Ex Parte Tarallo

Patent Trial and Appeal Board

May 22, 2013

11878169 (P.T.A.B. May. 22, 2013)

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.
11/878,169 07/20/2007 Stephen C. Tarallo 088581-0104 5626
22428 7590 05/22/2013
FOLEY AND LARDNER LLP
SUITE 500
3000 K STREET NW
WASHINGTON, DC 20007
EXAMINER
FRAZIER, BARBARA S
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
05/22/2013 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 STEPHEN C. TARALLO
__________

Appeal 2011-009525
Application 11/878,169
Technology Center 1600
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and JOHN A. EVANS,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition, which have been rejected for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1-4, 6-11, and 14-36 are on appeal. Claim 1 is representative
and reads as follows:
1. An oral dosage form of calcium acetate comprising a liquid
pharmaceutical composition comprising an aqueous solution of:
(a) 7-21% calcium acetate (w/v),
Appeal 2011-009525
Application 11/878,169

2
(b) an artificial sweetener selected from the group consisting of
sucralose, acesulfame potassium, aspartame and saccharin,
(c) a polyol selected from the group consisting of sorbitol, glycerine,
propylene glycol, xylitol, maltitol, and combinations thereof, and
(d) a taste masking agent comprising monoammonium
glycyrrhizinate.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1-4, 6-11, 14-17, 21-27, and 30-36 based on Dake,
1

Anaebonam,
2
and Nelson
3
(Answer 4);
• Claim 18 based on Dake, Anaebonam, Nelson, and Eby
4
(Answer
10);
• Claims 19 and 20 based on Dake, Anaebonam, Nelson, and Sass
5

(Answer 11); and
• Claims 28 and 29 based on Dake, Anaebonam, Nelson, Eby, and
Sass (Answer 12).
Each of the rejections on appeal depends on the combination of Dake,
Anaebonam, and Nelson. The Examiner finds that Dake discloses a
composition comprising a bulking agent such as a sugar polyol and a high
intensity sweetener, which “may include a taste masking agent such as
glycyrrhizin, and other sweeteners such as acesulfame potassium” (Answer
4). The Examiner finds that Dake also discloses that its composition can
contain calcium acetate as a source of calcium, and calculates that the

1
Dake et al., US 2003/0026872 A1, published Feb. 6, 2003.
2
Anaebonam et al., US 5,763,449, issued June 9, 1998.
3
Nelson, US 2006/0228424 A1, published Oct. 12, 2006.
4
Eby, US 5,095,035, issued Mar. 10, 1992.
5
Sass et al., US 4,093,710, issued June 6, 1978.
Appeal 2011-009525
Application 11/878,169

3
amounts disclosed by Dake correspond to 0.0004% to 12% calcium in a
liquid concentrate composition (id. at 6-7).
The Examiner finds that Anaebonam discloses that ammonium
glycyrrhizinate is a bitterness-masking agent (id. at 5) and that Nelson
discloses adding flavoring to a liquid composition comprising calcium
acetate to mask any unpleasant taste (id. at 6). The Examiner concludes that,
based on these teachings, the claimed composition would have been obvious
to a person of ordinary skill in the art (id. at 5-6).
Appellant argues that “Dake is directed to powder or concentrate
compositions that can be easily diluted for consumption as a beverage” not
pharmaceutical compositions of calcium acetate (Appeal Br. 13). Appellant
argues that the Examiner’s reasoning “ignore[s] the impact that the notorious
bad taste of calcium acetate would have had on the person looking to
formulate a beverage composition according to Dake” (id. at 15), and that a
skilled worker would not have had a reason to use calcium acetate in the
amount required by the claims (id. at 16-17)
We agree with Appellant that the Examiner has not persuasively
shown that the claimed composition would have been obvious based on the
teachings of Dake, Anaebonam, and Nelson. The evidence of record shows
that calcium acetate is known to have an unpleasant taste. The Specification
states that “calcium acetate . . . has a repugnant bitter taste” (Spec. 2, ¶ 6)
and that “solutions of calcium acetate are many times more potently
repugnant to the palate than are solid dosage forms” (id. at ¶ 7).
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Application 11/878,169

4
The Tarallo Declaration
6
likewise states that “[c]alcium acetate simply
tastes horrible, as I know from personal experience in taste-testing products
during development” (Tarallo Declaration, ¶ 9). Finally, Dennett states that
an “undesirable characteristic of calcium acetate is that it has a chalky taste
that is very unpleasant to the palate and is difficult to mask” (Dennett,
7
col.
2, ll. 36-38).
The Examiner’s rejections are based on the conclusion that a skilled
artisan reading Dake would have considered it obvious (1) to choose calcium
acetate from among the sixteen disclosed calcium sources (Dake 6, ¶ 94); (2)
to include at least 8750 mg of calcium acetate per 100 grams of dry
composition, based on Dake’s disclosure of including 40 to 15,000 mg
calcium per 100 grams of dry composition
8
(id. at 7, ¶ 95); and (3) to use the
resulting dry composition to formulate a liquid concentrate that comprises at
least 7% calcium acetate (id. at 8, ¶ 111).
As Appellant has pointed out,
[t]he selection of calcium acetate in the context of Dake
would amount to a “proposed modification” that involves
“extra work and greater expenses for no apparent reason.” That
is, the selection of calcium acetate as a source of calcium would
involve extra work and expense in masking its notoriously bad

6
Declaration under 37 C.F.R. § 1.132 of Stephen C. Tarallo, dated Nov. 16,
2009.
7
Dennett, Jr. et al., US 6,576,665 B2, issued June 10, 2003.
8
Since Dake’s liquid concentrates comprise no more than 80% dry
composition, the dry composition would have to contain at least 8.75%
calcium acetate in order for the liquid concentrate to contain 7% calcium
acetate, as claimed. A dry composition having 8750 mg calcium acetate in
100 grams of the composition contains 8.75% calcium acetate.
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Application 11/878,169

5
taste . . . that would not be required for other calcium sources
disclosed in Dake.
(Appeal Br. 16.)
This is especially true in view of the high amount of calcium acetate
that would have to be included in Dake’s composition in order to meet the
limitations of the claims on appeal. In view of the evidence showing that
calcium acetate was known to have an unpleasant taste, and the Examiner’s
failure to identify any off-setting advantage to using calcium acetate
specifically, and in the required amounts, we agree with Appellant that the
Examiner has not persuasively shown that a liquid composition comprising
at least 7% calcium acetate would have been obvious based on Dake.
The Examiner relied on Anaebonam and Nelson only with respect to
including ammonium glycyrrhizinate in Dake’s composition (Answer 5-6),
and relied on Eby and Sass only with respect to dependent claim limitations
(id. at 10-13), not with regard to the choice and amount of calcium acetate.
The Examiner therefore has not shown that these references make up for the
deficiency in Dake, and has not shown that the cited references support a
prima facie case of obviousness.
SUMMARY
We reverse all of the rejections on appeal.

REVERSED

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