Ex Parte Ryu et al

Patent Trial and Appeal Board

Feb 12, 2016

12632519 (P.T.A.B. Feb. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/632,519 12/07/2009
36802 7590 02/17/2016
PACESETTER, INC
15900 VALLEY VIEW COURT
SYLMAR, CA 91392-9221
FIRST NAMED INVENTOR
Kyungmoo Ryu
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.
A09Pl068 3951
EXAMINER
FLORY, CHRISTOPHER A
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
02/17/2016 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):
Patent.CRMDSylmar@sjm.com
lcancino-zepeda@sjm.com
epineiro@sjm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KYUNGMOO RYU and XIAOYI MIN
Appeal2013-007216
Application 12/632,519
Technology Center 3700
Before EDWARD A. BROWN, BRANDON J. WARNER, and
FREDERICK C. LANEY, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEivIENT OF THE CASE
Kyungmoo Ryu and Xiaoyi Min (Appellants)1 appeal under 35 U.S.C.
§ 134 from the Examiner's decision rejecting claims 1-11. Br. 3. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 The Appeal Brief identifies the real party in interest as Pacesetter, Inc., dba
St. Jude Medical, Cardiac Rhythm Management Division. Br. 3.
Appeal2013-007216
Application 12/632,519
CLAIMED SUBJECT MATTER
The disclosed invention relates to "techniques for optimizing pacing
therapies such as cardiac resynchronization therapy (CRT)." Spec. para. 1.
Claim 1, reproduced below, is representative of the claimed subject matter.
1. A method comprising:
providing a plurality of distances between electrodes of a
series of three or more ventricular electrodes associated with a
first ventricle;
selecting a ventricular electrode from the series;
delivering energy to the first ventricle via the selected
ventricular electrode, the energy sufficient to cause an evoked
response;
acquiring signals of cardiac electrical activity associated
with the evoked response via a plurality of the non-selected
ventricular electrodes of the series;
based on signals of cardiac electrical activity acquired via
the plurality of non-selected ventricular electrodes and the
plurality of distances, determining conduction velocities;
based on the conduction velocities, deciding if the selected
ventricular electrode comprises an optimal electrode for delivery
of a cardiac pacing therapy; and
where the selected ventricular electrode comprises an
optimal electrode for delivery of the cardiac pacing therapy,
calling for delivery of the cardiac pacing therapy using the
selected ventricular electrode.
Br., Claims App.
REJECTIONS
1. Claims 1-11 stand rejected under 35 U.S.C. § 112, second
paragraph.
2. Claims 1--4 and 6-11 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Mathis (US 2004/0106958 Al, published June 3,
2004).
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Application 12/632,519
3. Claim 5 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Mathis and Min (US 2005/0149138 Al, published July 7,
2005) or Pei (US 7,941,217 Bl, issued May 10, 2011).
ANALYSIS
Rejection 1
Claim 1 recites, inter alia, "based on the conduction velocities,
deciding if the selected ventricular electrode comprises an optimal electrode
for delivery of a cardiac pacing therapy," and "where the selected ventricular
electrode comprises an optimal electrode for delivery of the cardiac pacing
therapy, calling for delivery of the cardiac pacing therapy using the selected
ventricular electrode." Br., Claims App. (emphasis added). The Examiner
finds the "where" clause makes claim 1 indefinite because "it is unclear if
the conditions of the clause must be met and are positively recited, or what
the intended function of the device is in the alternative if the conditions of
the clause are not met." Final Act. 2. The Examiner asserts, "' [ w ]here' is
conditional in the same way as 'if,' and therefore unless the alternative
condition is recited or the conditions of the presented 'where' clause must be
met (e.g. if the clause were changed to 'when the selected ventricular
electrode .... '),"then the claim is indefinite because there could be an
"infinite number of alternative outcomes if the conditions of the clause are
not met." Ans. 3 (emphasis added).
In contrast, Appellants contend claim 1 "is clear that the selected
electrode will be used for delivering stimulation where the electrode has
been deemed to be an optimal electrode based on the measured conduction
velocities." Br. 5.
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Appeal2013-007216
Application 12/632,519
We agree with Appellants. Claim 1 requires performance of the
"deciding" limitation. We construe the term "where" in the "where" clause
to mean "when." We thus construe claim 1 to mean that "when" it is
decided that the selected ventricular electrode comprises an optimal
electrode, then "delivery of the cardiac pacing therapy using the selected
ventricular electrode" is called for. Claim 1 does not require deciding that
the selected ventricular electrode does comprise an optimal electrode, or
specify what occurs when it is decided the selected ventricular electrode
does not comprise an optimal electrode. The Examiner does not explain
adequately why the absence of such additional limitations makes the
meaning of claim 1 indefinite. Rather, viewing the "where" clause in
context, and in light of the Specification, it is clear that the clause is reciting
to perform the step of "calling for delivery of the cardiac pacing therapy
using the selected ventricular electrode" at the point in time when "the
selected ventricular electrode comprises an optimal electrode for delivery of
the cardiac pacing therapy."
We do not sustain the rejection of claims 1-11 under 35 U.S.C. § 112,
second paragraph.
Rejection 2
The Examiner finds Mathis discloses all limitations of claim 1, except
for "determining conduction velocities" to decide if the selected electrode is
an optimal electrode. Final Act. 3--4. The Examiner finds Mathis discloses
determining conduction delays and using the delays to decide if the selected
electrode is optimal for pacing therapy. Id. at 4 (citing Mathis, paras. 63, 65,
73; Fig. 13). The Examiner determines that using a velocity, rather than the
time segment (i.e., conduction delay) from which the velocity is calculated,
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Application 12/632,519
especially where the distance used in the calculation is a fixed, inter-
electrode distance, is a well-known equivalent or an obvious variant to using
the time segment itself. Id. The Examiner concludes that it would have
been obvious to modify Mathis' s method to use the conduction velocity
recited in claim 1, because Appellants have not disclosed that using the
conduction velocity, rather than the conduction delay from which the
conduction delay is necessarily calculated, provides an advantage, is used
for a particular purpose, or solves a stated problem. Id.
Appellants contend Mathis does not teach using conduction velocities
to select an optimal electrode for delivering cardiac pacing therapy. Br. 7.
We agree. Mathis discloses that "[ t ]he process of identifying the optimum
electrode or electrodes or a pattern of electrodes may be performed using
several different approaches." Mathis, para. 56. Mathis describes certain
treatments for which "the location of the electrode in the heart is important."
Id. With reference to Figure 13, Mathis describes determining the position
of each electrode of an implanted lead 14. Id. para. 59. Mathis further
discloses:
After the optimum stimulating electrode has been designated, the
cardiac stimulator or the programmer 100 may stimulate 314 the
heart and sense 316 the propagating wave front at each of the
remaining N-1 electrodes. The time delay from the origin of the
inserted signal until the signal is sensed at an electrode provides
a set of delta times representative of the preferred propagation of
a wave front across the heart. The time delays and position for
an electrode permits calculation of a wave velocity 318 across
the heart.
Id. para. 60 (emphases added).
We understand that "the optimum stimulating electrode" mentioned in
the technique described in paragraph 60 of Mathis is designated as such
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Application 12/632,519
based on the electrode's position in the heart. In other words, Mathis
discloses a technique that determines the optimal electrode by location.
Accordingly, the evidence does not support Examiner's purported finding
that "[t]he optimal electrode in Mathis is not determined by a location within
or on the heart." Ans. 4. After the optimal electrode has been designated in
Mathis, then "a wave velocity [] across the heart" is calculated. We agree
with Appellants that Mathis does not disclose the calculated wave velocity is
used to select the optimum stimulating electrode; rather, this selection
already has been made by the time the wave velocity is calculated. See Br.
7.
In addition, claim 1 recites, "based on signals of cardiac electrical
activity acquired via the plurality of non-selected ventricular electrodes and
the plurality of distances, determining conduction velocities." We construe
this limitation to require determining conduction velocities for each of the
plurality of non-selected ventricular electrodes. This construction is
consistent with the information shown in Figure 5 of Appellants'
application. This figure depicts a scheme where energy is delivered to the
left ventricle (L V) of the heart 102 via the L V2 electrode, and conduction
velocity is calculated for each of the electrodes LVl, LV3, and LV4
associated with the left ventricle, based on distance information and
measured time delays. See also Spec. paras. 80-81. In contrast, Mathis' s
description of calculating "a wave velocity" does not disclose "determining
conduction velocities" for a plurality of non-selected ventricular electrodes,
as required by claim 1.
Mathis discloses that a physiologic sensor can be used to determine if
the selected electrode is physiologically optimum. Mathis, para. 60. Mathis
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Application 12/632,519
further discloses that an external cardiac sensor may be used to detect the
external electrocardiogram (ECG) resulting from stimulation at the optimum
electrode, and then comparing the detected ECG to an ideal ECG for the
purpose of attempting to modifY the stimulation pattern. Id. Mathis teaches
that the stimulation pattern may be modified if the detected ECG resulting
from use of the optimum electrode is not ideal. Mathis does not teach
designating a different optimum electrode based on determined conduction
velocities.
Mathis discloses another technique, where information on the relative
locations of the electrodes in the heart, and with relationship to the heart
wall, is not absolutely necessary for providing therapy for congestive heart
failure, and where "[a] set of ordered time delays as a function of then
electrodes implanted in the heart may be sufficient to provide a clinical
benefit." Mathis, para. 61. Accordingly, Mathis discloses a technique
where the optimal electrode is not required to be determined by a location
within or on the heart, but instead is determined based on time delays.
Mathis describes two ways of determining the order of the electrodes
and their associated time delays. Id. The first way is "for patients with at
least some intrinsic cardiac function." Id. para. 62. Mathis discloses that the
first way results in identifying the optimum electrode "E[best]" by use of the
time delays. Id. para. 63. However, Mathis indicates that "the actual
location of the electrodes is unknown." Id. As velocity is defined as the
distance traveled divided by the elapsed time, the electrodes' positions must
also be known to determine conduction velocities for the electrodes.
Consistent with this requirement, Mathis does not mention that a wave
velocity is determined for any of the electrodes for the first way.
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Mathis discloses a second way of determining the order of the
electrodes and their associated time delays in order to identify the optimum
electrode, "when there is no intrinsic waveform or when the intrinsic
waveform is so unpredictable or sporadic that meaningful information
cannot be derived from it." Mathis, para. 64. But for the second way,
Mathis again fails to mention determining a wave velocity for any of the
electrodes. See id. paras. 64---65.
We agree with the Examiner that paragraph 65 of Mathis discloses
determining the optimal electrode based on measuring time delays ("Delta
T") for each electrode, not by "a location within or on the heart." Ans. 4.
The Examiner finds that "paragraphs [0076] and [0077] [of Mathis] establish
that the interelectrode distance is known and that conduction velocity is
merely a mathematical relation of the interelectrode distance and the applied
conduction delays by the equation shown." Id. Paragraphs 76 and 77
describe how to determine the number of electrodes to be deployed for a
patient. Paragraph 77 provides an equation for calculating the distance, d,
from the center of one electrode to the center of an adjacent electrode, which
equation includes the conduction velocity, cv, the maximum conduction
time, t, and the selected percent coverage, c, of the electrodes. Mathis
appears to teach using an approximate value of the conduction velocity of a
wave through the heart in this equation. That is, we note Mathis discloses
that "[t]he conduction velocity of a contraction wave form through a
ventricle is on the order of 500 mm/sec or 0.5 mm/ms." Id. para. 76. Mathis
does not disclose that the conduction velocity could be calculated using the
equation. Accordingly, paragraphs 65, 76, and 77 of Mathis also do not
teach determining conduction velocities for a plurality of non-selected
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ventricular electrodes "based on signals of cardiac electrical activity
acquired via the plurality of nonselected ventricular electrodes and the
plurality of distances," as recited in claim 1.
We do not sustain the rejection of claim 1, and claims 2--4 and 6-11
depending therefrom, as unpatentable over Mathis.
Rejection 3
Claim 5 depends from claim 1 and further calls for "acquiring signals
of cardiac electrical activity via the selected ventricular electrode," and
"based on signals of cardiac electrical activity acquired via the selected
ventricular electrode, determining a pacing latency." Br., Claims App. The
Examiner's application of Min to reject claim 5 does not cure the
deficiencies of the rejection of claim 1 discussed above. We do not sustain
the rejection of claim 5 as unpatentable over Mathis and Min.
DECISION
We reverse the Examiner's decision rejecting claims 1-11.
REVERSED
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