Maloney, Venda Porter. et al.

Patent Trials and Appeals Board

Mar 27, 2020

15287242 - (D) (P.T.A.B. Mar. 27, 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.
15/287,242 10/06/2016 Venda Porter Maloney 9120-00-US-C1-OC 6604
23909 7590 03/27/2020
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
WEBB, WALTER E
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
03/27/2020 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 VENDA PORTER MALONEY, VYOMA PATEL,
STEVEN WADE FISHER, ANDRE MICHELLE MORGAN,
MICHAEL PRENCIPE, and STANISLAV JARACZ
__________

Appeal 2019-003343
Application 15/287,2421
Technology Center 1600
__________

Before RICHARD M. LEBOVITZ, DEBORAH KATZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an 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
According to Appellant’s Specification, metal salt amounts are “often
limited as a result of unfavorable effects” to users such as “astringency, taste

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.)
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and mouth feel.” (Spec. ¶ 1.) This has “made it difficult to deliver an
effective amount of a metal ion to the soft and/or hard tissue of the oral
cavity” with these compositions. (Id. ¶ 2.) Appellant’s invention is directed
to compositions which address that problem. (Id.)
Claims 1, 7–14, and 18–23 are on appeal.2 Claim 1 is representative
and reads as follows:
1. An oral care composition comprising:
a first metal salt, having a solubility of greater than 0.001
g/100 mL in water at 20°C;
a second metal salt, having a solubility of 0.001 g/100
mL, or less, in water at 20°C; and
a free water content of greater than about 10%, by
weight;
wherein the first metal salt is selected from: zinc citrate,
zinc nitrate, and zinc glycinate;
the second metal salt is selected from: zinc oxide, zinc
phosphate, zinc pyrophosphate, zinc silicate, zinc oleate, zinc
hydroxide, zinc peroxide, and zinc sulfide;
wherein the composition comprises from about 0.1% to
about 5% by weight, of the first metal salt; and from about
0.05% to about 2% by weight, of the second metal salt;
wherein the second metal salt is present in an amount
effective to provide a synergistic increase in delivery of the
metal ion of the first or second metal salt; and
wherein the first metal salt and the second metal salt are
not contained in a film.
(Appeal Br. 16.)

The prior art relied upon by the Examiner is:

2 Claims 15 and 16 are also pending but have been withdrawn from
consideration.
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Name Reference Date
Roberts US 3,622,662 Nov. 23, 1971
Pader US 4,100,269 July 11, 1978
Piechota US 5,256,396 Oct. 26, 1993
Bilali US 6,169,118 B1 Jan. 2, 2001
Modak ’534 US 2011/0229534 A1 Sept. 22, 2011
Modak ’902 US 2012/0201902 A1 Aug. 9, 2012

The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 7–11, 14, and 18–20 under 35 U.S.C. § 103(a) as
unpatentable over Pader.
Claims 1, 7–14, and 18–23 under 35 U.S.C. § 103(a) as unpatentable
over Bilali.
Claims 12, 13, and 21–23 under 35 U.S.C. § 103(a) as unpatentable
over Pader and Bilali.
Claims 1, 7–14, and 18–23 under 35 U.S.C. § 103(a) as unpatentable
over Roberts and Piechota.
Claims 1, 11, 14, and 18–20 under 35 U.S.C. § 103(a) as unpatentable
over Modak ’534.
Claims 1, 7, 8, 14, and 18–20 under 35 U.S.C. § 103(a) as
unpatentable over Modak ’902.
Claims 12, 13, and 21–23 under 35 U.S.C. § 103(a) as unpatentable
over Modak ’902 and Roberts.
DISCUSSION
The Pader Rejection
We focus our analysis on claim 1.
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The Examiner finds that Pader teaches “controlling calculus on tooth
surfaces by administering ‘at least one physiologically acceptable zinc
compound.’” (Ans. 3.) The Examiner further finds that Pader teaches that
suitable zinc compounds to include in formulations include zinc
tribromosalicylanilide, zinc citrate, zinc oxide, and zinc silicate. (Final
Action 3 (citing Pader at col. 3).) In addition, the Examiner finds that Pader
teaches that “the amount of zinc salt ranges from 1/10% to about 25%.” (Id.
(citing Pader Abstract).)
The Examiner notes that Pader provides several examples of
compositions that include more than one zinc compound. (Ans. 3 (citing
Pader Examples 1, 5, and 6).) The Examiner points out that Example 1 is a
mouthwash composition that includes two insoluble zinc compounds,
namely zinc citrate at 5% and zinc tribromosalicylanilide at 0.125%. (Final
Action 3 (citing Pader Example 1 at col. 5).) The Examiner finds that the
mouthwash composition also includes free water greater than about 10 and
15% by weight. (Id.)
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to replace one acceptable zinc compound for another
“insofar as they are taught to be suitable for the same purpose.” (Ans. 3.)
Thus, for example, the Examiner finds that “replacing zinc
tribromosalicylanilide of Example 1 with zinc oxide . . . would have been
obvious.” (Id.; see also Final Action 3 (“Generally, it is obvious to replace
one component for another equivalent component if it is recognized in the
art that two components are equivalent and is not based on the Applicant’s
disclosure (see MPEP 2144.06.)”.)) The Examiner finds that in such a
combination, where the zinc oxide is replaced provided in the same amount
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of the tribromosalicylanilide at 0.125%, that amount would be expected to
have the property of being “effective to provide a synergistic increase in
delivery of the [zinc] metal ion.” (Final Action 3–4.)
Appellant argues that the Examiner has not made out a prima facie
case of obviousness because he did not provide an explanation of the
equivalency of substituting zinc oxide for zinc tribromosalicylanilide.
(Appeal Br. 5–6; Reply Br. 2–3.) We do not find this argument persuasive.
Pader teaches a composition that includes one or more relatively
insoluble zinc compounds as the active agent in a composition to control
calculus (Pader Abstract), and exemplifies multiple compositions including
at least two such zinc compounds (id. (Examples 1, 5, and 6).) Pader
explains that one of the benefits of using relatively insoluble zinc
compounds “is that through their use small quantities of these zinc
compounds will become lodged in the cracks, crevices, and interstices
between the teeth, as well as in dental plaque and other deposits, thereby
promoting longevity of action.” (Id. at 4:45–50) Pader provides a list of
thirteen compounds that are acceptably insoluble for use in calculus control
compositions, which includes, inter alia, zinc oxide, zinc citrate, and zinc
tribromosalicylanilide. (Id. at 3:12–33.)
“From the standpoint of patent law, a compound and all of its
properties are inseparable; they are one and the same thing.” In re Papesch,
315 F.2d 381, 391 (CCPA 1963). The solubility is a property of the zinc
compounds set forth in Pader’s list of thirteen compounds. Thus, whether
recognized or not, zinc citrate has a solubility in the first metal salt range
claimed, and zinc oxide, has a solubility in the second metal salt range
claimed.
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Although Pader does not demonstrate a specific example in which
zinc citrate is used in combination with zinc oxide, such is not necessary to
establish that such a combination is obvious. The test of obviousness is
“whether the teachings of the prior art, taken as a whole, would have made
obvious the claimed invention.” In re Gorman, 933 F.2d 982, 986 (Fed. Cir.
1991). Moreover, it is not necessary for an “[e]xpress suggestion to
substitute one equivalent for another . . . [to] be present to render such
substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). As
noted, Pader teaches that a small number (thirteen compounds) of relatively
insoluble zinc compounds are all equivalently useful to provide calculus
control. (Pader 3:12–33.)
That Pader does not identify zinc citrate as having a solubility that is
above 0.001 g/100 mL in water at 20 ºC whereas zinc oxide has a solubility
below 0.001 g/100 mL in water at 20 ºC is not necessary to establish that
Pader renders obvious a composition that includes both zinc oxide and zinc
citrate, because, as discussed above, a compound and its properties are
inseparable and Pader teaches that both compounds may be used in a
composition to control calculus. In re Lintner, 458 F.2d 1013, 1016 (CCPA
1972) (“The fact that appellant uses sugar for a different purpose does not
alter the conclusion that its use in a prior art composition would be prima
facie obvious from the purpose disclosed in the references.”). Indeed, for a
prima facie case of obviousness to be established, the references need not
recognize the problem solved by the Appellant. See In re Kemps, 97 F.3d
1427, 1430 (Fed. Cir. 1996); In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir.
1992).
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We agree with the Examiner that Pader’s teachings that a small
number (thirteen compounds) of relatively insoluble zinc compounds are
equivalently useful to provide calculus control over a period of time due to
deposition is sufficient to provide a reason to substitute zinc oxide for zinc
tribromosalicylanilide in Example 1 of Pader with a reasonable expectation
of obtaining a calculus controlling composition. Wm. Wrigley Jr. Co. v.
Cadbury Adams USA LLC, 683 F.3d 1356, 1364–65 (Fed. Cir. 2012)
(“strong case of obviousness” exists where the combination of ingredients
recited in the claims were based on selections from a finite number of
identified, predictable solutions). “Reading a list and selecting a known
compound to meet known requirements is no more ingenious than selecting
the last piece to put into the last opening in a jig-saw puzzle. It is not
invention.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327,
335 (1945); see also Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804,
807 (Fed. Cir. 1989); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007) (Picking one of a finite number of known solutions to a known
problem is obvious).
Nor does it matter that Pader does not teach anything regarding
synergistic uptake of zinc by the combination of zinc oxide with zinc citrate
(Reply Br. 3). We acknowledge that the claim requires an amount of zinc
oxide that will provide a synergistic increase in the delivery of the metal ion
of either the zinc citrate or zinc oxide. However, as noted above, the
references need not recognize the problem solved by the Appellant. Here,
the claim indicates a range for which the first and second metal salt need to
be present and thus, one would understand that any amount within that range
would provide the requisite synergy, absent evidence to the contrary. The
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combination suggested by Pader’s example includes a zinc compound in the
claimed first metal salt group and a zinc compound in the second metal salt
group in the amounts that Appellant’s claim indicates should result in the
synergistic result claimed, and Appellant has not provided evidence that
such synergy would not exist.
Secondary Considerations
Appellant further argues that evidence of unexpected synergy of the
claimed combination of zinc salts in an oral care composition has been
provided. In particular, Appellant explains that in Tables 2 and 3 of the
Specification it is demonstrated that a “combination of 2% zinc citrate with
0.5% zinc oxide results in a level of zinc ion uptake far exceeding the sum of
the zinc uptake obtained from 2% zinc citrate alone and 1% zinc oxide
alone.” (Appeal Br. 6.)3

3 We note that Example 2 of the Specification describes “delivery of zinc”
to a sample material. (Spec. ¶ 47.) To measure the delivery, the sample
material is digested. (Id. ¶ 48.) The measurement of this delivery is
described as “[z]inc uptake” and reported in units of micrograms per disk of
zinc uptake. (Id. (Table 2).) Similar assessment of delivery to other sample
material is described in Example 3 and reported as uptake in Table 3 and
reported in units of micrograms per square centimeter of zinc uptake. (Id.
¶¶ 51–53.) We understand from Appellant’s disclosure therefore, that
uptake can simply be the deposit of zinc on the sample material. This
understanding is consistent with Appellant’s discussion of additional
evidence in the Appeal Brief that Appellant contends supports unexpected
synergy. (Appeal Br. 7.) According to Appellant, the additional evidence is
the results “obtained using the same zinc deposition on hydroxyapatite disk
analytical method as described in Appellants’ specification.” (Id.) The
results report “Measured Zinc Deposition” in units of parts per million. (Id.)
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We agree with Appellant that Table 2 of the Specification provides
evidence of synergy in the uptake of zinc to hydroxyapatite4 where 2% zinc
citrate was combined with either 0.25% or 0.5% zinc oxide. In the
experiment, both zinc citrate and zinc oxide were tested individually
(Spec. 13), and thus, one is able to assess whether the combination of zinc
citrate and zinc oxide is more than the sum of the parts.
Table 3 provides evidence of synergy in zinc uptake to “Vitro-skin”5
where 2% zinc citrate was combined with 0.5% zinc oxide. Like the testing
in Example 2, which results are reported in Table 2, zinc citrate alone was
tested, as was zinc oxide alone. (Id. at 15.) And thus, again, one is able to
assess whether the combination of zinc citrate and zinc oxide is more than
the sum of the parts. However, no conclusion can be reached regarding
synergy for zinc uptake in the pig tongue6 experiment, which results are
reported in Table 3, as data was “not available” for a test of the composition
of zinc oxide alone.
The additional data that Appellant contends support its assertion of
unexpected synergy do not provide test results for all of the zinc compounds
individually. (Appeal Br. 7.)7 The only zinc composition tested individually

4 “It is generally accepted by dental experts that clinical supragingival
calculus (tartar) is a type of dental plaque which has crystallized with the
formation of a hydroxyapatite crystalline structure.” (Pader 1:29–32.)
5 “Vitro-skin is a commercial product used as a standard for in-vitro skin
related experiments.” (Spec. ¶ 54.)
6 “Pig tongue is a suitable tissue representing a human tongue.” (Id.)
7 Furthermore, this data is submitted in the Appeal Brief without any
accompanying declaration. As such, the data amounts to attorney argument,
not evidence. “Attorney argument is not evidence.” Icon Health & Fitness
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was zinc lactate. (Id.) Moreover, as the units of measure for this additional
data are not the same as for the data in Table 2, one cannot arrive at any
conclusions comparing the two tables of data. Thus, one is not able to assess
whether the combination of zinc compositions in the additional data is more
than the sum of the parts.
Notwithstanding the evidence of synergy in Tables 2 and 3 of the
Specification that we discuss above, the question remains as to whether the
“uptake” or delivery of the zinc to the surface tested would have been
unexpected to one of ordinary skill in the art.
“One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of ‘unexpected results,’ i.e., to show that
the claimed invention exhibits some superior property or advantage that a
person of ordinary skill in the relevant art would have found surprising or
unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). That “Pader
does not discuss anything regarding synergistic effect of zinc citrate and zinc
tribromosalicylanilide” (Appeal Br. 7) is not sufficient to establish
unexpected results over Pader. The result that Appellant contends is
unexpected is zinc deposition. As already noted above, Pader teaches that
the use of insoluble salts, those that have a solubility of not more than about
0.5 gm of zinc per 100 cc at 20 ºC, is advantageous in having quantities of
zinc lodging in cracks, crevices, and interstices between teeth and thereby
forming a reservoir of zinc ions released over a prolonged period of time.
(Pader 4:45–55.) These areas in which the zinc lodges are bounded by

v. Strava, 849 F.3d 1034, 1043 (Fed. Cir. 2017); In re Pearson, 494 F.2d
1399, 1405 (CCPA 1974).
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surfaces, presumably, on which the zinc is deposited. Thus, we understand
Pader to teach that its list of suitable zinc compounds to be ones that will
deposit on surfaces in light of their relative insolubility.
Appellant does not provide any evidence that the composition of
Example 1 of Pader that includes zinc citrate and zinc tribromosalicylanilide
would not deposit zinc in similar synergistic quantities as the zinc citrate
(2%) and zinc oxide (0.25% and 0.5%) shown to be deposited in Example 1
of Appellant’s Specification. Consequently, Appellant’s evidence does not
establish that the deposition observed with zinc citrate (2%) and zinc oxide
(0.25% and 0.5%) would have been an unexpected synergistic deposition to
one of ordinary skill in the art, where the art teaches deposition of zinc as
being the advantage of the zinc materials it discloses for use. For this
reason, we agree with the Examiner that Appellant has not tested the closest
prior art sufficient to establish unexpected results of zinc deposition.
Furthermore, as the Examiner explained, “[t]he evidence presented to
rebut a prima facie case of obviousness must be commensurate in scope with
the claims to which it pertains.” In re Dill, 604 F.2d 1356, 1361 (CCPA
1979) (emphasis added). “If an applicant demonstrates that an embodiment
has an unexpected result and provides an adequate basis to support the
conclusion that other embodiments falling within the claim will behave in
the same manner, this will generally establish that the evidence is
commensurate with [the] scope of the claims.” In re Kao, 639 F.3d 1057,
1068 (Fed. Cir. 2011). Even if we were to assume that Appellant has
provided evidence of an unexpected result of zinc deposition, we agree with
the Examiner that Appellant has not provided evidence of unexpected results
commensurate in scope with the claims. First, the claims provide for a
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group of first metal salts selected from zinc citrate, zinc nitrate, and zinc
glycinate and in a range of from 0.1% to about 5% by weight. Appellant has
only provided evidence using one of those salts (zinc citrate) and at only 2%.
Contrary to Appellant’s argument that its test of a single member of the
genus of compounds claimed and at one weight percent within the claimed
range to demonstrate synergistic deposit of zinc is sufficient (Appeal Br. 8),
we find that one data point is insufficient “to ascertain a trend . . . which
would allow [one having ordinary skill in the art] to reasonably extend the
probative value thereof.” In re Kollman, 595 F.2d 48, 56 (Fed. Cir. 1979).
Appellant’s reliance on In re Chupp, 816 F.2d 643 (Fed. Cir. 1987), to assert
otherwise, is not persuasive. In Chupp, the issue was whether evidence that
a novel compound, when compared against the closest prior art and two
commercial herbicides, that was demonstrated to have unexpectedly superior
herbicidal activity against two different types of weeds in corn and soybean
crops, but not in other crops, was sufficient to establish non-obviousness
over the prior art. 816 F.2d at 644–45. The court indicated that it was, even
though the evidence indicated only so-so herbicidal activity in other
“environment[s].” 816 F.2d at 646. In short, although only a single property
was tested, namely herbicidal activity, the data that was determined to
evidence unexpected superiority included more than one data point of
unexpected superiority. Chupp does not stand for the fact that a single data
point of a single property is sufficient to establish unexpected superiority of
a composition.
Second, the claims provide for a group of second metal salts selected
from eight different zinc compounds and in a range of from 0.05% to about
2% by weight. Only one of those eight compounds was tested in
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combination with a first compound sufficient to establish a synergistic
deposit of zinc as discussed above (i.e., zinc oxide) and only at 0.25% and
0.5% by weight. Although two data points from a percent by weight
standpoint have been established, only a single data point with respect to
compound has been established. Such evidence is insufficient to reasonably
extend the probative value to the additionally claimed compounds and their
combination with any one of the first metal salts claimed and in the weight
percentage range claimed.
Appellant argues that it is only claiming a second metal salt that “is
present in an amount effective to provide a synergistic increase in delivery
of the metal ion of the first or second metal salt” thereby excluding
“embodiments which do not provide a synergistic effect” (Reply Br. 3–4)
and thus its evidence of unexpected synergy is commensurate in scope. We
are not persuaded by this argument because it does not address the problem
that the claim is not directed to only the combination of the first metal salt
being zinc citrate and the second metal salt being zinc oxide.
Claims 7, 11, 14, and 18–20 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Claims 8–10 will be discussed below in a separate section.

The Bilali Rejection
The Examiner finds that Bilali teaches a composition for masking the
unpleasant taste of zinc, where the zinc is an ionizable zinc compound.
(Final Action 5.) The Examiner notes that Bilali describes compositions that
include mixtures of zinc compounds “selected from zinc oxide, zinc citrate
and zinc hydroxide.” (Id. (emphasis omitted) (citing Bilali claim 4).) The
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Examiner further finds that Bilali teaches benefits of the use of zinc citrate in
dental formulations as well as zinc oxide. (Id. at 5–6 (citing Bilali 2:33–34,
45–46).) In addition, the Examiner finds that Bilali teaches “‘the
concentration of zinc compounds in orally administered formulations varies
from 0.1 to 15%’, preferably ‘from about 0.2 to 2 wt.%.’” (Id. at 6 (citing
Bilali 2:49–55).)
In light of the foregoing, the Examiner concludes that
it would have been obvious to a person having ordinary skill in
the art at the time of applicant’s invention to combine zinc
citrate as a preferred zinc salt and zinc oxide for inhibiting
bacterial attack in a dentifrice, where the concentration of zinc
citrate fall within 0.1% and 5%, and the zinc oxide falls within
0.05 and 2%, since the amount of zinc in Bilali is preferably
from about 0.2 to 2 wt %.
(Id.)
Appellant argues that the Examiner’s rejection is in error because
Bilali teaches away from zinc compounds generally, noting that a known
drawback of incorporating zinc compounds into oral products is the
bitterness of zinc and “those of skill in the art would not blindly incorporate
combinations of zinc salts into oral care compositions.” (Appeal Br. 10.)
Appellant further argues that Bilali also “does not teach or suggest that a
combination of zinc oxide and zinc citrate at a concentration as recited in
claim 1 would have a desirable taste in the composition of Bilali.” (Id.)
Finally, Appellant argues that the teaching of masking the bitter taste of zinc
compounds in Bilali “does not somehow motivate one of skill in the art to
pick and choose the zinc compounds listed in the Appellant’s claims . . . and
combine the two zinc ingredients in an oral care composition with the hopes
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of obtaining some type of synergistic effect in the uptake of zinc.” (Reply
Br. 4.)
We find the Examiner has the better position.
We disagree with Appellant that Bilali does not suggest the
combination of zinc oxide and zinc citrate in a composition. Bilali
specifically identifies reasons why one of ordinary skill in the art would use
zinc oxide and zinc citrate in a dentifrice composition. It states that zinc
oxide is a “typical zinc compound[] used in dental formulations . . . for use
in inhibiting bacterial attack,” and zinc citrate “as an anti-odor ingredient[]”
and “for tartar removal effects” and being “preferred for dental
formulations.” (Bilali 2:33–46.) Furthermore, Bilali states “[t]he orally
administered formulations may contain one or more insoluble zinc
compounds depending on the application.” (Id. at 2:21–23 (emphasis
added).) Thus, Bilali is not limited to a single zinc compound in its
compositions. Also, claim 4 of Bilali provides a group of zinc compounds
from which to choose for an orally administered formulation. The group
only includes nine zinc compounds. We conclude these teachings in Bilali
provide a sufficient reason that one of ordinary skill in the art would have
included both zinc citrate and zinc oxide together in a composition for oral
administration.
Furthermore, we agree with the Examiner that Bilali provides a reason
that one of ordinary skill in the art would have included these two zinc
compounds together in amounts that are within the claimed range for each,
which range is sufficient to provide synergistic deposition according to
Appellant’s claim, as discussed above. As discussed above, for a prima
facie case of obviousness to be established, the references need not
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recognize the problem solved by the Appellant. See, e.g., In re Kemps, 97
F.3d at 1430. Bilali states in the summary of the invention that “[t]he
present invention relates to an orally administered formulation comprising
about 0.1 to 25 wt. % of an ionizable zinc compound having an undesirable
taste” that also includes flavoring agents in synergistic combination
“effective to mask the undesirable taste of said ionizable zinc compound.”
(Bilali 1:65–2:4.) Later, Bilali states:
In general, the concentration of zinc compounds in orally
administered formulations varies from about 0.1 to 15 wt. %.
The concentration can range up to as much as 25% depending
on the particular formulation in which the zinc compound is
incorporated. A more preferred amount is about 0.2 to 2 wt. %.
A most preferred amount is from about 0.5 to 2 wt.%.
(Bilali 2:49–55.) We determine that the amounts discussed here relate to the
amount of each zinc compound that has an undesirable taste included in a
composition. Zinc citrate and zinc oxide appear to be such compositions
having an undesirable taste from the teachings in Bilali. In light of the
foregoing, we agree with the Examiner that there is a suggestion in Bilali to
one of ordinary skill in the art to include zinc oxide in an amount of from 0.5
to 2 wt.% and zinc citrate in that same amount. Those amounts are within
the claimed range of “from about 0.1% to about 5% by weight, of the first
metal salt; and from about 0.05% to about 2% by weight, of the second
metal salt.”
Appellant’s arguments regarding the unexpected results are not
persuasive for the reasons discussed above regarding the fact that the
evidence is not commensurate in scope with the claims.
Claims 7, 11–14, and 18–23 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
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Claims 8–10 will be discussed below in a separate section.

The Pader-Bilali Rejection
Appellant has not separately argued the rejection of claims 12, 13, and
21–23 for obviousness based on the teachings of Pader and Bilali. We
summarily affirm the Examiner’s rejection of these claims. See MPEP
§ 1205.02 (“If a ground of rejection stated by the examiner is not addressed
in the appellant’s brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it, unless the examiner
subsequently withdrew the rejection in the examiner’s answer.”).

The Roberts-Piechota Rejection
The Examiner finds that Roberts teaches a dental cream that includes
0.6% zinc sulfate and 1.0% zinc oxide as well as 17% water. (Final Action
8 (citing Roberts Example 1A).) The Examiner further finds that Roberts
teaches zinc oxide be used in compositions from 0.15%–2% and that zinc
sulfate can be used from 0.25–3%. (Id. (citing Roberts 1:66–71, 2:5–8).) In
addition, the Examiner finds that Roberts teaches that the dental cream
includes “an astringent, such as zinc sulfate, zinc chloride, aluminum
chloride and the like.” (Id. (citing Roberts 2:4–6).) The Examiner, thus,
concludes that it would have been obvious to one of ordinary skill in the art
from the teachings in Roberts to replace zinc sulfate with another known
astringent. (Id.) In this regard, the Examiner finds that Piechota teaches
“[e]xamples of astringent compounds utilized in orally applied compositions
include zinc salts such as zinc chloride and zinc citrate which are soluble in
water.” (Id. at 8–9 (citing Piechota 4:55–63).) In light of these teachings,
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the Examiner concludes that it would have been obvious to one having
ordinary skill in the art to substitute the zinc sulfate of the Roberts
composition with zinc citrate “since they are recognized as equivalent in
regard to providing astringency to orally applied compositions.” (Id. at 9.)
Appellant argues that the Examiner’s rejection is in error because
although “Roberts may teach the use of some astringents,” it “does not teach
or suggest that any astringent would be used in Roberts’ composition.”
(Appeal Br. 11.) Furthermore, argues Appellant, the Examiner’s assertion of
equivalency is not supported where it is known that zinc citrate is different
from zinc sulfate and zinc chloride in that “[z]inc sulfate and zinc chloride
are highly water soluble in aqueous solutions and astringent, whereas zinc
citrate is slightly soluble in aqueous solutions and low astringent.” (Id. at
11–12.) Appellant argues that “[t]he Examiner has not provided a sufficient
articulated reason why one of skill in the art would be motivated to modify
Roberts’ dental cream by zinc sulfate with less astringent zinc citrate”
particularly where Piechota’s oral composition is different from Robert’s
dental cream and “[t]here is no teaching or suggestion in Roberts and
Piechota that zinc citrate would be used as an astringent in Roberts’ dental
cream containing hydrated alumina.” (Id. at 12.)
We do not find Appellant’s arguments persuasive. In particular, as
the Examiner points out, Roberts does not limit or discourage the use of
other astringents. (Ans. 6.) Indeed, Roberts teaches that zinc sulfate and
zinc chloride are only examples of astringents that can be used. (Roberts
2:5–6 (“it is particularly desirable to also include an astringent, such as zinc
sulfate, zinc chloride, aluminum chloride and the like”) (emphasis added).)
And we agree with the Examiner that one of ordinary skill in the art would
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have read Piechota as teaching that in general regarding orally applied
compositions zinc chloride and zinc citrate are both well-known water
soluble astringents. (Piechota 4:60–63 (“Examples of astringent compounds
utilized in orally applied compositions include zinc salts such as zinc
chloride and zinc citrate which are soluble in water.”).) Thus, irrespective of
the level of astringency of different known astringent zinc compounds, we
conclude that these general teachings in both Roberts and Piechota provide
one of ordinary skill in the art with sufficient motivation to have substituted
zinc citrate for the disclosed zinc sulfate in Example 1A of Roberts with a
reasonable expectation of achieving a composition that would have the
desirable astringency Roberts indicates when a composition also includes
hydrated alumina. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1374
(Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it
would have been obvious to one skilled in the art to substitute one ARC
[alkaline reactive compound] for another.”).
Neither Roberts nor Piechota needs to provide an express suggestion
that zinc citrate can be substituted for zinc sulfate to render the substitution
obvious. In re Fout, 675 F.2d at 301. And, even if the use of zinc citrate
might result in a formulation that is less astringent, such is not sufficient to
show the substitution would be non-obvious. In re Mouttet, 686 F.3d 1322,
1334 (Fed. Cir. 2012) (“[J]ust because better alternatives exist in the prior
art does not mean that an inferior combination is inapt for obviousness
purposes.”).8

8 We note that in the Answer the Examiner explains that zinc sulfate was
previously identified in the claims as a suitable first metal salt and thus the
composition of Roberts’ Example 1A “is expected to possess the claimed
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Furthermore, Appellant’s arguments regarding the unexpected results
(Appeal Br. 13) are not persuasive for the reasons discussed above regarding
the fact that the evidence is not commensurate in scope with the claims.
Claims 7, 11–14, and 18–23 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Claims 8–10 will be discussed below in a separate section.

The Modak ’534 Rejection
The Examiner finds that Modak ’534 teaches a toothpaste comprising
0.3% zinc lactate, 0.2% zinc oxide, and water at about 43%. (Final Acton 10
(citing Modak ’534 Example 5).) The Examiner further finds that “Modak
teaches zinc citrate as a suitable zinc salt.” (Id. (emphasis omitted) (citing
Modak ¶ 18).) Thus, similar to the prior rejections discussed above, the
Examiner finds that it would have been obvious to one of ordinary skill in
the art to have replaced zinc citrate in the Example 5 composition of Modak
’534 for the zinc lactate. (Id.) The Examiner alternatively finds that it
would have been obvious to add zinc citrate to the composition of Modak
’534 in light of the teachings. (Id.)
Appellant agrees with the Examiner’s position on the disclosure of
Modak ’534 but argues that the Examiner’s rejection is in error because the
Examiner has not demonstrated that Modak ’534 “discloses or suggests an

synergy.” (Ans. 7.) Even if that may be true, such does not establish the
obviousness or not of the invention as now claimed where zinc sulfate is not
one of the identified first metal salts. Nevertheless, for the reasons
discussed, we find sufficient evidence of record that establishes an
expectation of synergy for the obvious substitution of zinc citrate for the
zinc sulfate.
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oral care composition comprising a first metal salt and a second metal salt
recited in claim 1.” (Appeal Br. 12.) We disagree. Similar to the
disclosures of Pader and Bilali discussed above, Modak ’534 teaches a list of
suitable zinc salts for use in the oral care formulations that provide anti-
irritant and wound healing properties. (Modak ’534 ¶ 18.) The list includes
twelve zinc salts. Just as discussed above, we find the reference provides a
reason to add to an exemplified composition described in Modak ’534, or
substitute therein, any one of the zinc compounds, including zinc citrate,
from the list with a reasonable expectation of success in achieving a
composition that has wound healing and anti-irritant properties. Wrigley,
683 F.3d at 1364–65.
Furthermore, Appellant’s arguments regarding the unexpected results
(Appeal Br. 13) are not persuasive for the reasons discussed above regarding
the fact that the evidence is not commensurate in scope with the claims.
Thus, for the above reasons, we affirm the Examiner’s rejection of
claims 1, 11, 14, and 18–20 under 35 U.S.C. § 103(a) as unpatentable over
Modak ’534 .

The Modak ’902 Rejections
The Examiner finds that Modak ’902 teaches
antimicrobial/preservative compositions, such as mouth rinse and toothpaste,
comprising a combination of zinc salts. (Final Action 11.) The Examiner
further finds that a specific embodiment of a topical cream is taught that
comprises 0.2% zinc lactate, 0.3% zinc oxide, and 54.56% water. (Id.
(citing Modak ’902 Table 15B).) The Examiner notes that there are many
similar embodiments disclosed in Modak ’902. (Id.) The Examiner further
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finds, that like Modak ’534, Modak ’902 teaches zinc citrate as a suitable
zinc salt. (Id.) Additionally, the Examiner finds that Modak ’902 teaches
“‘[z]inc salts are used in amounts ranging from about 0.2 to about 1% w/w’
(p. 7, para. [0089]).” (Id. at 12.) Here, again, the Examiner concludes that it
would have been obvious to add in zinc citrate or substitute zinc citrate into
the composition. (Id.)
Here, as with the Modak ’534 rejection, Appellant agrees with the
Examiner’s recitation of the disclosure of Modak ’902. (Appeal Br. 12).
Appellant’s arguments against this rejection are the same as those noted for
the rejection of the claims over Modak ’534. (See Appeal Br. 12–13.) For
the reasons discussed above, we find that the Examiner has made out a
prima facie case of obviousness. Furthermore, Appellant’s arguments
regarding the unexpected results (Appeal Br. 13) are not persuasive for the
reasons discussed above regarding the fact that the evidence is not
commensurate in scope with the claims.
Claims 7, 14, and 18–20 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Claim 8 will be discussed below in a separate section.
Appellant does not separately address the rejection of claims 12, 13,
and 21–23 for obviousness over Modak ’902 and Roberts. We summarily
affirm the Examiner’s rejection of these claims. See MPEP § 1205.02 (“If a
ground of rejection stated by the examiner is not addressed in the appellant’s
brief, appellant has waived any challenge to that ground of rejection and the
Board may summarily sustain it, unless the examiner subsequently withdrew
the rejection in the examiner’s answer.”).

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Claims 8–10
Appellant appears to argue claims 8–10 separately for each set of art
rejections. (Appeal Br. 13–15.) However, Appellant does not specifically
address the teachings of any of the references with respect to these claims.
Rather, Appellant simply states that these claims “are directed to narrower
concentrations ranges regarding the amounts of the first and second salts”
and alleges that “the Examiner has not adequately demonstrated a
motivation to modify the disclosures in the cited art in order to arrive at the
Appellants specific amounts and ranges identified in claims 8-10.” (Id. at
13–14.)
A. Claim 8
We disagree with Appellant as to all rejections regarding claim 8,
which refers to a narrower range for both the first and second zinc metal salt
included in the composition. “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). This is true even where there is a “slight overlap” or the ranges “are
close enough such that one skilled in the art would have expected them to
have the same properties.” Id. As the Examiner explained, such is the case
here:
Pader teaches the amount of zinc salt ranges from 1/10% to
about 25% (Abstract); Bilali teaches a concentration range for
zinc compounds from 0.1 to 15% (col. 2, lines 49-55); Roberts
teaches a concentration range for zinc oxide of 0.15-2% (col. 1,
lines 66-71) and from 0.25-3% for astringents (col. 2, lines 5-
10), such as zinc sulfate.
(Ans. 9.) Modak ’534 and ’902 teach that zinc salts may be present “in
amounts ranging from about 0.1% to about 2.0% (w/w).” (Modak ’534 ¶ 19,
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Modak ’902 ¶ 89.) And, for the reasons discussed above, Appellant has not
established unexpected synergy of the range set forth in claim 8, and
certainly not across the group of first and second zinc salts included within
the scope of that claim.
Consequently, we affirm the Examiner’s rejection of claim 8 under 35
U.S.C. § 103(a) as being unpatentable over Pader, over Bilali, over Roberts
and Piechota, as well as over Modak ’902.

B. Claims 9 and 10
With respect to the specific amounts of zinc compounds claimed by
Appellant in claims 9 and 10, we note that it is prima facie obvious to
optimize the concentration of a known result effective variable. See, e.g., In
re Antonie, 559 F.2d 618, 620 (CCPA 1977); In re Boesch, 617 F.2d 272,
276 (CCPA 1980). Exceptions to this rule include (1) the results of
optimizing a variable were unexpectedly good and (2) the parameter
optimized was not recognized in the prior art as one that would affect the
results. In re Antonie, 559 F.2d at 620.
In each of the references discussed above, the amount of zinc to be
used in the composition is set forth as a range, which establishes that the
amount of zinc to achieve a particular result in each of these references was
a known result effective variable.
As discussed above, with respect to Pader, Appellant has not
established unexpected synergy of the concentrations recited in claims 9 and
10, much less across the group of first and second zinc salts included within
the scope of the claims. As noted above, the single data point with one
specific compound from the group one zinc salts and one specific compound
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from the group two zinc salts does not provide an adequate basis to support
the conclusion that other combinations of zinc salts falling within the claim
will behave in the same manner. In re Kao, 639 F.3d at 1068. This latter
point holds with respect to the remaining references.
Consequently, we affirm the Examiner’s rejection of claims 9 and 10
under 35 U.S.C. § 103(a) as being unpatentable over Pader, over Bilali, as
well as over Roberts and Piechota.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 7–11, 14,
18–20
103(a) Pader 1, 7–11, 14,
18–20

1, 7–14, 18–
23
103(a) Bilali 1, 7–14, 18–
23

12, 13, 21–
23
103(a) Pader, Bilali 12, 13, 21–
23

1, 7–14, 18–
23
103(a) Roberts, Piechota 1, 7–14, 18–
23

1, 11, 14,
18–20
103(a) Modak ’543 1, 11, 14,
18–20

1, 7, 8, 14,
18–20
103(a) Modak ’902 1, 7, 8, 14,
18–20

12, 13, 21–
23
103(a) Modak ’902,
Roberts
12, 13, 21–
23

Overall
Outcome
1, 7–14, 18–
23

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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)(1). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED