Ex Parte Trivedi et al

Patent Trial and Appeal Board

Nov 17, 2016

11256861 (P.T.A.B. Nov. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111256,861 10/24/2005
23909 7590 11/21/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Harsh M. Trivedi
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.
7443-00-0C 9991
EXAMINER
DA VIS, DEBORAH A
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
11/21/2016 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 HARSH M. TRIVEDI, TAO XU,
CORTNEY L. WORRELL, and KIMBERLEE PANALIGAN
Appeal2015-004326
Application 11/256,861
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving a method of
treating an inflammatory condition of the oral cavity. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Statement of the Case
Background
"Dentifrices in the form of toothpaste, mouth rinses, chewing gums,
edible strips, and the like have been formulated with a wide variety of active
materials that provide a number of benefits to the user. Among these
1 Appellants identify the Real Party in Interest as Colgate-
Palmolive Company (see App. Br. 2).
Appeal2015-004326
Application 11/256,861
benefits are antibacterial, anti-inflammatory, and antioxidant properties."
(Spec. if 2).
The Claims
Claims 45---60 are on appeal. Claim 45 is representative and reads as
follows:
1. A method of treating an inflammatory condition of the oral
cavity comprising administering to a subject in need thereof, an
effective amount of a composition comprising:
a humectant;
an abrasive material;
0.01 % to 0.6% by weight, of a source ofursolic acid and
camosic acid wherein the source contains containing
10% to 40% by weight of the source ofursolic acid
and 10% to 25% by weight of the source of camosic
acid; and
0.1 % to 2% by weight, of a halogenated diphenylether
compound; and
wherein said composition further comprises an anticaries
agent and an anionic polycarboxylate polymer.
The Issue
The Examiner rejected claims 45---60 under 35 U.S.C. § 103(a) as
obvious over Deasy, 2 Okuda, 3 Vogel4 and Van Der Ouderaa5 (Final Act. 2-
7).
2 Deasy et al., Effect of a Dentifrice Containing Triclosan and a Copolymer
on Plaque Formation and Gingivitis, 13 CLIN. PREVENTIVE DENTISTRY 12-
19 ( 1991) ("Deasy").
3 Okuda et al., JP 2003-261454 A, published Sept. 16, 2003, English
Translation pages numbered 1-15 ("Okuda").
4 Vogel et al., US 5,225,441, issued July 6, 1993 ("Vogel").
5 Van Der Ouderaa et al., US 5,240,696, issued Aug. 31, 1993 ("Van Der
Ouderaa").
2
Appeal2015-004326
Application 11/256,861
The Examiner finds Deasy teaches "a method of treating gingivitis (an
inflammatory condition of the oral cavity) comprising administering to a
subject in need thereof an effective amount of a composition comprising
0.3% triclosan, an abrasive material (silica) and an anticaries agent which is
a fluoride releasing compound (sodium fluoride)" (Final Act. 2-3). The
Examiner acknowledges that Deasy does not teach a composition further
containing "0.01 % to 0.6% by weight of a source ofursolic acid and
camosic acid, containing 10-40-% [sic] by weight of the sources of ursolic
acid and 10-25% by weight of the sources of camosic acid, or a humectant
or an anionic polycarboxylate polymer" (Final Act. 3).
The Examiner finds that Okuda teaches "rosemary extract decreased
PGE2 (had a PGE2 depressor effect) at concentrations of 0.5% and 1.0%"
and is "a source of ursolic acid and camosic acid, the cited concentrations of
0.5% and 1.0% of rosemary extract overlap the claimed ranges" (id.). The
Examiner finds Vogel teaches "prostaglandins are powerful mediators of
inflammatory and immune response agents which inhibit PGE synthesis in
the gingival tissue have therapeutic value in treating both gingivitis and
periodontitis when administered either systemically or topically" (id.). The
Examiner finds that Van Der Ouderaa teaches periodontitis treatment
compositions may comprise "the usual dentifrice ingredients, such as silica,
humectants including glycerol, sorbitol and propylene glycol (see e.g. col 2,
lines 56-68), binders and thickeners such as copolymers of
polyvinylmethylether with maleic anhydride" (Final Act. 4 ).
The Examiner finds it obvious that because "both triclosan and
rosemary extract (a source of ursolic acid and camosic acid as instantly
3
Appeal2015-004326
Application 11/256,861
claimed) are known to inhibit prostaglandins," "it would have been obvious
to one of ordinary skill in the art to combine rosemary extract and triclosan
for use in a method of treating inflammatory conditions of the oral cavity,
including gingivitis and periodontitis" (Final Act. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that claim 45 is obvious over the
cited prior art?
Findings of Fact
1. The Specification teaches that a "non-limiting example of
halogenated diphenylether compound is triclosan" (Spec. i-f 28).
2. The Specification teaches: "Rosemary extract contains camosic
acid, rosmarinic acid, ursolic acid ... Typically, the extract contains about
10% to about 40% by weight ofursolic acid and about 10% to about 25% by
weight camosic acid" (Spec. i-fi-121-22).
3. Deasy teaches a "double-blind, parallel 6-month clinical study
was conducted to determine the effect on supragingival plaque formation
and gingivitis, after an oral prophylaxis, of a dentifrice containing 0.3%
Triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base,
as compared to a 0.243% sodium fluoride/silica placebo dentifrice" (Deasy
18, col. 2).
4. Deasy teaches "[a]fter 6 months, the Triclosan/copolymer
dentifrice provided statistically significant reductions of 32.32% in
supragingival plaque formation and 25.64% in gingivitis, as compared to the
placebo dentifrice. Both reductions were statistically significant at the 99%
level of confidence" (Deasy 18, col. 2).
4
Appeal2015-004326
Application 11/256,861
5. Okuda teaches "an anti-inflammatory agent, a PGE2 production
depressant" including rosemary extract (Okuda i-fi-f l, 5).
6. Okuda teaches the "anti-inflammatory agent of this invention
can be made into pharmaceutical forms, such as lotions, milky lotions, a
cream kind, ointment, and packs, as skin external preparations, for example"
(Okuda i19).
7. Okuda teaches:
The example 2 of preparation [Preparation of a rosemary
extract] The fragment of the leave and stem of a rosemary was
air-dried and carried out, and it was immersed in the ethanol
solution 50% overnight, it filtered through the filter paper, and
the extract was obtained. According to Embodiment 1, PGE2
production depressor effect was examined using the
embodiment 7 (PGE2 production depressor effect of rosemary
extract) rosemary 50% ethanol extract. A result is shown in
drawing 7. So that clearly from drawing 7 a rosemary 50%
ethanol extract, It decreased to about 6 ng(s)/ml medium with
the 0.5% of rosemar; extract concentration solution, and
decreased that the PGE2 production amount was about 7
ng(s)/ml medium when this rosemary extract was not included
to about 5 ng(s)/ml medium with the solution 1.0%. Therefore,
the rosemary 50% ethanol extract had PGE2 production
depressor effect.
(Okuda i-fi-127-29).
8. Vogel teaches "ifthe omega-3 PUPA inhibits PGE synthesis in
the gingival tissue, they can very well have therapeutic value in the
treatment of both gingivitis and periodontitis when administered either
systemically or applied topically" (Vogel 3: 11-15).
9. Van Der Ouderaa teaches "[t]riclosan has a considerable anti-
cyclo-oxygenase activity, thus significantly inhibiting the formation of
5
Appeal2015-004326
Application 11/256,861
prostaglandins. Inhibiting the biosynthesis of the prostaglandins locally
would thereby significantly inhibit or prevent alveolar bone resorption.
Triclosan has been shown to be retained by gingival tissue both in vitro and
in vivo following topical application" (Van Der Ouderaa 1:47-54).
10. Van Der Ouderaa teaches:
The medicament furthermore may comprise further,
conventional ingredients, such as pharmaceutically acceptable
carriers like starch, sucrose, polyols, surfactants, water or
water/alcohol systems etc. When formulated into a dentifrice,
such formulation may contain all the usual dentifrice
ingredients. Thus, they may comprise particulate abrasive
materials such as silicas, aluminas, calcium carbonates,
dicalciumphosphates, hydroxyapatites, trimetaphosphates,
insoluble hexametaphosphates and so on, usually in amounts
between 5 and 60% by weight.
(Van Der Ouderaa 2:56-66).
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 'l 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.
Wrigley found a "strong case of obviousness based on the prior art
references of record. [The 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 (Fed.
Cir. 2012).
6
Appeal2015-004326
Application 11/256,861
Analysis
We adopt the Examiner's findings regarding the scope and content of
the prior art (Final Act. 2-7; FF 1-10) and agree that the claimed device
would have been obvious over the teachings of Deasy, Okuda, Vogel, and
Van Der Ouderaa. We address Appellants' arguments below.
Appellants contend
the Examiner relies on Okuda's disclosure of rosemary extract
having a PGE2 depressor effect. (Final Office Action, p 3).
However, when making the "as a whole determination," there is
no reason why one of skill in the art (who, unlike the Examiner,
would not have the Appellants' claims before them) would have
modified Deasy's composition to include this missing limitation
based on Okuda.
(App. Br. 5---6).
We do not find this argument persuasive because it fails to address the
combined teachings of all of the prior art references. The Examiner's
reasoning is that because Deasy teaches treatment of gingivitis (FF 34) and
Vogel teaches that compounds which "inhibit[] PGE synthesis in the
gingival tissue ... can very well have therapeutic value in the treatment of
both gingivitis and periodontitis" (FF 8), the ordinary artisan would have
been motivated to incorporate PGE inhibiting compositions into Deasy's
dentrifice (see Final Act. 5). Okuda teaches that rosemary extract is a
composition that inhibits PGE and functions as an anti-inflammatory (FF 5,
7) and the Examiner reasonably explains that because the prior "art
recognizes the link between inhibiting prostaglandins and treating both
gingivitis and periodontitis, it would have been obvious to one of ordinary
skill in the art to combine rosemary extract and triclosan for use in a method
7
Appeal2015-004326
Application 11/256,861
of treating inflammatory conditions of the oral cavity, including gingivitis
and periodontitis" (Final Act. 5).
Appellants contend that:
Okuda is directed toward topical applications for treating
inflammations on the skin. On the other hand, Deasy is directed
toward toothpastes for treating plaque and gingivitis inside the
mouth. Thus, these two references are directed to entirely
different fields, and one skilled in the art would not look to
Okuda to modify Deasy's composition.
(App. Br. 6).
We find this argument unpersuasive because dentrifices are topical
applications of medications to the oral cavity and because Okuda is pertinent
to the problems with which Deasy was concerned. The test for non-
analogous art is first whether the art is within the field of the inventor's
endeavor and, if not, whether it is "reasonably pertinent to the particular
problem \vith \vhich the inventor v,ras involved." Jn re TÂ¥ood, 599 F.2d
1032, 1036 (CCP A 1979). "A reference is reasonably pertinent if, even
though it may be in a different field" of endeavor, it logically would have
commended itself to an inventor's attention in considering his problem
"because of the matter with which it deals." In re Clay, 966 F.2d 656, 659
(Fed. Cir. 1992).
Here, Okuda's teaching appears to satisfy both prongs of the
analogous art test, as it relates to topical application of anti-inflammatory
compounds (FF 6) and Deasy teaches topically applied dentrifices for
treatment of the inflammatory condition, gingivitis (FF 3). Moreover, even
if Okuda were in a different field of endeavor, Vogel establishes that PGE
inhibitor compounds treat gingivitis (FF 8), the concern of Deasy (FF 3), and
8
Appeal2015-004326
Application 11/256,861
Okuda teaches that rosemary extract is a PGE inhibitor (FF 7). Thus, the
ordinary artisan would have found Okuda's teaching of topical application
of rosemary extract to reduce PGE induced inflammation pertinent to
Deasy' s dentrifice to reduce inflammation in the PGE induced condition of
gingivitis.
We recognize, but find unpersuasive, Appellants' contention that 'just
because a single ingredient such as an antiseptic (i.e., triclosan) can be used
in toothpaste and in hand cream/lotion does not mean that the hand
cream/lotion can be used as a toothpaste and vice versa" (App. Br. 6). The
Examiner's reasoning is not based on incorporation of an entire hand cream
composition into the dentrifice of Deasy, but rather upon incorporation of
the active, anti-inflammatory rosemary extract taught by Okuda as a PGE
inhibitor that can be applied topically (see Ans. 9).
Appellants contend that "[ n ]othing would have lead one skilled in the
art to specifically pick rosemary extract from among Okuda's laundry list of
anti-inflammatory agent choices, especially where Okuda specifically
teaches only three of those choices are outstanding or excellent" (App. Br.
7).
We are not persuaded. The Examiner's rejection is consistent with
Wrigley, where the Federal Circuit found a "strong case of obviousness
based on the prior art references of record. [The 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." Wrigley, 683 F.3d at 1364. Okuda establishes that each
of the extracts, including rosemary extract, were known prior art
9
Appeal2015-004326
Application 11/256,861
compositions that inhibit PGE and act as anti-inflammatories (FF 5, 7). The
flexible analysis set out by the Supreme Court in KSR 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 PGE inhibiting compounds for use in
treatment of gingivitis and that selection of one of the known alternative
compositions, rosemary extract, taught by Okuda (FF 7), was the "product
not of innovation but of ordinary skill and common sense." See Wrigley,
683 F.3d at 1364---65 (citing KSR, 550 U.S. at 421).
Appellants "submit that the Examiner's proposed modification was
impermissibly made using hindsight gleaned from Appellants' specification
and claims. MPEP 2142. Therefore, withdrawal of this rejection is
respectfully requested" (App. Br. 8).
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, incorporation of
Okuda's rosemary extract, a known PGE inhibitor and anti-inflammatory,
into Deasy' s dentrifice for treatment of the inflammatory condition
gingivitis, would have been reasonably expected to result in a therapeutic
treatment of gingivitis because Vogel teaches that PGE synthesis inhibitors
10
Appeal2015-004326
Application 11/256,861
"have therapeutic value in the treatment of both gingivitis and periodontitis
when administered ... topically" (FF 8).
Appellants contend that "one skilled in the art would use a rosemary
concentration greater than the 0.6% upper limit claimed in Appellants' claim
45 since Okuda teaches that 0.5% rosemary extract concentration only
decreased PGE2 production by 1 ng/ml, while a 1.0% rosemary extract
concentration decreased PGE2 production by 2 ng/ml" (App. Br. 8).
We do not find this argument persuasive because Okuda teaches that
both 0.5 % and 1 % functioned to reduce PGE2 production (FF 7), a range
that overlaps the requirement of claim 45. See In re Peterson, 315 F.3d
1325, 1329 (Fed. Cir. 2003) ("In cases involving overlapping ranges, we and
our predecessor court have consistently held that even a slight overlap in
range establishes a prima facie case of obviousness.") Appellants have
provided no persuasive evidence demonstrating any secondary consideration
that overcomes this prima facie case of obviousness.
Appellants contend that "Vogel teaches away from Appellants'
claimed invention because Vogel's primary teaching is his surprising
discovery that omega-3 PUPA can inhibit PGE synthesis (and thus teaching
away from using rosemary extract)" (App. Br. 8).
We find the teaching away argument unpersuasive. A teaching away
requires a reference to actually criticize, discredit, or otherwise discourage
the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)
("The prior art's mere disclosure of more than one alternative does not
constitute a teaching away from any of these alternatives because such
disclosure does not criticize, discredit, or otherwise discourage the solution
11
Appeal2015-004326
Application 11/256,861
claimed.") Appellants do not identify, and we do not find, any teaching in
Okuda or the other cited prior art that teaches that incorporation of rosemary
extract into a dentrifice would have been undesirable in any way. Disclosed
examples and preferred embodiments do not constitute a teaching away from
a broader disclosure or non-preferred embodiments. In re Susi, 440 F .2d
442, 446 n.3(CCPA 1971).
Appellants contend that "since Deasy's composition already contains
triclosan (which Ouderaa teaches inhibits prostaglandin formation),
Ouderaa's discovery would lead one skilled in the art not to modify Deasy's
composition at all" (App. Br. 9).
We do not find this argument persuasive because the person of
ordinary skill would have reasonably combined two known PGE inhibitors,
triclosan and rosemary extract, for treatment of gingivitis because the
combination of these two compositions is merely a "predictable use of prior
art elements according to their established functions." KSR, 550 U.S. at 417;
see also In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) ("It is prima facie
obvious to combine two compositions each of which is taught by the prior
art to be useful for the same purpose, in order to form a third composition
which is to be used for the very same purpose.").
Conclusion of Law
The evidence of record supports the Examiner's conclusion that claim
45 is obvious over the cited prior art.
12
Appeal2015-004326
Application 11/256,861
SUMMARY
In summary, we affirm the rejection of claim 45 under 35 U.S.C.
§ 103(a) as obvious over Deasy, Okuda, Vogel and Van Der Ouderaa.
Claims 46-60 fall with claim 45.
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
13