Ex Parte Ellingson et al

Patent Trial and Appeal Board

Oct 4, 2017

13096328 (P.T.A.B. Oct. 4, 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.
13/096,328 04/28/2011 Michael L. Ellingson P0035524.00/LG10126 4301
10/06/201727581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
FLORY, CHRISTOPHER A
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
10/06/2017 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 MICHAEL L. ELLINGSON, PATRICK L. PARISH,
and HYUN J. YOON
Appeal 2016-000971
Application 13/096,328
Technology Center 3700
Before EDWARD A. BROWN, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Michael L. Ellingson et al. (“Appellants”) appeal under 35 U.S.C.
§ 134(a) from the Examiner’s decision rejecting claims 1—27.1 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants submit the real party in interest is Medtronic, Incorporated
(now a Medtronic pic subsidiary). Appeal Br. 3.
Appeal 2016-000971
Application 13/096,328
THE CLAIMED SUBJECT MATTER
Appellants’ invention relates to “improving sensing by an implantable
medical device in a noisy environment.” Spec. 1,11. 6—7. Claim 1,
reproduced below, is illustrative of the claimed subject matter.
1. An implantable medical system comprising:
an implantable medical lead including at least one
electrode;
an implantable medical device coupled to the implantable
medical lead, the implantable medical device comprising:
a sensing module configured to obtain electrical signals
using a sensing vector that includes the at least one electrode of
the implantable medical lead, wherein the electrical signals
include cardiac signals and noise-induced signals;
a noise detection module configured to independently
obtain noise signals without using the sensing vector that
includes the at least one electrode of the implantable medical
lead; and
a control module configured to adjust a sensing threshold
of the sensing module to a value between an amplitude of the
noise-induced signals and an amplitude of the cardiac signals in
response to the detection of at least one of the noise signals
independently of the electrical signals obtained using the sensing
vector that includes the at least one electrode.
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Application 13/096,328
REJECTIONS2
1) Claims 1—6, 8, 9, 12—17, and 19-22 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kim (US 6,029,086, issued Feb. 22,
2000) and Paul (US 5,697,958, issued Dec., 16, 1997).
2) Claims 1—23 and 27 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Cooke (US 7,561,915 Bl, issued July 14, 2009)
and Kim, or, alternatively, over Cooke, Kim, and Paul.
3) Claims 24—27 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kim and Paul.
4) Claims 24—26 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Cooke, Kim, and Paul.
DISCUSSION
Rejection 1
Claims 1—4, 9, 12—15, 17, and 19—22
Appellants argue claims 1—4, 9, 12—15, 17, and 19-22 as a group.
Appeal Br. 5. We select claim 1 as representative and claims 2—4, 9, 12—15,
and 17—27 stand or fall with claim 1. 37 C.F.R. § 41.37 (c)(l)(iv).
The Examiner finds that Kim discloses all the limitations of claim 1
except a noise detection module that obtains noise signals independently
from the sensing vector of the sensing module. Final Act. 3—5. The
Examiner finds that Paul discloses using “independent means for detecting
and confirmation [of] the presence of electromagnetic noise in implantable
2 In the Examiner’s Answer, the Examiner withdrew a rejection of claims 1—
27 under 35 U.S.C. § 112, first paragraph, and a rejection of claims 1—6, 8,
9, 12—17, and 19-22 under 35 U.S.C. § 102(b) as anticipated by Kim. Ans.
2; Final Act. 2—3.
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Application 13/096,328
cardiac devices.” Id. at 5 (citing Paul 1:53—63, 2:21—26, 3:5—18, 5:50-60).
The Examiner concludes that it would have been obvious to modify Kim
with the additional independent noise detection circuit taught by Paul
because “such a modification would provide the predictable results of
providing better and more accurate detection of signals in extremely noisy
environments and detection of external field interference to ultimately
improve patient safety.” Id.
Appellants first contend that modifying Kim with Paul would render
Kim “inoperable for one of the ‘principle object[s] of the [] invention’ of
Kim, namely the performance of threshold sensing adjustments on a beat by
beat basis.” Appeal Br. 8. The Examiner responds that the addition of
Paul’s independent noise sensing means to Kim’s device has the
purpose of simply alerting the device of the presence of
environmental interference such that the device make take
appropriate steps already within the architecture of the device
would in no way prevent the device from performing beat-by­
beat adjustment of the sensing threshold. Column 5, lines 50-60
of Paul. . . indicate that the additional noise detection section is
coupled to the microprocessor of the device but functions
independently therefrom other than to alert the device to the
presence of noise, and therefore is clearly able to communicate
with but otherwise not interfere with the normal functionalities
of the device.
Ans. 4.
In reply, Appellants argue that the Examiner mischaracterizes
Appellants’ argument by stating that Appellants contend that modifying Kim
in view of Paul renders Kim “inoperable,” not inoperable for a principle
object of Kim. Reply Br. 2. The Examiner states sound reasons, based on
Paul, that Paul’s noise detection device will communicate with, but not
interfere with, the operation of Paul’s microprocessor. We are not persuaded
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by Appellants’ contention because Appellants do not provide persuasive
reasoning or evidence to show why combining Paul’s independent noise
detection with Kim’s device would prevent or interfere with the ability of
Kim’s device to adjust the sensing threshold on a beat by beat basis. We
disagree that the Examiner mischaracterized Appellants’ contention because
the Answer specifically addresses the issue raised by Appellants of whether
or not modifying Kim with Paul would render Kim inoperable for modifying
the sensing threshold on a beat-by-beat basis.
Appellants also contend that if Paul’s noise detection were to operate
independently in the background of Kim, then Kim as modified by Paul does
not render claim 1 unpatentable because claim 1 requires the control module
“to adjust the sensing threshold in response to the independent detection of
at least one of the noise signals.” Appeal Br. 8. Appellants’ argument
amounts to an attack on Paul and Kim individually despite the fact that the
rejection is based on the combined teachings of the references. Appellants
admit that Paul discloses “an apparatus and method for detecting the
presence of EMI in an IMD independent of other circuitry of the device and
signaling the device of the presence of interference such that appropriate
steps may be taken in response.” Appeal Br. 7 (emphasis added).
Appellants do not argue that it would be beyond the capabilities of one of
ordinary skill in the art to infer that automatically adjusting the sensing
threshold in Kim is an “appropriate step[]” to take in response to
independently detecting the presence of noise as disclosed in Paul. We “can
take account of the inferences and creative steps that a person of ordinary
skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
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418 (2007). Appellants’ contention, thus, does not apprise us of Examiner
error.
Appellants further contend that the rejection is based on
impermissible hindsight because “Appellants[’] disclosure includes the only
teaching on record of adjusting the sensing threshold in response to
independently detecting noise signals .... Adjusting sensing thresholds in
response to independently detected noise is completely absent from the cited
art and is only present in Appellants’] specification.” Appeal Br. 9. The
Examiner responds that Kim discloses “the foreseen need of additional or
better noise detection.” Ans. 5 (citing Kim 1:32—60). Paul discloses “the
benefit of an independent antenna for detecting environmental noise and
specifically implementing such an antenna with an implantable cardiac
device ... so that the device may take additional and appropriate steps in
proper response to detecting excess environmental/EMI noise.” Id. (citing
Paul 2:21—26, 15:28-47). We are not persuaded that the Examiner’s
rejection is based on impermissible hindsight because the rejection is based
on combined teachings derived from Kim and Paul, not Appellants’
Specification.
Appellants next contend that the Examiner’s rationale for the
combination of Kim and Paul as stated in the Advisory Action is
insufficient. Appeal Br. 9-10; see Advisory Act. 2 (dated Feb. 20, 2015).
Appellants argue that the portion of Paul relied on by the Examiner only
describes the advantages of an antenna external to the metal case and not the
benefit of enhancing both noise detection and cardiac signal detection. Id. at
10. Appellants continue that “neither Paul nor Kim provides any teaching or
suggestion that the amplitude of noise on a completely independent sensing
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vector could be used in for enhancing cardiac signal detection of another
sensing vector.” Id. The Examiner responds that claim 1 does not require
the use of the amplitude of the independent noise signal for enhancing
cardiac detection of another sensing vector. Ans. 2—3.3 The Examiner also
notes that Paul discloses that the implanted cardiac device takes steps in
response to detecting noise. Id. at 5 (citing Paul 2:21—26). We agree with
the Examiner that claim 1 does not require the use of the amplitude of the
independent noise signal in adjusting the sensing threshold. In addition,
Appellants’ argument that the rationale as stated in the Advisory Action is
insufficient does not apprise us of error because Paul discloses more than the
advantages of an external antenna for noise detection. Paul discloses that the
implanted device takes steps in response to detection of noise on the
antenna. See Paul 2:21—26.
We have considered all of Appellants’ arguments. We determine that
Appellants fail to persuasively apprise us of error in the Examiner’s factual
findings or rationale stated in the Final Office Action, quoted above, for the
combination of Kim and Paul, which we determine to be reasonable and
supported by rational underpinnings. See KSR, 550 U.S. at 416 (“[t]he
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results”). We, thus,
sustain the rejection of claim 1 under 35 U.S.C. § 103(a). Claims 2-4, 9,
12—15, 17, and 19-22 fall with claim 1.
3 Appellants do not dispute this finding by the Examiner. See Reply Br. 2.
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Claims 5, 6, 8, and 16
Claim 5 requires the control module “to compare the amplitude of the
noise-induced electrical signals ... to a threshold noise amplitude.” Appeal
Br. 14—15 (Claims App.). Claim 16 contains a substantially similar
limitation. Id. at 16. Appellants contend that Kim does not disclose “[a]
separate threshold noise amplitude.” Id. at 12. In response, the Examiner
asserts that Kim
discloses wherein the sensing threshold is set above the average
maximum noise amplitude, which is seen as reading on the
threshold noise amplitude. The noise refractory periods and
noise refractory windows wherein the device operationally
switches to a functionality focused on processing the noise and
adjusting the sensing threshold is seen as reading on the “noise
operating mode”. Any time a system enters a separate
operational window to perform a different function, it may be
considered in a particular operating mode.
Ans. 7.
In reply, Appellants argue that under the Examiner’s interpretation of
threshold noise amplitude, “Kim does not transition to processing the noise
and adjusting the sensing threshold (characterized as the ‘noise operating
mode’) when the amplitude of at least one of the noise induced electrical
signals exceeds the threshold noise amplitude” as required by claim 5
because Kim does this automatically “after every beat.” Reply Br. 6.
The Examiner relies, in part, on Kim’s Figure 4 in support of this
rejection. Final Act. 6. Kim’s Figure 4 discloses a sensing threshold 96,
noise deflections 94, and that the sensing threshold is adjusted after a noise
measurement interval. Kim, Fig. 4, 7:52—60; 8:20-40. The Examiner finds
that the period of time to the right of p-wave deflection 92 in Figure 4
corresponds to the “noise operating mode” recited in claim 5. See Ans. 7.
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The Examiner does not, however, direct us to any portion of Kim wherein
the amplitude of noise-induced electrical signal, p-wave deflection 92, is
compared to the average maximum noise amplitude, which the Examiner
determines corresponds to the “threshold noise amplitude” recited in claims
5 and 16. The Examiner finds that the portion of Figure 4 to the right of p-
wave deflection 92 is the “noise operating mode” and is also where the
sensing threshold is adjusted. Final Act. 6; Ans. 7. Even if Kim discloses
the comparison of amplitudes as recited in claims 5 and 16, the Examiner
does not adequately explain how the device of Kim enters “a noise operating
mode” if the amplitude of the noise induced signals exceeds the threshold
noise amplitude, but alternatively adjusts the sensing threshold when the
amplitude of the noise induced signals does not exceed the threshold noise
amplitude. Kim adjusts the sensing threshold in both cases. For these
reasons, we do not sustain the rejection of claims 5 and 16 and claims 6 and
8 which depend from claim 5.
Rejection 2
The Examiner finds that Cooke discloses all the limitations of
independent claims 1,12, and 19 except “the sensing threshold is adjusted to
a value between an amplitude of the noise-induced signals and an amplitude
of the cardiac electrical signals.” Final Act. 7—8. The Examiner relies on
Kim for disclosure of the limitation missing in Cooke and concludes it
would have been obvious to modify Cooke “with an automatically adjusted
sensing threshold as taught by Kim[], since such a modification would
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provide the predictable results of filtering noise, improving signal fidelity
and reducing the amount of false sensing of a system.” Id. at 8.4
Appellants contend that “Cooke describes an MRI-safe mode in
which sensing and tachy detection is turned off’ and “one of ordinary skill in
the art would not modify the MRI-safe mode of Cooke to turn sensing back
on as none of the brady or tachy therapies are dependent upon sensing.”
Appeal Br. 11. Appellants also contend that the Examiner’s explanation of
the rejection in the Response to Arguments is different than in the rejection
set forth in the Final Office Action because it adds Kim’s automatically
adjusted sensing mechanism to Cooke while maintaining Cooke’s MRI-safe
mode. Id. Appellants argue that combining Cooke and Kim in this fashion
does not arrive at the claimed invention because “sensing threshold
adjustment is done when reverting out of the MRI-safe mode instead of
when transitioning into the MRI-safe mode.” Id. at 12. The Examiner
responds that “[t]he fact that Cooke has an additional MRI-safe mode is
irrelevant to the claims and irrelevant to the reasons for combination.” Ans.
7. The Examiner further explains that the rejection does not suggest that
“the noise detection feature recited is somehow incorporated into the steps of
entering or exiting the MRI-safe mode, merely that they are of benefit
anytime the device is in a normal sensing mode.” Id. at 6—7. For the
following reasons, we do not sustain the rejection of claims 1,12, and 19.
4 The heading of this rejection states that claims 1—23 and 27 are
alternatively rejected in view of Cooke, Kim, and Paul. Final Act. 7.
However, this appears to be a typographical error because the “alternative”
rejection for claims 1,12, and 19 is substantially the same as rejection 1
wherein Kim is modified by Paul with no mention of Cooke. Id. at 8—9.
Further, Paul is not relied on in rejecting any of the other dependent claims.
See id. at 9—13.
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The Examiner finds that Cooke’s disclosure of switching to an MRI-
safe mode corresponds to the claim limitation of adjusting a sensing
threshold of the sensing module in response to detecting the noise signals via
the noise detection module. Final Act. 7 (citing Cooke 4:9—13). The
Examiner then adds Kim’s automatic adjusting of the sensing threshold to
Cooke’s device because, in the Examiner’s view, Cooke does not disclose
automatic adjustment of the sensing threshold in response to detecting the
independent detection of the noise signal. Ans. 6; Final Act. 16. As
Appellants correctly note, when Cooke detects a noise signal, sensing is
turned off. Appeal Br. 11. The Examiner does not provide adequate
technical reasoning regarding how Kim’s automatic adjustment of the
sensing threshold will perform that function in response to detection of a
noise signal if Cooke turns sensing off. We, therefore, do not sustain the
rejection of claims 1, 12, and 19. Claims 2—11 and 27 depend directly or
indirectly from claim 1, claims 13—18 depend directly or indirectly from
claim 12, and claims 20-23 depend from claim 19. We do not sustain the
rejection of these dependent claims for the same reasons.
Rejection 3
Claims 24—27 depend from claim 1. Appeal Br. 19 (Claims App.).
Appellants do not argue for the patentability of these claims apart from the
arguments raised in Rejection 1 with respect to claim 1. Id. at 5. We sustain
the rejection of claims 24—27 for the same reasons stated for claim 1 in
connection with Rejection 1.
Rejection 4
Claims 24—26 depend from claim 1. Appeal Br. 19 (Claims App.).
The Examiner does not rely on the additional disclosure of Paul to cure the
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deficiencies in the combination of Cooke and Kim stated above in
connection with Rejection 2. Appeal Br. 14. We do not sustain the rejection
of claims 24—26 as unpatentable over Cooke, Kim, and Paul for the same
reasons stated for claim 1 in connection with Rejection 2.
DECISION
The Examiner’s decision rejecting claims 1—4, 9, 12—15, 17, and 19-
22, and 24—27 as unpatentable over Kim and Paul is affirmed.
The Examiner’s decision rejecting claims 5, 6, 8, and 16 as
unpatentable over Kim and Paul is reversed.
The Examiner’s decision rejecting claims 1—23 and 27 as unpatentable
over Cooke and Kim is reversed.
The Examiner’s decision rejecting claims 24—26 as unpatentable over
Cooke, Kim, and Paul is reversed.
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
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