Ex Parte Sinclair

Board of Patent Appeals and Interferences

Jul 28, 2010

11031534 (B.P.A.I. Jul. 28, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/031,534 01/10/2005 John David Sinclair SINCL-002 2498
20374 7590 07/29/2010
KUBOVCIK & KUBOVCIK
SUITE 1105
1215 SOUTH CLARK STREET
ARLINGTON, VA 22202
EXAMINER
CARTER, KENDRA D
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
07/29/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN DAVID SINCLAIR

Appeal 2009-015257
Application 11/031,534
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 6-12, directed to a method of treating unhealthy eating behaviors.
The claims have been rejected on the grounds of lack of enablement and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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Application 11/031,534
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BACKGROUND
“The opioidergic system reinforces responses . . . when activated by
an opiate . . . [and] also when certain types of stimuli are experienced. The
stimuli cause a release of opioids in the brain, reinforcing the responses that
produced these stimuli” (Spec. 4: 6-8). “Opioidergic reinforcement is well
documented for food-related stimuli” (id. at 4: 11).
According to the Specification, “[n]arrowly limited experiments” have
shown that opioid antagonists (e.g., naloxone) can induce anorexia, as well
as inhibit it; they can also reduce the binge eating and purging associated
with bulimia; and can reduce normal eating as well (id. at 1: 5-9). “When
put into long term practice, however, the different effects [of the antagonists]
counteract each other” (id. at 1: 9-10), and “the methods used and previously
proposed for the treatment of eating disorders are unable to separate these
various actions” (id. at 1: 14-15).
“The key for . . . separat[ing] the actions of the antagonists comes
from an understanding of how the antagonists act in the nervous system to
produce benefits” (id. at 2: 3-11).
The Specification teaches that:
There are two basic processes through which long-term
change is made in the organization of the nervous system as a
result of experience: one causes learning by strengthening
synapses; the other causes habituation and extinction by
weakening synapses . . . Experimental results also show that the
two occur under different circumstances and follow different
rules. Thus, extinction is not simply learning to do something
else but rather a separate phenomenon. It is also distinct from
forgetting; it is an active process for removing unsuccessful
responses[.]
(Id. at 2: 5-11.)
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“When a highly palatable food is consumed, opioids are released and
as a result, after consolidation, the response is stronger” (Spec. 5: 13-15), in
some cases to the point where the response cannot be controlled. According
to the Specification, continuous use of an opioid antagonist coupled with
abstinence from the problem behavior and response can also make the
response stronger once the antagonist is discontinued. The Specification
suggests that this occurs because “the continual presence of an antagonist
produces up-regulation of opioid receptors . . . Consequently, a problem
response would produce more reinforcement after the end of antagonist
treatment, than it did before” (id. at 6: 24-27). However, “[w]hen the
response is emitted while an opiate antagonist blocks the reinforcement, the
response is weakened” (id. at 5: 16-17).

STATEMENT OF THE CASE
The present invention is based on a process of “selective extinction”
which, in turn, is based on the recognition that “[e]xtinction weakens only
those responses that are made while reinforcement is blocked” (Spec. 2: 14-
15, 6: 9). A person undergoing a selective extinction procedure “take[s] an
antagonist only before making the problem response but [is] free of the
antagonist at times when the problem response is not made” (id. at 6: 10-11).
In addition, strengthening alternative, healthy opioidergic responses in
conjunction with weakening problem responses is beneficial (id. at 9: 24).
“Thus extinction sessions, when mainly the problem response is weakened,
are interspersed with ‘learning periods’ when other competing response[s]
including healthy eating responses can regain their strength” (id. at 6: 11-
14).
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Claim 6 is representative of the subject matter on appeal:
6. A method for treating binge eating by selectively extinguishing
the behavior causing binge eating while strengthening normal health eating
behaviors, comprising the steps of:
administering naloxone to a subject suffering from binge eating before
the subject engages in binge eating behavior;
and soon after the amount of naloxone is no longer sufficient to block
opiate effects but while there still is an upregulation of opioid receptors,
having the subject make healthy eating responses to food items that do not
trigger binge eating for the subject; and repeating the steps of administration
of naloxone before binge eating behavior is made, followed by having a
naloxone-free period in which healthy eating occurs, until the binge eating
responses are sufficient[ly] weakened by extinction that the patient can
control them.
The Examiner has rejected claims 6-12, all the claims pending, as
failing to satisfy the enablement requirement of 35 U.S.C. § 112, first
paragraph (Ans. 3-7).
The Examiner has also maintained three rejections of the claims under
35 U.S.C. § 103(a): the rejection of claims 6, 7, 9, and 10 as unpatentable
over Drewnowski2 and Raymond;3 the rejection of claims 11 and 12 as

2 Adam Drewnowski et al., Naloxone, an opiate blocker, reduces the
consumption of sweet high-fat foods in obese and lean female binge eaters,
61 A J CLIN NUTR 1206-1212 (1995).
3 Nancy C. Raymond et al., Effect of a Very Low Calorie Diet on the
Diagnostic Category of Individuals with Binge Eating Disorder, 31 INT J
EAT DISORD 49-56 (2002).

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unpatentable over Drewnowski, Raymond, and Aungst;4 and the rejection of
claim 8 as unpatentable over Drewnowski, Raymond, and Fairburn.5
We will reverse these rejections.

ENABLEMENT
Issue
According to the Examiner, the Specification, “while being enabling
for reducing problem responses of eating disorders . . . does not reasonably
provide enablement for extinguishing the responses” (Ans. 3), which “reads
on completely extinguishing the behaviors causing eating disorders” (id. at
5).
The issue raised by this rejection is whether the Examiner has
properly interpreted the terms “extinguishing” and “extinction,” as used in
the Specification and claims, as requiring completely eliminating the
behaviors and problem responses of eating disorders.
Findings of Fact
FF1 Claim 6 is directed, in part, to “[a] method for treating binge
eating by selectively extinguishing the behavior causing binge eating . . .
until the binge eating responses are sufficient[ly] weakened by extinction
that the patient can control them.” The remaining claims have a similar
requirement.
FF2 The Specification teaches that when a problem response “is
emitted while an opiate antagonist blocks the reinforcement, the response is

4 U.S. Patent 4,626,539, issued December 2, 1986 to Aungst et al.
5 FAIRBURN ET AL., BINGE EATING NATURE, ASSESSMENT AND TREATMENT 9
(1993).
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weakened. . . . The antagonists can reduce purging if the behavior is emitted
while reinforcement is blocked because of extinction” (Spec. 5: 16-20).
Discussion
We agree with Appellant that the claims, by their express language,
“only require the eating response to be ‘sufficiently weakened’ by extinction
- not eliminated” (App. Br. 5), and that this use of the terms “extinction” and
“extinguishing” is entirely consistent with their use in the Specification.
While the claims might encompass completely eliminating problem
behaviors and responses, they don’t require it. The enablement analysis
must be focused on the product or method defined by the claims. “Title 35
does not require that a patent disclosure enable one of ordinary skill in the
art to make and use a perfected, commercially viable embodiment absent a
claim limitation to that effect.” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d
1333, 1338 (Fed. Cir. 2003). See also In re Cortright, 165 F.3d 1353, 1359
(Fed. Cir. 1999) (claims to method of “restoring hair growth” encompassed
achieving full head of hair but did not require it).
Conclusions
The Examiner has improperly interpreted the terms “extinguishing”
and “extinction” as requiring completely eliminating the behaviors and
problem responses of eating disorders.
As the Examiner has already acknowledged that the Specification is
enabling for reducing problem responses of eating disorders (Ans. 3), and as
this is all that the claims require, we will reverse the rejection of claims 6-12
under 35 U.S.C. § 112, first paragraph.

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OBVIOUSNESS
Issue
All three of the rejections of the claims on the grounds of obviousness
rest on the Examiner’s proposed combination of the methods of Drewnowski
and Raymond, and the dispositive issue in all three rejections is whether the
evidence of record supports the Examiner’s conclusion that it would have
been obvious for one skilled in the art to combine the teachings of the two
references in the manner required by the claims.
Findings of Fact
FF3 Drewnowski teaches that “opiate blockade . . . may be useful in
the clinical management of the binge-eating disorder” (Drewnowski,
Abstract).
To test the hypothesis that endogenous opiate peptides
selectively influence hedonic response to sweet and high-fat
foods, the opiate antagonist naloxone [a short-lasting μ
antagonist] . . . and a saline placebo were administered by
intravenous infusion to 16 obese and 25 normal-weight women.
Twenty of the women (10 obese, 10 lean) fulfilled DSM-III-R
diagnostic criteria for bulimia nervosa . . . During drug infusion
the women tasted and rated 20 sweetened dairy products and
were presented with eight snack foods of varying sugar and fat
content. Naloxone suppressed hedonic responses in all subject
groups and suppressed the consumption of sweet and high-fat
foods in binge eaters, but not in nonbingers.
(Id.)
FF4 Raymond “examined the effect of caloric restriction in the form
of a VLCD [very low calorie diet] on the diagnostic outcome of obese
individuals with BED [binge eating disorder], subthreshold BED (sub-BED),
and no binge eating symptoms (no-BE)” (Raymond 50).
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FF5 All of the participants in Raymond’s study participated in an
Optifast® core program.
The 24-week program consisted of 12 weeks of an 800-kcal
modified fast, a 6-week phase during which food was
reintroduced, and a 6-week weight stabilization phase. All
participants attended weekly psychoeducational/behavioral
weight management group meetings . . . throughout the 24
weeks. . . . After the first 2 weeks of the refeeding phase, one
half of the BED participants were assigned randomly to an
additional 10-week cognitive behavioral therapy (CBT)
component that focused on binge eating behavior . . .
Participants were seen for follow-up at 1 month, 6 months, and
1 year after completion of the VLCD program.
(Raymond 51.)
Discussion
Claim 6 requires administering naloxone to a subject suffering from
binge eating before the subject engages in binge eating behavior. Then,
soon after the naloxone is no longer sufficient to block opiate effects, but
while the subject’s opioid receptors are still up-regulated, having the subject
make healthy eating responses to foods that don’t trigger binge eating; and
repeating these steps until the binge eating responses are sufficiently
weakened that the subject can control them.
The Examiner acknowledges that Drewnowski doesn’t teach
[A]fter the amount of naloxone is no longer sufficient to block
opiate effects, having the subject make healthy eating responses
to food items that do not trigger the problem responses; and
repeating . . . administration of naloxone before the eating
behavior . . . is made, followed by having a naloxone-free
period in which healthy eating occurs, until the problem . . . is
extinguished[.]
(Ans. 9.)
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However, the Examiner cites Raymond as teaching “an alternating
therapy, in which the BED patients are treated (i.e. low calorie diets), and
then followed by having a diet free period, and then reintroduced with
therapy over a course of up to 1 year on the program” (Ans. 12).6
“Since . . . naloxone is a short-lasting μ opiate antagonist,” the
Examiner concludes that one of ordinary skill in the art would have found it
obvious to combine Drewnowski’s method with “another method that treats
binge eating disorder during the periods it is not effective such as the method
of Raymond et al., which encourages healthy eating” (Ans. 12-13). In
addition, the Examiner reasons that both Drewnowski and Raymond “teach
treatments for binge eating disorders, thus it is prima facie obvious to
combine the two methods such of which is taught by the prior art to be
useful for the same purpose, in order to form a third method to be used for
the very same purpose” (id. at 11).
Nevertheless, even if we were to accept the Examiner’s conclusion
that it would have been obvious to combine Drewnowski’s method with
Raymond’s, the Examiner has not explained how the combination would
result in having the subject make healthy eating responses to foods that don’t
trigger binge eating soon after the naloxone is no longer sufficient to block
opiate effects, but while the subject’s opioid receptors are still upregulated,

6 We disagree with the Examiner’s characterization of Raymond’s study.
Raymond indicates that “[p]articipants were seen for follow-up at 1 month, 6
months, and 1 year after completion of the VLCD program” to access the
long-term effects of the treatment on weight loss and binge behavior
(Raymond 51-52). The Examiner has not come forward with any credible
evidence that Raymond’s study involved “an alternating therapy . . . over a
course of up to 1 year on the program” (Ans. 12).
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and repeating these steps until the binge eating responses are sufficiently
weakened that the subject can control them.
Rather, we are persuaded by Appellant’s reasonable argument that
“[a] person simply combining the two methods . . . would try to have
naloxone continually present – perhaps by administering it as a slow-release
injection or implant – and while it is present . . . advis[ing] [patients] not to
make unhealthy eating response[s] and instead practice healthy eating”
(Reply Br. 5).
We agree with Appellant that the Examiner has not established that
“the proposed modification of Drewnowski will . . . result in the method of
the present invention as recited in the claims on appeal” (App. Br. 9-10).
Conclusions
The evidence of record is not sufficient to support the Examiner’s
conclusion that it would have been obvious for one skilled in the art to
combine the methods of Drewnowski and Raymond in the manner required
by the claims.

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SUMMARY
We reverse the rejection of claims 6-12 under the enablement
provision of 35 U.S.C. § 112, first paragraph, as well as the rejections of the
claims under 35 U.S.C. § 103(a).

REVERSED

alw

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