Nippon Soda Co., Ltd.

Patent Trials and Appeals Board

Feb 25, 2020

14749126 - (D) (P.T.A.B. Feb. 25, 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.
14/749,126 06/24/2015 Satoru ABE 107929-0128 4993
22428 7590 02/25/2020
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
02/25/2020 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 SATORU ABE and TAKASHI KATO
____________

Appeal 2019-001927
Application 14/749,126
Technology Center 1600
____________

Before RYAN H. FLAX, DAVID COTTA, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a solid formulation, which is a compression-molded form of coated
particles. Appellant appeals the Examiner’s rejection of claims 10 and 11
under 35 U.S.C. § 103.1,2 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R. § 1.42.
Appellant identifies itself, “NIPPON SODA CO., LTD.,” as the real party-
in-interest. Br. 3.
2 Oral argument was heard on January 30, 2020; a transcript of the hearing is
a part of the record. See Record of Oral Hearing Held Jan. 30, 2020, mailed
Feb. 12, 2020 (“Hr’g Tr.”).
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STATEMENT OF THE CASE
Independent claim 10, reproduced below, is representative of the
claims on appeal:
10. A solid formulation which is a compression-molded
form of coated particles, wherein each coated particle comprises:
a core particle; and
a coating layer that covers the core particle,
wherein the coating layer contains a hydroxypropyl
cellulose that has a viscosity of 1.10 mPa·s to 1.95 mPa·s in a
2%-concentration aqueous solution at 20°C, and has a content of
a hydroxypropyl group in the hydroxypropyl cellulose in a range
of 40% by weight to 80% by weight of the hydroxypropyl
cellulose,
the coating layer further contains drug particles, the
content of the hydroxypropyl cellulose in the coating layer dried
is 3% by weight to 30% by weight,
a volume average primary particle size of the core particle
is 5 μm to 1000 μm, and
a volume average primary particle size of the drug
particles is smaller than a volume average primary particle size
of the core particle, and
wherein the content of the hydroxypropyl cellulose in the
solid formulation is 3% by weight to 20% by weight,
wherein the solid formulation has an increased hardness
and decreased disintegration time compared to an identical solid
formulation except that the hydroxypropyl cellulose is replaced
with a hydroxypropyl cellulose having a viscosity of 2.69 mPa·s
in a 2%-concentration aqueous solution at 20°C.
Br. 16 (Claims Appendix). Claim 11, which is the only other claim on
appeal and depends from claim 10, requires that the solid formulation be a
tablet. Id.
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The Specification states that the prior art disclosed “a coating agent
containing hydroxypropyl cellulose [“HPC”], which has a viscosity of 2.0
mPa-s to 2.9 mPa-s in a 2%-concentration aqueous solution at 20°C, as a
binder [that] suppresses the aggregation of core particles to some extent and
increases the drug layering efficiency” and, further that “as tablet production
methods, direct tableting, granulation and compression, and the like are
known. It is known that in these production methods, hydroxypropyl
cellulose is used as a binder so as to improve compression moldability.”
Spec. ¶¶ 4–6 (citing Ichikawa et al., 156 Int. J. Pharm. 39–48 (1997);
Ichikawa et al., 7(S2) AAPA J. 301 (2005)). The Specification describes
that the use of such a coating agent did not sufficiently solve core particle
aggregation problems and did not “perfectly attach[] the drug to every single
core particle.” Id. ¶ 7. The Specification also describes that the use of such
a coating made it “difficult to obtain rapid disintegration properties with a
high degree of hardness.” Id.
In view of these issues, the Specification states “the present invention
aims to provide a binder that further reduces the aggregation rate of core
particles, further increases the drug layering efficiency, and is suitable for
obtaining tablets having excellent tablet hardness and disintegration
properties.” Id. The Specification describes that using “a hydroxyalkyl
cellulose that has a viscosity of 1.10 mPa-s to 1.95 mPa-s in a 2%-
concentration aqueous solution at 20°C” provides a solution to the prior art
issues. Id. at ¶ 8.
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The following rejection is on appeal:
Claims 10 and 11 stand rejected under 35 U.S.C. § 103 over Rogers3
or Mallon,4 combined with JP ’9655 or WO ’875,6 and combined with Lim7
and Nuwayser.8 Final Action 3.
DISCUSSION
I. LEGAL STANDARDS
“[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.
[Once] . . . that burden is met, the burden of coming forward with evidence
or argument shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). Arguments made by Appellant in the Appeal Brief have
been considered; arguments not so-presented are waived. See 37 C.F.R.
§ 41.37(c)(1)(iv) (2017); see also Ex parte Borden, 93 USPQ2d 1473, 1474
(BPAI 2010) (informative) (“Any bases for asserting error, whether factual
or legal, that are not raised in the principal brief are waived.”).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). The “case law is
clear that obviousness cannot be avoided simply by a showing of some
degree of unpredictability in the art so long as there was a reasonable

3 WO 2009/061821 A2 (published May 14, 2009) (“Rogers”).
4 WO 2009/061815 A1 (published May 14, 2009) (“Mallon”).
5 JP2010064965 A (published Mar. 25, 2010; EPO/Google-provided English
translation) (“JP ’965”).
6 WO 2010/023874 A1 (published Mar. 4, 2010; English translation) (“WO
’874”).
7 US 2003/0147952 A1 (published Aug. 7, 2003) (“Lim”).
8 US 4,568,559 (issued Feb. 4, 1986) (“Nuwayser”).
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probability of success. . . . [T]he proper standard [is that] the expectation of
success need only be reasonable, not absolute.” Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1364 (Fed. Cir. 2007); see also In re O’Farrell, 853 F.2d
894, 903–04 (Fed. Cir. 1988) (reasonable expectation of success, not
absolute predictability, is required).
“One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of ‘unexpected results,’ i.e., to show that
the claimed invention exhibits some superior property or advantage that a
person of ordinary skill in the relevant art would have found surprising or
unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). “To be
particularly probative, evidence of unexpected results must establish that
there is a difference between the results obtained and those of the closest
prior art, and that the difference would not have been expected by one of
ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb
Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). Also,
“[m]ere improvement in properties does not always suffice to show
unexpected results. In our view, however, when an applicant demonstrates
substantially improved results . . . and states that the results were
unexpected, this should suffice to establish unexpected results in the absence
of evidence to the contrary.” In re Soni, 54 F.3d at 751. However,
“‘differences in degree’ of a known and expected property are not as
persuasive in rebutting obviousness as differences in ‘kind’—i.e., a new
property dissimilar to the known property.” Bristol-Myers, 752 F.3d at 977.
With these standards in mind, we address the Examiner’s rejection
and Appellant’s arguments there-over.
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II. ANALYSIS
The Examiner determined that Rogers and Mallon each teach or
suggest a coating composition comprising hydroxyalkyl cellulose of low
viscosity from 1.2–2 mPa when measured at a concentration of 2% by
weight in an aqueous solution at 20°C, for coating drug particles and tablets,
where such coating compositions have 10–40% of such hydroxyalkyl
cellulose (by weight), and can form 10% of the coating. Final Action 4–5
(citing Rogers, Abstract, ¶¶ 5, 14, 29, 31–343, 43, 44, claims; Mallon,
Abstract, ¶¶ 5, 31–33, 53, 61, 69, claims). The Examiner also determined
that Rogers and Mallon each teach HPC. Id. The viscosity and
concentration ranges disclosed in the art overlap or abut the respective
claimed ranges. See E.I. DuPont de Nemours & Co., v. Synvina C.V., 904
F.3d 996, 1010 (2018) (claimed ranges overlapping or abutting range
disclosed in prior art were obvious).
The Examiner noted that neither Rogers nor Mallon teach that the
HPC of its coating has a hydroxypropyl group content of 40–80%, as
claimed, but cited JP ’965 and WO ’874 as each teaching HPC film forming
agents for coatings and drug containing layers that include 50–80%
hydroxypropyl groups. Final Action 5–6 (citing JP ’965 ¶¶ 6, 9, 17, 18; WO
’874 ¶¶ 1, 6, 7–9, 16–18). The Examiner found that the film formulations
with HPC of JP ’965 and WO ’874 had advantages making them attractive
for a coating as in Rogers or Mallon, such as improved stability, ease in
swallowing, fast dissolving, excellent handling properties, and bitterness
masking. Id. at 5–7. The Examiner further found that the person of ordinary
skill in the art would have reason to use the Rogers or Mallon viscosity
ranges (as claimed) for HPC coatings having hydroxypropyl content (as in
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JP ’965 or WO ’875) because Rogers and Mallon teach that these ranges are
advantageous, and because JP ’965 and WO ’875 taught a preferred
viscosity range near the Rogers/Mallon range and expressly indicated that
the viscosity of their HPC was not particularly limited. Id. Furthermore,
Rogers and Mallon state in their Abstracts that the low viscosity
characteristic of their HPC coatings enables the coating composition to have
a high concentration of cellulose ether, improves production efficiency of
the product, and improves coloring of the product. Rogers, Abstract;
Mallon, Abstract.
The Examiner also noted that Rogers and Mallon do not teach drug
particles in the coating layer, the size of the particulates coated with an HPC
coating, or that drug particles in the coating are smaller than the core, as
claimed. Final Action 5. For such teachings, the Examiner cited Lim for
teaching drug particles in a coating over a core, where the particles are 10
µm or smaller, and cited Nuwayser for teaching coating core microparticles
that are 1000 µm or smaller. Id. at 6 (citing Lim, Abstract ¶¶ 10, 11, 16, 36,
37; Nuwayser, Abstract, 2:20–26, 2:45–52). The Examiner found that Lim’s
and Nuwayser’s particles and coatings allow for an immediate release and/or
controlled release (uniform controlled delivery) formulation that can be in
the form of a direct-compressed tablet. Id. The Examiner found that a
person of ordinary skill in the art would have seen these characteristics as
reasons to combine Lim and Nuwayser with Rogers or Mallon because
controlling drug delivery would be a concern. Id. at 7–10.
Concerning the claim element requiring “the solid formulation has an
increased hardness and decreased disintegration time,” the Examiner
determined that, because it would have been obvious to combine the
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teachings of the above-discussed prior art, and doing so would result in a
formulation as claimed, this claimed characteristic would be an intrinsic
property of an obvious composition. Final Action 10. The Examiner also
found that such properties would have been expected based on the prior art.
Answer 4.
We find no error in, and agree with, the Examiner’s determinations on
and rationale for the obviousness of the appealed claims. We address
Appellant’s arguments below.
Appellant agrees with the Examiner’s determinations as to the subject
matter taught by the cited prior art. Hr’g Tr. 3:10–4:3.
Appellant argues that there would have been no motivation to
combine the Examiner’s cited prior art references. Br. 9. Appellant does
not identify persuasive evidence or argument challenging the motivation
rationale set forth by the Examiner. Instead, Appellant focuses its argument
on inherency, asserting that the Examiner does not explain how the
references would be combined with a level of specificity such that the
natural result would be a solid formulation that is compression-molded and
has “the claimed properties.” Id. at 9–11.
We do not find this argument persuasive. The Examiner’s rationale
for combining the cited prior art references is reasonable and derived from
the teachings of the references as to their offered advantages. Further, each
of the prior art references is from the same field of endeavor, that is, solid
pharmaceutical formulations with coatings.9 Rogers, Mallon, JP ’965, and

9 Although not specifically cited for such, we note Rogers discloses that
compression molding to form tablets was known. See, e.g., Rogers ¶¶ 76,
98. Lim discloses forming an immediate-release coated pharmaceutical
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WO ’874 each focus on HPC-containing coatings and Lim’s particles are
used with HPC. We conclude the Examiner has provided sufficient
reasoning to combine the cited prior art in the claimed fashion. Having
concluded that the Examiner provided sufficient explanation why a person
of ordinary skill in the art would arrive at a composition falling within the
scope of the claims, we agree with the Examiner that the obvious
composition would necessarily have the claimed properties with respect to
hardness and disintegration time. Ans. 3–4, 8; see Par Pharmaceutical, Inc.
v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014)
(holding that inherency may be used in an obviousness analysis). As
Appellant has not directed us to persuasive evidence that the compositions
suggested by the prior art would not have the claimed hardness and
disintegration time we are not persuaded that the suggested compositions are
not sufficiently specific to demonstrate the claimed properties. In re Best,
562 F.2d 1252, 1255 (C.C.P.A. 1977); Johnston v. IVAC Corp., 885 F.2d
1574, 1581 (Fed. Cir. 1989).
Appellant argues that the claimed invention provides superior,
unexpected properties, including increased hardness paired with decreased
disintegration time, as a result of the specific viscosity and hydroxypropyl
group content claimed. Br. 11. Appellant argues that these properties are
“generally in conflict to each other,” but with the invention they are

formulation by compressing particles to form a layered tablet. See Lim
¶¶ 12, 36–37. Nuwayser also teaches forming tablets by compressing
particles and coated particles. See Nuwayser 3:67–4:3, 4:57–61. The
Specification also states that compression molding to produce
pharmaceutical tablets was well known, as was using HPC as a binder in
such a process. Spec. ¶ 5.
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“exhibited in good balance.” Id. (citing Spec. ¶ 8, Examples, Figures).
Appellant argues that the Examiner, in asserting that hardness and
disintegration are not in conflict (Examiner’s example of sugar or salt being
hard and disintegratable), conflates disintegration with solubility and calls
Examiner’s example “unclear and nonsensical.” Id. at 13–14 (citing Final
Action 13–14). Appellant states, without citation to evidence, that
substances may be soluble, but strongly bonded to a tablet and, therefore,
only the surface might dissolve, but disintegration might be reduced, as an
example. Id. at 13. Appellant states that the skilled artisan understands that
increased tablet strength equates to reduced disintegration property. Id.
Appellant also cites to the Specification’s Table 1 (id. at 14), which
we reproduce below:

Table 1 compares the tablet hardness and disintegration time properties
reported in Example 5 (for compression molded tablets with particles
averaging 89 µm, with sprayed-on coatings containing 8% HPC of 1.7
mPa·s in 2%-concentration aqueous solution at 20°C) with the same
properties reported in comparative Example 4 (for compression molded
tablets with particles averaging 107 µm, produced in the same way that
particles of Example 5 were produced, and having coatings of 2% HPC
having a viscosity of 2.69 mPa·s in 2%-concentration aqueous solution at
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20°C). Table 1 shows Example 5 had a hardness of 10.1 Kg, which was 0.6
Kg higher than Example 4, and shows Example 5 had a disintegration time
of 4.3 minutes, which was 1.1 minute faster than Example 4. Appellant
asserts that the tablets of Example 5 show superior performance. Br. 14–15.
We are not persuaded by Appellant’s arguments. Appellant’s
arguments are not supported by persuasive evidence. Appellant’s allegation
that the Examiner has misunderstood, or that the person of ordinary skill in
the art would have understood, the relationship between hardness and
disintegration is not supported by any evidence of record. Appellant’s
arguments thus amount to mere attorney argument and “[a]ttorneys’
argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d
1574, 1581 (Fed. Cir. 1989).
Appellant’s evidence of unexpected results is not sufficient to
overcome the Examiner’s prima facie case for obviousness. Although
Appellant has presented some evidence of differences in hardness and
disintegration when comparing an example asserted to be within the scope of
the invention with one that is asserted not to be, it is unclear that the
differences amount to unexpected results sufficient to overcome a prima
facie showing of obviousness. There is no evidence that the results shown in
Table 1 were improvements differing in kind from the prior art (as opposed
to differing merely by degree) or that they were actually unexpected. The
Specification states “from the results of Example 5 and Comparative
example 4, it is understood that the tablets obtained using the hydroxyalkyl
cellulose of the present invention have a high degree of hardness and can
shorten the disintegration time.” Spec. ¶ 70. Although this statement may
suggest some degree of improvement relative to the comparative example,
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such a statement does not establish that the results are a difference in kind or
that there is any associated unexpected result.
We discern no error in the Examiner’s determinations, which we
conclude present a prima facie case for the claims’ obviousness over the
cited prior art combination. We have considered Appellant’s arguments
over the rejections in their entirety, but find them unpersuasive on the record
on appeal.
CONCLUSION
In summary, the obviousness rejection of claims 10 and 11 is
affirmed.

Claims Rejected Basis Affirmed Reversed
10, 11
§ 103 over Rogers or Mallon,
and JP ’965 or WO ’875, and
Lim and Nuwayser
10, 11
Overall
Outcome 10, 11

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED