Ex Parte Kohli et al

Patent Trial and Appeal Board

Jun 30, 2016

12866759 (P.T.A.B. Jun. 30, 2016)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/866,759 08/09/2010 Rajnish Kohli 8547-OO-OC 4253
23909 7590 07/05/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
KASSA, TIGABU
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
07/05/2016 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):
Paten t_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 RAJNISH KHOLI, RICHARD SCOTT ROBINSON,
RALPH PETER SANTARPIA, III, and JAMES R. BROWN1
Appeal 2014-008400
Application 12/866,759
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state the real party-in-interest is the Colgate-Palmolive
Company. App. Br. 2.
Appeal 2014-008400
Application 12/866,759
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1—4, 6, 8—17, 19, 20, and 26—28.2
Specifically, claims 1—4, 6, 8—13, 15—17, and 19 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Delmas et al. (US 2004/0265380 Al, December 30, 2004)
(“Delmas”) and Burch et al. (US 2004/0156931 Al, August 12, 2004)
(“Burch”).
Claims 14, 20, and 26 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Delmas, Burch, Wehling
et al. (US 5,223,264, June 29, 1993) (“Wehling”) and Centers for Disease
Control and Prevention, Recommendations for Using Fluoride to Prevent
and Control Dental Caries in the United States, 50 Morbidity and
Mortality Weekly Report 1 (August 17, 2001) (the “CDC Report”).
Claims 27 and 28 stand rejected as unpatentable under 35 U.S.C. §
103(a) as being obvious over the combination of Delmas, Burch, and
Schobel (US 4,687,662, August 18, 1987) (“Schobel”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to compositions and methods
compositions and methods to clean dental devices and improve the oral
health of the user. Spec. 13.
2 Claims 5, 7, 18, and 22 are canceled. App. Br. 11—13. Claims 21 and 23—
25 are withdrawn. Final Act. 1.
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REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal, and recites:
1. An effervescent dissolvable solid composition
comprising:
an acid source;
a soluble carbonate salt of a basic amino acid; and
a bleaching agent
App. Br. 11.
ISSUES AND ANALYSIS
We adopt the Examiner’s findings and conclusions that Appellants’
claims are prima facie obvious over the combined cited prior art. We
address the arguments raised by Appellants on appeal below.
A. Claims 1—4, 6, 8—13, 15—17 and 19
Issue
Appellants argue the Examiner erred by failing to provide an
articulated rationale for why one of ordinary skill in the art would have
combined the additives disclosed in Delmas, as evidenced by Burch. App.
Br. 4.
Analysis
Appellants first argue that the Examiner erred by failing to follow the
established framework for an obviousness analysis of chemical formulations,
which involves a “lead-modification” analysis similar to that involving novel
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compounds. App. Br. 3 (citing Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d
1352, 1361—62 (Fed. Cir. 2011), applying the analytical framework of
Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350,
1356 (Fed. Cir. 2007)). Appellants point out that the Federal Circuit has
held that “[m]ere identification in the prior art of each component of a
composition does not show that the combination as a whole would have
been obvious.” Id. (quoting In re Kahn, 441 F.3d 977, 986 (Fed. Cir.
2006)). Appellants allege the Examiner has analyzed and combined the
references solely on the basis of their proximity to the claimed invention,
and has impermissibly used hindsight to reconstruct the claimed invention
by picking and choosing from these disclosures the various elements of the
claims. Id. at 5.
Appellants next argue that the disclosure of the recited elements does
not,per se, support the legal conclusion of obviousness. App. Br. 4. Rather,
Appellants argue, the Examiner must provide a reason why a person of
ordinary skill in the art would have identified the cited art and then selected
the recited elements and combined them in the manner required to arrive at
the claimed invention. Id. at 3^4. Appellants contend the cited art neither
teaches nor suggests dissolvable solid formulations as required by the
claims. Id. at 5.
Appellants dispute the Examiner’s conclusion that the teachings of
Delmas with respect to the use of lubricants would have rendered the use of
surfactants obvious. App. Br. 5. Appellants assert that Delmas teaches that
the problem of solid ingredients sticking to surfaces in tablet presses can be
mitigated by the use of lubricants. Id. Appellants argue that the teaching of
Burch that some lubricants might have surfactant properties, would not have
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converted lubrication of tablet presses into a suggestion to include
surfactants in a composition, i.e., for their surfactant properties. Id. Rather,
Appellants contend the reason for including a material, the specific amount
chosen, and the concentration at which it would be used, are independent
considerations, depending on whether the material is included for its
surfactant properties or for its lubricating properties. Id. at 5—6. Therefore,
argue Appellants, the Examiner may not rely on Burch as teaching the
incorporation of any surfactant into the compositions of Delmas. Id. at 6.
Appellants argue further that, because Delmas does not teach or suggest any
need for a surfactant, a person of ordinary skill could not select, much less
optimize, the concentration of any such material. Id.
Appellants argue further that Delmas neither teaches nor suggests the
use of, or need for, bleaching agents. App. Br. 6. According to Appellants,
absent the recognition of the bleaching properties of those materials, one of
ordinary skill would not have a reason for including, much less optimizing,
the concentration of Delmas’ gas-generating “alkaline agents” to arrive at
the required bleaching agent required by the claims. Id.
The Examiner responds that Delmas teaches tablets which comprise
the same components, i.e., an acid source, a carbonate salt of an amino acid,
and a bleaching agent, that are recited in Appellants’ claim 1. Ans. 21. The
Examiner finds Delmas teaches sodium stearyl fumarate and polyethylene
glycol, which, the Examiner finds, are well-known in the art as surfactants.
Ans. 23 (see Delmas | 84). The Examiner finds that, whether Delmas refers
to these compounds as lubricants or as surfactants does not change the
nature of the chemicals. Id. Neither, the Examiner finds, does Delmas’
recognition of their utility as lubricants in any way detract from their
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surfactant properties. Id. The Examiner states that Burch is relied upon
simply as teaching that sodium stearyl fumarate and polyethylene glycol are
necessarily surfactants. Id. (see Burch 1153).
Similarly, the Examiner finds, the perborates and percarbonate taught
by Delmas are well-known in the art as bleaching agents, whether or not
Delmas explicitly refers to them as such. Ans. 23. The Examiner points out
that the claims fail to recite a percentage for the bleaching agent and so
whether a person of ordinary skill in the art would have been able to
optimize the concentration of perborate or percarbonate taught by Delmas is
irrelevant. Id.
We are not persuaded by Appellants’ arguments. As an initial matter,
Appellants’ contention that the Examiner was obliged to follow the
Unigene/Takeda analysis is inapposite. Our reviewing court stated in
Unigene that:
Where the patent at issue claims a chemical compound, a lead
compound is often used to show structural similarities between
the claimed compound and prior art.... In the context of a
composition or formulation patent where the patented formulation
was made to mimic a previously FDA-approved formulation, the
functional and pharmaceutical properties of the “lead compound”
can be more relevant than the actual chemical structure (though
not always mutually exclusive).
Unigene, 655 F.3d at 1361—62. Therefore, the analysis proposed by
Appellants is generally applicable when determining obviousness based
upon structural similarities between a claimed compound and a reference (or
lead) compound. Such is not the case in the instant appeal, where no
structural formula is set forth either in the claims or in the Specification.
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Secondly, Appellants argue that the combined cited prior art neither
teach nor suggest the claimed “dissolvable solid formulations.” See App.
Br. 5. However, Appellants adduce no evidence of record in support of this
assertion. As such, Appellants’ assertion is no more than attorney argument
and we accord it little probative weight. See In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997) (Attorney arguments and conclusory statements that
are unsupported by factual evidence are entitled to little probative value).
Furthermore, we agree with the Examiner that Delmas teaches all of
the limitations of the claims. Appellants admit that Delmas teaches sodium
stearyl fumarate and polyethylene glycol, but argues that it does not teach
their use as surfactants, only as lubricants. Similarly, Appellants admit that
Delmas teaches “anhydrous sodium perborate, effervescent perborate,
sodium perborate monohydrate, sodium percarbonate, sodium
dichloroisocyanurate, sodium hypochlorite, calcium hypochlorite, and
mixtures thereof’ but teaches them only as “alkaline agent[s].” See Delmas
151. However, the test for obviousness “is what the combined teachings of
the references would have suggested to those of ordinary skill in the art.” In
re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). We agree with the Examiner
that a person of ordinary skill in the art would recognize that sodium stearyl
fumarate and polyethylene glycol act were well-known in the art as
surfactants, as is explicitly taught by Burch. Similarly, we agree that a
person of ordinary skill would recognize the alkaline agents listed supra act
as bleaching agents.
Nor are we persuaded that the Examiner erred in failing to provide a
motivation for a person of ordinary skill to combine the references, because
the Examiner correctly found that Delmas teaches all of the limitations of
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claim 1 and relies upon Burch only to show that sodium stearyl fumarate and
polyethylene glycol were well-known in the contemporary art as having
surfactant properties. Indeed, it is possible that the Examiner could have
concluded Delmas anticipates these claims, however, that does not preclude
a conclusion that the claims are also obvious over Delmas, as anticipation is
recognized as the ultimate form of obviousness. See In re Kalm, 378 F.2d
959, 962 (C.C.P.A. 1967).
Nor are we persuaded by Appellants’ allegation that the Examiner
impermissibly employed hindsight analysis. Any judgment on obviousness
is, in a sense, necessarily a reconstruction based upon hindsight reasoning,
“but so long as it takes into account only knowledge which was within the
level of ordinary skill at the time the claimed invention was made and does
not include knowledge gleaned only from applicant’s disclosure, such a
reconstruction is proper.” In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A.
1971). Appellants adduce no evidence that the Examiner relied upon
knowledge that would not have been within contemporary level of ordinary
skill or which could only have been obtained from Appellants’ Specification.
We consequently affirm the Examiner’s rejection of claims 1—4, 6, 8—13,
15-17, and 19.
B. Claims 14, 20, and 26
Issue
Appellants argue the Examiner erred because neither Wehling nor the
CDC Report, singly or in combination, would have cured defects of Delmas
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and Burch, since neither would have taught or suggested a dissolvable solid
composition. App. Br. 7.
Analysis
Appellants admit that Wehling, like Delmas, is directed to an orally
disintegrating tablet for oral administration of therapeutic agents.
Appellants argue Wehling describes a solid tablet that will disintegrate to
form a dispersion, and would have failed to teach or suggest a dissolvable
solid composition. App. Br. 7 (citing, e.g., Wehling col. 6,11. 1—20).
Appellants also argue that the “nearly boundless” listing of
generically described therapeutic agents in Wehling should not be construed
as providing any guidance that would have led one of ordinary skill to any
particular component, much less set of components, recited in Appellants’
claims. App. Br. 7. Therefore, Appellants argue, the fact that Wehling
teaches the inclusion of fluoride supplements within a compendium of
conceivable therapeutic materials does not provide any reason why one of
ordinary skill would have selected that material for inclusion into the
particulate suspension forming compositions of Delmas. Id.
Appellants argue further that the CDC Report teaches away from the
Examiner’s asserted combination and modification of the art proposed in the
Final Office Action. App. Br. 7—8. Appellants argue the CDC Report
teaches fluoride should be included in lozenges to be sucked on and tablets
to be chewed in order to extend the residence time of the formulations and
delivery of fluoride in the oral cavity. Id. at 8. Therefore, Appellants argue,
the CDC Report teaches away from the use of rapidly disintegrating
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formulations intended to facilitate rapid ingestion and swallowing of the
components, as taught by Delmas and Wehling. Id.
The Examiner responds that the claim term “dissolvable” is defined as
“capable of being separated or reduced into its formative elements;
decomposable.” Ans. 21 citing (definition of “dissolvable,” Oxford English
Dictionary (2013)). The Examiner also finds the term “disintegrate” as used
by Delmas and Wehling is defined as “to separate into its component parts
or particles; to reduce to fragments, break up, destroy the cohesion or
integrity of.” Id. at 21—22 (definition of “disintegrate,” Oxford English
Dictionary (2013)). Therefore, the Examiner finds “dissolvable tablets” and
“disintegrating tablets” overlap strongly in scope. Id. Moreover, the
Examiner finds the preamble of claim 1 recites an “effervescent dissolvable
solid composition,” however the claim provides no limitation regarding the
type of medium in which the claimed composition dissolves. Id. Therefore,
the Examiner finds the tablets of Delmas and Wehling need not dissolve in
the mouth in order to be “dissolvable.” Id.
The Examiner also finds Wehling explicitly teaches the incorporation
of fluoride supplements. Ans. 26 (citing Wehling col. 4,1. 13). The
Examiner disagrees that the CDC Report can be reasonably construed as
teaching away from orally disintegrating/dissolvable tablets, because
chewable tablets would also constitute disintegrating tablets as the process
of chewing would reduce a tablet to fragments, exposing the fluoride to the
teeth. Id.
We agree with the Examiner. Appellants’ Specification provides no
explicit definition of the claim term “dissolvable” and the Examiner may
therefore employ the broadest reasonable interpretation of the term
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consistent with the Specification. See In re ICON Health & Fitness, Inc.,
496 F.3d 1374, 1379 (Fed. Cir. 2007). We agree with the Examiner that the
claim term “dissolvable” and disintegrate,” as taught by Delmas and
Wehling, overlap in scope sufficiently so as to render the claim term obvious
over the prior art.
Nor are we persuaded by Appellants’ assertion that the CDC Report
teaches away from combining the explicit teachings of Wehling with those
of Delmas. 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). More specifically, a reference
teaches away when “a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Appellants
point to no passage of the CDC Report that would explicitly discourage a
person of ordinary skill from combining the teachings of Wehling with those
of Delmas by adding fluoride to the compounds of Delmas. We decline,
therefore, to find that the CDC Report teaches away from the Examiner’s
combination of prior art references, and we affirm the Examiner’s rejection
of claims 14, 20, and 26.
C. Claims 27 and 28
Issue
Appellants argue the Examiner erred by failing to articulate a
factually-supported reason explaining why one of ordinary skill would have
combined the cited prior art references. App. Br. 9.
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Analysis
Appellants argue the compositions and methods of Delmas and
Schobel are mutually exclusive of one another. App. Br. 9. Appellants
assert Delmas teaches disintegrating materials that provide particulate
suspensions of materials for those having difficulty swallowing pills and
capsules. Id. Appellants contend Schobel teaches such formulations are
unpleasant and functionally inferior, and result in an “unpleasant mouthfeel
associated with ingesting powder like suspensions of medicinals.” Id.
(quoting Schobel, col. 1,11. 24—52). Appellants argue the formulations
taught by Schobel are formulated and function in a manner separate and
distinct from those of Delmas, reinforcing Appellants’ conclusion that the
presence of common ingredients between formulations cannot be construed
as defining the properties of those separate and distinct compositions and,
similarly, cannot be construed as establishing the obviousness of one such
composition over the other. Id.
The Examiner finds Schobel teaches effervescent compositions in the
form of tablets and that the compositions of Schobel and Delmas are
therefore substantially similar. Ans. 28. The Examiner also finds Delmas
explicitly teaches that its compositions have good mouthfeel. Id. (citing
Delmas 150, 158, 166, 174, 183, and 192). Therefore, the Examiner
finds, one of ordinary skill in the art, upon consulting the teachings of
Schobel and Delmas, would conclude that the formulations of Delmas are
suitable compositions for combination with the teachings of Schobel. Id.
Furthermore, the Examiner finds, Delmas explicitly teaches the
incorporation of mineral salts and Schobel, which also teaches mineral
supplements, specifically teaches the incorporation of potassium chloride.
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The Examiner concludes selection of known mineral salts is within the
purview of one of ordinary skill in the art. Id.
We are not persuaded by Appellants’ arguments. Both Delmas and
Schobel teach effervescent compositions in the form of tablets. See Delmas
Abstr., Schobel Abstr. We agree with the Examiner that a person of
ordinary skill in the art would have been motivated to include potassium
chloride, as taught by Schobel, in the effervescent compositions of Delmas,
because potassium chloride can serve as a mineral supplement. Final Act.
24. We also agree with the Examiner that a person of ordinary skill would
have had a reasonable expectation of success upon combining the teachings
of Delmas and Schobel in this manner, because both references teach similar
effervescent tablet compositions. We consequently affirm the Examiner’s
rejection of claims 27 and 28.
DECISION
The Examiner’s rejection of claims 1—4, 6, 8—17, 19, 20, and 26—28 as
unpatentable under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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