Hideki Ichikawa et al.

Patent Trials and Appeals Board

Jun 9, 2020

2019001525 (P.T.A.B. Jun. 9, 2020)

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.
13/701,619 12/03/2012 Hideki Ichikawa 047580-0122 5040
22428 7590 06/09/2020
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
CHICKOS, SARAH J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
06/09/2020 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HIDEKI ICHIKAWA, YOSHINOBU FUKUMORI,
SATORU ABE, and YUSUKE MASUE1
Appeal 2019-001525
Application 13/701,619
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
DEBORAH KATZ, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
coated particle, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real parties in interest as Kobe Gakuin Educational
Foundation and Nippon Soda Co., Ltd. Appeal Br. 3. We use the word
“Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a).
Appeal 2019-001525
Application 13/701,619

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STATEMENT OF THE CASE
“[T]he present inventors found that by dry-coating a nuclear particle
with hydroxyalkyl cellulose and a binder, a coating particle suitable for
gastric soluble solid preparation, enteric soluble solid preparation, sustained-
release solid preparation, bitterness-inhibiting solid preparation, and the like
[is] obtained.” Spec. ¶ 6. “The coating particle of the present invention has
high coating ratio, is easy to control an elution rate of medical agents, and
has excellent fluidity.” Spec. ¶ 9. “The hydroxyalkyl cellulose used in the
present invention has a volume average particle size of preferably from 0.1
to 20 µm.” Spec. ¶ 27.
“A dry coating method is preferred.” Spec. ¶ 37. “The dry-coating
method is a method of mixing a nuclear particle with hydroxyalkyl cellulose,
a binder and other coating base such as an elution controlling base and silica
. . . and stirring those, thereby adhesion-coating the surface of the nuclear
particle with the powder for a coating layer.” Spec. ¶ 38. “The coating
particles obtained by the dry-coating have excellent fluidity and sustained
releasability.” Spec. ¶ 40.
Claims 1–3 and 8–15 are on appeal. Claim 1, reproduced below, is
illustrative:
1. A coating particle comprising a nuclear particle covered
with a coating layer, wherein the coating layer is a layer
comprising hydroxyalkyl cellulose particles and a binder; and
the nuclear particle has a volume average particle size of from
50 to 500 µm and the hydroxyalkyl cellulose particle has a
volume average particle size of from 0.1 to 20 µm.

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Application 13/701,619

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OPINION
Obviousness
Claims 1–3 and 8–15 stand rejected under 35 U.S.C. § 103 as obvious
based on Yanai,2 Akiyama,3 Itoh,4 and Sonoda.5 Non-Final Action6 4. The
Examiner finds that Yanai teaches a “controlled release composition
contain[ing] a core comprising an active that is coated with a coating layer
that comprises a polymer, polyethylene glycol and silica.” Id. The
Examiner finds that “Yanai expressly teaches examples of polymers that
exhibit delayed dissolution type water solubility and the examples given are
hydroxyethylcelluloses, which are hydroxyalkyl celluloses.” Non-Final
Action 4–5. The Examiner finds that “Yanai teaches that an example of a
polymer that can be used in the coating is HPC-H. This hydroxypropyl
cellulose necessarily has a particle size of 6.27 micrometers as evidenced by
the [instant] specification.” Non-Final Action 5 (citation omitted). As
support, the Examiner cites the Specification’s description of HPC-H as
“hydroxypropyl cellulose having a volume average particles size of 6.27
μm.” Spec. 12:22–23.
The Examiner finds that Yanai does not teach a dry coating
preparation method, but finds that Sonoda “teaches the preparation of a

2 Yanai et al., US 2006/0177506 A1 (Aug. 10, 2006).
3 Akiyama et al., US 2006/0013868 A1 (Jan. 19, 2006).
4 Itoh et al., US 5,194,464 (Mar. 16, 1993).
5 Sonoda et al., Improvement of Dissolution Property of Poorly Water-
Soluble Drug by Using Dry Coating Method with Starches as Core-
particles, J. Soc. Powder Technol., Japan, 46:338–346 (2009).
6 Office Action mailed Jan. 16, 2018.
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coating particle in which a nuclear particle of starch is dry-coated with
hydroxyalkyl cellulose and a binder.” Id. at 7.7
The Examiner concludes that it would have been obvious for a person
of ordinary skill in the art making the coated tablet of Yanai to “use the
preparation method of Sonoda in order to have the improved dissolution
properties as taught by Sonoda.” Non-Final Action 8.
Appellant argues that “almost all coating processes disclosed in . . .
Yanai use a ‘coating solution.’ These coating processes are categorized as
‘wet-coating processes.’” Appeal Br. 9. Appellant argues that, “[i]n a film
obtained through a wet-coating process using a coating solution, it is not
reasonable to expect that the raw material (having a particle size) remains
because the raw material has been dissolved in a solvent.” Appeal Br. 9–10.
Thus, Appellant argues that “paragraph [0147] of Yanai merely discloses
‘[s]pecific examples of the polymer exhibiting delayed-dissolution type
water solubility.’ However, this does not mean that the polymer is still in
the form of a particle when in a coating layer.” Appeal. Br. 9.
With regard to Yanai’s disclosure of compression molding, Appellant
argues that compression molding might be categorized as a “dry-coating
process” but “the coating layer is formed by compressing raw materials.
Therefore, it is expected that there would be no remaining polymer particles
of the raw materials in a compression molded coating.” Appeal Br. 10.

7 The Examiner cites Akiyama for teaching coated particles having a specific
amount of hydroxypropyl cellulose, and Itoh as teaching polyethylene glycol
(PEG) with a particular particle size as a binder, as recited in some
dependent claims. Non-Final Action 6–7. Akiyama’s and Itoh’s teachings
are not germane to the prima facie case with respect to independent claim 1.
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Appellant concludes, “each of the coatings in Yanai has an absence of
particles – even if the starting material was in the form of particles, these
particles do not survive the coating process.” Appeal Br. 10.
We agree with Appellant that the evidence cited by the Examiner does
not support a case of obviousness. Yanai discloses a controlled release
composition for oral administration, wherein a core containing a
physiologically active substance is coated with a coating layer containing a
polymer. Yanai Abstract. Yanai discloses that the polymer in the coating “is
not particularly limited, as long as it can form a film structure having the
function of controlling release of the physiologically active substance
contained in the core.” Yanai ¶ 145. Yanai states that its composition “is
prepared by coating the core . . . with an aqueous dispersion or non-aqueous
solution of the coating polymer . . . and drying.” Yanai ¶ 174. “Alternatively,
the composition is also prepared by compression molding the coating polymer
on the periphery of the core to form a coating layer, for example, using the
same conventional methods in the art of preparation technology as in the
preparation of a multilayer tablet or a core-containing tablet.” Yanai ¶ 174.
To meet the claim limitation of a “hydroxyalkyl cellulose particle has
a volume average particle size of from 0.1 to 20 µm,” the Examiner finds
that “Yanai teaches that an example of a polymer that can be used in the
coating is HPC-H. This hydroxypropyl cellulose necessarily has a particle
size of 6.27 micrometers.” Ans. 5 (citation omitted). As evidence, the
Examiner cites the Specification’s statement that HPC-H is a
“hydroxypropyl cellulose having a volume average particles size of 6.27
μm.” Spec. 12:22–23.
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Thus, the Examiner appears to rely upon the doctrine of inherency to
conclude that the final product of Yanai will necessarily contain unaltered
particles of the hydroxyalkyl cellulose source material, such as HPC-H.
However,
[i]nherency . . . may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from
a given set of circumstances is not sufficient [Citations
omitted.] If, however, the disclosure is sufficient to show that
the natural result flowing from the operation as taught would
result in the performance of the questioned function, it seems to
be well settled that the disclosure should be regarded as
sufficient.
In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v.
Kemmer, 102 F.2d 212, 214 (CCPA 1939)) (bracketed material in original).
Here, the Examiner has not pointed to evidence or provided sound
technical reasoning to show that the final product of Yanai will necessarily
contain hydroxyalkyl cellulose particles having a volume average particle
size of 0.1 to 20 µm. As Appellant has pointed out, Yanai discloses two
processes for applying a coating layer: using a coating solution or
compression molding using the same conventional methods used to make
core-containing or multilayer tablets. See Yanai ¶ 174.
By contrast, Appellant’s Specification states that a dry-coating
method is preferred, and describes that method as “mixing a nuclear particle
with hydroxyalkyl cellulose, a binder and other coating base . . . and
stirring,” preferably while heating. Spec. ¶ 38. Such a process is described
in the example cited by the Examiner. Spec. ¶¶ 43–45. Thus, the fact that
Appellant’s Specification describes HPC-H particles of a certain size does
not mean that Yanai’s process would necessarily produce coating particles
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of HPC-H of the same size. Thus, the Examiner’s apparent reliance on
inherency to meet the size limitation of the hydroxyalkyl cellulose particles
recited in the claims is not supported by the cited evidence.
The Examiner also reasons that Sonoda teaches a dry-coating method,
and it would have been obvious to “use the preparation method of Sonoda in
order to have the improved dissolution properties as taught by Sonoda.”
Non-Final Action 8.
Appellant argues that Yanai and Sonoda “disclose disparate
formulation technologies.” Appeal Br. 11. Specifically, “[i]n Yanai, the
polymer contained in the coating layer is selected from those that can form a
film structure having the function of controlling release” of an active
substance, while “Sonoda teaches a dry coating in which a coating film is
not formed and the active substance is attached to the core particles.” Id.
Appellant argues that these different product structures reflect the different
purposes of the compositions: “Yanai aims to achieve ‘slow-release.’ On
the other hand, Sonoda aims to improve the dissolution property of poorly
water-soluble drug. That is, Sonoda aims to achieve ‘fast-release.’” Id. at
12.
The Examiner responds that “just because Sonoda aims to make the
release of the active ingredient fast whereas Yanai teaches a controlled
release composition does not mean that the teachings of the references
cannot be combined.” Ans. 8. The Examiner reasons that the improved
dissolution properties taught by Sonoda “mean greater control over the
release of the active ingredient and greater control for the formulator over
the dissolution time and place in the gastrointestinal tract.” Id. at 9. The
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Examiner also reasons that “[g]reater control over the release of the drug is
the common goal of both Yanai and Sonoda and a highly desirable and
sought after goal for the ordinarily skilled artisan formulator in this field of
endeavor.” Id.
We are not persuaded that the Examiner’s reasoning supports a prima
facie case of obviousness. “Obviousness requires more than a mere showing
that the prior art includes separate references covering each separate
limitation in a claim under examination.” Unigene Labs., Inc. v. Apotex, Inc.,
655 F.3d 1352, 1360 (Fed. Cir. 2011). “Rather, obviousness requires the
additional showing that a person of ordinary skill at the time of the invention
would have selected and combined those prior art elements in the normal
course of research and development to yield the claimed invention.” Id.
Sonoda discloses dry-coating a starch core particle with a mixture
containing flurbiprofen (drug). Sonoda Abstract. Yanai, by contrast, states
that its coating layer “does not contain a physiologically active substance.”
Yanai ¶ 144. Thus, modifying the drug-free film coating disclosed by Yanai
with the drug-containing coating disclosed by Sonoda would contradict the
express teaching of Yanai.
Yanai states that the disclosed “core containing the physiologically
active substance is coated with a coating layer containing a polymer, thus the
maximum blood concentration of the physiologically active substance can be
significantly lowered as compared with a rapid release preparation, and
thereafter, sustained drug release over a long time can be realized.” Yanai
¶ 5. Thus, the intended purpose of the coating layer disclosed by Yanai is to
achieve sustained drug release over a long time.
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In contrast, Sonoda discloses that the purpose of its composition is to
increase dissolution of the active agent. Sonoda Abstract. Modifying the
controlled release coating layer disclosed by Yanai with the rapid release
coating layer disclosed by Sonoda thus would defeat Yanai’s intended
purpose of providing sustained drug release over a long time.
In summary, the Examiner has not persuasively shown that a skilled
artisan would have had a reason to use Sonoda’s dry-coating method to
make the sustained release composition of Yanai. We conclude that the
rejection of claims 1–3 and 8–15 under 35 U.S.C. § 103(a) based on Yanai,
Akiyama, Itoh, and Sonoda is not supported by a preponderance of the
evidence, and we therefore reverse it.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 8–15 103 Yanai, Akiyama,
Itoh, Sonoda
1–3, 8–15

REVERSED