Ex Parte Kruisinga

Board of Patent Appeals and Interferences

Feb 4, 2009

10472029 (B.P.A.I. Feb. 4, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte ROELOF JOHANNES HENDRIK KRUISINGA
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Appeal 2008-5626
Application 10/472,029
Technology Center 1600
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Decided: February 4, 2009
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Before DONALD E. ADAMS, DEMETRA J. MILLS, 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 a claim to a method
for treating sleep latency. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

Appeal 2008-5626
Application 10/472,029

Statement of the Case
Background
“Melatonin (N-acetyl-5-methoxytryptamine) is an endogenous
hormone of the pineal gland” (Spec. 1:7-8). The Specification teaches that
“[e]xactly how melatonin induces sleep is not clear, but it is probably not
through a direct hypnotic effect” (Spec. 1:30-31). According to the
Specification, “[i]n addition to circadian phase-shifting effects, melatonin
has been shown to decrease nocturnal core body temperature, which helps
facilitate sleep” (Spec. 2:3-5). The Specification teaches that “ADHD
[attention deficit hyperactivity disorder] is a condition affecting a significant
proportion of children” (Spec. 3:23-24). According to the Specification, “a
traditional method of treating such children was by administration of
psychostimulant . . . While psychostimulants are useful in increasing
attention spans, they have major side effects, including . . . insomnia” (Spec.
3:26-28).
The Claims
Claims 2-6 are on appeal. We will focus on claim 6, which is
representative and reads as follows:
6. A method of treating sleep latency in ADHD disorder
in a human comprising administering to a human in need
thereof, a therapeutically effective amount of at least one
member of the group consisting of melatonin or a
pharmaceutically acceptable salt of melatonin.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Flaugh U.S. Patent 5,654,325 Aug. 5, 1997
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Application 10/472,029

Mark A. Stein, Unravelling Sleep Problems in Treated and Untreated
Children with ADHD, 9 J. CHILD ADOLESCENT PSYCHOPHARMACOLOGY 157-
168 (1999).

The issue
The Examiner rejected claims 2-6 under 35 U.S.C. § 103(a) as
obvious over Flaugh and Stein (Ans. 3-5).
The Examiner finds “Flaugh teaches a method of treating sleep
disorders (sleep latency) using various melatonin analogs of formula 1”
(Ans. 3). The Examiner finds that “[c]hildren with ADHD treated with
stimulants were reported to display a higher prevalence of nightly severe
sleep problems than did untreated children with ADHD” (Ans. 4). The
Examiner finds “it obvious to formulate a method of treating sleeplessness
of Flaugh with a method to treat ADHD, since Stein demonstrated that there
is a population overlap of children that have ADHD and sleep problems”
(Ans. 4).
Appellant contends that “Flaugh is directed to the use of a variety of
melatonin related compounds to treat sleeping disorders in humans with
DIMS disorders such insomnia and not treating sleep latency, let alone in
ADHD disorder patients” (App. Br. 3). Appellant contends that the “Stein
reference is directed to a study of sleep problems in stimulant treated and
untreated children with ADHD . . . It had nothing to do with teaching the
treatment of sleep latency in ADHD patients” (App. Br. 4).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
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Application 10/472,029

Did the Examiner err in finding that it would have been obvious to
treat the sleep problems of ADHD children disclosed by Stein using the
melatonin derivatives disclosed by Flaugh for treating sleep disorders?
Findings of Fact (FF)
1. Flaugh teaches “a method for treating sleep disorders by
employing certain melatonin analogs” (Flaugh, col. 2, ll. 4-6).
2. Flaugh teaches that the “compounds of Formula I . . . are useful
in treating sleep disorders in mammals. Such disorders . . . are characterized
by difficulty in initiating or maintaining sleep . . . or in obtaining restful
sleep” (Flaugh, col. 7, ll. 56-60).
3. Flaugh teaches that “sleep disorders . . . include insomnia, those
instances where the patient is only able to obtain a minimal period of sleep
or where the patient is only able to obtain a poor quality sleep in terms of
patient restfulness” (Flaugh, col. 7, ll. 61-65).
4. Flaugh teaches that the “amount of compound actually
administered will be determined by a physician, in light of the relevant
circumstances including the choice of compound to be administered, the
chosen rout of administration, the age, weight, and response of the
individual patient and the severity of the patient’s sleep disorder symptoms”
(Flaugh, col. 9, ll. 1-6).
5. Stein teaches that “[c]hildren with ADHD treated with
stimulants were reported to display a higher prevalence of nightly ‘severe’
sleep problems than did untreated children with ADHD” (Stein, abstract).
6. Stein teaches that “[c]hildren with ADHD taking stimulants
displayed almost a two-fold increase in long latencies (>30 minutes) to sleep
onset or insomnia at least once per week relative to untreated children with
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ADHD, while children with ADHD overall displayed almost double the rate
of insomnia reported for the pediatric controls” (Stein 160).
7. Stein teaches that “[t]his study adds to several previous studies
suggesting that children with ADHD who take stimulant medications are at
increased risk for several sleep problems, particularly insomnia” (Stein 166).
Principles of Law
In KSR, the Supreme Court rejected the rigid application of the
teaching, suggestion, and motivation test by the Federal Circuit, stating that
The principles underlying [earlier] cases are instructive
when the question is whether a patent claiming the
combination of elements of prior art is obvious. When a
work is available in one field of endeavor, design incentives
and other market forces can prompt variations of it, either in
the same field or a different one. If a person of ordinary skill
can implement a predictable variation, § 103 likely bars its
patentability.

KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007).
Analysis
Flaugh teaches the treatment of sleep disorders using melatonin
analogs (FF 1, 2, 4). Flaugh teaches that the sleep disorders include
insomnia and difficulty in initiating or maintaining sleep (FF 3). Stein
teaches that some patients with ADHD have severe sleep problems (FF 5).
Stein teaches that ADHD patients may experience sleep problems including
difficulty in initiating sleep and insomnia (FF 6-7).
Applying the KSR standard of obviousness to the findings of fact, it
would have been obvious to apply Flaugh’s method of treating patients with
sleep disorders with melatonin analogs to the ADHD patients of Stein, since
the patients were reporting identical symptoms and Flaugh teaches that the
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melatonin analogs “provide a safe, efficacious, method of treating sleep
disorders” (Flaugh, col. 2, ll. 13-14). The combination of Flaugh and Stein
uses known elements and combines them in predictable ways. Such a
combination is merely a “predictable use of prior art elements according to
their established functions.” KSR, 127 S. Ct. at 1740.
We are not persuaded by Appellant’s argument that “Flaugh is
directed to . . . treat sleeping disorders in humans with DIMS disorders such
[as] insomnia and not treating sleep latency, let alone in ADHD disorder
patients” (App. Br. 3). Flaugh is directed towards treatment of any patient
with a sleep disorder such as insomnia or difficulty in initiating sleep (FF 1-
4). Flaugh does not even limit the patient population to humans but claims a
“method of treating sleep disorders in a mammal” (Flaugh, col. 11, l. 35).
An ordinary artisan would have reasonably expected the method of Flaugh
to treat sleep disorders in any patient population. Stein teaches one
particular patient population, ADHD patients, with sleep disorders including
those named by Flaugh such as insomnia and difficulty in initiating sleep
(FF 5-7). The ordinary artisan would have found it reasonably predictable
that Flaugh’s method of treatment of sleep disorders with melatonin would
treat Stein’s population of ADHD patients with sleep disorders.
We also do not find persuasive Appellant’s argument that “[t]here is
no suggestion of treating patients with ADHD . . . and there is no teaching
that ADHD patients are equivalent to normal persons” (App. Br. 4). “The
obviousness analysis cannot be confined by a formalistic conception of the
words teaching, suggestion, and motivation.” KSR, 127 S. Ct. at 1741. The
KSR court found that “any need or problem known in the field of endeavor
at the time of invention and addressed by the patent can provide a reason for
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combining the elements in the manner claimed.” KSR, 127 S. Ct. at 1742.
Stein teaches the problem, that ADHD patients have increased incidence of
insomnia and difficulty in initiating sleep (FF 5-7). Flaugh teaches the
solution, that administration of melatonin analogs to patients treats insomnia
and difficulty in initiating sleep (FF 1-4). An ordinary artisan would have
found it obvious to apply Flaugh’s solution to Stein’s problem, resulting in
the treatment of ADHD patients with sleep disorders with melatonin analogs
(FF 1-7).
Conclusions of Law
The Examiner did not err in finding that it would have been obvious
to treat the sleep problems of ADHD children disclosed by Stein using the
melatonin derivatives disclosed by Flaugh for treating sleep disorders.
SUMMARY
In summary, we affirm the rejection of claim 6 under 35 U.S.C. § 112,
first paragraph. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also
affirm the rejection of claims 2-5 as these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED
LP
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