Ramji, Niranjan et al.

Patent Trials and Appeals Board

Aug 30, 2019

13076802 - (D) (P.T.A.B. Aug. 30, 2019)

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.
13/076,802 03/31/2011 Niranjan Ramji 11664M 4445
27752 7590 08/30/2019
THE PROCTER & GAMBLE COMPANY
Global IP Services
Central Building, C9
One Procter and Gamble Plaza
CINCINNATI, OH 45202
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
08/30/2019 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):
centraldocket.im@pg.com
mayer.jk@pg.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte NIRANJAN RAMJI, ANN GILLIGAN SNIDER,
LINA AURORA WITTE, BEVERLY D. BECKER,
BETH HANSELL STATT, ANDREA L. NOLAND,
and KRISTI MCKINNEY 1
__________

Appeal 2019-002998
Application 13/076,802
Technology Center 1600
__________

Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

HARDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
mouthrinse and dentifrice comprising an antibacterial agent and a
deodorizing or odor-neutralizing agent. The Examiner rejected the claims as
obvious over the prior art and for obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellants identify “The Procter & Gamble Company” as the real party in
interest. Br. 1.
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STATEMENT OF THE CASE
According to the Specification, the “present invention relates to oral
care compositions containing an antibacterial agent and a deodorizing or
odor neutralizing agent to provide whole mouth malodor control.” Spec.
1:9–10.
Claims 1, 6, 13, and 14 are on appeal. Final Act. 2. Claims 1, 6, and
13 are independent. Br. 15–19 (Claims Appendix). Claim 1 is illustrative,
and reads as follows:
1. A mouthrinse composition comprising:
(a) from about 0.01% to about 5.0%, by weight of the
composition of an antibacterial agent, wherein the antibacterial
agent comprises one or a mixture of quaternary ammonium
compounds selected from cetylpyridinium chloride,
tetradecylpyridinium chloride, N-tetradecyl-4-ethyl pyridinium
chloride or domiphen bromide; triclosan; triclosan
monophosphate; a stannous ion source; a zinc ion source; or a
copper ion source;
(b) a deodorizing or odor-neutralizing agent, wherein the
deodorizing or odor-neutralizing agent comprises one or a
mixture of compounds selected from 4-methoxybenzaldehyde
(anisaldehyde), 4-isopropylbenzaldehyde (cuminaldehyde);
1-(4-methoxy-phenyl)-2-methyl-propan-1-one; 1-(4-methoxy-
phenyl)-ethanone; 1-(4-methoxy-phenyl)-propan-1-one; 1-( 4-
methoxy-phenyl)-butan-1-one; 4-isobutylbenzaldehyde; 4-
propylbenzaldehyde; 4-butylbenzaldehyde; 2,4-dimethyl
benzaldehyde; 2,4,5 trimethyl benzaldehyde; 4-
phenylbenzaldehyde; 4-methoxybenzoic acid or
4-methoxybenzoic acid methyl ester;
(c) an orally-acceptable carrier; and
(d) from about 0.1% to about 1% by weight of the
composition of at least one of an anionic surfactant, cationic
surfactant, or zwitterionic surfactant;
(e) from about 0.001% to about 10% ethanol;
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wherein the deodorizing or odor-neutralizing agent is present in
a total amount of from about 0.01% to about 0.2% by weight of
the composition, and wherein the deodorizing or odor-
neutralizing agent provides a relative odor activity value of at
least about 4% wherein the mouthrinse composition has a
percent reduction of volatile sulfur compounds as compared to
water of at least about 77 .7%.
Br. 15–16 (Claims Appendix).
The claims stand rejected as follows:
Claims 1, 6, 13, and 14 are rejected under 35 U.S.C. § 103 as obvious
over Natsch et al., U.S. 2008/0247966 A1, published Oct. 9, 2008
(“Natsch”). Final Act. 2.
Claims 1, 6, 13, and 14 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1, 5, and 7–9 of U.S.
Patent Application No. 13/529,044 (now U.S. Patent 10,123,953 B2). Id. at
11.
ANALYSIS
“[T]he examiner bears the initial burden . . . of presenting a prima
facie case of unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.” In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). We have considered those arguments
made by Appellants in the Appeal Brief; arguments not so presented in
Appellants’ brief are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015); see
also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative)
(“Any bases for asserting error, whether factual or legal, that are not raised
in the principal brief are waived.”).
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Appellants did not provide separate arguments for dependent claim
14, which depends from independent claim 13. Accordingly, dependent
claim 14 stands or falls with claim 13. 37 C.F.R. § 41.37(c)(1)(iv).
Obviousness Over Natsch
Claims 1 and 6
We begin our analysis by addressing independent claims 1 and 6,
which we find are differently-situated than independent claim 13.
The Examiner began the obviousness analysis by purporting to
summarize the claimed invention. Final Act. 3. We find this summary,
however, was inaccurate with respect to independent claims 1 and 6, in that
it failed to address limitation (e) of those claims, which recites “from about
0.001% to about 10% ethanol.” See Br. 15–16 (Claims Appendix). We
determine that the Examiner has failed to explain how the formulation in
Natsch Example 6(d) teaches this claim limitation.
Claims 1 and 6 use the transition term “comprising,” “which means
that the named elements are essential, but other elements may be added and
still form a construct within the scope of the claim.” Genentech, Inc. v.
Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). The term “comprising,”
however, “is not a weasel word with which to abrogate claim limitations.”
Spectrum Int’l, Inc. v. Sterilite Corp., 164 F.3d 1372, 1380 (Fed. Cir. 1988);
Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed. Cir. 2007) (“The
presumption raised by the term ‘comprising’ does not reach into each of the
six steps to render every word and phrase therein open-ended . . . .”). Thus,
while compositions can contain alcohols other than ethanol and still fall
within the claims, they must contain “from about 0.001% to about 10%
ethanol.”
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The Natsch formulation includes 30% w/w alcohol. Natsch ¶ 55. We
acknowledge that Natsch does not specify the type of alcohol used in this
formulation, but the Examiner has not explained how the Natsch 6(d)
formulation includes ethanol in the percentages recited by claims 1 and 6.
And it is not apparent to us from Natsch’s disclosure that Example 6(d) does
in fact include ethanol only within the claimed range.
Because of the omission in the Examiner’s analysis, we conclude that
the Examiner has not met the initial burden of establishing a prima facie case
of obviousness of claims 1 and 6. In re Oetiker, 977 F.2d at 1445.
Claim 13
We now turn to independent claim 13, which does not require alcohol.
The Examiner found that the composition in Example 6(d) of Natsch met all
limitations of the claim, with two exceptions. First, the Examiner found that
Natsch’s mouth spray did not include any of the specific antibacterial agents
recited in limitation (a) of claim 13. Rather, the Examiner found that
Natsch’s mouth spray contains 0.2% eugenol as an antimicrobial agent,
while teaching that “the classical approach to reduc[ing] oral malodor” is to
use “one or more classical antibacterial agents such as triclosan, cetyl-
pyridinium chloride, chlorhexidine.” Final Act. 3–4, 9–10 (citing Natsch
¶ 4). The Examiner asserted that “one of ordinary skill in the art would have
recognized that one or more [of these] classical antibacterial agent[s] . . .
would have been suitable in place of eugenol at [a] similar concentration of
eugenol.” Id. at 3–4.
Second, as to limitation (d) of claim 13, the Examiner stated that
“[w]here cetylpyridinium chloride and chlorhexidine, i.e., two cationic
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surfactants, are combined as the antimicrobials,” this meets limitation (d) of
claim 13. Id. at 4.
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (id. at 3–11; Ans. 4–14), and agree that
claims 13 and 14 would have been obvious over Natsch for the reasons the
Examiner articulated. In particular, we note that Natsch specifically
identifies triclosan, cetylpyridinium chloride, and chlorhexidine as
equivalent alternatives to eugenol (¶ 22) for use in OMC compositions that
“may be used to reduce the concentration of known oral malodour
counteractants while keeping the OMC effect of the composition, or to
enhance the effect of a composition with known oral malodour
counteractants at a given concentration” (¶ 17). Thus, we agree with the
Examiner that “one of ordinary skill in the art would have recognized that
one or more [of these] classical antibacterial agent[s] . . . would have been
suitable in place of eugenol at [a] similar concentration of eugenol.” Final
Act. 3–4.
Moreover, we agree with the Examiner that it would have been prima
facie obvious to one of ordinary skill art from Natsch’s disclosure to have
included both cetylpyridinium chloride and chlorhexidine. Both of those
compounds are cationic surfactants, and thus, we agree with the Examiner
that such a composition would meet limitation (d) of claim 13, as well as
limitation (a). Id. We note that Appellants do not contest the foregoing.
We address Appellants’ arguments below.
First, Appellants make several arguments based on the Examiner’s
purported disregard of “the teaching in Natsch requiring all OMC
compositions to contain at least four Oral Malodor Compositions (OMC).”
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Br. 4, 13. For example, Appellants argue that Natsch does not describe the
individual ingredients, at the concentrations mentioned, as individually
having an in vivo oral malodor prevention effect, such that the ingredients
would meet the claim limitation “wherein the composition has a percent
reduction of volatile sulfur compounds as compared to water of at least
about 77.7%.” Id. at 5. Appellants also assert that Natsch “does not disclose
or suggest that any individual OMC components have an ‘in vivo’
deodorization effect at lower concentrations.” Id.
We are not persuaded by these arguments because they are based on a
misreading of the Examiner’s rejection. The rejection does not require use
of Natsch’s OMC compounds individually, or at lower concentrations than
specified in Natsch’s Example 6(d). Rather, the rejection posits that the only
change made to the formulation in Natsch’s Example 6(d) compared with
claim 13 is the substitution of eugenol with similar concentrations of other
classical antibacterial agents (triclosan, cetylpyridinium chloride,
chlorhexidine). Final Act. 3–4. As acknowledged by Appellants, the
resulting composition would still contain at least four OMC compounds.
See Br. 5 (acknowledging that “OMC flavor A in addition to Anisaldehyde
had four other OMC actives, as defined in Table 1 of Natsch’s Published
Application, namely ethyl 2-hexenoate, ethyl-2-octenoate, methyl octinoate
and dodecalactone gamma.”); see also Natsch Ex. 4(a) (showing that OMC
flavor A also includes citronellol and ocimene, both of which are defined in
Natsch’s Table 1 as OMC actives).
Appellants next assert that Natsch teaches the use of four or more oral
malodor-countering actives with a total concentration of 1% w/w, whereas
the “present application states that the disclosed mouthrinse does not need
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more than 0.2% of total flavor to achieve deodorization in the mouth, one of
the flavors being anisaldehyde.” Br. 5. Appellants further assert that the
clinical study described in the Ramji 2017 Declaration2 demonstrates the
deodorizing effect of the claimed compositions.
Appellants’ arguments are not persuasive. First, they are not
commensurate with Appellants’ claims. Claim 13 does not require the
presence of anisaldehyde. Rather, anisaldehyde is one of several
deodorizing or odor-neutralizing agents that can be selected from the
Markush group recited in claim 13’s limitation (b) for inclusion in the
claimed compositions. Appellants are silent regarding the relative
deodorizing power of other compositions that fall within the scope of the
claims. Second, the clinical study reported in the Ramji 2017 Declaration
does not establish any purported superiority—let alone any unexpected
superiority—of the claimed compositions compared to Natsch’s
composition, at least because: (1) Natsch’s composition was not tested in
the clinical study; and (2) Appellants have not demonstrated that the tested
composition falls within the scope of the claims, because the formulation
used in the clinical study was not revealed. See Ramji 2017 Decl. ¶ 5.
Appellants also argue that Natsch cites only in vitro deodorization
data for OMC flavors, and has not substantiated efficacy of the disclosed
compositions in vivo. Br. 6–7. This argument is not persuasive, because it
is not relevant to Appellants’ claims. Claim 13 does not require any specific
efficacy in vivo. While claim 13 does specify a “relative odor activity value
[(“ROAV”)] of at least about 4%,” the ROAV can be determined in vitro.

2 Declaration Under 37 C.F.R. § 1.132 by Niranjan Ramji, dated April 23,
2017 (“Ramji 2017 Declaration” or “Ramji 2017 Decl.”).
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See Spec. 7:8–8:23 (protocol for determining ROAV using gas
chromatography). Claim 13 also requires that the “composition has a
percent reduction of volatile sulfur compounds as compared to water of at
least about 77.7%.” The Specification indicates that one can measure a
reduction of volatile sulfur compounds in vivo or in vitro. See Spec. 15:6–
15:27, 32:7–34:7. Accordingly, we see no basis to read an in vivo efficacy
requirement into the claim.
Moreover, Natsch is presumed enabled. “[A] prior art publication
cited by an examiner is presumptively enabling barring any showing to the
contrary by a patent applicant.” In re Antor Media Corp., 689 F.3d 1282,
1288 (Fed. Cir. 2012). Here, Appellants merely speculate regarding a
purported lack of in vivo efficacy of Natsch’s compositions, but provide no
persuasive evidence supporting that speculation. Despite having recreated
the Natsch formulation (see, e.g., Ramji 2015 Decl.3 ¶ 5), Appellants did not
present the results of any in vivo testing of the deodorization effects of this
formulation to substantiate their contention.
Appellants argue that two mouthrinses that purportedly fall within the
claims deliver more anisaldehyde to the mouth than Natsch’s mouthspray,
and that a person of ordinary skill in the art thus would not have expected in
vivo deodorization based on the amount of anisaldehyde delivered by
Natsch’s mouthspray. Br. 11–12. These arguments are not persuasive.
First, Appellants’ estimate of the amount of anisaldehyde delivered to the
mouth from Natsch’s mouthspray is a function of the pump used in
Appellants’ experiment and the number of pumps selected by Appellants.

3 Declaration Under 37 C.F.R. § 1.132 by Niranjan Ramji, dated Aug. 24,
2015 (“Ramji 2015 Declaration” or “Ramji 2015 Decl.”).
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See Ramji 2015 Decl. ¶ 8. However, there is nothing inherent in Natsch’s
formulation or expressed in Natsch itself that requires use of the particular
selected pump or number of pumps. Second, as discussed above, Natsch’s
mouthspray includes additional active agents beyond anisaldehyde.
Appellants’ analysis has not addressed the contribution of these additional
agents on in vivo deodorization.
Appellants make several additional arguments based on purported
distinctions between the formulation requirements of mouthsprays (as
disclosed in Natsch) on the one hand, and “mouthwashes” and
“mouthrinses” on the other. Br. 7–12. These arguments are not persuasive,
because once again, they are not relevant to Appellants’ claims. Claim 13 is
directed to a “dentifrice,” not a mouthrinse. Appellants make no arguments
regarding whether the level of alcohol and solubilizer in Natsch’s Example
6(d) can or cannot be used in a dentifrice. In any event, on this record, we
are not persuaded that the preamble affords any patentable weight. “[A]s a
general rule preamble language is not treated as limiting.” Arctic Cat Inc. v.
GEP Power Prods., Inc., 919 F.3d 1320, 1327 (Fed. Cir. 2019) (internal
quotation marks and citations omitted). “[A] preamble is not limiting
‘where a patentee defines a structurally complete invention in the claim body
and uses the preamble only to state a purpose or intended use for the
invention.’” Id. at 1328 (quoting Catalina Mktg. Int’l, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). Here, in the
absence of any arguments that the preamble term “dentifrice” is limiting and
that Natsch’s Example 6(d) can’t be used as a dentifrice, we decline to
accord invention-defining effect to the preamble.
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For the above reasons, we affirm the rejection of claims 13 and 14
under 35 U.S.C. § 103 as being obvious over Natsch.
Nonstatutory Obviousness-Type Double Patenting
The Examiner provisionally rejected claims 1, 6, 13, and 14 over
claims 1, 5, and 7–9 of U.S. Patent Application No. 13/529,044. Final Act.
11. On November 13, 2018, this application issued as U.S. Patent
10,123,953 B2, with 8 claims. Accordingly, the rejection is no longer
deemed to be “provisional.”
On appeal, Appellants did not address the Examiner’s nonstatutory
obviousness-type double patenting rejection. See, e.g., Br. 4–13; Ans. 10.
Arguments not presented in a brief are waived. See 37 C.F.R.
§ 41.37(c)(1)(iv) (2015) (“Except as provided for in §§ 41.41, 41.47 and
41.52, any arguments or authorities not included in the appeal brief will be
refused consideration by the Board for purposes of the present appeal.”).
Accordingly, in view of Appellants’ lack of response, we summarily
affirm the uncontested nonstatutory obviousness-type double patenting
rejection of claims 1, 6, 13, and 14 over claims 1, 5, and 7–9 of U.S. Patent
Application No. 13/529,044 (now U.S. Patent 10,123,953 B2).
SUMMARY
The rejection of claims 1 and 6 under 35 U.S.C. § 103 as being
obvious over Natsch is reversed.
The rejection of claims 13 and 14 under 35 U.S.C. § 103 as being
obvious over Natsch is affirmed.
The rejection of claims 1, 6, 13, and 14 for nonstatutory double
patenting over claims 1, 5, and 7–9 of U.S. Patent Application No.
13/529,044 (now U.S. Patent 10,123,953) is affirmed.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED