Ex Parte Whitehurst et al

Patent Trial and Appeal Board

Feb 19, 2016

11951987 (P.T.A.B. Feb. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111951,987 12/06/2007
45458 7590 02/23/2016
SCHWEGMAN LUNDBERG & WOESSNER/BSC
POBOX2938
MINNEAPOLIS, MN 55402
Todd Whitehurst
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.
6279.039US 1 9389
EXAMINER
SO, ELIZABETH K
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/23/2016 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):
uspto@slwip.com
SLW@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte TODD WHITEHURST, RAFAEL CARBUNARU,
KRISTEN JAAX, ANDREW DIGIORE,
and BRETT D. SCHLEICHER
Appeal2013-010758
Application 11/951,987
Technology Center 3700
Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ERIC C. JESCHKE, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 13, 14, 18-26, 30-32, 43, 44, and 48-50. App. Br. 2.
Claims 1-12, 15-17, 27-29, 33--42, and 45--47 have been withdrawn. App.
Br. 2. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
Appeal2013-010758
Application 11/951,987
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates to tissue stimulation systems,
and more particularly, to systems and methods for trialing different types of
tissue stimulation systems." Spec. i-f 1. Sole independent claim 43 is
reproduced below and is illustrative of the claims on appeal:
43. A programmer for a multimodal neurostimulator,
compnsmg:
a user interface having a display and an input device;
a processor capable of generating a first programming
screen for a first neurostimulator type for display on the
monitor, and generating a second programming screen for a
second neurostimulator type for display on the monitor;
wherein the first programming screen is capable of
allowing a first set of stimulation parameters to be defined via
the input device for the first neurostimulator type, and the
second programming screen is capable of allowing a second set
of stimulation parameters to be defined for the second
neurostimulator type; and
output circuitry for transmitting the first and second
stimulation parameter sets.
REFERENCE RELIED ON BY THE EXAMINER
Jensen US 7,680,540 B2 Mar. 16, 2010
THE REJECTIONS ON APPEAL 1
Claims 13, 18-23, 25, 30-32, 43, and 50 are rejected under 35 U.S.C.
§ 102(e) as anticipated by Jensen.
Claims 14, 24, 26, 44, 48, and 49 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Jensen.
1 Referring to claim 43 (as set forth in the Claims Appendix attached to
Appellants' Appeal Brief), line 2 thereof recites the term "monitor." See
App. Br. 20 (Claims Appendix). In Appellants' Response After Final
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ANALYSIS
The rejection of claims 13, 18-23, 25, 30-32, 43, and 50
as anticipated by Jensen
Sole independent claim 43 recites "a first neurostimulator type" and
also "a second neurostimulator type." Paragraph 50 of Appellants'
Specification states "[ fJor the purposes of this specification, the term
'different type' with respect to a neurostimulator device, such as an IPG
[implantable pulse generator], shall refer to different fundamental
architectures of the stimulation circuitry contained in the neurostimulator
device (such as those described below)."2
Action filed December 12, 2012, Appellants sought to replace the original
term "display" with the new term "monitor" to resolve an indefiniteness
issue raised by the Examiner in the Final Office Action. See Final Act. 5.
However, although the Examiner indicated in a following Advisory Action
that this "amendment to claim 43 overcomes the 35 USC 112, second
paragraph, rejection," the Examiner did not enter this amendment. See Adv.
Act. 2 (mailed January 16, 2013). Nevertheless, the Examiner withdrew this
ground of rejection. Ans. 9. It is not made clear how or why this rejection
was withdrawn when Appellants' amendment seeking to make the necessary
correction was not entered. However, for purposes of this appeal, we will
not review the withdrawn rejection because Appellants have not had an
opportunity to respond. Nevertheless, upon return of this record to the
Examiner, the Examiner may wish to again consider whether original,
unamended claim 43 (i.e., containing the word "display"), which is before us
for review, as well as all the dependent claims, remain indefinite for the
reasons previously stated.
2 Appellants do not specifically identify where such different circuitry
architectures contained in the neurostimulator devices are "described
below." Specification paragraph 51 addresses the electrical stimulation
provided by IPGs "in accordance with a set of stimulation parameters."
These "stimulation parameters may comprise" electrode combinations, their
polarity, and also pulse parameters such as amplitude (current or voltage),
duration, and frequency. Spec. i-f 51. However, this paragraph (which
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Application 11/951,987
Appellants state that the claims must be broadly interpreted in light of
Appellants' Specification and also that "the Examiner must consider the
teachings of the specification when construing the claim language." Reply
Br. 2; see also App. Br. 7. The Examiner declares that "while Appellant
may be his own lexicographer, the recitation of different 'neurostimulator
types' is very broad and not limiting." Ans. 9. The "Examiner maintains
that 'neurostimulator type' can refer to different physical arrangement of the
circuitry as well as different stimulation parameters of a single physical
arrangement of circuitry." Ans. 10. Appellants contend that the Examiner's
interpretation of a different type of neurostimulator device (i.e., as including
either different circuitry or different parameters) is too broad. See App. Br.
7-9; see also Reply Br. 2-3. Appellants contend that "one of ordinary skill
in the art would understand that differences in stimulation parameters, leads,
electrode combinations, and polarities do not affect the fundamental
architecture of a neurostimulator." App. Br. 8.
We agree with the Examiner that "different physical arrangement[ s]
of the circuitry" is reasonably and broadly understood to constitute
"different fundamental architectures of the stimulation circuitry." However,
and in accordance with Appellants' Specification, we are not in agreement
that "different stimulation parameters" emanating from the neurostimulator
device are necessarily indicative of "different fundamental architectures of
the stimulation circuitry." This is because the parameters identified in
Appellants' Specification (i.e., polarity, amplitude, duration, frequency, see
immediately follows the discussion of "the term 'different type"' (Spec.
i-f 50)) is silent as to whether a change in any such stimulation parameter
constitutes "different fundamental architectures of the stimulation circuitry"
as required for a "different type" of neurostimulator device. See Spec. i-f 50.
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Application 11/951,987
supra) pertain to the amount or degree of stimulation provided, and the
Examiner does not indicate how a change in their values necessarily stems
from or indicates "different fundamental architectures of the stimulation
circuitry."
The distinction between differences in circuitry and differences in
parameters is important in view of the Examiner's rejection of claim 43 as
being anticipated by Jensen. 3 The Examiner, based on the above statement
(i.e., expressing that different types of neurostimulators include those having
different physical circuitry and also those having different parameters),
provides examples where Jensen purportedly teaches both different circuitry
and also different parameters. Ans. 10. For thoroughness, we address both
rationales relied upon by the Examiner.
Regarding Jensen's teaching of "different parameter values," the
Examiner relies on Jensen 2:32-50, 4:44--5:6, and 7:34--42. Ans. 10. These
citations describe a device that stores different instructions such that the
3 "A claim is anticipated only if each and every element as set forth in the
claim is found, either expressly or inherently described, in a single prior art
reference." Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628,
631 (Fed. Cir. 1987). "[R]ejections under 35 U.S.C. § 102 are proper only
when the claimed subject matter is identically disclosed or described in the
prior art." In re Arkley, 455 F.2d 586, 587 (CCP A 1972) (emphasis omitted).
Thus, it is not enough that the prior art reference discloses part of the
claimed invention, which an ordinary artisan might supplement to make the
whole, or that it includes multiple, distinct teachings that the artisan might
somehow combine to achieve the claimed invention. "[T]he [prior art]
reference must clearly and unequivocally disclose the claimed [invention] or
direct those skilled in the art to the [invention] without any need for picking,
choosing, and combining various disclosures not directly related to each
other by the teachings of the cited reference." Net MoneyIN, Inc. v.
Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (quoting In re Arkley,
455 F.2d at 587).
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Application 11/951,987
device can apply certain instructions so as to emulate the operation of a
certain selected stimulator. Specifically, Jensen states that "[t]he
instructions for a given application (A-D) may specify stimulation
parameters such as amplitude, pulse width, pulse rate, duration, timing,
electrode combinations, electrode polarities, and the like." Jensen 7:39-42;
see also id. at 4: 17-20. Elsewhere Jensen teaches that the operation "may
differ in terms of parameter settings, ramp rates, timing, multi-channel
stimulation capabilities, and the like." Jensen 4: 1--4. Other than perhaps for
"multi-channel stimulation capabilities," the identified variables are all
described in Jensen as being parameters that can be varied. Of course,
because the Examiner was only addressing the "parameters" portion of the
Examiner's understanding of a "different type" of stimulator, there was no
need here for the Examiner to elaborate as to how changes in Jensen's
parameters mandate different circuitry. Nevertheless, we note that the
Examiner does not explain how providing a different parameter value
necessarily requires different circuitry, nor does the Examiner indicate
where Jensen teaches this correlation.
Regarding Jensen's teaching of "different configurations" or
"different physical properties of the circuitry," the Examiner relies on Jensen
2:51-59, 5:21-37, and 8:33-9:3. Ans. 10. As above, these citations are
directed to Jensen's device that stores different instructions so as to emulate
the operation of a selected stimulating device. Jensen specifically states that
"stimulation parameters, types of connected leads, electrode combinations
and electrode polarities may change when using the trial stimulator for a
different application." Jensen 5:31-34. Regarding Jensen's discussion of
"types of connected leads," the Examiner does not make clear how
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Application 11/951,987
employing a different lead results in different circuitry. Regarding Jensen's
discussion of "electrode combinations and electrode polarities," paragraphs
50 and 51 of Appellants' Specification indicate that these variables either do
not involve "fundamental architectures of the stimulation circuitry" (i.e.,
number of electrodes) or are identified as a "parameter" (i.e., polarity). 4
The Examiner also references Jensen 3 :41--45, 6:21--46, 13:47-51,
and Fig. 1 in the Final Office Action (Final Act. 6), but these additional
locations in Jensen likewise fail to establish that different circuitry is
necessarily employed when generating the described stimulation. The
Examiner continuously seems to focus on equating a disclosure in Jensen of
a different parameter as a disclosure of a different type of neurostimulator.
See Ans. 10.
Based on the record presented, we are not persuaded that Jensen
"clearly and unequivocally" (Net Money!N, 545 F.3d at 1371) discloses the
limitation directed to different neurostimulator types. This is because the
variables disclosed in Jensen are parameters; are identified in Appellants'
Specification as a parameter; or, are described in Appellants' Specification
as not a "different fundamental architecture[] of the stimulation circuitry."5
Spec. i-f 50. Regarding Jensen's reference to "multi-channel stimulation
4 We note again that the claims are to be interpreted in light of the
Specification.
5 Appellants state that "programming a chronic stimulator with different
stimulation parameter sets [as in Jensen] does not mean that the chronic
stimulators are of different types. They are the same chronic stimulator with
the same fundamental stimulation circuitry architecture-just programmed in
different manners." Reply Br. 3. Further, "there is no disclosure in Jensen
that the circuitry of the 'different stimulators' is physically different." Reply
Br. 3.
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Application 11/951,987
capabilities" (Jensen 4: 1--4), the Examiner does not make clear how this
capability necessarily requires different circuitry.
For the above reasons, we are not persuaded that Jensen properly
anticipates independent claim 43. Accordingly, we reverse the Examiner's
rejection of independent claim 43, and dependent claims 13, 18-23, 25, 30-
32, and 50 as being anticipated by Jensen.
Regarding the Examiner's rejection of dependent claims 14, 24, 26,
44, 48, and 49 (Final Act. 9), their rejection is based upon the rejection of
parent claim 43, which we do not affirm. Accordingly, the rejection of
dependent claims 14, 24, 26, 44, 48, and 49 is likewise reversed.
However, for the sake of completeness, we also desire to separately
address different issues raised by Appellants regarding the rejection of
claims 23, 24, 38, and 39.
Claim 23
Claim 23 depends indirectly from claim 43; and further recites (a) "the
one or more stimulation leads are not directly matable to the external trial
stimulator," and (b) "a lead adapter capable of mating the one or more
stimulation leads to the external trial stimulator." As understood, an adapter
is needed to mate the lead to the external device since the lead and the
device are not themselves "directly matable" to each other as recited. The
Examiner finds that "Jensen's percutaneous extension is considered to be a
lead adapter." Final Act. 7; see also Ans. 11. Appellants contend that
Jensen's "percutaneous extension is not a lead adapter, because it does not
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Application 11/951,987
adapt the lead to the trial stimulator, but rather merely extends the lead."6
App. Br. 9; see also id. at 10 (discussion pertaining to what an "adapter" is).
There is merit to Appellants' contention. Jensen teaches that "[t]he
trial stimulator may reside externally to the patient and connect to one or
more implanted leads via a percutaneous extension." Jensen 2:7-9. Jensen
further teaches that "[i]f a percutaneous extension is attached to lead 16 for
trial stimulation, the percutaneous extension may be removed so that the
lead may be directly coupled to the chronically implanted stimulator."
Jens en 6: 65-7: 1. The Examiner identifies no teaching in Jens en of an
adapter (as contrasted with an extension), nor does the Examiner identify
any teaching in Jensen where the lead is "not directly matable" to the
external device, as recited. Instead, it appears that the Examiner relies on
Jensen's extension as resulting in an indirect mating of the lead and the
external device (see Final Act. 7; Ans. 11); but an indirect mating is not the
same as the two devices not being "directly matable" together as this
limitation is understood. See also App. Br. 11; Reply Br. 5. This additional
reason further supports our reversal of the Examiner's rejection of claim 23
as being anticipated by Jensen.
Claims 24, 48, and 49
These claims are rejected as being obvious over Jensen. Final Act. 9.
Dependent claims 24, 48, and 49 are each directed to a trial stimulator that
also has ablation and/or drug delivery capabilities. The Examiner finds that
Jensen discloses a device that can emulate "the operation of different
6 Appellants further contend that "the specification treats a 'lead adapter' as
being different from a 'lead extension,' whereas the Examiner equates these
two terms." App. Br. 10.
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chronically implanted stimulators." Final Act. 9--10; see also Ans. 13. The
Examiner finds that because Jensen can emulate one type of stimulator,
additional stimulators can likewise be emulated. Ans. 13-14; see also Final
Act. 11. The Examiner's findings are correct to the extent that Jensen
discloses that the device can be used to stimulate "the spinal cord, deep
brain, gastrointestinal tract, and pelvic floor" areas of the body. Final Act.
10-11; see also Jensen (Abstract). However, the use of Jensen's device in
these different body parts all pertain to these areas being stimulated. The
Examiner does not point to any teaching in Jensen where there is a
disclosure of employing the device for anything other than for stimulation,
such as for ablation (removal) or for drug delivery purposes as recited in
these dependent claims. See Reply Br. 8.
The fact that a manufacturer has other equipment for different
therapies is not indicative that this other equipment is compatible with, or
capable of being used with, Jensen's stimulation device. See Final Act. 11;
Ans. 14. In other words, we agree with Appellants that the Examiner does
not indicate where "Jensen suggests that the trial stimulator can be modified
to emulate tissue ablation and drug delivery devices" since "the entire focus
of Jensen is on chronically implanted stimulators." App. Br. 15; see also
Reply Br. 9. In short, the Examiner does not provide any articulated
reasoning with rational underpinning to support the conclusion that it would
have been obvious to incorporate wholly different devices, having diverse
therapy routines and procedures, into Jensen's stimulator device; or that any
such coupling/programming between the two would have been successful.
See Final Act. 10-11.
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These additional reasons further support our reversal of the
Examiner's rejection of claims 24, 48, and 49 as being obvious in view of
Jensen.
DECISION
The Examiner's rejection of claims 13, 18-23, 25, 30-32, 43, and 50
as anticipated by Jensen is reversed.
The Examiner's rejection of claims 14, 24, 26, 44, 48, and 49 as
unpatentable over Jensen is reversed.
REVERSED
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