Ex Parte Starkebaum et al

Patent Trial and Appeal Board

Feb 23, 2016

12236836 (P.T.A.B. Feb. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/236,836 09/24/2008
71996 7590 02/25/2016
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 300
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Warren L. Starkebaum
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.
1023-710US01/
P0028348.0l
CONFIRMATION NO.
8682
EXAMINER
GEDEON, BRIANT
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/25/2016 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):
pairdocketing@ssiplaw.com
medtronic _neuro _ docketing@cardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WARREN L. STARKEBAUM,
CHARLENE X. YUAN, ROLAND C. MAUDE-GRIFFIN,
and LUIZ GERALDO PIVOTTO
Appeal2013-006307
Application 12/236,836
Technology Center 3700
Before JILL D. HILL, LISA M. GUIJT, and JASON W. MEL VIN,
Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Warren L. Starkebaum et al. (Appellants) appeal under 35 U.S.C.
§ 134 from the Examiner's decision rejecting claims 7-29 and 34--41. 1 We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 Claims 1---6 and 30-33 have been withdrawn from consideration. Final
Act. 1.
Appeal2013-006307
Application 12/236,836
CLAIMED SUBJECT MATTER
Independent claim 7, reproduced below, illustrates the claimed subject
matter.
7. A device comprising:
means for receiving a request to deliver electrical gastric
stimulation therapy to a patient;
means for prohibiting delivery of the gastric stimulation
therapy if the request is received within a lockout period
following a previous delivery of gastric stimulation therapy;
and
means for permitting delivery of the gastric stimulation
therapy if the request is not received within a lockout period
following the previous delivery of gastric stimulation therapy.
Appeal Br. Claims App.
REJECTION
Claims 7-29 and 34--41 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Foley '780 (US 2002/0072780 Al, pub. June 13, 2002),
Mann (US 2002/0107476 Al, pub. Aug. 8, 2002), and Foley '638 (US
2005/0222638 Al, pub. Oct. 6, 2005).
OPINION
The Examiner finds that Foley '780 discloses a gastric stimulator
delivering electrical stimulation controlled by an information processor and
triggered by gastric electrical activity. Final Act. 5. The Examiner finds
that Foley '780 fails to disclose the claimed lockout period, but finds this
disclosure in Mann. Id. at 5---6 (citing Mann i-f 86). The Examiner then finds
that Foley '638 discloses a preference to manage the amount of electrical
stimulation applied to a patient to prevent patient desensitization and
increase power supply longevity. Id. at 6-7 (citing Foley '638 i-fi-121, 22).
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Application 12/236,836
The Examiner concludes that, "[i]n view of the teachings of Foley '638," it
would have been obvious to one skilled in the art to modify the system of
Foley '780 "to implement the therapy lockout period taught by Mann et al.
as a safety precaution to prevent excessive electrical stimulation from
causing tissue damage, conditioning (or desensitization) to the
electrostimulation pattern, and reduce drain on battery supply." Id. at 7.
Despite utilizing separate headings for Groups 1-12, Appellants'
arguments can be combined to address Groups 1, 3, 5, and 7 together,
Groups 2, 4, 6, and 8 together, and Groups 9-12 together.
Groups 1, 3, 5, and 7: Lockout Period Prohibits Delivery
Groups 1, 3, 5, and 7 include claims 7, 8, 10-12, 13, 14, 16-20, 22-
26, 28, and 29. Regarding these claims, Appellants argue that one skilled in
the art would not reasonably look to Mann to solve a problem in Foley '780
that is already solved by Foley '638. Appeal Br. 9, 10 ("it is unclear why
one of ordinary skill in the art would look to iviann to solve problems
recognized in Foley '63 8 instead of implementing the solutions to those
problems as laid out in Foley '638"). This logic, however, is contrary to the
Federal Circuit's holding that the disclosure of desirable alternatives does
not necessarily negate a suggestion for modifying the prior art to arrive at
the claimed invention. See In re Fulton, 391 F.3d 1195 (Fed. Cir. 2004);
KSR Int'] Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007). The existence of
other alternatives, regardless of whether they provide a solution that
preceded the Examiner's proposed combination, does not render the
Examiner's proposed combination improper. Thus, we are not persuaded by
Appellants' argument. The Examiner need not explain why one skilled in
the art would choose Mann's lockout period instead of shutting down as in
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Application 12/236,836
Foley '638, because the Examiner considered the two known alternatives
yielding predictable results. Final Act. 3; Ans. 8.
Appellants reply, regarding the Examiner's contention of predictable
results, that "the addition of a lockout period to Foley '780 does not improve
the Foley '780 device in a predictable manner (let alone in the manner
predicted by Mann)," because adding Mann's infusion lockout period
"would not yield the predictable result of reducing the risk of overdosing on
therapy" as overdosing on stimulation is not possible. Appeal Br. 12. This
argument is not persuasive, because the combination need not attain the
result predicted by Mann to be "predictable." Appellants have not explained
why the combination of Foley '780 and Mann would not yield the
predictable result of preventing desensitization and battery loss as proposed
by the Examiner and set forth in Foley '638.
Appellants also argue, regarding the shutdowns of Foley '638, that its
shutdowns are not based on "when therapy was last applied or whether it
may be applied again." Appeal Br. 12. We are not persuaded by this
argument because this language is not recited in the claims of Groups 1, 3, 5,
and 7.
Appellants next argue that Foley '638 shuts its device down "based on
detection that the patient has become conditioned, and not [based on
whether] a lockout period is currently occurring." Appeal Br. 12. This
argument is not persuasive, because it does not address the combination of
references proposed by the Examiner, wherein Foley '638 is relied upon
solely to teach the desirability of preventing battery drain and desensitization
to the electrostimulation pattern. Final Act. 7. It is Mann that the Examiner
relies on to teach treatment prevention during a lockout period.
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Application 12/236,836
Appellants then argue that "adding the lockout period may in fact
prevent Foley '780 from providing stimulation when required, e.g. in
response to normal intrinsic activity as sensed by the Foley '780 device."
Appeal Br. 12. This allegation, however, is mere attorney argument without
evidence or even an explanation, and we therefore are not persuaded. In re
Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a
brief cannot take the place of evidence.").
Appellants lastly argue that the Examiner's conclusion of obviousness
was improper because "just because a feature from one reference may be
added to another, i.e. it is technically possible and feasible to do so, does not
mean that such an addition represents an improvement or would be viewed
as advantageous in any way." Appeal Br. 13. This argument fails to address
the Examiner's stated rationale, and we are not persuaded that the
Examiner's rationale lacks a reasonable basis.
For the reasons set forth above, we sustain the rejection as it applies to
Groups 1, 3, 5, and 7, including claims 7, 8, 10-12, 13, 14, 16-20, 22-26,
28, and 29.
Groups 2, 4, 6, and 8: Prohibits Delivery after Specified Time Period
Groups 2, 4, 6, and 8 include claims 9, 15, 21, and 27, which recite
"prohibiting delivery of the gastric stimulation therapy if the request is not
received within a time period specified by a therapy schedule." Appeal Br.
24--27 (Claims App.). The Examiner initially found this teaching in Mann.
Final Act. 4 (citing Mann i-f 151).
Appellants argue that Mann's basal rate delivery program provides a
baseline amount of insulin delivered throughout the day and allows boluses
after eating, which does not disclose a lockout period prohibiting delivery of
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Application 12/236,836
the gastric stimulation therapy if the request is not received within a time
period specified by a therapy schedule. Appeal Br. 14.
The Examiner responds that the teaching in Foley '638 to prevent
desensitization and battery drain would render this limitation obvious.
Ans. 12 ("one of ordinary skill in the art would be motivated to employ
[means] to deny a request for therapy outside of a programmed therapy time
in order to prevent adverse events from occurring due to over applied
stimulation therapy.")
We are persuaded by Appellants' argument regarding Groups 2, 4, 6,
and 8. The Examiner has not adequately explained how the teaching in
Foley '638 to prevent desensitization and battery drain would render obvious
the recited "prohibiting delivery of gastric stimulation therapy when a
request is not received within a time period specified by a therapy schedule."
Accordingly, we do not sustain the Examiner's rejection of as it applies to
Groups 2, 4, 6, and 8, including claims 9, 15, 21, and 27.
Groups 9-12: Lockout Period Follows Each Delivery of Therapy
Groups 9-12 include claims 34--41. Claims 34, 3 6, 3 8, and 40 recite
that the lockout period "follows each delivery of gastric stimulation
therapy." Appeal Br. 28-29 (Claims App.). Claims 35, 37, 39, and 41
depend therefrom, respectively. The Examiner finds that Mann teaches this
limitation, because its lockout period occurs immediately following an
insulin bolus delivery. Final Act. 8 (citing Mann i-f 86); Ans. 14.
Appellants argue that setting a lockout period following an insulin
bolus delivery, as described in Mann, is not the same as the claimed lockout
period because "setting a lockout period following therapy is not the same as
[setting] a lockout period following each delivery of gastric stimulation."
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Appeal Br. 19. Appellants' arguments regarding Mann's therapy delivery
do not address the rejection proposed by the Examiner, which determines
that it would have been obvious to employ a lockout period (as taught by
Mann) following the Foley '780 gastric stimulation therapy delivery. Final
Act. 8; Ans. 14. We discern no error in the Examiner's findings and
conclusions as they pertain to Groups 9-12. Accordingly, we sustain the
Examiner's rejection of claims 34--41.
DECISION
We AFFIRM the rejection of claims 7, 8, 10-14, 16-20, 22-26, 28,
29, 34--41under35 U.S.C. § 103(a) as unpatentable over Foley '780, Mann,
and Foley '638.
We REVERSE the rejection of claims 9, 15, 21, and 27 under 35
U.S.C. § 103(a) as unpatentable over Foley '780, Mann, and Foley '638.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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