Micropure, Inc.

Patent Trials and Appeals Board

Nov 15, 2021

2021001148 (P.T.A.B. Nov. 15, 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.
16/133,359 09/17/2018 Jaiprakash G. Shewale 70878.00800 6546
20322 7590 11/15/2021
SNELL & WILMER L.L.P. (Main)
400 EAST VAN BUREN
ONE ARIZONA CENTER
PHOENIX, AZ 85004-2202
EXAMINER
ROBERTS, LEZAH
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
11/15/2021 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):
IPDOCKET@swlaw.com
chauff@swlaw.com
dgiancaterin@swlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAIPRAKASH G. SHEWALE,
WILLIAM E. COOLEY, JAMES L. RATCLIFF, and
ESMERALDA ANN GARCIA-SMITH1
Appeal 2021-001148
Application 16/133,359
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
composition (e.g., an oral care composition), which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellant identifies the real party in interest as Micropure, Inc. Appeal
Br. 2. “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42.
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STATEMENT OF THE CASE
The Specification describes a “multi-component composition
compris[ing] an aliphatic anionic compound and an oxidative compound.”
Spec. ¶ 8. The aliphatic anionic compound can be an N-acyl sarcosinate such
as sodium lauroyl sarcosinate. Id. ¶¶ 10–11. The oxidative compound can be
sodium chlorite. Id. ¶ 12. The composition can be formulated as “a mouth
rinse, a gum, a gel, a paste, a cream, [or] a lozenge.” Id. ¶ 13.
Claims 1–3, 5–11, 13, 14, 16–24, and 31–33 are on appeal. Claims 1
and 31, reproduced below, are illustrative:
1. A single phase composition comprising:
from about 0.01% to about 5.0% of an aliphatic anionic
compound, based on a total weight of the single phase
composition;
from about 0.001 to about 8.0% of an oxidative compound,
based on a total weight of the single phase composition;
a buffering system, wherein pH of the single phase composition
is between 6.0 and 8.0; and
water, wherein the aliphatic anionic compound provides
enhanced stability for the oxidative compound,
wherein the oxidative compound is sodium chlorite.

31. The single phase composition of claim 1, wherein the
buffering system comprises disodium hydrogen phosphate and
sodium dihydrogen phosphate.

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The claims stand rejected as follows:
Claims 1–3, 5–11, 13, 14, 16–18, and 20–24 under 35 U.S.C. § 103 as
obvious based on Witt2 (Final Action3 4) and
Claims 19 and 31–33 under 35 U.S.C. § 103 as obvious based on Witt
and Pilch4 (Final Action 6).
OPINION
Obviousness: Claims 1–3, 5–11, 13, 14, 16–18, and 20–24
Claims 1–3, 5–11, 13, 14, 16–18, and 20–24 stand rejected as obvious
based on Witt. The Examiner finds that Witt teaches single and dual phase
“oral care compositions comprising chlorite” that “are formulated into
toothpastes, gels, mouth rinses and lozenges.” Final Action 4. The Examiner
finds that “[t]he pH of the final composition is greater than 7” and “[t]he
compositions may comprise a buffer.” Id. The Examiner also finds that
“[a]nionic surfactants may be used and include sodium lauryl sulfate and
sodium lauroyl sarcosinates. The surfactant typically comprises from about
0.1% to about 5%.” Id.
The Examiner finds that Witt exemplifies a “single phase composition
compris[ing] water, sodium chlorite (3.750%) . . . [and] sodium alkyl sulfate
(4.00% of a 27.9% solution),” among other things. Id. The Examiner reasons
that “[t]he sodium lauroyl sarcosinate is an aliphatic anionic compound
recited by the instant claims and may be used in place of the sodium alkyl

2 US 2001/0006624 A1; published July 5, 2001.
3 Office Action mailed Dec. 27, 2019.
4 US 8,980,229 B2; issued Mar. 17, 2015.
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sulfate of Witt.” Id. at 4–5. “Therefore when sodium lauroyl sarcosinates is
used, it should enhance the stability of the oxidative compound.” Id. at 5.
The Examiner concludes that “[t]he prior art is not anticipatory insofar
as these combinations must be selected from various lists/locations in the
reference. It would have been obvious, however, to make the combination
since each component is taught as being useful in making the compositions
of the prior art.” Id.
We agree with the Examiner that the composition of claim 1 would
have been obvious to a person of ordinary skill in the art based on the
teachings of Witt, which discloses “oral care compositions, including
therapeutic rinses, especially mouth rinses, as well as toothpastes, . . .
comprising an effective amount of chlorite ion.” Witt ¶ 1. Witt discloses that
its “compositions . . . can be dual phase compositions or single phase
compositions.” Id. ¶ 58.
Witt states that, preferably, its “oral care compositions comprising
chlorite ion [have] relatively alkaline pHs, e.g. at pHs above 7, whereby no
(or only very low levels of) chlorine dioxide or chlorous acid is generated or
is present in the oral care composition at the time of use.” Id. ¶ 20. “For dual
phase compositions the pH is measured after the two phases are mixed
together.” Id. ¶ 54.
Witt discloses that, for its dual phase compositions, “[p]referably the
first phase, in addition to chlorite, comprises one (or more) compatible
binder, humectant, buffer and/or preservative. Preferably, the second phase,
which comprises no chlorite, comprises flavorant, surfactant, fluoride ion,
and/or abrasive.” Id. ¶ 61 (emphasis added).
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Witt states that “[t]he chlorite ion can come from any type of chlorite
salt. Examples include alkali metal chlorites,” etc. Id. ¶ 35. “Sodium chlorite
is particularly preferred.” Id.
Witt states that suitable surfactants include anionic surfactants such as
sodium alkyl sulfates. Id. ¶¶ 83, 89. “Other suitable anionic surfactants are
sarcosinates, such as sodium lauroyl sarcosinate.” Id. ¶ 89. Witt discloses
that its “composition typically comprises an anionic surfactant at a level of
from about 0.025% to about 9%, . . . most preferably from about 0.1% to
about 5%.” Id.
Witt exemplifies a single-phase dentifrice composition comprising,
among other things, water (62.777 wt%), sodium chlorite (3.750 wt%), and
sodium alkyl sulfate (4.000 wt% of a 27.9% solution). Id. ¶ 138 (Example 3).
Witt does not disclose the pH of this composition.
However, Witt also exemplifies a dual-phase dentifrice composition in
which the dentifrice phase comprises water (22.180 wt%) and sodium alkyl
sulfate (8.000 wt% of a 27.9% solution), among other things, and the chlorite
phase comprises water (91.07 wt%), 80% sodium chlorite (2.5 wt%), sodium
carbonate (0.53 wt%), and sodium bicarbonate (0.42 wt%). Id. ¶ 137
(Example 2). Witt states that, “[a]fter phases mixed in a 1:1 vol./vol. Ratio,
pH approximately 7.5.” Id.
We conclude that the composition of claim 1 would have been
obvious in view of Witt, which discloses dentifrice compositions that
comprise water, sodium chlorite, and sodium alkyl sulfate, in amounts that
are encompassed by claim 1. Witt, ¶¶ 137–138. Witt also suggests sodium
lauroyl sarcosinate as a suitable anionic surfactant (id. ¶ 89); thus,
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substituting sodium lauroyl sarcosinate for the sodium alkyl sulfate in Witt’s
exemplary compositions would have been an obvious modification.
Witt also discloses that its composition should have a pH above 7.0
(id. ¶ 20), a pH range that overlaps the one recited in claim 1. Witt discloses
using a buffer in its composition. Id. ¶ 61. Thus, it would have been obvious
to a skilled artisan to use a buffer in Witt’s composition in order to maintain
a pH above 7.0; e.g., between 7.0 and 8.0. Witt in fact discloses that, after
the two phases of its exemplary dual-phase composition are mixed, the pH
of the resulting (single-phase) composition is “approximately 7.5.” Id. ¶ 137.
Regarding the first “wherein” clause of claim 1—“wherein the
aliphatic anionic compound provides enhanced stability for the oxidative
compound”—the composition made obvious by Witt includes the same
components in the same amounts as the composition defined by claim 1.
Thus, the composition made obvious by Witt should have the same
properties as the composition of claim 21.
Appellant argues that, “[a]lthough Witt mentions stable compositions
with pH values of greater than 7 (which would overlap the claimed pH
range), Witt provides absolutely no teaching to support any such
composition. All of the examples for which Witt provided pH values had a
pH of about 10.” Appeal Br. 8. Appellant also argues that
Witt’s specification, in fact, suggests that, in addition to a high
pH, the best approach is to keep chlorite and other ingredients
in separate phases (and not a single phase as is claimed here)
until the time of use. Thus, Witt teaches away from combining
chlorite, a buffer system, and an aliphatic anionic compound at
a pH of 6.0 to 8.0 in a single phase composition.
Id. at 8–9.
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This argument is unpersuasive. Regarding Appellant’s argument
based on Witt’s examples, Witt does state that the chlorite phase of its
Example 2 has a pH of 10, but it also states that, after the phases were mixed
in a 1:1 ratio, the mixed (single-phase) composition had a pH of about 7.5.
Witt ¶ 137. Claim 1 does not require any particular degree of enhanced
stability, or stability for any particular length of time, and therefore reads on
the single-phase composition created by mixing the two phases of a dual-
phase composition, even if that mixing happens just before the composition
is used. Thus, Witt does not teach away from a single-phase composition
comprising sodium chlorite, a buffer system, and an aliphatic anionic
compound at a pH of 6.0 to 8.0.
Appellant also argues that “[t]he Examiner points to Example 3 of
Witt,” but “Example 3 does not teach a buffer, let alone a buffer contained
in the same phase as the sodium chlorite and sodium alkyl sulfate.” Appeal
Br. 9. Appellant argues that, “[g]iven that there is no buffering system taught
in Witt’s Example 3, it is impossible to determine what the pH might be. . . .
Whatever the initial pH of Example 3 might have been, it is surely not
inherent in Example 3 that the pH is, or is close to, the claimed range of 6.0
to 8.0 of the pending claims.” Id. at 10.
This argument is also unpersuasive because the rejection on appeal is
based on obviousness, not anticipation. Even though Witt does not disclose
all of the limitations of claim 1 in a single exemplified embodiment of its
composition, it would have made the claimed composition obvious because it
discloses all of the limitations of claim 1 and provides a reason to combine
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them in the manner claimed; i.e., in a single-phase composition with a pH
between 7.0 and 8.0.
Appellant argues that “[i]t is also not inherent that any of the
compositions disclosed by Witt are stable, since there is no data that
demonstrates stability. Facts must be shown to support the Examiner’s
premise that the compositions are stable.” Appeal Br. 10.
This argument does not persuade us that the Examiner erred. First, as
mentioned above, claim 1 does not require stability of any particular degree
or for any particular length of time. Appellant’s Specification states that “a
single phase multi-component composition, comprising for example the
combination of an oxidative compound and an aliphatic anionic compound
(e.g., an N-acyl sarcosinate compound), such composition may resist
significant degradation of the oxidative compound.” Spec. ¶ 122. Witt
teaches a single phase composition comprising an oxidative compound and
an aliphatic anionic compound (Witt ¶ 138), and suggests using sodium
lauroyl sarcosinate instead of sodium alkyl sulfate (id. ¶ 89). Thus, the
compositions disclosed and made obvious by Witt meet the Specification’s
conditions for enhancing stability. See In re Best, 562 F.2d 1252, 1255
(CCPA 1977):
Where . . . the claimed and prior art products are identical or
substantially identical . . . the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. Whether the
rejection is based on ‘inherency’ under 35 U.S.C. § 102, on
‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same.
Appellant’s arguments regarding claim 13 (Appeal Br. 11–13) are
unpersuasive for the same reasons discussed above with regard to claim 1.
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Appellant also argues that “Witt teaches nothing specific about
improving stability and provides no stability data. In contrast, Appellant has
demonstrated unexpected stability for chlorite compositions comprising a
buffer and an aliphatic anionic compound at a pH from 6.0 to 8.0.” Appeal
Br. 13.
Appellant argues that, “[i]n Example 2 of the present specification,
stability of prior art Toothpastes A and B (which Appellant submits is closer
prior art than Witt) and the stability of Toothpastes C and D, representing the
claimed compositions, were compared.” Id. Appellant points to Table 3 in
the Specification as evidence that “Toothpaste C and Toothpaste D are
significantly more stable than the prior art Toothpaste A and Toothpaste B.”
Id. at 14. Appellant states that “[t]his demonstrates a significant, and wholly
unexpected, improvement in stability of the claimed compositions as
compared to the closest prior art.” Id. at 15.
Appellant also points to Table 4 in the Specification as providing
stability data for Toothpastes E, F, and G. Id. Appellant states that the table
shows that “Toothpaste E lost 9.3% and Toothpaste F lost 0% of stabilized
chlorine dioxide after 3 months of accelerated stability testing. Even
Toothpaste G, which contained sodium lauroyl sarcosinate and sorbitol—a
known destabilizing agent—lost only 9.5% activity after 3 months of
accelerated testing.” Id. at 16. Appellant argues that these results
“demonstrate the long-term shelf stability of the claimed compositions.” Id.
We have considered the data in the Specification but do not agree that
it shows that the claimed combination of components results in unexpected
stability of the oxidative compound. Appellant points to the data shown in
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the Specification’s Tables 1–4, which pertain to Toothpastes A–H. Of these,
Toothpastes A, B, and H are outside the scope of claim 1. Toothpastes C–G
appear to be closest to the composition of claim 1, although all of the
exemplified toothpastes include stabilized chlorine dioxide, not sodium
chlorite, as the chlorite ion source, and the Specification does not disclose
the pH of any of the toothpastes. Spec. ¶ 156 (Table 1).
Appellant argues that the data show that Toothpastes C and D are
significantly more stable than Toothpastes A and B: “a significant, and
wholly unexpected, improvement in stability of the claimed compositions as
compared to the closest prior art.” Appeal Br. 14–15. This conclusion is not
supported by the data. First, as discussed above, Toothpastes C and D are
not “the claimed compositions,” because they do not include sodium chlorite
as the oxidative compound, as required by claim 1.
In addition, the comparison of Toothpastes C and D to Toothpastes A
and B cannot be relied upon to show that an aliphatic anionic compound
enhances the stability of the oxidative compound, because Toothpaste A
contains glycerin and sorbitol, and Toothpaste B contains sorbitol, as
humectants. Spec. ¶ 156 (Table 1). Toothpastes C and D do not contain
either glycerin or sorbitol. Id. Appellant’s Specification states that
“polyhydroxy compounds such as sorbitol and glycerin react with chlorite
salts thereby resulting in unstable compositions.” Id. ¶ 170. Thus, the
enhanced stability of Toothpastes C and D, relative to Toothpastes A and B,
appears to be due to the presence of glycerin and/or sorbitol in Toothpastes
A and B rather than the presence of sodium lauroyl sarcosinate in
Toothpastes C and D.
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This conclusion is supported by a comparison of Toothpaste C to
Toothpaste H, which are identical except that Toothpaste C includes sodium
lauroyl sarcosinate, and Toothpaste H does not include any aliphatic anionic
compound. Spec. ¶ 156 (Tables 1, 2). The results showed that Toothpaste
H—with no aliphatic anionic compound and no humectant—lost 9.5% of its
stabilized chlorine dioxide (SCD) activity after 3 months, while Toothpaste
C—with sodium lauroyl sarcosinate and no humectant—lost 16.6% of its
SCD activity after 3 months. Id. ¶ 169. In other words, in the absence of a
polyhydroxy compound like glycerin or sorbitol, the inclusion of sodium
lauroyl sarcosinate decreased the stability of Toothpaste C relative to an
identical composition lacking sodium lauroyl sarcosinate (Toothpaste H).
For the reasons discussed above, the evidence of record does not
support the statements in the Appeal Brief and in the Specification that
aliphatic anionic compounds or N-acyl sarcosinate compounds enhance the
stability of oxidative compounds, unexpectedly or otherwise.
Appellant also argues that “[t]he inventive compositions also provide
unexpectedly superior efficacy,” with regard to stimulating fluoride uptake,
stimulating remineralization, pellicle cleaning ability, and oxidizing salivary
biomolecules. Appeal Br. 16–19. Appellant relies on data from the
Specification comparing the performance of Toothpaste C with that of
Toothpaste B. Id.5

5 The Specification also includes some data for Crest 3D White Mild Mint
and Colgate Total Advanced Whitening toothpastes, the US Pharmacopoeia
Reference Standard dentifrice, and the American Dental Association
reference dentifrice, but does not include any description of the composition
of these toothpastes. Spec. ¶¶ 176, 196–202, 211, 212.
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We are not persuaded that the cited data provide evidence of
unexpected results that outweigh the evidence favoring obviousness. First, as
discussed above, Toothpaste C includes stabilized chlorine dioxide rather
than sodium chlorite as the oxidative compound, and therefore is not
encompassed by claim 1. See Spec. ¶ 12 (listing sodium chlorite and
stabilized chlorine dioxide as different oxidative compounds).
Second, as also discussed above, Toothpastes B and C differ not only
by the presence or absence of sodium lauroyl sarcosinate but also by the
presence or absence of sorbitol, which is known to react with oxidative
compounds such as stabilized chlorine dioxide. Spec. ¶¶ 5, 170.
Finally, and even if the results for Toothpaste C were extrapolated to
the claimed compositions, and even if comparing Toothpastes B and C was
assumed to be a valid comparison, Toothpaste C is only a single
composition, providing a single data point with respect to all of the
compositions that are encompassed by Appellant’s claim 1. Toothpaste C
includes sodium lauroyl sarcosinate, while claim 1 encompasses any
aliphatic anionic compound; Toothpaste C includes 2.5 wt% sodium lauroyl
sarcosinate and 0.14 wt% stabilized chlorine dioxide, and has an undisclosed
pH, while claim 1 encompasses 0.01–5.0 wt% of an aliphatic anionic
compound, 0.001 to about 8.0 wt% of an oxidative compound, and a pH
between 6.0 and 8.0.
Appellant has not pointed to an evidentiary basis in the record to show
that any results seen for Toothpaste C are representative of other claimed
embodiments, and therefore commensurate with the scope of claim 1. See
In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“If an
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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 summary, we affirm the rejection of claims 1 and 13 under
35 U.S.C. § 103(a) based on Witt. Claims 2, 3, 5–11, 14, 16–18, and 20–24
were not argued separately, and therefore fall with claims 1 and 13.
37 C.F.R. § 41.37(c)(1)(iv).
Obviousness: Claims 19 and 31–33
Claims 19 and 31–33 stand rejected as obvious based on Witt and
Pilch. Appellant argues these claims as a group. Appeal Br. 20–23. We select
claim 31 as representative of the rejected claims. 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Witt does not disclose the specific buffering
system recited in claim 31, but Pilch discloses, in the context of a dentifrice,
that “[b]uffer[s] are used to maintain the pH between 4 and 10 and include
disodium hydrogen phosphate and sodium dihydrogen phosphate.” Final
Action 6. The Examiner concludes that “[i]t would have been obvious to
have used a combination of disodium hydrogen phosphate and sodium
dihydrogen phosphate as the buffer in Witt et al. because the combination is
suitable for toothpaste compositions.” Id.
We agree with and adopt the Examiner’s fact-finding and conclusion.
Appellant argues that “Pilch fails to make up for the shortcomings of
Witt.” Appeal Br. 20. Appellant argues that “Pilch teaches an entirely
different, unrelated solution to the problem of providing an improved
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dentifrice, and thus fails to complement or make up for the shortcomings of
Witt.” Id. at 21.
For the reasons discussed above, however, we do not agree that Witt
is deficient in suggesting the composition of claim 1. Appellant’s argument
based on Pilch is therefore unpersuasive.
Appellant also revisits the arguments based on allegedly unexpected
results. Appeal Br. 22. Appellant’s unexpected result argument is addressed
above and is no more persuasive with respect to the rejection based on the
combination of Witt and Pilch.
Finally, Appellant argues that “the Examiner provides no rationale as
to why one of ordinary skill in the art would combine Pilch with Witt,” and
the rejection is based on hindsight. Appeal Br. 20–21, 22–23.
This argument is unpersuasive as well. The Examiner pointed to
Pilch’s disclosure of disodium hydrogen phosphate and sodium dihydrogen
phosphate as a buffer system and concluded that it would have been obvious
to use that system in Witt’s composition because Witt suggests using a
buffer and Pilch teaches that the disodium hydrogen phosphate/sodium
dihydrogen phosphate combination is suitable for toothpaste compositions.
Final Action 6. We see no error in the Examiner’s reasoning.
In summary, we affirm the rejection of claim 31 under 35 U.S.C.
§ 103(a) based on Witt and Pilch. Claims 19, 32, and 33 fall with claim 31
because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(iv).
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 5–11,
13, 14, 16–
18, 20–24
103 Witt 1–3, 5–11,
13, 14, 16–
18, 20–24

19, 31–33 103 Witt, Pilch 19, 31–33
Overall
Outcome
1–3, 5–11,
13, 14, 16–
24, 31–33

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