Ex Parte Kokubo et al

Board of Patent Appeals and Interferences

Apr 12, 2010

09842466 (B.P.A.I. Apr. 12, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte HIROYASU KOKUBO and SAKAE OBARA
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Appeal 2009-010550
Application 09/842,466
Technology Center 1600
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Decided: April 12, 2010
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Before ERIC GRIMES, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
coated solid preparation, e.g., a pharmaceutical tablet. The Patent Examiner
rejected the claims for obviousness. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
Appeal 2009-010550
Application 09/842,466

STATEMENT OF THE CASE
The invention relates to “film-coated tablets having a pattern of two or
more colors.” (Spec. 9:6-8.) Claims 6-9, 11, 13-20 and 31-47, which are all
the pending claims, are on appeal. Independent claims 31 and 33 read as
follows:
31. A solid preparation coated with a multi-colored continuous film
coating layer, prepared by the process of

coating a solid preparation with a continuous film coating layer
having one or more colorants; and,

exposing a first part of the coating layer to a first amount of radiation
and exposing a second part of the coating layer to a second amount of
radiation under conditions sufficient to result in the first and second
parts of the coating layer having different coloration.

33. A solid preparation coated with a multi-colored continuous film
coating layer, prepared by the process of

coating a solid preparation with a continuous film coating layer
having one or more colorants; and,

changing the coloration of one or more parts of the coating layer by
irradiating those parts of the coating layer to the exclusion of the
remainder of the coating.

The Examiner rejected claims 6-9, 11, 13-20 and 31-47 under
35 U.S.C. § 103(a) as unpatentable over Berta1 and Hogan.2

1 US 4,820,524, issued to Norbert I. Berta, Apr. 11, 1989.
2 US 6,406,738 B1, issued to John E. Hogan et al., Jun. 18, 2002.
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OBVIOUSNESS
The Issue
The Examiner set out alternative explanations for the conclusion of
obviousness. Both explanations rely on interpreting the claims as “product-
by-process” claims. The first theory is that the claimed product is the
product Berta described, although defined by different words and made by a
different process, and that it therefore would have been obvious. (Ans. 3-5.)
The second theory is that the claimed product would have been obvious over
the combined teachings of Berta and Hogan. (Ans. 5-6.)
Appellants contend that the rejection failed to state a prima facie case
of obviousness “because (1) the combination of references fails to teach each
and every claim element and (2) because there is no motivation to combine
the references” (App. Br. 5), and “the irradiation step of Hogan cannot be
applied to the tablet of Berta in a predictable manner” (id. at 9).
More specifically, Appellants dispute that the references “disclose or
suggest . . . a multi-colored continuous film coating layer.” (Id. at 5.)
According to Appellants: (a) “the coating described in Berta is not a single
continuous coating, but rather comprises two separate coatings that are
separately applied to each half of the tablet;” and (b) “Hogan teaches a tablet
having two separate coatings covering distinct halves of the tablet and does
not have the presently claimed multi-colored continuous coating layer.” (Id.
at 6, emphasis deleted.) Further, Appellants contend it was improper for the
Examiner to “ignore” the recited process steps (Reply Br. 6), and Hogan
does not teach irradiation to form a multicolored continuous coating (id.).
The issues are:
did the Examiner err by discounting the recited process steps;
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does the evidence support the Examiner’s finding that Berta taught or
suggested a multi-colored continuous film coating layer;
does the evidence support the Examiner’s finding that Hogan taught
or suggested a multi-colored continuous film coating layer;
does the evidence support the Examiner’s finding that a person of
ordinary skill in the art would have been motivated to combine Berta’s
teachings with Hogan’s teachings; and
does the evidence support the Examiner’s finding that the Berta and
Hogan teachings could be combined with a reasonable expectation of
success?

Findings of Fact
1. Berta described capsule-like medicaments having smooth, multi-
colored gelatinous coatings. (Berta, col. 4, ll. 31-34.)
2. Berta formed the coating by dipping each end of the medicament in
turn into gelatinous material, with the “depth of the dip . . . preferably
cam-regulated to the desired capsule size, color scheme and ‘seam’
requirements.” (Id. at col. 8, ll. 28-30.)
3. Berta taught: “As indicated in FIGS. 8a-d, the color scheme can be
bifurcated . . . and a seam . . . can be provided by overlapping the
gelatinous coatings on the first and second ends.” (Id. at col. 8, ll. 30-
34.)
4. Berta taught: “Coloring can be added to the coatings to produce
opaque or transparent colors such as red, white, pink, green, reddish
brown, blue, yellow and black. Colored medicaments are necessary to
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give a specialty product a distinctive appearance.” (Id. at col. 9, ll. 1-
7.)
5. Berta taught: “The first and second gelatinous coatings substantially
cover the caplet to form a simulated capsule-like medicament with a
seam about a transverse axis of the medicament.” (Id. at col. 10, ll.
38-41.)
6. Hogan described electrostatic powder coating for pharmaceutical
tablets. (Hogan, col. 1, ll. 6-19.)
7. Hogan treated the powder with infra red or electromagnetic radiation
to form a film coating on the tablet. (Id. at col. 4, ll. 32-35.)
8. Hogan taught: “The change in the powder material during the
treatment may simply be a physical change from a solid to a liquid
and then, on cooling, to a continuous solid film. Alternatively, the
powder material may include a polymer which is cured during the
treatment, for example by irradiation with energy in the gamma, ultra
violet or radio frequency bands, to form a cross-linked polymer.” (Id.
at col. 4, ll. 38-44.)
9. Hogan taught: “Preferably the powder material includes a first
component which is fusible to form a continuous film on the surface
of the core . . . . The first component may comprise polyethylene
glycol which has good fusibility properties and, after treatment, can
form a good continuous coat over the surface of the substrate.” (Id. at
col. 7, l. 61 – col. 8, l. 16.)
10. Hogan taught: “Preferably the powder coating material further
includes one or more colourants, for example metal oxides or lakes . .
. .” (Id. at col. 9, ll. 57-58.)
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11. Hogan taught: “different coating materials may be used for coating
different parts of the core. For example, a different coloured coating
may be formed on each of the opposite faces of the tablet.” (Id. at col.
12, ll. 40-44.)

Principles of Law
“If the product in a product-by-process claim is the same as or
obvious from a product of the prior art, the claim is unpatentable even
though the prior product was made by a different process.” In re Thorpe,
777 F.2d 695, 697 (Fed. Cir. 1985). “[E]ven though product-by-process
claims are limited by and defined by the process, determination of
patentability is based on the product itself.” Id., quoted in Abbott Labs. v.
Sandoz, Inc., 566 F.3d 1282, 1292 (Fed. Cir. 2009) (en banc).
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006). “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” KSR, 550 U.S. at 416. “[I]f a technique has been used
to improve one device, and a person of ordinary skill in the art would
recognize that it would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his or her skill.”
Id. at 417.

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Analysis
The Examiner interpreted the claims on appeal as “product-by-
process” claims. We agree. For this kind of claim, patentability is
determined by the product, not the process by which the product is made.
We therefore reject Appellants’ allegation that the Examiner treated the
recited process steps improperly.
We first address the case for obviousness based on Berta alone. (Ans.
3-5.) Berta disclosed a multi-colored coating comprising two films meeting
at a seam. (FF3.) Berta’s use of “seam” in the ordinary sense means that the
coating had abutting edges3 or a joining area of some kind, e.g., an overlap.
See, e.g., Berta’s Fig. 8a (showing abutting edges) or Fig. 8b (showing
overlapping edges). Appellants’ film is claimed as “continuous,” which has
the ordinary meaning “uninterrupted.”4 Because Berta’s coating had a seam,
it was not continuous in the ordinary sense of the word and the Examiner has
provided no reason to interpret the word otherwise. We therefore reverse the
rejection based on Berta taken alone.

3 seam. (2010). In Merriam-Webster Online Dictionary. Retrieved April 1,
2010, from http://www.merriam-webster.com/dictionary/seam:
1 a : the joining of two pieces (as of cloth or leather) by sewing usually near
the edge b : the stitching used in such a joining
2 : the space between adjacent planks or strakes of a ship
3 a : a line, groove, or ridge formed by the abutment of edges . . . c : a line
left by a cut or wound; . . . .
4 : a weak or vulnerable area or gap

4 continuous. (2010). In Merriam-Webster Online Dictionary. Retrieved
April 6, 2010, from http://www.merriam-
webster.com/dictionary/continuous:
1 : marked by uninterrupted extension in space, time, or sequence
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Turning to the case for obviousness based on combining the teachings
of Berta and Hogan, we first agree with the Examiner that a person of
ordinary skill in the art would have viewed these references as being in the
same field (coated pharmaceutical formulations), and would have thought
their teachings were available for combination. The Examiner made
thorough findings on the scope and content of Hogan’s disclosure. (Ans. 5-
6; FF7-11.)
After making those findings, the Examiner concluded: “[i]t would
have been obvious to one of ordinary skill in the art at the time the invention
was made to incorporate the powder coating material methods of Hogan,
which comprise the step of employing radiation, within the multi-colored
tablet of Berta.” (Ans. 6.) According to the Examiner, “[t]he expected
result would be an enhanced, multi-colored continuous coating layer having
different colors along the body of the tablet for a pleasing colorful
appearance for the consumer.” (Id.) However, claim 31 defines “first and
second parts of the coating layer having different coloration,” and does not
require that the coloration be “along the body of the tablet” as shown in
Berta at, e.g. Fig 8a. The evidence the Examiner cited was sufficient to
show that Hogan alone disclosed the product defined in appealed claims 31
and 33. We agree that the combination of Berta’s coloration pattern with
Hogan’s similar teaching (FF11) would have been obvious, but it was not
needed for the prima facie case of obviousness.
Appellants argue that one of skill in the art would not have had “an
expectation of success in irradiating the caplets of Berta as taught by
Hogan.” (Reply Br. 8.) The statement of the rejection did not propose that
it would have been obvious to irradiate Berta’s caplets. Instead, its focus
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was on a product with Berta’s color pattern along the body of the tablet.
(Ans. 6.) In the “Response to Argument” part of the Answer, the Examiner
disagreed with Appellants’ argument that irradiating Berta’s caplets was
pertinent, and emphasized the obviousness of the product, not the process by
which it would have been made. (Id. at 9-10.) We agree with the Examiner
that Appellants’ argument is misdirected and unpersuasive.
The dependent claims have not been argued separately and therefore
fall with claims 31 and 33. 37 C.F.R. § 41.37(c)(1)(vii).

CONCLUSIONS
The Examiner properly followed “product-by-process” precedent and
did not err by basing the patentability determination on the product rather
than the process steps.
The evidence does not support the Examiner’s finding that Berta alone
taught or suggested a continuous film coating layer.
The evidence supports the Examiner’s finding that Hogan taught a
continuous film coating layer with at least two differently colored parts.
The evidence supports the Examiner’s finding that a person of
ordinary skill in the art would have been motivated to combine Berta’s
teachings with Hogan’s teachings.
The evidence supports the Examiner’s finding that the Berta and
Hogan teachings could be combined with a reasonable expectation of
success.

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Application 09/842,466

SUMMARY
We affirm the rejection of claims 6-9, 11, 13-20 and 31-47 under
35 U.S.C. § 103(a) as unpatentable over the combined teachings of Berta
and Hogan.
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

cdc

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