Ex Parte Prencipe et al

Patent Trial and Appeal Board

Oct 31, 2012

11614455 (P.T.A.B. Oct. 31, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL PRENCIPE and SAYED IBRAHIM
__________

Appeal 2012-001803
Application 11/614,455
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, JACQUELINE WRIGHT BONILLA,
and SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to oral
compositions. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

Appeal 2012-001803
Application 11/614,455

2
STATEMENT OF THE CASE
According to Appellants, the invention relates to oral compositions
comprising a first and a second abrasive of distinct hardness (such as a
SYLODENT® XWA 650, a silica hydrogel composed of particles of
colloidal silica, and ZEODENT® 115, a precipitated silica), where both the
first and second abrasive is present in the composition in the amount of 15 %
to 19 % by weight. (Specification, ¶¶ [0009], [0027], [0031] and [0033].)
Claims 1-7, 10, 11 and 13-26 are on appeal. The claims have not been
argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 11 is representative and read as follows:
11. An oral composition comprising:
a first abrasive comprising silica, having an Einlehner hardness
of greater than 5 mg loss per 100,000 revolutions and an oil of
absorption of less than 90 cm3/100 g; and
a second abrasive comprising silica, having an Einlehner
hardness of less than 5 mg loss per 100,000 revolutions and an oil of
absorption of greater than 90 cm3/100 g;
wherein the first abrasive is present in an amount of 15% to
19% by weight and the second abrasive is present in an amount of
15% to 19% by weight of the composition.

The claims stand rejected as follows:
I. Claims 11 and 13-27 under 35 U.S.C. § 103(a) in view of US
Patent No. 6,290,933 B1, issued Sep. 18, 2001, to Durga et al.
II. Claims 1-7, 10, 11, 13-20 and 26 under 35 U.S.C. § 103(a) in view
of US Patent No. 6,379,654 B1, issued Apr. 30, 2002, to
Gebreselassie et al.

Appeal 2012-001803
Application 11/614,455

3
I.
Issue
The Examiner has rejected claims 11 and 13-27 under 35 U.S.C. §
103(a) as obvious over Durga. The Examiner finds that “Durga et al. does
not teach the specific weight percentages, ratios or particle sizes of the
abrasives,” however, “[w]hen the general conditions of a claim are disclosed
in the prior art, it is not inventive to determine the optimum or workable
ranges through routine experimentation.” (Ans. 6.)
Appellants contend that “[o]ne skilled in the art armed with Durga
would not have been motivated to increase the total levels of abrasive in
order to reduce abrasive damage.” (App. Br. 9.) Specifically, Appellants
contend that the data presented in Durga “would suggest to a person of
ordinary skill in the art that less silica, certainly Zeodent 115, should be
used.” (Id.) Appellants also contend that the data presented in Tables II, IV
and V at pages 21-23 of the Specification are evidence of unexpected results.
(Id. at 9-11.)
The issues with respect to this rejection are:
Does the evidence of record support the Examiner’s conclusion that
the Durga renders obvious the oral composition of claim 11?
If so, have Appellants presented evidence of secondary considerations
that, when weighed with the evidence of obviousness, is sufficient to support
a conclusion of non-obviousness?
Appeal 2012-001803
Application 11/614,455

4
Findings of Fact
FF1. Durga discloses “[a] high cleaning low abrasion dentifrice
containing a silica hydrogel having … an Einlehner hardness of from 1 to
about 20; an oil absorption of about 40 to less about 100 cc/g … whereby,
the dentifrice composition has a RDA of 110 to 200 and a PCR from about
150 to about 300.” (Durga, Abstract.)
FF2. Durga discloses that the dentifrice compositions of their
invention may contain “about 5 to about 30% by weight silica hydrogel
particles” such as Sylodent 650 XWA. (Durga, col. 2, ll. 43-49 and col. 4, l.
13.)
FF3. Durga discloses that “[t]he silica hydrogel abrasive can be used
as the sole abrasive in preparing the dentifrice composition of the present
invention or in combination with other known dentifrice abrasives or
polishing agents’” including “precipitated silicas… such as Zeodent 115.”
(Durga, col. 4, ll. 26-33.)
FF4. Durga discloses that “[t]he total quantity of abrasive present in
the dentifrice compositions of the present invention is at a level of from
about 5% to about 40% by weight, preferably from about 5% to about 30%
by weight.” (Durga, col. 4, ll. 41-44.)
FF5. Table II of Durga provides a comparison of Pellicle Cleaning
Ratio (PCR) and Radioactive Dentin Abrasion (RDA) values for two
compositions, Composition 1 and Composition 2, and is reproduced below.
(Durga, col. 8.)
App
App

ZEO
of ZE
Tabl
B. (

RDA
Dent
eal 2012-0
lication 11
Compos
DENT® 1
ODENT®
FF6. Ta
e I lists ing
Spec. 20.)
FF7. Ta
values fo
ifrice B, a
01803
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ition 1 com
15. (Durg
115. (Id
ble I of th
redient ra
ble II of t
r three com
nd is repro
prises 10
a, Table I
.)
e Specific
nges for D
he Specifi
positions
duced bel
5
% of each
, col. 7.) C
ation is rep
entrifice 1
cation prov
: Dentifric
ow. (Id. a
SYLODE
ompositio
roduced b
, Dentrific
ides a com
e 1, Denti
t 21.)
NT® XW
n 2 comp
elow:
e A, and D
parison o
frice A an

A 650 and
rises 20%
entrifice
f PCR and
d

App
App

20%
21%
SYL
Polis
Dent
note
of a
comm
from
“dete
eal 2012-0
lication 11
Dentifric
of ZEOD
of SYLOD
ODENT®
FF8. Ta
h Increme
ifrice C an
Dentifric
d above. (
regular cle
ercially a
Procter an
FF9. Tab
rmine the
01803
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e 1 compr
ENT® 115
ENT® X
XWA 65
ble IV of t
nt” for fou
d Dentifri
e 1 and D
FF6.) “De
aning silic
vailable a
d Gamble
le V of th
delivery a
ises 15-18
. Id. at 20
WA 650.
0 and 8-14
he Specifi
r composi
ce D and i
entifrice B
ntifrice C
a abrasive
s CREST®
of Cincin
e Specific
nd retentio
6
% of SYL
, Table I.)
(Id.) Den
% of ZEO
cation pro
tions, Den
s reproduc
are the sa
is a conve
.” (Id. at 2
Dual Ac
nati, OH.”
ation prov
n of triclo
ODENT®
Dentifric
tifrice B c
DENT® 1
vides a co
tifrice 1, D
ed below.
me compo
ntional de
3.) “Den
tion White
(Id. at 21
ides the re
san to a [s
XWA 65
e A comp
omprises 7
15. (Id.)
mparison “
entifrice
(Id. at 23
sitions in
ntifrice ha
tifrice D is
ning Toot
-22.)
sults of a t
aliva coat

0 and 15-
rises 19-
-14% of
Mean
B,
.)

Table II
ving 20%

hpaste
est to
ed

App
App

(SCH
copo
C, an
in Ta
inven
Iron
2004
prim
comp
comp
diffe
prior
In re
116
eal 2012-0
lication 11
AP)] disk
lymer” for
d is repro
Dentifric
ble II and
“[W]her
tion falls
Grip Barb
). See als
a facie cas
osition ov
lete overl
rence show
One “ma
art teache
Peterson,
F.3d 1465
01803
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from a de
three com
duced belo
e 1, Denti
IV noted
e there is a
within tha
ell Co. v.
o, In re Ha
e of obvio
erlap the r
ap of the c
s a prima
y rebut a p
s away fro
315 F.3d
, 1469 (Fe
ntifrice co
positions
w. (Id. at
frice B an
above. (FF
Princ
range dis
t range, th
USA Sport
rris, 409 F
usness ari
anges disc
laimed ran
facie case
rima faci
m the clai
1325, 133
d. Cir. 199
7
ntaining t
, Dentifric
24.)
d Dentifric
6, FF7.)

iples of La
closed in t
ere is a pre
s, Inc., 39
.3d 1339,
ses when t
losed in th
ge and th
of obviou
e case of o
med inven
1 (Fed. Cir
7). Howe
riclosan an
e 1, Dentif
e C are th

w
he prior ar
sumption
2 F.3d 131
1341 (Fed
he ranges
e prior ar
e prior art
sness”) (c
bviousnes
tion in any
. 2003); c
ver, for a r
d an anion
rice B and
e same com
t, and the
of obviou
7, 1322 (F
. Cir. 200
of a claim
t. . . . Even
range, a m
itations om
s by show
material
iting In re
eference t
ic
Dentifric
positions
claimed
sness.”
ed. Cir.
5) (“a
ed
without
inor
itted).
ing that th
respect.”
Geisler,
o teach

e

e
Appeal 2012-001803
Application 11/614,455

8
away, it must state more than a general preference for an alternative
invention. It must ‘“criticize, discredit, or otherwise discourage”’
investigation into the invention claimed. DePuy Spine, Inc. v. Medtronic
Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009), quoting In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).

Analysis
Appellants argue that
Durga teaches away from the claimed ranges. Based on
intuition and the experience of testing the conventional
formulations, increasing the level of abrasive materials would
lead to increased RDA and greater risk of enamel damage. The
exemplified composition of Durga having two different
abrasive materials is similar to Dentifrice B of the instant
application, with a total abrasive level of 20%. Composition 1
in Table 1 (columns 7 and 8) includes only 10% by weight of
the inventive silica of Durga, whereas Composition 2 contains
0% by weight of the inventive silica but 20% by weight of the
optional silica Zeodent 115. Composition I, which used a lower
amount of Zeodent 115 (albeit an optional silica in Durga) than
Composition 2, had a Pellicle Cleaning Ratio (PCR) nearly 5
times as great. This would suggest to a person of ordinary skill
in the art that less silica, certainly Zeodent 115, should be used.
(App. Br. 9.)

After reviewing the record before us, we find Durga to disclose an
oral combination having abrasives (FF3) falling within the scope of claim
11, such as SYLODENT® XWA 650 (FF2) and ZEODENT® 115 (FF3), in
amounts that fall within the ranges required by claim 11 (FF4). Claim 11 is
therefore presumed obvious in view of Durga. Iron Grip Barbell Co. v. USA
Appeal 2012-001803
Application 11/614,455

9
Sports, Inc., 392 F.3d at 1322. Given the disclosure in Durga, we find the
determination of workable or optimum ratios would have been within the
level of the ordinary skill and thus Durga renders claim 11 obvious.
We are not persuaded by Appellants’ arguments that Durga contains a
teaching away from the embodiments encompassed by claim 11. The fact
that the embodiment tested in Durga having 20% of ZEODENT® 115
displayed inferior properties does not reach to the level of a teaching away.
(FF5.) Durga “does not ‘criticize, discredit, or otherwise discourage’
investigation into the invention claimed.” DePuy Spine, 567 F.3d at 1327.
The most that might be reasonably said about Durga is that it expresses a
preference for the alternative invention (an oral composition with increased
RDA and PCR values) (FF5). Durga does not discourage investigation into
oral compositions having PCR and RDA values of below that of
Composition 1 of Durga, for example. (See FF5.) Appellants have pointed
to no part of Durga that criticizes or discredits such an embodiment.
Appellants also contend that the results in Tables II, IV and V of the
Specification are evidence of unexpected results. (App. Br. 9-11.)
Specifically, Appellants argue that Table II shows “the claimed
compositions provide an unexpectedly low RDA (with only an 18% increase
over Dentifrice B) while achieving a 27% increase in PCR over Dentifrice
B.” (App. Br. 10.) With reference to Table IV, Appellants argue that
“Dentifrice 1 shows an 11 % increase when based on the control (Dentifrice
C), whereas Dentifrice B (the inventive composition of Durga and closest
prior art) only had a 7% increase.” (Id. at 11.) Finally, with reference to
Table V, Appellants argue that “Dentifrice B and C had about the same
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Application 11/614,455

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average triclosan uptake, whereas Dentifrice A had an average uptake of
about 80,” which “represents an improvement of about 23%.” (Id.)
We are not persuaded by Appellants’ arguments that the data
presented in Tables II, IV and V of the Specification are unexpected results.
Here, we note that the Specification discloses concentration ranges for the
amounts of SYLODENT® XWA 650 and ZEODENT® 115 present in the
test compositions Dentifrice 1, Dentifrice A and Dentifrice B. (FF6-7; Spec.
20, Table I.) As such, we cannot determine with any degree of certainty
what was actually compared and thus cannot judge whether or not the results
are truly unexpected. For example, because Table I discloses ranges of
ingredients, rather than specific amounts, Table I of the Specification
suggests it is possible that Dentifrice 1 contains 15% of both SYLODENT®
XWA 650 and ZEODENT® 115 while Dentifrice B contains 14% of these
same components. (FF6.) In that situation, are results presented in Table II
of the Specification a comparison of these embodiments of Dentifrice 1 and
Dentifrice B?
Second, “[i]t is well settled that unexpected results must be
established by factual evidence. Mere argument or conclusory statements in
the specification does not suffice.” In re De Blauwe, 736 F.2d 699, 705 (Fed.
Cir. 1984). Here, we note that all discussion of Examples II-IV at pages 20-
24 of the Specification are written in the present tense and therefore are
presumed to be prophetic. See Atlas Powder Co. v. E.I. du Pont De
Nemours & Co., 750 F.2d 1569, 1578 (Fed. Cir. 1984) (“the examples were
written in the present tense to conform with the PTO requirements on
prophetic examples.”) While the data presented in Tables II, IV and V
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suggest that the experiments may have been performed, given that the
Examples are written in the present tense and present a range of
concentrations for components of the test compositions, we also find that it
is not clear whether the data of the tables relied on by Appellants are
prophetic data or evidence. Since the weight of the evidence supports a
finding that the examples are prophetic due to the lack of specificity in Table
I as to what was actually being compared and the use of the present tense
regarding all information presented in Tables II-IV, we do not find the
results sufficient to overcome the Examiner’s prima facie case of
obviousness.

Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Durga renders obvious the oral compositions of claim 11.
Appellants have not presented evidence of secondary considerations
that, when weighed with the evidence of obviousness, is sufficient to support
a conclusion of non-obviousness.
II.
Issue
The Examiner has rejected claims 1-7, 10, 11, 13-20 and 26 under 35
U.S.C. § 103(a) in view Gebreselassie. The Examiner finds that
“Gebreselassie et al. do not teach a composition comprised of a first and
second abrasive in the weight percentages, ratios and particle size of the
instant invention,” however, “[w]hen the general conditions of a claim are
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disclosed in the prior art, it is not inventive to determine the optimum or
workable ranges through routine experimentation.” (Ans. 8.)
Appellants contend that “[l]ike Durga, Gebreselassie, fails to provide
any motivation to optimize the abrasive by providing two abrasives, each at
a total level of 15-19%.” (App. Br. 12.)
The issue with respect to this rejection is:
Does the evidence of record support the Examiner’s conclusion that
the Gebreselassie renders obvious the oral composition of claim 11?

Additional Findings of Fact
FF9. Gebreselassie discloses abrasive dentifrice compositions
containing “low oil absorption silica abrasive having an oil absorption value
of less than 100 cc/100 g silica.” (Gebreselassie, Abstract.)
FF10. Gebreselassie discloses that Sylodent 650 XWA “is a preferred
example of a low oil absorption silica abrasive useful in the practice of the
present invention.” (Gebreselassie, col. 2, ll. 24-34; see also, Ans. 7.)
FF11. Gebreselassie discloses that “[t]he low oil absorption silica
abrasive can be used as the sole abrasive in preparing the dentifrice
composition of the present invention or in combination with other known
dentifrice abrasives.” (Gebreselassie, col. 2, ll. 41-44; see also, Ans. 7.)
FF12. Gebreselassie discloses that “[t]he total quantity of abrasive
present in the dentifrice compositions of the present invention is at a level of
from about 5% to about 40% by weight, preferably from about 5% to about
30% by weight when the dentifrice composition is a toothpaste.”
(Gebreselassie, col. 2, ll. 56-60; see also, Ans. 7.)
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FF13. Gebreselassie discloses that “[c]ommercially available
abrasives which may be used in combination with the low oil absorption
silica abrasive include precipitated silicas … such as Zeodent 115.”
(Gebreselassie, col. 2, ll. 45-48; see also, Ans. 7.)
Analysis
Appellants argue that “[o]ne skilled in the art armed with
Gebreselassie would have no reason to believe that modifying the abrasive
concentration would be desirable.” (App. Br. 12.) We are not persuaded.
Rather, we agree with the Examiner’s fact finding and analysis and adopt
them as our own. (Ans. 7-8.) In particular, we find Gebreselassie to
disclose an oral combination having abrasives (FF11) falling within the
scope of claim 11, such as SYLODENT® XWA 650 (FF10) and
ZEODENT® 115 (FF13), in amounts that fall within the ranges required by
claim 11 (FF12). Claim 11 is therefore presumed obvious in view of
Gebreselassie. Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d at 1322.
Given the disclosure in Gebreselassie, we find the determination of workable
or optimum ratios would have been within the level of the ordinary skill and
thus Gebreselassie renders claim 11 obvious.
Appellants also contend that “the claimed compositions demonstrate
surprising advantages over compositions like those disclosed in
Gebreselassie.” (App. Br. 12) However, for the same reasons discussed in
the section above, we are not persuaded by Appellants’ arguments that the
Examiner’s prima face case of obviousness is rebutted by evidence of
unexpected results.
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Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Gebreselassie renders obvious the oral compositions of claim 11.

SUMMARY
We affirm the rejection of claim 11 under 35 U.S.C. § 103(a) in view
of Durga. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii), we also affirm the
rejection of claims 13-27 under 35 U.S.C. § 103(a) in view of Durga.
We affirm the rejection of claim 11 under 35 U.S.C. § 103(a) in view
of Gebreselassie. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii), we also affirm
the rejection of claims 1-7, 10, 13-20 and 26 under 35 U.S.C. § 103(a) in
view of Gebreselassie.

AFFIRMED

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