James Ratcliff et al.

Patent Trials and Appeals Board

Jan 28, 2021

2020002938 (P.T.A.B. Jan. 28, 2021)

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.
13/115,815 05/25/2011 James L. Ratcliff 2886-A-93 4196
26740 7590 01/28/2021
BYCER LAW, PLC
Matthew L. Bycer
7220 N 16TH STREET
SUITE H
PHOENIX, AZ 85020
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
01/28/2021 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):
Kathi@BycerLaw.com
Matt@BycerLaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES L. RATCLIFF, KAREN BLACK,
WILLIAM E. COOLEY and ESMERALDA ANN GARCIA
__________

Appeal 2020-002938
Application 13/115,815
Technology Center 1600
__________

Before FRANCISCO C. PRATS, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 42–44, 46, 53–56, 59, 61–65, and 67–
72. Appellant presented oral argument on January 7, 2021. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Rowpar Pharmaceuticals, Inc., of
Scottsdale, Arizona, as the real party in interest. Appeal Br. 3.
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STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 42–44, 46, 53–56, 59, 61–65, and 67–72, under 35 U.S.C.
§ 103, as being unpatentable over Ratcliff,2 Elton,3 and Gaffar4 (Ans. 3–15);
and
(2) Claims 42–44, 46, 53–56, 59, 61–65, and 67–72, provisionally
rejected for obviousness-type double patenting over claims 27, 30, 31, and
40–45 of copending application 13/131,506 in view of Ratcliff and Elton
(Ans. 15–16).
Appellant’s claim 42 is representative of the subject matter on appeal,
and reads as follows:
42. An antimicrobial and anticaries oral care single phase
composition comprising:
(a) a chlorine dioxide source at a concentration ranging
from 0.05% to 0.6% (w/w) wherein chlorite ion and chlorine
dioxide are in equilibrium;
(b) at least two buffering compounds, wherein a first
buffering compound comprises a phosphate ion selected from
the group consisting of disodium hydrogen phosphate,
trisodium phosphate, and a pyrophosphate salt and a second
buffering compound is selected from the group consisting of
citric acid, acetic acid, and fumaric acid;
(c) said buffer adapted to achieve and maintain the pH of
the composition in the range from 6.5 to 8.0;
(d) an emulsified flavoring system comprising a flavoring
agent and an emulsifier;

2 US 5,348,734 (issued Sept. 20, 1994).
3 US 4,420,471 (issued Dec. 13, 1983).
4 US 5,531,982 (issued July 2, 1996).
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(e) a source of fluoride ion comprising stannous fluoride,
sodium fluoride and sodium monofluorophosphate;
(f) a sweetener comprising sucralose, sodium saccharin,
and/or sucrose; and
(g) water;
wherein said composition generates safe and efficacious
amounts of chlorine dioxide upon administration in the
oral cavity.
Appeal Br. 9.
OBVIOUSNESS
The Examiner’s Prima Facie Case
In rejecting Appellant’s representative claim 42 for obviousness, the
Examiner cited Ratcliff as disclosing mouthwashes and toothpastes that
include a chlorine dioxide source in an amount encompassed by claim 42,
the phosphate compounds recited in claim 42, flavorings, fluoride, and water
as recited in claim 42, the compositions having a pH encompassed by claim
42. Ans. 3–6.
The Examiner found that Ratcliff’s oral compositions differ from the
oral compositions recited in representative claim 42 in that
Ratcliff does not expressly teach: (b) the specific acid
claimed (e.g., citric acid; acetic acid; and fumaric acid), (d) a
flavor agent and an emulsifier (e) the presence of each of
stannous fluoride, sodium fluoride and sodium
monofluorophosphate, and (f – in Claim 42) . . . the specific
sweetener claimed (sucralose; sodium saccharin; and/or
sucrose).
Ans. 6–7 (italics and emphases omitted).
The Examiner cited Elton as evidence that it would have been obvious
to include citric acid, acetic acid, and/or fumaric acid in Ratcliff’s oral care
compositions, as well as the sweeteners and flavor/emulsifier flavoring
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system recited in claim 42. Ans. 7–8. The Examiner cited Gaffar as
evidence that it would have been obvious to include stannous fluoride,
sodium fluoride, and sodium monofluorophosphate in Ratcliff’s oral care
compositions. Ans. 8.
In particular, the Examiner reasoned that a skilled artisan would have
considered it obvious “to incorporate a flavor agent and emulsifier as
described by Elton in the mouthwash disclosed by Ratcliff as it was
conventional to incorporate a flavor agent and emulsifier into a mouthwash”
and also would have found it obvious “to incorporate a sweetener (e.g.,
sucrose, saccharin, maltose, etc.) as disclosed by Elton into the mouthwash
disclosed by Ratcliff.” Ans. 9.
The Examiner reasoned that, “[r]egarding the second buffering agent,
Elton teaches that the flavor agent tartness may be accentuated by adding a
flavor adjunct such as, inter alia, acetic, citric, fumaric acids” and that a
skilled artisan, therefore, “would have found it obvious to incorporate a
flavor adjunct such as citric, fumaric or acetic acid into the compositions
suggested by Ratliff and Elton.” Ans. 9–10.
The Examiner further reasoned:
Given that well known anticarious [sic] agents such as sodium
fluoride, stannous fluorides, sodium monofluorophosphate
(MFP) and mixtures thereof provide additional anticaries
activity at provided amounts ranging from 250 ppm to 1500
ppm as described by Gaffar, one of ordinary skill in the art
would have recognized that their addition to the oral care
compositions taught by Ratcliff (see Table 1; Table 4) would
provide anticaries effectiveness to Ratcliff compositions.
Ans. 11.
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Analysis
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.
In the present case, having carefully considered all of the arguments
and evidence advanced by Appellant and the Examiner, Appellant does not
persuade us that the preponderance of the evidence fails to support the
Examiner’s conclusion that the oral care composition recited in Appellant’s
representative claim 42 would have been obvious in view Ratcliff, Elton,
and Gaffar.
As the Supreme Court has explained, “when a patent simply arranges
old elements with each performing the same function it had been known to
perform and yields no more than one would expect from such an
arrangement, the combination is obvious.” KSR Int'l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007) (internal quotations omitted).
Here, it is undisputed that each of the ingredients in the composition
recited in Appellant’s claim 42 was known in the art to be useful in oral care
compositions. Specifically, as the Examiner found, and Appellant does not
dispute, Ratcliff discloses oral care compositions, including mouthwashes,
which contain a stabilized chlorine dioxide source encompassed by claim 42,
and which also includes the phosphate compounds recited in the claim, and
the claimed pH. See Ratcliff, abstract (disclosing a “stable mouth wash or
dentifrice composition containing stabilized chlorine dioxide and
phosphates” in which “[t]he preferred concentration ranges are between
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about 0.005%–0.5% chlorine dioxide,” and in which “[t]he phosphate
retards escape of chlorine dioxide in the pH range (6.0 to 7.4) typically
found in a mouth”); see also id. at 4:17–22 (disclosing that “an activating
inhibitor phosphate such as disodium hydrogen phosphate, sodium
dihydrogen phosphate, or, preferably, trisodium phosphate, will allow the
stabilized chlorine dioxide to remain stable and effective at a lower Ph than
has been thought possible”).
While Ratcliff does not disclose including the fluoride sources recited
in Appellant’s representative claim 42 in its oral care compositions, Gaffar
discloses that the claimed fluoride compounds were known to be useful in
oral care compositions. See Gaffar 8:32–34 (disclosing oral compositions in
which “[a]lkali metal and tin fluorides, such as sodium and stannous
fluorides, sodium monofluorophosphate (MFP) and mixtures thereof, are
preferred”) (emphasis added). Appellant does not assert, nor do we discern,
error in the Examiner’s findings that, based on the teachings in Gaffar, a
skilled artisan had sufficient reason for, and a reasonable expectation of
success in, including the fluoride sources recited in Appellant’s
representative claim 42 in Ratcliff’s oral care compositions.
Turning to the flavoring system of Appellant’s representative claim
42, largely at issue in this appeal, although Ratcliff does not disclose that its
compositions contain a flavoring system composed of a flavor agent and
emulsifier as recited in claim 42, Ratcliff does disclose combining its
stabilized chlorine dioxide/phosphate composition with flavor-containing
toothpastes. See Ratcliff 6:61–62 (disclosing “Aquafresh for Kids Fluoride
toothpaste bubblemint flavor” for use in stability experiments); see also id.
at 7:66–8:25 (“Chlorine dioxide content in Aqua Fresh toothpaste remained
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stable for the first 21 days (78–100% of ClO2 remaining) at all Ph levels. A
sharp drop in chlorine dioxide concentration occurred on day 28; the reason
for the decrease is not clear.”).
Elton, moreover, discloses that it was useful to include a flavoring
system composed of a citrus oil flavor agent and emulsifier in mouthwashes,
and that combining the flavoring agent and emulsifier is advantageous
because it alleviates flammability hazards involved in handling volatile
alcohols used in conjunction with the flavor oils. See Elton, abstract (“A
method is disclosed for preparing visually clear, stable aqueous citrus
flavored mouthwash compositions. The procedure reduces flammability
hazards associated with mixing volatile alcohols and eliminates the necessity
of certain production equipment.”).
Elton explains that the steps involved in preparing the mouthwash
include “(a) preparing a blend of the alcohol with the citrus flavor oil; (b)
preparing a second blend of water and the emulsifier; (c) subsequently
combining blends (a) and (b); and (d) intimately mixing the resultant
combination.” Elton, abstract.
Elton discloses that the emulsified flavor oil can be mixed with typical
mouthwash ingredients, in a variety of sequences:
A stable, clear citrus flavored mouthwash is prepared by
mixing ethanol with citrus flavor. This mixture is then added to
a water solution containing a food additive approved low-off
flavor nonionic emulsifier, a humectant and dyes. Additional
ingredients such as sodium lauryl sulfate, saccharin and other
typical mouthwash components may be either dissolved prior to
or subsequent to the addition of the ethanol/flavor mix.
The subject process allows for the mixing of all normally
used mouthwash ingredients with the exception of the flavor
and ethanol into the water phase of the formulation. Dependant
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[sic] upon the exact formulation of the mouthwash and the
mixing facilities, the order of ingredient addition can be varied.
The only restriction is that the emulsifier be mixed into the
water prior to the addition of the ethanol/flavor blend.
Elton 2:38–54.
As the Examiner found, and Appellant does not dispute, Elton
discloses that the acids and sweeteners recited in Appellant’s representative
claim 42 are among the typical mouthwash ingredients that may be
combined with its emulsified flavor agents. See Elton 4:47–5:1 (disclosing
that the “water phase, either prior to or after the addition of alcohol/flavor oil
may contain adjunct mouthwash ingredients” among them “[s]uitable
sweetening agents includ[ing] sucrose . . . [and] saccharin” as well as
preferred “tartness accentuators” such as “citric, ascorbic, acetic, malic,
succinic, fumaric and maleic acids”).
Thus, to summarize, Elton teaches that its emulsified flavoring agents
are advantageous because they alleviate flammability hazards involved in
handling volatile alcohols used in conjunction with the flavor oils in
mouthwashes, and Ratcliff teaches that its stabilized chlorine dioxide
components are compatible with flavor containing components used in oral
care compositions. We therefore agree with the Examiner that a skilled
artisan had sufficient motivation for, and a reasonable expectation of success
in, including Elton’s emulsified flavoring agents, as well as the sweeteners
and acids disclosed in Elton, in a mouthwash composition containing
Ratcliff’s stabilized chlorine dioxide components. We therefore also agree
with the Examiner that, when the teachings in Ratcliff and Elton are viewed
alongside the teachings in Gaffar, a skilled artisan would have considered
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the composition recited in Appellant’s representative claim 42 to be prima
facie obvious.
Appellant’s arguments do not persuade us to the contrary. Appellant
contends that a skilled artisan would not have arrived at the claimed
invention by combining Ratcliff and Elton in the manner posited by the
Examiner, as evidenced by the disclosure in Appellant’s Specification that a
specific set of ingredients, and a specific order of combining those
ingredients, is required to create a stable flavored chlorine dioxide
composition. Appeal Br. 10–17; Reply Br. 2–5. We do not find these
arguments persuasive of Examiner error.
As an initial matter, we note that Appellant’s representative claim 42
does not include any express limitations regarding the stability of the
claimed composition. See Appeal Br. 27. Accordingly, to the extent
Appellant argues that the combined teachings of Ratcliff, Elton, and Gaffar
would not have led a skilled artisan to a stable flavored chlorine dioxide
composition, Appellant’s argument is not directed to a limitation in
Appellant’s representative claim 42.
We note, moreover, that representative claim 42 does not require the
claimed composition to be prepared by combining the flavoring agent and
the emulsifier before adding the other ingredients to the composition. See
Appeal Br. 27.
Appellant, however, repeatedly contends that combining the flavoring
agent and the emulsifier before adding the other ingredients is critical to
achieving a composition distinct from that suggested by the cited prior art:
[A] stable flavored single-phase aqueous SCD [stabilized
chlorine dioxide] oral care composition . . . is accomplished by
emulsifying flavor oils, with non-ionic, polar surfactants prior
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to a combination with SCD. This specific composition has
been discovered to shield[] the flavor oils from premature
reaction with chlorine dioxide so as to allow persistence of
flavor, up to the time of use.
Appeal Br. 10–11; id. at 14 (“As shown in the Specification, the mere
combination of ingredients would not result in a successful SCD [stabilized
chlorine dioxide] composition unless the method taught by the present
disclosure is followed, and a specific flavor system is []reacted and then
added to the SCD aqueous solution.”); Reply Br. 4–5; see also Spec. 47–48
(Examples 1 and 2 describing preparation of a first mixture composed of
flavoring agent and emulsifier, and then combining first mixture with a
second mixture composed of water, sweetener, phosphate buffer, and
stabilized chlorine dioxide liquid, and then adjusting pH with organic acid).
Thus, to the extent Appellant argues that the method of preparation
distinguishes the claimed composition from the composition suggested by
the cited references, Appellant’s argument is again not directed to a
limitation in Appellant’s representative claim 42.
We are also not persuaded that the ingredients of claim 42 would
inherently result in a stable composition, notwithstanding the absence of any
express limitation in claim 42 as to stability. We acknowledge, as Appellant
contends, that Oral Rinses 4 and 5, which have ingredients substantially
consistent with representative claim 42, and include polysorbate as the
emulsifier, have significant stability. See Spec. 43–47.
Appellant’s representative claim 42, however, encompasses the use of
any “emulsifier” in the claimed composition. Appeal Br. 27. Representative
claim 42 therefore does not require the presence of polysorbate, which is the
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sole emulsifier shown in the Specification to provide the stability properties
asserted as distinguishing over the cited prior art.
Indeed, claim 42 encompasses the use of ethoxylated hydrogenated
castor oil as the emulsifier in the claimed composition. See Spec. 23
(disclosing that ethoxylated hydrogenated castor oils are surfactants which
emulsify the flavoring agent). However, Oral Rinses 1–3, which Appellant
identifies as not providing the stability properties distinguishing the claimed
invention over the prior art (see Appeal Br. 17 n.24), use ethoxylated
hydrogenated castor oil as the emulsifier, and include ingredients
substantially consistent with representative claim 42. See Spec. 40.
We note, moreover, that although Appellant’s representative claim 42
encompasses ethoxylated hydrogenated castor oils as the emulsifier in the
claimed composition, Appellant’s Specification expressly describes
ethoxylated hydrogenated castor oils as being unsuitable for providing the
stability properties alleged to distinguish the claimed composition over the
composition suggested by the cited prior art. See Spec. 43 (“Castor oil and
castor oil derivatives (including hydrogenated castor oils and ethoxylated
hydrogenated castor oils) are excluded as emulsifiers for the present
invention because it is believed the structure of these compounds do not
make them compatible with chlorine dioxide sources or chlorine dioxide.”).
In sum, for the reasons discussed, we are not persuaded that
Appellant’s representative claim 42 includes express limitations, particularly
as to stability, that distinguish the composition of claim 42 from the
compositions suggested by Ratcliff, Elton, and Gaffar. Appellant’s
representative claim 42, moreover, encompasses ingredients, in particular
emulsifiers, which do not inherently impart the stability properties asserted
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by Appellant as distinguishing the claimed composition over the cited prior
art. Appellant does not persuade us, therefore, that following the teachings
of Ratcliff, Elton, and Gaffar would not have led a skilled artisan to a
composition encompassed by Appellant’s representative claim 42.
Appellant contends that the Examiner used improper hindsight in
finding that a skilled artisan would have combined Ratcliff and Elton,
because Elton requires a sequence of combining its ingredients which would
have been expected to result in reaction of the alcohol in Elton’s flavoring
system with Ratcliff’s stabilized chlorine dioxide. Appeal Br. 17–19; Reply
Br. 9–11. We are not persuaded.
We acknowledge, as Appellant contends, that Ratcliff discloses that
chlorine dioxide was known to react with alcohols. See Ratcliff 3:1–8
(“Chlorine dioxide, ClO2, functions biochemically in many ways other than
as a germicide. These functions include . . . (5) oxidation of alcohols . . . .”).
As the Examiner contends, however, Ratcliff later distinguishes the
normal reactivity of chlorine dioxide with the stabilized chlorine dioxide of
its invention, which allows its incorporation into oral care compositions. See
Ratcliff 3:66–4:2 (“The addition of activating inhibitor phosphates to the
stabilized chlorine dioxide retards the rapid escape of chlorine dioxide gas at
the Ph range of 6.5 to 7.0 typical of the mouth.”).
Moreover, as noted above, and as the Examiner also points out,
Ratcliff discloses that its stabilized chlorine dioxide formulation is
compatible with flavor containing oral care compositions. See Ratcliff 6:61–
62 (disclosing “Aquafresh for Kids Fluoride toothpaste bubblemint flavor”
for use in stability experiments); see also id. at 7:66–8:25 (“Chlorine dioxide
content in Aqua Fresh toothpaste remained stable for the first 21 days (78–
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100% of ClO2 remaining) at all Ph levels. A sharp drop in chlorine dioxide
concentration occurred on day 28; the reason for the decrease is not clear.”)
(emphasis added).
Thus, while we acknowledge that Elton’s flavoring compositions
contain alcohols such as ethanol, Appellant does not persuade us that Elton
or Ratcliff include teachings that would have dissuaded a skilled artisan
from incorporating Elton’s emulsified flavoring compositions into a
mouthwash containing Ratcliff’s stabilized chlorine dioxide formulation.
We again note, moreover, that Appellant’s representative claim 42 does not
include any express limitations as to the stability of the claimed
composition. Thus, to the extent that Ratcliff might have suggested that the
composition would be stable for only 21 days (see Reply Br. 3–4 (citing
Ratcliff Table 2)), Appellant’s argument as to the allegedly superior stability
of the claimed composition is not directed to a limitation actually present in
Appellant’s representative claim 42.
Appellant advances the declarations of Drs. Cooley and Shewale as
evidence that, notwithstanding Ratcliff’s express disclosures that its
stabilized chlorine dioxide formulations retard chlorine dioxide reactivity, a
skilled artisan would nonetheless have expected Ratcliff’s stabilized chlorine
dioxide formulations to react with the alcohols in Elton’s flavoring systems,
and therefore would have been dissuaded from combining the teachings of
Ratcliff and Elton as posited by the Examiner:
It is known in the art that the combination of alcohol and
stabilized chlorine dioxide is highly reactive in aqueous
solution. It would not be apparent to mix a flavor agent,
emulsifier and stabilized chlorine dioxide in the presence of
alcohol, as one would expect the chlorine dioxide to react with
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the alcohol, and the final solution would shortly he devoid of
chlorine dioxide.
Cooley Declaration5 ¶ 9; see also Shewale Declaration6 ¶ 12 (identical
statement); see also Appeal Br. 21–22 (arguing teaching away).
It is well settled, however, that to be persuasive of nonobviousness,
an expert’s opinion must be supported by objective evidence. See Ashland
Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir.
1985) (“Lack of factual support for expert opinion going to factual
determinations . . . may render the testimony of little probative value in a
validity determination.”) (citing In re Altenpohl, 500 F.2d 1151, 1158
(CCPA 1974)).
In the present case, neither Dr. Cooley nor Dr. Shewale cites to any
objective evidence, such as a prior art publication, to support their
statements regarding the knowledge in the art. In contrast, as seen above,
the Examiner relies on the express teachings of Ratcliff as suggesting that
Ratcliff’s stabilized chlorine dioxide formulations would have been expected
to have reduced chlorine dioxide reactivity.
In addition, despite the alleged knowledge in the art of the reactivity
between alcohols and stabilized chlorine dioxide formulations, a number of
prior art disclosures identified by Appellant nonetheless describe preparing
oral care compositions containing stabilized chlorine dioxide and alcohols.
See Spec. 5 (citing “US 6582682” as describing flavored oral care
compositions containing stabilized chlorine dioxide and glycerin (glycerol));
id. at 7 (citing “TheraBreath” as describing flavored oral care compositions

5 Declaration of Dr. William E. Cooley (signed September 19, 2017).
6 Declaration of Dr. Jaiprakash G. Shewale (signed September 19, 2017).
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containing stabilized chlorine dioxide, glycerin, and xylitol)). Appellant
does not persuade us, therefore, that the testimony of Drs. Cooley and
Shewale is evidence sufficient to show that, notwithstanding the teachings in
Ratcliff and Elton identified by the Examiner, an ordinary artisan, armed
with the knowledge generally available to those skilled in the art, lacked
motivation or a reasonable expectation of success in combining Ratcliff and
Elton in the manner posited by the Examiner. Indeed, because skilled
artisans, as noted above, combined alcohols and stabilized chlorine dioxide
formulations when preparing oral care compositions, notwithstanding the
alleged knowledge in the art of the reactivity between those two
components, we do not find Appellant’s teaching away arguments
persuasive.
We note again, moreover, that Appellant’s representative claim 42
does not include any express limitations as to the stability of the claimed
composition. Thus, even if a skilled artisan might only have expected
stability for the time periods taught in Ratcliff, representative claim 42 lacks
express limitations sufficient to distinguish the claimed composition from
the composition suggested by the teachings of Ratcliff when combined with
Elton and Gaffar.
Appellant also does not persuade us that Elton fails to describe
combining its flavoring agent and emulsifier in a sequence that, when
combined with Ratcliff’s stabilized chlorine dioxide composition, would
arrive at the composition recited in Appellant’s representative claim 42. See
Appeal Br. 17–19.
In that regard, we again note Appellant’s repeated contention that
combining the flavoring agent and the emulsifier before adding the other
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ingredients is critical to achieving a composition distinct from that suggested
by the cited prior art, based on its stability. See Appeal Br. 10–11, 14; Reply
Br. 4–5; Spec. 47–48. Again, however, Appellant’s representative claim 42
does not require the claimed composition to be prepared by any particular
sequence of steps. Nor does representative claim 42 include any express
limitations as to stability. Thus, in arguing that a skilled artisan would not
have used the sequence of steps urged by Appellant as distinguishing over
the cited prior art, Appellant’s argument is not directed to a feature recited in
Appellant’s representative claim 42.
We note, moreover, that Elton discloses that the sequence of
combining its mouthwash ingredients can be varied, as long as the
flavor/alcohol/emulsifier emulsion is prepared before additional ingredients
are added:
A stable, clear citrus flavored mouthwash is prepared by
mixing ethanol with citrus flavor. This mixture is then added to
a water solution containing a food additive approved low-off
flavor nonionic emulsifier, a humectant and dyes. Additional
ingredients such as sodium lauryl sulfate, saccharin and other
typical mouthwash components may be . . . dissolved . . .
subsequent to the addition of the ethanol/flavor mix.
The subject process allows for the mixing of all normally
used mouthwash ingredients with the exception of the flavor
and ethanol into the water phase of the formulation. Dependant
[sic] upon the exact formulation of the mouthwash and the
mixing facilities, the order of ingredient addition can be varied.
The only restriction is that the emulsifier be mixed into the
water prior to the addition of the ethanol/flavor blend.
Elton 2:38–54 (emphasis added).
Thus, when read in context, while Elton’s disclosure includes the
“restriction . . . that the emulsifier be mixed into the water prior to the
addition of the ethanol/flavor blend” (Elton 2:52–54), Elton states expressly
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that the “other typical mouthwash components may be . . . dissolved . . .
subsequent to the addition of the ethanol/flavor mix” (id. at 2:44–45
(emphasis added)). Accordingly, as the Examiner contends, the teachings of
Elton encompass first preparing an emulsion that contains the flavoring
agent, alcohol, and emulsifier, and then adding the remaining mouthwash
ingredients, such as Ratcliff’s stabilized chlorine dioxide formulation—a
sequence of preparative steps consistent with those described in Appellant’s
Specification, and argued by Appellant, as providing a stabilized flavored
chlorine dioxide oral preparation.
In sum, for the reasons discussed above, Appellant does not persuade
us that the evidence of record fails to support the Examiner’s determination
that the composition recited in Appellant’s representative claim 42 would
have been prima facie obvious to a skilled artisan in view of Ratcliff, Elton,
and Gaffar. For the reasons discussed below, Appellant does not persuade
us that it has advanced objective evidence of nonobviousness, also known as
secondary considerations, sufficient to outweigh the prior art evidence of
obviousness advanced by the Examiner.
As objective evidence of nonobviousness, Appellant advances the
significant effort that was required to achieve a stable flavored chlorine
dioxide oral composition, the long-felt need for achieving a stable flavored
chlorine dioxide oral composition, alleged teachings away (which we
addressed above), and commercial success. Appeal Br. 19–25; Reply Br.
12–15.
As our reviewing court has explained, “[f]or objective evidence to be
accorded substantial weight, its proponent must establish a nexus between
the evidence and the merits of the claimed invention.” In re GPAC Inc., 57
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F.3d 1573, 1580 (Fed. Cir. 1995). In particular, the objective indicia “must
be tied to the novel elements of the claim at issue” and must “‘be reasonably
commensurate with the scope of the claims.’” Institut Pasteur & Universite
Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013)
(quoting Rambus Inc. v. Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)).
In the present case, we agree with the Examiner that Appellant has not
shown sufficiently that the composition of Appellant’s representative claim
42 has a nexus to the objective evidence advanced by Appellant, nor has
Appellant shown that objective evidence is reasonably commensurate in
scope with the composition recited in representative claim 42.
We acknowledge Appellant’s argument, supported by Declarations by
Drs. Ratcliff, 7 Cooley, and Shewale, that significant effort was required to
achieve a stable flavored chlorine dioxide oral composition. Appeal Br. 19–
21.
As discussed above, however, and as Appellant repeatedly argues, the
culmination of Appellant’s efforts disclosed in the Specification are Oral
Rinses 4 and 5, which are stable oral rinses that are prepared by a specific
sequence (combining flavor and emulsifier first and then combining the
other ingredients), and which have a specific emulsifier (polysorbate) that
Appellant concedes is critical to the asserted superior stability. As also
discussed above, Appellant’s representative claim 42 does not recite any
limitations as to the stability of the claimed composition, nor does
representative claim 42 require the claimed ingredients to be combined in
any particular order. And, as also discussed above, Appellant’s

7 Declaration of Dr. James L. Ratcliff (signed September 20, 2017).
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representative claim 42 as currently drafted encompasses any emulsifier,
including emulsifiers shown in Appellant’s own Specification to not provide
the asserted stability advantages. Accordingly, because representative claim
42 does not recite limitations that are tied to the features of the embodiments
representing the successful culmination of Appellant’s efforts, we agree with
the Examiner that Appellant has not established a sufficient nexus between
the invention as claimed, and the evidence of significant efforts, nor has
Appellant explained sufficiently why representative claim 42 is
commensurate in scope with the embodiments asserted as being superior to
the composition suggested by the prior art.
We acknowledge Appellant’s argument that the claimed invention
solves a long-felt need. Appeal Br. 23–24; Reply Br. 14–15. Again,
however, Appellant repeatedly characterizes solving the long-felt need as
providing a stable composition, superior to the allegedly unstable prior art
flavored chlorine dioxide compositions. See id.
While Oral Rinses 4 and 5 are asserted as solving the long-felt need,
we again note that those compositions are stable oral rinses that are prepared
by a specific sequence of steps (combining flavor and emulsifier first and
then combining the other ingredients), and which have a specific emulsifier
(polysorbate) that Appellant concedes is critical to the asserted superior
stability. Again, Appellant’s representative claim 42, as currently drafted,
does not recite any limitations tied to any of the features (stability, sequence
of ingredient mixing, polysorbate) of the Specification’s embodiments
asserted as solving the alleged long-felt need. Accordingly, we are not
persuaded that Appellant has established a sufficient nexus between the
invention as claimed, and the evidence of solving a long-felt need, nor are
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we persuaded that Appellant has explained sufficiently why representative
claim 42 is commensurate in scope with the embodiments asserted solving
the alleged long-felt need.
We acknowledge Appellant’s arguments regarding commercial
success. Appeal Br. 24–25; Reply Br. 13–14.
In particular, we acknowledge Dr. Ratcliff’s testimony that, since the
2014 introduction of the ClōSYS “GentleMint Flavored Oral Rinse” the
percentage of flavored oral rinse products has grown to 19% of the total
ClōSYS oral rinse sales, and also that sales of ClōSYS oral rinses have
increased by 73%. Ratcliff Declaration ¶ 9–10.
Dr. Ratcliff also testifies that, since the 2011 introduction of ClōSYS
Mint Flavored Fluoride Toothpaste, the percentage of mint flavored fluoride
toothpaste products has grown to 60% of the total ClōSYS toothpaste sales,
and also that sales of ClōSYS toothpastes have increased by 54%. Ratcliff
Declaration ¶ 11–12.
The list of ingredients provided in Exhibit A of the Ratcliff
Declaration for ClōSYS Gentle Mint Flavor Oral Rinse is as follows:
“Active ingredient- sodium fluoride 0.05% (0.02 w/v fluoride ion)[;]
Inactive ingredients- water, stabilized chlorine dioxide, trisodium phosphate,
citric acid, peppermint flavor, sucralose.” Exhibit A, page 1.8
The ingredient list for the flavored fluoride-containing toothpaste
disclosed in Exhibit A of the Ratcliff Declaration is as follows: “sodium
fluoride, water, hydrated silica, sorbitol, stabilized chlorine dioxide,

8 Exhibit A of the Ratcliff Declaration does not include page numbers. We
numbered the pages consecutively.
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cellulose gum, dibasic sodium phosphate, titanium dioxide, flavor, sodium
phosphate, sucralose.” Exhibit A, page 3.
The ingredient list for the flavored fluoride-free toothpaste disclosed
in Exhibit A of the Ratcliff Declaration is as follows: “water, hydrated silica,
sorbitol, glycerin, stabilized chlorine dioxide, cellulose gum, trisodium
phosphate, titanium dioxide, flavor, sodium saccharin.” Exhibit A, page 4.
As is evident, none of the commercial products asserted in the Ratcliff
Declaration as proving the increased sales includes an emulsifier. This is
consistent with Appellant’s argument, which also fails to list an emulsifier
among the ingredients in the commercial products providing increased sales.
See Reply Br. 13 n. 44 (“The listing of ingredients for the embodied product
includes: Purified water, stabilized chlorine dioxide, trisodium phosphate,
citric acid, flavor, sucralose.).
Appellant’s representative claim 42, however, requires the claimed
composition to contain an emulsifier. See Appeal Br. 27. Indeed, as
discussed above, and as Appellant repeatedly argues, an emulsifier is critical
to the stability of Appellant’s compositions asserted as distinguishing over
the compositions suggested by the prior art. Thus, the commercial products
asserted by Appellant as providing commercial success lack a component
recited in claim 42, and which component is asserted by Appellant to be
critical to the improvement of the claimed invention over the cited prior art.
We therefore agree with the Examiner that Appellant has not established a
sufficient nexus between the invention as claimed, and the evidence of
commercial success, nor are we persuaded that Appellant has explained
sufficiently why representative claim 42 is commensurate in scope with the
embodiments asserted as providing commercial success.
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In sum, for the reasons discussed, Appellant does not persuade us that
the evidence of record fails to support the Examiner’s determination that the
composition recited in Appellant’s representative claim 42 would have been
prima facie obvious to a skilled artisan in view of Ratcliff, Elton, and Gaffar.
For the reasons discussed, Appellant does not persuade us that it has
advanced objective evidence of nonobviousness that, when considered
together with prior art evidence of obviousness, suffices to show the claim to
be nonobvious.
We determine, therefore, that the preponderance of the evidence
supports the Examiner’s conclusion that the composition recited in
Appellant’s representative claim 42 would have been obvious. Accordingly,
we affirm the Examiner’s rejection of representative claim 42 over Ratcliff,
Elton, and Gaffar. Because they were not argued separately, claims 46, 53–
56, 59, 61–65, 67, and 69–72 fall with representative claim 42. See 37
C.F.R. § 41.37(c)(1)(4) (“A statement which merely points out what a claim
recites will not be considered an argument for separate patentability of the
claim.”).
Appellant’s claim 43 reads as follows:
43. The composition as set forth in Claim 42 wherein
said emulsifier is comprised of a non-ionic, polar surfactant,
selected from the group consisting of: polyoxyethylene sorbitan
ester, polysorbate 20 or polysorbate 80 or a mixture of the two;
and wherein the concentration of said emulsifier is in the range
of 0.001 %.1 to 40.000% (w/w).
Appeal Br. 27–28.
As to claim 43, the Examiner found that “Elton teaches that the
suitable emulsifiers for the invention include, inter alia, Tween 80, Tween
40 and Tween 20 about 0.1 to about 2%. Elton, Claims 1,[]3.” Ans. 10; see
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also Elton 10:11–26 (Elton’s claim 1 reciting a mouthwash comprising
“about 0.1 to about 2.0% emulsifier” and claim 3 reciting “wherein the
emulsifier is . . . Polyoxyethylene 20 Sorbitan Trioleate” among other
polyoxyethylene sorbitan esters).
Appellant contends that the Examiner erred in finding that the
combined teachings of Ratcliff, Elton, and Gaffar render the composition
recited in Appellant’s claim 43 obvious because, “[e]ven if it would have
been obvious to combine an emulsified flavor system in an SCD
composition, the specific surfactants have been discouraged in the prior art
and are therefore independently patentable.” Appeal Br. 25. Appellant,
however, identifies no evidence of record to support the assertion that,
notwithstanding the teachings in Elton, a skilled artisan would have been
discouraged from including the emulsifiers recited in Appellant’s claim 43
in a mouthwash. We therefore affirm the Examiner’s rejection of
Appellant’s claim 43 for obviousness. Claim 68 falls with claim 43 because
it was argued in the same claim grouping. See 37 C.F.R. § 41.37(c)(1)(4)
Appellant’s claim 44 reads as follows:
44. The composition as set forth in Claim 42 wherein
said flavoring agent is comprised of oil of peppermint, oil of
spearmint, oil of wintergreen, oil of cinnamon, eucalyptus oil,
and artificial flavors, or a mixture thereof, wherein the
concentration of said flavoring agent is in the range of 0.005%
to 10.000% (w/w).
Appeal Br. 28.
As to claim 44, the Examiner found that “One of ordinary skill in the
art would have found it obvious to incorporate a desired flavor, including oil
of citrus oil (natural or synthetic), peppermint, oil of spearmint, oil of
wintergreen, and/or artificial flavors at concentrations 0.1- 0.5% or 0.25% to
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impart that flavor in the mouthwash.” Ans. 10 (citing Elton 2:55–65); see
also Elton 57–65 (disclosing the use of synthetic citrus flavor oils at
concentrations if about 0.01 to about 0.5% in its mouthwashes).
Appellant contends that the Examiner erred in finding that the
combined teachings of Ratcliff, Elton, and Gaffar render the composition
recited in Appellant’s claim 44 obvious because, “[e]ven if it would have
been obvious to combine an emulsified flavor system in an SCD
composition, the specific flavor oils have been discouraged in the prior art
and are therefore independently patentable.” Appeal Br. 25–26. Appellant,
however, identifies no evidence of record to support the assertion that,
notwithstanding the teachings in Elton identified by the Examiner, a skilled
artisan would have been discouraged from including the flavor oils recited in
Appellant’s claim 44 in a mouthwash. We therefore affirm the Examiner’s
rejection of claim 44 for obviousness.
DOUBLE PATENTING
In provisionally rejecting claims 42–44, 46, 53–56, 59, 61–65, and
67–72, for obviousness-type double patenting over claims 27, 30, 31, and
40–45 of copending application 13/131,506 in view of Ratcliff and Elton,
the Examiner applied a rationale similar to that advanced in the obviousness
rejection discussed above:
While the copending claims do not expressly claim a
flavor agent, emulsifier and water, the teachings of Ratcliff and
Elton are outlined above. One of ordinary skill in the art would
have found it obvious to incorporate a flavor agent with an
emulsifier as described by Elton in the copending composition
as it was conventional to incorporate water, a flavor agent and
emulsifier. The artisan would have also found it obvious to
combine the teachings of Ratcliff with the copending claims in
order to make the composition because, like the copending
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claims, Ratcliff teaches how to make stabilized ClO2
compositions useful for treating oral disease.
Ans. 15–16.
In traversing the Examiner’s double patenting rejection, Appellant
relies on the arguments advanced against the Examiner’s obviousness
rejection, discussed above. See Appeal Br. 26. (“As set forth above, the
invention as presently claimed is patentably distinct and non-obvious in
view of the prior art. Therefore, with the withdrawal of Section 103
rejections to the claims, the double patenting rejection should also be
withdrawn.”). Accordingly, for the reasons discussed above in relation to
the Examiner’s obviousness rejection, we also affirm the Examiner’s
provisional rejection for obviousness-type double patenting.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
42–44, 46,
53–56, 59,
61–65, 67–
72
103 Ratcliff, Elton,
Gaffar
42–44, 46,
53–56, 59,
61–65, 67–
72

42–44, 46,
53–56, 59,
61–65, 67–
72
Double Patenting
over Application
13/131,506,
Ratcliff, Elton
42–44, 46,
53–56, 59,
61–65, 67–
72

Overall
Outcome
42–44, 46,
53–56, 59,
61–65, 67–
72

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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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED