Ex Parte Boyd et al

Patent Trial and Appeal Board

Apr 27, 2017

11014571 (P.T.A.B. Apr. 27, 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.
11/014,571 12/16/2004 Thomas J. Boyd 7052-05-0C 4620
23909 7590 05/01/2017
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
ROBERTS, LEZAH
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
05/01/2017 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 THOMAS J. BOYD, GUOFENG XU,
M. TERESA CARALE, and BETH ANN BOFF1
Appeal 2016-001774
Application 11/014,571
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
DAVID COTTA, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to an oral care composition. The Examiner rejects the claims as obvious and
on the ground of nonstatutory obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Colgate-Palmolive
Company. Appeal Br. 3.
Appeal 2016-001774
Application 11/014,571
STATEMENT OF THE CASE
Claims 1—7, 9, 10, 13—19, 26-42, 44, 46—64, and 73—80 are on appeal,
and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is
representative of the claims on appeal, and reads as follows:
1. An oral care composition comprising a film entrained in a
carrier, wherein said film comprises a film forming polymer and
a functional material, and wherein said carrier comprises a gel, a
colloid, or a fibrillar network comprising from about 5% to about
95% water, wherein said film has a Dissolution Value from about
2 to about 200 seconds and is operable to effect release of said
functional material during use of said composition.
The following grounds of rejection are before us for review:
I. claims 1—7, 9, 10, 13—19, 26-42, 44, 46—64, and 73—80 under 35
U.S.C. § 103(a) as unpatentable over Roberts2 in view of Zerbe;3
II. claims 1—7, 9, 10, 13—19, 26-42, 44, 46—64, and 73—804 are rejected
on the ground of nonstatutory obviousness-type double patenting over
claims 14—35 of copending application 10/720,462, now claims 1—19
of US 7,763,235, issued July 27, 2010 (“the ’235 patent”); and
III claims 1—7, 9, 10, 13—19, 26-42, 44, 46—64, and 73—80 are rejected on
the ground of nonstatutory obviousness-type double patenting over
claims 1—8 of US 6,669,929, issued Dec. 30, 2003 (“the ’929 patent”).
2 Roberts et al., US 4,089,943, issued May 16, 1978 (“Roberts”).
3 Zerbe et al., US 2003/0053962 Al, published Mar. 20, 2003 (“Zerbe”).
4 We note that the Claims Appendix of the Appeal Brief reflects that claims
20, 21, and 45 have previously been canceled. See Claim amendments
submitted Dec. 5, 2007 and May 5, 2009. The statement of rejection in the
Final Office Action mailed Aug. 15, 2008 and Answer, however, incorporate
these claims. We interpret the inclusion of these claims in the statement of
rejection to be an inadvertent typographical error.
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I. Obviousness over Roberts in view of Zerbe
The Examiner finds that Roberts “disclose[s] toothpaste formulations
comprising a plurality of agglomerated particles. The agglomerates are
particularly well suited for incorporation into transparent gel dental vehicles,
meeting the limitation of a gel, a colloid or a fibrillary network. The
[agglomerated] particles may include functional materials such as polishing
agents.” Final Act. 3. The Examiner acknowledges that Roberts “does not
disclose that the agglomerates are in the form of films or lamellar
fragments.” Final Act. 3.
The Examiner looks to Zerbe for disclosing “multi-layered films that
include a first layer having at least one flavor ingredient, and a second layer
having at least one different flavor ingredient,” and formulating the films so
that they “disintegrate upon contact with the mucosal tissue in less than a
minute, and often in less than 30 seconds.” Final Act. 4. The Examiner
acknowledges that Zerbe “does not disclose [that] the films are entrained in
an aqueous gel, colloidal or fibrillar network carrier.” Final Act. 4.
The Examiner concludes that
[i]t would have been obvious to one of ordinary skill in the art to
have made films with multiple layers and dissolution rates
comprising flavorants along with abrasives and incorporated
them into the compositions of Roberts et al. in place of or along
with the agglomerates motivated by the desire to create various
taste characteristics, such as sequential flavoring characteristics,
as disclosed by Zerbe et al.
Final Act. 5.
Appellants contend that there is no motivation to combine the
teachings of the references (see Appeal Br. 7—8), that Zerbe teaches away
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from the combination (see Appeal Br. 8), and that there is no reasonable
expectation to “conclude that the Zerbe moisture-sensitive films would [not]
dissolve in the moist [environment of] Roberts toothpaste formulation, and
[thereby] fail to sequester its active [functional material] prior to use.”
Appeal Br. 10.
The issue is: Does the preponderance of the evidence of record
support the Examiner’s conclusion that the combination of Roberts and
Zerbe renders the oral care composition obvious?
Findings of Fact
FF1. Roberts teaches “[toothpaste formulations having dispersed therein a
plurality of agglomerated particles of dental polishing agent that are
visible, palpable and substantially insoluble in the toothpaste.”
Roberts, Abstract. “Typically, the polishing agent may comprise a
major proportion e.g., about 75-100% by weight, preferably 75-99%,
of the finished agglomerate particles.” Roberts 4:20—23.
FF2. “[T]he agglomerating agent is blended with the polishing agent in any
suitable manner.” Roberts 4:31—32. “The agglomerating agent can be
water soluble so that it dissolves in saliva when the particles are
broken down by mild mechanical action or it can be a water-insoluble
material.” Roberts 2:61—64.
Agglomerating agents which may be employed to assist
formation of the polishing agent into agglomerated
particles include water-soluble materials such as gum
acacia (arabic), gelatin, starches, alkali metal
carboxymethyl celluloses, polyethylene glycols, glucose,
sucrose, methyl cellulose, carboxy ethyl hydroxymethyl
celluloses, sodium alginate, polyvinyl pyrrolidone,
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polyvinyl alcohol, Irish moss, gum tragacanth, magnesium
aluminum silicate gel and the like.
Roberts 3:67-4:11.
FF3. Zerbe teaches that “[t]he flavored films of this invention typically
disintegrated in less than 60 seconds, with most of the films
disintegrating in about 30 seconds or less, and many of the films
disintegrating in about 15 seconds.” Zerbe 139.
FF4. Zerbe teaches that “a combination of hydroxypropyl cellulose and a
modified starch provides improved solubility properties that enable
rapid disintegration of the film upon contact with even low levels of
moisture.” Zerbe 114.
FF5. Zerbe teaches that film forming agents should be optimized to provide
the right balance of tensile strength and rapid disintegrating
properties. See Zerbe 120.
Examples of suitable film-formers that are soluble or
swellable in water include polyvinyl alcohol, natural and
synthetic gums like guar gum, xanthan gum, gum arabic,
cellulose gum, acacia gum, tragacantha, sodium alginate,
sodium carboxymethyl cellulose, hydroxyethyl cellulose,
gelatin, polycarbophil, acrylate-based water-dispersible
resins like methyl methacrylate copolymers, or other
suitable water-soluble or swellable polymers.
Zerbe |20.
Principle of Law
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011).
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Analysis
As we understand it, the Examiner’s rationale for rejecting the claims,
based on the combination of Roberts and Zerbe, is that the only difference
between the agglomerates of Roberts and the film of Zerbe “is the shape.”
Adv. Act. 2; Ans. 4. “Roberts is only deficient insofar as the shape of the
agglomerates. Since the agglomerates of Roberts are incorporated into
toothpastes and dissolve to release the polishing agents when introduced into
saliva, the agglomerates have the same function as the films of the instant
claims.” Ans. 7—8.
Appellants contend that there is no reasonable expectation of success
because the skilled artisan would “conclude that the Zerbe moisture-
sensitive films would dissolve in the moist [environment of] Roberts
toothpaste formulation, and [thereby] fail to sequester its active [functional
material] prior to use.” Appeal Br. 10.
We find that Appellants have the better position. Here, Roberts
discloses the production of toothpaste containing agglomerates with
polishing agents entrained in the agglomerate. FF1, FF2. Roberts teaches
that the agglomerates are formulated so that they will dissolve in saliva once
they are broken down by mild mechanical action. FF2. Roberts discloses
that the agglomerates can be made up of water soluble materials such as
starch, gum acacia (arabic), gelatin, sodium alginate, and gum tragacanth
among others. FF2. Zerbe similarly teaches the production of films
including ingredients such as starch, gum arabic, gelatin, sodium alginate,
and tragacantha among others. FF4, FF5. Zerbe also teaches that the films
disintegrate rapidly upon exposure to moisture. FF4. Zerbe teaches that the
films can be designed and formulated so that they disintegrate in less than 30
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seconds. FF3. We recognize the Examiner’s position that agglomerates of
Roberts and the films of Zerbe may be formulated, at least in theory, using
the same components such as: starch, gum arabic, sodium alginate, gelatin,
and tragacantha. However, merely using similar ingredients does not
necessarily mean that the compositions will behave similarly in all
environments.
Zerbe recognizes that “the concentration of the film-forming agent
should be optimized to provide a good balance of rapid disintegrating
properties (upon contact with a precooked food item) and good tensile
strength (to allow the flavored film to be easily removed from a carrier
substrate without breaking).” Zerbe 120. Zerbe further teaches that the use
of starch is necessary for the production of rapidly disintegrating film. “An
attempt to replace the starch in the polymer base completely by film-forming
agents such as cellulose gum or gelatin to achieve better film properties was
unsuccessful. The resulting film properties were poor, indicating that the
presence of a modified starch in the film is required to achieve the desired
film properties.” Zerbe 121. Thus, changing the film formulation of Zerbe
to include additional film forming polymers altered the disintegration
properties of the film.
Claim 1 requires that the “film has a Dissolution Value from about 2
to about 200 seconds and is operable to effect release of said functional
material during use of said composition.” The claim clarifies that the film
should not release the functional material before the composition is in use.
In other words, this limitation is reasonably interpreted that the film should
not disintegrate while the film is associated with the carrier during storage or
before use in the oral cavity. Zerbe’s film would meet the requisite
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dissolution requirements as claimed, however, the film of Zerbe would also
disintegrate when placed with the carrier as claimed. FF4.
On the other hand, taking Roberts agglomerate and changing the
shape from an agglomerate to a film would not necessarily provide a film
composition that has the claimed dissolution value from about 2 to about
200 seconds. What is missing from the Examiner’s rationale is some
explanation why changing of the shape of Roberts agglomerate would
necessarily result in a film having the requisite dissolution value.
Although we understand that Roberts and Zerbe recite several
overlapping ingredients for the formulation of the agglomerate or film,
merely identifying that similar ingredients can be used to formulate an
agglomerate or a film is not sufficient evidence to establish that composition
that is made of those ingredients will have the same dissolution value. The
Examiner’s rejection has not articulated a reason why the ordinary artisan
would want to modify Roberts agglomerate to have a dissolution value to be
in the range of 2 to 200 seconds or why one would want to modify Zerbe’s
film so that it will not disintegrate when stored in the carrier but have the
requisite disintegration profile one in the oral cavity. See KSR Int 7 Co. v.
Teleflex Inc., 550 U.S at 418 (obviousness rejections require “some
articulated reasoning with some rational underpinning”).
We conclude that the preponderance of the evidence of record does
not support the Examiner’s conclusion that the combination of Roberts and
Zerbe teaches an oral care composition having all limitations of independent
claim 1 and dependent claims thereto. We thus reverse the rejection under
35 U.S.C. § 103(a) that relies on the teachings of Roberts and Zerbe.
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II. Obviousness-Type Double Patenting over the ’235 Patent
Appellants do not argue the merits of the rejection, but note that they
will consider submitting a terminal disclaimer upon the indication of
allowable subject matter. Appeal Br. 10-11. Therefore, we summarily
affirm, and will not further discuss, this rejection. See Manual of Patent
Examining Procedure § 1205.02 (“If a ground of rejection stated by the
examiner is not addressed in the appellant’s brief, that ground of rejection
will be summarily sustained by the Board.”).
III. Obviousness-Type Double Patenting over the ’929 Patent
Claims 1 and 3 of the ’929 patent recite:
1. A dentifrice composition comprising an orally acceptable
vehicle which a transparent clear gel dentifrice comprising a
polishing agent, surfactant, a thickening or gelling agent and
humectant in an aqueous vehicle, said clear gel dentifrice
containing an aesthetically shaped decorative film flake matrix
comprising (A) titanium coated mica, and admixtures of (A) with
(B) polyethylene powder colored with F. D & C dyes; and/or (C)
F. D. & C certified food color additive colorants, dyes, pigments,
and lakes, and (D) mixtures of (A) (B) and (C), said decorative
film flake matrix being aesthetically shaped to appeal to
consumers and to their children when visible in said transparent
substantially clear gel dentifrice, said decorative film flake
matrix being formed from a dried film matrix of F. D & C
certified food color additive colorant, a water soluble
hydroxyalkyl cellulose polymer and a starch, said dried film then
being cut or punched into various attractive shapes, including
hearts, stars, diamonds, and circles, said shaped flakes having a
particle size of 0.01 to 0.50 inches.
3. A dentifrice according to claim 1 wherein the film flake matrix
has further entrained therein a therapeutic constituent.
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The Examiner finds that “[t]he sets of claims [of the pending
application and the ’929 patent] differ insofar as the instant claims are
broader in scope in some instances such as the water hydratable polymers
and the type of compositions.” Ans. 6. The Examiner concludes that one of
ordinary skill in the art at the time the invention was made would have been
motivated by Zerbe with “the desire to make functional films that dissolve
rapidly when in the mouth under any mouth conditions and will deliver
different types therapeutic agents rapidly to the mouth.” Ans. 6.
Appellants contend that “Zerbe teaches the application of its films
directly (i.e., not in a carrier) to a moist surface (i.e., oral cavity, food, etc.),
and then their quick dissolution to release flavor. . . . The Zerbe films
‘enable rapid disintegration of the film upon contact with even low levels of
moisture.’” Appeal Br. 11—12.
We are not persuaded. Here, the claims of the ’929 patent describe a
dentifrice composition that already contains film flakes in an aqueous
vehicle carrier. Claim 1 of the ’929 patent recites a “film flake matrix being
formed from a dried film matrix of F. D & C certified food color additive
colorant, a water soluble hydroxyalkyl cellulose polymer and a starch.”
Zerbe teaches that the combination of hydroxyalkyl cellulose polymer and a
modified starch produce films with improved solubility. FF4. Zerbe also
teaches that film forming agents need to be optimized to have the right
balance of tensile strength and disintegrating properties. FF5. Here, the
flakes recited in the ’929 patent are made of the same material as the film in
Zerbe that are taught to be optimizable with respect to their disintegration
properties. We find no error with the Examiner’s reliance on Zerbe for
teaching that disintegration rates are optimizable with respect to the
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hydroxyalkyl cellulose polymer and a modified starch film product. We
agree with the Examiner’s conclusion that the differences in the claims of
the ’929 patent and the present claims are not so great as to render the claims
unobvious when viewed in conjunction with the teachings of Zerbe.
Accordingly, we affirm the rejections of claim 1 on the ground of
nonstatutory obviousness-type double patenting over claims 1—8 of the ’929
patent. Claims 2—7, 9, 10, 13—19, 26-42, 44, 46—64, and 73—80 were not
argued separately and fall with claim 1.
SUMMARY
We reverse the rejection of claims 1—7, 9, 10, 13—19, 26-42, 44, 46—
64, and 73—80 under 35 U.S.C. § 103(a) as unpatentable over Roberts and
Zerbe.
We affirm the rejection of claims 1—7, 9, 10, 13—19, 26-42, 44, 46—
64, and 73—80 on the ground of nonstatutory obviousness-type double
patenting over claims 14—35 of copending application 10/720,462, now
claims 1—19 of US 7,763,235, issued July 27, 2010 (“the ’235 patent”).
We affirm the rejection of claim 1—7, 9, 10, 13—19, 26-42, 44, 46—64,
and 73—80 on the ground of nonstatutory obviousness-type double patenting
over claims 1—8 of US 6,669,929, issued Dec. 30, 2003 (“the ’929 patent”).
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).
AFFIRMED
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