Ex Parte Wang

Patent Trial and Appeal Board

Apr 28, 2016

12609700 (P.T.A.B. Apr. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/609,700 10/30/2009
27581 7590 05/02/2016
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Li Wang
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.
P0023242.00 8922
EXAMINER
BAYS,PAMELAM
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
05/02/2016 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 LI WANG
Appeal2014-003655
Application 12/609,700
Technology Center 3700
Before EDWARD A. BROWN, GEORGE R. HOSKINS and
AMANDA F. WIEKER, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEivIENT OF THE CASE
Li Wang (Appellant)1 appeals under 35 U.S.C. § 134(a) from the
Examiner's decision rejecting claims 1-27. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
1 The Appeal Brief identifies Medtronic, Inc., as the real party in interest.
Br. 2.
Appeal2014-003655
Application 12/609,700
CLAIMED SUBJECT MATTER
Appellant's invention "relates to implantable medical devices, and,
more particularly, to collection of diagnostic information by implantable
medical devices." Spec. para. 1. Claims 1, 12, 22, 26, and 27 are
independent. Claim 1 illustrates the claimed subject matter:
1. A method comprising:
identifying, with an implantable medical device (IMD)
implanted within a patient, at least one physiological event; and
measuring an interval within a cardiac cycle for one or
more cardiac cycles in response to the identification of the at
least one physiological event to generate one or more measured
intervals.
Br. 13, Claims App.
REJECTIONS
The claims stand rejected as follows:
1. Claims 1-10, 12-19, and 21-27 under 35 U.S.C. § 102(b) as
anticipated by Bardy (US 6,336,903 Bl, issued Jan. 8, 2002).
2. Claims 11 and 20 under 35 U.S.C. § 103(a) as unpatentable
over Bardy and Van Dam (US 6,671,549 B2, issued Dec. 30, 2003).
ANALYSIS
Anticipation by Bardy (Claims 1-10, 12-19, and 21-27)
Claims 1-10
Claim 1 recites "measuring an interval within a cardiac cycle for one
or more cardiac cycles in response to the identification of the at least one
physiological event to generate one or more measured intervals" (emphasis
added) (hereafter "disputed limitation"). The disputed limitation requires
the interval be measured after, i.e., "in response to," the identification of the
physiological event.
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Appeal2014-003655
Application 12/609,700
The Examiner found that the flowchart shown in Figures 13A-13B of
Bardy discloses the disputed limitation. Final Act. 3, 8-9. Particularly, the
Examiner found that Bardy discloses identifying at least one physiological
event (decreased cardiac output 240, decreased mixed oxygen score 241,
decreased patient activity score 243, and increased PADP 245) (Final Act. 3
(citing Bardy, Fig. 13A)), and measuring an interval within a cardiac cycle
for one or more cardiac cycles (heart rate 24 7; measuring other intervals,
such as PR interval, AV interval, QRS measures, ST-T wave measures, and
QT interval) (id. (citing Bardy, col. 7, 11. 35--45; Figs. 13A-13B)) in
response to the identification of the physiological event (id. (citing Bardy,
Fig. 13A)). The Examiner found that Bardy "only analyzes heart rate from
interval data if other triggers are met." Id. (citing Bardy, col. 17, 11. 35-50).
According to the Examiner, the intervals (heart rate 24 7) are only "taken into
consideration, or 'measured,'" when the "physiological event" triggers are
activated (i.e., the "yes" arrows corresponding to blocks 240, 241, 243, 245,
etc. in Figures 13A and 13B). Ans. 9 (citing Bardy, col. 17, 11. 35-50).
Appellant contends that the intervals in Bardy identified by the
Examiner "are measured as part of the process previous to the detection of a
physiological event." Br. 6. In regard to heart rate, Appellant contends that
"the analysis of heart rate" in Bardy is based upon intervals measured
"previously to" the identified physiological event, not on any measurements
of heart cycle durations made after the identification of the physiological
event. Id. at 7. Appellant acknowledges that "analysis of the previously
measured intervals occurs responsive to the identification of the
physiological event," but asserts that "analysis of the measured intervals
isn't measurement of the intervals." Id. at 10 (emphasis added).
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Appeal2014-003655
Application 12/609,700
Appellant's contentions are persuasive. Figures 13A-13B of Bardy
are flow diagrams showing a routine for determining the onset of congestive
heart failure (CHF). See Bardy, col. 17, 11. 34--36; Figs. 13A-13B. Bardy
discloses that CHF is possible based on the symptom categories of reduced
exercise capacity (block 244) and respiratory distress (block 250). Id. at col.
17, 11. 36-39. Bardy describes blocks 240-243 and 245-250 as "individual
indications" for determining the onset of CHF. Id. at col. 17, 11. 54--59. The
individual indication "Increased heart rate?" (block 247) in Figure 13B is
considered only if the indication "Increased respiratory rate?" (block 246) is
answered affirmatively. Id. at Fig. 13B.
Bardy also teaches that cardiovascular information can be recorded
for a patient by an implantable device. Id. at col. 7, 11. 19-54; see also col.
3, 11. 21-25. The patient's information is recorded on a regular basis and
stored in a record 40. Id. at col. 7, 11. 19-54; see also col. 3, 11. 25-27. The
regularly collected data sets for a patient are categorized as monitoring
sets. Id. at col. 7, 1. 61---col. 8, 1.
Bardy teaches that patient status change is determined by comparing
one or more recorded measures from each monitoring set to at least one
other recorded measure. Bardy, col. 3, 11. 42--44. Bardy also teaches that
patient status change is tested against an "indicator threshold" corresponding
to the same type of patient information as the recorded measures that were
compared. Id. at col. 3, 11. 46--48. Figure 1 lA of Bardy is a flow diagram
for testing threshold limits 139. Id. at col. 14, 11. 17-19. "Calculate heart
rate" (block 173) is one indicator threshold 129 (Fig. 5). Id. at col. 15, 11. 6-
9, 15-19; Fig. 1 lA. The stored indicator thresholds relate to the individual
indications shown in Figure 13A-13B. See id. at col. 15, 1. 10---col. 16, 1. 23.
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Appeal2014-003655
Application 12/609,700
Appellant's contention that the Examiner has identified "no intervals
measured after or responsive to identification of the physiological event" is
persuasive. Br. 11. Assuming that the blocks in Figures 13A and 13B that
precede block 247 noted by the Examiner correlate to physiological events,
the Examiner has not shown by a preponderance of the evidence that
increased heart rate (block 24 7) is determined by measuring an interval
within a cardiac cycle in response to the identification of a physiological
event to generate one or more measured intervals. Bardy appears to
compare measured data stored in different monitoring sets to determine
patient status change, and then test the status change against stored indicator
thresholds, such as heart rate. The Examiner has not shown that when heart
rate is "taken into consideration" at block 24 7, an interval within a cardiac
cycle is "measured" in response to the identification of a physiological event
as represented by a block in Figures 13A and 13B preceding block 247.
Appellant's assertion that Bardy instead teaches that "analysis of the
previously measured intervals occurs responsive to the identification of the
physiological event" is consistent with disclosure in Bardy discussed above.
Br. 10. The Examiner has not shown that such analysis of measured
intervals is the same as measurement of the intervals.
The Examiner also states that in the method of Figure 1 lA of Bardy,
the heart rate 173 is only calculated after the respiratory rate 170 is
measured, which is another example of measuring an interval in response to
a physiological event. Ans. 10. However, as discussed above, Figure 1 lA
relates to a routine for testing threshold limits, including "Calculate heart
rate" (block 173). Assuming that "Calculate respiratory rate" (block 170)
corresponds to identification of a physiological event, as claimed, the
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Appeal2014-003655
Application 12/609,700
Examiner has not shown that calculating heart rate in this routine includes
the disputed limitation.
Accordingly, we do not sustain the rejection of claim 1, and claims 2-
10 depending therefrom, as anticipated by Bardy.
Claims 12-19 and 21
Claim 12 recites an implantable medical device comprising, inter alia,
"an interval measurement unit configured to measure an interval within a
cardiac cycle for one or more cardiac cycles in response to the identification
of the at least one physiological event to generate one or more measured
intervals." Br. 14, Claims App. (emphasis added). The Examiner's findings
for claim 12 are substantially the same as those for claim 1. Final Act. 3.
Accordingly, we also do not sustain the rejection of claim 12, and claims
13-19 and 21 depending therefrom, as anticipated by Bardy.
Claims 22-25
Claim 22 is directed to a system comprising an implantable medical
device configured to "measure an interval within a cardiac cycle for one or
more cardiac cycles in response to the identification of the at least one
physiological event to generate one or more measured intervals." Br. 15-16,
Claims App. (emphasis added). The Examiner's findings for claim 22 are
substantially the same as those for claim 1. Final Act. 4. Accordingly, we
also do not sustain the rejection of claim 22, and claims 23-25 depending
therefrom, as anticipated by Bardy.
Claim 26
Claim 26 is directed to a non-transitory computer-readable storage
medium and recites the same noted limitation as claim 22. Br. 16, Claims
App. The Examiner's findings for claim 26 are substantially the same as
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Appeal2014-003655
Application 12/609,700
those for claim 1. Final Act. 6. Accordingly, we also do not sustain the
rejection of claim 26 as anticipated by Bardy.
Claim 27
Claim 27 is directed to a system comprising, inter alia, "means for
measuring an interval within a cardiac cycle for one or more cardiac cycles
in response to the identification of the at least one physiological event to
generate one or more measured intervals." Br. 16-17, Claims App.
(emphasis added). The Examiner found that the systems disclosed in Bardy
are functional equivalents to those disclosed in Appellant's Specification.
Final Act. 6-7.
However, the Examiner has not shown by a preponderance of the
evidence that Bardy discloses the measuring function of the "means for
measuring" recited in claim 27. Accordingly, the Examiner has not shown
that Bardy discloses all limitations of claim 27. Thus, we also do not sustain
the rejection of claim 27 as anticipated by Bardy.
Obviousness over Bardy and Van Dam (Claims 11and20)
Claims 11 and 20 depend from claims 1 and 12, respectively, and
recite that "the interval comprises a QRS width." Br. 14--15, Claims App.
The Examiner's application of Van Dam to claims 11 and 20 does not cure
the deficiencies of the rejection of claims 1 and 12 discussed above. Final
Act. 7. Accordingly, we do not sustain the rejection of claims 11 and 20 as
unpatentable over Bardy and Van Dam.
DECISION
The Examiner's decision to reject claims 1-27 is reversed.
REVERSED
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