Ex Parte Rau

Board of Patent Appeals and Interferences

Jun 23, 2011

11263976 (B.P.A.I. Jun. 23, 2011)

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.
11/263,976 11/02/2005 Allen H. Rau PHYZ-0015-CO1 3949
80308 7590 06/24/2011
Steven B. Kelber
Berenato & White, LLC
6550 Rock Spring Drive
Suite 240
Bethesda, MD 20817
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
06/24/2011 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ALLEN H. RAU
____________

Appeal 2010-003858
Application 11/263,976
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
STEPHEN WALSH, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1 and 3-5, the only
claims pending in this application. We have jurisdiction under 35 U.S.C.
§ 6(b).
STATEMENT OF THE CASE
The claims are directed to a tablet composition. Claim 1 is
representative and is reproduced in the “Claims Appendix” of Appellant‟s
Brief (App. Br. 24).
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2
Claims 1 and 3-5 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Arnold,
1
Zimmermann,
2
Howell,
3
and
Noyes.
4

Claims 1 and 3-5 stand provisionally rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1-11 and 14-23
5
of Rau.
6

We affirm the rejection under 35 U.S.C. § 103(a). However, because
our rationale differs from that of the Examiner, we designate our affirmance
as a new ground of rejection. We reverse the rejection under the judicially
created doctrine of obviousness-type double patenting.

Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS
FF 1. Appellant discloses that lubricants within the scope of the claimed
invention includes magnesium stearate and sodium lauryl sulfate (Spec. 8:
16-17).

1
Arnold, US 6,086,854, issued July 11, 2000.
2
Zimmermann, US 2,211,485, issued August 13, 1940.
3
Howell, US 3,962,417, issued June 8, 1976.
4
Noyes, US 536,155, issued March 10, 1895.
5
While the Examiner included Rau‟s claims 24 and 25 in the statement of
the rejection (Ans. 7), these claims are no longer pending in Rau‟s
application. Accordingly, we have not included these claims in our
deliberations.
6
Rau, U.S. Patent Application 20070071817, published March 29, 2007.
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Application 11/263,976

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FF 2. Appellant discloses that sweeteners within the scope of the claimed
invention include “calcium or sodium saccharin, [and] aspartame” (Spec. 9:
3).
FF 3. Appellant discloses that flavor additives within the scope of the
claimed invention includes “mint types (peppermint, spearmint,
wintergreen)” (Spec. 9: 12-13).
FF 4. Appellant discloses that “[a]nticaries ingredients such as . . .
stannous fluoride” may be included in the composition (Spec. 10: 3-4).
FF 5. Howell teaches “[a]n effervescent dentifrice in chewable tablet form
. . . comprising a compressed homogenous mixture of an acid neutralizer, a
caries preventative, an acid, a wetting agent, and flavoring and sweetening
agents. Upon crushing the dentifrice tablet in the mouth, a pleasant-tasting,
effective microbicide is released” (Howell, Abstract).
FF 6. Howell exemplifies a dentrifrice tablet comprising saccharin, sodium
lauryl sulphate, magnesium stearate, magnesium carbonate, calcium
carbonate, sodium bicarbonate, citric acid, sealva floral mint, sealva
peppermint, and stannous fluoride (Howell, col. 3, ll. 6-18).
FF 7. Howell teaches that “[t]he tablet is particularly useful in cleaning
teeth and controlling decay, and is particularly effective in neutralizing
Bacillus Acidophilios” (Howell, col. 1, ll. 8-10).
FF 8. “[N]one of the ingredients of the dentifrice of . . . [Howell‟s]
invention are abrasive” (Howell, col. 2, ll. 41-43; Ans. 5).
FF 9. Howell discloses that “the tablet comprises approximately 70-75%
by weight, acid neutralizer and approximately 17-20%, by weight, acid,”
which suggests a carbonate to acid ratio range of 3.5:1 to 4.4:1 (70% acid
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Application 11/263,976

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neutralizer : 20% acid to 75% acid neutralizer : 17% acid) (Howell, col. 2, ll.
23-25).
FF 10. Howell exemplifies a composition that has a bicarbonate to acid ratio
of 3.9:1 (Howell, col. 3, ll. 6-18; Ans. 7; App. Br. 16).
FF 11. Howell‟s composition comprises “an excipient in order to provide
for a tabletable [sic] product,” e.g., a binder (Howell, col. 2, ll. 37-38).
FF 12. Arnold teaches an effervescent oral dentifrice composition (Arnold,
abstract and col. 1, ll. 9-11).
FF 13. Arnold‟s “invention is directed towards non-aqueous oral
compositions comprising a pharmaceutically acceptable form of bicarbonate
salt, or carbonate salt, or combinations thereof; an amorphous silica; and a
form of xylitol” (Arnold, col. 2, l. 66 - col. 3, l. 2; Ans. 3-4).
FF 14. Arnold teaches that “[t]he composition also contains a non-aqueous
pharmaceutically acceptable acid source” (Arnold, col. 3, ll. 39-40).
FF 15. Arnold teaches that “[c]itric acid is [the] preferred” fruit acid
(Arnold, col. 6, l. 11).
FF 16. Arnold teaches that the composition “most preferably [comprises]
from about 1 part fruit acid to about 1.5 part to 5 parts bicarbonate ion”
(Arnold, col. 6, ll. 21-23; Ans. 4).
FF 17. Arnold teaches that xylitol is an anti-caries agent (Arnold, col. 3, l.
15).
FF 18. Arnold exemplifies a dentrifrice tablet comprising aspartame,
sodium lauryl sulphate, magnesium stearate, sodium bicarbonate, citric acid,
mint flavoring, and xylitol (Arnold, col. 6, ll. 50-63; Ans. 3-4).
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FF 19. Arnold teaches that “[i]f a carbonate source is used in place of
bicarbonate, the amount of fruit acid should be adjusted accordingly to
maintain pH of neutral or greater in test solution” (Arnold, col. 6, ll. 15-18).
FF 20. Arnold teaches that
Sufficient bicarbonate or carbonate salt is employed in
the composition so that in an aqueous pH test mixture of the
composition, the acid or the acid salt is completely neutralized
by the bicarbonate or carbonate salt, and that an excess of the
bicarbonate or carbonate salt is employed such that a basic pH
of the aqueous solution (>7), is maintained from minimum of 1
minute to about 1 hour, or greater, depending on the patient and
specific composition of the present invention that is employed.

(Arnold, col. 3, ll. 48-57; Ans. 4.)
FF 21. The Examiner relies on Howell, Zimmerman, and Noyes to establish
that a variety of carbonate to acid component ratios were known in the art at
the time this invention was made (Ans. 4-6).
ANALYSIS
Appellant states that “[c]laims 1 and 3-5 stand or fall together with
respect to this rejection” (App. Br. 13). Claim 1 is representative.
Howell suggests a tablet composition for use in the oral cavity of a
user (FF 5). Howell‟s effervescent composition comprises a combination of
an acid component and a carbonate salt component (FF 5, 6, 9, and 10).
Howell suggests the use of magnesium carbonate, calcium carbonate,
sodium bicarbonate, and citric acid (FF 6). Howell‟s composition further
comprises a flavoring agent, a binder, a lubricant and is free of materials that
are abrasive to the oral cavity of the user (FF 5, 6, 8, and 11; Cf. 1-4).
Howell differs from the claimed invention by suggesting a carbonate
to acid ratio range of 3.5:1 to 4.4:1 (FF 9). In this regard, we recognize that
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Howell exemplifies a composition that has a bicarbonate to acid ratio of
3.9:1 (FF 10). In addition, Howell fails to identify the pH of a 1.0% by
weight aqueous solution of the composition.
Arnold, however, makes up for the forgoing deficiencies in Howell.
Arnold suggests an effervescent oral dentifrice composition that is
substantially similar to that of Howell (see FF 18; Cf. FF 6).
7
While
Arnold‟s dentifrice composition includes an abrasive (amorphous silica),
Howell suggests a dentifrice composition that utilizes non-abrasive materials
(see FF 13; Cf. FF 8). In addition, Arnold suggests that the carbonate to acid
ratio in effervescent oral dentifrice compositions, like Howell‟s, can be in
the range of 1.5:1 to 5:1 (see FF 16; Cf. FF 9-10).
Therefore, the range suggested by the combination of Howell and
Arnold encompasses Appellant‟s claimed range of 2.33:1 to 3.33:1.
“[W]here there is a range disclosed in the prior art, and the claimed
invention falls within that range, there is a presumption of obviousness.”
Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir.
2004). Further, as the Examiner explains, a variety of carbonate to acid
component ratios were known in the art at the time this invention was made
(see, e.g., FF 9, 10, 16, and 21). “[I]t is not inventive to discover the
optimum or workable ranges by routine experimentation.” In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997), quoting In re Aller, 220 F.2d 454, 456
(CCPA 1955).

7
Accordingly, we are not persuaded by Appellant‟s contention that Howell‟s
composition is “totally different” or “diametrically different” from Arnold‟s
“suggestion for treating teeth or the oral cavity” (Reply Br. 5). To the
contrary Howell suggests compositions “particularly useful in cleaning teeth
and controlling decay” (FF 7).
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Given the foregoing, we are not persuaded by Appellant‟s contention
that despite the range of carbonate to acid component ratios set forth in the
prior art, the specific ratio of carbonate to acid component set forth in
Appellant‟s claimed invention would not have been obvious to a person of
ordinary skill in this art at the time the invention was made because “too
much carbonate leads to a salty taste, and can inhibit dissolution of the
product in the mouth [and] [t]oo much acid [can] make a bitter product
which is damaging to the teeth” (App. Br. 15). As discussed above, the prior
art suggests a variety of carbonate to acid component ratios including a
range that encompasses the claimed range. Given the foregoing, we find
that it would have been prima facie obvious to a person of ordinary skill in
this art at the time the invention was made to optimize the carbonate to acid
component ratio by routine experimentation.
Appellant contends that the “comparative experiments presented in
the specification” establish that “too low a ratio (1.67:1) gives a bitter or tart
product, Example A, B and C, Table 1, page 12” (App. Br. 15; Spec. 12:
Table 1). We are not persuaded. Not only is Appellant‟s contention based
on a subjective measurement (i.e., a particular individual‟s taste), the data
itself fails to support Appellant‟s contention. As presented in Example D of
Appellant‟s Table 1, a composition having a carb/acid ratio of 2.67:1, which
is within Appellant‟s claimed range, resulted in a slightly tart composition
(Spec. 12: Table 1(Example D)). Therefore, notwithstanding Appellant‟s
contention to the contrary the data presented in Appellant‟s Specification
establishes that a composition comprising a carbonate to acid ratio within the
scope of Appellant‟s claimed invention results in a bitter product.
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We disagree with Appellant‟s contention that Arnold is limited to a
teaching of “a ratio of carbonate component to acid component of more than
5:1” (App. Br. 16; see also Reply Br. 3; Cf. FF 16). However, we agree with
Appellant that Zimmerman, Howell, and Noyes each teach a carbonate to
acid ratio that is outside of the claimed range (App. Br. 16). Nevertheless,
we agree with the Examiner‟s finding that the combination of references
suggest that a variety of carbonate to acid ratios were known in the art at the
time this invention was made, including a range that encompasses the
claimed range (FF 9, 10, 16, and 21 ).
8
Accordingly, we conclude that it
would have been obvious to determine an optimum or workable range by
routine experimentation (Geisler, 116 F.3d at 1470), as a presumption of
obviousness exists when a claimed range falls within a range disclosed in the
prior art (Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d at 1322).
Therefore, we are not persuaded by Appellant‟s contention that the prior art
fails to suggest the claimed invention because the precise range for the ratio
of carbonate to acid set forth in claim 1 was not expressly stated in the prior
art (App. Br. 17). Further, to the extent that Appellant contents that Table 1
of the Specification establishes an unexpected results related to the claimed
invention, we are not persuaded for the reasons set forth above.
Further, in addition to suggesting a range for the ratio of carbonate to
acid that encompasses Appellant‟s claimed range, Arnold suggests that the
dentifrice composition provides for a pH of “>7” (FF 19-20). We find a pH

8
We recognize and agree with Appellant‟s interpretation of the Zimmerman
reference (Reply Br. 2). Nevertheless, we find no error in the Examiner‟s
reliance on Zimmerman and other references to establish that the prior art
suggested compositions comprising carbonate and acid at various ratios (FF
9, 10, 16, and 21).
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of >7 reads on a pH of about 7.0 as is required by Appellant‟s claimed
invention. Accordingly, we are not persuaded by Appellant‟s contention
that the prior art relied upon by the Examiner fails to suggest a composition
that “gives a pH on dissolution of . . . about 7.0” (App. Br. 19; see also
Reply Br. 4).
We are not persuaded by Appellant‟s contentions regarding the
abrasive in Arnold‟s composition (App. Br. 19-20; see also Reply Br. 5).
Howell‟s composition does not require an abrasive material and we find no
nothing in the combination of prior art relied on by the Examiner to suggest
that Howell‟s composition be modified to include an abrasive.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 1 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Arnold, Zimmermann, Howell, and
Noyes is affirmed. However, because our rationale differs from that of the
Examiner, the affirmance is designated a new ground of rejection. Because
they are not separately argued claims 3-5 fall together with claim 1.
37 C.F.R. § 41.37(c)(1)(vii).

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10
Provisional Obviousness-type Double Patenting:
ISSUE
Does the preponderance of evidence on this record support the
Examiner‟s provisional obviousness-type double patenting rejection?
FACTUAL FINDINGS
FF 22. Claim 1 of Rau is directed to a “composition comprising an
effervescent combination of an acid and a carbonate salt dissolved in water,
wherein the composition has an osmolality of 310 mOsm/kg of water or
less” (Rau, claim 1).
FF 23. Rau‟s claims 2-11 and 14-18 depend directly from claim 1 (Rau,
claims 2-11 and 14-18).
FF 24. Rau‟s claim 8 depends from and further limits the composition of
claim 1 to further comprise “binders, fillers, and/or lubricants” (Rau, claim
8).
FF 25. Rau‟s claim 19 is directed to a “method comprising: dissolving a
solid composition comprising an effervescent acid and a carbonate salt in
water to form an effervescent solution; and contacting the effervescent
solution with oral tissue of a subject; wherein the solution has an osmolality
of 310 mOsm/kg or less” (Rau, claim 19).
FF 26. Rau‟s claims 20-23 depend directly from claim 19 (Rau, claims 20-
23).
FF 27. The Examiner finds that “[o]smolality is a function or property of the
components in a composition” (Ans. 8).
ANALYSIS
Based on the foregoing facts the Examiner concludes that “it is
reasonable that the same components with an equivalent pH will reasonably
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have the same osmolality because „[p]roducts of identical chemical
composition can not [sic] have mutually exclusive properties‟” (Ans. 11).
We are not persuaded that the Examiner has established, by a preponderance
of evidence, that Rau‟s claims suggest a composition that comprises the
same components as the composition set forth in the claims before us on
appeal.
As the Examiner recognizes, the osmolality of a composition “is a
function or property of the components in a composition” (FF 27).
Appellant agrees and explains that the osmolality of a composition varies
dependent on the choice of lubricant, binder, carbonate salt(s), acid(s), and
flavoring selected to be part of the composition (Reply Br. 9). Therefore,
Appellant concludes that two compositions “having a similar pH could have
very similar, or wildly different, osmolalities” (id.). We agree.
On this record, the Examiner failed to establish an evidentiary basis to
support a conclusion that a composition within the scope of the claims
before us on appeal would necessarily comprise the particular components
necessary to provide the composition with an osmolality of 310 mOsm/kg of
water or less as is required by Rau‟s claimed invention. Stated differently,
the Examiner‟s intimation that the composition set forth in the claims before
us on appeal would necessarily have the same osmolality as a composition
suggested by Rau‟s claims rejection (see Ans. 11) lacks the requisite
evidentiary foundation necessary to support the provisional obviousness-
type double patenting.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support the
Examiner‟s provisional obviousness-type double patenting rejection. The
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provisional rejection of claims 1 and 3-5 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1-11 and 14-23 of Rau is reversed.

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .

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; 37 C.F.R. § 41.50(b)

cdc