Ex parte KEENAN

Board of Patent Appeals and Interferences

Jun 23, 1998

08012379 (B.P.A.I. Jun. 23, 1998)

Application for patent filed February 2, 1993.1
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THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for
publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 24
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte ROBERT M. KEENAN
__________
Appeal No. 95-2851
Application 08/012,3791
___________
ON BRIEF
___________
Before KIMLIN, WARREN and OWENS, Administrative Patent Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the examiner’s refusal to allow claims 1, 2, 4-6, 8-13,
15-17, 19-24, 26-28, 30-33, 67, 68 and 70-99 as amended after final rejection. These
are all of the claims remaining in the application.
THE INVENTION
Appeal No. 95-2851
Application 08/012,379
2
Appellant’s claimed invention is a method for alleviating the tobacco withdrawal
syndrome in a human by administering to the human a specified amount of a nicotine
metabolite or combination of nicotine metabolites, or their pharmaceutically acceptable
salts, and an article for carrying out the method. Claims 1 and 67 are illustrative and
read as follows:
1. A therapeutic method to alleviate the tobacco withdrawal syndrome in a
human comprising:
administering an amount of a nicotine metabolite or combination of nicotine
metabolites or their pharmaceutically acceptable salts thereof to a human in need of
such treatment, in an amount in the range of 1 to 100 milligrams per kilogram of body
weight of the human per day calculated as the nicotine metabolite or combination of
nicotine metabolites in the free base form that is effective to reduce or eliminate
symptoms of tobacco withdrawal syndrome.
67. An article of manufacture comprising packaging material and a unit dosage
form of a pharmaceutical agent contained within said packaging material, wherein:
said pharmaceutical agent comprises a nicotine metabolite or combination of
nicotine metabolites or their pharmaceutically acceptable salts thereof in an amount
effective to alleviate tobacco withdrawal syndrome, symptoms of nicotine withdrawal
and wherein said packaging material includes instruction means which indicate that
said nicotine metabolite or combination of nicotine metabolites or said pharmaceutically
acceptable salts thereof can be used by a person in the range of 1 to 100 milligrams
per kilogram of body weight of the person per day calculated as the nicotine metabolite
or combination of nicotine metabolites in the free base form for alleviating (a) symptoms
of tobacco withdrawal syndrome, (b) symptoms of nicotine withdrawal, and (c) the
craving associated with the cessation of nicotine use.
THE REFERENCES
References relied upon by the examiner
Appeal No. 95-2851
Application 08/012,379
Abood ‘916 is a division of Abood ‘162. 2
3
Hutchinson et al. (Hutchinson) 4,748,181 May 31, 1988
Abood (Abood ‘162) 4,835,162 May 30, 1989
Bannon et al. (Bannon) 4,946,853 Aug. 7, 1990
Abood (Abood ‘916) 4,966,916 Oct. 30, 1990
Joseph F. Borzelleca et al., “Studies on the Respiratory and Cardiovascular Effects of
(-)-Cotinine”, 137 J. Pharm. Exper. Therapeutics, 313-18 (1962) (Borzelleca).
References relied upon by the board
Keenan (Keenan ‘774) 5,573,774 Nov. 12, 1996
Keenan et al. (Keenan ‘007) 5,596,007 Jan. 21, 1997
THE REJECTION
Claims 1, 2, 4-6, 8-13, 15-17, 19-24, 26-28, 30-33, 67, 68 and 70-99 stand
rejected under 35 U.S.C. § 103 as being unpatentable over Abood ‘916, Abood ‘162,
Bannon, Hutchinson, Borzelleca and appellant’s admissions on pages 4-7 of the
specification.2
OPINION
We have carefully considered all of the arguments advanced by appellant and
the examiner and agree with appellant that the aforementioned rejection is not well
founded. Accordingly, this rejection will be reversed. We will introduce new grounds of
rejection of claims 1, 2, 4-6, 8-13, 15-17, 19-24, 26-28, 30-33, 67, 68 and 70-74 and
91-99 under the provisions of 37 CFR § 1.196(b).
The examiner argues that the Abood references, Bannon and Hutchinson teach
Appeal No. 95-2851
Application 08/012,379
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that use of nicotine and nicotine agonists and antagonists for the treatment of tobacco
withdrawal syndrome was known in the art, and that appellant admits at pages 4-7 of
the specification that nicotine was known to metabolize in vivo (answer, page 6).
Because nicotine metabolizes in vivo, the examiner argues, administering nicotine by
methods including smoking provides an amount of nicotine metabolites which is
effective to reduce or eliminate symptoms of tobacco withdrawal syndrome as recited in
appellant’s claims (answer, pages 8-10). The examiner relies upon Borzelleca for
further motivation to use metabolites of nicotine for treating tobacco withdrawal
syndrome (answer, page 7). This reference teaches that isolation of nicotine
metabolites makes possible the investigation of the role of metabolites of nicotine in
controlling or limiting the response to nicotine (page 313). Borzelleca discloses that in
a reported preliminary study of anesthetized dogs, several nicotine metabolites
produced depression, and high dosages produced death (page 314). Borzelleca
reports that in his studies, (-)-cotinine produced depression in most mice and
hyperexcitability in a few (page 316). We find in this reference no indication that
nicotine metabolites are effective for reducing or eliminating the symptoms of tobacco
withdrawal syndrome.
The examiner’s argument is not well taken because the examiner has provided
no evidence or convincing reasoning which shows that the amount of cotinine produced
by metabolism of nicotine ingested during smoking is within the range recited in
Appeal No. 95-2851
Application 08/012,379
Neal L. Benowitz et al., “Cotinine disposition and effects”, 34 Clin. Pharmacol.3
Ther. 604-11 (1983).
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appellant’s claims and is sufficient to reduce or eliminate symptoms of tobacco
withdrawal syndrome. The Benowitz article cited in appellant’s specification (page 8)3
teaches that cotinine is the major metabolite of nicotine and is present in the blood of
tobacco smokers in much higher concentrations and remains longer than nicotine after
cessation of smoking (page 604). Benowitz infused the fumarate salt of cotinine into
subjects at a rate of 4 Fg base/kg/min for 60 min (page 605). This amount “was
selected as one which would induce blood concentrations of cotinine in the range of
that achieved by moderately heavy cigarette smokers” (page 605). Benowitz states
that the cotinine infusion produced a significant reduction in the desire to smoke (page
607) but also states that this reduction “was of a magnitude consistent with the
expected reduction in preexperimental anxiety and tension that we usually see with
similar subjects and paradigms that also include placebo infusions” (page 610).
Benowitz concludes that “at levels to which smokers are generally exposed, cotinine
exerts little, if any, pharmacologic effect” (page 610).
The amount of cotinine infused by Benowitz, i.e., 4 Fg/kg/min for 60 min, which,
Benowitz states, is an amount which would induce blood concentrations of cotinine in
the range of that achieved by moderately heavy cigarette smokers (page 605), is 240
Fg/kg, which is less than one fourth the minimum amount of nicotine metabolite recited
Appeal No. 95-2851
Application 08/012,379
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in appellant’s claims, and Benowitz concludes that the infused amount has little if any
pharmacologic effect (page 610). This reference, therefore, indicates that the amount
of cotinine which is in the bloodstream of a moderately heavy cigarette smoker would
not have the pharmacologic effect of reducing or eliminating symptoms of tobacco
withdrawal syndrome.
Furthermore, Bannon teaches that as nicotine levels fall after smoking,
additional nicotine is required to suppress the urge to smoke (col. 1, lines 53-68).
The examiner does not point out, and we do not find in the references relied
upon by the examiner, any indication that the total nicotine metabolites produced by
smoking would build up in the blood stream in an amount which is within the range
recited in appellant’s claims and which would be effective for reducing or eliminating
symptoms of tobacco withdrawal syndrome as required by these claims.
For the above reasons, we conclude that the examiner has not carried her
burden of establishing a prima facie case of obviousness of appellant’s claimed
invention.
Under the provisions of 37 CFR § 1.196(b), we enter the following new grounds
of rejection.
Claims 1, 2, 4-6, 8-13, 15-17, 19-24, 26-28, 30-33, 67, 68, 70-74 and 91-99 are
rejected under the judicially created doctrine of obviousness-type double patenting over
claims 1-26 of Keenan ‘007 in view of appellant’s admitted prior art, and claims 67, 68
Appeal No. 95-2851
Application 08/012,379
No rejection is applied to claims 75-90.4
Keenan ‘007 at col. 6, lines 11-17 indicates that the amount of cotinine which,5
as recited in the Keenan ‘007 claims 13 and 26, is the same as the amount recited in
appellant’s independent claims, is calculated as (-)-cotinine in the free base form.
7
and 70-74 are rejected under the judicially created doctrine of obviousness-type double
patenting over claims 1-17 of Keenan ‘774 in view of appellant’s admitted prior art.4
Claims 13 and 26 of Keenan ‘007 differ from appellant’s independent
method claims 1, 12, 23 and 91 in that the Keenan ‘007 claims recite administering
cotinine or a pharmaceutical salt thereof, whereas appellant’s claims 1, 12, 23 and 915
recite administering a nicotine metabolite or combination of nicotine metabolites or
pharmaceutical salts thereof. Appellant’s dependent claims 2, 13, 24 and 92 recite that
the nicotine metabolite can be, inter alia, (-)-cotinine. The teaching by Keenan ‘007 of
use of cotinine would have fairly suggested, to one of ordinary skill in the art, use of a
nicotine metabolite because, as acknowledged by appellant (specification, page 4),
cotinine was a known nicotine metabolite. Use of the methods of administering the
nicotine metabolite recited in appellant’s claims which depend from claims 1, 12, 23
and 91 would have been prima facie obvious to one of ordinary skill in the art in view of
the recitation of such methods in the dependent claims of Keenan ‘007.
Regarding appellant’s article claims 67, 68 and 70-74, given that cotinine is
administered as recited in the Keenan ‘007 claims, it would have been apparent to one
Appeal No. 95-2851
Application 08/012,379
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of ordinary skill in the art that an article which contains the appropriate amount of
cotinine and instructions for administering it would be needed to carry out the method.
Appellant’s claims 67, 68 and 70-74 differ from the Keenan ‘774 claims in that
appellant’s claims recite that the article contains a means for instructing that the
contents can be used in an amount of 1 to 100 mg/kg of body weight to alleviate the
symptoms of tobacco withdrawal, nicotine withdrawal, and craving associated with the
cessation of nicotine use. Given that the Keenan ‘774 article is for use by a human to
suppress appetite, prevent weight gain or induce weight loss as recited in the Keenan
‘774 independent claims, it would have been prima facie obvious to one of ordinary skill
in the art to include instructions as to how to administer the contents of the article for
that purpose. The instructions would differ from those recited in appellant’s claims only
in the wording of the instructions. Because the printed matter in the instructions has no
functional relation with the substrate on which it appears, it does not distinguish
appellant’s claimed invention over that of Keenan ‘774. See In re Gulack, 703 F.2d
1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983). Hence, the article recited in
appellant’s claims 67, 68 and 70-74 would have been prima facie obvious to one of
ordinary skill in the art over claims 1-17 of Keenan ‘774.
DECISION
The rejection of claims 1, 2, 4-6, 8-13, 15-17, 19-24, 26-28, 30-33, 67, 68 and
70-99 under 35 U.S.C. § 103 over Abood ‘916, Abood ‘162, Bannon, Hutchinson,
Appeal No. 95-2851
Application 08/012,379
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Borzelleca and appellant’s admissions on pages 4-7 of the specification is reversed.
New grounds of rejection of claims 1, 2, 4-6, 8-13, 15-17, 19-24, 26-28, 30-33, 67, 68,
70-74 and 91-99 have been entered under 35 U.S.C. § 1.196(b).
This decision contains in a new ground of rejection pursuant to 37 CFR
§ 1.196(b) (amended effective Dec. 1, 1997, by final rule notice, 62 Fed. Reg. 53,131,
53,197 (Oct. 10, 1997), 1203 Off. Gaz. Pat. & Trademark Office 63,122 (Oct. 21,
1997)). 37 CFR § 1.196(b) provides that “[a] new ground of rejection shall not be
considered final for purposes of judicial review.”
37 CFR § 1.196(b) also provides that the appellant, WITHIN TWO MONTH
FROM THE DATE OF THE DECISION, must exercise one of the following two options
with respect to the new ground of rejection of avoid termination of proceedings (37 CFR
§ 1.197(c)) as to the rejected claims:
Appeal No. 95-2851
Application 08/012,379
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(1) Submit an appropriate amendment of the claims
so rejected or a showing of facts relating to the claims so
the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the
application will be remanded to the examiner . . . .
(2) Request that the application be reheard under
§ 1.197(b) by the Board of Patent Appeals and
Interferences upon the same record . . . .
No time period for taking subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).
REVERSED, 37 CFR § 1.196(b)
)
EDWARD C. KIMLIN )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
CHARLES F. WARREN )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
TERRY J. OWENS )
Administrative Patent Judge )
Richard O. Bartz
Appeal No. 95-2851
Application 08/012,379
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Burd, Bartz & Guttenkauf
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Minneapolis, MN 55402