Ex Parte Zhou et al

Patent Trial and Appeal Board

May 22, 2017

12697019 (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.
12/697,019 01/29/2010 XiaohongZhou P0033516.01/1111-070US01 1147
80584 7590 05/24/2017
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
EXAMINER
WEHRHEIM, LINDSEY GAIL
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):
pairdocketing @ ssiplaw.com
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,
PAUL G. KRAUSE, and WILLIAM T. DONOFRIO
Appeal 2015-007395
Application 12/697,019
Technology Center 3700
Before LISA M. GUIJT, ERIC C. JESCHKE, and GORDON D. KINDER,
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 July 16, 2014 (“Final Act.”), rejecting claims 1—27.1 We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify Medtronic, Inc. as the real party in interest.
Appeal Br. 3.
Appeal 2015-007395
Application 12/697,019
BACKGROUND
The disclosed subject matter relates to “medical devices configured to
deliver electrical stimulation therapy to a patient.” Spec. 12. Claims 1, 14,
24, and 26 are independent. Claim 1 is reproduced below, with emphasis
added:
1: A method comprising:
sensing at least one physiological parameter
of a patient;
determining whether a heart of the patient is
in an electromechanical dissociation state based on
the at least one sensed physiological parameter,
and
delivering electrical stimulation to a tissue
site of the patient to at least one of modulate afferent
nerve activity or inhibit efferent nerve activity upon
determining that the heart is in the
electromechanical dissociation state,
wherein the tissue site comprises at least one
of a nonmyocardial tissue site or a nonvascular
cardiac tissue site.
REJECTIONS
1. Claims 1, 2, 5, 6, 11, 14—17, 22, and 24—27 stand rejected under
35 U.S.C. § 102(b) as anticipated by Ben-Ezra (US 2006/0271115 Al,
published Nov. 30, 2006).
2. Claims 3 and 4 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Ben-Ezra and Kleckner (US 2007/0299477 Al, published
Dec. 27, 2007).
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Application 12/697,019
3. Claims 7—9 and 18—20 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Ben-Ezra and Rubin (US 2004/0030365 Al, published
Feb. 12, 2004).
4. Claims 10, 12, 13,21, and 23 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Ben-Ezra in view of In re Aller, 220 F.2d 454
(CCPA 1955).
DISCUSSION
Rejection 1 — The rejection of claims 1, 2, 5, 6, 11, 14—17,
22, and 24—27 under 35 U.S.C. § 102(b)
Each of the four independent claims requires either performing the
step of, or a component that performs the function of, determining whether
the heart of a patient is in an electromechanical dissociation (EMD) state
based on at least one sensed physiological parameter.2,3
2 As background, we note that the Specification provides: “In an EMD
state, the heart of the patient exhibits what may be considered typical
electrical activity (e.g., a normal sinus rhythm observed in an electrogram or
electrocardiogram), but does not exhibit proper mechanical contractions.”).
3 Claim 1 recites the step of “determining whether a heart of the
patient is in an electromechanical dissociation state based on the at least one
sensed physiological parameter.” Appeal Br. 23 (Claims App.). Claim 14
recites a system including “a processor that determines whether a heart of
the patient is in an electrical mechanical dissociation state based on the at
least one sensed physiological parameter.” Id. at 26. Claim 24 recites a
system including “means for determining whether a heart of the patient is in
an electrical mechanical dissociation state of a heart of the patient based on
the at least one sensed physiological parameter.” Id. at 28. Claim 26 recites
the step of implanting a “medical device system” that includes “a processor
that determines whether the heart of the patient is in an electrical mechanical
dissociation state based on at least one sensed physiological parameter.” Id.
at 29.
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Appeal 2015-007395
Application 12/697,019
To address these “determining” limitations in the rejection of the
independent claims, the Examiner cited paragraphs 96 and 432 of Ben-Ezra.
See Final Act. 2. The relevant disclosure in each of these paragraphs
provides:
For some applications, atrial motion is increased using the
techniques described herein upon the termination of AF, for
example, to prevent or treat electro-mechanical-dissociation
(EMD), in which cardiac electrical activity is not coupled with
appropriate mechanical contraction.
See also Ben-Ezra 193 (showing that “AF” refers to “atrial fibrillation”).
Appellants argue that the Examiner has “failed to establish that
Ben-Ezra discloses the feature” required by the “determining” limitations.
Appeal Br. 7. We agree. Below, we address each of the Examiner’s three
alternative positions regarding these limitations.
First, the Examiner takes the position that, by disclosing “using the
techniques” described in Ben-Ezra to, in certain instances, “treat electro-
mechanical-dissociation” (Ben-Ezra 96, 432), “then there is necessarily a
determination that EMD is present” in “the delivery of the treatment that is
used to terminate EMD.” Ans. 6; id. (“The determination step takes place
when the stimulation is delivered to treat EMD.”). The Examiner states that
“Ben-Ezra specifically states the system/method treats EMD, not that the
system/method is configured to treat EMD” and that “[t]his feature requires
that the heart is in an EMD state.” Id.', see also id. at 7 (stating that “this
treatment feature positively requires [the] presence of EMD”).
Although we agree with the Examiner that using the techniques
described in Ben-Ezra to actually treat EMD does require the presence of an
EMD state in the heart of a patient, we do not agree that this demonstrates
that the relevant passage in Ben-Ezra inherently discloses determining
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Application 12/697,019
whether the heart is in an EMD state. See Appeal Br. 11 (“[E]ven assuming,
arguendo, that Ben-Ezra describes delivering electrical stimulation that
treats EMD following AF, it does not necessarily follow that Ben-Ezra first
determines whether or not a patient is actually in an EMD state prior to
delivery of such therapy. One of ordinary skill in the art would recognize
that the electrical stimulation to treat EMD could be delivered upon
termination of AF regardless of whether or not the heart of the patient is
actually determined to be in an EMD state.”). As argued by Appellants,
“[o]n the chance that the heart may enter an EMD state following
termination of the AF, the therapy that is delivered may still be characterized
as treating EMD even though no affirmative determination was made before
delivering the EMD therapy that the heart of the patient was in an EMD
state.” Id.
Second, the Examiner states that, by disclosing “using the techniques”
described in Ben-Ezra to, in certain instances, “treat electro-mechanical-
dissociation” (Ben-Ezra 96, 432), “then there is necessarily a
determination that EMD is present” in “the sensed termination of AF such
that EMD occurs.'” Ans. 6 (emphasis added). With this, we understand the
Examiner as taking the alternative position that Ben-Ezra discloses
“sensing” the termination of atrial fibrillation and—because an EMD state
allegedly necessarily follows termination of atrial fibrillation—thereby
inherently discloses “determining” that the heart of the patient is in an EMD.
See also Panel Decision from Pre-Appeal Brief Review (dated Nov. 26,
2014) at 3 (“Therefore, the system [of Ben-Ezra] necessarily includes a
means to determine AF is terminated (a physiological parameter) and
provides EMD therapy, where the system determines EMD upon termination
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Application 12/697,019
of AFT (emphasis added)); Ans. 5—6 (“In this case, the sensed physiological
parameter is the sensed termination of AF.”).
To the extent the Examiner takes this position, we agree with
Appellants that the Examiner has not provided a basis in fact or technical
reasoning to support that an EMD state necessarily follows termination of
atrial fibrillation. See Appeal Br. 9—10; id. at 10 (“[T]he Examiner has not
shown that EMD always occurs following termination of AF, such that the
termination of AF disclosed by Ben-Ezra must necessarily include a
determination that a heart of a patient is in an electromechanical dissociation
state.”).
Third, the Examiner indicates an alternative position: that Ben-Ezra
satisfies the “determining” limitations because the system disclosed is “fully
capable of performing” the act of “determining an EMD state.” Ans. 6; see
also Panel Decision from Pre-Appeal Brief Review at 3 (“Further, the
disclosure of Ben-Ezra enables an indication of EMD via sensors (e.g., pars
[0215]—[0216]). Therefore, the disclosure of Ben-Ezra includes features that
are fully capable of determining EMD.”).
To the extent the Examiner takes this position, we agree with
Appellants that, even assuming that the system(s) disclosed in Ben-Ezra
“may be capable of determining whether a heart of the patient is in an
electromechanical dissociation state based on at least one sensed
physiological parameter, the mere fact that the device is capable of
performing an action does not actually disclose performing that action,”
either expressly or inherently. Appeal Br. 9.
For these reasons, we do not sustain the rejection of independent
claims 1, 14, 24, and 26, and also do not sustain the rejection of claims 2, 5,
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Application 12/697,019
6, 11, 15—17, 22, 25, and 27, each of which depend from one of the
independent claims.
Rejections 2 through 4 — The rejection of claims 3, 4,
7—10, 12, 13, 18—21, and 23 under 35 U.S.C. § 103(a)
Claims 3, 4, 7—10, 12, 13, 18—21, and 23 each depend from one of the
four independent claims addressed in the discussion of Rejection 1. The
Examiner’s reliance on Kleckner (regarding Rejection 2), Rubin (regarding
Rejection 3), and In re Aller (regarding Rejection 4) does not remedy the
deficiencies in the teachings of Ben-Ezra discussed above (see supra
Rejection 1). Thus, for the same reasons discussed above, we do not sustain
the rejection of claims 3, 4, 7—10, 12, 13, 18—21, and 23.
DECISION
We REVERSE the decision to reject claims 1—27.
REVERSED
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