Ex Parte Prakash et al

Patent Trial and Appeal Board

May 25, 2016

13307827 (P.T.A.B. May. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/307,827 11130/2011
27581 7590 05/27/2016
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Rajan Prakash
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.
P0024146.USU4 1061
EXAMINER
LA VERT, NICOLE F
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/27/2016 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):
medtronic_crdm_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAJAN PRAKASH and RODOLPHE KATRA
Appeal2014-005480
Application 13/307,827
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
to detect relaxation abnormality in heart tissue. The Examiner rejected the
claims on the ground of anticipation. We have jurisdiction under 35 U.S.C.
§ 6(b). We reverse.
Statement of the Case
Background
"Effective HF [heart failure] therapy can depend upon early detection
of lusitropy or diastolic dysfunction" (Spec. 1 :25-26). Appellants' invention
1 Appellants identify the Real Party in Interest as Medtronic, Inc. (See App.
Br. 3.)
Appeal2014-005480
Application 13/307,827
"relates generally to implantable medical devices, and, more particularly, to
an implantable medical device and associated method for detecting and/or
delivering therapy for left ventricular lusitropy" (Spec. 1: 14--16).
The Claims
Claims 1-22 are on appeal. Independent claim 1 is representative and
reads as follows (emphasis added):
1. An automated method to detect relaxation abnormality in
heart tissue through a chronically implanted medical device
connected to a medical electrical lead, the method comprising:
sensing a L V accelerometer signal through an implantable
mechanical sensor affixed to the medical electrical lead, the
mechanical sensor disposed at or near a right ventricle (RV) or a
left ventricle (L V) of a patient;
extracting complete relaxation period data from the L V
accelerometer signal;
comparing the extracted complete relaxation period data
to baseline data; and
determining whether relaxation abnormality in the heart
tissue exists based upon comparing the extracted complete
relaxation cycle data to the baseline data.
The Issue
The Examiner rejected claims 1-22 under 35 U.S.C. § 102(b) as being
anticipated by Chinchoy2 (Final Act. 2).
The Examiner finds that Chinchoy teaches
an automated method to detect relaxation abnormality in heart
tissue through a chronically implanted medical device (e.g.,
element 14) connected to a medical electrical lead (e.g., elements
16, 32, 52), the method comprising [e.g., 0002]: sensing a LV
accelerometer signal through an implantable mechanical sensor
(e.g., via element 62) affixed to the medical electrical lead, the
2 Chinchoy et al., US 2008/0234771 Al, published Sept. 25, 2008.
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Application 13/307,827
(Id.)
mechanical sensor disposed at or near a right ventricle (RV) or a
left ventricle (LV) of a patient {e.g., [0011]-[0012], [0028]-
[0029] & (Fig IA)}; extracting complete relaxation period data
from the L V accelerometer signal; comparing the extracted
complete relaxation period data to baseline data; and determining
whether relaxation abnormality in the heart tissue exists based
upon comparing the extracted complete relaxation cycle data to
the baseline data and quantifying a magnitude of the relaxation
abnormality.
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's findings that Chinchoy teaches "extracting
complete relaxation period data from the L V accelerometer signal" as
required by claim 1?
Findings of Fact
1. Chinchoy teaches
A system and method for monitoring at least one chamber
of a heart (e.g.; a left ventricular chamber) during delivery of
extrasystolic stimulation to determine if the desired extrasystole
(i.e., ventricular mechanical capture following refractory period
expiration) occurs. . . . The device receives and processes
acceleration sensor signals to determine a signal characteristic
indicative of chamber capture resulting from one or more pacing
stimulus delivered closely following expiration of the refractory
period. A threshold optimization method optionally evaluates
capture and at least one of: runs an iterative routine to establish
or re-establish chamber capture for the PESP therapy, sets a
logical flag relating to chamber capture status and stores
parameter( s) relating to successful chamber capture for one or
more subsequent cardiac cycles.
(Chinchoy Abstract.)
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Application 13/307,827
2. Chinchoy teaches that
a data collection window is set. L V acceleration data is
preferably collected during ventricular systole and most
preferably during the isovolumic contraction phase. In one
embodiment, the data collection window is a fixed time interval
triggered by a sensed R-wave or a ventricular pacing pulse. The
data collection window may begin immediately after, or
following a predefined interval after delivery of a first or second
L V pacing pulse (herein a primary "P 1" pacing pulse and/ or an
ESS pulse "P2") and preferably extending for a period of time
thereafter.
(Id. i-f 52.)
3. Figure 5 of Chinchoy is reproduced below:
Figure 5 shows
a plot 500 of sample L V lateral wall acceleration data (L VA)
502 and simultaneous hemodynamic and electrical data
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Appeal2014-005480
Application 13/307,827
acquired during one cardiac cycle wherein a first evoked
depolarization due to a first pacing stimulus (P 1) is followed
by a second pacing stimulus (P2) delivered outside the
refractory period (represented by dashed line 504) . ... The
S 1 phase indicated on plot 500 corresponds to the isovolumic
contraction phase of ventricular systole and is associated with
the first heart sound (S 1) which occurs at the beginning of
systole. L V free wall acceleration during this isovolumic
phase, also referred to herein as "S 1 phase", is not constant.
(Id. i-f 53.)
(Id.)
4. Chinchoy teaches that
[d]uring this phase, associated with the second heart sound,
S2, the LVA signal 502 exhibits one or more peaks that are
typically lower in amplitude than the S 1 peaks. In the
preferred embodiment of the present invention, the L VA
signal 502 is acquired at least during a portion or all of the
isovolumic, S 1 phase.
5. The Specification teaches that "[t]he complete relaxation cycle
or period generally occurs after the T wave and before the P wave" (Spec.
15:9-10).
Principles of Law
"The protocol of giving claims their broadest reasonable interpretation
during examination does not include giving claims a legally incorrect
interpretation. This protocol is solely an examination expedient, not a rule
of claim construction." In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir.
2009).
Analysis
Appellants contend that Chinchoy "does not expressly or inherently
demonstrate 'extracting relaxation period data from the L V accelerometer
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Application 13/307,827
signal; comparing the extracted complete relaxation period data to baseline
data; and determining whether relaxation abnormality in the heart tissue
exists based upon comparing the extracted complete relaxation cycle data to
the baseline data[]'" (App. Br. 5; see also Reply Br. 2--4).
The Examiner responds that:
Based on the broadest interpretation of the claims the
examiner notes that the claims do not explicitly state that said
complete relaxation period data must be extracted during the
argued period, i.e. before the S 1 phase or after the S2 phase,
and never provides any reason to, but rather that said data be
extracted from a L V accelerometer signal, which Chinchoy
specifically mentions determining LV chamber capture based
on a L V acceleration data so as to determine if a patient is
suffering from diminished cardiac performance, thus
providing a means of extracting complete relaxation period
data (e.g., [0063]-[0069]). The examiner also notes that the
applicant's specification states that a processing means can be
configured to extract data of a complete relaxation cycle or
period from a sensed L V accelerometer signal [e.g., Prakash
et al., 0050], therefore it is knov,rn that said L V accelerometer
signal, as disclosed by Chinchoy is capable of providing the
claimed extracted complete relaxation period data.
(Ans. 2; emphasis added.)
We find that Appellants have the better position. The Examiner
broadly interprets the phrase "extracting complete relaxation period data
from the L V accelerometer signal" so that it is met by Chinchoy' s teaching
of LV chamber capture based on a LV acceleration data (id.). While we
interpret claims using the broadest reasonable interpretation, that reasonable
interpretation must be consistent with the language of the claim itself in light
of the Specification. The Specification teaches that "[ t ]he complete
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Application 13/307,827
relaxation cycle or period generally occurs after the T wave and before the P
wave" (FF 5).
Chinchoy, at best, teaches "ventricular mechanical capture following
refractory period expiration" (FF 1 ), "L V acceleration data is preferably
collected during ventricular systole and most preferably during the
isovolumic contraction phase. In one embodiment, the data collection
window is a fixed time interval triggered by a sensed R-wave or a
ventricular pacing pulse." (FF 2), "data acquired during one cardiac cycle
wherein a first evoked depolarization due to a first pacing stimulus (P 1) is
followed by a second pacing stimulus (P2) delivered outside the refractory
period" (FF 3), and "the L VA signal 502 is acquired at least during a portion
or all of the isovolumic, SI phase" (FF 4). While Chinchoy, as the
Examiner asserts, might be capable of providing the claimed extracted
relaxation period data, in the context of an anticipation rejection, the
Examiner failed to establish an evidentiary basis to support a finding that
Chinchoy teaches "extracting complete relaxation period data from the L V
accelerometer signal" as required by claim 1.
Conclusion of Law
The evidence of record does not support the Examiner's finding that
Chinchoy teaches "extracting complete relaxation period data from the L V
accelerometer signal" as required by claims 1 and 9. Because claims 2-8
depend on claim 1 and claims 10-22 depend on claim 9, we reverse the
rejection of these claims as well.
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Application 13/307,827
SUMMARY
In summary, we reverse the rejection of claims 1-22 under 35 U.S.C.
§ 102(b) as being anticipated by Chinchoy.
REVERSED
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