Ex Parte Theoharides

Board of Patent Appeals and Interferences

Jul 23, 2003

09056707 (B.P.A.I. Jul. 23, 2003)

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for publication and is not binding precedent of the Board.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. 34

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte THEOHARI C. THEOHARIDES
__________

Appeal No. 2003-14181
Application No. 09/056,707
__________

ON BRIEF
__________

Before WINTERS, WILLIAM F. SMITH, and GRIMES, 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, 3, 4, and 6. Claims 7-21 are also pending but have
been withdrawn from consideration. See Paper No. 11, mailed July 12, 2000.
The claims on appeal read as follows:
1. A method of treating an atopic allergic disease in a mammal
characterized by numbers of mast cells or levels of biochemicals
secreted by said mast cells sufficiently high to cause said atopic
allergic disease, comprising the step of the administration to said
mammal of a pharmaceutically effective amount of a proteoglycan

1 Appellant filed a Petition to Make Special (see Paper No. 30, filed Dec. 19, 2002), which was
granted (Paper No. 31, mailed Feb. 4, 2003). Accordingly, we have taken up the appeal in this
case out of its usual turn. See MPEP § 708.02.
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Application No. 09/056,707

with mast cell secretion inhibitory activity, said proteoglycan
comprising a chondroitin sulfate, alone or together with one or more
synergistic adjuvants.

3. The method of claim 1, wherein said adjuvant is a flavonoid.

4. The method of claim 3, wherein said flavonoid is selected from the
group consisting of myrisetin, quercetin, kaempferol, genistin, a 2-
phenylchromone and 2-phenylbenzopyrone.

6. The method of claim 1, wherein said atopic allergic disease is
selected from the group consisting of allergic asthma, allergic
rhinitis, allergic conjunctivitis, allergic otitis media, allergic
dermatitis, food allergy and allergic urticaria.

The examiner relies on the following references:
Wagner et al. (Wagner) 5,260,335 Nov. 9, 1993
Ahmed 5,980,865 Nov. 9, 1999

Claims 1, 3, 4, and 6 stand rejected under 35 U.S.C. § 103 as obvious in
view of Ahmed and Wagner.
We reverse.
Background
“Mast cells are a normal component of connective and mucosal tissues and
play an important role in allergy and inflammation.” Specification, page 1. “Each
mast cell contains up to 500 secretory granules, each storing more than 20 potent
biological compounds. Mast cells secrete the contents of these granules (i.e.,
degranulate) when triggered by various specific and non-specific mechanisms,
such as the allergic reaction involving immunoglobulin E (IgE) and antigen.” Id.
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The specification discloses “a method for preventing and treating the
harmful biological effects of secretion of biochemicals from mast cells in the
organs of warm blooded animals and more especially human beings. These
harmful effects include allergy (including but not limited to allergic conjunctivitis,
allergic rhinitis, allergic otitis, asthma, and atopic dermatitis).” Id., page 4. “[T]he
method consists of administering to said animals and especially to human beings
an amount of a proteoglycan with mast cell secretion inhibitory activity, such as
chondroitin sulfate.” Id., pages 4-5. The proteoglycan can also be administered
in combination with “one or more synergistic adjuvants (such as those belonging
to the class of flavonoids . . . ).” Id., page 5.
“Proteoglycans are high molecular weight polyanionic macromolecules
(heteropolysaccharide) consisting of many different glycosaminoglycan chains
linked covalently to a protein core that constitutes up to about 5% of the total
macromolecules. . . . Chondroitin sulfate, like other proteoglycans, is naturally
occurring, and is a natural constituent of connective tissues. It is available over
the counter as a food supplement.” Id., page 4.
Discussion
The claims are directed to a method of treating an atopic allergic disease,
such as allergic asthma or allergic rhinitis, by administering a pharmaceutically
acceptable amount of chondroitin sulfate, either alone or in combination with a
synergistic adjuvant.
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Application No. 09/056,707

The examiner rejected the claims as obvious over Ahmed and Wagner.
The examiner cited Ahmed as “teach[ing] proteoglycans such as chondroitin
sulfate to be useful in treating allergic conditions such as asthma [and] allergic
rhinitis.” See Paper No. 11, mailed July 12, 2000, page 3. The examiner cited
Wagner as teaching “the flavonoid quercetin to be useful in treating allergic
diseases and bronchial asthma.” Id. Thus, she concluded that it would have
been obvious to treat asthma with a combination of chondroitin sulfate and
quercetin, since treatment of asthma with each ingredient individually was taught
in the prior art. See id., pages 3-4.
We begin by construing the claims. “[N]ot unlike a determination of
infringement, a determination of anticipation, as well as obviousness, involves
two steps. First is construing the claim, . . . followed by, in the case of
anticipation or obviousness, a comparison of the construed claim to the prior art.”
Key Pharms. Inc. v. Hercon Labs. Corp., 161 F.3d 709, 714, 48 USPQ2d 1911,
1915 (Fed. Cir. 1998).
Claim 1 is directed to a method of treating an atopic allergic disease by
administering “a pharmaceutically effective amount of a proteoglycan with mast
cell secretion inhibitory activity, said proteoglycan comprising a chondroitin
sulfate.” The specification states that chondroitin sulfate is a proteoglycan, and
that proteoglycans, in turn, are “high molecular weight polyanionic
macromolecules (heteropolysaccharide) consisting of many different
glycosaminoglycan chains linked covalently to a protein core.” Page 4. Thus,
when the claims are read in light of the specification, they should be construed as
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Application No. 09/056,707

being directed to a method of treating atopic allergic disease by administering the
proteoglycan chondroitin sulfate, i.e., the intact, high molecular weight
macromolecule consisting of many different glycosaminoglycan chains linked
covalently to a protein core.
Ahmed teaches a method of treating late phase allergic reactions, such as
asthma or allergic rhinitis, by administering “ultra-low molecular weight heparins
(ULMWH) or other sulfated polysaccharides having average molecular weights of
about 1,000-3,000 daltons.” Abstract. With regard to chondroitin sulfate, Ahmed
states that
[w]hile the sulfated polysaccharides used in the method and
compositions of the invention are generally referred to herein as
ultra-low molecular weight heparins, i.e., ultra-low molecular weight
fractions derived from naturally occurring heparin . . ., the invention
may also encompass the use of sulfated polysaccharides derived
from . . . chondroitin sulfate. . . . The subject sulfated
polysaccharide fractions must, however, have an average molecular
weight of about 1,000-3,000 daltons.

Column 10, lines 38-48.
We agree with Appellant that this disclosure would not have suggested the
instantly claimed method. The following passage from Appellant’s brief sums up
the argument well:
The sole reference to proteoglycans other than heparin is found in
col. 10, lines 38-52, in a single sentence in which chondroitin sulfate
among other proteoglycans is mentioned. However, in this same
location is found the statement that the drugs described are derived
from heparin or other proteoglycans, that is to say, they are low
molecular weight sulfated polysaccharides (1,000-3,000 Da) that
have been chemically removed from heparin or other proteoglycans,
and isolated. Such sulfated polysaccharides, by definition, contain
no protein and thus are no longer proteoglycans; they are different
chemical entities. Thus, this reference neither suggests nor
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Application No. 09/056,707

provides motivation for using intact chondroitin sulfate to treat
subjects.

Appeal Brief, page 10 (emphasis in original). That is, although Ahmed suggests
treatment of asthma and allergic rhinitis with sulfated polysaccharides derived
from chondroitin sulfate and having a molecular weight of 1000 to 3000 daltons, it
does not suggest modifying the disclosed method of treatment by administering
intact chondroitin sulfate, as required by the instant claims. Wagner does not
remedy this deficiency and therefore the cited references do not support a prima
facie case of obviousness.
Summary
The references relied on by the examiner would not have suggested the
instantly claimed method to a person of ordinary skill in the art. The rejection
under 35 U.S.C. § 103 is reversed.

REVERSED

Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
William F. Smith )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Eric Grimes )
Administrative Patent Judge )
Appeal No. 2003-1418 Page 7
Application No. 09/056,707

Melvin Blecher
4329 Van Ness Street NW
Washington, DC 20016-5625

EG/jlb