Ex Parte Lu et al

Patent Trial and Appeal Board

Aug 10, 2018

14211884 (P.T.A.B. Aug. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/211,884 03/14/2014
27581 7590 08/14/2018
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Richard M.T. Lu
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.
C0003515.USU2 8075
EXAMINER
HOLMES,REXR
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/14/2018 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 RICHARD M.T. LU,
SUBHAM GHOSH, and ROBERT W. STADLER
(APPLICANT: MEDTRONIC, INC.)
Appeal2017-004965
Application 14/211,884 1
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1-10, 13, 15-
17, and 23-26 (App. Br. 2). 2 Examiner entered rejections under 35 U.S.C.
§ 101, 35 U.S.C. § 102(b), and 35 U.S.C. § 103(a)3• We have jurisdiction
under 35 U.S.C. § 6(b ).
We REVERSE.
1 Applicant, Medtronic, Inc., is the real party in interest (App. Br. 2).
2 Pending "[ c ]laims 11, 12, 14 and 18 - 22 are allowable but depend from
rejected claims" (App. Br. 2).
3 We herein refer to the Specification, filed Mar. 14, 2014 ("Spec."); Appeal
Brief, filed Oct. 12, 2016 ("App. Br."); the Examiner's Answer, mailed Dec.
1, 2016; and the Reply Brief, filed Jan. 31, 2017 ("Reply Br.").
Appeal2017-004965
Application 14/211,884
STATEMENT OF THE CASE
Appellants' "disclosure pertains to cardiac pacing methods and
systems, and, more particularly, to cardiac resynchronization therapy
(CRT)" (Spec. 1: 17-18). According to Appellants:
Cardiac resynchronization therapy devices operate by either
delivering pacing stimulus to both ventricles or to one ventricle
with the desired result of a more or less simultaneous
mechanical contraction and ejection of blood from the
ventricles. Ideally, each pacing pulse stimulus delivered to a
ventricle evokes a response from the ventricle. Delivering
electrical stimuli that causes the ventricle to respond is
commonly referred to as capturing a ventricle.
(Id. at 11. 21-26.)
Appellants' claims 1 and 24 are representative and reproduced below:
1. An apparatus for determining whether a ventricular pacing
stimulus is capturing a paced ventricle during atrial fibrillation,
compnsmg:
processing means for determining whether a patient is
experiencing atrial fibrillation;
delivering means for delivering the ventricular pacing
stimulus in response to determining the patient is in atrial
fibrillation;
sensing means for sensing a signal in response to the
ventricular pacing stimulus;
processing means for determining whether the ventricular
pacing stimulus is effectively capturing the paced ventricle;
modifying means for modifying a pacing rate during
atrial fibrillation in response to the determination of effective
capture; and increasing a percentage of effective ventricular
capture during atrial fibrillation responsive to modifying the
pacing rate during atrial fibrillation.
(App. Br. 12.)
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Application 14/211,884
24. A method for determining whether a ventricular pacing
stimulus is capturing a paced ventricle during atrial fibrillation,
compnsmg:
determining whether a patient is experiencing atrial
fibrillation;
delivering the ventricular pacing stimulus in response to
determining the patient is in atrial fibrillation;
sensing a signal in response to the ventricular pacing
stimulus;
determining whether the ventricular pacing stimulus is
effectively capturing the paced ventricle;
modifying a pacing rate during atrial fibrillation in
response to the determination of effective capture; and
increasing a percentage of effective ventricular capture
during atrial fibrillation responsive to modifying the pacing rate
during atrial fibrillation.
(App. Br. 16.)
The claims stand rejected as follows:
Claims 1-3, 10, 12, 15-17, and 23 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Dawson. 4
Claims 4, 5, 8, and 9 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Dawson and Enrooth. 5
Claims 6 and 7 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Dawson, Enrooth, and More. 6
Claims 24--26 stand rejected under 35 U.S.C. § 101.
4 Dawson et al., US 5,999,850, issued Dec. 7, 1999.
5 Enrooth et al., US 2012/0165897 Al, published Jun. 28, 2012.
6 More et al., US 2011/0319951 Al, published Dec. 29, 2011.
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Application 14/211,884
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Dawson teaches Appellants' claimed invention?
ANALYSIS
Examiner finds that the apparatus of Appellants' claim 1 7 "only
requires [ components that] determin[ e] atrial fibrillation, deliver[]
ventricular stimulation in response to the determined fibrillation, sens[ e] a
response to the ventricular stimulation, determin[ e] ventricular capture,
[and] modify[] the pacing rate in response to the capture" (Ans. 7). In this
regard, Examiner finds that Dawson "includes each and every limitation ...
[and is] capable of performing the intended use," and, therefore, anticipates
Appellants' claimed apparatus (id.). We are not persuaded that Examiner
established an evidentiary basis on this record to support a finding that
Dawson anticipates Appellants' claimed apparatus.
Dawson discloses "a pacemaker having means for providing atrial
defibrillation using defibrillation pulses applied precisely in synchronism
with ventricular activity. Moreover [Dawson] ... pertains to an implantable
atrial defibrillator which monitors the ventricle and stabilizes the same if
7 Appellants' claims 2, 3, 10, 12, 15-17, and 23 depend directly or indirectly
from Appellants' claim 1 (see App. Br. 12-16).
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Application 14/211,884
necessary, before the application of atrial defibrillation pulses" (Dawson 1:
11-17). For clarity, Dawson's Figure 4 is reproduced below:
FIG.4
Dawson's "FIG. 4 shows a flow chart for applying defibrillation therapy in
accordance with [Dawson's] invention" (Dawson 3: 2-3 (emphasis
omitted)). In this regard, Dawson discloses:
Starting in FIG. 4 with step 200, [a] microprocessor[] monitors
the atrium, using [an] atrial rate monitor []. In step 202 a
determination is made as to whether an atrial defibrillation
episode is detected or not[.] ...
If no atrial fibrillation is detected then [a] state machine
[] continues its standard pacing protocol ... and then returns to
monitoring the atrium (step 200).
If atrial fibrillation is detected in step 202, then in step
204 the atrial rate monitor sends a pacing mode command to
switch the pacing mode of the state machine [] to another (non-
atrial coupled) mode such as VDI®. In step 206, atrial
monitoring continues. If atrial fibrillation ceases then in step
208, the state machine is returned to its original pacing mode
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(i.e., in this case, DDDR). If atrial fibrillation continues, then a
measurement is made of the ventricular rate stability in step
210. The reason for this step ... is to insure that any atrial
defibrillation therapy applied to the heart will not cause a
potentially fatal ventricular tachyarrhythmic episode. For
example, such an undesirable event may occur if the atrial
defibrillation therapy is applied while the RR interval between
successive ventricular events is too short. Stabilizing the
ventricular rate insures that short cycles occur less frequently
and generally reduces the potential for an induced ventricular
arrhythmia.
. . . If the ventricular rate is found in test 212 not to be
stable, then in step 214 a preselected procedure is followed to
stabilize the ventricle first, before any defibrillation therapy is
applied .... [S]tabilization may be accomplished by adjusting
the ventricular pacing rate until adequate stabilization is
confirmed e.g., when ventricular rate or interval variability is
reduced below a threshold.
More specifically, and as part of this mode of operation,
... [a] ventricular monitor[] selects a new, higher ventricular
pacing rate (if required to stabilize the ventricular rate) ... and
sends this new rate to [a] pacing calculator [].
In step 212, a test is performed to determine if the
ventricle stability as determined in step 210 is satisfactory ....
If in step 212 it is determined that the ventricular rate is
unstable then in step 214 an attempt is made to stabilize the
same. For instance, the pacing rate may be increased by a small
amount D 1 from the previous pacing rate. D 1, for example,
may be 5 ppm. The whole process is repeated until the
ventricular rate is stabilized as determined in steps 212 and 216
for at least 64 cycles, or alternatively the atrial fibrillation
spontaneously converts to sinus rhythm.
In step 218, ventricular rate stability is confirmed, for
example by determining that within a running 5 minute
window, the ventricular rate did not change by more than ±10
bpm. If ventricular rate stability is not confirmed then in step
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220, the ventricular pacing is reduced by a small amount (i.e., 5
ppm), and the whole process is recycled.
If ventricular rate stability is confirmed in step 218, then
in next step 222 the next ventricular event ( either intrinsic or
paced) is detected. In step 224 the current RR interval is
measured. If this interval is too short, (for example less than
400 ms), then the process is repeated. If this interval exceeds
an interval threshold DZ, then in step 226 an atrial defibrillation
pulse is applied.
(Dawson 5: 6- 7: 6 (emphasis omitted).)
Dawson's Figures 1 and 2, as relied upon by Examiner, are
reproduced below:
VENT DtFlB. LEAD 34 :
I FIG. 1 1 ___________________________ J
Dawson's "FIG. 1 shows a block diagram for an atrial defibrillator
constructed in accordance with [Dawson's] invention" (Dawson 2: 64---65
( emphasis omitted)).
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Application 14/211,884
FIG.2
"FIG. 2 shows details of the pacing, sense and defibrillator circuit of FIG. 1"
(Dawson 2: 66-67 (emphasis omitted)).
According to Examiner, Dawson's system
includes a processing means ( e.g. 16) for determining if a
patient is experiencing atrial fibrillation ( e.g. Figure 4, element
202), a delivering means (e.g. 14, 46, 54) for delivering the
ventricular pacing stimulus in response to determining the
patient atrial fibrillation (e.g. Figure 4, element 204), a sensing
means ( e.g. 14, 42, 50) for sensing a signal in response to the
ventricular pacing stimulus ( e.g. Figure 4; element 206),
processing means ( e.g. 16) for determining whether there is
effective ventricular capture (e.g. Figure[] 4 ... ; elements 212
... ) and a modifying means (e.g. 16) for modifying a pacing
rate in response to effective capture ( e.g. Figure 4; element
214).
(Ans. 7.) As Appellants explain, however, "Dawson's mechanism as
disclosed does not meet the limitations of the claims because ventricular rate
stability as disclosed [in Dawson] does not correspond to a determination of
effective ventricular capture," as required by Appellants' claimed invention
(App. Br. 8; see also Reply Br. 5). In this regard, Appellants contend that
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Application 14/211,884
Dawson makes "[ n Jo attempt to sense signals in response to delivered pacing
pulses to determine efficacy of capture," but instead Dawson "[ o ]nly
[analyzes] the rate of sensed ventricular depolarizations" (App. Br. 9).
Thus, Appellants' contend, Dawson's "device stabilizes the ventricular rate
not by increasing the percentage of pulses that effectively capture the
ventricle but by increasing the pacing rate to above that of the general rate of
the intrinsically conducted ventricular depolarizations" (id.).
To make up for the deficiency in Examiner's rationale, which, as
highlighted above, was identified by Appellants, Examiner asserts that
Dawson's device "is capable of and/or programmed to do each of
[Appellants'] stated functions" (Ans. 7-8; see also id. at 8 ("Since Dawson
includes each and every [apparatus] limitation it is capable of performing the
intended result")). We are not persuaded.
As Appellants explain,
Examiner does not refute Applicant's [sic] arguments but
simply argues, without any support whatsoever, that Dawson is
capable of being re-programmed to perform [the] function
[ required by Appellants' claims].
There is nothing in Dawson that identifies the function as
claimed. There is nothing in Dawson that discloses that the
device could be re-programmed to perform the function as
claimed. There is nothing in Dawson that discloses that the
function as claimed should be performed.
(Reply Br. 5.) We agree with Appellants. To establish anticipation,
Dawson's device must perform Appellants' claimed function; it is not
sufficient that Dawson's device may simply be capable of being
programmed to perform the functions required by Appellants' claimed
invention. See Typhoon Touch Techs., Inc. v. Dell, Inc., 659 F.3d 1376,
13 81 (Fed. Cir. 2011) ( affirming district court holding that "memory for
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storing" limitation "requires that the memory is actually programmed or
configured to store the data collection application"). Thus, on this record,
Examiner failed to establish an evidentiary basis to support a finding that
Dawson's device performs according to the requirements of Appellants'
claimed invention.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner's finding that Dawson teaches Appellants' claimed invention.
The rejection of claims 1-3, 10, 12, 15-17, and 23 as being anticipated by
Dawson.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Examiner finds that "Dawson discloses [Appellants'] claimed
invention except for the exact electrode placing and effective capture
parameters" and relies upon Enrooth to make up for this deficiency (Ans. 4--
5). In addition, Examiner finds that the combination of Dawson and Enrooth
fails to suggest "more than two electrodes in the left ventricle" and relies on
More to make up for this deficiency in the combination of Dawson and
Enrooth (id. at 5). Thus, Examiner concludes that, at the time of Appellants'
invention, it would have been prima facie obvious in view of the
combination of Dawson and Enrooth to modify Dawson's system to include
multiple electrode locations and capture modes as taught by Enrooth (see id.
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4--5). Examiner further finds that it would have been prima facie obvious, at
the time of Appellants' claimed invention, to modify the system suggested
by the combination of Dawson and Enrooth to include "four electrodes in
the left ventricle, as taught by More" (id. at 5). We are not persuaded by
Examiner's conclusion that Dawson in combination with Enrooth alone, or
in combination with More, makes up for the deficiency discussed above with
respect to Dawson (see App. Br. 10 (Examiner's obviousness rejections "fail
for the same reasons as the [anticipation] rejection"); cf Ans. 8 (Examiner
asserts that "the 103 rejections stand as the 102 rejections stand for the
reasons above" with respect to the anticipation rejection)).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 4, 5, 8, and 9 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Dawson and Enrooth is reversed.
The rejection of claims 6 and 7 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Dawson, Enrooth, and More is
reversed.
Patent Eligible Subject Matter:
ISSUE
Does the evidence of record support Examiner's finding that
Appellants' claimed invention is directed to non-statutory subject matter?
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ANALYSIS
Examiner finds that Appellants' claimed invention is directed to
patent ineligible subject matter, specifically an abstract idea without
significantly more (see Ans. 2-7). According to Examiner, Appellants'
claims "do not include additional elements that are sufficient to amount to
significantly more than the judicial exception because processing heart rates
are previously known to the industry as evidence[d] by the [prior] art
applied" in the prior art rejections on this record (id. at 2-3). We are not
persuaded.
Even if Examiner is correct in finding that Appellants' claimed
invention encompasses an abstract idea, for the reasons set forth above,
Examiner failed to establish a factual basis on this record to support a
finding that the prior art relied upon teaches that the elements of Appellants'
claimed invention beyond the abstract idea were routine, conventional, well-
understood or, in Examiner's parlance, well-known, in this art (see generally
Reply Br. 2--4). See Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir.
2018) ("[ w ]hether something is well-understood, routine, and conventional
to a skilled artisan at the time of the patent is a factual determination").
CONCLUSION OF LAW
The evidence of record fails to support Examiner's finding that
Appellants' claimed invention is directed to non-statutory subject matter.
The rejection of claims 24--26 under 35 U.S.C. § 101 is reversed.
REVERSED
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