Ex Parte Collins et al

Board of Patent Appeals and Interferences

Jan 5, 2012

12399681 (B.P.A.I. Jan. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GARY L. COLLINS, MARCIE HARGISS,
MARK LADA, and ROBERT T. MCKEE
__________

Appeal 2011-009078
Application 12/399,681
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
ophthalmic composition. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Appeal 2011-009078
Application 12/399,681

2
Statement of the Case
The Claims
Claims 1-9 and 11-36 are on appeal. Claim 1 is representative and
reads as follows:
1. An ophthalmic composition comprising a pH
between about 6 and about 8, about 50 to about 1000
ppm hydrogen peroxide, about 10 to 100 ppm of at least
one saturated, polymeric quaternium salt and a phosphate
buffer.

The issues

A. The Examiner rejected claims 1-9, 15, and 20-33 under 35 U.S.C. §
103(a) as obvious over Karagoezian
1
and Huth
2
(Ans. 4-6).
B. The Examiner rejected claims 1-9, 11-15, 19-33, and 35 under 35
U.S.C. § 103(a) as obvious over Karagoezian, Huth, and Rupp
3
(Ans. 6-8).
C. The Examiner rejected claims 1-9, 11, 15-34, and 36 under 35 U.S.C.
§ 103(a) as obvious over Karagoezian, Huth, Tsao,
4
and Xia
5
(Ans. 8-10).
A. 35 U.S.C. § 103(a) over Karagoezian and Huth
The Examiner finds that Karagoezian teaches “ophthalmic anti-
microbial solutions (Abs.), comprising from about 0.005 to about 0.20 wt%
chlorite compound, from about 0.005 to about 0.05 wt% peroxy compound,
and a pH from 5.0 to 8.8 (Id.), wherein the chlorite is a metal chlorite such
as sodium, the peroxy is hydrogen peroxide, and the pH is preferably 7.0-

1
Karagoezian, H., US 2007/0104798 A1, published May 10, 2007.
2
Huth et al., US 5,356,555, issued Oct. 18, 1994.
3
Rupp et al., US 5,382,599, issued Jan. 17, 1995.
4
Tsao, F., US 2005/0244509 A1, published Nov. 3, 2005.
5
Xia et al., US 6,309,596 B1, issued Oct. 30, 2001.
Appeal 2011-009078
Application 12/399,681

3
7.4” (Ans. 4). The Examiner finds that “Karagoezian further teaches 0.10 to
0.25 wt% sodium phosphate monobasic and 0.10 to 0.40 wt% sodium
phosphate dibasic” (id.). The Examiner finds that “Karagoezian does not
specifically teach a particular composition which includes a saturated
polymeric quaternium salt, despite its teaching that, in general, it is
advisable to include such a compound in its composition” (id. at 5).
The Examiner finds that “Huth teaches that suitable disinfecting
agents are those generally employed in ophthalmic solutions including
quaternary ammonium salts” (id.). The Examiner finds it obvious “to
combine two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition to be used
for the very same purpose” (id.).
Appellants contend that “[e]ven if there was a motivation to add an
additional antimicrobial agent to the formulations of Karagoezian, Examiner
has provided no basis for his assertion that one of skill in the art would select
a saturated polyquaternium salt from the many antimicrobial agents
disclosed in Huth” (App. Br. 4). Appellants contend that the “Examiner has
also provided no reason why one of skill in the art would expect a phosphate
buffer system to improve antifungal efficacy. As shown by the AquaSoft
ophthalmic solution data included in the present application at Table 5,
phosphate buffers do not inherently possess antifungal activity” (id. at 5).
Appellants contend that “the present application contains surprising
results which show that solutions which comprise both hydrogen peroxide
and a saturated polyquaternium salt display improved antifungal efficacy
only when a phosphate buffer is used” (id.). Appellants contend that the
Appeal 2011-009078
Application 12/399,681

4
“present application clearly provides data which shows that the combination
of a phosphate buffer with peroxide and saturated polyquaternium shows
surprising improvement in efficacy against c. albicans when compared with
solutions containing borate buffer” (App. Br. 8).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner’s finding that
Karagoezian and Huth render claim 1 obvious?
(ii) If so, have Appellants presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, are
sufficient to support a conclusion of non-obviousness?
Findings of Fact
1. Karagoezian teaches “preparations which contain chlorite (e.g.,
a metal chlorite such as sodium chlorite) in combination with a small
amount of hydrogen peroxide in neutral aqueous (pH 5.0-8.8, preferably pH
7.0-7.8, and more preferably pH 7.0-7.4) solution” (Karagoezian 5 ¶ 0060).
2. Karagoezian teaches that “an aqueous solution containing 400
ppm chlorite plus 100 ppm hydrogen peroxide remains stable beyond 18
months at room temperature, and is effective to reduce Candida albicans
activity by 1.0 log within six hours of challenge” (Karagoezian 5 ¶ 0060).
3. Karagoezian teaches that the “chlorite/H2O2 solutions of the
present invention are sufficiently stable to be formulated in combination
with polymeric lubricants . . . and/or in combination with block polymer
based surfactants” (Karagoezian 5 ¶ 0061).
Appeal 2011-009078
Application 12/399,681

5
4. Karagoezian teaches, in claim 19, an “antimicrobial ophthalmic
composition of claim 15 wherein the ophthalmic composition additionally
comprises:
”
(Karagoezian 18, claim 19).
5. Karagoezian teaches “adding to the formulation a
pharmaceutically acceptable and effective amount (e.g., typically 1-20
percent by weight) of a sustained release component such as a polymer
matrix or one or more of the following . . . polyvinylpyrolidone”
(Karagoezian 6 ¶¶ 0070-0082).
6. Huth teaches a “method for simultaneously cleaning and
disinfecting contact lenses . . . comprising combining the lenses with a
multipurpose non-irritating aqueous solution containing a disinfecting agent
and a proteolytic enzyme for a time sufficient to clean and disinfect the
lenses” (Huth, col. 2, ll. 42-47).
7. Huth teaches that “disinfecting agents are defined as non-
oxidative organic chemicals which derive their activity through a chemical
or physiochemical interaction with the organisms. Suitable disinfecting
agents are those generally employed in ophthalmic applications and include,
but are not limited to, quaternary ammonium salts used in ophthalmic
applications” (Huth, col. 6, ll. 19-26).
8. Huth teaches that the “compounds which act to detoxify the
active ingredient of the above Formula A, yet allow the active ingredient to
Appeal 2011-009078
Application 12/399,681

6
retain its bactericidal properties, are one or more of the following
detoxifying compounds: water soluble polyhydroxyethyl methacrylate,
carboxymethy1cellulose, non-toxic, non-ionic surfactants,
polyvinylpyrrolidone” (Huth, col. 7, ll. 10-16).
9. The Specification teaches that:
The solutions of the present invention containing
phosphate buffer, Examples 8-13, display markedly
improved efficacy against candida albicans (1.4-2.2 log
reduction) compared to the borate buffered solution of
Example 14 (0.7 log reduction). There was no reason to
expect that changing the buffer would increase the efficacy
of the disinfection capability of the solution by two to three
times.

(Spec. 15.)
10. Table 4 of the Specification is reproduced below:

Appeal 2011-009078
Application 12/399,681

7

Table 4 shows the amounts of the components used in Examples 8-14 (see
Spec. 13-14).
11. Table 5 of the Specification is reproduced below:

Table 5 shows additional components used in Examples 8-14 and the results
on five different microorganisms (see Spec. 14-15).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability.” Id. at 417. As noted by the Court in KSR,
Appeal 2011-009078
Application 12/399,681

8
“[a] person of ordinary skill is also a person of ordinary creativity, not an
automaton.” 550 U.S. at 421.
Analysis
Obviousness
Karagoezian teaches an ophthalmic composition which comprises a
pH between 7 and 7.8 (FF 1), 100 ppm hydrogen peroxide (FF 2), and a
phosphate buffer (FF 4). Karagoezian suggests that additional components
may be included in the composition (FF 5).
Huth teaches that “[s]uitable disinfecting agents are those generally
employed in ophthalmic applications and include, but are not limited to,
quaternary ammonium salts used in ophthalmic applications” (Huth, col. 6,
ll. 19-26; FF 7).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that an ordinary artisan would have reasonably found it obvious to
follow the direct guidance of Huth to incorporate disinfecting agents such as
quaternary ammonium salts used in ophthalmic applications into the
ophthalmic composition of Karagoezian since both Karagoezian and Huth
were interested in reducing pathogen activity (FF 2, 7, 8). Such a
combination is merely a “predictable use of prior art elements according to
their established functions.” KSR, 550 U.S. at 417.
Appellants contend that “[e]ven if there was a motivation to add an
additional antimicrobial agent to the formulations of Karagoezian, Examiner
has provided no basis for his assertion that one of skill in the art would select
a saturated polyquaternium salt from the many antimicrobial agents
Appeal 2011-009078
Application 12/399,681

9
disclosed in Huth” (App. Br. 4).
We are not persuaded. It is well settled that it is a matter of
obviousness for one of ordinary skill in the art to select a particular
component from among many disclosed by the prior art as long as it is
taught that the selection will result in the disclosed effect, even when the
possible selections number 1200 or in the thousands. Merck & Co., Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771
F.2d 1496, 1500 (Fed. Cir. 1985). In the instant situation, Huth provides
specific reasons to select the quaternary ammonium salts as a desirable
addition to ophthalmic compositions such as those of Karagoezian when
Huth notes that “[s]uitable disinfecting agents are those generally employed
in ophthalmic applications and include, but are not limited to, quaternary
ammonium salts used in ophthalmic applications” (Huth, col. 6, ll. 19-26; FF
7).
Appellants contend that the “Examiner has also provided no reason
why one of skill in the art would expect a phosphate buffer system to
improve antifungal efficacy. As shown by the AquaSoft ophthalmic solution
data included in the present application at Table 5, phosphate buffers do not
inherently possess antifungal activity” (App. Br. 5).
We are not persuaded. The reason to select and use phosphate buffer
is that Karagoezian teaches and claims the use of phosphate buffer in the
ophthalmic composition (FF 4). While it might be true that Appellants’
purpose for forming the claimed composition is different than the reason
suggested by Karagoezian and Huth, that fact does not undermine the
Examiner’s prima facie case. See KSR, 550 U.S. at 419 (“In determining
Appeal 2011-009078
Application 12/399,681

10
whether the subject matter of a patent claim is obvious, neither the particular
motivation nor the avowed purpose of the patentee controls. What matters is
the objective reach of the claim. If the claim extends to what is obvious, it is
invalid under § 103.”).
Unexpected Results
Appellants contend that “the present application contains surprising
results which show that solutions which comprise both hydrogen peroxide
and a saturated polyquaternium salt display improved antifungal efficacy
only when a phosphate buffer is used” (App. Br. 5). Appellants contend
that the “present application clearly provides data which shows that the
combination of a phosphate buffer with peroxide and saturated
polyquaternium shows surprising improvement in efficacy against c.
albicans when compared with solutions containing borate buffer” (id. at 8).
In this case, the asserted unexpected results are based on Appellants’
comparison between Example 14 in Table 5 which uses a borate buffer and
Examples 8-13 which each use a phosphate buffer. However, the closest
prior art would be the composition defined by claim 19 of Karagoezian,
which includes the peroxy compound, phosphate buffer, and surfactant
required by claim 1 on appeal but does not specify a saturated polymeric
quaternium salt as the surfactant. Appellants’ Specification provides no
comparison to Karagoezian’s claim 19 composition, and we note that
Karagoezian teaches that “an aqueous solution containing 400 ppm chlorite
plus 100 ppm hydrogen peroxide remains stable beyond 18 months at room
temperature, and is effective to reduce Candida albicans activity by 1.0 log
within six hours of challenge” (Karagoezian 5 ¶ 0060; FF 2). See In re
Appeal 2011-009078
Application 12/399,681

11
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.”).
Conclusion of Law
(i) The evidence of record supports the Examiner’s finding that
Karagoezian and Huth render claim 1 obvious.
(ii) Appellants have not presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, are
sufficient to support a conclusion of non-obviousness.
B. 35 U.S.C. § 103(a) over Karagoezian, Huth, and Rupp
The Examiner finds that the “combination of Rupp with the
disclosures of Huth and Karagoezian constitute analogous art because they
are concerned with the same field of endeavor, namely disinfecting and
cleaning ophthalmic solutions comprising buffering agents, surfactants and
disinfecting agents” (Ans. 7). The Examiner finds it obvious “to combine
two compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition to be used for the very
same purpose” (id.).
The Examiner provides sound fact-based reasoning for combining
Rupp with Huth and Karagoezian. We adopt the fact finding and analysis of
the Examiner as our own. Appellants argue the underlying obviousness
rejection over Huth and Karagoezian, but Appellants do not identify any
material defect in the Examiner's reasoning for combining Rupp with Huth
and Karagoezian. Since Appellants only argue the underlying rejection of
Appeal 2011-009078
Application 12/399,681

12
Huth and Karagoezian which we affirmed above, we affirm this rejection for
the reasons stated by the Examiner.
C. 35 U.S.C. § 103(a) over Karagoezian, Huth, Tsao, and Xia
The Examiner finds that the “combination of the disclosures of Tsao
and Xia with the disclosures of Huth and Karagoezian constitute analogous
art because they are concerned with the same field of endeavor, namely
disinfecting and cleaning ophthalmic solutions comprising buffering agents,
surfactants and disinfecting agents” (Ans. 10). The Examiner finds it
obvious “to combine two compositions each of which is taught by the prior
art to be useful for the same purpose, in order to form a third composition to
be used for the very same purpose” (id.).
The Examiner provides sound fact-based reasoning for combining
Tsao and Xia with Huth and Karagoezian. We adopt the fact finding and
analysis of the Examiner as our own. Appellants argue the underlying
obviousness rejection over Huth and Karagoezian, but Appellants do not
identify any material defect in the Examiner's reasoning for combining Tsao
and Xia with Huth and Karagoezian. Since Appellants only argue the
underlying rejection of Huth and Karagoezian which we affirmed above, we
affirm this rejection for the reasons stated by the Examiner.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
103(a) as obvious over Karagoezian and Huth. Pursuant to 37 C.F.R. §
41.37(c)(1), we also affirm the rejection of claim 2-9, 15, and 20-33 as these
claims were not argued separately.
Appeal 2011-009078
Application 12/399,681

13
We affirm the rejection of claims 1-9, 11-15, 19-33, and 35 under 35
U.S.C. § 103(a) as obvious over Karagoezian, Huth, and Rupp.
We affirm the rejection of claims 1-9, 11, 15-34, and 36 under 35
U.S.C. § 103(a) as obvious over Karagoezian, Huth, Tsao, and Xia.

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

cdc