Ex Parte Kador et al

Board of Patent Appeals and Interferences

Jan 24, 2012

11892307 (B.P.A.I. Jan. 24, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/892,307 08/21/2007 Peter F. Kador 28430.00 7475
37833 7590 01/24/2012
LITMAN LAW OFFICES, LTD.
PATENT LAW BUILDING
8955 CENTER STREET
MANASSAS, VA 20110
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
01/24/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PETER F. KADOR, MILTON WYMAN,
and DANIEL M. BETTS
__________

Appeal 2010-010395
Application 11/892,307
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) from the
rejection of claims directed to a method of inhibiting formation of diabetic
cataracts in dogs. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
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STATEMENT OF THE CASE
According to the Specification, “[d]iabetic dogs . . . are prone to
develop bilateral cataracts, and research [h]as shown that this is related to
AR [aldose reductase] levels in the lens.” (Spec. 7, [0014].) The
Specification explains that oral administration of aldose reductase inhibitors
[ARIs] to dogs has been “effective in the prevention of cataracts resulting
from diabetes,” but that oral administration of ARIs has “several
shortcomings.” (Id. at 8, [0015].) “Thus, a topical treatment of cataracts in
dogs solving the aforementioned problems is desired.” (Id. at 9, [0017].)
Claims 4-14 are on appeal. Claim 4, which incorporates material
from claims 1 and 3 by reference, reads as follows (incorporated material in
brackets):
4. A method for achieving an effect in a dog, comprising the step of
administering an effective amount of [a topical composition for treatment of
optical complications of diabetes in dogs, comprising:
a topical carrier having by weight about 2.5% carbomer, 1.5%
glycerin, 0.02% EDTA and 0.01 % benzalkonium chloride, the balance
being water; and
an aldose reductase inhibitor mixed with the topical carrier to form an
ophthalmic gel[, wherein said aldose reductase inhibitor has the
formula:

or a pharmaceutically acceptable salt thereof, the aldose reductase
inhibitor being between 5% and 6% by weight of the ophthalmic gel]] to the
dog, wherein the effect is inhibiting the formation of diabetic cataracts.

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The claims stand rejected as follows:
 claims 4, 6, 7, and 9-14 under 35 U.S.C. § 103(a) as unpatentable over
Mylari,1 Jani,2 and Sato;3 and
 claims 4-14 under 35 U.S.C. § 103(a) as unpatentable over Mylari,
Jani, Sato, and Hu.4
OBVIOUSNESS
The Issue
The Examiner’s position is that Mylari described using aldose
reductase inhibitors [ARIs] in ophthalmic compositions to treat diabetic
cataracts, but not the ARI named in claim 4’s method (2-methyl sorbinil).
However, the Examiner concluded that because Sato described
administering 2-methyl sorbinil as an ARI to arrest sugar cataract formation
in dogs, it would have been obvious to use it to treat dogs with Mylari’s
topical administration method. According to the Examiner, while Sato
disclosed that cataract formation was not prevented
at the doses used, Sato suggests this is merely a function of
insufficient dosing with 2-methyl sorbinil rather than a biochemical
shortcoming, as the inhibition of sugar cataract formation appears
dose dependent. (Pg. 1931). This suggests to the person having
ordinary skill in the art that it is possible to prevent the formation of
cataracts in dogs by simply adjusting the amount of the aldose
reductase inhibitor 2-methyl sorbinil used. Furthermore, while
acknowledging differences in the appearance of cataracts in rats and

1 Banavera L. Mylari et al., US 5,866,578, issued Feb. 2, 1999.
2 Rajni Jani et al., US 4,911,920, issued March 27, 1990.
3 Sanai Sato et al., Progression of Sugar Cataract in the Dog, 32 INVEST.
OPHTHALMOL. VIS. SCI. 1925-1931 (1991).
4 Tian-Sheng Hu et al., Reversal of Galactose Cataract with Sorbinil in Rats,
24 INVEST. OPTHALMOL. VIS. SCI. 640-644 (1983).
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dogs, Sato also indicates that the formation of cataract in different
species are initiated by the same biochemical mechanism. (Id.)

(Ans. 5.) Mylari’s topical composition was not a gel, and did not comprise
the excipients listed in claim 4, but because Jani described a topical
ophthalmic gel said to increase the comfort and sustained release of an
active ingredient, the Examiner concluded it would have been obvious to
formulate a topical ophthalmic gel composition using Jani’s excipients and
Sato’s inhibitor as the ARI in Mylari’s topical treatment method. (Id.)
Appellants contend that a person of ordinary skill would consider
Mylari’s teachings “inoperative as applied to the prevention or treatment of
diabetic cataracts.” (App. Br. 10-12.) Appellants state that “[a]lthough
[Jani’s] carrier contains the ingredients of the carrier of the present
invention, the carrier also contains an ion exchange resin and the active
ingredient must be or form a positive ion so that the active ingredient is
transferred to the eye by ion exchange.” (Id. at 13.) According to
Appellants, “ion exchange will not work with 2-methyl sorbinil, which is a
neutral compound . . . .” (Id.) Appellants also contend that “the prediction
in the 1991 Sato et al. article for the prevention of cataracts in dogs by the
oral administration of 2-methyl sorbinil by adequate dosing would prove,
upon subsequent experimentation, to be unrealizable due to the short half-
life of 2-methyl sorbinil in dogs and liver toxicity, that topical treatment with
conventional ophthalmic solutions would prove infeasable [sic] due to
excessive tear formation in dogs, etc.” (Id. at 15.)
Findings of Fact
1. The Examiner’s findings concerning the scope and content of the prior
art may be found in the Answer at 3-7.
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2. Jani described a “sustained release, comfort formulation for glaucoma
therapy.” (Jani, title.)
3. Jani’s
formulations . . . are characterized as long lasting (sustained release)
and are initially and continually comfortable to the eye. Specifically,
the invention relates to formulations of the above characteristics
which comprise, inter alia, a basic active and a cationic exchange
resin (finely divided) dispersed in an aqueous solution or gel of an
acidic, mucomimetic polymer.

(Id. at col. 1, ll. 12-19.)
4. The rejection found that “[t]he compositions described by Jani are
taught to increase both the comfort of and sustained release of active
agent from the ophthalmic solution.” (Ans. 4, citing Jani col. 1, ll. 20-
23).
5. The rejection found that “[o]ne having ordinary skill in the art would
have been motivated to use the gel of Jani to increase both the comfort
of the composition [suggested by Mylari and Sato] as well as the
residence time in the eye and sustain the release of the active agent.”
(Id. at 5.)
6. Jani stated that its “aqueous gel or pourable liquid formulations are
characterized by controlled cationic-anionic interactions, which
appear to be responsible for the resulting comfort and sustained
release properties.” (Jani, col. 1, ll. 20-23.)
7. Appellants refer to “Affidavit Or Declaration Under 37 CFR § 132”
by Peter F. Kador, dated June 19, 2009, to support their argument that
“ion exchange will not work with 2-methyl sorbinil, which is a neutral
compound.” (App. Br. 13.)
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8. Declarant Kador states:
[Jani’s] cation exchange resin and the carbomer hold the active agent
for time release, which is accomplished by ion exchange of the active
ingredient with cations in the tears (sodium and potassium ions). The
cation exchange resin, however, would serve no purpose in the present
invention, since 2-methyl sorbinil is a neutral molecule . . . .
(Kador Decl. 4, ¶ 4.)
Principles of Law
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006). “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” KSR, 550 U.S. at 416. “Only a reasonable expectation
that the beneficial result will be achieved is necessary to show obviousness.”
In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citations
omitted).
Analysis
The rejection rests on a finding that a person of ordinary skill in the
art would have been motivated to use Jani’s gel in Mylari’s method, with
Sato’s 2-methyl sorbinil as the ARI, with an expectation that the suggested
gel would retain the comfort feature Jani described. (FF 5.) The evidence of
record does not support that finding. Jani specifically attributed the comfort
feature to cationic-anionic interactions. (FF 6.) Appellants’ contention that
2-methyl sorbinil is a neutral compound (FF 7) is undisputed. Thus,
Declarant Kador explains that Jani’s cation exchange resin would serve no
purpose in the present invention, unlike in Jani’s composition where the
basic active participates in cationic-anionic interactions. (FF 8.) As Jani
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attributed the comfort feature to cationic-anionic interactions, and 2-methyl
sorbinil does not participate in similar cationic-anionic interactions, evidence
that Jani’s comfort feature would occur in a gel made with 2-methyl sorbinil
is lacking. Put another way, evidence that a cationic-anionic interaction
dependent comfort feature would have been reasonably predicted for a 2-
methyl sorbinil gel is lacking.
SUMMARY
We reverse the rejection of claims 4, 6, 7, and 9-14 under 35 U.S.C.
§ 103(a) as unpatentable over Mylari, Jani, and Sato.
We reverse the rejection of claims 4-14 under 35 U.S.C. § 103(a) as
unpatentable over Mylari, Jani, Sato, and Hu.

REVERSED

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