Ex Parte Musley et al

Patent Trial and Appeal Board

Nov 30, 2017

13803346 (P.T.A.B. Nov. 30, 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.
13/803,346 03/14/2013 ShaileshKumar V. Musley C00005376.USU1/LG10126 7529
27581 7590 12/04/2017
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
EXAMINER
FLORY, CHRISTOPHER A
MINNEAPOLIS, MN 55432-9924 ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
12/04/2017 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):
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 SHAILESH KUMAR V. MUSLEY, BRUCE D. GUNDERSON,
WALTER H. OLSON, and JENNIFER P. MILLER1
Appeal 2016-008582
Application 13/803,346
Technology Center 3700
Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
DAVID COTTA, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1—5, 7, 9-16, and 18—20, directed to an implantable medical system
comprising an implantable medical device and at least one implantable
medical lead, and a method of using the system. The claims have been
rejected on the grounds of anticipation and obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as Medtronic, Inc., of
Minneapolis, Minnesota. Appeal Br. 3.
Appeal 2016-008582
Application 13/803,346
BACKGROUND
The Specification is directed to “identifying lead related conditions”
in implantable medical devices (IMDs) “that include one or more leads to
sense electrical signals within a patient and/or deliver electrical signals to a
patient.” Spec. 12. According to the Specification, leads implanted for
cardiac applications may become damaged over time due to stresses caused
by continuous flexing, rubbing between two lead bodies, patient movement,
material degradation, etc. Id. 1 60. The damage may include a breach in the
insulation of the lead body and extemalization of lead conductors, resulting
in inappropriate operation of the IMD. For example, the IMD may fail to
deliver therapy (such as high voltage defibrillation therapy) when needed,
may generate stimulation therapy that is not successfully conducted to the
heart, or deliver unneeded therapy. Id.
STATEMENT OF THE CASE
Claims 1—5, 7, 9-16, and 18—20 are on appeal. Independent claims 1
and 12 are representative of the subject matter on appeal and read as follows:
1. An implantable medical system comprising:
at least one implantable medical lead; and
an implantable medical device coupled to the at least one
implantable medical lead, wherein the at least one implantable
medical lead includes a plurality of electrodes, wherein the
implantable medical device includes:
a signal generator configured to generate a test
signal and deliver the test signal via a first electrode
vector that includes at least one of the plurality of
electrodes; and
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Application 13/803,346
a processor configured to obtain an electrical
signal generated on the lead by delivery of the test signal
and analyze the electrical signal to determine whether a
lead-related condition exists, wherein the electrical signal
is sensed on a second electrode vector that has at least
one electrode of the plurality of electrodes different than
the first electrode vector.
12. A method comprising:
delivering, with an implantable medical device, a test
signal via a pair of electrodes from a plurality of electrodes
implanted within the body of a patient, wherein the test signal is
delivered via a first electrode vector that includes at least one of
the plurality of electrodes;
sensing, with the implantable medical device, an
electrical signal induced on at least one implantable medical
lead by the test signal, wherein the electrical signal is sensed on
a second electrode vector that has at least one electrode of the
plurality of electrodes different than the first electrode vector;
and
analyzing, with the implantable medical device, the
electrical signal sensed on the second electrode vector to
determine whether a lead-related condition exists.
The claims stand rejected as follows:
Claims 1—5, 7, 9-16, and 18 under 35 U.S.C. § 102(b) as anticipated
by Patel (U.S. Patent Application Publication 2011/0098765 Al, published
April 28, 2011; and
Claims 19 and 20 under 35 U.S.C. § 103(a) as unpatentable over
Patel.
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Overview of Patel
Patel discloses “techniques for detecting lead related conditions, such
as lead fractures or other lead integrity issues.” Patel 19. Patel teaches, in
relevant part, that:
[Processor 80 performs lead integrity testing automatically
during the delivery of any therapeutic electrical signal to patient
14. If an integrity issue is detected along one electrical path
through which the signal is delivered, processor 80 may test
alternate electrode configurations to identity which conductor or
connector of the path is experiencing an integrity issue. For
example, if an integrity issue is detected when two of electrodes
62,64,66 are activated to deliver a defibrillation or cardioversion
shock to patient 14, processor 80 may test any of electrodes 62,
64, 66 independently, e.g., by separately testing each of 62, 64,
66 in combination with housing electrode 58, to determine which
one of electrodes 62, 64, 66 is causing the issue.
Patel 1 66.
ANTICIPATION
Claims 1—5, 7, 9-16, and 18 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Patel.
In the Final Office Action (“Final Act.”), the Examiner took the
position that Patel discloses all the limitations of the implantable medical
system of claim 1 and the method of claim 12. Specifically, the Examiner
found that Patel discloses, in relevant part, signal generator 84, “configured
to generate a test signal and deliver the test signal via a first electrode vector
that includes at least one of the plurality of electrodes” on at least one
implantable medical lead. Final Act. 2 (citing Patel 66, 77, 92, Fig. 7). In
addition, the Examiner found that Patel discloses processor 80, “configured
to obtain an electrical signal generated on the lead by delivery of the test
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signal and analyze the electrical signal generated on the lead by delivery of
the test signal and analyze the electrical signal to determine whether the
lead-related condition exists” “wherein the electrical signal is sensed on a
second electrode vector that has at least one electrode of the plurality of
electrodes different than the first electrode vector.” Id. at 2—3 (citing Patel
11 10-13, 26, 34—36, 46, 47, 50, 53, 57-61, 66, 77, 92, Fig. 7).
In their Appeal Brief, Appellants acknowledge that paragraphs 35 and
36 of Patel disclose that “both sensing and stimulation may be done via a
variety of electrode vectors.” Appeal Br. 9. Nevertheless, Appellants
contend that paragraph 66 of Patel teaches “that if an issue is detected during
a first test according to the techniques described in paragraphs [59—61] when
a therapeutic first pulse is delivered between two of electrodes 62, 64, 66,
processor 80 may perform subsequent tests of each of the two electrodes
separately to determine which of the two electrodes is the source of the
integrity issue.” Appeal Br. 12—13. Appellants contend that “[e]ach of the
subsequent tests would include delivery of a subsequent pulse, and a
subsequent measurement of voltage or current during the delivery of the
subsequent pulse, e.g., using internal sample and hold circuitry, in
accordance with techniques described in paragraphs [59—61].” Appeal Br.
13. Appellants contend that “[n]either the first test, with delivery of a
therapeutic pulse and a first measurement of voltage or current, nor the
subsequent tests, with delivery of subsequent pulses and corresponding
subsequent measurements of voltage or current, involves measuring a signal
with a second electrode vector that has at least one electrode different than
the first electrode vector used to deliver the pulses.” Id.
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Appellants contend that it is irrelevant whether Patel’s device “is able
to deliver stimulation across one combination of electrodes, and then, at
some other time, sense some other, unrelated signal across another
combination of electrodes.” Appeal Br. 8. Appellants contend that “the
mere disclosure that both sensing and stimulation may be done via a variety
of electrode vectors is not a disclosure of the use of different electrode
vectors for the delivery of a pulse and the sensing of an electrical signal
generated on a lead by that same pulse.” Id. at 9. Consequently, Appellants
contend that Patel fails to disclose a signal generator or a processor
configured in the manner required by claim 1. Id. at 13. Similarly, with
respect to claim 12, Appellants contend that Patel fails to disclose a step
“wherein the test signal is delivered via a first electrode vector that includes
at least one of the plurality of electrodes,” and “sensing, with the
implantable medical device, an electrical signal induced on at least one
implantable medical lead by the test signal, wherein the electrical signal is
sensed on a second electrode vector that has at least one electrode of the
plurality of electrodes different than the first electrode vector” (id. at 15—16),
or “analyzing, with the implantable medical device, the electrical signal
sensed on the second electrode vector to determine whether a lead-related
condition exists” (id. at 16).
In responding to Appellants’ arguments presented in the Appeal Brief,
the Examiner contends that Patel’s system “is constructed such that the IMD
is able to deliver pacing or defibrillation pulses (i.e. test signals) across any
combination of electrodes 40, 42, 44, 46, 48, 50, 62, 64 and 66.” Ans. 3.
The Examiner, citing paragraph 66 of Patel, further contends that Patel
“states that the alternate electrode configurations being tested by the
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processor 80 identify which element of the path is experiencing an integrity
issue” {id. at 6) “by testing different electrode combination[s] tha[n] that
over which the therapeutic electrical signal was delivered” {id.). According
to the Examiner, this “clearly constitutes a second electrical path or second
electrode vector that has at least one electrode of the plurality of electrodes
different than the first electrode vector.” Id. at 7.
Thus, the Examiner finds that Patel “has more than sufficient
structural and operational capabilities for delivering the shock and sensing
[pulses] across two separate vectors” {id. at 3 (emphasis added)), as well as
“providing a test signal across a first vector and obtaining/sensing the
resultant signal across a second different vector” {id. at 5). In other words,
the Examiner contends that Patel is capable of accomplishing the specific
purposes recited in the “configured to” clauses of claim 1, and the
“delivering,” “sensing,” and “analyzing” steps of claim 12.
We are not persuaded that the Examiner has established that Patel
anticipates the device of claim 1 or the method of claim 12. The Federal
Circuit has held that “configured to” is analogous to “made to,” “adapted
to,” and “designed to.” In re Man Mach. Interface Techs. LLC, 822 F.3d
1282, 1286 (Fed. Cir. 2016). We determine that “configured to” has a
narrower meaning than “capable of.” Specifically, we find that a person of
ordinary skill in the art would understand that the claimed implantable
medical device is specially designed to accomplish the specific purposes
recited in the last two clauses of claim 1. See Aspex Eyewear, Inc. v.
Marchon Eyewear, Inc., 672 F.3d 1335, 1349 (Fed. Cir. 2012) (using the
terms “designed to” and “configured to” as “to accomplish a specific
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purpose”); see also In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014)
(accord).
Regardless of whether Patel is capable of accomplishing the steps of
claim 1, we agree with Appellants that the Examiner has not established that
Patel discloses an IMD with a processor “configured to obtain an electrical
signal generated on the lead by delivery of the test signal. . . wherein the
electrical signal is sensed on a second electrode vector that has at least one
electrode of the plurality of electrodes different than the first electrode
vector,” as required by independent claim 1. Similarly, we agree with
Appellants that the Examiner has not established that Patel discloses the
steps of “sensing, with the implantable medical device, an electrical signal
induced on at least one implantable medical lead by the test signal, wherein
the electrical signal is sensed on a second electrode vector that has at least
one electrode of the plurality of electrodes different than the first electrode
vector,” and “analyzing, with the implantable medical device, the electrical
signal sensed on the second electrode vector to determine whether a lead-
related condition exists,” as required by independent claim 12.
Accordingly, the rejection of claims 1—5, 7, 9—16, and 18 as
anticipated by Patel is reversed.
OBVIOUSNESS
Claim 19, which depends from claim 1, and claim 20, which depends
indirectly from claim 12, stand rejected as unpatentable over Patel.
As discussed above, the evidence of record does not support the
Examiner’s finding that Patel anticipates claims 1 and 12. The Examiner’s
obviousness rationale relies on that finding. Accordingly, the rejection of
claims 19 and 20 as obvious over Patel is reversed as well.
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SUMMARY
The rejection of claims 1—5, 7, 9-16, and 18 under 35 U.S.C. § 102(b)
as anticipated by Patel is reversed; and
The rejection of claims 19 and 20 under 35 U.S.C. § 103(a) as
unpatentable over Patel is reversed.
REVERSED
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