Robinson, Richard Scott. et al.

Patent Trials and Appeals Board

May 8, 2020

2019005367 (P.T.A.B. May. 8, 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.
12/866,786 08/09/2010 Richard Scott Robinson 8569-00-US-01-OC 4463
23909 7590 05/08/2020
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
05/08/2020 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 RICHARD SCOTT ROBINSON, DIANE CUMMINS,
RICHARD J. SULLIVAN, and ROGER ELLWOOD
__________

Appeal 2019-005367
Application 12/866,786
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, CHRISTOPHER G. PAULRAJ, and
JAMIE T. WISZ, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to a
method of treating early enamel caries. The Examiner rejected the claims as
obvious. 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 Appeal Br. 2).
2 We have considered and refer to the Specification of Aug. 9, 2010
(“Spec.”); Final Action of Aug. 10, 2018 (“Final Act.”); Appeal Brief of Jan.
14, 2019 (“Appeal Br.”); Examiner’s Answer of May 7, 2019 (“Ans.”); and
Reply Brief of July 8, 2019 (“Reply Br.”). We note that the Examiner was
affirmed in Appeal 2012-012158, 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, 7, 11, 20, 21, 26, and 27 are on appeal3. Claim 1 is
representative and reads as follows:
1. A method of treating early enamel caries comprising:
applying an effective amount of a dentifrice composition
to the oral cavity, the dentifrice composition having a base
formulation comprising dicalcium phosphate dihydrate, the
dentifrice composition further comprising
arginine, in free or salt form, and
an effective amount of sodium monofluorophosphate,
wherein the arginine is provided in the amount of from 1
to 10 wt % based on the total weight of the dentifrice
composition; and
wherein the sodium monofluorophosphate is present in
an amount of from 0.01 wt% to 2 wt % of the composition.

The Issues
A. The Examiner rejected claims 1, 7, 11, 20, 21, 26, and 27 under 35
U.S.C. § 103(a) as obvious over Kleinberg4 and Norfleet5 (Final Act. 3–5).

3 Claims 2, 5, 6, 8–10, 12–19, 22, and 25 were cancelled and claims 4, 23,
and 24 are withdrawn (see Appeal Br., Claims Appendix).
4 Kleinberg et al., US 6,217,851 B1, issued Apr. 17, 2001.
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B. The Examiner rejected claim 3 under 35 U.S.C. § 103(a) as obvious
over Kleinberg, Norfleet, and Stookey6 (Final Act. 5–6).

A. 35 U.S.C. § 103(a) over Kleinberg and Norfleet
The Examiner finds Kleinberg teaches that one “method to prevent the
formation of cavities is to reduce the acids present in the oral cavity” and
“[a]nother strategy is to reduce the dissolution and demineralization of
enamel using fluoride” (Final Act. 3). The Examiner finds “Kleinberg
teaches using a composition comprising arginine, calcium and a cariostatic
anion for these purposes” (id.).
The Examiner acknowledges that “[w]hile emphasizing the
importance of calcium phosphate generally, Kleinberg does not explicitly
teach the addition of calcium phosphate dihydrate” (Final Act. 4). The
Examiner finds that “Norfleet teaches that it was known in the art to
formulate desensitizing anti-tartar dentifrices using calcium phosphates,
specifically calcium phosphate dihydrate as a polishing agent” (id.). The
Examiner also finds that Norfleet teaches incorporation of sodium fluoride
(id. at 5).
The Examiner finds it obvious for “the dentifrice of Kleinberg to
incorporate the ingredients of Norfleet, given that the ingredients are taught
to be used for the same purpose, i.e. to provide oral anti-tartar and
desensitizing” (Final Act. 5).

5 Norfleet et al., US 5,505,933, issued Apr. 9, 1996.
6 Stookey et al., US 2004/0202356 A1, published Oct. 14, 2004.
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The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner’s conclusion
that Kleinberg and Norfleet render the claims prima facie obvious?
(ii) If so, has Appellant provided evidence of unexpected results that
outweighs the evidence supporting the prima facie case of obviousness?
Findings of Fact
1. Kleinberg teaches “a method of reducing dental caries
comprising delivering a therapeutically effective amount of the oral
compositions . . . capable of retarding or preventing dental caries”
(Kleinberg, 5:53–59).
2. Kleinberg teaches that: “Fluoride has been found to inhibit the
dissolution of enamel by dental plaque acids by reducing the rate of
solubilization, increasing remineralization” (Kleinberg 2:15–17).
3. Kleinberg teaches that a “therapeutic amount of calcium,
arginine and a cariostatic anion as defined by this invention is an amount of
these anti-caries agents sufficient to . . . reduce demineralization or increase
remineralization of the dental enamel” (Kleinberg, 4:24–29).
4. Kleinberg teaches that
In one preferred embodiment, the oral compositions contain
calcium in an amount ranging from 5 µg/mg to 200 µg/mg,
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; emphasis added).
5. The Examiner finds that Kleinberg’s arginine range overlaps
that recited in claim 1, specifically teaching that in Kleinberg “arginine is
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present from 5 μg/mg to 700 μg/mg (i.e. 0.5% to 70%), and the instant
application recites that arginine is present at 2–10% by weight” (Final Act.
5).
6. Kleinberg teaches that the “‘cariostatic’ denotes agents which
are capable of retarding or preventing dental caries including
remineralization of caries lesions” (Kleinberg, 4:1–3).
7. Kleinberg teaches the “[c]ariostatic anions may . . . provide an
organic phosphate source to act as a surface covering or ‘poison’ or to be
hydrolyzed by the plaque bacteria” (Kleinberg 3:6–10). Kleinberg teaches
the “anti-caries agents are also referred to as calcium arginine phytate (CAP)
salts” (Kleinberg 6:44–46).
8. Kleinberg teaches that “[d]entifrice pastes or gels may contain,
for example . . . a conventional abrasive such as . . . insoluble alkali metal
metaphosphates and the like in a standard amount of 20–60% wt” (Kleinberg
5:27–31).
9. Norfleet teaches “the oral composition is a desensitizing anti-
tartar toothpaste or gel which, when the teeth are brushed with it, aids in
removal of at least some tartar and prevents its reappearance, and at the
same time diminishes any tooth pain that the brusher would otherwise
experience due to such brushing” (Norfleet, abstract).
10. Norfleet teaches “polishing agents may be employed too,
including . . . calcium phosphate dihydrate, anhydrous dicalcium phosphate”
(Norfleet 6:21–25).
11. Norfleet teaches that “the useful sources of fluoride ions are
water soluble alkali metal fluorides, such as . . . sodium and potassium
monofluorophosphates . . . or a mixture thereof” (Norfleet 4:55–65).
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12. Norfleet teaches that the “the desired fluoride ion will usually
be in the range of 0.03 to 0.7%” (Norfleet 8:22–23).
13. The Specification teaches, in Example 1, an experiment
comparing an undefined amount of dicalcium phosphate dehydrate, 1.5%
neutralized arginine and 1450 ppm of sodium monofluorophosphate with a
composition lacking the arginine and finds that the three part composition
results in a % mineral change of +8.27 while the two part composition
lacking arginine results in % mineral change of -1.87 (see Spec. ¶ 84).
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).
Analysis
Prima facie obviousness
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3–5; FF 1–12) and agree that
Kleinberg and Norfleet render the claims obvious. We address Appellant’s
arguments below.
Appellant contends “[t]here is no teaching or suggestion in Kleinberg
of a dentifrice composition comprising the specific combination of arginine,
sodium monofluorophosphate and dicalcium phosphate dihydrate for
treating early enamel caries” (Appeal Br. 5). Appellant contends “neither
dicalcium phosphate dihydrate nor sodium monofluorophosphate is
contained in any exemplary formulations in Norfleet. Neither Kleinberg nor
Norfleet teach or suggest the use of dicalcium phosphate dihydrate, sodium
monofluorophosphate and arginine in an oral care composition for treating
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early enamel caries” (id.). Appellant also contends that “Kleinberg provides
no motivation to employ any other polishing agent. Kleinberg contains only
a single reference to a polishing agent, and merely identifies calcium
carbonate as a known polishing agent” and “Kleinberg does not disclose or
suggest dicalcium phosphate dihydrate as a calcium-containing compound”
(id. at 6).
We find Appellant’s arguments unpersuasive because “[n]on-
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).
Here, Kleinberg teaches a method of treating caries using oral
compositions (FF 1) that include arginine in amounts overlapping those
recited in claim 1 (FF 4–5), fluoride containing components in amounts
overlapping claim 1 (FF 2, 4), and polishing agents composed of alkali metal
phosphates (FF 8). Norfleet also teaches a method of treating caries using
oral compositions (FF 9) that include sodium monofluorophosphate as a
useful source of fluoride ions in an overlapping range with claim 1 (FF 11–
12) and an alkali metal phosphate polishing agent like calcium phosphate
dihydrate (FF 10).
We agree with the Examiner that the ordinary artisan would have
found it obvious to select Norfleet’s useful fluoride source of sodium
monofluorophosphate and polishing agent of calcium phosphate dehydrate
for fluoride ion and polishing agents in Kleinberg because “a person of
ordinary skill has good reason to pursue the known options within his or her
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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 examples anticipating the claims, “a reference is not
limited to the disclosure of specific working examples.” In re Mills, 470
F.2d 649, 651 (CCPA 1972).
Appellant contends:
There is no teaching or suggestion in Kleinberg that inorganic
phosphate has cariostatic activities. If dicalcium phosphate
dihydrate is added into Kleinberg’s composition, one of skill in
the art might well expect that inorganic phosphate released
from dicalcium phosphate dihydrate might interfere with the
formation of calcium/arginine/cariostatic anion complex.
Similarly, one of skill in the art might well expect that
monofluorophosphate (an inorganic phosphate) released from
sodium monofluorophosphate might interfere with the
formation of calcium/arginine/cariostatic anion complex. Thus,
one of skill in the art would not be motivated to replace calcium
carbonate (which contains a cariostatic anion) with dicalcium
phosphate dihydrate (which does not contain a cariostatic
anion).
(Appeal Br. 7).
We find this argument unpersuasive for several reasons. First, claim 1
does not exclude the use of multiple fluoride ions and therefore encompass
the use of sodium monofluorophosphate along with other fluoride ion
sources. Indeed, Kleinberg teaches that fluoride sources result in
remineralization of enamel (FF 2) and Norfleet expressly teaches that
mixtures of fluoride compounds can be used (FF 11). Second, the
arguments relating to interference of different ions are entirely attorney
speculation without any evidentiary support. However, “attorney argument
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[is] not the kind of factual evidence that is required to rebut a prima facie
case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Unexpected Results
Appellant contends:
The data in Example I . . . shows that the addition of arginine
into the dicalcium phosphate dihydrate /sodium
monofluorophosphate formulation not only reduces
demineralization but also increases remineralization. Neither
Kleinberg nor Norfleet teaches or suggests this technical effect.
. . .
There is no teaching or suggestion anywhere in Kleinberg that
arginine, dicalcium phosphate dihydrate or fluoride, much less
the combination of them, would enhance tooth remineralization.
Kleinberg at most teaches that the calcium/arginine/cariostatic
anion complex would increase remineralization. Thus, the data
in Example 1 of the present application is unexpected.
(Appeal Br. 9). Appellant also points to a post-filing date publication by
Kraivaphan7 that shows “adding arginine and calcium salt to fluoride
toothpaste makes it more effective in preventing dental caries than simply
providing fluoride alone” (id. at 10).
Appellant further contends, regarding these asserted results, that the
results are commensurate in scope with the evidence because a “skilled
artisan could ascertain a trend in the exemplified data that would allow him
to reasonably extend the probative value thereof to the claimed method as
recited in claims 1 and 7” (Appeal Br. 10).

7 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).
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We find the argument that Kleinberg does not teach remineralization
unpersuasive because Kleinberg specifically teaches that fluoride
compositions are capable of “retarding . . . dental caries” (FF 1). Kleinberg
further teaches that fluoride containing compositions may “increase
remineralization of the dental enamel” (FF 2) and that the particular
composition described may assist in “remineralization of caries lesions” (FF
6). Thus, Kleinberg expressly disclosed remineralizing dental caries as well
as preventing dental caries (FF 1, 2, 6).
We also find the assertion of unexpected results unpersuasive for
several reasons. First, Appellant acknowledges that 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; Appeal Br. 10).
Thus, Kraivaphan is consistent with Kleinberg’s composition, which may
contain calcium arginine phytate and fluoride (FF 4, 7) and where Kleinberg
teaches that the combination will be effective (FF 2, 3). Thus, we find that
results in the Specification (FF 13) and Kraivaphan are the expected results
based on the prior art disclosure, not unexpected results. See In re Skoner,
517 F.2d 947, 950 (CCPA 1975) (“Expected beneficial results are evidence
of obviousness of a claimed invention.”)
Second, we are not persuaded that the results of either Example 1 of
the Specification, or Kraivaphan, which are both limited to a single
composition composed of 1.5% arginine, 1450 ppm sodium
monofluorophosphate, and an undisclosed amount of dicalcium phosphate
dihydrate, are commensurate in scope with the recitation in claim 1 of
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arginine from 1–10 wt% and sodium monofluorophosphate from 0.01 wt%
(100 ppm) to 2 wt% (20,000 ppm). And of course, there is no limitation on
the amount of dicalcium phosphate dehydrate in claim 1, and the
Specification teaches that there may be anywhere from “about 15 wt.% to
about 70 wt.%” of this component (Spec. 7). Consequently, this single
example selecting single values from three different large ranges of
composition components 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.”)
Appellant’s cited case, In re Clemens, 622 F.2d 1029 (CCPA 1980),
also does not support Appellant’s position 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 of temperature tested at two different values, but rather three
different variable ranges of composition, each range tested at only a single
value in a single experiment, 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).
Third, given the direct suggestion by Kleinberg of a composition
comprising arginine, calcium, and fluoride (FF 4) combined with
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Kleinberg’s teaching of remineralization (FF 2, 6) and Kleinberg’s teaching
that an exemplified composition, when added to the tooth powder resulting
in a “regain of the 20% loss” (Kleinberg 15:5) balanced against the
approximately 10% remineralization change disclosed in Example 1 of
Appellant’s Specification (FF 13), we conclude that even if there is some
showing of unexpected results, the showing is insufficient to overcome the
strong showing of obviousness in this case. See Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1372 (Fed. Cir. 2007) (“[W]e hold that even if Pfizer showed
that amlodipine besylate exhibits unexpectedly superior results, this
secondary consideration does not overcome the strong showing of
obviousness in this case. Although secondary considerations must be taken
into account, they do not necessarily control the obviousness conclusion”).
Claim 7
Appellant does not provide any arguments specific to claim 7, but
relies upon arguments we found unpersuasive with regard to claim 1 for the
reasons discussed above.
Conclusions of Law
(i) The evidence of record supports the Examiner’s conclusion that
Kleinberg and Norfleet render the claims prima facie obvious.
(ii) Appellant has not provided evidence of unexpected results that
outweighs the evidence supporting the prima facie case of obviousness.

B. Kleinberg, Norfleet and Stookey
Appellant does not argue separately claim 3 in this obviousness
rejection, instead relying upon overcoming Kleinberg (see Appeal Br. 9).
Having found no deficiency in the combination of Kleinberg and Norfleet as
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it relates to Appellant’s claim 1, we are not persuaded by Appellant’s
contention to the contrary.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 7, 11, 20,
21, 26, 27
103 Kleinberg,
Norfleet
1, 7, 11,
20, 21, 26,
27

3 103 Kleinberg,
Norfleet, Stookey
3
Overall
Outcome
1, 3, 7, 11,
20, 21, 26,
27

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