Wayne Alden et al.

Patent Trials and Appeals Board

Oct 28, 2021

2021001238 (P.T.A.B. Oct. 28, 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.
12/967,813 12/14/2010 Wayne Stewart Alden IV Z-3546MD 1262
27752 7590 10/28/2021
THE PROCTER & GAMBLE COMPANY
GLOBAL IP SERVICES
CENTRAL BUILDING, C9
ONE PROCTER AND GAMBLE PLAZA
CINCINNATI, OH 45202
EXAMINER
LEWIS, RALPH A
ART UNIT PAPER NUMBER
3772
NOTIFICATION DATE DELIVERY MODE
10/28/2021 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):
centraldocket.im@pg.com
mayer.jk@pg.com
pair_pg@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WAYNE STEWART ALDEN, DAVID VIVIAN TYNDALL,
KENNETH TRAVIS DODD, MARIANNE ZSISKA,
WILLIAM RALPH BROWN JR.,
ALEXANDER TIMOTHY CHENVAINU,
THOMAS AURELE CHRISTMAN, JEREMY WAYNE DUCHARME,
MARK EDWARD FARRELL, PAUL ALBERT SAGEL, and
DAVID ANDREW JAKUBOVIC
Appeal 2021-001238
Application 12/967,813
Technology Center 3700
Before JENNIFER D. BAHR, CHARLES N. GREENHUT, and
LISA M. GUIJT, Administrative Patent Judges.
GREENHUT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 31 and 33–35. See Final Act. 1. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as The Procter
& Gamble Company. Appeal Br. 1.
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CLAIMED SUBJECT MATTER
The claims are directed to an oral care compositions, methods,
devices, and systems. Claim 31, reproduced below, is illustrative of the
claimed subject matter:2
31. A method for the sequential delivery of a dentifrice
composition and a gel composition to at least one tooth in an oral
cavity in a single oral care session comprising:
a) dispensing the dentifrice composition from a first dispenser
onto a toothbrush, the dentifrice composition comprising:
i) from about 0.05% to about 10% of a zinc salt, by weight
of the dentifrice composition;
ii) from about 0.05% to about 1.1 % of stannous fluoride,
by weight of the dentifrice composition; and
iii) from about 30% to about 60% glycerin, by weight of
the dentifrice composition
b) contacting the dentifrice composition with the at least one
tooth in the oral cavity and brushing for about 60 seconds
c) dispensing the gel composition from a second dispenser onto
the toothbrush, the gel composition comprising:
i) from about 1 % to about 10% hydrogen peroxide, by
weight of the gel composition; and
ii) pyrophosphate
d) contacting the gel composition with the at least one tooth and
brushing for about 60 seconds wherein the application of the
dentifrice composition is prior to the application of the gel
composition and no subsequent treatment of the dentifrice
composition or the gel composition occurs after the application
of the gel composition to the dentifrice composition, the first
dispenser and the second dispenser are separate packages and not
a part of the toothbrush.

2 We refer to the last entered claims filed December 2, 2019 which the
Appeal Brief Claims Appendix should, but does not, match.
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REFERENCES
The prior art relied upon by the Examiner is:

REJECTIONS
Claims 31 and 33–35 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Final Act. 2, 3.
Claims 31 and 33–35 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Collins, Riley, Wasylucha, and Sagel. Final Act. 5.
OPINION
Written Description
On pages 3–5 of the Final Action the Examiner noted several
limitations3 for which, according to the Examiner, there exists only a generic
disclosure lacking sufficient specificity for the skilled artisan to immediately
envisage the specific subject matter claimed. Appellant and the Examiner
correctly agree that our reviewing court’s predecessor laid down the general

3 The “mixing . . .” limitation was cancelled in the December 2, 2019
amendment and therefore no longer needed to be addressed by the Examiner
in the March 19, 2020 Final Action. See Final Act. 5.
Name Reference Date
Riley US 5,094,842 Mar. 10, 1992
Sagel US 6,582,708 B1 June 24,2003
Wasylucha US 8,602,774 B2 Dec. 10, 2013
Luisa Z. Collins et al. (“Collins”), Safety evaluation of a novel whitening
gel, containing 6% hydrogen peroxide and a commercially available
whitening gel containing 18% carbamide peroxide in an exaggerated use
clinical study 32 J. Dentistry 47–50 (2004)
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framework to be applied in such situations in In re Ruschig, 379 F.2d 990,
995 (CCPA 1967) using a trail marking analogy:
It is an old custom in the woods to mark trails by making blaze
marks on the trees. It is no help in finding a trail or in finding
one’s way through the woods where the trails have disappeared
— or have not yet been made, which is more like the case here
— to be confronted simply by a large number of unmarked trees.
Appellants are pointing to trees. We are looking for blaze marks
which single out particular trees. We see none.
Appeal Br. 5–6; Ans. 3. As Appellant correctly points out:
there is no requirement that there be a disclosure of a single
species that falls within the claims so long as there are “blaze
marks” to lead an ordinary skilled investigator towards such a
species among a slew of competing possibilities.
Appeal Br. 6. The Examiner agrees, stating: “The examiner is in general
agreement with the ‘blaze mark’ analogy, but finds such blaze marks for the
claimed invention lacking.” Ans. 3.
Although the disclosure of each single species is not necessarily
required to support a claim directed to that species, the skilled artisan must
have the “blaze marks” to immediately envisage such species based on the
disclosure as originally filed. Each case must be decided on its own facts:
The size of the genera disclosed, number of possibilities presented, the
manner in which the species falling within those genera are described,
instructions regarding to how to select among the species, and level of skill
in the art, are all factors to consider in making the determination as to
whether a generic disclosure supports a claim directed to something more
specific. This principle was reaffirmed by our reviewing court in Fujikawa v.
Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) and Purdue Pharma L.P. v.
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Faulding Inc., 230 F.3d 1320, 1328, (Fed. Cir. 2000), both of which are
discussed in the Manual of Patent Procedure (“MPEP”) §§ 2163.05(II)–(III)
and 2163(I)(A). Indeed, from a policy standpoint it makes sense that an
applicant for a patent should not be able to file within the PTO a disclosure
containing a vast matrix of possible permutations, wait for the relevant
market to develop, and then decide (in this case many years later) what
subject matter for which they seek the right to exclude their competitors. “As
the Supreme Court has cautioned, ‘a patent is not a hunting license. It is not
a reward for the search, but compensation for its successful conclusion.’”
University of Rochester v. GD Searle & Co., Inc., 358 F.3d 916 (Fed. Cir.
2004) (quoting Brenner v. Manson, 383 U.S. 519, 536 (1966)).
In Fujikawa, the court stated:
just because a moiety is listed as one possible choice for one
position does not mean there is ipsis verbis support for every
species or sub-genus that chooses that moiety. Were this the case,
a “laundry list” disclosure of every possible moiety for every
possible position would constitute a written description of every
species in the genus. This cannot be because such a disclosure
would not “reasonably lead” those skilled in the art to any
particular species.
Fujikawa, 93 F.3d at 1571.
In Purdue the court stated:
[T]he specification does not clearly disclose to the skilled artisan
that the inventors . . . considered the [] ratio to be part of their
invention . . . . There is therefore no force to Purdue’s argument
that the written description requirement was satisfied because the
disclosure revealed a broad invention from which the [later-filed]
claims carved out a patentable portion.
Purdue 230 F.3d at 1328.
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Appellant is able to draw an ex post facto roadmap as to how one
arrives at the particular aspects of claim 31 called into question by the
Examiner. Appeal Br. 6–9. The trouble is that there is no such roadmap in
the Specification to lead the skilled artisan to this specific arrangement from
among the vast number of possibilities presented.
The Specification relates to oral care treatment’s involving the
delivery of two ingredients or components. Spec. p. 2, ll. 26–31. One must
select each of the two components from among a variety of possibilities as
well as the delivery method from among various delivery methods.
According to the Examiner, “[the Specification does] not mention a
dentifrice followed by a hydrogen peroxide gel.” Final Act. 3. In raising this
issue, the Examiner does recognize that the first row of the thirty-seven row
long Table 1 of the Specification lists, among many other possibilities both
in the table itself and in each cell of the first row, “stannous fluoride” as a
first component and “hydrogen peroxide” as a second component. Final Act.
3–4. Appellant asserts this constitutes a sufficient disclosure of the
sequential use of those components. Appeal Br. 6. However, insofar as the
inclusion of each component in a respective dentifrice and gel, Appellant
only points out that the Specification includes the very general statement:
“[t]he first and second components of Table 1 can be delivered using any of
the regimens, dosages, steps, or methods, in whole or part, described
herein.” Appeal Br. 7 (quoting Spec. p. 40, ll. 19–21).
The next issue raised by the Examiner is that, even were one to pick
out the “stannous fluoride” followed by “hydrogen peroxide” from Table 1,
and choose to use them sequentially in a single oral care session, there
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remains no disclosure of the specific dentifrice and gel including the
respective constituent ingredients recited. Final Act. 3–4.
In an effort to show stannous fluoride being delivered as an ingredient
of dentifrice, Appellant asserts that the Specification discloses that dentifrice
includes, “an active ingredient,” (Appeal Br. 7 (quoting Spec. p. 36, ll. 19–
23)) and that among such “active ingredient[s]” are “stannous salts” and a
type of “stannous salt[]” is “stannous fluoride” (Appeal Br. 7 (quoting Spec.
p. 38, ll. 19–294)) which may be included in the proportion recited (Appeal
Br. 9 (citing Spec. p. 32, ll. 14–22)). Appellant also asserts that zinc salts are
“active ingredients,” implying one skilled in the art would understand “an
active ingredient” in the dentifrice to allow for one or more active
ingredients. It does not seem unreasonable to regard the singular “active
ingredient” as permitting a plurality of active ingredients. However, this
does add to the matrix of possibilities from which one must arrive at the
claimed subject matter.
Although there is a general discussion regarding the inclusion of zinc
salts on lines 8–20 of page 35 of the Specification, Appellant does not direct
our attention to any disclosure regarding the inclusion of zinc salt in
combination with stannous fluoride in a dentifrice, in particular. It is not
clear, and Appellant offers us no explanation whether and, if so why, the
zinc salts described on page 35 of the Specification should be regarded as
something used in combination with the stannous fluoride described at page
32 of the Specification. Zinc salts are mentioned in other proportions at
various locations in the Specification (e.g., pp. 17, 28, 34, 35).

4 Appellant appears to have mistakenly cited page 39 in place of 38 and line
29 in place of line 30 of the disclosure as originally filed.
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With regard to “glycerin,” Appellant contends that the Specification
indicates a dentifrice may also include a “humectant” (Appeal Br. 8 (citing
Spec. p. 36, ll. 19–23)), and that “glycerin” is among the possible
“humectant[s]” listed in the Specification(Appeal Br. 8 (citing Spec. p. 38,
ll. 12–15)). A “humectant” is one of eight items in an open-ended list of
components which a “dentifrice may also include.” Spec. p. 36, ll. 19–23.
“[G]lycerin” is among a list of seven possible “humectants” in an open-
ended list of examples that may or may not be used in combination with one
another. Spec. p. 38, ll. 11–15. Additionally, Appellant does not explain why
the cited portion of the Specification recites a humectant proportion in the
range of about 10% to about 60% which differs from the lower end of the
range recited “of about 30%.”
Thus, in order to arrive at the recited dentifrice, one skilled in the art
would have needed to select both stannous fluoride and a zinc salt as two
particular active ingredients from the page-long list of possible active
ingredients spanning pages 38–39 of the Specification, and then select their
proportions, which at least for zinc salts, the Specification discloses a
number of options. One skilled in the art would have also needed to elect to
use a humectant from among the list of possible dentifrice additives and, in
particular, one would have needed to select glycerin as that humectant from
among the list of possible humectants. One skilled in the art would also have
needed to depart from the express guidance in the Specification regarding
the minimum amount of glycerin humectant to include.
Turning to the gel composition, Appellant points out that the
Specification states, “[s]taining can be reduced by the use of a dual
component composition containing pyrophosphate ions and stannous
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compounds.” Appeal Br. 8–9 (quoting Spec. p. 32, ll. 15–16). Appellant also
points out that the Specification states, “hydrogen or urea peroxide is
dissolved in a nontoxic gel for use in combination with a separately stored
but substantially simultaneously dispensed paste.” Appeal Br. 9 (quoting
Spec. p. 33, ll. 18–20). Appellant does not direct our attention to any portion
of the Specification suggesting, first, the combination of hydrogen peroxide
and pyrophosphate in a gel; and second, that such combination exists in a gel
that is sequentially applied after dentifrice. The portion of the Specification
cited by Appellant describes simultaneous dispensing of the gel. Although
claim 31 perhaps does not necessarily preclude simultaneous dispensing of
the dentifrice and the gel, it does require “application of the dentifrice
composition is prior to the application of the gel” and “the first dispenser
and the second dispenser are separate packages,” both of which at least
suggest the cited simultaneous dispensing of the gel and paste is not
necessary for the claimed method and may relate to an embodiment that is
separate and distinct from that to which claim 31 is directed. Appellant does
not direct our attention to any discussion of the range recited with regard to
the hydrogen peroxide. The Specification does mention four possible ranges
for hydrogen peroxide in a gel with each having unique lower and upper
limits. Spec. p. 35, ll. 22–27. The recited lower limit of 1% is mentioned as
one possible lower limit in the stated optimal range of between about “1%
and 3%.” Spec. p. 35, l. 27. The recited upper limit of 10% is mentioned as
one possible upper limit in the largest and most encompassing stated range
of “about 0.1% to about 10%.” Spec. p. 35, l. 25.
Thus, to arrive at the recited gel, the skilled artisan would have needed
to elect to use both hydrogen peroxide and pyrophosphate in a gel, where as
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far as Appellant has informed us, the Specification only indicates that
hydrogen peroxide may be included in a gel without indication that
pyrophosphate may also be included in that same gel. The skilled artisan
would also need to select from one of four possible lower limits as to the
proportion of hydrogen peroxide to include in that gel as well as one of four
possible upper limits to arrive at a lower limit and upper limit that never
appears to be disclosed or suggested as being combined. Appellant does not
direct our attention to any guidance in the Specification regarding how to
select such values.
Lastly, with regard to the specific time periods of “about 60 seconds”
recited in the sequential applications, the Examiner points out (Final Act. 4),
subject matter purportedly distinguishing the claimed subject matter from
the prior art should have clear support in the original disclosure as opposed
to being “an afterthought.” See, e.g., Graham v. John Deere Co. of Kansas
City, 383 U.S. 1, 25 (1966) (quoting Lincoln Eng’g Co. of Ill. v. Stewart-
Warner Corp., 303 U.S. 545 (1938)) (Characterizing an attempt to
distinguish the claimed subject matter from the prior art as an afterthought
where “[n]o such function . . . is hinted at in the specifications of the patent”
and stating, “[i]f this were so vital an element in the functioning of the
apparatus, it is strange that all mention of it was omitted.”). Appellant points
out that the Specification states, “[i]n some embodiments, the components
can be applied to the oral cavity in safe and effective amounts. These
amounts (e.g.[,] from about 0.3 to about 15 g), if it is a toothpaste or
mouthwash, are kept in the mouth for from about 15 to about 60 seconds.”
Appeal Br. 9 (quoting Spec. p. 33, ll. 14–15). We understand “a toothpaste”
to be a form of dentifrice. However, Appellant does not direct our attention
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to anything in the Specification regarding the subsequent application of a gel
for “about 60 seconds.” Thus, to arrive at the subject matter recited, one
would need to select only the upper limit of the disclosed time for using
toothpaste as the single particular time, without indication as to why to do
so, and also select that same amount of time for the gel application without
any direction at all in that regard.
If, in the context of a prior-art analysis, broad expansive disclosures of
multiple genera do not always suffice to anticipate or render obvious all
possible permutations of species that may be derived therefrom (see, e.g., In
re Baird, 16 F.3d 380, 382 (Fed. Cir. 1994); In re Jones, 958 F.2d 347,
350 (Fed. Cir. 1992)), it should follow that broad expansive disclosures of
multiple genera do not always suffice to provide support adequate to satisfy
the written description requirement for each possible permutation of species
that may be derived therefrom. See, e.g., Vas-Cath Inc. v. Mahurkar, 935 F.
2d 1555 (Fed. Cir. 1991) (citing In re Lukach, 442 F.2d 967 (CCPA 1971))
(discussing similarities and differences between “claim-supporting
disclosures” and “claim-anticipating disclosures”). In both contexts,
“covering everything effectively tells us nothing.” Allergan, Inc. v. Apotex
Inc., 754 F.3d 952, 973 (Fed. Cir. 2014) (CHEN, Circuit Judge, dissenting-
in-part).
Here, as discussed above, Appellant provides a “laundry list”
disclosure of many possible moieties which does not appear to include the
precise one recited in claim 31 or paint so-called “blaze marks” from which
the precise one recited in claim 31 may be singled out. One cannot envisage
the particular subject matter claimed without making both a number of
unguided selections from a vast number of possibilities and a number
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unguided departures from the subject matter actually disclosed. See
Fujikawa v. Wattanasin, supra. Further, the Specification does not clearly
disclose to the skilled artisan that the inventors considered the ranges now
recited to be part of their invention. In this regard one must again make a
number of unguided departures from the subject matter actually disclosed.
See Purdue Pharma L.P. v. Faulding Inc., supra.
The Examiner has reasonably raised the written description issues
discussed above and, in response, Appellant has not adequately
demonstrated how, based on Appellant’s disclosure as originally filed, one
skilled in the art would have been able to immediately envisage, or have
been reasonably lead to, the subject matter now claimed. See Hyatt v. Dudas,
492 F.3d 1365, 1371, (Fed. Cir. 2007) (cited at MPEP § 2163(II)(B)) (“The
burden was [] properly shifted to [the inventor] to cite to the examiner where
adequate written description could be found or to make an amendment to
address the deficiency.”). Accordingly, we agree with the Examiner that
Appellant’s disclosure does not “reasonably lead” those skilled in the art to
the particular subject matter claimed.
The Examiner provides a thorough, comprehensive, and correct
analysis in response to Appellant’s arguments (Ans. 3–8) which we adopt as
our own in addition to the remarks above.
For the foregoing reasons, we sustain the Examiner’s written
description rejection.

Obviousness
Appellant’s sole contention with regard to the obviousness rejection is
that no reference expressly discloses the recited pair of sequential 60 second
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time periods and including such time periods would not have been an
obvious modification to Collins. Appeal Br. 10–12. Collins clearly discloses
following a brushing regimen with a peroxide-based whitening gel. Final
Act. 6 (citing Collins p. 485). The Examiner reasons that the skilled artisan
would understand a certain amount of time is required to clean and whiten
teeth with diminishing returns occurring thereafter, after the teeth have been
subject to the treatment. Ans. 10. Although the Examiner does not cite any
particular reference for this assertion, it seems to be reasonable and
persuasive, and Appellant does not apprise us of any flaws therein. Further,
it is noted that Collins makes it expressly clear that contact time is a known
result-effective variable in tooth-whitening. Collins p. 48, col. 1. Although
Collins may suggest a contact time of 1 hour per day for hydrogen peroxide,
and to the extent that such is precluded by the claim language, such a
disclosure does not change the fact that contact time was a known result-
effective variable. The Examiner correctly asserts there was no showing of
criticality, for example in the form of unexpected results in the selection of
“about 60 seconds” from among other possibilities. Ans. 9.
We note that it is not clear upon what disclosure Appellant bases the
assertion that “Collins directs users to apply whitening gels after the
completion of a 2-minute brushing session.” Appeal Br. 11. In any case,
obviousness does not require the cited references to expressly disclose the
subject matter claimed, and the Examiner has provided sound and unrebutted
reasoning concerning adjusting the brushing and whitening times to “about
60 seconds.”

5 The Examiner appears to have mistakenly typed 14 in place of 48.
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“Appellant disagrees that it would have been obvious to a person of
ordinary skill in the art to direct a user to brush for less time and apply a
whitening gel for less time and actually receive more benefits. . . . And while
consumers might have hurried through the procedures in Collins, the
whitening efficacy would have clearly suffered.” Appeal Br. 11. This
argument overlooks the fact that, in Collins, the goal of the selected
exposure times is not whitening per se. Rather, the exposure times are
“exaggerated” in order to evaluate the safety of hydrogen or carbamine
peroxide exposure. Collins, p. 1, Summary. Thus, one skilled in the art
would read Collins as actually recognizing and suggesting adjustment of
whitening times for the purpose of effective whitening.
For the foregoing reasons, we sustain the Examiner’s obviousness
rejection.
CONCLUSION
The Examiner’s rejections are AFFIRMED.
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DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
31, 33–35 112, first
paragraph
Written
Description
31, 33–35
31, 33–35 103(a) Collins, Riley,
Wasylucha, Sagel
31, 33–35
Overall
Outcome
31, 33–35
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