Ex Parte Myatt

Board of Patent Appeals and Interferences

Dec 27, 2011

10263516 (B.P.A.I. Dec. 27, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GRAHAM JOHN MYATT
__________

Appeal 2011-008375
Application 10/263,516
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
composition comprising an inner core and three surrounding layers. The
Patent Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
The Specification states that the compositions of the claimed
invention “are particularly useful wherein the composition comprises a
component that is susceptible to moisture or may otherwise be compromised
by environmental factors. The compositions comprise an inner core and at
least two surrounding layers, wherein the surrounding layers protect the
inner core from moisture or such other factors.” (Spec. 1, ll. 8-12.)
Claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 are on appeal.
Claim 1, the only independent claim, is representative and reads as follows:
1. A composition comprising:
(a) an inner core comprising one or more components, including
bacteria, wherein at least one or more components has a water
activity of about 0.3 or less as measured at a temperature of
from about 20°C to about 25°C;
(b) a capsule layer which is joined to the inner core;
(c) an inner layer which is joined to the inner core, wherein the
inner layer is selected from the group consisting of continuous
coatings which are insoluble at a pH of about 3 or less,
continuous coatings having a coating weight of from about
3 mg/cm2 to about 25 mg/cm2, and combinations thereof; and
wherein the inner layer is an anionic copolymer selected from
the group consisting of methacrylic acid, methacrylate, acrylic
acid, acrylate and combinations thereof; and
(d) an outer layer which is joined to the inner core, wherein the
outer layer is a continuous hydrophobic coating comprising a
material selected from the group consisting of fatty acids, fatty
acid derivatives, polymers, and mixtures thereof; and which
exhibits a water vapor transmission rate of less than about 200
mg/m2/24 hours; wherein the inner layer is a preceding layer
relative to the outer layer.

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The Examiner rejected the claims as follows:
• claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 under 35
U.S.C. § 103(a) as unpatentable over Kim1 in view of Freeman,2 Colorcon,3
Signorino,4 Mills,5 Pozzi,6 Yamishita ‘561,7 Yamishita ‘641,8 and Sudoma;9
and
• claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 under 35
U.S.C. § 103(a) as unpatentable over Yamishita ‘641in view of Kim,
Freeman, Colorcon, Signorino, Mills, Pozzi, Yamishita ‘561, and Sudoma.

OBVIOUSNESS
The Issue
I. The Rejection over a combination including Kim as the primary
reference.
The Examiner’s position is that Kim taught a composition comprising
an inner core comprising Lactobacillus acidophilus, Lactobacillus bifidus,
and Streptococcus faecalis surrounded by a continuous inner layer of

1 Patent Application Publication No. WO 99/20745 by Dong Kim et al.,
published Apr. 29, 1999.
2 Freeman LLC, All About Zein (2005),
http://www.freemanllc.com/zein.htm.
3 Colorcon, Opalgos®, Technical Data Sheet (2003).
4 US Patent No. 3,738,952 issued to Charles A. Signorino, Jun. 12, 1973.
5 John S. Mills and Raymond White, Natural Resins and Lacquers, 2 THE
ORGANIC CHEM. OF MUSEUM OBJECTS, 115-118 (1987).
6 Patent Application Publication No. GB 2 245 492 A by Franco Pozzi et al.,
published Aug 1, 1992.
7 Patent Application Publication No. JP 03-076,561, Teiji Yamashita,
published Apr. 2, 1991.
8 US Patent No. 6,030,641 issued to Sadaji Yamashita et al., Feb. 29, 2000.
9 US Patent No. 4,927,763 issued to A. Louis Sudoma et al., May 22, 1990.
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alginate, which was surrounded by a layer of Opaglos® liquid shellac, corn
zein, and glycerine. (Ans. 5.) The Examiner found that Kim also taught that
the inner layer may comprise hydroxypropylmethylcellulose (HPMC). (Id.)
The Examiner found that Freeman provided evidence that zein is
hydrophobic. (Id.) Additionally, the Examiner found that Colorcon
provided evidence that Opaglos® is a modified shellac composition. (Id.)
The Examiner cited Signorino as evidence that Opaglos® comprises shellac
and polyvinylpyrrolidone. (Id.) Also, the Examiner cited Mills “as evidence
that shellac inherently comprises various fatty acids and fatty acid
derivatives, including aleuritic acid, butolic acid, jalaric acid, and laccijalaric
acid.” (Id.)
The Examiner found that Kim did not teach that its composition
comprised “an outer layer comprising a fat or wax,” or “a core surrounded
by three layers,” i.e., including a capsule layer. (Id. at 6.)
The Examiner found that Pozzi taught delayed-release, multi-layered
pharmaceutical compositions comprising an inner core that comprises a drug
within a protective inner layer that is surrounded by a hydrophobic outer
layer. (Id.) The Examiner found that Pozzi disclosed that the protective
inner layer comprised HPMC and that the outer layer comprised carnauba
wax and beeswax. (Id.) Additionally, the Examiner found that Pozzi taught
that the composition may take the form of various types of tablets or
capsules. (Id.)
According to the Examiner, a person of ordinary skill in the art at the
time the invention was made would have been motivated to include “the
protective HPMC capsule layer of Pozzi” in the composition of Kim because
Pozzi taught that such a layer aids in timed release of ingredients of the inner
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core and because Kim taught that HPMC was an appropriate material for
encapsulating bacteria. (Id. at 8.) Therefore, the Examiner concluded that it
would have been obvious to a person of ordinary skill in the art at the time
the invention was made to include an additional layer between the inner core
and the inner layer of Kim because Pozzi taught that such a layer protects
the active ingredients of the inner core. (Id. at 9.)
The Examiner did not make any additional findings or conclusions
regarding the outer layer in the combination.
Appellant’s contentions include an assertion that “[t]he cited
references do not teach or suggest all of the claim limitations of independent
claim 1 ….” (App. Br. 6.) In particular, Appellant asserts (App. Br. 8) that
Kim did not teach or suggest the claim limitations for the outer layer, i.e.,
“wherein the outer layer is a continuous hydrophobic coating …and which
exhibits a water vapor transmission rate of less than about 200 mg/m2/24
hours ….” (Claim 1.)
II. The Rejection over a combination including Yamashita ‘641 as
the primary reference.
The Examiner found that Yamashita ‘641 taught capsules comprising
a core of Bifidobacterium longum surrounded by a gelatin capsule, which
was surrounded by a coating of hardened oil, which was surrounded by a
polysaccharide/polyhydric alcohol coating comprising carrageenan,
glucomannan, guar gum, and alginic acid. (Ans. 10-11.) The Examiner
found that Yamashita ‘641 did not teach a composition comprising “an outer
layer comprising a fat or wax.” (Id. at 11.)
The Examiner repeated the findings for Kim, Freeman, Colorcon,
Signorino, Mills and Pozzi as set forth in the rejection including Kim as the
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primary reference. (Ans. 11-12.) The Examiner additionally found that Kim
taught that the composition of the inner layer and the outer layer may vary.
(Id. at 11.)
According to the Examiner, the selection of outer layer material
“would have been a routine matter of optimization on the part of the artisan
of ordinary skill ….” (Id. at 13.) The Examiner found that Kim taught that
“corn zein may be used as the outer layer of sustained-release compositions
of bacteria.” (Id. at 13-14.) Additionally, the Examiner concluded that it
would have been obvious to a person of ordinary skill in the art at the time
the invention was made to substitute the protective HPMC capsule layer of
Pozzi for the gelatin layer between the inner core and the inner layer of
Yamashita ‘641 (i.e., the capsule layer) because Pozzi taught that such a
layer protects the active ingredients of the inner core and Kim taught that
HPMC was an appropriate material for encapsulating bacteria. (Id. at 14.)
The Examiner did not make any additional findings or conclusions
regarding the outer layer in the combination.
Appellant’s contentions include an assertion that “[t]he cited
references do not teach or suggest all of the claim limitations of independent
claim 1” (App. Br. 11) in particular, the recited outer layer. Appellant
asserts that the Examiner acknowledged that neither Yamashita nor Kim
taught “an outer layer comprising fat or wax ….” (Id.) Further, Appellant
asserts that “Kim provides no teaching, suggestion, predictability or
expectation of success with adding other than water-miscible coatings to
compositions of or similar to Kim.” (Id. at 11-12.)
The issue is whether the Examiner has established that the cited
references would have led a skilled artisan at the time of the invention to
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arrive at composition comprising an outer layer “wherein the outer layer is a
continuous hydrophobic coating …and which exhibits a water vapor
transmission rate of less than about 200 mg/m2/24 hours.”
Findings of Fact
1. We agree with the Examiner’s explicit findings regarding the scope
and content of the prior art references (see Ans. 4-15) except that we
additionally find:
2. Kim’s exemplary formulation of an outer layer (i.e., second coating-
solution) comprising Opaglos®, Zein, and glycerine, additionally comprised
80% ethanol. (Kim 11, Ex. 2.)
3. Kim’s exemplary formulation of an outer layer (i.e., second coating-
solution) comprising Zein, additionally comprised 80% ethanol and
glycerine. (Kim 13, Ex. 5.)
Principles of Law
A conclusion that the claimed subject matter is prima facie obvious
must be supported by evidence, as shown by some objective teaching in the
prior art or by knowledge generally available to one of ordinary skill in the
art that would have led that individual to combine the relevant teachings of
the references to arrive at the claimed invention. See In re Fine, 837 F.2d
1071, 1074 (Fed. Cir. 1988).
Analysis
We agree with Appellant (App. Br. 6, 11) that the Examiner has not
established a prima facie case of obviousness for the rejection including Kim
as the primary reference, or for the rejection including Yamashita ‘641 as the
primary reference. Specifically, the Examiner has not provided evidence
that a skilled artisan at the time of the invention would have combined the
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references to arrive at the claimed composition comprising an outer layer
“wherein the outer layer is a continuous hydrophobic coating …and which
exhibits a water vapor transmission rate of less than about 200 mg/m2/24
hours,” as recited in independent claim 1. See Fine, 837 F.2d at 1074.
I. The Rejection over a combination including Kim as the primary
reference.
With respect to the rejection involving Kim as the primary reference,
the Examiner found that Kim disclosed a composition comprising an outer
layer comprising some components known to be hydrophobic, i.e., liquid
shellac and corn zein. (Ans. 5-6, 11.) However, the Examiner did not find
that these components provided or even suggested an outer layer that was a
hydrophobic coating. (Id.) Indeed, the Examiner also found that Kim’s
outer layer also comprised glycerine. (Id.) Further, Kim disclosed that the
outer layer (i.e., second coating) additionally comprised 80% ethanol. (FF-
2.) Additionally, as Appellant has correctly asserted, Kim disclosed that
water-miscible coating materials could be used in the outer layer of its
composition. (App. Br. 7.) Thus, the Examiner did not establish that Kim
taught or suggested a composition comprising an outer layer that was a
continuous hydrophobic coating, as required by the claims.
Moreover, while the Examiner found that Pozzi disclosed a
composition comprising an outer layer comprising carnauba wax and
beeswax, the Examiner’s combination did not include substituting or
combining Pozzi’s outer layer with Kim’s outer layer, or otherwise
modifying Kim’s outer layer. (See Ans. 5-9.) Rather, the Examiner relied
on Pozzi in the combination as providing a “protective capsule layer.” (See,
e.g., Ans. 6, 14.) Further, the rejection does not provide any explanation or
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reasoning, supported by the evidence, that a skilled artisan would have been
motivated to combine Kim and Pozzi with a reasonable expectation of
successfully arriving at the claimed outer layer. (Id. at 5-9.)
Regarding water vapor transmission rate, the Examiner did not make
any findings regarding this claim limitation. (Id.) In the Response, the
Examiner stated that “the fact that applicant has recognized another
advantage which would flow naturally from following the suggestion of the
prior art cannot be the basis for patentability when the differences would
otherwise be obvious.” (Id. at 18-19, citing Ex parte Obiaya, 227 USPQ 58,
60 (BPAI 1985), aff’d mem., 795 F.2d 1017 (Fed. Cir. 1986)). However, as
discussed, the Examiner has not established that the differences between the
combined prior art and the claimed invention would have been “otherwise”
obvious. Consequently, the Examiner did not establish that the combined
prior art inherently or implicitly taught or suggested an outer layer which
exhibits the recited water vapor transmission rate.
Accordingly, we reverse the obviousness rejection over the
combination including Kim as the primary reference.
II. The Rejection over a combination including Yamashita ‘641 as
the primary reference.
In the rejection including Yamashita ‘641 as the primary reference,
the Examiner did not find that Yamashita disclosed an outer layer as recited
in independent claim 1. (See Ans. 10-12.) Regarding water vapor
transmission rate, the Examiner did not make any findings regarding this
claim limitation. (Id. 10-15.) Rather, the Examiner found that the selection
of outer layer material “would have been a routine matter of optimization on
the part of the artisan of ordinary skill ….” (Id. at 13.) According to the
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Examiner, Kim taught that corn zein may be used as the outer layer of
sustained-release compositions of bacteria. (Id. at 13-14.) However, in
Kim’s exemplary formulation of an outer layer comprising Zein-DP, Kim
disclosed the coating-solution additionally comprised 80% ethanol and
glycerine. (FF-3.) Moreover, as discussed, Kim taught that its outer layer
may comprise water-miscible material. (See App. Br. 7.) Consequently, we
do not find that the Examiner established that Kim’s teaching to use a
coating composition comprising corn zein taught or suggested a hydrophobic
coating. Nor did the Examiner rely on Pozzi in the combination as teaching
or suggesting an outer layer, as recited in independent claim 1. (See Ans.
13-14)(combining Pozzi to provide a “protective HPMC capsule layer”).
Accordingly, we reverse the obviousness rejection including
Yamashita ‘641 as the primary reference.

CONCLUSIONS OF LAW
The Examiner has not established that the cited references would have
led a skilled artisan at the time of the invention to arrive at a composition
comprising an outer layer “wherein the outer layer is a continuous
hydrophobic coating …and which exhibits a water vapor transmission rate
of less than about 200 mg/m2/24 hours.”

SUMMARY
We reverse the rejection of claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27,
28, and 33-35 under 35 U.S.C. § 103(a) as unpatentable over Kim in view of
Freeman, Colorcon, Mills, Pozzi, Yamishita ‘561, Yamishita ‘641, and
Sudoma; and
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we reverse the rejection of claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27,
28, and 33-35 under 35 U.S.C. § 103(a) as unpatentable over Yamishita
‘641in view of Kim, Freeman, Colorcon, Signorino, Mills, Pozzi, Yamishita
‘561, and Sudoma.

REVERSED

cdc