Ex Parte Zerbe et al

Patent Trial and Appeal Board

Feb 21, 2013

11635361 (P.T.A.B. Feb. 21, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte HORST G. ZERBE, NADINE PAIEMENT,
and POMPILIA ISPAS-SZABO
__________

Appeal 2011-005243
Application 11/635,361
Technology Center 1600
__________

Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
nutritional solid oral dosage form. The Patent Examiner rejected the claims
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
The Specification states that “[i]t is well recognized that concurrent
calcium and iron supplementation using a single oral dosage form has been
difficult due to undesirable interactions between these minerals, which
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reduce bioavailability,” in particular, the significant inhibition of iron
absorption by calcium. (Spec. [0003].) However, various forms of calcium,
such as lactate, gluconate, carbonate, citrate, and citrate malate salts have
been suggested to improve iron bioavailability. (Id.) The Specification
states that “[t]he present invention provides an innovative solution to the
problem of preventing and/or reducing interactions between a calcium
nutrient and an iron nutrient present in a single dosage form by isolating the
calcium nutrient in an enterically coated particle, granule or pellet.” (Id. at
[0008].)
Claims 1, 3, and 6-13 are on appeal. Claim 1 is representative and
reads as follows:
1. A nutritional solid oral dosage form, comprising:
an immediate release matrix material in which are dispersed
enterically coated particles, granules or pellets containing a calcium nutrient
and a nutritionally acceptable acid selected from the group consisting of
citric acid, tartaric acid, malic acid, succinic acid, fumaric acid, phosphoric
acid, gluconic acid, acetic acid, tannic acid, lactic acid and glycolic acid, the
nutritionally acceptable acid being present in an amount that is effective to
provide a microenvironment that facilitates conversion of the calcium
nutrient into a form exhibiting enhanced bioavailability, wherein the dosage
form further comprises an iron nutrient located in the immediate release
matrix material external to the enterically coated particles, granules or
pellets.

The Examiner rejected the claims 1, 3 and 6-13 under 35 U.S.C. §
103(a) as unpatentable over Anastasia
1
and Andon.
2

1
Patent Application Publication No. EP 0 208 362 A1 by Frank Bernard
Anastasia et al., published Jan. 14, 1987.
2
US Patent No. 5,468,506 issued to Mark B. Andon, Nov. 21, 1995.

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Claims 3 and 6-13 have not been argued separately and therefore
stand or fall with independent claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Examiner found that Anastasia taught a dietary supplement
containing immediate release iron and delayed release calcium so that the
calcium does not interfere with the absorption of the iron. (Ans. 4-5.) The
Examiner also found that Anastasia taught that the calcium source is a
calcium salt such as calcium citrate, calcium lactate, calcium gluconate, and
particularly preferred, calcium carbonate and mixtures of calcium citrate and
calcium malate. (Id. at 5.) According to the Examiner, Anastasia’s
supplement differed from the claimed nutritional solid dosage form by not
including a nutritionally acceptable acid in the granules containing the
calcium nutrient. (Id. at 6.)
However, the Examiner found that Andon disclosed a highly
bioavailable calcium source containing calcium and a combination of citric
and malic acid. (Id.) According to the Examiner, it would have been
obvious to a person of ordinary skill in the art at the time the invention was
made to couple citric and malic acids with a calcium nutrient, as taught by
Andon, to increase the bioavailability of the calcium source. (Id. at 7.)
Appellants contend that “[n]either of the applied prior art references
recognize the problem of reduced solubility and reduced bioavailability
associated with release of a solid calcium nutrient from a solid oral dosage
form in the higher pH regions of the gastrointestinal tract” nor do the
references suggest “adding a nutritionally acceptable acid to a solid oral
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dosage form to enhance bioavailability of a calcium nutrient in the higher
pH regions of the gastrointestinal tract.” (App. Br. 4.)
We are not persuaded by this argument that the claimed invention is
nonobvious. Establishing a case of prima facie obviousness does not require
the prior art to provide the same reasoning as Applicants for combining
known elements. See In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990).
Rather, the test is whether the combined teachings of the prior art provided
an apparent reason to combine the known elements in the fashion claimed.
KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”). Here, the
Examiner soundly reasoned that Andon provided motivation to substitute its
calcium salt combination in place of the calcium salt used in Anastasia’s
dosage form to improve the bioavailability of the calcium. (Ans. 7, 9.)
Appellants also assert that Andon did “not teach anything relevant to
simultaneous coadministration of an iron nutrient and a calcium nutrient
from a solid oral dosage form, and does not recognize or address any
problems associated with solid oral dosage forms containing iron and/or
calcium nutrients.” (App. Br. 4-5.)
We remain unpersuaded by this argument. The Examiner concluded
that the claimed invention was obvious over a combination of Anastasia and
Andon. In the combination, the Examiner correctly found that Anastasia
squarely addressed potential interactions of iron and calcium when
simultaneously administered in a solid oral dosage form and disclosed a
solution to overcome this problem, i.e., applying a delayed release coating to
the calcium source. (Ans. 4-5.)
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With respect to the combination of Anastasia and Andon, Appellants
assert that “Andon is limited to disclosing concentrated bioavailable calcium
sources in the form of liquid sweetener supplements… [and] is not
reasonabl[y] pertinent to the problems addressed by Anastasia et al., such
that the person of ordinary skill in the art would not know how to apply the
teachings of Andon to the [solid] oral dosage forms of Anastasia et al.” (Id.
at 5.) In particular, Appellants assert that (a) “Andon only discloses liquid
compositions in which all of the solid components, including the calcium
salt, the malic acid and the citric acid must be dissolved in water” (Reply Br.
2) and; (b) that “improved bioavailability is achieved only in the presence of
sugar” (id.). Thus, according to Appellants, Andon’s teachings would have
led a person having ordinary skill in the art away from expecting a beneficial
result from adding solid edible acids to enterically coated calcium particles
as disclosed by Anastasia. (App. Br. 6-7; Reply Br. 2.)
We are not persuaded by Appellants’ arguments. Andon is reasonably
pertinent to Anastasia in that both references are directed to calcium
supplementation. The analogous nature of the prior art is unchanged by the
fact that Andon’s calcium supplement is in the form of a liquid sweetener
rather than a solid dosage form. See In re Clay, 966 F.2d 656, 658-659 (Fed.
Cir. 1992). Appellants assert that Andon’s solid components must be
dissolved in water. (Reply Br. 2.) However, Andon is directed toward a
liquid supplement, so we understand that Andon’s teaching to dissolve the
solids in water is necessary to achieve an effective liquid supplement.
However, we do not find, nor have Appellants provided evidence, that the
enhanced bioavailability of Andon’s combination of calcium salt, edible
acids and sugar is dependent upon the dissolution of the solids in water.
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Rather, as Appellants stated, Andon taught that “improved bioavailability is
achieved only in the presence of sugar.” (Reply Br. 2.)
With respect to the addition of a sugar, both Anastasia and the
claimed invention use the open claim language “comprise” or “comprising”
when reciting the components of their respective dosage forms. Thus, both
the supplement of Anastasia and the claimed invention are open to adding
sugar to the calcium source, as taught by Andon. Thus, we do not agree
with Appellants that Andon taught away from combining a calcium salt with
malic acid, citric acid and a sugar in a solid dosage form. See In re Gurley,
27 F.3d 551, 553 (Fed. Cir. 1994).
Consequently, we agree with the Examiner that modifying the
supplement of Anastasia according to the teachings of Andon amounted to a
predictable variation that could have been implemented by a person of
ordinary skill in the art. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 417.
Accordingly, we affirm the obviousness rejection.

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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