Ex Parte Donofrio et al

Patent Trial and Appeal Board

Mar 21, 2017

12362792 (P.T.A.B. Mar. 21, 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.
12/362,792 01/30/2009 William T. Donofrio P0032696.01/1111-071US01 1779
80584 7590
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
EXAMINER
MAHMOOD, NADIA AHMAD
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
03/23/2017 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 WILLIAM T. DONOFRIO, JOHN E. BURNES,
PAUL G. KRAUSE, GERALD P. ARNE,
DAVID J. PEICHEL, XIAOHONG ZHOU,
JAMES D. REINKE, and TIMOTHY DAVIS
Appeal 2014-000166
Application 12/362,792
Technology Center 3700
Before JOHN C. KERINS, EDWARD A. BROWN, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
William T. D’Onofrio et al. (“Appellants”) appeal under 35 U.S.C.
§ 134(a) from the Examiner’s decision rejecting claims 1—62.1 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b).
1 Appellants submit the real party in interest is Medtronic, Inc. Appeal Br.
3.
Appeal 2014-000166
Application 12/362,792
THE CLAIMED SUBJECT MATTER
Appellants’ invention relates to implantable medical devices
“including at least two therapy delivery modules.” Spec. 12. Claim 1,
reproduced below, is illustrative of the claimed subject matter.
1. A method comprising:
determining a noise characteristic of a first electrical
signal sensed by a first implantable medical device (IMD) while
a second IMD is delivering a second electrical signal to a tissue
site within a patient, wherein the first and second IMDs are
implanted within the patient;
comparing the characteristic of the first electrical signal to
a threshold value; and
in response to comparing the noise characteristic of the
first electrical signal to a threshold value, modifying at least one
of a stimulation parameter with which the second IMD generates
electrical stimulation that is delivered to the tissue site or a
sensing parameter with which the first IMD senses the first
electrical signal based on the comparison.
REJECTIONS
1) Claims 30-59 are rejected under 35U.S.C. § 101 as drawn to non-
statutory subject matter for reciting part of a human.
2) Claims 60 and 61 are rejected under 35U.S.C. § 101 as drawn to
non-statutory subject matter namely a transitory propagating
signal.
3) Claims 1-3, 5, 6, 21, 30-34, 36-38, 44, 52-54, 57, 60 and 62 are
rejected under 35 U.S.C. § 103(a) as unpatentable over Heil (WO
2005/063332 Al, published July 14, 2005) and Molin (US
5,522,860, issued June 4, 1996).
2
Appeal 2014-000166
Application 12/362,792
4) Claims 4, 7-20, 25-29, 39-42, 43, 45-51, 58, 59, and 61 are
rejected under 35 U.S.C. § 103(a) as unpatentable over Heil,
Molin, and Libbus (US 2006/0116737 Al, published June 1,
2006).
5) Claims 22, 23, 55, and 56 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Heil, Molin, and Funke (4,987,897, issued Jan.
29, 1991).
6) Claims 24 and 35 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Heil, Molin, and Tivig (US 5,189,609, issued
Feb. 23, 1993).
DISCUSSION
Rejection 1
The Examiner rejects claims 30—59 as directed to non-statutory
subject matter because claims 30 and 33 recite “part of a human, i.e. “. . . a
tissue site . . .” Final Act. 2.2 Appellants contend that claim 30 does not
recite a human but, rather, the recitation of “a tissue site” describes “the
structural features of the claimed system.” Appeal Br. 34. Appellants argue
that they are “not claiming the tissue site, but, rather, reciting that the recited
first IMD senses a first electrical signal and the second IMD delivers a
second electrical signal” and, therefore, claims 30 and 33 are directed to
patentable subject matter. Id.
We are persuaded by Appellants’ argument. Claim 33 is directed a
system comprising a first implantable medical device and a second
implantable medical device. Both devices are implanted within a human.
2 The same recitation appears in independent claim 57.
3
Appeal 2014-000166
Application 12/362,792
See Spec. 61, Fig. 1. The entire claim limitation at issue in claim 30 is “a
second IMD that delivers a second electrical signal to a tissue site within the
patient.” Appeal Br. 44 (Claims App.)(emphasis added). This limitation
recites the function of the second IMD when implanted within the patient
and is not an affirmative recitation of a human tissue site.
We, thus, do not sustain the rejection under 35 U.S.C. § 101 of claim
30 and claims 31—56 which depend directly or indirectly from claim 30. We
also do not sustain the rejection of independent claim 57, and claims 58 and
59 which depend from claim 57, for the same reason.
Rejection 2
Claims 60 and 61 are directed to “[a] computer-readable medium
comprising instructions that cause . . .” Appeal Br. 51 (Claims App.). The
Examiner finds that these claims are “broad enough to cover a transitory
propagating signal that carries a programmed instruction set” and thus, do
not fall within one of the four categories of invention set forth in 35 U.S.C.
§101. Final Act. 3. Appellants contend that claims 60 and 61 comprise
statutory subject matter when construed in light of the Specification. Appeal
Br. 35 (citing Spec. 119, 417). For the following reasons, we sustain the
rejection of claims 60 and 61.
The “broadest reasonable interpretation of ‘computer readable
medium’ typically encompasses non-statutory subject matter.” Ex Parte
Mewherter et al., 2013 WL 4477509, *3 (PTAB-Precedential 2013).3 We
note that paragraphs 119 and 417 of the Specification cited by Appellants do
not indicate an express intent to limit the claim term “computer readable
medium” to only non-transitory signals, nor do claims 60 and 61 expressly
3 Decision available at http://e-foia.uspto.gov/Foia/PTABReadingRoom.jsp.
4
Appeal 2014-000166
Application 12/362,792
or implicitly limit the claims to non-transitory embodiments. See id. at *6,
n.5. Therefore, we sustain the rejection of claims 60 and 61 under 35 U.S.C.
§101.
Rejection 3
The Examiner finds that Heil discloses all the limitations of claim 1
except for “determining a noise characteristic of a sensed signal and
comparing it to a threshold value.” Final Act. 4—6 (citing Heil, Abst., Fig.
12, p. 18). The Examiner finds that Molin discloses “an implantable cardiac
stimulation device and sensing of a noise signal that is then compared to a
threshold value.” Id. at 6 (citing Molin, col. 1 1. 59 — col. 2,1. 9). The
Examiner concludes it would have been obvious to one of ordinary skill in
the art “to modify the system of Heil to include a noise determination as
taught by Molin, since such a modification would provide the predictable
results of taking into account any noise interference that would affect the
sensed signal.” Id.
Appellants contend that Molin does not disclose determining a noise
characteristic of a first electrical signal sensed by a first IMD while a second
IMD is delivering a second electrical signal because it measures noise
corresponding “to a voltage measured in the absence of the delivery of any
electrical signal by the IMD.” Appeal Br. 11. Appellants further contend
that neither Heil nor Molin discloses modifying either at least one
stimulation parameter or a sensing parameter in response to comparing a
noise characteristic to a threshold value as recited in claim 1. Id. Appellants
also contend that Molin fails to provide any reason for modifying a
stimulation parameter or sensing parameter based on the noise characteristic.
Id.
5
Appeal 2014-000166
Application 12/362,792
The Examiner responds that Heil discloses determination of a first
electrical signal sensed by a first IMD while a second IMD is delivering a
signal. Ans. 13 (citing Heil at 22). The Examiner also finds that Heil
discloses embodiments wherein “communication between the two devices
allows for delivery of appropriate therapy based on data received from the
other device . ., which could allow for selection of a more appropriate
sensing or stimulating parameter.” Id. at 14 (citing Heil at 18). For the
following reasons, we do not sustain the rejection of claim 1.
Appellants’ Specification shows two medical devices implanted in a
patient. See Fig. 1. The Specification describes that “ICD 16 may sense
electrical noise and interpret the electrical noise as cardiac electrical signals
. . . The misinterpretation of electrical noise may cause ICD 16 to oversense
cardiac signals, and in some cases, erroneously detect an arrhythmia.” Spec.
192. ICD 16 can “sense the electrical stimulation signals . . . generated by
and delivered to target tissue site by INS 26.” Id. f 94. The signals
generated by INS 26 and sensed by ICD 16 are referred to as “electrical
noise” or “interference.” Id.
Heil discloses a system with an implantable neural stimulator (NS)
device 1237 and an implantable cardiac rhythm management (CRM) device
1238. Heil at 18, Fig. 12. Heil discloses that (NS) device 1237 and (CRM)
device 1238 can communicate data to each other “to deliver more
appropriate therapy.” Id. The data communicated between devices 1237
and 1238 are based on electrophysiological parameters. Id. at 19. Heil
discloses that the (NS) device 1237 communicates an alert to the (CRM)
device 1238 during generation of a stimulation signal so that “the functions
6
Appeal 2014-000166
Application 12/362,792
of the CRM device are not adversely affected by detecting far-field noise
generated by baroreflex stimulation, even when the baroreflex stimulations
are generated near the heart and the CRM sensors that detect cardiac
electrical activation.” Id. at 21; see also id. at 22, Fig. 16B.
Molin discloses a “process of control of a medical device,” such as a
cardiac pacemaker or cardiac defibrillator. Molin, Abst., col. 1,11. 12—13.
Molin also discloses a device that measures a physiological parameter
represented by a voltage “sensed between a sensing electrode and the case
(reference electrode) of the medical device.” Id. col. 1,11. 64—67. Molin
discloses that the voltage is “first measured during an injection of current. . .
and then measured in the absence of current injection to determine the
noise.” Id. col. 2,11. 1^4. The voltage corresponding to the noise is
compared to a threshold value and, if the noise exceeds the threshold value,
a control device possibly suspends “the rate responsive pacing function.” Id.
col. 2,11. 4-9.
Heil discloses certain specific data that are communicated between
(NS) device 1237 and (CRM) device 1238 to deliver more appropriate
therapy. Heil at 19. The Examiner has not, however, directed us to any
disclosure in Heil that the data communicated between (NS) device 1237
and (CRM) device 1238 includes a noise characteristic of a first electrical
signal, or that Heil determines a noise characteristic of a first electrical
signal for comparison to a threshold. The Examiner also has not directed us
to any disclosure in Molin of determining a noise characteristic of a first
electrical signal sensed by a first IMD while a second IMD delivers a second
electrical signal. As discussed above, Heil prevents noise from (NS) device
1237 from interfering with (CRM) 1238 device by means of an alert sent
7
Appeal 2014-000166
Application 12/362,792
from (NS) device 1237 to (CRM) device 1238. While we appreciate the
Examiner’s reference to Molin’s disclosure of determining a noise
characteristic, the Examiner does not offer persuasive evidence or technical
reasoning to show why one of ordinary skill in the art would have modified
Heil to incorporate Molin’s measurement of a noise characteristic and
compare that noise characteristic to a threshold value given that Heil
specifically discloses a method for preventing noise or interference from the
(NS) device from affecting the performance of the (CRM) device. We, thus,
do not sustain the rejection of claim 1 under 35 U.S.C. § 103(a) because the
Examiner has not provided a reason supported by a rational underpinning for
the combination of Heil and Molin. Claims 2, 3, 5, 6, and 21 all depend
from claim 1. We do not sustain the rejection of these dependent claims for
the same reasons.
The Examiner rejects independent claims 30, 57, 60, and 62 based on
Heil and Molin based on the same findings and reasoning as for claim 1.
Final Act. 4—6. These claims all contain limitations similar to claim 1 of
determining a noise characteristic of a first electrical signal and comparing
the noise characteristic to a threshold value. Appeal Br. 44, 50, 51, 52
(Claims App.). Appellants submit essentially the same contentions of error
as for claim 1. Id. at 12—13, 17—18. We, therefore do not sustain the
rejection of claims 30, 57, 60, and 62 under 35 U.S.C. § 103(a) for the same
reasons discussed above in connection with claim 1. We also do not sustain
the rejection of claims 31—34, 36—38, 44, and 52—54, which depend directly
or indirectly from claim 30, for the same reasons as for claim 30.
8
Appeal 2014-000166
Application 12/362,792
Rejections 4 6
Claims 4, 7—20, and 22—29 depend directly or indirectly from claim 1.
Appeal Br. 37-43 (Claims App.). Claims 35, 39-43, 45—51, 55, and 56
depend directly or indirectly from claim 30. Id. at 44-49. Claims 58 and 59
depend from claim 57. Id. at 50-51. Claim 61 depends from claim 60. Id.
at 51. The Examiner rejects all of these dependent claims based on various
combinations of Heil and Molin with additional disclosure from Libbus,
Funke, and Tivig. Final Act. 7—13. The Examiner does not rely on the
additional disclosure from Fibbus, Funke, or Tivig to cure the deficiencies in
the combination of Heil and Molen stated above for claims 1, 30, 57, and 60.
Therefore, we do not sustain the rejection of claims 4, 7—20, 22—29, 35, 39—
43, 45—51, 55, 56, and 58—60 for the same reasons stated above for claims 1,
30, 57, and 60.
New Ground of Rejection:
35 U.S.C § 112, firstparagraph-Written Description
To satisfy the written description requirement of 35 U.S.C. § 112, a
specification must describe the claimed invention in sufficient detail that one
skilled in the art can reasonably conclude that the inventor had possession of
the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562—63
(Fed. Cir. 1991). Specifically, the specification must describe the claimed
invention in a manner understandable to a person of ordinary skill in the art
and show that the inventor actually invented the claimed invention. Id.;
AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
2010)(en banc). In addition, the specification must “demonstrate that the
patentee possessed the full scope of the invention recited in the claim.”
9
Appeal 2014-000166
Application 12/362,792
LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F. 3d. 1336, 1345
(Fed. Cir. 2005).
The written description requirement of 35 U.S.C. 112, first paragraph,
applies to all claims, including original claims that are part of the disclosure
as filed. Ariad, 598 F.3d at 1349. As stated by the Federal Circuit,
“[although many original claims will satisfy the written description
requirement, certain claims may not.” Id.', see also LizardTech, Inc., 424
F.3d at 1343—46; Regents of the University of California v. Eli Lilly & Co.,
119 F.3d 1559, 1568 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164, 1170
(Fed. Cir. 1993) (rejecting the argument that “only similar language in the
specification or original claims is necessary to satisfy the written description
requirement”). In addition, original claims may fail to satisfy the written
description requirement when the invention is claimed and described in
functional language, but the specification does not sufficiently identify how
the invention achieves the claimed function. Ariad, 598 F.3d at 1349
In this case, we find that claims 1, 2, 3, 5—9, 11—15, 21—24, 26—29,
30-40, 43, 44, 49, 50, and 54—62 encompass more than is described in
Appellants’ original disclosure. Independent claim 1 recites the steps, inter
alia, of determining a noise characteristic of a first electrical signal,
comparing the noise characteristic to a threshold value, and in response to
comparing the noise characteristic to the threshold value, modifying at least
one of a stimulation parameter or a sensing parameter. Appeal Br. 37
(Claims App.). Claim 1 does not condition the “modifying” step upon any
particular result of the comparison between the noise characteristic and a
threshold value. However, claim 4, which depends from claim 1, recites
modifying the stimulation parameter or the sensing parameter “if the
10
Appeal 2014-000166
Application 12/362,792
characteristic of the first electrical signal is greater than or equal to the
threshold value.” Id.
According to the doctrine of claim differentiation ‘“the presence of a
dependent claim that adds a particular limitation raises a presumption that
the limitation in question is not found in the independent claim.’” Bancorp
Servs. L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1275
(Fed. Cir. 2012). Applying claim differentiation, specifying that modifying
is performed if the characteristic is greater to or equal to the threshold value
in claim 4 raises a presumption that modifying if either of these conditions is
met is not required in claim 1. Otherwise, construing claim 1 to require the
limitations of claim 4 would result in claim 4 not further limiting claim 1
and being indefinite. That is, claim 4 would fail to meet the requirements of
either 35 U.S.C. § 112, fourth paragraph, or second paragraph.
Consequently, the scope of claim 1, which is necessarily broader than claim
4, encompasses modifying the stimulation parameter or sensing parameter
not only if the noise characteristic is greater than or equal to the threshold
value, but also if the characteristic is less than the threshold value.
Independent claims 30, 57, 60, and 62 similarly recite determining a noise
characteristic, comparing the noise characteristic to a threshold value, and
then modifying either a stimulation parameter or a sensing parameter. Id. at
44, 50, 51, 52.
Appellants’ Specification describes that the modification of a
stimulation parameter or sensing parameter occurs when the noise
characteristic is greater than or equal to the threshold value. Spec. 306,
314—316, 321—330. The Specification specifically states:
11
Appeal 2014-000166
Application 12/362,792
If the first and second values do not differ from each other by at least
the threshold value (or threshold level), processor 130 of programmer
24 may determine that the extent of the crosstalk between INS 26 and
ICD 16 is within an acceptable range. That is, if the difference between
the first and second is less than or equal to the threshold value,
processor 130 of programmer 24 may determine that the possibility that
ICD 16 may sense the neurostimulation signals delivered by INS 26
and mischaracterize the neurostimulation signals as cardiac signals is
relatively low. Processor 130 may then determine that modifications
to the operating parameters of INS 26 or the sensing parameters of ICD
16 are not necessary.
Id. 1323 (emphasis added).
The Specification generally describes the type of modification that
may occur when the noise characteristic exceeds a threshold value. Id.
326—328, 330. The Specification does not describe the circumstances
under which modification would occur if the noise characteristic is less than
a threshold value, or the type of modification in those circumstances. See,
e.g., id. 11323, 329.
Based on the foregoing, we determine that one of ordinary skill in the
art, after reading the Specification, would not reasonably conclude that
Appellants possessed the full scope of the Invention recited in independent
claims 1, 30, 57, 60, and 62 due to the lack of any written description for
modifying the stimulation parameter or the sensing parameter if the noise
characteristic is less than a threshold value. Therefore, we enter a new
ground of rejection against claims 1, 30, 57, 60, and 62 for failure to comply
with the written description requirement set forth in the first paragraph of 35
U.S.C. § 112.
Claims 2, 3, 5—9, 11—15, 21—24, and 26—29 all depend directly or
indirectly from claim 1. Appeal Br. 37-43 (Claims App.). None of these
12
Appeal 2014-000166
Application 12/362,792
dependent claims limit the method of claim 1 to modifying the stimulation
parameter or sensing parameter to only if the noise characteristic is greater
than or equal to a threshold value. Therefore, we enter a new ground of
rejection against claims 2, 3, 5—9, 11—15, 21—24, and 26—29 for failure to
comply with the written description requirement of 35 U.S.C. § 112, first
paragraph.
Claims 31—40, 43, 44, 49, 50, and 54—56 all depend directly or
indirectly from claim 30. Appeal Br. 44-46 (Claims App.). None of these
dependent claims limit the system of claim 30 to modifying the stimulation
parameter or the sensing parameter only if the noise characteristic is greater
than or equal to a threshold value. Therefore, we enter a new ground of
rejection against claims 31—40, 43, 44, 49, 50, and 54—56 for failure to
comply with the written description requirement of 35 U.S.C. § 112, first
paragraph.
Claims 58 and 59 depend from claim 57. Appeal Br. 50—51 (Claims
App.). Neither of these claims limit the system of claim 57 to modifying the
stimulation parameter or the sensing parameter only if the noise
characteristic is greater than or equal to a threshold value. Therefore, we
enter a new ground of rejection against claims 58 and 59 for failure to
comply with the written description required of 35 U.S.C. § 112, first
paragraph.
Claim 61 depends from claim 60. Appeal Br. 51 (Claims App.).
Claim 61 does not limit the instructions of claim 60 to modify the
stimulation parameter or the sensing parameter only if the noise
characteristic is greater than or equal to a threshold value. Therefore, we
13
Appeal 2014-000166
Application 12/362,792
enter a new ground of rejection against claim 61 for failure to comply with
the written description required of 35 U.S.C. § 112, first paragraph.
DECISION
The Examiner’s decision rejecting claims 30-59 under 35 U.S.C.
§101 is reversed.
The Examiner’s decision rejecting claims 60 and 61 under 35 U.S.C.
§ 101 is affirmed.
The Examiner’s decision rejecting claims 1—62 under 35 U.S.C.
§ 103(a) is reversed.
We enter a new ground of rejection against claims 1, 2, 3, 5—9, 11—15,
21—24, 26—29, 30-40, 43, 44, 49, 50, and 54—62 for failure to comply with
the written description requirement of 35 U.S.C. § 112, first paragraph.
FINALITY OF DECISION
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” 37 C.F.R. § 41.50(b) also provides:
When the Board enters such a non-final decision, [Appellants],
within two months from the date of the decision, must exercise one of
the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new Evidence relating to the claims
so rejected, or both, and have the matter reconsidered by the
examiner, in which event the prosecution will be remanded
to the examiner. The new ground of rejection is binding
14
Appeal 2014-000166
Application 12/362,792
upon the Examiner unless an amendment or new Evidence
not previously of Record is made which, in the opinion of
the examiner, overcomes the new ground of rejection
designated in this decision. Should the examiner reject the
claims, [Appellants] may again appeal to the Board pursuant
to this subpart.
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of
rejection and state with particularity the points believed to
have been misapprehended or overlooked in entering the
new ground of rejection and also state all other grounds
upon which rehearing is sought.
Further guidance on responding to new grounds of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED-IN-PART; 37 C.F.R, $ 41.50(b)
15