Ex Parte Hayashi et al

Board of Patent Appeals and Interferences

Sep 14, 2011

10534423 (B.P.A.I. Sep. 14, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte YASUO HAYASHI, KAZUYA YANO,
TSUTOMU AWAMURA, and KAZUYOSHI SUDEJI
__________

Appeal 2010-010640
Application 10/534,423
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and FRANCISCO C.
PRATS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
and apparatus for making an edible film, which the Examiner has rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 39-76 are on appeal. Each of the independent method claims
includes the steps of taking two edible agent layers formed on resin film and
joining them by pressing them together, then removing one of the resin films
Appeal 2010-010640
Application 10/534,423

2
from the laminated layers (see claims 39, 49, 56, and 62, reproduced in the
Claims Appendix of the Appeal Brief). Similarly, the independent apparatus
claim requires a pair of press rolls arranged to press together two edible
agent layers formed on resin films and “a delamination roll . . . disposed at a
position forward of said pair of press rolls in a conveying direction; [and] a
winding shaft arranged to draw and delaminate only one of said two resin
films sandwiching said orally administrable edible agent layers conveyed
from said pair of press rolls” (see claim 69, reproduced in the Claims
Appendix of the Appeal Brief).
The Examiner has rejected claims 39-76 under 35 U.S.C. § 103(a) as
obvious based on Roreger1 and Nogami2 (Answer 4). The Examiner finds
that Roreger discloses a method and apparatus that meets the limitations of
the claims on appeal except that Roreger does not use an edible film (id. at
5-7). The Examiner finds that Nogami discloses “a layered edible film
composition for administering an active agent” (id. at 7) and concludes that
it would have been obvious “to make the edible, layered, active agent-
containing composition of Nogami by using the films in Nogami as the base
layers in the laminate composition-producing method and apparatus as
taught by Roreger et al. and produce the instant invention” (id. at 9).
Appellants argue that Roreger teaches removing a protective layer
from its base material layers before laminating those layers together, not
afterward as required by the claims (see, e.g., Appeal Br. 10). Appellants
conclude that

1 Roreger et al., US 6,618,087 B1, Nov. 16, 2004
2 Nogami, US 2004/0137040 A1, July 15, 2004
Appeal 2010-010640
Application 10/534,423

3
as none of the Roreger and Nogami references discloses or
suggests delaminating only one of the two resin films by
conveying the two resin films sandwiching the bonded orally
administrable edible agent layers in a substantially tangential
direction at a pressurization zone of the pair of press rolls, as
required by independent claims 39 and 56, the combination of
the Roreger and Nogami references does not disclose or suggest
delaminating only one of the two resin films by conveying the
two resin films sandwiching the bonded orally administrable
edible agent layers in a substantially tangential direction at a
pressurization zone of the pair of press rolls, as required by
independent claims 39 and 56.
(Appeal Br. 12-13; see also id. at 18, 21-22 (same argument with respect to
the other independent claims).)
We agree with Appellants that the Examiner has not established that
Roreger and Nogami would have made obvious the step of (or mechanism
for) delaminating one of the protective layers of Roreger’s base material
after bonding its two layers together. Roreger describes bonding two layers
of matrix base material together to form “a single-layer matrix, containing
active substance” (Roreger col. 3, ll. 18-19). Roreger discloses that each of
the strips of base material has a layer of protective material on both sides (id.
at col. 4, ll. 38-40). In Roreger’s process, one of the protective layers is
removed from each strip of base material (id. at col. 4, ll. 45-48), active
substance is applied to one of the strips (id. at col. 5, ll. 7-13), and the two
strips are bonded together by a pair of rollers (id. at col 5, l. 62 to col. 6, l. 5;
see also Fig. 1).
Thus, the product of Roreger’s process is a bonded layer of base
material, containing active substance, sandwiched between layers of
protective material (id. at col. 6, ll. 35-40; see also Fig. 2). Roreger
Appeal 2010-010640
Application 10/534,423

4
discloses that this product is stored, or “matured,” for a period of time to
allow the active substance to diffuse throughout the base material layers and
achieve a uniform distribution (id. at col. 6, ll. 35-43). Roreger does not
describe its process as including the removal of either of the protective
layers after the layers of base material are bonded together, nor does it
provide any reason to expect that an advantage would be gained by
removing one of the protective layers.
The Examiner reasoned that “it would have been obvious to remove
none, one, or both protective films depending on the desired further
processing (storage, cutting, direct patient administration, etc.)” (Answer
12). However, the Examiner has not identified any reason a skilled worker
would remove one of the protective films in order to facilitate any of these
subsequent processing steps. See KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 418-19 (2007) (“[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 . . . because inventions
in most, if not all, instances rely upon building blocks long since uncovered,
and claimed discoveries almost of necessity will be combinations of what, in
some sense, is already known.”). Therefore, we agree with Appellants that
the Examiner has not adequately shown that the claimed process and
apparatus would have been obvious based on the disclosures of Roreger and
Nogami.
Appeal 2010-010640
Application 10/534,423

5
SUMMARY
We reverse the rejection of claims 39-76 as obvious based on Roreger
and Nogami.

REVERSED

lp