Ex Parte Gilkerson et al

Patent Trial and Appeal Board

Oct 19, 2012

10756897 (P.T.A.B. Oct. 19, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES O. GILKERSON, DOUG M. BIRKHOLZ,
and DAVID L. PERSCHBACHER
__________

Appeal 2011-012800
Application 10/756,897
Technology Center 3700
__________

Before LORA M. GREEN, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims directed to an implantable defibrillator. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 25-33 and 36-45 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief (App. Br. 20-25). Claims 25 and 37 are the
independent claims. Claim 25 is representative of the claims on appeal, and
reads as follows (emphasis added):
25. A system, comprising:
an implantable monitoring circuit comprising:
a first sensing input configured to receive information
indicative of a ventricular electrical signal corresponding to a
ventricular event;
a second sensing input configured to receive information
indicative of an atrial electrical signal corresponding to an atrial event;
and
a memory circuit configured to store an adjustable blanking
interval; an implantable therapy circuit configured to provide
electrical energy to be therapeutically delivered to a heart as directed
by the implantable monitoring circuit;
wherein the implantable monitoring circuit is configured to
inhibit sensing, for a duration corresponding to the adjustable
blanking interval, of at least one of (1) the atrial electrical signal when
the information indicative of the ventricular electrical signal received
by the first sensing input includes a ventricular event, or (2) the
ventricular electrical signal when the information indicative of the
atrial electrical signal received by the second sensing input includes
an atrial event;
wherein the implantable monitoring circuit is configured to
receive the information indicative of at least one of (1) the atrial
electrical signal, or (2) the ventricular electrical signal, during a noise
window interval, the noise window interval derived from a difference
between a preset refractory period and the adjustable blanking
interval; and
wherein the implantable monitoring circuit is configured to
ignore the information received during the noise window interval, for
at least the purpose of directing the implantable therapy circuit to
provide pacing therapy.
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The following grounds of rejection are before us for review:
The Examiner has rejected claims 25-33 and 36 under 35 U.S.C.
§ 102(b) as being anticipated by Levine.
1

The Examiner has rejected claims 37-45 under 35 U.S.C. § 103(a) as
unpatentable over Levine.
The Examiner has rejected claims 25-33 and 36-45 under 35 U.S.C.
§ 103(a) as unpatentable over Lu
2
in view of Levine.

ISSUE
The Examiner takes the position that Levine disclosed a pacemaker
that is programed with an absolute blanking interval (Ans. 6), and this
absolute blanking interval is “considered to correspond to applicant‟s
adjustable blanking interval.” (Ans. 5.) The device of Levine is also
programed with a “maximum or total blanking interval [that] is considered
to correspond to applicants preset refractory period.” (Ans. 5.) Levine
disclosed relative blanking intervals that can repeat until the maximum total
blanking interval is reached, the sum of the repetitive relative blanking
intervals that reach the maximum interval are “considered to correspond to
applicant‟s noise window.” (Ans. 5.)
Appellants assert that “the duration of Levine‟s initial absolute
blanking interval is not adjustable” (App. Br. 13) and that “the total of all
the relative blanking intervals are clearly not the same as a noise window

1
Levine et al., US 5,776,167, issued Jul. 7, 1998.
2
Lu, US 5,591,214, issued Jan. 7, 1997.
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that is „derived from a difference between a preset refractory period and the
adjustable blanking interval‟” (App. Br. 14).
The issue presented is: Does the evidence of record support the
Examiner‟s conclusion that Levine anticipates claim 25, and that the
combination of Lu and Levine render claims 25 and 37 obvious?

FINDINGS OF FACT
FF1. The Specification does not provide a definition of an “adjustable
blanking interval.” The Specification provides an exemplary cross chamber
blanking interval as a “[r]efractory period 306 represents the result of
retrieving a programmed cross-chamber-blanking setting from memory
portion 144b, which defines where blanking period 306a ends and noise
window 306b begins. . . . Atrial sensing is blanked during blanking period
306a. . . . Events occurring within noise window 306b are assumed to be
noise and are thus similarly ignored.” (Spec. 7, ll. 18-25.)
FF2. The “noise window based on the difference between a preset
refractory period value (also stored in memory portion 144b), such as 86
milliseconds, and the retrieved cross-chamber blanking period . . . a
refractory period having two parts, the cross-chamber blanking part and the
noise window part, with the duration of the noise window contingent on the
cross-chamber blanking period.” (Spec. 6, ll. 21-26.)
FF3. Levine disclosed that to alleviate “the effects of crosstalk is to
disengage the sensing circuitry in the channel in which the crosstalk is
anticipated for a predetermined length of time known as a blanking
interval.” (Levine col. 2, ll. 35-38.) “[W]ith this approach, the blanking
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interval may periodically be adjusted by a physician, for practical purposes
the interval is fixed. As a result, the blanking interval is generally chosen to
be „long enough‟ to ensure that crosstalk will not affect the pacemaker under
a variety of conditions.” (Id. ll. 44-49.) Blanking-induced under sensing is a
phenomenon where the blanking period is set too long so that a natural
cardiac event is not picked up by the device. (Id. ll. 49-56.)
FF4. With safety standby pacing the pacemaker is set to a predetermined
absolute blanking interval followed by a special sensing window. (Levine
col. 10, ll. 3-5.) “During the absolute blanking interval all input sensing
circuitry is disabled to avoid the effects of crosstalk. . . . because the pulse is
applied at an abbreviated interval it serves as a marker to a physician that
safety standby pacing is being invoked. This allows the physician to
programmably shorten the length of the absolute blanking interval to more
thoroughly eliminate blanking-induced undersensing.” (Id. ll. 5-15.)
FF5. “[T]he blanking interval is made up of an initial absolute blanking
interval (e.g., 12 ms), during which the sense amplifiers [] are preferably
disabled, followed by a retriggerable relative blanking interval (e.g., 4-8 ms
each), during which signals may be sensed, but are presumed to be
crosstalk.” (Levine col. 7, ll. 30-36.) The blanking period is terminated if a
blanking interval passes without a signal or “whenever the total length of the
crosstalk sensing interval reaches a predetermined maximum blanking
interval.” (Id. ll. 43-45.)
FF6. “[I]f no relative blanking interval passes without detected signals,
blanking is still terminated when the total length of the blanking intervals
reaches a predetermined maximum blanking interval.” (Levine col. 4, ll. 48-
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52.) “The maximum blanking interval preferably can be adjusted to any
suitable length between zero and the length of the AV delay.” (Id. col. 8, ll.
57-59.)
FF7. “The blanking period is a function of sensing/pacing polarity;
sensitivity; pacing amplitude, pulse width, lead maturation, and position of
leads. In general, in prior art devices, the durations of these blanking periods
was either fixed at the factory, or was one of the adjustable programmer
parameters.” (Lu col. 1, ll. 37-44.)
FF8. “The calculator 26 includes an atrial noise sensor 106 and a
ventricular noise sensor 108. These sensors receive respectively the atrial
and ventricular intracardiac signals as shown in FIG. 1. The calculator 26
also includes an atrial pace command generator 102 and a ventricle pace
command generator 104.” (Lu col. 4, ll. 8-13.)
FF9. Lu‟s Fig. 1A is reproduced below.

Lu Fig. 1A. shows that the prior art recognized eight possible blanking
periods in a pacemaker (Lu col. 1, ll. 29-37).
FF10. After “test blanking signal Bat, the atrial noise sensor 106 starts
monitoring the atrial intracardiac signal. . . . Noise signal 302 sensed in the
atrium decays after a time duration Tan at which time its peak falls below
the sensor threshold level ATH.” (Lu col. 4, ll. 47-58.)
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FF11 “[T]he blanking period is then calculated or set by adding Bat + Tan
(longest) + safety factor.” (Lu col. 5, ll. 15-16.)
FF12. The Tmax is set “[i]n order to insure that the blanking period does not
exceed the A-V interval, the period Tvn is limited to 80 msec (TMax).” (Lu
col. 5, ll. 1-3.)

PRINCIPLES OF LAW
“The law of anticipation does not require that the reference „teach‟
what the subject [application] teaches. Assuming that a reference is properly
„prior art,‟ it is only necessary that the claims under attack . . . „read on‟
something disclosed in the reference, i.e., all limitations of the claim are
found in the reference.” Kalman v. Kimberly-Clark Corp., 713 F.2d 760,
772 (Fed. Cir. 1983).
“The Patent Office has the initial duty of supplying the factual basis
for its rejection. It may not . . . resort to speculation, unfounded assumptions
or hindsight reconstruction to supply deficiencies” in the cited references. In
re Warner, 379 F.2d 1011, 1017 (CCPA 1967). “[R]ejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 417-18 (2007).

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ANALYSIS
Anticipation by Levine
The Examiner takes the position that Levine anticipates the claims
because “the maximum or total blanking interval is considered to correspond
to applicant's preset refractory period, and Levine‟s absolute blanking
interval is considered to correspond to applicant's adjustable blanking
interval, and Levine‟s relative blanking interval is considered to correspond
to applicant's noise window.” (Ans. 5.) The Examiner asserts that “memory
to store operation data, such as time intervals, AV delays, etc must be
inherent in the device of Levine for it to operate.” (Ans. 5.)
Appellants‟ arguments are that Levine does not teach an “adjustable
blanking interval where „the implantable monitoring circuit is configured to
inhibit sensing, for a duration corresponding to the adjustable blanking
interval‟. . . . The total blanking interval mentioned by Levine „is made up
of an initial absolute blanking interval . . . followed by a retriggerable
relative blanking interval.”‟ (App. Br. 13.) Appellants assert that “the
duration of Levine‟s initial absolute blanking interval is not adjustable”
(App. Br. 13) and “the total of all the relative blanking intervals are clearly
not the same as a noise window that is „derived from a difference between a
preset refractory period and the adjustable blanking interval‟” (App. Br. 14).
Appellants assert that the “Office Action fails to point out where Levine
discloses the adjustable blanking interval or how the relative blanking
interval of Levine meets the claimed recitation of a noise window.” (App.
Br. 14.)
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We are not persuaded by Appellants‟ arguments. We agree with the
Examiner‟s position that the “absolute blanking interval” disclosed in Levine
is encompassed by the “adjustable blanking interval” of independent claim
25. We are also not persuaded by Appellants argument that the duration of
the absolute blanking interval of Levine is not adjustable. Levine not only
disclosed that the absolute blanking interval is adjustable to eliminate
blanking induced under sensing (FF3), Levine also disclosed that the
maximum blanking interval is also adjustable (FF6). The maximum or total
blanking interval is found by the Examiner to correspond to the preset
refractory period. (Ans. 5.) The sensing circuitry is enabled during Levine‟s
relative blanking intervals (Levine col. 4, ll. 42-44), and these intervals were
found by the Examiner to correspond to the measurements taken in
Appellants noise window. The Examiner finds that “if one were to subtract
the absolute blanking interval of Levine, from the total blanking interval [or
maximum blanking interval] of Levine, one is left with the relative blanking
interval, which is considered to be applicant‟s noise window interval.”
(Ans. 9.) Levine‟s device is configured to inhibit sensing during the
absolute blanking interval (FFs 4, 5), and allows for sensing during the
relative blanking interval (FF5). In instances were a noise signal is received
during a relative blanking interval time another blanking interval is initiated
this pattern can continue until the maximum blanking interval has passed at
that time blanking interval stops and a new sensing interval is started. (FF6.)
Levine‟s goal was is to shorten the blanking interval in order to avoid
problems associated with blanking-induced under sensing. (FF5.) However,
there will be instances where the relative blanking period will take up the
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entire period starting from the time the absolute blanking interval stops (that
is the period were the sensing is inhibited) and the relative blanking period
begins and continues until the maximum blanking interval is reached. (FF5.)
A reference does not fail as to anticipate merely because it does not contain
a description of the subject matter of the appealed claim in ipsissimis verbis.
See In re May, 574 F.2d 1082, 1090 (CCPA 1978). With Levine‟s device
there will be circumstances where the relative blanking period continues
until the maximum blanking interval is reached under these conditions
Levine‟s system meets the claim limitation of “the noise window interval
derived from a difference between a preset refractory period and the
adjustable blanking interval.”
We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that Levine anticipates the implantable
monitoring circuit of claim 25. As Appellants do not argue the claims
separately, claims 26-33 and 36 fall with that claim. 37 C.F.R. § 41.37
(c)(1)(vii).

Obviousness over Levine
The Examiner takes the position that “a memory which can store
instructions is considered to be inherent in the device of Levine”. (Ans. 6.)
“[F]or the implanted device to perform as desired, it must be programmed
with instructions that control its operation.” (Ans. 6.) The Examiner asserts
that “one of ordinary skill in the art would also consider that including all of
the instructions of claim 37 into a memory circuit would be well known to
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do in the art, and would be necessary in order to initially program and
subsequently adjust the instructions as needed by the patient.” (Ans. 6.)
Appellants contend that “the Office Action has failed to articulate
some rational underpinning supporting the § 103 rejection . . . because the
Office Action entirely omits any discussion of the majority of the recitations
of claim 37, other than the memory circuit.” (App. Br. 15.)
We are not persuaded by Appellants‟ arguments. As discussed above,
Levine discloses the limitations of inhibiting sensing for the duration of the
adjustable blanking period, and ignoring signals received during the
adjustable blanking period and noise window interval. As explained above,
there will be circumstances where the relative blanking period continues
until the maximum blanking interval is reached, under these conditions
Levine‟s device meets the claim limitation of “the noise window interval
derived from a difference between a prese[]t refractory period and the
adjustable blanking interval.” Levine disclosed safety standby pacing (FF4),
thus, the device can therapeutically deliver electrical energy to the heart
based on the information gathered by the sensors. The Examiner asserts that
the presence of a memory circuit for storing the adjustable blanking interval
in the implantable stimulation device of Levine is an inherent feature of the
device in order for the device to function. “The inherent teaching of a prior
art reference, a question of fact, arises both in the context of anticipation and
obviousness.” In re Napier,55 F.3d 610, 613 (Fed. Cir. 1995). In order to
overcome a rejection based on inherency Appellant can “prove that the
subject matter shown to be in the prior art does not possess the characteristic
relied upon.” In re Swinehart 439 F.2d 210, 213 (1971). Appellants have
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not shown that Levine does not possess a memory circuit or the ability to
store an adjustable blanking period. Accordingly, the rejection of claims 37-
45 under 35 U.S.C. 103(a) is affirmed.

Obviousness over Lu in view of Levine
The Examiner takes the position that Lu teaches the ability to sense
and stimulate both atrium and ventricle. Lu disclosed eight different possible
blanking periods in a pacemaker (FF9). “Lu teaches programming a
blanking interval, but does not explicitly recite the use of a noise window
interval. . . . the patent to Levine teaches the use of a relative blanking
interval, which is considered to be applicant's noise window.” (Ans. 7.)
“[T]o use a noise window, shown as a relative blanking interval in Levine,
would have been obvious since it would be a combination of known
elements yielding a predictable result, and that using a noise window would
further eliminate crosstalk. Further, as is well known, implanted devices
store instructions in a memory so that such instructions allow for the proper
functioning of the device.” (Ans. 8.)
Appellants assert that “Levine fails to disclose the claimed noise
window . . . [and] Lu does not cure this deficiency as Lu does not appear to
mention a noise window so configured.” (App. Br. 16.) Appellants assert
that the Examiner‟s rejection is based on conclusory statements without
providing any articulated reason with a rational underpinning to support the
legal conclusion. (App. Br. 17.)
We are not persuaded by Appellants‟ arguments. As discussed above
Levine teaches an absolute blanking interval that can be adjusted by the
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physician or programmer (FFs 3, 4), this absolute blanking interval is a time
period were no input is received from the sensor (FF5). Levine also teaches
a maximum blanking interval that serves as the stop for any repetitive
relative blanking periods that begin to run after the absolute blanking period
ends (FF6). The relative blanking period is a time period where the sensors
receive signal but this signal is presumed crosstalk. (FF5.) “Lu teach[es]
that the various blanking periods can be modified in a physician‟s office via
a programmer which downloads programming parameters into the implanted
pacemaker.” (Ans. 7) The microprocessor in Lu‟s pacemaker contains a
blanking period calculator to determine and adjust blanking periods. (Lu
col. 3, l. 65 to col. 4, l. 7.) In the atrium, the atrial sensor is turned off for a
Bat period (test blank period), after that period the sensor is turned on and
monitors the noise signal until it falls below a set threshold level, this time
period is designated the Tan period. (FF10.) In Lu the blanking period is
calculated or set by adding Bat (test blanking signal about 20-30 msec) +
Tan (longest) + safety factor (about 15 msec). (FF11.) Changes to the
blanking periods can be made or modified in the physician‟s office while the
pacemaker is coupled to a programmer (Lu col. 4, ll. 17-20), or they may be
determined by the pacemaker itself using the calculator that is part of the
implanted device. (Lu col. 5, ll. 61-62). The Examiner takes the position
that the feature of programming and storing different blanking instructions
were inherent in the device of Levine to be operational (Ans. 5) and
concludes that it would have been obvious to combine the reference with Lu
that “explicitly teach the ability to store blanking periods in an implanted
device.” (Ans. 8.)
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We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that the combination of Lu in view of
Levine renders obvious implantable system and monitoring circuit of
claims 25 and 37. We thus affirm the rejection of claims 25 and 37 under 35
U.S.C. § 103(a) as being obvious. As Appellants do not argue the claims
separately, claims 26-33 and 36 fall with those claims. 37 C.F.R. § 41.37
(c)(1)(vii).

SUMMARY
We affirm the rejection of claims 25-33 and 36 under 35 U.S.C.
§102(b) as anticipated by Levine.
We affirm the rejection of claims 37-45 under 35 U.S.C. §103(a) as
unpatentable over Levine.
We affirm the rejection of claims 25-33 and 36-45 under 35 U.S.C.
§103(a) as unpatentable Lu in view of Levine.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2006).

AFFIRMED

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