Ex Parte Levy et al

Board of Patent Appeals and Interferences

Jul 27, 2006

09799251 (B.P.A.I. Jul. 27, 2006)

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for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOSEPH LEVY and YOAV SHARONI
__________

Appeal No. 2006-1083
Application No. 09/799,251
__________

HEARD: July 13, 2006
__________

Before SCHEINER, ADAMS and MILLS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL

This appeal involves claims to a unit dosage form composition comprising at least
one of a number of specified steroidal hormones, and at least one carotenoid, with the
proviso that the composition is substantially free of any other active components. The
examiner has rejected claims 1-10, the only claims remaining in the application, as
obvious over the prior art. We have jurisdiction under 35 U.S.C. § 134. We find that the
examiner has not established a prima facie case of obviousness, and reverse the
rejection.
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Application No. 09/799,251

Background
According to appellants, “[t]reatment protocols using estrogen [ ] significantly
reduce the risks of cardiovascular disease and osteoporosis . . . [and] [t]he protective
effect of estrogen against heart disease is related to its ability to raise levels of circulating
HDL and lower levels of LDL.” Specification, page 2. Nevertheless, “long-term use of
estrogens is positively correlated with an increased risk for endometrial cancer
development. This risk may be reduced by simultaneous administration of a progestin,
which prevents overgrowth of endometrial cells . . . [but] [t]his form of combination
therapy [ ] apparently diminishes the beneficial effects of estrogen on the plasma lipid
profile.” Id.
Certain carotenoids, on the other hand, have been shown to exhibit various
beneficial effects. For example, “[t]he carotenoid astaxanthin has been demonstrated to
have anti-tumorigenic effects . . . in rodent models” (id., page 4), “phytoene has also
demonstrated anti-cancer activity” (id.), while lycopene “is strongly associated with anti-
oxidant and anti-cancer activities” (id., page 5).
The specification describes compositions, in unit dosage form, “compris[ing] a
physiologically effective amount of at least one hormone and at least one carotenoid in
an [effective] amount” (id., page 10), which “can be used to prevent the adverse effects
associated with the administration of . . . hormones such as, for example, steroidal
estrogens and progestins, without inhibiting the beneficial activity of such hormones.”
Id., page 7.

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Application No. 09/799,251

The Claims
Claim 1 is representative of the subject matter on appeal:
1. A unit dosage form composition suitable for once daily administration to a
human comprising

active components which consist essentially of

(1) a physiologically effective amount of at least one hormone selected from the
group consisting of steroidal estrogen, estradiol, estrone, medroxyprogesterone,
norethindrone, norethisterone, progestin, norgestrel, and progesterone, and

(2) at least one carotenoid wherein said carotenoid is in an amount effective to
prevent the adverse effects which may result from the administration of said hormone,

said composition being substantially free of any other active components.

“As used throughout [the] specification, ‘hormone’ refers to steroidal estrogens,
progestins, and nonsteroid estrogens (phytoestrogens) derived from higher plants”
(Specification, page 9), while “‘steroidal estrogen’ or ‘estrogen’ refers to estradiol,
estrone, [and] estriol” (id.), and “‘progestin’ refers to . . . progesterone,
medroxyprogesterone, norethindrone, norethistrone, [and] norgestrel” (id.).
Discussion
The examiner rejected claims 1-10 under 35 U.S.C. § 103 as unpatentable in view
of Jackson1 and Shlyankevich.2 Jackson describes dietary supplements “designed to
meet a woman’s health needs at each particular stage of her life” (Jackson, column 3,
lines 49-50). “[E]ach of the dietary supplements . . . provides a variety of nutrients,
including antioxidants to increase the resistance of LDL cholesterol to oxidation,
elements to enhance calcium absorption and utilization, nutrients to address iron

1 Jackson et al., U.S. Patent 5,807,586, issued September 15, 1998.
2 Shlyankevich, U.S. Patent 5,424,331, issued June 13, 1995.

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Application No. 09/799,251

deficiency anemia, folic acid to prevent neural tube defects, [and] compounds to reduce
serum homocysteine and improve the lipid profile” (id., lines 57-62). In addition,
phytoestrogens, “a class of isoflavones or isoflavenoids derived from plants, commonly
soy beans” (id., column 4, lines 65-67), “are included in each of the dietary supplements”
(id., lines 51-54). In addition, the dietary supplements may optionally contain provitamin
A carotenoids, like cryptoxanthin, and/or non-provitamin carotenoids, such as lutein and
lycopene (id., column 6, line 63 to column 7, line 5). According to Jackson,
phytoestrogens “modulate the menstrual cycle, reduce menopausal symptoms, and
lower LDL cholesterol levels” (id., column 4, lines 53-55), moreover, “diets rich in
phytoestrogen[s] . . . [result in] a decreased incidence of breast cancer, menopausal
symptoms and osteoporosis” (id., lines 57-59), while lycopene “has been inversely
associated with the risk of cervical cancer” (id., column 7, lines 7-8).
Shlyankevich describes dietary supplements “effective in the prevention of the
onset of clinical manifestations of osteoporosis” (Shlyankevich, column 3, lines 12-13).
The supplements comprise at least eight “active ingredients” (id., lines 15-16), including
phytoestrogens, licorice root extract, calcium, magnesium, zinc, beta-carotene,
cholecalciferol, and vitamin E (id., lines 18-31). Shlyankevich teaches that
phytoestrogens “have the ability to improve hormonal balance, [ ] are highly effective in
the treatment of osteoporosis” (id., column 5, line 68 to column 6, line 1), and are
“associated with the reduction of free plasma estradiol, and the risk of breast cancer” (id.,
column 2, lines 58-61). Thus, “[n]atural dietary phytoestrogens can replace estrogen
therapy” (id., column 5, lines 65-66), without the “side effects and other risk factors
associated with using estrogens . . . to prevent postmenopausal osteoporosis” (id.,

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Application No. 09/799,251

column 1, lines 58-65). According to Shlyankevich, “200 mg of isoflavones are
functionally equivalent to the daily dosage of conjugated steroidal estrogen used in
hormone replacement therapy” (id., column 3, lines 42-45).
The examiner acknowledges that Jackson does not teach the “selection of
hormones” required by the claims (Answer, page 4), but nevertheless concludes that
“[t]here is no significant difference observed between the instant invention and the prior
art” (id.). Alternatively, the examiner argues that “it would have been obvious for one of
ordinary skill in the pharmaceutical art to substitute” steroidal estrogens for the non-
steroidal phytoestrogens in Jackson’s or Shlyankevich’s supplements (id.), citing
Shlyankevich as evidence that phytoestrogens and estrogens are equivalent.
“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). “[I]dentification
in the prior art of each individual part claimed is insufficient to defeat patentability of the
whole claimed invention. Rather, to establish obviousness based on a combination of
the elements disclosed in the prior art, there must be some motivation, suggestion or
teaching of the desirability of making the specific combination that was made by the
applicant.” In re Kotzab, 217 F.3d 1365, 1369-70, 55 USPQ2d 1313, 1316 (Fed. Cir.
2000).
We find that the evidence relied on by the examiner is insufficient to establish that
it would have been obvious for one skilled in the art to substitute the specific hormones
required by the claims for the phytoestrogens required in either Shlyankevich’s or

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Application No. 09/799,251

Jackson’s carotenoid-containing supplements. Each of the claimed compositions
requires steroidal estrogen, estradiol, estrone, medroxyprogesterone, norethindrone,
norethisterone, progestin, norgestrel, and/or progesterone, together with a carotenoid -
regardless of whether it contains any other “active components.” Both of the prior art
references describe supplements which minimally contain plant-derived phytoestrogens
as essential components, and which may or may not additionally contain one or more
carotenoids. Jackson does not mention any of the hormones required by the claims.
Shlyankevich, on the other hand, teaches that 200 mg of isoflavones are “functionally
equivalent to the daily dosage of conjugated steroidal estrogen used in hormone
replacement therapy” (id., column 3, lines 42-45), but also teaches that “there are side
effects and other risk factors associated with using estrogens . . . to prevent
postmenopausal osteoporosis” (id., column 1, lines 58-65).
Thus, although it is clear that steroidal estrogens and phytoestrogens were known
to have similar activities in many respects, we agree with appellants that “there is a
difference in kind between phytoestrogens and [the] steroidal hormones” required by the
claims (Brief, page 9). Inasmuch as Shlyankevich specifically avoids estrogens in his
supplements, we cannot agree with the examiner’s assertion that they would have been
regarded as “equivalent” for purposes of either of the prior art dietary supplements. Nor
do we see any other “motivation, suggestion or teaching of the desirability of making the
specific combination that was made by the applicant” (Kotzab, 217 F.3d at 1369-70, 55
USPQ2d at 1316) stemming from either the references or the rationale relied on by the
examiner.

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Application No. 09/799,251

On this record, we find that the examiner has not established a prima facie case
of obviousness for the claimed invention. Accordingly, the rejection of claims 1-10 under
35 U.S.C. § 103 is reversed.
REVERSED

Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Donald E. Adams )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Demetra J. Mills )
Administrative Patent Judge )

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Application No. 09/799,251

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