Ex Parte Gu

Patent Trial and Appeal Board

Aug 11, 2016

13262353 (P.T.A.B. Aug. 11, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/262,353 09/30/2011
23909 7590 08/15/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Ben Gu
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.
8442-00-0C 4872
EXAMINER
PHAN, DOANTHI-THUC
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
08/15/2016 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
uspto@thebellesgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BEN GU 1
Appeal2015-001246
Application 13/262,353
Technology Center 1600
Before JEFFREY N. FREDMAN, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) involving claims to a
desensitizing, anti-tartar oral care composition, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
"Dental hypersensitivity represents a lowering [of] tooth pain
threshold due to pulpal inflammation .... An over-the-counter (OTC)
desensitizing dentifrice is the most popular choice for the treatment of
1 Appellant identifies the Real Party in Interest as Colgate-Palmolive
Company. (Br. 2.)
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sensitive teeth." (Spec. ilil I-2.) "Dental calculus, also called tartar or
calcified plaque, is a primary factor to cause periodontal disease ... and can
... be prevented by using a dentifrice containing an anti-tartar agent .... "
(Id. at i-f 4.) According to the Specification, "a need exists to provide
desensitizing oral care compositions ... exhibiting good desensitizing and
tartar control benefits which can be produced cost effectively." (Id. at i-f 9.)
Claims 1, 3-5, 9, and 19 are on appeal. Claim 1 is illustrative and
reproduced below:
1. A desensitizing, anti-tartar oral care composition
compnsmg:
(i) an orally acceptable vehicle;
(ii) an effective desensitizing and anti-tartar amount of
tetrapotassium pyrophosphate;
(iii) an anti-calculus amount of sodium
tripolyphosphate; and
(iv) about 30% to 65% of a humectant selected from
the group consisting of glycerine, sorbitol, xylitol
and propylene glycol;
wherein, the tetrapotassium pyrophosphate comprises the
sole potassium salt in the composition, the tetrapotassium
pyrophosphate is present in an amount of from about 1 to
about 8 wt % based on the weight of the composition and
the sodium tripolyphosphate is present in an amount of
from about 1 to about 10 wt % based on the weight of the
composition.
The Examiner rejects claims 1 and 3-5 under 35 U.S.C. § 103(a) as
being unpatentable over Gaffar2 and Andersen, 3 as evidenced by Norfleet. 4
(Ans. 3.)
2 Gaffar et al., US 4,931,273, issued June 5, 1990 ("Gaffar").
3 Andersen, US 2008/0152602 Al, published June 26, 2008.
4 Norfleet et al., US 5,240,697, issued Aug. 31, 1993 ("Norfleet").
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The Examiner rejects claims 9 and 19 under 35 U.S.C. § 103(a) as
being unpatentable over Gaffar, Andersen, and Xu. 5 (Ans. 5---6.)
I.
Issue
The Examiner has rejected claims 1 and 3-5 under 35 U.S.C. § 103(a)
as being unpatentable over Gaffar and Andersen, as evidenced by Norfleet.
The Examiner finds that Gaffar discloses an oral dentifrice composition
comprising tetrapotassium pyrophosphate (TKPP) as an anti-tartar agent, a
humectant selected from glycerine, propylene glycol, sorbitol,
polypropylene glycol and/or polyethylene glycol, and an orally acceptable
vehicle. (Ans. 3--4.) The Examiner finds Gaffar discloses that the oral
dentifrice composition comprises at least 4.3% by weight of TKPP and 0%
to about 80% by weight of the humectant, and further finds that Gaffar
discloses exemplary compositions having 4.5% by weight of TKPP. (Id. at
4.) The Examiner also finds that Gaffar discloses examples of compos1t10ns
where TKPP is the sole potassium salt in the composition. (Id. at 10.)
The Examiner finds that Gaffar does not specifically teach TKPP as
desensitizing. However, the Examiner finds that such a property would be
inherent, as evidenced by Norfleet's disclosure that TKPP is a superior anti-
tartar agent that helps to desensitize teeth. (Id. at 4.) Likewise, the
Examiner finds that Gaffar does not teach a composition comprising sodium
tripolyphosphate (NaTPP). (Id.) However, the Examiner finds that
Andersen discloses an anti-calculus composition comprising TKPP, NaTPP
5 Xu et al., US 2006/0127329 Al, published June 15, 2006 ("Xu").
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Application 13/262,353
in an amount from 0.1 % to about 90% by weight, and an orally acceptable
carrier. (Id.)
The Examiner concludes that it would have been obvious to a skilled
artisan to combine the teachings of Gaffar and Andersen with a reasonable
expectation of success: Andersen shows that "an oral care composition can
contain a combination of [TKPP] and [NaTPP] to effectively reduce or
remove dental calculus or tartar," while "Gaffar shows that an oral care
composition can be [] admixed with [TKPP] and another anti-calculus
agent." (Id. at 5.)
Appellant cites Unigene for the proposition that in analyzing the
obviousness of chemical formulations a lead formulation should first be
identified from the prior art before determining whether the suggested
modifications would be obvious. (Br. 3.) Appellant contends that the
Examiner has not identified a lead formulation from Gaffar or explained
why Gaffar would be "a logical starting point for one seeking to make a
desensitizing, anti-tart[a]r oral care composition." (Id. at 4.)
Appellant further contends that the claimed compositions provide both
desensitizing and anti-tartar effects where TKPP provides desensitization
and acts in synergy with NaTPP to provide enhanced anti-tartar effect.
Appellant contends that there is no motivation to modify or optimize the
prior art compositions to arrive at the claimed invention, since nothing in the
cited art suggests these combined results. (Id. at 3.)
Appellant does not argue claims 1 and 3-5 separately. Thus, we focus
our analysis on claim 1. The issue with respect to this rejection is whether
the evidence of record supports the Examiner's conclusion that claim 1 is
prima facie obvious.
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Findings of Fact
1. Gaffar teaches "[a Jn oral dentifrice composition ... containing
as anticalculus agent about 4.3% to about 7% of alkali metal pyrophosphates
comprising at least 4.3% of [TKPP] alone or admixed with up to 2.7% of
tetrasodium pyrophosphate" and further containing an orally acceptable
vehicle. (Gaffar Abstract, 2:62-3:4.)
2. Gaffar discloses two dental gel formulations containing 4.5
parts by weight of TKPP as the only potassium salt. (Id. at 10:30-50.)
3. Gaffar discloses that,
[i]n a toothpaste, the liquid vehicle may comprise water and
humectant typically in an amount ranging from about 10% to about
90% by weight of the preparation. Glycerine, propylene glycol,
sorbitol, polypropylene glycol and/or polyethylene glycol (e.g. 400-
600) exempify suitable humectants/carriers. Also advantageous are
liquid mixtures of water, glycerine and sorbitol. In clear gels where
the refractive index is an important consideration, about 3-30 wt.% of
water, 0 to about 80 wt. % of glycerine, and about 20-80 wt. % of
sorbitol is preferably employed.
(Id. at 6:52---62.)
4. Norfleet teaches that "potassium pyrophosphates are considered
to be superior as anti-tartar agents that help to desensitize the teeth" and that
"[a] most preferred pyrophosphate is tetrapotassium pyrophosphate."
(Norfleet 3:7-10.)
5. Andersen teaches an anti-calculus composition comprising two
or more anti-calculus agents. (Andersen i-f 25.)
6. Andersen teaches that suitable anti-calculus agents include
tripolyphosphates and TKPPs and that, "[i]n general, the anti-calculus agents
each are employed in the ... composition in the amount from about 0.1 to
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about 90%, from about 1 to about 80%, or from about 2 to about 50% by
weight." (Id.)
7. Andersen claims a method of "treating subgingival calculus in a
subgingival pocket with an anti-calculus composition comprising ... a
solution or suspension comprising pyrophosphate and a polyphosphate in a
pharmaceutically acceptable carrier." (Id. at claim 1.)
8. Andersen further claims the method described in FF7 where the
pyrophosphate in the composition is a pharmaceutically acceptable salt
selected from a group including TKPP. (Id. at claim 3.)
9. Andersen further claims the method described in FF7 where the
polyphosphate is a pharmaceutically acceptable salt selected from a group
including sodium tripolyphosphates. (Id. at claim 6.)
10. Andersen provides an exemplary composition comprising both
TKPP and STPP. (Id. at i-f 30.)
Analysis
Gaffar teaches an anti-tartar oral composition comprising an orally
acceptable vehicle, at least about 4.3% TKPP alone or admixed with up to
2.7% of tetrasodium pyrophosphate (TNaPP), and 10% to 90% by weight of
water and humectants chosen from among, e.g., glycerine, propylene glycol,
and sorbital. (FF 1-FF3.) Gaffar further provides exemplary formulations
where TKPP is the only potassium salt. (FF2.) Andersen teaches an anti-
calculus composition comprising two or more anti-calculus agents, where
suitable anti-calculus agents include TKPP and NaTPP and where such
agents are employed in the composition in an amount from about 0.1 % to
90%. (FF5-FF9.)
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We agree with the Examiner that a skilled artisan would find it
obvious to combine Gaffar and Andersen with reasonable expectation of
success. Both Gaffar and Andersen disclose anti-calculus oral compositions
containing two or more anti-calculus agents (FF 1, FF5); Gaffar discloses an
amount of TKPP in the composition within the claimed range (FFl, FF2),
and Andersen disclose both TKPP and NaTPP as suitable anti-calculus
agents and further discloses using such agents in an amount encompassing
the claimed ranges (FF6-FF9). We further find that the Examiner has
established a reasonable basis for finding that the oral composition
suggested by the combination of Gaffar and Andersen would be inherently
desensitizing, given that Gaffar discloses using an amount of TKPP within
the claimed range and further in light of the disclosure in Norfleet of TKPP's
desensitizing effect. (FFl, FF2, FF4.) Accordingly, we find the evidence of
record supports the Examiner's conclusion that claim 1 is obvious over
Gaffar and Andersen, as evidenced by Norfleet.
Appellant contends that the Examiner has not satisfied the criteria set
forth in Unigene because Unigene requires the Examiner to identify a lead or
reference formulation for modification. (Br. 3--4.) We disagree because
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
Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1361-1362 (Fed. Cir. 2011).
Unigene cannot run counter to the flexible analysis set out by the Supreme
Court in KSR, which recognized that "[ t ]he combination of familiar elements
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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). Likewise, we note but find unpersuasive Appellant's argument
that prior art does not provide a motivation to modify and optimize prior art
formulations because the prior art does not suggest the claimed desensitizing
effects. (Br. 3.) "In determining whether the subject matter of a patent
claim is obvious, neither the particular motivation nor the avowed purpose
of the patentee controls. . . . [A ]ny need or problem known in the field of
endeavor at the time of invention and addressed by the patent can provide a
reason for combining the elements in the manner claimed." KSR, 550 U.S.
at 419-20. In this case, Gaffar and Andersen provide a reason to combine
TKPP and NaTPP for their anti-calculus effects, and the evidence supports
the Examiner's finding that the combination would inherently be
desensitizing.
Appellants argue that even if the desensitizing property of TKPP is
inherent, Gaffar does not recognize such property. (Br. 4--5.) Thus,
Appellants argue that Gaffar would neither be an obvious starting point nor
provide "motivation to optimize the effective ranges of TKPP for a purpose
that Gaffar does not recognize." We are not convinced. As already
discussed, Unigene does not require the selection of a "lead" formulation.
Furthermore, since Gaffar discloses an amount of TKPP that is within the
claimed range, the Examiner has established a reasonable basis for finding
the desensitizing property to be inherent without the need for further
optimization of the TKPP amount in the composition.
Appellant also argues that Norfleet does not teach that TKPP can be a
stand-alone desensitizing agent or the sole potassium salt in a desensitizing
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composition. (Br. 5.) This is not persuasive because, as the Examiner points
out, the composition suggested by the combination of Gaffar and Andersen
is inherently desensitizing, and Norfleet was cited only as evidence of the
inherent desensitizing property of TKPP. (Ans. 9.) As the Examiner also
points out and as discussed above, Gaffar discloses a composition where
TKPP is the sole potassium salt in the composition (id. at 1 O; FF2), and the
desensitizing effect "cannot become nonobvious simply by ... claiming the
[result] .... To hold otherwise would allow any formulation-no matter
how obvious-to become patentable merely by testing and claiming an
inherent property." Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354
(Fed. Cir. 2012).
Appellant further argues that Andersen teaches "oral care
compositions [that] are quite different from the toothpastes disclosed in
Gaffar or Norfleet and does not disclose any desensitizing properties in its
compositions. (Br. 6-7.) Appellant argues that, therefore, a skilled artisan
"would therefore not look to Andersen as a reference to be directly
combined with the teachings of Gaffar or Norfleet," and Andersen also
provides no motivation to optimize the levels of TKPP and NaTPP to
provide an oral care composition having both desensitizing and anti-tartar
effects. (Id. at 8.) We are not persuaded. Whether or not the "specific
teachings" of Andersen is directed to "an anti-calculus composition [that]
must additionally, and in a separate step, be converted to a suitable oral care
composition" (id. at 7), Andersen clearly teaches that the oral composition of
its invention may be in the form of, for instance, toothpaste. (Andersen i-f
20.) Likewise, Andersen teaches that the concentration ofNaTPP is a result
effective variable at least with respect to the composition's anti-calculus
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property; thus, we find that it would be obvious for a skilled artisan to
optimize this parameter to arrive at the claimed range of an "anti-calculus
amount of [NaTPP]" recited in claim 1. "[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." In re Aller, 220
F.2d 454, 456 (CCPA 1955).
Finally, Appellant argues that Andersen describes an exemplary
embodiment containing concentrations of TKPP and NaTPP outside of the
claimed ranges and further argues that the exemplary formulation "cannot
possibly contain 30% to 65% of a humectant as required by Claim 1,
because the disclosed ingredients add up to 98.02%, and [Andersen]
provides no specific teaching as to how the presence of large amounts of
humectant might affect the properties of such a formulation." (Br. 7.) This
argument is not persuasive. A prior art reference is relevant for all that it
teaches to those of ordinary skill in the art, not simply for what is
exemplified. See In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992).
Likewise, "[ n ]on-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986). Here, Andersen teaches that anti-calculus agents such as NaTPP
and TKPP may be employed "in an amount from 0.1 to about 90%" (FF6),
and Gaffar further specifies using TKPP in an amount within the claimed
range, between 4.3% to 7% (FFl, FF2). Andersen also specifically
contemplates the use ofhumectants. (Andersen i-f 21 (stating that "'orally-
acceptable carrier"' refers to a suitable vehicle for applying the anti-calculus
compositions to the oral cavity and may include humectants ). )
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Accordingly, we affirm the Examiner's rejection of claim 1. Claims
3-5 have not been argued separately and therefore fall with claim 1.
37 C.F.R. § 41.37(c)(l)(iv).
II.
Issue
The Examiner has rejected claims 9 and 19 under 35 U.S.C. § 103(a)
as being unpatentable over Gaffar, Andersen, and Xu. Claim 9 depends
indirectly from claim 1, and further requires that TKPP be present in an
amount of about 4 wt% and NaTPP be present in an amount of about 7 wt
%. Claim 19 depends from claim 1 and further requires that TKPP be
present in an amount of about 4 wt% and NaTPP be present in an amount of
about 2 wt %. The Examiner finds that Gaffar and Andersen do not teach
the specific amounts ofNaTPP recited in claims 9 and 19. (Ans. 6.)
However, the Examiner finds that Xu teaches a tartar control oral care
composition comprising 7% by weight ofNaTPP and also teaches NaTPP
being in an amount of about 1 to about 3% by weight of the composition.
(Id.) The Examiner finds that it would have been obvious to a skilled artisan
to utilize the teachings from Xu regarding the amount ofNaTPP and arrived
at the claimed amount through routine optimization. (Id.) The Examiner
further finds that it would have been obvious to a skilled artisan to combine
the teachings of Gaffar, Andersen, and Xu to arrive at the claimed invention
with a reasonable expectation of success, because Andersen shows that "an
oral care composition can contain a combination of [TKPP] and [NaTPP] to
effectively reduce or remove dental calculus or tartar" while Gaffar and Xu
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show that such a composition can comprise, respectively, TKPP and NaTPP
in combination with another anti-tartar or anti-calculus agent. (Id. at 7.)
Appellant contends that claims 9 and 19 are not obvious because
claim 1 is not obvious. Appellant also contends that the Examiner has not
established that claims 9 and 19 are prima facie obvious over Gaffar,
Andersen, and Xu,
[b ]ecause there is no motivation to modify the formulations of Gaffer
with Anderson (which relates to a totally different kind of
formulation) and Xu (which uses a different tartar control system[)],
for the purpose of optimizing combined desensitization and anti-tartar
benefits (desensitization not being mentioned as an objective or
benefit in any of these disclosures).
(Br. 10.) The issue with respect to this rejection is whether the evidence of
record supports the Examiner's conclusion that claims 9 and 19 are prima
facie obvious.
Findings of Fact
11. Xu discloses a stable and efficacious anti-plaque, anti-calculus,
and anti-gingivitis oral composition comprising an anti-calculus system
comprising 0.5 or 1 to about 2.5% TNaPP and 1 to about 10% NaTPP. (Xu
Abstract, if 8.)
12. Xu discloses an exemplary dentifrice formulation containing
NaTPP in amount of 7.0% by weight. (Id. at Table 1.)
13. Xu claims an oral composition comprising an anti-calculus
system, "wherein the anticalculus system comprises [TNaPP] at about 0.5 to
about 2.5% and [NaTPP] at about 1 to about 3%." (Id. at claim 8.)
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Analysis
As discussed above, we find that the evidence of record supports the
Examiner's conclusion that claim 1 is obvious over Gaffer and Andersen.
We also find that the evidence of record supports the Examiner's conclusion
that claims 9 and 19 are prima facie obvious over Gaffer, Andersen, and Xu.
In particular, Gaffar discloses embodiments of its oral care composition
containing 4.5% TKPP, which we find meets the limitation of "about 4 wt
%" TKPP under the broadest reasonable construction of the term. (FF2.)
Xu discloses an oral composition comprising an anti-calculus system
comprising 1 to about 10% NaTPP. (FFl 1.) More specifically, Xu also
discloses an exemplary composition containing NaTPP in an amount of
7.0% by weight, as claimed in claim 9 of the instant application, and claims
a composition comprising NaTPP at about 1 to about 3% by weight, which
encompasses the amount ofNaTPP ("about 2 wt.%") recited in claim 19 of
the instant application. (FF 11-FF 13.) We further agree with and adopt the
Examiner's reasoning and conclusion that a skilled artisan would find it
obvious to combine the disclosure of Gaffar, Andersen, and Xu to arrive at
the claimed invention with a reasonable expectation of success. (Ans. 8.)
Appellant contends that Xu, like Gaffar and Andersen, has no
teaching regarding desensitizing formulations or the use of TKPP as a
desensitizing agent. (Br. 8.) Thus, Appellant argues that there is no
motivation to include TKPP or optimize the amount of TKPP to achieve a
claimed desensitizing formulation, and no motivation to arrive at the
"specific combination of [TKPP] and [NaTPP] in the specific amounts
required by the claims." (Id. at 8-9.) We disagree for essentially the
reasons already discussed. The prior art provides a reason to combine TKPP
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and Na TPP in the amounts required by the claims, because both are known
anti-calculus agents in about the claimed amounts, and 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. The
Examiner also has established a reasonable basis that such a composition
would be inherently desensitizing. Thus, the Appellant's avowed purpose of
creating an anti-tartar and desensitizing oral care composition does not
control the obviousness inquiry. Id. at 419--20.
Appellant further argues that Xu teaches combining TN aPP, rather
than TKPP, with NaTPP. (Br. 9.) Appellant argues that, as a result, the
combination of Gaffar and Xu teaches away from the claimed invention, and
there is also no motivation to modify Gaffar and/or Andersen by using the
specific amounts ofNaTPP disclosed in Xu in combination with TKPP. (Id.
at 9--10.) We remain unpersuaded because, as discussed above, the
combination of the anti-calculus agents disclosed in Gaffar, Andersen, and
Xu is simply a combination of familiar elements according to known
methods. Furthermore, the combination of Gaffar and Xu does not teach
away from the claimed invention, because Xu does not suggest that its anti-
calculus system ofNaTPP and TNaPP may not be combined with other anti-
calculus agents such as TKPP or otherwise discourage, discredit or criticize
the combination. (See, e.g., Xu claim 8 (using open-ended transitional
phrase "comprising.") Likewise, Gaffar specifically suggests that the at
least 4.3% TKPP in its oral care formulation may be admixed with up to
2.7% ofTNaPP. (FFI.)
Accordingly, we affirm the Examiner's rejection of claims 9 and 19.
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SUMMARY
For the reasons above, we affirm the Examiner's decision rejecting
claims 1 and 3-5 as obvious over Gaffar and Andersen, as evidenced by
Norfleet. We also affirm the Examiner's decision rejection claims 9 and 19
as obvious over Gaffar, Andersen, and Xu.
TIME PERIOD FOR RESPONSE
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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