Ex Parte Christopherson et al

Patent Trial and Appeal Board

Jun 27, 2017

12992511 (P.T.A.B. Jun. 27, 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.
12/992,511 03/07/2011 Mark Christopherson 1618.102.102 7866
25281 7590 06/29/2017
DICKE, BILLIG & CZAJA
FIFTH STREET TOWERS
100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS, MN 55402
EXAMINER
CATINA, MICHAEL ANTHONY
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
06/29/2017 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):
USPTO.PATENTS @dbclaw.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK CHRISTOPHERSON, TIMOTHY HERBERT, and
QUANNI,
Appeal 2016-001105
Application 12/992,5111
Technology Center 3700
Before TAWEN CHANG, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
treating respiratory dysfunction, including sleep apnea. The Examiner
entered final rejections for obviousness. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the real party in interest as Inspire Medical Systems,
Inc. App. Br. 3.
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Application 12/992,511
STATEMENT OF THE CASE
Background
Sleep apnea generally refers to the cessation of breathing
during sleep. One type of sleep apnea, referred to as obstructive
sleep apnea (OSA), is characterized by repetitive pauses in
breathing during sleep due to the obstruction and/or collapse of
the upper airway, and is usually accompanied by a reduction in
blood oxygenation saturation.
One treatment for obstructive sleep apnea has included
the delivery of electrical stimulation to the hypoglossal nerve,
located in the neck region under the chin. Such stimulation
therapy activates the upper airway muscles to maintain upper
airway patency.
Spec. 113^1.
In addition to the electrode that delivers therapy to the hypoglossal
nerve, “obstructive sleep apnea treatment may include the use of a sensor . . .
implanted in a region that has pressure continuity with the intrapleural
space,” which surrounds the lungs. {Id. 1 5, Fig. 2 (showing intrapleural
space 90 and lung 80).) The Specification explains that “[cjhanges in
intrapleural pressure provide a characteristic respiratory effort waveform,
and therefore the sensor enables respiratory effort waveform information to
be utilized to determine increased respiratory effort, which is then used to
control delivery of therapy in response to determined increases in respiratory
effort.” {Id.) The Specification notes that sensors may be attached to the
trachea or esophagus, implanted in the suprasternal notch (the space between
the trachea and esophagus), positioned intercostally (i.e., between the ribs,)
or “secured in a position for sensing pressure at the posterior side of the
manubrium” (the upper part of the sternum). {Id.)
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The Specification discloses “an implantable stimulation system for
stimulating and monitoring soft tissue in a patient, and more particularly, the
invention relates to a method and apparatus for sensing respiratory pressure
to control delivery of therapy to nerve tissue.” Id. 12.
The Claims
Claims 1, 2, 4, 10-20, 44, 45, and 59-63 are on appeal. App. Br. 1.
Claims 1 and 59 are illustrative and read as follows:
1. A method of treating a respiratory dysfunction, the
method comprising:
positioning a pressure sensor of a lead, via an intercostal
access point lateral to the sternum on one side of a patient’s
body, into an implanted location in which the pressure sensor is
coupled relative to respiratory pressures of a pleural space and
in which a single side of the pressure sensor provides a single­
direction pressure sensing element, wherein the single side
directly faces, and overlies, a portion of the lungs;
maintaining the pressure sensor in the implanted location
via securing a portion of the lead that is proximal to, and spaced
apart from, the pressure sensor relative to the patient’s body
without directly securing the pressure sensor at the location of
the pressure sensor;
sensing, via the pressure sensor, the respiratory pressure;
and
triggering electrical stimulation of an airway-patency-
related nerve, from an implantable pulse generator coupled to
the pressure sensor, based on at least one parameter of the
sensed respiratory pressure.
App. Br. 28 (Claims App.).
59. A method of treating obstructive sleep apnea, the method
comprising:
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locating and forming a subcutaneous, intercostal access
point between a pair of immediately adjacent ribs on a right
side of a patient’s body lateral to the sternum; and
inserting and advancing a distal portion of a sensor lead,
including a pressure sensor, through the intercostal access point
to implant the distal portion on the right side of the patient’s
body to couple the pressure sensor relative to respiratory
pressures of a pleural space with a single side of the pressure
sensor oriented to directly face toward a lung, wherein the
single side includes a single-direction sensing element, and
wherein the distal portion is generally parallel to the adjacent
ribs and pointing toward a centerline of the body with the
pressure sensor located at or lateral to a costochondral joint of
the adjacent ribs to overly the portion of the lung;
implanting a pulse generator on the right side of the
patient’s body and coupling the pressure sensor relative to the
pulse generator;
sensing, via the pressure sensor, the respiratory pressure
to provide a respiratory waveform; and
triggering electrical stimulation of an airway-patency-
related nerve, from the pulse generator, based on at least one
parameter of the respiratory waveform.
Id. at 34 (Claims App.).
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The Issues
The following rejections are before us to review:
Claims 1, 2, 4, 10-20, 44, 45, and 59-63 are rejected under pre-AIA
35 U.S.C. § 103(a) as obvious over Christopherson2 and Lee.3 Final Act. 3.
Claims 11—13, 44, 45, 59, and 60 are rejected under pre-AIA 35
U.S.C. § 103(a) as obvious over Christopherson, Lee, and Bolea.4 Id. at 11.
ANALYSIS
Rejection over Christopherson and Lee
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the claims are obvious over
the cited references?
The Examiner has rejected claims 1, 2, 4, 10-20, 44, 45, and 59-63 as
obvious over Christopherson and Lee. The Examiner finds that
Christopherson discloses a method of treating a respiratory dysfunction
comprising:
positioning a sensor portion of a lead, via an intercostal access
point, into an implanted location in which the sensor portion is
coupled relative to respiratory pressures of a pleural space . . .
and in which a single side of the pressure sensor provides a
single direction pressure sensing element, wherein the single
side directly faces and overlies a portion of the lungs (. . .
wherein the sensor can sense from both directions but either
porthole only senses the pressure from the single side);
maintaining the pressure sensor in the implanted location via
securing a portion of the lead that is proximal to and spaced
apart from, the pressure sensor relative to the patient’s body
2 US 6,132,384, issued Oct. 17, 2000 (“Christopherson”).
3 US 2005/0074741 Al, issued Apr. 7, 2005 (“Lee”).
4 US 2008/0103545 Al, published May 1, 2008 (“Bolea”).
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without directly securing the pressure sensor at the location of
the pressure sensor (.. . where the anchors are secured outside
the rib cage. The sensor is not secured in that it can be placed
elsewhere other than through the manubrium, like the
intercostal space . . . and the anchors still fix the sensor lead).
sensing, via the sensor portion at the implanted location, at least
one of a temperature and the respiratory pressure . . . ; and
. . . triggering the application of an electrical stimulation signal,
from an implantable pulse generator coupled to the sensor
portion, based on the substantial change in the amplitude of at
least one of the sensed temperature and the sensed respiratory
pressure.
Final Act. 3^4.
In other words, the Examiner appears to find that Christopherson
teaches all limitations of claim 1, but notes that it does not teach
locating and forming the intercostal access point between a pair
of immediately adjacent ribs on one side of a patient’s body;
and inserting and advancing a distal portion of the sensor lead,
including the sensor portion, through the intercostal access
point to orient the distal portion to be generally parallel to the
adjacent ribs and pointing toward a centerline of the body.
Id. at 4.5
The Examiner finds that Lee “teaches implanting the sensor in the
correct orientation (. . . the sensor is between adjacent ribs, parallel in
orientation and pointing inward).” Id.
The Examiner concludes that it would have been obvious
to combine the device of Christopherson with Lee as both are
known positions for respiratory sensors thus the combination
would have resulted in the predictable outcome of positioning
5 We note that the above-cited limitations are in fact limitations of claim 11
rather than claim 1. We address Appellants’ argument with respect to this
point later in our opinion.
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Christopherson’s sensors in the recited manner and the
combination is no more than the predictable use of prior art
elements for their established purpose. Furthermore
Christopherson discloses various positions as long as they are
near or along the sternum.
Id. at 4—5.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
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.
We select claim 1 as representative of the claims subject to this
ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv). Unless otherwise noted,
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. We
conclude that the Examiner has established a prima facie case that the
method of claim 1 would have been obvious over Christopherson and Lee.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner’s determinations 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) (2015).
Appellants argue Christopherson does not provide sufficient
information or illustration regarding an intercostal positioning to guide the
skilled artisan to use this positioning with a pressure sensor as claimed.
App. Br. 9. Appellants further argue that the skilled artisan would not be
motivated to combine the teachings of Lee with those of Christopherson,
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because “the placement of the pressure sensor in Christopherson is for a
[different] purpose (measuring pressure) than the purpose (measuring
impedance) of the placement of the electrode assembly 308 in Lee.” Id. at
16.
We are not persuaded. Christopherson teaches that its “pressure
sensor 60 is surgically implanted in a region that “has pressure continuity
with the intrapleural space such as ... an intercostal placement” and that the
location for placement of the sensor is
at least in part, chosen as a function of delay, i.e. propagation
time of a pressure waveform characteristic of respiratory effort
propagating from the respiratory point of origin to the sensor
position and as a function of the amount of filtering necessary to
achieve a usable sensed signal at a particular location, i.e.
filtering necessary to remove waveforms other than the
waveform of the sensed characteristic, such as cardiac
waveform activity.
Christopherson 8:54—9:7; see also id. at 2:28—33 (prior art teaches intercostal
placement of sensor). Christopherson further teaches that preferable
placement of the sensor is
implanted through a drilled hole in the manubrium 63 as shown
in FIGS. 10a and 10b. However, the sensor assembly 115
could be implanted through the sternum 64 at any location
thereof or through any other bone such that the sensing element
126 is in communication with the intrathoracic region or a
region with pressure changes characteristic of respiratory effort.
Id. at 11:42-49. Accordingly, because Christopherson recognizes both
intercostal positioning and positioning along or through the sternum as
positions providing sufficient continuity with the pleural space as to permit
proper calculation of the waveform, and expressly instructs the skilled
artisan that these positions may be used, we are persuaded that the artisan
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would be able to achieve the claimed position (i.e., “via an intercostal access
point lateral to the sternum on one side of a patient’s body”) using the
guidance of Christopherson alone.6
We note, however, that the Examiner relies upon Lee to teach
positioning of the sensor. Ans. 2. We agree with the Examiner that Lee also
teaches intercostal positioning (see Lee, Lig. 3,1 56) of a sensing and/or
stimulation device and further find that Christopherson’s teaching is not
limited to pressure sensors. Christopherson 2:59—60 (pressure sensing
element is one embodiment), 4:39-49 (invention broadly described as a
system including an implantable sensing element for sensing “a
characteristic of respiratory effort”). Christopherson specifically teaches
that the characteristic monitored by Lee, intrathoracic impedance, can also
be used to obtain respiratory effort waveforms that are sufficiently
identifiable for use with its pressure sensors to monitor respiratory effort:
“[rjespiratory effort waveforms having similar identifiable characteristics
can be provided by monitoring other physiological signals such as
intrathoracic pressure, intrathoracic impedance or electromyographic
potentials. ” Id. at 7:12—16. Lor this reason we are persuaded that the skilled
artisan would have reason to combine the teachings of Christopherson and
Lee and agree with the Examiner that there “are limited positions in which a
sensor can be placed in the thoracic cavity and, as such, it would not require
undue experimentation to determine an optimum position for lung
6 The Board may rely upon fewer than all the references cited by the
Examiner. See In re May, 574 L.2d 1082, 1090 (CCPA 1978).
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monitoring especially given that intercostal positioning of sensors is known
as shown in Lee.” Ans. 2.7
Appellants next argue that Christopherson’s conflicts with the claim
requirement that “a single side of the pressure sensor provides a single
direction pressure sensing element, wherein the single side directly faces and
overlies a portion of the lungs” because neither of the disclosed directions of
the porthole pressure sensor directly faces the lungs but instead “face[s]
generally parallel to the lungs.” App. Br. 9—10. Appellants argue, the
skilled artisan would understand that “the sensing section 120 in
Christopherson detects pressure from two opposite directions via the
oppositely oriented portholes 128.” Id at 10.
We are not persuaded. Claim 1 requires that “a single side of the
pressure sensor provides a single-direction pressure sensing element,
wherein the single side directly faces, and overlies, a portion of the lungs.”
Figures 11a and 1 lb of Christopherson are reproduced below:
7 We acknowledge Appellants’ argument that claim 11, not claim 1, contains
the language that the Examiner finds is taught by Lee and that Appellants
argue this fact renders the Examiner’s proposed combination of
Christopherson and Lee without “rationale.” App. Br. 15. We are not
persuaded as Lee is analogous art that provides design options for to the
skilled artisan to consult as how to place a sensor with regard to orientation
and placement in the intercostal space. See In re Kuhle, 526 F.2d 553, 555
(CCPA 1975) (“[T]he particular placement of the contact provides no novel
or unexpected result.”). Furthermore, claim 11 depends from claim 1. To
the extent Christopherson and Lee render claim 11 obvious, they also render
the broader claim 1 obvious.
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\
FIG.IIa
US
FIG.IIb
Figures 11a and 1 lb of Christopherson depict, respectively, a side view and
a cutaway view of an embodiment of its pressure sensor. Christopherson
5:33—37. Referring to Figure 11, Christopherson discloses that the “pressure
sensor assembly 115 .. . includes a sensing section 120.” Id. 9:12—13.
Christopherson teaches that “[t]he relative pressure sensing element 126
senses respirational pressures through the use of piezo-electric crystals
attached to a sensor diaphragm lying perpendicular to a longitudinal axis
125 extending through assembly 115.” Id. at 9:18—22 (emphasis added).
Christopherson’s Figure 10a is reproduced below:
Christopherson’s Figure 10a is an “illustration^ showing [a]
position[] or configuration^ for mounting the sensor.” Id. at 5:29—32.
As shown in Figure 10a, a sensor diaphragm lying perpendicular to
62
/,
115
FIG.10a
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the longitudinal axis of assembly 115 appears to face the direction of
the lung. We further agree with the Examiner that claim 1 does not
require that the pressure sensor receive input only from the side it
faces, but simply that it senses pressure at the location of the sensor.
Final Act. 14; Ans. 3. As demonstrated above in Figure 10a of
Christoperson, the sensor faces the patient’s lung sufficiently to detect
pressure. Ans. 3.
As the Examiner further points out, Fee teaches a sensor in a
disordered breathing classification and/or discrimination system
overlying a portion of the lung. Ans. 3; Fee Fig. 3. Appellants argue
that a skilled artisan viewing Fee’s Figure 3 would “likely observe
that the placement of the electrode assembly 307 is not likely to
significantly overlie lung tissue.” Appeal Br. 14 (emphasis added).
However, we are not persuaded because we agree with the Examiner
that claim 1 does not specify a “degree to which the sensor must
overlie the lung.” Ans. 3.
In sum, we find the Examiner has established a prima facie case
of obviousness with respect to the limitation and that the burden shifts
to Appellants to prove otherwise. In re Oetiker, 977 F.2d at 1445.
Appellants have provided only unpersuasive attorney argument. See
In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[Attorney
argument [is] not the kind of factual evidence that is required to rebut
a prima facie case of obviousness”).
Appellants next argue that certain embodiments of Christopherson do
not teach the claim limitation: “maintaining the pressure sensor in the
implanted location via securing a portion of the lead that is proximal to, and
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spaced apart from, the pressure sensor relative to the patient’s body without
directly securing the pressure sensor at the location of the pressure sensor.”
App. Br. 11—13. This argument is not persuasive because, as the Examiner’s
notes, Christopherson discloses at least one embodiment comprising anchors
on the lead of the sensor that secure the lead and maintain the sensor’s
location but do not directly secure the sensor body itself. Ans. 3;
Christopherson Figs. 10c (anchoring elements 178 securing a portion of the
lead that is proximal to but spaced apart from the sensing element 197) and
11a (pressure sensor assembly or sensor lead comprising a sensing section
120 and a separate “lead anchoring” section 122). This is sufficient to
establish obviousness, as “[i]t is well settled that a prior art reference is
relevant for all that it teaches to those of ordinary skill in the art.” In re
Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992).
Appellants next argue that Fee fails to cure the deficiencies of
Christopherson such that the combination of Fee and Christopherson does
not render claim 1 obvious. App. Br. 13—15. We are not persuaded for the
reasons discussed above. Finally, we note but are not persuaded by
Appellants’ argument in the Reply Brief that the Examiner’s obviousness
rejection is based on a combination of different embodiments in
Christopherson and Fee. (Reply 2, 3—4.) There is no requirement in an
obviousness rejection that all of the limitations be disclosed in a single
embodiment. Moreover, while Appellants argue that the various
embodiments conflict with or are inconsistent with each other, Appellants
have provided no evidence or persuasive argument that any such differences
in the embodiments would render their combination inoperable or non-
obvious. Cf. Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1013
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(Fed. Cir. 1983) (explaining that the fact that two prior art devices could not
physically be combined does not mean that those skilled in the art would
have found combining features of the two devices to be nonobvious).
Accordingly, we affirm the rejection of claim 1.
Claim 11
Appellants argue that Lee does not teach ‘“locating and forming an
intercostal access point’ at the location ‘between a pair of immediately
adjacent ribs’” because it is relatively silent “regarding a manner and/or
location of securing electrode assembly 307.” App. Br. 17.
This argument is not persuasive because Figure 3 of Lee shows the
sensor in the precise position recited in the claim, and paragraph 55
describes the device of Figure 3 as follows (emphasis added):
The ITCS device may, for example, be implanted
subcutaneously such that all or selected elements of the device
are positioned on the patient’s front, back, side, or other body
locations suitable for sensing cardiac activity and delivering
cardiac stimulation therapy. Elements of the ITCS device may
be located at several different body locations, such as in the
chest, abdominal, or subclavian region with electrode elements
respectively positioned at different regions near, around, in, or
on the heart.
We find that with this description and the teachings of Lee and
Christopherson regarding intercostal placement discussed above, the
intercostal implantation as recited of claim 11 would have been obvious to
the skilled artisan.
Appellants further argue that, in contrast to the Examiner’s assertion
that Appellants have not disclosed an advantage to placing the device on the
right side of the body, paragraphs 67—69 of the Specification demonstrate
the advantage of placing the sensor on the right side of the body, which is to
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“maximize its spacing from the cardiac activity associated with the apex of
the heart and with the left ventricle, which are on the left side of the body. . .
. [thereby minimizing] the impact of cardiac artifacts on sensing respiratory
pressures via the pressure sensor.” App Br. 17; Spec. ^fl[ 67—69.
This argument is not persuasive. Christopherson explicitly teaches
that “the location for placement of the sensor is, at least in part, chosen . . .
as a function of the amount of filtering necessary ... to remove waveforms
other than the waveform of the sensed characteristic, such as cardiac
waveform activity.'” Christopherson 8:66—9:7 (emphasis added).
Accordingly, it would have been obvious for the skilled artisan “to optimize
the location of the sensor to get less interference as there are limited
positions with[in] the chest cavity to try” (Ans. 4) and the prior art has
indicated that any of them are suitable so long as the sensor is in a position
that “has pressure continuity with the intrapleural space” and a stable
waveform signal can be obtained. Christopherson 8:54—9:7. For these
reasons we are also unpersuaded by Appellants’ argument that the
Examiner’s citation to Figure 3 and paragraphs 63—64 of Lee as teaching
implantation of the sensor in the claimed orientation is hindsight
reconstruction. Indeed,
[a]ny judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395, (CCPA 1971). The Examiner’s
rejection is properly based on prior art.
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To the extent Appellants argue that the placement of claim 11 permits
them to obtain unexpected results such that the invention is not obvious,
Appellants’ argument is further unpersuasive without evidence of results
superior to the closest prior art, which was not provided. See In re Baxter
TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art”). Neither have
Appellants shown that any superior results are unexpected, given
Christopherson’s teaching that minimizing cardiac waveform activity is
desirable in determining sensor placement. Appellants’ attorney argument
alone is unpersuasive. See In re Geisler, 116 F.3d at 1470 (“[Attorney
argument [is] not the kind of factual evidence that is required to rebut a
prima facie case of obviousness”). Accordingly, we affirm the rejection of
claim 11.
Claims 12, 15, and 20
Appellants argue that the location of the sensor placement in claim 12
— at or lateral to the costochondral joint — is not obvious based on the
Examiner’s combination of prior art references. App. Br. 19. According to
Appellants, the positioning of the disordered breathing classification system
in Lee’s Figure 3 is “such that electrode assembly 307 is apparently located
medially of the costochondral joint of the ribs (and their associated costal
cartilages) immediately adjacent the electrode assembly 307” as opposed to
the claimed ‘“at or lateral to the costochondral joint of the adjacent ribs.’”
Id.
Similarly, Appellants argue that the location of the sensor in claim 15,
“between the fifth and sixth rib” is nonobvious because it “helps to
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overcome the stated problem of avoiding cardiac artifacts . . . and/or
avoiding a more invasive pectoral location for sensor implant” thereby
“significantly contributing] to alleviating respiratory dysfunction.” Id. at
20.
Appellants additionally argue that the placement of the sensor and
anchor lead in claim 20, in which the “fixed first anchor is spaced apart from
the pressure sensor about 3 to about 9 centimeters along a length of the
sensor lead” is not obvious because the Specification “articulate[s] an
advantage and purpose . . . that provides a meaningful difference” provided
by this arrangement and neither cited reference discloses it. Id. at 21—22.
Once again we are unpersuaded due to the disclosures of
Christopherson and Lee, as discussed above, that a sensor as claimed could
be placed in multiple locations near the sternum based on consideration of
factors including the minimization of cardiac artifacts, as well as the ability
of the skilled artisan to optimize placement based on the measurement to be
obtained.
To the extent that Appellants argue that their claimed placement
provides an unexpected advantage over the prior art, this argument alone is
unpersuasive without evidence that this particular placement provides an
unexpected advantage as compared to the closest prior art, and that such a
benefit was indeed “unexpected.” In re Geisler, 116 F.3d at 1470.
On this record, the evidence supports the Examiner’s finding that the
combination of Christopherson (e.g., Figure 10b—lOd) and Lee suggests:
“arranging the implanted location of the pressure sensor to be at or lateral to
costochondral joint of the adjacent ribs,” “wherein the adjacent pair of ribs
comprises the fifth uppermost rib and the sixth uppermost rib” and wherein a
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“fixed first anchor is spaced apart from the pressure sensor about 3 to about
9 centimeters along a length of the sensor lead.” Accordingly, we affirm the
rejection of claims 12, 15, and 20.
Claim 17
Appellants argue that the claim limitation “securing, via a fixed first
anchor on the sensor lead that is proximal to the sensor portion, the sensor
lead relative to a subcutaneous connective tissue that is external to the
intercostal access point” is not disclosed by Christopherson. App. Br. 21.
The Examiner cited Figure 10 as teaching that the fixed first anchor of the
sensor lead is proximal to the sensor portion and the lead is external to the
intercostal access point and that the “anchors are secured outside the rib
cage.” Final Act. 4. Figure 10 is an embodiment reflecting a configuration
with an anchor outside the rib cage and alongside the right arm:
185
Appellants provide no evidence or persuasive explanation why Figure 10b
does not teach the recited configuration or why the proposed combination
does not render claim 17 obvious. Presenting a statement that merely points
out what a claim recites is not an argument for the separate patentability of
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the claims. 37 C.F.R. § 41.37(c)(l)(iv). See also In reLovin, 652 F.3d
1349, 1357 (Fed. Cir. 2011) (noting that separately arguing a claim requires
“more substantive arguments in an appeal brief than a mere recitation of the
claim elements and a naked assertion that the corresponding elements were
not found in the prior art.”). Accordingly we affirm the rejection of claim
17.
Claims 59, 60, and 61
Appellants rely on their prior arguments in support of their request to
reverse the rejection of these claims and provide no separate arguments. In
re Lovin, 652 F.3d at 1357. Accordingly, we affirm their rejection.
Conclusion of Law
We affirm the rejection of claims 1, 11, 12, 15, 17, 20, and 59-61 as
obvious over Christopherson and Lee. Claims 2, 4, 10, 13, 14, 16, 18, 19,
44, 45, 62, and 63 were not argued separately; their rejection is also
affirmed. 37 C.F.R. § 41.37(c)(l)(iv).
Rejection over Christopherson, Lee, and Bolea
The Examiner has rejected claims 11—13, 44, 45, 59, and 60 as
obvious over Christopherson, Lee, and Bolea. The Examiner finds that:
Christopherson as modified does not specifically disclose
placing the lead and IPG on the right side of the patient. Bolea,
however, teaches implanting the IPG on the right side and the
respiration sensor between the 5th and 6th rib ... . Therefore it
would have been obvious ... to combine the device of
Christopherson with the teachings of Bolea in order to leave
space for a pacemaker traditionally implanted on the left side.
Final Act. 11.
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Appeal 2016-001105
Application 12/992,511
We select claim 11 as representative of the claims subject to this
ground of rejection. 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. We conclude that the Examiner has established a prima facie
case that the method of claim 11 would have been obvious over
Christopherson, Lee, and Bolea. Appellants have not produced evidence
showing, or persuasively argued, that the Examiner’s determinations are
incorrect.
Appellants reiterate their prior arguments regarding the teachings of
Christopherson and Lee. For the reasons above, those arguments are
unpersuasive. Appellants also argue that Bolea does not cure the
deficiencies of Christopherson and Lee, because it
fails to disclose any arrangement corresponding to [jlocating
and forming the intercostal access point between a pair of
immediately adjacent ribs on a right side of the patient’s
body; and inserting and advancing a distal portion of the
sensor lead, including the pressure sensor, through the
intercostal access point to orient the distal portion on the
right side of the patient’s body to be generally parallel to the
adjacent ribs and pointing toward a centerline of the body.
App. Br. 24. According to Appellants, Bolea’s “mention of the ‘right side of
the patient’s body’” is insufficient to teach this arrangement. Id.
We are not persuaded. Bolea explicitly teaches placement of its
implantable neurostimulator (INS) sensor on the right side of the patient:
the bio-Z vector may be arranged such that the proximal
combination electrode is located just to the right of and above
the xiphoid below the pectoral muscle between the 5th and 6th
ribs and the distal current-carrying electrode is located
midlateral between the 7th and 8th ribs, with the distal voltage­
sensing electrode positioned between the 6th and 7th ribs 10 mm
proximal of the distal current-carrying electrode. This
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Appeal 2016-001105
Application 12/992,511
arrangement places the electrodes along the interface between
the right lung, diaphragm and liver on the right side of the
thoracic cavity.
Bolea 1176; see also id. 177—179. In addition, Christopherson and Lee
both teach placement in multiple locations adjacent to the sternum, as
discussed above. As further discussed above, to the extent Appellants allege
unexpected superior effect of the claimed placement, this is unsupported
attorney argument. Accordingly, we affirm the rejection.
Claim 12
Appellants argue that because Bolea discloses a “trans-thoracic
impedance measurement technique,” the skilled artisan would recognize that
the proximal combination electrode is located nearly immediately adjacent
the sternum and, therefore, cannot be “at or lateral to a costochondral joint of
the adjacent ribs.” App. Br. 25. Appellants also argue “to the extent that the
Final Office Action focuses on a single electrode as being between the fifth
and sixth ribs, this particular electrode (the ‘proximal combination
electrode’) is placed closer toward the Left side of the body, and therefore
closer toward the likely position of the heart”. Id.
We are not persuaded. As discussed above, Christopherson and Lee
suggest a wide flexibility of placement. As noted by the Examiner, Bolea
teaches positioning of the IPG on the right side and a respiration sensor
between the 5th and 6th rib. Final Act. 11. Claim 12 recites “wherein
positioning the pressure sensor comprises: arranging the implanted location
of the pressure sensor to be at or lateral to a costochondral joint of the
adjacent ribs”. App. Br. 29 (Claims App.). The positioning shown in Bolea
teaches “at or lateral to a costochondral joint of the adjacent ribs” and is
shown on the right side of the patient. Bolea Tflf 176—179, Fig. 37.
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Appeal 2016-001105
Application 12/992,511
Appellants have not provided arguments or evidence that, when considered
together with the Examiner’s reasonable fact-based conclusions, render the
claim non-obvious. Accordingly, we affirm the rejection of claim 12.
Appellants raise no further substantive argument regarding the
rejected claims. Accordingly, we affirm the rejection of claims 13, 44, 45,
59, and 60.
SUMMARY
We affirm the rejection of claims 1, 2, 4, 10—20, 44, 45, and 59-63
under pre-AIA 35 U.S.C. § 103(a) as obvious over Christopherson and Lee.
We affirm the rejection of claims 11—13, 44, 45, 59, and 60 under pre-
AIA 35 U.S.C. § 103(a) as being obvious over Christopherson, Lee, and
Bolea.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.L.R. § 1.136(a)(1). See 37 C.L.R.
§ 1.136(a)(l)(iv).
ALLIRMED
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