Ex Parte Shastry et al

Patent Trial and Appeal Board

Dec 11, 2017

11285871 (P.T.A.B. Dec. 11, 2017)

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.
11/285,871 11/23/2005 Ramachandra Shastry 7334-OO-US-Ol-OC 8826
23909 7590 12/18/2017
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
PACKARD, BENJAMIN J
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/18/2017 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):
Paten t_Mail @ colpal. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAMACHANDRA SHASTRY, YELLOJI RAO MIRAJKAR,
NAGARAJ DIXIT, RYAN CAMERON, QIN WANG,
LYNETTE ZAIDEL, SUMAN K. CHOPRA, MICHAEL PRENCIPE
Appeal 2017-003614
Application 11/285,8711
Technology Center 1600
Before DEMETRA J. MILLS, LORA M. GREEN, and
ROBERT A. POLLOCK, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 The real party in interest is the Assignee, Colgate-Palmolive Company.
App. Br. 2
Appeal 2017-003614
Application 11/285,871
STATEMENT OF CASE
The claimed invention is directed to an oral care composition. The
following claim is representative.
1. An oral care composition, comprising:
(a) a peroxide composite comprising a peroxide
compound and a porous cross-linked polymer forming a
polymeric matrix in which the peroxide compound is sorbed, at
a level of from 70% to 90% by weight of the peroxide
compound to the crosslinked polymer, wherein the porous
cross-linked polymer comprises a polymerized polyunsaturated
monomer selected from the group consisting of polyacrylates,
polymethacrylates, polyitaconates, and mixtures thereof, and
wherein the peroxide composite is present in the composition in
an amount of from 10% to 25% by weight of the oral care
composition; and wherein the peroxide compound comprises
hydrogen peroxide, urea peroxide, sodium percarbonate or a
mixture of two or more thereof; and
(b) an orally acceptable carrier, wherein the
composition has a product form selected from the group
consisting of a dentifrice, a rinse, a powder, a gel, a
confectionary and a paint.
Grounds of Rejection
Claims 1, 3—7, 9-18 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kuo (US 2003/0211440 Al; published Nov. 13, 2003) and
Sojka (WO 00/41528; published July 20, 2000), as evidenced by Advanced
Polymer Systems (Advanced Polymer Systems Asset Purchase Agreement,
TechAgreements, http://www.techagreements.com/ agreement-
preview. aspx?.num=41769 (1 of 11) (last visited 5/29/2008), Won (US
5,145,675; issued Sep. 8, 1992), and Piechota (US 4,582,701; issued Apr.
15, 1986). Final Act. 2.
2
Appeal 2017-003614
Application 11/285,871
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 2—10. The following facts are highlighted.
1. Kuo discloses an oral delivery composition for delivery of an agent
to the oral environment. The agent may be a bleaching agent such
as carbamide peroxide. Kuo 10, 11, 20.
2. In Kuo, the agent may be encapsulated or entrapped by a number
of materials, including polyacrylic acids. Id. f 68.
3. In Kuo, the encapsulating material may be an ion exchange resin
having a very high surface area and able to absorb a large quantity
of agent. An exemplary resin is sold under the name of
MICROSPONGE (Advanced Polymer Systems) as described in
U.S. Pat. No. 5,145,675. Id. flO.
4. Kuo incorporates a bleaching material, such as 18—37% carbamide
peroxide, which may be delivered to the oral environment in a
resin material or a gel. Id. 120. The bleaching agent itself may be
absorbed into the pores of the resin material, or the agent may be
suspended in a carrier which is absorbed into the pores of the resin
material. Id. 127.
5. Sojka teaches compositions comprising an adsorbent polymer, an
active agent, and a release retardant which has improved ability to
release active agent over an extended period of time. Sojka
Abstract, page 1, lines 15—22, page 4, lines 8—10. Thus, the
problem of premature release of an active agent from controlled
release compositions is overcome (page 4, lines 8—10).
3
Appeal 2017-003614
Application 11/285,871
6. The adsorbent polymer microparticles of Sojka are highly porous
in the form of spheres about 1—300 microns (id. at page 8, lines
27—33). The active agent is absorbed onto the adsorbent polymer
(page 4, lines 21—26).
7. Sojka teaches that topically active agents such as antibacterial
compounds are useful in the composition (page 16, line 33, page
17, lines 1—6). The amount of adsorbent polymer present in a
controlled release composition is related to the amount of active
agent in the composition. Page 16,11. 10-23. The amount of
active agent required to perform its intended function is
determined, then the amount of adsorbent polymer is determined
based on considerations such as the identity of the adsorbent
polymer and active agent, and the ability of the active agent to
absorb the active agent. (Page 14, 1. 39—15, 1, 4.) Such a
determination is easily performed by persons skilled in the art
(page 14, line 29-page 15, line 6 and page 16, lines 18—23), i.e. the
amount of device incorporated into a composition can be
optimized by persons skilled in the art.
8. In Sojka, the microparticles are made by a suspension
polymerization process of two polyunsaturated monomers,
ethylene glycol dimethylacrylate and allyl methacrylate (page 9,
lines 15—19). Sojka discloses that an adsorbent polymer
Microsponge ® can alternately be used in the invention, i.e. the
polymers produced by polymerization of ethylene glycol
dimethylacrylate and allyl methacrylate, and Microsponge ® are
functionally equivalent (Sojka, page 14, lines 22—25). To retard or
4
Appeal 2017-003614
Application 11/285,871
eliminate displacement of the active agent from the absorbent
polymer, a release retardant is added; the release retardant can be
added simultaneously with the active agent (page 27, lines 17—24).
The active release retardants include mineral oil, waxes, silicone
oils and block polymers of polyethylene oxide and polypropylene
oxide (page 30, lines 7—15, lines 17—18, page 31, lines 13—16).
9. Sojka discloses that
The only limitation on the adsorbent polymer is an ability at adsorb
at least an equal weight amount of a solid or a liquid active agent,
and preferably an ability to adsorb a greater than equal weight
amount of an active agent. The adsorbent polymer typically
adsorbs about 4 to about 5 times its weight of an active agent, and
often about 10 times, and up to about 20 times, its weight of an
active agent.
Sojka, p. 14,11. 11-21.
10. Sojka discloses that
The active agent is present in the controlled release composition in
an amount to perform its intended function, typically in an amount
of about 0.1% to about 30%, by weight, of the composition
when in liquid form, and about 50% to about 95%, by weight, of
the composition when in solid form. Semisolid forms of a
controlled release composition contain about 0.1% to about 75%,
by weight, of the active agent. Persons skilled in the art are
aware of the amount of active agent needed to perform its
intended function, and are capable of determining the amount
active agent to incorporate into the composition
based on the form, e.g., solid, semisolid, or liquid, of the
composition.
Sojka, p. 16,11. 10-24.
11. Sojka discloses that
Preferably, the micro-particles of adsorbent polymer
have a total sorption capacity for mineral oil of
about 82-93% by weight, more preferably about 84%
5
Appeal 2017-003614
Application 11/285,871
by weight or greater, most preferably about 85-93%
by weight or greater.
Sojka, p. 16,11. 10-24.
12. Won ‘675 discloses the controlled release of an active
substance from a polymeric delivery system which may be a bead or
microsphere. Col. 1,11. 21—29, Col. 2, 11. 42—50.) The beads maybe
made of polyenthyenically unsaturated monomers including ethylene
glycol diacrylate and allyl acrylate. (Col. 6, 11. 32-40.)
13. Won ‘675, col. 7,11. 30-38, discloses that “[t]he impregnant [of
the controlled release composition], whether it be pure active
ingredient, a mixture of active ingredients or a solution of active
ingredient, will generally comprise between approximately 5% and
approximately 65% of the total weight of the impregnated beads.”
14. Won ‘675 discloses that the
The bead diameter is normally maintained in the range from
about 5 microns to 100 microns, usually being about 10
microns to 50 microns, and the total pore volume is in the
range from about 0.1 to 2.0 cc/g, usually being in the range
from about 0.3 to 1.0 cc/g. The surface area of the beads
will range from about 1 to 500 m2/ g, usually being in the
range from about 20 to 200 m2/ g. The precise dimensions
and characteristics of the beads are controlled by varying
process parameters such as agitation speed and nature of the
porogen.
Col. 2, 1. 66—col. 3, 1. 8. (emphasis added).
15. Won discloses that the outward diffusion (release rate) of the
impregnants is dependent upon the pore size. Abstract, col. 16,11. 33-
36.
16. Won discloses that the beads may be in the form of a
microsponge. Col. 13,11. 19-38.
6
Appeal 2017-003614
Application 11/285,871
17. Won discloses a rigid cross-linked polymer beads having a total
pore volume in the range from about 0.01 cc/g to about 4.0 cc/g.
Won, claim 6.
18. Won discloses benzoyl peroxide, a bleaching agent, as the active
inside the pores of porous solid particles or microspheres. Won,
Claim 15.
19. The Specification, 113 discloses that, “[t]he peroxide composite
preferably comprises a peroxide compound at a level of about 50% to
about 95% optionally about 70 to about 90% by weight of the
peroxide composite.”
20. The Specification discloses that, “the polymer comprises porous
particulates having a BET ... pore volume of about 0.05 to about
0.3cc/g, optionally about 0.1 to about 0.2 cc/g, optionally about 0.14
to about 0.16 cc/g.” Spec. 3 113.
21. The Specification page 8,125, discloses that
Porous cross-linked polymers among those useful herein are
disclosed in U.S. Patents 5,955,552; and 6,387,995, the contents
of each of which are incorporated herein by reference. Such
polymers include those commercially available as:
MICROSPONGE® 5640, marketed by A.P. Pharma, Redwood
City, California, U.S.A.; POLYTRAP® 6603 and POLYPORE ®
200 series, marketed by Amcol International Corp, Arlington
Heights, Illinois, U.S.A.; and DSPCS®-12 series and SPCAT®-12
series, marketed by Kobo Products, Inc., South Plainfield, New
Jersey, U.S.A.
22. Piechota discloses a dentifrice which includes bleaching agents,
such as, sodium perborate, hydrogen peroxide, sodium percarbonate,
and urea peroxide. Col. 4,11. 18—29.
7
Appeal 2017-003614
Application 11/285,871
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
The meaning of the word “about” or “approximately” is dependent on
the facts of a case, the nature of the invention, and the knowledge imparted
by the totality of the earlier disclosure to those skilled in the art. Eiselstein
v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995); see also, Ex parte Eastwood,
Brindle and Kolb, 163 USPQ 316 (Bd. Pat. App. & Int. 1968) (The
descriptive word “about” is not indefinite as argued by the examiner. . . .
Rather, the term is clear but flexible and is deemed to be similar in meaning
to terms such as “approximately” or “nearly”.)
Such broadening usages as ‘about’ [or ‘approximately’] must be given
reasonable scope; they must be viewed by the decision maker as they would
be understood by persons experienced in the field of the invention.
Although it is rarely feasible to attach a precise limit to ‘about,’ [or
‘approximately’] the usage can usually be understood in light of the
technology embodied in the invention. Modine Mfg. Co. v. U.S. Int’l Trade
Comm’n, 75 F.3d 1545, 1554, (Fed. Cir. 1996) (internal citations omitted).
In re Woodruff, 919 F.2d 1575, 1576 (Fed. Cir. 1990), held that, “the term
‘about 1-5%’ does allow for concentrations slightly above 5%.”
8
Appeal 2017-003614
Application 11/285,871
Furthermore, “[precedent illustrates the fact-dependency of determinations
of the technologic scope of ‘about’ and similar terms [such as
approximately], depending on their contexts and the precision or
significance of the measurements used.” Modine Mfg., 75 F.3d at 1554.
Obviousness Rejection
Claims 1, 3—7, 9-18 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kuo and Sojka, as evidenced by Advanced Polymer
Systems, Won, and Piechota.
The Examiner finds that the cited references, in combination, support
rejection of the pending claims. Particularly relevant is the disclosure of
Won.
Won ‘675 discloses a polymeric delivery system
comprising impregnants inside the pores of porous solid
particles or microspheres. (Abstract.) The polymer beads or
micro spheres may be used alone or may be incorporated into a
secondary carrier or vehicle composition. (Col. 2, lines 27-30.)
Won ‘675, col. 7, lines 30-38, further discloses that, “[t]he
impregnant [of the controlled release composition], whether it
be pure active ingredient, a mixture of active ingredients or a
solution of active ingredient, will generally comprise between
approximately 5% and approximately 65% of the total weight
of the impregnated beads.” Won ‘675 further teaches the use of
the polymeric delivery system allows avoiding incompatibility
of actives, such as chemical or physical interactions. (Col. 2,
lines 24-41).
Examiner considers the active ingredient of Won ‘675
which is “approximately 65%” of the total weight of the
impregnated beads to read on the claimed 70% value where the
range is close. Further, where the overall range is about 60%,
the term “approximately” would be interpreted to be broader in
scope than a narrower range, and as such, variance of 5% is
reasonable.
9
Appeal 2017-003614
Application 11/285,871
Ans. 3.
Appellants contend that
Kuo discloses that many agents including carbamide peroxide
may be releasably attached to the elastic repositioning
appliance in a number of forms. Kuo also discloses many
means for releasing an agent to the oral environment. Although
Kuo makes a general statement that agents may be encapsulated
or entrapped by a number of materials, including polyacrylic
acid, and Kuo discloses Microsponge as an exemplary resin,
Kuo does not disclose or teach peroxide composites comprising
a peroxide compound and porous cross-linked polymers as
specified in the present claims. Kuo also fails to teach that the
peroxide should be sorbed to the polymer, or the specific
amounts of peroxide suitable for use in such a system, or the
specific amounts of the peroxide composite. This failure is not
cured by the other cited references, none of which disclose or
teach a peroxide compound sorbed to the crosslinked polymer
as recited in the claims.
Especially, with regard to claims 3, 5 and 18, Kuo does
not disclose any polymer comprising polymethacrylate (as
recited in claims 3 and 18) or comprising allyl methacrylates
polymerized with ethylene glycol dimethacrylate (as recited in
claim 5).
App. Br. 6. Appellants further contend that, “[njeither Kuo nor the other
cited references teach the range (70 to 90%) of a peroxide compound sorbed
to the cross-linked polymer that is recited in the present claims.” App. Br. 7.
Appellants argue that
Moreover, if one were to accept the Examiner's
argument, then the language “'approximately” would suggest
that Won did not consider the range of 5-65% to be critical, or a
result effective variable. As stated in MPEP 2144.05:
A particular parameter must first be recognized as
a result-effective variable, i.e., a variable which
achieves a recognized result, before the
determination of the optimum or workable ranges
10
Appeal 2017-003614
Application 11/285,871
of said variable might be characterized as routine
experimentation. In re Antonie, 559F.2d618, 195
USPQ 6 (CCPA 1977)[.]
Ap. Br. 9.
ANALYSIS
Individual claims are not separately argued in Appellants’ Brief,
therefore we select claim 1 as representative claim. We agree with the
Examiner’s fact finding, statement of the rejection and responses to
Appellants’ arguments as set forth in the Answer. We find that the
Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner’s argument set forth in the Final Office Action and Answer.
Claim Interpretation
Claim 1 recites the limitation, “a peroxide composite comprising a
peroxide compound and a porous cross-linked polymer forming a polymeric
matrix in which the peroxide compound is absorbed, at a level of from 70%
to 90% by weight of the peroxide compound to the crosslinked polymer.”
The Specification, 113 discloses that, “[t]he peroxide composite preferably
comprises a peroxide compound at a level of about 50% to about 95%
optionally about 70 to about 90% by weight of the peroxide composite.”
(Emphasis added).
We interpret the claim 1 phrase “from 70% to 90% by weight of the
peroxide compound” in the claim to read on the active ingredient, peroxide,
amount of approximately 65% of the total weight of the impregnated beads,
disclosed in Won. In addition, the Appellants’ Specification, 113 discloses
that, “[t]he peroxide composite preferably comprises a peroxide compound
11
Appeal 2017-003614
Application 11/285,871
at a level of about 50% to about 95%,” indicating a lack of criticality within
a range encompassing the approximately 65% disclosed in Won. Indeed, we
do not discern any teaching in the Specification suggesting a criticality or
difference in properties over the broadest disclosed range.
We are not persuaded by Appellants’ arguments that the cited
references, in combination, do not disclose the claimed range of a peroxide
compound sorbed to the crosslinked polymer. The Specification, 113
discloses that, “[t]he peroxide composite preferably comprises a peroxide
compound at a level of about 50% to about 95% optionally about 70 to
about 90% by weight of the peroxide composite.” Thus the Specification
contemplates a wide range of effective amounts of the active agent,
peroxide, in the peroxide composite. Appellants do not establish criticality
or unexpected results for the narrow range of peroxide amount claimed, in
view of the broader range disclosed in the Specification 113. “The law is
replete with cases in which the difference between the claimed invention and
the prior art is some range or other variable within the claims. ... In such a
situation, the applicant must show that the particular range is critical,
generally by showing that the claimed range achieves unexpected results
relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990). Criticality is shown by some noticeable difference in the
qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933).
Appellants argue that
The disclosure of Won cited by the Examiner only states that
5.3 parts/in 381 parts total; i.e. 1.4%, of a 70% active
solution of benzoyl peroxide, is added to the mixture to initiate
polymerization. That is, the “benzoyl peroxide at 70% active
ingredient” that the Examiner refers to is not active ingredient
in the Won composition, but merely the percentage of active
12
Appeal 2017-003614
Application 11/285,871
peroxide in the solution that is added to the Won
polymerization mixture as catalyst.
App. Br. 8.
We are not persuaded by Appellants’ argument. Won discloses that,
“[t]he impregnant [of the controlled release composition], whether it be pure
active ingredient, a mixture of active ingredients or a solution of active
ingredient, will generally comprise between approximately 5% and
approximately 65% of the total weight of the impregnated beads.” FF15.
Won discloses benzoyl peroxide, a bleaching agent, as the active. Won,
Claim 15. FF18. It would have been obvious to include benzoyl peroxide in
an amount of from 70% to 90% by weight of the peroxide compound to the
crosslinked polymer as claimed, in view of Won’s disclosure of benzoyl
peroxide as an active in impregnated beads or microsponge system, and that
actives may be present in the controlled release microspheres in amount of
approximately 65% (interpreted to include 70%). Appellants have provided
no argument as to why the term “approximately 65%” in Won does not
include 70%. Appellants have not established criticality of the 70%
minimum amount of active by showing a difference in properties of the
peroxide composites.
In addition, Sojka’s improved controlled release composition includes
an adsorbent polymer that typically adsorbs about 4 to about 5 times its
weight of an active agent, and often about 10 times, and up to about 20
times, its weight of an active agent. FF10. Sojka discloses that the micro­
particles of adsorbent polymer have a total sorption capacity of about 82-
93% by weight, more preferably about 84% by weight or greater, most
preferably about 85—93% by weight or greater. FF12. Moreover, Kuo
(FF3), Won (FF18) and Sjoka (FF9) disclose absorbent polymers include
13
Appeal 2017-003614
Application 11/285,871
microsponge products similar to those disclosed in Appellants’ Specification
(FF22). Thus it would have been obvious to one of ordinary skill in the art
at the time of the invention that the absorptive, microsponge polymers of
Sokja, and the cited references in combination, can absorb and deliver higher
amounts of active agent, including active agent at a level of from 70% to
90% by weight of the peroxide compound to the cross-linked polymer.
Appellants argue that the non-precedential and unpublished case, In
Re Rajen M. Patel, 566 F. Appx. 1005 (Fed. Cir. 2014) (non-precedential)
supports a finding of non-obviousness in the present case. App. Br. 9-10.
We are not persuaded. In Patel, the court found that “[wjhere differences
clearly exist and there is no evidence that they are either not meaningful or
one of skill in the art would know to discard the limits set by the prior art,
proximity alone is not enough to establish a prima facie case of
obviousness.” Id. at 1010; App. Br. 10. In contrast, in the present case, for
the reasons presented above, evidence has been presented that the range end
points are not critical, that the cited art teaches higher amounts of active
agent, and that and that the ordinary artisan would understand that the
claimed amount of active agent is encompassed by the cited prior
artespecially in view of the prior art teachings that absorbent polymers for
incorporating the active agent that include microsponge products similar to
those disclosed in Appellants’ Specification. Compare, Titanium Metals
Corporation of America v. Banner, 778 F2d 775, 782 (Fed. Cir. 1985) (The
alloy proportions between the prior art and that claimed are so close that
prima facie one skilled in the art would have expected them to have the same
properties. Appellee produced no evidence to rebut that prima facie case.)
The obviousness rejection is affirmed for the reasons of record.
14
Appeal 2017-003614
Application 11/285,871
CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections,
which are affirmed for the reasons of record. All pending, rejected claims
fall.
AFFIRMED
15