Ex Parte Gunderson

Patent Trial and Appeal Board

Sep 15, 2016

11969068 (P.T.A.B. Sep. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111969,068 01/03/2008
27581 7590 09/19/2016
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Bruce D. Gunderson
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
P0031300.00/LG10126 1070
EXAMINER
BAYS,PAMELAM
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
09/19/2016 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@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRUCE D. GUNDERSON
Appeal2014-007464
Application 11/969,068
Technology Center 3700
Before LYNNE H. BROWNE, THOMAS F. SMEGAL, and
ERIC C. JESCHKE, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Bruce D. Gunderson (Appellant) seeks review, under 35 U.S.C.
§ 134(a), of the Examiner's decision to reject claims 1, 5, 9, 12-16, 19-22,
27-29, and 31-38. 1 We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant identifies Medtronic, Inc. as the real party in interest.
Appeal Br. 3.
Appeal2014-007464
Application 11/969,068
BACKGROUND
The disclosed subject matter "relates to a method and apparatus for
automatically identifying cardiac and non-cardiac oversensing by an
implantable cardiac device and automatically adjusting detection parameters
to reduce inappropriate detection." Spec. i-f 2. Claims 1, 15, 25, and 34 are
independent. Claim 1 is reproduced below:
1. An implantable medical device (IMD)
compnsmg:
at least one lead that includes at least one
sensing electrode to sense cardiac data from a heart
of a patient in accordance with programmed sensing
parameters for a plurality of cardiac cycles; and
a housing coupled to the leads and containing
a processor configured to analyze the sensed cardiac
data to determine if an oversensing criteria is
satisfied, identify whether a lead failure exists based
on the oversensing criteria being satisfied and at
least one other criteria, and automatically adjust a
programmed number of intervals to detection (NIU)
from the programmed number to an increased value
in response to identifying that the lead failure exists,
and maintain the NID at the programmed number in
response to determining that the oversensing criteria
is satisfied and not identifying that the lead failure
exists.
REJECTIONS
1. Claims 1, 5, 9, 12-14, 25, 27, and 31-38 stand rejected under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
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2. Claims 1, 15, 25, and 27-29 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Ousdigian (US 2005/0154421 Al, published July
14, 2005).
3. Claims 5, 16, 22, 32, 33, 37, and 38 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Ousdigian and Jorgenson (US
2002/0120307 Al, published Aug. 29, 2002).2
4. Claim 31 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Ousdigian and Gunderson (US 2005/0137636 Al,
published June 23, 2005).
5. Claims 9, 12-14, and 19-21 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Ousdigian.
DISCUSSION
Rejection 1- The rejection of claims 1, 5, 9, 12-14, 25,
27, and 31-38 under 35U.S.C.§112,firstparagraph
The Examiner rejected claims 1 and 25 (and claims depending
therefrom) based on the limitation "maintain the NID at the programmed
number in response to determining that the oversensing criteria is satisfied
and not identifying that the lead failure exists." Final Act. 3. In addition,
the Examiner rejected claim 34 (and claims depending therefrom) based on
2 Although claim 34 is listed in the header to this Rejection in the
Office Action (Final Act. 7 (dated June 20, 2013)), the Examiner does not
discuss that claim in the body of the Rejection. The Examiner also removes
claim 34 from the header to this Rejection in the Answer. See Ans. 6.
Moreover, in the Office Action, the Examiner stated that "[c]laim[s] 34--36
would be allowable if rewritten or amended to overcome the rejection(s)
under 35 U.S.C. 112 set forth in this Office action." Final Act. 12. Thus,
claim 34 is not considered rejected based on prior art.
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Application 11/969,068
the limitation "maintains the NID at the programmed number in response to
determining that one of the first or second oversensing criteria is satisfied,
but the impedance criteria and the remaining one of the first and second
oversensing criteria are not satisfied." Id. According to the Examiner,
neither of these steps are "disclosed within the Applicant's Specification as
originally filed," and thus, they are "considered to be New Matter." Id.
The test for compliance with the written description requirement is
"whether the disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date." Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane). We find that the
Specification provides sufficient written description support for the
limitations at issue.
To aid the discussion, we first provide some background of the
disclosed invention. As stated by Appellant, "FIG. 3 describes [a] two-
tiered approach in which the method first predicts the presence of a lead-
related condition, Block 340, and once the presence of a lead-related
condition is detected, the method determines whether oversensing is likely
taking place, Block 342." Reply Br. 2 (citing Spec. i-f 50). In addition, as
stated by Appellant, "FIG. 4 illustrates one example method for detecting a
lead related condition, which may be utilized in block 340 of FIG. 3." Reply
Br. 2; see also Spec. i-f 51 ("FIG. 4 is a flow chart of a method for detecting a
lead-related condiction [sic] in a method for delivering therapy according to
an embodiment of the present invention."). Further, describing a process of
detecting whether a lead-related condition (such as a lead failure) exists,
paragraphs 51and52 disclose (as discussed by Appellant (Appeal Br. 8-9)),
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Application 11/969,068
the use of a (1) "first oversensing criteria," (2) "second oversensing criteria,"
and (3) an "impedance criteria." In particular, paragraph 52 provides: "If it
is determined that more than one of the criteria have been met, such as both
of the oversensing criteria or at least one of the oversensing criteria and the
impedance criteria, the likelihood of a lead-related condition is satisfied."
As discussed by Appellant (Appeal Br. 7-8), paragraph 131 provides:
As illustrated in FIG. 20, a determination is made to whether a
lead failure is likely present, Block 1395, using lead failure
analysis such as the lead failure detection method described
above. Lead failure may result in oversensing. According to an
embodiment of the present invention, once a lead failure is
determined likely to be present, yes in Block 1400, the
programmed number of intervals to detection (NID) is increased,
Block 1402, and an alert is generated to notify the patient of the
possible presence of the lead failure, Block 1404.
Spec. ,-r 131.
We first address the relationship between the disclosures of paragraph
131 (Figure 20) and paragraphs 51-52 (Figure 4). Appellant contends that
the phrase "using lead failure analysis such as the lead failure detection
method described above" in paragraph 131 (as set forth above) refers to the
methods disclosed in paragraphs 51 and 52 (discussed above). Appeal Br. 8.
The Examiner responds that the "method of the flowchart in Fig. 20 is
described in the Specification as being a distinct method [from] those in the
flowcharts of Figs. 3 and 4." Ans. 13. In support, the Examiner notes that
the Specification ( 1) describes Figure 4 as providing "a flow chart of a
method for detecting a lead-related condiction [sic] in a method for
delivering therapy according to an embodiment of the present invention"
(Ans. 13 (quoting Spec. i-f 51, with emphasis added)), and (2) describes
Figure 20 as "a flow diagram ... providing an overview of the operations
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Application 11/969,068
included in a preferred embodiment of the present invention for reducing the
likelihood of inappropriate detection of noise in an implantable medical
device" (Ans. 13 (quoting Spec. i-f 131, with emphasis added)).
We agree with Appellant that the reference to "the lead failure
detection method described above" in paragraph 131 would be understood
by one of ordinary skill in the art to refer to the disclosures in paragraphs 51
and 52. As noted by Appellant, "the method of FIG. 4 appears to be the only
method of detecting a lead-related condition [described by] Appellant's
[S]pecification." Reply Br. 2. Further, we agree with Appellant's
description of what paragraphs 131, 51, and 52 would, together, provide to
one of ordinary skill in the art:
Using the lead failure detection method described in FIG.
4 in steps 1395 and 1400 of FIG. 20 (as inferred by paragraph
[00131]), when a determination is made that lead failure exists
based on the oversensing criteria being satisfied and at least one
other criteria (e.g., the other oversensing criteria and/or the
impedance criteria in the example of FIG. 4), block 1402
increases the NID as described in paragraph [00131]. In
response to determining that the oversensing criteria is satisfied
and not identifying that the lead failure exists (e.g., scenarios (1)
and (2) for not detecting a lead related condition when less than
one of the criteria have been met), the NID is not adjusted per
block 1402 (i.e., it is maintained) and the lead failure predictor
analysis ofblock 1395 is continued ('NO' branch ofblock 1400).
Appeal Br. 9-10 (addressing claims 1 and 25); see also id. at 17 (similar
argument for claim 34 ). We find that these paragraphs satisfy the written
description requirement for the limitations at issue.
We tum now to the Examiner's position that "Fig. 3 only discloses the
first step of determining i[ fJ a lead-related condition exists (Step 340), then
determining if oversensing is taking place (Step 342), and then either
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delivering or withholding therapy (Step 344, 346)" and that "[i]f the first
Step of 'Lead-related condition' 340 is 'No', then the process of Fig. 3 ends,
and therefore does not disclose 'determining that the oversensing criteria is
satisfied and not identifying that the lead failure exists"' as recited in claims
1 and 25 (or the similar limitation in claim 34). Ans. 12; see also id.
(discussing paragraph 106 of the Specification and stating that "the
determination of whether the oversensing criteria has been satisfied is
performed after a lead-related condition/failure has been detected").
As noted by Appellant, the Examiner's position "fails to appreciate
that the lead failure detection method of FIG. 4 analyzes a first oversensing
criteria (702), second oversensing criteria (706) and an impedance criteria
(710) and a lead related condition is detected when more than one of the
criteria have been met" and, importantly, does not acknowledge that "[t]his
analysis of oversensing criteria is separate and distinct from the oversensing
analysis done in block 342 of FIG. 3 and described in detail with respect to
FIGs. 13-18 (see paragraph [0052])." Reply Br. 3. In other words, the
"oversensing criteria" in the limitations at issue relate to the first tier in the
disclosed approach-predicting the presence of a lead-related condition (see,
e.g. Spec., Fig. 3 (Block 340), i-fi-150-52}-rather than to the second tier in
the disclosed approach---determining whether oversensing is likely taking
place (see, e.g. Spec., Fig. 3 (Block 342), i-fi-1 50, 52).
For these reasons, we do not sustain the rejection of claims 1, 5, 9,
12-14, 25, 27, and 31-38 under 35 U.S.C. § 112, first paragraph.
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Application 11/969,068
Rejection 2-The rejection of claims 1, 15,
25, and 27-29 under 35 U.S.C. § 102(b)
A. Claims 1, 25, and 27-29
Independent claim 1 recites, among other limitations, a processor
configured to "identify whether a lead failure exists based on the
oversensing criteria being satisfied and at least one other criteria." Appeal
Br. 18 (Claims App.). Independent claim 25 recites, among other
limitations, the step of "identifying whether a lead-related condition exists
based on the oversensing criteria being satisfied and at least one other
criteria." Id. at 20. To address these limitations, the Examiner relied on
paragraphs 13, 51, and 79 of Ousdigian. See Final Act. 4, 6.
To aid the discussion, we first provide some background of
Ousdigian. As noted by Appellant, "Ousdigian describes an IMD employing
number of intervals to detect (NID) thresholds for detection of ventricular
arrhythmias" in which, "[ s ]ubsequent to the NID threshold being reached,
the IMD determines whether the detected ventricular rhythm is a suspected
non-lethal rhythm despite satisfying the NID threshold." Appeal Br. 10
(citing Ousdigian, Abstract); see also Ousdigian i-f 51. The suspected
nonlethal arrhythmia can be a supraventricular tachycardia (SVT), a
monomorphic ventricular tachycardia (VT), "or a rhythm cause[ d] by
cardiac or non-cardiac oversensing." Ousdigian i-f 51. If the system
identifies cardiac or non-cardiac oversensing, the system can perform
various actions, including increasing the NID threshold and modifying the
scheduled therapy. See id. i-f 13 ("When the IMD identifies cardiac or non-
cardiac oversensing, the IMD classifies the ventricular rhythm as a suspected
non-lethal cardiac rhythm, and can increase the NID threshold and/or modify
a scheduled therapy as described above."), i-f 80 ("In response to identifying
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cardiac or non-cardiac oversensing, microprocessor 60 can increase the NID
threshold and/or modify a scheduled therapy as described above.").
Appellant argues that although Ousdigian "can be viewed as
determining whether oversensing is occurring," Ousdigian "does not identify
whether a lead failure exists or whether the oversensing is caused by a
source other than a lead failure." Appeal Br. 11. We agree. As disclosed by
Ousdigian, lead failure is one of several possible causes of non-cardiac
oversensing. See Ousdigian i-f 78 (providing that "noncardiac oversensing is
caused by noise within a detected cardiac signal, such as noise caused by
lead failure, a loose set screw, or the like"). And non-cardiac oversensing is,
in tum, one of two types of oversensing (in addition to cardiac oversensing),
both of which trigger an increase to the NID threshold. See id. i-fi-113, 78-80.
We tum now to the Examiner's statement that "Ousdigian specifically
discloses increasing NID in response to identifying a oversensing due to a
lead failure (Paragraph[s] 0013, 0051, 0079)" because
Ousdigian discloses that NID is not increased if oversensing due
to a lead failure is not suspected, even if NID threshold to deliver
therapy is reached, because the NID threshold being reached may
be caused by a dangerous rhythm (Paragraphs 0064---0065, 0072-
0073), and that treatment should not be delayed by increasing the
NID.
Ans. 16. Review of the paragraphs relied upon by the Examiner further
supports Appellant's position, in that those paragraphs disclose a system that
determines whether oversensing exists (and performs actions based on that
determination) but that does not specifically identify "whether a lead failure
exists" or "whether a lead-related condition exists," as recited in claims 1
and 25, respectively.
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For these reasons, we do not sustain the rejection of claim 1 and 25, or
the rejection of claims 27-29, which depend from claim 1.
B. Claim 15
Independent claim 15 recites, among other limitations, a processor
configured to "identify a lead failure." Appeal Br. 19 (Claims App.).
Addressing this limitation, the Examiner relied on paragraphs 13, 51, and 7 9
of Ousdigian. See Final Act. 5.
Appellant argues that Ousdigian does not satisfy this limitation
because, although Ousdigian "does indicate that the suspected non-lethal
rhythms could be caused by cardiac or non-cardiac oversensing," Ousdigian
"does not provide any techniques to distinguish between the two or
techniques for distinguishing among all the possible sources of non-cardiac
oversensing." Appeal Br. 13. For the same reasons discussed above, we
agree that Ousdigian does not disclose a processor configured to "identify a
lead failure." Thus, we do not sustain the rejection of claim 15.
Rejections 3 and 4 - The rejection of claims 5, 16, 22,
31-33, 37, and 38 under 35 U.S.C. § 103(a)
Claims 5, 31-3 3, and 3 7 depend from independent claim 1, claims 16
and 22 depend from independent claim 15, and claim 38 depends from
independent claim 25. Appeal Br. 18, 19, 21, 22 (Claims App.). The
Examiner's reliance on Jorgenson (regarding Rejection 3) and Gunderson
(regarding Rejection 4) does not remedy the deficiencies in the teachings of
Ousdigian, discussed above (see supra Rejection 2). Thus, for the reasons
discussed above, we do not sustain the rejection of claims 5, 16, 22, 31-33,
37, and 38.
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Rejection 5 - The rejection of claims 9, 12-14,
and 19-21under35 U.S.C. § 103(a)
Claims 9 and 12-14 depend from independent claim 1, and claims 19-
21 depend from independent claim 15. Appeal Br. 18, 19 (Claims App.).
The Examiner does not articulate any additional findings or reasoning and
does not propose any modification of Ousdigian to remedy the deficiencies
discussed above (see supra Rejection 2). Thus, for the reasons discussed
above, we do not sustain the rejection of claims 9, 12-14, and 19-21.
DECISION
We REVERSE the decision to reject claims 1, 5, 9, 12-16, 19-22, 27-
29, and 31-38.
REVERSED
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