Ex Parte Burke

Patent Trial and Appeal Board

Sep 12, 2013

12054577 (P.T.A.B. Sep. 12, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SUSAN E. BURKE1
__________

Appeal 2012-003066
Application 12/054,577
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and ERICA A.
FRANKLIN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
ophthalmic composition, which have been rejected for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellant identifies the Real Party in Interest as Bausch & Lomb, Inc.
(Appeal Br. 3).
Appeal 2012-003066
Application 12/054,577

2
STATEMENT OF THE CASE
Claims 1, 4-6, and 8-16 are on appeal. Claim 1 is illustrative and
reads as follows:
1. An aqueous ophthalmic composition comprising one or more
antimicrobial components selected from the group consisting of 0.2 ppm to 3
ppm poly(hexamethylene biguanide), from 0.5 ppm to 5 ppm α-[4-tris(2-
hydroxyethyl)ammonium chloride-2-butenyl]poly[1-dimethyl ammonium
chloride-2-butenyl]-ω-tris(2-hydroxyethyl) ammonium chloride and
alexidine, and a dipeptide, wherein the dipeptide comprises a glycine moiety
and another amino acid moiety other than glycine, and the dipeptide is
present in an amount to enhance the biocidal efficacy of the ophthalmic
composition.

Claim 8, the only other independent claim, is also directed to an
ophthalmic composition containing an antimicrobial component and “a
dipeptide comprising a glycine moiety and another amino acid moiety other
than glycine” (claim 8).
The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1, 4-6, 8, 13, and 14 based on Chowhan ‘8172 and Yagi3
(Answer 5);
• Claims 9 and 11 based on Chowhan ‘817, Yagi, and Nestor4
(Answer 7);
• Claims 10 and 15 based on Chowhan ‘817, Yagi, and Chowhan
20045 (Answer 7);

2 Chowhan et al., US 5,741,817, Apr. 21, 1998.
3 Yagi et al., US 6,429,220 B1, Aug. 6, 2002.
4 Nestor, Jr., et al., US 2002/0142346 A1, Oct. 3, 2002.
5 Chowhan et al., US 2004/0253280 A1, Dec. 16, 2004.
Appeal 2012-003066
Application 12/054,577

3
• Claim 12 based on Chowhan ‘817, Yagi, and Yanni6 (Answer 8);
and
• Claim 16 based on Chowhan ‘817, Yagi, and Chowhan ‘7977
(Answer 9).
All of the rejections on appeal are premised on the combination of
Chowhan ‘817 and Yagi. The Examiner finds that Chowhan ‘817 discloses
a composition comprising poly(hexamethylene biguanide) and glycine, but
does not disclose a glycine-containing dipeptide (Answer 5). The Examiner
finds that “Yagi teaches an antimicrobial composition comprising an
aminocarboxylic acid compound which may be glycine or glycylserine”
(id.), which “stabilize[s] the antimicrobial ingredient and reduce[s] irritation
caused by the antimicrobial ingredient” (id. at 6).
The Examiner concludes that it would have been obvious to “use the
glycylserine of the secondary reference in place of glycerine [sic, glycine] in
the composition of the primary reference because it shares the common
stabilizing activity and thus would be reasonably predicted to provide
corresponding effects” (id.). The Examiner also concludes that the
stabilizing activity disclosed by Yagi would have led a skilled worker to
expect increased antimicrobial activity compared to an unstabilized solution
(id.).
Appellant argues that Yagi teaches only that glycine and glycylserine
share an ability to stabilize a class of compounds known as isothiazolones in
industrial environments (Appeal Br. 9-10) and that “[a]lthough Chowhan

6 Yanni et al., US 2004/0132704 A1, July 8, 2004.
7 Chowhan et al., US 6,620,797 B2, Sept. 16, 2003.
Appeal 2012-003066
Application 12/054,577

4
does teach that glycine can be used to enhance the biocidal efficacy of
[solutions containing the antimicrobial agents recited in claim 1] there is no
knowledge on record that glycylserine would also possess this property” (id.
at 9).
Appellant argues that the agents recited in claim 1 do not share
structural similarity or chemical equivalence with isothiazolones (id. at 11)
and that “the examiner’s argument incorrectly assumes that glycine or
glycine-XXX will exhibit a chemical stabilization across each and every
class of compounds known to possess some form of antimicrobial activity.
Again, the examiner points to no technical evidence or secondary citation
that supports the assumptions made.” (Id. at 13.) Appellant argues that “as
to glycine and glycylserine there is no known functional equivalency with
respect to the ability of both glycine and glycylserine to enhance the biocidal
activity of” the agents recited in claim 1 (id. at 17).
We agree with Appellant that the Examiner has not identified a
persuasive reason to combine the ophthalmic composition of Chowhan ‘817
with Yagi’s glycylserine. Chowhan ‘817 discloses that “glycine and other
low molecular weight amino acids . . . enhance the activity of antimicrobial
preservatives” (Chowhan ‘817, col. 1, ll. 45-48) and “can be utilized in
various types of ophthalmic compositions” (id. at col. 1, ll. 52-53).
Chowhan ‘817 discloses compounds that are representative of the amino
acids that can be used in its invention (id. at col. 1, l. 63 to col. 2, l. 12). The
representative compounds are all amino acids, and do not include any
dipeptides.
Appeal 2012-003066
Application 12/054,577

5
Yagi discloses that isothiazolones are “widely used as slime control
agents, bactericides, algaecides and fungicides in various systems such as
cooling water systems, paper and pulp industry, coating materials industry,
adhesive materials industry, treatments of cutting oils and sewage
treatments” (Yagi, col. 1, ll. 21-25). Yagi also discloses that “isothiazolone
compounds are very unstable” (id. at col. 1, l. 26) and “often irritate skin”
(id. at col. 2, l. 1).
Yagi discloses that “specific aminocarboxylic acids and derivatives
thereof exhibit the effect of stabilizing isothiazolone compounds and
reducing irritation of skin caused by isothiazolone compounds” (id. at col. 2,
ll. 17-20). Yagi discloses that such aminocarboxylic acids and derivatives
thereof include glycine (id. at col. 4, l. 40) and glycylserine (id. at col. 4,
l. 57). Yagi does not disclose any properties of glycine or glycylserine with
respect to antimicrobial compounds other than isothiazolones.
We therefore agree with Appellant that the Examiner’s rejections are
based on an unsupported assumption; specifically, that because glycine and
glycylserine have a stabilizing effect on isothiazolones, they would also have
a similar effect on the antimicrobial agents recited in claim 1. As Appellant
pointed out, the Examiner has not provided evidence or sound technical
reasoning to support the conclusion that the effect of glycine and
glycylserine on isothiazolones would have led those skilled in the art to
expect a similar effect on other compounds, especially where the other
compounds have not been shown to be structurally related to isothiazolones.
While the Examiner is correct (Answer 6) that it would have been
obvious to use glycylserine in place of glycine in Yagi’s composition
Appeal 2012-003066
Application 12/054,577

6
because they share a common stabilizing activity with respect to
isothiazolones, the same is not true for substituting Yagi’s glycylserine for
the glycine in the ophthalmic composition of Chowhan ‘817, which contains
a structurally different antimicrobial agent.
SUMMARY
We reverse all of the rejections on appeal.

REVERSED

lp