SAMSUNG FINE CHEMICALS CO., LTD.

Patent Trials and Appeals Board

Nov 15, 2021

2021000449 (P.T.A.B. Nov. 15, 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.
14/415,006 01/15/2015 Jin Ryul Son YPL1533US 4464
23413 7590 11/15/2021
CANTOR COLBURN LLP
20 Church Street
22nd Floor
Hartford, CT 06103
EXAMINER
PEETS, MONIQUE R
ART UNIT PAPER NUMBER
1763
NOTIFICATION DATE DELIVERY MODE
11/15/2021 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):
usptopatentmail@cantorcolburn.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JIN RYUL SON, SANG YOUB LEE,
JYUNG HEE JEON, SUNG HWAN BANG, and
JU HEE SHIN
____________

Appeal 2021-000449
Application 14/415,006
Technology Center 1700
____________

Before ADRIENE LEPIANE HANLON, JEFFREY B. ROBERTSON, and
JANE E. INGLESE, Administrative Patent Judges.

INGLESE, Administrative Patent Judge.

DECISION ON APPEAL
The Appellant1 requests review under 35 U.S.C. § 134(a) of the
Examiner’s final rejection of claims 1, 5, and 6.2 We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” refers to the “applicant” as defined in 37 C.F.R. § 1.42. The
Appellant identifies Samsung Fine Chemicals Co., Ltd. as the real party in
interest. Appeal Brief filed May 15, 2020 (“Appeal Br.”), 2.
2 Final Office Action entered December 18, 2019 (“Final Act.”), 1.
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Application 14/415,006

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CLAIMED SUBJECT MATTER
The Appellant claims an aqueous composition for preparing a hard
capsule. Appeal Br. 2. Claim 1, the sole pending independent claim,
illustrates the subject matter on appeal, and reads as follows:
1. An aqueous composition for preparing a hard capsule, the
aqueous composition comprising a cellulose ether solution, the
cellulose ether solution comprising:
a water-soluble cellulose ether;
an alcohol; and
water,
wherein non-dissolved materials are absent from the
aqueous composition,
wherein the aqueous composition comprises 10 to 25
wt% of the water-soluble cellulose ether, 5 to 30 wt% of the
alcohol and 0.05 to 5.0 wt% of a gelation agent;
wherein the alcohol comprises ethanol, methanol,
isopropanol, butanol, or a mixture of two or more of these;
wherein the water-soluble cellulose ether comprises
hydroxypropyl methylcellulose(HPMC), hydroxyethyl
methylcellulose(HEMC), methylcellulose(MC), or a mixture of
two or more of these.

Appeal Br. Claims Appendix, i (emphasis and spacing added).
REJECTION
The Examiner maintains the rejection of claims 1, 5, and 6 under 35
U.S.C. § 103(a) as unpatentable over Cade in view of Wong in the
Examiner’s Answer entered November 1, 2019 (“Ans.”).3

3 The Examiner withdrew the rejection of claim 1 under 35 U.S.C. § 112,
second paragraph (Final Act. 2–3) in the Advisory Action entered March 6,
2020.
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Application 14/415,006

3
FACTUAL FINDINGS AND ANALYSIS
Upon consideration of the evidence relied upon in this appeal and
each of the Appellant’s contentions, we reverse the Examiner’s rejection of
claims 1, 5, and 6 under 35 U.S.C. § 103(a), for reasons set forth in the
Appeal and Reply Briefs, and below.
We need address only independent claim 1, which requires the recited
aqueous composition for preparing a hard capsule to comprise a cellulose
ether solution comprising a water-soluble cellulose ether, an alcohol
comprising ethanol, methanol, isopropanol, butanol, or a mixture of two or
more of these, and water.
The Examiner finds that Cade discloses a film-forming composition
for producing a hard capsule comprising a water-soluble cellulose ether,
water, a gelling agent, an auxiliary gelling agent, and propylene glycol.
Final Act. 4 (citing Cade ¶¶ 60, 61, 63–67, 69–71, 83–85). The Examiner
finds that although propylene glycol “reads on alcohol,” Cade “does not
discuss alcohol such as ethanol, methanol, isopropanol and butanol.” Final
Act. 4. The Examiner finds, however, that Wong discloses “a process and
composition for a capsule (soft and hard) with controlled liquid release
wherein the solvents used are water and alcohol such as ethanol, methanol,
isopropanol and butanol.” Final Act. 4 (citing Wong ¶ 88). In view of this
disclosure in Wong, the Examiner concludes that it would have been
obvious to one of ordinary skill in the art to add alcohol to the water
included in Cade’s composition “as taught by Wong as suitable solvent
combination for compositions for making hard capsules.” Final Act. 4.
On the record before us, however, the Examiner does not provide a
sufficient factual basis to establish that the relied-upon disclosures of Cade
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Application 14/415,006

4
and Wong would have led one of ordinary skill in the art to include ethanol
in Cade’s composition, for reasons expressed by the Appellant (Appeal Br.
6–9) and discussed below.
Cade discloses manufacturing hard capsules by dispersing, in hot
water, a water-soluble cellulose ether derivative, one or more hydrocolloids,
an optional gelling agent, and an optional plasticizer such as propylene
glycol, cooling the dispersion, dipping a capsule mold pin into the dispersion
to cause a portion of the dispersion to adhere to the mold pin, and gelling
and drying the adhered dispersion to form a hard capsule. Cade ¶¶ 20, 35,
39, 45, 46, 49, 81, 83.
Wong discloses a dosage form for controlled release of a liquid active
agent formulation from a gelatin capsule. Wong ¶ 2. Wong discloses that
the dosage form comprises a multilayer wall superposed on the gelatin
capsule that comprises, in outward order from the capsule, a barrier layer, an
expandable layer, and a semipermeable layer. Wong ¶¶ 5, 40. Wong
discloses that the dosage form includes an exit orifice formed through the
multilayer wall that does not extend through the gelatin capsule’s wall.
Wong ¶¶ 5, 32.
Wong discloses that the gelatin capsule component of the dosage form
“may be manufactured in accordance with conventional methods.” Wong
¶ 35; see also ¶ 31 (describing “simple and economical construction of
useful controlled release dosage forms from conventionally manufactured
gelatin capsules.”). Wong discloses that the expandable layer of the dosage
form comprises “a hydroactivated composition that swells in the presence of
water,” and Wong indicates that suitable compositions for forming the
expandable layer include an osmotic composition comprising an osmotic
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solute, or a hydrogel. Wong ¶ 33. Wong explains that the expandable layer
imbibes and/or absorbs external fluid in the dosage form’s environment of
use and expands as a result, thereby applying a push pressure against the
gelatin capsule. Wong ¶ 40. Wong discloses that the gelatin capsule
dissolves in the area exposed to the exit orifice, and the push pressure
applied to the capsule by the expandable layer forces the active agent
formulation from the capsule and through the exit orifice, effecting
controlled release of the active agent. Wong ¶¶ 33, 40.
The disclosure of Wong cited by the Examiner is part of Wong’s
Example 1, which describes a “general procedure for the formation of a
composite wall consisting of a barrier layer, an expandable layer and a
semipermeable layer formed on soft or hard gelatin capsules.” Wong ¶ 86.
Wong discloses that the procedure first involves forming a “coating solution
for the barrier membrane,” and spraying the solution onto soft or hard
gelatin capsules. Wong ¶ 87. Wong discloses that the procedure next
involves forming an expandable layer “as an osmotic membrane coating” by
suspending sodium carboxymethyl cellulose and methyl cellulose in ethanol,
dissolving sodium chloride in water, adding the sodium chloride solution to
the ethanol suspension, and spraying the resulting “suspension” onto the
barrier-coated capsules. Wong ¶ 88. Wong goes on to describe spraying a
semipermeable layer onto the expandable layer. Wong ¶¶ 89, 90.
Wong thus discloses applying multiple coating layers onto a
“conventionally manufactured gelatin capsule,” and forming one of the
layers as an expandable “osmotic membrane coating” by spraying sodium
carboxymethyl cellulose and methyl cellulose suspended in ethanol and salt
water onto a conventional gelatin capsule coated with a barrier layer. As the
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Application 14/415,006

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Appellant argues, Wong does not include any disclosure that describes
producing gelatin capsules, and does not include any disclosure that
describes compositions used to produce gelatin capsules. Appeal Br. 8–9.
Rather, Wong describes applying multiple coating layers to conventionally-
prepared gelatin capsules to form a composite wall over the capsules to
transform the conventional capsules into controlled-release dosage forms.
As discussed above, the Examiner determines that it would have been
obvious to one of ordinary skill in the art to add alcohol to the water
included in Cade’s composition “as taught by Wong as suitable solvent
combination for compositions for making hard capsules.” Final Act. 4. On
the record before us, however, the Examiner does not provide any objective
evidence to support the Examiner’s implicit finding that a combination of
ethanol and water as disclosed in Wong would be a “suitable solvent
combination for compositions for making hard capsules,” particularly when
Wong does not disclose using such a solvent combination to produce hard
capsules. The Examiner’s unsupported assertion of the suitability of ethanol
and water as a solvent combination for producing hard capsules, therefore,
appears to be based on improper speculation. In re Warner, 379 F.2d 1011,
1017 (CCPA 1967) (“The Patent Office . . . may not . . . resort to
speculation, unfounded assumptions or hindsight reconstruction to supply
deficiencies in its factual basis.”); In re Sporck, 301 F.2d 686, 690 (CCPA
1962).
Nor does the Examiner provide objective evidence to establish that
one of ordinary skill in the art would have understood that ethanol, like
propylene glycol, would function as a plasticizer in Cade’s composition, so
as to suggest substituting ethanol for Cade’s propylene glycol plasticizer.
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Application 14/415,006

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As a consequence, on the record before us, the Examiner does not
provide a sufficient factual basis to establish that, in view of Wong’s
disclosure of suspending sodium carboxymethyl cellulose and methyl
cellulose in ethanol and salt water to form an osmotic layer applied to a
barrier-layer coated conventional gelatin capsule, one of ordinary skill in the
art reasonably would have found it useful to add ethanol to Cade’s
composition for forming hard capsules. The Examiner, therefore, does not
establish that one of ordinary skill in the art would have had a reason to
combine the relied-upon disclosures of Cade and Wong so as to arrive at a
composition as recited in claim 1.
We, accordingly, do not sustain the Examiner’s rejection of claim 1,
and claims 5 and 6 which each depend from claim 1, under 35 U.S.C.
§ 103(a).
DECISION SUMMARY

Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
1, 5, 6 103(a) Cade, Wong 1, 5, 6

REVERSED