Colgate-Palmolive Company

Patent Trials and Appeals Board

Sep 4, 2020

2020000488 (P.T.A.B. Sep. 4, 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.
15/366,327 12/01/2016 Carl Myers 10926-00-US-01-OC 1207
23909 7590 09/04/2020
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
GULLEDGE, BRIAN M
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
09/04/2020 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 CARL MYERS and REHANA BEGUM-GAFUR1
Appeal 2020-000488
Application 15/366,327
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
LILAN REN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an oral
care composition, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Specification states that “[o]ne approach to reducing staining and
erosion [of teeth] as well as reducing biofilm formation is the use of anionic

1 Appellant identifies the real party in interest as Colgate-Palmolive
Company. Appeal Br. 2. We use the word “Appellant” to refer to “applicant”
as defined in 37 C.F.R. § 1.42.
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polymers that help coat and protect the enamel.” Spec. ¶ 8. “These polymers,
however, can interact with cationic antimicrobial agents, leading to
formulation incompatibilities.” Id.
The Specification discloses that “addition of a stabilizing amount of an
orally acceptable polyamine compound, e.g., lysine, to formulations
comprising an anionic polymer and a cationic antibacterial agent inhibits the
association of these components and enhances delivery to the teeth.” Id. ¶ 10.
Claims 1, 4–16, and 19 are on appeal. Claim 1, reproduced below, is
illustrative:
1. An oral care composition comprising
a) an orally acceptable acidic polymer, wherein said acidic
polymer comprises a copolymerized product of a mixture
of acrylic acid, methacrylic acid, and 2-hydroxyethyl
methacrylate phosphates of Formula 1:

wherein n is 0, 1 or 2;
b) an orally acceptable nonionic polymer;
c) an effective amount of orally acceptable cationic active
agent, in free or orally acceptable salt form;
d) a polyamine compound, in free or orally acceptable salt
form, present in an amount sufficient to stabilize the
cationic active agent, wherein the polyamine is lysine or
polylysine; and
e) water.
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The claims stand rejected as follows:
Claims 1, 4–6, 8–12, 14–16, and 19 under 35 U.S.C. § 103 as obvious
based on Prencipe2 and Subramanyam3 (Ans. 3);
Claim 7 under 35 U.S.C. § 103 as obvious based on Prencipe,
Subramanyam, and Gaffar4 (Ans. 5); and
Claim 13 under 35 U.S.C. § 103 as obvious based on Prencipe,
Subramanyam, and Dolan5 (Ans. 6).
OPINION
All of the claims stand rejected as obvious based on Prencipe and
Subramanyam, by themselves, or combined with either Gaffar or Dolan with
respect to claims 7 and 13, respectively. Appellant has waived arguments
based on Gaffar or Dolan. See Appeal Br. 9–10. We therefore address the
rejections together.
The Examiner finds that Prencipe “discloses oral care compositions
comprising a phosphate/acrylate copolymer,” and specifically “the instantly
elected species of acidic polymer, and which reads upon instantly recited
element a).” Ans. 3. The Examiner also finds that Prencipe’s “composition
also can comprise a humectant such as polyethylene glycol . . . , which reads
upon instantly recited element b).” Id. Finally, the Examiner finds that
Prencipe “suggests the inclusion of antibacterial agents, such as a bisguanide
antiseptic such as chlorhexidine and zinc salts . . . , which reads upon

2 WO 2015/094336 A1; June 25, 2015.
3 US 2011/0052509 A1; Mar. 3, 2011.
4 US 5,525,330; June 11, 1996.
5 US 2004/0101492 A1; May 27, 2004.
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instantly recited element c).” Id. “Thus, Prencipe et al. teaches all of the
limitations recited by instant claim 1 except for the polyamine compound
recited as element d),” although Prencipe “suggests anti-caries agents in
from 0.1 to 10 wt%.” Id.
The Examiner finds that Subramanyam “discloses oral care
compositions with a basic amino acid in free or salt form and a soluble
carbonate or bicarbonate salt,” where “[t]he basic amino acid can be lysine”
or its hydrochloride salt. Id. at 4. The Examiner finds that Subramanyam
discloses that “basic amino acids are useful in inhibiting cavity formation
. . . , and the combination taught provides for reducing the accumulation of
plaque,” among other benefits. Id.
The Examiner concludes that it would have been obvious “to have
included lysine hydrochloride in the composition taught by Prencipe et al.,
and to do so in the amount taught therein [for an anti-caries agent]” because
“it is prima facie obvious to select a known material for incorporation into a
composition, based on its recognized suitability for its intended use.” Id. The
Examiner finds that “such an amount of the anti-caries agent would provide
for the stability instantly recited by claim 1, as this amount is taught as such
by the instant specification (paragraph [22]).” Id.
We agree with the Examiner that the claimed composition would have
been obvious to a skilled artisan based on Prencipe and Subramanyam.
Prencipe discloses “an oral care composition comprising a phosphate/
acrylate co-polymer, a synthetic anionic linear polycarboxylate, and an
orally acceptable carrier,” as well as “a method of forming the composition
as a mouth rinse that includes the phosphate/acrylate co-polymer and the
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synthetic anionic linear polycarboxylate polymer as well as a zinc salt and a
cationic antibacterial agent.” Prencipe ¶¶ 9, 10. The resulting mouth rinse
also comprises water. Id. ¶ 10. One phosphate/acrylate co-polymer disclosed
by Prencipe is the same as the “acidic polymer” recited in claim 1. Id. ¶ 16.
Prencipe suggests including a humectant in its composition to “keep[]
oral care compositions from hardening upon exposure to air,” as well as to
“impart desirable sweetness or flavor to oral care compositions.” Id. ¶ 31.
One of the humectants suggested by Prencipe is polyethylene glycol. Id.
Appellant’s Specification states that polyethylene glycol is an example of
the “orally acceptable nonionic polymer” recited in claim 1. Spec. ¶ 29.
Thus, Prencipe suggests an oral care composition (e.g., a mouth rinse)
comprising components a), b), c), and e) of claim 1. Prencipe does not
suggest including lysine or polylysine in the composition. However,
Subramanyam discloses an “oral care composition, e.g., a dentifrice,
comprising a basic amino acid, e.g., arginine, . . . together with a soluble
carbonate salt, e.g., sodium carbonate, sodium bicarbonate or mixtures
thereof, wherein a bicarbonate of the basic amino acid is formed in situ.”
Subramanyam ¶ 6.
Subramanyam discloses that its compositions “are effective in
inhibiting or reducing the accumulation of plaque, reducing levels of acid
producing (cariogenic) bacteria, remineralizing teeth, and inhibiting or
reducing gingivitis.” Id. ¶ 5. Subramanyam discloses that the basic amino
acid can be “arginine, lysine, citrullene [sic], ornithine,” etc. Id. ¶ 9
(Composition 1.0.1). Subramanyam discloses that the basic amino acid can
be present in an amount of “about 0.1—about 20%, e.g., about 1 wt. % to
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about 10 wt. % of the total composition weight.” Id. ¶ 9 (Composition
1.0.8). Subramanyam also discloses that its composition can be a
mouthrinse. Id. ¶ 9 (Composition 1.0.62).
Based on these disclosures, it would have been obvious to modify
Prencipe’s composition to include a basic amino acid, such as lysine, and a
soluble carbonate salt, because Subramanyam discloses that these
components provide several beneficial effects: “inhibiting or reducing the
accumulation of plaque, reducing levels of acid producing (cariogenic)
bacteria, remineralizing teeth, and inhibiting or reducing gingivitis.” Id. ¶ 5.
It would have been obvious to provide the basic amino acid (e.g., lysine) in
an amount of 1–10 wt% of the total composition, because Subramanyam
expressly suggests using that amount in order to gain the benefits described
by Subramanyam. Appellant’s Specification discloses that 1–5% lysine or
2–4% lysine hydrochloride is an appropriate amount to provide the desired
stabilizing effect. Spec. ¶ 22 (Compositions 1.35, 1.37). Thus, the
composition of claim 1 would have been obvious to a skilled artisan based
on the disclosures of Prencipe and Subramanyam.
Appellant argues that “[o]ne problem with the Examiner’s logic is that
if Subramanyam is intended to provide an antibacterial agent, why would
one of skill in the art pick lysine rather than arginine, which Subramanyam
expressly prefers and identifies?” Appeal Br. 5. This argument is
unpersuasive, because Subramanyam expressly suggests using basic amino
acids other than arginine. See Subramanyam ¶¶ 9, 21. “[I]n a section 103
inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not
controlling, since all disclosures of the prior art, including unpreferred
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embodiments, must be considered.’” Merck & Co. Inc. v. Biocraft Labs.,
Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d
747, 750 (CCPA 1976).)
Appellant also argues that “the Examiner takes the view that the
lysine is the antibacterial agent, thus presumably no cationic antibacterial
agent would be required.” Appeal Br. 6. This argument is also unpersuasive,
because Prencipe expressly suggests specific anti-bacterial agents, including
cationic agents, and suggests that “mixtures thereof” are suitable for use in
its composition. Prencipe ¶ 48. Based on this teaching, it would have been
obvious to use a mixture of anti-bacterial agents in Prencipe’s composition.
In addition, Subramanyam discloses that a basic amino acid, such as lysine,
provides other benefits besides reducing the level of cariogenic bacteria. See
Subramanyam ¶ 5.
Appellant argues that “[n]either Prencipe nor Subramanyam disclose,
recognize, or solve the problem of incompatibilities between the claimed
acidic polymer and cationic active agent.” Appeal Br. 6. This argument is
also unpersuasive, because Prencipe discloses a method of making a
composition comprising a phosphate/acrylate copolymer, which can be the
same polymer as recited in part a) of Appellant’s claim 1, and a cationic
antibacterial agent. See Prencipe ¶ 78. Prencipe states that “[t]he method can
form a stable composition that is stable and transparent.” Id.
Appellant argues that “[t]he Examiner has not suggested that the
amount of lysine or polylysine should be ‘in an amount sufficient to stabilize
the cationic active agent’ as claimed.” Appeal Br. 6. This argument is
unpersuasive, because the Examiner pointed out that the amount of lysine
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suggested by Subramanyam encompasses the amounts of lysine or lysine
hydrochloride disclosed in Appellant’s Specification as effective to stabilize
the claimed composition. See Ans. 4, Spec. ¶ 22 (Compositions 1.35, 1.37).
Thus, the amount suggested by the prior art is “an amount sufficient to
stabilize the cationic active agent,” as recited in claim 1.
Appellant also argues that “[t]he skilled artisan, upon studying the
cited prior art, would have no motivation to use lysine as a stabilizer.”
Appeal Br. 6. That is, “lysine, while known in the art as an anti-caries agent,
was not known for its ability to stabilize a composition characterized by the
presence of a negatively charged polymer and a cationic active agent.” Id.
Thus, Appellant argues,
the Examiner still has not shown that the combination of
Prencipe and Subramanyam would have rendered lysine’s
stabilizing effect on the claimed composition to be obvious. At
best, the Examiner has only shown that lysine could be used if a
composition called for an anti-caries agent. As argued
exhaustively already, that is not the purpose of the claimed
lysine.
Id. at 8.
These arguments are also unpersuasive. “In determining whether the
subject matter of a patent claim is obvious, neither the particular motivation
nor the avowed purpose of the patentee controls.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 419 (2007). “[A]ny need or problem known in the field
of endeavor at the time of invention and addressed by the patent can provide
a reason for combining the elements in the manner claimed.” Id. at 420.
Here, the cited references provide a reason to include lysine in Prencipe’s
composition: as an anti-caries agent. Whether the prior art suggests
including lysine as a stabilizer is immaterial to the issue of whether the
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claimed composition would have been obvious to a skilled artisan. See KSR,
550 U.S. at 419 (“What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under § 103.”).
Appellant also argues that its position is supported by Leo
Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013).
Appeal Br. 7. Appellant argues that
[i]n Leo, the USPTO found prior art accounting for more than
eight different classes of additives (e.g., diluents, buffers,
thickeners, lubricants), and more than ten different categories of
composition forms (e.g., liniments, lotions, Appellants [sic,
applicants], oil-in-water or water-in-oil emulsions such as
creams, ointments, pastes, or gels). Leo at 1356. The Board
concluded that a person of ordinary skill in the art would have
been capable of selecting the correct formulation from available
alternatives. Id. The Federal Circuit rejected such analysis,
holding “[t]o the contrary, the breadth of these choices and the
numerous combinations indicate that these disclosures would
not have rendered the claimed invention obvious to try.” Id.
Id.
We do not agree that Leo supports Appellant’s position. As Appellant
correctly notes, the rejection in Leo depended on choosing the claimed
elements from prior art disclosures of eight different classes of additives and
more than ten different composition forms, on the basis that a skilled artisan
“would have been capable of selecting the correct formulation from
available alternatives.” Leo, 726 F.3d at 1356. Here, by contrast, a skilled
artisan need only choose lysine from among the basic amino acids disclosed
by Subramanyam, and include it in Prencipe’s composition for the reason
disclosed by Subramanyam, in order to achieve the claimed composition.
The facts of this case are therefore readily distinguishable from those of Leo.
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Finally, Appellant argues that the Specification’s
data show [that] combining the anionic polymer with the
cationic active agent interferes with both the anti-staining
properties of the former and the antibacterial activity of the
latter, but the addition of lysine, in accordance with the claims,
is able to restore these activities – an unexpected effect which
could not have been predicted from the art cited.
Appeal Br. 8.
We have considered the data presented in the Specification, but do not
agree that it demonstrates unexpected results that support a conclusion of
nonobviousness. Appellant argues that the “stabilizing effect of the lysine
turns out to be absolutely critical in preserving . . . both the anti-stain
efficacy of the anionic polymer (DV8801; see, Table 3, para. [0060] –
[0061]) and the antibacterial effect of the cationic active agent (CHX; see,
Table 5, para. [0064] – [0065]).” Appeal Br. 8.
However, Table 3 does not include samples containing an acidic
polymer (e.g., DV8801) and a cationic active agent (e.g., CHX), with and
without lysine, that would demonstrate the criticality of lysine in preserving
the activity of DV8801 and CHX. Rather, the only compositions in Table 3
that contain both DV8801 and CHX also contain lysine, another polymer
(Gantrez S-97), and a surfactant (SLS), or all of those components plus PEG
10K. Spec. ¶ 61, Table 3 (see also id. ¶ 59, Table 2).
Similarly, while the Specification’s Table 5 shows that the
combination of CHX and DV8801 has much less antibacterial activity than
CHX alone, the table does not include a sample containing only CHX,
DV8801, and lysine, which would demonstrate the criticality of lysine in
restoring CHX’s antibacterial activity in the presence of DV8801. Rather,
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the composition that adds lysine to CHX and DV8801 also adds Gantrez
S-97, SLS, and PEG 10K. Spec. ¶ 64, Table 5. The data therefore do not
demonstrate that lysine provides an unexpected effect on a composition
comprising a cationic active agent and an acidic polymer.
Consistent with the results shown in Tables 3 and 5, the Specification
states that “CHX and DV can be formulated in such a way to prevent
precipitation (or to re-dissolve the precipitate) through the inclusion of
lysine (Lys), polyethylene glycol (PEG), and low levels of sodium lauryl
sulfate.” Spec. ¶ 59 (emphasis added). The Specification also states that
“[w]hen chlorhexidine digluconate is combined with the acidic polymers
(DV and Gantrez S-97), and Lys alone (solution 4), no CHX is deposited on
to the HAP [hydroxyapatite] surface, likely because [it] existed as a
precipitate. . . . The addition of SLS . . . brings CHX back into solution, and
re-enables its ability to deposit to HAP.” Id. ¶ 63.
The evidence relied on by Appellant therefore does not show that
lysine provides an unexpectedly beneficial effect when combined with a
cationic active agent and an acidic polymer, as recited in claim 1.
In summary, a preponderance of the evidence of record supports the
Examiner’s rejection of claim 1 under 35 U.S.C. § 103 based on Prencipe and
Subramanyam. We affirm the rejection of claim 1. Claims 4–6, 8–12, 14–16,
and 19 fall with claim 1 because they were not argued separately. 37 C.F.R.
§ 41.37(c)(1)(iv). For the reasons discussed above, we also affirm the
rejection of claim 7 under 35 U.S.C. § 103 based on Prencipe, Subramanyam,
and Gaffar, and the rejection of claim 13 under 35 U.S.C. § 103 based on
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Prencipe, Subramanyam, and Dolan, because Appellant has waived
arguments directed to Gaffar or Dolan.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4–6, 8–
12, 14–16,
19
103 Prencipe,
Subramanyam
1, 4–6, 8–
12, 14–16,
19

7 103 Prencipe,
Subramanyam, Gaffar
7
13 103 Prencipe,
Subramanyam, Dolan
13
Overall
Outcome
1, 4–16, 19

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