Ex Parte Karst et al

Patent Trial and Appeal Board

Dec 18, 2012

11541302 (P.T.A.B. Dec. 18, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte EDWARD KARST and CLARK R. BAKER JR.
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Appeal 2012-000637
Application 11/541,302
Technology Center 3700
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Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of administering a treatment to a patient. The Examiner rejected the claims
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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Statement of the Case
Background
“The present invention relates generally to monitoring parameters
associated with a therapy, and more particularly, to systems and methods for
assuring that a therapy is applied correctly and that a monitor accurately
reflects an underlying physiological parameter” (Spec. 1).
The Claims
Claims 1-11 are on appeal. Claim 1 is representative and reads as
follows:
1. A method comprising:
administering a treatment non-invasively at a
specified level to a patient;
after administration of the treatment has begun and
while continuing to provide some level of treatment,
temporarily increasing or decreasing the treatment and
returning to the specified level after the temporary increase
or decrease;
non-invasively measuring a parameter associated with
the treatment; and
evaluating the measured parameter values to ascertain
whether the temporary increases or decreases in the
treatment are observed in the parameter values.

The issue
The Examiner rejected claims 1-11 under 35 U.S.C. § 103(a) as
obvious over Darvish
1
and Sorenson
2
(Ans. 4-6).

1
Darvish et al., US 2002/0183682 A1, published Dec. 5, 2002.
2
Sorenson et al., US 5,207,752, issued May 4, 1993.
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The Examiner finds that:
Darvish discloses a method, comprising increasing or
decreasing a treatment (e.g. paras [0077]-[0107], [0140]);
non-invasively measuring a parameter indicative of the
underlying physiological state of the patient (e.g. paras
[0108], [0118], [0148]) where the treatment may be external
(para [0048]); and evaluating the parameter values to
ascertain whether the treatment is observed in the parameter
values (e.g. paras [0108], [0118]). The treatment may be
non-invasive, for instance, the apparatus for treatment may
rest completely outside the body and the therapy may be
administered by iontophoresis, electrophoresis, or
electroporation . . . . The device may also temporarily
increase or decrease the treatment by virtue of temporarily
turning on and turning off treatment (para [0016]). The
device may also temporarily increase or decrease treatment
by controlling the dosage or timing of the administration
(para [0018]).

(Ans. 4-5.) The Examiner finds that “Sorenson discloses an improved
method of delivering a treatment to the body, for example by electrophoresis
in an analogous way to Darvish, teaching that it is optimal to consider
temporarily increasing or decreasing a rate of administration and then
returning to a continual maintenance level” (id. at 5).
The Examiner finds it obvious to “consider allowing a device to
temporarily increase or decrease (for instance, by initiating a turning-on or
turning-off sequence) while ensuring that a continual maintenance level is
achieved so as not to completely interrupt drug administration as necessary,
or to ensure that a patient is not deprived of at least a continued amount of
drug” (id.).
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Appellants contend that “the measured parameter is evaluated to
determine whether the temporary increases or decreases in the [treatment]
can be observed as a corresponding change in the parameter. The Examiner
fails to address Appellants arguments that this subject matter is believed to
be absent from the Darvish reference” (App. Br. 10). Appellants contend
that “there is no indication that temporary changes are made to the treatment
and the monitored parameters subsequently evaluated to determine whether
the temporary change in treatment is observable” (id.).
Appellants contend that Sorenson teaches
away from a combination with the Darvish reference. In
particular, all of the approaches mentioned above in regard
to the Sorenson reference, rely on applying a continuous
current to maintain the steady-state therapeutic level of the
treatment. In direct contrast, the device in the Darvish
reference relies on short non-excitatory pulses to transport
molecules to excitable tissues without activating these
tissues in an undesirable manner.

(Id. at 12.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Darvish and Sorenson render
claim 1 obvious?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. Darvish “relates to using a non-excitatory pulse to control
molecule availability at or near excitable tissue, such as the heart, the uterus
or the GI tract, which might be activated in an undesirable manner by an
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applied electric field. The exerted control may include . . . iontophoresis of
the molecule into tissues” (Darvish 1 ¶ 0007).
2. Darvish teaches that “some or all of the non-excitatory signals
generated by device 100 are used to transport a molecule into the heart tissue
or surrounding tissues,” specifically teaching that “[o]ne or more electrode
leads 104 provide electricity from device 100 to one or more electrodes 106.
A pacer signal electrode 110 may be used to pace the heart, possibly every
beat” (Darvish 5 ¶ 0063).
3. Darvish teaches that “device 100 is external . . . the electrodes
may be external to the body, for example as used in some external
pacemakers.” (Darvish 8 ¶¶ 0120-0121.)
4. Darvish teaches that “[o]ne or more sensors (in some cases the
field application electrodes can double as sensors) may be used to provide an
indication of the heart's current status or its response to certain treatments”
(Darvish 13 ¶ 0192).
5. Darvish teaches that the “sensors may measure various cardiac
parameters, including, for example, pCO2, pO2pH, SO2,wall motion, local or
global electrical activity, endocardial acceleration, regional impedance,
regional APD, HR variability, LVP or aortic pressures (peak, max dP/dt),
respiration rate, cardiac output and/or thoracic impedance (for estimating
changes in stroke volume)” (Darvish 13 ¶0193).
6. Darvish teaches that “the sensors maybe outside the body”
(Darvish 14 ¶ 0194).
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7. Darvish teaches that “[v]arious pacing schemes may be applied
to increase the capture of the heart rate by the pacing signal and to avoid
certain types of arrhythmia” (Darvish 14 ¶ 0207).
8. Darvish teaches a watchdog monitor which “monitors one or
more cardiac parameters and/or the response of the heart to various stimuli,
to determine if the supplied molecules have an adverse effect on the heart.
As a result, protective measures, such as fencing, may be applied, or the
dosage or other parameters of drug delivery may be modified” (Darvish ¶
0199).
9. Sorenson teaches “a high current level for a predetermined time
to quickly drive the iontophoretic drug into the body to reach the therapeutic
level, after which the current is automatically reduced to achieve a steady-
state administration of the drug at a maintenance level” (Sorenson, col. 2, ll.
1-5).
10. Sorenson teaches that the “system would thus allow the patient
to temporarily increase the narcotic dosage to alleviate pain in peak periods,
after which the dosage would automatically return to a maintenance level”
(Sorenson, col. 4, ll. 3-6).
Principles of Law
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima face case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992).
To establish a prima facie case of obviousness, the Examiner must
find “a reason that would have prompted a person of ordinary skill in the
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relevant field to combine the elements in the way the claimed new invention
does.” KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
While Darvish clearly teaches non-invasively administering either
drugs by iontophoresis or electrical shocks at a specified level (FF 1-7),
Darvish does not teach temporarily increasing or decreasing a treatment
followed by a return to the specified level as required by claim 1. The
Examiner points to Sorenson, who teaches a system which allows a “patient
to temporarily increase the narcotic dosage to alleviate pain in peak periods,
after which the dosage would automatically return to a maintenance level”
(Sorenson, col. 4, ll. 3-6; FF 10). The Examiner finds that it would have
been obvious “to consider allowing a device to temporarily increase or
decrease (for instance, by initiating a turning-on or turning-off sequence)
while ensuring that a continual maintenance level is achieved so as not to
completely interrupt drug administration as necessary, or to ensure that a
patient is not deprived of at least a continued amount of drug” (Ans. 5).
However, the Examiner’s obviousness logic is not based on a reason
to combine, but rather represents a conclusion that the combination would
have been obvious. The Examiner does not provide any reasons why the
ordinary artisan would have chosen to modify Darvish’s system of
administering drugs or shocks to permit temporary increases or decreases in
treatment. The Examiner’s reference to “turning-on” or “turning-off” are
permanent changes in treatment, not temporary modifications, since once the
device is off, the only way to return to a “maintenance level” would be by
turning the device back on. At best, Darvish teaches a watchdog monitor
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which “monitors one or more cardiac parameters and/or the response of the
heart to various stimuli, to determine if the supplied molecules have an
adverse effect on the heart. As a result, protective measures, such as fencing,
may be applied, or the dosage or other parameters of drug delivery may be
modified” (Darvish ¶ 0199; FF 8). However, there is no indication that
these changes in dosage or parameters of drug delivery would be
“temporary” with any return to a maintenance level.
While Sorenson clearly does teach such “temporary” changes in
treatment, these changes are initiated by the patient and there is no reason
why the parameters of the treatment would be measured or evaluated since
the reason Sorenson provides for the temporary changes is mitigation of pain
by the patient. Thus, there is no reason to combine Sorenson’s temporary
changes in treatment for pain relief with Darvish’s method of treatment.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Darvish and Sorenson render claim 1 obvious.
SUMMARY
In summary, we reverse the rejection of claims 1-11 under 35 U.S.C.
§ 103(a) as obvious over Darvish and Sorenson.

REVERSED

cdc