Ex Parte Xia

Patent Trial and Appeal Board

Dec 2, 2014

11842394 (P.T.A.B. Dec. 2, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ERNING XIA
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Appeal 2012-006823
Application 11/842,394
Technology Center 1600
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Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
composition and method for providing relief to a discomfort of an eye
resulting from dry eye syndrome. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellant identifies the Real Party in Interest as Bausch &
Lomb Incorporated (see App. Br. 2).
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Application 11/842,394

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Statement of the Case
Background
“Dry eye . . . a disorder manifested as insufficient tear film for
lubrication of the ocular surface, can be the result of environmental factors
or diseases” (Spec. 1 ¶ 3). “Therefore, there is a continued need to provide
improved ophthalmic compositions for the relief of ocular discomfort”
(Spec. 2 ¶ 4).
The Claims
Claims 1, 3, 12, 13, 17, and 18 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A composition consisting essentially of: alginate,
glycerine, propylene glycol, a hydroxyalkyl phosphonate,
boric acid, borate, and water, wherein said composition has
a osmolality of about 200-260 mOsm/kg, and a pH of about
6.5-7.5, and said composition is devoid of preservatives.

The issue
The Examiner rejected claims 1, 3, 12, 13, 17, and 18 under 35 U.S.C.
§ 103(a) as being obvious over Nitta2 and Hu3 (Ans. 5).
The Examiner finds that “Nitta et al. teach the use of alginate in an
ophthalmic solution for the treatment of dry eye. . . . Nitta et al. also teach
the use of propylene glycol, glycerin, boric acid and borax in a composition
being used for the treatment of dry eye” (Ans. 5). The Examiner finds that
Nitta does not teach the use of hydroxyalkyl phosphonate (id.). The
Examiner finds that “Hu et al teach the use of hydroxyalkyl phosphonate in

2 Nitta et al., US 6,511,949 B1, issued Jan. 28, 2003.
3 Hu et al., US 7,037,469 B2, issued May 2, 2006.
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an ophthalmic solution for providing comfort for contact lens users and
prevention of eye dryness” (id.).
The Examiner finds it obvious to “incorporate hydroxyalkyl
phosphonate in the composition of Nitta et al., motivated by the teachings of
Hu et al., which teaches the use of hydroxyalkyl phosphonate in an
ophthalmic composition, which is used for providing comfort to the contact
lens users” (id.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the combination of Nitta and Hu
renders the claims obvious?
Findings of Fact
1. Nitta teaches “the composition of the present invention can
moisten solid surface and therefore is expected to accelerate the wetting of
cornea surface, whereby it is useful as eye drops for treating dry eye of
patients with or without contact lenses” (Nitta, col. 4, ll. 22-26).
2. Nitta teaches that “[e]xamples of thickener useable in the
ophthalmic composition of the present invention include . . . sodium
alginate, propylene glycol alginate” (Nitta, col. 5, ll. 22-25).
3. Nitta teaches that “[v]arious pharmaceutically acceptable
substances which do not affect the contact lenses may be added to the
ophthalmic composition of the present invention. For example . . . boric
acid, borax . . . glycerol [i.e. glycerine]. . . propylene glycol” (Nitta, col. 6,
ll. 32-51).
4. Hu teaches “an ophthalmic solution for soft contact lenses for
controlled release of polyethers into an eye’s tear film” (Hu, abstract).
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5. Table 5 of Hu is reproduced below:

“The multi-purpose lens care formulation identified as Solution F in Table 5
below, is illustrative of a preferred embodiment of the present invention
using a borate-phosphate buffer” (Hu, col. 7, l. 25 to col. 8, l. 20).
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.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 5-7; FF 1-5) and agree that claim 1 is
obvious over Nitta and Hu. We address Appellant’s arguments below.
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Appellant contends that “Nitta’s objective would not have been
realized if polyoxyethylene polyoxypropylene glycol or polyoxyethylene
polyoxypropylene substituted ethylenediamine is absent from his
composition. Thus, Nitta could not have suggested a composition that is
affirmatively devoid of this essential ingredient, such as the presently
claimed composition” (App. Br. 5). Appellant contends that
Nitta’s required polyoxyethylene polyoxypropylene glycol
or polyoxyethylene polyoxypropylene substituted
ethylenediamine is necessarily absent in each of the claims
by virtue of the transitional phrase. Such necessary absence
of an ingredient is a limitation of the claim that must be
taught or suggested by the prior art in order to render the
claim obvious.

(App. Br. 8).
We find this argument unpersuasive. Claim 1 does not employ the
closed transitional phrase “consisting of,” but rather uses “consisting
essentially of.” Appellant does not identify evidence showing a clear
definition of the scope of “consisting essentially of” in the Specification.
Indeed, Appellant does not point to the Specification at all. Therefore,
absent a clear indication in the Specification or claims of the basic and novel
characteristics of the claimed composition, the term “consisting essentially
of” is reasonably construed as equivalent to “comprising”. See PPG
Industries v. Guardian Industries Corp., 156 F.3d 1351, 1354 (Fed. Cir.
1998). (“By using the term ‘consisting essentially of’ the drafter signals that
the invention necessarily includes the listed ingredients and is open to
unlisted ingredients that do not materially affect the basic and novel
properties of the invention.”) See also In re Zletz, 893 F.2d 319, 321 (Fed.
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Cir. 1989) (“[D]uring patent prosecution when claims can be amended,
ambiguities should be recognized, scope and breadth of language explored,
and clarification imposed. . . . An essential purpose of patent examination is
to fashion claims that are precise, clear, correct, and unambiguous. Only in
this way can uncertainties of claim scope be removed, as much as possible,
during the administrative process.)
Appellant contends that “[a]dding Nitta’s polymeric glycol would
change the fundamental characteristics of the claimed composition because
adding Nitta’s polymeric glycol would negate the present low viscosity and
would greatly blur the vision, both contrary to the disclosed desire” (Reply
Br. 3).
We are not persuaded. Appellant provides no evidence that Nitta’s
polymeric glycol would blur the vision, but simply relies upon argument.
See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[A]ttorney
argument [is] not the kind of factual evidence that is required to rebut a
prima facie case of obviousness”). We will not further address this
argument, since it was not present in the Appeal Brief, thereby denying us
the expertise and insight of the Examiner. See Ex parte Borden, 2010 WL
191083 (BPAI 2010) (The Board is not required to consider arguments first
presented in a Reply Brief, in the absence of a showing of good cause).
Appellant provides no evidence of good cause.
Appellant contends that “nowhere does Nitta disclose a composition
that must have propylene glycol, which is an affirmatively recited ingredient
of each of the present claims” (App. Br. 6). Appellant contends that “Nitta
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does not teach propylene glycol and alginate, as two individual, distinct
molecules. Instead, Nitta teaches propylene glycol alginate.” (App. Br. 7-8).
We are not persuaded. Nitta teaches that “[v]arious pharmaceutically
acceptable substances which do not affect the contact lenses may be added
to the ophthalmic composition of the present invention. For example . . .
boric acid, borax . . . glycerol [i.e. glycerine]. . . propylene glycol” (Nitta,
col. 6, ll. 32-51; FF 3). This is an express suggestion to add propylene
glycol, not propylene glycol alginate (FF 3).
In addition, Nitta teaches that “[e]xamples of thickener useable in the
ophthalmic composition of the present invention include . . . sodium
alginate, propylene glycol alginate” (Nitta, col. 5, ll. 22-25; FF 2). We agree
with the Examiner that Nitta teaches sodium alginate, the salt form of
alginate, separately from propylene glycol (FF 2-3; Ans. 6-7).
Appellant contends that the “Examiner’s picking propylene glycol out
of this list to combine with alginate to come up with the instant claims is
clearly a hindsight reconstruction using Appellant’s claims as the template,
and is prohibited” (Reply Br. 4).
We find this argument unpersuasive. 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. See Merck & Co.,
Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“That the
‘813 patent discloses a multitude of effective combinations does not render
any particular formulation less obvious.”); In re Corkill, 771 F.2d 1496,
1500 (Fed. Cir. 1985) (obviousness rejection affirmed in light of prior art
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teaching that “hydrated zeolites will work” in detergent formulations, even
though “the inventors selected the zeolites of the claims from among
‘thousands’ of compounds”). In the instant situation, Nitta specifically
teaches that propylene glycol and alginate are desirable additions to
ophthalmic compositions (FF 2-3).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Nitta and Hu renders the claims obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as being obvious over Nitta and Hu. Pursuant to 37 C.F.R.
§ 41.37(c), claims 3, 12, 13, 17, and 18 fall with claim 1, as these claims
were not argued separately.

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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