Colgate-Palmolive Company

Patent Trials and Appeals Board

Dec 20, 2021

2021000619 (P.T.A.B. Dec. 20, 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.
15/805,219 11/07/2017 Carl Myers 11343-00-US-01-OC 2617
23909 7590 12/20/2021
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
WEBB, WALTER E
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/20/2021 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):
Patent_Mail@colpal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CARL MYERS
Appeal 2021-000619
Application 15/805,219
Technology Center 1600
Before RICHARD M. LEBOVITZ, DEBORAH KATZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims to a two phase composition that
includes a copolymerized product of a mixture of acrylic acid, methacrylic
acid, and anionic 2-hydroxyethyl methacrylate phosphate polymer for being
of improper dependent form, as being obvious, and for non-statutory double
patenting. 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 the real party in interest as Colgate-Palmolive
Co. (Appeal Br. 2.)
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STATEMENT OF THE CASE
“Dental plaque is a biofilm that adheres to tooth and other oral
surfaces, particularly at the gingival margin, and is implicated in the
occurrence of gingivitis, periodontitis, caries and other forms of periodontal
disease.” (Spec. ¶ 2.) “Anaerobic bacteria in plaque metabolize sugar to
produce acids that dissolve tooth minerals, damaging the enamel and
eventually forming dental caries.” (Id.) “Various antibacterial agents can
retard the growth of bacteria and thus reduce the formation of biofilm on
oral surfaces.” (Id. ¶ 3.) “In many cases, these antibacterial agents are
cationic.” (Id.)
Discoloration of the tooth surface can occur from the use of tobacco
products, and eating or drinking certain foods and beverages. (Id. ¶ 4.) The
“color causing substances in these materials become part of the pellicle layer
and can permeate the enamel layer.” (Id.) “[T]he compounds that stain the
teeth are typically anionic materials.” (Id. ¶ 6.) “[C]ationic antibacterial
agents can cause or enhance staining by facilitating the deposit of
chromogens or by forming salts with minerals.” (Id.)
“One approach to reducing staining and erosion as well as reducing
biofilm formation is the use of anionic polymers that help coat and protect
the enamel, discouraging bacterial attachment and repelling chromagens.”
(Spec. ¶ 7.) These polymers “can interact with cationic antimicrobial agents
. . ., particularly in high water formulations, such as mouthwashes, and [can]
inhibit[] delivery of the antimicrobial agent and/or the polymer.” (Id.)
Appellant’s claimed invention is directed to “aqueous biphasic
compositions useful for combining and delivering poorly compatible
ingredients, for example to deliver effective levels of cationic antibacterial
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agents in combination with polymers that protect against erosion and
staining.” (Id. ¶ 1.)

Claims 1, 5, 6, and 8–18 are on appeal. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A composition comprising an aqueous solution of
a) an acidic polymer, wherein the acidic polymer is selected
from a combination of
i) 1:4 to 4:1 copolymers of maleic anhydride or acid
with another polymerizable ethylenically
unsaturated monomer, wherein some or all of the
anhydride moieties are hydrolyzed to provide free
carboxyl groups,
and
ii) co-polymerized products of a mixture of acrylic
acid, methacrylic acid, and 2-hydroxyethyl
methacrylate phosphates of Formula 1:

wherein n is 0, 1 or 2;
b) a nonionic polymer selected from polyethylene glycol
having a molecular weight of 5kD to 35kD;
c) optionally an effective amount of cationic active agent;
d) a stabilizing amount of lysine, in free or salt form, wherein
the lysine is present in an amount of about 1 to 10% by
weight, relative to the total weight of the composition;
e) water; and
f) an orally acceptable carrier;
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wherein the solution comprises two distinct aqueous phases
having different composition and density.
(Appeal Br. 10 (Claims App.).)
The prior art relied upon by the Examiner is:
Name Reference Date
Montgomery US 6,475,469 B1 Nov. 5, 2002
Mello et al. US 2013/0078197 A1 Mar. 28, 2013
Prencipe et al. US 2009/0202451 A1 Aug. 13, 2009
Kigawa H et al.2 JP2005-145889 A June 9, 2005
Zaidel WO 2015/094332 A1 June 25, 2015
lsbu Water Structure and Behavior:
Aqueous biphasic system,
available at
www.water.lsbu.ac.uk/water/aque
ous_biphasic.html
2006

The following grounds of rejection by the Examiner are before us on
review:
Claim 17 under 35 U.S.C. § 112(d), as being of improper dependent
form for failing to further limit the subject matter of the claim upon which it
depends.
Claims 1, 5, 6, and 8–18 under 35 U.S.C. § 103 as unpatentable over
Mello, lsbu, Zaidel, Prencipe, and Montgomery.
Claims 1, 5, 6, and 8–18 under 35 U.S.C. § 103 as unpatentable over
Kigawa H, Mello, lsbu, Zaidel, and Montgomery.

2 The Examiner relied on the DERWENT Translation (Final Action 7), as
do we.
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Claims 1, 5, 6, and 8–18, provisionally, on the ground of nonstatutory
double patenting as being unpatentable over claims 1, 3–16, and 18 of
copending Application No. 15/366,327.
Claims 1, 5, 6, and 8–18, provisionally, on the ground of nonstatutory
double patenting as being unpatentable over claims 1–20 of copending
Application No. 15/668,913.
Claims 1, 5, 6, and 8–18, provisionally, on the ground of nonstatutory
double patenting as being unpatentable over claims 1–17 of copending
Application No. 15/806,400.
DISCUSSION
Appellant does not contest the Examiner’s rejection of claim 17 under
35 U.S.C. § 112(d) or the Examiner’s provisional nonstatutory double
patenting rejections. Nor has Appellant filed a terminal disclaimer to
obviate the obviousness-type double patenting rejections. Accordingly, we
summarily affirm each of these rejections. Hyatt v. Dudas, 551 F.3d 1307,
1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of
rejection to the Board, . . . the Board may treat any argument with respect to
that ground of rejection as waived.”).

I. Obviousness: Mello, lsbu, Zaidel, Prencipe, Montgomery
The Examiner found that Mello teaches oral care compositions that
include arginine and a mucoadhesive polymer and provides a specific
mouthwash composition that includes an acidic polymer that is a copolymer
of methyl vinyl ether/maleic anhydride (0.65% gantrez, in which the
copolymer is from 1:4 to 4:1 methyl vinyl ether to maleic anhydride), 0.8%
arginine, 1.2% PEG40, and 4% propylene glycol, with the balance of the
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composition being water. (Final Action 3 (citing Mello Table 1, formula 1).)
The Examiner explained that “[b]ecause this embodiment comprises water
and a nonionic polymer, i.e. polyethylene glycol, it has an aqueous biphase,
as evidenced by lsbu.” (Id. at 4.) The Examiner states that “[a]lthough PEG
is inherently denser than water, it occupies the upper layer.” (Id.)
The Examiner noted that Mello also teaches that the composition can
include cetylpyridinium chloride (CPC) from 0.01–10%, as well as anionic
surfactants, and poloxamers from 0.01–10%. (Final Action 4.) The
Examiner also found that Mello teaches the oral compositions can include
less than 5% hydrophobic ingredients. (Id.)
The Examiner recognized that Mello does not teach inclusion of the
copolymer of Formula 1 (Final Action 4), or that the polyamine is lysine (id.
at 6), or that the PEG has a molecular weight within 5 kilodaltons (kDa) to
35 kDa (id.). However, the Examiner finds that the inclusion of these
materials in an oral composition would have been obvious to one of ordinary
skill in the art in light of the teachings of Zaidel, Prencipe, and Montgomery.
(Id. at 5–7.) In particular, the Examiner found that Zaidel teaches a mouth
rinse formulation that includes Gantrez S-97 and the claimed anionic
polymer of Formula 1 and that the Gantrez may help to deposit the
phosphate/acrylate copolymer on a dental surface and the phosphate/acrylate
copolymer is useful for treating or inhibiting “chemical stain, plaque, and/or
tartar on a dental surface.” (Id. at 5 (citing Zaidel ¶¶ 36, 54).) The
Examiner found that Prencipe teaches an oral care composition, including a
mouthwash, that can include a basic amino acid, such as lysine (Lys), which
basic amino acid is “useful for ‘combating cavity formation and tooth
sensitivity’.” (Id. at 6 (citing Principe ¶¶ 3, 8).) The Examiner also found
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that Prencipe teaches that the combination of basic amino acids and fluoride
unexpectedly promotes reminerlization, repairing pre-carious lesions, and
enhances oral health better than either compound separately. (Id. (citing
Prencipe ¶ 19).) The Examiner found that Montgomery teaches an oral care
composition for removing stains, including a mouthwash, that includes a
complexing agent that has an “affinity for the disassociated chromogen,”
such as PEG that preferably has a molecular weight between 2 kDa and 10
kDa. (Id. at 7 (citing Montgomery Abstr., 4:44–49, and 5:52).)
The Examiner explained that it would have been obvious to one
having ordinary skill in the art to have provided a PEG in the Mello
mouthwash composition having a molecular weight within the claimed range
in light of Montgomery’s teaching of the advantages of PEGs having a
molecular weight between 2 kDa and 10 kDa, namely, providing for stain
removal by complexing with a staining chromagen. (Id. at 7.) The
Examiner also explained that it would have been obvious to one having
ordinary skill in the art to have added a phosphate/acrylate copolymer of
Formula 1 in the Mello mouthwash composition in light of Zaidel’s teaching
of the advantage that such a phosphate copolymer has and Zaidel’s teaching
that Gantrez, such as used in Mello, can help the phosphate/acrylate
copolymer of Formula 1 deposit on the dental surface. (Id. at 5.) In
addition, the Examiner explained that it would have been obvious to one
having ordinary skill in the art to have substituted lysine for arginine in the
Mello composition for the advantages that Prencipe teaches lysine would
provide. (Id. at 6.)
Appellant has argued claim 1 and claim 6 separately. We address
claim 1 first. We agree with the Examiner’s conclusion of obviousness.
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Claim 1
Claim Construction
During prosecution, we interpret terms in a claim using the broadest
reasonable interpretation in light of the Specification. In re Morris, 127 F.3d
1048, 1055 (Fed. Cir. 1997). Claim 1 recites the following with respect to
the components of the composition: “A composition comprising . . . a) an
acidic polymer . . . b) a nonionic polymer selected from polyethylene glycol
. . . c) optionally an effective amount of cationic active agent d) a stabilizing
amount of lysine . . . , e) water; and f) an orally acceptable carrier . . . .”
(Appeal Br. 10 (emphasis added).) Notably, the plain language of the claim
indicates that inclusion of a “cationic active agent” is optional. Cadence
Pharms. Inc. v. Exela PharmSci Inc., 780 F.3d 1364, 1372 (Fed. Cir. 2015)
(“The plain and ordinary meaning of ‘optionally . . . topped . . . and placed’
is that both the topping and placing steps are optional.”)
Appellant’s Specification teaches that staining and erosion, as well as
reducing biofilm formation can be reduced by the use of anionic polymers,
and describes compositions without cationic active agents. (Spec. ¶¶ 7, 9,
11.) Consequently, we do not find Appellant’s statement that “by any
reading of the claims, the cationic active agents are represented in claim 1”
persuasive to establish that a cationic active agent is required by claim 1.
Thus, to find claim 1 obvious, the Examiner need not have established the
prior art teaches inclusion of a cationic agent.
Obviousness Analysis
As the Examiner noted in the Final Action, Table 1 of Mello discloses
a mouthwash composition that includes “Gantrez” (a copolymer of
polyvinylmethylether/maleic anhydride), arginine, PEG 40, and water.
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(Mello ¶ 70 (Table 1); see also id. ¶ 30 (describing Gantrez brand
copolymers).) Moreover, Mello discloses that Gantrez S-97 is a preferred
Gantrez mucoadhesive polymer. (Id. ¶ 30.) Although Mello Table 1 does
not specifically identify Gantrez S-97 was used, in light of Mello teaching
this is a preferred Gantrez copolymer of polyvinylmethylether/maleic
anhydride for use, we conclude that either the Gantrez identified in Table 1
that was used was Gantrez S-97 or it would have been obvious to have used
it in the compositions disclosed in Table 1. Also included are a number of
ingredients that Appellant’s Specification describes as “orally acceptable
carriers” (Spec. ¶¶ 26, 42, 43), e.g., flavor, sweeteners (sucralose, saccharin),
humectant (glycerin, sorbitol, propylene glycol) (Mello Table 1).
Mello states that “[a]rginine and other basic amino acids have been
proposed for use in oral care and are believed to have significant benefits in
combating cavity formation and tooth sensitivity” and notes that combining
basic amino acids in oral care compositions has proven challenging. (Id.
¶ 8.) Mello also notes that in mouthwash compositions in particular,
“[w]hile a variety of agents can be included . . . , their concurrent use may
not be possible due to interactivity, adverse reactions among reactive agents,
resulting in loss of activity.” (Id. at 9.) However, the purpose of Mello is to
provide a mouthwash composition that includes a variety of ingredients to
treat a variety of dental conditions, “including for example, dentinal
hypersensitivity, anticaries, bad breath, plaque formation, tartar control, stain
prevention/whitening, dry mouth, erosion, gingivitis, etc.” (Id., see also id.
¶ 10.) Mello states that “[t]he compositions provide mucoadhesivity and
film-forming properties that can be used to address hypersensitivity, dry
mouth, acid resistance, deminerialization, and the like. (Mello ¶ 23.) Mello
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also states that inclusion of a surfactant, such as a nonionic surfactant, in the
composition is provided to “compatibilize other components of the
composition and thereby provide enhanced stability.” (Id. ¶ 56.)
The Examiner provided adequate evidence that lsbu establishes that a
composition with PEG and water, which the Mello composition described in
Table 1 includes, would necessarily form an aqueous biphasic system which
is required by claim 1 (“wherein the solution comprises two distinct aqueous
phases”). Thus, as the Examiner explained, what is not taught in the
composition of Mello that is claimed, is a phosphate/acrylate copolymer of
Formula 1, a PEG having a molecular weight within the claimed range, and
lysine.
We find that the Examiner has provided sufficient evidence in the
record to establish a reason to provide a phosphate/acrylate copolymer of
Formula 1 to the composition of Mello from the teachings of Zaidel. “In
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.
What matters is the objective reach of the claim. If the claim extends to
what is obvious, it is invalid under § 103.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 419 (2007).
Zaidel explains regarding the use of phosphate/acrylate copolymer,
which refers to “a mixture of acrylic acid, methacrylic acid, and 2-
hydroxyethyl methacrylate phosphates of Formula l” (Zaidel ¶ 15), which is
identical to the recitation in claim 1 (ii), in mouthwash compositions:
The phosphate side group of a phosphate/acrylate co-polymer,
as disclosed herein, may function as an anchor to deposit the
co-polymer onto the tooth surface thereby forming a physical
layer on the tooth surface that may inhibit staining and/or
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biofilm formation. The copolymer may also prevent bacteria
from sticking together.
(Id. ¶ 23.) In addition, Zaidel teaches that combining such a
phosphate/acrylate copolymer with a polyvinylmethylether/maleic anhydride
(PVME/MA) copolymer such as Gantrez S-97, which is taught to be used in
the oral compositions of Mello, “may help phosphate/acrylate co-polymer
deposit on a dental surface due to its film forming property even though the
phosphate group as the side group in the phosphate/acrylate co-polymer can
anchor itself as well.” (Id. ¶ 54.) Consequently, the teachings of Mello and
Zaidel provide one of ordinary skill in the art with a reason to include the
claimed phosphate/acrylate copolymer in the composition of Mello that
includes the basic amino acid arginine, which is believed to help combat
tooth sensitivity, and the mucoadhesive polymer Gantrez, which is used to
“enhance the delivery and retention of the agents to, and retention thereof on
oral surfaces” (Mello ¶ 30).
In addition, we find that the Examiner has provided sufficient
evidence in the record from the teachings of Montgomery for adding a PEG
within the molecular weight range recited by claim 1. Montgomery teaches
that PEG having a molecular weight between 2 kDa and 10 kDa “does not
contribute significantly to the viscosity of the oral care composition” but is
suitable for use as a complexing agent so as to be able to complex with
phenolic chromogenic substances which form tooth stain when present on
pellicle on a surface of a tooth. (Montgomery 3:13–15, 44–60, 4:44–54.)
Finally, we conclude that Prencipe teaches the equivalence of arginine
and lysine in oral care compositions for their use in combating tooth
sensitivity that include an anionic surfactant such as a copolymer of methyl
vinyl ether and maleic anhydride, e.g., Gantrez S 97. (Prencipe ¶¶ 3, 15, 20,
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47, 75, 142–143, 183.) It is obvious to those skilled in the art to substitute
one known equivalent for another. See In re Omeprazole Patent Litigation,
483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in
[the] conclusion that it would have been obvious to one skilled in the art to
substitute one ARC [alkaline reactive compound] for another.”). The fact
that arginine or lysine may be part of the composition for a different purpose
(Appeal Br. 6) does not counsel against a finding of nonobviousness. In re
Lintner, 458 F.2d 1013, 1016 (CCPA 1972) (“The fact that appellant uses
sugar for a different purpose does not alter the conclusion that its use in a
prior art composition would be prima facie obvious from the purpose
disclosed in the references.”).
“[I]nterrelated teachings of multiple patents; the effects of demands
known to the design community or present in the marketplace; and the
background knowledge possessed by a person having ordinary skill in the
art, all [should be considered] in order to determine whether there was an
apparent reason to combine the known elements in the fashion claimed.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Here, the Examiner
has relied on prior art teachings of ingredients that are known to be used in
mouthwash compositions to provide specific benefits to establish a reason to
include all of the claimed elements recited by claim 1, and which address
stated features that Mello desires to provide in a therapeutic oral
composition. (Mello ¶ 10.) Thus, the fact that the prior art does not
recognize the problem to be solved is not determinative of non-obviousness
in this case. Consequently, we do not find Appellant’s reliance on Leo
Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013)
(Appeal Br. 5), which presented a very different factual scenario than
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presented here, establishes error in the Examiner’s rejection. In Leo
Pharmaceutical, prior art discouraged combining vitamin D analogs and
corticosteroids in a single formulation because of stability problems, thus
teaching away from mixing topical Vitamin D formulations with other
drugs. Leo Pharm., 726 F.3d at 1353. Other prior art relied on by the
Examiner in the rejection combined Vitamin D and corticosteroid but not
with the solvents claimed and Leo Pharmaceuticals presented experimental
evidence to the Board that demonstrated that the solvents that were used,
“harmed the storage stability of the vitamin D analog and corticosteroid
combination.” Id. at 1354. Beyond the foregoing, the prior art references
teaching the combination of Vitamin D and corticosteroid did not recognize
the storage stability problems. Id. There is no evidence here that the prior
art taught away from the combination of acidic polymers with a basic amino
acid. Nor is there evidence that the combination of acidic polymers with a
basic amino acid has some formulation problem.
Appellant also argues against the conclusion of obviousness by
asserting that the composition has an unexpected advantage. (Appeal Br. 4–
7.) In particular, Appellant notes that the acidic phosphate/acrylate co-
polymer claimed that has a phosphate side group has a stability problem in a
composition that also includes a cationic active agent, which problem “has
unexpectedly been solved by the addition of a polyamine.” (Id. at 5.)
Appellant states that “[i]t was not known at the time of the invention that the
claimed polyacrylic acid polymer would deactivate the cationic active agent
through precipitation.” (Id.)
Appellant further notes that “this unexpected stabilization effect is
established by data in the application.” (Id.) In particular, Appellant points
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to Example 3, compositions 2 and 3, which differ only by the absence or
presence of lysine. (Id.) Appellant explains that composition 2 included 6
wt. % PEG, 2.5 wt. % of the claimed polyacrylic acid polymer and 0.075 wt.
% CPC, and showed precipitation by the fact that only 15% CPC was taken
up on hydroxyapatite discs, but when lysine was added to the composition,
i.e., composition 3, “CPC uptake reached the maximum set by the control
containing CPC but no polyacrylic acid polymer (Composition 1).” (Id.)
Appellant further notes that “when glutamic acid was used in place of lysine
(Composition 6), CPC uptake was decreased dramatically.” (Id.) Appellant
states that the “composition containing lysine showed a 37% improvement
over the composition containing glutamic acid” which “results were
unexpected, and they establish that lysine uniquely stabilized the present
composition.” (Id.)
We do not find Appellant’s argument and test data persuasive to
establish non-obviousness of claim 1. Claim 1, as just discussed, does not
require the presence of a cationic active agent, much less CPC. Thus, even
if an unexpected result regarding the stabilization of CPC might be
demonstrated by Appellant’s data, that data does not establish non-
obviousness with respect to a claimed composition that does not require a
cationic active agent be present. The Examiner has provided an adequate
reason to include lysine rather than arginine in the composition of Mello that
does not include CPC. Appellant’s data does not establish that lysine would
not have been considered an equivalent alternative to arginine in a mouth
wash composition of Mello that does not include CPC. “In determining
whether the subject matter of a patent claim is obvious, neither the particular
motivation nor the avowed purpose of the patentee controls. What matters is
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the objective reach of the claim. If the claim extends to what is obvious, it is
invalid under § 103.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419
(2007).
In light of the foregoing, we affirm the Examiner’s rejection of claim
1 as being obvious from Mello, lsbu, Zaidel, Prencipe, and Montgomery.
Claims 8–15 and 18 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Claims 5, 6, 16, and 17
We next address Appellant’s arguments as they relate to claims
requiring the presence of a cationic agent. Claim 5 depends from claim 1
and requires that the oral composition of claim 1 further includes a cationic
agent selected from various groups. Claim 6 requires that the oral
composition of claim 1 include a cationic agent selected from several
different specified agents, of which CPC is but one. Dependent claims 16
and 17 require the presence of at least CPC as the cationic agent.
First, we note that Zaidel teaches that an antibacterial agent such as
CPC can be included in the composition that has both Gantrez, the claimed
polymer of i) of the claim,and a polymer of Formula 1, the claimed polymer
of ii) if the claim. Thus, there is a reasonable expectation of success in
achieving a composition having the claimed ingredients recited by these
claims. Thus, we conclude that the Examiner has established a prima facie
case of obviousness for these claims, just as was done for claim 1.
We also conclude, as the Examiner did, that Appellant’s results are
not commensurate in scope with the claims so as to establish unexpected
results. Moreover, with respect to claims 5, 6, 16, and 17, we conclude that
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the comparison was not to the closest prior art, and that there is no evidence
that the results even with respect to what was tested were unexpected.
Appellant’s Specification and data only describe an incompatibility of
CPC with anionic polymers like DV8801 “because of the resulting
precipitation of both components.” (Spec. ¶ 67.) The group of cationic
active agents recited in claims 5 and 6, however, is much broader in scope
than CPC. For example, the category includes cationic amino acids and
metal cations, as well as chlorhexidine digluconate, all of which are very
different in chemical structure from each other and from CPC.
“Commensurate in scope” means that the evidence provides a
reasonable basis for concluding that untested embodiments encompassed by
the claims would behave in the same manner as the tested embodiment. See
In re Lindner, 457 F.2d 506, 508 (CCPA 1972). Here there is no such
evidence. See id. (“Here, only one mixture of ingredients was tested. . . .
The claims, however, are much broader in scope, . . . and we have to agree
with the Patent Office that there is no ‘adequate basis for reasonably
concluding that the great number and variety of compositions included by
the claims would behave in the same manner as the [single] tested
composition.’”); see also In re Kollman, 595 F.2d 48, 56 (Fed. Cir. 1979)
(one data point is insufficient to “to ascertain a trend in the exemplified data
which would allow [one having ordinary skill in the art] to reasonably
extend the probative value thereof.”).
We note that Appellant’s Specification has a general statement that
“anionic polymers that help coat and protect the enamel” “can interact with
cationic antimicrobial agents, leading to formulation incompatibilities,
particularly in high water formulations” (Spec. ¶ 7) and it further states that
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chlorhexidine and CPC, which “are cationic in charge,” “typically” are
rendered inactive in combination “with anionic polymers such as phosphate-
containing DV8801 (Mirapol 8801) or Gantrez . . . through complexation or
precipitation” (id. ¶ 68). However, Appellant’s Specification does not
provide any test data to demonstrate that chlorhexidine is stabilized by the
addition of Lys like CPC is. Appellant’s Specification only indicates that
“[t]he addition of Lys provides needed stability and competition between the
acid functionality of the polymer[, DV8801,], the acid and the amine of Lys
and CPC – each act to free CPC and make it more available for interaction
with bacteria.” (Id. ¶ 67.) Appellant does not provide evidence that such
would necessarily be the case with chlorhexidine, which is a biguanide
compound not a cationic quaternary ammonium compound, which CPC is.
Moreover, Appellant does not provide evidence that any other of the
identified cationic active agents in claim 6, or the category of all cationic
amino acids, or all metal cations as recited in claim 5, would complex with
anionic polymers like DV8801 or that Lys would compete with the acid
functionality of the polymer with them to prevent complexation and thus
stabilize the composition.
Furthermore, it is not clear that Appellant has provided a comparison
to the closest prior art. Mello teaches a composition that includes arginine,
gantrez and PEG in Table 1, and teaches that cationic active agents can be
included in such a composition (see Mello ¶ 35). Appellant’s comparisons
in Examples 2 and 3 are of formulations that include (1) CPC and PEG as a
control, (2) CPC with DV and PEG, and then (3) CPC with DV, Lys (or Glu,
or Lys and Glu), and PEG. We assume from Appellant’s Specification that
Gantrez and DV are both “incompatible” with CPC without Lys. (See Spec.
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¶¶ 12, 67.) The closest prior art for comparison would have been Mello’s
compositions in Table 1 (preferred embodiments) that teach arginine (a basic
amino acid just as Lys is3), and Gantrez, with PEG and the teaching at Mello
paragraph 35 indicating “[t]he compositions of the preferred embodiments
also may optionally contain one or more antibacterial agents . . . [which]
may be selected from . . . bisguanide antiseptics (e.g., chlorhexidine . . .),
quaternary ammonium compounds (e.g., cetylpyridinium chloride . . . metal
ions (e.g., zinc salts . . . ).”
Furthermore, there is a fundamental requirement that “any superior
property must be unexpected to be considered as evidence of non-
obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir.
2007). However, other than statements by the Attorney (see, e.g., Appeal
Br. 4, 5), Appellant provides no evidence that the results of adding CPC to
an aqueous biphasic composition that includes gantrez and a basic amino
acid, such as Arginine, as taught by Mello, is unexpected. We note that an
electronic word search of the Specification does not find any usage of either
the terms “unexpected,” “synergistic,” or “surprising.” No declaration or
affidavit has been submitted to show that the stabilizing effect with the
presence of the basic amino acid Lysine or the efficacy of CPC uptake
would have been surprising or unexpected to one of ordinary skill in the art.
We note that the statement that the presence “of Lys provides needed
stability and competition between the acid functionality of the polymer, the
acid and the amine of Lys, and CPC – each act to free CPC and make it
more available for interaction with bacteria” (Spec. ¶ 67. see also ¶ 68

3 Glu is a basic amino acid at a neutral pH.
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(“Biofilm removal increases when amino acids Lys (and Glu) are added,
which act to free CPC from the anionic polymer through competing charge
interaction, thereby increasing its efficacy.”)) does not suggest the results are
unexpected. Therefore, the only indication that the results constitute an
unexpected result is naked attorney argument in the Appeal Brief and these
statements are not evidence. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir.
1997); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s
argument in a brief cannot take the place of evidence.”).
As Geisler explains in distinguishing In re Soni, 54 F.3d 746 (Fed.
Cir. 1995), in Soni the applicants stated “in their application that the
improved properties exhibited by the claimed compositions were ‘much
greater than would have been predicted,’ . . . while Geisler made no such
assertion in his application. Nor did Geisler submit any such statement
through other evidentiary submissions, such as an affidavit or declaration.”
Geisler, 116 F.3d at 1470–71 (citation omitted). Geisler concluded that
“naked attorney argument is ‘insufficient to establish unexpected results.’”
Id. at 1471 (citing Soni, 54 F.3d at 750).
In light of the foregoing, we affirm the Examiner’s rejection of claims
5, 6, 16, and 17 as being obvious from Mello, lsbu, Zaidel, Prencipe, and
Montgomery.

II. Obviousness: Kigawa H, Mello, lsbu, Zaidel, and Montgomery
The Examiner found that Kigawa H teaches a mouthwash formulation
having excellent disinfectant effect on oral cavities comprising 1% lysine,
ethanol, glycerol, polyoxyethylene-60-castor oil (nonionic polymer), l-
menthol, fragrance, and purified water. (Final Action 7–8.) The Examiner
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further found that Kigawa H teaches in general that the compositions can
include cationic surfactants such as CPC, anionic surfactants, and nonionic
surfactants, and that the lysine can be present in from 0.01 to 20%. (Id. at 8
(citing Kigawa H ¶¶ 30, 39, 41).) As with Mello, the Examiner found that
because Kigawa H teaches a “mouthwash that comprises a nonionic
surfactant, polyethylene glycol, and water[,] it is an aqueous biphasic system
as evidenced by lbsu.” (Id.)
The Examiner found that it would have been obvious to add to the
Kigawa H mouthwash the 1:4 to 4:1 copolymer of mal[ei]c [anhydride] or
acid and the mixture of acrylic acid, methacrylic acid, and 2-hydroxyethyl
methacrylate phosphates of Formula 1 as taught by Mello and Zaidel “for
the advantage of the treatment and/or inhibition of a chemical stain, plaque,
and/or tartar on a dental surface, as taught by Zaidel et al.” (Id.) The
Examiner relies on the teachings of Montgomery for the obviousness of
adding PEG within the claimed molecular weight for the same reasons as in
the rejection based on Mello. (Id. at 9.)
We agree with the Examiner’s conclusion of obviousness.
Appellant argues that the rejection is in error because Kigawa H does
not teach the use of an acidic polymer, and there “can be no motivation to
combine” the reference with either one of Mello or Zaidel “because the
relevant problem to be solved (combination of an acidic polymer and a
cationic surfactant) is not presented.” (Appeal Br. 7.) We do not find this
argument persuasive. The Examiner recognized that Kigawa H does not
teach the use of an acidic polymer, and relied on the teachings of Mello and
Zaidel’s teachings of using such polymers in mouthwash compositions to
teach the obviousness of adding such a polymer to the mouthwash of
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Kigawa H. “Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellant’s argument that there is no motivation to combine is
unpersuasive because the references need not recognize the problem solved
by the Appellant for a prima facie case of obviousness to be established. See
In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996); In re Beattie, 974 F.2d
1309, 1312 (Fed. Cir. 1992). The Examiner provided sufficient reason from
the prior art references to add the acidic polymer and the claimed phosphate
polymer to the mouthwash composition of Kigawa H.
Appellant also argues that lysine is present in the Kigawa H
composition to provide a substrate for lysyl oxidase which is “hardly
instructive for using lysine in order to stabilize incompatibilities between
ingredients.” (Appeal Br. 7.) We do not find this argument persuasive of
nonobviousness. “When determining the patentability of a claimed
invention which combines two known elements, ‘the question is whether
there is something in the prior art as a whole to suggest the desirability, and
thus the obviousness, of making the combination.’” In re Beattie, 974 F.2d
1309, 1311–12 (Fed. Cir. 1992) (quoting Lindemann Maschinenfabrik
GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1462 (Fed. Cir.
1984)). That lysine is present in Kigawa H at the claimed amount for a
different intended purpose does not establish nonobviousness of the use of
lysine in the Kigawa H composition. Accord Lintner, 458 F.2d at 1016. The
fact that the ingredient is taught to be part of a mouthwash composition in an
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amount in the range claimed together with a PEG nonionic polymer and
water is sufficient. And as just discussed the prior art as a whole suggests
the desirability of adding the acidic polymer combination claimed. The
stabilization that lysine would provide to the composition that also included
the acidic polymer and CPC would be an inherent result of its presence in
the composition given that it is taught to be present in the claimed range..
“What is important regarding properties that may be inherent, but unknown,
is whether they are unexpected. All properties of a composition are inherent
in that composition, but unexpected properties may cause what may appear
to be an obvious composition to be nonobvious.” Honeywell International
Inc. v. Mexichem Amanco Holding SA DE C.V., 865 F.3d 1348, 1355 (Fed.
Cir. 2017).
Appellant’s additional arguments regarding the unexpected results
against this ground of rejection are the same as those discussed in section I.
above. (See Appeal Br. 3–7.) For the reasons discussed in the Mello based
rejection, we do not find those arguments persuasive of non-obviousness as
to claim 1, which does not require a cationic active agent. We also conclude
that with respect to claims 5 and 6, Appellant’s results are not commensurate
in scope with the claims so as to establish unexpected results. Moreover,
with respect to claims 5, 6, 16, and 17, we conclude that the comparison was
not to the closest prior art, and that there is no evidence that the results even
with respect to what was tested were unexpected.
Here again claims 8–15 and 18 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
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In view of the foregoing, we affirm the Examiner’s rejection of claims
1, 5, 6, and 8–18 as being obvious over Kigawa H, Mello, lsbu, Zaidel, and
Montgomery.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
17 112(d) Improper
Dependency
17
1, 5, 6, 8–18 103 Mello, lsbu,
Zaidel, Prencipe,
Montgomery.
1, 5, 6, 8–18
1, 5, 6, 8–18 103 Kigawa H, Mello,
lsbu, Zaidel,
Montgomery
1, 5, 6, 8–18
1, 5, 6, 8–18 Provisional
Nonstatutory
Double Patenting
Application No.
15/366,327
1, 5, 6, 8–18
1, 5, 6, 8–18 Provisional
Nonstatutory
Double Patenting
Application No.
15/668,913
1, 5, 6, 8–18
1, 5, 6, 8–18 Provisional
Nonstatutory
Double Patenting
Application No.
15/806,400
1, 5, 6, 8–18
Overall
Outcome
1, 5, 6, 8–18

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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) (2019).
AFFIRMED