Rajnish Kohli et al.

Patent Trials and Appeals Board

May 20, 2020

2019005587 (P.T.A.B. May. 20, 2020)

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.
12/866,655 08/06/2010 Rajnish Kohli 8566-00-US-01-OC 3229
23909 7590 05/20/2020
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
05/20/2020 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 RAJNISH KOHLI, RICHARD SCOTT ROBINSON,
RICHARD J. SULLIVAN, and DIANE COMMINS
__________

Appeal 2019-005587
Application 12/866,655
Technology Center 1600
__________

Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to an oral
care composition. The Examiner rejected the claims as obvious and on the
grounds of obviousness-type 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 Company (see App. Br. 2).
2 We have considered and refer to the Specification of Aug. 6, 2010
(“Spec.”); Final Action of July 27, 2018 (“Final Act.”); Appeal Brief of Dec.
28, 2018 (“Appeal Br.”); Examiner’s Answer of May 10, 2019 (“Ans.”); and
Reply Brief of July 10, 2019 (“Reply Br.”). We note that the Examiner was
affirmed in Appeal 2014-009336, the previous appeal in this application.
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Statement of the Case
Background
“Arginine 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” (Spec. ¶ 3). “Combining these basic amino
acids with minerals having oral care benefits, e.g., fluoride and calcium, to
form an oral care product having acceptable long term stability, however,
has proven challenging” (Spec. ¶ 3).
The Claims
Claims 1, 3–6, 8, 9, 11, 12, 15–17, 19, 20, 22, and 25–28 are on
appeal. Independent claim 1 is representative and reads as follows:
1. An oral care composition comprising:
a. an effective amount of a basic amino acid, in free or
salt form;
b. a fluoride ion source which provides from 200 to
600 ppm by weight fluoride per weight of the composition;
and
c. an anionic polymer;
wherein the basic amino acid is arginine and wherein
the composition is a toothpaste, and wherein the basic amino
acid is present in an amount of 1 to 10 weight % of the total
composition, the weight of the basic amino acid being
calculated as free base form, wherein the salt form of the
basic amino acid is selected from arginine phosphate,
arginine bicarbonate, arginine hydrochloride, and arginine
sulfate, and wherein the fluoride ion source is selected from
sodium fluoride, sodium monofluorophosphate, stannous
fluoride, potassium fluoride, sodium fluorosilicate,
ammonium fluorosilicate, amine fluoride, ammonium
fluoride, and combinations thereof.

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The Issues
A. The Examiner rejected claims 1, 3–6, 8, 9, 11, 12, 15–17, 19, 20, 22,
and 25–28 under 35 U.S.C. § 103(a) as obvious over Kleinberg3 and
Norfleet4 (Ans. 3–4).
B. The Examiner rejected claims 1, 3–6, 8, 9, 11, 12, 15–17, 19, 20, 22,
and 25–28 on the ground of nonstatutory obviousness-type double patenting
as being unpatentable over claims 1–18 of US Patent 9,682,026 (Ans. 4–5).
C. The Examiner rejected claims 1, 3–6, 8, 9, 11, 12, 15–17, 19, 20, 22,
and 25–28 on the ground of nonstatutory obviousness-type double patenting
as being unpatentable over claims 1–48 of US Patent 9,682,027 (Ans. 5).
D. The Examiner rejected claims 1, 3–6, 8, 9, 11, 12, 15–17, 19, 20, 22,
and 25–28 on the ground of nonstatutory obviousness-type double patenting
as being unpatentable over claims 1–20 of US Patent 10,130,597 in view of
Kleinberg (Ans. 5–6).
E. The Examiner rejected claims 1, 3–6, 8, 9, 11, 12, 15–17, 19, 20, 22,
and 25–28 on the ground of nonstatutory obviousness-type double patenting
as being unpatentable over claims 1–23 of US Patent 9,918,918 in view of
Kleinberg (Ans. 6–7).

A. 35 U.S.C. § 103(a) over Kleinberg and Norfleet
The Examiner finds that “Kleinberg teaches an oral composition
comprising arginine and 200-1500ppm fluoride . . . with a cariostatic anion
such as bicarbonate” and “a foaming agent such as sodium laurel sulfate”

3 Kleinberg et al., US 6,217,851 B1, issued Apr. 17, 2001.
4 Norfleet et al., US 5,505,933, issued Apr. 9, 1996.
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(Ans. 3). The Examiner finds Kleinberg teaches the “amount of arginine
present in a preferred embodiment ranges from 5μg/mg-700mg/mg (equal to
0.5%-70%)” (id.). The Examiner finds that Kleinberg teaches the
“composition may take the form of a dentifrice paste” (id.). The Examiner
acknowledges that Kleinberg “does not teach the inclusion of an anionic
polymer” (Id.).
The Examiner finds that “Norfleet teaches a desensitizing anti-tartar
dentifrice comprising tooth pain inhibiting compounds including potassium
nitrate . . . and a potassium salt of a copolymer of maleic anhydride with
methyl vinyl ether” as well as “sodium fluoride” (Ans. 4). The Examiner
finds it obvious to formulate
the anticaries composition of Kleinberg to incorporate the
desensitizing components of Norfleet in order to reduce tooth
pain. Upon doing so, the skilled artisan would have a
reasonable expectation of producing a dentifrice which has both
the anti-caries property of Kleinberg and the tooth
desensitization of Norfleet. Such a combination of two dental
cleaning compositions to form a third dental cleaning
composition is prima facie obvious according to MPEP 2144.06
(I).

(Ans. 4).
The issues with respect to this rejection are:
(i) Does a preponderance of the evidence of record support the
Examiner’s conclusion that the combination of Kleinberg and Norfleet
render claim 1 obvious?
(ii) If so, has Appellant provided evidence of unexpected results that
outweighs the evidence supporting the prima facie case of obviousness?
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Findings of Fact
1. Kleinberg teaches “oral compositions containing therapeutic
amounts of calcium, arginine and a cariostatic anion distributed in an oral
vehicle. In one preferred embodiment, the oral composition is supplemented
with fluoride. The present invention further relates to a method of preparing
oral compositions containing anti-caries agents” (Kleinberg 3:20–27).
2. Kleinberg teaches “[e]xamples of dental care products include,
for example, dentifrices, solutions or pastes” (Kleinberg 2:18–20).
3. Kleinberg teaches that in “one preferred embodiment, the oral
compositions contain . . . arginine in an amount ranging from 5 µg/mg to
700 µg/mg . . . In a more preferred embodiment, the oral compositions
further contain fluoride in an amount ranging from 200 to 1500 ppm.
(Kleinberg, 4:35–43).
4. The Examiner finds that Kleinberg’s arginine range overlaps
that recited in claim 1, specifically teaching that in Kleinberg “amount of
arginine present in a preferred embodiment ranges from 5μg/mg–700mg/mg
(equal to 0.5%-70%)” (Final Act. 3).
5. Kleinberg teaches the use of arginine bicarbonate, teaching
“[w]ith arginine bicarbonate, the further solubilization was 16%. By
contrast, the calcium bicarbonate/arginine bicarbonate (1:1) combination not
only showed no further solubilization but showed instead regain of the 20%
loss” (Kleinberg 1:1–5).
6. Norfleet teaches “a desensitizing, anti-tartar oral composition
comprises an orally acceptable vehicle or base for such composition, an
effective anti-tartar proportion of poly phosphate, and a desensitizing or
tooth pain inhibiting proportion of a tooth pain inhibiting potassium salt
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which passes through exposed dentin tubules to tooth nerves and neurons”
(Norfleet 1:49–55).
7. Norfleet teaches “[a]mong such tooth pain inhibiting
compounds there may be mentioned . . . the composition includes a
potassium salt of a copolymer of maleic anhydride or maleic acid with vinyl
methyl ether” (Norfleet 1:55–61).
8. The Specification teaches “an anionic polymer, e.g., a
copolymer of methyl vinyl ether and maleic anhydride” (Spec. ¶ 13).
9. Norfleet teaches:
The water soluble fluoride or source of fluoride ions for the
present compositions, which helps to stabilize the
pyrophosphate against enzymatic attack, while also contributing
its tooth hardening and anti-caries properties to the
compositions, may be slightly soluble in water, highly soluble
or fully soluble, so long as it can provide such ions in the oral
compositions and/or in use, in the mouth. . . .
Among the useful sources of fluoride ions are water soluble
alkali metal fluorides, such as sodium and potassium fluorides
. . .
it is preferred to employ potassium fluoride, potassium
monofluorophosphate or other potassium salt or a mixture
thereof because added potassium ion serves to deaden pain
stimuli to the tooth nerves, and the salt also is a source of
fluoride ion.
(Norfleet 4:45–51).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
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ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
Prima facie obviousness
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3–4; FF 1–9) and agree that claim 1
is rendered obvious by Kleinberg and Norfleet. We address Appellant’s
arguments below.
Appellant contends:
Although Kleinberg discloses that one embodiment of its
composition is supplemented with fluoride, there is no
exemplification of a composition containing arginine and
fluoride. Moreover, although Kleinberg discloses a broad range
(200 to 1500 ppm) of fluoride in oral compositions, Kleinberg
does not disclose or teach a toothpaste comprising a low
amount (200-600 ppm) of fluoride.
(Appeal Br. 5).
We find these arguments unpersuasive because Kleinberg is not cited
as anticipating the claims, nor is Kleinberg cited alone for teaching the
claimed elements, but the Examiner’s rejection relies upon the combination
of Kleinberg and Norfleet. “Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references.” In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986).
Here, Kleinberg teaches a method of treating caries using oral
compositions (FF 1) that include arginine in both type and amounts
overlapping those recited in claim 1 (FF 3–4) and fluoride containing
components in amounts overlapping claim 1 (FF 3). Norfleet teaches a
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method of treating caries using oral compositions (FF 6) that include
fluoride sources within the scope of claim 1 (FF 9) and anionic copolymers
that identical to those recited by Appellant’s Specification (FF 7–8).
We agree with the Examiner that the ordinary artisan would have
found it obvious to select Norfleet’s useful fluoride sources and copolymers
for use with Kleinberg because Norfleet teaches that the copolymer helps
inhibit tooth pain, thereby encouraging brushing (FF 7). “[A] person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the
product not of innovation but of ordinary skill and common sense.” KSR,
550 U.S. at 421. Also, to the extent that Appellant argues neither Kleinberg
nor Norfleet have working examples, “a reference is not limited to the
disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651
(CCPA 1972).
Appellant contends “[t]here is no teaching or suggestion anywhere in
Kleinberg that a low amount (200-600 ppm) of fluoride would be
therapeutically effective in a toothpaste” (Appeal Br. 5).
We find this argument unpersuasive because Kleinberg teaches
amounts of 200 to 1500 ppm are effective amounts, and Appellant provides
no evidence that the lower end of the range would have been expected to be
ineffective (see FF 3). “A prima facie case of obviousness typically exists
when the ranges of a claimed composition overlap the ranges disclosed in
the prior art.” In re Applied Materials, 692 F.3d 1289, 1295 (Fed. Cir.
2012); also see In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)
(Arguments and conclusions unsupported by factual evidence carry no
evidentiary weight.)
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Unexpected Results
Appellant contends the “invention is based on a surprising finding that
a basic amino acid such as arginine in combination with an amount of
fluoride which would otherwise be subtherapeutic can nevertheless deliver
enhanced oral care benefits” (Appeal Br. 6). Appellant contends “[t]his
effect is disclosed in Example 1 of the present application. Example 1 in the
present application shows that incorporation of L-arginine in a toothpaste
formulation containing 0.075% sodium fluoride enhances delivery of
fluoride effect of the formulation” (id.).
Appellant cites post-filing date references including Kraivaphan5 and
Cheng6 to also establish unexpected results (see Appeal Br. 6). Appellant
cites Kraivaphan to show that “the two groups using the dentifrices
containing 1.5% arginine, an insoluble calcium compound and 1450 ppm
fluoride showed statistically significantly lower DMFT increments (21.0 and
17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%)
compared to the control dentifrice” (id.). Appellant cites Cheng to show
“that arginine/NaF solution (2.5% arginine/500 ppm) significantly enhances
enamel fluoride uptake compared with NaF solution (500 ppm)” (id. at 6–7).
Appellant contends, regarding the issue of whether the results are
commensurate in scope with the claim, that a “skilled artisan could ascertain
a trend in the exemplified data that would allow him to reasonably extend

5 Kraivaphan et al., Two-Year Caries Clinical Study of the Efficacy of Novel
Dentifrices Containing 1.5% Arginine, an Insoluble Calcium Compound and
1,450 ppm Fluoride, 4 Caries Res. 582–90 (2013).
6 Cheng et al., Arginine promotes fluoride uptake into artificial carious
lesions in vitro, Australian Dental J. 60:104–111 (2015).
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the probative value thereof to a toothpaste composition comprising arginine
and a low amount (200-600 ppm) of a fluoride ion source” (Appeal Br. 7–8).
We find the evidence of unexpected results unpersuasive. Appellant
relies on post-filing date references to establish unexpected results.
Kraivaphan teaches “dentifrices containing 1.5% arginine, an insoluble
calcium compound and 1,450 ppm F provide significantly greater protection
against caries lesion cavitation, in a low to moderate caries risk population,
than dentifrices containing 1,450 ppm F alone” (Kraivaphan 582, abstract).
Similarly, Cheng teaches “in combination with fluoride, arginine
significantly increased fluoride uptake compared with fluoride alone”
(Cheng 104, abstract), where Cheng tested a composition comprising
“arginine/NaF solution (2.5% arginine, 500 ppmF)” (Cheng 105, col. 1).
Neither tested composition falls within the scope of claim 1.
Appellant did not establish the either composition comprises the ionic
polymer required by claim 1. Thus, it cannot be ascertained whether the
observed results are due to the fluoride concentration or the absence of the
anionic polymer. In addition, Kraivaphan contains an amount of fluoride,
1,450 ppm, outside the 200 to 600 ppm range recited by claim 1.
We also are not persuaded that the results of Cheng, that has amounts
of two of the three required components of claim 1 within the ranges recited
by claim 1, are commensurate in scope with the claim. Cheng is limited to a
single composition composed of 2.5% arginine and 500 ppmF. This single
point is not commensurate in scope with the recitation in claim 1 of a
number of different arginine sources from 1–10 wt%, any of a variety of
different fluoride sources from 200 to 600 ppm, and any amount of any
anionic polymer.
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Consequently, this one example that is a selection from two different
large ranges of composition components out of three ranges recited by the
claim does not establish that the unexpected result is commensurate in scope
with claim 1. See E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d
996, 1012 (Fed. Cir. 2018) (“[O]nly a single pressure of 20 bars (4.2 bars
PO2) was tested in the experiments disclosed in table 1, so any unexpected
results demonstrated . . . were not commensurate with the scope of the
claims.”)
In re Clemens, 622 F.2d 1029 (CCPA 1980) also does not support
Appellant’s position that there is a trend in the exemplified data because
Clemens explains that a single variable temperature range, tested using
comparative tests conducted at two temperatures, was “not a case in which
the probative value of a narrow range of data can be reasonably extended to
prove the unobviousness of a broader claimed range.” Id. at 1036. Here,
where there is not a single variable such as the temperature range tested in
Clemens tested at two different values, but rather three different variable
ranges of composition, each range tested at best at two values, the evidence
is even less capable of extension to the broader range than the situation in
Clemens. Unexpected results must be “commensurate in scope with the
degree of protection sought by the claimed subject matter.” In re Harris,
409 F.3d 1339, 1344 (Fed. Cir. 2005).
Therefore, as we balance all of the evidence of secondary
considerations and prima facie obviousness, we find that the evidence
supports the Examiner’s finding that the claims would have been obvious
over Kleinberg and Norfleet.
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Conclusion of Law
(i) A preponderance of the evidence of record support the Examiner’s
conclusion that the combination of Kleinberg and Norfleet render claim 1
obvious.
(ii) Appellant has not provided evidence of unexpected results that
outweighs the evidence supporting the prima facie case of obviousness.

B. Double Patenting
Appellant contends that the evidence demonstrates
that arginine in combination with an amount of fluoride that
would otherwise be subtherapeutic can nevertheless deliver
enhanced oral care benefits. This beneficial effect is not taught
or suggested by the cited pending applications, cited patents
and Kleinberg. Thus, it would not be obvious to add a low
amount of fluoride ion source (e.g., an amount that provides
from 200 to 600 ppm fluoride as recited in claims I and 12) and
arginine into a toothpaste.
(Appeal Br. 8–9).
We are not persuaded because, as discussed above, we do not find the
evidence of unexpected results persuasive. We note that Appellant does not
otherwise argue that the combination of the claims of the related US patents
and Kleinberg fails to show a prima facie case of obviousness.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28
103 Kleinberg,
Norfleet
1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28

1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28
Obviousness-
type Double
Patenting
US 9,682,026 1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28

1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28
Obviousness-
type Double
Patenting
US 9,682,027 1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28

1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28
Obviousness-
type Double
Patenting
US 10,130,597 1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28

1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28
Obviousness-
type Double
Patenting
US 9,918,918 1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28

Overall
Outcome
1, 3–6, 8, 9, 11,
12, 15–17, 19,
20, 22, 25–28

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED