Ex Parte Archibald et al

Board of Patent Appeals and Interferences

Sep 9, 2010

10610306 (B.P.A.I. Sep. 9, 2010)

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.
10/610,306 06/30/2003 Don A. Archibald B4700-83B 9271
26158 7590 09/09/2010
WOMBLE CARLYLE SANDRIDGE & RICE, PLLC
ATTN: PATENT DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
KRISHNAN, GANAPATHY
ART UNIT PAPER NUMBER
1623
MAIL DATE DELIVERY MODE
09/09/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DON A. ARCHIBALD, QI FANG, LINUS G. FONKWE,
GREGORY L. DIETEL, and CHARLES S. CASAULT
__________

Appeal 2009-014093
Application 10/610,306
Technology Center 1600
__________

Before ERIC GRIMES, TONI R. SCHEINER, and MELANIE L. McCOLLUM,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-221, 285, and 286 on the grounds of anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-014093
Application 10/610,306

2
STATEMENT OF THE CASE
According to the Specification, “[w]hen forming a film for subsequent
use in medicinal, cosmetic, or nutritional capsule manufacture, the resultant
physical properties of sealability, extensibility, and tensile strength are
important” (Spec. 3: 8-12). “Many non-gelatin film-forming compositions
require a high percentage of water . . . to allow the hydrocolloids to fully
hydrate and/or to allow the composition to be flowable enough for easy use
in manufacturing” (id. at 14: 3-5). However, “[m]ost films do not have
sufficient strength at such a high water content to be directly usable in a
rotary die encapsulation process” and “[f]ilms cast [from] compositions
having a high water content take too long to dry to practically be used in a
continuous rotary die encapsulation process” (id. at 14: 5-8).
All of the claims on appeal are directed to a method of producing a
film from a non-gelatin hydrocolloid, wherein a high percentage of water
and a plasticizer are added to the hydrocolloid to make a film-forming
composition, and a portion of the water is extracted from the film-forming
composition prior to forming the film-forming composition into a film (id. at
4: 22-28).
Claim 1 is representative of the subject matter on appeal:
1. A method of producing a non-gelatin film, the method comprising:
(a) combining at least one non-gelatin hydrocolloid, water, and at
least one plasticizer into a substantially homogeneous film-forming
composition comprising at least about 40 percent water by weight;
(b) extracting a portion of the water from the film-forming
composition to form a dried portion having a water content of less than or
equal to about 25 percent by weight; and
(c) forming the dried portion of the film-forming composition into
a film.

Appeal 2009-014093
Application 10/610,306

3
The Examiner rejected claims 1-6, 8, 9, 31, 32, 34-43, 45, 62-64, 68,
71-80, 82, 99-104, 108-117, 119, 136-153, 155, 172-190, 192, 209-216, 218-
221 and 285-286 under 35 U.S.C. § 102(b) as anticipated by Asanuma.2
In addition, the Examiner rejected claims 7, 10-30, 33, 44, 46-61, 65-
67, 69, 70, 81, 83-98, 105-107, 118, 120-135, 154, 156-171, 191, 193-208,
and 217 under 35 U.S.C. § 103(a) as unpatentable over Asanuma, Tanner,3
and Masahiro.4
We reverse.
ANTICIPATION
Issue
Appellants contend that the claimed invention is “a method wherein
the water content of a highly hydrated, low-viscosity non-gelatin film
forming composition is reduced before film formation” (App. Br. 8), in
contrast to Asanuma’s method, “wherein a composition having a very high
water content and a very low viscosity is first poured or cast onto a heated
roller to form a film layer, and then [heat is] externally appl[ied] . . . to dry
the already-formed film” (id. at 10).
The Examiner found that Asanuma describes a method in which a
film forming composition containing about 55% water and a non-gelatin
hydrocolloid is extruded “at a high temperature under pressure” to produce a
film with a water content of about 10% (Ans. 3). According to the
Examiner, “some water [is removed] during the extrusion to form a mixture

2 Japanese Patent Application JP 501-5766, published August 20, 1975 (all
citations are to the English language translation).
3 International Application WO 01/03677, published January 18, 2001.
4 Japanese Patent Application JP 133-2140, published August 20, 1991 (all
citations are to the English language translation).
Appeal 2009-014093
Application 10/610,306

4
that has a water content of less than or equal about 25% in weight in the
extruder, which is further extruded and finally dried to give a film with a
water content of less than or equal to 25%” (id.).
Given the opposing positions of Appellants and the Examiner, the
issue raised by this appeal is whether the evidence of record supports the
Examiner’s finding that Asanuma describes a method of producing a film
from a non-gelatin hydrocolloid, wherein water and a plasticizer are added
to the hydrocolloid to make a film-forming composition, and a portion of the
water is extracted from the film-forming composition prior to forming the
film-forming composition into a film.
Findings of Fact (FF)
1. Asanuma describes an amylose film “prepared by speedily
drying the discharged dissolved dope when extrusion molding a composition
prepared by mixing amylose, water, and a plasticizer” (Asanuma 3).
2. Specifically:
A mixture consisting of amylose, water, and a plasticizer
. . . is supplied through an extruder by setting the supply area at
50 - 120°C. Then, the extruder is heated to 100 - 160°C, and
further heated to 150 - 180°C to press-dissolving the mixture.
Next, the mixture is measured using a gear pump . . . and
discharged by adjusting the T-die or slit at 80 - 90°C. Then, the
dope film is completely dried within 2 min. from the time of
discharging the dope film in the atmosphere of at least 70°C, on
the support body (e.g., heated roller) heated to 50°C or higher,
under an infrared ray heater, or using a combination of these
methods.
(Asanuma 5.)
3. A composition comprising 100 parts amylose, 25 parts sorbit,
and 150 parts water by weight (55% water by weight) “was molded under
Appeal 2009-014093
Application 10/610,306

5
the conditions described above, [and] a clear, thin dope film was discharged
from a T-die. This discharged dope film was supplied onto a heated roller
(80°C; 500 mmΦ), adhered within 2 seconds from the time of supplying this
film, and rolled off at 1.5 m/min” (Asanuma 6-7). “The water content ratio
of the obtained film was 10%” (id. at 7).
Discussion
Appellants contend that Asanuma “describes a process wherein a very
wet and low-viscosity stream of material is discharged from a T-die or slit
onto a support body or roller to form a film” (App. Br. 10). Appellants
contend that Asanuma “neither teaches nor suggests draining excess liquid
water or venting water vapor from the heated mixture before the mixture is
discharged from a T-die or slit onto a support roller to form a film” (id.), and
therefore, “does not describe a process in which water is extracted from a
highly hydrated mixture . . . to form a dried portion before film formation”
(id.).
The Examiner concedes that Asanuma does “not explicitly teach that
water is physically drained” (Ans. 7), but argues that:
[Asanuma’s] composition is extruded under pressure starting at
50° C and going up[ ] to about 170° C and then drying to give a
film. The extrusion is done at a high temperature. One of skill
in the art knows that water boils at 100°C at atmospheric
pressure. In the process of . . . [Asanuma] the temperature is
taken to 170° C. At this high a temperature water will be
removed during the extrusion and forced out through the
extrusion slit, resulting in a mixture that has a water content of
less than or equal about 25% in weight in the extruder, which is
further dried to give a film. With the temperature taken to 170°
C, removal or venting (or in other words, extraction) of water is
inherent.
(Id.)
Appeal 2009-014093
Application 10/610,306

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We find that the Examiner’s inferences are not supported by the
evidence of record. Asanuma discloses that amylose was mixed with water
and dissolved at 150-180°C, under pressure. The amylose-water mixture
was subsequently “discharged by adjusting the T-die . . . at 80 - 90°C. Then,
the dope film [was] completely dried” (Asanuma 5; FF2). Even if we were
to accept, for the sake of argument, that the pressure in the extruder would
have been insufficient to prevent the mixture from boiling during the “press-
dissolving” step, there is nothing in the reference to indicate that provision
was made for venting steam from the extruder, or for draining water from
the mixture, much less reducing the water content of the mixture to 25% or
less. In any case, Asanuma teaches that the temperature of the mixture was
well below 100°C by the time it reached and was extruded from the T-die
and subsequently dried.
Conclusion
The evidence of record does not support the Examiner’s finding that
Asanuma describes a method of producing a film from a non-gelatin
hydrocolloid, wherein water and a plasticizer are added to the hydrocolloid
to make a film-forming composition, and a portion of the water is extracted
from the film-forming composition prior to forming the film-forming
composition into a film.

OBVIOUSNESS
The Examiner rejected claims 7, 10-30, 33, 44, 46-61, 65-67, 69, 70,
81, 83-98, 105-107, 118, 120-135, 154, 156-171, 191, 193-208, and 217
under 35 U.S.C. § 103(a) as unpatentable over Asanuma, Tanner, and
Masahiro.
Appeal 2009-014093
Application 10/610,306

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As discussed above, the Examiner has not established that water is
extracted from Asanuma’s film-forming composition before the film-
forming composition is made into a film, as required by all the claims on
appeal. Neither Tanner nor Masahiro makes up for this underlying
deficiency.

SUMMARY
The rejection of claims 1-6, 8, 9, 31, 32, 34-43, 45, 62-64, 68, 71-80,
82, 99-104, 108-117, 119, 136-153, 155, 172-190, 192, 209-216, 218-221
and 285-286 under 35 U.S.C. § 102(b) as anticipated by Asanuma is
reversed.
The rejection of claims 7, 10-30, 33, 44, 46-61, 65-67, 69, 70, 81, 83-
98, 105-107, 118, 120-135, 154, 156-171, 191, 193-208, and 217 under 35
U.S.C. § 103(a) as unpatentable over Asanuma, Tanner, and Masahiro is
reversed.

REVERSED

alw

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