Captek Softgel International, Inc.

Patent Trials and Appeals Board

Oct 1, 2021

2021003047 (P.T.A.B. Oct. 1, 2021)

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.
16/289,416 02/28/2019 Ronnie E. BAYLESS 102897-000210US-1125162 2331
20350 7590 10/01/2021
Kilpatrick Townsend & Stockton LLP - West Coast
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
10/01/2021 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
KTSDocketing2@kilpatrick.foundationip.com
ipefiling@kilpatricktownsend.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RONNIE E. BAYLESS and
TIMOTHY BRIAN CHIPRICH

Appeal 2021-003047
Application 16/289,416
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims directed to a soft capsule as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Captek
Softgel International, Inc. Appeal Br. 3. Herein we refer to the Final Office
Action of May 21, 2020 (“Final Act.”), Appeal Brief of November 16, 2020
(“Appeal Br.”), Examiner’s Answer of February 2, 2021 (“Ans.”), and Reply
Brief of April 2, 2021 (“Reply Br.”).
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We AFFIRM IN PART, however, because our rationale differs from
that of Examiner’s, we designate the affirmance a new ground of rejection.
STATEMENT OF THE CASE2
The Specification explains that “[s]oft gel capsules provide a useful
means of packaging and delivering various compounds, including nutritional
supplements and various drug compounds.” Spec. 1. The use of carrageenan-
based films provides a suitable replacement for gelatin-based films,
however, carrageenan has been associated with inflammation-related side-
effects. Id. Hence, there is a need for film forming products that are free of
animal products and carrageenan. Spec. Abstract.
Claims 21–23, 25–35, 38–41, and 43–69 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief. Claims 21, 23, 47, and
51 are independent claims and are reproduced below:
21. A soft capsule, comprising:
(a) a fill material; and
(b) an outer shell encapsulating the fill material, wherein the
outer shell is formed by encapsulating the fill material with a
film-forming composition comprising
(i) from 0 to 10 percent by weight of a hydroxyalkylated
plant starch, and from 0 to 60 percent by weight of a plant
sugar, wherein the film forming composition comprises
from 1 to 60 percent by weight of a combination of the
hydroxyalkylated plant starch and the plant sugar;
(ii) from 1 to 30 percent by weight agar; and
(iii) from 30 to 80 percent by weight water;
wherein the percents by weight are based on the total weight of
the film-forming composition.
Appeal Br. 15.

2 An oral hearing was held September 20, 2021, and a transcript of the
hearing will be placed into the record.
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23. A soft capsule, comprising:
(a) a fill material; and
(b) an outer shell encapsulating the fill material, wherein the
outer shell comprises:
(i) from 0 to 12 percent by weight of a hydroxyalkylated
plant starch, and from 0 to 80 percent by weight of a plant
sugar, wherein the outer shell comprises 1 to 80 percent by
weight of a combination of the hydroxyalkylated plant
starch and the plant sugar; and
(ii) from 1 to 60 percent by weight agar;
wherein the percents by weight are based on the total weight of
the outer shell.
Id. (formatting added).
47. A soft capsule, comprising:
(a) a fill material; and
(b) an outer shell encapsulating the fill material, wherein the
outer shell is formed by encapsulating the fill material with a
film-forming composition comprising
(i) from 1 to 60 percent by weight of a hydroxyalkylated
plant starch, a plant sugar, or a combination thereof;
(ii) from 15 to 30 percent by weight agar; and
(iii) from 30 to 80 percent by weight water;
wherein the percents by weight are based on the total weight of
the film-forming composition.
Id. at 18.
51. A soft capsule, comprising:
(a) a fill material; and
(b) an outer shell encapsulating the fill material, wherein the
outer shell comprises:
(i) from 1 to 80 percent by weight of a hydroxyalkylated
plant starch, a plant sugar, or a combination thereof; and
(ii) from 15 to 60 percent by weight agar;
wherein the percents by weight are based on the total weight of
the outer shell.
Id. at 18–19 (formatting added).

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REJECTION
Appellant requests review of Examiner’s rejection of claims 21–23,
25–35, 38–41, and 43–69 under 35 U.S.C. § 103 as being unpatentable over
Yang3, in view of Chen,4 Udell,5 and Li6.
OPINION
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that soft capsules are obvious over the cited art.
A. Findings of Fact (FF)
We agree with and adopt Examiner’s findings of fact and reasoning
regarding the scope and content of the prior art as set out in the Final Office
Action and Answer. For emphasis only we highlight the following:
FF1. Yang teaches “non-animal soft capsule shell composition that is
typically made of starch or a starch derivative, gums, a
plasticizer, a buffering agent, and purified water.” Yang,
Abstract. Specifically, the capsule shell composition contains:
i) 15-30 wt % of at least one starch selected from raw
starch, acid modified starch, hydroxypropylated modified
starch, a-modified starch, cross-linked modified starch,
starch hydrozylate and/or mixed starch of raw starch and
modified starch;
ii) 1.0-10 wt% of at least one gum selected from arabic
gum, tragacanth gum, karaya gum, ghatti gum, guar gum,
locust bean gum, tara gum, konjac, algin, agar,
carrageenan, pullulan, pectin, gellan, mannan and/or
xanthan gum; and
iii) 1.0-20 wt% of plasticizer, 0.001-5 wt% of buffering

3 US 2013/0302309 A1, pub. Nov. 14, 2013.
4 US 2003/0161872 A1, pub. Aug. 28, 2003.
5 US 2007/0292501 A1, pub. Dec. 20, 2007.
6 EP 1925298 A1, pub. May 28, 2008.
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agent, 0.001-3 wt% of disintegration agent, 0.001-2 wt%
of antioxidant and a suitable amount of purified water.
Id. ¶ 18 (highlighting and formatting added for emphasis). A
suitable amount of purified water is between 45–60 wt%. See
id. ¶¶ 19, 21.
FF2. Yang teaches that the “plasticizer can be at least one selected
from mannitol, crystalline or non-crystalline sorbitol, sorbitan,
sucrose, xylitol, erythritol, maltitol, oligo sugar, iso-malto oligo
sugar, glycerin, diglycerol or triglycerol.” Yang ¶ 30.
FF3. Yang teaches modifying starch by reacting starch and propylene
oxide in the presence of alkali catalyst in order to form a
hydroxypropylated starch, and specifically teaches the
hydroxypropylated modification of tapioca starch. Yang. ¶ 39.
Yang teaches that “hydroxypropylated tapioca starch [by itself]
cannot have enough film strength, even though it has sufficient
elasticity and viscosity for soft capsule film.” Id. ¶ 40. Yang
teaches examples that include mixtures of starch and
hydroxypropylated starch. The table below shows a side-by-
side comparison between Yang’s preparation example and
Yang’s comparative example.
Preparation
example 27
(see id. ¶ 60
(Table 2)
Comparative
Preparation
example 2
(see id. ¶ 65
(Table 4)
HP tapioca starch 14.0 8.0

7 Amounts presented are based on 100 kg solution.
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Preparation
example 27
(see id. ¶ 60
(Table 2)
Comparative
Preparation
example 2
(see id. ¶ 65
(Table 4)
cross-linked potato
starch
6.0 4.0
HP maize starch 2.5 2.5
iota-carrageenan 4.0 4.0
glycerin 8.5 8.5
D-sorbitol solution 8.0 8.0
sodium phosphate,
dibasic
0.7 0.7
α-amylase 0.1 0.1
coloring agent,
flavoring agent and
antioxidant
0.8 0.88
purified water 55.4 63.4
Total 100 100

FF4. Yang teaches that the preparation examples having starch
within their preferred ranges “shows better disintegration
stability compared to conventional soft capsule film
composition made by starch.” Yang ¶ 69.
FF5. Li teaches the use of inhibited starch filler for the production of

8 We note that the 30.8 amount listed in table 4 of Yang appears to be a
typographical error because the amount of water does not reflect a coloring,
flavoring, and antioxidant in the amount of 30.8 percent. Yang ¶ 65.
Paragraph 64 further supports the position that the only difference between
these compositions in Yang is the of starch content. See id. ¶ 64.
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gelatin-free films and soft capsules. Li, Abstract. “The films
and the soft capsules will typically comprise from about 0.1 to
about 20 dry weight percent of the inhibited fillers.” Li ¶ 22.
Inhibited starch filler is the modification of starch to
improve process tolerance to temperature, pH and shear
through control of granular swelling under adverse
conditions. There are various methods to form highly
inhibited starch fillers. Non-limiting examples of highly
inhibited starches include crosslinking starch with
chemical treatments such as phosphorus oxychloride,
sodium trimetaphosphate, epichlorohydrin, and mixtures
of adipic anhydride and acetic anhydride. Other non-
limiting methods of inhibition include physical (heat or
radiation) treatments of starch.
Li ¶ 16. The inhibited starch will “swell less than about 150%
in their original granule size after cooking.” Li ¶ 18. Suitable
inhibited starch can include modified tapioca starch among
others. Li ¶ 17.
FF6. Li teaches that matrix starch can be native or modified starch.
Li ¶ 23. Li teaches that the matrix starch may be physically
modified. ¶ 25.
The matrix starch may also be chemically modified,
including without limitation, inhibited, acetylated,
organically esterified, hydroxyethylated,
hydroxypropylated, phosphorylated, inorganically
esterified, cationic, anionic, nonionic, and zwitterionic,
and succinate (succinylated) and substituted succinate
derivatives thereof. Such modifications are known in the
art, for example in Modified Starches: Properties and
Uses, Ed. Wurzburg, CRC Press, Inc., Florida (1986).
Particularly suitable starches, without limitation, include
hydroxyalkylated starches such as hydroxypropylated or
hydroxyethylated starches, and succinated (succinylated)
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starches such as octenylsuccinated (octenylsuccinylated)
or dodecylsuccinated (dodecenylsuccinylated) starches.
Li. ¶ 26. Li teaches that matrix starch is present in an amount between
40 to about 95% by dry weight of the film and/or capsule. Li ¶ 30,
claim 7. Li teaches that matrix starch can include tapioca starch
among others. Li ¶ 24.
FF7. Li teaches that the films and soft capsules may additionally
include gums and hydrocolloids.
Exemplary gums and hydrocolloids which may be used
in the present invention include, without limitation,
gellan gum, xanthan gum, tragacanth gum, guar gum,
locust bean gum, acacia gum, gum Arabic, carrageenan,
and galactomanans. . . . The gums or hydrocolloids may
be used in any amount necessary to achieve the desired
elasticity and rigidity. Particularly, gellan gum may be
used up to 20% of the total dry weight of the
composition.
Li ¶ 32.
B. Analysis
Examiner finds that Yang teaches film forming material that contains
at least one hydroxypropylated starch, agar, and water. Final Act. 5.
Examiner acknowledges that “Yang fails to teach that the film-forming
composition comprising (i) from 0 to 10 percent by weight of a
hydroxyalkyated plant starch or 0-12% and the_outer shell of the soft
capsule further comprises plant sugars and lecithin.” Id. at 6; FF1–FF4.
Examiner looks to the teachings of Chen, Udell, and Li for these limitations.
More specifically, Examiner relies on Li for teaching a soft capsule
“comprising 0.5-15% hydroxyalkylated starch” Final Act. 5 (citing Li ¶ 22);
FF5–FF6. Examiner relies on Chen for teaching that the outer shell of a
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capsule can be mixed with polyglycols, lecithin, and sugar. Final Act. 5
(citing Chen ¶¶ 27, 29, claim 4). Examiner relies on Udell for teaching a
chewable soft gel including glucose, fructose, and glycerin. Id. (citing Udell
¶¶ 8, 163, 171, claims 30, 31, and 57). Based on these disclosures, Examiner
concludes that one of ordinary skill in the art at the time the invention was
made would have been motivated to expand the teaching of Yang “to
formulate a soft capsule with a fill material, an outer shell with the
modification in the amount [set out in Li] because they are drawn to same
technical fields.” Id. at 7. In addition, Examiner concludes that
“[o]ptimization of parameters is a routine practice that would be obvious for
a person of ordinary skill in the art to employ.” Id.
1. Claims 21, 22, 43, and 44
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that soft capsules containing from 0–10%
hydroxyalklyated plant starch are obvious over the cited art.
We begin with claim construction, giving the claims their broadest
reasonable interpretation consistent with the Specification. In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). Independent claim 21, recites in pertinent
part, “from 0 to 10 percent by weight of a hydroxyalkylated plant starch, and
from 0 to 60 percent by weight of a plant sugar, wherein the film forming
composition comprises from 1 to 60 percent by weight of a combination of
the hydroxyalkylated plant starch and the plant sugar.” We determine that
this limitation includes a composition that minimally has 1 percent by
weight of a hydroxyalkylated plant starch and no plant sugar, or 1 percent
plant sugar and no plant starch, and maximally a composition that contains
no more than 10 percent by weight of a hydroxyalkylated plant starch with
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no plant sugar, and a composition that has 60 percent per weight of a plant
sugar and no hydroxylated plant starch. We note that the claim also allows
for mixtures of the two components provided that the mixture does not
exceed 60 percent by weight of the composition and still meets the less than
10 percent by weight of hydroxyalkylated plant starch limitation. In other
words, the outer shell, if it includes a hydroxyalkylated plant starch, can only
have that starch present in up to 10 percent by weight.
Both Appellant and Examiner agree that Yang does not teach
concentrations of hydroxyalkylated plant starch below 10%. See Appeal Br.
6; Final Act. 5; see also Ans. 4 (“Examiner cited prior art references to cure
the deficit. Li is cited for its teaching of a soft capsule (0002) comprising
0.5-15%, hydroxyalkylated starch”). Appellant contends that Examiner’s
reliance on Li for teaching hydroxyalkylated plant starch below 10% is
misplaced because the only hydroxyalkylated plant starch identified in Li is
“‘matrix starch[]’ [that] can be present only in concentrations of about 40%
to about 95%.” Appeal Br. 7 (citing Li ¶ 30). Appellant contends that “Li
teaches the non-hydroxyalkylated ‘highly inhibited starch filler’ can be
present in compositions in concentrations of about 0.5 to 15 %.” Appeal Br.
7 (citing Li ¶ 22). Appellant contends Li “distinguishes ‘inhibited’ starches
from ‘hydroxyalkylated’ starches, so Li implicitly teaches that the ‘highly
inhibited starch filler’ cannot be hydroxyalkylated.” Appeal Br. 7; see Reply
Br. 3–5.
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. . . . After evidence or argument is submitted by
the applicant in response, patentability is determined on the
totality of the record, by a preponderance of evidence with due
consideration to persuasiveness of argument.
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In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
We find that Appellant has the better position. Li teaches that the
purpose of the inhibited plant starch is “to improve process tolerance to
temperature, pH and shear through control of granular swelling under
adverse conditions.” FF5. Li provides examples of manufacturing process
that produce inhibited plant starch, these processes “include crosslinking
starch with chemical treatments such as phosphorus oxychloride, sodium
trimetaphosphate, epichlorohydrin, and mixtures of adipic anhydride and
acetic anhydride. Other non-limiting methods of inhibition include physical
(heat or radiation) treatments of starch.” FF5. Li teaches that
hydroxyalkylated plant starch are produced via different methods. FF6. We
agree with Appellant that Li distinguishes inhibited plant starch from
hydroxyalkylated plant starch. Appeal Br. 7. Because inhibited plant starch
is produced by different methods than hydroxyalkylated plant starch we
agree with Appellant that they are not identical chemical structures as urged
by Examiner. See Appeal Br. 7; Ans. 4.
On this record, we find that Appellant has the better position because
Examiner has not met the burden of setting out a prima facie case with
respect to claim 21. Specifically, Examiner does not cite evidence or provide
evidence-based technical reasoning to support the position that
hydroxyalkylated plant starch and inhibited plant starch are the same
chemical entity. Examiner does not sufficiently articulate why based on the
teaching of Li one of ordinary skill in the art at the time the invention was
made would have reduced the hydroxyalkylated plant starch in Yang to
concentrations below 10 percent by weight.
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We conclude that the preponderance of the evidence of record does
not support Examiner’s conclusion that the combination of Yang, Chen,
Udell, and Li teaches a soft shell capsule that contains from 0 to 10%
hydroxyalkylated plant starch and having all limitations of independent
claim 21. Because claims 22, 43, and 44 depend from claim 21, we reverse
the rejections of these claims for the same reason set out for claim 21.
Accordingly, we reverse the rejection of claims 21, 22, 43, and 44 under
35 U.S.C. § 103(a) that rely on the teachings of Yang, Chen, Udell, and Li.
2. Claims 23, 25–35, 38, 41, 45, and 46
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that soft capsules containing from 0–12%
hydroxyalkylated plant starch are obvious over the cited art.
(a) Claim 23
We begin with claim construction, giving the claims their broadest
reasonable interpretation consistent with the Specification. In re Hyatt, 211
F.3d at 1372. Independent claim 23, recites in pertinent part, “from 0 to 12
percent by weight of a hydroxyalkylated plant starch, and from 0 to 80
percent by weight of a plant sugar, wherein the outer shell comprises from 1
to 80 percent by weight of a combination of the hydroxyalkylated plant
starch and the plant sugar.” Similar to claim 21, we determine that this
limitation includes a composition that minimally has 1 percent by weight of
a hydroxyalkylated plant starch and no plant sugar or 1 percent plant sugar
and no hydroxyalkylated plant starch, and maximally a composition that
contains no more than 12 percent by weight of a hydroxyalkylated plant
starch with no plant sugar, and a composition that has 80 percent by weight
of a plant sugar and no hydroxyalkylated plant starch. We note that the claim
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also allows for mixtures of the two components provided that the mixture
does not exceed 80 percent by weight of the composition and still meets the
less than 12 percent by weight of a hydroxyalkylated plant starch limitation.
In other words, the outer shell, if it includes a hydroxyalkylated plant starch,
can only have that starch present in up to 12 percent by weight.
Yang’s comparative preparation teaches a soft film composition that
contains 10.5 % hydroxypropylated starch (8% HP tapioca starch and 2.5 %
HP maize starch) in addition to 4% crosslinked potato starch. FF3. Yang’s
example, therefore, meets the requirement of claim 23 having an outer shell
material comprising from 0 to 12 percent by weight of a hydroxyalklated
plant starch. Yang’s comparative example lists water as making up 63.4% of
the composition.
Yang teaches using 4% carrageenan, specifically iota-carrageenan, as
a gelling agent. FF3. In addition to carrageenan, Yang lists other suitable
gums including agar and gellan among others as gelling agents. FF1.
Although Yang does not exemplify a composition containing agar. It is
prima facie obvious to those skilled in the art to substitute one known
equivalent for another. See In re Omeprazole Patent Litig., 483 F.3d 1364,
1374 (Fed. Cir. 2007). Here, Yang identifies suitable gum equivalents by
providing a list of gums for incorporation into the capsule shell. FF1 (listing
agar, carrageenan, and gellan as suitable gums). Moreover, it is well settled
that “in a section 103 inquiry, ‘the fact that a specific [embodiment] is taught
to be preferred is not controlling, since all disclosures of the prior art,
including unpreferred embodiments, must be considered.’” Merck & Co. Inc.
v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In
re Lamberti, 545 F.2d 747, 750 (CCPA 1976)); see also In re Mills, 470
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F.2d 649, 651 (CCPA 1972) (“All the disclosures in a reference must be
evaluated, including nonpreferred embodiments, and a reference is not
limited to the disclosure of specific working examples.” (Citations omitted).)
In reaching our decision, we rely on additional evidence in the record
not relied on by Examiner. In order to give Appellant a fair opportunity to
respond, we designate the affirmance of claim 23 as a new ground of
rejection. As Appellant does not argue claims 25–35 and 38 separately, they
fall with claim 23. 37 C.F.R. § 41.37 (c)(1)(iv).
(b) Claim 41
Appellant contends that “[t]he Office fails to identify any teaching in
the prior art of an outer shell comprising no more than 5 % by weight of
product derived from animals and fails to identify any apparent reason to
modify the prior art to include that limitation.” Appeal Br. 9.
We are not persuaded. We begin with claim construction of dependent
claim 41, which depends directly from claim 23 and further recites “wherein
the outer shell comprises no more than 5 percent by weight of products
derived from animals, based on the total weight of the outer shell.” We note
that claim 23 does not require the inclusion of any animal products. We,
therefore, interpret the limitation “comprises no more than 5 percent by
weight” as recited in claim 41 to be an optional limitation because it allows
for, but does not require, the inclusion of an animal product in the
composition forming the outer shell. In other words, “contains no more than
5 percent” is reasonably interpreted to be a range from 0–5 percent by
weight. Therefore, when there is no animal product in the composition,
Yang’s comparative composition renders claim 41 obvious for the same
reason discussed above for claim 23.
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(c) Claim 45
Appellant contends that “the Office fails to identify any teaching or
suggestion in the prior art of a composition comprising no more than 0.5
percent by weight carrageenan and fails to identify any apparent reason to
modify the prior art to include that limitation.” Appeal Br. 10.
We are not persuaded. We begin with claim construction of dependent
claim 45, which depends directly from claim 23 and further recites “wherein
the outer shell comprises no more than 0.5 percent by weight carrageenan.”
We note that claim 23 does not require any carrageenan. We interpret the
limitation “comprises no more than 0.5 percent by weight” as recited in
claim 45 to be an optional limitation because it allows for, but does not
require, the inclusion of carrageenan in the composition forming the outer
shell. In other words, “contains no more than 5 percent” is reasonably
interpreted to be a range from 0–0.5 percent by weight. Therefore, when
there is no carrageenan in the composition, Yang’s comparative composition
renders claim 45 obvious for the same reason discussed above for claim 23.
(d) Claim 46
Claim 46 depends directly from claim 23 and further recites “wherein
the outer shell comprises at least 15 percent by weight agar.” Here, the claim
requires that an agar concentration is at least 15 percent. Because claim 46
depends from claim 23, the agar concertation is reasonably interpreted to be
a range from 15 to 60 percent by weight.
Appellant contends that “[t]he Office fails to identify any teaching or
suggestion in the prior art of a film forming composition comprising at least
15 % by weight agar and fails to identify any apparent reason to modify the
prior art to include that limitation.” Appeal Br. 8.
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We are not persuaded. Examiner explains that “the amounts of a
pharmaceutical composition is clearly a result effective parameter that a
person of ordinary skill in the art would routinely optimize. Optimization of
parameters is a routine practice that would be obvious for a person of
ordinary skill in the art to employ.” Final Act. 7; see also Ans. 10 (“The
characteristics of agar and carrageenan are well known in the art and
therefore it is expected that one of ordinary skill would have basic
knowledge of how to use and optimize [the use of gum in a capsule]
additionally Appellant should note that determination of the optimum or
workable dosage range would have been well within the practice of routine
experimentation by the skilled artisan.”)
Yang teaches the incorporation of gum into the capsule and suggests
that gums such as carrageenan, agar, and gellan are equivalents. FF1. Li also
incorporated gum into a capsule. FF7. Specifically, Li explains that gums are
incorporated into a capsule in “any amount necessary to achieve the desired
elasticity and rigidity. Particularly, gellan gum may be used up to 20% of the
total dry weight of the composition.” FF7. Here, Li recognizes that
incorporation of gum into a capsule is a result effective variable, and if one
wanted to make the capsule more rigid one of ordinary skill in the art at the
time the invention was made would have known to modify the amount of
gum, including by increasing it, to achieve the desired elasticity and rigidity
as suggested by Li. Id. Li does not recite using agar but suggests an agar
equivalent gum – gellan – at a concentration of up to 20 percent by weight.
See FF7. Based on these disclosures, we determine that the art sufficiently
supports Examiner’s conclusion that one of ordinary skill in the art at the
time the invention was made would have understood that increasing the
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amount of agar would reasonably affect the rigidity of the capsule shell
rendering higher concentrations of agar obvious. See Final Act. 7; Ans. 10.
3. Claims 47, 48, 49, and 50
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that soft capsules containing from 15–30 percent by
weight agar is obvious over the cited art.
(a) Claims 47, 48, and 49
Appellant contends that the combined references lack a “composition
comprising from 15 to 30 percent by weight agar and fails to identify any
apparent reason to modify the prior art to include that limitation.” Appeal
Br. 11; see Reply Br. 11–14.
We are not persuaded. For the reasons discussed above with respect to
claim 46, we determine that Examiner made a sufficient showing that the
combination of Yang, Chen, Udell, and Li renders an agar concentration
above 15 percent by weight obvious. Specifically, we determine that the art
sufficiently supports Examiner’s conclusion that one of ordinary skill in the
art at the time the invention was made would have understood that
increasing the amount of agar would reasonably effect the rigidity, thereby,
rendering higher concentrations of agar obvious. See Final Act. 7; Ans. 10.
Accordingly, we affirm the rejection of claim 47. As Appellant does not
argue claims 48 and 49 separately, they therefore fall with claim 47. 37
C.F.R. § 41.37 (c)(1)(iv).
(b) Claim 50
Appellant contends that “the Office fails to identify any teaching or
suggestion in the prior art of a composition comprising no more than 0.5
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percent by weight carrageenan and fails to identify any apparent reason to
modify the prior art to include that limitation.” Appeal Br. 12.
We are not persuaded. We begin with claim construction of dependent
claim 49, which depends directly from claim 47 and further recites “wherein
the film-forming composition comprises no more than 0.5 percent by weight
carrageenan.” We note that claim 47 does not require any carrageenan. We
interpret the limitation “comprises no more than 0.5 percent by weight” as
recited in claim 50 to be an optional limitation because it allows for, but
does not require, the inclusion of carrageenan in the film-forming
composition. In other words, “contains no more than 5 percent” is
reasonably interpreted to be a range from 0–0.5 percent by weight. For the
reasons discussed above with respect to claim 47 we determine that the
combination of Yang, Chen, Udell, and Li renders the recited soft capsule
obvious.
4. Claims 51–69
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that soft capsules containing from 15–60 percent by
weight agar is obvious over the cited art.
(a) Claim 51–66 and 68
Appellant contends that the combined references lack a “composition
comprising from 15 to 60 % by weight agar and fails to identify any
apparent reason to modify the prior art to include that limitation.” Appeal
Br. 12; see Reply Br. 14–15.
We are not persuaded. For the same reasons discussed above with
respect to claim 46, we determine that Examiner made a sufficient showing
that the combination of Yang, Chen, Udell, and Li renders an agar
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concentration above 15 percent by weight obvious. Specifically, we
determine that the art sufficiently supports Examiner’s conclusion that one
of ordinary skill in the art at the time the invention was made would have
understood that increasing the amount of agar would reasonably effect the
rigidity, thereby, rendering higher concentrations of agar obvious. See Final
Act. 7; Ans. 10. Accordingly, we affirm the rejection of claim 51. As
Appellant does not argue claims 52–66 and 68 separately, they therefore fall
with claim 51. 37 C.F.R. § 41.37 (c)(1)(iv).
(b) Claim 67
Appellant contends that “[t]he Office fails to identify any teaching in
the prior art of an outer shell comprising no more than 5 % by weight of
product derived from animals and fails to identify any apparent reason to
modify the prior art to include that limitation.” Appeal Br. 13.
We are not persuaded. We begin with claim construction of dependent
claim 67, which depends directly from claim 51 and further recites “wherein
the outer shell comprises no more than 5 percent by weight of products
derived from animals, based on the total weight of the outer shell.” We note
that claim 51 does not require any animal products. We interpret the
limitation “comprises no more than 5 percent by weight” as recited in claim
67 to be an optional limitation because it allows for, but does not require, the
inclusion of an animal product in the composition forming the outer shell. In
other words, “contains no more than 5%” is reasonably interpreted to be a
range from 0–5% by weight. For the reasons discussed above with respect to
claim 51 we determine that the combination of Yang, Chen, Udell, and Li
renders the recited soft capsule obvious.
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(c) Claim 69
Appellant contends that “the Office fails to identify any teaching or
suggestion in the prior art of a composition comprising no more than 0.5
percent by weight carrageenan and fails to identify any apparent reason to
modify the prior art to include that limitation.” Appeal Br. 13.
We are not persuaded. We begin with claim construction of dependent
claim 69, which depends directly from claim 51 and further recites “wherein
the outer shell comprises no more than 0.5 percent by weight carrageenan.”
We note that claim 51 does not require any carrageenan. We interpret the
limitation “comprises no more than 0.5 percent by weight” as recited in
claim 69 to be an optional limitation because it allows for, but does not
require, the inclusion of carrageenan in the outer shell composition. In other
words, “contains no more than 5 percent” is reasonably interpreted to be a
range from 0–0.5 percent by weight. For the reasons discussed above with
respect to claim 51 we determine that the combination of Yang, Chen, Udell,
and Li renders the recited soft capsule obvious.
C. Conclusion
The preponderance of the evidence of record does not support
Examiner’s conclusion that claims 21, 22, 43 and 44 are rendered obvious
over the Yang, Chen, Udell, and Li.
The preponderance of the evidence of record supports the conclusion
that claims 23, 25–35, 38–41, 45, and 46 are rendered obvious over Yang,
Chen, Udell, and Li. Because our reasoning differs from that of Examiner’s
we designate this portion of the decision as new ground of rejection.
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The preponderance of the evidence of record supports Examiner’s
conclusion that claims 47–69 are rendered obvious over Yang, Chen, Udell,
and Li.
DECISION SUMMARY
In summary:
Claims
Rejected
Basis Affirmed Reversed New Ground
21–23, 25–35,
38–41, 43–69
103 47–69 21, 22, 43, 44 23, 25–35,
38–41, 43–46

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION,
must exercise one of the following two options with respect to
the new ground of rejection to avoid termination of the appeal
as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .
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 IN PART; 37 C.F.R. § 41.50(b)