Ex Parte Goetz et al

Patent Trial and Appeal Board

Oct 25, 2017

11414786 (P.T.A.B. Oct. 25, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/414,786 04/28/2006 Steven M. Goetz 1023-478US01 1167
71996 7590 10/27/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
10/27/2017 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_neuro_docketing @ cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN M. GOETZ, NATHAN A. TORGERSON, and
MICHAEL T. LEE1
Appeal 2016-007770
Application 11/414,786
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
and system for determining the functionality of a lead of an implanted
medical device, which have been rejected as being directed to patent-
ineligible subject matter and as anticipated. We have jurisdiction under 35
U.S.C. § 6(b).
We reverse.
1 Appellants identify the real parties in interest as Medtronic, Inc. and
Medtronic pic. (Appeal Br. 3.)
Appeal 2016-007770
Application 11/414,786
STATEMENT OF THE CASE
“Implantable medical devices may be used to deliver therapeutic
electrical stimulation to patients to treat a variety of symptoms or
conditions.” (Spec. 13.) “The impedance of the various electrical paths
provided by a lead may vary over the life of an implantable medical device,”
due to material degradation, insulation failure, or fracture. {Id. 14.)
“Changes in lead impedance impair the ability of an implantable medical
device to effectively sense electrical activity and/or deliver stimulation.
Consequently, it may be desired to identity such changes in order to take
corrective action.” {Id. 15.)
“Traditionally, clinicians have used a programming device during an
office visit to manually direct an implantable medical device to perform a
lead integrity or functionality test.” {Id.) However, “a conductor short or
fracture may be intermittent, and more likely to manifest during periods
when the patient is changing posture, within a particular posture, or
otherwise active. In such cases, a clinician may not be able to detect a
conductor problem with a manual lead functionality test performed during
an office visit.” {Id. 1 8.)
The Specification discloses “techniques for testing the functionality of
implanted electrical leads. . . . The medical device may automatically
perform a lead functionality test, e.g., without receiving a command to
perform the test from a user or programming device, outside of a clinic
setting.” {Id. 19.)
2
Appeal 2016-007770
Application 11/414,786
Claims 1—3, 6—12, 15—21, and 24—31 are on appeal. Claim 1 is
illustrative and reads as follows:
Claim 1: A method comprising:
determining whether a patient is within at least one of a
target activity state or a target posture based on a physiological
sensor signal, wherein determining whether the patient is within
the target activity state comprises determining at least one of
whether body movement of the patient exceeds a threshold,
whether the patient is changing postures, or whether the patient
is exercising;
automatically performing a lead functionality test for at
least one electrical lead implanted within the patient in response
to the physiological sensor signal indicating that the patient is
within the target activity state or target posture, wherein
automatically performing the lead functionality test comprises
measuring an electrical parameter for at least two different
combinations of electrodes; and
generating information that indicates at least one of
whether the functionality of the at least one electrical lead has
degraded or whether the at least one electrical lead has failed
based on the measurements of the electrical parameter for the at
least two different combination of electrodes, wherein at least
one of the determining, automatically performing, or generating
is performed via a processor.
Claims 10, 21, and 26 are also independent and each is directed to a
system for carrying out the method of claim 1. Claims 10 and 26 require a
processor that, among other things, “measures an electrical parameter for at
least two different combinations of electrodes to perform [a] lead
functionality test.” (Appeal Br. 28, 31 (Claims App’x).) Claim 21 requires
a “means for performing the lead functionality test [that] comprises means
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Appeal 2016-007770
Application 11/414,786
for measuring an electrical parameter for at least two different combinations
of electrodes.” {Id. at 30.)
The claims stand rejected as follows:
Claims 1—3, 6—12, 15—21, and 24—31 under 35 U.S.C. § 101 as being
directed to patent-ineligible subject matter (Final Action2 2), and
Claims 1-3, 6-12, 15-21, and 24—31 under 35 U.S.C. § 102(b) as
anticipated by Lu3 (Final Action 3).
I
The Examiner has rejected claims 1—3, 6—12, 15—21, and 24—31 on the
basis that they are directed to an abstract idea:
The method/system in the independent claims include elements
which receive and process information; however, there is no
tangible result or end goal and the claim does not include
additional elements sufficient to amount to significantly more
than the judicial exception. There is only the receipt of
information and the processing of that information involving the
broad determining lead degradation. Accordingly, the system
simply appears to be an abstract idea, similar to a mathematical
algorithm, which does not actively accomplish anything or have
an end result or purpose.
(Final Action 2.)
We agree with Appellants, however, that “claim 1 is directed to a
specific solution that is necessarily rooted in receiving and processing
information to overcome a problem in the field of delivering therapy to a
patient using one or more leads of a medical device implanted in a patient.”
(Appeal Br. 10.) Specifically, the Specification states that
2 Office Action mailed May 21, 2015.
3 Lu et al., US 6,188,927 Bl, issued Feb. 13, 2001 (“Lu”).
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Application 11/414,786
some lead functionality problems, such as, e.g., conductor short
or fracture, may be intermittent and more likely to manifest
during periods when the patient is changing posture, within a
particular posture, or otherwise active. . . . Independent claim 1
is directed to providing a solution through determining whether
a patient is within at least one of a target activity state or a target
posture based on a physiological sensor signal, [and]
automatically performing a lead functionality test.
{Id. at 10—11. See also Spec. 1 8.)
The Examiner reasons that
[t]he method includes a determination step which does not
actively require any acquisition of data but rather a determining
step “based on a physiological sensor” which does not require
sensing of a physiological parameter but could be performed by
an individual simply watching a screen or light; therefore, it is
considered insignificant pre-solution activity. As to the
performing of a lead functionality test, this element/step is still
merely a computational algorithm stored on a tangible medium.
(Ans. 2.)
The Specification discloses, however, that lead functionality testing is
a known technique:
For example, to perform lead impedance testing, the IMD may
deliver a non-therapeutic pulse via a combination of two
electrodes, measure final voltage or current amplitude for the
pulse, and determine an impedance for the combination based on
the measured final amplitude. Testing may be repeated for a
plurality of electrode combinations.
(Spec. 165.)
Thus, the “determining” step of claim 1 requires actively delivering an
electric current to electrodes and measuring the voltage or amplitude in order
to determine the impedance for a combination of electrodes. We do not
agree with the Examiner’s reasoning that this step does not actively require
acquisition of data.
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Application 11/414,786
In summary, the Examiner has not persuasively shown that the
claimed method and system amount to no more than an abstract idea. We
therefore reverse the rejection of claims 1—3, 6—12, 15—21, and 24—31 under
35 U.S.C. § 101.
II
The Examiner has rejected claims 1—3, 6—12, 15—21, and 24—31 as
anticipated by Lu. The Examiner finds that Lu discloses a method and
system meeting all of the limitations of the independent claims, including
“automatically performing lead functionality test compris[ing] measuring an
electrical parameter for at least two different combinations of electrodes
(e.g. Col 3,11 62-67 - where the protection/switching network necessarily
switches between the different combinations of electrodes when calculating
impedance values).” (Final Action 3.)
Appellants argue that “Lu fails to describe wherein automatically
performing the lead functionality test comprises measuring an electrical
parameter for at least two different combinations of electrodes.” (Appeal Br.
17.) Appellants also argue that the Examiner has not established that this
limitation is inherent in Lu’s method and system. {Id. at 17—19.)
We agree with Appellants that the Examiner has not established that
Lu expressly or inherently describes “automatically performing the lead
functionality test comprises measuring an electrical parameter for at least
two different combinations of electrodes,” as required by claim 1. Lu
describes “[a]n implantable cardiac stimulation system . . . which
automatically optimizes its ability to rate-responsively pace by enabling
calibration when the patient is at rest and has a functioning lead.” (Lu,
abstract.)
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Application 11/414,786
As relevant to the disputed limitation, Lu states that its system
includes “leads 12,14 [that] are electrically and physically connected to the
pacemaker 10 through a connector 16.” {Id. at 3:58—59.) “The connector 16
is electrically connected to a protection/switching network 17, which
network 17 switchably couples the electrodes to the appropriate sensing and
pacing configuration and to the appropriate measurement circuitry (such as
. . . physicologic sensor 70).” {Id. at 3:62 to 4:1.) Lu states that “[t]he
network 17 further electrically protects circuits within the pacemaker 10
from excessive shocks or voltages that could appear on the electrodes 18, 20
in the event such electrodes 18, 20 were to come in contact with a high
voltage signal, e.g., from a defibrillator shock.” (Id. at 4:1—6.)
The Examiner reasons that “the protection/switching network
necessarily switches between the different combinations of electrodes when
calculating impedance values.” (Final Action 3.) We agree with Appellants,
however, that this finding is not supported by the reference. Lu states that
“the second sensor 70 generates an excitation signal between ring electrode
21 and the case electrode and then senses the voltage between the tip
electrode 20 and the case electrode. The resultant voltage is then transmitted
to control system 32 for determination of the impedance value.” {Id. at
6:16—20.) Lu thus describes measuring impedance (in order to determine
whether it is within an acceptable tolerance range; see id. at 6:35 40) using
only a single combination of electrodes.
Lu states: “For a more detailed description of this method of
monitoring minute ventilation, see, for example, U.S. Pat. No. 5,562,712,
issued Oct. 8, 1996 to Steinhaus et al.” {Id. at 6:22—25.) The Examiner
reasons that Steinhaus describes using more than one combination of
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Application 11/414,786
electrodes. (Ans. 5—6.) However, the passages from Steinhaus that are
reproduced in the Answer describe using either the combination of
“pacemaker case 5 and tip electrode 11” or the combination of “electrode 13
and case 30.” The quoted passages thus do not describe testing lead
functionality using at least two different combinations of electrodes, as
required by the claims on appeal.
Because the Examiner has not shown that Lu discloses a method and
system meeting all of the limitations of the claims, we reverse the rejection
of claims 1—3, 6—12, 15—21, and 24—31 as anticipated by Lu.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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