Ex Parte Libbus

Board of Patent Appeals and Interferences

Mar 17, 2010

10962845 (B.P.A.I. Mar. 17, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte IMAD LIBBUS
____________________

Appeal 2009-002001
Application 10/962,845
Technology Center 3700
____________________

Decided: March 17, 2010
____________________

Before: WILLIAM F. PATE III, LINDA E. HORNER, and
KEN B. BARRETT, Administrative Patent Judges.

PATE III, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1-
15 and 17-47. App. Br. 9. We have jurisdiction under 35 U.S.C. § 6(b).
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The claims are directed to a medical device and method for baroreflex
stimulation. Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A medical device, comprising:
a baroreflex stimulator to generate a stimulation signal,
the stimulation signal being adapted to stimulate a baroreflex;
and
a controller to communicate with the baroreflex
stimulator and implement a baroreflex stimulation protocol to
vary an intensity of the baroreflex stimulation provided by the
stimulation signal to abate baroreflex adaptation.

23. An implantable medical system, comprising:
means for generating a baroreflex stimulation signal to
stimulate a baroreflex; and
means for abating baroreflex adaptation, including means
for changing at least one parameter of the baroreflex
stimulation signal such that the baroreflex stimulation ranges
within a range from a first baroreflex stimulation level and a
second baroreflex stimulation level.

30. A method, comprising:
generating a baroreflex stimulation signal to stimulate a
baroreflex; and
abating baroreflex adaptation, including changing at least
one parameter of the baroreflex stimulation signal such that the
baroreflex stimulation ranges within a range from a first
baroreflex stimulation level and a second baroreflex stimulation
level.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:

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Kieval US 6,522,926 B1 Feb. 18, 2003
David US 2004/0193231 A1 Sep. 30, 2004

REJECTIONS
Claims 1, 2, 4, 10-15, 17-19, 21-24, 28-31, 35, 37, 38, 40-44, and
46 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Kieval.
Ans. 3.
Claim 3 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kieval. Ans. 7-8.
Claims 5-9, 25, 27, 32-34, 36, 39, 45 and 47 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Kieval and David. Ans. 8.
If the language of a claim renders its scope “unclear,” that claim
should be rejected under 35 U.S.C. § 112 second paragraph and not merely
objected to. The Examiner has apparently withdrawn any rejection/objection
to claim 17 for a lack of clarity since the Examiner does not address
Appellant’s arguments on the subject in the Answer. App. Br. 21; Final Rej.
2.

ISSUES
Appellant argues claims 1, 2, 4, 10-15, 17-19, 21-24, 28-31, 35, 37,
38, 40-44, and 46 as a group. App. Br. 12. Separate subheadings are
provided for claims 1, 23 and 30 wherein Appellant relies upon the
arguments set forth in sections B(1) through B(5). App. Br. 18. Given the
varied scope of independent claims 1, 23 and 30, we will discuss the claims
separately.
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With regard to the limitation in question, “abating baroreflex
adaptation”, method claim 30 is the narrowest, requiring actual performance
of the step. In contrast claim 1 recites that step as a function performed by
the claimed apparatus. Claim 23, employing means-plus-function language,
requires the corresponding structure in the Specification for performing that
function or an equivalent. As discussed below, despite inclusion in this
group, claims 2, 15, 24, 31 and 38 are argued separately. Separate arguments
are not provided regarding claims 4, 10-14, 17-19, 21-23, 28-29, 35, 37, 40-
44, and 46. Claims 4, 10-14, 17-19, 21-23, 28-29, 35, 37, 40-44, and 46 will
therefore stand or fall with their respective parent claims. 37 C.F.R.
§ 41.37(c)(1)(vii).
Appellant and the Examiner agree that Kieval does not expressly
disclose “abating baroreflex adaptation.” The Examiner contends that since
Kieval performs exactly the same steps, with exactly the same structure, the
result is necessarily an abatement of baroreflex adaptation. Ans. 9-10.
Appellant correctly identifies this as a finding of inherency but contends that
abating baroreflex adaptation is not necessarily present in Kieval and a
person of ordinary skill in the art would not recognize its presence. App. Br.
16-18; Reply Br 3-7. At the outset, we reject the second prong of
Appellant’s inherency test. Schering Corp. v. Geneva Pharmaceuticals, Inc.,
339 F.3d 1373, 1377 (Fed. Cir. 2003) (“inherent anticipation does not
require that a person of ordinary skill in the art at the time would have
recognized the inherent disclosure”). Accordingly, we must consider
whether the Examiner erred in finding that Kieval inherently discloses “a
controller to . . . implement a stimulation protocol to vary an intensity of the
baroreflex stimulation provided by the stimulation signal to abate baroreflex
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adaptation”, a “means for abating baroreflex adaptation”, or “abating
baroreflex adaptation”, as required by claims 1, 23 and 30, respectively.
Appellant argues claims 2, 15, 24, 31 and 38 as a group. App. Br. 19.
It is noted that separate comments are provided for claims 2, 15, 23, 30 and
38. App. Br. 20. Based on the limitations noted in the Brief, “claim 23” and
“claim 30” should apparently have read “claim 24” and “claim 31,”
respectively. The issue raised by Appellant regarding claims 2, 15, 24, 31
and 38 is whether the Examiner erred by concluding that Kieval discloses
those limitations associated with detecting a pulse rate and modulating the
signal at a rate corresponding thereto. App. Br. 19-20; Reply Br. 7; Ans. 4,
10-12.
Appellant’s arguments regarding the rejection of claim 3 as being
unpatentable over Kieval and the rejection of claims 5-9, 25, 27, 32-34, 36,
39, 45 and 47 as being unpatentable over Kieval and David, are based solely
upon dependency. App. Br. 21.
FINDINGS OF FACT
1. Kieval discloses a system to selectively and controllably activate
baroreceptors in order to reduce excessive blood pressure, sympathetic
nervous system activation and neurohormonal activation, thereby
minimizing their deleterious effects on the heart, vasculature and other
organs. Col. 3, ll. 13-24.
2. Kieval discloses a control system 60, which generates a control signal
dictated by an algorithm contained in a memory 62. The signal may be
generated as a function of a received sensor 80 signal to activate,
deactivate or otherwise modulate a baroreceptor activation device 70.
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Modulation of the baroreceptor activation device 70 may cause or
modify activation of baroreceptors 30. Col. 7, ll. 26-40; fig. 3.
3. Kieval additionally discloses that the signal generated by the control
system 60 may be continuous, periodic, episodic or a combination
thereof. Examples of continuous control signals include constant pulse,
triggered pulse, and triggered chain of pulses. Examples of periodic
control signals include continuous control signals having a designated
start time, e.g., each minute, hour or day, and a designated duration,
e.g., 1 second, 1 minute, 1 hour. Examples of episodic control signals
are those triggered by an episode such as activation by the
patient/physician or increased blood pressure. Col. 9, ll. 52-65.
4. Kieval additionally discloses that the sensor 80 may measure pulse
pressure. Col. 8, ll. 40-41.
5. Kieval does not discuss baroreflex adaptation.
6. The Specification acknowledges that it is known to stimulate
baroreceptors because activation of baroreceptors causes inhibition of
sympathetic nerve activity (SNA) and a reduction in systemic arterial
pressure by decreasing vascular resistance. Spec. 2:15-21.
7. One particular problem associated with baroreflex stimulation
perceived by Appellant is the quick adaptation of the baroreflex to
increased stimulation which causes the baroreflex to reset and return to
a baseline response. This renders static stimulation ineffective. Spec.
2:25-3:5.
8. Appellant has recognized that when carotid sinus pressure 1350 is
increased from a low and constant state 1353 to an elevated and
constant state 1354, SNA 1351 and mean arterial pressure (MAP) 1352,
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initially decrease due to the baroreflex and then increase due to the
quick adaptation of the baroreflex to the increased sinus pressure. In
contrast, when the carotid sinus pressure pulsates similar to naturally-
occurring blood pressure pulses 1355, the SNA and MAP decrease to
relatively low levels and are maintained at these relatively low levels,
thus abating baroreflex adaptation. Spec. 19:27- 20:8; Fig. 13.
9. The Specification states that “[s]ome stimulation protocol embodiments
closely correspond to the pulse. For example, some embodiments
modulate the stimulation signal with a period of modulation
approximately equal to the pulse period (e.g., on the order of
approximately 1 Hz for resting pulse rate to approximately 2 Hz for
exercise). In addition some embodiments modulate the stimulation
signal approximately in-phase with the pulse phase….” Spec. 22:25 –
23:1.
10. The Specification further states that “FIG. 19B illustrates amplitude
modulation corresponding to the pulse signal” (illustrated in 19A).
“FIG. 19C illustrates frequency modulation corresponding to the pulse
signal.” “FIG. 19D illustrates…both amplitude and frequency
modulation.” Spec. 23:7 – 25:9; Figs. 19A-D.
11. The Specification also provides that burst frequency modulation may be
employed to mimic the effects of pulsate pressure. The duty cycle
modulation period may be larger than the pulse period and may have a
maximum interval between duty cycles under 60 seconds. Spec. 25:25-
30
12. The Specification further provides that references to modulation and
periodic modulation as depicted in Figures 19A-D and 20A-B, are
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exemplary, and other protocols may be employed to abate baroreflex
adaptation. Spec. 26:6-14.
13. The stimulation protocols 928, 1628, 1728, 1828 in cooperation with
the controller circuitry 923, 1023, 1623, 1723, 1823 is the structure
corresponding to the claimed “means for abating baroreflex adaptation”
of claim 23. App. Br. 7-8.
14. Since Kieval’s controller 60 can implement a baroreflex stimulation
signal, as dictated by an algorithm (a “protocol”) contained in memory
62, to vary an intensity of the baroreflex stimulation (Facts 1 to 3) in the
same manner that Appellant’s Specification discloses will lead to the
abatement of baroreflex adaptation (Facts 6-11), Kieval’s controller and
algorithm-containing memory inherently can function to abate
baroreflex adaptation.
15. When Kieval provides a triggered train of pulses, or a periodic signal
starting each minute, Kieval uses the same device as Appellant, to
perform the same steps that Appellant’s Specification discloses will
lead to the abatement of baroreflex adaptation. See Facts 1, 3, and 6-11.
Using Kieval’s device in the manner described by Kieval therefore
inherently will cause abatement of baroreflex adaptation.

PRINCIPLES OF LAW
A determination of anticipation, as well as obviousness, involves two
steps. First is construing the claim, a question of law, followed by, in the
case of anticipation or obviousness, a comparison of the construed claim to
the prior art. This comparison process involves fact-finding. Key
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Pharmaceuticals v. Hercon Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998)
(citations omitted).
A patent applicant is free to recite features of an apparatus either
structurally or functionally. See In re Swinehart, 439 F.2d 210, 212 (CCPA
1971) (“[T]here is nothing intrinsically wrong with [defining something by
what it does rather than what it is] in drafting patent claims.”). Yet,
choosing to define an element functionally, i.e., by what it does, carries with
it a risk. In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). As stated in
Swinehart:
where the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to
require the applicant to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.
439 F.2d at 213.
While features of an apparatus may be recited either structurally or
functionally, claims directed to an apparatus must be distinguished from the
prior art in terms of structure rather than function. See, e.g., In re Schreiber,
128 F.3d at 1477-78.
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. See In re
Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“The discovery of a new
property or use of a previously known composition, even when that property
and use are unobvious from prior art, can not impart patentability to claims
to the known composition.”); Titanium Metals Corp. of Am. v. Banner, 778
F.2d 775, 782 (Fed. Cir. 1985) (composition claim reciting a newly
discovered property of an old alloy did not satisfy section 102 because the
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alloy itself was not new); In re Pearson, 494 F.2d 1399, 1403 (CCPA 1974)
(intended use of an old composition does not render composition claim
patentable); In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969) (“[M]ere
statement of a new use for an otherwise old or obvious composition cannot
render a claim to the composition patentable.”); In re Sinex, 309 F.2d 488,
492 (CCPA 1962) (statement of intended use in an apparatus claim failed to
distinguish over the prior art apparatus); In re Hack, 245 F.2d 246, 248
(CCPA 1957) (“the grant of a patent on a composition or a machine cannot
be predicated on a new use of that machine or composition”); In re Benner,
174 F.2d 938, 942 (CCPA 1949) (“no provision has been made in the patent
statutes for granting a patent upon an old product based solely upon
discovery of a new use for such product”).
While new uses of known processes may be patentable, newly
discovered results of known processes directed to the same purpose are not
patentable because such results are inherent. Bristol-Myers Squibb Co. v.
Ben Venue Laboratories, Inc. 246 F.3d 1368, 1376-1377 (Fed. Cir. 2001)
(citing In re May, 574 F.2d 1082, 1090 (CCPA 1978); Verdegaal Bros., Inc.
v. Union Oil Co., 814 F.2d 628, 633 (Fed. Cir. 1987); MEHL/Biophile Int'l
Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999)). Claims differing
from a prior-art process by no more than the recitation of a result do not
distinguish those claims over the prior art. Bristol-Myers Squibb, 246 F.3d at
1376-1377 (The prior art disclosed each and every step of the claimed
process but admitted that the effectiveness of that process in treating cancer
was unknown. The recitation of a result, efficacy in cancer patients, was
found non-limiting and therefore did not distinguish the claims over the prior
art.). Processes may be directed to the “same purpose” without achieving the
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same result. In re May, 574 F.2d at 1090 (A method for effecting non-
addictive analgesia, and a method for effecting analgesia were both methods
for effecting analgesia.); Bristol-Myers Squibb, 246 F.3d at 1376-1377 (A
method including administering a drug and a method including
administering an effective amount of that drug were both methods for
treating cancer).
The express, implicit, and inherent disclosures of a prior art reference
may be relied upon in the rejection of claims under 35 U.S.C. §§ 102 or 103.
“The inherent teaching of a prior art reference, a question of fact, arises both
in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610,
613 (Fed. Cir. 1995). Our reviewing court rejects the contention that
inherent anticipation requires recognition in the prior art. Schering Corp. v.
Geneva Pharmaceuticals, 339 F. 3d 1373, 1377 (Fed. Cir. 2003). A
reference may anticipate even when the relevant properties of the thing
disclosed were not appreciated at the time. The general principle that a
newly-discovered property of the prior art cannot support a patent on that
same art is not avoided if an applicant explicitly claims that property. Abbott
Laboratories v. Baxter Pharmaceutical Products, Inc. 471 F.3d 1363 (Fed.
Cir. 2006) (citing Schering Corp. 339 F. 3d at 1377). In relying upon the
theory of inherency, a basis in fact and/or technical reasoning is required to
reasonably support the determination that the allegedly inherent
characteristic necessarily flows from the teachings of the applied prior art.
Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990).
In order for a prior art element to meet a section 112, paragraph 6
means-plus-function limitation, the prior art element must either be the same
as the disclosed structure or be a section 112, paragraph 6 equivalent. In re
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Donaldson Co., 16 F.3d 1189, 1195 (Fed. Cir. 1994) (en banc). Two
structures may be “equivalent” for purposes of section 112, paragraph 6 if
they perform the identical function, in substantially the same way, with
substantially the same result. Kemco Sales, Inc. v. Control Papers Co., 208
F.3d 1352, 1364 (Fed. Cir. 2000).
A reference that is not enabling is not anticipating. Forest
Laboratories v. Ivax Pharmaceuticals, Inc., 501 F. 3d 1263, 1268 (Fed. Cir.
2007) (citing Elan Pharm., Inc. v. Mayo Found. For Med. Educ. &
Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003)).

ANALYSIS
The Examiner reasonably found that Kieval’s controller and
algorithm-containing memory inherently can function “to abate baroreflex
adaptation” as recited in claim 1. Fact 14. Kieval’s controller and algorithm-
containing memory performs the identical process of outputting a modulated
stimulation signal that is described by Appellant’s Specification to abate
baroreflex adaptation. Facts 1-3, 9-11. Kieval does not elaborate on the
specifics of the parameters of the signal, citing only general examples, but
the claim does not specify any specific values for the change, or rate of
change, of the signal intensity. Appellant has not provided any evidence to
establish that Kieval’s controller and algorithm, when employed, would not
necessarily vary an intensity of the baroreflex stimulation thereby “abat[ing]
baroreflex adaptation.”
The Examiner reasonably found that Kieval’s controller and algorithm
inherently disclose a “means for abating baroreflex adaptation” as recited in
claim 23. Kieval’s controller and algorithm perform substantially the same
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function, outputting a modulated signal, in substantially the same way, via
computer controlled electronics connected to a baroreflex activator, to
produce substantially the same result, baroreflex stimulation. While the
Specification describes the importance of choosing an effective frequency
(Facts 9-11), the Specification also recognizes that stimulation protocols
other than those specifically mentioned could be effective in abating
baroreflex adaptation. Fact 12. The stimulation protocols in cooperation with
the controller circuitry are the structure corresponding to the claimed “means
for abating baroreflex adaptation.” Fact 13. Appellant does not contend that
any specific frequency of operation is required by the claimed means, and in
light of the Specification’s indication that protocols other than those
specifically mentioned may be effective, we decline to import such a
limitation into the claims.
The Examiner reasonably found that using Kieval’s device, in the
manner described by Kieval, inherently will result in “abating baroreflex
adaptation” as recited in claim 30. Fact 15. Although Kieval may not have
recognized this important result of his process (Fact 5), the recitation of a
particular result, such as “abating baroreflex adaptation,” does not
distinguish the claimed method from Kieval. Newly discovered results of
known processes directed to the same purpose—baroreflex stimulation to
reduce sympathetic nervous system activity, and therefore blood pressure,
(Facts 1 and 6-8)—are not patentable because such results are inherent. See
Bristol-Myers Squibb, 246 F.3d at 1376-1377. While we recognize the
importance of the signal frequency at achieving the desired result, as
discussed in the Specification, claim 30 does not require any specific rate of
change for the stimulation signal parameter or any specific change in
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stimulation level. As noted above, the Specification recognizes that
protocols other than those specifically mentioned could be effective in
abating baroreflex adaptation. Fact 12. It would be improper to read
limitations from the Specification pertaining to the specific stimulation
protocol into the claims where Appellant has specifically chosen to omit
them. See, e.g., Verdegaal Bros., 814 F.2d 628, 633 (Claimed process for
making fertilizer was anticipated by a disclosure of the same process for
making fertilizer even though the prior-art process did not recognize the
“inventive concept” of using the “heel1” added to a batch of fertilizer as a
heat sink. The argument that the prior art does not anticipate because in the
prior-art method sulfuric acid is added slowly, whereas the claimed process
allowed for rapid addition, was found unpersuasive because there was no
limitation in the subject claims with respect to the rate at which sulfuric acid
was added. “It must be assumed that slow addition would not change the
claimed process in any respect including the function of the recycled
material as a heat sink”). Since the specific signal variation is not claimed,
we must assume that it is not essential to achieving the claimed result. See,
e.g., In re Mayhew, 527 F.2d 1229, 1233 (CCPA 1976) (Method claims
lacked an enabling disclosure for omitting a step, without which, the
invention as claimed could not produce the claimed product). Thus, even if
due to a lack of explicit discussion in Kieval, it were assumed that Kieval
modulates the stimulation signal differently from the manner described in
Appellant’s Specification, such variation would not negate a finding of

1 A previously-made batch of liquid fertilizer-known as a “heel” can serve as
the heat sink to which more reactants are added. Verdegaal Bros., 814 F.2d
at 630.
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anticipation of the claimed process. See, e.g., Invitrogen Corp. v. Biocrest
Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“‘comprising’ in a method
claim indicates that the claim is open-ended and allows for additional
steps.”) (Citations omitted). Since the claimed method is indistinguishable
from Kieval’s, we must conclude that the same result, abating baroreflex
adaptation, is also achieved by Kieval’s process.
Furthermore, since Kieval expressly describes at least one method of
use that, according to Appellant’s Specification, will abate baroreflex
adaptation, we need not rely solely upon the assumption that the specific
signal variation is not essential to achieving the claimed result, discussed
above, to find the claimed result inherent. As disclosed in the matrix of
possibilities expressly suggested by Kieval, periodically generating a control
signal every minute for a duration of 1 second amounts to generating a
signal employing burst frequency modulation with an interval of 59 seconds
between duty cycles—within the 60 seconds described by the Specification.
Cf. Facts 3, 11, and 15. Additionally, one of ordinary skill in the art would
recognize that since the periodic pulses, which may be, for example, as short
as 1 second, include continuous pulses having a start time and duration, the
“train of pulses” contemplated by Kieval, in at least this specific example,
must have a frequency of 1 Hz or greater—a frequency also acknowledged
to produce the claimed result of abating baroreflex adaptation. Facts 3 and 9.
Thus, if Kieval performed his process on a patient that did not
experience baroreflex adaptation, he would literally infringe claim 30. That
which would literally infringe if later anticipates if earlier. Bristol-Myers
Squibb, 246 F.3d at 1378 (citations omitted).
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Appellant’s characterization of Kieval as “modulating” only when a
“change” is desired as compared to the claimed invention which varies the
stimulation signal when “no change” is desired is an inaccurate
characterization of both Kieval and the claimed subject matter. App. Br. 16-
17; Reply Br. 5-7. If the “otherwise modulating” described by Kieval
referred to simply changing between an activated or deactivated state, as
Appellant suggests, there would have been no point in including “otherwise
modulate” in the list of “activate, deactivate or otherwise modulate.”
Additionally, “activating” would not be interpreted by one of ordinary skill
in the art as limited to the process of changing the state of the activation
device. It would be understood as including both changing and maintaining
the state of the activation device in order to activate the baroreceptors. See
Fact 1. While Kieval acknowledges that “modulation” may be used to
modify activation of the baroreceptors, Kieval also recognizes that
modulation may be used to cause activation thereof. Fact 2. Thus one of
ordinary skill in the art would recognize that Kieval’s “modulation” could be
used to cause and maintain an activated, as opposed to a deactivated, state of
the baroreceptor stimulation device and not simply to switch between those
states as Appellant suggests.
The claimed subject matter operates in the same fashion. The
baroreceptor stimulation signal, causing inhibition of SNA, and thereby a
reduction in MAP, is first changed, then maintained by the signal variation.
Facts 6 and 8; cf. sections 1353 and 1355 of Fig. 13. All that is lacking in
Kieval is the recognition that using a signal comprising a constant train of
pulses or a periodically-activated signal, as opposed to a constant-pulse
signal, would have the effect of maintaining the baroreflex response to the
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signal, and, in turn, maintaining the SNA and MAP at the desired low levels,
i.e., abating baroreflex adaptation. As discussed above, this step, along with
the capability of Kieval’s structure to perform it, although not recognized by
Kieval, are inherent characteristics of Kieval’s method and device.
Appellant’s reliance on Elan is misplaced. Anticipation requires the
prior art to disclosure how to make or use the anticipating device or perform
the anticipating process. It does not require a disclosure of the result of using
that device or the outcome of that process. See Bristol-Myers Squibb, 246
F.3d at 1378.
Regarding the limitation requiring a signal modulation at a rate
“corresponding to a naturally occurring pulse rate,” the Specification does
not use the term “correspond” to refer exclusively to signal and pulse rates
having the same frequency. See Facts 10 and 11; also cf. claims 2 and 15. It
is therefore reasonable to read Kieval’s modulation, which may be a
function of the naturally occurring pulse rate, as modulation at a rate
“corresponding to a naturally occurring pulse rate” as required by claim 31.
See Facts 2 and 4. Kieval’s controller, capable of producing signals having a
variety of frequencies in response to the sensed pulse, which varies with the
patient, is “adapted to” output a signal to “correspond to” or “equal” a
detected pulse, as required by claims 2 and 15. In combination with Kieval’s
sensor, the controller is the same as the structure corresponding to the means
of claim 24. App. Br. 8. Sensing a pulse would be understood as sensing a
“pulse rate” as required by claim 38.
Misquoting a passage of Kieval, does not, without more establish
error in the Examiner’s position. App. Br. 19. Two paragraphs after the
passage quoted by Appellant (App. Br. 19-20), Kieval elaborates that the
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sensor, which the control system is responsive to, is able to measure a
patient’s pulse. Facts 2 and 4. Appellant’s contention that “there is no
indication that the device of Kieval detects a pulse rate, or modulates the
intensity of the stimulation to correspond to the pulse rate” is therefore
inaccurate. Reply Br. 7

CONCLUSIONS OF LAW
The Examiner did not err in finding that Kieval inherently discloses “a
controller to…implement a stimulation protocol to vary an intensity of the
baroreflex stimulation provided by the stimulation signal to abate baroreflex
adaptation”, a “means for abating baroreflex adaptation”, or “abating
baroreflex adaptation”, as required by claims 1, 23 and 30, respectively. The
Examiner did not err by concluding that Kieval discloses those limitations
associated with detecting a pulse rate and modulating the signal at a rate
corresponding thereto.

DECISION
For the above reasons, the Examiner’s rejection of claims 1-15 and
17-47 are 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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2009).

AFFIRMED

Vsh

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SCHWEGMAN, LUNDBERG & WOESSNER, P.A.
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