Ex Parte Xia et al

Board of Patent Appeals and Interferences

Dec 3, 2010

11373571 (B.P.A.I. Dec. 3, 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.
11/373,571 03/10/2006 Erning Xia P03942 7047
23702 7590 12/03/2010
Bausch & Lomb Incorporated
One Bausch & Lomb Place
Rochester, NY 14604-2701
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
12/03/2010 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 ERNING XIA, PAUL T. LAVOIE,
ALYCE K. DOBIE, and TAMMY J. KLEIBER
__________

Appeal 2010-008192
Application 11/373,571
Technology Center 1600
__________

Before DEMETRA J. MILLS, 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
pharmaceutical formulations comprising a polyanionic material and a zinc-

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.

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based compound, a method for making the formulation, and a method for
providing safety and/or comfort to users of the formulation. The Patent
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm. We also exercise our authority under
37 C.F.R. § 41.50(b), and enter a new ground of rejection.
STATEMENT OF THE CASE
The Specification states that the invention “relates to ophthalmic
solutions that provide improved safety and/or comfort to the users.” (Spec.
[0001]).
Claims 1, 3-11, 13-19, 21, 23, 25-28, 31, 33, 35 and 36 are on appeal.
Claim 1 is representative and reads as follows:
1. A pharmaceutical formulation comprising at least a polyanionic
material and at least a zinc-based compound that is soluble in an aqueous
medium;
wherein said at least a polyanionic material is selected from the group
consisting of alginic acid, carboxymethyl cellulose, carboxymethyl starch,
carboxymethyl dextran, dextran sulfate, carboxymethyl chitosan, hyaluronic
acid, chondroitin sulfate, xanthan gum, physiologically acceptable salts
thereof, combinations thereof, and mixtures thereof;
wherein said at least a zinc-based compound is present in an amount
effective to reduce a concentration of viable bacteria, recovered per milliliter
of the solution, at the fourteenth day after challenge, by not less than 3 logs,
and after a rechallenge at the fourteenth day, said amount is also effective to
reduce the concentration of viable bacteria, recovered per milliliter of the
solution, at the twenty-eighth day, by not less than 3 logs; and said amount is
effective to keep a concentration of viable yeasts and molds, recovered per
milliliter of the solution, at or below the initial concentration at the
fourteenth day, within an experimental uncertainty of ± 0.5 log, and after a
rechallenge at the fourteenth day, said amount is also effective to keep the
concentration of viable yeasts and molds, recovered per milliliter of the
solution, at or below the initial concentration, within an experimental
uncertainty of ±0.5 log, at the twenty-eighth day; and
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wherein the pharmaceutical formulation is free of cationic organic
nitrogen-containing compounds.

(Indentations added, see 37 CFR §1.75(i)).

The Examiner rejected the claims as follows:
• claims 1, 3-11, 13-15, 19, 21, 23, 25-27, 31, 33, 35 and 36 under
35 U.S.C. § 103(a) as unpatentable over Braswell2 and Hahnenberger;3 and
• claims 1, 3-11, 13-19, 21, 23, 25-28, 31, 33, 35 and 36 under
35 U.S.C. §103(a) as unpatentable over Braswell, Hahnenberger, and
Di Napoli.4
OBVIOUSNESS
The Issue
The Examiner’s position is that Braswell disclosed an eye drop
formulation including an ocular lubricant, for example, carboxymethyl
cellulose. (Ans. 3-4.) The Examiner found that Braswell disclosed that any
known, suitable eye drop composition lubricant may be used in its
composition. (Id. at 4.)
The Examiner found that Hahnenberger described hyaluronic acid as a
commonly used eye drop lubricant in eye formulations including
formulations for the treatment of dry eye diseases. (Id.)
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

2 Patent Application Publication No. WO 98/32435 by A. Glenn Braswell et
al., published Jul. 30, 1998.
3 US Patent No. 5,908,866 issued to Rudolph Wolfgang Hahnenberger, Jun.
1, 1999.
4 US Patent No. 6,677,304 B2 issued to Guido Di Napoli, Jan. 13, 2004.
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substituted the hyaluronic acid of Hahnenberger for the carboxymethyl
cellulose of Braswell in the formulation of a topical ophthalmic drop
solution. (Id.) The Examiner reasoned that the artisan would have been
motivated to do so because of the art-recognized equivalence of hyaluronic
acid and carboxymethyl cellulose in topical eye drop formulations, and
because Braswell expressly taught that any known, suitable eye drop
composition lubricant could be used in place of the preferred carboxymethyl
cellulose lubricant. (Id.)
The Examiner interpreted the “wherein” clauses in claims 1, 11, 19
26, and 31 referring to the amounts of zinc-based compounds “as simply
reciting properties of the composition defined by the remainder of the
claim.” (Id.) The Examiner explained:, “[b]ecause the remainder of the
body of the claim fully and intrinsically sets forth all of the limitations of the
claimed invention, this language is not considered a limitation and is of no
significance to the construction of the instant claims.” (Id.)
The Examiner interpreted the language in claim 25 concerning the
formulation’s applicability to the care of contact lenses to recite an intended
use as a contact lens solution that has the capability to soak, clean, disinfect,
wet, or rewet a contact lens which “is afforded no significance in claim
construction.” (Id. at 4-5.)
Regarding the rejections over the combination of Braswell,
Hahnenberger and Di Napoli, the Examiner further found that Braswell and
Hahnenberger did not recite the inclusion of compounds such as
immunosuppressives in the disclosed eye formulations. (Id. at 5.) However,
the Examiner found that Di Napoli taught that ophthalmic solutions
comprising both hyaluronate and cyclosporine are known for the treatment
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of dry eye disease. (Id.) 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 cyclosporine into a topical ophthalmic solution
for the treatment of dry eye disease which comprised a polyanionic material
such as hyaluronate and a zinc-based compound such as zinc sulfate. (Id.)
The Examiner reasoned that the skilled artisan would have been motivated to
combine the prior art compositions for the treatment of dry eye disease
because it is generally “prima facie 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 “[n]owhere in the combination [of] Braswell
and Hahnenberger can the preservative efficacy that is recited in the instant
claims be found.” (App. Br. 9.) According to Appellants, the Examiner
erred in stating that the “wherein” clause relating to the amount of a zinc-
based compound is intrinsic “because a mere presence of a zinc-based
compound does not always (i.e., does not inherently or necessarily) provide
the recited anti-microorganism efficacy.” (Reply Br. 4.)
Further, Appellants contend that Braswell’s composition must contain
glutathione, which Appellants assert “is a cationic organic nitrogen-
containing compound, carrying a positive charge on the amino moiety (and
negative charges on the carboxyl moieties)….” (App. Br. 9.) Therefore,
Appellants assert that a combination including Braswell’s composition does
not meet the instant claim limitation “wherein the pharmaceutical
formulation is free of cationic organic nitrogen-containing compounds.”
(Id.; Claim 1.)
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Appellants challenge the rejection over the combination including
Di Napoli for these same reasons set forth above, while also asserting that
“[a]dding Di Napoli merely to show disclosure of cyclosporine still does not
cure this deficiency of the combination of Braswell and Hahnenberger.” (Id.
at 12.)
The issue with respect to these rejections is whether the record
supports the Examiner’s conclusion that the cited references suggest the
claimed pharmaceutical formulation and method of making the claimed
formulation comprising an effective amount of zinc-based compound and
free of cationic organic nitrogen-containing compounds.

Findings of Fact
1. Braswell disclosed an eye treatment composition comprising reduced
glutathione, vitamin A and vitamin E, and one or more of zinc sulfate, boric
acid and potassium as buffering agents, and optionally a lubricant and a
preservative. (Braswell, Abstract.)
2. Braswell disclosed using its composition in a method of treating eyes
for the alleviation of irritations and/or dryness, as well as for the prevention
and treatment of cataracts. (Id.)
3. Braswell’s vitamin A, vitamin E and reduced glutathione were said to
be antioxidants that cooperated with one another. (Id. at 4, l. 15 – 5, l. 9.)
4. Braswell disclosed that typically the total amount of buffering agents,
such as zinc sulfate, present in its composition ranges from 1 to 15% by
weight. (Id. at 5, ll. 27-29.)
5. Braswell disclosed that when zinc sulfate, boric acid and potassium
are all present in its composition, the amount of zinc sulfate is from, for
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example, 0.01 to 5% by weight, preferably from 0.05 to 2% by weight, and
more preferably from about 0.05 to about 1% by weight. (Id. at 5, ll. 30-34).
6. According to Braswell, “[a]n additional benefit of including zinc
sulfate as a buffering agent is the material[’]s role as a cofactor in
antioxidant systems.” (Id. at 6, ll. 6-8.)
7. Braswell disclosed that “any known, suitable eye drop composition
lubricants may be used” and that a preferable lubricant is sodium
carboxymethyl cellulose. (Id. at 6, ll. 14-24.)
8. Braswell disclosed that the lubricant is contained in the composition
“in an amount of from, for example, 0.01 to 5% by weight….” (Id. at 6, ll.
20-22).
9. Braswell disclosed an exemplary eye drop composition prepared in
accordance with its invention comprising glutathione, carboxymethyl
cellulose, and zinc sulfate in an amount of <0.1% by weight. (Id. at p. 8, ll.
11-19.)
10. The Specification describes an embodiment of the invention wherein
“the amount of the soluble zinc compound is in the range from about 0.0001
to about 5 percent by weight of the solution.” (Spec. [0026]; Claim 7)
11. The Specification discloses two exemplary formulations of the
invention comprising zinc chloride in an amount of 0.025% by weight and
designated as passing “the preservative efficacy … of a pharmaceutical
formulation of the present invention against microorganism.” (Id. at [0051],
[0062] and [0063].)
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12. The ordinary meaning5 of “cation” is: “the ion in an electrolyzed
solution that migrates to the cathode; broadly: a positively charged ion.”

Principles of Law
It is well settled that “claims in an application are to be given their
broadest reasonable interpretation consistent with the specification and that
claim language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.” In re Sneed, 710 F.2d 1544,
1548 (Fed. Cir. 1983).
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
Anticipation has been found when a prior art range “does not exactly
correspond to [the] claimed range,” but the prior art range “does not
significantly deviate from [the] claimed ranges.” See Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005).
When the claimed and prior art products appear to be identical or
substantially identical, the Examiner can require Appellants to prove that the
prior art product does not inherently possess the characteristics of the
claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977).

5 Merriam-Webster, www.merriam-webster.com/dictionary/cation, last
visited Nov. 30, 2010.
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Analysis
A. Claim Interpretation
Appellants and the Examiner differ in their interpretations of the claim
phrase “wherein the pharmaceutical formulation is free of cationic organic
nitrogen-containing compounds.” In Appellants’ view, the limitation has the
effect of excluding glutathione from the claimed formulation. (App. Br. 9.)
According to Appellants, glutathione is a required component of Braswell’s
formulation and Braswell did not suggest a formulation that excludes
glutathione. The Examiner disagrees that the claim phrase excludes
glutathione. (Ans. 6.) We agree with the Examiner.
Appellants assert that glutathione is a “cationic organic nitrogen-
containing compound” because it carries a positive charge on the amino
moiety. As shown in Appellants’ Brief, glutathione has a positive charge
and two negative charges. (App. Br. 9.) The Examiner asserts that
glutathione is not a “cationic organic nitrogen-containing compound”
because it carries a net negative charge (one positive plus two negatives
yields a total negative charge). (Ans. 8-9.) The Examiner’s position is
consistent with the ordinary meaning of cation. (FF-12.) Because
glutathione carries a net negative charge, it is not a positively charged ion,
and would not migrate to the cathode.
We recognize that a skilled artisan might also read the phrase “free of
cationic organic nitrogen-containing compounds” to exclude any compound
having a cationic nitrogen, such as glutathione. The issue here is whether
the Examiner’s interpretation is reasonable. Because the Examiner’s claim
interpretation is consistent with the ordinary meaning of “cation,” we think it
is. “Absent an express definition in their specification, the fact that
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appellants can point to definitions or usages that conform to their
interpretation does not make the PTO's definition unreasonable when the
PTO can point to other sources that support its interpretation.” In re Morris,
127 F.3d 1048, 1056 (Fed. Cir. 1997).
Summarizing: glutathione is not a cationic compound and the phrase
“free of cationic organic nitrogen-containing compounds” does not exclude
glutathione.
B. Braswell’s Disclosure
Braswell’s eye treatment formulation comprised glutathione (FF-1)
which according to our claim interpretation is not excluded by the instant
claims. Therefore, we are not persuaded by Appellants’ assertion that a
combination including Braswell’s composition does not meet the instant
claim limitation “wherein the pharmaceutical formulation is free of cationic
organic nitrogen-containing compounds.” (See App. Br. 9.)
We agree with Appellants that the Examiner erred in interpreting the
“wherein” clauses referring to the amounts of zinc-based compounds “as
simply reciting properties of the composition defined by the remainder of the
claim.” (See Ans. 4; Reply Br. 4.) The recitation “at least a zinc-based
compound is present in an amount effective to reduce a concentration of
viable bacteria” is a claim limitation.
However, we do not agree with Appellants (see Reply Br. 5) that this
amount of zinc sulfate is not disclosed in the prior art. Braswell disclosed
that its formulation comprised zinc sulfate as a buffering agent typically in
an amount ranging from 1 to 15% by weight. (FF-2, 4.) Braswell also
disclosed that when zinc sulfate, boric acid and potassium are all present in
its composition, the amount of zinc sulfate is from, for example, 0.01 to 5%
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by weight, preferably from 0.05 to 2% by weight, and more preferably from
about 0.05 to about 1% by weight. (FF-5.) The instant Specification
describes “the amount of the soluble zinc compound is in the range from
about 0.0001 to about 5 percent by weight of the solution.” (FF-10; see also
instant dependent claims 7-10.) Braswell’s disclosed ranges of zinc sulfate
overlap the range of the zinc compound disclosed in the instant Specification
and recited in dependent claims 7-10 such that it would have been expected
to have the same properties as the zinc compound recited in the claim 1. See
Perricone, 432 F.3d at 1377; Best, 562 F.2d at 1255. Therefore, Braswell
disclosed a zinc-based compound present in an amount effective to reduce a
concentration of viable bacteria.
Braswell also disclosed that glutathione acts as an antioxidant (FF-2)
which reads on the inclusion of an antioxidant as set forth in independent
claim 19 and its dependent claims 21, 23 and 25, and the therapeutic agent
of independent claim 11 and its dependent claims 13, 14, and 15.
Additionally, Braswell disclosed that its formulation comprised
carboxymethyl cellulose, a polyanionic material included in the group of
polyanionic materials recited in the instant claims. (Ans. 3; FF-9.) Braswell
disclosed that its lubricant, preferably sodium carboxymethyl cellulose, “is
contained in the composition in an amount of from, for example, 0.01 to 5%
by weight (FF-10) which reads on the amounts specifically recited in
dependent claims 3, 4, and 5.
Based upon the Examiner’s findings, and those we make here, we find
that Braswell anticipated each of the limitations of claims 1, 3-11, 13-15, 19,
21, 23, 25-27, 31, 33, 35 and 36. See Verdegaal Bros., 814 F.2d at 631.
Although we affirm the rejection of these claims, our grounds and reasoning
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differ sufficiently from the Examiner’s such that we designate the
affirmance a new ground of rejection under 37 C.F.R. § 41.50 (b).
C. The Combination of Braswell, Hahnenberger and Di Napoli
Appellants do not challenge the Examiner’s substitution of
Hahnenberger’s hyaluronic acid for Braswell’s carboxymethyl cellulose
lubricant. (See App. Br. 9; Reply Br. 2.) Nor do Appellants challenge the
Examiner’s inclusion of Di Napoli’s immunosuppressive in the combination.
(See App. Br. 12.) Rather, Appellants challenge this rejection for the same
reasons discussed supra, i.e., that Braswell’s composition must comprise
glutathione to satisfy its intended purpose but glutathione is a cationic
organic nitrogen-containing compound and excluded from the appealed
claims. (Id.) We are not persuaded by this argument for the reasons
discussed in the “Claim Interpretation” section. Although we affirm the
obviousness rejection of claims 1, 3-11, 13-19, 21, 23, 25-28, 31, 33, 35 and
36 over the combination Braswell, Hahnenberger and Di Napoli, our
reasoning differs from the Examiner’s regarding the combination of
Braswell. Accordingly, we designate the affirmance a new ground of
rejection under 37 C.F.R. § 41.50 (b).
CONCLUSIONS OF LAW
The record supports the Examiner’s conclusion that the cited
references suggest the claimed pharmaceutical formulation and method of
making the claimed formulation comprising an effective amount of zinc-
based compound and is free of cationic organic nitrogen-containing
compounds.
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SUMMARY
We enter a new ground of rejection of claims 1, 3-11, 13-15, 19, 21,
23, 25-27, 31, 33, 35 and 36 under 35 U.S.C. §102(b) as anticipated by
Braswell.
We affirm the rejection of claims 1, 3-11, 13-19, 21, 23, 25-28, 31,
33, 35 and 36 under 35 U.S.C. §103(a) as unpatentable over Braswell,
Hahnenberger, and Di Napoli, but designate the affirmance as a new ground
of rejection.
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.…

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(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

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