Ex Parte Wang et al

Patent Trial and Appeal Board

Oct 31, 2016

13701227 (P.T.A.B. Oct. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
131701,227 11130/2012
23909 7590 11/02/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Wei Wang
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
8768-00-0C 1687
EXAMINER
WEBB, WALTERE
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
11/02/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
Patent_Mail@colpal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WEI WANG, JAMES R. BROWN,
HARSH M. TRIVEDI, and JOE V AZQUEZ 1
Appeal2014-009539
Application 13/701,227
Technology Center 1600
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
TA WEN CHANG, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a mouthwash
composition. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner's rejection of
claims 1-3, 8, 9, and 21under35 U.S.C. § 103(a) as being unpatentable over
Weiss.2 Final Action 2--4. 3
1 Appellants state that the "real party in interest for this appeal and for the
above-referenced application is the assignee, Colgate-Palmolive
Company." Br. 2.
2 U.S. Patent No. 5,840,322 (issued Nov. 24, 1998).
Appeal2014-009539
Application 13/701,227
Claim 1, the sole independent claim on appeal, is representative and
reads as follows (App. Br. 8, paragraphing added):
1. An oral care composition in the form of a mouthwash
comprising cranberry extract nondialyzable material and an
orally acceptable vehicle,
wherein the cranberry extract non-dialyzable material is
present in the composition in a concentration of about 0.3%
w/w and
wherein the composition does not contain a component
that deactivates the cranberry extract non-dialyzable material.
OBVIOUSNESS
The Examiner found that Weiss describes mouthwash compositions
having nearly all of the features of claim 1, but conceded that Weiss differs
from claim 1 in that Weiss does not teach that the cranberry extract non-
dialyzable material is present in Weiss's compositions at a concentration of
about 0.3% w/w. Final Action 2-3. The Examiner concluded, however, that
because Weiss "teaches that the effective amount [of the active ingredient] is
determined by the person having ordinary skill in the art, it would have been
obvious to adjust the concentration of the extract to about 0.3%." Id. at 3.
The Examiner reasoned in particular that it would have been a matter
of routine optimization to determine suitable concentrations of the active
ingredient and thereby arrive at the concentration of cranberry extract non-
dialyzable material required by claim 1. Id. at 3--4 (citing MPEP § 2144.05,
II. A; In re Aller, 220 F.2d 454, 456 (CCPA 1955)). The Examiner reasoned
further that, because the claimed concentration of active ingredient falls
within the prior art's suitable concentration range, the claimed concentration
3 Final Action entered October 21, 2013.
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Application 13/701,227
would have been prima facie obvious. Id. at 4 (citing Jn re Peterson, 315
F.3d 1325, 1329 (Fed. Cir. 2003)).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
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.
We select claim 1 as representative of the rejected claims. 37 C.F.R.
§ 41.37(c)(l)(iv). Appellants' arguments do not persuade us that a
preponderance of the evidence fails to support the Examiner's prima facie
case of obviousness as to claim 1.
Appellants argue initially that Weiss does not teach or suggest
claim l's requirement for the mouthwash to contain 0.3 % w/w cranberry
extract non-dialyzable material. App. Br. 5-6; Reply Br. 3.
We are not persuaded. Weiss discloses "a non-food oral hygiene
composition comprising a suitable carrier and an effective amount of the
isolated [antibacterial] adhesion inhibitory fraction from juice from berries
of the plant genus V accinium. . . . The preferred embodiment is prepared
from cranberry juice or juice concentrate." Weiss 3:31-54.
As the Examiner found, and as required by claim 1, Weiss discloses a
method of inhibiting oral bacteria in which "the inventive compositions may
constitute an integral part of a toothpaste, dental cream or gel, tooth powder,
or mouthwash .... " Id. at 4:41--43 (emphasis added).
As the Examiner found, Weiss discloses that its active ingredient is
produced by dialyzing cranberry juice to produce "non-dialyzable material
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Appeal2014-009539
Application 13/701,227
(NDM)," which is then lyophilized and fractionated on a polyacrylamide
resin column to produce ultimately an antibacterial active fraction
designated "PF-1." Id. at 4:52-65.
As the Examiner found, and as required by claim 1, Weiss discloses
that the NDM can be used as the active ingredient in the disclosed
compositions:
NDM as shown in the examples can be used in the
present invention to inhibit or reverse intergeneric
coaggregation/adhesion of oral bacteria, and a pharmaceutically
acceptable carrier. The concentration of NDM however in the
carrier is between 25 µg/ml and 100 mg/ml. For inhibition of
coaggregation a range between 0.05 mg/ml and 0.4 mg/ml can
be used. For reversal of coaggregation a range between 1
mg/ml and 4 mg/ml can be used.
Id. at 4:66-5:6; see also id. at 6:32-37 ("In a preferred embodiment an
effective amount of the isolated adhesion inhibitory fraction PF-1 is used.
However, in an alternative embodiment NDM can be used.").
As the Examiner found, Weiss discloses that its active ingredient may
be present in oral hygiene compositions at a "concentration of the isolated
adhesion inhibitory fraction ... between 1 µg and 10 mg per milliliter." Id.
at 22:53-54 (claim 1 ).
As the Examiner found, and Appellants do not dispute, the range
recited in Weiss's claim 1 converts to a range of 0.0001 % to 1 %. Ans. 3;
see also App. Br. 5 (" 1 µg to 10 mg/ml is the approximate equivalent of
0.0001 % to 1 % concentration.").
As the Examiner found, Weiss discloses that the effective amount of
its active ingredients can be determined by a skilled artisan:
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Appeal2014-009539
Application 13/701,227
The pharmaceutically "effective amount" for purposes herein is
determined by such considerations as are known in the art. The
amount must be effective to achieve improvement including but
not limited to inhibition and/or reversal of oral intra- and inter-
bacterial species coaggregation as described in the Examples
herein below and to improvement or elimination of symptoms
and other indicators as are selected as appropriate measures by
those skilled in the art.
Id. at 6:22-30.
In view of Weiss's teaching (id.) that the effective amount of its active
ingredient can be determined by skilled artisans, we agree with the Examiner
that, absent evidence of some unexpected property inhering from the
claimed concentration of 0.3 % w/w of the NDM, the concentration recited
in claim 1 would have been prima facie obvious. See In re Aller, 220 F .2d at
456 ("[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation."); see also In re Peterson, 315 F.3d at 1330 ("[A]n
applicant may overcome a prima facie case of obviousness by establishing
that the claimed range is critical, generally by showing that the claimed
range achieves unexpected results relative to the prior art range.") (internal
quotations and bracketing omitted). In the instant case, Appellants do not
advance persuasive evidence that the claimed concentration produces an
unexpected result.
As the court also explained in Peterson, "even a slight overlap in
range establishes a prima facie case of obviousness." In re Peterson, 315
F.3d at 1329. Thus, that Weiss's suitable concentration range for its active
ingredient, including the range recited in Weiss's claims 6, 8, and 10, may
have been relatively broad (see App. Br. 5-6), or that the concentration in
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Appeal2014-009539
Application 13/701,227
Appellants' claim 1 might be outside Weiss's preferred range (Reply Br. 3),
does not persuade us that an ordinary artisan would have failed to recognize
that claim l's concentration of NDM is within the broadest range of suitable
concentrations taught in Weiss, and therefore would have been prima facie
obvious.
To that end, Appellants contend that the concentration range recited in
Weiss's claim 1 relates to Weiss's PF-1 fraction, which is distinct from
Weiss's NDM fraction, the active agent required by Appellants' claim 1.
Reply Br. 2-3.
We do not find this argument persuasive. We first note that, despite
the opportunity, this new argument was not made in Appellants' Appeal
Brief, and therefore constitutes improper new argument:
Any argument raised in the reply brief which was not
raised in the appeal brief, or is not responsive to an argument
raised in the examiner's answer, including any designated new
ground of rejection, will not be considered by the Board for
purposes of the present appeal, unless good cause is shown.
37 C.F.R. § 41.4l(b)(2). In any event, as noted above, Weiss discloses that
in its compositions, the "concentration ofNDM ... in the carrier is
between 25 µg/ml and 100 mg/ml" (Weiss 5:2-3), a concentration range
that, like the range recited in Weiss's claim 1, includes the concentration of
NDM recited in Appellants' claim 1.
Accordingly, for the reasons discussed, Appellants do not persuade us
that the Examiner erred in finding that Weiss suggests a mouthwash
composition that includes the concentration of cranberry extract NDM
recited in Appellants' claim 1.
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Appeal2014-009539
Application 13/701,227
Appellants also do not persuade us that Weiss fails to suggest a
mouthwash composition that does not contain a component that deactivates
the cranberry extract non-dialyzable material, as claim 1 also requires. In
that regard, Appellants contend that Weiss discloses that its mouthwash
compositions can contain up to 15% anionic and nonionic surfactants, which
include well known poloxamer surfactants, and which inhibit the activity of
cranberry extract NDM. App. Br. 6; Reply Br. 3--4. Appellants note in
particular that poloxamers are specifically excluded from the claimed
mouthwash by Appellants' claim 21, which depends from claim 1. App. Br.
6. In addition, Appellants contend, the Examiner's finding that it would be
common sense to ensure the absence of components that deactivate Weiss's
active ingredient is based on improper hindsight, because no prior art
suggests that poloxamers deactivate Weiss's cranberry extract NDM. App.
Br. 6-7; Reply Br. 4-6.
We are not persuaded. We acknowledge the disclosure in Appellants'
Specification that "the present inventors discovered that oral compositions
comprising surfactants inhibit the ability of cranberry extract non-dialyzable
material [NDM] to inhibit bacterial co-aggregation." Spec. ,-i 20. The sole
specific compounds identified in the Specification as deactivating cranberry
extract NDM are the poloxamer surfactants Poloxamer 33 8 NF and
Poloxamer 407 NF. Id. at ,-i,-i 44--45 (Example 2).
Turning to the prior art, as to surfactants in its mouthwashes, Weiss
discloses that "[ m ]outhwashes are typically comprised of a water/alcohol
solution, flavor, humectant, sweetener, foaming agent, and colorant." Id. at
6:48-50. Although Weiss does not mention poloxamers specifically, Weiss
discloses that "[ s Jui table foaming agents include soap, anionic, cationic,
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Application 13/701,227
nonionic, amphoteric and/or zwitterionic surfactants. These may be present
at levels of 0 to 15%, preferably 0.1 to 15%, more preferably 0.25 to 10% by
weight." Id. at 7:12-15.
Thus, while Weiss might prefer including surfactants in its
mouthwashes, Weiss nonetheless discloses expressly that its mouthwashes
may contain 0%, that is, no surfactant. Because Weiss discloses that its
mouthwashes may contain no surfactant, Appellants do not persuade us that
Weiss fails to teach or suggest a mouthwash that does not include a
component that deactivates the cranberry extract non-dialyzable material, as
claim 1 requires, or that preparing a mouthwash lacking that component
would be based on improper hindsight.
That a mouthwash lacking surfactant might not have been Weiss's
preference does not demonstrate that Weiss fails to suggest a surfactant-free
composition, given its express disclosure that its mouthwashes may contain
no surfactant. See Merck & Co. Inc. v. Biocraft Labs. Inc., 874 F.2d 804,
807 (Fed. Cir. 1989) ("[I]n a section 103 inquiry, the fact that a specific
[embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered.") (internal quotations omitted); see also See DePuy Spine, Inc. v.
Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) ("A
reference does not teach away ... if it merely expresses a general preference
for an alternative invention but does not criticize, discredit, or otherwise
discourage investigation into the invention claimed.") (internal quotations
omitted).
Moreover, because Weiss discloses that its mouthwashes may contain
no surfactant, and thus expressly suggests compositions that meet the
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Application 13/701,227
negative limitation in Appellants' claim 1, we do not find Appellants'
arguments (Reply Br. 5-6) based on Leo Pharmaceutical Products, Ltd. v.
Rea, 726 F.3d 1346 (Fed. Cir. 2013), persuasive.
We first note that, despite the opportunity, this new argument in the
Reply Brief based on Leo Pharmaceutical was not made in Appellants'
Appeal Brief, and therefore constitutes improper new argument. See 37
C.F .R. § 41.41 (b )(2). That an ordinary artisan might not have recognized
that poloxamers deactivate cranberry extract NDM does not negate Weiss's
express disclosure of the suitability of including no surfactant in its
mouthwashes. That is, even if it were true that poloxamers were not known
to deactivate cranberry extract NDM, Weiss, nonetheless, suggests a
mouthwash that lacks poloxamers, and thereby meets the limitation at issue.
In addition, Appellants do not persuade us that the Examiner erred in
suggesting that it would have been common sense to exclude deactivating
agents, or that an ordinary artisan would have considered it obvious that
conventional excipients might interfere with the cranberry extract NDM's
antibacterial activity. To the contrary, Weiss expressly teaches that active
ingredient-inhibiting excipients should be avoided:
The present invention provides for a composition
comprising an effect[ive] amount of an isolated adhesion
inhibitory fraction from V accinium, in a preferred embodiment
the isolated adhesion inhibitory fraction from cranberry juice,
PF-1, and a pharmaceutically acceptable carrier which does
not react with the active ingredients of the invention and which
does not decrease the biological activity of the present
invention.
Weiss 6:9-16 (emphasis added).
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Application 13/701,227
In sum, for the reasons discussed, Appellants' arguments do not
persuade us that Weiss fails to teach or suggest a cranberry extract
NDM-containing mouthwash that does not contain a component that
deactivates the NDM, as required by Appellants' claim 1. Because Weiss
teaches that its mouthwashes may contain no surfactant, Appellants also do
not persuade us that Weiss fails to teach or suggest a mouthwash that does
not contain a poloxamer, as recited in Appellants' claim 21.
Accordingly, because Appellants do not persuade us, for the reasons
discussed, that a preponderance of the evidence fails to support the
Examiner's conclusion that Weiss renders obvious a composition having all
of the ingredients and features recited in claims 1 and 21, we affirm the
Examiner's rejection of those claims over Weiss. The remaining claims fall
with claims 1 and 21.
SUMMARY
For the reasons discussed, we affirm the Examiner's rejection of
claims 1-3, 8, 9, and 21under35 U.S.C. § 103(a) as being unpatentable over
Weiss.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED
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