Ex Parte Pimenta et al

Patent Trial and Appeal Board

Sep 27, 2016

13514986 (P.T.A.B. Sep. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/514,986 06/10/2012
23909 7590 09/29/2016
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.
8635-00-0C 2723
EXAMINER
BRANSON, DANIELL
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
09/29/2016 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 PALO MA PIMENTA, SHIRA PILCH, and
JAMES MASTERS 1
Appeal2015-002972
Application 13/514,986
Technology Center 1600
Before DEMETRA J. MILLS, ULRIKE W. JENKS, and TA WEN CHANG,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
dentifrice formulation comprising an in situ produced silica gel/precipitate
silica composite, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
"Abrasive materials have historically been used in dentifrice
compositions to remove ... substances that can cause ... tooth
1 Appellants identify the Real Party in Interest as Colgate-Palmolive
Company. (Appeal Br. 2.)
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discoloration," and "[s]ilica dental abrasives of various types are preferred."
(Spec. i-f 6.) According to the Specification, however, "[ w ]ith traditional
silica materials, a strong relationship exists between mechanical stain
removal and abrasion [and] incremental gains in cleaning performance[,]
resulting in significant increase in dentin abrasivity."2 (Id. at i-f 7.) The
Specification states that, as a result, there is a need for "the development of
high cleaning materials that provide superior stain removing, while
supporting a low level of abrasivity." (Id. at i-f 8.) The Specification further
states that "[ fJlavor is one of the more important attributes of any product
that is applied ... orally," and that "[t]he ideal next generation high cleaning
dentifrice should possess some uniqueness in terms of its flavor release
profile, retention and intensity." (Id. at i-fi-19-10.)
According to the Specification, the invention relates to "dentifrice
formulations containing [high cleaning, low abrasion] abrasives in the form
of [in situ] generated compositions of precipitated silicas and gel silicas,"
which exhibit beneficial characteristics such as "enhanced flavor retention
and superior modulation of actives" depending on the "particular structure
and surface chemistry of the ... hybrid gel/silica abrasives." (Id. at i-fi-12-3.)
The Specification explains that "[ t ]he in situ formation of precipitate I gel
hybrid silica materials ... preferably provides the silica with ... a ratio of
accessible to total pore volume of silica (CT AB ( cetyl trimethyl ammonium
bromide) surface area of 60-110 [ m2/g], Oil Absorption of 80-130 cell 00 g,
2 "A tooth is comprised of an inner dentin layer and an outer hard enamel
layer that is the protective layer of the tooth." (Spec. i-f 4.)
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CTAB/OA ratio of 0. 7 to 1) that enables them to entrap an unusually high
level of hydrophobic compounds."3 (Id. at i-f 30.)
Claims 1--4, 7-9, 11, and 13-15 are on appeal. 4 Claim 1 is
illustrative and reproduced below:
1. A dentifrice formulation comprising an in situ produced
silica gel/precipitate silica composite,
wherein said formulation comprises 10-30% by weight of
silica gel/precipitate composite, and
the composite exhibits a cetyl trimethyl ammonium
bromide (CT AB) surface area of from about 60 to about 110 m2
I g and a ratio of CT AB surface area to oil absorption of from
about 0.7 to about 1.0; and
wherein the formulation further comprises an effective
amount of flavorant in an amount of up to about 0.6% by weight
of the formulation; and
wherein said composition has
a PCR (Pellicle Cleaning Ratio) value of from about 81 to
about 100,
a RDA (Radioactive Dentin Abrasion) level of from about
75 to about 135,
and a PCR to RDA ratio of from about 0.70 to about 1.25;
and
wherein the elastic modulus of the dentifrice is within the
range of from about 65,000 to about 100,000 dyn/cm2.
(Appeal Br. 11 (Claims App'x).)
The Examiner rejects claims 1--4, 7-9, 11, and 13-15 under 35 U.S.C.
§ 103(a) as being unpatentable over McGill. (Ans. 2.)
3 "CT AB external surface area of silica is determined by absorption of
CTAB ... on the silica surface" where "[t]he external surface of the silica is
determined from the quantity of CT AB adsorbed." (McGill et al., US
7,267,814 B2, issued Sep. 11, 2007 ("McGill") 17:49-55.) Oil absorption is
related to the structure of the in situ generated precipitate I gel composites.
(Id. at 1:7-25, 8:48-56, 16:10-21.)
4 Claim 12 has been cancelled. (Advisory Act. 2 (Dec. 24, 2013).)
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Issue
DISCUSSION
The Examiner finds that McGill teaches "dentifrices that contain silica
gel and precipitated silica composites that are prepared in situ and that have
high cleaning and low abrasive properties." (Ans. 2.) The Examiner finds
that "[ o ]ne of the composites [McGill discloses] has a CT AB of 90 and an
oil absorption of 111 [,] ... giving a CTAB to oil absorption ratio of 0.81."
(Id.) The Examiner finds that McGill teaches that its composites "may be
incorporated into a dentifrice composition at 20% by weight of the whole
dentifrice composition, giving a PCR of 100 and a RDA of 142 and a
PCR:RDA ratio of 0.7 for example." (Id.) The Examiner finds that McGill
teaches incorporating flavoring agent in the dentifrice "at less than 5 % by
weight, such as 0.65 % by weight." (Id. at 2-3.) Finally, the Examiner finds
that McGill teaches that "[c]ombinations of the composites may be used to
formulate dentifrices giving a PCR of 90, 92 and 95 and RDA of 96, 97 and
113 and corresponding PCR: RDA ratios of 0.94, 0.95 and 0.84." (Id. at 3.)
Appellants and the Examiner agree that McGill does not disclose "a
single formulation which contains all of the recited CT AB, oil absorption,
PCR and RDA values of the claimed invention" and does not specifically
teach the elastic modulus or the flavor retention value as claimed. (Appeal
Br. 5; Ans. 3.)
Appellants contend that, given the lack of these disclosures, it is
improper for the Examiner to "suggest that since other properties regarding
the claimed composition and McGill are similar, one of ordinary skill would
have been motivated to fill in the gaps of the prior art and arrive at the
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Application 13/514,986
claimed invention." (Appeal Br. 5.) Appellants contend that the Examiner
is instead relying on hindsight in making the rejection. (Id. at 9.)
Appellants contend that "the Examiner has not provided any evidence
that any of the ingredients disclosed in McGill would have the properties
which are characteristic of the compositions being claimed." (Id. at 5, 7-8.)
Similarly, Appellants contend that "there is nothing to indicate that a skilled
artisan would have had a reasonable expectation that [experimenting with
McGill's silica gel composites such as Example 14] would succeed in
arriving at the claimed dental composition." (Id. at 7.) Appellants contend
that McGill in fact teaches away from the claimed invention. (Id.)
Finally, Appellants argue that they have "provide[ d] comparative data
in Example 2 showing unexpected superior results over the closest prior art
Zeodent 105 as evidence of non-obviousness." (Id. at 9-10.)
Appellants did not separately argue the claims. Thus, we focus our
analysis on claim 1. The issue with respect to this rejection is whether the
evidence of record supports the Examiner's finding that claim 1 is prima
facie obvious over McGill and, if so, whether Appellants have provided
evidence of unexpected results that, when considered with the evidence of
obviousness, is sufficient to support a conclusion of non-obviousness.
Findings of Fact
1. McGill teaches that, "[i]deally, an effective dentifrice abrasive
material maximizes pellicle film removal while causing minimal abrasion
and damage to the hard tooth tissues." (McGill 1 :43--46.)
2. McGill teaches that "[b ]oth PCR and RDA results vary
depending upon the nature and concentration of the components of the
dentifrice composition." (Id. at 19:11-14.)
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Application 13/514,986
3. McGill discloses "abrasive and/or thickening materials that are
in situ generated compositions of precipitated silicas and silica gels."
(McGill 1:7-9.)
4. McGill discloses that its in-situ produced composites "exhibit
different beneficial characteristics depending on the structure of the
composite." (Id. at 1:9-11.) In particular, McGill discloses that
[ w ]ith low structured composites ( ... oil absorption levels from 40 to
100 ml oil absorbed/I 00 g composite), simultaneously high pellicle
film cleaning properties and moderate dentin abrasion levels are
possible . . . . Increased amounts of high structure composite
materials tend to accord greater viscosity build and thickening
benefits together with such desirable abrasion and cleaning properties,
albeit to a lesser extent than for the low structure types. Thus, mid-
range cleaning materials will exhibit oil absorption levels from an
excess of 100 to 150, and high thickening/low abrasion composite
exhibit oil absorption properties in excess of 150.
(Id. at 1:11-25; see also id. at 4:52---66, 10:14--23, 11:22-33, 11:49-58,
11:62---67, 12:34--42.)
5. Similarly, McGill discloses that
[t]he inventive in situ generated composites ... of silica gel and
precipitate are useful for various functions, including, without
limitation, three primary types: i) high-cleaning, dental abrasives with
correlative lower abrasiveness (with an RDA level of less than 250,
for instance) than typical high-cleaning silica-based products; ii) mid-
range cleaning dental abrasives with reduced high cleaning levels (as
compared with the high cleaning materials from above), but much
lower RDA measurements (at most about 150, for instance); and iii)
thickening (viscosity-modifying) products that exhibit certain levels
of cleaning and abrasiveness (such as an exhibited PCR of less than
90 and a measured RDA of below 80).
(Id. at 8:59-9:4; see also id. at 10:29-33, 11:38--42, 12:52-56.)
6. McGill discloses that production of the type of abrasives or
thickening product in its method is "based upon different factors, such as
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reaction conditions (e.g., temperature, agitation/shear, addition rates of
reactants, amount of gel component, and the like), and concentrations of
reactants (e.g., mole ratios of silicate to acid, as one example)." (Id. at 9:5-
9; see also id. at 4:18-29, 5:16-22, 5:28-34, 7:58---64, 8:32-38, 10:11-20,
10:44--50, 11:4--11, 11:19-29, 11:62---67, 12:34--42, 19:26-31.) McGill
discloses that "the inventive method ... permits the producer to target a
range of amounts of silica gel and precipitated silica components as well as
structures of precipitated components to impart the desired level of
cleaning/abrasion through controlled parameters during production." (Id. at
6:27-33.)
7. McGill discloses that its Examples 5, 10, 12, 14, 16, and 17
show "methods of producing ... mid-range products (and further
exemplified within dentifrice formulations 2, 7, 9, and 10, below)." (Id. at
10:50-53.)
8. McGill's Example 14 is an in situ generated composition of
precipitated silicas and silica gels having a CT AB value of 90 m2 I g and oil
absorption value of 111 ml/100 g. (Id. at 23:46-24:10, Table 8.)
9. McGill discloses that "[its] inventive mid-range cleaning
gel/precipitated silica combination generally have the following properties:
... within a test dentifrice formulation ... RDA ... values between about
95 to about 150, and (within the same test dentifrice formulation) PCR ...
values of 90 to 120, with a ratio of PCR to RDA within the range of 0.7 to
1.1.") (Id. at 11 :34--42.)
10. McGill discloses that its precipitate/gel silica composite, "when
incorporated into dentifrice compositions, is present at a level of from about
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5% to about 50% by weight, more preferably from about 10% to about 35%
by weight." (Id. at 13: 19-23.)
11. McGill teaches dentifrice formulations incorporating its
inventive abrasive that further incorporates flavorants at <5.0%, e.g., 0.65%.
(Id. at 13:29--45, Table 11.)
12. McGill's Formulas 2, 7, 9, 10, 12, 13, and 14 have PCR values
of 100, 98, 97, 91, 90, 92, and 95 respectively, RDA values of 143, 134, 117,
107, 96, 97, and 113 respectively, and PCR/RDA ratios of 0.7, 0.73, 0.83,
0.93, 0.94, 0.95, and 0.84, respectively. (Id. at Table 12, Table 14.)
13. McGill teaches adding its composites "with other abrasive
materials ... to target certain high levels of cleaning with lower
abrasiveness thus providing the optimization of cleaning while providing a
larger margin of abrasion protection to the ultimate user." (Id. at 4:30-39;
see also id. at 9:26-31, 12:64--13:5.)
14. McGill's dentifrice formulations 11-14 "were prepared using a
combinations of 2 [of its] inventive silicas [or] an inventive silica and a
commercial silica." (Id. at 27:15-19, Table 13.) For example, McGill's
Formula 12 contains 5% of McGill's Example 7 silica and 15% of McGill's
Example 8 silica. (Id. at Table 13.)
15. McGill's Example 7 is a silica precipitate I gel composite that
have CTAB values of76 m2/g and oil absorption values of 81 ml/lOOg. (Id.
at Table 4.)
16. McGill teaches that "[t]he cleaning ability of these
combinations, in particular Formulas 12, 13, and 14, evince a highly
surprising and effective dental polishing and film removal material with
much lower abrasion levels." (Id. at 27:64--66.)
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Application 13/514,986
Analysis
We adopt the findings and reasons set forth by the Examiner in the
Final Action, the Dec. 24, 2013 Advisory Action ("Adv. Act."), and
the Answer. (Final Act. 4--8; Adv. Act. 2; Ans. 2-10; FFl-16.) We address
Appellants' arguments below.
Appellants contend that McGill does not disclose "a single
formulation which contains all of the recited CT AB, oil absorption, PCR and
RDA values of the claimed invention" and does not specifically teach the
elastic modulus or the flavor retention value as claimed. (Appeal Br. 5.)
Appellants contend that "the Examiner has not provided any evidence that
any of the ingredients disclosed in McGill would have the properties which
are characteristic of the compositions being claimed." (Id. at 5, 7-8.)
Appellants contend that "there is nothing to indicate that a skilled artisan
would have had a reasonable expectation that [experimenting with McGill's
silica gel composites such as Example 14] would succeed in arriving at the
claimed dental composition having, for example, the required elastic
modulus or flavor retention properties in combination with the claimed
[PCR, RDA, and PCR to RDA ratio.]" (Id. at 7.)
We are not persuaded. Obviousness does not require all limitations of
a claim to be present in a single formulation. McGill teaches that the
composite of its Example 14, which exhibits the claimed CT AB surface area
and CTAB to oil absorption ratio, is useful in producing mid-range abrasive
products" (FF7; Adv. Act. 2), and further teaches that such mid-range
abrasive products generally have ranges of PCR, RDA and PCR to RDA
ratios that substantially overlaps those of claim 1. (FF9; Adv. Act. 2.)
McGill also discloses adjusting reaction conditions of the in-situ silica
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composite production (FF6), and/or mixing the composite with another
composite or with a conventional abrasive (FF 13; Ans. 6-7), to adjust a
formulation's cleaning and abrasion characteristics. McGill further discloses
that Formulations 12-14, which exhibit PCR, RDA, and PCR/RDA ratios
within the claimed range (FF12), "in particular ... evince a highly surprising
and effective dental polishing and film removal material with much lower
abrasion levels." (FF16; Ans. 6-7.) Thus, McGill's disclosure provides a
skilled artisan with reason and a reasonable expectation of success for
incorporating a composite with the claimed CTAB and CT AB/oil absorption
ratio (e.g., Example 14) into a formulation with the claimed PCR, RDA, and
PCR/RDA ratio.
Given that we find McGill suggests a dentifrice formulation that (1)
incorporates composites having substantially the same CT AB surface area,
CT AB to oil absorption ratio, and manufactured process (i.e., in situ
production) as the composites of claim 1, and (2) possesses substantially the
same PCR, RDA, and PCR to RDA ratio as those claimed, we also find that
the Examiner has established a reasonable basis for finding that the claimed
elastic modulus would be an inherent property of such a formulation (Ans. 4,
8) T) 1R f:Jf l' . 'J'Ilf!j'J-)h ' l 11 ·~ F' id 1186' 1104 9-;;:; 'f'· l . r i . . 1arm., nc. v . .. 1-r arms., nc., .. _, ·- , _. _l -· { ec.
Cir. 2014) (explaining that inherency may supply a missing claim limitation
in an obviousness analysis, if "the limitation at issue necessarily must be
present, or the natural result of the combination of elements explicitly
disclosed by the prior art.'} Appellants have not provided persuasive
evidence showing that the fonnufation suggested by 1\tfcGill would not have
the requisite elastic modulus. In re Spada, 911 F.2d 705, 708 (Fed. Cir.
1990) (holding that "when the PTO shows sound basis for believing that the
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Application 13/514,986
products of the applicant and the prior art are the same, the applicant has the
burden of showing that they are not").
Appellants further argue that "McGill has given no indication of
which parameters were critical," "has not given any direction of which of the
many, if not infinite, possible choices [regarding CTAB, oil absorption,
PCR, RDA, and/or PCR/RDA ratio] is likely to be successful," and "has not
provided "correlation between the CT AB and oil absorption parameters of
the silica gel composites and the expected PCR, RDA[,] and ... PCR/RDA
ratios of the dentifrice." (Id. at 6.)
We are not persuaded. As discussed above, McGill clearly discloses
that PCR, RDA, and PCR/RDA ratios are important to the relative cleaning
ability and abrasion level of the formulation and teaches using a composite
having the claimed CT AB and CT AB to oil absorption ratios to achieve
formulations having PCR, RDA, and PCR/RDA ratios similar to those
claimed. (FF5, FF7-9; Adv. Act. 2.) McGill also teaches, for instance, that
oil absorption values reflect the structure of the composite, which in tum is
related to characteristics such as pellicle film cleaning properties, dentin
abrasion levels, and viscosity build and thickening benefits (FF4); and
further teaches that certain formulations having claimed PCR, RDA, and
PCR/RDA ratios "in particular ... evince a highly surprising and effective
dental polishing and film removal material with much lower abrasion
levels." (FF12, FF16; Ans. 6-7.) Finally, as already discussed, McGill
discloses adjusting reaction conditions of the in-situ silica composite
production (FF6), and/or mixing the composite with another composite or
with a conventional abrasive, to adjust a formulation's cleaning and abrasion
characteristics (FF13; Ans. 6-7). Accordingly, we agree with the Examiner
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that McGill provides sutlicient guidance to a skilled artisan to arrive at the
claimed dentifrice formulation.
We also note but are not convinced by Appellants' arguments that
McGill teaches away from the claimed invention and that the Examiner
employed hindsight in making the obviousness rejection. (Id. at 7, 9.) For
the reasons already discussed above, we find that the Examiner's rejection is
properly based on McGill's disclosures rather than hindsight. (Ans. 9.) As
to Appellants' argument that McGill teaches away from the claimed
invention because the composite of Example 14, which exhibits the claimed
CT AB surface area and CT AB to oil absorption ratio, was not used in any of
McGill's example formulations, we agree with the Examiner that "the mere
disclosure of more than one alternative does not constitute a teaching away
from any of those alternatives because such a disclosure does not criticize,
discredit or otherwise discourage the solution claimed." (Ans. 7-8 (citing In
re Fulton, 391 F.3d 1195 (Fed. Cir. 2004).)
Finally, Appellants argue that they have "provide[ d] comparative data
in Example 2 showing unexpected superior results over the closest prior art
Zeodent 105 as evidence of non-obviousness." (Id. at 9-10.) This argument
is not persuasive. As the Examiner points out, the composites disclosed in
McGill, rather than Zeodent 115,5 is the closest prior art. 6 (Ans. 10.)
5 The Specification states that Zeodent® 115, rather than Zeodent® 105, was
used as the control in Example 2 of the Specification. (Spec. i-f 64.) The
difference in the Specification and Appeal Brief with respect to the control
used in Example 2 does not change our analysis.
6 Zeodent 115 appears to be a conventional high cleaning silica material
rather than an in situ produced silica composite. (Spec. i-f 64 (Example 2
described as comparing the claimed hybrid silicas with "a known high
cleaning silica material").)
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However, "when unexpected results are used as evidence ofnonobviousness,
the results must be shown to be unexpected compared with the closest prior
art." In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Appellants have not provided such a comparison.
Accordingly, we affirm the Examiner's rejection of claim 1. Claims
2--4, 7-9, 11, and 13-15, which were not separately argued, fall with
claim 1. 37 C.F.R. § 41.37( c )(1 )(iv).7
SUMMARY
For the reasons above, we affirm the Examiner's decision rejecting
claims 1--4, 7-9, 11, and 13-15.
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
7 Appellants refer to "flavor retention values" and "flavor intensity value" in
the Appeal Brief. (Appeal Br. 5, 8.) These limitations are recited only in
dependent claims 9 and 15, and 8 and 14, respectively. However, "merely
point[ing] out what a claim recites will not be considered an argument for
separate patentability of the claim." 37 C.F.R. § 41.37(c)(l)(iv) ("[C]laim(s)
argued separately ... shall be argued under a separate subheading that
identifies the claim(s) by number."). In any event, we find that the
Examiner has established a reasonable basis for finding that such flavor
retention and intensity values are inherent in the prior art. (Ans. 4, 8.)
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