Ex Parte Rau

Patent Trial and Appeal Board

Apr 21, 2015

11234312 (P.T.A.B. Apr. 21, 2015)

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.
11/234,312 09/26/2005 Allen H. Rau PHYZ-0011-UT1 1054
80308 7590 04/22/2015
Steven B. Kelber
Law Offices of Marc R. Labgold, P.C.
12007 Sunrise Valley Drive
Suite 110
Reston, VA 20191
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
04/22/2015 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ALLEN H. RAU
__________

Appeal 2013-000004
Application 11/234,312
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ROBERT A. POLLOCK, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
composition comprising an effervescent combination of citric acid and
sodium bicarbonate dissolved in water. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellant identifies the Real Party in Interest as Tower
Laboratories, Ltd. (see App. Br. 2).

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Application 11/234,312

Statement of the Case
Background
“This application relates generally to oral care products and, in
particular, to effervescent oral care compositions that include an effervescent
acid and a carbonate salt and to the use of these compositions” (Spec. 1, ll.
11–13).
The Claims
Claims 1, 2, 8, and 10–17 are on appeal. Appellant does not
separately argue dependent claims 2, 8, and 10–17. Therefore, these claims
fall with claim 1. 37 C.F.R. § 41.37(c)(1). Independent claim 1 reads as
follows:
1. A composition comprising an effervescent
combination of citric acid and sodium bicarbonate dissolved
in water, wherein the composition has an osmolality of 310
mOsm/kg of water or less.

The issue
The Examiner rejected claims 1, 2, 8, and 10–17 under 35 U.S.C.
§ 103(a) as obvious over Ammon,2 Sack,3 Alka-Seltzer Gold,4 and Rudnic5
(Ans. 3–6).
2 Ammon, Jr., et al., US 2004/0204496 A1, published Oct. 14,
2004.
3 Sack, D., US 5,741,680, issued Apr. 21, 1998.
4 Alka-Seltzer Gold, http://www.alka-seltzer.com/as/as_gold.html
(accessed 4/20/2010).
5 Rudnic, E. and Schwartz, J., Oral Solid Dosage Forms, in
Remington’s Pharmaceutical Sciences 1633–1665 (Alfonso R.
Gennaro Ed. 1990).
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Application 11/234,312

The Examiner finds that “Ammon teaches a disinfecting solution . . .
Said composition has a pH 4-9, and preferably 6-8 and an osmolality of
preferably 175 to 320 mOsm/kg” (Ans. 3). The Examiner finds that
“Ammon further teaches that suitable buffers for the composition include
citric acid and sodium bicarbonate and combinations thereof” (Ans. 3). The
Examiner finds that “Ammon, while teaching that sodium bicarbonate and
citric acid can be present as buffers, fails to directly exemplify their use in
combination” (Ans. 4).
The Examiner finds that Sack teaches “that Alka-Seltzer is a
commercially known buffering agent for oral compositions which comprises
sodium bicarbonate, citric acid, and potassium bicarbonate” (Ans. 4).
The Examiner finds the claims obvious because “Ammon teaches that
the composition of Ammon is useful for oral delivery (see [0078])], wherein
the buffer can comprise citric acid and sodium bicarbonate (see [0019]),
wherein Sack identifies that Alka-Seltzer is a known oral buffering agent
which comprises said citric acid and sodium bicarbonate” (Ans. 4). The
Examiner notes that “[w]ith regard to the limitation that the composition has
an osmolality of 310 or less, . . . Ammon teaches that the osmolality is most
preferably 175-320 mOsm/kg” (Ans. 5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Ammon, Sack, Alka-Seltzer Gold
and Rudnic render the claims prima facie obvious?
Findings of Fact
1. Ammon teaches “solutions effective for rapidly disinfecting
bacterial endospore laden surfaces, air and/or water comprising bacterial
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endosporicidally effective amounts of a biguanide or water-soluble salts
thereof” (Ammon 1 ¶ 8).
2. Ammon teaches that the “pH of the subject solutions can range
between 4.0 to 9.0 . . . . As mentioned above, one or more buffers may be
employed to obtain the desired pH value” (Ammon 2 ¶ 19).
3. Ammon teaches that the “the subject solutions may include a
‘mixed buffer’ of tromethamine [TRIS] and one or more other buffer agents”
(Ammon 2 ¶ 19).
4. Ammon teaches that:
Other suitable buffers include for example but are not
limited to borate buffers such as but not limited to boric
acid, potassium tetraborate, potassium metaborate, sodium
borate and mixtures thereof, phosphate buffers such as but
not limited to Na2HPO4, NaH2PO4 , KH2PO4 and mixtures
thereof, citrate buffers such as for example but not limited to
sodium citrate, potassium citrate, citric acid and mixtures
thereof, sodium bicarbonate, amino alcohol buffers and
combinations thereof.

(Ammon 2 ¶ 19; emphasis added). Ammon claims a disinfecting solution
“wherein said solution includes one or more buffers selected from the
group consisting of tromethamine, borate buffers, phosphate buffers, citrate
buffers, Tris (hydroxymethyl)aminomethane, sodium bicarbonate and
amino alcohol buffers” (Ammon 11, claim 15; emphasis added).
5. Ammon teaches that “[o]ne or more buffers are preferably
added to solutions of the present invention in amounts ranging between
approximately 0.01 to 2.0 weight percent by volume” (Ammon 2 ¶ 19).
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6. Table I of Ammon is reproduced, in part, below:

Table I shows four solutions, solutions 34, 35, 36, and 37, that include two
buffering agents, either the combination of Na Borate (0.018%) and Boric
acid (0.12%) or Na Phos. (m) (0.08%) and Na Phos. (di) (0.39%), but do not
include a Tris buffering agent.
7. Ammon teaches that:
Solutions of the present invention may be designed
for a variety of osmolalities. Preferably, solutions in
accordance with the present invention have an osmotic value
of less than about 350 mOsm/kg, more preferably from
about 175 to about 330 mOsmlkg, and most preferably from
about 175 to about 320 mOsm/Kg. One or more osmolality
adjusting agents may be employed in the subject solutions to
obtain the desired final osmolality.

(Ammon 2 ¶ 20).
8. Ammon teaches “examples of pharmaceutically acceptable
forms of the subject solutions include . . . oral . . . or in any other form
effective to deliver active components of the present invention to a site of
microorganism infection” (Ammon 10 ¶ 78).
9. Sack teaches “a commercially available buffer (STANDARD
BUFFER) Alka-Seltzer (registered Trademark)” (Sack, col. 6, ll. 39–41).
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10. Alka-Seltzer Gold teaches that the active ingredients are
effervescent and comprise anhydrous citric acid, potassium bicarbonate and
sodium bicarbonate (Alka-Seltzer Gold).
Principles of Law
“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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
“A prima facie case of obviousness typically exists when the ranges
of a claimed composition overlap the ranges disclosed in the prior art.” In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)
Analysis
Ammon teaches disinfecting compositions (FF 1) that may be orally
administered (FF 8). Ammon teaches that the compositions “have an
osmotic value of less than about 350 mOsm/kg . . . most preferably from
about 175 to about 320 mOsm/Kg” (FF 7), substantially overlapping the
range recited in claim 1 “wherein the composition has an osmolality of 310
mOsm/kg of water or less.” Peterson, 315 F.3d at 1329.
Ammon teaches a pH range of 4 to 9 and that “one or more buffers
may be employed to obtain the desired pH value” (Ammon 2 ¶ 19; FF 2).
Ammon teaches the use of a variety of buffers including citric acid and
sodium bicarbonate and “combinations thereof” (FF 4), specifically teaching
mixed buffers (FF 3). While many of Ammon’s exemplary compositions
include mixed buffers with TRIS as one of the buffer constituents (FF 3),
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Ammon does not require the use of TRIS in mixed buffers. Ammon
specifically teaches four exemplary compositions, solutions 34–37, that do
not include TRIS. Solutions 34 and 35 teach the combination of Na Borate
and boric acid as the mixed buffers in combination (FF 4, 6). Solutions 36
and 37 teach the combination of Na2HPO4 and NaH2PO4 as the mixed
buffers in combination (FF 4, 6).
Sacks evidences that the combination of sodium bicarbonate and citric
acid found in Alka-Seltzer is “a commercially available buffer” (FF 9) and
Alka-Seltzer Gold confirms that the combination of sodium bicarbonate and
citric acid is effervescent, as required by claim 1 (FF 10).
Under these circumstances, we agree with the Examiner that it is fair
to say that there were “a finite number of identified, predictable solutions” to
the problem of finding physiological buffering agents for the biguanide
solution of Ammon, and that the combination of sodium bicarbonate and
citric acid as the buffer combination chosen was “the product not of
innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421.
That Ammon “discloses a multitude of effective combinations does not
render any particular formulation less obvious.” Merck & Co., Inc. v.
Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). We note
that Appellant provides no evidence of any secondary consideration such as
unexpected results.
This result is consistent with the Wrigley, where the Federal Circuit
found a “strong case of obviousness based on the prior art references of
record. [The claim] recites a combination of elements that were all known
in the prior art, and all that was required to obtain that combination was to
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Application 11/234,312

substitute one well-known . . . agent for another.” Wm. Wrigley Jr. Co. v.
Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). The
instant case is also factually similar to Wrigley. In Wrigley there was a
single reference which taught a number of different cooling agent
combinations as well as additional prior art teaching that the specific
combination of cooling agents was also known. Id. at 1361, 1364. The
Examiner’s rejection tracks this fact pattern, with Ammon suggesting a
number of different buffers which may be used in combination (FF 2–6),
Sacks teaching that the specific combination of sodium bicarbonate and
citric acid was well known as Alka-Seltzer, a commercially available buffer
(FF 9) and Alka-Seltzer Gold further establishing the effervescent nature of
the buffer combination (FF 10).
For these reasons, we adopt the Examiner’s findings of fact and
reasoning regarding the scope and content of the prior art (Ans. 5–8; FF 1–
10) and agree that the claims are rendered obvious by Ammon, Sack, and
Alka-Seltzer Gold. We address Appellant’s arguments below.
Appellant contends that “Ammon is simply not directed to, or even
close to, an oral care composition” (App. Br. 9).
We find this argument unpersuasive because Ammon specifically
teaches that “examples of pharmaceutically acceptable forms of the subject
solutions include . . . oral . . . or in any other form effective to deliver active
components of the present invention to a site of microorganism infection”
(Ammon Jr. 10 ¶ 78; FF 8). In light of Ammon’s express teaching that the
composition may be delivered orally, we find Appellant’s arguments,
lacking supporting evidence, insufficient to rebut the express teaching of
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Ammon. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997)
(“[A]ttorney argument [is] not the kind of factual evidence that is required to
rebut a prima facie case of obviousness”).
Appellant contends that “Sack suggests as a buffer a carbohydrate rich
(high osmolality) buffer coupled with an electrolyte” (App. Br. 10).
Appellant contends that “Rau specifically notes that one of skill in the art,
using or starting with Alka-Seltzer Gold as a buffer, could not prepare a
solution having an osmolality of 310 mOsm/kg or less, even if motivated to
do so” (App. Br. 11). Appellant contends that “modifying Ammon to
include Alka-Seltzer Gold as a buffer will give a solution of even higher
osmolality, because at a minimum that solution must include the biguanide
that is the central and essential ingredient of Ammon” (App. Br. 11).
We find these arguments unpersuasive. Ammon specifically teaches
that the osmolality of the solution is preferably within the range of 175 to
320 mOsm/Kg (FF 7). Ammon teaches, consistent with the knowledge of
the ordinary artisan, that “[s]olutions of the present invention may be
designed for a variety of osmolalities” (Ammon 2 ¶ 20; FF 7). The
Examiner also points out that the Rau Declaration6 teaches that the ordinary
artisan would minimally have an “undergraduate degree from a major
University in chemistry or a similar discipline, and have experience in the
measurement of osmolality. They would further be able to prepare solutions
as directed, and consider the osmolality of various solutions so prepared.”
(Rau Dec. 3 ¶ 5).
6 Declaration of Allen Rau, filed November 3, 2011.
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Therefore, the evidence of record supports the Examiner’s position
that the ordinary artisan, informed by Ammon that the desirable osmolality
of the solution is within the range of 175 to 320 mOsm/Kg, would have been
able to select amounts of buffers such as the combination of sodium
bicarbonate and citric acid taught by Sack and Alka-Seltzer Gold, which
when combined with biguanide and other desired components would have
routinely modified to resulte in the desired osmolality. Ammon exemplifies
solutions with osmolalities in the desired (and instantly claimed) range as
shown by solutions 30 to 37 which have osmolalities ranging from 190 to
227 mOsm/kg (FF 6), well within the range required by claim 1. Indeed, the
highest osmolality in the 50 solutions exemplified by Ammon was 234
mOsm/kg for solution 17 (see Ammon, table 1), which is also below the
upper limit of 310 mOsm/kg specified in claim 1.
Appellant contends that “there is no way to modify [Alka-Seltzer
Gold] to arrive at Appellant’s claims. If one begins with Alka-Seltzer Gold -
what can one add to it to reduce the osmolality? Nothing!” (App. Br. 12).
Appellant contends that “one of skill in the art has nowhere to begin. The art
assembled by the Examiner teaches a minimum osmolality of more than 310
mOsm/kg. Much more. There is no teaching in the art how to reduce that
value and maintain a functional solution” (App. Br. 13). “‘Alka-Seltzer
Gold®’ as relied upon by the Examiner . . . contains its own teaching away
from dilution. This reference is specific - dissolve two tablets in four ounces
of water. . . . there simply is no teaching anywhere to alter that value, to
dilute the buffer, and doing so would run counter to common sense” (Reply
Br. 3).
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We are not persuaded. As we have already discussed above,
modifying osmolality is within the skill level of the ordinary undergraduate
chemistry student (see Rau Dec. 3 ¶ 5), who would know precisely where to
begin such a modification, whether by dilution as discussed by the Examiner
(Ans. 8) or ab initio by adding different amounts of the buffers to the
composition as shown by Ammon (FF 6). Ammon teaches the addition of
different amounts of buffers into solutions, exemplifying the use of 0.25 %
TRIS in solutions 30 and 31, 0.14 % TRIS and 0.22 % Na Borate in
solutions 32 and 33, 0.018% Na Borate and 0.12% Boric acid in solutions 34
and 35, and 0.08 % Na Phos. (m) and 0.39 % Na Phos. (di) in solutions 36
and 37, while maintaining the osmolality in a narrow range between 190 and
227 mOsm/kg (FF 6). We agree with the Examiner that there “would be a
reasonable expectation of success since Ammon and Sack are both teaching
the components as buffers, and further, wherein Ammon teaches that the
buffer can comprise citric acid and sodium bicarbonate, which Sack
identifies are the two primary ingredients of Alka-Seltzer” (Ans. 4).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Ammon, Sack, Alka-Seltzer Gold and Rudnic render the claims prima facie
obvious.

SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Ammon, Sack, Alka-Seltzer Gold, and Rudnic.
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Pursuant to 37 C.F.R. § 41.37(c), claims 2, 8, and 10–17 fall with claim 1, as
these claims were not argued separately.

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
tc
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