Ex Parte Sheldon et al

Patent Trial and Appeal Board

Jun 19, 2017

12913400 (P.T.A.B. Jun. 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.
12/913,400 10/27/2010 Todd J. Sheldon P0038717.00/1111-249US01 3801
80584 7590
Medtronic, Inc.
710 Medtronic Parkway
MS: LC340
Minneapolis, MN 55432
06/21/2017 EXAMINER
PHAM, MINH DUC GIA
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
06/21/2017 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 TODD J. SHELDON and BRUCE D. GUNDERSON
Appeal 2016-002696
Application 12/913,4001
Technology Center 3700
Before ERIC B. GRIMES, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
for delivering pacing therapy to the heart and detecting lead related
conditions and a system to carry out the method, which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The prior art discloses medical devices that deliver therapy to the
heart which include the delivery of electrical signals. (Spec. 12.) Some of
these medical devices, such as implantable cardiac pacemakers or
1 Appellants identify the Real Party in Interest as Medtronic, Inc. and
Medtronic pic. (Appeal Br. 3.)
Appeal 2016-002696
Application 12/913,400
cardioverter-defibrillators, employ “one or more elongated electrical leads
carrying electrodes for the delivery of therapeutic electrical signals.” {Id.
2, 4.) “Implantable cardiac pacemakers may also detect whether the pacing
pulses have captured the cardiac tissue, i.e., resulted in depolarizations or
contractions of the cardiac tissue.” {Id. 1 5.)
“Implantable medical leads typically include a lead body containing
one or more elongated electrical conductors that extend through the lead
body from a connector assembly provided at a proximal lead end to one or
more electrodes located at the distal lead end or elsewhere along the length
of the lead body.” {Id. 1 6.) Over time “stresses may fracture a conductor
within the lead body. . . . Also, the wear and degradation of the insulation
between the conductors may result in shorting.” {Id. 17.) “Additionally, the
electrical connection between medical device connector elements and the
lead connector elements can be intermittently or continuously disrupted.”
{Id. 1 8.) “Lead fracture, disrupted connections, or other causes of short
circuits or open circuits may be referred to, in general, as lead related
conditions.” {Id. 19.) “A lead related condition may result in an increased
pacing threshold and/or loss of capture.” {Id. 124.) Appellants’ invention
“is directed toward modifying the evaluation of cardiac capture in response
to detection of a lead related condition.” {Id. 110.)
Claims 1—6, 9-19, and 22—25 are on appeal. Claim 1 is representative
and reads as follows:
1. A method comprising:
delivering a pacing therapy to a heart of a patient;
periodically determining whether the pacing therapy
captures the heart of the patient;
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Application 12/913,400
detecting a lead related condition, in response to at least
one of detecting a threshold number of lead integrity episodes
or detecting a threshold number of lead integrity episodes
within a predetermined period of time, wherein the lead
integrity episodes are at least one of: (1) one or more R-R
intervals below a threshold indicating that the R-R intervals are
due to one or more non-physiological factors; or (2) a series of
R-R intervals, each of the R-R intervals below a tachycardia or
fibrillation threshold, the series not sustained for enough R-R
intervals to result in detection of tachycardia or fibrillation; and
in response to the detection of the lead related condition,
increasing a frequency of determining whether the pacing
therapy captures the heart.
(Appeal Br. 16.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1—3, 9, 11—16, 22, 24, and 25 under 35 U.S.C. § 103(a) as
unpatentable over Ferek-Petric2 and Ousdigian.3
Claims 4—6 and 17—19 under 35 U.S.C. § 103(a) as being unpatentable
over Ferek-Petric, Ousdigian, and Fu.4
Claims 10 and 23 under 35 U.S.C. § 103(a) as being unpatentable
over Ferek-Petric, Ousdigian, and Gunderson.5
DISCUSSION
The Examiner finds that Ferek-Petric discloses a technique for cardiac
capture testing that includes detecting lead integrity (by measuring the lead
2 Ferek-Petric, US 2004/0172082 Al, published Sept. 2, 2004.
3 Ousdigian et al., US 2009/0299422 Al, published Dec. 3, 2009.
4 Fu, US 6,885,893 Bl, issued Apr. 26, 2005.
5 Gunderson, US 2006/0116733 Al, issued June 1, 2006.
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Application 12/913,400
impedance) in a process where pacing therapy is delivered to the heart and
increasing a frequency of determining whether the pacing therapy captures
the heart in response to detecting a lead related condition. (Final Action 2—
3; Ans. 3—4.) The Examiner further finds that Ferek-Petric discloses “pacer
timing/control circuitry 94 that may be used for computing intervals such as
R-R intervals for detecting the present of tachyarrhythmia.” (Final Action
3.) The Examiner notes, however, that Ferek-Petric does not disclose “the
step of detecting a lead related condition is in response to at least one of
detecting a threshold number of lead integrity episodes.” (Ans. 4.)
The Examiner finds that this step is rendered obvious in light of the
teachings of Ousdigian. (Ans. 4; Final Action 3.) The Examiner finds that
Ousdigian teaches a method for storing and evaluating electrograms (EGMs)
associated with sensed episodes associated with a lead integrity condition,
such as a fracture or short, where an impedance integrity criterion is used in
the sensed episode. (Final Action 3; Ans. 4.) The Examiner notes that the
method of Ousdigian involves detecting short R-R intervals that are “shorter
than a threshold that may indicate a sensing integrity condition.” (Final
Action 3.) According to the Examiner, Ousdigian teaches that these
measurements are “a series of rapid ventricular or atrial depolarization[s]
that did not meet the criterion for classification as a tachycardia or
fibrillation.” (Ans. 4—5.)
According to the Examiner, it would have been obvious to combine
the technique of Ousdigian using cardiac R-R intervals as an evaluating
factor for detecting a lead-related condition in the method of Ferek-Petric as
an alternative way for detecting lead-related condition with a lead
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Application 12/913,400
impedance measure to provide “a more accurate method for determining
lead integrity of an implantable device.” (Ans. 5; Final Action 4.)
We agree with the Examiner’s factual findings and conclusion of
obviousness.
Appellants argue that the Examiner’s rejection is in error because the
Examiner has failed to establish that the combination of references “would
result in the feature of detecting a lead related condition in response to at
least one of detecting a threshold number of lead integrity episodes or
detecting a threshold number of lead integrity episodes within a
predetermined period of time.” (Appeal Br. 9; Reply Br. 2—3.) This
argument depends upon the construction of “a threshold number of lead
integrity episodes.”
Claim Construction
Claims should be given their broadest reasonable interpretation during
examination. “[Djuring patent prosecution when claims can be amended,
ambiguities should be recognized, scope and breadth of language explored,
and clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).
Although the term “episodes” in the claims is plural, the usage of the term in
conjunction with “a threshold number” indicates that a single episode could
meet the threshold number. Moreover, claim 1 indicates that the lead
integrity episodes can be “one or more R-R intervals below a threshold.”
(Emphasis added.) This further supports an interpretation that the phrase in
question can include a single measurement as the threshold number.
We turn next to the Specification to see if any special meaning is
given this phrase. We find none. This phrase is mentioned twice in the
Specification and both in the same paragraph, i.e., paragraph 84. That
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Application 12/913,400
paragraph is uninformative as to whether the threshold number can be one
episode or must be more than one episode. Moreover, the Specification does
not describe a specific example of assessing a lead related condition
employing the concept of a “threshold number of lead integrity episodes.”
The Specification does, however, note that a lead related condition
may be based on a single measurement or a series of
measurements. For example, processor 80 may detect a lead
related condition based on a single impedance measurement
outside of the bounds stored in memory 82. As another
example, processor 80 may detect a lead related condition based
on the frequency of non-sustained high-rate cardiac episodes or
the frequency of short ventricular intervals counted on a sensing
integrity counter.
(Spec. 1106.) Thus, the Specification discloses that a single measurement
can provide information on which to determine a lead related condition.
This supports a conclusion that the “threshold number of lead integrity
episodes” as used in claim 1 can be a single episode.
Consequently, we find that under the broadest reasonable construction, the
phrase “[a] threshold number of lead integrity episodes” means one or more
episodes.
Ferek-Petric and Ousdigian teach detecting a lead related condition
in response to at least one of detecting a threshold number of lead
integrity episodes
In light of the construction set forth above, we disagree with
Appellants that the combination of Ferek-Petric and Ousdigian fails to teach
detecting a lead related condition in response to at least one of detecting a
threshold number of lead integrity episodes as required by claim 1.
Ousdigian teaches that a “user” such as a physician or technician “may use
programmer 24 to retrieve information from IMD 16 regarding the
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Application 12/913,400
performance or integrity of IMD 16 or other components of system 10, such
as leads 18, 20 and 22.” (Ousdigian 140.) Moreover, Ousdigian teaches
that “IMD 16 is an example of a device that may store electrograms (EGMs)
that are associated with sensed episodes or events that may be non-
physiological and, instead, associated with a sensing integrity condition.”
{Id. 143.) Ousdigian teaches that “[t]he EGMs may be considered in
conjunction within other sensing integrity data, such as lead impedance data,
which may also be stored by IMD 16, and retrieved and displayed by
programmer 24.” {Id.)
Ousdigian further teaches “Processor 80 may use the count in the
interval counters to detect NSTs [non-sustained tachyarrhythmias, id. 110],
suspected non-physiological NSTs, and short intervals based on R-R or P-P
intervals” {Id. 1 64) and that “[processor 80 may also store cardiac EGMs
for NSTs within episode logs 92, in response to detection of the NSTs” {Id. 1
75). Moreover, regarding “a threshold number of lead integrity episodes,”
Ousdigian states:
processor 80 may analyze the measured impedance values, and
may compare these values, or other computed values, to
determined thresholds and identify any possible conditions with
one or more electrical paths that include two or more of the
electrodes. For example, processor 80 may, as a result of one
or more comparisons, determine that one or more of leads 18,
20, and 22 has a lead-related condition, or more specifically that
one or more electrodes or associated conductors within the
leads may have an integrity condition.
{Id. f 92.) This particular paragraph of Ousdigian teaches that at least one
lead integrity episode is detected and used to determine whether or not there
is an integrity condition.
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Ferek-Petric and Ousdigian are concerned with measuring lead
integrity
Appellants’ argument that Ferek-Petric “monitors parameters for
which a change would indicate a possible change to the stimulation intensity
required to cause the heart to beat,” whereas Ousdigian describes detection
of short intervals that may be indicative of sensing integrity conditions and
“fails to describe that sensing of a short interval is in any way indicative of a
possible change in the stimulation intensity required to cause the heart to
beat” (Appeal Br. 10; Reply Br. 3) is also unpersuasive. We disagree with
Appellants’ narrow reading of the references. “It is well settled that a prior
art reference is relevant for all that it teaches to those of ordinary skill in the
art.” In reFritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992).
While it may be true that Ferek-Petric does teach monitoring
parameters that could indicate a change to required stimulation intensity, and
irrespective of whether Ferek-Petric uses the terms “lead integrity episode”
or lead integrity condition (Reply Br. 5), as the Examiner pointed out, Ferek-
Petric also teaches measurements of changes of certain cardiac parameters,
such as a change in lead impedance, can demonstrate an integrity condition,
such as loss of insulation or fracture of a filament. (Ans. 5; see Ferek-Petric
19) (“increases in lead impedance accompanied by increases in the capture
threshold may indicate a problem with an implanted lead”), |13 (indicating
that a cardiac parameter that may be measured, such as impedance of a lead
may pertain to the performance of an implantable medical device), |30
(“damage to a lead that delivers the stimuli may affect the ability of IMD 10
to capture the heart”), || 33—34 (noting IMD 10 may measure cardiac
parameters that may pertain to the performance of IMD 10 with leads and
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that measuring “a change in lead impedance” could indicate “a loss of
insulation or the fracture of a filament”), 152 (“These cardiac parameters
may be measured more frequently than the capture test frequency, and may
therefore provide an earlier indication of a potential problem than a capture
test.”) H 54—59 (noting that IMD 10 may determine whether a change in the
measured cardiac parameter is significant and that repeated measurements of
the capture threshold and lead impedance may indicate a fracture of a
filament in a lead).) Thus, we agree with the Examiner that “Ferek-Petric
teaches a method for identifying problems and forecasting possible loss of
capture using data including lead impedance trends that may indicate a
problem with an implanted lead.” (Ans. 6.)
Moreover, Ousdigian states that “impedance changes in the
stimulation path due to lead related conditions may affect sensing and
stimulation integrity for pacing, cardioversion, or defibrillation.” (Ans. 7,
citing Ousdigian 17.) And, as discussed above, Ousdigian teaches that the
comparison of measurements made regarding short intervals based on R-R
measurements can be used to determine “that one or more of leads 18, 20,
and 22 has a lead-related condition, or more specifically that one or more
electrodes or associated conductors within the leads may have an integrity
condition.” (Ousdigian f 92.) Consequently, we agree with the Examiner
that “both cited references are concerned with a method for measuring lead
impedance of implantable medical devices.” (Ans. 6.) And, we further
agree with the Examiner that it would have been obvious to alternatively use
the step of checking lead integrity as taught by Ousdigian using one or more
R-R intervals in the process of Ferek-Petric to assess the presence of a lead-
related condition more accurately.
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In response to Appellants’ argument that the Examiner has relied on
impermissible hindsight to reject claim 1 (Reply Br. 7), we note that “[a]ny
judgment on obviousness is in a sense necessarily a reconstruction based
upon hindsight reasoning, but so long as it takes into account only
knowledge which was within the level of ordinary skill at the time the
claimed invention was made and does not include knowledge gleaned only
from applicant’s disclosure, such a reconstruction is proper.” In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). For the reasons discussed
above, we find the Examiner has relied only on the teachings of the prior art
references, which are broader than the narrow assessment provided by
Appellants, and has not relied on impermissible hindsight.
Thus, for the foregoing reasons, Appellants do not persuade us that
the Examiner erred in maintaining the obviousness rejection of claim 1.
Claims 2, 3, and 9 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Appellants’ brief purports to argue the remaining claims separately.
(See Appeal Br. 13—15.) However, each of the purported separate
arguments relies solely on the argument Appellants set forth with respect to
claim 1. Consequently, we find that the claims have not been separately
argued and that the rejection of claims 11—16 and 22, 24, and 25 fall with
claim 1. Likewise, Appellants’ arguments that the Examiner’s rejections of
claims 4—6 and 17—19 and claims 10 and 23 are in error is not persuasive for
the reasons discussed above.
SUMMARY
We affirm the rejection of claims 1—3, 9, 11—16, 22, and 24—25 under
35 U.S.C. § 103(a) as unpatentable over Ferek-Petric and Ousdigian.
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Application 12/913,400
We affirm the rejection of claims 4—6 and 17—19 under 35 U.S.C. §
103(a) as being unpatentable over Ferek-Petric, Ousdigian, and Lu.
We affirm the rejection of claims 10 and 23 under 35 U.S.C. § 103(a)
as being unpatentable over Ferek-Petric, Ousdigian, and Gunderson.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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