Ex Parte Ellington et al

Board of Patent Appeals and Interferences

Apr 16, 2010

10431634 (B.P.A.I. Apr. 16, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOANNA E. ELLINGTON and SYLVIA ADAMS OLIVER
__________

Appeal 2009-0106661
Application 10/431,634
Technology Center 1600
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Decided: April 16, 2010
__________

Before ERIC GRIMES, DONALD E. ADAMS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a
nonspermicidal lubricant. The Examiner rejected the claims as anticipated
and obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 Bio-Origyn LLC is the real party in interest (App. Br. 2).
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Application 10/431,634

STATEMENT OF THE CASE
Claims 20 and 21 are on appeal and read as follows (App. Br. 13):

20. A nonspermicidal lubricant comprising a balanced
salt solution, a nonspermicidal lubricious compound which is
able to lubricate vaginal mucosa, and arabinogalactan.

21. The lubricant of claim 20 wherein the
nonspermicidal lubricious compound comprises a carbomer.

The following rejections are before us for review:
(1) Claim 20, rejected under 35 U.S.C. § 102(b) as anticipated by
Hecht et al.2 (Ans. 3); and
(2) Claims 20 and 21, rejected under 35 U.S.C. § 103(a) as being
obvious in view of Hecht and Dikstein3 (Ans. 4).
ANTICIPATION
ISSUE
In finding that Hecht anticipates claim 20, the Examiner contended
that the water in Hecht’s “[F]ormulation 2” met claim 20’s requirement of “a
nonspermicidal lubricious compound which is able to lubricate vaginal
mucosa” (Ans. 3).
Appellants contend that water “cannot perform the necessary function
(‘to lubricate vaginal mucosa’) of the lubricious compound in the lubricant
of claim 20” (App. Br. 8), and cite evidence, in the form of a Declaration

2 U.S. Patent No. 4,039,662 (filed Dec. 4, 1975).
3 U.S. Patent No. 5,106,615 (filed Nov. 30, 1990).
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under 37 C.F.R. § 1.132 of Dr. Loyd V. Allen, Jr.,4 to support that position
(id. at 8-9).
The Examiner responds that “‘water’ . . . is characterized by at least
some viscosity and that it is capable to reduce friction between moving
surfaces would be a lubricating agent within the broadest reasonable
meaning of the claims” (Ans. 5). The Examiner also argues that the
examples of lubricious compounds in Appellants’ Specification do not
expressly exclude water, and include compounds “‘like’” the compounds
that are specifically listed (id.). Moreover, the Examiner argues, the
limitation at issue is merely a recitation of intended use that is met by any
prior art structure capable of performing that use (id. at 5-6).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner reasonably
interpreted claim 20’s recitation of “a nonspermicidal lubricious compound
which is able to lubricate vaginal mucosa” as encompassing the water in
Hecht’s compositions.
FINDINGS OF FACT (“FF”)
1. The Specification states that “[t]he present invention relates generally
to the use of polysaccharides containing arabinose, galactose and/or
hexuronic acid in promoting in vivo and in vitro survival and improved
function of sperm, oocytes, and embryos” (Spec. 1:9-11).
2. To that end, the Specification discloses the usefulness of
nonspermicidal lubricants in both natural and artificial insemination (id. at
5:5-16).

4 Declaration of Loyd V. Allen, Jr., first entered April 24, 2007.
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3. The Specification thus discloses, in one embodiment, “a
non-spermicidal lubricant for increasing fertilization potential in animals . . .
comprising a non-spermicidal lubricious compound” which may be
“glycerine, methylcellulose, propylene glycol, plant oils, or petroleum jelly,
or a combination of glycerin and petroleum jelly, or a combination of
polyethylene oxide, sodium carboxypolymethylene and methylparaben” (id.
at 7:17-23).
4. The Specification later provides a more extensive list of lubricious
compounds:
The base of the lubricant is a nonspermicidal lubricious
compound. Such lubricants include petroleum jelly, vegetable
oil, glycerin, polycarbophil, hydroxyethyl cellulose,
methylcellulose, silicon oil, carbomer (e.g., carbomer 934),
alginate, methylparaben, palm oil, cocoa butter, aloe vera, other
plant oils, alginate propylene glycol, unibase (Warner-Chilcott),
mineral oil, a combination of polyethylene oxide, sodium
carboxypolymethylene and methylparaben, and the like.

(Id. at 19:21-27.)
5. The Declaration of Dr. Loyd V. Allen, Jr. includes the following
statements:
9. The tables listing vaginal lubricants in the
Handbook of Nonprescription Drugs (2004 edition and the
previous edition) contain selected ingredients but do not contain
water in the list.

10. It is well known in the art that water is not able to
provide the viscosity needed for a lubricant to mucous
membranes, and thus products such as K-Y® Jelly are marketed.
If water were sufficient, there would be no need for such
products.

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11. Applicants’ composition of claim 20 requires “a
balanced salt solution” which includes water. Thus, if water
were “a lubricious compound”, there would be no need for the
composition of claim 20 to separately require “a lubricious
compound” since water is already present in the composition
via the balanced salt solution.

(Declaration of Dr. Loyd V. Allen, Jr., p. 2.)
6. Hecht discloses “an ophthalmic solution which is an aqueous solution
of a particular polysaccharide and benzalkonium chloride. Preferably the
ophthalmic solution also includes monovalent cation containing salts at a
level sufficient to make the solution isotonic” (Hecht, col. 2, ll. 4-9).
7. Formulation 2 of Hecht, cited by the Examiner, is essentially a
comparative formulation lacking benzalkonium chloride (id. at col. 5, ll. 24-
25). Hecht’s Formulation 2 contains 0.5% arabinogalactan, 0.9 % sodium
chloride, and water (id. at col. 5, ll. 30-40).
PRINCIPLES OF LAW
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

“During examination, ‘claims . . . are to be given their broadest
reasonable interpretation consistent with the specification, and . . . claim
language should be read in light of the specification as it would be
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interpreted by one of ordinary skill in the art.’” In re American Academy Of
Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004) (quoting In re
Bond, 910 F.2d 831, 833 (Fed. Cir. 1990)).
ANALYSIS
We agree with Appellants that, in finding that the water in Hecht’s
composition is encompassed by the recitation of “a nonspermicidal
lubricious compound which is able to lubricate vaginal mucosa,” the
Examiner interpreted claim 20 too broadly.
In our view, an ordinary artisan viewing claim 20 in light of the
Specification would have interpreted the language at issue as encompassing
compounds that provide vaginal lubrication adequate for natural or artificial
insemination (FF 1-4). Appellants provided evidence, in the form of the
Declaration of Dr. Loyd, that an ordinary artisan would not have interpreted
water as being a compound that provides adequate vaginal lubrication (FF
5).
The Examiner, in contrast, points to no evidence showing that an
ordinary artisan interpreting claim 20 in light of the Specification would
have considered it reasonable to interpret the language at issue as
encompassing water. The preponderance of the evidence therefore supports
Appellants’ contention that water is not encompassed by the language at
issue.
We acknowledge that water makes many surfaces slippery. Claim 20,
however, recites a specific type of lubrication that, when viewed in light of
the Specification, is not reasonably provided by water, given the evidence of
record. This interpretation is further bolstered by the fact that claim 20
recites “a balanced salt solution” which necessarily contains water, yet also
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separately recites “a nonspermicidal lubricious compound which is able to
lubricate vaginal mucosa.”
In sum, we are not persuaded that the water in Hecht’s composition is
encompassed by the recitation of “a nonspermicidal lubricious compound
which is able to lubricate vaginal mucosa.” As Hecht therefore does not
meet all of the elements required by claim 20, we reverse the Examiner’s
anticipation rejection of that claim over Hecht.
OBVIOUSNESS
ISSUE
In rejecting claims 20 and 21 as obvious over Hecht and Dikstein, the
Examiner conceded that Hecht did not disclose claim 21’s carbomer in its
compositions, and cited Dikstein to meet that feature (Ans. 4). Based on the
references’ teachings, the Examiner concludes that an ordinary artisan would
have considered it obvious “to add polymer carbomer to the composition of
[Hecht] with a reasonable expectation of success in providing lubricious
effects as adequately taught and/or suggested by [Dikstein] for the expected
benefits in enhancing viscosity of topical ophthalmic compositions” (id.).
Appellants contend that the Examiner’s obviousness conclusion is not
supported by the references’ disclosures because Dikstein teaches that its
ophthalmic solutions should contain no more than about 0.01 weight percent
of salt, whereas Formulation 2 of Hecht cited by the Examiner contains
0.9% w/v sodium chloride (App. Br. 10). Thus, Appellants argue, the
combination of features proposed by the Examiner is “in opposition of the
teachings of Dikstein” (id.).
The Examiner responds that Hecht and Dikstein “are relied upon for
the disclosure of the components of the ophthalmic solutions but not for
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their amounts since the issue of the component amounts is not within the
scope of the instant claims” (Ans. 6). Specifically, the Examiner urges,
“[t]he claimed limitation ‘balanced salt solution’ is generic and it does not
provide any specific limitations to evaluate whether or not the prior art
solutions meet the same structural and functional meaning of the instant
claims” (id.).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner’s conclusion
of obviousness is supported by the references’ teachings.
FINDINGS OF FACT
8. Regarding its compositions, Hecht discloses that, “[f]or most
ophthalmic uses it is desirable that the ophthalmic solution be isotonic”
(Hecht, col. 4, ll. 31-32).
9. Hecht discloses, however, that “solutions free of divalent cations
show enhanced tearfilm stability” and therefore “the salts used to establish
an isotonic condition should be monovalent, i.e., sodium chloride, potassium
chloride, or mixtures thereof. Generally, the monovalent salts are added in
an amount sufficient to give a freezing point depression or osmotic pressure
equivalent to that provided by 0.5% to 1.5% sodium chloride” (id. at col. 4,
ll. 50-59).
10. Hecht’s Examples all contain at least about 0.9 % w/v salt in the form
of sodium chloride, or a combination of sodium and potassium chlorides
and/or other metal chlorides and organic sodium salts (id. at col. 5, ll. 30-55;
col. 7, l. 55 through col. 8, l. 8).
11. Dikstein discloses “ophthalmic solutions [which] contain in
combination an effective humectant, generally in isotonic concentration, and
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an anionic polymer which is used to obtain a predetermined viscosity, the
solutions being characterized by a non-Newtonian rheology” (Dikstein, col.
1, ll. 18-22).
12. Dikstein discloses that carbomers are among the preferred anionic
polymers (id. at col. 3, ll. 28-35).
13. Dikstein discloses, however, that “[i]t has been surprisingly
discovered that the presence of salt, such as sodium chloride, destroys the
non-Newtonian rheology, and thus it is stipulated that the solutions of the
invention ought not to contain more than about 0.01 weight per cent” (id. at
col. 1, ll. 31-35 (emphasis added)).
PRINCIPLES OF LAW
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question. The Court also reaffirmed, however, that
it can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added.)
The Court also noted that claims are likely to be unobvious when
“when the prior art teaches away” from their practice. Id. at 416 (citing
United States v. Adams, 383 U.S. 39, 51-52 (1966)).
Ultimately, therefore, as the Federal Circuit has stated, “[i]n
determining whether obviousness is established by combining the teachings
of the prior art, the test is what the combined teachings of the references
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would have suggested to those of ordinary skill in the art.” In re GPAC Inc.,
57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted).
ANALYSIS
We agree with Appellants that the Examiner’s conclusion of
obviousness is not supported by the references’ teachings. Claim 21,
through its dependency on claim 20, recites a composition having three
ingredients, (1) a balanced salt solution, (2) a nonspermicidal lubricious
compound which comprises a carbomer, and (3) arabinogalactan.
We acknowledge that Hecht describes ophthalmic compositions that
contain arabinogalactan and a salt solution that is encompassed by the claims
(FF 7). We also acknowledge that Dikstein discloses that carbomers are
useful in ophthalmic solutions (FF 12).
However, as Appellants point out, Dikstein explicitly states that its
solutions should contain no more than 0.01 weight percent salts (FF 13),
which is significantly lower than 0.5% w/v sodium chloride, the lowest
concentration of salt disclosed by Hecht as being useful in its compositions
(FF 9). Given Dikstein’s teaching that the desirable effects of including
carbomers in ophthalmic solutions are only achieved when the composition
has much less salt in it than the compositions described by Hecht, we are not
persuaded that an ordinary artisan would have been prompted to add
Dikstein’s carbomer to Hecht’s composition, as the Examiner posits.
We note, as the Examiner argues, that the claims do not recite any
particular concentration for the salts. However, to achieve a composition
containing all three of the claimed ingredients, salts, arabinogalactan, and
carbomer, one must rely on the teachings of both references.
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In this regard, the Examiner points to no disclosure in either reference,
or in the knowledge generally available to an ordinary artisan, that it would
have been desirable, or even suitable, to reduce the salts in Hecht’s
compositions to the concentrations required by Dikstein. Thus, while the
claims might not recite specific amounts of the claimed ingredients, the
references applied by the Examiner recite ingredient concentrations that
render them incompatible, given the evidence of record.
In sum, for the reasons discussed, we agree with Appellants that the
Examiner’s conclusion of obviousness is not supported by the references’
teachings. We therefore reverse the Examiner’s obviousness rejection of
claims 20 and 21 in view of Hecht and Dikstein.
SUMMARY
We reverse the Examiner’s rejection of claim 20 as anticipated by
Hecht. We also reverse the Examiner’s obviousness rejection of claims 20
and 21 in view of Hecht and Dikstein.

REVERSED

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