Ex Parte Maitra et al

Patent Trial and Appeal Board

Dec 30, 2013

12132359 (P.T.A.B. Dec. 30, 2013)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/132,359 06/03/2008
23909 7590 03/15/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Prithwiraj Maitra
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
7472-01-0C 7579
EXAMINER
ROBERTS, LEZAH
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
03/15/2016 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 PRITHWIRAJ MAITRA, LYNETTE ZAIDEL,
SUMAN K. CHOPRA, GUISHENG PAN, MICHAEL PRENCIPE, and
SYED IBRAHIM 1
Appeal2014-003185
Application 12/132,359
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and
ROBERT A. POLLOCK, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final office
action dated October 2, 2012, and in light of claim amendments entered
January 3, 2014. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Colgate-Palmolive
Company. App. Br. 2.
Appeal2014-003185
Application 12/132,359
STATEMENT OF THE CASE
Appellants' invention relates to oral care compositions comprising a
tooth whitening agent and an acrylic film forming polymer. Spec. Abstract,
i-fi-19-10. "In certain embodiments, the polymer is a terpolymer." Id. i125.
Claims 1, 2, 4--25, and 36 are on appeal. 2 Independent claim 1 is
illustrative:
1. An oral care composition, comprising:
(a) a whitening agent;
(b) a terpolymer wherein the terpolymer comprises a polymer
of a first monomeric unit and at least two different second
monomeric units; and
( c) a silicone polymer selected from the group consisting of
silicone adhesives, silicone elastomers, silicone fluids,
silicone resins, silicone gums and mixtures thereof.
Claims 1, 2, 4--6, 8, 9, 11,12, and 15-17 stand rejected under 35
U.S.C. 103(a) as unpatentable over the combination ofMirajkar3 and
Miranda.4
Claims 1,2, 4--25, and 36 stand rejected under 35 U.S.C. 103(a) as
unpatentable over the combination of Singh, 5 Marchant, 6 and Miranda.
The double patenting rejection in view of claims 1, 2, and 16-20 of
Application No. 10/870,848 was withdrawn in the final office action of
October 2, 2012, and is not before us. See Ans. 26.
2 We note that claims 1, 2, and 7 were amended in Appellants' response of
Feb. 4, 2013. The Examiner has indicated that the amendments were
entered. (Advisory Action mailed Jan. 7, 2014.)
3 Mirajkar et al., US 5,800,803, issued Sept. 1, 1998.
4 Miranda et al., US 5,656,286, issued Aug. 12, 1997.
5 Singh et al., US 2003/0152528 Al, published Aug. 14, 2003.
6 Marchant et al., US 6,297,337 Bl, issued Oct. 2, 2001.
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Application 12/132,359
ANALYSIS
We have reviewed Appellants' contentions that the Examiner erred in
rejecting claims 1, 2, 4--25, and 36 as unpatentable over the cited art. (Br. 3-
16.) We disagree with Appellants' contentions and adopt the findings
concerning the scope and content of the prior art set forth in the Examiner's
Answer. For emphasis, we highlight and address the following:
FF 1. Mirajkar discloses oral compositions such as dentifrices, gels,
mouthwashes, chewing gums and lozenges, useful for increasing the
uptake of non-cationic antibacterial agents in dental tissue and thereby
reducing plaque. Mirajkar, Title, Abstract, 1:59-2:7, 2:24--29. The oral
compositions comprise anionic copolymers derived from hydrophilic-
type and hydrophobic-type monomers. Id. at 1 :59-2:7. The polymers
may be derived from monomers of acrylic acid, methacrylic acid, ethyl
methacrylate, ethyl acrylate, t-butyl acrylate, and substituted acrylamides
such as tertbutyl acrylamide. Id. at 2:62-3:2; 3:11-25; 35-37. In a
preferred embodiment, the copolymers are terpolymers, having "the
general formula ABC, wherein: A is styrene, B is methylacrylate and C is
selected from a mixture of acrylic acid and AMPS
[acrylamidomethylpropylsulfonic acid]" Id. at 3:5-8, 38--41. "A
representative and especially preferred anionic copolymer is the sodium
salt of a methylacrylate/styrene/ AMPS/acrylic acid copolymer
(hereinafter AMPS terpolymer salt)." Id. at 2:6-17.
FF2. Mirajkar further discloses that the oral compositions may include
thickeners such as polyvinylpyrrolidone [PVP], tooth whitening agents
such as hydrogen peroxide, and silicones. Id. at 5:33--41, 63----67.
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Application 12/132,359
FF3. Miranda discloses a drug delivery system comprising a pressure-
sensitive adhesive composition having "at least two polymers, or at least
one polymer and a soluble polyvinylpyrrolidone, in combination with a
drug." Miranda, Abstract; see id. at 1 :24--34. "In a particularly preferred
embodiment of the invention, the multiple polymer adhesive system
comprises a pressure-sensitive adhesive blend of an acrylic polymer, a
silicone polymer, and a soluble PVP." Id. at 9:34--37; see id. at 11 :30-
32, 44--53; see also id. at 6:35--42 ("[T]he term 'pressure-sensitive
adhesive' refers to a viscoelastic material which adheres instantaneously
to most substrates with the application of very slight pressure and
remains permanently tacky."). The "soluble [PVP] can be used to
prevent crystallization of the drug, without affecting the rate of drug
delivery from the pressure-sensitive adhesive composition." Id. Abstract.
FF4. Although Miranda is generally directed to the delivery of drugs to the
skin (see e.g., id. at 1 :24--34), the reference broadly discloses the delivery
of a wide variety of compounds (e.g., "pesticides, insect repellents, sun
screens, cosmetic agents") to both plants and animals (see id. at 6:60-66).
In particular, Miranda makes clear that the disclosed composition is
applicable to oral use for the delivery of dental analgesics such as
"Chlorobutanol, Clove, and Eugenol," and "[d]ental carries [sic, caries]
prophylactics such as Sodium Fluoride." Id. at 12:49-50, 28:19.
FF5. Singh discloses a tooth whitening composition comprising "a water-
swellable, water-insoluble polymer, a blend of a hydrophilic polymer and
a complementary oligomer capable of hydrogen bonding to the
hydrophilic polymer, and a whitening agent, preferably a peroxide."
Singh, Abstract. "When the water-swellable, water-insoluble polymer is
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Application 12/132,359
an acrylate polymer or copolymer, a composition is provided that is
generally substantially nontacky prior to contact with water, but becomes
tacky upon contact with a moist surface." Id. at i-f 58. Acrylate-based
copolymers may comprise a mixture of "acrylic acid, methacrylic acid,
methyl acrylate, ethyl acrylate, methyl methacrylate, ethyl methacrylate
and/or other vinyl monomers." Id. at i-f 62; see id. at claim 7.
FF6. Marchant discloses bioadhesive polymer compositions comprising
"homopolymer, copolymer, terpolymer, or interpolymer hydrogels,"
useful as pharmaceutical controlled release excipients. Marchant, Title,
Abstract, 2:65-3: 10; 22: 1---6; 23:56---61. "The polymers for use in the
invention may be homopolymers, copolymers, and block copolymers,
including diblock, triblock, multiblock, graft, or starblock copolymers,
and interpolymers with other hydrophilic polymers so long as the
polymers are crosslinked to form a gel network and are swellable." Id. at
6: 17-22. Monomers used to make the polymers include mixtures
combining vinyl esters, methacrylic acid, ethyl acrylate and isobutyl
acrylate. See generally, id. at cols. 6-8;
Rejection in view of Mirajkar and Miranda
The Examiner finds that Mirajkar discloses an oral care composition
comprising a whitening agent and a terpolymer, whereas Miranda discloses a
pressure-sensitive adhesive composition comprising silicone polymer such
as the "silicone adhesives, silicone elastomers, silicone fluids, silicone
resins, silicone gums and mixtures thereof," required by claim 1. See Ans.
5. The Examiner concludesthat one of ordinary skill in the art would have
found it obvious to combine the oral care composition of Mirajkar with the
silicone adhesives of Miranda "motivated by the desire to use a component
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Application 12/132,359
that would provide controlled delivery of the active to the teeth." Id. at 5;
see id. at 16. Moreover, because Mirajkar teaches that the oral care
composition may include silicones,
one of ordinary skill in the art would look to the prior art to
determine what silicone compounds would be suitable.
Miranda specially [sic, specifically?] discloses that the
silicone adhesive may be mixed with acrylate polymers and
polyvinyl pyrrolidone and help control the release of the
active. Therefore one would be motivated to use the
silicones of Miranda as the silicones of Mirajkar because
they are compatible with acrylate polymers, which are
disclosed by Mirajkar, and would help control the release of
the whitening agent to the teeth.
Id. at 12; see id. at 13.
Appellants argue that the Examiner has failed to articulate sufficient
rationale for combining the oral care composition of Mirajkar with the
silicone compounds of Miranda because Miranda "is directed toward
transdermal drug delivery systems for the delivery of a drug through the
skin." Br. 6. We do not find Appellants' argument persuasive. As noted by
the Examiner, although Miranda discloses "transdermal delivery as the
preferred embodiment, the reference clearly teaches oral care components
are added to the delivery systems." Ans. 9-10; see FF4. In particular,
because Miranda teaches the addition of "dental caries prophylactic sodium
fluoride," "[ o ]ne of ordinary skill in the art would conclude that the delivery
compositions may be used in the mouth because in order for the sodium
fluoride to be effective, it must be applied to the teeth." Ans. 10; FF4.
Appellants argue that the Examiner's rejection is in error because
neither Mirajkar nor Miranda teach "a whitening agent as the main active
component of their invention." Br. 7. We do not find this argument
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Application 12/132,359
persuasive. Mirajkar discloses oral compositions comprising anionic
antibacterials and whitening agents. FF 1, 2. Appellants' claims are set forth
using comprising language, which does not foreclose additional, unrecited
elements. Appellants present no argument or evidence suggesting that the
claims on appeal exclude any of the components of oral compositions taught
by Mirajkar, including the use of an anionic antibacterial.
Appellants further argue that the Examiner errs in combining Mirajkar
and Miranda because "the invention of Miranda is not isolated to the use of
polysiloxane alone, but to the use of soluble polyvinylpyrrolidone (PVP) to
prevent crystallization of the drug which is necessary within the context of
Miranda's invention in order to provide the proper drug flux ... " Br. 6; see
also id. at 13 (regarding propriety of combining Singh with Miranda). As
above, we note that the comprising language of Appellants' claims in no
way precludes the addition of PVP. Moreover, we accept the Examiner's
reasoning that if the active components of the invention as claimed do not
require PVP to prevent crystallization, "one of ordinary skill in the art would
not add PVP," or would add PVP as a thickening agent as taught by
Mirajkar. See Ans. 10-11; FF2.
Appellants further contend the combination of Mirajkar and Miranda
represents an infinite number of permuations for the types of
active ingredients which can be used as well as the types of
polymers which can be used of which there is no specific
direction to arrive at the simultaneous combination of an oral
care composition which comprises of a whitening agent, a
terpolymer and a silicone polymer.
Br. 9. Appellants argue that this is particularly true for claims 6 and 8,
which specify that the terpolymer is comprised of selected monomer units
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(acrylic acid, t-butyl acrylate, ethyl acrylate, methacrylic acid, and N-
tertbutyl acrylamide ). Id. at 1 O; see id. at 16.
We do not find Appellants' argument persuasive.
Under KSR, a "combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Similarly,
the Federal Circuit has long held that it is obvious for one of ordinary skill in
the art to select a particular component from among many disclosed by the
prior art as long as the prior art teaches that the selection will result in the
disclosed effect (see Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804,
807 (Fed. Cir. 1989) ("That the '813 patent discloses a multitude of effective
combinations does not render any particular formulation less obvious."); In
re Corkill, 771F.2d1496, 1500 (Fed. Cir. 1985) (obviousness rejection
affirmed in light of prior art teaching that "hydrated zeolites will work" in
detergent formulations, even though "the inventors selected the zeolites of
the claims from among 'thousands' of compounds")). The Examiner in the
present case has identified each of the claimed elements in the cited
references and provided an adequate rationale for combining those teachings
as set forth in the claims on appeal. Appellants neither persuade us that any
of these elements (including those recited in claims 6 and 8) would not work
for their intended purpose, nor present evidence of secondary considerations
to rebut the Examiner's prima facie case.
Accordingly, we agree with the Examiner that one would be
motivated to use the silicones of Miranda as the silicones of Mirajkar
because they are compatible with acrylate polymers, which are disclosed by
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Application 12/132,359
Mirajkar, and would help control the release of the whitening agent to the
teeth.
Rejection in view of Singh, Marchant, and Miranda
The Examiner finds that Singh teaches oral hydrogel compositions
comprising whiteners and acrylic based copolymers made from mixtures of
monomers including acrylic acid, methacrylic acid, methyl acrylate and/or
ethyl acrylate (see Ans. 6); Marchant teaches terpolymer compositions
useful as bioadhesive and pharmaceutical controlled release excipients (id. at
7); and "Miranda discloses systems for delivering drugs to parts of the body
such as the teeth using a combination of a pressure sensitive polymer and a
soluble polyvinyl pyrrolidine" (id.).
The Examiner finds that it would have been obvious to use the
terpolymers of Marchant in the oral whitener compositions of Singh
"motivated by the desire to make delivery systems with improved
bioadhesiveness as taught by iviarchant." Id. The Examiner finds that it
would have been further obvious to include the silicone pressure sensitive
adhesives of Miranda "motivated by the desire to use a component that
would adhere instantaneously to most substrates with the application of very
slight pressure, remain permanently tacky and provide controlled delivery of
the active to the teeth." Id. at 7-8.
Appellants contend that the Examiner errs in the rejection for much
the same reasons discussed with respect to the rejection in view of Mirajkar
and Miranda. In both cases, the Examiner's explanation provides sufficient
factual basis and technical reasoning to support a determination of
obviousness, which Appellants have not rebutted.
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Accordingly, for the reasons set forth above, and in the Examiner's
Answer, the rejections of record are affirmed.
SUMMARY
We affirm the rejection of claims 1, 2, 4---6, 8, 9, 11-12, and 15-17
under 35 U.S.C. 103(a) as unpatentable over the combination of Mirajkar
and Miranda.
We affirm the rejection of claims 1, 2, 4--25, and 36 under 35 U.S.C.
103 (a) as unpatentable over the combination of Singh, Marchant, and
Miranda.
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).
AFFIRivIED
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