Ex Parte Rosenbloom

Board of Patent Appeals and Interferences

Mar 31, 2004

09847121 (B.P.A.I. Mar. 31, 2004)

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for publication and is not binding precedent of the Board.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. 15

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RICHARD ROSENBLOOM
__________

Appeal No. 2004-0340
Application No. 09/847,121
__________

ON BRIEF
__________

Before MILLS, 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 1-6, 10, 12, 13, and 15. Claims 7-9, 11, and 14 are also
pending but have been withdrawn from consideration. Claim 1 is representative
and reads as follows:
1. A composition for the treatment of diabetic neuropathy by a method
of administration selected from the group consisting of oral administration,
parenteral administration and inhalation, the composition comprising a mixture of
an amount of a compound that promotes synthesis of nerve growth factor
selected from the group consisting of vitamin D3, 1(S), 3(R)-dihydroxy-20(R)-(1-
ethoxy-5-ethyl-5-hydroxy-2- heptyn-1-yl)-9, 10-seco-pregna-5(Z), 7(E), 10 (19)-
triene, pharmaceutically acceptable salts thereof and mixtures thereof, which is
effective when administered in the composition to promote synthesis of nerve
growth factor, an amount of an aldose reductase inhibitor which is effective when
Appeal No. 2004-0340 Page 2
Application No. 09/847,121

administered in the composition to inhibit aldose reductase and an effective
amount of an antioxidant.

The examiner relies on the following reference:
Riley 5,976,568 Nov. 02, 1999

Claims 1-6, 10, 12, 13, and 15 stand rejected under 35 U.S.C. § 103 as
obvious in view of Riley.
We reverse.
Background
Diabetes mellitus causes long-term tissue damage. “This damage may
take many forms but the major types are damage to the eyes (retinopathy),
nerves (neuropathy), kidneys (nephropathy) and cardiovascular system.”
Specification, page 1. “There are many approaches to reducing or preventing
these forms of damage. . . . [A] number of pharmaceutical companies have been
developing aldose reductase inhibitors for the purpose of reducing diabetic
neuropathy.” Id.
The specification discloses “compositions for the treatment of diabetic
neuropathy. The compositions comprise a mixture of a compound that promotes
synthesis of nerve growth factor, an aldose reductase inhibitor and an
antioxidant.” Page 3. “Exemplary compounds that promote synthesis of nerve
growth factor are vitamin D3 [and] vitamin D3 derivatives.” Page 4. These
compounds are “used in an amount effective to promote the synthesis of nerve
growth factor of about 6-14.3 IU per kg of body weight of the patient.” Id.
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“The second active ingredient of the compositions . . . is an aldose
reductase inhibitor. Numerous suitable aldose reductase inhibitors are known to
persons skilled in the art.” Page 5. One specific example is quercetin. Page 6,
lines 11-12. “The aldose reductase inhibitor is used in an amount that provides
substantially the same level of aldose reductase inhibition as 13-21.4 mg/kg body
weight of the patient per day of quercetin.” Page 6, lines 24-25.
“Another active ingredient in the compositions . . . is the antioxidant.”
Page 6, lines 31-32. Preferred antioxidants include “ascorbyl palmitate, ascorbic
acid (vitamin C), vitamin A, [and] vitamin E.” Page 7, lines 11-12. “Ascorbyl
palmitate may be used in amounts of 11-28.6 mg/kg body weight of the patient
per day. . . . When vitamin E is employed as mixed tocopherols, an amount of
about 4-11.4 IU per kg body weight of the patient, per day may be employed. . . .
When vitamin A is employed, an amount of about 170-357.1 IU per kg body
weight of the patient, per day, is employed.” Page 7, lines 22-31.
“Dosages may be administered 1-10 times per day. . . . Thus, the
composition of the invention may comprise anywhere from one tenth of the daily
minimum dosage of the various active ingredients up to a maximum of the daily
maximum dosage of the various active ingredients.” Page 10, lines 22-28.
Discussion
The claims are directed to a composition comprising three compounds:
vitamin D3 (or a specific derivative thereof) in an amount effective to promote
synthesis of nerve growth factor; an aldose reductase inhibitor in an amount
effective to inhibit aldose reductase; and “an effective amount of an antioxidant.”
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The examiner rejected the claims as obvious in view of Riley, reasoning
that Riley
discloses an oral daily supplement composition comprising
Vitamins A, D, E, C (Buffered Calcium Ascorbate, Ascorbic Acid
and Ascorbyl Palmitate) and quercetin, see claim 2. Riley . . . also
discloses an oral daily supplement composition comprising vitamins
A, C, D3 and E, see claim 3. See also Table II, columns 25 and 28.

It would have been obvious to one of ordinary skill in the art at the
time the invention was made to employ an amount [e]ffective to
promote nerve growth of a vitamin D3 derivative, ascorbyl palmitate
and quercetin in a single . . . composition.

Examiner’s Answer, page 3. The examiner also asserted that “the
interconversion of dosage forms, i.e., the conversion of two-three modular
formulations into a single composition is within the skill of the artisan, and is
therefore obvious.” Id., page 6.
Appellant argues that Riley does not suggest combining all of the active
ingredients required by the instant claims into a single composition. Rather,
“Riley teaches that the total daily dosage of claim 2 should be divided into
several distinct modular formulations. . . . Thus, Riley does not disclose the
composition containing vitamins A, D, E, C and quercetin that the Examiner relies
upon in support of the rejection.” Appeal Brief, page 6 (emphases in original).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness.” In re Rijckaert, 9 F.3d
1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993). When determining
obviousness, “the prior art as a whole must be considered. The teachings are to
be viewed as they would have been viewed by one of ordinary skill.” In re Hedges,
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783 F.2d 1038, 1041, 228 USPQ 685, 687 (Fed. Cir. 1986). “It is impermissible
within the framework of section 103 to pick and choose from any one reference
only so much of it as will support a given position, to the exclusion of other parts
necessary to the full appreciation of what such reference fairly suggests to one of
ordinary skill in the art.” Id.
In this case, we agree with Appellant that Riley would not have suggested
the claimed composition. Riley teaches administration of dietary supplements in
the form of a system of “modular” supplements. The modular compositions
disclosed by Riley contain different combinations of vitamins, minerals, etc. For
example, “Module 1, the basic formula, . . . consists of vitamins and minerals
essential for the prevention of vitamin and mineral deficiency diseases and for
the promotion of general good health.” Column 4, lines 51-55. Module 1
contains, among other things, vitamins A, C, D3, and E. See Table 2 in columns
25-26. Module 1 does not contain quercetin. See id.
Module 3, on the other hand, is for “assisting in the reduction of risk
factors of chronic disease such as coronary heart disease and cancer. It
contains not only the basic daily nutrient needs, but specific doses of vitamin[s],
minerals and other compounds, such as antioxidants and folic acid, which have
been found to reduce some of the nutritional determinants of these diseases.”
Column 5, lines 3-9. Module 3 contains quercetin and vitamins A, C, and E. See
Table 2. Module 3 does not contain vitamin D3. See id.
Riley teaches that providing different supplements in different
compositions provides advantages over conventional vitamin supplements. The
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Application No. 09/847,121

modular formulations “provide the right amount of the right micronutrients at the
right time to avoid and overcome the problems commonly seen with vitamin
supplementation today.” Column 5, lines 22-25.
Thus, Riley describes the disclosed modular formulations as providing
advantages over compositions comprising all of the disclosed micronutrients in a
single composition. Modifying the reference’s teaching as suggested by the
examiner—by combining the components of the different modules into a single
composition—would destroy the very advantages touted by Riley. Thus, we do
not agree with the examiner that Riley would have rendered obvious the
composition of the instant claims.
The examiner argues that Riley discloses that “Modules 1-3 . . . may be
administered together or independent of one another.” Column 6, lines 40-42.
Thus, “[i]f one were to consider each module as a dosage form such as a tablet,
following the teaching of Riley one would take the three tablets (Modules 1-3)
concomitantly.” Examiner’s Answer, page 4. The examiner argues that
Appellant’s argument—that three tablets do not suggest a single composition—
amounts to an argument that “the difference between the instant claims and
Riley’s teaching is that Riley teaches a modular formulation comprising Vitamins
A, C, D, E and quercetin in more than one tablet while appellant teaches Vitamins
A, C, D, E and quercetin in a single tablet.” Examiner’s Answer, page 5.
We agree with the examiner that this difference is what distinguishes the
claimed composition from those disclosed in the prior art. We also agree with the
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Application No. 09/847,121

examiner’s statement that “[t]he reference should be taken as a whole and all of
its teachings must be considered.” Examiner’s Answer, page 6.
Where we disagree with the examiner is in the conclusion to be drawn
from applying the correct legal standard to the facts of this case. The examiner
seems to believe that combining the components of two separate dietary
supplement compositions into a single composition is such a trivial difference that
the claimed composition would be prima facie obvious even in the absence of a
suggestion to modify the prior art compositions. We disagree.
“[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). “Even when
obviousness is based on a single prior art reference, there must be a showing of
a suggestion or motivation to modify the teachings of that reference.” Id. at 1370,
55 USPQ2d at 1316. No such suggestion is apparent here.
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Application No. 09/847,121

Summary
The examiner has not adequately explained why Riley would have
suggested, to a person skilled in the art, a single composition combining the
components of the prior art’s Modules 1 and 3. In the absence of such a
suggestion, the reference does not support a prima facie case of obviousness.
The rejection under 35 U.S.C. § 103 is reversed.

REVERSED

Demetra J. Mills )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

EG/dym

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Application No. 09/847,121

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