Ex Parte Ndife et al

Board of Patent Appeals and Interferences

May 31, 2005

10603464 (B.P.A.I. May. 31, 2005)

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for publication and is not binding precedent of the Board.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 LOUIS I. NDIFE, BOOKER T. LUCAS III,
and STEPHENE L. HOHMAN
____________
Appeal No. 2005-1290
Application No. 10/603,464
____________
ON BRIEF
____________
Before GARRIS, PAK, and WALTZ, Administrative Patent Judges.
PAK, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134 from the examiner’s final
rejection of claims 1 through 11 and 14, which are all the claims pending in the above-
identified application.
APPEALED SUBJECT MATTER
The subject matter on appeal is directed to a single serving infant formula tablet
which can be dissolved rapidly in water. See the specification, page 1, lines 4-6.
According to the appellants (specification, page 3, lines 3-5), this dissolution characteristic
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is due to “the force used to compress the tablet”. The tablet is formed under a particular
pressure to prevent a film of fat from forming on the exterior tablet surface. Details of the
appealed subject matter are recited in representative claims 1 and 14 which are
reproduced below:
1. An infant formula in tablet form comprising:
a) a source of protein, present in the amount of 10 to 20 w/w%;
b) a source of carbohydrate, present in the amount of 40 to 70 w/w%; and
c) a source of fat present in the amount of at least 20 w/w%;
wherein the infant formula is a tablet formed under a pressure selected from
within a range of from about 400 psi to about 1500 psi, and wherein the pressure is
selected so that a film of fat does not form on the exterior tablet surface, and wherein the
resulting infant formula tablet dissolves within 60 seconds in accordance with a manual
dissolution test.
14. An infant formula in tablet form comprising, based on a 100 kcal basis:
a) about 8 to about 16 grams of a source of carbohydrate,
b) about 3 to about 6 grams of a source of fat, and
c) about 1.8 to about 3.3 grams of a source of protein,
wherein the infant formula is a tablet formed under a pressure selected from
within a range of from about 400 psi to about 1500 psi, and wherein the pressure is
selected so that a film of fat does not form on the exterior tablet surface, and wherein the
resulting infant formula tablet dissolves within 60 seconds in accordance with a mechanical
dissolution test.
The claimed terminologies “infant”, “manual dissolution test” and “mechanical
dissolution test” are defined at pages 3 and 4 of the specification.
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1 The examiner has not included Merk, Online, Lamb and Jang in the statement of rejection.
Normally, we do not consider the references not included in the statement of the rejection. In re Hoch,
428 F.2d 1341, 1342 n.3, 166 USPQ 406, 407 n.3 (CCPA 1970)(“Where a reference is relied on to support
a rejection, whether or not in ‘a minor capacity,’ there would appear to be no excuse for not positively
including the reference in the statement of the rejection.”). However, even were we to consider them, our
determination below would not be altered for the reasons set forth infra.
PRIOR ART REFERENCES
The prior art references relied upon by the examiner are1:
Lamb 3,608,064 Sep. 21, 1971
Jang et al. (Jang) 4,894,236 Jan. 16, 1990
Brochner 894,001 Apr. 18, 1962
(Published British Patent Application)
Ozalvo et al (Ozalvo) WO 03/077664 A1 Sep. 25, 2003
(Published International Patent Application)
The Merck Index, 10th ed., page MISC-87 (1983) (hereinafter referred to as “Merck”).
OnlineConversion.com (Pressure Conversion)(unknown publication date). (hereinafter
referred to as “Online”)
REJECTIONS
Claims 1 through 11 and 14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combined disclosures of Brochner and Ozalvo.
OPINION
We have carefully reviewed the claims, specification and applied prior art, including
all of the arguments advanced by both the examiner and the appellants in support of their
respective positions. This review has led us to conclude that the examiner’s Section 103
rejection is not well founded. Accordingly, we will not sustain the examiner’s Section 103
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rejection for essentially those reasons set forth in the Brief. We add the following primarily
for emphasis and completeness.
As our reviewing court stated in In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d
1443, 1444 (Fed. Cir. 1992):
[T]he examiner bears the initial burden, on review of the prior art or on any
other ground, of presenting a prima facie case of unpatentability.
This initial burden is not met unless the examiner supplies a sufficient factual basis to
support her rejection. In re Warner, 379 F.2d 1011, 1017, 154 USPQ 173, 178 (CCPA
1967), cert. denied, 389 U.S. 1057 (1968)(The examiner may not resort to speculation to
supply deficiencies in its factual basis.).
Here, we find that Ozalvo teaches Enfamil premature powder produced by Mead
Johnson which were formed into tablets by compressing under a weight of 0.25 tons in a
press machine. See page 11. We find that Ozalvo then goes on to imply that this
tabulating method may not be applicable to different infant formulas. Id. Thus, on this
record, notwithstanding the examiner’s position to the contrary, we determine that the
examiner has not demonstrated that the tabulating method (compression weight) for
Enfamil premature powder is desirable for the composition of the type described in
Brochner. See In re Kotzab, 217 F.3d 1365, 1369-70, 55 USPQ2d 1313, 1316 (Fed. Cir.
2000)(“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 this regard, we note
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that the examiner has not identified any teaching or suggestion of desirability of tabulating
Brochner’s composition containing “10-29% of butter fat, 7-15% of milk proteins, 15-65% of
milk carbohydrates and minor amounts of inorganic milk constituents and water” in the
same manner as Enfamil premature powder.
Even if the tabulating method (the same compression weight) used for forming
Enfamil tablets were employed in tabulating the composition described in Brochner as
proposed by the examiner, we determine that the examiner has not demonstrated that the
resulting tablets would necessarily have the same characteristics as those claimed, i.e.,
tablets having a specific dissolution rate and no fat film. As properly argued by the
appellants (Brief, page 4), for example, to avoid a film of fat on the surface of the tablets,
the claims require a further selection of an appropriate pressure from the recited pressure
range. The examiner has not demonstrated that the prior art references relied upon
recognize, inter alia, a particular pressure as a solution to avoiding the problem associated
with the composition of the type described in Brochner (i.e., forming a film of fat on the
surface of the tablets). Nor has the examiner demonstrated that the employment of the
tabulating method taught in Ozalvo would necessarily result in tablets having the claimed
attributes. Thus, on this record, the examiner has not supplied sufficient facts to
demonstrate that the prior art references would have suggested the claimed tablets or that
the tablets suggested would necessarily or inherently have the claimed features. In re
Spormann, 363 F.2d 444, 447, 150 USPQ 449, 452 (CCPA 1966)(“[T]he inherency of an
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advantage and its obviousness are entirely different questions. That which may be
inherent is not necessarily known. Obviousness cannot be predicated on what is
unknown.”).
Under the circumstances recounted above, we determine that the examiner has not
established a prima facie case of obviousness regarding the claimed subject matter.
Accordingly, we reverse the examiner’s decision rejecting the claims on appeal under
Section 103.
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CONCLUSION
In view of the foregoing, we reverse the examiner’s Section 103 rejection.
REVERSED
BRADLEY R. GARRIS )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
CHUNG K. PAK ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
THOMAS A. WALTZ )
Administrative Patent Judge )
CKP/lp
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ROSS PRODUCTS DIVISION OF ABBOTT LABORATORIES
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625 CLEVELAND AVENUE
COLUMBUS, OH 43215-1724