Ex Parte Kafrissen et al

Board of Patent Appeals and Interferences

Jan 9, 2012

11466504 (B.P.A.I. Jan. 9, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL E. KAFRISSEN and GODFREY OAKLEY
__________

Appeal 2011-005958
Application 11/466,504
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
administering folic acid to a subject taking an oral contraceptive. The
Examiner entered a rejection for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 21 and 25-27 stand rejected and appealed (App. Br. 5).1
Appellants have not argued the claims separately, so the claims stand or fall
together. See 37 C.F.R. § 41.37(c)(1)(vii).
Claim 21 is representative and reads as follows:
Claim 21. A method of administering folic acid to a subject for
whom an oral contraceptive is indicated, which comprises
administering to the subject a pharmaceutical composition, wherein
the pharmaceutical composition comprises an oral contraceptive and
at least 400 µg of folic acid.

The sole rejection before us for review is the Examiner’s rejection of
claims 21 and 25-27 under 35 U.S.C. § 103(a) as obvious over Bamji,2
Bielenberg,3 and Oakley4 (Ans. 3-5).
DISCUSSION
The Examiner cited Bamji as disclosing a study which found that
co-administering oral contraceptives and vitamins, including folic acid, to
low income women was advantageous because the vitamins treated
nutritional deficiencies common in such women, and also because the
vitamins would be helpful should conception occur due to irregular
contraceptive use or discontinuation of contraceptive (Ans. 4). As additional

1 Appeal Brief entered August 23, 2010.
2 Mahtab S. Bamji et al., VITAMIN SUPPLEMENTS TO INDIAN WOMEN
USING LOW DOSAGE ORAL CONTRACEPTIVES, 32 CONTRACEPTION
405-416 (1985).
3 Jens Bielenberg, FOLIC ACID AND VITAMIN DEFICIENCY DUE TO
ORAL CONTRACEPTIVES, 14 MED. MO. PHARM. 244-247 (1991) (as
translated).
4 Godfrey P. Oakley Jr., et al., Prevention of folic acid-preventable
spina bifida and anencephaly, NEURAL TUBE DEFECTS 212-231 (1994).
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evidence that an ordinary artisan would have considered it desirable to
co-administer oral contraceptives and folic acid, the Examiner cited
Bielenberg as evidence that “oral contraceptives can induce folic acid
deficiency” (id.).
The Examiner conceded that neither Bamji nor Bielenberg disclosed
administering at least 400 µg of folic acid alongside the oral contraceptive,
but found that Oakley suggested doing so, given Oakley’s teaching that “all
women of child-bearing age should consume 0.4 mg of folic acid per day to
prevent spina bifida and anencephaly in the child” (id.).
Based on the references’ combined teachings, the Examiner reasoned
that an ordinary artisan would have been prompted to combine the claimed
amount of folic acid with an oral contraceptive “in a single composition and
administer said composition with the expectation that the folic acid
contained therein would reduce the risk of neural tube defects should the
woman become pregnant during or immediately after contraceptive use since
oral contraceptives can cause folic acid deficiency” (id. at 5). As additional
impetus for combining the two ingredients in a single composition, the
Examiner further reasoned that “a single composition would be more
convenient for the woman to take than having to remember to take two
separate compositions” (id.).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

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Appellants’ arguments do not persuade us that a preponderance of
evidence fails to support the Examiner’s conclusion that claim 21 would
have been prima facie obvious to an ordinary artisan in view of the cited
references.
As the Supreme Court has stated, “when a patent ‘simply arranges old
elements with each performing the same function it had been known to
perform’ and yields no more than one would expect from such an
arrangement, the combination is obvious.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273
(1976)).
Here, claim 21 recites a method of administering folic acid to a
subject for whom an oral contraceptive is indicated. Claim 21 requires the
practitioner to administer to the subject a pharmaceutical composition that
contains an oral contraceptive and at least 400 µg of folic acid.
Bamji describes a study in which women taking oral contraceptives
also received separate multivitamin pills containing 300 µg folic acid (see
Bamji 405-407). Based on its findings, Bamji concluded that, “[i]n view of
the high prevalence of vitamin deficiency among the low-income group
women of developing countries, the delivery system for oral contraceptive
can be effectively used for giving vitamin supplements as well” (id. at 405).
Bamji noted in particular that using the “same delivery system . . . for
administering OC [oral contraceptive] and vitamins . . . would help in the
event of conception occurring due to irregular OC intake or discontinuation
of OC. Recent studies from UK suggest that periconception vitamin
supplements may prevent neural tube defects” (id. at 414 (citation omitted)).

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As the Examiner points out, Bielenberg discloses the existence of
“more and more reports that the long-term administration of estrogen-
containing, oral contraceptives can induce a deficiency in folic acid and
vitamin-B. In the advanced stage, a folic acid-hypovitaminosis can result in
a disruption in hematopoesis which can be manifested in hyperchromic
macrocytic anemia” (Bielenberg 3). As the Examiner also points out,
Oakley teaches that the US Public Health Service has issued a
recommendation “that all women of child-bearing age who are capable of
becoming pregnant should consume 0.4 mg of folic acid per day” (Oakley
212; see also id. at 216-17 (administering 0.4 mg per day of folic acid to
women would prevent neural tube defects in children)).
Thus, given Bielenberg’s teaching that oral contraceptives produce
folic acid deficiency, and given Bamji’s teaching that co-administering folic
acid-containing multivitamins and oral contraceptives was useful in
preventing neural defects in pregnancies occurring as a result of irregular or
discontinued oral contraceptive use, and further given Oakley’s teaching that
0.4 mg of folic acid per day is a suitable dosage for preventing neural tube
defects, we agree with the Examiner that an ordinary artisan would have
been prompted to combine at least 400 µg folic acid (i.e. 0.4 mg), with an
oral contraceptive in a single composition, and to have administered that
composition daily. Because the Examiner’s prima facie case is supported by
the explicit teachings in the references, we are not persuaded, as Appellants
argue, that the rejection is based on improper hindsight.
We acknowledge that Bamji’s teaching of administering the vitamins
and contraceptives using the same “delivery system” (Bamji 405, 414) might
be ambiguous as to whether Bamji meant that the ingredients should be
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delivered in the same pill or composition, as opposed to the same package.
Again, however, given Bamji’s explicit teaching that folic acid and oral
contraceptives should be co-administered, we detect no error in the
Examiner’s finding that an ordinary artisan would have been prompted to
combine those two ingredients into a single composition so as to accomplish
that co-administration. See, e.g., KSR, 550 U.S. at 418 (“[T]he
[obviousness] analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ.”); id. at 421 (“A person of ordinary skill is . . . a person of
ordinary creativity, not an automaton.”).
In sum, as Appellants’ arguments do not persuade us that the
Examiner erred in concluding that an ordinary artisan would have
considered claim 21 prima facie obvious in view of Bamji, Bielenberg and
Oakley, we affirm the Examiner’s rejection of that claim over those
references. The remaining claims fall with claim 21. See 37 C.F.R.
§ 41.37(c)(1)(vii).

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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