparatus claims 10 and 15 other than the "determination of a potentially
developing dysfunction and then recording data based upon that
determination." Id. at 6. The Examiner found that
Bardy discloses a method for diagnosing and monitoring the
consequences of the onset, progression, regression and status of
atrial fibrillation and describes in paragraph [0069] "indicator
threshold for detecting a trend indicating an adverse consequence
of atrial fibrillation or a state of imminent or likely
cardiovascular or cardiopulmonary deterioration" (determination
of dysfunction) and further "the presence of atrial fibrillation is
determined and if present, atrial fibrillation is logged" (recording
of data once determined).
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Appeal2014-004484
Application 12/333, 176
Id. at 6-7. The Examiner concluded that it would have been obvious to
modify Nappholz in view of Bardy's disclosure of determining a potential
dysfunction to yield "the predictable results of determining if the signals are
indicative of a potential dysfunction and being able to act accordingly in
order to treat the patient." Id. at 7.
In response to the rejection of claims 1, 10, and 15, Appellant
contends the Examiner erred because Nappholz "uses a timing characteristic
that is very different from the interatrial conduction delay recited in the
claimed invention." Br. 8. Appellant argues that
Nappholz measures and processes cardiac potential signals
evoked by a stimulating pulse to derive a paced depolarization
integral (PDI) parameter. For example, for a ventricular pacing
pulse the PDI is a time integral of the depolarization voltage
amplitude over the interval lasting essentially from the 0-point
to the S-point of an evoked QRS complex.
Id. at 9. Appellant concludes that "Nappholz analyzes characteristics of a
depolarization (no matter the chamber) in response to pacing pulses in that
chamber. Nappholz does not however, disclose or suggest determining the
inter-atrial conduction delay as recited in the claimed invention." Id.
Neither Appellant nor the Examiner has provided us with guidance as
to the meaning of the phrase "determining an interatrial conduction delay,"
as it appears in claim 1. We, thus, look to Appellant's Specification. The
term "interatrial conduction delay" is not defined in Appellant's
Specification, but is referred to in several places. See Spec. i-fi-1 49, 55. For
example, inter-atrial conduction delay is described in connection with
Appellant's Figure 3. Figure 3 discloses two P-waves sensed by two atrial
channels 205 and 210. See id. i154, Fig. 3. The two channels
"independently sense the initiation and conclusion of a P-wave." Id. i155.
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Appeal2014-004484
Application 12/333, 176
Appellant's Specification discloses that "'sensing' is reserved for the noting
of an electrical signal, and 'detection' is the processing of these sensed
signals and noting the presence of an arrhythmia." Id. i-f 38. After
"determining the relative timing of these multiple events, 220a, 224a, 226a,
and 228a, a measurement or determination of conduction delays can be
determined." Id. i-f 55. Based on this disclosure, one of ordinary skill in the
art would understand that "determin[ation] of an interatrial conduction
delay," as recited in claim 1, requires several necessary preceding steps, i.e.,
sensing signals relating to a patient's P-waves2, processing the sensed
signals, determining the relative timing of multiple events, and then
determining an interatrial conduction delay.
In response to Appellant's argument regarding Nappholz' PDI
parameter, the Examiner does not refer us to any disclosure in Nappholz or
Bardy of "determining an interatrial conduction delay" as we have construed
that phrase, or any other analysis of P-waves to determine an atrial timing
characteristic or otherwise point us to evidence establishing that Nappholz'
PDI process is equivalent to determining an interatrial conduction delay, as
claimed. Ans. 8. The Examiner's finding that Nappholz discloses the
limitation in claim 1 of "determining an interatrial conduction delay" is,
thus, not supported by a preponderance of the evidence. As the rejection is
based on an erroneous factual finding, the conclusion of obviousness cannot
2 We understand that "P-waves" and the "QRS complex" referred to by
Appellant in connection with Nappholz are distinct portions of a patient's
electrocardiogram. See PQRST complex, (2006) in C. Brooker (Ed.),
Churchill Livingstone's dictionary of nursing. Philadelphia, PA: Elsevier
Health Sciences. Retrieved from
http:// search. credoreference. com/ content/ entry I ehscldictnursing/pqrst_compl
ex/O. (last visited April 27, 2016).
5
Appeal2014-004484
Application 12/333, 176
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."). Therefore,
we do not sustain the rejection, under 35 U.S.C. § 103(a), of claim 1 and
claims 2-7 which depend thereon.
Contrary to Appellant's argument for patentability of apparatus claims
10 and 15, unlike claim 1, claims 10 and 15 do not recite the limitation of
"determining an interatrial conduction delay." Claim 10 recites "at least one
sensor is adapted to sense signals indicative of electrical activity of the
heart" and "the controller evaluates at least one parameter of the signals
received from the sensor that relates to interatrial conduction delay to
determine if signals corresponding to atrial activity of the heart are
indicative that the heart is potentially developing a future dysfunction."
Appeal Br. 13, Claims App. (emphasis added). As noted above, Appellant
discloses that sensing of signals is merely the noting of the electrical signal.
There is no recitation in claim l 0 of "detecting," i.e., "processing," the
sensed signals, determining the relative timing of multiple events, and then
determining an interatrial conduction delay. Based on Appellant's
disclosure, we do not construe the phrase "the controller evaluates at least
one parameter of the signals received ... that relates to interatrial
conduction" recited in claim 10 to mean that it "determin[ es] an interatrial
conduction delay," as recited in claim 1, because claim 10 does not recite
that the controller "detect" or "process" the sensed signals, determine the
relative timing of multiple events, or "determine" an interatrial conduction
delay. The claim simply requires a controller that evaluates a parameter
related to interatrial conduction delay.
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Appeal2014-004484
Application 12/333, 176
Claim 15 recites "at least one sensor that is adapted to sense signals
indicative of atrial activity," and a "controller [that] evaluates an interatrial
conduction delay from the atrial signals." Appeal Br. 14, Claims App. For
the same reason as for claim 10, we do not construe the phrase "the
controller evaluates an interatrial conduction delay ... ,"recited in claim 15,
to mean that the controller "detects" or "processes" the sensed signals,
determines the relative timing of multiple events, and then "determines" an
interatrial conduction delay. The controller recited in claim 15 evaluates an
interatrial conduction delay, but does not "determin[ e] an interatrial
conduction delay," as we have construed that phrase with respect to claim 1.
Accordingly, Appellants' contentions in regard to the limitation
"determin[ es] an interatrial conduction delay" as recited in claim 1 are not
persuasive in regard to claims 10 or 15. Claims App.
Appellant does not offer any other arguments for patentability of
claim 10 or claim 15. Further, Appellant does not dispute the Examiner's
factual findings with respect to claims l 0 and 15 to which we referred supra.
Thus, Appellant has not apprised us of any error by the Examiner in the
rejection of independent claims 10 and 15. Appellant did not offer separate
arguments for the patentability of any of the dependent claims 11, 13, 14, or
16. Br. 10. Consequently, we sustain the Examiner's rejection of claims 10,
11 and 13-16 under 35 U.S.C. § 103(a).
Claim 12-0bviousness- Nappholz, Bardy, and Chirife
Claim 12 depends from claim 10. Appellant's argument for the
patentability of claim 12 is the same as for claims 1, 10, and 15, i.e.,
Nappholz does not disclose "determining an interatrial conduction delay."
Br. 10. As claim 12 also does not recite this limitation, we sustain the
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Appeal2014-004484
Application 12/333, 176
rejection of claim 12 under 35 U.S.C. § 103(a) for the same reasons as claim
10.
DECISION
The Examiner's decision rejecting claims 1-7 is REVERSED. The
Examiner's decision rejecting claims 10-16 is AFFIRMED.
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
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