Ex Parte Torgerson et al

Patent Trial and Appeal Board

Jun 29, 2017

12359958 (P.T.A.B. Jun. 29, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/359,958 01/26/2009 Nathan A. Torgerson 1023-589US02 5437
71996 7590 07/03/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
EVANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
07/03/2017 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
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 NATHAN A. TORGERSON, ROBERT LEINDERS,
MARC STEIN, TODD P. GOBLISH, TODD D. HEATHERSHAW,
and JOHN DELFIN RODRIGUEZ
Appeal 2015-006883
Application 12/359,958
Technology Center 3700
Before JOHN C. KERINS, WILLIAM A. CAPP, and
SEAN P. O’HANLON, Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the final
rejection of claims 1—3, 6—13, 16—18, and 40—51. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal 2015-006883
Application 12/359,958
THE INVENTION
Appellants’ invention relates to implantable neurostimulators.
Spec. 13. Claim 1, reproduced below, is illustrative of the subject matter on
appeal.
1. An apparatus comprising:
a waveform generator configured to generate a neurological
stimulation waveform; and
a waveform controller that includes programmable
waveform parameters, wherein the waveform controller is
configured to set one or more respective values associated with
each of the programmable waveform parameters to control the
waveform generator, the programmable waveform parameters
including:
a parameter for specifying a duration of an initial interval,
of the neurological stimulation waveform, during which
stimulation is ceased;
a parameter for specifying a width, amplitude, or amount of
charge of a first stimulation pulse, of the neurological
stimulation waveform, the first stimulation pulse having a first
polarity and beginning immediately upon completion of the
initial interval;
a parameter for specifying a duration of a time delay, of the
neurological stimulation waveform, during which stimulation is
ceased, the time delay beginning immediately upon completion
of the first stimulation pulse; and
a parameter for specifying a width, amplitude, or amount of
charge of a second stimulation pulse, of the neurological
stimulation waveform, the second stimulation pulse having a
second polarity opposite the first polarity and beginning
immediately upon completion of the time delay,
wherein the waveform generator is configured to generate
the neurological stimulation waveform during each of a
plurality of rate period intervals and according to the one or
more respective values associated with each of the
programmable waveform parameters.
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THE REJECTIONS
The Examiner relies on Archer (US 2002/0077670 Al, pub. June 20,
2002) as evidence in support of the rejections. The following rejections are
before us for review:
1. Claims 1—3, 6—10, and 40-43 are rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which the applicant regards as the
invention.
2. Claims 1, 2, 6—9, 11, 12, 17, 18, and 40-51 are rejected under
35 U.S.C. § 102(e) as anticipated by Archer.
3. Claims 3, 10, 13, 16, 40, 44, and 48 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Archer.
OPINION
Indefiniteness
The Examiner rejected claim 1 and its depending claims because the
term “the plurality of rate period intervals” lacked antecedent basis. Final
Action 2. Subsequently, Appellants filed an after-final amendment
amending “the” to “a.” The Examiner then issued an advisory action
indicating that the amendment would be allowed. See Oct. 2, 2014,
Advisory Action. Neither Appellants nor the Examiner argue the
indefmiteness rejection on appeal. We do not sustain this rejection.
Anticipation by Archer
Claims 1, 2, 6—9, and 40—43
Appellants argue claims 1, 2, 6—9, and 40-43 as a group. Appeal
Br. 7—12. We select claim 1 as representative. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2016). The Examiner finds that Archer contains all of the
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Application 12/359,958
limitations of claim 1. Final Action 3^4. In particular, the Examiner finds
that Archer discloses adjustable time duration parameters including an initial
interval. Id. at 4 (citing Archer, 1103, Figs. 19, 20). In addition, the
Examiner finds that:
Archer discusses the use of adjustable/variable pulse to pulse
intervals (i.e. rate period intervals) for figures 10 and 11,
and since the pulses are adjusted based on feedback, there will
be different waveform parameters for subsequent rate period
intervals (e.g. para 77-79, etc.).
Id.
Appellants traverse the rejection by first arguing that Archer does not
disclose a “time delay” as claimed. Appeal Br. 9. In response, the Examiner
states:
This argument is not persuasive for several reasons.
1. Figure 20 of Archer shows the waveform at zero
immediately upon completion of the first stimulation pulse.
2. Paragraph 103 of Archer does not state the waveform is
not zero, just that it approaches zero. The waveform also has a
positive pulse, the positive pulse approaches zero, is zero, then
inverts to the negative pulse.
3. The waveform does go to zero since it goes from a
positive pulse to a negative pulse.
4. The waveform does not have to be continuous. Archer
states in paragraph 100 that the waveforms may be made by
step wise approximations.
Therefore Archer does contain a parameter for specifying a
time delay of the waveform during which stimulation is ceased,
where the time delay begins immediately upon completion of
the first stimulation pulse.
Ans. 3.
In reply, Appellants argue that the Examiner did not adequately
explain how the haversine pulse of Figure 20 is a programmable waveform
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with a programmed time delay of the neurological stimulation waveform
during which stimulation is ceased. Reply Br. 3.
Appellants’ attempt to distinguish Archer based solely on the
waveform depicted in Figure 20 is not persuasive. Appellants’ argument
fails to comprehend the teachings of Archer as a whole, including that:
FIGS. 19-20 depict a variation where the stimulating waveform
is generated having a largely smooth waveform, but having the
additional feature where the interval between waveforms is
set by varying a selectable delay, as would be used with the
square pulse waveforms described previously. In FIG. 19,
the stimulating waveforms are segments of a sine wave
separated in time (of course the same technique could be used
for the truncated ramp, or other arbitrary morphologies).
Archer 1103 (emphasis added). Figure 19 of Archer depicts prolonged
portions of a waveform at zero amplitude immediately after segments of a
sine wave. Id. Fig. 19. Thus, while Figure 20 of Archer does disclose a
haversine pulse for exemplary purposes, Archer is not limited to haversine
pulses, and other embodiments of Archer disclose varying a selectable delay
between waveforms in an interval during which stimulation is ceased. Id.
Appellants never address the Figure 19 embodiment of Archer or the
accompanying disclosures in paragraph 103 of Archer and, consequently,
does not apprise us of Examiner error.
Appellants next argue that the Examiner’s findings of fact are
deficient in the following regard:
According to the Examiner, in order to support the rejection of
claim 1 Archer need only disclose “that the controller be
capable of setting [each of] the 4 parameters [recited in claim 1 ]
for the waveform.” This is itself reversible error. Instead, to
support the rejection of claim 1, the Examiner must
demonstrate that Archer in fact discloses a waveform controller
that is in fact configured to set, not merely capable of setting,
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one or more respective values associated with each of the four
recited programmable waveform parameters.
Appeal Br. 12 (footnote omitted). Appellants’ legal argument, which is
unsubstantiated by citation to any legal authority, runs contrary to applicable
legal precedent. It is well settled that where all the structural elements of a
claim exist in a prior art product, and that prior art product is capable of
satisfying all functional or intended use limitations, the claimed invention is
nothing more than an unpatentable new use for an old product. In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).1 Thus, Appellants’
“capable of’ argument does not apprise us of Examiner error.
We have considered Appellants’ remaining arguments and find them
to be without merit. In view of the foregoing discussion, we determine the
Examiner’s findings of fact are supported by a preponderance of the
evidence, and that the Examiner’s legal conclusion of unpatentability is
well-founded. Accordingly, we sustain the Examiner’s unpatentability
rejection of claims 1, 2, 6—9, and 40-43.
Claims 11, 12, and 44^47
In traversing the rejection of these claims, Appellants rely solely on
arguments that we previously considered and found unpersuasive with
respect to the rejection of claim 1 regarding a claimed “time delay” and find
equally unpersuasive here. Appeal Br. 13. We sustain the rejection of
claims 11, 12, and 44-47.
1 “It is well settled that the recitation of a new intended use for an old
product does not make a claim to that old product patentable.” Id. (citing In
re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990)).
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Claims 17, 18, and 48—51
In traversing the rejection of these claims, Appellants rely solely on
arguments that we previously considered and found unpersuasive with
respect to the rejection of claim 1 regarding a claimed “time delay” and find
equally unpersuasive here. Appeal Br. 13. We sustain the rejection of
claims 17, 18, and 48—51.
Unpatentability of
Claims 13, 10, 13, 16, 40, 44, and 48 over Archer
Claims 3 and 13
Appellants argue claims 3 and 13 together. Appeal Br. 15—17. We
select claim 3 as representative. Claim 3 depends from claim 1 and adds the
following limitations:
wherein the time delay is a subsequent time delay,
wherein the initial interval comprises an initial time delay
and a setup interval beginning immediately upon completion of
the initial time delay,
wherein the waveform generator comprises a plurality of
capacitors, and
wherein, during the setup interval, the waveform controller
is further configured to change a configuration of the capacitors
of the waveform generator from a charge configuration to a
stack configuration for generation, by the waveform generator,
of at least the first stimulation pulse of the neurological
stimulation waveform.
Claims App. With respect to the foregoing limitations, the Examiner finds
as follows:
Archer does not disclose the use of a capacitor arrangement
from a charge configuration to a stack configuration for the first
and/or second pulse, and in the alternative, the use of two
intervals for the initial interval and a passive recharging
beginning immediately upon completion of the second pulse. It
would have been obvious to one having ordinary skill in the art
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at the time the invention was made ... to modify the
stimulation system and method as taught by Archer, with the
use of a capacitor arrangement from a charge configuration to a
stack configuration for the first and/or second pulse, the use the
initial interval being split into two intervals, and a passive
recharge since it would provide the predictable results of: the
use of a capacitor arrangement from a charge configuration to a
stack configuration for the first and/or second pulse to allow the
device to change the configuration to rapidly charge the
capacitors and then deliver a multitude of pulse parameters for
each pulse; allowing one time interval to be split into different
intervals that are equal to the one time interval so different
functions can be performed during the different intervals; and
passive recharging to allow the device to remove the extra
charge from the electrodes to allow the electrodes to be quickly
used for sensing, to prevent degradation of the electrodes,
and/or to decrease the use of the battery and thereby increase
battery lifetime by passively recharging the device and not
forming a stimulation pulse to remove the excess charge.
Final Action 4—5.
Appellants argue that the Examiner errs by failing to cite the teaching
of a secondary reference for the foregoing claim limitations. Appeal Br. 15.
Appellants characterize the Examiner’s rationale as “conclusory.” Id.
Appellants argue that a “predictable results” rationale requires that the
Examiner demonstrates that modification to the primary reference is an
element or technique that is known in the prior art and that the modification
with the known element or technique provides no more than predictable
results. Id. at 16. Appellants argue that the Examiner fails to demonstrate
that the subject matter of claim 3 was “even known at the time of
[Appellants’] invention.” Id.
In response, the Examiner reiterates the position taken in the Final
Action and states that the rejection is supported with articulated reasoning
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with rational underpinning as required by KSR Int 7 Co. v. Teleflex Inc., 550
U.S. 398,418 (2007). Ans. 4.
[T]he rejection contained articulated reasoning with some
rational underpinning to support the legal conclusion of
obviousness—i.e. the rejection stated “since it would provide the
predictable results of: the use of a capacitor arrangement from a
charge configuration to a stack configuration for the first and/or
second pulse to allow the device to change the configuration to
rapidly charge the capacitors and then deliver a multitude of
pulse parameters for each pulse; allowing one time interval to
be split into different intervals that are equal to the one time
interval so different functions can be performed during the
different intervals. . . .”
Id.
Appellants’ “secondary reference” argument is unpersuasive. It is
well settled that a rejection under Section 103 does not require, in every
situation and circumstance, the citation of a secondary reference. Patent
claims have been determined to be unpatentable over a single prior art
reference in the past.
In appropriate circumstances, a single prior art reference can
render a claim obvious. See, e.g., B.F. Goodrich Co. v. Aircraft
Braking Sys. Corp., 72 F.3d 1577, 1582 (Fed. Cir. 1996); In re
O'Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988). However, there
must be a showing of a suggestion or motivation to modify the
teachings of that reference to the claimed invention in order to
support the obviousness conclusion. See B.F. Goodrich, 72
F.3d at 1582. This suggestion or motivation may be derived
from the prior art reference itself, see O'Farrell, 853 F.2d at
902, from the knowledge of one of ordinary skill in the art, or
from the nature of the problem to be solved.
SIBIA Neurosciences, Inc. v. Cadus Pharma Corp., 225 F.3d 1349, 1356
(Fed. Cir. 2000); see also Boston Scientific Scimed, Inc. v. Cordis Corp., 554
F.3d 982 (Fed. Cir. 2009). The key consideration in an obviousness analysis
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is whether the differences between the subject matter sought to be patented
and the prior art are such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having ordinary skill
in the art to which said subject matter pertains. See 35 U.S.C. § 103(a).
In the instant case, the Examiner maintains that the subject matter of
claim 3 merely entails predictable results from the use of a capacitor
arrangement from a charge configuration to a stack configuration. Ans. 4;
Final Action 5. Essentially, we interpret the Examiner’s rejection as
invoking the knowledge of one of ordinary skill in the art to implement a
predictable variation of the prior art. This approach is appropriate under
KSR.
When a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it,
either in the same field or a different one. If a person of
ordinary skill can implement a predictable variation, § 103
likely bars its patentability.
KSR, 550 U.S. at 417. In appropriate circumstances, it is permissible for an
Examiner to rely on his or her own knowledge and expertise regarding the
knowledge of a person of ordinary skill in the art.
As persons of scientific competence in the fields in which they
work, examiners ... are responsible for making findings,
informed by their scientific knowledge, as to the meaning of
prior art references to persons of ordinary skill in the art and the
motivation those references would provide to such persons.
Absent legal error or contrary factual evidence, those findings
can establish a prima facie case of obviousness.
In re Berg, 320 F.3d 1310, 1315 (Fed. Cir. 2003).
“The PTO bears the initial burden of showing a prima facie case of
obviousness.” In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014). It is
our view that the Examiner combined the teachings of Archer with the
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knowledge available to a person of ordinary skill in the art using appropriate
reasoning and rationale to make out a prima facie case of obviousness. This
is sufficient to shift the burden to Appellants to rebut the Examiner’s prima
facie case, because “[w]hen a prima facie case of obviousness is made, the
burden then shifts to the applicant to come forward with evidence and/or
argument supporting patentability.” Id.
Turning now to Appellants’ Appeal Brief, we observe that Appellants’
arguments are all directed to challenging the adequacy of the Examiner’s
prima facie case. There is, however, no evidence or technical reasoning
tending to show that the Examiner’s findings and rationale are incorrect or
that the proposed modification exceeds the capabilities of a person of
ordinary skill in the art. Thus, Appellants have failed to rebut the
Examiner’s prima facie case of obviousness.
Accordingly, we sustain the rejection of claims 3 and 13.
Claims 40, 44, and 48
Appellants argue these claims as a group. Appeal Br. 17—19. We
select claim 40 as representative. Claim 40 depends from claim 1 and adds
the limitation: “wherein the programmable waveform parameters further
include a parameter for specifying a duration of a passive recharge, of the
neurological waveform, beginning immediately upon completion of the
second stimulation pulse.” Claims App. The Examiner finds that it would
have been obvious to a person of ordinary skill in the art at the time of the
invention to modify Archer with passive recharging capability. Final
Action 5. According to the Examiner, a person of ordinary skill in the art
would have done this:
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to allow the device to remove the extra charge from the
electrodes to allow the electrodes to be quickly used for
sensing, to prevent degradation of the electrodes, and/or to
decrease the use of the battery and thereby increase battery
lifetime by passively recharging the device and not forming a
stimulation pulse to remove the excess charge.
Id.
Appellants traverse the rejection by arguing, once again, that the
Examiner failed to cite a secondary reference as teaching the additional
limitation of claim 40. Appeal Br. 17. This argument is unpersuasive for
the same reasons discussed above in connection with the rejection of
claim 3.
Appellants next argue that Archer teaches that a neurostimulator
according to its disclosure stimulates with charge-balanced active pulses.
Appeal Br. 18—19. Based on this disclosure in Archer, Appellants conclude
that a person of ordinary skill in the art would not have seen any reason to
modify the system and method of Archer to provide a passive recharge
interval beginning immediately upon completion of the second stimulation
pulse. Id. at 19.
In response, the Examiner explains:
While the use of a charge balanced pulse does result in most of
the residual charge being removed, it does not ensure all of the
residual charge left on the electrodes is removed. Removal of
all of the charge prevents electrode degradation and
electrochemical effects at the electrode site. Therefore a
passive recharge is recommended. The examiner previously
provided evidence of this in the action of 12/1/2011 of
Galbraith, Patent number 4592359, col. 9, lines 35-40, shorting
the electrodes to ground, and stated Archer performs this
function when he shorts his electrodes to ground (e.g. para. 97
and 98). In addition, there are numerous other pieces of art
showing the use of an active biphasic pulse with a passive
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recharge phase of shorting the electrodes to ground, such as US
Patents 6301505, col. 4, lines 1-25, 4408608, col. 17, lines 22-
38, 4532930, col, 50, lines 27-34, etc.
Ans. 5—6. We have considered the competing positions of Appellants and
the Examiner and, in our opinion, the Examiner has stated the more
convincing position.
We sustain the rejection of claims 40, 44, and 48.
Claims 10 and 16
Claim 10 depends from claim 1 and claim 16 depends from claim 11.
Claims App. Appellants do not argue for the separate patentability of claims
10 and 16 apart from arguments presented with respect to claims 1 and 11,
which we have previously considered. See 37 C.F.R. § 41.37(c)(iv) (failure
to separately argue claims).
We sustain the unpatentability rejection of claims 10 and 16.
DECISION
The decision of the Examiner to reject claims 1—3, 6—10, and 40-43
are rejected under 35 U.S.C. § 112, second paragraph, as indefinite is
reversed.
The decision of the Examiner to reject claims 1, 2, 6—9, 11, 12, 17, 18,
and 40-51 as anticipated by Archer is affirmed.
The decision of the Examiner to reject claims 3, 10, 13, 16, 40, 44,
and 48 as unpatentable over Archer is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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