Ex Parte Prencipe et al

Patent Trial and Appeal Board

Apr 5, 2016

12058209 (P.T.A.B. Apr. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/058,209 03/28/2008
23909 7590 04/07/2016
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.
8272-00-0C 2695
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
04/07/2016 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 MICHAEL PRENCIPE, RA VI SUBRAMANY AM,
SARITA V. MELLO, DONGHUI WU, SUMAN CHOPRA,
ANDRE M. MORGAN, DIANE CUMMINS, RICHARD J. SULLIVAN,
RALPH PETER SANTARPIA III, LYNETTE ZAIDEL, QIN WANG,
GARY EDWARD TAMBS, VIRGINIA MONSUL BARNES,
RAJNISH KOHLI, RICHARD SCOTT ROBINSON,
SERGIO LEITE, and ERIC A. SIMON
Appeal2013-010567
Application 12/058,209
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to an oral
care composition. The Examiner rejected the claims as obvious and for
nonstatutory obviousness-type double patenting. 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 Br. 2).
Appeal2013-010567
Application 12/058,209
Statement of the Case
Background
"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. i-f 3). "[T]here is a need for a stable
oral care product that provides a basic amino acid and also provides
beneficial minerals such as fluoride and calcium, and also a product
providing improved delivery of antimicrobial agents" (Spec. i-f 5).
The Claims
Claims 1--4, 7-15, 18-23, and 25--40 are on appeal.2 Independent
claims 1 and 18 are representative and read as follows:
1. An oral care composition comprising
a. an effective amount of a basic amino acid, in free or
salt form; and
b. an effective amount of an antibacterial agent,
\'I/herein the bacterial agent is triclosan.
18. An oral care composition comprising a basic amino
acid, in free or salt form, and an antibacterial agent for use
in the antibacterial treatment of an oral cavity of a subject,
wherein the antibacterial agent is triclosan.
The Issues3
A. The Examiner rejected claims 18-23 and 25-30 under 35 U.S.C.
§ 103(a) as obvious over Kleinberg4 and Doyle5 (Ans. 5-8).
2 Claims 16, 17, and 48 are withdrawn, and claims 5, 6, 24, and
41--47 were cancelled (see Br. 4).
3 The provisional double patenting rejection over US 12/275,361 is
moot because that application was abandoned.
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Application 12/058,209
B. The Examiner rejected claims 18 and 31-34 under 35 U.S.C. § 103(a)
as obvious over Kleinberg and Fujisawa6 (Ans. 8-10).
C. The Examiner rejected claims 1--4, 7-13, 15, and 35--40 under
35 U.S.C. § 103(a) as obvious over Doyle, Kleinberg, Gaffar,7 and Grove8
(Ans. 11-13).
D. The Examiner rejected claim 14 under 35 U.S.C. § 103(a) as obvious
over Doyle, Kleinberg, Gaffar, Grove, and Fujisawa (Ans. 13-14).
E. The Examiner provisionally rejected claims 1--4, 7-15, 18-23, and
25--40 on the ground of nonstatutory obviousness-type double patenting as
being unpatentable over
• Claims 1-22 and 25-28 of copending Application No.
12/866,655;
• Claims 15, 17, 21, and 22 of copending Application No.
12/866,766;
• Claims 1-16 and 19-35 of copending Application No.
12/058,278;
• Claims 1-18, 21--45, and 54--56 of copending Application No.
12/058,424;
• Claims 1-10 of copending Application No. 12/272,257;
• Claims 1-3 and 14 of copending Application No. 12/058,387;
and
• Claims 1-24 of copending Application No. 12/356,837.
(Ans. 14--17).
4 Kleinberg et al., US 6,217,851 Bl, issued Apr. 17, 2001.
5 Doyle et al., US 2007/0053849 Al, published Mar. 8, 2007.
6 Fujisawa, US 2004/0146465 Al, published July 29, 2004.
7 Gaffar et al., US 5,192,530, issued Mar. 9, 1993.
8 Grove et al., Improving the aqueous solubility of triclosan by
solubilization, complexation, and in situ salt formation, 54 J.
Cosmet. Sci. 537-550 (2003).
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Application 12/058,209
Appellants contend that the "rejections of claims 1, 4, 7-13, 15, and
35--40 and 14 are improper in a Final Office Action since the new grounds
of rejection were not necessitated by the amendments" (Br. 9). Challenging
the finality of an Office Action, however, is a petitionable, not appealable,
matter. Manual of Patent Examining Procedure§ 706.07(c) (8th ed., rev. 9,
Aug. 2012) (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 Board"); see also Ex parte Frye, 94 USPQ2d 1072,
1077-78 (BPAI 2010) (precedential). We therefore do not reach this
argument
A-D. 35 U.S.C. § 103(a)
Because the same issues are argued by Appellants regarding all of the
prior art obviousness rejections, and are therefore dispositive for all of these
rejections, we will consider the prior art obviousness rejections together.
The issues with respect to these rejections are:
(i) Does the evidence of record support the Examiner's conclusion
that the prior art renders the claims obvious?
(ii) 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?
Findings of Fact
1. Kleinberg teaches "oral compositions containing therapeutic
amounts of calcium, arginine and cariostatic anion distributed in an oral
vehicle" (Kleinberg, col. 3, 11. 65---67).
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Application 12/058,209
2. Kleinberg teaches that "[a]cceptable oral vehicles include, for
example, any conventional oral delivery system, such as dental care
products, food products and chewing gum. Examples of dental care products
include, for example, dentifrices, solutions or pastes" (Kleinberg, col. 4, 11.
15-20).
3. Doyle teaches "oral care compositions comprising the
combination of particular antibacterial agents with agents having anti-
inflammatory activity" (Doyle i-f 16).
4. Doyle teaches that "[ s ]uitable antibacterial agents include cetyl
pyridinium chloride (CPC), stannous ion agent, zinc ion agent, copper ion
agent, iron ion agent, triclosan, ascorbyl stearate; oleoyl sarcosine, dioctyl
sulfosuccinate, alkyl sulfate and mixtures thereof' (Doyle i-f 69; emphasis
added).
5. Doyle teaches an exemplary dentrifice composition comprising
0.280 % weight percent triclosan along with other components (Doyle
,-r 143).
6. Fujisawa teaches that the "oral composition of the present
invention may be formulated into forms such as a tooth powder, toothpaste,
gel, prophylaxis paste, pasta, chewing gum, tablet, etc., according to the
known procedures. A dentifrice is particularly preferable" (Fujisawa i-f 44).
7. Fujisawa teaches that "[ e ]xamples of active ingredients include
cationic bactericides such as ... triclosan" (Fujisawa i-f 62).
8. Fujisawa teaches an exemplary toothpaste that contains
triclosan and abrasive silica components (Fujisawa i-f 88).
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9. Grove teaches that "the antimicrobial activity of the five
solubilizers that improved the solubility of triclosan in water the most, N-
methylglucamine, L-arginine, ethanolamine, SLS, and ~CD, were tested ...
the bacteriostatic efficacy of triclosan increased when combined with the
solubilizers" (Grove 547-548; emphasis added).
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).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 5-8; FF 1-5) and agree that the
claims are rendered obvious by Kleinberg and Doyle. We address
Appellants' arguments below.
Appellants contend that:
Triclosan is but one of many alternative antibacterial agents
disclosed in Doyle (see Tables 1 and 2) and Doyle teaches
that it is relatively ineffective. Clearly, there is no
motivation to select triclosan over other, allegedly more
potent agents. Doyle, of course, did not test triclosan in
combination with a basic amino acid or in other
formulations as claimed herein
(Br. 10).
We are not persuaded. Doyle teaches a specific list of ten different
"[s]uitable antibacterial agents" including triclosan (FF 4). As in Wrigley,
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
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Application 12/058,209
substitute one well-known ... agent for another." Wm. Wrigley Jr. Co. v.
Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). Here,
Doyle directly suggests incorporation of antibacterial agents into oral care
compositions (FF 3), identifies triclosan as a suitable agent (FF 4), and
provides an example using triclosan (FF 5).
Appellants contend that:
The Examiner's suggestion that one skilled in the art could
combine such reactive components without regard for their
possible interactions, either with one another or with the
other formulation excipients, is not plausible and is not
supported by scientific reasoning. The art provides no
reasonable expectation of success. As the courts have long
acknowledged, the combination of chemicals in a
formulation can be especially unpredictable, as they can
react with one another and affect the properties of one
another in unpredictable ways.
(Br. 10).
We do not find this argument persuasive. The Examiner reasonably
relies upon Grove to evidence that the combination of triclosan and arginine
has a reasonable expectation of success given the improved efficacy of
triclosan in the combined mixture (FF 9; cf Ans. 21 ). Appellants provide no
evidence that the combination would be unpredictable in any way or that
there would not be a reasonable expectation of success. See In re 0 'Farrell,
853 F.2d 894, 904 (Fed. Cir. 1988) ("For obviousness under§ 103, all that is
required is a reasonable expectation of success.") Moreover, "[a]ttomey's
argument in a brief cannot take the place of evidence." In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974).
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Appellants contend that "the combination of references is therefore
based on hindsight" (Br. 11 ).
We are not persuaded. While we are fully aware that hindsight bias
may plague determinations of obviousness, Graham v. John Deere Co., 383
U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly
stated that the "combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR, 550 U.S. at 416. In the instant case, the combination of
Kleinberg's dentrifice containing arginine (FF 1-2) with Doyle's dentrifice
containing triclosan (FF 3---6) would yield the predictable result of improving
Kleinberg' s dentrifice with an antibacterial agent as well as increasing the
solubility of the triclosan as taught by Grove (FF 9).
Appellants contend that the "failure of the Examiner to select a lead
formulation from Doyle and the failure to provide any specific rationale for
modifying the lead, as required under Unigene Laboratories Inc. et al. v.
Apotex, Inc., et al. 655 F.3d 1352, 1361---62 (Fed. Cir. 2011) is reversible
error" (Br. 11 ).
We are not persuaded 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
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Application 12/058,209
counter to the flexible analysis set out by the Supreme Court in KSR that
recognizes the obviousness of pursuing known options within the technical
grasp of the skilled artisan, e.g., known equivalents. See 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,
particularly agents that solubilized the triclosan desired by Doyle and that
the selection of triclosan in a toothpaste as suggested by Doyle was "product
not of innovation but of ordinary skill and common sense." See Wrigley,
683 F.3d at 1364---65.
Appellants contend that "there is extensive data presented regarding
the formulations of the invention, particularly in Examples 1--4 and 7 ...
these results are very surprising in view of the teachings of the references,
which do not suggest such combinations" (Br. 13).
We find the unexpected results argument unpersuasive. Example 1 of
the Specification teaches that "[i]ncorporation of L-arginine in the
commercial formulation enhances the amount of soluble triclosan available
from the formulation .... This enhanced delivery leads directly to an
enhancement of the antibacterial effect of the formulation" (Spec. i-fi-1 96, 98),
but in light of Grove's teaching that arginine enhances triclosan' s solubility
and bacteriostatic efficacy (FF 9), this is an expected result. See In re
Skoner, 517 F .2d 94 7, 950 (CCP A 197 5) ("Expected beneficial results are
evidence of obviousness of a claimed invention. Just as unexpected
beneficial results are evidence ofunobviousness.") Appellants do not
address why the results would remain unexpected in light of the Grove
reference.
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Conclusion of Law
(i) The evidence of record supports the Examiner's conclusion that the
prior art renders the claims obvious.
(ii) 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.
B. Double Patenting
We summarily affirm the provisional obviousness-type double
patenting rejections. See Manual of Patent Examining Procedure§ 1205.02
("If a ground of rejection stated by the examiner is not addressed in the
appellant's brief, that ground of rejection will be summarily sustained by the
Board."). Appellants do not identify any error in the rejections.
SUMMARY
In summary, we affirm all of the rejections.
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
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