James Ratcliff et al.

Patent Trials and Appeals Board

Jul 1, 2021

2020006130 (P.T.A.B. Jul. 1, 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.
13/131,506 08/11/2011 James L. Ratcliff 70878.00100 6202
20322 7590 07/01/2021
SNELL & WILMER L.L.P. (Main)
400 EAST VAN BUREN
ONE ARIZONA CENTER
PHOENIX, AZ 85004-2202
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
07/01/2021 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte JAMES L. RATCLIFF, LEE E. KIRSCH,
JESSICA K. WARD DYKSTRA, WILLIAM E. COOLEY,
GARY ARMITAGE, ROBERT ASHLEY, and
ESMERALDA ANN GARCIA

Appeal 2020-0061301
Application 13/131,506
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 44–46 and 49–60. We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM.

1 Although Appellant asserts that there are no related appeals (see Appeal
Br. 3), Appeal 2020-002938 (Application 13/115,815; decision entered Jan.
28, 2021) involved claimed subject matter similar to that involved in the
present appeal.
2 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Micropure, Inc.
Appeal Br. 2.
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CLAIMED SUBJECT MATTER
Appellant’s invention is directed to oral rinses that contain stabilized
chlorine dioxide and sodium fluoride.
Appellant’s claim 44, the only independent claim on appeal, is
representative of the appealed subject matter and reads as follows:
44. An oral rinse composition for enhancing tooth
remineralization, comprising:
a. stabilized chlorine dioxide that remains stable in
the composition, the stabilized chlorine dioxide
capable of reacting with acidic elements of oral
biofilms to produce chlorine dioxide gas;
b. sodium fluoride; and
c. a pharmaceutically acceptable buffer effective at
establishing an effective pH range of the
composition from about 6.0 to about 7.4 for
maintaining the stability of the chlorine dioxide in
the composition;
wherein the stabilized chlorine dioxide and the sodium
fluoride in combination are more effective at enhancing tooth
remineralization and reducing tooth demineralization than
either of the stabilized chlorine dioxide or the sodium fluoride
alone.
Appeal Br. 18 (emphasis added to claim limitation at issue).
REJECTION(S)
The following rejections are before us for review:
(1) Claims 44–46 and 49–60 under 35 U.S.C. § 112(b) or 35 U.S.C.
§ 112 (pre-AIA), second paragraph, as being indefinite (Ans. 3–4); and
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(2) Claims 44–46 and 49–60 under 35 U.S.C. § 103 as being
unpatentable over the Christopfel,3 Oxyfresh C,4 and Jensen,5 as evidenced
by Hill.6 Ans. 4–11.
INDEFINITENESS
The Examiner’s Rejection
The Examiner determines that the recitation in Appellant’s claim 44,
“‘stabilized chlorine dioxide that remains stable in the composition’” renders
claim 44 indefinite “because the claim does not provide a discernable
boundary on what provides the functional characteristic to the stabilized
chlorine dioxide (SCD).” Ans. 3. In particular, the Examiner determines
that, although “there are multiple ways to help stabilize chlorine dioxide, it
is unclear which of those ways are encompassed by the claim.” Id. The
Examiner reasons as follows:
For example, it is not clear whether the functional characteristic
(i.e., “remains stable in the composition”) is due to the addition
of some other structure (such as pH modifiers, stabilizers, etc.),
absence of destabilizing agents (such as stannous chloride),
other features of the composition (such as specific pH ranges)
encompassed by the claim, or whether the claim is limited to
compositions that have functional characteristic due to a
sequence of steps by which it is made or by some other means,
or a certain combination of these.
Id. at 3–4.

3 US 6,325,997 B1 (issued Dec. 4, 2001).
4 “Oxyfresh C” (“Fluoride Kit.” Oral Health Care. Oxyfresh Worldwide, Inc.
http://web.archive.org/web/20080509170508/http://oxyfresh.com/dental/
rinse_fluoride.asp. 10/23/2007).
5 US 2005/0084551 A1 (published Apr. 21, 2005).
6 US 2015/0017107 A1 (published Jan. 15, 2015).
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The Examiner also finds that the Specification “does not provide a
clear explanation of what constitutes ‘remaining stable in the composition’.”
Ans. 4. In particular, the Examiner finds that the Specification “may be
interpreted differently by different individuals. One may interpret this to
mean that as long as there is some amount of chlorine dioxide in the
composition at any given point in time, the SCD ‘remains stable in a
composition’.” Id. The Examiner finds that “[a]nother may interpret this to
require that none of the chlorine dioxide can be altered in any way after 12
months or more of storage.” Id. The Examiner reasons, therefore, that a
skilled artisan “is not apprised of the metes and bounds of the claimed
invention.” Id.
Analysis
The Supreme Court has stated that “a patent is invalid for
indefiniteness if its claims, read in light of the specification delineating the
patent, and the prosecution history, fail to inform, with reasonable certainty,
those skilled in the art about the scope of the invention.” Nautilus, Inc. v.
Biosig, Insts., Inc., 572 U.S. 898, 901 (2014) (internal quotations omitted);
see also id. at 910 (“The definiteness requirement, so understood, mandates
clarity, while recognizing that absolute precision is unattainable.”).
Thus, as our reviewing court has explained, a claim does not comply
with 35 U.S.C. § 112, second paragraph, “when it contains words or phrases
whose meaning is unclear.” In re Packard, 751 F.3d at 1310, 1314 (Fed.
Cir. 2014) (approving, for pre-issuance claims, the standard from MPEP §
2173.05(e).); see also Ex parte McAward, Appeal 2015-006416, 2017 WL
3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (adopting the approach
for assessing indefiniteness approved by the Federal Circuit in Packard).
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That is, “claims are required to be cast in clear—as opposed to ambiguous,
vague, indefinite—terms.” Packard, 751 F.3d at 1313.
In the present case, we agree with the Examiner that Appellant’s
claims do not inform skilled artisans about the scope of the claimed
invention with reasonable certainty. In particular, we agree with the
Examiner that it is not clear what specific amounts of stabilized chlorine
dioxide are encompassed by the recitation “stabilized chlorine dioxide that
remains stable in the composition” as recited in Appellant’s claim 44.
We agree with Appellant that, in “the situation in which a patent
applicant has elected to be a lexicographer by providing an explicit
definition in the specification for a claim term . . ., the definition selected by
the patent applicant controls.” Renishaw PLC v. Marposs Societa’ per
Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
We are not persuaded, however, that the definition of stability
provided in Appellant’s Specification informs skilled artisans about the
scope of the claimed invention with reasonable certainty.
Appellant’s Specification states as follows: “Stability is defined for
the purposes of the present invention as the ability to maintain levels of the
fluoride ion source, chlorine dioxide source, and pH within the levels
specified by the present invention when the final composition is placed
under normal storage conditions and accelerated conditions (described
above).” Spec. 34. However, we find that there are no “levels specified by
the present invention.”
As to the normal storage conditions and accelerated storage conditions
specified in the definition of “stability,” Appellant’s Specification states as
follows:
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1) Normal storage conditions of approximately 25 degrees
Celsius (C) and 60% Relative Humidity for a storage period of
one (1) year, preferably two (2) years, but most preferred for
three (3) years, or
2) Accelerated conditions of approximately 40 degrees C and
75% Relative Humidity for a storage period of three (3)
months, but preferably six (6) months
Spec. 34.
Thus, as seen above, the storage conditions do not identify levels of
chloride dioxide source that are maintained nor does the definition of
stability. The portions of the Specification identified by Appellant as
allegedly providing clarity simply require the source chlorine dioxide levels
to be maintained “within the levels specified by the present invention” when
the final composition is placed in either the normal storage conditions or the
accelerated storage conditions described in the Specification. Spec. 34.
However, Appellant does not explain which particular chlorine
dioxide levels are “specified by the present invention.” See Appeal Br. 6–7
(citing definition on page 34 of Specification but not identifying any
particular chlorine dioxide levels as being “specified by the present
invention”); see also Reply Br. 6–7 (same). Nor does Appellant identify
where those particular levels may be found in the Specification. See id.
Although Appellant argues that the definition and storage description
establishes that the phrase at issue “means that the stabilized chlorine
dioxide ingredient of the composition remains within the claimed levels
during storage and is available to release chlorine dioxide gas when used by
a consumer, i.e., when introduced into the oral cavity,” Appeal Br. 7
(emphasis added), the claims do not indicate ranges that meet the definition,
nor does the Specification definition.
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Although not cited in Appellant’s arguments, the Specification’s
Table 5 shows a 90 day accelerated stability test in which Stabilized
Chlorine Dioxide is in the composition at a starting concentration of 0.125%
(w/w) and after 90 days the Stabilized Chlorine Dioxide concentration is
reduced to 0.04%. See Spec. 35. The Specification relies on this stability
study in concluding that the definition of stability “is achievable.” Spec. 35.
However, the example does not identify “levels specified by the present
invention.”
Elsewhere, although again not cited in Appellant’s arguments, the
Specification provides that, “[f]or the present invention, the instructed levels
of the chlorine dioxide source in the oral care compositions are 0.005% to
0.800% weight/weight (w/w) or weight/volume (w/v) stabilized chlorine
dioxide.” Spec. 17 (emphasis added).
We do not find the foregoing establishes clarity regarding the claim
requirement of “stabilized chlorine dioxide that remains stable in the
composition.” The Specification defines stability in terms of “levels” of
chlorine dioxide source maintained “within the levels specified by the
present invention” when placed under certain storage conditions. The
Specification, however, provides multiple different concentration levels of
stabilized chlorine dioxide (and its source) which are described as being
“within the levels specified by the present invention.” It is therefore unclear
how much stabilized chlorine dioxide must remain in the composition after
being stored under the specified conditions, in order to be stable according to
the definition of stability provided in Appellant’s Specification.
Accordingly, we find that the definition of stability provided by Appellant’s
Specification is ambiguous, and therefore fails to inform a skilled artisan
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about the scope of Appellant’s invention with reasonable certainty. We
therefore agree with the Examiner that claim 44’s recitation of “stabilized
chlorine dioxide that remains stable in the composition” renders claim 44,
and its dependent claims, indefinite.
In sum, for the reasons discussed, Appellant does not persuade us that
the Examiner erred in determining that claim 44, and its dependent claims
45, 46, and 49–60 are ambiguous, and therefore fail to inform a skilled
artisan about the scope of Appellant’s invention with reasonable certainty.
Accordingly, we affirm the Examiner’s rejection of claims 44–46 and 49–60
for indefiniteness.
OBVIOUSNESS
In rejecting claims 44–46 and 49–60 for obviousness, the Examiner
determined that a skilled artisan would have had motivation and a reasonable
expectation of success in including sodium fluoride in the stabilized chlorine
dioxide-containing compositions of Christopfel, based on the teachings in
Oxyfresh C and Jensen. Ans. 7.
Appellant contends that, because the xylitol in the compositions of
Christopfel, Oxyfresh C, and Jensen degrades stabilized chlorine dioxide,
Christopfel, Oxyfresh C, and Jensen therefore do not describe or suggest
compositions that meet claim 44’s requirement for the claimed composition
to contain “stabilized chlorine dioxide that remains stable in the
composition.” See Appeal Br. 9–11 (citing Grootveld Declaration);7 Reply
Br. 9.

7 Declaration of Martin Grootveld, Ph.D., signed Nov. 12, 2018.
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As discussed above, we agree with the Examiner that independent
claim 44’s recitation of “stabilized chlorine dioxide that remains stable in the
composition” renders claim 44, and its dependent claims, indefinite. In
particular, as discussed above, it is unclear on the current record how much
stabilized chlorine dioxide must remain in the claimed composition when
stored under the conditions described in the Specification, in order for the
chlorine dioxide to “remain[] stable in the composition” as required by claim
44. We find, therefore, that the scope of the claimed subject matter is so
uncertain that we cannot meaningfully perform the required comparison
between the composition recited in claim 44, and the compositions of the
cited prior art. See In re Steele, 305 F.2d 859, 863 (CCPA 1962)
(obviousness rejection of indefinite claim reversed where claim
interpretation required resort to “unsupported speculative assumptions” as to
scope of claimed subject matter).
Because review of the merits of the appealed obviousness rejection of
claims 44–46 and 49–60 would require resort to unsupported speculative
assumptions as to the scope of the claimed subject matter, we reverse the
Examiner’s obviousness rejection of claims 44–46 and 49–60 pro forma.
See Ex parte Miyazaki, 89 USPQ2d at 1217 (precedential) (reversing
rejections pro forma under In re Steele when consideration of merits of
rejections requires “speculative assumption as to the meaning of the
claims”).
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DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
44–46,
49–60
112 Indefiniteness 44–46, 49–60
44–46,
49–60
103 Christopfel,
Oxyfresh C,
Jensen, Hill
44–46, 49–60
Overall
Outcome
44–46, 49–60

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