Ex Parte Stroebel

Patent Trial and Appeal Board

Jan 31, 2017

13412120 (P.T.A.B. Jan. 31, 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.
13/412,120 03/05/2012 John C. Stroebel P0020243 .US C10 8877
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
SO, ELIZABETH K
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/02/2017 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 JOHN C. STROEBEL
Appeal 2014-009413
Application 13/412,120
Technology Center 3700
Before: JENNIFER D. BAHR, BRANDON J. WARNER, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1—
3 and 5—12. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM and designate our affirmance as a NEW GROUND OF
REJECTION under 37 C.F.R. § 41.50(b).
Appeal 2014-009413
Application 13/412,120
CLAIMED SUBJECT MATTER
The claims are directed to a method of providing a ventricular pacing
pulse. Spec. 48 (Abstract). Claims 1, 6, and 10 are independent. Appeal
Br. 14—15 (Claims App.). Claim 1, reproduced below, is illustrative of the
claimed subject matter:
1. A method of selectively providing cardiac pacing with an
implantable medical device comprising:
setting a flag during a given cardiac cycle in response to
ventricular activity; and
precluding a ventricular pacing pulse during a current
cardiac cycle if the flag is present at the onset of the current
cardiac cycle; and
wherein the given cardiac cycle is defined by an A-A
interval.
Appeal Br. 14 (Claims App.).
The prior art relied upon by the Examiner in rejecting the claims on
REJECTION
Claims 1,3, and 5—12 are rejected under 35 U.S.C. § 102(b) as
anticipated by Limousin, or, in the alternative, under 35 U.S.C. § 103(a) as
unpatentable over Limousin and Rueter.
REFERENCES
appeal is:
Rueter
Limousin
US 4,523,593
US 5,318,594
June 18, 1985
June 7, 1994
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OPINION
Claim 1
The Examiner finds that Limousin teaches “setting a flag during a
given cardiac cycle in response to ventricular activity and precluding a
ventricular pacing pulse during a current cardiac cycle if the flag is present
at the onset of the current cardiac cycle.” Final Act. 3 (citing Limousin,
2:10-38). Regarding the step of “precluding a ventricular pacing pulse” as
recited in claim 1, the Examiner finds that, in Limousin, “if ventricular
activity was detected, a flag somewhere in the system is implied to have
been set in order for the system to be switched into an AAI mode — with no
pacing pulse delivered— if any R-waves are detected during an AV
interval.” Final Act. 3^4 (emphases added). Thus, the Examiner finds that
the AAI mode precludes a ventricular pacing pulse.
As an alternative to finding that Limousin implicitly discloses setting
a flag, the Examiner finds that Rueter “teaches determining whether or not a
flag has been set in order to deliver or withhold pacing” and “shows that
when an R-wave is sensed, then a flag is set; when the flag is set, no pacing
pulse is delivered.” Final Act. 4. The Examiner also finds that in Rueter,
“[i]f no flag has been set, then a ventricular pacing pulse is delivered. Final
Act. 4 (citing Rueter, Fig. 4). The Examiner reasons that it would have been
obvious to set a flag in Limousin after ventricular activity “to mark the event
and notify the system to withhold a ventricular pacing pulse if the flag is
present at the onset of the current cardiac cycle.” Final Act. 4.
Appellant asserts “for purposes of interpreting the Examiner’s
rejection, we must understand that the AAI mode she refers to in Limousin
is part of the DDD mode as presently defined.” Appeal Br. 7.
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Application 13/412,120
We disagree. As set forth in the Final Action, the Examiner relies on
Limousin’s switch into the AAI mode “with no pacing pulse delivered” as
qualifying as “precluding a ventricular pacing pulse” as recited in claim 1.
Final Act. 3^4. Limousin discloses operating in the AAI mode and
“automatically switching to pacing the heart in the DDD mode in response
to a lack of atrio-ventricular condition, and automatically switching back to
the AAI mode after atrio-conduction is restored.” Limousin, 2:20—24. One
of the stated objects in Limousin is “to provide a cardiac pacemaker of the
DDD type that will operate in the DDD mode solely during period of crisis,
and will operate in the AAI mode outside of the period of crisis.” Limousin,
1:67—2:2. Specifically, in Limousin, “[t]he pacemaker will operate in the
AAI mode as long as the atrio-ventricular conduction is normal, that is, as
long as each atrial event E (outside of the refractory periods) is followed by
a synchronous ventricular detection R.” Limousin, 4:45 49. Thus, contrary
to Appellant’s contention, Limousin switches between distinct modes,
namely, the DDD mode and the AAI mode, and the Examiner relies on a
switch between these modes in the rejection of claim 1.
Appellant further asserts “[i]n the Limousin device, if the flag can be
set during a ‘given’ cardiac cycle (A-A interval) the device is necessarily
operating in what would now be called DDD mode. The flag, however,
cannot be present at the onset of ‘given’ cardiac cycle (A-A interval)
because it is necessarily set after the given cardiac cycle begins.” Appeal
Br. 8. Appellant asserts that “in Reuter, ventricular pacing is similarly [to
the process in Limousin] not precluded in one cardiac cycle in response to a
ventricular event in a previous cardiac cycle.” Appeal Br. 8. Therefore,
according to Appellant, “[b]oth references thus lack the same required
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Application 13/412,120
teaching. Adding flags to Limousin doesn’t make the invention.” Appeal
Br. 8.
We disagree with Appellant’s contention that a flag, in the Examiner’s
proposed combination of Limousin and Rueter, cannot be present at the
onset of a cycle. Limousin teaches that its device, after switching to the AA1
mode from the DDD mode, remains in the AA1 mode until there is a crisis.
See, e.g., Limousin, 4:45—49. Thus, the AA1 mode in Limousin, which
precludes the ventricular pulse, persists from cycle to cycle until a need
arises for the device to operate in the DDD mode. The Examiner’s proposed
modification to Limousin, based on the teachings of Rueter, adds a step of
setting a flag for the purpose of marking the ventricular activity and
notifying the system to withhold ventricular pacing pulses. See final Act. 4.
As Limousin’s use of the AA1 mode persists from cycle to cycle, it follows
that the flag set by the Examiner’s proposed modification to Limousin would
also persist from cycle to cycle. Thus, the flag would be present at the
beginning of a cycle occurring after the cycle in which the flag is set and
would continue to be present in (and at the onset of) subsequent cycles until
a crisis occurs.
Appellant asserts:
When both an A-A cardiac cycle and ventricular sensing
are available as required by the claims, the device of Limousin
indisputably works exactly according to what would now be
described as “DDD” mode. In DDD mode, following an atrial
event, an A-V interval is initiated. In the absence of a sensed
ventricular event during the A-V interval, a ventricular pacing
pulse is delivered on expiration of the A-V interval.
Yes, Limousin has an A-A cardiac cycle in a mode in
which it is possible to set a flag in response to ventricular sensing
in a given cardiac cycle. No, it doesn’t preclude ventricular
pacing during any subsequent (current) cardiac.
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Application 13/412,120
Appeal Br. 9 (italicization added).
Claim 1 requires “setting a flag during a given cardiac cycle in
response to ventricular activity; and precluding a ventricular pacing pulse
during a current cardiac cycle if the flag is present at the onset of the current
cardiac cycle.” Id. at 14 (Claims App.). Appellant does not explain
persuasively why switching to the AA1 mode from the DDD mode, and then
maintaining the AA1 mode for subsequent cycles as taught by Limousin,
fails to qualify as the recited step of precluding ventricular pacing during a
subsequent (current) cardiac cycle. This, along with the flag setting step
provided by the Examiner’s proposed modification to Limousin, satisfies the
“setting” and “precluding” steps in claim 1.
Appellant also states:
For the sake of completeness, it should also be mentioned
that when Limousin as disclosed operates according to what
would now be defined as AAI mode, there would be no A-V
interval initiated and no flag could be set in response to
ventricular sensing. How could there be? In AAI mode as now
defined, and as in stand-alone mode in Limousin, there is never
any ventricular pacing. There would be no need to set a flag to
preclude it. Preclusion of ventricular pacing would occur in
response to programming the AAI mode, not in response to any
flag set during a previous cardiac cycle.
Appeal Br. 10 (italicization added).
Appellant’s argument on this point is unpersuasive. The Examiner’s
proposed combination of Limousin and Rueter does not rely exclusively on
the AAI mode of Limousin as corresponding to the recited step of setting a
flag during a given cardiac cycle in response to ventricular activity. Rather,
the rejection of claim 1 as unpatentable over Limousin and Rueter relies on
the AAI mode of Limousin for precluding a ventricular pacing pulse and
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adds to Limousin the teaching of flag setting explicitly taught by Rueter.
See Final Act. 3^4.
Additionally, Appellant has not apprised us of error in the Examiner’s
reasoning for the proposed modification to Limousin to include flag setting
as taught by Rueter. As the Examiner correctly finds (Final Act. 4), Rueter
teaches the use of a flag to deliver or withhold pacing pulses (see Rueter,
Abstract). The Examiner’s finding that Limousin discloses a switch (from
the DDD mode) to the AA1 mode in which no ventricular pulses are
provided, based on ventricular activity, is supported by a preponderance of
the evidence. See Final Act. 3^4; see also Limousin, 2:10—38, 9:5—10.
Limousin teaches that its AA1 mode persists from cycle to cycle until a crisis
arises. See, e.g., Limousin, 1:67—2:2; 4:45 49. As the Examiner correctly
finds, Rueter teaches a method of providing pacing pulses comparable to the
one Limousin teaches. See Final Act. 4.1 As the Examiner also correctly
finds, when Rueter sets the flag, Rueter does not provide ventricular pacing.
Rueter (Abstract). Appellant does not explain persuasively why the
Examiner’s rationale for including the setting of a flag as taught by Rueter in
the method taught by Limousin, in order to mark the event, is inadequate.
We agree with the Examiner that Limousin recognizes certain activity that
triggers a switch to the AA1 mode. See Final Act. 3^4 (stating “a flag
somewhere in the system [of Limousin] is implied to have been set in order
for the system to be switched into an AA1 mode — with no pacing pulse
delivered — if any R-waves are detected during an AV interval.”).
1 We understand the Examiner’s statement “[w]here Limousin shows the
same method as Limousin without referring to the response to ventricular
activity as ‘setting a flag’” on page 4 of the Final Action to inadvertently
compare Limousin to itself rather than to Rueter.
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Moreover, to make this recognition in Limousin explicit by setting a flag as
taught by Rueter would merely have been the use of a known technique to
improve a similar method to yield predictable results.
In the Reply Brief, Appellant states:
[T]he Examiner has apparently not reviewed her previous
arguments because they were directed to the switch from “AAI”
mode in Limousin to the “DDD” mode in Limousin. The
Examiner’s Answer now expressly argues that the claims are met
by the reverse, i.e. the switch “from DDD mode to AAI mode”
in Limousin. This new argument makes less sense than the
original argument. A ventricular sense event in the “DDD” mode
of Limousin does not trigger a switch to “AAI” mode. The
device remains in “DDD” mode and begins a new V-A escape
interval.
Reply Br. 3 (emphasis added).
We disagree with Appellant’s contention that the Examiner’s position,
in the Answer, relying on the switch to the AAI mode in Limousin, is new.
Rather, the Linal Office Action articulates this position, stating, “if
ventricular activity was detected, a flag somewhere in the system is implied
to have been set in order for the system to be switched into an AAI mode —
with no pacing pulse delivered — if any R-waves are detected during an AV
interval).” Linal Act. 3^4.
Appellant further contends:
The newly argued switch to “AAI” mode is in response to
an atrial event, not a ventricular event, so there is no necessity
that any flag set by a preceding ventricular event would persist
after initiation if the V-A interval. Implicitly, it would be
expected to have been cleared after initiation of the V-A interval
timer, as it has no further disclosed function to perform. There
is no implicit necessity or reasonable expectation that it would
persist until a subsequent mode switch to “AAI” mode in
response to a later atrial event.
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The Examiner’s new argument with regard to claim 1 is
clearly erroneous for this reason.
Reply Br. 4—5 (emphasis added); see also Reply Br. 6 (stating, “A V-sense
event in DDD mode doesn’t even trigger a mode change to “AAI” mode, so
the whole argument seems nonsensical”).
Appellant’s argument on this point is both untimely and unpersuasive.
As discussed above, the Examiner’s position regarding the disclosure in
Limousin with respect to switching to an AAI mode has not changed.
Further, a preponderance of the evidence supports the Examiner’s finding
that the switch occurs in response to ventricular activity. For example,
Limousin discloses:
The process of the reversal of the pacemaker to the AAI
mode takes place as soon as one of the following conditions is
met:
(1) recovery of a spontaneous ventricular activity (a
ventricular detection R occurs before the end of the A VD),
(2) transition from a paced atrial activity A to an atrial
detection P (which may be indicating the end of a vagal
syndrome),
(3) after 100 cycles with ventricular pacing (because the
automatic DDD mode is intended for use with paroxystic
conduction troubles).
Limousin, 9:5—16 (emphases added); see also 3:34—50. Thus, Limousin
teaches switching to the AAI mode in response to ventricular activity. As
for Appellant’s argument, raised for the first time in the Reply Brief, that
any flag “would be expected to have been cleared after initiation of the V-A
interval timer,” because it has no disclosed function to perform, we are not
persuaded inasmuch as Appellant points to no objective evidence that the
flag would not perform a function. Further, Appellant provides no
persuasive evidence or technical reasoning as to why the flag would be
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cleared before a change in conditions in Limousin would prompt a return to
the DDD mode from the AAI mode.
Appellant also asserts that “if the switch is from “DDD” to “AAI” as
newly argued, then the “given” cardiac cycle is a V-V cycle. (V-A + A-V =
V-V).” Reply Br. 5.
We do not agree with this argument. As explained above, Limousin
maintains the AAI mode of operation until a crisis occurs causing a switch to
the DDD mode. This period of time may include many consecutive cycles.
Therefore, contrary to Appellant’s assertion, the AAI mode in Limousin
persists over at least an A-A cycle. Appellant’s subsequent assertion that
“[t]his is the reason that the Examiner’s previous arguments all implicitly
were directed to the ‘given’ and the ‘current’ cardiac cycles of the claims
being the same cardiac cycle” (Reply Br. 5) is unpersuasive for the same
reason.
As for Appellant’s argument that “[f]or the sake of completeness, it is
again noted that the ‘given’ cardiac cycle in ‘DDD’ mode[] isn’t an A-A
cardiac cycle anyway, because it begins with a ventricular event (V-A
interval),” {Id. at 7) we are not apprised of Examiner error. Claim 1 recites
“setting a flag during a given cardiac cycle in response to ventricular
activity” and “wherein the given cardiac cycle is an A-A interval.” Appeal
Br. 14 (Claims App.). Appellant does not persuasively explain why the
DDD mode in Limousin, operating over multiple consecutive cycles (see
e.g., Limousin, 9:5—16), would not encompass an A-A cycle (or multiple A-
A cycles), regardless of the particular interval within an A-A cycle in which
the DDD mode begins.
We have considered all of Appellant’s arguments for the patentability
of claim 1, but we are not apprised of Examiner error. Accordingly, we
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affirm the Examiner’s rejection of claim 1 as unpatentable over Limousin
and Rueter. Because we affirm one of the alternative bases for the rejection,
we affirm the rejection. Claims 3 and 5 depend from claim 1 (Appeal Br. 14
(Claims App.)), and Appellant makes no additional arguments for the
patentability of these claims (see Appeal Br. 12—13). Accordingly, we
affirm the rejection of claims 3 and 5 as unpatentable over Limousin and
Rueter. furthermore, our claim interpretation of claim 1 is different from
the Examiner’s, as explained below, and we therefore designate our
affirmance of the rejection of claims 1 and 3—5 as a NEW GROUND of
rejection.
Conditional Limitations
Claim 1
Although the Examiner made findings in Limousin and Rueter to
address the “precluding” step in claim 1, it was not necessary for the
Examiner to do so. During examination, claims are given their broadest
reasonable interpretation consistent with the specification. See In re Am.
Acad. ofSci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Claim 1
recites, in part “precluding a ventricular pacing pulse during a current
cardiac cycle if the flag is present at the onset of the current cardiac cycle.”
Appeal Br. 14 (Claims App.). Appellant points to “steps, 502, 530, 535,
540, 545, 590 and 600 of Figure 15 as described at page 38, line 29 to page
40, line 11” as providing support for this limitation. Appeal Br. 3. Although
we appreciate the flow-chart provided in Figure 15 includes certain decision
steps and action steps that Appellant considers to be part of the invention,
claim 1 does not include language requiring the flag to be present at the
onset of the current cardiac cycle. In other words, in the method recited in
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claim 1, this triggering event may not occur.2 Therefore, the action triggered
by this condition (the “precluding” step) is not necessarily required by the
broadest reasonable interpretation of claim 1. Claim 1 covers two possible
scenarios. In one scenario, the flag is present at the onset of the current
cardiac cycle, and the precluding step is performed. In the other scenario,
the flag is not present at the onset of the current cardiac cycle, in which case
claim 1 requires no further action. In other words, claim 1 covers at least
two methods, one in which the prerequisite condition (the flag being present
at the onset of the current cardiac cycle) for the precluding step is met and
one in which the prerequisite condition is not met. Nothing in claim 1
requires iterating the method until both events (the flag being present at the
onset of the current cardiac cycle and the flag not being present at the onset
of the current cardiac cycle) occur. Accordingly, under the broadest
reasonable interpretation of claim 1, there is a scenario in which only the
“setting” step is required be performed, and the given cycle is defined by an
A-A interval. See Ex parte Schulhauser, Appeal No. 2013-007847 (PTAB
April 28, 2016) (precedential) (stating that “[i]f the condition for performing
a contingent step is not satisfied, the performance recited by the step need
not be carried out in order for the claimed method to be performed”
(quotation omitted)).
Claim 6
Addressing the rejection of claim 6, Appellant makes similar
arguments to those made above for claim 1 (see, e.g., Appeal Br. 10-11; see
also Reply Br. 7), and for the reasons discussed above, we are not persuaded
by these arguments.
2 Although the “setting” step in claim 1 causes a flag to be set, this step does
not require the flag to be present at the onset of the current cardiac cycle.
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Additionally, independent claim 6 recites, in part, “further comprising
initiating an atrial escape interval at a start of the current cardiac cycle if the
flag is present at the onset of the current cardiac cycle.” Appeal Br. 14
(Claims App.).
The Examiner finds that Limousin discloses this feature inasmuch as,
in the AAI mode, Limousin initiates an atrial escape interval to be shortened,
final Act. 5 (citing Limousin, 3:45—59).
Appellant asserts,
claim 6 more specifically sets forth the flag being set at the onset
of an atrial escape interval. Neither Reuter nor Limousin
discloses this aspect of the operation of the devices therein in the
DDD mode. In addition, this limitation further moots any
possible argument by the Examiner that the cardiac cycles of the
claims could possibly be read on AV and VA intervals during the
same atrial escape interval (A-A interval) defined by the device,
finally, this limitation also moots any possible argument by the
Examiner that the current cardiac cycle can be the cardiac cycle
in which the V-event flag was set.
Appeal Br. 11.
Appellant’s argument does not address the Examiner’s finding that
Limousin initiates an atrial escape interval in the AAI mode. Thus, this
argument is unpersuasive, and we affirm the Examiner’s rejection of claim
6. Claims 7—9 depend from claim 6 (Appeal Br. 14—15 (Claims App.)), and
Appellant makes no additional arguments for the patentability of these
claims (see Appeal Br. 12—13). Accordingly, we affirm the rejection of
claims 7—9 as unpatentable over Limousin and Rueter.
Additionally, we note that the step of initiating an atrial escape
interval is contingent upon the presence of the flag at the onset of the current
cycle, and, as discussed above, the flag may not be present at the onset of
this cycle. Accordingly, the “initiating” step in claim 6 is not necessarily
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required under the broadest reasonable interpretation of the claim. As our
claim interpretation for claim 6 is different from the Examiner’s, as was our
interpretation of claim 1, and we designate our affirmance of the rejection of
claims 6—9 as a NEW GROUND of rejection.
Claim 10
Claim 10 recites the “setting” and “precluding” steps of claim 1, but,
unlike claim 1, also specifies the actions taken if the flag is absent at the
onset of the current cardiac cycle. Appeal Br. 15 (Claims App.). Claim 10
does not require iterating the method until all possible scenarios are
exhausted. Accordingly, under the broadest reasonable interpretation of
claim 10, it was necessary for the Examiner to address either (i) the actions
taken when the flag is present at the onset of the current cardiac cycle, or (ii)
the actions taken when the flag is absent at the onset of the current cardiac
cycle, but not necessarily both. We addressed the actions in option (i) above
with respect to claim 1, and for the same reasons, we affirm the Examiner’s
rejection of claim 10 as unpatentable over Limousin and Rueter. Claims 11
and 12 depend from claim 10 (Appeal Br. 15 (Claims App.)), and Appellant
makes no additional arguments for the patentability of these claims (see
Appeal Br. 12—13). Accordingly, we affirm the rejection of claims 11 and
12 as unpatentable over Limousin and Rueter. As our affirmance of the
rejection of claims 10—12 relies on a different claim interpretation than the
one used by the Examiner, we designate it as a NEW GROUND of rejection.
DECISION
The Examiner’s rejection of claims 1,3, and 5—12 as unpatentable
over Limousin and Rueter is affirmed. We designate our affirmance of the
rejection of claims 1,3, and 5—12 as a new ground of rejection.
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This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Section 41.50(b) also provides:
When the Board enters such a non-final decision, Appellant,
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 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 the decision. Should the examiner reject the claims,
appellant 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 a new ground 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: 37 C.F.R, $ 41.50(b)
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