Ex Parte Szymczak

Board of Patent Appeals and Interferences

Sep 12, 2011

10176832 (B.P.A.I. Sep. 12, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHRISTOPHER E. SZYMCZAK
__________

Appeal 2011-003580
Application 10/176,832
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical dosage form which the Examiner has rejected under grounds
of obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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Application 10/176,832

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Statement of the Case
The Claims
Claims 3-9, 12-17, 19, 22, and 31-33 are on appeal. Claim 3 is
representative and reads as follows:
3. A pharmaceutical dosage form comprising a core
having an outer coating, said outer coating comprising,
based upon the dry weight of the coating:
a) carrageenan; and
b) sucralose, wherein the coating is comprised of,
based upon the total dry weight of the coating,
[a) sic c)]from about 0.5 percent to about 20 percent
of carrageenan; and
[b) sic d)] from about 75 percent to about 99.5 percent
of sucralose.

The issue
The Examiner rejected claims 3-9, 12-17, 19, 22, and 31-33 under 35
U.S.C. § 103(a) as obvious over Cherukuri
1
and Sharp
2
(Ans. 5-6).
The Examiner finds that Cherukuri teaches “the use of the sweeteners
in oral pharmaceutical and oral hygiene preparation” (Ans. 5). The
Examiner finds that Cherukuri “also teaches the use of hydrophilic
polymers, such as carrageenans and a sweetener such as sucralose in the
outer coating” (Ans. 5). The Examiner finds that “Sharp et al. teach the use
of carrageenan and sucralose in combination in a fruit spread” (Ans. 5). The
Examiner finds that the “determination of optimum proportions or amounts
is considered to be within the skill of the artisan in the absence of evidence
to the contrary” (Ans. 6).

1
Cherukuri et al., US 4,981,698, issued Jan. 1, 1991.
2
Sharp et al., US 5,270,071, issued Dec. 14, 1993.
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Appellant contends that “nowhere in Cherukuri et al. does it teach, or
suggest, the combination of carrageenan and sucralose in the inner coating,
let alone the outer coating. In fact, the only further disclosure of either
sucralose or carrageenan in Cherukuri et al. is in two unrelated claims,
namely claims 12 and 18” (App. Br. 6). Appellant contends that “the Final
Office Action fails to adequately state why one of ordinary skill in the art
would look to the unrelated field of soft, spreadable fruit spreads for making
a solid coating for a dosage form. Certainly the fact that these ingredients
may have been used in a fruit spread does not mean that it would obviously
be useful in the coating of a dosage form (App. Br. 6). Appellant contends
that the “discovery that these two ingredients (which independently are not
suitable) are able to form a film when combined that can be used as an outer
coating of a dosage form was completely unexpected and unobvious” (App.
Br. 7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Cherukuri and Sharp render claim 1
obvious?
Findings of Fact
1. Cherukuri teaches a delivery system which
comprises a first high intensity sweetener encapsulated in a
first core coating, and a second outer hydrophilic coating
containing up to the solubility limit of the second coating of
a second sweetener. The resulting delivery system may be
incorporated into a variety of comestible products including
. . . oral pharmaceuticals.

(Cherukuri, abstract).
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2. Cherukuri teaches a delivery system where the “second outer
coating is selected from the group consisting of gum arabic, tragacanth,
karaya, ghatti, agar, alginates, carrageenans, fucellan, psyllium, and mixtures
thereof” (Cherukuri, col. 18, ll. 6-9, claim 12).
3. Cherukuri teaches a delivery system “wherein both the first and
second sweeteners are natural or artificial high intensity sweeteners and are
each selected from the group consisting of . . . sucralose” (Cherukuri, col.
18, ll. 36-41, claim 18).
4. Sharp teaches “[a] reduced calorie fruit spread comprising the
gelled product of: a. water; b: fruit or fruit flavoring; c. sucralose high
intensity sweetener; d. low methoxy pectin or carrageenan; e.
carboxymethylcellulose; f. guar gum; and g. locust bean gum” (Sharp,
abstract).
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).
An invention “composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art…. [I]t can be important to identify a reason that
would have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does.” KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
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Analysis
The Examiner finds it obvious “to use sucralose and carrageenan in a
coating composition or in a food product, motivated by the teachings of
Cherukuri et al. and Sharp et al., which teach the use of such components in
combination in pharmaceutical and food products as old and well known”
(Ans. 5-6).
We are not persuaded. The Examiner provides no reason to combine
carrageenan and sucralose in the outer coating of a pharmaceutical of
Cherukuri other than their joint presence in the fruit spread of Sharp. In our
opinion, Sharp is not analogous art to Cherukuri. The test for non-analogous
art is first whether the art is within the field of the inventor’s endeavor and,
if not, whether it is “reasonably pertinent to the particular problem with
which the inventor was involved.” In re Wood, 599 F.2d 1032, 1036 (CCPA
1979). “A reference is reasonably pertinent if, even though it may be in a
different field” of endeavor, it logically would have commended itself to an
inventor’s attention in considering his problem “because of the matter with
which it deals.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992).
There can be no reasonable dispute that oral pharmaceuticals are not
in the same field of endeavor as fruit spreads. Therefore, the issue is whether
Sharp was pertinent to Cherukuri. The Examiner does not identify, and we
do not find, any reason why the fruit spread of Sharp would have been
pertinent to oral pharmaceuticals. We therefore agree with Appellant that
these are nonanalogous and that no reason to combine carrageenan and
sucralose was presented.

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Conclusion of Law
The evidence of record does not support the Examiner’s finding that
Cherukuri and Sharp render claim 1 obvious.

CONCLUSION
In summary, we reverse the rejection of claims 3-9, 12-17, 19, 22, and
31-33 under 35 U.S.C. § 103(a) as obvious over Cherukuri and Sharp.

REVERSED

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