Ex Parte Huston et al

Patent Trial and Appeal Board

Nov 8, 2017

12259208 (P.T.A.B. Nov. 8, 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.
12/259,208 10/27/2008 Jared M. Huston 10642-703.500 1552
66854 7590 11/13/2017
SHAY TtT FNN T T P
EXAMINER
2755 CAMPUS DRIVE D ABREU, MICHAEL JOSEPH
SUITE 210
SAN MATEO, CA 94403 ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
11/13/2017 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):
info@ shayglenn.com
shayglenn_pair @ firsttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JARED M. HUSTON and KEVIN J. TRACEY
Appeal 2016-0084171
Application 12/259,208
Technology Center 3700
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
RYAN H. FLAX, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a method for treating an
inflammatory disorder in a patient comprising stimulating the vagus nerve
with an electrical signal. The Examiner rejected the claims under 35 U.S.C.
§ 103 as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
The rejections are affirmed.
1 The Appeal Brief (“Appeal Br.”) identifies The Feinstein Institute for
Medical Research as the real party in interest. Appeal Br. 2.
Appeal 2016-008417
Application 12/259,208
STATEMENT OF THE CASE
Claims 1—13 and 20 are pending and stand rejected by the Examiner
as follows:
1. Claims 1—5, 7—12, and 20 under pre-AIA 35 U.S.C. § 103(a) as
obvious over Boveja2 in view of Tracey3 or Errico.4 Ans. 2.
2. Claims 6 and 13 under pre-AIA 35 U.S.C. § 103(a) as obvious over
Boveja in view of Tracey or Errico, and further in view of Whitehurst.5 Id.
at 5.
Claim 1 is representative of the claimed subject matter. Claim 1 is
reproduced below (indentations added to emphasize limitations of the
claim):
1. A method of treating an inflammation in a patient, the
method comprising:
stimulating in a patient suffering from inflammation the
patient’s vagus nerve with an electrical signal to achieve a
therapeutic effect for treating the inflammation,
wherein the signal current is from 1 mA to 100 mA,
pulse width is from 0.1 ms to 5 ms;
signal frequency is from 0.1 Hz to 30 Hz;
signal on-time is from 1 second to 120 seconds; and
waiting for an off-time of at least 2 hours before re­
stimulating the patient’s vagus nerve,
wherein the therapeutic effect persists for at least 2 hours
after stimulation has ended.
2 U.S. Pat. Appl. Pub. No. 2005/0154425 Al, pub. July 14, 2005 (“Boveja”).
3 U.S. Pat. Appl. Pub. No. 2004/0204355 Al, pub. Oct. 14, 2004 (“Tracey”).
4 U.S. Pat. Appl. Pub. No. 2009/0281593 A9, pub. Nov. 12, 2009 (“Errico”).
5 U.S. Pat. Appl. Pub. No. 2003/0236557 Al, pub. Dec. 25, 2003
(“Whitehurst”).
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Application 12/259,208
FINDINGS OF FACT (“FF”)
Boveia
FF1. Boveja discloses vagus nerve electrical stimulation to provide
therapy for neuropsychiatric disorder and cognitive impairments. Boveja
11-
FF2. Boveja {id. 193) discloses “the approximate range of
parameters” for vagus nerve stimulation as follow:
TABLE 1
Electrical ffammctw raitse delivered to Iho nerve
PARAMER RANGE
Puke Amplitude 0,1 Volt-10 Volts
Pulse width 20 5 niSec.
Frequency 5 Hz-200 Hz
On-time 10 Sees-24 hours
Oft-tisse 10 Sees-24 hours
FF3. Boveja also teaches currents of 0.75, 1.5, 2.0, and 3.0 milliamps.
Id. HllO-113.
Tracey
FF4. Tracey teaches that “[stimulation of the efferent vagus nerve
attenuates systemic inflammatory responses and inhibits TNF release.”
Tracey 1 8.
FF5. Tracey discloses electrical stimulation of the vagus nerve with 1
volt, 2 ms, and 1 Hz, resulted in suppression of TNF. Id. ^fl[ 106, 220, Fig. 5.
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Errico
FF5. Errico teaches that the “use of electrical stimulation for
treatment of medical conditions has been well known in the art for nearly
two thousand years.” Errico 16.
FF6. Errico teaches treating bronchial constriction which is known to
be caused by inflammation. Id. ^2, 13, 14. Errico also teaches treating
COPD, which includes bronchitis. Id. 25, 28.
FF7. Errico teaches:
The stimulating, blocking and/or modulating impulse signal
410 preferably has a frequency, an amplitude, a duty cycle, a
pulse width, a pulse shape, etc. selected to influence the
therapeutic result, namely stimulating, blocking and/or
modulating some or all of the transmission of the selected
nerve.
Id. 1 66.
FF8. Errico teaches the frequency may be about 1 Hz or greater, such
as between about 15 Hz to 50 Hz, more preferably around 25 Hz. Id.
FF9. Errico teaches the pulse width may be “selected to influence the
therapeutic result, such as about 20 gS or greater, such as about 20 pS to
about 1000 pS.” Id.
FF10. Errico teaches “peak voltage amplitude selected to influence
the therapeutic result, such as about 0.2 volts or greater, such as about 0.2
volts to about 20 volts.” Id.
REJECTION 1
The Examiner found that Boveja describes treating a subject with
vagal nerve stimulation where the electrical stimulation parameters (FF2)
overlap with those that are claimed:
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Application 12/259,208
Compare an off-time of at least 2 hours recited in claim 1 to 10
seconds—24 hours disclosed by Boveja (FF2).
Compare a pulse width of 0.1 ms—5 ms recited in claim 1 to 20 pS—5
mSec disclosed by Boveja (FF2).
Compare a signal frequency of 0.1 Hz—30 Hz recited in claim 1 to
5Hz—200 Hz disclosed by Boveja (FF2)
Compare a signal on-time of 1—120 seconds recited in claim 1 to 10
seconds—24 hours disclosed by Boveja (FF2).
Compare signal current of from 1—100 mA as recited in claim 1 to 1.5,
2.0, and 3.0 mA disclosed by Boveja (FF3).
The Examiner found that because the recited stimulation parameters
are the “same” as those in Boveja, the therapeutic effect would persist for at
least two hours after electrical stimulation as required by the claim. Final
Act. 3.
Although the Examiner acknowledged that Boveja does not disclose
treating inflammation as claimed, the Examiner found that Tracey teaches
vagal nerve stimulation for the same purpose as claimed (FF4, FF5) and
specifically identified the same parameters as claimed of 2 ms (compare
claim 1 of 0.1 ms—5 ms), and 1 Hz (compare claim 1 of 0.1 Hz—30 Hz).
Final Act 3. The Examiner also found that Errico also teaches treating
inflammation (FF6) with electrical stimulation parameters that overlap with
the claim. Id. (FF8—FF10).
The Examiner determined it would have been obvious to utilize the
stimulation parameters of Boveja (FF2, FF3), Tracey (FF5), and Errico
(FF8—FF10) to treat inflammation. Final Act. 3.
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DISCUSSION
Are the fields of endeavor different and consequently would there have been
no reasonable expectation of success?
Appellants contend that Tracey and Errico are not in the same field of
endeavor as Boveja and, consequently, one of ordinary skill in the art would
not have sought to combine them to achieve the claimed method of treating
inflammation. Appeal Br. 9—10. Appellants contend:
There is no articulated reasoning why a person of ordinary skill
in the art would consider references teaching methods of
treating inflammation and bronchial constriction relevant to
improving Boveja’s method of treating neuropsychiatric
disorders and cognitive impairment when the mechanisms of
action of the methods described in each of these references are
completely different.
Id. at 10.
Appellants contend that “[bjecause the function of the prior art is
different than the claimed function, the argument that it would be an
‘obvious design choice’ [as stated by the Examiner] to modify Boveja to
treat inflammation is improper.” Id. Appellants also contend there would
have been no reasonable expectation of success that using the parameters of
Boveja to treat inflammation would work when the mechanisms of action
are different. Id. at 4, 9; Reply Br. 6.
This argument does not convince us that the Examiner erred.
First, we do not agree that the fields of endeavor are so disparate that
one of ordinary skill in the art would not have found Boveja’s vagal nerve
teaching pertinent to the teaching of using vagal nerve stimulation to treat
inflammation as taught Tracey and Errico. All three publications utilize the
same technology of nerve stimulation, making it reasonable for one of
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ordinary skill in the art to have looked to Boveja as guidance to determine
stimulation conditions for the vagus nerve in Tracey and Shafer.
It is well-established that there are two criteria to be applied when
determining whether a reference is analogous prior art: (1) whether the
reference is from the “same field of endeavor” as the claimed invention, and
(2) if the reference is not within the same field of endeavor, “whether the
reference still is reasonably pertinent to the particular problem with which
the inventor is involved.” In re Clay, 966 F.2d 656, 658—59 (Fed. Cir.
1992). In this case, the field of endeavor is vagal nerve stimulation.
Appellants have defined it too narrowly, restricting the field to the narrower
purpose for which the stimulation is applied.
Errico discloses electrical stimulation had been used to various
medical conditions for years (FF5), indicating that the skilled worker
considered the field of endeavor to be more generally electrical stimulation
and broader than the narrower field defined by Appellants. Appellants have
not provided objective evidence to support their contention that the field of
endeavor of the claims, Tracey, and Errico is different from that of Boveja.
Even if the fields of endeavor are different, it is reasonable that one of
ordinary skill in the art would have looked to other fields in which vagal
nerve stimulation had been accomplished as guidance to determine the
optimal stimulation parameters because the same purpose is sought — to
alleviate a medical condition experienced by a subject.
As to the alleged lack of an expectation of success, we begin by
summarizing the stimulation parameters of claims 1 and 3 as compared to
those disclosed in Boveja, Tracy, and Errico:
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Current Off-Time On-Time
Pulse
Width Frequency
Claim 1 1—100 inA At least 2
hrs.
1—120 sec. 0.1-5
msec.
0.1-30 Hz
Boveja 0.75, 1.5,
2.0, 3 mA
10 secs —
24 hrs.
10 secs —
24 hrs.
20 psec —
5 msec.
5-200 Hz
Tracy 2 msec. 1 Hz
Errico 20 psec.—
1000 psec.
(1 msec.)
1-50,
preferable
25 Hz
As shown in the summary above, the values in Tracey and Errico
overlap with Boveja in pulse width and frequency. Because of the overlap
in stimulation parameters between Boveja, Tracey, and Errico, one of
ordinary skill in the art would had a reasonable expectation that Boveja’s
parameters would work in Tracey’s and Errico’s method of treating
inflammation. Accordingly, the Examiner’s determination that it would
have been obvious to combine Boveja’s stimulation parameters for treating
neuropsychiatric disorders with Tracey and Errico is supported by a
preponderance of the evidence. Thus, even if the mechanisms differ, as
argued by Appellants, the overlap between parameters reasonably suggests
that a stimulation regime for treating a neuropsychiatric condition would
work for treating inflammation.
While the frequency value of 1 Hz disclosed in Tracey is less than the
5 Hz end point disclosed by Boveja, Boveja characterizes its values as
“approximate” (FF2) and the five-fold difference (1 versus 5) is much less
than 40-fold difference of Boveja’s entire range (5 to 200 or 40-fold
difference between endpoints). Nonetheless, Errico discloses a frequency
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that overlaps with Boveja, indicating that a wide range of frequencies,
including those of Boveja, are used to treat inflammatory conditions.
Is a two-hour waiting step obvious?
Appellants contend that “the Examiner improperly dismisses this
required two-hour waiting step [off-time] and the associated requirement
that the therapeutic effect persist for at least two hours as inherent.” Appeal
Br. 6.
We do not agree. Boveja teaches a range of off-times of 10 secs to 24
hours (FF2), which overlap with the claimed range of “at least 2 hours.”
When there is a range disclosed in the prior art, and the claimed invention
overlaps or falls within that range, there is a presumption of obviousness. In
re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). One of ordinary skill in
the art would have reason to optimize the prior art range to achieve the
highest therapeutic effect. As held in Peterson, there is a “normal desire of
scientists or artisans to improve upon what is already generally known.”
Peterson, 315 F.3d at 1329—30.
Are the claimed ranges non-obvious?
Appellants contend that the claimed ranges are critical and “wholly
unexpected.” Appeal Br. 7; Reply Br. 4. Appellants argue:
Boveja ranges for acceptably stimulating the vagus nerve are
not identical to the ranges recited in the claims. This is
particularly significant where, as described in the Applicant’s
specification, simulation outside of the claimed ranges of
parameters may result in desensitization, resulting in either no
therapeutic effect or a therapeutic effect that does not persist for
at least two hours after stimulation.
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Application 12/259,208
Appeal Br. 7.
To support this contention, Appellants cite the following paragraphs
from the Specification (hereinafter, the “’208 Specification” or “’208
Spec.”) (emphasis added):
[000138] The description above may be readily generalized to
describe various parameters and effects for vagus nerve
stimulation that are new and very unexpected. In particular, the
extremely low level of stimulation (both low intensity, and low
duty-cycle) have been seen to have a profound - and chronic -
effect on the immune response. By low duty-cycle effect, we
are referring to the time stimulation is “on” compared to the
time stimulation is “off’ (e.g., the ratio of “on” to “off’). Thus,
the stimulation (and particularly chronic stimulation) described
herein is “off’ much more that in it is “on”. The high efficacy
of these low duty-cycle modulation parameters is unexpected,
and may have a profound effect on the wav that treatment of
immune response (humor and/or cellular) are performed. For
example, chronic (or long-term) stimulation may be effectively
performed without the risk of negative effects associated with
known stimulation protocols of the vagus nerve.
[000139] Furthermore, the low-intensity (and low duty cycle)
situation may be used safely without interfering with other
aspects controlled by the vagus nerve. For example; altered
heart rate and blood pressure are not seen with the low-
intensity, low duty-cycle modality stimulation. Thus, the vagus
nerve may be stimulated either mechanically or electrically in a
low-intensity and low duty-cycle fashion without desensitizing
the vagus nerve or its targets, and without invoking a
potentially unwanted physiological effect (e.g., on heart rate,
heart tone, blood pressure, gastric processes, or any other effect
attributed to vagal nerve stimulation except the targeted
immune response).
Both paragraphs 138 and 139 of the Specification refer to “low-
intensity” and “low-duty” stimulation. The Specification refers to voltage as
an example of intensity. ’208 Spec. 148. Claim 1 is not limited to a
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specific voltage. Consequently, the claims are not limited to the asserted
stimulation regime. Unexpected results must be “commensurate in scope
with the degree of protection sought by the claimed subject matter.” In re
Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005). In this case, the asserted
result of stimulating “without desensitizing the vagus nerve or its targets”
required both low-intensity and low-duty (’208 Spec. 1139), but the claims
are not limited as to intensity.
The ’208 Specification (| 138) indicates that the “on-time” refers to
the duty-cycle (“By low duty-cycle effect, we are referring to the time
stimulation is ‘on’ compared to the time stimulation is ‘off . . .”).
Claim 1 recites a signal on-time from 1 to 120 seconds (i.e., a recited
duty-cycle). The ’208 Specification discloses that “high efficacy of these
low duty-cycle modulation parameters is unexpected, and may have a
profound effect on the way that treatment of immune response (humor
and/or cellular) are performed.” ’208 Spec. 1138. However, Appellants
have not guided us to a definition of “low duty” that defines it to be same
range as claimed. Consequently, even if the low-duty cycle, alone, achieve
unexpected results, Appellants have not established that these parameters
correspond to those recited in claim 1.
Furthermore, Appellants have not provided objective to substantiate
their assertion of unexpected results.
An applicant cannot prove unexpected results with attorney
argument and bare statements without objective evidentiary
support. See In re Lindner, 59 C.C.P.A. 920, 457 F.2d 506, 508
(CCPA 1972); In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)
(“attorney argument [is] not the kind of factual evidence that is
required to rebut a prima facie case of obviousness”); In re
Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) (“It is well settled that
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unexpected results must be established by factual evidence.
Mere argument or conclusory statements . . . [do] not suffice.”)
(quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003).
For example, while unexpected results and criticality is asserted,
Appellants have not provided objective evidence that ranges outside the
claimed range do not achieve these results. Appellants have not even
provided evidence that an on-time of over the entire claimed range (claim 1
recites “signal on-time is from 1 second to 120 seconds”) would achieve the
claimed therapeutic effect and asserted results stated in paragraphs 138 and
139 of the ’208 Specification.
Appellants reproduced Figure 5 from the ’208 Specification as
evidence that “[stimulation within the specific, narrower claimed ranges
results in a low duty cycle stimulation, i.e. a stimulation with a relatively
short signal on-time, to generate a long lasting reduction in inflammation.”
Reply Br. 3; Appeal Br. 11—12. Appellants did not identify the stimulation
parameters used to generate Figure 5. Nonetheless, it appears from Example
2 of the ’208 Specification that the figure was generated from “electrical
stimulation for 30 sec (1 mA, 0.5ms, 30 Hz).” ’208 Spec. ^fl[ 106, 107.
Appellants have not established that ah parameters within the scope of
the claim would produce the data said to be unexpected for the single set of
conditions described in Example 2 of the ’075 Specification and that
stimulation conditions outside this range, such as those of Boveja, Tracey, or
Errico, would not result in the stated therapeutic persistence.
When unexpected results are proffered by an appellant to rebut a
prima facie case of obviousness, the appellant must “provide[] an adequate
basis to support the conclusion that other embodiments falling within the
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claim will behave in the same manner” in order to “establish that the
evidence is commensurate with [the] scope of the claims.” In re Kao, 639
F.3d 1057, 1068 (Fed. Cir. 2011). One data point is insufficient to “to
ascertain a trend in the exemplified data which would allow [one having
ordinary skill in the art] to reasonably extend the probative value thereof.”
In re Kollman, 595 F.2d 48, 56 (CCPA 1979). Here, Appellants must,
therefore, demonstrate or explain why the result of the single tested set of
stimulation conditions would establish the asserted result for the full scope
of claim 1. We conclude they have not done so.
Inherency
Appellants contend that the Examiner did not “establish that
stimulation using the different parameter ranges of Boveja would necessarily
result in a therapeutic effect that persists for greater than 2 hours after
stimulation has ended.” Appeal Br. 7—8.
This argument does not persuade us that the Examiner erred.
Appellants contend that the patentability of the claimed subject matter rests
on the result (“the therapeutic effect persists for at least 2 hours after
stimulation has ended”) of specifically recited stimulation parameters which
the Examiner found to be suggested by Boveja, Tracey, and Errico. Because
the PTO has no facilities for determining whether or not the stimulation
parameters described by these prior art publications would produce the
claimed result, the Examiner reasonably concluded, based on the identity of
the overlap of the stimulation parameters between the claims and the cited
publications, that such parameters would produce the claimed persistent
therapeutic effect. The Examiner’s position is sound and scientifically
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logical because producing a therapeutic effect that persists for 2 hours after
stimulation has ended is a direct consequence of the stimulation conditions
in claim 1 which overlaps with the three cited publications. Under these
circumstances, it is well-established by precedent that the burden shifts to
the Applicants to prove the prior art, namely, Boveja, Tracey, and Errico
would not necessarily result in the claimed therapeutic result. In re Best,
562 F.2d 1252, 1254—55 (CCPA 1977). Applicants have not met this burden
on the record before us. Appellants assert that the claimed range produces
the recited therapeutic effect, but they did not show that values outside the
range would not.
Appellants contend that the ranges in Boveja “encompass high duty-
cycle stimulation” and that the Examiner has not established that stimulation
“using the different parameter ranges of Boveja would necessarily result in a
therapeutic effect that persists for greater than 2 hours after stimulation has
ended.” Appeal Br. 7—8. As explained above, Appellants have the burden
of showing that ranges outside those which are claimed do not exhibit the
recited therapeutic persistence.
Summary
For the foregoing reasons, the rejection of claim 1 as obvious in view
of Boveja and Tracey or Errico is affirmed. Claims 2—5, 7—12, and 20 were
not argued separately and fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
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REJECTION 2
Claims 6 and 13 recite measuring cytokine levels, which the Examiner
found described in Whitehurst. Appeal Br. 5. Appellants make the same
argument for claims 6 and 13 that they did for claim 1. Consequently, we
affirm the rejection of claims 6 and 13 for the same reasons.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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