Ex Parte Deno et al

Patent Trial and Appeal Board

Mar 28, 2014

11342785 (P.T.A.B. Mar. 28, 2014)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.
11/342,785 01/30/2006 D.Curtis Deno P0022582.00/LG10126

EXAMINER

MEDTRONIC, INC. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 LEGAL PATENTS
MINNEAPOLIS, MN 55432-9924
PORTER, JR. GARY A
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE

03/28/2014 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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte D. CURTIS DENO and WILLIAM J. HAVEL
__________

Appeal 2011-011774
Application 11/342,785
Technology Center 3700
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 13-18, 21, and 23. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Medtronic Inc. (App. Br. 3).
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STATEMENT OF THE CASE
The Specification discloses that “electrical defibrillation restoring
normal sinus rhythm (NSR) after a prolonged period of fast ventricular
tachyarrhythmia (VT) or ventricular fibrillation (VF) may not . . . restore
adequate mechanical function of the heart” (Spec. 1, ¶ 03). “[T]his
condition, known as pulseless electrical activity (PEA), is likely due to
ischemic stunning” (id.). According to the Specification, “[i]n some cases of
mechanical cardiac dysfunction, PESP [post-extrasystolic potentiation]
therapy has been found to restore an adequate response of the cardiac muscle
to electrical depolarization, thereby increasing cardiac output” (id. at 1,
¶ 02). “PESP is achieved by delivering electrical pulses to a ventricle soon
after a refractory period of a previous ventricular depolarization expires”
(id.).
Claim 13 is representative of the claims on appeal and reads as
follows (emphasis added):
13. A medical device system adapted for implantation in a patient
having a heart for the treatment of the heart having an arrhythmia having a
duration from an onset of the arrhythmia to a termination of the arrhythmia,
the system comprising:
a pair of electrodes;
a set of low polarization electrodes configured to sense electrical
activity of the heart;
a counter operatively coupled to the set of low polarization electrodes
and configured to log the duration of the arrhythmia from the onset of the
arrhythmia to the termination of the arrhythmia; and
a therapy module operatively coupled to the pair of electrodes and the
counter, and configured to deliver over the pair of electrodes:
an electrical stimulation to terminate the arrhythmia; and
electrical potentiation pulses when the duration of the
arrhythmia from the onset of the arrhythmia to the termination of the
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arrhythmia is longer than approximately 30 seconds and is shorter
than approximately 300 seconds corresponding to a prescribed time
window.

Issue
The Examiner has rejected claims 13, 14, 18, 21, and 23 under
35 U.S.C. § 103(a) as obvious in view of Deno2 (Ans. 3-6). Claims 14, 18,
21, and 23 have not been argued separately from claim 13 and therefore
stand or fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). The Examiner
has also rejected, under 35 U.S.C. § 103(a), claim 15 over the combination
of Deno and Lovett3 (Ans. 6) and claims 16 and 17 over the combination of
Deno and Bennett4 (id. at 6-7). Because Appellants only argue that Lovett
and Bennett do not remedy the deficiencies of Deno, we will consider these
rejections together (App. Br. 18-20).
The issue presented is: Has the Examiner established by a
preponderance of the evidence that Deno would have made obvious a
medical device system for the treatment of heart arrhythmia comprising a
therapy module configured to deliver electrical potentiation pulses when the
arrhythmia duration, from onset to termination, “is longer than
approximately 30 seconds and is shorter than approximately 300 seconds,”
as required by claim 1?

2 Deno et al., US 2004/0049235 A1, published Mar. 11, 2004.
3 Lovett et al., US 2004/0215240 A1, published Oct. 28, 2004.
4 Bennett et al., US 5,331,966, issued Jul. 26, 1994.
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Findings of Fact
FF1. The Examiner finds that “Deno discloses an ICD [implantable
cardioverter/defibrillator] system 14 . . . comprising electrodes at the end of
endocardial leads 16, 32 and 52 that are configured to pace the heart and/or
sense the response of the heart to therapy” (Ans. 3-4).
FF2. The Examiner finds that Deno “discloses that these leads are
low polarization lead systems” (id. at 4).
FF3. The Examiner finds that Deno’s Example 2 “discloses a counter
configured to log a duration of any detected tachyarrhythmia from beginning
to termination and then subsequently initiates therapy with a therapy module
if the duration of the episode exceeds a predetermined threshold value” (id.).
FF4. The Examiner finds that “Deno does not explicitly disclose that
the predetermined threshold range is between 30 seconds and 300 seconds”
(id.).
FF5. The Examiner finds that the instant Specification indicates “that
a time frame of greater than 30 seconds is needed to result in ischemic
stunning of the heart while not attributing any criticality to the upper limit of
300 seconds” (id., citing the Spec. at 6, ¶ 19).
FF6. The Examiner finds that, with regard to
the lower threshold of 30 seconds, . . . [Deno] states ‘If the
duration of the episode exceeded a programmable threshold
before being terminated, indicating that the likelihood was high
that cardiac mechanical function was severely impaired, the
device would initiate a NES/PESP therapy for a fixed duration
following the episode
(Id. at 11, citing Example 2).
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FF7. The Examiner finds that “[r]egarding the upper threshold of 300
seconds claimed by Appellants, the Examiner notes that a general upper
limit of 300 seconds exists in the teaching of Deno” (id. at 8).
FF8. The Examiner finds that Deno
states ‘A patient with a history of HF may not tolerate a
tachyarrhythmia well for more than a few minutes . . . Despite
prompt and good care, defibrillation after a prolonged several
minutes of cardiac ischemia may result in EMD/PEA or
asystole and death.’ Deno ‘235 clearly states that allowing an
arrhythmia to persist for longer than a ‘few minutes’ would be
detrimental to the patient.

(Id.)
FF9. The Examiner concludes that
it would have been obvious to one having ordinary skill in the
art . . . to set the detection threshold between 30 seconds and
300 seconds, since it has been held that where the general
conditions of a claim are disclosed in the prior art (in this case,
the general condition is treating ischemic stunning with PESP),
discovering the optimum or workable ranges involves only
routine skill in the art. In re Aller, 105 USPQ 233.

(Id. at 4-5.)
FF10. The Examiner reasons that “finding the optimal time frame for
indicating that ischemic stunning is present after the termination of a
tachyarrhythmia would only require routine skill in the art in light of the
Deno . . . teaching” (id. at 5).
FF11. Deno discloses that “[d]elivering pacing during the refractory
period is a type of non-excitatory stimulation (NES) that causes the release
of catecholamines such as norepinephrine within the tissue of the heart . . .
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[that] results in an increased contractility of the cardiac tissue” (Deno 4, ¶
0027).
FF12. Deno discloses that “[a]nother type of electrical stimulation
can be provided during the nonrefractory period of the cardiac cycle. This
type of stimulation results in an additional electrical depolarization and,
when appropriately timed, results in post extrasystolic potentiation (PESP)”
(id. at 4, ¶ 0030).
FF13. In Example 2, Deno discloses that “[d]uring a tachyarrhythmia,
the coronary blood flow perfusing the heart can become severely impaired,
leading to ischemia and a temporary loss in cardiac contractility referred to
as stunning. If the loss in contractility is severe . . . further ischemia will
result” (id. at 25, ¶ 0246).
FF14. In Example 2, Deno discloses that
[a]n example of a PESP/NES stimulation therapy would include
treating impaired cardiac mechanical function following a
tachyarrhythmia. . . . If the duration of the episode exceeded a
programmable threshold before being terminated, indicating
that the likelihood was high that cardiac mechanical function
was severely impaired, the device would initiate a NES/PESP
therapy . . . to hasten re-perfusion of the heart . . .

(Id. at 25, ¶ 0247.)
FF15. In Example 4, Deno discloses that a “patient with a history of
HF may not tolerate a tachyarrhythmia well for more than a few minutes”
(id. at 26, ¶ 0256).

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Analysis
Appellants argue that Deno “does not show, disclose or suggest a
therapy module that triggers electrical potentiation therapy when the
duration logged in a counter is longer than approximately 30 seconds and is
shorter than approximately 300 seconds” (App. Br. 11). Appellants argue
that Deno “does not set a lower limit for a timeframe, i.e., does not show,
disclose or suggest that the duration . . . must . . . be greater than a particular
time” (id.).
That argument is not persuasive. As recognized by the Examiner
(Ans. 11), Deno discloses a programmable threshold for an arrhythmia
duration that would trigger the initiation of NES/PESP therapy following
termination of the arrhythmia episode. Deno also discloses that achievement
of the threshold indicates a high likelihood that cardiac mechanical function
has occurred. “[W]here general conditions of a claim are disclosed in the
prior art, it is not inventive to discover the optimum or workable ranges by
routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Thus, in accord with In re Aller, because Deno discloses both the concept of
a threshold and the purpose of the threshold, it would have been obvious for
one of skill in the art to optimize the length of the threshold duration to
deliver post-arrhythmia therapy to only those patients that require such
therapy.
Appellants also argue that Deno “does not discuss withholding PESP
therapy unless the duration is less than approximately 300 seconds since
Deno . . . sets no upper limit whatsoever” (App. Br. 12). Appellants argue
that although Deno’s Example 2 discloses PESP therapy after the
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termination of the arrhythmia, the Examiner improperly relied Deno’s
Example 4, which relates to PESP during supraventricular tachycardias, for
the suggestion of an upper limit.
Those arguments are not persuasive. Although Deno’s Example 4
relates to PESP during supraventricular tachycardias, Example 4 provides
the concept that patients with different heart conditions may tolerate
arrhythmias to different degrees and that for some patients, arrhythmia’s that
last longer than five minutes may present different considerations. The
Supreme Court has emphasized that “the [obviousness] analysis need not
seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” KSR Int’l v.
Teleflex Inc., 550 U.S. 398, 418 (2007); see also id. at 421 (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”). “If
a person of ordinary skill can implement a predictable variation, § 103 likely
bars its patentability.” (Id.) Here, since Deno suggests that different patients
may tolerate arrhythmia’s differently, it would have been obvious to set an
upper limit on the duration of an arrhythmia that would be followed by
PESP therapy so that other interventions could be employed in situations
where longer-duration arrhythmia’s would be problematic.
Thus, we affirm the rejection of claim 13 as being obvious in view of
Deno, and claims 14, 18, and 23 fall with claim 13. 37 C.F.R.
§ 41.37(c) (1) (vii).

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As to claim 21, Appellants reiterate the argument made with respect to
claim 13, that is that Deno “does not show, disclose or suggest a therapy
module operatively coupled to the pair of electrodes and the counter, and
configured to deliver over the pair of electrodes the first electrical
stimulation pulse and the second electrical stimulation pulse to terminate the
arrhythmia and electrical potentiation pulses when the duration between the
first electrical stimulation and the second electrical stimulation is longer than
approximately 30 seconds and is shorter than approximately 300 seconds
within a prescribed time window” (App. Br. 17). That argument is not
found to be convincing for the reasons set forth above.
The Examiner has also rejected dependent claims 15, 16, and 17 under
35 U.S.C. § 103(a) in view of Deno and further in view of either Lovett or
Bennett. Appellants argue that neither Lovett nor Bennett cures the
deficiencies of Deno with respect to the claim 13 limitation of delivering
electrical potentiation pulses when the duration of the arrhythmia is longer
than approximately 30 seconds and is shorter than approximately 300
seconds (App. Br. 18-20). Those arguments are not persuasive because, as
discussed above, we have concluded that claim 13 is obvious in view of
Deno.
Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that Deno would have made obvious a medical device system for
the treatment of heart arrhythmia comprising a therapy module configured to
deliver electrical potentiation pulses when the arrhythmia duration, from
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onset to termination, is longer than approximately 30 seconds and is shorter
than approximately 300 seconds.
SUMMARY
We affirm the rejection of claims 13-18, 21, and 23 under 35 U.S.C.
§ 103(a).
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).

AFFIRMED

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