Ex Parte Kohli et al

Patent Trials and Appeals Board

Jan 11, 2019

12866639 - (D) (P.T.A.B. Jan. 11, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/866,639 11/15/2010
23909 7590 01/15/2019
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Rajnish Kohli
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.
8551-00-US-01-0C 3155
EXAMINER
WEBB, WALTERE
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
01/15/2019 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 RAJNISH KOHLI,
RICHARD SCOTT ROBINSON, RICHARD J. SULLIVAN,
DIANE COMMINS, and NAGARAJA JAY ARAMAN
Appeal 2017-011757
Application 12/866,639
Technology Center 1600
Before JEFFREY N. FRED MAN, ULRIKE W. JENKS, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a dual
component dental composition. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm.
1 Appellants identify the Real Party in Interest as the Colgate-Palmolive
Company (see App. Br. 2).
2 We have considered and herein refer to the Specification of Aug. 6, 2010
("Spec."); Final Office Action of Sept. 30, 2016 ("Final Act."); Appeal Brief
of Apr. 28, 2017 ("App. Br."); Examiner's Answer of July 21, 2017
("Ans."); and Reply Brief of Sept. 21, 2017 ("Reply Br.").
Appeal 2017-011757
Application 12/866,639
Statement of the Case
Background
"Exposure of the dentine, which is generally due to recession of the
gums, or loss of enamel, frequently leads to hypersensitivity" (Spec. ,r 4).
"Arginine and other basic amino acids have been proposed for use in oral
care and are believed to have significant benefits in combating cavity
formation and tooth sensitivity" (Spec. ,r 9). "Combining these basic amino
acids with minerals having oral care benefits e.g., fluoride and calcium, to
form an oral care product having acceptable long term stability, however,
has proven challenging" (Id.).
The Claims
Claims 1, 7, and 1 7 are on appeal. 3 Independent claim 1 is
representative and reads as follows:
1. A dual component dental composition comprising
a first component having an alkaline pH of 8.5 to 9.7
comprising a calcium source,
wherein the calcium source is dicalcium phosphate,
a second component having a substantially neutral pH
of 6.5 to 7 comprising an anion source, wherein the anion
source is a fluoride ion source which delivers a fluoride ion
concentration of about 25 to about 25,000 ppm, and wherein
the fluoride ion source is sodium fluoride;
wherein at least one of the components contains
arginine, or a salt thereof, the first and
second components being maintained separate from
each other until dispensed and combined.
3 Claims 2---6 and 16 were cancelled and claims 8-15, 18 and 19 were
withdrawn (see App. Br. 11-12).
2
Appeal 2017-011757
Application 12/866,639
The Issue
The Examiner rejected claims 1, 7, and 17 under 35 U.S.C. § 103(a)
as obvious over Chow, 4 Brown, 5 and McCormack6 (Final Act. 3-5).
The Examiner finds Chow teaches "compositions employing calcium
and fluoride in two-component delivery systems, where one component
comprises a source of calcium Ions and the other component comprises a
source of fluoride Ions" (Final Act. 3). The Examiner finds Chow teaches
the use of sodium fluoride at "a fluoride concentration of 228 ppm" (id.).
The Examiner finds Chow teaches "pH ranges for the components ranging
from pH 7 to pH 9 .4" and teaches "the preferred pH and concentration need
to be determined" (id.).
The Examiner finds Brown (a reference cited by Chow 2:59-62)
teaches dicalcium phosphate as a calcium source (see Final Act. 3--4). The
Examiner acknowledges that Chow and Brown do not teach arginine, but
finds McCormack teaches "arginine and potassium salts may be combined
with teeth cleaning and strengthening compositions comprising calcium and
fluoride" (see id. at. 4). The Examiner finds it obvious "to add arginine and
potassium of McCormack to the compositions of Chow et al. in order to
provide the added benefit of a fast effective analgesic in treating teeth and to
minimize dentine sensitivity, as suggested by McCormack" (id.).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that the prior art
renders claim 1 obvious?
4 Chow et al., US 5,891,448, issued Apr. 6, 1999.
5 Brown et al., US 4,556,561, issued Dec. 3, 1985.
6 McCormack, K., GB 2,354,441 A, published Mar. 28, 2001.
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Appeal 2017-011757
Application 12/866,639
Findings of Fact
1. Chow teaches "a two-phase fluoride delivery system in which
one phase contains a source of calcium ions and the other a source of
fluoride ions" (Chow 4:51-54) in order to "achieve enhanced fluoride
deposition in the oral environment" (Chow, abstract).
2. Chow teaches that "[u]seful fluoride sources include
compounds of the desired solubility which are non-toxic enough for oral use
at the intended level on a regular basis, and stable for the desired shelf life.
Examples of suitable fluorides include sodium fluoride" (Chow 7:2-7).
3. Chow teaches a fluoride concentration such as 228 ppm (see
Chow 8:12).
4. Chow exemplifies pH ranges for the components ranging from
pH 7 to pH 9.4 as shown in Table 4, reproduced below:
'I:'\BLE 4
l:SHIJlT!10:\ EFFECT OF PHOSPH/1.TE V·'IRff>; \VHh oH
pH J
G.1 m,11Dl/L ph,,,;phatc
24 mmol;'L N,iF
pH 7.S
G. ! mmoUL ptm~plrntr.
24 mmol/1.. N,;F
pH 8.3
0. 1 m mnlil.. ph c,~plm, ,·
24 mmoV.L N;;F
pH 9.4
C . .l mmlilil.. plrn~ptm,c
2Cl mr,wlfL C;,Cl_, 2.7 ,,; G.!i
pH 7
20 Jl\t:K~L"l.- (:~~(:l) ~i~~ ±: "L1
pH? 5
:::o mm,;!/[, Ci.tel? 11.7 :t ·i.s
pH:L,
20 t~ 1~1.c: ]/L c·«r~J .J c< .,, ') .-~
pH9A
"Table 4 shows that the inhibition effect of phosphate is also sensitive to pH.
The ideal pH seems to be above 6-7 and below 9" (Chow 12:41--43).
5. Chow teaches that "the preferred pH and concentration need to
be determined" (Chow 7:51-52).
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Appeal 2017-011757
Application 12/866,639
6. Chow teaches that an "inhibitor of calcium fluoride formation is
also present in one or both phases" (Chow 4:54--55).
7. Chow teaches that "[ e ]xamples of appropriate calcium salts
include calcium chloride, calcium acetate, calcium butylate, calcium lactate,
and all other non-toxic salts of calcium" (Chow 6:57---60).
8. Chow teaches that "U.S. Pat. No. 4,556,561 [Brown] discloses
solutions, gels, and substantially nonaqueous dispersions that form
dicalcium phosphate dihydrate under appropriate conditions, as well as
methods of their use. These compositions are useful in topically fluoridating
and/or mineralizing dental tissue" (Chow 2:59---63).
9. Brown teaches "topically fluoridating and/or mineralizing
dental tissue by treating the surface of the tissue with an aqueous solution or
gel containing DCPD [ dicalcium phosphate dehydrate] ... ( di calcium
phosphate anhydrous, DCP A)" (Brown 4:22-26).
10. McCormack teaches "a composition for treating dentine
hypersensitivity that contains a potassium salt and the amino acid L-
arginine" (McCormack 2:19-20).
11. McCormack teaches that the "composition may also include
other substances for strengthening, cleaning, brightening or protecting the
teeth, for example fluoride (sodium monofluorophosphate ), calcium
( calcium glycerophosphate )" (McCormack 3: 1-3 ).
12. McCormack teaches that the "composition comprises a
toothpaste or tooth gel that contains per 50g portion of the composition a
quantity of potassium chloride in the range 4--100 mg" (McCormack 3: 14--
15).
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Appeal 2017-011757
Application 12/866,639
Principles of Law
The combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417. As noted by the Court in KSR, "[a] person of
ordinary skill is also a person of ordinary creativity, not an automaton." 550
U.S. at 421.
Analysis
We adopt the Examiner's findings of fact and conclusions of law (see
Final Act. 3-5; FF 1-10) and agree that the combination of Chow, Brown,
and McCormack renders the claims obvious. We address Appellants'
arguments below.
Appellants contend:
the Examiner has improperly relied on the Board's conclusion
regarding broader limitations that are no longer in the claims,
and has not actually satisfied the initial burden of demonstrating
that the narrower recited pH ranges which are actually in the
claims are obvious or somehow the product of routine
optimization, the Applicants respectfully request withdrawal of
the final rejection.
(App. Br. 6). Appellants also contend that the "logic of [In re Baird, 16 F.3d
380, 382 (Fed. Cir. 1994)] applies to the selection of the instantly claimed
amount of pH ranges and those in Chow" (Reply Br. 2). Appellants contend
"there has never been a consideration of the size of the pH ranges or any
teachings that would have guided one of skill in the art one way or the other
in developing the claimed composition" (Reply Br. 2-3).
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Application 12/866,639
We agree with Appellants that our earlier decision did not address the
specific pH limitations now included in claim 1. 7 However, we agree with
the Examiner that "there is a clear overlap in the in the pH ranges claimed by
appellant and the pH range taught in the prior art. Accordingly it would
have been obvious to have arrived at those values simply by following the
general teachings of the reference" (Ans. 3). We do not find Appellants'
reliance on Baird persuasive in the context of a routinely optimizable
variable such as pH.
In particular, claim 1 requires two pH ranges, of 8.5 to 9.7 for the
calcium source and of 6.5 to 7 for the fluoride source. Table 4 of Chow
teaches compositions where the calcium source has a pH of 8.3 and 9.4 and
where the fluoride source has a pH of 7 (FF 4 ). Chow further explains that
the "ideal pH seems to be above 6-7 and below 9" (FF 4). Thus, Chow
suggests pH values within the claimed range for both the calcium source and
the fluoride source.
Chow also teaches that "the preferred pH and concentration need to be
determined" (FF 5), thereby establishing pH as a "result-effective variable."
In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (citing
In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). We therefore agree with
the Examiner that it would have been obvious to optimize the pH values
within the ranges disclosed by Table 4 based on the teachings of Chow to
optimize (FF 4--5). See In re Aller, 220 F.2d 454, 456 (CCPA 1955)
7 Challenging the finality of an Office Action, however, is a petitionable, not
appealable, matter. MPEP § 706.07(c) (9th ed., rev. 8, Jan. 2018) (stating
"any question as to prematureness of a final rejection ... may therefore not
be advanced as a ground for appeal, or made the basis of complaint before
the Patent Trial and Appeal Board.")
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Application 12/866,639
("[W]here the general conditions of a claim are disclosed in the prior art, it is
not inventive to discover the optimum or workable ranges by routine
experimentation.")
Appellants contend:
the framework for analysis as to the obviousness of chemical
formulations and their uses involves a "lead-modification"
analysis similar to that involving novel compounds. Unigene
Laboratories, Inc. et al. v. Apotex, Inc., et al., 655 F.3d 1352,
1361-1362 (Fed. Cir. 2011) ... First a lead or reference
formulation is identified from the art and then a flexible
teaching-suggestion-motivation (TSM) test is applied to
determine whether there is reason or motivation to modify the
lead formulation to make the claimed invention with a
reasonable expectation of success. Id.
(App. Br. 7; cf Reply Br. 3--4). Appellants contend "Chow would not have
been a logical lead reference for one of ordinary skill in the art. The
Examiner has not demonstrated that Chow discloses a dental composition
which contains any basic amino acids - much less suggest that any of its
compositions could specifically contain arginine" (id.).
We find this argument unpersuasive because the court in Unigene
merely stated that "[a] prima facie case of obviousness in the chemical arts is
often based on a ... 'lead compound"' and that in the context of a
composition or formulation patent the "lead compound" might more
appropriately be referred to as a "reference composition." Unigene, 655
F.3d at 1361---62. There is no requirement, however, that the obviousness
analysis for a composition or formulation claim must always be based on a
motivation to modify a particular reference composition. Indeed, Unigene
cannot run counter to the flexible analysis set out by the Supreme Court in
KSR that recognizes the obviousness of pursuing known options within the
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Application 12/866,639
technical grasp of the skilled artisan, e.g., known equivalents. KSR, 550
U.S. at 421.
Here, "it is fair to say that there were 'a finite number of identified,
predictable solutions' to the problem of finding toothpaste components for
optimal dental hygiene, including fluoride and calcium ions as well as
components to treat dentine hypersensitivity (FF 1-12). Combining these
known toothpaste components into a single composition is the "product not
of innovation but of ordinary skill and common sense" because the instant
claim "recites a combination of elements that were all known in the prior art,
and all that was required to obtain that combination was to substitute one
well-known ... agent for another." Wm. Wrigley Jr. Co. v. Cadbury Adams
USA LLC, 683 F.3d 1356, 1364---65 (Fed. Cir. 2012).
Moreover, even if a lead composition analysis was appropriate, Chow
teaches the use of two phase fluoride delivery with fluoride and calcium ions
at optimized pH values (FF 1-8), and therefore reasonably serves as a lead
composition. The Examiner provides strong reasons for incorporating the
arginine of McCormack into Chow's known composition for "the added
benefit of a fast effective analgesic in treating teeth and to minimize dentine
sensitivity" (Final Act. 4). Thus, the Examiner has provided a specific
reason for forming the combination of Chow, Brown, and McCormack.
Appellants contend the "problem addressed by selection of recited
ingredients, in the particularly recited ratios, and sequestered prior to use -
e.g., to improve desensitization - was not known, the solution was not
predictable, and it would not be routine to formulate such a composition"
(App. Br. 8).
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Application 12/866,639
We find this argument unpersuasive because "[ o ]bviousness does not
require absolute predictability of success ... all that is required is a
reasonable expectation of success." In re Kubin, 561 F.3d 1351, 1360 (Fed.
Cir. 2009). Here, Chow provides a number of working examples of dual
component dental compositions with fluoride sources within the claimed
range (FF 3), calcium sources (FF 7), along with overlapping pH examples
(FF 4). While Chow does not teach the use of arginine, McCormack teaches
inclusion of arginine into a toothpaste with fluoride and calcium (FF 10-11 ).
Appellants provide no evidence challenging the teachings of either Chow or
McCormack, nor any evidence of any unpredictability or secondary
consideration in making this combination. Consequently, we find that the
prior art provides a reasonable expectation of success (FF 1-12).
Appellants contend the "Examiner's rejection primarily relies on
picking and choosing various ingredients, e.g., including calcium
diphosphate and sodium fluoride ( at particular amounts, and neither of
which), from a laundry list of possible sources of calcium and fluoride"
(App. Br. 8-9).
We do not find the "laundry list" argument persuasive because, as
already discussed, Chow teaches a two phase toothpaste composition with
selection from a list of two FDA approved fluoride compositions including
sodium fluoride (see Chow 7:7-9), as well as directly pointing to Brown's
teaching of dicalcium phosphate dehydrate as useful in "topically
fluoridating and/or mineralizing dental tissue" (FF 8-9). Chow teaches
overlapping pH ranges (FF 4-5) and McCormack teaches only two
components to treat dentine hypersensitivity, potassium salt and arginine (FF
10). Thus, rather than selection from an extensive list, the selections
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Application 12/866,639
required in the instant case are from very small genera. Moreover, simply
because the prior art "discloses a multitude of effective combinations does
not render any particular formulation less obvious." Merck & Co. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). In Corkill, an
obviousness rejection was affirmed in light of prior art teachings that
"hydrated zeolites will work" in detergent formulations, even though "the
inventors selected the zeolites of the claims from among 'thousands' of
compounds." In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that the prior art renders claim 1 obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Chow, Brown, and McCormack. Claims 7 and 17
fall with claim 1.
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
11