Ex Parte Fischer

Patent Trial and Appeal Board

Jun 4, 2013

11733490 (P.T.A.B. Jun. 4, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAN E. FISCHER
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Appeal 2012-003010
Application 11/733,490
Technology Center 1600
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Before DONALD E. ADAMS, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
Claims 1-20 are pending and rejected. Claims 1 and 15 are
representative.
1. A method of bleaching a person's teeth and reducing tooth
sensitivity, comprising:
providing a dental bleaching and desensitizing composition comprised of:
a peroxide dental bleaching agent included in an amount so as to have
a tooth whitening effect when used to bleach teeth;
potassium nitrate in an amount so as to at least partially offset tooth
sensitivity caused by the peroxide dental bleaching agent;
a fluoride salt in an amount so as to at least partially offset tooth
sensitivity caused by the peroxide dental bleaching agent; and
a carrier; and
contacting a person's teeth with the dental bleaching and desensitizing
composition for at least about 15 minutes and so that the peroxide dental
bleaching agent has a whitening effect on the person's teeth,
the potassium nitrate and fluoride salt both acting to at least partially
offset tooth sensitivity caused by the peroxide dental bleaching agent.

6. A method as recited in claim 1, wherein the potassium nitrate is
included in a range of about 0.01 % to about 2% by weight of the dental
bleaching and desensitizing composition.

7. A method as recited in claim 1, wherein the potassium nitrate is
included in a range of about 0.05% to about 1 % by weight of the dental
bleaching and desensitizing composition.

8. A method as recited in claim 1, wherein the potassium nitrate is
included in an amount of about 0.5% by weight of the dental bleaching and
desensitizing composition.

15. A method of bleaching a person's teeth and reducing tooth
sensitivity, comprising:
providing a dental bleaching and desensitizing composition comprised of:
a peroxide dental bleaching agent included in an amount so as to have
a tooth whitening effect when used to bleach teeth;
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potassium nitrate in an amount in a range of about 0.01 % to about 2%
by weight of the dental bleaching and desensitizing composition so as to at
least partially offset tooth sensitivity caused by the peroxide dental
bleaching agent;
fluoride in an amount of about 0.1 % to about 1 % by weight of the
dental bleaching and desensitizing composition so as to at least partially
offset tooth sensitivity caused by the peroxide dental bleaching agent; and
a carrier; and
contacting a person's teeth with the dental bleaching and desensitizing
composition for at least about 15 minutes and so that the peroxide dental
bleaching agent has a whitening effect on the person's teeth,
the potassium nitrate and fluoride both acting to at least partially
offset tooth sensitivity caused by the peroxide dental bleaching agent.

18. A method of bleaching a person's teeth and reducing tooth sensitivity,
comprising:
providing a dental bleaching and desensitizing composition comprised of:
a peroxide dental bleaching agent included in an amount so as to have
a tooth whitening effect when used to bleach teeth;
potassium nitrate in an amount so as to at least partially offset tooth
sensitivity caused by the pro xi de dental bleaching agent;
a fluoride salt in an amount so as to at least partially offset tooth
sensitivity caused by the peroxide dental bleaching agent; and
a carrier comprising a tackifying agent and a polyol;
introducing a quantity of the dental bleaching and desensitizing composition
into a dental tray; and
placing the dental tray over a person's teeth for at least about 15
minutes in order for the dental bleaching and desensitizing composition to
contact and have a whitening effect on the person's teeth,
the potassium nitrate and fluoride salt both acting to at least partially
offset tooth sensitivity caused by the peroxide dental bleaching agent.

19. A method as recited in claim 18, the potassium nitrate being
included in a range of about 0.05% to about 1 % by weight of the dental
bleaching and desensitizing composition.

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Cited References

Frazier et al. US 4,980,152 Dec. 25, 1990
Yarborough US 4,983,380 Jan. 8, 1991
Ibsen et al. US 6,458,340 B1 Oct. 1, 2002

Grounds of Rejection
Claims 1-20 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ibsen in view of Frazier.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 5-
17.

Discussion
ISSUE
The Examiner finds that
Ibsen et al. disclose desensitizing bleaching gels
comprising at least 25% by weight of an organic polyol, a
thickening agent, at least 10% by weigh carbamide peroxide or
equivalent and a desensitizing agent (Abstract). Bleaching
agents include hydrogen peroxide and carbamide peroxide (col.
4, lines 15-20). The desensitizing agent comprises 0.1 to 10%
by weight and includes potassium nitrate (ref. claims 10-13).
The compositions are delivered by a dental tray (col. 6, lines
48-52). The reference also discloses that gels are used to
deliver fluorides (col. 1, lines 23-25). The reference differs
from the instant claims insofar as it does not disclose fluoride is
used in the disclosed dental gels.
Frazier et al. disclose compositions comprising hydrogen
or urea peroxide and about 0.01 % to about 2% of a fluoride
containing component (Abstract). The fluoride is used to add
anti-caries activity. With the cleansing ability of the peroxide,
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the fluoride would have maximum opportunity to reach the
tooth surface and gingival margins (col. 1, lines 30-34). The
compositions also comprise thickening agents and glycerine
(Abstract). The reference differs from the instant claims insofar
as it does not disclose a method for bleaching and desensitizing
teeth or a potassium nitrate desensitizing agent.

[I]t is prima facie obvious to select a known material for
incorporation into a composition, based on its recognized
suitability for its intended use. … It would have been obvious
to one of ordinary skill in the art to have added fluoride to the
compositions to use in the bleaching methods of Ibsen et al
motivated by the desire to provide effective anti-caries activity
to the compositions when applying the bleaching gel to the
teeth as disclosed by Frazier et al.

(Ans. 5-6.)

Appellant contends that Ibsen teaches an anhydrous dental bleaching
gel while Frazier teaches an aqueous oral disinfecting rinse. Appellant
further argues that
As evidenced by Frazier et al., besides its use as a dental
bleaching agent, peroxides have also been used in curative or
prophylactic treatments with respect to caries, dental plaque,
gingivitis, and periodontitis. Peroxides can exert a chemo-
mechanical action by generating thousands of tiny disinfecting
oxygen bubbles produced by interaction with tissue and
salivary enzymes. The swishing action of a mouth rinse
enhances this inherent chemo-mechanical action (See col. 1
lines 9-17 of Frazier et al.). Importantly, the contact time of the
peroxide with the teeth is substantially shorter for such
treatments (e.g., typically not more than about 1 minute) as
compared to dental bleaching methods according to the claimed
invention, which require a minimum contact time of about 15
minutes to be effective to bleach teeth and also cause acute
tooth sensitivity.

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(App. Br. 6.) Appellant argues that Frazier does not contain any teaching or
suggestion that fluoride is effective in treating tooth sensitivity caused by
peroxide bleaching agents. (Id. at 7.) Appellant concludes that,
one of skill in the art would not look to Frazier et al., and have
no logical reason to consider the fluoride teachings of Frazier et
al. and they modify Ibsen et al. by addition of a fluoride salt
because they are concerned with quite different problems
(whitening of teeth with relatively long-term application of
peroxide versus short-term application of a peroxide/fluoride
composition to disinfect).

(Id. at 7-8.) Appellant argues that the comparative example in the
Specification at pages 29-30 evidences unexpected results for the
composition with 0.5% potassium nitrate (claims 6-7). (Id. at 10-11.)
The issue is: Does the cited prior art support the Examiner’s
conclusion that the claimed subject matter is legally obvious? Are
Appellant’s proffered unexpected results sufficient to rebut the Examiner’s
prima facie case of obviousness?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
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issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“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 combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“[T]here must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006).
The motivation to combine references does not have to be identical to
the applicants to establish obviousness. In re Kemps, 97 F.3d 1427, 1430
(Fed. Cir. 1996).

ANALYSIS
Appellant provides separate argument for claims 6-8, 15 and 19.
(App. Br. 10-12.) These claims recite specific amounts of potassium nitrate
and fluoride. We address these limitations together with the primary
rejection.
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellant’s arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness.
The method of claim 1 provides a dental bleaching and desensitizing
composition comprised of specific ingredients. No amount of potassium
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nitrate or fluoride is recited in claim 1. The composition provided in the
method of claim 1 is open to other ingredients including water, as the dental
bleaching and desensitizing composition claim language uses the transitional
phrase “comprised of.” We further note that Appellant’s Example 2, Spec.
page 28, includes 20% water.
We find that the Examiner has presented a prima facie case of
obviousness on the evidence before us. Ibsen essentially teaches each
element claimed except for the inclusion of fluoride in its peroxide
containing dental gel composition. Frazier discloses that it is known to
include 0.2% to about 1% fluoride in a peroxide containing dental gel
composition. (Col. 1, ll. 5-7; col. 2, ll. 33-48.) This disclosure encompasses
the specifically claimed fluoride amount of claims 9 and 15. According to
Appellant’s Specification page 21, a desensitizing amount of fluoride is in
the range of 0% to about 1%, more preferably from 0.1% to about 0.5% of
the dental whitening composition. The Specification at page 8, further
indicates that fluoride salts have been found to inherently offset tooth
sensitivity that may be caused by a peroxide bleaching agent.
While Appellant argues that Frazier does not teach that fluoride
offsets tooth sensitivity (App. Br. 7), we note that the Examiner’s motivation
to combine the cited references does not have to be the same as Appellants
to establish a prima facie case of obviousness. In re Kemps, 97 F.3d at 1430.
The Examiner’s finding that it is well known to include fluoride, at
concentration that falls within the scope of Appellant’s claimed invention,
in a peroxide containing dental gel for its anti-caries activity (Frazier, col. 1,
l. 31) is sufficient to support a prima facie case of obviousness. Adding
fluoride to treat dental caries as suggested by Frazier in the gel of Ibsen
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would inherently offset tooth sensitivity caused by the peroxide bleaching
agent. (Spec. 21.) See, In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Appellant argues that the contact time of the peroxide with the teeth in
Frazier is substantially shorter for such treatments (e.g., typically not more
than about 1 minute) as compared to dental bleaching methods according to
the claimed invention, which require a minimum contact time of about 15
minutes to be effective to bleach teeth and also cause acute tooth sensitivity.
(App. Br. 6.) We are not persuaded.
The Examiner relies on Ibsen for the disclosure of the claimed
contacting time of the bleaching and desensitizing gel composition. Ibsen
teaches a contact time “ranging anywhere from thirty minutes to eight
hours.” (Col. 6, ll. 58-62.) In addition, Frazier discloses that peroxide
containing gels and pastes are desirable where it is required to selectively
treat areas for more than a few seconds. (Col. 1, ll. 25-30.) “Such gels and
pastes tend to remain at the site of application for a time sufficient for the
peroxide to manifest its maximum effectiveness.” (Id.) We find that the
prior art cited by the Examiner suggests a minimum contact time of 15
minutes in a peroxide containing gel composition, as claimed.
Appellant argues that the “use of substantial water in Frazier et al.
entirely contradicts the critical requirement in Ibsen et al. that the
composition be anhydrous to prevent it from being quickly diluted by saliva
and washed into the oral cavity.” (App. Br. 7.) We are not persuaded by
Appellant’s argument. As discussed herein, Frazier not only discloses liquid
peroxide dental containing compositions, but also discloses peroxide
containing gels and pastes, similar to those disclosed by Ibsen (col. 1, l. 9).
While Ibsen’s gel compositions are “substantially anhydrous” “in some of
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the gel components. Small amounts of water are not overly detrimental.”
(Col. 2, ll. 38-44.) Thus, we find no incompatibility between the
disclosures of Ibsen and Frazier with respect to water content of the peroxide
containing gel composition. We further agree with the Examiner that, “when
the compositions of Ibsen comprising fluoride are placed on the teeth, the
fluoride will gradually be released and contact the teeth when the
compositions are exposed to the saliva in the mouth.” (Ans. 7.)
“[W]hen a prima facie case is made, the burden shifts to the applicant
to come forward with evidence and/or argument supporting patentability.”
In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002). In this case Appellant
puts forth rebuttal evidence in the form of unexpected desensitizing results
which are obtained when using the claimed method. (App. Br. 11; Reply Br.
9.)
The Examiner finds Appellant’s evidence of unexpected results to be
unconvincing and not commensurate in scope with the pending claims.
(Ans. 15-17.) We also are not persuaded by Appellant’s evidence of
unexpected results. To begin, Appellant relies on comparative results set
forth in Table 1, pages 29-30 of the Specification. Table 1 compares the
composition of Appellant’s Example 2 (Spec. 28) [Table 1 Compound E]
with four other comparative compositions. We note however, that the
claims require fluoride be present in the peroxide containing gel composition
and Example 2 of the Specification contains no fluoride. Thus, Appellant’s
comparative data is not commensurate in scope with the pending claims. In
addition, Claim 1 does not specify an amount of potassium nitrate and is not
limited to the amount of 0.5% used in Example 2 of the Specification.
Therefore the one potassium nitrate data point argued by Appellant as
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providing unexpected results is not commensurate in scope with the breadth
of potassium nitrate in claim 1. While claim 15 does limit the amount of
potassium nitrate to an amount in a range of about 0.01 % to about 2%,
comparative Examples B-D in Table 1 of the Specification specify 3% of
potassium nitrate. Therefore the claim 15 potassium nitrate range of about
2% could potentially include the 3% of the comparative examples B-D. Put
another way, Appellant’s attempt to show unexpected results for one data
point, 0.5% potassium nitrate, but their results do not support data points up
to about 2% potassium nitrate within the scope of the pending claims. Such
argument also applies to the specifically claimed ranges of potassium nitrate
in claims 6-8, 15 and 19.
We do not find Appellant’s evidence of unexpected results to be
commensurate in scope with the pending claims. The obviousness rejection
is affirmed for the reasons of record.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection.
Appellant’s evidence of unexpected results is not commensurate in scope
with the pending claims.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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