Ex Parte Zhou et al

Patent Trial and Appeal Board

May 22, 2017

11000541 (P.T.A.B. May. 22, 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.
11/000,541 12/01/2004 Xiaohong Zhou P0020810.00/LG10126 6596
27581 7590 05/24/2017
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/24/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte XIAOHONG ZHOU, THOMAS J. MULLEN,
JEFFREY M. GILLBERG, and ROBERT W. STADLER
Appeal 2015-007381
Application 11/000,541
Technology Center 3700
Before STEVEN D.A. McCARTHY, NATHAN A. ENGELS, and
ERIC C. JESCHKE, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Xiaohong Zhou et al. (“Appellants”) seek review under 35 U.S.C.
§ 134(a) of the Examiner’s decision, as set forth in the Final Office Action
dated June 19, 2014 (“Final Act.”), rejecting claims 39, 41—52, 57—60, and
62.1 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify Medtronic, Inc. as the real party in interest.
Appeal Br. 3.
Appeal 2015-007381
Application 11/000,541
BACKGROUND
The disclosed subject matter “relates generally to implantable cardiac
stimulation/monitoring devices and in particular to an implantable device
system and method for assessing T-wave altemans and predicting cardiac
events in response to a TWA assessment.” Spec. 11.2 Claim 39, the sole
independent claim, is reproduced below, with emphasis added:
39. A system, comprising:
a plurality of electrodes adapted for
implantation in a patient's body for sensing an
electrical cardiac signal having a plurality of cardiac
cycles;
an R-wave detector coupled to a sensing
electrode pair selected from the plurality of
electrodes determining a heart rate of said patient
based on said plurality of cardiac cycles;
an automatic gain control sensing amplifier,
operatively coupled to the plurality of electrodes,
configured to receive the cardiac signal and
automatically adjust a gain of the cardiac signal,
said gain being variable based, at least in part, on a
T-wave signal voltage amplitude of the cardiac
signal, and
a processor, operatively coupled to the R-
wave detector, the automatic gain control sensing
amplifier and the plurality of electrodes, configured
to:
compute a T-wave parameter
associated with a T-wave of each of the
plurality of cardiac cycles as adjusted by the
2 The Specification provides: “T-wave altemans is a phenomenon
observable on surface electrocardiogram (ECG) recordings as a beat-to-beat
alternation in the morphology, amplitude, and/or polarity of the T-wave.”
Spec. 12.
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Application 11/000,541
automatic gain control sensing amplifier and
associated with a heart rate greater than a
predetermined threshold; and
determine a severity of a T-wave
altemans of the plurality of cardiac cycles
based, at least in part, on the parameter
associated with the T-wave;
wherein the automatic gain control
amplifier is configured with an adjustable
gain for an R-wave signal of the cardiac
signal independently of an adjustable gain
for the T-wave of the cardiac signal.
REJECTIONS
1. Claims 39, 41—52, 57—60, and 62 stand rejected under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
2. Claims 39, 41—46, 57—60 and 62 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Arnold (US 5,713,367, issued Feb. 3, 1998)
and Armstrong (US 5,861,009, issued Jan. 19, 1999).
3. Claims 47—52 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Arnold, Armstrong, and Mann (US 2005/0165456 Al,
published July 28, 2005).
DISCUSSION
Rejection 1 — The rejection of claims 39, 41—52, 57—60,
and 62 under 35 U.S.C. § 112, first paragraph
The Examiner rejected all pending claims under 35 U.S.C. § 112, first
paragraph, stating that, in claim 39, “the newly amended claim language
which specifies the automatic gain control amplifier configured to have
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Application 11/000,541
independent adjustable gains for both R and T waves of the cardiac cycle, in
combination with the elements of the independent claim, fail to be supported
by the specification.” Final Act. 2—3. The Examiner stated that “[i]t is clear
that the specification fails to support a configuration of the automatic gain
control amplifier to adjust gain for an R wave signal at all — let alone in
conjunction and independent of the T wave adjustable gain” and that “[a]t
the most, the specification . . . provides support for a sense amplifier
included in the R-wave detector which adjusts sensitivity for accurate R-
wave detection (the term ‘adjustable gain’ is never used), but this is not a
feature or configuration of the automatic gain control amplifier.” Id. at 3.
Appellants highlight certain disclosures in paragraphs 21 and 22 of the
Specification and state that those paragraphs “describe separate circuit
components 30 and 32, concurrently in existence and in use, which
respectively adjust the signal gain based on R-wave detection and T-wave
detection.” Appeal Br. 6.3 The Examiner responds that “the sense amplifier
and R-wave detector are separate unit[]s with separate sense amplifiers.”
Ans. 2. The Examiner also states:
The use of EGM signal segments for use in specialized analysis
extracted from EGM signals obtained by the same sense
3 The disclosures identified provide: (1) “R-wave detector 30 includes
a sense amplifier having frequency response characteristics and beat-by-beat
automatic adjusting sensitivity for accurate R-wave detection.” (Spec. 121);
(2) “In an exemplary embodiment, EGM sense amplifier 32 is embodied as
an automatic gain control sense amplifier enabled for automatic gain
adjustment responsive to the amplitude of sensed T-wave signals.” (Spec.
122); and (3) “EGM signal segments for use in specialized analyses may be
extracted from EGM signals obtained by sense amplifier 32 based on
relative timing from R-waves detected by R-wave detector 30.” (Spec. 122).
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Application 11/000,541
amplifier 32 does not provide evidence of a configuration where
the automatic gain control amplifier is configured to adjust gain
for an R wave signal at all — let alone in conjunction and
independent of the T-wave adjustable gain, as set forth in the
claim language.
Id.4
The test for compliance with the written description requirement is
“whether the disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (enbanc). Appellants have not shown
error in the Examiner’s finding that the Specification does not reasonably
convey to one of ordinary skill in the art that the inventors had possession of
the entire scope of the last limitation in claim 39. The limitation at issue
requires not only “an adjustable gain for an R-wave signal of the cardiac
signal independently of an adjustable gain for the T-wave of the cardiac
signal,” but also requires that “configur[ation]” to be present in the
previously recited “automatic gain control sensing amplifier.” See Appeal
Br. 10 (Claims App.).
4 Appellants state that the Examiner “asserts that ‘the specification
only indicates the gain adjustment for T- waves but does not mention an
independent gain for the R wave at the same time,’” but Appellants state that
“[tjhis assertion is incorrect.” Appeal Br. 6 (quoting Non-Final Office
Action, mailed Dec. 20, 2013, at 3). This statement is consistent with the
Examiner’s findings in the Final Action and the Answer. We understand the
Examiner to mean that paragraphs 22 and 45 of the Specification do not
describe EGM sense amplifier 32 as being configured with an adjustable
gain for an R-wave signal of the cardiac signal independent of an adjustable
gain for the T-wave of the cardiac signal.
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Application 11/000,541
Paragraphs 21, 22, and 45 of the Specification, in contrast, describe
two separate amplifiers: (1) an unnumbered “sense amplifier,” included in
“R-wave detector 30,” that has “frequency response characteristics and beat-
by-beat automatic adjusting sensitivity for accurate R-wave detection”
(Spec. 121) and (2) an “EGM sense amplifier 32 that may be used for
acquiring EGM signals for specialized signal analyses” and that, in an
exemplary embodiment, “is embodied as an automatic gain control sense
amplifier enabled for automatic gain adjustment responsive to the amplitude
of sensed T-wave signals” (Spec. 122). See also Spec. 145 (discussing “the
EGM sense amplifier gain” and the “gain of the sense amplifier included in
the R-wave detector” separately). These disclosures support the Examiner’s
finding that “the sense amplifier and R-wave detector are separate unit[]s
with separate sense amplifiers.'1'’ Ans. 2 (emphasis added); see also Spec.
122 (“EGM sense amplifier 32 provides a wider band of frequency response
than R-wave detector 30 and a separately adjustable gain setting.’ '’
(emphasis added)).
Appellants do not dispute and, in fact, agree that paragraphs 21 and 22
“describe separate circuit components 30 and 32, concurrently in existence
and in use, which respectively adjust the signal gain based on R-wave
detection and T-wave detection.” Appeal Br. 6 (emphasis added). Thus, we
see no error in the Examiner’s finding that “the specification provides
support for a sense amplifier included in the R-wave detector, which adjusts
sensitivity for accurate R-wave detection . . ., but this is not a feature or
configuration of the [disclosed] automatic gain control amplifier.” Ans. 2—3.
Because the Examiner has found that the Specification fails to describe an
“automatic gain control amplifier” configured as recited in the entirety of the
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Application 11/000,541
limitation at issue in independent claim 39, and Appellants have not rebutted
this finding, we sustain the rejection of claim 39, and claims 41—52, 57—60,
and 62 depending therefrom, as lacking written description support.
Rejection 2 — The rejection of claims 39, 41—46,
57—60 and 62 under 35 U.S.C. § 103(a)
The Examiner rejected various claims, including independent claim
39, as unpatentable over Arnold and Armstrong. See Final Act. 4—5. In
clarifying the positions regarding the final limitation in claim 39, the
Examiner states, “[a]s noted in the rejection, Arnold amplifies the cardiac
signal based, in part, on the amplitude of the R-wave signal voltage, because
it [is] used in measuring the cardiac wave acquired” and states “Armstrong
is incorporated as a secondary reference to obviate this limitation by
disclosing the use of the T-wave signal voltage, as the gain is adjusted in
response to changes in the amplitude of the T-wave (e.g. Col 3, lines 23—
24).” Ans. 3. The Examiner also states that “the incorporation of the T-
wave adjustable gain of Armstrong, with the adjustable gain of Arnold,
using two different components, would result in independent adjustable gain
from one another.” Ans. 3—4.
Appellants argue that Arnold “does not show, disclose nor suggest
adjusting the gain of R-wave sensing independently of the adjustment in
gain of T-wave sensing” and that Armstrong “does not show, disclose nor
suggest adjusting the gain of an R-wave sensing amplifier any differently
than the gain of a T-wave sensing amplifier.” Appeal Br. 8. Appellants
contend that “[s]ince Armstrong . . . only discloses one amplifier gain that
affects both R-wave sensing and T-wave sensing identically, then Armstrong
. . . does not show, disclose nor suggest adjusting the gain of R-wave sensing
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Application 11/000,541
independently of the adjustment in the gain of T-wave sensing.” Id.
Appellants argue that “[t]he Examiner’s suggestion that it would be obvious
to add a second R-wave amplifier from Arnold . . . (which is not adjustable)
to Armstrong . . . (which already adjustable R-wave and T-wave amplifiers
which are not independent) strains reasonable logic.” Reply Br. 5.
Here, the Examiner has not demonstrated that the modified device
satisfies the final limitation in claim 39, when properly construed. As noted
above, the limitation at issue requires not only “an adjustable gain for an R-
wave signal of the cardiac signal independently of an adjustable gain for the
T-wave of the cardiac signal,” but also requires that that “configuration]” is
present in the previously recited “automatic gain control sensing amplifier.”
See Appeal Br. 10 (Claims App.). In addressing the last limitation, the
Examiner clarifies that the modified device includes “two different
components”—i.e., two different amplifiers—to provide adjustable gain of
the R-wave signal independent of adjustable gain of the T-wave signal. Ans.
3^4. Because the modified device, as proposed by the Examiner, does not
include an “automatic gain control amplifier” configured as recited in the
entirety of the limitation at issue in claim 39, we do not sustain the rejection
of claim 39, or the rejection of claims 41—46, 57—60 and 62, which depend
from claim 39.
Rejection 3 — The rejection of claim 47—52 under 35 U.S.C. § 103(a)
Claims 47—52 depend from claim 39. Appeal Br. 11—12 (Claims
App.). The Examiner’s added reliance on Mann does not remedy the
deficiencies in the combined teachings of Arnold and Armstrong, discussed
above (see supra Rejection 2). Thus, for the same reasons discussed above,
we do not sustain the rejection of claims 47—52.
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DECISION
We AFFIRM the decision to reject claims 39, 41—52, 57—60, and 62
under 35U.S.C. § 112, first paragraph, and REVERSE the decision to reject
claims 39, 41—52, 57—60, and 62 under 35 U.S.C. § 103(a).5
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
5 See 37 C.F.R. § 41.50(a)(1) (“The affirmance of the rejection of a
claim on any of the grounds specified constitutes a general affirmance of the
decision of the examiner on that claim, except as to any ground specifically
reversed.”).
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