ARCORAL PHARMA AS

Patent Trials and Appeals Board

Jan 1, 2021

2020003236 (P.T.A.B. Jan. 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.
14/441,901 05/11/2015 Silvia Boschetti GJE0011US 1004
23413 7590 01/01/2021
CANTOR COLBURN LLP
20 Church Street
22nd Floor
Hartford, CT 06103
EXAMINER
FRAZIER, BARBARA S
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
01/01/2021 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):
usptopatentmail@cantorcolburn.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SILVIA BOSCHETTI and MASSIMILIANO ROSSI
____________

Appeal 2020-003236
Application 14/441,901
Technology Center 1600
____________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1, 3, 5–23, 26, and 27 (Appeal Br. 2).2 We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “EUSA
Pharma (UK) Limited” (Appellant’s November 27, 2019 Appeal Brief
(Appeal Br.) 2).
2 Pending claims 24 and 25 stand withdrawn from consideration (Appeal Br.
2).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to an effervescent tablet, which upon
dissolution in water provides a solution useful as a mouth wash or oral rinse
for the prevention or treatment of inflammatory processes of the soft tissues
of the mouth, throat and oral cavity” (Spec. 1:4–7). Claim 1 is reproduced
below:
1. An effervescent tablet comprising:
a) a pharmaceutically effective amount of one or more
sodium phosphate salts;
b) a pharmaceutically effective amount of calcium
chloride;
c) one or more effervescing organic acid component; and
d) one or more effervescing base component;
wherein said tablet upon dissolution in 50 mL of water
provides a supersaturated solution of calcium and phosphate
ions, wherein the concentration of calcium ions provided in the
obtained supersaturated solution upon dissolution of the
effervescent tablet in the 50 mL of water is 2.5-16 mM, and
wherein the concentration of phosphate ions provided in the
obtained supersaturated solution upon dissolution of the
effervescent tablet in the 50 mL of water is 1.5-10 mM,
wherein the tablet upon dissolution in 50 mL of water
results in a solution that remains clear for at least 15 minutes.
(Appeal Br. 9.)

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Grounds of rejection before this Panel for review:
I. Claims 1, 3, 5–7, 10–14, 16, 18–20, 26, and 27 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over the combination
of Tung,3 Lauster,4 Winston,5 and Johansen.6
II. Claims 8 and 9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Tung, Lauster, Winston,
Johansen, and Warner.7
III. Claims 15 and 17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Tung, Lauster, Winston,
Johansen, and Bilgic.8
IV. Claims 21–23 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Tung, Lauster, Winston,
Johansen, Warner, and Bilgic.

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Tung discloses:
[U]nder atmospheric conditions, in an aqueous solution the
maximum concentration of carbonate ions in equilibrium with
the carbon dioxide in the air increases dramatically with the
increase in the pH of the solution. . . . . This property makes it
possible to prepare stable alkaline carbonated solutions that

3 Tung, WO 96/25914, published Aug. 29, 1996.
4 Lauster et al., US 3,651,207, issued Mar. 21, 1972.
5 Winston et al., US 5,817,296, issued Oct. 6, 1998.
6 Johansen et al., US 5,993,785, issued Nov. 30, 1999.
7 Warner-Lambert Company, GB 1 269 620, published Apr. 6, 1972.
8 Bilgic et al., WO 2012/002918 A1, published Jan. 5, 2012.
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Application 14/441,901
4
contain a large quantity of carbonate ions. Therefore, by
increasing the pH, a solution containing a high concentration of
carbonate can be maintained without the need for maintaining
the solution under a pressurized carbon dioxide atmosphere to
keep the carbon dioxide from escaping the solution.
(Tung 5:9–38; see generally Ans. 3–4.)
FF 2. Tung discloses:
[A]lkaline carbonated solutions . . . contain[ing] phosphate.
Such solutions are stable with respect to both carbonate and
phosphate. These alkaline carbonated phosphate solutions can
be mixed with stable aqueous solutions containing high
concentration of calcium ions at acidic pH. The resulting
mixed solutions are supersaturated with respect to calcium
phosphate and carbon dioxide. These mixed calcium phosphate
solutions thus contain high calcium and phosphate
concentrations at lower pH (preferably 5 to 7.5). Because of
the supersaturated nature of the mixed solutions, calcium
phosphate compounds will precipitate out of the mixed solution
as the pH of the solution increases due to the release of carbon
dioxide to the air. Therefore, when the mixed solution is put in
the mouth, carbon dioxide will be released and calcium
phosphate will precipitate on and in the teeth. The calcium
phosphate then reacts with the dental tissue and forms apatite.
The pH of the alkaline carbonated solutions is preferably
between 8 and 12 and more preferably between 9 and 10. The
desired pH and concentrations of the mixed carbonated calcium
phosphate solution will determine what the acid concentration
of the acidic calcium solution should be; the acid concentration
is such as to make the pH of the mixed carbonated calcium
phosphate solutions in the preferred range of 5 to 7.5.
(Tung 6:5–23; see also id. at 7:4–7 (Tung’s “mixed carbonated solutions . . .
may further include other beneficial components including: . . . further
mineralizing materials, such as strontium”); id. at 3:8–10 (Tung’s “invention
involves methods and compositions for preparation of unstable carbonated

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phosphate solutions, which are supersaturated with respect to calcium
phosphate solids and carbon dioxide” (emphasis added)); see generally Ans.
3–4.)
FF 3. Tung discloses that its
mixed solution can also be obtained from the dissolution of
solids in water. Stable solid powders containing all the
ingredients in the mixed solutions can be created. These
powders contain a mixture of calcium salts, phosphate salts,
solid acid (such as acetic acid and/or citric acid) and carbonate
salts with or without fluoride. When water is added to these
powders, the solids will dissolve rapidly and the same
carbonated calcium phosphate solutions as the mixed solutions
can be obtained.
(Tung 6:31–7:3; see generally Ans. 3–4.)
FF 4. Tung claims:
14. A method of treating dental tissue comprising:
(1) mixing a stable nonpressurized alkaline carbonated
solution containing carbonate with a stable nonpressurized
acidic solution containing calcium ions where either or both
said solutions contain phosphate ions, to create a mixed
solution supersaturated with calcium phosphate and carbon
dioxide; and
(2) promptly applying the mixed solution to the dental
tissue whereby the carbon dioxide escapes and calcium
phosphate is deposited on and in the dental tissue.
(Tung 11:7–14 (emphasis added).)
FF 5. Tung claims:
22. A method of treating dental tissue comprising:
(1) adding water to a solid mixture containing calcium
salt, phosphate salt and carbonate salt to create an unstable
carbonated solution supersaturated with respect to calcium
phosphate and carbon dioxide; and
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(2) promptly applying the solution to the dental tissue
whereby the carbon dioxide escapes and calcium phosphate is
deposited on and in the dental tissue.
(Tung 12:3–9 (emphasis added).)
FF 6. Examiner finds that Tung does not disclose a “formulation in the
form of a tablet,” a phosphate salt in the form of sodium phosphate, a
calcium salt in the form of calcium chloride, or a composition comprising
2.5–16 mM calcium ions or 1.5–10 mM phosphate ions (Ans. 4 and 6).
FF 7. Lauster discloses
a mouthwash preparation, in powder form, which can be used
in such form, through small amounts added to water, or can be
compressed, through admixture with a suitable binder, into
tablet or wafer form, which tablets or wafers can be dropped
into a glass of water to provide the mouthwash.
(Lauster 1:40–46; see also Ans. 4 (Examiner finds that “Lauster teaches
compositions comprising phosphate salt, effervescent couple, and excipients
for use in mouthwash may be formulated as a loose powder or can be
compressed with a suitable binder into [a] tablet”); Ans. 5 (Examiner finds
that Lauster’s effervescent powder contains sodium phosphate).)
FF 8. Winston “relates to remineralization, without demineralization, by
applying to the teeth a composition which is present in either one or in two
phases and which does not react to any large extent until introduced into the
oral cavity and upon such introduction does not rapidly precipitate”
(Winston, Abstract).
FF 9. Winston discloses, inter alia, mouthwashes, which comprise calcium
compounds, such as calcium chloride, and phosphate compounds, such as
sodium phosphate salt (Winston 1:16–17; id. at 6:47–63).
FF 10. Winston discloses “dry-mix [compositions] for us[e] as an
effervescent mouthwash” (Winston 17:13–14; see id. at 4:20–23 (Winston
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discloses that dry mix compositions “usually contain[] acidic or basic
compounds which provide that the pH is between about 4.0 and 7.0,
preferably, between about 5.0 and 5.75 when the dry mix is solubilized or
the final aqueous solution is prepared”)).
FF 11. Johansen discloses “solutions supersaturated with calcium and
phosphate” “for use as mouthwashes or dental rinses” (Johansen 1:9–12).
FF 12. Johansen discloses that “the concentration of calcium ions . . . in the
supersaturated solution is in the range of from 2 to about 40 mM” and “the
concentration of phosphate ions . . . in the supersaturated solution is in the
range of from about 0.5 to about 32 mM” (Johansen 3:38–65).
FF 13. Examiner finds that the combination of Tung, Lauster, Winston, and
Johansen fails to disclose “a mixture of sodium carbonate and sodium
hydrogen carbonate (i.e., sodium bicarbonate)” and relies on Warner to
make up for this deficiency (Ans. 8–9).
FF 14. Examiner finds that the combination of Tung, Lauster, Winston, and
Johansen fails to disclose “sweeteners such as glucose, fructose, or sucrose .
. ., or other sweeteners such as saccharin, aspartame, or acesulfame” and
relies on Bilgic to make up for this deficiency (Ans. 9–10).
ANALYSIS
I
Based on the combination of Tung, Lauster, Winston, and Johansen,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious to formulate Tung’s effervescent
composition as a tablet comprising calcium chloride and sodium phosphate
salt, wherein the tablet, when dissolved in water, provides a calcium ion
concentration of 2.5 to 16 mM and a phosphate ion concentration from 1.5 to
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Application 14/441,901
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10 mM that remains clear for at least 15 minutes (see FF 1–12). We are not
persuaded.
As Appellant explains:
When the solutions of Tung contain both phosphate and
carbonate, “[b]ecause of the supersaturated nature of the
solutions, calcium phosphate compounds will precipitate out of
the mixed solution as the pH of the solution increases due to the
release of carbon dioxide in the air. Therefore, when the mixed
solution is put in the mouth, carbon dioxide will be released and
calcium phosphate will precipitate in and on the teeth.”
(Reply Br. 4 (citing Tung 6:5–17) (alteration original).) Appellant further
explains that when Tung’s alkaline carbonate solution is combined with
Tung’s acidic solution containing calcium ions––calcium phosphate
precipitates out of solution as carbon dioxide is released from the solution
and this is why Tung’s mixed solution is promptly applied to dental tissue
(Reply Br. 4–6; see also FF 1–5). Thus, Tung fails to support a conclusion
that its mixed solution will remain clear for at least 15 minutes; to the
contrary, a person of ordinary skill in this art would understand, as Appellant
explained, that calcium phosphate would precipitate out of Tung’s mixed
solution as carbon dioxide is released (see Reply Br. 7 (Appellant “submit[s]
that the mixed solution of Tung would not remain clear for at least 15
minutes as required by . . . [Appellant’s] claims”)).
Examiner failed to establish an evidentiary basis on this record to
support a conclusion that the combination of Tung with Lauster, Winston, or
Johansen would change Tung’s mechanism of operation such that the
composition suggested by the combination of Tung, Lauster, Winston, and
Johansen would remain clear for at least 15 minutes (see Reply Br. 8–9).

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II–III
Examiner failed to establish that Warner and Bilgic, alone or in
combination, make up for the foregoing deficiencies in the combination of
Tung, Lauster, Winston, and Johansen (see Reply Br. 10; cf. FF 1–14; see
also Ans. 8–15).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1, 3, 5–7, 10–14, 16, 18–20, 26, and 27 under
35 U.S.C. § 103(a) as unpatentable over the combination of Tung, Lauster,
Winston, and Johansen is reversed.
The rejection of claims 8 and 9 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Tung, Lauster, Winston, Johansen, and
Warner is reversed.
The rejection of claims 15 and 17 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Tung, Lauster, Winston, Johansen, and
Bilgic is reversed.
The rejection of claims 21–23 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Tung, Lauster, Winston, Johansen,
Warner, and Bilgic is reversed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 5–7,
10–14, 16,
18–20, 26,
27
103 Tung, Lauster,
Winston, Johansen
1, 3, 5–7,
10–14,
16,
18–20,
26, 27
8, 9 103 Tung, Lauster,
Winston, Johansen,
Warner
8, 9
15, 17 103 Tung, Lauster,
Winston, Johansen,
Bilgic
15, 17
21–23 103 Tung, Lauster,
Winston, Johansen,
Warner, Bilgic
21–23
Overall
Outcome
1, 3,
5–23,
26, 27

REVERSED