Ex Parte Keefe et al

Patent Trial and Appeal Board

May 19, 2017

13491492 (P.T.A.B. May. 19, 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.
13/491,492 06/07/2012 James M. Keefe 1001.3709101 9947
11050 7590 05/23/2017
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
WEHRHEIM, LINDSEY GAIL
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/23/2017 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES M. KEEFE and RICK SANGHERA1
Appeal 2016-001933
Application 13/491,492
Technology Center 3700
Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method and apparatus for providing cardiac rhythm management (CRM),
which have been rejected as anticipated and obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as Cameron Health, Inc., a
subsidiary of Boston Scientific Corporation. (App. Br. 3.)
Appeal 2016-001933
Application 13/491,492
STATEMENT OF THE CASE
Appellants’ “invention relates to ventricular tachyarrhythmia
management in implantable therapy systems.” (Spec. 12.) According to the
Specification, “[a]nti-tachycardia pacing (ATP) is a method of rapid pacing
used in an attempt to terminate rapid tachycardias. ... A typical use for
ATP is to attempt to terminate ventricular tachyarrhythmia (VT).” {Id. at
114.) The Specification describes a form of VT called “monomorphic VT
(MVT) in which a similar beat-to-beat conduction pattern is noted” and is
“caused by an electrical loop within the cardiac muscle.” {Id. at 115.) This
electrical loop is referred to as the “reentrant circuit.” {Id.)
The Specification discloses:
Conventional CRM systems utilize electrodes which are placed
in or on the heart for sensing and to pace and shock the heart.
The most common such system is a transvenous system, which
uses a lead that is threaded through the vasculature and into the
heart for attachment in a heart chamber or in a blood vessel of
the heart itself. Before the advent of transvenous technology,
systems were placed epicardially, with electrodes placed on
exterior of the heart in an open-chest surgery.
{Id. at 13.)
As explained in the Specification “[djelivery of a pacing pulse using
only subcutaneous electrodes that do not touch the heart has a less localized
effect on the heart than prior conventional transvenous or epicardial pacing
systems.” {Id. at 120.) Also, “[b]y delivery of pacing with subcutaneous
electrodes, a global capture of the cardiac tissue is achieved.” {Id.)
According to the Specification, “[t]he inventors have recognized that this
global capture can take away the variability inherent in the proximity-
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Application 13/491,492
dependence of the transvenous or epicardial approach to ATP.” (Id.) And,
more specifically, “rather than a long pulse train of ATP delivered from
transvenous or epicardial electrodes, the present invention . . . breaks a
reentrant circuit with just one or two pulses delivered by subcutaneous
electrodes. This therapy is referred to herein as single termination pulse
(STP) therapy which can be delivered subcutaneously, rather than
transvenously or epicardially.” (Id. at 121; see also id. at 134 (“STP and
ATP are distinguished from one another by the following rules: . . . delivery
of one or more sets of 1-4 pulses separated by assessment of the success of
the previous pulses, is considered STP.”).)
Claims 1, 2, 4—6, and 8 are on appeal. Claim 1 is illustrative:
1. A method of treating a patient in an implantable cardiac
rhythm management device (CRMD) comprising a canister
housing circuitry for performing data analysis and therapy
delivery, coupled to a lead electrode having electrodes for body
implantation suitable for sensing electrical signals, the method
comprising:
receiving cardiac signals from the patient using one or
more of the electrodes on the lead;
identifying that a tachycardia is occurring based on the
received cardiac signals showing a cardiac rate in excess of a rate
threshold;
determining that the tachycardia is not supraventricular in
nature and declaring a treatable episode of tachycardia;
determining that the tachycardia is monomorphic;
delivering one to four synchronized pacing pulses to the
patient using far-field electrodes in response to the monomorphic
tachycardia;
calculating the cardiac rate of the patient following the
delivery of the one to four synchronized pacing pulses;
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Application 13/491,492
determining that the cardiac rate dropped in response to
the one to four synchronized pacing pulses; and
terminating the episode.
(App. Br. 14 (Claims App’x).)
The claims stand rejected as follows:
I. Claims 1 and 5 as anticipated under 35 U.S.C. § 102(b) by
Adams2 (“Rejection I”).
II. Claims 2 and 6 under 35 U.S.C. § 103(a) over Adams and
Bardy3 (“Rejection II”).
III. Claims 4 and 8 under 35 U.S.C. § 103(a) over Adams
(“Rejection III”).
I-ANTICIPATION
The Examiner rejected claims 1 and 5 as anticipated by Adams. The
Examiner finds that Adams discloses, inter alia,
delivering one to four synchronized pacing pulses to the patient
using far-field electrodes in response to monomorphic
tachycardia (col 1, In 60-68, col 8, In 25-32, where Adams
clarifies in col 2, In 15-22 that the far-field electrodes as
disclosed are also used to provide defibrillation pulses as well as
pacing pulses.
(Final Act. 3.) The Examiner further finds that Adams teaches “calculating
the cardiac rate of the patient following the delivery of one to four
synchronized pacing pulses” as required in claim 1 because “Examiner
2 Adams et al., US 5,366,487, issued Nov. 22, 1994.
3 Bardy et al., US 2002/0091414 Al, published July 11, 2002.
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Application 13/491,492
interprets that the system of Adams performs the disclosed procedure on a
continuous basis and necessarily recalculates cardiac rate at a time point
after delivery of pacing stimulation.” {Id. (citing Adams 8:7—36).) And,
according to the Examiner, the “claims as currently worded do not require a
specific order of steps, nor require a relationship between pacing pulse
delivery and the determined cardiac data.” {Id.)
Appellants raise several arguments. Appellants argue “[cjlaim 1
specifically recites the pacing pulses are delivered from far-field electrodes”
and this claim element is not disclosed in Adams. (App. Br. 6.) At best,
according to Appellants, Adams discloses that one of the defibrillation
electrodes may serve as a common electrode to provide pacing or pulse
detection, in addition to defibrillation. {Id.) As Appellants explain, “[t]his
means the other electrode would still be a near field electrode located in or
on the heart” and, thus, not teach that pacing pulses are provided by far-field
electrodes {plural) as required by claim 1. {Id. at 6—7.)
Appellants also argue “claims 1 and 5 specifically recite rate
recalculation must occur in response to the delivery of the pacing therapy”
and that this and other claim elements following the delivery of pulses are
absent in Adams. (App. Br. 7.)
Appellants further argue the claims require not just pacing pulses but
“synchronized pacing pulses.” (App. Br. 10.) According to Appellants, the
Examiner has, in effect, read the term “synchronized” out of the claim. {Id.;
see also Reply Br. 3—4.)
For the reasons discussed below and on this record, we conclude that
Appellants have the better position.
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Adams does not provide a clear teaching of an apparatus or method
using at least two far-field electrodes that deliver one to four synchronized
pacing pulses as required in claims 1 and 5. We recognize, but are not
persuaded by, the Examiner’s response that Adams suggests the use of
additional electrodes and the Examiner’s assertion that Adams’ “system is
intended to use electrodes for multiple purposes, including defibrillation and
pacing.” (Ans. 4 (citing Adams 3:9-13 and 5:64—66).) As Appellants point
out, in context, Adams’ disclosure concerning adding electrodes (e.g.,
subcutaneous-patch electrodes) appears to provide additional channels for
sensing signals — not delivering pacing pulses in the way that is claimed.
(Reply Br. 2.) Moreover, although the portion of column 5 cited by the
Examiner includes a generic disclosure regarding a potential use of
electrodes for multiple purposes, this is a rejection under § 102(b). Net
MoneylN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (To
anticipate “it is not enough that the prior art reference discloses part of the
claimed invention, which an ordinary artisan might supplement to make the
whole, or that it includes multiple, distinct teachings that the artisan might
somehow combine to achieve the claimed invention.”).4 Whether claims 1
or 5 would have been obvious over Adams is not the issue before us.
4 For anticipation purposes, the “reference must clearly and unequivocally
disclose the claimed compound or direct those skilled in the art to the
compound without any need for picking, choosing, and combining various
disclosures not directly related to each other by the teachings of the cited
reference. Such picking and choosing may be entirely proper in the making
of a 103, obviousness rejection . . . but it has no place in the making of a
102, anticipation rejection.” In reArkley, 455 F.2d 586, 587 (CCPA 1972)
(emphasis in original).
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We also disagree with the Examiner’s determination that no order of
steps is required by claim 1. For example, the step of “calculating the
cardiac rate of the patient following the delivery of the one to four
synchronized pacing pulses” logically and literally must follow the prior step
of delivering pulses. (App. Br. 7.) The Examiner asserts that “Adams is
drawn to a continuous monitoring and treatment by the system.” (Ans. 5.)
But the Examiner fails to direct us to any clear and persuasive support in
Adams for this assertion. It might well be obvious to repeat Adams’
diagnostic steps after a shock is delivered, but again the rejection is for
anticipation, not obviousness. And the present record lacks findings or
reasoning of the Examiner supporting a § 103 rejection of claims 1 or 5.
Finally, we agree with Appellants that the Examiner’s interpretation
of “synchronized” is not reasonable.5 According to the Examiner, the
“claim as currently worded does not clarify what the pacing pulse is
synchronized to” and thus the Examiner interprets the term to encompass a
5 Appellants also argue that “cardioversion [in Adams] is not pacing” as
claimed. (App. Br. 10.) In support, Appellants contend “[cjardioversion is
applied at about 1 Joule using transvenous electrodes in Adams, an order of
magnitude stronger than pacing as described in Applicants’ specification
from a subcutaneous-only system.” {Id. at 9.) Inasmuch as Appellants seek
to distinguish cardioversion and the pacing pulses that are claimed based on
the amount of energy applied alone, we are not persuaded. We note, for
example, that Appellants’ Specification also suggests pacing pulses at higher
energies, including above 1 Joule. (See Spec. 130 (“Various amplitudes and
signal types may apply instead, for example . . . waveforms delivering a
particular amount of energy,from 0.01 Joules to 5 Joules, for example.”)
and 134 (“STP therapy is different from defibrillation or cardioversion
therapy in that the output is much smaller in energy level {often less than a
Joule of energy).”) (emphases added).)
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“shock [that] is synchronized with the identification of the tachycardia” as
allegedly disclosed in Adams. (Ans. 6.)
Although we give claim terms their broadest reasonable interpretation
during prosecution, that does not include an interpretation divorced from the
Specification. In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009) (“The
protocol of giving claims their broadest reasonable interpretation during
examination does not include giving claims a legally incorrect
interpretation.”) As Appellants persuasively argued, the meaning of
“synchronized” in the claims and Specification means the pacing pulses are
synchronized with the heart beat — in particular, a QRS signal. (Reply Br.
4; see also Spec. 136 (“STP therapy may be delivered either synchronized
with or offset by a few milliseconds from the peak of a QRS signal”)
(emphasis added).)6 So interpreted, the Examiner has not shown that Adams
discloses “synchronized pacing pulses” as required in claims 1 and 5.
For the above reasons, we conclude the Examiner did not establish by
a preponderance of the evidence that Adams anticipates claims 1 or 5.
II & III - OBVIOUSNESS
The Examiner rejected claims 2 and 6 over Adams and Bardy
(Rejection II), and claims 4 and 8 as obvious over Adams (Rejection III).
6 Appellants also persuasively argued that the Examiner’s interpretation
would make other claim language redundant because the “delivering one to
four synchronized pacing pulses” limitation already requires delivery of the
pulses “in response to the monomorphic tachycardia.” (Reply Br. 4.) See
Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007)
(rejecting construction that makes claim terms superfluous).
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With respect to Rejection II, the Examiner finds that Adams does not
disclose “a subcutaneous-only CRMD” and turns to Bardy. (Final Act. 4.)
According to the Examiner, “Bardy discloses it was known in the art to
implement a subcutaneous-only CRMD for pacing and defibrillation
purposes.” (Id.) The Examiner has not, however, shown that Bardy makes
up for the deficiencies of Adams noted above with respect to claims 1 and 5,
from which claims 2 and 6 depend, respectively. Accordingly, we reverse
Rejection II for the reasons provided concerning Rejection I.
With respect to Rejection III, the Examiner finds Adams discloses
“the rate threshold is in the range of 60-120 beats per minute” but “does not
explicitly disclose the range is 120-220 beats per minute” as recited in
dependent claims 4 and 8. (Id. at 5.) The Examiner concludes that a
modification of the range would have been obvious as a matter of routine
optimization or design choice. (Id.) The Examiner did not, however,
provide any findings or reasoning that make up for the deficiencies of
Adams discussed above concerning claims 1 and 5, from which claims 4 and
8 depend, respectively. Accordingly, we reverse Rejection III for the
reasons provided concerning Rejection I.
SUMMARY
We reverse the rejection of claims 1 and 5 as anticipated under 35
U.S.C. § 102(b) by Adams.
We reverse the rejection of claims 2 and 6 as obvious under 35 U.S.C.
§ 103(a) by Adams and Bardy.
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We reverse the rejection of claims 4 and 8 as obvious under 35 U.S.C.
§ 103(a) over Adams.
REVERSED
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