Colgate-Palmolive Company

Patent Trials and Appeals Board

Oct 8, 2021

2020005618 (P.T.A.B. Oct. 8, 2021)

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.
15/518,838 04/13/2017 Shao Peng XU 10470-00-US-01-OC 3474
23909 7590 10/08/2021
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
WEBB, WALTER E
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
10/08/2021 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 SHAO PENG XU,
MAHMOUD HASSAN, and XIAO YI HUANG
Appeal 2020-005618
Application 15/518,838
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 9, 13, 20, 41, and 60.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Colgate-
Palmolive Company. Appeal Br. 2.
2 Claims 21 and 40 were cancelled after the Final Rejection. Appeal Br. 10
(Claims App.).
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STATEMENT OF THE CASE
“Dental plaque is a biofilm that adheres to tooth and other oral
surfaces, particularly at the gingival margin, and is implicated in the
occurrence of gingivitis, periodontitis, caries and other forms of periodontal
disease.” Spec. ¶ 1. The Specification states that various antibacterial
agents, including zinc and other metal compounds/salts, can “retard the
growth of bacteria and thus reduce the formation of biofilm on oral
surfaces.” Id. ¶¶ 2–3. The Specification states that “[i]t would be desirable
to provide an oral care composition which exhibits even greater biofilm
reduction efficacy than previously-known compositions.” Id. ¶ 4.

CLAIMED SUBJECT MATTER
The claims are directed to an oral care composition and a method of
reducing or inhibiting biofilm formation in an oral cavity. Claim 1 is
illustrative:
1. An oral care composition comprising:
a. arginine, in free or salt form, in an amount of about
1.5 wt%;
b. serine, wherein the serine is either in an amount of 0.1
wt% or 0.15 wt%;
c. about 1 wt % zinc oxide;
d. about 0.5 wt% zinc citrate, and;
e. a silica abrasive,
wherein the amounts are based on the total weight of the
composition.
Appeal Br. 10 (Claims App.).

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REJECTION(S)
Claims 1, 9, 13, 20, 21, 40, 41, and 60 are rejected under 35 U.S.C.
§ 103 as being unpatentable over Porter3 and Gaffar.4

OPINION
A. Issue
The Examiner finds that Porter teaches or suggests all of the
limitations of independent claims 1 and 41, except that it does not teach zinc
citrate. Final Act. 3–4. The Examiner finds Gaffar teaches that using
sparingly soluble zinc salts such as zinc citrate “in dentifrice formulations []
prolong the anti-calculus and anti-plaque effectiveness of zinc ions due to
the slow dissolution of salts in the saliva.” Id. at 4. The Examiner asserts
that it would have been obvious to a skilled artisan to add zinc citrate to
Porter’s composition, because “zinc citrate is known for prolonging anti-
plaque effectiveness of zinc ions, as taught by Gaffar,” and “would also
contribute to the antiplaque treatment of Porter.” Id. The Examiner further
asserts that, “[g]iven the function of zinc citrate to enhance antiplaque
effectiveness of zinc ions it would have been obvious to optimize a
[concentration] range for the combination of zinc citrate and zinc oxide.” Id.
Appellant contends that a skilled artisan would not have had reason to
combine the teachings of the cited prior art references to arrive at the
claimed invention, with a reasonable expectation of success. Appeal Br. 5–
7. Appellant also contends that the claimed subject matter demonstrates

3 Porter et al., US 2013/0017240 A1, published Jan. 17, 2013.
4 Gaffar, US 4,138,477, issued Feb. 6, 1979.
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unexpected results. Id. at 4–5, 7–8. With respect to claims 41 and 60, which
recites “a method of reducing or inhibiting biofilm formation in an oral
cavity” comprising contacting the oral cavity with the composition of claim
1, Appellant further contends that “the Examiner has not demonstrated that
the combination of Gaffar and Porter teach[es] or suggest[s] using the
recited composition to reduce or inhibit biofilm.” Id. at 9.
With the exception of claims 41 and 60, which are argued together,
Appellant does not separately argue the claims. We therefore focus our
analysis on claims 1 and 41 as representative. The issues with respect to this
rejection are (1) whether a skilled artisan would have had a reason to
combine the teachings of Gaffar and Porter to arrive at the invention of
claim 1, with a reasonable expectation of success; (2) whether the
combination of Gaffar and Porter renders obvious the method recited in
claim 41; and (3) whether Appellant has provided evidence of unexpected
results that, when considered together with the evidence of obviousness,
shows claims 1 and/or 41 to be non-obvious.
B. Findings of Fact
1. Porter’s invention relates to “an oral care composition, for
example a dentifrice composition, for enhanced delivery of an
antiplaque/anticalculus agent to the oral surfaces in the oral cavity,” as well
as “a method of delivering an antiplaque/anticalculus agent to the oral
surfaces in the oral cavity.” Porter ¶ 1; see also id. ¶ 92 (teaching that the
oral care compositions “may be formulated into any delivery form that
permits contact of the metal oxide particles and the amino acid . . . to the
tooth surface).
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2. Porter teaches oral compositions comprising “an orally
acceptable vehicle, metal oxide particles . . . and at least one amino acid
capable of chelating the metal oxide.” Id. Abstr.
3. Porter teaches that “[t]he metal oxide particles may be present
in an amount of up to 5% by weight, . . . , for example in an amount of from
0.5 to 2% by weight,” and that the metal oxide may comprise zinc oxide.
Id. ¶ 17, Abstr.
4. Porter teaches that zinc oxide may be used as an
antiplaque/anticalculus agent and that “[i]t is also known to use complexes
of divalent or trivalent metal ions as antiplaque agents.” Id. ¶ 8.
5. Porter teaches that, “[t]ypically, the at least one amino acid [in
its composition] is selected from L-arginine, cysteine, isoleucine, L-lysine,
glutamic acid, serine, and mixtures thereof.” Id. ¶ 20.
6. Porter teaches that its oral care composition may include
arginine bicarbonate. Id. ¶ 78.
7. Porter teaches that “the at least one amino acid is present in an
amount of up to 5% by weight, further optionally from 0.5 to 5% by weight,
still further optionally from 2.5 to 4.5% by weight, based on the total weight
of the oral care composition.” Id. ¶ 22.
8. Porter teaches that
charged amino acids and peptides have an affinity for the
soft and/or hard tissue in the oral cavity and are also
capable of chelating a metal oxide, such as zinc oxide,
stannous oxide, or copper oxide, which has anti plaque/
anticalculus efficacy when present in a therapeutically
effective amount. Upon introduction of such a complex
into the oral cavity . . . , the amino acid/peptide can act to
deliver the metal oxide to the desired location in the
mouth. For example, if zinc oxide is delivered to dentin,
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the zinc oxide amino acid complex can occlude dentin
tubules and provide hypersensitivity relief. Yet further the
metal oxide can provide antiplaque/anticalculus treatment
or prevention.
Id. ¶ 36.
9. Porter teaches that its oral care composition may include “a
silica that . . . functions not only as a dentin tubule-occluding particulate but
also as an abrasive particulate.” Id. ¶ 63.
10. Gaffar teaches a composition
to prevent and control mouth odor, which is also effective
in preventing calculus, plaque, caries and periodontal
disease containing as the essential agent, a zinc-polymer
combination formed by the reaction or interaction of a zinc
compound with an anionic polymer containing carboxylic,
sulfonic and/or phosphonic acid radicals.
Gaffar Abstr.
11. Gaffar teaches that
[s]paringly soluble zinc salts such as zinc citrate, C14-alkyl
maleate, zinc benzoate, zinc caproate, zinc carbonate, zinc
citrate, etc. have been used in dentifrice formulations to
prolong the anti-calculus and anti-plaque effectiveness of
the zinc ions due to the slow dissolution of the zinc salts
in the saliva. The sparingly soluble characteristic of these
zinc salts promotes longevity of action against plaque and
calculus at the expense of initial or immediate efficacy.
Id. at 1:21–29.
12. Gaffar teaches that its oral preparations may be “applied by
brushing the teeth or rinsing the oral cavity.” Id. at 10:43–47.
13. Examples 1 and 2 in the Specification evaluated compositions
1–8 for their ability to reduce biofilm growth. Spec. ¶¶ 84, 90.
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14. Table 1 of Example 1 is reproduced below:

Spec. ¶ 84. Table 1 sets forth the ingredients of Compositions 1–4. Id.
15. Table 2 of Example 1 is reproduced below:

Spec. ¶ 88. Table 2 sets forth “[t]he results obtained [for Compositions 1–4]
using the biofilm growth inhibition test.” Id. The Specification states that
“[i]n Table 2 . . . , formulae where the avg. log10 CFU/ml results share the
same superscript letter do not show a significant difference in their ability to
inhibit biofilm growth.” Id.
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16. Table 3 of Example 2 is reproduced below:

Spec. ¶ 90. Table 3 sets forth the ingredients of Compositions 5–8. Id.
17. Table 4 of Example 2 is reproduced below:

Spec. ¶ 94. Table 4 sets forth “[t]he results obtained [for Compositions 5–8]
using the biofilm growth inhibition test.” Id. The Specification states that
“[i]n Table 4 . . . , formulae where the avg. log10 CFU/ml results share the
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same superscript letter do not show a significant difference in their ability to
inhibit biofilm growth.” Id.
C. Analysis
Unless otherwise noted, we adopt the Examiner’s findings of fact and
reasoning regarding the scope and content of the prior art (Final Act. 3–6;
Ans. 3–7) and agree with the Examiner that claims 1 and 41 are obvious
over the combination of Porter and Gaffar. We address Appellant’s
arguments below.
1. Motivation to Combine / Reasonable Expectation of Success
a) Arginine and Serine
Appellant contends that “Porter does not specifically teach or suggest
that arginine and serine can (or should) be specifically combined” and that
the Examiner has not articulated a reason why a skilled artisan “would have
been motivated to . . . [add] both arginine and serine in specified amounts,
. . . or explained why this would provide an obvious and predictable
advantage.” Appeal Br. 5; see also Reply Br. 3 (arguing that Porter does not
teach the beneficial effects of the particular claimed combination at the
claimed amounts), 5–6. Appellant contends that “Porter’s Table 3 looks at
zinc uptake with formulations that contain serine or arginine separately, and
not in combination with one another at the amounts recited in the claims.”
Appeal Br. 5.
We are not persuaded. Porter teaches an oral composition comprising
particles of metal oxide, such as zinc oxide, and at least one amino acid
capable of chelating the metal oxide. FF2, FF3. Porter specifically teaches
that “the at least one amino acid” in its composition is typically selected
from “L-arginine, cysteine, isoleucine, L-lysine, glutamic acid, serine, and
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mixtures thereof.” FF5 (emphasis added). Thus, Porter does suggest
combining arginine and serine. We are not persuaded by Appellant’s
arguments that Porter’s Table 3 only looks at formulations containing serine
or arginine separately, not in combination with each other at the claimed
amounts, because all disclosures of the prior art, not just the examples or
preferred embodiments, must be considered in obviousness analysis. In re
Lamberti, 545 F.2d 747 (CCPA 1976).
Appellant contends that
where Porter lists six potential amino acids at paragraph
[0020], this still includes a number of various
combinations with those same amino acids, and the Office
still needs to demonstrate some reasonable expectation of
enhanced inhibition of biofilm growth – specifically from
the combination of arginine and serine – and it cannot rely
upon a motivation to simply vary the different amino acids
or to try different combinations without some expectation
of success.
Reply Br. 6; see also id. at 4 (contending that “the number of possible
combinations [of amino acids] based on Porter is large” and that, “[e]ven if
we are strictly limited to the short list of six amino acids at para. [0020] of
Porter, that is still 64 (26) combinations”), Appeal Br. 6 (contending that “the
Examiner has not demonstrated that it would have been expected or
predicted that the addition of arginine and serine could have an impact on
biofilm reduction),
Citing to the data in Porter’s Table 3, which lists the zinc uptake of
arginine and serine as ca. 99 and 170 micrograms, respectively, Appellant
further contends that
[o]ne might reasonably expect based on this data that the
use of these two amino acids in combination would
provide a result somewhere between the use of the two
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amino acids separately; there would not be a motivation
based on these data to combine arginine with serine, rather
than use serine alone.
Reply Br. 3. Appellant contends that, as “Porter offers no reason to think
that a combination of arginine and serine would be better than one of the
other alone, so as to motivate one to make such a combination.” Id. at 4.
We are not persuaded. As to Appellant’s argument that Porter
discloses a large number of possible amino acid combinations, we note that
“disclos[ing] a multitude of effective combinations does not render any
particular formulation less obvious. This is especially true [where] the
claimed composition is used for the identical purpose taught by the prior
art.” Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir.
1989) (finding claimed combination obvious where prior art patent disclosed
genus of 1200 effective combinations of compounds, including claimed
combination).
As the Merck court explained, an invention may merely be obvious to
try, without being obvious within the meaning of Section 103, where “the
prior art [gives] either no indication of which parameters [are] critical or no
direction as to which of many possible choices is likely to be successful.”
Id. (quoting In re O’Farrell, 853 F2d 894, 903 (Fed. Cir. 1988)). Here, in
contrast, Porter expressly teaches that “charged amino acids and peptides
have an affinity for the soft and/or hard tissue in the oral cavity and are also
capable of chelating a metal oxide, such as zinc oxide” and that, when a
complex of metal oxides and charged amino acids is introduced into the oral
cavity, “the amino acid/peptide can act to deliver the metal oxide to the
desired location in the mouth” such that “the metal oxide can provide
antiplaque/anticalculus treatment or prevention.” FF8. Thus, as in Merck,
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“‘success’ is not dependent upon random variation of numerous
parameters.” Merck, 874 F.2d at 807.
As for Appellant’s suggestion that the Examiner needs to demonstrate
reasonable expectation of “enhanced inhibition of biofilm growth . . .
specifically from the combination of arginine and serine,” we note that “[i]n
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, 419–20 (2007). In this case, the claims, other than
claims 41 and 60 that are discussed separately below, do not contain
limitations regarding “inhibition of biofilm growth,” much less enhanced
inhibition of biofilm growth. Thus, to establish obviousness of the claims it
is not necessary to establish a reasonable expectation that the combination of
arginine and serine would enhance inhibition of biofilm growth. In any
event, as noted above, Porter does in fact suggest that any of the amino acids
listed in its paragraph 20, including mixtures of the amino acids, would
enhance inhibition of biofilm growth (i.e., contribute to
antiplaque/anticalculus treatment or prevention) when used together with
metal oxides such as zinc oxide. FF5, FF8.
Finally, to the extent Appellant is arguing that the Examiner must
demonstrate reasonable expectation that the combination of arginine and
serine enhances inhibition of biofilm growth beyond that expected for
individual amino acids/other amino acid mixtures, we are not persuaded.
“[T]he question is whether there is something in the prior art as a whole to
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suggest the desirability, and thus the obviousness, of making the
combination, not whether there is something in the prior art as a whole to
suggest that the combination is the most desirable combination available.”
In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted).5
Neither are we persuaded by Appellant’s argument that “the Examiner
does not bother at all to address the specific amounts of the specific amino
acids as claimed, nor their specific combination with particular amounts of
both zinc citrate and zinc oxide.” Appeal Br. 6. As the Examiner points out,
Porter teaches that “the at least one amino acid is present in an amount of up
to 5% by weight, further optionally from 0.5 to 5% by weight, still further
optionally from 2.5 to 4.5% by weight, based on the total weight of the oral
care composition.” FF7. Thus, the claimed amounts of arginine (about 1.5
wt%) and serine (0.1 wt% or 0.15 wt%), individually and in combination,

5 Appellant’s citations to In re Stepan Co., 868 F.3d 1342 (Fed. Cir. 2017) is
inapposite. In that case, the claim required a concentrate having a cloud
point above at least 70ºC, and “[t]he Board failed to explain why it would
have been ‘routine optimization’ to select and adjust the claimed surfactants
and achieve a cloud point above at least 70ºC.” Id. at 1344–1346. In this
case, as discussed above, the claims (including claims 41 and 60) do not
require enhanced inhibition of biofilm growth. Furthermore, we have
explained why a skilled artisan would in fact have a reasonable expectation
that the claimed combination would enhance inhibition of biofilm growth.
Finally, while the Stepan court explained that reasonable expectation of
success requires more than a motivation to “vary all parameters or try each
of numerous possible choices until one possibly arrived at a successful
result,” id. at 1347, we have explained above in our discussion with respect
to Merck why a skilled artisan would have had a reasonable expectation of
success of arriving at the claimed invention, without needing to randomly
vary all parameters or to try numerous possible choices without direction as
to which choice is likely to be successful.
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fall within the range disclosed in Porter. Our reviewing court has explained
that “[a] prima facie case of obviousness typically exists when the ranges of
a claimed composition overlap the ranges disclosed in the prior art,” and
“[s]electing a narrow range from within a somewhat broader range disclosed
in a prior art reference is no less obvious than identifying a range that simply
overlaps a disclosed range. . . . The normal desire of scientists or artisans to
improve upon what is already generally known provides the motivation to
determine where in a disclosed set of percentage ranges is the optimum
combination of percentages.” In re Peterson, 315 F.3d 1325, 1329–30 (Fed.
Cir. 2003).
Appellant contends that Porter specifies a 1.4:1 molar ratio of amino
acid to zinc oxide in Examples 2–7, which would provide compositions
comprising, respectively, about 1.8% serine and about 3% arginine, while
the composition of Porter’s Example 1 provides 4.3% arginine. Reply Br. 6.
Appellant contends that “Porter offers no rationale for selecting a
formulation comprising about 1.5% arginine (half the lowest level
specifically taught by Porter) and 0.1 or 0.15% serine (less than 1110th the
amount exemplified in Porter), and further comprising about 0.5% zinc
citrate in addition to 1 % zinc oxide.” Id. We are not persuaded because, as
discussed above, all disclosures of the prior art, not just the examples or
preferred embodiments, must be considered in obviousness analysis. In re
Lamberti, 545 F.2d at 750. As also discussed above, Porter suggests
amounts of amino acid for its formulation that encompasses the claimed
amounts of serine and arginine, thereby establishing a prima facie case of
obviousness as to these limitations. In re Peterson, 315 F.3d at 1329–30.
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To the extent Appellant’s argument is that the cited prior art does not
address the concentrations of zinc oxide and zinc citrate, we are similarly not
persuaded. Porter teaches that metal oxide particles may be present in its
oral care formulation in an amount of up to 5% by weight, for example from
0.5 to 2% by weight, and that the metal oxide may comprise zinc oxide.
FF3. Thus, Porter suggests amounts of zinc oxide for its formulation that
encompasses the claimed amount, thereby establishing a prima facie case of
obviousness as to that limitation. In re Peterson, 315 F.3d at 1329–30.
Furthermore, Porter teaches that zinc oxide is useful for treating
plaque/calculus, FF8, and Gaffar teaches that “[s]paringly soluble zinc salts
such as zinc citrate . . . have been used . . . to prolong the anti-calculus and
anti-plaque effectiveness of the zinc ions,” FF11. As the Examiner points
out,
[g]iven the function of zinc citrate to enhance antiplaque
effectiveness of zinc ions it would have been obvious to
optimize a range for the combination of zinc citrate and
zinc oxide . . . . Accordingly, “where 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” (see MPEP 2144.05 IIA quoting
In re Aller, 220 F.2d 454, 456 . . .).
Final Act. 4.
Citing to In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir.
2012), Appellant contends that, “where a particular parameter (here a
particular combination of ingredients in particular amounts) provides an
effect which is different in kind and not merely in degree from the results of
the prior art, the parameter is not recognized as ‘result effective,’ thus its
optimization cannot be considered obvious.” Appeal Br. 6.
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Appellant misreads Applied Materials, which states that “[t]he
outcome of optimizing a result-effective variable may still be patentable if
the claimed ranges are ‘critical’ and ‘produce a new and unexpected result
which is different in kind and not merely in degree from the results of the
prior art.’” 692 F.3d at 1297. In other words, a variable may be result-
effective and optimizable for purposes of establishing a prima facie case;
nevertheless, the outcome of such optimization may be patentable if
Appellant can show criticality of the claimed range in producing unexpected
results. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (“[T]he burden of
showing unexpected results rests on he who asserts them. Thus it is not
enough to show that results are obtained which differ from those obtained in
the prior art: that difference must be shown to be an unexpected
difference.”). As discussed later in the opinion, Appellant has not
persuasively shown that the subject matter of the claims demonstrate
unexpected results.
b) Zinc Citrate
Appellant contends that “Gaffar does not teach or suggest that zinc
citrate could be combined and incorporated with zinc oxide, arginine and
serine (with any predictable result) as required in the current claims, and at
the particularly amounts required.” Appeal Br. 6. Appellant contends that
“the Examiner has not provided an articulated reason why one of skill in the
art would be motivated to add zinc citrate into . . . Porter’s composition
containing zinc oxide, much less that doing so would yield any predictable
or expected results.” Id.
We are not persuaded. The Examiner articulated a well-supported
rationale for adding zinc citrate into Porter’s composition. Final Act. 4
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(explaining that “zinc citrate is known for prolonging anti-plaque
effectiveness of zinc ions” and “would . . . contribute to the antiplaque
treatment of Porter”); see also FF11.
Appellant contends that “the Examiner has not sufficiently shown that
the cited references address the specific problem solved by the instant
invention – e.g., developing an oral composition which is effective in
biofilm reduction using a combination of particular zinc salts and amino
acids.” Appeal Br. 7. In particular, Appellant contends that “Gaffar is
primarily directed to a decidedly different purpose than the claimed
invention – i.e., control of mouth odor,” and “does not teach or suggest what
kind of biofilm reduction results would be expected from any combination
of zinc citrate with one, or both, of arginine and serine.” Id. at 6–7.
We are not persuaded. As an initial matter, and as discussed above,
“neither the particular motivation nor the avowed purpose of the patentee
controls” in determining whether a claim is obvious. KSR, 550 U.S. at 419.
Thus, it is not necessary for the Examiner to show that Gaffar and Porter
address the alleged specific problem addressed by the claimed invention, so
long as there is a “need or problem known in the field of endeavor at the
time of invention and addressed by the patent.” Id. at 420.6
Moreover, Porter and Gaffar indeed addresses a problem alleged to be
solved by the claimed invention, i.e., to “provide an oral care composition

6 Appellant’s citation to Leo Pharmaceutical is inapposite. Leo Pharm.
Products, Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013). In that case, unlike
here, “the prior art either discouraged combining [two of the claimed
ingredients] in a single formulation, or attempted the combination without
recognizing or solving the storage stability associated with the
combination.” Id. at 1353.
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which exhibits . . . greater biofilm reduction efficacy.”7 Spec. ¶ 4. See, e.g.,
FF4 (Porter teaches use of zinc oxide as antiplaque/anticalculus agent), FF8
(Porter teaches that charged amino acids such as arginine and serine can
deliver the metal oxide to the desired location in the mouth to, e.g., provide
antiplaque/anticalculus treatment or prevention), FF10 (Gaffar teaches a
formulation that controls mouth odor and “is also effective in preventing
calculus [and] plaque”), FF11 (Gaffar teaches that zinc citrate can “prolong
the anti-calculus and anti-plaque effectiveness of the zinc ions”).
2. Claims 41 and 60
Claim 41 recites “[a] method of reducing or inhibiting biofilm
formation in an oral cavity, the method comprising[] contacting the oral
cavity with [the] oral care composition” of claim 1. Appeal Br. 10–11
(Claims App.).
Appellant “incorporates and maintains” the arguments with respect to
claim 1 in the arguments regarding claim 41. Appeal Br. 8. Appellant
contends that, “as one of skill in the art would not expect or predict . . .
Appellant’s surprising biofilm reduction from the cited references, then it
stands that the method of . . . reducing or inhibiting biofilm formation with
the same composition recited in claim 1 would be similarly new and
inventive.” Id. We are not persuaded for the reasons already discussed.

7 To the extent Appellant argues that the “specific problem” solved by the
claims is “developing an oral composition which is effective in biofilm
reduction using a combination of particular zinc salts and amino acids,” we
are not persuaded: This is not so much a description of the problem
allegedly solved, as a restatement of the claim language.
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Appellant further argues that the “intended use [set forth in the
preamble] is relevant to the entirety of the claim” and should be given
“adequate patentable weight.” Appeal Br. 9. Appellant contends that “the
Examiner has not demonstrated that the combination of Gaffar and Porter
teach or suggest using the recited composition to reduce or inhibit biofilm –
much less that the specifically recited combinations of arginine and serine
could be used to achieve unexpected efficacy in biofilm reduction.” Id.; see
also Reply Br. 8 (contending that the Examiner has not shown that “the
significant advantages of this particular formulation for this particular
claimed use” would be obvious to skilled artisans such that they “would be
motivated to select this formulation over the formulations of Porter or other
cited art for this purpose, with a reasonable expectation of success”).
As an initial matter, we are not persuade for the reasons also discussed
above with respect to claim 1, namely that the combination of Gaffar and
Porter does suggest the composition of claim 1 may be used to treat or
prevent plaque/calculus (i.e., biofilm),8 FF8, FF11; that none of the claims,
including claims 41 and 60, require unexpected efficacy in biofilm reduction;
and that prior art does not need to suggest a formulation is superior to other
prior art formulations in order to render it obvious. Moreover, we agree with

8 In response to the Examiner’s explanation that “compositions taught to
possess anti-plaque properties, would have reasonably been expected to
reduce biofilm,” because plaque is “essentially a mass of proteins and
bacteria,” Ans. 7, Appellant contends that “biofilm is more resistant to
treatment than isolated bacteria.” Reply Br. 7–8. We are not persuaded
because the Examiner’s point is that the compositions of Porter and Gaffar
are taught to have anti-plaque properties, and, as the Specification
acknowledges, “[d]ental plaque is a biofilm that adheres to tooth and other
oral surfaces.” Spec. ¶ 1.
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the Examiner that the limitations in the preamble would inherently achieved
by the methods suggested by the cited prior art. Ans. 7.
Appellant contends that MPEP § 2112.01 — which states that,
“[w]here the claimed and prior art products are identical or substantially
identical in structure or composition, or are produced by identical or
substantially identical processes, a prima facie case of either anticipation or
obviousness has been established” — does not apply to method of treatment
claims. Reply Br. 7.
We are not persuaded. Our reviewing court has held that “[n]ewly
discovered results of known processes directed to the same purpose are not
patentable because such results are inherent.” Bristol-Myers Squibb Co. v.
Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). In this case,
Appellant’s claimed method is directed to the same use (i.e., oral care) and
consists of the same steps as suggested by the prior art (i.e., contacting the
oral cavity with the claimed oral care composition). Even assuming for
argument’s sake the prior art did not suggest that such a method would
reduce or inhibit biofilm formation in the oral cavity,9 claim 41 at most
claims a newly discovered result of a known process, which is not patentable
because it is inherent.10

9 As discussed above, we find that the combination of Porter and Gaffar does
suggest that contacting the oral cavity with the claimed composition would
reduce or inhibit biofilm formation.
10 “We are skeptical that a proper interpretation of the claims would include
an efficacy requirement. In Bristol–Myers Squibb Co. v. Ben Venue
Laboratories, Inc., we construed a similar method-of-treatment claim . . .
and held that it “merely express[ed] a purpose of reducing hematologic
toxicity” rather than requiring a particular result. 246 F.3d 1368, 1371, 1375
(Fed.Cir.2001). Such a construction is even more appropriate here in the
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In this regard, we note that claim 41 is more similar to the claim in
Bristol-Myers than the claims in Jansen and Rapapport, which Appellant
cites in support of its argument. In those cases, the claims recite,
respectively, a method of “treating or preventing” a particular disease by
administering a composition “to a human in need thereof,” and “[a] method
for treatment” of a particular disease comprising administration of a
compound “to a patient in need of such treatment.” Jansen v. Rexall
Sundown, 342 F.3d 1329, 1333 (Fed. Cir. 2003); Rapoport v. Dement, 254
F.3d 1053, 1055 (Fed. Cir. 2001). In this case, the preamble at most requires
a result — i.e., reducing or inhibiting biofilm formation in an oral cavity —
similar to the preamble language in Bristol-Myers of “[a] method for
reducing hematologic toxicity,” which does not result in any manipulative
difference in the steps of the claim.
Appellant further contends that, even if the rationale of MPEP
§ 2112.01 applies to method claims, “there . . . can be no ‘inherency’ as
argued by the Examiner, because the cited art does not teach compositions
with the ‘identical chemical structure’ as what is claimed.” Reply Br. 8. In
particular, Appellant contends that “the evidence shows that the prior art
products (here, comprising a single amino acid in combination with a single
zinc compound) do not necessarily possess the characteristics of the claimed
product (here, comprising a particular combination of zinc oxide, zinc
citrate, serine, and arginine).” Id.

examination context.” In re Montgomery, 677 F.3d 1375, 1370 (Fed. Cir.
2012).
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We are not persuaded. To the extent Appellant’s argument is that
inherency only applies when a prior art reference teaches an otherwise
anticipating composition, we note that “‘inherency may supply a missing
claim limitation in an obviousness analysis’ where the limitation at issue is
‘the natural result of the combination of prior art elements.’” Persion
Pharm. LLC v. Alvogen Malta Operations Ltd., 945 F.3d 1184, 1191 (Fed.
Cir. 2019) (quoting Par Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d at 1186,
1194–1195 (Fed. Cir. 2014)).
In this case, the combination of Porter and Gaffar renders obvious the
composition of claim 1, as discussed above. Furthermore, Porter and Gaffar
both teach contacting the oral cavity with their respective formulations.
FF1, FF12. It would have been obvious, therefore, to contact the oral cavity
with a composition encompassed by claim 1, based on the teachings of
Porter and Gaffar. The combination of these prior art elements naturally
(i.e., inherently) result in “reducing or inhibiting biofilm formation in an oral
cavity,” as recited in the preamble of claim 41.
3. Unexpected Results
Appellant contends that
Examples 1 and 2 in the present specification show that
the compositions containing both arginine and serine, in
the specified amounts recited in the claims, and a
combination of zinc oxide and zinc citrate (Compositions
1 and 5) provide increased biofilm reduction efficacy,
compared to comparative formula containing serine only
(Composition 2) or arginine only (Composition 6)
together with a combination of zinc oxide and zinc citrate.
Compositions 6 and Compositions 2 in the present
specification are similar to Porter's dentifrices containing
arginine (Example 2) or serine (Example 4) respectively.
The Examiner has not demonstrated that the Appellant’s
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surprising results are somehow predictable in view of
either Porter or Gaffar, either alone or in combination.
Appeal Br. 4; see also id. at 7–8, Reply Br. 2–4, 6–7.
We are not persuaded. As discussed above, “the burden of showing
unexpected results rests on he who asserts them. Thus it is not enough to
show that results are obtained which differ from those obtained in the prior
art: that difference must be shown to be an unexpected difference.” In re
Klosak, 455 F.2d at 1080. To the extent the results in Examples 1 and 2
show that compositions containing the claimed amounts11 of zinc oxide, zinc
citrate, and both arginine and serine provide increased biofilm reduction
efficacy compared to formulas containing only serine or only arginine,
Appellant has not shown why such results are unexpected.
In particular, Porter suggests that positively charged amino acids,
including both arginine and serine, can improve antiplaque/anticalculus
treatment or prevention. FF8. Appellant does not explain why a skilled
artisan would not have expected the antiplaque/anticalculus effects of
arginine and serine to be at least additive; neither has Appellant shown how
the results in Examples 1 and 2 demonstrate more than additive effect.12

11 We note that the claim recites arginine in an amount of about 1.5 wt%,
although the amount of arginine used in composition 1 and 5 appears to be
1.0 wt%.
12 Indeed, the Specification states that “formulae where the avg. log10
CFU/ml results share the same superscript letter do not show a significant
difference in their ability to inhibit biofilm growth.” FF15, FF17. Tables 2
and 4 show, respectively, that the avg. log10 CFU/ml results for
Compositions 1 (1 wt% arginine + 0.1 wt% serine) and 2 (0.15 wt% serine)
share the same superscript letter C, and Compositions 5 (1 wt% argining +
0.1 wt% serine) and 6 (1.5 wt% arginine) share the same superscript letter B.
Id. Thus, it does not even appear that compositions containing both arginine
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Accordingly, we affirm the Examiner’s rejection of claims 1 and 41 as
obvious over Porter and Gaffar. Claims 9, 13, 20, 21, 40, and 60, which are
not separately argued, fall with claims 1 and 41.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
1, 9, 13, 20,
41, 60
103 Porter, Gaffar 1, 9, 13, 20,
41, 60

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED

and serine perform better than compositions containing either amino acid
individually in terms of their ability to inhibit biofilm growth.