Michael Prencipe et al.

Patent Trials and Appeals Board

Mar 2, 2020

15307782 - (D) (P.T.A.B. Mar. 2, 2020)

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.
15/307,782 10/28/2016 Michael Prencipe 10305-00-US-01-OC 2255
23909 7590 03/02/2020
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
LIU, TRACY
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
03/02/2020 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 and STEVEN WADE FISHER1
____________

Appeal 2018-007986
Application 15/307,782
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Colgate-Palmolive Company as the
real party-in-interest. App. Br. 2.

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1, 2, 5–12, and 14–16 as unpatentable
under 35 U.S.C. § 103 over Patel et al. (US 2012/0264078 A1, October 18,
2012) (“Patel”).
Claim 13 stands rejected as unpatentable under 35 U.S.C. § 103 over
the combination of Patel and Robinson et al. (US 2006/0286044 A1,
December 21, 2006) (“Robinson).2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to an oral care composition including
a silica abrasive having a particle size no greater than the diameter of a
dentin tubule, zinc citrate, a bioadhesive agent, and an anticalculus agent.
Spec. ¶ 8.

REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. An oral care composition comprising

2 The Examiner withdrew a rejection of claims 1, 2, and 5–16 on the ground
of nonstatutory double patenting over claims 1, 4, and 9 of co-pending
Application No. 15/337,226 in view of Patel. Ans. 3.
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(a) a silica abrasive having an average particle size of 1.5–6
microns in an amount of 2% to 10% by weight based on the total
weight of the composition;

(b) zinc citrate in an amount of 0.2% to 5% by weight based on
the total weight of the composition,

(c) a bioadhesive agent, and

(d) an anticalculus agent,

wherein the bioadhesive agent is a polyvinyl methyl ether/maleic
anhydride copolymer in amount of 0.5 % to 4% by weight based
on the total weight of the composition, and

wherein the anticalculus agent is tetrapotassium pyrophosphate
or tetrasodium pyrophosphate in an amount of from 0.5% to 5%
by weight based on the total weight of the composition.

App. Br. 14.

ISSUES AND ANALYSIS
We agree with, and expressly adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are obvious over the combined
prior art. We address below the arguments raised by Appellant.

Issue 1
Appellant argues there is no sufficient motivation to modify Patel to
obtain the specific combination of components recited by the claimed
composition. Appeal. Br. 5.
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Analysis
The Examiner finds that Patel teaches an oral care composition in the
form of a dentifrice. Final Act. 3 (citing Patel Abstr., ¶ 31). The Examiner
finds that the oral composition includes at least one abrasive in an amount of
5% to 70% by weight of the composition. Id. (citing Patel ¶ 79). The
abrasive may include less than 6% by weight silica having a particle size of
0.1 to 30 μm. Id. The Examiner finds that the oral composition may include
zinc citrate in an amount of 0.05% to 3% by weight. Id. (citing Patel ¶ 72).
The Examiner finds that the composition may include one or more
anticalculus agents in a total amount of 0.01% to 50% by weight. Id. (citing
Patel ¶ 67). The anticalculus agents may include tetrasodium pyrophosphate
and polyvinyl methyl ether/maleic anhydride (PVME/MA) copolymer. Id.
The Examiner determines that, although the components of the oral
care composition “must be selected from various lists/locations in the
reference,” “[i]t would have been obvious to make the combination since
each component is taught as being useful in making the compositions of the
prior art.” Final Act. 4. The Examiner determines that the modification
represents “nothing more than the predictable use of prior art elements
according to their established functions.” Id. at 5. With respect to the
specific amounts and particle size of components recited in the claims, the
Examiner determines that Patel discloses amount and size ranges that
overlap with the claimed ranges. Ans. 8. Accordingly, the Examiner
concludes that the claims would have been prima facie obvious over the
prior art. Id.
Appellant argues that “[a]lthough Patel mentions silica abrasive, zinc
citrate, [PVME/MA copolymer], and tetrasodium pyrophosphate in several
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different places, Patel does not disclose or suggest the specific combination
of them, much less the amounts of them recited in claim 1.” App. Br. 5.
Appellant contends that the Examiner has failed to provide “any rationale as
to why the invention as claimed would have been obvious to a person of
ordinary skill in the art at the time of invention.” Id. at 6.
Appellant contends the Examiner should apply a “lead-modification
analysis” for obviousness of chemical formulation. App. Br. 5 (citing
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1361–1362 (Fed.
Cir. 2011). Appellant argues that Patel at Table 3 discloses a dentifrice that
should serve as the lead formulation. Id. Appellant argues that the disclosed
dentifrice does not contain zinc citrate, PVME/MA copolymer, or silica
adhesive having a particle size of 1.5–6 microns. Id.
Appellant argues further that Patel teaches photosensitive GRAS
(Generally Regarded as Safe) dyes provide anti-bacterial activity to the
disclosed compositions, and thus “are essential elements” in Patel’s
compositions. App. Br. 7. Appellant argues that the “Examiner has not
provided any articulated reasoning why one of skill in the art would be
motivated to add the specific combination of” silica, zinc citrate, PVME/MA
copolymer, and anticalculus agent “into Patel’s compositions containing
photosensitizing dyes.” Id.
Finally, Appellant argues that, although Patel teaches an abrasive with
an average particle size of 0.1 to 30 microns, Patel does not teach or suggest
“the use of a silica having an average particle size of 1.5–6 microns.” App.
Br. 7 (emphasis in original). Appellant argues “[t]here is no teaching or
suggestion anywhere in Patel that would motivate one of skill in the art to
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use a silica having an average particle size of 1.5–6 microns … much less
the claimed amount of it.” Id. at 8.
We are not persuaded by Appellant’s arguments. Patel teaches oral
compositions including conventional dentifrice components, e.g., abrasives,
anticalculus agents, and antimicrobial agents. See Patel ¶¶ 60, 61, 77. These
conventional dentifrice components more specifically include silica
abrasive, zinc citrate antimicrobial agent, and tetrasodium pyrophosphate
and PVME/MA copolymer anticalculus agents. See Patel ¶¶ 67, 72, 79. The
Examiner has identified a reason to combine these components for their
established functions in a dentifrice. See App. Br. 5. “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 Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420
(2007).
Furthermore, we do not agree with Appellant with respect to applying
a “lead-modification analysis.” Unigene, upon which Appellant relies, held
that a reference composition analysis, which refers to new formulations of
known compounds as Appellant claims, in contrast to new compounds, is
appropriate only in certain infringement contexts, which are not applicable
here. See Unigene, 655 F.3d at 1361–62; see also Eisai Co. v. Dr. Reddy’s
Labs., Ltd., 533 F.3d 1353, 1357 (Fed. Cir. 2008) (“Obviousness based on
structural similarity thus can be proved by identification of some motivation
that would have led one of ordinary skill in the art to select and then modify
a known compound (i.e., a lead compound) in a particular way to achieve
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the claimed compound. See Takeda Chem. Indus. v. Alphapharm Pty., Ltd.,
492 F.3d 1350, 1356 (Fed.Cir.2007).”). Moreover, 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 technical
grasp of the skilled artisan. KSR, 550 U.S. at 420–421. Accordingly, we do
not agree with Appellant that Patel’s teachings are limited to the dentifrice
formulation of Table 3. Rather, Patel’s teachings must be taken as a whole,
including the suggestion to combine conventional dentifrice components for
their established functions.
Likewise, we are not persuaded by Appellant’s argument that Patel’s
teaching of “essential” GRAS dyes distinguishes the prior art from the
claimed composition. First, the claim 1 recites “an oral care composition
comprising ….” Use of the transitional term “comprising” “creates a
presumption … that the claim does not exclude additional, unrecited
elements.” Crystal Semiconductor Corp. v. TriTech Microelectronics Int'l,
Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001). Therefore, the claims do not
exclude additional components taught by Patel, e.g., GRAS dyes. Second,
as discussed supra, Patel teaches that the conventional dentifrice
components may be combined in oral care compositions, including those
containing GRAS dyes, for their known functions. “[A]ll disclosures of the
prior art, including unpreferred embodiments, must be considered.” In re
Lamberti, 545 F.2d 747, 750 192 USPQ 278, 280 (C.C.P.A. 1976).
Finally, we are not persuaded by Appellant’s argument that Patel does
not teach the identical amounts of components and particle size of silica
abrasive. Patel teaches the same components in ranges that overlap the
claimed ranges. Likewise, Patel teaches abrasives, e.g., silica, having a
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particle size range that overlaps the claimed range.3 “A prima facie case of
obviousness typically exists when the ranges of a claimed composition
overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003). We consequently agree with the Examiner that
claims 1, 2, 5–12, and 14–16 would have been prima facie obvious over
Patel.
Appellant repeats the same arguments against the combination of
Patel and Robinson with respect to claim 13. For the reasons set forth supra,
we are not persuaded. We consequently agree with the Examiner that claim
13 would have been prima facie obvious over Patel and Robinson.

Issue 2
Appellant argues the Examiner is required to consider the data
presented in the Examples demonstrating beneficial effects of the claimed
composition. App. Br. 8.

Analysis
Appellant argues the data in Example 2 of the Specification shows
that the claimed composition (Formula A), has greater efficacy in inhibiting
biofilm growth than the comparative unclaimed compositions (Formula C,
D, E, and Competitive dentifrice 1). App. Br. 8. Appellant argues the data

3 Appellant’s Specification acknowledges that the “[u]se of silica particles
having an average particle size of no greater than the diameter of a dentin
tubule for occluding dentinal tubules and treating dentinal hypersensitivity
is disclosed in US patent application no. 2009/0092562.” Spec. ¶ 6.
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in Example 2 shows that Formula A has higher efficacy against plaque than
Competitive dentifrice 2. Id. Appellant contends that the compositions of
Formula C, D, E, and Competitive dentifrices 1 and 2, “are closer to the
claimed composition than Patel’s dentifrice formulation” taught in Table 3.
Id. at 9. Although the amounts of anticalculus agent vary among the
Examples, Appellant argues “each anticalculus or antiplaque agent has its
own effective concentration range” and “a lower amount of amount of an
anticalculus agent could exhibit greater efficacy in inhibiting biofilm growth
than a higher amount of another anticalculus agent.” Id.
Appellant further argues that the data in Example 4 shows Formula A
“provides a strong tooth hypersensitivity benefit by comparing it with
Formula B (Colgate cavity protection toothpaste).” App. Br. 10. Appellant
contends “Patel does not discuss anything regarding tooth hypersensitivity.”
Id. Therefore, Appellant contends that the closer prior art is Formula B,
which contains dicalcium phosphate dehydrate for treating hypersensitive
dentine. Id. Appellant contends “[t]he beneficial effects of the claimed
combination shown in Examples 2–4 … are not taught or suggested by
Patel.” Id.
The Examiner finds that Formula A contains 3.94% anticalculus
agents (tetrapotassium pyrophosphate and PVME/MA copolymer) as
compared to Formula B (0.25% tetrapotassium pyrophosphate), Formula C
(3% tetrasodium and tetrapotassium pyrophosphates), Formula D (2%
tetrasodium and tetrapotassium pyrophosphates), and Formula E (0%
anticalculus agents). Final Act. 7–8. The Examiner finds “[o]ne of ordinary
skill in the art would reasonably expect a composition with more
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anticalculus agents to have a greater reduction in biofilm growth compared
to compositions with lesser amounts of anticalculus agents.” Id. at 8.
With respect to hypersensitivity, the Examiner finds that “[t]he instant
claims do not recite treating tooth hypersensitivity.” Ans. 12. The Examiner
determines that Formula B is not the closest prior art for comparison to
Formula A, as Formula B contains dicalcium phosphate dehydrate as a
desensitizing agent, and not silica. Id.
We are not persuaded by Appellant’s arguments and evidence with
respect to the allegedly unexpected results. We agree that the Specification
arguably shows a difference of efficacy between the described formulations.
However, Appellant has not shown that the difference would have
been unexpected. Rather, we agree with the Examiner that the “greater
efficacy in inhibiting biofilm growth” and “higher efficacy against plaque”
would have been expected given the increase in anticalculus agent. See
Spec. ¶¶ 79, 82. Appellant’s argument that each anticalculus agent has its
own effective range is unsupported by any evidence of probative value. “An
assertion of what seems to follow from common experience is just attorney
argument and not the kind of factual evidence that is required to rebut a
prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470, 43
USPQ2d 1362, 1365 (Fed. Cir. 1997).
Finally, we address the difference in tooth sensitivity effectiveness
between Formula A and Formula B. Appellant contends that Formula A,
containing a silica abrasive having an average particle size of 1.5–6 microns,
shows improved tooth sensitivity as compared to Formula B, containing
dicalcium phosphate dehydrate. App. Br. 10. Even if we agree that the
results of the tooth sensitivity test are unexpected, unexpected results that
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are probative of nonobviousness are those that are “different in kind and not
merely in degree from the results of the prior art.” Iron Grip Barbell Co. v.
USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (citation omitted).
Appellant does not adduce any evidence of record to persuade us that the
differences between the properties of the claimed oral composition and those
of Formula B are differences in kind, rather than merely of degree.
We are consequently not persuaded that the Examiner erred in
concluding that the claims would have been obvious over Patel (and
Robinson for claim 13), and we affirm the Examiner’s rejection of the
claims.

CONCLUSION
The rejection of claims 1, 2, and 5–16 as unpatentable under 35
U.S.C. § 103, 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).

AFFIRMED
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1, 2, 5–12,
14–16
103 Patel 1, 2, 5–12,
14–16

13 103 Patel, Robinson 13
Overall
Outcome
1, 2, 5–16