Ex Parte Stahmann et al

Patent Trials and Appeals Board

Mar 15, 2019

14793325 - (D) (P.T.A.B. Mar. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/793,325 07/07/2015
11050 7590 03/19/2019
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Jeffrey E. Stahmann
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.
1001.3561101 6123
EXAMINER
TEJANI, ANKIT D
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
03/19/2019 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 JEFFREY E. STAHMANN, MICHAEL J. KANE,
WILLIAM J. LINDER, HOW ARD D. SIMMS, and KEITH R. MAILE
Appeal2018-002267
Application 14/793,325 1
Technology Center 3700
Before STEFAN STAICOVICI, MICHAEL J. FITZPATRICK, and
WILLIAM A. CAPP, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE-
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
decision in the Final Office Action ( dated Mar. 20, 2017, hereinafter "Final
Act.") rejecting claims 1-20. We have jurisdiction over this appeal under 35
U.S.C. § 6(b ).
1 Cardiac Pacemakers, Inc. is the applicant and is identified as the real party
in interest in Appellants' Appeal Brief (filed Sept. 14, 2017, hereinafter
"Appeal Br."). Appeal Br. 3.
Appeal2018-002267
Application 14/793,325
We REVERSE.
SUMMARY OF DECISION
INVENTION
Appellants' invention relates to a system and method "for detecting
cardiac arrhythmias and coordinating therapy between multiple devices."
Spec. 1, 11. 11-12.
Claims 1, 12, and 15 are independent. Claims 1 and 15 are illustrative
of the claimed invention and read as follows:
1. A medical device system for delivering electrical
stimulation therapy to a heart of a patient, the system
compnsmg:
a leadless cardiac pacemaker (LCP) configured to be
implanted within a heart of a patient and configured to
determine an arrhythmia type of a detected cardiac arrhythmia;
the LCP configured to ascertain if the determined
arrhythmia type is susceptible to anti-tachycardia pacing (ATP)
therapy;
a medical device configured to deliver defibrillation
shock therapy to the patient, wherein the LCP and the medical
device are spaced from one another and communicatively
coupled, and
wherein:
if the LCP ascertains that the determined
arrhythmia type is susceptible to anti-
tachycardia pacing (ATP) therapy, the LCP
is configured to:
send an instruction to the medical
device instructing the medical
device to hold off on delivering
the defibrillation shock therapy;
and
deliver the ATP therapy to the
patient's heart; and
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Application 14/793,325
if the LCP ascertains that the determined
arrhythmia type is not susceptible to
anti-tachycardia pacing (ATP) therapy,
allow the medical device to deliver the
defibrillation shock therapy to the patient
without first waiting for the delivery of the
ATP therapy by the LCP.
15. A medical device system for delivering electrical
stimulation therapy to a heart of a patient, the system
compnsmg:
a leadless cardiac pacemaker (LCP) configured to sense
one or more physiological parameters of the heart of the patient
and to recognize an occurrence of an arrhythmia based at least
in part on the one or more sensed parameters;
the LCP further configured to determine an arrhythmia
type based at least in part on the one or more sensed
physiological parameters of the heart of the patient; and
a medical device communicatively coupled to the LCP,
the medical device configured to recognize the an occurrence of
an arrhythmia and deliver electrical shock therapy to the heart
of the patient, wherein the electrical shock therapy comprises:
charging a capacitor to a predetermined level, and
delivering one or more electrical shocks to the
heart of the patient after charging the
capacitor to the predetermined level; and
wherein the medical device is configured to alter the
electrical shock therapy based on instructions communicated
from the LCP in accordance with the determined arrhythmia
type.
REJECTION
The Examiner rejects claims 1-20 under 35 U.S.C. § 103 as being
unpatentable over Greenhut et al. (US 8,744,572 Bl, iss. June 3, 2014,
hereinafter "Greenhut").
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Application 14/793,325
ANALYSIS
Claims 1-14
Independent claim 1 requires, inter alia, a leadless cardiac pacemaker
(hereinafter "LCP") configured to "send an instruction to the medical device
instructing the medical device to hold off on delivering the defibrillation
shock therapy" and to deliver anti-tachycardia pacing (hereinafter "ATP")
therapy to a patient's heart. See Appeal Br. 13 (Claims App.) (emphasis
added). Similarly, independent claim 12 recites an "LCP ... instructing the
medical device to hold off on delivering the shock therapy program of the
medical device while the LCP delivers the ATP therapy." Id. at 15
( emphasis added).
The Examiner finds that Greenhut discloses a medical system 10
including, inter alia, leadless pacing device LPD 16 ("hereinafter "LPD")
and medical device 30, i.e., implantable cardioverter defibrillator
(hereinafter SICD"), wherein LPD 16 is configured to "send an instruction
to the medical device [30] instructing the medical device to hold off on
delivering ... the defibrillation shock therapy and deliver the ATP therapy
to the patient's heart." Final Act. 3-5 (citing Greenhut, col. 6, 11. 30-31, col.
10, 11. 36-41, col. 11, 11. 50-67, col. 12, 11. 35-38, 56-57). The Examiner
further finds that SICD 30 communicates to LPD 16 to deliver ATP therapy
to terminate tachyarrhythmias before SICD 30 applies defibrillation shock
therapy and SICD 30 requires a period of time to charge before being able to
deliver the shock. Id. at 5 ( citing Greenhut, col. 10, 11. 49---63). Thus, the
Examiner determines "that the 'period of time to charge prior to the SICD
[30] being capable of delivering the shock' is analogous to the 'suspend
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Application 14/793,325
message,' as both act to delay the shock by the SICD [30] ... until after the
ATP is delivered by the leadless cardiac pacemaker," i.e., LPD 16. Id.
Appellants argue that
Simply disclosing that the SICD requires a period of time to
charge prior to the SICD being capable of delivering the shock
does not relate or disclose in any way an instruction or
message, let alone an instruction or message that is sent from
the LCP to the medical device that instructs the medical device
to "hold off on delivering defibrillation shock therapy."
Appeal Br. 7.
In response, the Examiner notes that Greenhut' s system determines
whether ATP or defibrillation shock therapy is required and triggers either
LCP 16 or SICD 30. Examiner Answer 16-17 (dated October 27, 2017,
hereinafter "Ans."). The Examiner explains that "[w]hen ATP therapy is
warranted, Greenhut's system sends a message to the SICD that it should
instead monitor for the presence of ATP therapy" and "when defibrillation
shock therapy is warranted, Greenhut's system delivers the defibrillation
shock therapy first ... before involving the LPD and any potential ATP
therapy." Id. at 17 (citing Greenhut, col. 10, 1. 64---col. 11, 1. 20, Figs. 8,
lOA, lOB). Hence, according to the Examiner,
Greenhut suggests wherein the LPD instructs the SICD to "hold
off on delivering the shock therapy program" when it is
determined that the arrhythmia may be susceptible to ATP
therapy. In so doing, Greenhut's system avoids delivering both
therapies at the same time, especially when it is determined that
one form of therapy may be more advantageous than the other.
The result is a safer device that avoids "over-treatment," or
providing more therapeutic intervention than is necessary.
Id ( emphasis added).
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Application 14/793,325
Although we appreciate that the charging time of Greenhut's SICD 30
delays the application of shock therapy, nonetheless, we agree with
Appellants that "Greenhut does not actually disclose the LPD sending a
message to [ or instructing] the SICD" "to hold off on delivering" shock
therapy, as called for in each of independent claims 1 and 12. Reply Brief 2
(filed December 27, 2017, hereinafter "Reply Br."). Rather, as Appellants
correctly note, Greenhut discloses communication from SICD 30 to LPD 16
(see id.), where SICD 30 transmits a communication to LPD 16 to deliver
ATP therapy and charging of SICD 30 occurs during ATP delivery. See
Greenhut, col. 10, 11. 50-58, col. 36, 11. 30-31.
Furthermore, we note that in a separate embodiment, Greenhut
discloses that SICD 30 may begin charging after LPD 16 "requests," that is,
sends a message to or instructs SICD 30, to "wake up" from a "sleep mode"
and begin charging to deliver defibrillation shock therapy. See Greenhut,
col. 29, 11. 24--26, col. 36, 11. 33-35, and 40-41. Hence, although in this
situation Greenhut discloses LPD 16 sending a message to or instructing
SICD 30, the message or instruction is not "to hold off on delivering" shock
therapy, as called for by each of independent claims 1 and 12, but rather to
begin shock therapy. Even though Greenhut discloses that "charging of
SICD 30 may occur after ATP delivery," this does not mean that prior to
ATP delivery LPD 16 necessarily sends a message to or instructs SICD 30
"to hold off on delivering" shock therapy as SICD 30 may by default be in a
"sleep mode" until it receives the "wake up" signal. See Greenhut, col. 11,
11. 22-26.
In conclusion, the Examiner does not point to any portion of
Greenhut, and we could not find any, that discloses LPD 16 sending a
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message to or instructing SICD 30 "to hold off on delivering" shock therapy,
as called for each of independent claims 1 and 12. The Examiner's
modification does not remedy the deficiency of Greenhut discussed supra.
See Final Act. 5-6. Accordingly, for the foregoing reasons, we do not
sustain the rejection under 35 U.S.C. § 103 of claims 1-14 as unpatentable
over Greenhut.
Claims 15-20
The Examiner finds that Greenhut discloses, inter alia, a leadless
cardiac pacemaker LCP 16 (LPD) configured to sense physiological
parameters of a patient's heart and determine an arrhythmia type based on
the sensed parameters and a medical device 30 (SICD) configured to
recognize the occurrence of arrhythmia and deliver electrical shock therapy
to the heart of the patient. See Final Act. 13-14 ( citing Greenhut, col. 4, 11.
53-62, col. 11, 11. 50-67, col. 12, 11. 35-38, and col. 17, 11. 4--12). The
Examiner further finds that Greenhut discloses that medical device 30 is
"configured to alter electrical shock therapy based on instructions
communicated from the LCP in accordance with the determined arrhythmia
type" because Greenhut's LPD 16 instructs SICD 30 "to 'wake up from a
low power 'sleep mode' to ... deliver anti-tachyarrythmia shock therapy."'
Id. at 14 (citing Greenhut, col. 29, 11. 20-26). However, the Examiner notes
that Greenhut fails to "disclose wherein the LCP itself determines whether or
not to administer the ATP." Id. at 15. Rather, according to the Examiner,
"Greenhut's device, instead, delivers a signal to the SICD, and the SICD
makes this determination." Id. Thus, the Examiner concludes that
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Id.
[I]t would have been obvious to a person having ordinary skill
in the art at the time the invention was filed to incorporate the
ATP determination step into the LCP itself, as doing so
advantageously allows for more of the processing to occur at
the level of the LCP and allows for the ATP determination step
to occur sooner.
Appellants argue that Greenhut "does not disclose the particular
medical device system of claim 15," and in particular, does not disclose a
medical device that "is configured to alter the electrical shock therapy based
on instructions communicated from the LCP in accordance with the
determined arrhythmia type." Appeal Br. 11 (underlining omitted).
Although we appreciate that Greenhut's SICD 30 is configured to
recognize the occurrence of arrhythmia and deliver electrical shock therapy
to the heart of the patient (see Greenhut, col. 12, 11. 33-38), we do not agree
with the Examiner's position that it is also configured to "alter" the electric
shock therapy based on instructions communicated from LPD 16. See Ans.
18-19. Claim 15 requires, inter alia, a "medical device configured to ...
deliver electrical shock therapy to the heart of the patient" and to "alter the
electrical shock therapy based on instructions communicated from the LCP."
See Appeal Br. 16 (Claims App.) (emphasis added). In other words, claim
15 requires altering an existing electrical shock therapy program (i.e.,
delivered). Such an interpretation is consistent with Appellant's
Specification, which describes "modify[ing] the defibrillation shock therapy
program of [ medical] device 2" by "alter[ing] ... the number of
defibrillation pulses, the amplitude of the defibrillation pulses, the pulse
width of the defibrillation pulses, the phases of the defibrillation pulses,
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and/or other morphological features of the defibrillation pulses." Spec. 37,
11. 5-15.
We do not agree with the Examiner's position, which equates
"alter[ing] the electrical shock therapy based on instructions communicated
from the LCP" with Greenhut sending an instruction from LPD 16 to SICD
30 to "wake up" from a low power "sleep mode." See Ans. 18-19. We
appreciate that waking up Greenhut's SICD 30 from a sleep mode alters its
state from an OFF condition to an ON condition. However, because in the
OFF condition, i.e., sleep mode, SICD 30 does not deliver electrical shock
therapy, waking up SICD 30 does not constitute "alter[ing] the electrical
shock therapy" as there is no electrical shock therapy in the sleep mode.
Therefore, Greenhut's SDIC 30 is not configured to deliver electrical shock
therapy and to alter the electrical shock therapy, as understood by a person
of ordinary skill in the art, in light of Appellant's Specification.
Accordingly, because the Examiner's modification does not remedy
the deficiency of Greenhut discussed supra (see Final Act. 15), we also do
not sustain the rejection under 35 U.S.C. § 103 of claims 15-20 as
unpatentable over Greenhut.
SUMMARY
The Examiner's decision to reject claims 1-20 under 35 U.S.C. § 103
as unpatentable over Greenhut is reversed.
REVERSED
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