Ex Parte Dhanaraj et al

Board of Patent Appeals and Interferences

Apr 13, 2011

12059915 (B.P.A.I. Apr. 13, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SRIDEVI DHANARAJ and CARRIE H. FANG
__________

Appeal 2011-000009
Application 12/059,915
1

Technology Center 1600
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
treating mammalian articular cartilage disorders. The Examiner rejected the
claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1
This application is a divisional of Application Serial No. 11/235,850,
which was appealed to this Board as Appeal No. 2010-008203 (see App. Br.
2).
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Application 12/059,915

2
STATEMENT OF THE CASE
Claims 16-27 stand finally rejected and appealed (App. Br. 2).
2
Claim
16, the only independent claim, is representative and reads as follows:
16. A method of treating mammalian articular cartilage
disorders, said method comprising:

parenterally administering a therapeutically effective
amount of a parenteral composition, said composition
comprising:

between about 0.001% to about 1% by weight of an
extract of Centella comprising asiatic acid, madecassic
acid, and asiaticoside and a parenterally acceptable
carrier,

wherein the composition is administered to an affected site
having mammalian articular cartilage disorder.

The following rejections are before us for review:
(1) Claims 16-20, under 35 U.S.C. § 103(a) as obvious over Fuji
3
and
Pinnell
4
(Ans. 3-5); and
(2) Claims 16-27, under 35 U.S.C. § 103(a) as obvious over Fuji,
Pinnell, Pike,
5
and Kato
6
(Ans. 6-8).

OBVIOUSNESS
The Examiner cited Fuji as teaching that agents that promote collagen
synthesis are useful for treating cartilage metabolic error diseases, such as

2
Appeal Brief filed March 11, 2010.
3
JP 06-312931 (published November 1994) (as translated).
4
U.S. Patent App. Pub. No. 2005/0089500 A1 (published April 28, 2005).
5
U.S. Patent App. Pub. No. 2003/0134792 A1 (published July 17, 2003).
6
U.S. Patent No. 4,675,183 (issued June 23, 1987).
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3
osteoarthritis (Ans. 3-4). The Examiner conceded, however, that Fuji differs
from claim 16 in that Fuji does not teach using the claimed Centella extract
as the collagen synthesis-stimulating ingredient (id. at 4).
To meet that feature, the Examiner cited Pinnell as disclosing that the
claimed Centella extract was known in the art to stimulate collagen synthesis
(id.). Based on the references‟ teachings, the Examiner concluded that an
ordinary artisan would have considered it obvious to administer Pinnell‟s
Centella extract to treat osteoarthritis in view of Fuji‟s teaching “that
increasing collagen synthesis is a useful treatment for osteoarthritis” (id. at
5).
Appellants contend, among other things, that the Examiner‟s
conclusion of obviousness is based on an impermissible “hindsight
reconstruction of the presently claimed method. There is no reason
whatsoever to believe that one of skill in the art would have looked to a
reference (Pinnell) disclosing a topical composition for motivation to modify
a reference (Fuji et al.) which suggests a parenterally acceptable
composition” (App. Br. 6).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

As the Federal Circuit has also stated, “it is not enough to simply
show that the references disclose the claim limitations; in addition, „it can be
important to identify a reason that would have prompted a person of
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ordinary skill in the art to combine the elements as the new invention does.‟”
Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA,
Inc., 617 F.3d 1296, 1303 (Fed. Cir. 2010) (quoting KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 401 (2007) (emphasis added).
Ultimately therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
While this is arguably a close case, we agree with Appellants that a
preponderance of the evidence does not support the Examiner‟s prima facie
case of obviousness.
Claim 16 recites a method of treating mammalian articular cartilage
disorders. According to claim 16, the practitioner must parenterally
administer, that is, inject into a patient, a therapeutically effective amount of
a composition that contains a parenterally acceptable carrier and between
about 0.001% to about 1% by weight of a Centella extract that in turn
contains asiatic acid, madecassic acid, and asiaticoside. Claim 16 also
requires the composition to be administered to an affected site having a
mammalian articular cartilage disorder.
As the Examiner points out, Fuji describes osteoarthritis as a
“cartilage metabolic error disease . . . resulting from the denaturation of the
articular cartilage by aging and wear” (Fuji [0003]). To that end, Fuji
discloses that certain vitamin D derivatives “promote differentiation of
chondrocyte, and promote the collagen synthesis and proteoglycan synthesis
in chondrocyte” (id. at [0008]).
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Thus, because Fuji‟s vitamin D derivative-containing composition
stimulates chondrocyte differentiation, “especially the collagen synthesis in
chondrocyte, and/or proteoglycan synthesis of an ingredient in a substrate
are promoted, . . . it has the operation which makes the amount of cartilage
matrices increase, for example, is very useful as a remedy of cartilage
metabolic error diseases, such as osteoarthritis and rheumatoid arthritis” (id.
at [0020]).
Fuji also discloses that its cartilage metabolic error-treating
compositions can be provided in the form of “oral agents . . . and injections
using a suitable excipient” (id. at [0016]).
Pinnell, in contrast, discloses skin care compositions, in particular “a
skin-firming cream and an eye-firming cream, comprising at least one
component that supports the collagen structure (firming), and at least one
component that supports the body‟s own defense/repair mechanisms
(protective), and most preferably, at least one component that supports the
skin lipid system (barrier)” (Pinnell [0002]). As the Examiner points out,
Pinnell discloses that the collagen-supporting component of its skin care
composition can be a Centella extract that contains the components required
in claim 16 (id. at [0008]).
Pinnell explains the known properties of its Centella extract:
It is used for wound-healing, for example, by increasing the
cellular proliferation and collagen synthesis at the wound site,
venous insufficiency, anti-wrinkle toning, cellulite and stretch
marks, and has also been found to be effective in the
cicatrisation of burns, as well as providing healing and soothing
properties to the skin. Extracts of Centella asiatica containing
various levels of the active ingredients have also been shown to
have effectiveness in wound healing and related treatments, as
well as to have anti-microbial properties.
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(Id.)
We are not persuaded, however, that the Examiner has adequately
explained why an ordinary artisan, advised that a Centella extract provides
therapeutic benefits to skin when topically applied, would have been
prompted to inject that ingredient into the site of a patient‟s articular
cartilage disorder.
We acknowledge Fuji‟s disclosure that certain vitamin D derivatives
that promote chondrocyte differentiation also act to stimulate collagen
production, and in turn are useful in treating osteoarthritis and rheumatoid
arthritis. Nonetheless, the Examiner points to no evidence suggesting that an
ordinary artisan would have considered a substance‟s capacity to stimulate
collagen synthesis in skin cells, and thereby ameliorate conditions such as
wrinkles, cellulite, and stretch marks, relevant to, or suggestive of, whether
that substance would also be useful in cartilage repair in a manner analogous
to the compounds used by Fuji.
Thus, in view of the widely differing objectives in the two treatments,
and the absence of direct evidence suggesting that an ordinary artisan would
have considered the therapeutic benefits to skin of Pinnell‟s composition
applicable to the cartilage treatments of Fuji, we are not persuaded that an
ordinary artisan would have been prompted to inject Pinnell‟s Centella
extract into the site of an articular cartilage disorder in the manner required
by claim 16. Accordingly, we reverse the Examiner‟s obviousness rejection
of that claim, and its dependents, over Fuji and Pinnell.
The Examiner also rejected claims 16-27 as obvious over Fuji,
Pinnell, Pike, and Kato (Ans. 6-8). The Examiner cited Pike as evidence
that an ordinary artisan would have considered it obvious to use the carriers
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recited in certain dependent claims in methods in which therapeutic agents
were injected into patients‟ joints, and cited Kato as evidence of the
obviousness of using arginine and lysine as solubilizing agents (id.).
However, as neither Pike nor Kato remedies the shortcomings of Fuji
and Pinnell, discussed above with respect to claim 16, we reverse this
rejection as well.
SUMMARY
We reverse the Examiner‟s rejection of claims 16-20, under 35 U.S.C.
§ 103(a) as obvious over Fuji and Pinnell.
We also reverse the Examiner‟s rejection of claims 16-27, under 35
U.S.C. § 103(a) as obvious over Fuji, Pinnell, Pike, and Kato.

REVERSED

alw