Ex Parte Pimenta et al

Patent Trial and Appeal Board

Jul 10, 2018

13997344 (P.T.A.B. Jul. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/997,344 06/24/2013
23909 7590 07/12/2018
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Paloma Pimenta
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.
9222-00-US-Ol-OC 7985
EXAMINER
CHANG, KYUNG SOOK
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
07/12/2018 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
Exparte PALOMA PIMENTA and JASONNESTA 1
Appeal2017-006606
Application 13/997 ,344
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and ELIZABETH A. LA VIER,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Colgate-Palmolive Company as the real party-in-
interest. App. Br. 3.
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Application 13/997 ,344
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1, 2, 11-15, 18, 19, and 22-26 as
unpatentable under 35 U.S.C. § I03(a) over the combination of Van Nieuw
Amerongen et al. (WO 95/20971, August 10, 1995) ("Comelis")2 and Stier
(US 2003/0091514 Al, May 15, 2003) ("Stier").
Claims 1, 2, 11-15, 18, 19, and 22-26 also stand rejected as
unpatentable under 35 U.S.C. § I03(a) over the combination of
Comelis, Stier, and Shastry et al. (US 2005/0210615 Al, September 29,
2005) ("Shastry").
Claims 1, 2, 11-15, 18, 19, and 22-26 also stand provisionally
rejected as unpatentable under the judicially-created doctrine of
obviousness-type double patenting over claims 1--4, 6, 7, 10, 11, 13-15, and
17-25 of Appellants' co-pending Application Ser. No. 13/997,381.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to mouthwash or mouthrinse
compositions comprising one or more structuring agents. Abstract.
2 Van Nieuw Amerongen is the surname of the first named inventor of WO
95/20971. However, because both Appellants and the Examiner refer to
this reference as "Comelis," we employ that usage to avoid possible
confusion of the references.
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Application 13/997 ,344
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites 3:
1. A fluid composition comprising:
structuring agents of:
a colloidal gum;
a cellulosic polymer;
an acrylate polymer; and
optionally, a clay or fine particulate; and
an orally acceptable aqueous carrier;
wherein the total concentration of the structuring agents is
from about 0.03% to about 2%, by weight, of the composition;
wherein the composition is a mouthwash or mouthrinse,
and
wherein the composition has a Flow Rate Index from
about 0.1 to about 0.85, a Consistency Index of from about 10 to
about 2000 and a G'/G" ratio of 1 to 15;
wherein the colloidal gum is selected from the group
consisting of agar, agarose, albumin, algae colloid, alginates,
alginic acid and salts thereof, amber, ammoniac, amylopectins,
arabinans, arabinogalactan, arabinoxylans, asafetida, bdellium,
carageenans, casein, chicle, collagen, copal, curdlan, dermatin
sulfate, dextrans, cross-linked dextrans, dextrin, emulsan,
gelatin, fenugreek, frankincense, furcellarans,
galactoglucomannans, galactomannans, gamboge, gellan, gellan
gum, glucomannans, glycogens, guar, guar gum,
hydroxypropylated guar gums, carboxymethyl guar gum,
carboxymethyl(hydroxypropyl) guar gum, hydroxyethyl guar
3 Appellants have chosen as their elected species xanthane gum as the
colloidal gum, carboxy methylcellulose ("CMC") as the cellulosic
polymer, and polyvinyl methyl ether as the acrylate polymer. See Final
Act. 7.
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Application 13/997 ,344
gum, gum arabic, gum elastic, gum ghatti, gum karaya, gum
tragancanth (tragacanthin), heparin, hyaluronic acid, India
rubber, inulin, karaya gum, keratin sulfate, konjac flour, konjac
mannan, labdanum, laminarans, laurdimonium, laxseed
saccharide (acidic), levan, locust bean gum, myrrh, okra gum,
pectic acids, pectin, polydextrose, polyquatemium-4,
polyquatemium-10, polyquatemium-28, protopectins, psyllium
seed gum, pullulan, quince seed gum, sodium hyaluronate,
raffinose, rhamsan, scleroglucan, sodium alginate, stachylose,
starch from rice, com, potato or wheat, tapioca starch,
succinoglycan, tamarind seed gum, trant gum, water-soluble
soybean polysaccharide, whelan, xanthan, xanthan gum, xylans,
xyloglucans, and mixtures thereof;
wherein the cellulosic polymer is selected from the group
consisting of: cellulose; methyl cellulose; ethyl cellulose; propyl
cellulose; butyl cellulose; carboxymethyl cellulose; carboxyethyl
cellulose; carboxymethyl methyl cellulose; carboxyethyl ethyl
cellulose; carboxyethyl methyl cellulose; carboxymethyl ethyl
cellulose; hydroxyalkyl cellulose; hydroxyethyl cellulose;
hydroxypropyl cellulose; hydroxybutyl cellulose; hydroxyethyl
methyl cellulose; hydroxypropyl methyl cellulose; hydroxybutyl
methyl cellulose; hydroxyethyl ethyl cellulose; hydroxypropyl
ethyl cellulose; hydroxybutyl ethyl cellulose;
hydroxyethylpropyl cellulose; hydroxypropyl propyl cellulose;
hydroxybutyl propyl cellulose; hydroxyethyl butyl cellulose;
hydroxypropyl butyl cellulose; hydroxybutyl butyl cellulose;
hydroxypropyl oxyethyl cellulose; steardimonium hydroxyethyl
cellulose; cocodimonium hvdroxypropvl oxyethyl cellulose;
sodium carboxymethyl cellulose; nitrocellulose; sodium
cellulose sulfate; chondroitin; chitin; chitosan; chitosan
pyrrolidone carboxylate; chitosan glycolate chitosan lactate or
mixtures thereof;
wherein the acrylate polymer is selected from the group
consisting of homopolymers of acrylic acid, crosslinked with an
allyl ether pentaerythritol, allyl ether of sucrose or allyl ether of
propylene, polyvinyl methylether, and carboxyvinyl polymer;
polyoxyethylene polymers; polyoxyethylene/polyoxypropylene
copolymers; acrylic polymers, sodium polyacrylate, polyethyl
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acrylate and polyaclylamide; synthetic water-soluble polymers,
polyethyleneimine, cationic polymers; semi-synthetic water-
soluble polymers, silicone-modified pulllan; water-soluble
inorganic polymers, bentonite, aluminum magnesium silicate,
montmorillonite, beidellite, notronite, saponite, hectorite, silicic
anhydride and mixtures thereof.
App. Br. 13-14.
ISSUE AND ANALYSIS
We adopt the Examiner's findings of fact and conclusions that the
appealed claims are obvious over the cited prior art. We address the
arguments raised by Appellants below.
A. Rejection under 35 U.S.C. § 103(a) over Comelis and Stier
Issue 1
Appellants argue the Examiner erred because the combined cited prior
art references neither teach nor suggest the combination of a colloidal gum, a
cellulosic polymer, and an acrylate polymer, nor the recited viscosity
parameters defining the claimed composition. App. Br. 7.
Analysis
Appellants contend that the oral care composition of claim 1 requires
a particular combination of ingredients with specific rheological parameters,
which provide "a significant advantage in terms of providing a
differentiating mouth feel as well as the ability to deposit a polymer film
onto oral cavity surfaces to facilitate the delivery of actives." App. Br. 7
( quoting Spec. ,r 90). Specifically, Appellants argue, claim 1 requires a
colloidal gum, a cellulosic polymer, and an acrylate polymer in combination,
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with the total concentration of the structuring agents being from about
0.03% to about 2%, by weight, of the composition. Id. The composition has
a Flow Rate Index from about 0.1 to about 0.85, a Consistency Index of
from about 10 to about 2000, and a G'/G" ratio of 1 to 15. Id.
Appellants acknowledge that Comelis teaches a list of suitable
polymers including xanthan gum or guar gum, carboxymethyl cellulose
("CMC"), and polyacrylic acid (although not in combination as instantly
claimed). Id. ( citing Comelis 2). However, Appellants assert, Comelis
discloses neither the combination of a colloidal gum, a cellulosic polymer,
and an acrylate polymer nor the recited viscosity parameters in claim 1 to
define the claimed composition. Id. Nor, Appellants argue, does Stier cure
the alleged deficiencies of Comelis. Id.
The Examiner responds that Comelis teaches at least one polymer
including xanthan gum, sodium CMC, and/or polyacrylic acid for treating
mouth dryness. Ans. 4 ( citing Comelis 2). The Examiner finds that
Comelis also specifically names a limited number of polymers of
scleroglucan, guar gum, xanthane gum, sodium CMC, hydroxyethyl
cellulose, polyacrylic acid, and polyvinyl alcohol as structuring agents in
specified quantities, and further teaches that: "xanthan gum, guar gum,
CMC, alginic acid and polyacrylic acid" were exceptionally suitable
polymers for application in a therapeutic composition. Id. (citing Comelis 2,
8). The Examiner further finds that Comelis teaches using amounts of about
0.001 %- 2% of xanthan gum, about 0.01 % - 5% of CMC, and about 0.01 %
- 5% of acrylate polymer, which overlaps the ranges recited in Appellants'
dependent claim 2. Id.
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The Examiner also finds that Table 2 of Comelis teaches using 0.1 %
of polymers within the ranges recited in claim 2, resulting in a G'/G" ratio
that is within the range recited claim 1 (about 0.03%-2% of total structuring
agent). Id. Furthermore, the Examiner finds that, because Comelis teaches
the components in amounts that overlap the claimed composition, the
claimed rheological parameters as instantly claimed would be inherent upon
combining the three polymers. Id. at 5.
We are not persuaded by Appellants' arguments. Comelis is directed
to:
[A] therapeutic compos1t10n compnsmg an aqueous
solution of at least one polymer and at least one electrolyte,
wherein the aqueous solution is preferably buffered and
optionally contains at least one mucin. The polymer can be
chosen for instance from the group which consists of
scleroglucan, guar gum, xanthane gum, sodium carboxymethyl
cellulose, hydroxyethyl cellulose, polyacrylic acid and polyvinyl
alcohol.
Comelis Abstr. ( emphases added). More specifically, Comelis teaches:
To this end the invention provides a therapeutic
composition, comprising a buffered, aqueous solution of at least
one polymer and at least one electrolyte.
The polymer is preferably chosen from the group which
consists of scleroglucan (in a concentration of about 0.001 % to
2% (w/v)), guar gum (about 0.001 % to 5% (w/v)), xanthane gum
(about 0.001% to 2% (w/v)), sodium carboxymethyl cellulose
( for instance of the type Blanose® 7HF, in a concentration of 0.01
to 5% (w/v)), hydroxyethyl cellulose (for instance of the type
Natrosol 250 HX Pharm, in a concentration of 0.01 to 5% (w/v)),
polyacrylic acid (for instance of the types Carbopol 934P® and
Carbopol 974P®, in a concentration of 0.01 to 5% (w/v)) and
polyvinyl alcohol (for instance with a degree of hydrolysis
between 71.6 and 100 mol%, an ester value between O and 285 g
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KOH/g, a molecular weight between 14,000 and 205,000 and a
degree of polymerization between 360 and 4500). Another
suitable product can however be chosen as desired from the large
supply of available polymers, and particularly polysaccharides.
Cornelis 2 ( emphases added). Cornelis thus contemplates the use of more
than one polymer in its therapeutic compositions, and expressly teaches, as
preferred polymers, elements recited in Appellants' elected species of claim
1. Furthermore, Cornelis teaches the use of such polymers in concentrations
that substantially subsume the concentrations recited in Appellants'
dependent claim 2.
With respect to the rheological properties of the compositions taught
by Cornelis, we agree with the Examiner that compositions and
concentrations based upon those teachings would necessarily, and thus
inherently, possess the recited properties. See In re Best, 562 F.2d 1252,
1255 (CCPA 1977):
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
. . . Whether the rejection is based on "inherency" under 35
U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C.
§ 103,jointly or alternatively,[] the burden of proof is the same,
and its fairness is evidenced by the PTO' s inability to
manufacture products or to obtain and compare prior art
products.
Appellants have adduced no evidence in support of their argument
that the compositions taught by Cornelis would not necessarily have the
claimed properties of: "a Flow Rate Index from about 0.1 to about 0.85, a
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Consistency Index of from about 10 to about 2000 and a G'/G" ratio of 1 to
15," as recited in claim 1.
Appellants dispute the Examiner's finding that, according to the
teachings of Comelis, the G'/G" ratio of the structuring agent combination of
claim 1 could be anything: bigger than 1 or less than 1 or equal to 1. Reply
Br. 3. According to Appellants, the teachings of Comelis do not indicate
additive effects of the structuring agent combination of claim 1. Id. We
agree with Appellants that Comelis does not expressly teach a G'/G" ratio
for the combination of polymers taught by Comelis and recited in the claims.
However, as we have explained, Appellants bear the burden of showing by
evidence that the compositions made obvious by Comelis would not have
those properties, and they have not done so. We consequently do not find
Appellants' arguments persuasive.
Issue 2
Appellants argue that the Examiner erred by failing to identify
sufficient motivation to select and combine the elements of the claims from
the cited art. App. Br. 8.
Analysis
Appellants argue that the Examiner has not identified any apparent
reason why one of ordinary skill in the art would have combined colloidal
gum (xanthan gum), a cellulosic polymer ( carboxymethylcellulose ), and an
acrylate polymer (polyvinyl methyl ether) to arrive at the composition of the
elected species. App. Br. 8. Appellants acknowledge that Comelis discloses
an artificial saliva composition that comprises "at least one" polymer, but
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argue that this is not equivalent to disclosing a specific combination having
specific rheological properties as claimed. Id. According to Appellants,
with the exception of the single mention of "at least one" polymer, Comelis
is devoid of any guidance on the preparation or use of the mixture, or how to
achieve the rheological properties recited in claim 1. Id.
We are not persuaded by Appellants' arguments. As an initial matter,
Appellants' claims on appeal are all directed to "compositions" and not to
any method of preparing the claimed composition. Consequently, we look
to see whether the cited prior art teaches or suggests the structural
characteristics of Appellants' claimed composition.
Appellants' claims stand rejected under 35 U.S.C. § 103(a) as being
obvious over the teachings and suggestions of the cited prior art. The
analysis we therefore follow seeks to determine, not whether the claimed
composition is expressly disclosed within the four comers of Comelis, as we
would for a rejection under Section 102, but, rather, what the combined
teachings of the references would have suggested to those of ordinary skill
in the art. See In re Keller, 642 F.2d 413,425 (C.C.P.A. 1981).
Comelis expressly teaches the use of "at least one" polymer in its
therapeutic compositions, and thus expressly contemplates the use of
multiple polymers. See Comelis 2. Comelis also expressly teaches, as
preferred elements, the use of guar or xanthane gum, carboxymethyl
cellulose, and polyacrylate in concentrations overlapping the range of
concentrations recited in claim 2 and encompassed by 1. Id. Furthermore,
Comelis teaches that: "From the experiments it was found that particularly
xanthane gum, Guar gum, carboxymethyl cellulose, alginic acid and
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polyacrylic acid were exceptionally suitable polymers for application in a
therapeutic composition according to the invention." Comelis 8.
We therefore agree with the Examiner that a person of ordinary skill
in the art, understanding the teachings of Comelis, would have been
motivated to combine the preferred polymers in the concentrations taught by
Comelis, to arrive at Appellants' claimed invention.
Issue 3
Appellants argue the Examiner erred because a person of ordinary
skill in the art would not have had a reasonable expectation of success in
obtaining the specific rheological parameters recited in claim 1. App. Br. 8.
Analysis
Appellants argue that the rheological parameters of an oral care
composition comprising, in combination, a colloidal gum, a cellulosic
polymer, and an acrylate polymer, as recited in claim 1, cannot be predicted
by a simple summation of the viscosity and elasticity data of Example 2 and
Table 2 of Comelis. App. Br. 8-9. Appellants contend that these data from
Comelis apply only to oral care compositions containing a single ingredient
selected from xanthan gum, CMC, or guar gum. Id. at 9.
Appellants dispute the Examiner's finding that the results described in
Example 2 in Comelis indicate that replacing guar gum with polyacrylic acid
would generate predictable, additive effects. Id. (citing Final Act. 13-14).
Appellants point to E.-A. Brujan, CAVITATION IN NON-NEWTONIAN FLUIDS
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WITH BIOMEDICAL AND BIOENGINEERING APPLICATIONS (2011) ("Brujan"). 4
According to Appellants, Brujan teaches that the viscosity (rl'), and rigidity-
elasticity (rl"), are related to the storage modulus (G') and the loss modulus
(G") as follows: 11' = G"/co and 11" = G'/co, where co is the shear rate
frequency. Id. (citing Brujan 9). Consequently G'/G" = 11"/11'. Id.
Appellants argue that Comelis teaches that: "[T]he viscosity of a mixture of
PAA [polyacrylic acid] and MG 1 [high molecular weight saliva mucin]
results in a higher viscosity.. . . At ratio of 1: 1 this gave an increase in the
viscosity ±300% and increase in the elasticity of± 250% .... " Id. ( quoting
Comelis 8). Appellants assert that Comelis therefore teaches that adding
PAA would therefore decrease the G'/G" ratio of a composition because
G'/G" = 11"/11' and PAA increases viscosity 11' more than elasticity 11". Id.
Appellants contend that data presented in the Specification
demonstrates that adding an extra colloidal gum can increase G'/G". App.
Br. 9. Appellants assert that, in their Specification, Composition I differs
from Composition II in that Composition II includes an additional colloidal
polymer, gellan gum. Id. ( citing Spec. ,r,r 87-88). Appellants point out that
G'/G" of Composition II (7.96), is significantly larger than G'/G" of
Composition I (1.48). Id. (citing Spec. Table 2).
Therefore, Appellants argue that, contrary to the Examiner's finding
that modification of the formulations of Comelis to include the combination
recited in claim 1 would yield only "predictable results," i.e., "additive
effects," the parameters of the claimed composition combining the polymers
4 Submitted as Appendix A of Appellants' Response to Final Office Action,
June 28, 2016.
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cannot be predicted from those of Comelis, which contain only a single
structure agent. App. Br. 9. Appellants contend that the data disclosed in
Appellants' Specification show synergistic effects of the combination of
xanthan gum, carboxy methylcellulose, and polyvinyl methyl ether, rather
than additive effects. Id.
Furthermore, argue Appellants, data disclosed by Example 1 of
Comelis show synergistic effects of the combination of xanthan gum,
carboxymethylcellulose, and polyvinyl methyl ether, rather than additive
effects. App. Br. 9. Appellants contend that the data presented in Table 2 of
Comelis indicate that an increase in concentration of a colloidal gum and a
cellulosic polymer would generally increase G'/G". Id. at 10. Therefore,
Appellants argue, a person of ordinary skill in the art, understanding Table 2
of Comelis, would have concluded that increasing the concentration of
xanthan gum and carboxymethylcellulose could increase the G'/G" ratio of
the composition. Id.
However, Appellants assert, the data of the Specification's Example 1
do not support such an extrapolation from the data in Table 2 in Comelis.
App. Br. 10. According to Appellants, Composition I of Example 1
contains, in part, 0.083 wt% xanthan gum; 0.083 wt% carboxymethyl
cellulose; and 0.05 wt% acrylate polymer, whereas Composition III
contains, in part, 0.041 wt%, xanthan gum; 0.03 wt% carboxymethyl
cellulose; and 0.05 wt% acrylate. Id. ( citing Spec. ,r,r 87-89). According to
Appellants, Example 1 discloses that although Composition I has more
xanthan gum and carboxymethyl cellulose than Composition III, the G'/G"
ratio of Composition I, i.e., 1.48, is much lower than that of Composition III,
i.e., 5.57. Id. (citing Spec. Table 2). Therefore, argue Appellants, the
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rheological parameters of the composition including the combination of a
colloidal gum, a cellulosic polymer, and an acrylate polymer cannot be
predicted from those of the Comelis composition containing only a single
structure agent. Id. Appellants therefore argue that a person of ordinary
skill in the art would have had no reasonable expectation of success in
arriving at the claimed invention.
We are not persuaded by Appellants' arguments. We agree with
Appellants that Comelis is silent with respect to the rheological properties of
compositions comprising a combination of a colloidal gum, a cellulosic
polymer, and an acrylate polymer and that prediction of the properties of
such a combination must therefore be speculative. Nevertheless, and as we
have explained, the teachings of Comelis would teach a person of ordinary
skill in the art that the claimed composition of polymers could be
successfully combined in a therapeutic oral composition. Furthermore, a
person of ordinary skill in the art, seeking to achieve the desirable
rheological properties for an oral therapeutic composition, would be able to
optimize the rheological properties by combining the constituents in such a
manner as to achieve them. See, e.g., Comelis 1.
Finally, because the teachings of Comelis directly suggest such a
composition, the burden shifts to Appellants to show, via evidence of record,
that the claimed rheological properties would not be inherent to such a
composition. This they have not done, and we consequently affirm the
Examiner's rejection of claim 1.
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B. Rejection under 35 U.S.C. § 103(a) over Shastry, Comelis, and Stier
Appellants rely upon essentially the same arguments presented supra,
and further assert that Shastry does not cure the alleged deficiencies of
Cornelius and Stier. App. Br. 12. We affirm the Examiner's rejection for
the reasons set forth in Section A of this decision.
C. Provisional rejection under the judicially-created doctrine of
obviousness-type double patenting
Appellants request that, because the rejection on this ground is
provisional, the rejections be held in abeyance until such time as otherwise
allowable subject matter is identified in the present Application. App. Br.
12.
Because we affirm the Examiner's rejection of the claims under
35 U.S.C. § 103(a), and because Appellants do not argue this rejection on
the merits, we summarily affirm the Examiner's rejection upon this ground.
DECISION
The Examiner's rejection of claims 1, 2, 11-15, 18, 19, and 22-26 as
unpatentable under 35 U.S.C. § 103(a) is affirmed.
The Examiner's provisional rejection of claims 1, 2, 11-15, 18, 19,
and 22-26 for obviousness-type double patenting 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 )(iv).
AFFIRMED
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