Ex Parte Sheldon et al

Patent Trial and Appeal Board

Feb 27, 2019

14605040 (P.T.A.B. Feb. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/605,040 01/26/2015
27581 7590 03/01/2019
Medtronic, Inc. (CVG)
8200 Coral Sea Street NE.
MS:MVC22
MINNEAPOLIS, MN 55112
FIRST NAMED INVENTOR
Todd J. Sheldon
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.
P0041329.USC8/LG10126.L33 4926
EXAMINER
HOLMES,REXR
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
03/01/2019 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):
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TODD J. SHELDON AND WADE M. DEMMER1
Appeal2017-003847
Application 14/605,040
Technology Center 3700
Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
KRISTI L. R. SA WERT, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an implantable cardiac pacing
system configured to be wholly implanted on or in a patient's heart. The
Examiner rejected the claims as anticipated under 35 U.S.C. § 102 and as
obvious under 35 U.S.C. § 103. Pursuant to 35 U.S.C. § 134, Appellant
appeals the Examiner's determination that the claims are unpatentable. We
have jurisdiction under 35 U.S.C. § 6(b). The§ 102 and§ 103 rejections are
reversed. A new ground of rejection pursuant to 37 C.F.R. § 1.50 is set forth
under§ 103.
1 The Appeal Brief ("Br." entered June 9, 2016) lists Medtronic, Inc., as the
real party in interest. Br. 2.
Appeal2017-003847
Application 14/605,040
STATEMENT OF THE CASE
The Examiner finally rejected the claims as follows:
Claims 1--4, 11, and 12 under 35 U.S.C. § I02(a)(l) as anticipated by
Bradley et al. (U.S. Pub. 2003/0208241 Al, published Nov. 6, 2003)
("Bradley"). Ans. 2.
Claims 5, 8, 9, and 14 under 35 U.S.C. § I03(a) as obvious in view of
Bradley and Ferek-Petric (U.S. Pub. 2004/0172082 Al, published Sept. 2,
2004). Ans. 4.
Claim 1, the only independent claim on appeal, is reproduced below
(bracketed numbering added for reference to the three "means for"
limitations of the claim):
1. An implantable cardiac pacing system configured to be
wholly implanted on or in a patient's heart, the system
including a pulse generator having a microprocessor based
control circuit, the control circuit comprising:
[ 1] means for triggering periodic pacing threshold
searches, wherein the periodic pacing threshold searches
comprise applying a series of test pacing pulses at incremented
and/ or decremented levels of pulse energy and detecting evoked
responses thereto;
[2] means for setting an operational pacing pulse energy
based upon the results of the pacing threshold search; and
[3] means for reducing pacing rate responsive to the
operational pacing pulse energy being set greater than a
predetermined maximum desirable pulse energy.
Br. 15 (Claims Appendix).
ANTICIPATION BY BRADLEY
The three "means for" limitations in claim 1 are addressed below in
separate headings.
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[ 1] "means for triggering periodic pacing threshold searches, wherein the
periodic pacing threshold searches comprise applying a series of test pacing
pulses at incremented and/or decremented levels of pulse energy and
detecting evoked responses thereto"
The Examiner found that Bradley describes performing an "automatic
capture threshold detection search" which corresponds to the claimed
"periodic pacing threshold search." Final Act. 5; Bradley, Fig. 3 (212). The
Examiner further found that the threshold detection search described in
Bradley comprises steps of "decrement[ing] the pulse magnitude" and
"increment[ing] the pulse magnitude", which meet the claimed step of
"applying a series of test pacing pulses at incremented and/or decremented
levels of pulse energy." Final Act 5; Bradley, Fig. 4 (302, 312). As
explained below, the Examiner's findings are supported by a preponderance
of the evidence.
Bradley describes a method of performing "overdrive pacing" to heart
tissue to prevent or terminate arrhythmias by delivering overdrive pulses.
Bradley ,r,r 1, 3, 4. An "overdrive pulse" is one that is delivered "at a rate
somewhat faster than the intrinsic heart rate of the patient" for the purpose of
"preventing or terminating arrhythmias." Id. at ,r 3. The automatic capture
threshold detection search is performed by Bradley to identify a pulse
magnitude for the overdrive pulse which "can be kept as low as possible
while still ensuring that substantially all overdrive pulses are properly
captured [by the heart] such that backup pulses are not often needed." Id. at
,r 11. Bradley explains that "[ t ]his further helps reduce power
consumption." Id. Bradley further describes the "automatic capture
threshold detection search" in paragraphs 11 and 50-58.
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Application 14/605,040
As stated above, Bradley teaches that "capture" is measured during
the "automatic capture threshold detection search" upon delivery of a pacing
pulse. Bradley, Fig. 4 ("Capture Detected?"). "Capture" is an atrial
contraction2 elicited by the pacing pulse and therefore is an "evoked
response" to the test pacing pulse as required by the claim.
Appellants did not dispute that the claimed "periodic pacing threshold
search" corresponds to Bradley's automatic capture threshold detection
search."
[2] "means for setting an operational pacing pulse energy based upon the
results of the pacing threshold search"
The Examiner found that Bradley describes a step of "Set pulse
magnitude to current magnitude pulse safety margin and return to Fig. 3."
Final Act. 6; Bradley. Fig. 4 (318). The Examiner determined that this step,
which is part of the "automatic capture threshold detection search," meets
the limitation of the claimed "means for setting an operational pacing pulse
energy based upon the results of the pacing threshold search." Final Act. 6.
As explained in more detail below, the Examiner's determination is
supported by a preponderance of the evidence.
Bradley teaches that, in performing the automatic capture threshold
detection search, "Upon detection of a first recapture event following the
previous two consecutive LOCs, processing simply returns to step 302 for
delivery of another overdrive pulse." Bradley ,r 57. LOC is a "loss-of-
2 "However, in order for this scheme to work, it must be assured that each
overdrive pulse actually triggers an atrial contraction, i.e. that the overdrive
pulses are captured by the atria. If overdrive pulses are not captured, i.e. a
loss-of-capture (LOC) occurs." Bradley ,r 7.
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capture" event which occurs when an overdrive pulse does not trigger atrial
contraction and therefore the atrium does not "capture" the pulse by
contracting. Id. at ,r 7. Capture is when contraction is elicited. In other
words, when a pulse results in a capture by the heart ("first recapture
event"), another overdrive pulse is delivered.
Bradley further teaches that, when a second recapture event is
detected upon administering a second, consecutive overdrive pulse, "step
318 is ... performed wherein the standard pulse magnitude is reset to be
equal to the current pulse magnitude plus a safety margin of 0.5 volts."
Bradley ,r 57. The "standard pulse magnitude" is therefore set ("reset")
based on the threshold detection search. The "standard pulse magnitude"
corresponds to the claimed "operational pacing pulse energy." Thus, the
"operational pacing pulse energy" is set based on the threshold search,
meeting the corresponding claim limitation of "setting an operational pacing
pulse energy based upon the results of the pacing threshold search."
In sum, when a pulse is delivered that results in two consecutive
captures by the heart, the standard pulse is reset and the "threshold detection
search is thus complete and processing returns to step 212 of PIG. 3 for
further overdrive pacing using the newly reset pulse magnitude." Bradley
,r 57 ( emphasis added). The "newly result pulse magnitude" is used as the
new "standard pulse magnitude" and the claimed "operational pacing pulse
energy."
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[3] "means for reducing pacing rate responsive to the operational pacing
pulse energy being set greater than a predetermined maximum desirable
pulse energy"
The Examiner found that Bradley describes increasing the pulse
magnitude to high output mode (HOM), which the Examiner determined
corresponded to the claimed limitation of "operational pacing pulse energy
being set greater than a predetermined maximum desirable pulse energy."
Final Act. 6. The Examiner also found that the pulse rate is reduced in
response to increasing the pulse magnitude, meeting the corresponding
limitation of "reducing pace rate" in response to setting the pulse energy
greater (HOM) than the "operational pacing pulse energy." Final Act 6;
Bradley, Fig. 6 (502 ("Decrement overdrive rate")).
Appellants contend that the Examiner "does not identify any
predetermined maximum desirable energy level that is less than the energy
level of the HOM pulses, as would be necessary to meet the limitations of
the claims." Br. 8. Appellants argue that the "mere fact that HOM is the
greatest available energy level does not mean that it is greater than the
required 'predetermined maximum desirable energy level'." Id. at 9.
Appellants further contend: "As far as can be determined from the teaching
of Bradley, no pulse energy less than HOM is identified or predetermined to
be undesirable." Id.
Appellants' argument does not persuade us that the Examiner erred in
finding the disputed limitation met by Bradley.
The Examiner found that the "predetermined maximum desirable
pulse energy" is the pacing energy (pulse magnitude) set based on the
threshold search. Limitation 2, as described above, performs this step. The
Examiner found that this pulse magnitude is less than the HOM. Ans. 5---6.
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This determination, as explained in more detail below, is supported by a
preponderance of the evidence.
We begin by addressing Bradley's disclosure. As shown in Figure 3
of Bradley, after the automatic capture threshold detection search is
performed (212 ), and a new pulse magnitude is set (318 of Fig. 4 ), a routine
is performed to determine whether "rate recovery" will be performed (208 of
Fig. 3) "to establish a new lower overdrive [pulse] rate." Bradley ,r 51. The
rate recovery method is used to reduce the pulse rate delivered to the heart.
The Examiner cites this method as meeting "means for" limitation 3.
In the rate recovery method described in Fig. 6 of Bradley, the first
step comprises increasing the pulse magnitude to high output mode (HOM).
Bradley, Fig. 6 (500). Bradley explains that "upon initial entry into the rate
recovery mode, the overdrive pacing unit increases the pulse magnitude to
the HOM voltage, at step 500, to help ensure that loss of capture does not
occur." Bradley ,r 65. Just prior to entering the rate recovery mode, the
pulse magnitude was set to the magnitude determined in the threshold
search. Therefore, the subsequent adjustment to the HOM voltage is
necessary higher than the pulse magnitude. For this reason, we find that
Appellants' argument that "no pulse energy less than HOM is identified"
(Br. 8) is not supported by the factual evidence in this record.
Appellants also argue that "no pulse energy less than HOM is ...
predetermined to be undesirable." Br. 8. This argument is also not
persuasive because of a lack of factual underpinnings.
Figure 4 of Bradley, which shows the automatic capture threshold
detection method, has a step in which the pulse magnitude is decreased:
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At step 302, the overdrive unit decrements the current pulse
magnitude by a preprogrammed pulse magnitude decrement
(e.g. 0.25V) then, at step 304, delivers a pacing pulse at the new
lower pulse magnitude.
Bradley ,r 56.
If capture by the heart is not detected (no atrial contraction; namely,
an LOC event) using the decremented pulse magnitude, additional steps are
taken in which the magnitude is then increased until capture is detected:
If the pulse was not captured, a backup pulse is delivered at the
HOM voltage at step 308 and a Consecutive LOC Counter is
incremented at step 310 for use in counting consecutive LOC
events. Processing then continues at step 302 wherein the pulse
magnitude is further decremented every other cycle. Another
pulse is delivered and capture verification is again performed. If
a second consecutive LOC is detected, the overdrive unit
increases the pulse magnitude by a preprogrammed pulse
magnitude increment (e.g. 0.125V) at step 312 and enables the
counting ofpost-LOC beats using a Recapture Counter.
Bradley ,r 56 (emphasis added).
Bradley explains that the threshold is determined "a result of the
various increments and decrements" of the pulse magnitude. Bradley ,r 57.
"Thus the pulse magnitude is decremented every other pulse until two
consecutive LOCs are detected, then the pulse magnitude is increased
slightly until two consecutive captures are again evoked." Bradley ,r 58.
The automatic capture threshold detection process (the claimed
"periodic pacing threshold search") therefore lowers the pulse magnitude
until no capture is detected and then raises it incrementally until capture by
the heart ( contraction) is detected. By this method, the pulse magnitude is
first adjusted to a new level that causes capture, but is then reduced to find a
lower magnitude that still elicits capture by the heart. The higher magnitude
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pulse is therefore considered by Bradley to be undesirable because Bradley
seeks to reduce its magnitude to a lower value that still evokes atrial
contraction and heart capture. As explained above, this threshold searching
process results in a pulse magnitude that is lower than the HOM.
Appellants' argument that "no pulse energy less than HOM is identified or
predetermined to be undesirable" is therefore not supported by the evidence
in this record.
Bradley is also seeking the "maximal desirable pulse energy" in its
threshold search that reliably evokes capture each time since any lower value
would not do so. Thus, the corresponding claim limitation is also met.
Appellants argue that HOM "is not set based on the results of any
prior threshold search. It is set as a part of initiating a threshold search." Br.
10.
Along this same line, Appellants further argue that "the threshold
search of Figure 4 is initiated in response to the occurrence of two
successive LOC events." Br. 13. Namely, when two pulse do not result in
atrial contraction, a new pulse threshold is sought that reliably produces
contraction. As a result, Appellants state "the process of Figure 6 relied
upon by the Examiner clearly occurs as part of a process that triggers a
following capture threshold search in Figure 4. Therefore, it cannot possibly
occur 'in response to' a threshold." Br. 13. The "it" is apparently the HOM
of Bradley, the feature the Examiner relied upon to find that the "greater"
pulse magnitude in the third limitation of claim 1 is met by Bradley.
Appellants state that therefore the "process of Figure 6, including setting the
pulse level to HOM is conducted regardless of the energy level resulting
from any preceding threshold search of Figure 4." Br. 13.
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This argument does not persuade us that the Examiner erred.
Claim 1 recites that "the operational pacing pulse energy [is] being set
greater than a predetermined maximum desirable pulse energy." Appellants
have not identified language in this limitation that would require the
"greater" energy pulse, or the HOM in Bradley, to be based on a "prior
threshold search" or to be in response to a threshold. Br. 10, 13. The claim
merely recites that the energy is "set greater than a predetermined maximum
desirable pulse energy." Appellants are arguing a limitation that does not
appear in the claim. The claim does not require that the HOM be set in
response to a threshold search.
Appellants correctly state (Br. 13) that the threshold search in Figure 4
occurs when two loss of capture events (LOC) are observed, leading to a
process which results in new pulse magnitude. Bradley ,r 57. However, we
do not see, and Appellants have not explained, the relationship between this
step and setting "the operational pacing pulse ... greater than a
predetermined maximum desirable pulse energy" as required by the third
limitation of claim 1.
Appellants also state, in this same argument, that "the process of
Figure 6 [the recovery method in which the pulsing rate is reduced] ...
clearly occurs as part of a process that triggers a following capture threshold
search in Figure 4." It is true that once the recovery pulse rate is set by the
process of described in Figure 6, Bradley teaches returning to the process of
Figure 3 where it is determined whether a new capture threshold detection
search is necessary. Bradley, Fig. 6 (318); ,r 65.
Based on these latter two factual points (Br. 13), Appellants conclude
that therefore HOM - which is set as a part of the rate recovery method of
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Figure 6 - "cannot possibly occur 'in response to' a threshold (Br. 13).
However, as we already concluded, the claim does not state that the HOM
(i.e., "the operational pacing pulse energy being set greater than a
predetermined maximum desirable pulse energy") occurs "in response" to a
threshold. Appellants have not directed us to language in the claim which
would require such a step.
Nonetheless, even if the claim required the HOM to be set in response
to a threshold search, Bradley would meet this limitation. The second
limitation of claim 1 recites that the "operational pacing pulse energy based
upon the results of the pacing threshold search." The "operational pacing
pulse energy" is based on the results of the threshold search and HOM is
subsequently set above it. Bradley ,r 65. Thus, because the pulse magnitude
of HOM is set above the pulse magnitude determined in the automatic
capture threshold detection search (Bradley ,r 65, Fig. 6 (500) as discussed in
detail above), HOM is, in fact, set based on the results of the threshold
search or a response thereto contrary to Appellants' argument (Br. 10-11).
Claim preamble
Claim 1 is directed to an "implantable cardiac pacing system
configured to be wholly implanted on or in a patient's heart." The Examiner
found that this limitation is met by Bradley, identifying Figure 1 of Bradley
as support. Final Act. 5. However, as argued by Appellants, Figure 1 shows
the stimulation device 10 outside the heart. The Examiner did not identify
disclosure in Bradley describing where the device is positioned. The
Examiner also did not provide adequate evidence that the device is of the
size, material, etc., that would make it capable of being implanted on or in a
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patient's heart. The Examiner's reference to the device being capable of
implanted in an elephant or blue whale (Final Act. 5) is not a persuasive
since the Examiner did not provide evidence that such mammals utilize
pacing systems, that they could be provided with one, or that the device of
Bradley would even be capable of being implanted on or in a heart of an
elephant or whale. The Examiner bears the initial burden of presenting a
prima facie case ofunpatentability. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992); In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984).
Because this burden was not met, we are compelled to reverse the rejection
based on 35 U.S.C. ,r 102.
Nonetheless, the Specification teaches in its "Background" section:
Mechanical complications often associated with elongate lead
wires, which are well known to those skilled in the art, have
motivated the development of cardiac pacing systems that are
wholly contained within a relatively compact package for
implant in close proximity to the pacing site, for example,
within the right ventricle RV of the heart.
Spec. 1: 18-22.
Jacobson (WO 2007/047681 A2, published April 26, 2007; listed on
IDS statement filed by Appellants on Mar. 27, 2015), describes a cardiac
pacing device that is placed or attached to the inside or outside of a cardiac
chamber. Jacobson ,r 39. One of ordinary skill in the art would have had
reason to have utilized Bradley's pacing method in the Jacobson cardiac
pacing device, which is implanted in a patient's heart as required by claim 1,
to avoid mechanical complications (such as inflammation).
For the foregoing reasons, pursuant to 37 C.F.R. § 4I.50(b), a new
ground of rejection of claim 1 is set forth under 35 U.S.C. § 103(a) as
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obvious in view of Bradley and Jacobson. We leave it to the Examiner to
determine the obviousness of dependent claims 2- 4, 11, and 12.
REJECTION BASED ON BRADLEY AND FEREK-PETRIC
The rejection of claim 5, 8, 9 and 14 under 35 U.S.C. § 103(a) as
obvious in view of Bradley and Ferek-Petric is based on Bradley describing
a device wholly implanted on or in a patient's heart. Because we determined
that this limitation is not met by Bradley, the rejection is reversed. We leave
to the Examiner to determine the obviousness of rejected claims 5, 8, 9, and
14 in view of Bradley, Jacobson, and Ferek-Petric.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.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, the 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.
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(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 MPEP § 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)(l). See 37 C.F.R.
§§ 41.50(±), 4I.52(b).
REVERSED; 37 C.F.R. § 4I.50(b)
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