Ex Parte Rogowski et al

Patent Trial and Appeal Board

Dec 7, 2012

11804720 (P.T.A.B. Dec. 7, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ROBERTA L. ROGOWSKI,
SUSAN E. DUBE, and PHILIP JOCHELSON
__________

Appeal 2011-012031
Application 11/804,720
Technology Center 1600
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for reducing early awakenings and for decreasing fragmented sleep in the
8th hour of a sleep period. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1-16 and 18-23 are pending and on appeal (App. Br. 2). We
will focus on claims 1, 9, and 23, the only independent claims on appeal,
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which are set forth in the Claims Appendix to the Appeal Brief (id. at 15-
16). Claim 1 is illustrative and reads as follows:
1. A method for reducing or preventing early awakenings in a patient
in need thereof, comprising:
identifying a patient having a sleep disorder in which, for a given
8 hour period of desired sleep, the patient experiences a sleep period that
terminates during the final 60 minutes of said period; and
providing to the patient doxepin or a pharmaceutically acceptable salt
thereof in a dosage between about 0.5 and 6 mg that is effective to lengthen
the sleep period.
Claims 1-16 and 18-23 stand rejected under 35 U.S.C. § 103(a) as
obvious Kavey
1
in view of Erman
2
(Ans. 4).
The Examiner relies on Kavey for teaching “a method for treating
transient, chronic, and non-chronic forms of insomnia comprising
administration of doxepin, at a dosage ranging from 0.5 to 20 mg., and
particularly exemplifies dosages of about 10 mg. or less; 5 mg.; or 2 mg”
(id.). The Examiner finds that “Kavey teaches that doxepin is administered
to treat maintenance insomnia and to allow the patient to maintain a normal
sleep period” (id. at 4-5).
The Examiner relies on Erman for teaching “that transient insomnia is
associated with a sleep deficiency such as WASO [wake after sleep onset]
. . . and that normal subjects sleep for an 8-hour period” (id. at 5). The
Examiner also relies on Erman for teaching “a sleep deprivation study in
which subjects were awakened after 7.5 hours” (id.).

1
Kavey, US 6,211,229 B1, Apr. 3, 2001.
2
Erman et al., Comparative efficacy of zolpidem and temazepam in transient
insomnia, 16 HUMAN PSYCHOPHARMACOLOGY CLIN. EXP. 169-176 (2001).
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The Examiner concludes that, “as normal subjects are taught to sleep
for an 8-hour period, it would have been prima facie [obvious] to one of
ordinary skill in the art to associate sleep disorders as including sleep which
terminates prior to the end of the eighth hour of sleep” (id.). The Examiner
also concludes:
[I]t would have been prima facie obvious for one of ordinary
skill in the art, such as a medical practitioner, to first identify
the patient population in need of treatment, prior to providing
treatment. Therefore, it would have been prima facie obvious
to one of ordinary skill in the art to identify a patient that
experiences a sleep period that terminates during the final
60 [minutes] of an 8-hour period of sleep, prior to
administration of doxepin.
(Id. at 8.)
Appellants argue:
Kavey does not discuss whether doxepin has any effect during
the 8th hour of a sleep period. Treatment of maintenance
insomnia, for example, could mean that a patient waking at
hour 5 now sleeps into hour 6. Erman tested different drugs,
having different mechanisms of action. Neither drug was
known to have any 8th hour effect. In fact, Erman terminated
his testing at 7.5 hours. Erman’s WASO and sleep efficiency
data cover awakenings during the entire 7.5 hour period, so it is
impossible to determine what, if any, effect they had during the
8th hour versus the 1st, 2nd, 3rd, etc. Neither reference
identifies a patient with a sleep period that terminates during
the final 60 minutes of an 8 hour sleep period. Thus, even a
combination of the references does not result in the claimed
invention.
(App. Br. 7.) We conclude that Appellants have the better position.
Claims 1 and 23 both require “identifying a patient having a sleep
disorder in which, for a given 8 hour period of desired sleep, the patient
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experiences a sleep period that terminates during the final 60 minutes of said
period” and providing doxepin or its salt to that patient. Similarly, claim 9
requires “identifying a patient suffering from fragmented sleep during the
8th hour of a sleep period” and providing doxepin or its salt to that patient.
As noted by the Examiner, Kavey discloses the use of doxepin “for
the treatment of . . . maintenance insomnia” (Kavey, col. 2, ll. 39-63).
Kavey also discloses that “the point of [its] invention is to induce and
maintain normal sleep without exposing the patient to residual effect of
medication” (id. at col. 3, ll. 51-54).
However, the Examiner acknowledges that “Kavey does not explicitly
teach . . . treating patients who experience sleep termination during the final
60 . . . minutes of the 8-hour sleep period” (Ans. 5). Nor does the Examiner
find that Kavey discloses treating patients suffering from fragmented sleep
during the 8th hour of a sleep period.
Erman is directed to a study comparing the hypnotic effects of
zolpidem, temazepam, and placebo in healthy adults (Erman, Abstract).
Erman discloses that “[s]ubjects were normal sleepers as defined by the
following criteria: a customary total sleep time of 7-8 h . . .” (id. at p. 171,
col. 1). Thus, Erman includes those who sleep for 7 hours within its
definition of “normal sleepers.”
We do not agree with the Examiner that Erman suggests that doxepin
would be expected to be effective during the 8th hour of a sleep period.
Thus, we agree with Appellants that the Examiner has not set forth a prima
facie case of obviousness as to claims 1, 9, and 23 or as to claims 2-8, 10-16,
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and 18-22, which depend from claims 1 or 9. We therefore reverse the
obviousness rejection.

REVERSED

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