Ex Parte Sambelashvili

Patent Trial and Appeal Board

Sep 9, 2016

12047903 (P.T.A.B. Sep. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/047,903 03/13/2008
27581 7590 09/13/2016
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Aleksandre T. SAMBELASHVILI
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.
P003 l 913.00/LG10126 3878
EXAMINER
CAREY, MICHAEL JAMES
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
09/13/2016 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
Exparte ALEKSANDRE T. SAMBELASHVILI
Appeal2014-007907
Application 12/047,903
Technology Center 3700
Before DONALD E. ADAMS,
JEFFREYN. FREDMAN, and RACHEL H. TOWNSEND, Administrative
Patent Judges.
PER CURIAM
DECISION ON APPEAL 1
This is an appeal under 35 U.S.C. § 134 involving claims 7-17 (Br.
2). Examiner entered a rejection under 35 U.S.C. §103(a). We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
Appellant's invention relates to
methods and apparatus for dynamically monitoring paced and/or
sensed P-wave duration, P-wave end, and/or QRS duration in a
1 Appellant identifies "[ t ]he real party in interest [as] Medtronic, Inc." (Br.
2.)
Appeal2014-007907
Application 12/047,903
patient [that] provides diagnostic and clinical benefit allowing
for predictions about possible future arrhythmias, advanced
notification, alert and intervention as well as providing acute and
chronic information regarding cardiac status, including both
possibly declining and/or possibly improving cardiac function
(Spec. if 1 ). Independent claim 7 is representative and reproduced in the
Claims Appendix of Appellant's Brief.
Claims 7-17 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Laguna2 and Ferek-Petric. 3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Laguna discloses that an "electrocardiogram (ECG) is characterized
by a recurrent wave sequence (P, Q, R, S, T) associated with each beat.
Various time intervals defined by the onsets and ends of these waves are
important in electrocardiographic diagnosis" and the "[ d]irect measurement
of these intervals requires knowledge of the locations of the boundaries (the
onsets and ends) of the P, QRS, and T waves" (Laguna 45).
FF 2. Laguna discloses
2.1. Preprocessing
The first step consists of a single-lead filtering process for
noise reduction and a nonlinear transformation to improve QRS
2 Laguna et al., Automatic Detection of Wave Boundaries in Multilead ECG
Signals: Validation with the CSE Database, 27 Computers and Biomedical
Research 45---60 (1994).
3 Ferek-Petric, US 2005/0027321 Al, published Feb. 3, 2005.
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Appeal2014-007907
Application 12/047,903
detection []. The linear filtering uses a second-order bandpass
Lynn filter (0.8-18 Hz, -3 dB) [] to attenuate baseline drift and
high-frequency contamination. Once the bandpass-filtered
signal (ECGPB) is reached, a low-pass differentiator [] is applied
to get the information about changes in the signal slope. This
differentiated signal is called ECGDER. The nonlinear
transformation we use is the moving-window integration of the
squared signal ... with an integration width of 95 msec.
(Laguna 47 (endnotes removed); see Ans. 2.)
FF 3. Examiner finds that "Laguna [] does not disclose wherein the
electrodes are coupled to an IMD, or wherein the detecting is done via an
IMD, or wherein the PW d or QRS values are stored in an IMD and
compared to previous values of the subject, and CRT therapy is based on P-
wave and QRS measurements" and relies on Ferek-Petric to make up for the
foregoing deficiencies in Laguna (Ans. 4).
ANALYSIS
Appellant's independent claim 7 requires, inter alia, the step of
"calculating a time derivative of the first portion of the PQRST signal"
(Appellant's claim 7). Appellant's claims 8-17 depend directly or indirectly
from Appellant's claim 7.
Examiner finds that Laguna teaches "calculating a time derivative of
the first portion of the PQRST signal (Page, 62,[4J Paragraphs 1-2, Page 47,
Section 2.1, calculating time functions)" (Ans. 2). Therefore, based on the
combination of Laguna and Ferek-Petric, Examiner concludes that, at the
4 We note that page 62 does not exist in the Laguna reference.
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Appeal2014-007907
Application 12/047,903
time Appellant's invention was made, it would have been prima facie
obvious to
use an IMD coupled to the electrodes in a patient in order to
detect P-wave durations and compare them for evaluation for
CRT therapy as taught by Ferek-Petric, in the P-wave duration
analysis system disclosed by Laguna et al., in order to provide
specific treatment for an individual patient, and that it's within
the scope of the art to perform preliminary research on a
detection method (as disclosed by Laguna et al.) before
programming implanted devices with the algorithm.
(Id. at 4.) We are not persuaded.
Laguna suggests a method comprising "a single-lead filtering process
for noise reduction and a nonlinear transformation to improve QRS
detection," and that this process leads to a "differentiated signal [] called
ECGDER", wherein, "[t]he nonlinear transformation ... use[d] is the
moving-window integration of the squared signal ... with an integration
width of 95 msec" (FF 2). Examiner failed to establish an evidentiary basis
on this record to support a conclusion that Laguna's single-lead filter process
is the same as, or suggests, the step of "calculating a time derivative of the
first portion of the PQRST signal" as required by Appellant's claimed
invention (see Ans. 2-13; cf Appellant's claim 7). In this regard, Appellant
contends that Laguna's "integration over a [95] ms moving window
necessarily destroys the details of the signal that might be used for P-wave
endpoint detection" and "the 'non-linear processing' referred to in Laguna is
not used in conjunction with measurement of P-wave width as would
otherwise be required by the claims of the present application" (Br. 6). In
sum, Appellant contends that "Examiner's argument is too unclear to meet
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Appeal2014-007907
Application 12/047,903
the requirements of establishing a prima-facie case of obvio[]usness" (id. at
10). We agree. "[R ]ejections on obviousness grounds cannot be sustained
by mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
CONCLUSION OF LAW
The preponderance of the evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 7-17 under 35 U.S.C. § 103(a) as unpatentable
over Laguna and Ferek-Petric is reversed.
REVERSED
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