Ex Parte Tsao

Board of Patent Appeals and Interferences

Dec 13, 2010

10346013 (B.P.A.I. Dec. 13, 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.
10/346,013 01/16/2003 Fu-Pao Tsao OP/4-32320A 2897
1095 7590 12/13/2010
NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080
EXAMINER
FAY, ZOHREH A
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
12/13/2010 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 FU-PAO TSAO
__________

Appeal 2010-010109
Application 10/346,013
Technology Center 1600
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of inhibiting Cladosporium growth in an aqueous opthalmic solution
and to an ophthalmic solution. The Patent Examiner rejected the claims as

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 2010-010109
Application 10/346,013

2
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. We also
enter a new ground of rejection, exercising our authority under 37 C.F.R.
§ 41.50(b).
STATEMENT OF THE CASE
Claims 1-20 are on appeal. Claims 1 and 13 are representative and
read as follows:
1. A method of inhibiting Cladosporium growth in an aqueous
ophthalmic solution comprising a cellulose derivative and a hydrogen
peroxide source, comprising:
providing an aqueous solution comprising a cellulose derivative and a
hydrogen peroxide source, wherein said solution will support Cladosporium
growth if contaminated with Cladosporium; and
admixing an effective amount of an alkaline earth metal salt with said
solution to yield an alkaline earth metal-containing solution which, if
contaminated with Cladosporium, will allow less Cladosporium growth than
an otherwise identical solution that does not comprise an alkaline earth metal
salt.

13. An ophthalmic solution comprising:
(a) a hydrogen peroxide source
(b) a cellulose derivative
(c) water; and
(d) an effective amount of an alkaline earth metal salt such that if said
solution is contaminated with Cladosporium, less Cladosporium growth will
occur in said solution than an otherwise identical solution that does not
comprise an alkaline earth metal salt.

The Examiner rejected all of the claims under 35 U.S.C. § 103(a) as
unpatentable over Martin,2 Richard,3 and a Japanese Patent Abstract.4

2 US Patent No. 5,607,698 issued to Stephen M. Martin et al., Mar. 4, 1997.
3 US Patent No. 5,858,937 issued to Wanda G. Richard et al., Jan. 12, 1999.
4 JP60146807 A issued to Nippon Caloxide KK et al., Feb. 8, 1985.
Appeal 2010-010109
Application 10/346,013

3
Claims 2-20 have not been argued separately and therefore stand or fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is that Martin taught the use of a hydrogen
peroxide source, a hydrogen stabilizer, and a cellulose derivative in an
ophthalmic solution. (Ans. 3.) The Examiner found that Martin differed
from the claimed invention in the presence of an alkaline earth metal salt, for
example, calcium chloride dehydrate. (Id.)
The Examiner found that Richard taught an ophthalmic solution
comprising an antimicrobial agent, phosphonic acid and an alkaline earth
metal, i.e., calcium chloride. (Id.) Additionally, the Examiner found that
the Japanese patent abstract taught the use of hydrogen peroxide as a
fungicide in combination with hydroxyl propylcellulose and stabilizers,
including phosphates. (Id. at 4.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have
incorporated an alkaline earth metal salt into the composition of Martin,
motivated by Richard’s teaching that the addition of an alkaline earth metal
salt, such as calcium chloride dehydrate, to an ophthalmic solution with
antimicrobial activity was old and well known. (Id.) The Examiner also
reasoned that the prior art established that a hydrogen peroxide source, a
stabilizer such as phosphonic acid, a cellulose derivative, and an alkaline
earth metal salt previously had been used in an ophthalmic formulation.
Appeal 2010-010109
Application 10/346,013

4
(Id.) Further, the Examiner found that Appellant had not presented evidence
establishing that the claimed invention provided unexpected results. (Id.)
Appellant contends that “there would have been no motivation to
combine Richard, Martin and the Japanese Abstract as asserted by the
Examiner….” (App. Br. 9-10.) According to Appellant, “there is no
teaching in the prior art which would motivate one of skill in the art to
arbitrarily select a ‘tonicity enhancer’ from Richard and employ it with the
solution of Martin in quantities sufficient to impart enhanced Cladosporium
inhibiting properties to said solution.” (Id. at 11.)
Further, Appellant asserts that Richard taught away from using
hydrogen peroxide in combination with its ingredients by teaching a
“complete non-oxidative cleaning regime.” (Id. at 10.) Appellant also
asserts that the Japanese Abstract represented non-analogous art because its
teachings are directed to a fungicide for bathroom cleansers. (Id. at 11.)
Additionally, Appellant asserts that each of the references failed to teach or
suggest (a) a method of inhibiting Cladosporium growth, and (b) an
ophthalmic solution which exhibits antifungal activity against
Cladosporium. (Id. at 9-11.)
The issue with respect to the rejection is whether the record supports
the Examiner’s conclusion that the cited references would have made the
claimed method and opthalmic solution prima facie obvious.

Appeal 2010-010109
Application 10/346,013

5
Findings of Fact
1. We agree with the Examiner’s explicit findings regarding the scope
and content of the prior art references. (See Ans. 3-4.)
2. Martin disclosed that hydrogen peroxide was a well-known germicidal
agent for use in contact lens solutions to kill any contaminating
microorganisms. (Martin, col. 1, ll. 19-23.)
3. Martin disclosed adding one or more tonicity agents to its stabilized
hydrogen peroxide opthalmic solution. (Id. at col. 7, ll. 38-55.)
4. Martin taught that “[t]he function of such tonicity enhan[c]ing agents
is to assure approximate physiological tonicity to the solution which is
instilled in the eye or to help assure such tonicity upon dilution if dilution is
necessary prior to contact with the eye due to peroxide content . . . .” (Id.)
5. Richard disclosed adding tonicity agent(s) to its ophthalmic solution,
such as the alkaline earth metal salts calcium and magnesium chloride, in
amounts ranging from about 0.01 to 2.5% w/v, and preferably from about
0.2 to about 1.5% w/v. (Richard, col. 7, ll. 1-18.)
6. Richard taught that the tonicity agents were used “to approximate the
osmotic pressure of normal lacrimal fluids,” and that “a hypertonic solution .
. . will cause stinging and eye irritation.” (Id. at col. 7, ll. 1-12.)
7. The Specification discloses using soluble alkaline earth metal salts in
amounts between about 0.01 and 0.2% or 0.05 and 0.1% by weight of the
preserved solution. (Spec. 3, ll. 23-27.)

Principles of Law
“[A]ny need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining
Appeal 2010-010109
Application 10/346,013

6
the elements in the manner claimed.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 420 (2007). As long as some suggestion to combine the
elements is provided by the prior art as a whole, the law does not require that
they be combined for the reason or advantage contemplated by the inventor.
See e.g., In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig,
539 F.2d 1300, 1304 (CCPA 1976).
“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.
“Mere recognition of latent properties in the prior art does not render
nonobvious an otherwise known invention.” In re Baxter Travenol Labs.,
952 F.2d 388, 392 (Fed. Cir. 1991).
Analysis
We agree with the Examiner that the claimed methods and opthalmic
solutions would have been obvious over the combined art to a skilled artisan
at the time of the invention. Specifically, adding an alkaline earth metal to
the Martin’s stabilized hydrogen peroxide ophthalmic solution would have
been obvious because Martin expressly disclosed adding one or more
tonicity agents to its solution. (FF3.) As Appellant has aptly noted (App.
Br. 11) Richard disclosed using alkaline earth metal salts, i.e., calcium or
magnesium chloride, as effective tonicity agents in its contact lens solution.
(FF5.) We find that a skilled artisan would have been motivated to select
one of Richard’s tonicity agents as the tonicity agent in Martin’s solution.
Doing so would have amounted to no more than the combination of familiar
elements according to known methods. KSR, 550 U.S. at 416. Again, the
reason for combining the elements of the prior art need not be the same
Appeal 2010-010109
Application 10/346,013

7
contemplated by the inventor. Beattie, 974 F.2d at 1312; Kronig, 539 F.2d
at 1304.
The selection of one of Richard’s tonicity agents, and its substitution
for one of the agents Martin listed, would have resulted in a solution having
the function of the claimed invention, i.e., allowing less Cladosporium
growth. Richard taught the addition of its tonicity agent(s) in amounts
ranging from about 0.01 to 2.5% w/v (FF5) which overlaps the range of
alkaline earth metal salts disclosed in the Specification, i.e., amounts
between about 0.01 and 0.2% or 0.05 and 0.1% (FF5). See In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003)( “[E]ven a slight overlap in range
establishes a prima facie case of obviousness.”). Here, the claimed range for
the amount of alkaline earth metal salt is encompassed by Richard’s amount.
See id. at 1330 (where the “claimed ranges are completely encompassed by
the prior art, the conclusion [that the claims are prima facie obvious] is even
more compelling than in cases of mere overlap.”). We find that a skilled
artisan would have expected the ophthalmic solutions of the combined prior
art to have the same properties as those claimed. (Compare FF 4 and FF6.)
Absent evidence of unexpected results, [t]he recitation that the
claimed solution and method “will allow less Cladosporium growth …”
does not change this result as it merely recognizes a latent property of an
obvious prior art combination. See Baxter-Travenol Labs., 952 F.2d at 392.
Put another way, addressing Martin’s tonicity problem with Richard’s
tonicity agents would have resulted in an ophthalmic solution having the
property Appellant recites. See KSR, 550 U.S. at 419-420 (“[o]ne of the
ways in which a patent’s subject matter can be proved obvious is by noting
Appeal 2010-010109
Application 10/346,013

8
that there existed at the time of invention a known problem for which there
was an obvious solution encompassed by the patent’s claims.”).
Appellant asserts that Richard taught away from using hydrogen
peroxide in its solution (App. Br. 10), but we are not persuaded as the
argument is misdirected. The Examiner’s combination did not require
adding hydrogen peroxide to Richard’s composition. Rather, the
combination involved using Richard’s disclosed alkaline metal salt tonicity
agent as Martin’s tonicity agent.
Nor are we persuaded of nonobviousness by Appellant’s assertion that
the Japanese Abstract represents non-analogous art. (App. Br. 11.) The
Examiner referenced the Abstract for its teaching that hydrogen peroxide
was a known fungicide. (Ans. 4.) This teaching merely complements
Martin’s teaching that hydrogen peroxide was a known germicidal agent.
(FF2.) The Abstract was not relied upon to establish the safe or effective use
of hydrogen peroxide in eye care, as this teaching was expressly understood
from Martin’s disclosure. Therefore, we find that a skilled artisan would
have considered the Examiner’s reference to the Abstract to be reasonably
pertinent to the subject matter of the claimed invention. See In re Kahn,
441 F.3d 977, 986-87 (Fed. Cir. 2006).
Although we affirm the obviousness rejection of claims 1-20 over the
combination Martin, Richards, and the Japanese Patent Abstract, our
reasoning differs from the Examiner’s reasoning. (See Ans. 4.)
Accordingly, we designate the affirmance a new ground of rejection
under 37 C.F.R. § 41.50 (b).

Appeal 2010-010109
Application 10/346,013

9
CONCLUSION OF LAW
The record supports the Examiner’s conclusion that the cited
references would have made the claimed method and opthalmic solutions
prima facie obvious.
SUMMARY
We affirm the rejection of claims 1-20 under 35 U.S.C. § 103(a) as
unpatentable over Martin, Richards, and the Japanese Patent Abstract.

37 C.F.R. § 41.50(b)
Regarding the affirmed rejections, 37 C.F.R. § 41.52(a)(1) provides
“[a]ppellant may file a single request for rehearing within two months from
the date of the original decision of the Board.”
In addition to affirming the examiner's rejection(s) of one or more
claims, this opinion contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
CFR § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the examiner, in which
event the proceeding will be remanded to the examiner.…
Appeal 2010-010109
Application 10/346,013

10

(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record.…

Should the appellant elect to prosecute further before the examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If the appellant elects prosecution before the examiner and this does
not result in allowance of the application, abandonment or a second appeal,
this case should be returned to the Board of Patent Appeals and Interferences
for final action on the affirmed rejection, including any timely request for
rehearing thereof.

AFFIRMED

cdc

NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080