Ex Parte Ignagni et al

Patent Trial and Appeal Board

Jun 30, 2017

12122482 (P.T.A.B. Jun. 30, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/122,482 05/16/2008 Anthony R. Ignagni 10091-708.200 8929
66854 7590 07/05/2017
SHAY TtT FNN T T P
EXAMINER
2755 CAMPUS DRIVE HOEKSTRA, JEFFREY GERBEN
SUITE 210
SAN MATEO, CA 94403 ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
07/05/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY R. IGNAGNI and RAYMOND P. ONDERS
Appeal 2016-004244
Application 12/122,4821
Technology Center 3700
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods of
diagnosing or tracking the progression of treatment of a neurological
disorder that affects the function of the diaphragm. The Examiner entered
three rejections, all for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse one of the
rejections, but affirm the other two, except as to three claims.
1 Appellants state that the “real party in interest herein is Synapse
Biomedical, Inc., Assignee by virtue of an assignment executed by the
inventors to Synapse Biomedical, Inc.” App. Br. 2.
Appeal 2016-004244
Application 12/122,482
STATEMENT OF THE CASE
The Specification discloses that the neurodegenerative disease
amyotrophic lateral sclerosis (ALS) “is difficult to diagnose at an early
stage, and it is difficult to discern the rate of progression of [the] disease,
especially once therapy has been initiated.” Spec. 1 6.
Appellants’ invention is based on “the surprising observation that the
electromyographic [EMG] measurements made from the same location of
the same patient’s diaphragm over time can provide a remarkably sensitive
measure of the presence or progression of ALS, and the efficacy of treatment
of ALS.” Id. 18.
Claims 11 and 24, the independent claims on appeal, are illustrative
and reads as follows (App. Br. 11, 13):
11. A method of diagnosing or tracking the progression or
treatment of a neurological disorder that affects the function of
a diaphragm, the method comprising:
measuring a first EMG signal during a volitional
breathing maneuver at an initial recording time
before the start of therapy from one or more
electrodes chronically implanted in a diaphragm;
measuring a second EMG signal from the same one or
more electrodes at a later recording time during a
volitional breathing maneuver after the start of the
therapy; and
comparing one or more characteristics of the first EMG
signal and the second EMG signal and
characterizing the presence, progression or
treatment of a neurological disorder based on the
comparison.
24. A method of diagnosing or tracking the progression or
treatment of a neurological disorder that affects the function of
a patient’s diaphragm, the method comprising:
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determining a first activity index from a patient’s
diaphragm motor point EMG at a first time during
a volitional breathing maneuver before the start of
a therapy, wherein the first activity index is a first
measure of a first component of the EMG that is
combined with a first measure of a respiratory
parameter value;
determining a second activity index from the patient’s
diaphragm motor point EMG at a second time
during a volitional breathing maneuver after the
start of the therapy, wherein the second activity
index is a second measure of the first component
of the EMG that is combined with a second
measure of the respiratory parameter value;
comparing the first activity index and the second activity
index; and
characterizing the presence, progression or treatment of a
neurological disorder based on the comparison
between the first activity index and the second
activity index.
The following rejections are before us for review:
(1) Claims 11—21, 36, and 39, under 35 U.S.C. § 103(a), for
obviousness over McDonald2 and Ignagni3 (Final Action 3—6 (entered April
23,2014));
(2) Claims 22—24, 27, 30, 32, 37, 38, and 40-44, under 35 U.S.C.
§ 103(a), for obviousness over McDonald and Sinderby4 (Final Action 7—
10); and
(3) Claims 25, 26, and 45, under 35 U.S.C. § 103(a), for obviousness
over McDonald, Sinderby, and Ignagni (Final Action 10).
2 US 2004/0127954 A1 (published July 1, 2004).
3 US 2005/0021102 A1 (published Jan. 27, 2005).
4 US 2008/0121231 A1 (published May 29, 2008).
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Application 12/122,482
OBVIOUSNESS—
MCDONALD AND IGNAGNI
The Examiner’s Prima Facie Case
In rejecting claims 11—21, 36, and 39 over McDonald and Ignagni, the
Examiner cited McDonald as disclosing methods of tracking the treatment of
neurological disorders, such as ALS, using an implanted needle to measure
EMG signals during voluntary movement of a subject’s diaphragm before
and after treatment. Final Action 3^4. The Examiner found, and Appellants
do not dispute, that “voluntary movement of diaphragm inherently involves
a volitional breathing maneuver” as independent claim 11 recites. Id. at 4.
The Examiner found that McDonald differs from claim 11 in that
“McDonald fails to explicitly disclose the method whether the electrodes are
chronically implanted or not.” Id.
The Examiner noted however that
McDonald does disclose making measurements at the phrenic
nerve at various times (see paragraph [0124]), using electrical
stimulation for breathing (see paragraphs [0055, 0057]) and that
i[t] can apply to subjects with ALS (see paragraph [0053]) and
Ignagni teaches a method of stimulating the diaphragm and
monitoring EMG of the diaphragm in subjects with ALS (see
paragraph [0004] of Ignagni) wherein the electrodes are
chronically implanted adjacent to the phrenic nerve (see
paragraph [0024]).
Id. (brackets in original).
Based on the combined teachings of McDonald and Ignagni, the
Examiner reasoned that it would have been obvious
to modify the method of McDonald such that the electrode, i.e.
needle, was chronically implanted as taught by Ignagni in order
for the needle to be stable and chronically placed such that the
same needle at the same location can be used for multiple
readings at different times for more accurate results (prevent
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errors based on different needles or different placement of
needles) and provides chronic placement of needle for
providing the electrical stimulation to the diaphragm during
treatment (see paragraph [0030] of Ignagni; in order to provide
continuously or periodic stimulation, the electrode would
inherently have to be chronically implanted).
Final Action 4 (brackets in original).
Analysis
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.
In the present case, Appellants persuade us that a preponderance of
the evidence does not support the Examiner’s conclusion that it would have
been obvious to chronically implant McDonald’s EMG-sensing electrodes in
a subject’s diaphragm, as required by independent claim 1.
As an initial matter, we agree with Appellants that claim 1 l’s
requirement for the electrodes to be “chronically implanted in a diaphragm”
(App. Br. 11) does not encompass repeated re-implantations as the Examiner
asserts (Ans. 3), particularly when the claim is read in light of the
Specification’s disclosure, noted above, that the EMG readings must be
made from the same location of the same patient’s diaphragm over time
(Spec. 1 8).
As to the Examiner’s assertion that chronic implantation would allow
more consistent readings over time, the Examiner directs us to no specific
teaching in either of the cited prior art references, or elsewhere in the record,
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suggesting that EMG measurements suffered from accuracy problems so
substantial that it would have been desirable to maintain EMG electrodes in
a patient’s diaphragm for the multiple years during which McDonald’s
treatment was undertaken. See McDonald 1124 (comparing diaphragm
EMG measurements in 1995 and 2001).
The Examiner contends that the accuracy advantages of chronic
sensor electrode implantation are “extremely well known in the art. It is
well known in the medical field or simply scientific field (not restricted to
only EMG measurements) that variations in sensor placements between
measurement times for any kind of biological measurement can lead to
variations and/or errors in the measurement readings.” Ans. 4. Again,
however, absent specific support for these assertions, we are not persuaded
that the Examiner has advanced an adequate evidentiary basis for finding
that any alleged accuracy advantages inherent in chronic EMG sensor
electrode placement would have suggested maintaining those electrodes in a
patient’s diaphragm for the multiple years during which McDonald’s
treatment was undertaken.
The Examiner finds that Ignagni provides motivation for chronic
electrode implantation. Ans. 3^4. As the Examiner notes, however (id. at
4), Ignagni’s electrodes are chronically implanted so as to stimulate the
diaphragm over an extended time to build endurance in the muscle. See,
e.g., Ignagni 140. Given the very different purposes, we are not persuaded
that Ignagni’s teaching of chronic implantation of therapeutic stimulating
electrodes would have suggested chronically implanting McDonald’s EMG
sensing electrodes in a patient’s diaphragm, as Appellants’ independent
claim 11 requires.
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In sum, for the reasons discussed, we are not persuaded that a
preponderance of the evidence supports the Examiner’s conclusion that a
process having all of the steps and features of claim 11 would have been
obvious to an ordinary artisan. We, therefore, reverse the Examiner’s
rejection of claim 11, and its dependent claims 12—21, 36, and 39 for
obviousness over McDonald and Ignagni.
OBVIOUSNESS—
MCDONALD AND SINDERBY
The Examiner’s Prima Facie Case
In rejecting claims 22—24, 27, 30, 32, 37, 38, and 40-44 over
McDonald and Sinderby, the Examiner again cited McDonald as disclosing
methods of tracking the treatment of neurological disorders, such as ALS,
using an implanted needle to measure EMG signals during voluntary
movement of a subject’s diaphragm before and after treatment. Final Action
7—8. The Examiner again found, and Appellants do not dispute, that
“voluntary movement of diaphragm inherently involves a volitional
breathing maneuver” as independent claim 24 recites. Id. at 8.
The Examiner found that McDonald differs from independent claim
24 in that McDonald “fails to disclose the method wherein the indices
include the EMG component with a respiratory parameter value.” Id.
To address that deficiency, that Examiner cited Sinderby as teaching
“a method of monitoring status of a subject (see paragraph [0010] of
Sinderby) based on the combination of EMG and respiratory values (see
paragraphs [0014, 0025, 0034, 0035, 0036, 0041] of Sinderby).” Id. Based
on the references’ combined teachings, the Examiner reasoned that it would
have been obvious to modify McDonald’s methods to “measure respiratory
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parameters in addition to the EMG signal obtained and combine them to
provide an activity index as taught by S inderby to provide means obtaining
more data for a more thorough method of tracking the status of a
subject/patient. Such combination would yield predictable results.” Final
Action 8.
Analysis
As an initial matter, we note that claims 22 and 23, both subject to this
rejection, depend from claim 11, discussed above, and require the
chronically implanted sensor electrodes, also discussed above. See App. Br.
13. Because Sinderby does not remedy the shortcomings, discussed above,
of McDonald as to claim 11, we reverse this rejection as to claims 22 and 23.
As to the remaining claims, however, Appellants do not persuade us
that the Examiner’s prima facie case lacks adequate evidentiary support.
McDonald discloses methods whereby patients suffering from central
nervous system (CNS) damage are treated with “a therapeutically effective
amount of functional electronic stimulation (FES) sufficient to evoke
patterned movement in the subject’s muscles, the control of which has been
affected by the CNS damage.” McDonald, Abstract. McDonald discloses
that patients treatable according to its methods include ALS sufferers. Id.
1 53. McDonald includes an example of treating a patient suffering from a
chronic spinal cord injury. Id. ]Hf 77—78 (Example 1).
As to Appellants’ claim 24, McDonald discloses that it tracked the
progression of its treatment methods in the patient by evaluating EMG
signals in the diaphragm before and after the treatment. See id. 1124 (“The
EMG analysis of volitional movements was completed in the winter of 2001
(Table 4), and the results were compared with those from phrenic nerve
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Application 12/122,482
testing performed on Jun. 21, 1995, shortly after the injury.”). McDonald
notes that, at the time of the initial diaphragm evaluation, “right and left
amplitudes were 0.9 mV and 0.5 mV, respectively,” whereas, “[i]n contrast,
amplitudes were greater in 2001 (2—7 mV), but there was further evidence of
denervation (Table 4).” Id.
Thus, as required by Appellants’ claim 24, McDonald describes
comparing first and second activity indices of its patient, the EMG
amplitude measurements taken at different times over the course of the
treatment, and includes that comparison in characterizing the progression of
its treatment methods. McDonald does not appear to describe combining its
EMG measurements with a respiratory parameter as an index of the patient’s
activity, as recited in Appellants’ claim 24.
Nonetheless, Sinderby discloses, in relation “to a method and device
for determining a level of ventilatory assist to a ventilator-dependent
patient” (Sinderby, Abstract), that measurements of the diaphragm’s
electrical activity (i.e., EMG measurements) can be combined with
respiration parameters such as tidal volume, esophageal pressure, and gastric
pressure:
FIG. 1 is a schematic representation of a non-limitative
example of experimental set-up. On the left, an esophageal
catheter-mounted multi-electrode array 5 is used to measure
diaphragm’s electrical activity EAdi and balloons 8 and 9
mounted on the catheter on opposite sides of the electrode array
5 are used to measure esophageal pressure P„ and gastric
pressure Pga. The catheter 6 was passed trans-nasally and
positioned at the gastro-esophageal junction 10. Respiratory
airflow was measured with a pneumotachograph 3 and tidal
volume Vy was obtained by integrating inspiratory flow. On
the right, the target transdiaphragmatic pressure Pdi and the
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root-mean-square (RMS) of the diaphragm’s electrical activity
EAdi are displayed on line.
Sinderby 125.
Sinderby, thus, teaches that when evaluating a compromised patient’s
respiratory health, it is useful to combine EMG measurements of the
patient’s diaphragm with respiration parameters such as tidal volume,
esophageal pressure, and gastric pressure. Accordingly, contrary to
Appellants’ arguments (Reply Br. 7), we agree with the Examiner that an
ordinary artisan had good reason for, and a reasonable expectation of
success in, using a combination of EMG diaphragm measurements and other
respiration parameters as an index for evaluating the progression of
McDonald’s treatments of patients with CNS disorders, particularly given
that McDonald, like Sinderby, uses EMG diaphragm measurements as an
indicator of the efficacy of its treatments. We, therefore, also agree with the
Examiner that the method recited in Appellants’ claim 24 would have been
prima facie obvious to an ordinary artisan.
In addition to arguing that an ordinary artisan lacked a reason to
combine the references in the manner posited by the Examiner, Appellants
contend that Sinderby does not combine “the EMG and respiratory
parameter measurements into an index. Moreover, neither McDonald nor
Sinderby teach comparing such indexes to characterize the presence,
progression or treatment of a neurological disorder. At most, Sinderby
teaches using the EMG and respiratory parameters to determine diaphragm
fatigue in a patient on a ventilator.” App. Br. 7.
In that regard, Appellants contend that the Examiner interpreted the
term “index” unreasonably broadly in concluding that the term encompasses
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the EMG data values presented in Table 4 of McDonald, as evidenced by
115 of the Specification, “along with the common usage of the term index
in the medical field, such as the Clinical Disease Activity Index for
rheumatoid arthritis for example, makes it clear that a table of data, as
described in Table 4, is not an activity index.” Reply Br. 6; see also App.
Br. 8 (“An EMG index takes one or more parameters from the EMG and
then processes the parameters into a form suitable for the index, which then
can be compared to indices of EMG signals from later times. See
paragraphs [0068]—[0069] of Applicants’ application as published.”).
We are not persuaded. Claim 24 recites, as to the limitation at issue,
determining a first activity index from a patient’s diaphragm
motor point EMG at a first time during a volitional breathing
maneuver before the start of a therapy, wherein the first activity
index is a first measure of a first component of the EMG that is
combined with a first measure of a respiratory parameter
value.
App. Br. 13 (emphasis added).
As is evident, claim 24 does not require the first activity index (or the
later-recited second activity index to which the first index is compared) to be
the result of any specifically defined data manipulation that combines the
EMG measurement with the respiratory parameter value in a particular
fashion. Appellants, moreover, do not identify in their Specification, a
specific definition of the term “activity index.”
To the contrary, as seen in one of the paragraphs of the Specification
cited by Appellants, the determined activity index may be “non-numeric
(e.g., Boolean, qualitative, etc).” Spec. 115 (emphasis added). Appellants
do not persuade us, therefore, that the activity indices recited in claim 24 fail
to encompass a qualitative assessment or indication of a patient’s respiratory
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condition which, as discussed above, Sinderby teaches may be based on a
combination of EMG diaphragm measurements and other respiratory
parameters, as recited in claim 24.
In sum, for the reasons discussed, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s prima facie
case of obviousness as to claim 24. Because Appellants do not advance
secondary evidence of nonobviousness that outweighs the evidence of prima
facie obviousness, we affirm the Examiner’s rejection of claim 24 over
McDonald and Sinderby. Because they were not argued separately, claims
27, 30, 32, and 40-44 fall with claim 24. 37 C.F.R. § 41(c)(l)(iv).
Claim 37 recites, “[t]he method of claim 24, further comprising
determining and presenting a score based on the comparison.” App. Br. 15.
The Examiner concluded that it would have been obvious to use a
score to present the progression of McDonald’s treatments, based on
McDonald’s teaching of “using scores to as means for reporting levels of
improvements/degrees of change (see paragraph [0119]).” Final Action 9.
Appellants contend that, although McDonald discloses that various
well known clinical scoring systems were used to classify injury or disease
state, those systems “rely on numerous subjective evaluations from the
physician on ability to move a particular body part or feel a sensation, and
none rely on quantitative data from EMG and respiratory parameter
measurements.” App. Br. 8. Thus, Appellants argue, “[t]here is no
indication how or why the clinical scoring systems disclosed in McDonald
would be modified to include EMG and respiratory parameter measurements
and still provide meaningful clinical utility.” Id.
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We are not persuaded. Given the undisputed evidence from
McDonald that it was known in the art to use scores to track and compare
physiological parameters, Appellants do not persuade us that the Examiner
erred in concluding that it would have been obvious to use a scoring system
to track the progression of McDonald’s treatments, when using respiratory
parameters such as McDonald’s diaphragm EMG assessments as a measure
of efficacy, even when combined with another respiratory parameter, as
taught by Sinderby. Given that it was undisputedly known in the art to use
scores to track and compare physiological parameters, Appellants do not
persuade us, moreover, that an ordinary artisan lacked sufficient skill to
predictably design a scoring system for use with such respiratory parameters.
Because Appellants do not persuade us, for the reasons discussed, that
the Examiner erred in concluding that the method recited in claim 37 would
have been obvious to an ordinary artisan, we affirm the Examiner’s rejection
of that claim over the cited references. Claim 38 falls with claim 37.
37C.F.R. §41(c)(l)(iv).
OBVIOUSNESS—
MCDONALD, SINDERBY, AND IGNAGNI
The Examiner’s Prima Facie Case
In rejecting claims 25, 26, and 45, which depend directly or ultimately
from claim 24 discussed above, the Examiner cited McDonald as evidence
that it would have been obvious to implant a diaphragm-sensing electrode at
a phrenic nerve motor point, as recited in claim 26, and cited Ignagni as
evidence that it would have been obvious to map a patient’s diaphragm to
determine the phrenic nerve motor point, as recited in claim 25, for
deployment of McDonald’s diaphragm-sensing electrodes. Final Action 10.
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The Examiner noted that, as required by claim 45, Ignagni described
chronically implanting electrodes in a patient’s diaphragm. Id.
Appellants contend that Ignagni fails to remedy the previously argued
deficiencies in the combination of McDonald and Sinderby, in relation to
their alleged failure to teach or suggest an activity index based on a
combination of diaphragm-sensed EMG signals and another measured
respiratory parameter value, as recited in claim 24. App. Br. 8—9. Because,
for the reasons discussed above, we do not find those arguments persuasive,
we affirm the Examiner’s rejection of claims 25 and 26 over McDonald,
Sinderby, and Ignagni.
As discussed above, however, we agree with Appellants that the
Examiner did not provide a sufficient evidentiary basis for concluding, based
on the combination of McDonald and Ignagni, that it would have been
obvious to chronically implant McDonald’s diaphragm-sensing electrodes.
Because the Examiner did not identify, nor do we discern, any teaching in
Sinderby that remedies that deficiency, we, reverse the Examiner’s rejection
of claim 45 over McDonald, Sinderby, and Ignagni.
SUMMARY
For the reasons discussed:
(1) We reverse the Examiner’s rejection of claims 11—21, 36, and 39
for obviousness over McDonald and Ignagni;
(2) We reverse the Examiner’s rejection of claims 22 and 23 for
obviousness over McDonald and Sinderby;
(3) We affirm the Examiner’s rejection of claims 24, 27, 30, 32, 37,
38, and 40-44 for obviousness over McDonald and Sinderby;
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(4) We affirm the Examiner’s rejection of claims 25 and 26 for
obviousness over McDonald, Sinderby, and Ignagni; and
(5) We reverse the Examiner’s rejection of claim 45 for obviousness
over McDonald, Sinderby, and Ignagni.
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).
AFFIRMED-IN-PART
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