Ex Parte Salamone et al

Board of Patent Appeals and Interferences

Jun 13, 2011

11391060 (B.P.A.I. Jun. 13, 2011)

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.
11/391,060 03/28/2006 Joseph Salamone P03508 3203
23702 7590 06/13/2011
Bausch & Lomb Incorporated
One Bausch & Lomb Place
Rochester, NY 14604-2701
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
06/13/2011 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 JOSEPH SALAMONE, ERNING XIA,
and X. MICHAEL LIU
____________

Appeal 2010-007292
Application 11/391,060
Technology Center 1600
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and STEPHEN
WALSH, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 1-6, 8-10, 13, 14,
47-52, 54-56, 59, and 601. We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a dry eye composition. Claims 1, 2, and 14
are representative and are reproduced below:
1. A dry eye composition comprising an aqueous solution that
comprises carboxymethylcellulose and a polyol, wherein a concentration of

1 Pending claims 11 and 57 stand withdrawn from consideration as drawn to
a non-elected species (App. Br. 2; see also Ans. 2).
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said carboxymethylcellulose is 1 percent, and a concentration of the polyol
is 3 percent, by weight of the composition.

2. The dry eye composition of claim 1, wherein the polyol contains 2
to 6 carbon atoms.

14. The composition of claim 1, wherein the solution further
comprises a buffer selected from the group consisting of phosphate buffer,
borate buffer, MOPS buffer, citrate buffer, an aminoalcohol buffer and
combinations thereof.

Claims 1-6, 8-10, 13, 47-52, 54-56, and 59 stand rejected under 35
U.S.C § 103(a) as unpatentable over Shively.2
Claims 14 and 60 stand rejected under 35 U.S.C § 103(a) as
unpatentable over the combination of Shively and Bergamini.3

The rejection over Shively alone:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS
FF 1. The polyol of Appellants’ invention “is typically a polyol containing
2 to 6 carbon atoms” and includes, inter alia, “glycerin, ethylene glycol,
poly(ethylene glycol), propylene glycol, sorbitol, manitol and
monosaccarides, disaccharides, oligosaccharides and neutral polysaccharide”
(Spec. 4: ¶ [0019]).

2 Shively, US 4,409,205, issued October 11, 1983.
3 Bergamini et al., US 5,679,665, issued October 21, 1997.
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FF 2. Shively discloses an ophthalmic aqueous solution for treating dry
eye conditions that comprises a non-ionic synthetic polymer such as
polyethylene glycol and a non-ionic tonicity adjusting agent (Shively,
Abstract and col. 10, ll. 10-21; Ans. 3).
FF 3. Shively discloses that the non-ionic tonicity adjusting agent “may be
selected from the group consisting of mannitol, sorbitol, dextrose, sucrose,
urea and glycerol” and mixtures thereof (Shively, col. 2, ll. 19-21 and col.
10, ll. 21-23; Ans. 4).
FF 4. Shively discloses that “when polyethylene glycol is utilized it will
comprise from about 0.25% to about 3.5% of the solution” (Shively, col. 3,
ll. 46-48; see also id. at col. 10, ll. 28-31; Ans. 4).
FF 5. Shively discloses that “[r]egardless of which tonicity adjusting agent
is selected, it will be present in the solution in a concentration of from about
0.5% to about 5%” (Shively, col. 3, l. 67 - col. 4, l. 2; Ans. 4).
FF 6. Shively discloses that viscosity increasing agents, such as
carboxymethylcellulose, can be added to the composition when it is intended
for use in connection with contact lenses (Shively, col. 4, ll. 4-12 and col.
10, ll. 32-40; see Ans. 4).
FF 7. Shively discloses that the viscosity increasing agent is present in
solution “at a level of from about 0.05% to about 10% by weight” (Shively,
col. 10, ll. 44-47; Ans. 4).
FF 8. The Examiner finds that “Shively does not expressly teach an
example with CMC [(carboxymethylcellulose)] and polyol at the ratio of 1
percent and 3 percent respectively” (Ans. 4).

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ANALYSIS
Appellants provide separate arguments for claims 2-4, 10, 48-50, and
56 (App. Br. 9). Therefore, we have considered Appellants’ contentions as
they relate to the following two groups of claims: I. Claims 1, 5, 6, 8, 9, 13,
47, 51, 52, 54, 55, and 59 and II. Claims 2-4, 10, 48-50, and 56. Claims 1
and 2 are representative.

Claim 1:
Based on the foregoing factual findings (FF 2-8) the Examiner
concludes that
It would have been obvious to one of ordinary skill in the
art at the time the claimed invention was made to utilize the
components taught such as CMC and a polyol such as
polyethylene glycol, mannitol, sorbitol, or glycerin, and
optimize the amount of non-ionic polymer, tonicity agent, and
viscosity agent within the ranges taught by Shively, and
produce the instant invention.

(Ans. 5.) We find no error in the Examiner’s prima facie case of
obviousness. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“‘[I]t is
not inventive to discover the optimum or workable ranges by routine
experimentation.’”) (quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955)).
Appellants contend that Shively teaches away from a composition that
comprises a non-ionic synthetic polymer, such as polyethylene glycol, a
non-ionic tonicity adjusting agent, and the viscosity enhancing agent (App.
Br. 4-9; Reply Br. 2-3). We are not persuaded (see FF 2-8). Based on
Shively’s disclosure a person of ordinary skill in the art at the time of
Appellants’ invention would have produced an ophthalmic composition for
treating dry eye that comprises a non-ionic synthetic polymer, such as
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polyethylene glycol, a non-ionic tonicity adjusting agent, such as mannitol,
and a viscosity enhancing agent, such as carboxymethylcellulose (see FF 2-
8; see also Ans. 8; Cf. Reply Br. 2).

Claim 2:
Appellants contend that “Shively does not teach or suggest that his
non-ionic polymer is a polyol and has 2-6 carbon atoms such as glycerin,
ethylene glycol, propylene glycol, sorbitol, mannitol and monosaccharides”
(App. Br. 9). We are not persuaded (see FF 3). We are also not persuaded
by Appellants contention that Shively fails to “teach or suggest that an ionic
polymer like carboxymethylcellulose can be substituted for his essential
non-ionic polymer” (App. Br. 9). Since Appellants’ claims are open to
include all the components of Shively’s composition, there is no reason to
make such a substitution. Instead, based on Shively’s disclosure a person of
ordinary skill in the art at the time of Appellants’ invention would have
produced a composition that comprises a non-ionic synthetic polymer, such
as polyethylene glycol, a non-ionic tonicity adjusting agent, and the
viscosity enhancing agent (see FF 2-8).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claims 1 and 2 under 35 U.S.C § 103(a) as
unpatentable over Shively is affirmed. Because they are not separately
argued claims 5, 6, 8, 9, 13, 47, 51, 52, 54, 55, and 59 fall together with
claim 1; and claims 3, 4, 10, 48-50, and 56 fall together with claim 2.

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The rejection over the combination of Shively and Bergamini:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS
FF 9. The Examiner relies on Shively as discussed above (FF 2-8).
FF 10. In addition, the Examiner finds that Shively’s composition can
include buffers “that are commonly employed in ophthalmic solutions” and
that Shively’s compositions have a pH “from about 5 to about 8, particularly
from about 6 to about 8” (Ans. 6).
FF 11. The Examiner finds that “Shively does not expressly teach the
incorporation of particular buffers” (id.).
FF 12. The Examiner relies on Bergamini to teach “that citrates, borates,
and phosphates are used as pH buffers in ophthalmic and otic compositions”
in a range of “between 0.01% and 2.0%” (id.).
ANALYSIS
Based on the combined teachings of Shively and Bergamini (FF 9-12)
the Examiner concludes that it would have been prima facie obvious to a
person of ordinary skill in the art at the time the invention was made to
utilize Bergamini’s conventional ophthalmic and otic buffers in Shively’s
composition (see Ans. 6). We find no error in the Examiner’s prima facie
case of obviousness.
Having found no error or deficiency in the Examiner’s reliance on
Shively, we are not persuaded by Appellants’ contention that Bergamini fails
to make up for the deficiencies in Shively (App. Br. 10).

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CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 14 under 35 U.S.C § 103(a) as
unpatentable over the combination of Shively and Bergamini is affirmed.
Because it is not separately argued, claim 60 falls together with claim 14.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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