Ex Parte Sawchuk

Patent Trial and Appeal Board

Aug 5, 2016

12179166 (P.T.A.B. Aug. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/179, 166 07/24/2008
27581 7590 08/09/2016
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Robert T. Sawchuk
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.
P0023178.0l/ll l l-017US01 7662
EXAMINER
PATEL, NATASHA
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
08/09/2016 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 ROBERT J. SAWCHUK
Appeal2013-004419
Application 12/179, 166
Technology Center 3700
Before JOHN C. KERINS, JAMES P. CAL VE, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
KERINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Robert T. Sawchuk (Appellant) seeks our review under 35 U.S.C.
§ 134(a) of the Examiner's final rejection of claims 1---6, 9-23, and 26-46.
Claims 7, 8, 24, and 25 are canceled. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We AFFIRM.
Appeal2013-004419
Application 12/179, 166
THE INVENTION
Appellant's invention is directed to a method for evaluating sensing
integrity of an implantable medical device. Independent claim 1, reproduced
below, is illustrative:
1. A method comprising:
obtaining sensed signal information representative of a plurality
of responses evoked by tissue in response to electrical
stimulation of the tissue by an implantable medical device,
wherein the plurality of responses are sensed at different times
from one another via a same sensing vector; and
evaluating sensing integrity of the implantable medical device
based on analysis of the plurality of responses.
THE REJECTIONS ON APPEAL
The Examiner has rejected:
(i) claims 1-14, 16-31, 33-38, and 40-46 under 35 U.S.C.
§ 103(a) as being unpatentable over Sawchuk (US
2004/0088018, published May 6, 2004);
(ii) claims 14 and 31under35 U.S.C. § 103(a) as being
unpatentable over Sawchuk in view of Sloman (US 6,865,422
B 1, issued Mar. 8, 2005); 1 and
1 The heading for this ground of rejection in the Final Action and in the
Examiner's Answer erroneously identifies the rejection as applying to claims
15, 32, and 39. This is an obvious typographical error, in that the ensuing
analysis identifies claims 14 and 31, as well as the pertinent limitations
found in claims 14 and 31. Final Act. 6; Ans. 8.
2
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Application 12/179, 166
(iii) claims 15, 32, and 39 under 35 U.S.C. § 103(a) as being
unpatentable over Sawchuk in view of Dong (US
2006/0247694 Al, published Nov. 2, 2006).
ANALYSIS
Claims 1-14, 16--31, 33-38, and 40--46---Unpatentable over Sawchuk
Appellant does not argue for the patentability of any claim separate
and apart from claim 1.2 Appeal Br. 6-11. Accordingly, we will take claim
1 as representative, and the remaining claims subject to this rejection will
stand or fall with claim 1.
The Examiner, relying on Figure 11 of Sawchuk, finds that Sawchuk
discloses all method steps set forth in claim 1, with the exception that
Sawchuk does not disclose that "a plurality of responses are sensed at
different times via a same vector." Final Act. 3. The Examiner additionally
notes that Sawchuk is relied on for its teaching of evaluating the integrity of
the sensing process. Adv. Act. 2. 3 The Examiner concludes that it would
have been obvious "to make all of the measurements serially using a single
vector instead of using separate parallel vectors" because a single vector
"would require less hardware, such as electrodes and conductors, thereby
reducing production costs." Final Act. 3.
Appellant responds mainly that the Examiner's proposed modification
of Sawchuk is erroneous because there would have been no apparent reason
2 Appellant includes separate subheadings for (i) claims 18-31, 33, 45, and
46; (ii) claims 34--41; and (iii) claim 42. Appeal Br. 10-11. Under each of
those subheadings, Appellant refers back to the arguments presented in
connection with claim 1 as the basis for seeking reversal of the rejection.
3 Advisory action dated August 30, 2012.
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to make such a modification in Sawchuk, in particular because such a
modification would render Sawchuk unsuitable for its intended purpose of
being able to automatically select an optimal evoked response sensing
vector, based on an evaluation of evoked response signal quality of more
than one vector. Appeal Br. 6-10; Reply Br. 5-8. Appellant does not
contest the Examiner's position that the proposed modification would
require less hardware and reduce production costs.
Even though the Examiner's proposed modification would have no
need to avail itself of the automatic optimal sensing vector selection aspects
of Sawchuk, as pointed out by Appellant, the proposed modification does
involve the use of Sawchuk' s disclosure as to assessing the reliability or
integrity of evoked responses sensed in the process. This is an intended
purpose of Sawchuk as well, as it enables the further optimal sensing vector
selection process.4 Rather than rendering Sawchuk unsuitable for its
intended purpose, the proposed modification is seen as obtaining one
advantage at the expense of losing a different feature or advantage, which
does not preclude a finding of obviousness. See Medichem, S.A. v. Rolabo,
S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) ("[A] given course of action
often has simultaneous advantages and disadvantages, and this does not
necessarily obviate motivation to combine.").
Indeed, Sawchuk explicitly recognizes that its method for selecting an
optimal electrode sensing vector is applicable to "cardiac pacing systems
4 The assessment of reliability and integrity of sensed evoked responses
additionally enables a determination that no sensing vector is suitable for
reliable sensing of evoked responses. See, e.g., Sawchuk, Fig. 4A, steps
118, 120; Fig. 7, steps 194, 198; Fig. 9, steps 184, 198.
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employing a lead system that provides only one possible evoked response
sensing vector," for "validat[ing] the sensing vector as being reliable for
capture detection." Sawchuk, para. 51. Paragraph 51 refers particularly to
the process of Figure 4A, which "may be performed upon detecting loss of
capture, on a periodic basis, or after receiving a manual command."
Sawchuk, para. 4 7 (emphasis added).
That the assessment of the reliability or integrity of the sensed evoked
responses is an important aspect of the Sawchuk disclosure is further
evidenced in Figure 11. See Final Act. 2-3 (relying on Figure 11 ). Steps
402 through 414 in Figure 11, in view of the attendant textual description at
paragraphs 81-86, are understood as being performed iteratively using the
same sensing vector, provided that "YES" determinations are made at each
of steps 408 and 414. Steps 410 and 412 of that process involve evaluating
sensing integrity by determining what signal quality parameters are to be
assessed, and then assessing them to determine whether the signal quality is
or is not acceptable. Sawchuk, Fig. 11. Paragraph 81 notes that
"[ v ]erification of signal quality may be performed on a beat-by-beat basis
during beat-by-beat capture verification or on a less frequent sampled basis,"
thus iteratively evaluating sensing integrity based on analysis of the plurality
of responses.
A further step of sensing vector optimization, which might result in
the process switching to a different sensing vector, only occurs when "NO"
determinations are made at both step 408 and step 412, or when a "NO"
determination is made at step 414. Again, while having this capability is the
main thrust of the Sawchuk disclosure, persons of ordinary skill in the art
would readily see the desirability of employing the applicable portions of the
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Sawchuk process even when only a single sensing vector is present. "[A]
person of ordinary skill is also a person of ordinary creativity, not an
automaton." KSR v. Teleflex, 550 U.S. 398, 421 (2007).
The rejection of claim 1 is thus sustained based upon the Examiner's
original stated grounds of rejection. Claims 2-14, 16-31, 33-38, and 40-46,
not being separately argued, fall with claim 1.
Although not necessary to reach our decision, we wish to address an
additional issue joined between the Examiner, in the Response to Argument
section of the Answer, and Appellant, in the Reply Brief. The Examiner,
apparently believing Appellant's arguments to be in the nature of Sawchuk
"teaching away" from the proposed modification, points to paragraphs 66,
67, 70, and 74 of Sawchuk as evidencing that a same sensing vector is used
to re-run a collection of responses, with the iterative nature necessarily
meaning that the responses are from different points in time. Ans. 9.
Appellant responds that "the Examiner is now alleging that Sawchuk
does in fact disclose a plurality of responses being sensed at different times
via the same sensing vector," and that this "is entirely inconsistent with the
position taken previously in [the] Final Office Action and Advisory Action."
Reply Br. 6. Appellant argues that, as a result, the Examiner has failed to
clearly articulate the particular differences between the claims and the
Sawchuk disclosure. Id. Further, Appellant argues that, in any event, the
cited portions do not disclose "evaluating sensing integrity of the
implantable medical device based on analysis of the plurality of responses,"
as required by claim 1, but instead are directed to using the plurality of
responses sensed by the same sensing vector "to identify an acceptable ER
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sensing margin for a sensing vector for use in a pacing threshold search."
Id. at 7.
Although the Examiner states, in the grounds of rejection, that
"Sawchuk does not disclose that a plurality of responses are sensed at
different times via a same vector," the statement is made in the context of
the preceding findings directed to Sawchuk disclosing the obtention of
sensed signal information representative of a plurality of responses, and
evaluating sensing integrity based on analysis of the plurality of responses.
See, e.g., Final Act. 2-3. In other words, the Examiner's statement noting
that Sawchuk does not disclose employing responses sensed at different
times via "a same sensing vector," is in the context of the entire set of
operative steps of the overall method of Sawchuk. 5 We thus view the
Examiner's statements in the Response to Argument section of the Answer
as pointing out that Sawchuk discloses instances in which a same sensing
vector is used in obtaining a plurality of responses that are sensed at
different times from one another, in support of the position that it would
have been obvious to modify Sawchuk to employ only a single sensing
vector to sense a plurality of responses in order to analyze those responses
for evaluating sensing integrity.
Appellant's attempt to distinguish between using the analysis of the
plurality of the responses to evaluate sensing integrity, 6 as claimed, and
5 As noted above, however, the process in Figure 11 of Sawchuk, when steps
412 and 416 result in a "YES" determination, does employ responses sensed
at different times via a same sensing vector.
6 Sensing integrity generally refers to the ability of the implantable device to
accurately and reliably sense particular events in order to properly record
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using the plurality of responses to identify an acceptable evoked response
(ER) sensing margin for a sensing vector for use in a pacing threshold
search, as disclosed in cited paragraph 66 of Sawchuk, also appears
misplaced. Paragraph 66, relied on by the Examiner, is directed to an aspect
of the process illustrated in Figure 7. At steps 176-178-180-184-186, an
evoked response obtained using a sensing vector is analyzed to determine
whether a signal-to-noise ratio and an ER sensing margin are at or above
acceptable levels. Sawchuk, Fig. 7. If, at step 186, an ER sensing margin is
not at or above the acceptable level, a reference sensing threshold is adjusted
(generally lowered), and the test, including a pacing threshold search (see,
e.g., para. 3) and the steps noted above, is repeated using a new response via
the same sensing vector. Upon again reaching step 186, if the ER sensing
margin is determined to be at or above the acceptable value, the sensing
vector will be established as the evoked response testing vector. Sawchuk,
para. 64.
The sequence discussed above thus evaluates and assures the ability of
the implantable device to accurately and reliably sense particular events in
order to properly record such events and/or control therapy in response to
sensed events, or, in other words, evaluates and assures sensing integrity.
We therefore do not find the Examiner's reliance on these paragraphs in the
Answer as including any flaws that would create reversible error in the
rejection of claim 1 as obvious. In any event, as noted above, this analysis
of this additional issue does not affect in any way our determination that the
Examiner did not err in concluding that the subject matter of claim 1 is
such events and/or control therapy in response to sensed events. Spec., para.
30.
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unpatentable over Sawchuk. It is provided in order that it will be apparent
that all of Appellant's arguments presented on appeal have been considered.
Claims 14 and 31-- Unpatentable over Sawchuk and Sloman
Appellant argues that these claims depend from one of independent
claims 1, 18, and 34, and that Sloman fails to overcome the deficiencies
alleged to exist in Sawchuk. Appeal Br. 11. Because we have determined
above that Sawchuk is not deficient in rendering the independent claims
unpatentable, this argument is not persuasive of error.
The rejection of clams 14 and 31 is sustained.
Claims 15, 32, and 39--Unpatentable over Sawchuk and Dong
Appellant argues that these claims depend from one of independent
claims 1, 18, and 34, and that Dong fails to overcome the deficiencies
alleged to exist in Sawchuk. Appeal Br. 12. Because we have determined
above that Sawchuk is not deficient in rendering the independent claims
unpatentable, this argument is not persuasive of error.
The rejection of clams 15, 32, and 39 is sustained for the reasons
stated above.
DECISION
The rejection of claims 1-14, 16-31, 33-38, and 40-46 under 35
U.S.C. § 103(a) as being unpatentable over Sawchuk is AFFIRMED.
The rejection of claims 14 and 31under35 U.S.C. § 103(a) as being
unpatentable over Sawchuk in view of Sloman is AFFIRMED.
The rejection of claims 15, 32, and 39 under 35 U.S.C. § 103(a) as
being unpatentable over Sawchuk in view of Dong is AFFIRMED.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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