Ex Parte Sachs

Board of Patent Appeals and Interferences

Oct 18, 2002

08422381 (B.P.A.I. Oct. 18, 2002)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.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 DAVID P.L. SACHS
__________

Appeal No. 2001-0870
Application No. 08/422,381
__________

ON BRIEF
__________

Before SCHEINER, GRIMES, and GREEN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 37-46, all of the claims remaining. Claim 37 is
representative and reads as follows:
37. A method for determining a nicotine dosage necessary to achieve a
target nicotine serum concentration in an individual patient who is
ceasing smoking, said method comprising:

(A) measuring a patient nicotine concentration while the patient
is still smoking; and

(B) determining the nicotine dosage as follows:

(i) for male patients:

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Application No. 08/422,381

determining the values of at least a body mass factor
and a cumulative smoking factor; and

determining the dosage to achieve the target nicotine
serum concentration based on the patient’s measured
nicotine concentration, the body mass factor value, and the
cumulative smoking factor value; or

(ii) for female patients:

determining at least the value of a psychological
dependence factor and age; and

determining the dosage to achieve the target nicotine
serum concentration based on the patient’s measured
nicotine concentration, the psychological dependence factor
value and the age.

The examiner relies on the following references:
Goodman & Gilman’s: The Pharmacological Basis of Therapeutics, 6th Ed.,
pp. 43-48 (1980)

DiPiro et al. (DiPiro), ”Chapter 2/ Drug Delivery and Administration,”
Pharmacotherapy : A Pathophysiologic Approach, pp. 15-17 (1989)

Chan et al. (Chan), ”Pharamacokinetics of a single transdermal dose of nicotine
in healthy smokers,” Journal of Controlled Release, Vol. 14, pp. 145-151 (1990)

Claims 37-46 stand rejected under 35 U.S.C. § 103 as obvious in view of
the combined disclosures of Chan, DiPiro, and Goodman & Gilman.
We reverse.
Background
“[A] number of products have been commercially developed for providing
nicotine replacement while a patient is undergoing smoking cessation . . .,
including gums, transdermal patches, nasal spray, inhalers, lozenges, and the
like.” Specification, page 1. The specification discloses that the dosage of
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Application No. 08/422,381

nicotine delivered during nicotine therapy affects the long-term success of the
therapy. “[L]ong term patient abstinence is achieved more often in those patients
where at least 40%, usually at least 50%, of pre-cessation blood nicotine levels
. . . are maintained by the replacement therapy.” Page 3.
The specification discloses methods for determining the optimal dosage
for nicotine replacement therapy for a particular patient. The disclosed method
takes into account several factors, including “a body mass factor, a cumulative
smoking factor, a psychological dependence factor, age, and menopausal
status.” Page 3. However, not all of these factors are important for every
patient.
The preferred patient characteristics will vary between males and
females. For males, the preferred patient characteristics include at
least the body mass factor and the cumulative smoking factor. The
psychological dependence factor and patient age are also useful,
although not as predictive as the body mass factor and the
cumulative smoking factor. For females, the preferred patient
characteristics include at least the psychological dependence factor
and age. Menopausal status is also a significant factor, although
less so than the previously mentioned factors. The cumulative
smoking factor appears to be of little relevance to predicting the
relationship between dosage and blood nicotine levels in women.

The specification provides further details on the meaning of, e.g., “body
mass factor,” “cumulative smoking factor,” and “psychological dependence
factor” on pages 6-7.
Discussion
The claims are directed to a method for determining a nicotine dosage
based on at least, for males, the patient’s body mass factor and cumulative
smoking factor or, for females, the patent’s psychological dependence factor and
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Application No. 08/422,381

age. The examiner rejected all of the claims as obvious in view of Chan, DiPiro,
and Goodman & Gilman.
The examiner characterizes Chan as “teach[ing] that nicotine replacement
therapy is well known as an aid in smoking cessation therapy.” Examiner’s
Answer, page 4. The examiner concedes that Chan does not teach “methods for
determining or optimizing nicotine replacement dosages based on values
corresponding to various patient characteristics,” id. at page 5, but relies on
DiPiro and Goodman & Gilman to make up this deficiency.
The secondary references teach the individualization of drug
therapy, broadly, based on factors similar to those therein [sic], is
conventional in the pharmaceutical art. See, e.g., in DiPiro et al.
page 16, Table 2.1 and Goodman [&] Gilman et al. page 43, Figure
3.1. One of ordinary skill would therefore have ample motivation to
determine nicotine replacement dosages in therapy by employing
such factors. Further, the optimization of amounts of agents to be
employed is deemed to be within the skill of the artisan.

Examiner’s Answer, page 5
Appellant argues that the examiner’s references do not teach or suggest
all of the claim limitations. See the Appeal Brief, page 10:
[N]o reference or combination thereof teaches or suggests that a
nicotine replacement dosage can be individualized and based on
particular characteristics specific to an individual patient.
Furthermore, no reference or combination thereof remotely implies
that nicotine dosage determinations for male and female patients
depend on entirely different sets of primary factors, as set forth in
claim 37.

Appellant also argues that, in addition to not teaching the limitations of the
claims, the cited reference do not provide adequate motivation to combine what
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they do teach, nor do they provide a reasonable expectation of success. Appeal
Brief, pages 12-14.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
met, does the burden of coming forward with evidence or argument shift to the
applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993). The test of obviousness is “whether the teachings of the prior art, taken
as a whole, would have made obvious the claimed invention.” In re Gorman, 933
F.2d 982, 986, 18 USPQ2d 1885, 1888 (Fed. Cir. 1991).
In this case, we agree with Appellant that the examiner has not
established a prima facie case of obviousness. The references cited by the
examiner disclose that nicotine patches were known in the art (Chan), and that
the effective dose of a therapeutic drug would depend on a number of factors,
including “disease state,” “sex,” and “age” (DiPiro, page 16), as well as “body
size and composition” and “physiological variables” generally (Goodman &
Gilman, page 43). However, none of the references discuss factors to consider
in optimizing the dosage of nicotine specifically. In fact, none of the references
even recognize a need to optimize nicotine dosages, let alone suggest using the
factors recited in the claims to do so. The claimed method requires considering
specific factors, which vary depending on the sex of the patient, in order to
calculate an individualized dosage. The examiner has pointed to nothing in the
references that would have led those of skill in the art to consider specifically the
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factors recited in the claims, and in particular, to have considered different factors
depending on whether the patient was male or female.
“The admonition that ‘obvious to try’ is not the standard under § 103 has
been directed mainly at two kinds of error. In some cases, what would have
been ‘obvious to try’ would have been to vary all parameters or try each of
numerous possible choices until one possibly arrived at a successful result,
where the prior art gave either no indication of which parameters were critical or
no direction as to which of many possible choices is likely to be successful.”
In re O’Farrell, 853 F.2d 894, 903-04, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988)
(citations omitted). In this case, the references cited by the examiner may have
made it obvious to try varying different factors to see if they affected the dosage
effectively delivered by a nicotine patch, but they would not have rendered
obvious the claimed method.
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Summary
We reverse the rejection under 35 U.S.C. § 103 because the references
cited by the examiner do not support a prima facie case of obviousness.

REVERSED

Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )
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