Ex Parte Libbus et al

Patent Trial and Appeal Board

Nov 6, 2017

14582999 (P.T.A.B. Nov. 6, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/582,999 12/24/2014 Imad Libbus 279.871US5 1001
45458 7590 11/08/2017
smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER
PO BOX 2938 BERTRAM, ERIC D
MINNEAPOLIS, MN 55402
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
11/08/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IAMD LIBBUS, ANDREW P. KRAMER,
WILLIAM J. LINDER and JEFFREY E. STAHMANN,1
Appeal 2017-001238
Application 14/582,999
Technology Center 3700
Before DONALD E. ADAMS, DEBORAH KATZ,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to neural
stimulation systems, which have been rejected for obviousness-type double
patenting and as being obvious. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Cardiac Pacemakers, Inc.
Appeal Br. 2.
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Application 14/582,999
STATEMENT OF THE CASE
“Neural stimulation is applied to treat various pathological
conditions.” Spec. 1. For example, neural stimulation is used “to regulate
cardiac functions and hemodynamic performance.” Id. “While a patient
with neurological and/or other disorders may potentially benefit from neural
stimulation, improper delivery of electrical energy to the nervous system
may cause nerve injury and unintended effects in various physiological
functions.” Spec. 2. The Specification describes “[a] neural stimulation
system [that] includes a safety control system that prevents delivery of
neural stimulation pulses from causing potentially harmful effects.” Id.
Claims 21—27, 32—38, and 40 are on appeal.2 Claims 21 and 33 are
the sole independent claims and read as follow:
21. A neural stimulation system for delivering neural
stimulation to the autonomic nervous system of a patient,
comprising:
a stimulation output circuit configured to deliver neural
stimulation pulses to the autonomic nervous system;
a stimulation controller coupled to the stimulation output
circuit, the stimulation controller configured to control the
delivery of the neural stimulation pulses using stimulation
parameters; and
a safety controller coupled to the stimulation controller,
the safety controller including:
a safety-control event detection module including an
unintended effect detection module and a stimulation parameter
detection module, the unintended effect detection module
configured to detect an unintended effect caused by the delivery
of the neural stimulation pulses to the autonomic nervous
2 Claims 28—32 and 39 are also pending but have been withdrawn from
consideration. Final Act. 1.
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Application 14/582,999
system, the stimulation parameter detection module configured
to detect at least a first parameter value being a value of a first
parameter of the stimulation parameters, the safety-control
event detection module configured to indicate a detection of a
safety-control event in response to a detection of the unintended
effect and in response to the value of the first parameter
exceeding a threshold; and
a safety response module configured to adjust one or
more parameters of the stimulation parameters in response to
the detection of the safety-control event.
33. A method for operating a neural stimulation system
including a stimulation output circuit, a stimulation controller,
and a safety controller, comprising:
delivering neural stimulation pulses to the autonomic
nervous system of a patient from the stimulation output circuit;
controlling the delivery of the neural stimulation pulses
using stimulation parameters using the stimulation controller;
detecting a safety-control event using the safety
controller, including detecting an unintended effect resulting
from the delivery of the neural stimulation pulses to the
autonomic nervous system and detecting a first parameter value
being a value of a first parameter of the stimulation parameters;
indicating a detection of the safety-control event in
response to a detection of the unintended effect;
indicating a detection of the safety-control event in
response to the first parameter value exceeding a first threshold
value; and
adjusting one or more parameters of the stimulation
parameters, using the safety controller, in response to the
detection of the safety-control event.
The claims stand rejected3 as follows:
3 Claims 2—27 and 33—38 were rejected under 35 U.S.C. § 102(b) as
anticipated by Stahmann. Final Act. 4. The Examiner withdrew this
rejection. Ans. 5.
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Claims 21—27, 29, and 32-40 have been rejected for obviousness-type
double patenting over claims 1—19 of US 7,551,958 B2.4
Claims 21—27, 29, and 32-40 have been rejected for obviousness-type
double patenting over claims 1—20 of US 8,050,753 B2.5
Claims 21—27, 29, and 32-40 have been rejected for obviousness-type
double patenting over claims 1—20 of US 8,391,972 B2.6
Claims 21—27, 29, and 32-40 have been rejected for obviousness-type
double patenting over claims 1—20 of US 8,923,962 B2.7
Claims 21—27 and 33—38 have been rejected under 35 U.S.C. § 103(a)
as unpatentable over Baker8 in view of Stahmann.9
Claims 32 and 40 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Baker in view of Stahmann and Ni.10
OBVIOUSNESS-TYPE DOUBLE PATENTING
Appellants have not presented any arguments with respect to these
rejections. See Reply Br. 2. We, therefore, summarily affirm these
rejections.
4 Libbus et al., US 7,551,958 B2, issued June 23, 2009.
5 Libbus et al., US 8,050,753 B2, issued Nov. 1, 2011.
6 Libbus et al., US 8.391,972 B2, issued Mar. 5, 2013.
7 Libbus et al., US 8,923,962 B2, issued Dec. 30, 2014.
8 Baker, Jr., US 5,222,494, issued June 29, 1993. (“Baker”).
9 Stahmann et al., US 6,493,586 Bl, issued Dec. 10, 2002. (“Stahmann”).
10 Ni et al., US 2004/0111041 Al, published June 10, 2004. (“Ni”).
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Application 14/582,999
OBVIOUSNESS
BAKER COMBINED WITH STAHMANN
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 21—27 and 33—
3 8 would have been obvious over Baker combined with Stahmann.
The Examiner finds that Baker discloses an implantable
neurostimulator comprising a safety control unit “that detects the current (a
first parameter) of the output signal and adjust the amplitude of the voltage
or a pulse width/frequency (a second parameter) in order to maintain a
constant current output.” Final Act. 6. The Examiner finds that while Baker
does not teach detection of unintended effects stemming from the
neurostimulation, Stahmann teaches a system for detecting such effects.
Final Act. 7. The Examiner concludes that
it would have been obvious to one of ordinary skill in the art at
the time of the applicant's invention to modify the system of
Baker to include an unintended event detection system in order
to prevent unintended events [from occurring] in the patient,
which may increase their discomfort.
Id.
Appellants contend that Stahmann does not teach an “unintended
effect detection module configured to detect an unintended effect caused by
the delivery of the neural stimulation pulses to the autonomic nervous
system.” Appeal Br. 12; see generally Reply Br. 3^4. Appellants argue that
Baker does not teach the detection of unintended effects. Appeal Br. 12.
Appellants also argue that the combination of Baker and Stahmann is
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Application 14/582,999
improper as Baker is directed to stimulation of non-cardiac tissue whereas
Stahmann is directed to stimulation of cardiac tissue. Id.
Principles of Law
“[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case of unpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant. After evidence or argument is submitted by the
applicant in response, patentability is determined on the totality
of the record, by a preponderance of evidence with due
consideration to persuasiveness of argument.”
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established that
the claims would have been obvious over Baker combined with Stahmann.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner’s determinations on obviousness are incorrect. Only those
arguments made by Appellants in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv). We have identified claims 21 and 33 as representative;
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therefore, claims 22—27 and 34—38 fall with claims 1 and 33, respectively.
We address Appellants’ arguments below.
Appellants contend that Stahmann does not teach or suggest detecting
an unintended effect resulting from stimulation of the autonomic nervous
system. Appeal Br. 12; see generally Reply Br. 3^4. Appellants argue that
Stahmann is directed to unintended stimulation of non-cardiac tissue
whereas the present invention is directed to intentional stimulation of non­
cardiac tissue.
We have considered Appellants’ argument and find it unpersuasive.
Stahmann teaches of a system for detecting unintended events. Final Act. 7,
Ans. 5; see Stahmann 11:1-21 (“Another example of a failure indication can
be based on detecting unintended stimulation of non-cardiac tissue, such as
phrenic nerve stimulation (causing "hiccups") or thoracic muscle stimulation
(e.g., "pocket twitch"). Baker is relied upon for the remaining limitations
including intentional neural stimulation. Final Act. 6. We agree with the
Examiner that it would have been prima facie obvious to include Stahmann’s
system for detecting unintended events in Baker’s neural stimulation system
in order to prevent unintended events to occur in the patient, which may
increase their discomfort. Final Act. 7. Thus, we agree with the Examiner
that the combined references teach the limitations of the claims. Ans. 4—5.
Appellants next argue that Baker does not teach a system for detecting
unintended effects resulting from stimulation of the autonomic nervous
system. Appeal Br. 12; see Reply Br. 4. Again we are unpersuaded. While
Appellants may be correct with regard to the teachings of Baker, as
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discussed above, Stahmann teaches the use of a system to detect unintended
effects. Again, it is the combined teachings of the references which renders
the instant claims obvious.
Appellants go on to argue that one skilled in the art would not
combined the teachings of Baker with those of Stahmann as Baker deals
with stimulation of non-cardiac tissue and Stahmann relates to stimulation of
cardiac tissue. Appeal Br. 12; see Reply Br. 3^4. Again we find this
argument unpersuasive. Both Baker and Stahmann relate to
electrostimulation of non-cardiac tissue. Baker, col. 4,11. 36-39 (describing
Figures 2A and 2B,which depict an implanted device for stimulating the
vagus nerve); Stahmann col. 11,11. 5—21 (discussing phrenic nerve
stimulation). Both references teach the use of safety control modules to
ensure patient safety. Baker col. 1,11. 35—40, Stahmann col. 11,11. 5—21.
We agree with the Examiner that the art is related and analogous such that
one skilled in the art would look to Stahmann’s stimulation technology for
ways to improve the stimulation device taught in Baker. See, Ans. 6. See
also, In re Clay, 966 F.2d 656, 658-9 (Fed. Cir. 1992).
With respect to claims 22—27 and 34—38, Appellants argue that the
claims depend from either claim 21 (claims 22—27) or claim 33 (claims 34—
38) and are patentable for the same reasons as claims 21 and 33. See,
Appeal Br. 12. As discussed above, we conclude that the Examiner’s
rejection is well founded and that claims 21 and 33 are unpatentable. Since
Appellants offer no separate arguments as to the patentability of the
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dependent claims, those claims fall with claims 21 and 33. 37 C.F.R.
§ 41.37(c)(l)(iv).
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 21—27 and 33—38 would have been
obvious over Baker combined with Stahmann.
BAKER COMBINED WITH STAHMANN AND NI
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 32 and 40
would have been obvious over Baker combined with Stahmann and Ni.
The Examiner finds that while Baker is silent with respect to adjusting
a threshold associated with a first parameter value by suing a second
parameter value, the Examiner finds that this element is taught by Ni. The
Examiner concludes that
it would have been obvious to one of ordinary skill in the art at
the time of the applicant's invention to modify Baker to
dynamically adjust a first threshold associated with a first
parameter by using a second parameter value as taught by Ni, as
Ni discloses this as an improved method for optimizing a
threshold value using a closed loop feedback.
Final Act. 8,
Appellants contend neither Baker nor Stahmann alone or in
combination teach or suggest the limitation of adjusting a threshold value as
required by the claims. Appeal Br. 13—14. In their Reply Brief Appellants
argue that Ni does not teach the limitation as Ni does not teach a threshold
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Application 14/582,999
for detecting whether the value of stimulation parameters exceeds the
threshold. Reply Br. 5.
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established that
the claims would have been obvious over Baker combined with Stahmann
and Ni. Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations on obviousness are incorrect.
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv). We address Appellants’ arguments
below.
Appellants argue that neither Baker nor Stahmann teach the limitation
regarding adjustment of a first threshold associated with a first parameter
using a second parameter. Appeal Br. 13—14. We are unpersauded. The
Examiner acknowledged this deficiency in the Final Action and added the
teachings of Ni to address this deficiency. Final Act. 8, citing Ni ^fl[7 ar|d
28. We agree with the Examiner’s conclusion that the combination of
Baker, Stahmann, and Ni render the claims obvious.
In their Reply Brief Appellants address for the first time the teachings
of Ni. Reply Br. 5. Appellants do not offer any reason why this argument
was not presented in the Appeal Brief other than to suggest that the Final
Rejection was unclear. See, Reply Br. 4. We have reviewed the Final
Action and do not find that the rejection was unclear. The Examiner
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Application 14/582,999
explicitly stated that Ni was relied upon to teach the limitation with regards
to adjusting a threshold and give specific citations to Ni to support the
Examiner’s conclusion. Final Act. 8. Since Appellants have offered no
other reason for failing to address Ni in their Appeal Brief, we will not
consider the arguments raised in the Reply Brief with respect to Ni. 37
C.F.R. § 41.41(b)(2). See also, Ex parte Borden, 93 USPQ2d 1473, 1474
(BPAI 2010) (informative) (Appellant fails to “explain what ‘good cause’
there might be to consider the new argument. On this record, Appellant’s
new argument is belated.”).
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 32 and 40 would have been obvious over
Baker combined with Stahmann and Ni.
SUMMARY
We affirm the rejections for obviousness-type double patenting.
We affirm the rejections 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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