Ex Parte Boyd et al

Patent Trial and Appeal Board

Oct 18, 2016

11457610 (P.T.A.B. Oct. 18, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111457,610 07/14/2006
23909 7590 10/20/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Thomas J. Boyd
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.
7937-00 7439
EXAMINER
LAZARO, DOMINIC
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
10/20/2016 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 THOMAS J. BOYD, RENSL DILLON, JEFFREY M. MILLER,
DAVID B. VISCIO, and ABDUL GAFF AR
Appeal2015-003995
Application 11/457,6101
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS and
DAVID COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of making an oral care, personal care, cleansing and/ or home care
composition. The Examiner rejected the claims on appeal as obvious under
35 U.S.C. § 103(a).
We affirm-in-part.
1 The real party in interest is Colgate-Palmolive Company. Reel/frame
017936/0214; see also, App. Br. 2.
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Application 11/457 ,610
STATEMENT OF THE CASE
Claims 3, 6, 8, 9, 12, 15-22, 28 and 29 are on appeal. Independent
claims 12 and 29 read as follows:
12. A method of making an oral care, a personal care,
a cleansing and/or a home care composition, the method
compnsmg:
introducing a film into a medium comprising an
active ingredient, wherein the film is substantially free of
the active ingredient;
transferring at least a portion of the active ingredient
from the medium to the film due to a concentration
gradient of the active ingredient between the medium and
the film, wherein the transferring occurs until the film
comprises an effective amount of transferred active
ingredient, so that the film is suitable for use as at least one
of the oral care, the personal care, the cleansing and/ or the
home care compositions; and
preparing the composition by introducing the film
comprising the transferred active ingredient into a carrier
film, wherein a dissolution rate of the carrier film is greater
than the dissolution rate of the film comprising the active
ingredient, and wherein the film comprising the
transferred active ingredient is stable during storage of the
composition.
29. A method of making an oral care, a personal care,
a cleansing and/or a home care composition comprising a
film, the method comprising:
submerging a film into a medium comprising an
active ingredient, wherein the film is substantially free of
the active ingredient wherein the active agent is a
peroxide; and
introducing at least a portion of the active
ingredient from the medium into the film due to a
concentration gradient of the active ingredient between
the medium and the film, wherein the introduction of the
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Application 11/457 ,610
active ingredient is performed until the film comprises an
effective amount of introduced active ingredient, so that
the film is suitable for use as at least one of the oral care,
the personal care, the cleansing and/ or the home care
compositions; and
preparing the composition by introducing and
dispersing the film comprising the introduced active
ingredient into a carrier, wherein the film comprising the
introduced active ingredient is stable during storage of
the composition,
wherein substantially free means that the active
ingredient is absent from the film to the extent that it is
not present at an efficacious level and/ or cannot be
detected,
wherein the film is porous;
wherein an amount of the introduced active
ingredient into the film is greater than 0.5% by weight of
the film; and
wherein the film comprises a polymer selected
from the group consisting of cellulose ethers, acrylate
polymers, methacrylate polymers, polyvinyl alcohol,
polyalkylenes, polyalkylene okides, polystyrene,
polyvinylpyrrolidone, polyvinylphosphonates,
polysiloxanes, polyvinyl pyrrolidone-vinyl acetate
copolymers, ethylene oxide graft copolymers of PV A,
vinylcaprolactam/sodium acrylate polymers, maleic
polyvinylalkyl ether-maleic acid copolymer, vinyl acetate
and crotonic acid copolymers, terpolymers of
acrylomethyl propyl sulphonic acid/methyl
acrylate/styrene monomers, and mixtures thereof.
The claims stand rejected as follows:
Claims 3, 6, 9, 12, 15-18, 21, 22 and 28 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Wiesel2 and Boyd3 ("the First
2 Wiesel, U.S. Patent No. 6,287,120 Bl, issued Sept. 11, 2001 ("Wiesel").
3 Boyd et al., U.S. Patent Publication No. 2004/0136924 Al, published July
15, 2004 ("Boyd").
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Application 11/457 ,610
Rejection").
Claims 8, 19, 20 and 29 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Wiesel, Boyd, and Moro4 ("the Second Rejection").
Claims 3, 6, 8, 9, 12, 15-22, and 28-29 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Kochinke5 and Boyd6 ("the Third
Rejection").
Claims 19 and 20 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Kochinke, Boyd, and Christina-Beck7 ("the Fourth
Rejection").
ANALYSIS WITH RESPECT TO CLAIMS 3, 6, 8, 9, 12, 15-22 AND 28
Claim 12 requires that there be two films: a film onto which an active
ingredient is transferred (hereafter, "the Active Film"), and a film on which
the Active Film is carried, i.e., a "carrier film." Each of the Examiner's four
obviousness rejections relies on Boyd for the disclosure of a "carrier film."
As a result of the Examiner's common reliance on Boyd; a single issue is
dispositive with respect to all four of the Examiner's rejections as applied to
claims requiring a "carrier film." Accordingly, we address all four rejections
with respect to those claims together.
The carrier film limitation of claim 12 requires "introducing the film
comprising the transferred active ingredient into a carrier film, wherein a
4 Moro et al., U.S. Patent Publication No. 2004/0062724 Al, published Apr.
1, 2004 ("Moro").
5 Kochinke, U.S. Patent Publication No. 2003/0185872 Al, published Oct. 2,
2003 ("Kochinke").
6 Boyd et al., U.S. Patent Publication No. 2004/0136924 Al, published July
15, 2004 ("Boyd").
7 Christina-Beck et al., U.S. Patent No. 5,766,574, issued June 16, 1998
("Christina-Beck")
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Application 11/457 ,610
dissolution rate of the carrier film is greater than the dissolution rate of the
film comprising the active ingredient." With respect to the Examiner's First
and Second Rejections, the Examiner found that Wiesel met all of the
limitations of claim 12 with the exception that it did not disclose the "carrier
film" limitation. Ans. 3--4, 7. In the Examiner's Third and Fourth
Rejections, the Examiner similarly found that Kochinke met all of the
limitations of claim 12 with the exception of the "carrier film" limitation.
Id. at 9-11, 14.
With respect to all four rejections, the Examiner found that Boyd
taught the claimed "carrier film." The Examiner then concluded that it
would have been obvious to modify the teeth whitening apparatus of Wiesel
and the drug delivery system of Kochinke to include Boyd's carrier film. Id.
at 4--5, 7, 11-12 and 14. The Examiner's explanation with respect to the
First Rejection is representative:
It would have been prima facie obvious to one of
ordinary skill in the art at the time of the invention to
entrain the impregnated film materials of Wiesel in a
carrier film (e.g., a gel) as taught by Boyd (Boyd, par.
[0085]). One would have been motivated to do so in
order to provide a tooth whitening composition capable
of sustained release of the whitening agent as taught by
Boyd. Boyd, par. [0008] and [0009].
Id. at 5 (emphasis added).
Appellants argue that entraining an Active Film in a gel, as taught in
Boyd, is distinct from entraining an Active Film in a "carrier film" as recited
in claim 12. App. Br. 10. We agree that the Examiner erred in finding that
Boyd's gel meets the claimed limitation of a carrier film. The Examiner
cites to several passages from Boyd, including passages teaching that the
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carrier can be "any material" and that the carrier can be "a liquid, a semi-
solid or solid," as evidence that Boyd does not exclude films as possible
carriers of its Active Film. Ans. 19-22. But the fact that Boyd does not
exclude carrier films does not make it obvious to use a carrier film. This is
particularly true where claim 12 requires not just any carrier film, but a
carrier film with a dissolution rate that is "greater than the dissolution rate of
the film comprising the active ingredient." The Examiner does not explain
how or why it would have been obvious for the carrier film to have a greater
dissolution rate than the Active Film.
The Examiner states that "Appellants' specification provides no
definition or indication that a film is distinguishable from a gel." Ans. 22.
The Examiner then contends that "a gel carrier, taught by Boyd as a 'semi-
solid' carrier, reasonably meets the requirement of the instant claims for a
'carrier film."' Id. at 23 (internal citations omitted). The Examiner,
however, does not point to any portion of the Specification that indicates that
the term "carrier film" should be given the same meaning as "gel." or
"carrier gel." Moreover, the Specification discusses the use of a carrier film
separately from discussing gels. Compare, Specification i-fi-1 94--94 with i-fi-1
72, 87 and 98. Claim 15 also separately recites a film and a gel, suggesting
that they are different. The Specification also describes the "film" as a
structure with a fixed thickness (at i-fi-179, 80-81). Consistent with this
description, we interpret the recited "film" to be a layer of material with a
specific structure. In contrast, the gel of Boyd is not described as having
such a specific layer structure. Accordingly, we find that the Specification
does not support the Examiner's position that a gel as described in Boyd
meets the requirement of a "carrier film" as recited in claim 12. For this
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reason, and the reasons set forth above, we reverse all four of the Examiner's
rejections with respect to claims 3, 6, 8, 9, 12, 15-22 and 28- i.e. all of the
appealed claims that require a "carrier film."
ANALYSIS WITH RESPECT TO CLAIM 29
Claim 29 does not require that the Active Film be introduced into a
"carrier film." Instead, claim 29 requires "introducing and dispersing the
film comprising the introduced active ingredient into a carrier, wherein the
film comprising the active ingredient is stable during storage of the
composition." Accordingly the error identified with respect to the
Examiner's rejection of claims 3, 6, 8, 9, 12, 15-22 and 28 does not apply to
claim 29.
As discussed above, all four of the Examiner's rejections are premised
on entraining an Active Film in Boyd's gel carrier. With respect to the First
and Second Rejections, Appellants argue that entraining Wiesel's film in a
gel carrier would "reduce the concentration of Wiesel's active ingredient
mixture and render it useless for its intended purpose." App. Br. 8.
Appellants further argue that Wiesel teaches away from the use of gels.
App. Br. 8-9. We are not persuaded.
Wiesel expressly contemplates using its film in connection with a gel.
Wiesel states:
In one embodiment, the carrier is coated or impregnated with a
paste, gel, or solution which contains medicaments which
decrease teeth sensitivity. In another embodiment, a carrier is
coated or impregnated with a paste, gel, or solution which
contains medicaments which promote the repair or
remineralization of tooth enamel. In yet another embodiment,
the carrier is coated or impregnated with a paste, gel, or
solution which contains therapeutic medicaments such as
antibiotics.
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Wiesel Abstract; see also, id. at col. 8, 11. 4--9. Wiesel specifically teaches
that the carrier can be a tape, i.e., a film. Id. at col. 4, 11. 5-8; col. 5, 11. 1-8;
Fig. 12.
Boyd teaches the use of films entrained in a gel. Boyd if 85 ("if the
composition is a dentifrice comprising both a gel and film fragments, a film
fragment can be totally surrounded by the gel, or partially or totally exposed
on the surface of the gel."). Boyd also teaches that its compositions allow
for "controlled delivery of functional materials." Id. at if 9.
We find that Appellants' argument that the use of a gel would render
Wiesel's active ingredient useless for its intended purposes is not supported
by persuasive evidence. Appellants' argument is also contradicted by
Wiesel's teaching of multiple embodiments of films that can be used with
gels and by Boyd's teaching that films may be entrained in a gel. We further
find that a person of ordinary skill in the art would not have been
discouraged from using a gel by Wiesel; s criticism of aspects of prior art
gels at least because Wiesel expressly approves the use of gels with its film.
Accordingly, we affirm the Examiner's First and Second Rejections as
applied to claim 29.
With respect to the Examiner's Third and Fourth Rejections,
Appellants argue that entraining Kochinke's drug delivery system in a gel
carrier would "enlarge Kochinke' s system and render it useless for its
intended purpose." App. Br. at 12. Appellants further argue that
incorporating Boyd's carrier would require "putting Kochinke' s system into
a different system (i.e., Boyd's entrainment system)" which would serve to
"make diffusion of the therapeutic agent more difficult to control." Id. at 13.
We are not persuaded.
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Application 11/457 ,610
Kochinke teaches that its drug delivery system may optionally contain
inactive materials "such as buffering agents and pH adjusting agents ...
degradation/release modifiers; drug release adjusting agents; emulsifiers;
preservatives ... solubility adjusting agents; stabilizers; cohesion modifiers .
. . and so forth." Kochinke i-f 97. Kochinke further teaches that "[a]dditional
structural features can be added to the system to control the rate of diffusion
of the therapeutic agent from the system." Id. at i-f 105. Finally, Kochinke
teaches that its drug delivery system can be a "film or sheet." Id. at i-f 100.
As discussed above, Boyd teaches that its compositions, which
include films entrained in a gel, see Boyd i-f 85, allow for "controlled
delivery of functional materials." Id. at i-f 9.
We find that Appellants' argument that the use of a gel would render
Kochinke' s drug delivery system useless for its intended purposes is not
supported by persuasive evidence. Appellants' argument is also
contradicted by Kochinke' s teaching that its drug delivery system can
incorporate multiple types of inactive materials and that its system can
include "additional structural features ... to control the rate of diffusion."
We further find that a person of ordinary skill in the art would have been
motivated to entrain Kochinke' s drug delivery system in a gel to control the
rate of diffusion as taught by Boyd and as suggested by Kochinke. See Boyd
at i-f 9, Kochinke at i-f 105. Accordingly, we affirm the Examiner's Third and
Fourth Rejections as applied to claim 29.
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survnvIARY
For the reasons set forth herein, the Examiner's final decision to reject
claims 3, 6, 8, 9, 12, 15-22 and 28 is reversed.
For the reasons set forth herein, and those set forth in the Examiner's
Answer, the Examiner's decision to reject claim 29 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED-IN-PART
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