Ex Parte Marquart et al

Board of Patent Appeals and Interferences

Sep 29, 2010

11099854 (B.P.A.I. Sep. 29, 2010)

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.
11/099,854 04/06/2005 Mary E. Marquart Marquart 04M20 2073
25547 7590 09/30/2010
PATENT DEPARTMENT
TAYLOR, PORTER, BROOKS & PHILLIPS, L.L.P
P.O. BOX 2471
BATON ROUGE, LA 70821-2471
EXAMINER
FAY, ZOHREH A
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
09/30/2010 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 MARY E. MARQUART and RICHARD J. O’CALLAGHAN
__________

Appeal 2010-008296
Application 11/099,854
Technology Center 1600
__________

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

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims directed to a method of inhibiting damage to a cornea. The claims
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2010-008296
Application 11/099,854
2
STATEMENT OF THE CASE
According to the Specification,
[T]opical application of cholesterol is effective in preventing,
treating, or ameliorating damage to the cornea caused by an
infection of Streptococcus pneumoniae. Topical administration
of cholesterol caused a significant decrease in the inflammation
of the eye. In addition, cholesterol was surprisingly found to be
a bactericide to Streptococcus pneumoniae outside the cornea.
The effect of cholesterol can be enhanced by further
administering a steroid or an antibiotic to the cornea.
(Spec. ¶ 15.)
Claims 1 and 8 are representative of the subject matter on appeal:
1. A method for inhibiting damage to a mammalian cornea infected
with Streptococcus pneumoniae, comprising topically administering a
therapeutically effective amount of soluble cholesterol in solution to a
mammalian cornea that is infected with Streptococcus pneumoniae.

8. A method for inhibiting Streptococcus pneumoniae infiltration
across the cornea of a mammalian eye, said method comprising periodically
administering topically a therapeutically effective amount of soluble
cholesterol in solution to a mammalian cornea that is known to have greater
than average susceptibility to infiltration of Streptococcus pneumoniae.

Claims 1-13 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Guo2 and Hofland.3
We reverse.

2 U.S. Patent 4,804,539, issued February 14, 1989, to Luke S.S. Guo et al.
3 U.S. Application Publication US 2004/0224010 A1 of Hans Hofland et
al., published November 11, 2004.
Appeal 2010-008296
Application 11/099,854
3

ISSUE ON APPEAL
The Examiner finds that Guo’s disclosure of “a liposomal formulation
containing cholesterol” for incorporation and delivery of pharmaceutically
active agents to the ocular surface meets all the limitations of the claimed
invention, except for “the presence of antibiotics” (Ans. 4-5). The Examiner
finds that Hofland discloses “a liposomal drug delivery composition having
cholesterol derivatives for the delivery of ophthalmic active ingredients to
the eye, in order to treat the claimed disorders” and also teaches “the use of
steroids . . . and antibiotics” (id. at 4). The Examiner concludes that “it
would have been obvious to incorporate antibiotics to the composition of
Guo” because Hofland “teaches the addition of antibiotics to the liposomal
formulation having lipids and cholesterol derivatives as old and well known”
(id. at 5).
Appellants contend that independent “Claims 1 and 8 require ‘topical
administration of a therapeutically effective amount of soluble cholesterol in
solution.’” (App. Br. 9), and “‘[s]oluble cholesterol in solution’ is not the
same as cholesterol bound as a component of a lipid membrane as in a
liposome” (id. at 7). Appellants contend that both Guo and Hofland “teach
the use of liposomes to adhere to the surface of the cornea and to act as
vehicles to deliver drugs to the surface of the cornea” and both references
“point out the disadvantages of drugs in solution when applied topically to
the eye” (id. at 13). Appellants contend that “[n]either reference suggests,
teaches, or implies that cholesterol itself would have any therapeutic value,
nor that cholesterol should instead be applied in solution” (id.).

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Application 11/099,854
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Given these conflicting positions, the issue raised by this appeal is
whether the evidence of record supports the Examiner’s finding that the
ophthalmic compositions disclosed by Guo and Hofland contain “soluble
cholesterol in solution” as required by all the claims on appeal. If not, the
issue is whether the Examiner has otherwise established that it would have
been obvious to topically apply soluble cholesterol in solution to a cornea.

FINDINGS OF FACT
1. Guo teaches that “many ophthalmic drugs are applied in
solution form to the ocular surface” but “[a] major problem with this
approach is limited drug uptake, since the drug solution is rather quickly
washed away by tearing action” (Guo, col. 1, ll. 56-60).
2. Guo discloses a “drug/liposome composition which has
significantly enhanced retention on ocular tissue” (Guo, col. 2, ll. 51-53),
wherein
[T]he outer surfaces of the liposomes contain positive surface
charges which are (a) anchored to the lipid outer lipid bilayer
structure by vesicle-forming lipids which are relatively tightly
associated with the membrane, and (b) spaced by at least about
a 3 atom spacer from the polar head regions of such vesicle
forming-lipids. . . . In addition to the spacing of positive
charges from the liposome surfaces, relatively tight packing in
the bilayer membrane has been found to contribute to the
enhancement of liposome retention on ocular tissue. This
packing effect can be achieved either by the presence of
cholesterol or a cholesterol derivative, at a concentration of
between about 20-50 mole percent . . . The positive charges can
be derivatized to either phospholipids or cholesterol
components forming the vescicles.
(Id. at col. 2, l. 62 to col. 3, l. 13.)
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Application 11/099,854
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3. The Examiner does not point to anything in Guo which
discusses cholesterol in any context other than its role in contributing a
“packing effect” to the liposomes.
4. Hofland is similar to Guo in disclosing “lipid formulations, e.g.,
liposomal formulations, for delivering ophthalmic drugs to the eye”
(Hofland ¶ 5). According to Hofland, “[u]nlike topically applied solutions,
the lipid formulations, e.g., liposomal formulations, can target and adhere to
the corneal surface” (id.). Thus, “by incorporating ophthalmic drugs into the
lipid formulations . . . a higher maximum concentration (Cmax) and longer
drug residence time (T1/2) in ocular tissues can be achieved” (id.).
5. Hofland lists a cholesterol derivative among many lipids
suitable for incorporation into the lipid phase of the liposomal formulation
(Hofland ¶ 10), but the Examiner has not pointed to anything in the
reference that discusses cholesterol or cholesterol derivatives in any other
context.
DISCUSSION
Appellants contend that Guo and Hofland are directed to liposomal
drug delivery formulations containing cholesterol or cholesterol derivatives
as part of a lipid membrane encapsulating a therapeutic agent, but all of the
claims on appeal require topical application of “soluble cholesterol in
solution.”
In response, the Examiner asserts that “the claims of the instant
application use ‘comprising’, which permits the cholesterol to be in a
liposome. Furthermore, the instant specification does not provide any
limiting definition of ‘soluble’ [and] [t]he prior art cholesterol is at least
Appeal 2010-008296
Application 11/099,854
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soluble in a liposome phase, which accordingly reads on ‘a soluble
cholesterol’” (Ans. 6).
When determining whether a claim is obvious, an Examiner must
make “a searching comparison of the claimed invention - including all its
limitations - with the teachings of the prior art.” In re Ochiai, 71 F.3d 1565,
1572 (Fed. Cir. 1995). We agree with Appellants that “‘[s]oluble cholesterol
in solution’ is not the same as cholesterol bound as a component of a lipid
membrane as in a liposome” (App. Br. 7). The Examiner’s assertion that the
use of the term “comprising” in the claim permits the cholesterol to be in a
liposome is without merit. The claim might be open to the inclusion of
liposomes in addition to “a therapeutically effective amount of soluble
cholesterol in solution,” but that doesn’t eliminate the claims’ explicit
requirement for “soluble cholesterol in solution” (emphasis added).
Appellants further contend that both Guo and Hofland “teach the use
of liposomes to adhere to the surface of the cornea and to act as vehicles to
deliver drugs to the surface of the cornea” and both references “point out the
disadvantages of drugs in solution when applied topically to the eye” (id. at
13). Appellants contend that “[n]either reference suggests, teaches, or
implies that cholesterol itself would have any therapeutic value, nor that
cholesterol should instead be applied in solution” (id.).
We agree with Appellants’ assessment, and the Examiner has not
provided a rationale that establishes that an ordinary artisan would have
considered the lipid-based compositions of Guo and Hofland to be solutions
of soluble cholesterol, or that those references suggest administering such
solutions to a patient’s eye.

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Application 11/099,854
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CONCLUSION
The evidence of record does not support the Examiner’s finding that
the ophthalmic compositions disclosed by Guo and Hofland contain “soluble
cholesterol in solution” as required by all the claims on appeal.
As the Examiner has not otherwise established that it would have been
obvious to apply “soluble cholesterol in solution” to a cornea, we will
reverse the rejection of claims 1-13 as unpatentable over Guo and Hofland.

REVERSED

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PATENT DEPARTMENT
TAYLOR, PORTER, BROOKS & PHILLIPS, L.L.P
P.O. BOX 2471
BATON ROUGE, LA 70821-2471