Ex Parte Prencipe et al

Patent Trial and Appeal Board

Aug 1, 2018

12866766 (P.T.A.B. Aug. 1, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/866,766 08/09/2010
23909 7590 08/03/2018
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Michael Prencipe
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.
8565-00-US-Ol-OC 4289
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
08/03/2018 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
Ex parte MICHAEL PRENCIPE, RICHARD SCOTT ROBINSON,
RAJNISH KOHLI, and RICHARD J. SULLIVAN
Appeal2017-005623
Application 12/866,766
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ROBERT A. POLLOCK, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a dental
sealant composition. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ). We reverse.
Statement of the Case
Background
"Dental caries consist of demineralization of a tooth caused by
bacteria ... Tooth sensitivity is also a common problem affecting children
and adults. Generally, tooth sensitivity may be caused by gingival recession,
1 Appellants identify the Real Party in Interest as Colgate-Palmolive
Company (see App. Br. 3).
Appeal2017-005623
Application 12/866,766
dentine exposure due to erosion or abrasion, or periodontal surgery that
includes root planning" (Spec. ,r,r 3--4).
[T]he present invention relates to a method of treating sensitive
teeth with a basic amino acid in free or salt form (BAA) in a
sealant composition, preferably in the presence of fluoride. The
method involves: (1) attaching a BAA-releasing sealant
composition to a person's tooth; and (2) allowing a BAA to be
slowly released over time in order to reduce chronic and/or
acute tooth sensitivity. Preferably, the sealant acts also as a
fluoride releasing composition as well.
(Spec. ,r 10).
The Claims
Claims 1 7, 21, 22, 2 7, and 2 8 are on appeal. 2 Independent claim 21 is
representative and reads as follows:
21. A dental sealant composition comprising a basic
amino acid in free or salt form (BAA) and a fluoride ion
source, wherein said fluoride ion source is present at a
concentration of at least about 12 percent, by weight, of the
composition and is selected from stannous fluoride, sodium
monofluorophosphate, sodium fluorosilicate, ammonium
fluorosilicate, amine fluoride, aluminum fluoride, sodium
hydrogen fluoride, sodium fluoride, calcium fluoride,
magnesium fluoride, and potassium fluoride,
wherein the composition is adapted for incorporation
into a dental material and said dental material is selected
from the group consisting of a dental amalgam, a fissure
sealant resin, a composite bonding material, an orthodontic
appliance, a dental prosthetic, a resin varnish, and an oral
surgery implant, and
wherein the composition has a daily dissolution rate
of from about 0.1 to about 0.5%.
2 Claims 1, 3, 6, 9-12, 14, 25, 26, 29, 32, and 33 were withdrawn
as directed to a non-elected invention (see App. Br. 5).
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Application 12/866,766
The issues
A. The Examiner rejected claims 17, 21, 22, 27, and 28 under 35 U.S.C.
§ 112, second paragraph as indefinite (Ans. 2).
B. The Examiner rejected claims 17, 21, 22, 27, and 28 under 35 U.S.C.
§ I03(a) as obvious over Takei3 and Kleinberg4 (Ans. 3--4).
A. 35 US.C. § 112, second paragraph
The Examiner finds:
The claims recite that the daily dissolution rate (DDR) of the
claimed composition is from about 0.1 % to about 0.5%.
Because the instant claims recite multiple components, it is
unclear which of the components the DDR refers to because the
claimed DDR could refer to the dissolution of the recited
fluoride, the dissolution of the recited basic amino acid (BAA)
or the dissolution of an unrecited component. Since the claim
is amenable to multiple plausible interpretations with no basis
for determining which interpretation is proper, the claim is
considered to be indefinite.
(Ans. 2).
Appellants contend: "It is clear that the term 'daily dissolution rate'
recited in claim 21 refers to the dental sealant composition of this claim.
Claim 21 covering a dental sealant composition states that the composition
has a daily dissolution rate of from about 0.1 to about 0.5%" (Reply Br. 2).
Appellants contend: "Since the composition in claim 21 contains a BAA and
a fluoride ion source, it is clear that the claimed DDR of the composition
refers to both a BAA and a fluoride ion source. Thus, Appellants submit
that the claims are definite" (Id.).
3 Takei et al., US 2009/0068123 Al, published Mar. 12, 2009.
4 Kleinberg et al., US 6,436,370 Bl, issued Aug. 20, 2002.
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Application 12/866,766
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that the phrase "daily dissolution rate of
from about 0.1 to about 0.5%" is indefinite?
Findings of Fact
1. The Specification teaches
The daily dissolution rate (DDR) of the composition under
conditions in the mouth may range from about 0.1 to about
100% per day. The required DDR of the sealant composition
will depend upon the duration of BAA release required. For
example, if the composition is required to release a BAA over a
long period, such as 1-2 years, the DDR is preferably about 0.1
to about 0.5%.
(Spec. ,r 14 ).
2. The Specification teaches "(1) attaching a BAA-releasing
sealant composition to a person's tooth; and (2) allowing a BAA to be
slowly released over time in order to reduce chronic and/or acute tooth
sensitivity. Preferably, the sealant acts also as a fluoride releasing
composition as well" (Spec. ,r 10).
Principles of Law
[The indefiniteness] requirement is not a demand for
unreasonable precision. The requirement, applied to the real
world of modem technology, does not contemplate in every
case a verbal precision of the kind found in mathematics. Nor
could it do so in a patent system that actually works, in practice,
to provide effective protection for modem-day inventions.
Rather, how much clarity is required necessarily invokes some
standard of reasonable precision in the use of language in the
context of the circumstances.
In re Packard, 751, F.3d 1307, 1313 (Fed. Cir. 2014).
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Application 12/866,766
Analysis
Claim 21 uses the definite article "the" in providing antecedent basis
for "the composition" in the claim phrase "the composition has a daily
dissolution rate of from about 0.1 to about 0.5%." See Claim 21. The article
"the" refers to "a dental sealant composition" that comprises both "a basic
amino acid" and "a fluoride ion source." Therefore, the reasonable intrinsic
interpretation requires "the composition" to be the "dental sealant
composition" that comprises both the amino acid and fluoride ion
components. See Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348,
1356 (Fed.Cir.2003) ("[I]t is a rule of law well established that the definite
article 'the' particularizes the subject which it precedes. It is a word of
limitation as opposed to the indefinite or generalizing force of 'a' or 'an."').
This understanding is consistent with the Specification, which clearly
suggests that both the basic amino acid and the fluoride ion source may be
released by daily dissolution (FF 1-2).
Consequently, we agree with Appellants that the "claimed DDR of the
composition refers to both a BAA and a fluoride ion source" (Reply Br. 2)
and we agree that claim 21 is definite.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the phrase "daily dissolution rate of from about 0.1 to about 0.5%" is
indefinite.
B. 35 US.C. § 103(a) over Takei and Kleinberg
The Examiner finds "Takei teaches a fluoride ion releasable
composition for dental purposes which may be in the form of a dental
sealant" (Ans. 3). The Examiner finds Takei teaches "a slower release of the
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Appeal2017-005623
Application 12/866,766
fluoride ions thereby exhibiting a dental caries preventing effect over a long
period of time .... The release of the fluoride is demonstrated to last over a
year" (Id.).
The Examiner acknowledges that "Takei does not teach the addition
of a basic amino acid" (Ans. 3).
The Examiner finds "Kleinberg teaches a dental anti-hypersensitivity
composition for calcifying dental tissue, filling cavities, and plugging
dentinal tubules ... The composition comprises arginine salt" (Ans. 3). The
Examiner finds that Kleinberg's composition "may also contain fluoride in
an effective amount ... The fluoride ion source is preferably calcium
fluoride and the fluoride ions are preferably released over long periods of
time" (Id.).
The Examiner finds it obvious to modify Takei's composition "to add
arginine and a calcium carbonate in order to suppress tooth hypersensitivity,
given that tooth pain associated with decay is a primary reason for
application of dental sealants and fillings" (Ans. 4).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that Takei and Kleinberg render the
claims obvious?
Findings of Fact
3. Takei teaches the "present invention relates to a fluoride ion
releasing dental composition that exhibits a dental caries preventing effect
through a dentine reinforcing function of fluoride ions" (Takei ,r 1 ).
4. Takei teaches that in the prior art, there is a "problem that they
cannot provide dentine with high caries resistibility over a long period of
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Application 12/866,766
time because fluoride ions are completely released in a short period of time
of several months in a humid environment of an oral cavity" (Takei ,r 11 ).
5. Takei teaches "an object of the invention is providing a fluoride
ion releasing dental composition capable of providing dentine with a high
cariostatic property over a long period of time by gradually releasing
fluoride ions" (Takei ,r 15).
6. Takei teaches:
Fluoride ions eluted into the phosphate buffer were determined
with a fluoride ion electrode 30 days, 60 days, 120 days, 240
days and 3 60 days after the immersion, so as to calculate an
average fluoride ion releasing amount (µg/g/day) per gram of
the cured substance and per day attained in each of periods of 1
through 30 days, 31 through 60 days, 61 through 120 days, 121
through 240 days and 241 through 3 60 days after the
. .
1mmers10n.
(Takei ,r 120).
7. Table 2 of Takei is reproduced in part below:
TABLE 2
,-\vel',1ge !'hwri,fo. inn r.;fo<;sing m:mm.nt 121.--240 days
Avernge .nuo.rid;:.~ inn H·k:wing :w1nunt: :!41 · HiU ,fay~
Emb.
4.J
4.4
4.4
25 (1
8. .. 3
Takei teaches, in tables 2 and 3, stable fluoride releasing amounts that range
from 4.2 to 25.0 µg/g/day over 360 days (see Takei 9, Table 2).
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8. Takei teaches the use of sodium fluoride and teaches the
"content of the fluoride ion releasing material (b) is preferably 0.01 through
70 wt%" (Takei ,r,r 55-56).
9. Kleinberg teaches a method for treating tooth "hypersensitivity
by delivering into the oral cavity an oral composition containing a
therapeutically effective amount of arginine bicarbonate and calcium
carbonate distributed in an oral vehicle. The amount of arginine bicarbonate
and calcium carbonate sufficient to reduce or prevent dentinal
hypersensitivity is an amount sufficient to promote dentinal plugging"
(Kleinberg 4:31-38).
10. Kleinberg teaches that the "oral composition further contains a
therapeutically effective amount of fluoride, for example, 10 to 1500 ppm.
Any conventional ingredients for the particular oral vehicle may further be
added to the oral compositions" (Kleinberg 5: 5 8---61 ).
11. Kleinberg teaches that the "oral composition of the present
invention may also be used in a prophylaxis paste for polishing teeth or
treating sensitive teeth or preventing the development of sensitive teeth after
scaling, root planing or stain removal by a dentist or hygienist" (Kleinberg
7:41--45).
Principles of Law
An invention "composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art .... it can be important to identify a reason that would
have prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398,418 (2007).
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Application 12/866,766
Analysis
Appellants contend
First, the teaching by Takei is about the release of fluoride ions
while the statement of the Specification is about the release of a
BAA vs. the release of the composition containing the BAA.
Second, "over the course of a year or more" does not suggest
anything regarding a daily dissolution rate. Thus, "the release
of fluoride ions over a period of a year or more" does not
necessarily amount to release of the compositions at a daily
dissolution rate of from about 0.1 to about 0.5% recited in
independent claim 21.
(App. Br. 7). Appellants also contend the "Examiner has not provided any
evidence or reasoning for why one of skill in the art would predict that
arginine and calcium carbonate are slowly released over time from the
Takei's composition containing polysiloxane" (Reply Br. 3).
The Examiner responds "the instant claims do not require any specific
dissolution rate for the recited components" (Ans. 5). The Examiner also
finds "there is a reasonable expectation of success with the arginine being
free or released from the composition because the ingredients in in such
compositions are released and free to interact with anything else present in
the oral cavity" (Ans. 7).
We find that Appellants have the better position. While we previously
found that the combination of fluoride and arginine would have been
obvious (see Ex Parte Prencipe, 2015 WL 393133 at *4), we agree with
Appellants that there is no evidence that the arginine in this obvious
combination would have been released at the rate recited in claim 21. The
Examiner provides no specific reason or evidence supporting a finding that
the specific claimed daily dissolution range of about 0.1 % to about 0.5%
recited in Claim 21 would have been obvious. Contrary to the position of
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Application 12/866,766
the Examiner, there is no evidence of any overlapping range of dissolution
on the record.
Indeed, Takei, the reference relied upon for dissolution, teaches
measuring "an average fluoride ion releasing amount (µg/g/day) per gram"
(FF 6). Takei also teaches a range of releasing amounts from 4.2 µg/g to 25
µg/g, that when calculated in percentage terms represent 0.00042% to
0.0025% daily release (FF 7) of the fluoride ion. Thus, Takei's highest
release rate is about 40 fold lower than the lowest release rate recited in
claim 21 of 0.1 %. The Examiner provides no evidence or reasoned basis to
suggest a higher release rate based on Takei.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Takei and Kleinberg render the claims obvious.
SUMMARY
In summary, we reverse the rejection of claims 17, 21, 22, 27, and 28
under 35 U.S.C. § 112, second paragraph as indefinite.
We reverse the rejection of claims 17, 21, 22, 27, and 28 under 35
U.S.C. § 103(a) as obvious over Takei and Kleinberg.
REVERSED
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