Ex Parte Bolea et al

Patent Trial and Appeal Board

Jun 8, 2018

12980840 (P.T.A.B. Jun. 8, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/980,840 12/29/2010 Stephen L. Bolea
137985 7590 06/12/2018
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
104292-1314 5443
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
06/12/2018 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN L. BOLEA, THOMAS B. HOEGH,
BRIAND. KUHNLEY, DALE G. SUILMANN, BRUCE J. PERSSON,
JOHN P. BECK, SIDNEY F. HAUSCHILD, PAULA M. KAPLAN,
ADAM K. HOYHTY A, WONDIMENEH TESF A YESUS,
and ROBERT E. ATKINSON
Appeal2017-004842 1
Application 12/980,840
Technology Center 3700
Before FRANCISCO C. PRATS, ELIZABETH A. LA VIER, and
RYAN H. FLAX, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods of
positioning an electrode cuff on a patient's hypoglossal nerve. The
Examiner rejected the claims as being directed to subject matter ineligible
for patenting, for failing to comply with the written description requirement,
as anticipated, and for obviousness.
1 Appellants state that the "real party of interest in this appeal is Cyberonics,
Inc., the assignee of this application." Appeal Br. 2.
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Application 12/980,840
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We reverse.
STATEMENT OF THE CASE
Appellants' invention involves the use of a "hypoglossal nerve
stimulation (HGNS) system ... [which] treats obstructive sleep apnea
(OSA) by restoring neuromuscular activity to the genioglossus muscle via
stimulation of the hypoglossal nerve (HGN) synchronous with inspiration to
mitigate upper airway collapse during sleep." Spec. i-f 36.
"Stimulation is generated by an implantable neurostimulator (INS)
1100, synchronized with inspiration as measured by respiration sensing
leads (RSLs) 1200 using bio-impedance, and delivered to the hypoglossal
nerve by a stimulation lead (STL) 1300." Id. (discussing Fig. 1).
Claims 13 and 41 are the independent claims on appeal, and read as
follows:
13. A method of positioning an electrode cuff on a
hypoglossal nerve of a patient, the method comprising:
positioning the electrode cuff at a first location on the
hypoglossal nerve, wherein the electrode cuff includes a
plurality of electrode contacts;
delivering a first electrical stimulation to the hypoglossal
nerve via the electrode cuff at the first location on the
hypoglossal nerve;
monitoring an upper airway of the patient at a first time
to evaluate a positioning of the electrode cuff at the first
location on the hypoglossal nerve, wherein monitoring the
upper airway includes visualizing the upper airway, and
wherein the monitoring at the first time indicates that a
predetermined response is not fully achieved; and
repositioning the electrode cuff at a second location on
the hypoglossal nerve, wherein the second location on the
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hypoglossal nerve is different from the first location on the
hypoglossal nerve;
delivering a second electrical stimulation to the
hypoglossal nerve via the electrode cuff at the second location
on the hypoglossal nerve; and
monitoring the upper airway of the patient at a second
time for the predetermined response to evaluate a positioning of
the electrode cuff at the second location on the hypoglossal
nerve.
41. A method of positioning an electrode on a
hypoglossal nerve of a patient, the method comprising:
positioning the electrode at a first location on the
hypoglossal nerve;
delivering an electrical stimulation to the hypoglossal
nerve;
confirming desired positioning of the electrode by
monitoring an upper airway of the patient for a desired
response, wherein monitoring the upper airway includes
visualizing the upper airway with an imaging device; and
repeating the steps of positioning the electrode and
delivering an electrical stimulation until the desired response is
observed.
Appeal Br. 26, 28 (Claims App 'x).
The following rejections are before us for review:
(1) Claims 13, 15-21, 23, and 40-47, as being directed to subject
matter ineligible for patenting (Final Act. 5-6);
(2) Claims 13, 15-21, 23, 40, and 43--47, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement (id.
at 7);
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(3) Claim 41, under 35 U.S.C. § 102(e) as being anticipated by
Meadows2 (id. at 8); and
(4) Claims 13, 15-21, 23, and 42, under 35 U.S.C. § 103(a) as being
obvious over Meadows, Frei, 3 and Boggs4 (id. at 8-11). 5
STANDARD OF REVIEW
As stated in Jn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
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.
PATENT ELIGIBILITY
The Examiner's Position
The Examiner originally determined that the process recited in claim
13 "includes steps which require positioning of an electrode cuff, delivering
electrical stimulation, and repositioning the electrode cuff based on the
observed stimulation results; however, these limitations do not require
additional elements beyond the abstract idea of organizing human activity."
Final Act. 6.
The Examiner rejected claim 41 "under the same rationale, along with
all claims dependent on the two independent claims [13 and 41]." Id.
2 US 2010/0094379 Al (published Apr. 15, 2010).
3 US 2004/0138581 Al (published July 15, 2004).
4 US 2006/0149345 Al (published July 6, 2006).
5 Although the Examiner's rejection includes claims 14, 22, 24, 27-31, and
33 (Final Act. 9), those claims have been canceled (see Appeal Br. 26-27
(Claims App'x)).
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In the Examiner's Answer, however, the Examiner conceded that he
"misapplied what constitutes 'organizing human activities', based on the
updated Subject Matter Eligibility [guidance] clearly indicating that the
category does not cover human operation of machines." Ans. 2.
The Examiner determined, however, that "based upon consideration
of all of the relevant factors with respect to the claim as a whole, the claims
appear to be directed to a judicial exception (i.e. an abstract idea) without
significantly more." Id. Specifically, the Examiner determined that claim
13 "does not require additional elements beyond the abstract idea of
evaluating a positioning of the electrode cuff." Id.
In making those determinations, the Examiner reasoned as follows:
[T]hese [claimed] steps/elements describe limitations
corresponding to concepts identified as abstract ideas by the
courts - similar to "Diagnosing an abnormal condition by
performing clinical tests and thinking about the results", with
various other extra, pre, and post solution activity which fail in
providing meaningful limitations which result in significantly
more than the judicial exception. Essentially, the claim can be
accomplished by a basic computing device, software program,
or algorithm, without any non-standard hardware or elements.
Viewed as a whole, the claim lacks elements that provide
meaningful limitations to transform the abstract idea into a
patent eligible application of the abstract idea with additional
elements to add significantly more than the judicial exception
(i.e. any tangible result, problem solved, or end goal, etc.).
Id. at 3.
Analysis
35 U.S.C. § 101 states that "[w]hoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title."
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The Supreme Court has "long held that this provision contains an
important implicit exception: Laws of nature, natural phenomena, and
abstract ideas are not patentable." Alice Corp. Pty. Ltd. v. CLS Bank Int 'l,
134 S. Ct. 2347, 2354 (2014).
Our reviewing court has summarized the Supreme Court's two-part
test for distinguishing between claims to patent-ineligible exceptions, and
claims to patent-eligible applications of those exceptions, as follows:
Step one asks whether the claim is "directed to one of
[the] patent-ineligible concepts." [Alice, 134 S. Ct. at 2354]. If
the answer is no, the inquiry is over: the claim falls within the
ambit of § 101. If the answer is yes, the inquiry moves to step
two, which asks whether, considered both individually and as
an ordered combination, "the additional elements 'transform the
nature of the claim' into a patent-eligible application." Id.
(quoting Mayo [Collaborative Services v. Prometheus Labs,
Inc., 566 U.S. 66, 1297 (2012)]).
Step two is described "as a search for an 'inventive
concept."' Id. (quoting Mayo, [566 U.S. at 71-73]). At step
two, more is required than "well-understood, routine,
conventional activity already engaged in by the scientific
community," which fails to transform the claim into
"significantly more than a patent upon the" ineligible concept
itself. Mayo, [566 U.S. at 79-80, 71-73].
Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed.
Cir. 2016) (paragraphing added).
In the present case, Appellants persuade us that the preponderance of
the evidence does not support the Examiner's conclusion that the rejected
claims recite subject matter ineligible for patenting. In particular,
Appellants persuade us that the Examiner has not sufficiently shown that
Appellants' claims are directed to abstract ideas.
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Appellants persuade us that the Alice inquiry, therefore, ends in this
case at step one, with our conclusion, as discussed further below, that the
claims recite subject matter eligible for patenting. Even applying step two of
the Alice inquiry, however, we are not persuaded that the Examiner has
sufficiently shown that the physical steps required by independent claims 13
and 41 were routine and conventional activity already engaged in by the
scientific community.
As to step one of the Alice inquiry, our reviewing court has explained
that, when determining whether a claim is directed to an abstract idea, "both
this court and the Supreme Court have found it sufficient to compare claims
at issue to those claims already found to be directed to an abstract idea in
previous cases." Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327, 1334 (Fed.
Cir. 2016).
As noted above, the Examiner reasons that Appellants' claims involve
"concepts identified as abstract ideas by the courts - similar to 'Diagnosing
an abnormal condition by performing clinical tests and thinking about the
results', with various other extra, pre, and post solution activity which fail in
providing meaningful limitations which result in significantly more than the
judicial exception." Ans. 3. The Examiner, however, does not specifically
identify any prior cases in which claims similar to Appellants' independent
claims 13 and 41 were held to be abstract ideas.
Nor does the Examiner cite any specific case as the source of the
"[d]iagnosing" language quoted on page 3 of the Answer. In that regard, the
Examiner appears to rely on MPEP § 2106.04(a)(2)(III)(A), which identifies
as abstract ideas "[ c ]oncepts relating to data comparisons that can be
performed mentally or are analogous to human mental work" (emphasis
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omitted). In particular, subsection (ii) of§ 2106.04(a)(2)(III)(A) identifies,
as "[an] example[] of this type of concept ... diagnosing an abnormal
condition by performing clinical tests and analyzing the results." MPEP
§ 2106.04(a)(2)(III)(A)(ii) (citing In re Grams, 888 F.2d 835, 840 (Fed. Cir.
1989) and CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372
n.2 (Fed. Cir. 2011) (describing the abstract idea in Grams)).
In Grams, the sole physical process step in the claims at issue was
collecting data by performing a plurality of unspecified clinical tests, for
which little detail was provided in the supporting specification. Grams, 888
F.2d at 836-37, 840. Because the specification provided few specific details
regarding the clinical tests, and instead focused on the algorithm recited in
the claim for analyzing the data, the court concluded that the claims at issue
were directed to the algorithm itself, and were therefore ineligible for
patenting. Id. at 840-41.
Although relating to credit card transactions, in CyberSource the
claims held to be patent-ineligible were directed to unspecified data
gathering steps and subsequent analysis of the gathered data. Cy her Source,
654 F.3d at 1376 ("[T]he method consists of only the general approach of
obtaining information about credit card transactions utilizing an Internet
address and then using that information in some undefined manner to
determine if the credit card transaction is valid.").
In contrast to undetailed data gathering steps like those in Grams and
CyberSource, Appellants' claim 13 recites the tangible, specific process
steps of placing a particular device (an electrode cuff) on a particular nerve
(the hypoglossal nerve), using the electrode cuff to deliver electrical
stimulation to that particular nerve, and visually monitoring the patient's
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upper airway to determine the response to the stimulation. Appeal Br. 26
(Claims App'x). Appellants' claim 41 also includes those steps, as well as
the use of an imaging device to monitor the response of the patient's airway
to the stimulation. Id. at 28. Appellants' Specification makes it clear that
placing the electrode on the hypoglossal nerve, which lies under the skin,
requires surgical intervention, which may be performed according to a
detailed exemplified procedure. Spec. i-fi-1 90-96. The Specification also
provides significant details as to the electrode cuff that may be used in the
claimed methods. Id. i-fi-139--45; Figs. 2, 3A, 3B.
Thus, although Appellants' claims 13 and 41 include the mental steps
of evaluating whether placing the electrode at a particular location elicits a
predetermined response, those claims also include tangible and specific
physical process steps that involve surgical activity, as opposed to mere data
gathering, as evidenced by detailed disclosures in Appellants' Specification.
Because the processes recited in Appellants' claims involve tangible and
specific physical process steps rather than simple data gathering and
subsequent analysis of that data, we are not persuaded that the Examiner has
shown sufficiently that, under step one of the Alice inquiry, Appellants'
claims are directed to an abstract idea.
In addition, as seen below, the sole reference cited by the Examiner as
evidence that it was known in the art to place an electrode on the
hypoglossal nerve, Meadows, is not prior art to the appealed claims.
Accordingly, even if we were persuaded that analysis under step two of the
Alice inquiry was required in this instance, the Examiner has not established
that, beyond the asserted abstract idea, the specific process steps recited in
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Appellants' claims were routine and conventional activities already engaged
in by the scientific community.
WRITTEN DESCRIPTION
The Examiner's Position
In rejecting claims 13, 15-21, 23, 40, and 43--47, as failing to comply
with the written description requirement, the Examiner determined that, in
claim 13, Appellants' "newly added phrase, 'wherein the monitoring at the
first time indicates that a predetermined response is not fully achieved' and
in claims 43-47, the phrase 'the predetermined response', in combination
with the other steps of the claim, fails to be supported by the originally filed
disclosure." Final Act. 7.
The Examiner determined, in particular, that the Specification
"indicates that the cuff may be repositioned at a different location to obtain
the desired effect, and that incorrect placement of the cuff on the nerve is
indicated based on specific responses in airway or tongue observation;
however, there is not a broad 'predetermined response' described within the
[S]pecification." Id. The Examiner also determined that a "similar issue is
present in the final claim limitation of claim 13, where the upper airway is
monitored again for the predetermined response." Id.
Analysis
As stated in Turbo Care Division of Demag Delaval Turbomachinery
Corp. v. General Electric Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001):
The written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed
subject matter on the application filing date. When the
applicant adds a claim or otherwise amends his specification
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after the original filing date ... , the new claims or other added
material must find support in the original specification.
However, "[i]t is not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes
including those limitations." In re Wertheim, 541F.2d257, 262 (CCPA
1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) ("In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.").
In this instance, Appellants persuade us that a preponderance of the
evidence does not support the Examiner's determination that Appellants'
claims fail to comply with the written description requirement. Paragraph
97 of the Specification, cited by Appellants in response to the Examiner's
rejection, describes performing a "test stimulation ... to confirm correct
positioning of the [electrode] cuff 1350 on the nerve." Spec. i-f 97.
The Specification explains how correct placement of the electrode
cuff may be determined:
Id.
Correct placement of the cuff on the nerve may be confirmed
by, for example, observing tongue protrusion, an increase in
retroglossal airway caliber, an increase in retro-palatal airway
caliber, an increase in stiffness of the anterior and/or lateral
walls of the retro-glossal airway with or without an increase in
airway caliber, anterior movement with or without inferior
movement of the hyoid bone, among others.
The Specification then explains how incorrect placement of the
electrode cuff may be determined: "Incorrect placement of the cuff on the
nerve is indicated, for example, when the tongue is observed to retract
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(posterior movement), a decrease in retro-glossal airway caliber, a decrease
in retro-palatal airway caliber, superior movement and particularly unilateral
superior movement of the hyoid bone, among others." Id.
The Specification then explains that, "[i]f necessary, the cuff 1350
may be repositioned at a different location along the length of the nerve to
obtain the desired effect." Id. (emphasis added).
We acknowledge, as the Examiner found, that the Specification does
not use the term "predetermined response" recited in claim 13 or "desired
response" in claim 41. See App. Br. 26, 28 (Claims App 'x). We
acknowledge also the Examiner's apparent concern that the scope of a
"predetermined response" is broader than the specific responses exemplified
at paragraph 97 of the Specification. Ans. 4.
As noted above, however, word-for-word support is not necessary
under the written description requirement. Purdue Pharma, 230 F.3d at
1323. Moreover, as seen above, the Specification at paragraph 97 describes
an electrode cuff-positioning process, which specifically identifies desired
effects produced by stimulation when the electrode is correctly placed, as
well as the effects of stimulation when the electrode is placed incorrectly.
Given the disclosure at paragraph 97, the Examiner does not persuade us that
the Specification fails to describe determining whether stimulation fully
achieves a predetermined or desired response, as required by claims 13 and
41, or that Appellants failed to possess a process having those steps.
Because the Examiner does not persuade us that claims 13 and 41 fail
to comply with the written description requirement, we reverse the
Examiner's rejection of those claims, and their dependent claims, on that
ground.
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ANTICIPATION
The Examiner's Position
In determining that Meadows anticipates claim 41 under 35 U.S.C.
§ 102( e ), the Examiner cited paragraph 118 of Meadows as describing the
claimed step of confirming desired positioning of the electrode by
monitoring an upper airway of the patient for a desired response via an
imaging device. Final Act. 8.
Analysis
Appellants persuade us that the preponderance of the evidence does
not support the Examiner's prima facie case of anticipation. In particular,
Appellants persuade us that paragraph 118 of Meadows, relied upon by the
Examiner to show anticipation, is not prior art to Appellants' claims.
It is undisputed that each of Appellants' claims on appeal are entitled
to a priority date of December 31, 2008, the filing date of provisional
application 61/204,008. Spec. i-f 1. Accordingly, the provisions of 35 U.S.C.
§ 102( e) apply to Appellants' claims. See the Leahy-Smith America Invents
Act ("AIA"), Pub. L. No. 112-29, 125 Stat. 284, § 3(n)(l) (2011) (first
inventor to file provisions of AIA only apply to applications with effective
filing date on or after March 16, 2013).
Although Meadows' filing date of October 2, 2009 (Meadows, cover
sheet) is after Appellants' earliest priority date, Meadows "claims the benefit
of U.S. Provisional Patent Application No. 61/136,857 [('the '857
provisional')] filed Oct. 9, 2008" (Meadows i-f 1 ), which is before
Appellants' earliest priority date.
While published non-provisional applications like Meadows are
properly cited as prior art under 35 U.S.C. § 102(e)(l), for Meadows to be
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prior art as of the filing date of the '857 provisional, the disclosures in
Meadows relied upon by the Examiner as being anticipatory must find
descriptive support in the '857 provisional, in a manner that complies with
35 U.S.C. § 112, first paragraph. See 35 U.S.C. § 119(e)(l).
Regarding the limitation in Appellants' claim 41 of using an imaging
device to confirm a desired response upon stimulation of the hypoglossal
nerve by an electrode, paragraph 118 of Meadows, cited by the Examiner as
anticipating, discloses as follows:
Stimulation is started at the threshold amplitude and slowly
increased to the target amplitude until significant tongue
movement is observed. Significant movement is defined as at
least one movement that decreases airway resistance or results
in increased airway air flow. The movement of the tongue and
its [e]ffect on the airway can be observed with an endoscope
placed in the nasal cavity, by use of jluoroscopy, or by
observing the front of the oral cavity and the overall position of
the tongue. Other ways of observing known to those skilled in
the art can be used without departing from the scope of the
invention. This is the operational point or targeted
stimulation level that will be used if it is decided that this
contact is to be included in the programmed stimulation
protocol designed to affect the tongue during the sleeping
session.
Meadows i-f 118 (emphases added).
The Examiner contends that paragraphs 23 and 58 of the '857
provisional provide support for the above disclosure, in a manner that
complies with 35 U.S.C. § 112. Ans. 5. We are not persuaded.
Rather than describing a step of monitoring a patient's airway with an
imaging device, paragraph 23 of the '857 provisional describes how
injection of dyes may be used to map the hypoglossal nerve:
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Referring to exemplary FIGS. 7 - 11, the present
invention's novel method of mapping hypoglossal nerve
efferents using ... fluorescent dyes manufactured by Molecular
Probes, discloses a surprising and unexpected anatomical and
topographical organization. This anatomical and topographical
organization permits selective stimulation of portions of the
hypoglossal nerve to maximize the efficacy of the stimulation.
The '857 provisional i-f 23.
Similarly, paragraph 58 of the '857 provisional does not describe
monitoring the airway of an individual whose hypoglossal nerve has been
stimulated, but instead simply describes the muscles targeted by that
stimulation:
In one embodiment, the method of treating, controlling,
or preventing obstructive sleep apnea consists essentially of the
recruitment of protrusor 410 motor efferents. In one
embodiment, the method includes activating at least one
protrusor 400 muscle. In one embodiment, the at least one
protrusor muscle 400 activated is the genioglossus muscle. In
one embodiment, the method includes selective stimulation of
protrusor 410 motor efferents located within the hypoglossal
nerve proper 100 that activate the genioglossus muscle, causing
protrusion of the tongue to increase the patency of the upper
airway channel. In one embodiment, the method consists of the
recruitment of a ratio of retrusor 310 to protrusor 410 motor
efferents such as the ratios described above for the treatment of
a neurological disorder.
Id. i-f 58.
We are not persuaded that the disclosures in the '857 provisional of
using fluorescent dyes to map the hypoglossal nerve, and of muscles which
may potentially be activated in hypoglossal nerve-stimulating sleep apnea
treatments, discloses using an imaging device to confirm a desired response
upon stimulation of the hypoglossal nerve by an electrode, as described by
paragraph 118 of Meadows, and as required by Appellants' claim 41.
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Accordingly, because the disclosures in Meadows relied upon by the
Examiner are not prior art to Appellants' claim 41, we reverse the
Examiner's rejection of claim 41 as anticipated by Meadows.
OBVIOUSNESS
The Examiner's Position
In rejecting claims 13, 15-21, 23, and 42 over Meadows, Frei, and
Boggs, the Examiner determined that Meadows described a process having
nearly all of the steps and features required by the rejected claims, and again
cited paragraph 118 of Meadows for its disclosure of using an imaging
device to monitor an upper airway of a patient for a predetermined response
to hypoglossal nerve stimulation. Final Act. 9.
The Examiner determined that Meadows differs from the claimed
processes in that Meadows "fails to teach removing and repositioning of the
electrode at a second location, different from the first location, if the desired
response is not observed." Id. at 10.
In determining that the claimed processes nonetheless would have
been obvious, the Examiner asserted that it is "notorious in the art of
implantable medical devices to reposition electrodes in order to be closer to
their target location" and cited Frei and Boggs in support of that assertion.
Id.
Based on the references' combined teachings, the Examiner
concluded that it would have been "an obvious design choice ... to remove
and reposition the electrode cuff at a second location as exemplified by
Boggs OR Frei, in order to yield the predictable results of providing the best
positioning of the cuff electrode for stimulation delivery to the target
location." Id.
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Analysis
In traversing the Examiner's obviousness rejection, Appellants again
assert that Meadows is not prior art to the rejected claims because paragraph
118 of Meadows, relied upon by the Examiner in the obviousness rejection,
lacks support in the '857 provisional. Appeal Br. 20.
In response, the Examiner relies on the assertions, discussed above in
relation to the anticipation rejection, that paragraphs 23 and 58 of the '857
provisional support the disclosure in paragraph 118 of Meadows of
monitoring the upper airway of the stimulated patient. See Ans. 6
("Appellant[ s '] argument with respect to Meadows not eligible as prior art
has been addressed above with respect to the[§] 102(e) rejection.").
As discussed above, however, we are not persuaded that paragraphs
23 and 58 of the '857 provisional support the disclosure in the Examiner's-
relied-upon paragraph 118 of Meadows of monitoring the upper airway of
the stimulated patient. The Examiner, moreover, provides no specific
explanation why any disclosures available as prior art in Meadows or the
'857 provisional teach or suggest monitoring the upper airway of the
stimulated patient in the fashion required by the rejected claims, even when
combined with Frei or Boggs. To the contrary, the Examiner asserts that
"Frei and Boggs are used in combination with Meadow[ s] to obviate the
claimed repositioning of the electrode cuff at a second location. Meadow[ s]
clearly anticipates the other steps of the claimed method as clearly indicated
and cited in the rejection." Ans. 6.
In sum, for the reasons discussed above, the Examiner does not
persuade us that paragraph 118 of Meadows is available as prior art against
the rejected claims. Because the Examiner does not explain specifically why
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any disclosures in Meadows available as prior art teach or suggest
monitoring the upper airway of the stimulated patient in the fashion required
by the rejected claims, even viewed alongside Frei or Boggs, we reverse the
Examiner's rejection of claims 13, 15-21, 23, and 42 over Meadows, Frei,
and Boggs.
SUMMARY
For the reasons discussed, we reverse each of the Examiner's
rejections.
REVERSED
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