Ex Parte Dilorenzo

Patent Trial and Appeal Board

Aug 27, 2014

11706630 (P.T.A.B. Aug. 27, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte DANIEL JOHN DILORENZO
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Appeal 2012-004864
Application1 11/706,630
Technology Center 3700
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Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method of managing epileptic seizures. The Examiner has rejected the
claims as anticipated and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
STATEMENT OF THE CASE
The Specification is directed to a method of preventing an epileptic
seizure by determining the propensity of a patient to experience a future

1 Appellant identifies NeuroVista Corporation as the Real Party in Interest.
(App. Br. 2.)
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seizure and “communicating to the patient and/or a health care provider a
therapy recommendation.” (Spec. 4: ¶ 17.)
Some embodiments will provide a recommendation or
instruction to take an acute dosage of a specified
pharmacological agent (e.g., neuro-suppressant, sedative, AED
or anticonvulsant, or other medication which exhibits seizure
prevention effects). However, the instructions or
recommendations may suggest adjusting the timing or dosage
of a chronically prescribed pharmacological agent, performing a
specific action such as assuming a safe posture or position,
activating an implanted drug dispenser, manually activating a
neuromodulation treatment such as vagus nerve stimulation
(VNS), deep brain stimulation (DBS), cortical stimulation, or
the like.
(Spec. 5: ¶ 23.)
Claims 1–11 and 23–27 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claims 1 and 23 are representative of the
claims on appeal, and read as follows:
1. A method of managing epileptic seizures, the method
comprising:
determining that a patient has an increased propensity for
having a future epileptic seizure within a time period prior to
the occurrence of the epileptic seizure; and
providing an output communication to the patient that
indicates to the patient a therapeutically effective dosage of a
pharmacological agent treatment to be administered that will
provide a clinically therapeutic threshold amount of the
pharmacological agent within the time period prior to the
occurrences of the epileptic seizure;
wherein the therapeutically effective dosage is less than a
dosage that is effective after the seizure has begun.

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23. A method of managing epileptic seizures, the method
comprising:
determining that a patient has an increased propensity of
a future epileptic seizure within a time period prior to the
occurrence of the epileptic seizure; and
providing an output communication to the patient that is
indicative of a therapeutically effective dosage of a
pharmacological agent treatment that will provide a clinically
therapeutic threshold amount of the pharmacological agent
within the time period prior to the occurrences of the epileptic
seizure.
The following grounds of rejection are before us for review:
I. claims 1–4, 11, and 23–25 under 35 U.S.C. § 102(b) as
anticipated by Echauz;2
II. claims 5–10 are rejected under 35 U.S.C. § 103(a) over Echauz;
and
III. claims 26 and 27 under 35 U.S.C. § 103(a) as unpatentable over
Echauz in view of Sillén.3

I. The Issue: Anticipation by Echauz
Does the evidence of record support the Examiner’s finding that
Echauz disclosed determining a patient’s propensity of a future seizure as
well as communicating a therapy suggestion to the patient?
Findings of Fact
FF1. We adopt the Examiner’s findings and analysis concerning the
scope and content of the prior art. The following facts are repeated for
reference convenience.

2 Echauz et al., US 2002/0103512 A1, published Aug. 1, 2002.
3 Sillén et al., US 5,672,154, issued Sept. 30, 1997.
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FF2 Echauz disclosed:
A method and apparatus for forecasting and controlling
neurological abnormalities in humans such as seizures . . . .
Forecasting is achieved by indicating the probability of an
oncoming seizure within one or more time frames, which is
accomplished through an inner-loop control law and a feedback
necessary to prevent or control the neurological event by either
electrical, chemical, cognitive, sensory, and/or magnetic
stimulation.
(Echauz, Abstract.)
FF3. Echauz disclosed notifying a patient of an imminent seizure.
“The probability output of having a seizure for one or more time frames is
shown on a portable display . . . . When this probability is higher than an
adaptive threshold, a sound, visual, and/or tactile alarm(s) is(are) activated to
alert the patient of the oncoming seizure.” (Echauz, 6: ¶ 88; see also
Ans. 4.)
FF4. Echauz disclosed therapy in the form of:
Stimulations at the patient level include sensory/perceptive and
cognitive stimulations, and at the device level include electrical,
chemical, magnetic, and certain types of sensory
stimulation. . . .
The low level supervisory control or implanted closed-
loop control 300 is activated manually from the external
portable module 500 or automatically via the high level
supervisory control 400 through the external portable module.
(Echauz, 7–8: ¶¶ 94-95 (emphasis added); see also Ans. 4.)
FF5. Echauz disclosed:
Prediction times on the order of minutes to an hour can be
obtained with this invention . . . , and in the worst cases on the
order of seconds . . . . This represents ample time to avoid a
seizure by releasing small quantities of a drug (chemical
stimulation), by electrically stimulating focal points to ward off
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synchronized nerve impulses, by wearing a special helmet that
provides a magnetic stimulation, by solving high cognitive
problems, or by experimenting with sensory stimulation such as
music, flavors, images, tactile sensations, or odors.
(Echauz, 8: ¶ 96; see also Ans. 5.)
FF6. Echauz disclosed:
[A]ctive therapeutic agents are infused or otherwise released in
the brain regions where seizures are generated, or to where
seizures may spread. As seizures become more likely, the
amount, concentration or spatial distribution through which a
chemical agent is delivered are all increased. As with electrical
or other therapeutic interventions, patterns of delivery can
include infusing a drug directly in the epileptic focus, in an area
surrounding it, or to regions involved in early spread, or to
more central or deep brain regions, which may modulate seizure
propagation. These same therapeutic principles apply to
distribution of maximal therapy when electrical seizure onset is
detected, including distributing therapy to regions where
seizures are known to spread and propagate. Last-minute
treatment may include release of larger amounts of drug into the
cerebrospinal fluid (CSF) space for circulation over wide
regions of the brain or into the cerebral circulation. Other types
of pharmacological agents may also be used in this scheme,
such as agents which are activated by oxidative stress, which
may themselves increase the concentration and distribution of
an active therapeutic agent as seizure precursors evolve and the
probability of seizures increases.
(Echauz, 8: ¶ 99; see also Ans. 5.)
Principle of Law
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
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Analysis
Appellant contends that “[s]imply providing an alarm, however, does
not ‘indicate[s] to the patient a therapeutically effective dosage of a
pharmacological agent treatment to be administered.’” (Reply Br. 2; see
also App. Br. 6.) “There is a significant difference between indicating a
therapeutically effective dosage, as recited in claim 1, and merely indicating
THAT a dosage will be administered.” (Reply Br. 3.)
We are not persuaded. Claim interpretation is at the heart of patent
examination because a claim cannot be compared to the prior art without
ascertaining its proper scope. In this case, Appellant contends that the
claims require that the output information include information about the
dosage to be administered. Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928,
933 (Fed. Cir. 2003). Specifically, the claims require an output
communication to the patient that “indicates to the patient a therapeutically
effective dosage of a pharmacological agent treatment to be administered’
(claim 1) or “providing an output communication to the patient that is
indicative of a therapeutically effective dosage of a pharmacological agent
treatment that will provide a clinically therapeutic threshold” (claim 23).
The Examiner interprets the claims to be sufficiently broad to encompass
“that merely indicating [that] a dosage is ready via a light or sound indicates
to a patient the effective dosage of the treatment.” (Ans. 7.)
We do not agree with Appellant’s contention that “merely indicating
THAT a dosage will be administered” does not meet the limitation of
providing “indicating a therapeutic effective dosage” (Reply Br. 3). Here,
the dependent claims contain the limitation that the output communication
“specifies the therapeutically effective dosage” (see claims 26 and 27).
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Appellants seek to read this limitation from the dependent claims into the
independent claims. However, a claim construction that results in a
dependent claim having the same scope as the independent claim from
which it depends, and which thus renders the dependent claim superfluous,
is “presumptively unreasonable.” Beachcombers, Int’l Inc. v. Wildewood
Creative Prods., Inc., 31 F.3d 1154, 1162 (Fed. Cir. 1994). Accordingly, we
agree with the Examiner’s interpretation that the sounding on of an alarm to
indicate to the patient that the dosage, presumably a therapeutic dosage, is
ready to be administered meets the claim limitation of providing an output
communication
We agree with the Examiner’s finding that Echauz discloses a method
and apparatus for evaluating a patient’s likelihood of having a seizure (FF 1–
6), as well as providing an alarm that indicates a seizure is imminent (FF3),
In addition, the alarm sounds in sufficient time to activate treatment either
automatically or manually (FF 3–5). Echauz disclosed that “[t]he intensity
of intervention, modality of therapy and spatial distribution of therapy are all
adjusted as the probability of seizures increases over time.” (Echauz, 8:
¶ 97.) Furthermore, Echauz disclosed that the earlier the treatment is
initiated the lower the stimulus or chemical dose required (FF6).
We conclude that the preponderance of evidence of record supports
the Examiner’s finding that the claims are anticipated. Appellant does not
present arguments for the separate patentability of claims other than claim 1
(App. Br. 7). Thus, all claims fall with the corresponding representative
claim. 37 C.F.R. § 41.37(c)(1).

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II. The Issue: Obviousness over Echauz
Does the preponderance of evidence of record support the Examiner’s
conclusion that Echauz renders obvious the percent dose reduction of a
patient treatment protocol?
Analysis
Appellant contends that Echauz “provides no examples of any
therapeutically effective dosage relative to a dosage that is effective after the
seizure has begun.” (App. Br. 9.)
We are not persuaded. Echauz recognizes that the earlier treatment is
administered, the lower the dosage of the treatment agent that may be
required to prevent the seizure from progressing into a full blown seizure
(FF6). The Examiner finds that “Echauz discloses that the largest amounts
[of drug] (100%) are required at seizure onset (paragraph 99).” (Ans. 7.)
An obviousness inquiry “requires[] consideration of common knowledge
and common sense.” DyStar Textilfarben GmbH & Co. v. C.H. Patrick Co.,
464 F.3d 1356, 1367 (Fed. Cir. 2006). We agree with the Examiner’s
position that one of ordinary skill in the art versed in the treatment of
seizures (e.g., a physician) would know the pharmacological dosage required
for administration during a full blown seizure. The Examiner concludes that
“using any number of lesser treatments to prevent a seizure as long as an
increased propensity for a seizure is detected. Thus, Echauz actually
discloses all percent[ages] between zero and 100.” (Ans. 7; see also 5–6.)
Modifying the pharmaceutical dosage would be recognized as a result
effective variable that may be adjusted to within the claimed range of in
order to achieve optimal prevention of a seizure within the earliest detection
a seizure onset (FF 1–6). See In re Applied Materials, Inc., 692 F.3d 1289,
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1295 (Fed. Cir. 2012) (overlap of prior art range with claimed range
“provides sufficient motivation to optimize the ranges”); In re Boesch, 617
F.2d 272, 276 (CCPA 1980) (“discovery of an optimum value of a result
effective variable in a known process is ordinarily within the skill of the
art”). We agree with the Examiner’s position that one of ordinary skill in the
art would know the dosages to administer to a patient during a seizure. That
information in conjunction with the recognition that the earlier the dose is
administered the lower the dosage to prevent the patient from reaching a full
blown seizure would provide the dosage range for treatments (FF6, see also
Ans. 7). We find no error with the Examiner’s conclusion that determining
the optimal dosage for a particular drug is a result effective variable where
the optimization lies within a known range.
Accordingly, we affirm the rejection of claims 5–10.

III. The Issue: Obviousness over Echauz and Sillén
Does the preponderance of evidence of record support the Examiner’s
conclusion that the combination of Echauz and Sillén renders obvious an
output device for communicating information regarding the patient treatment
protocol?
Findings of Fact
FF7. Sillén disclosed “a device for giving patients individualized
situation-dependent medication advice . . . . When the knowledge-based
system (6) finds that a medicine should be taken the computer emits a signal
providing information on the type of medicine and the dose.” (Sillén,
Abstract.)
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FF8. Sillén disclosed “[w]hen the system is operating the reminder
function block 1 cause the computer to emit a signal when a pharmaceutical
preparation is to be taken (or some other activity is to be performed), and
which indicates the type of preparation to be taken as well as the dosage.”
(Sillén, col. 2, l. 66 to col. 3, l. 3; see also Ans. 6.)
Principle of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
The Examiner finds, and Appellant does not dispute, that Sillén
teaches a “computer [that] emits a signal when medication delivery or some
other action is to occur and which then indicates the type of preparation to
be taken as well as the dosage.” (Ans. 6; see also App. Br. 9.) Appellant,
however, asserts that
Because the stimulation [in Echauz] is automated, the patient
has no need to receive an output communication that indicates
to the patient a therapeutically effective dosage of a
pharmacological agent treatment to be administered. There is
therefore no rational reason to combine the personal reminder
teachings from Sillen with the method of automated chemical
stimulation from Echauz.
(App. Br. 10.)
We are not persuaded by Appellant’s contention. As discussed above,
we agree with the Examiner’s finding that Echauz discloses a method and
apparatus for evaluating a patient’s likelihood of having a seizure (FF 1–6),
as well as providing an alarm that indicates a seizure is imminent (FF 3).
The alarm is sounded in sufficient time to administer treatment either
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manually or automatically (FF 4–5). Echauz also discloses that the earlier
the treatment is initiated the lower the stimulus or chemical dose required
(FF 6). We also agree with the Examiner’s finding that Sillén teaches a
computer that signals to the patient the type and dosage of medicine to be
administered (FF 7–8).
Applying the KSR standard of obviousness to the findings of fact (FF
1–8), we agree with the Examiner’s conclusion that the combination of
references provides an apparatus for the detection of seizures and delivery of
therapy, and “[w]hen the system is operating, the computer emits a signal
when medication delivery or some other action is to occur and which then
indicates the type of preparation to be taken as well as the dosage.”
(Ans. 6.) An obviousness inquiry “requires[] consideration of common
knowledge and common sense.” DyStar Textilfarben,464 F.3d at 1367; see
KSR, 550 U.S. at 421(“Rigid preventative rules that deny fact finders
recourse to common sense, however, are neither necessary under our case
law nor consistent with it.”) Here, Echauz disclosed alerting the patient in
sufficient time in order to activate treatment either automatically or
manually (FF 4–5). Additionally, Echauz disclosed that “[a]s seizures
become more likely, the amount, concentration or spatial distribution
through which a chemical agent is delivered are all increased” (FF6). In
other words, Echauz recognizes that the earlier treatment is administered the
lower the dosage of the treatment agent that may be required. This applies
to electrical as well as chemical treatment. We agree with the Examiner’s
rationale that it would have been obvious to one of ordinary skill in the art to
“to modify the alert of Echauz to further indicate the type of preparation and
the dosage as taught by Sillen to give the patient individualized, situation-
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dependent medication advice [and] to optimize the patient’s sense of well-
being.” (Ans. 6.) Here, common sense explains that providing information
with respect to administration and dosage of medicines allows the patient to
be more involved in their treatment protocol and thereby achieving and
maintaining improved overall health.
We affirm the rejection of claims 26 and 27.

SUMMARY
We affirm the rejection of claims 4, 11, and 23–25 under 35 U.S.C.
§ 102(b) by Echauz.
We affirm the rejection of claims 5–10 under 35 U.S.C. § 103(a) over
Echauz.
We affirm the rejection of claims 26 and 27 under 35 U.S.C. § 103(a)
over Echauz in view of Sillén.

TIME PERIOD FOR RESPONSE
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

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