Shin Sugimoto

Patent Trials and Appeals Board

Jul 31, 2019

15514020 - (D) (P.T.A.B. Jul. 31, 2019)

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.
15/514,020 03/24/2017 Shin SUGIMOTO 502152US 1195
22850 7590 07/31/2019
OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314
EXAMINER
COLEMAN, BRENDA LIBBY
ART UNIT PAPER NUMBER
1624
NOTIFICATION DATE DELIVERY MODE
07/31/2019 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):
OBLONPAT@OBLON.COM
iahmadi@oblon.com
patentdocket@oblon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SHIN SUGIMOTO
____________

Appeal 2019-002914
Application 15/514,020
Technology Center 1600
____________

Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant submits this appeal1 under 35 U.S.C. § 134 involving
claims to a pharmaceutical preparation and method for suppressing
discoloration of an aqueous composition, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Claims 1–12 are on appeal, and can be found in the Claims Appendix

1 Appellant identifies the real party in interest as Kowa Company, Ltd.
Appeal Br. 2. Herein we refer to the Non-Final Office Action mailed
August 21, 2017 (“Non-Final Act.”), Appeal Brief filed October 1, 2018
(“App. Br.”), Examiner’s Answer mailed December 26, 2018 (“Ans.”), and
Reply Brief filed February 21, 2019 (“Reply”).
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of the Appeal Brief. Claims 1 and 4 are independent claims. Those claims
read as follows:
1. A pharmaceutical preparation, comprising: an aqueous
composition comprising a compound of Formula (1):

wherein X represents a halogen atom, or a salt thereof, or a
solvate of the compound or the salt thereof; and a container
made of polyolefin-based resin and containing the aqueous
composition.

4. A method for suppressing discoloration of an aqueous
composition, comprising:
storing an aqueous composition in a container made of
polyolefin-based resin, wherein the aqueous composition
comprises a compound of Formula (1):

wherein X represents a halogen atom, or a salt thereof, or a
solvate of the compound or the salt thereof.
App. Br. 18–19. Claims 7 and 8 additionally limit Formula (1) to
“ripasudil” and the polyolefin-based resin to “polyethylene or
polypropylene” for claims 1 and 4 respectively. Id. at 19. Claim 10 further
limits the pharmaceutical preparation to an “amount from 0.05 to 5 w/v%”
of ripasudil. Id. at 20.
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Appellant seeks review of Examiner’s rejection of claims 1–12 under
35 U.S.C. § 103 as unpatentable over Hidaka2 and Ganka.3
The issue then is: Does the preponderance of evidence of record
support Examiner’s conclusion that the cited prior art renders obvious
Appellant’s claims?
Findings of Fact
FF1. Hidaka teaches therapeutic agents “in the form of eye drops” for
treating glaucoma. Hidaka Abst. The therapeutic agents taught in Hidaka
include ripasudil and the compound in Formula I of Appellant’s claims. Id.
¶¶ 25 (formula 4), 43. Hidaka teaches the preparation of eye drops
comprising 1% by weight of such agents in aqueous solution. See id. ¶¶ 117,
131.
FF2. Ganka teaches that “polypropylene (PP), polyethylene (PE),
polyethylene terephthalate (PET), polycarbonate (PC), and the like” are
“commonly used” as “the material of eye drop bottles.” Ganka 1. Ganka
further teaches that because these materials have different “permeability for
gas, water, and light” the “stability of the drug” will be altered by transferring
“the content of an eye drop bottle to another eye drop bottle.” Id.

2 Hiroyoshi Hidaka et al., US 2008/0064681 A1, published March 13, 2008
(“Hidaka”).
3 Appellant submitted the “Ganka” reference in an Information Disclosure
Statement filed March 24, 2017, citing it there as “Ganaka New Insight Vol.
2, Tengan’yaku–Joshiki to Hijoshiki, July 10, 1987, 7 pages with partial
English translation.” The citations to Ganka herein refer to the partial
English translation provided by Appellant.
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Analysis
Examiner determined that claims 1–12 are obvious over the
combination of Hidaka and Ganka. Specifically, Examiner found that
Hidaka teaches the compound of formula 1 formulated in an aqueous eye
drop solution. See Non-Final 2–3. According to Examiner, “Ganka was
cited as a supporting reference” to demonstrate that polypropylene (PP) and
polyethylene (PE) are commonly used materials for eye drop bottles. Ans.
4; see also Non-Final 3.
Appellant argues that Examiner’s rejection should be reversed
because “the claimed combination of . . . the compound of formula (1) inside
a polyolefin-based resin container,” such as a container made of PP or PE,
“obtains unexpected superior results compared to a pharmaceutical
preparation comprising the compound in a different container.” App. Br. 10.
Appellant relies on the Declaration of named inventor, Shin Sugimoto, dated
January 25, 2018 (“Sugimoto Decl.”), which reports results from a
“preservation test” in which an “aqueous solution comprising ripasudil” was
stored in a container made of PE, PP, polyvinyl chloride (PVC) or PET for a
period of three months at high temperature. Sugimoto Decl. ¶¶ 8–9. The
Sugimoto Declaration states that the solution in containers made of PE and
PP had a lower “ΔY1” value (4.07 and 4.42) as compared to that in the PVC
and PET containers (7.45 and 5.52). Id. ¶ 8 (Table A). In addition,
Appellant argues that “the Iyakuhin reference”4 and Table 3 of Ganka teach

4 The Iyakuhin reference was attached to the Sugimoto Declaration where it
was cited as “Iyakuhin No. Hososekkei, 1st print, 20 October 1984, ISBN 4-
525-77711-7, pp. 290–291, Table 8–7.” Sugimoto Decl. ¶ 13. Appellant
has submitted a partial English language translation, which it relies upon for
its arguments here. See App. Br. 6–7.
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that PE and PP have a higher oxygen permeability and are, therefore,
“inferior in terms of the stability of the content in the container.” See App.
Br. 7–8. Appellant argues that based on these references “the skilled person
would have understood that the stability of a medicinal content would not be
acceptable in a container made of PE or PP,” but that Appellant
“surprisingly found the opposite result.” See Reply Br. 2–3, 9.
Having considered Appellant’s arguments and evidence in light of the
record as a whole, we determine that Examiner’s rejection is supported by
the preponderance of the evidence and are not persuaded by the arguments
Appellant makes to the contrary. We begin by observing that Examiner
presents a strong prima facie showing of obviousness. Hidaka teaches eye
drops comprising the claimed aqueous composition, but it does not disclose
the particular material for the container used to store such drops. FF1.
Ganka teaches that four materials––two of which (PE and PP) are
polyolefin-based resins––are “commonly used” as materials for eye drop
containers. FF2. Thus, the record supports that eye drop containers
comprising PE and PP were amongst the “‘known options within [the]
technical grasp’” of a skilled artisan and a prima facie obvious choice for
storing Hidaka’s eye drop compositions. See In re Translogic Technology,
Inc., 504 F.3d 1249, 1262 (Fed. Cir. 2007) (quoting KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398 (2007)).
Appellant’s evidence of unexpected or surprising results is insufficient
to overcome Examiner’s strong showing of obviousness on this record.
Appellant argues that it was surprising and unexpected that PE and PP
would “achieve the significant effect[] of suppressing discoloration,”
whereas another of Ganka’s commonly-used materials (PET) did not. See
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App Br. 10. But Ganka teaches that the choice of material can affect
stability of the eye drop solution. Id. Thus, the record supports that a skilled
artisan would expect that stability could vary to some extent depending on
the material used for the eye drop container. Appellant has not shown that
any such variation for the materials claimed here was so “substantially
improved” as to be unexpected or surprising. See In re Geisler, 116 F.3d
1465, 1471 (Fed. Cir. 1997).
The data in the Sugimoto Declaration does not persuasively
demonstrate unexpected results. Appellant relies on the ΔYI values in the
Sugimoto Declaration. See App. Br. 9–10. But the declaration does not
explain what ΔYI measures or, more importantly, how that value
demonstrates unexpectedly improved properties. At most, the declaration
suggests that “ΔY1” 5 is a measurement of “discoloration.” Sugimoto Decl.
¶¶ 9–10. The declaration provides no evidence that the ΔYI value correlates
with the relative stability of the pharmaceutical preparation. In its Reply,
Appellant states “ΔYI is an index indicating the degree of change in
yellowness” and “can be an indication of the level of degradation of the
compound in the pharmaceutical preparation” and “may indicate instability.”
Reply Br. 7 (emphases added). Those statements, however, are merely
attorney argument and not evidence of unexpected results. See Geisler, 116
F.3d at 1471 (“naked attorney argument is insufficient to establish
unexpected results”) (internal quotations and citations omitted).

5 Appellant does not explain why the Sugimoto Declaration refers to “ΔY1”
as opposed to “ΔYI.” Compare Sugimoto Decl. ¶¶ 8–9 with Reply Br. 7–8.
For our analysis here, we assume the two designations refer to the same
metric.
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Even if there was evidence that demonstrated a connection between
Appellant’s ΔYI values and stability, Appellant has not shown that the ΔYI
values for PE and PP are “substantially improved” as compared to the ΔYI
values for other materials taught in Ganka. See Geisler, 116 F.3d at 1471.
According to Appellant’s test results, the ΔYI for PE (4.07) PP (4.42) was
about 20–26% lower than the ΔYI for PET (5.52). See Sugimoto Decl.
¶¶ 8–9. As explained above, the mere fact that there is a difference is not an
indication that the difference is unexpected because the prior art teaches that
stability may vary based on the material of the eye drop bottle. FF2. Rather,
to be “probative of nonobviousness,” the results must be “different in kind
and not merely in degree from the results of the prior art.” Galderma Labs.,
L.P. v. Tolmar, Inc., 737 F.3d 731, 739 (Fed. Cir. 2013) (internal quotations
omitted). Appellant relies on a “technical reference” attached to its Reply
Brief as evidence that the 1.1 difference between the ΔYI for PP and PET is
“significant.” See Reply Br. 8 (relying on a webpage available at
https://www.nippondenshoku.co.jp/web/english/colorstory/08_
allowance_by_color.htm (“NIPPON Document”)). However, nothing in the
NIPPON document suggests that one of skill in the art would consider the
information there be applicable in to pharmaceutical preparations or eye
drop solutions. To the contrary, the NIPPON Document refers to the
“standard” of the “Defense Agency,” “National Police Agency,” and
“general ship inspection,” as well as color tolerance of “color chips.”
NIPPON Doc. 1.
Even if it were applicable, the NIPPON Document does not support
Appellant’s position. The NIPPON Document groups “Color difference
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ΔE*” values6 from “3.2~6.5” in the same “Grade B Color tolerance”
category and states that “colors of this range are regarded as the same
colors.”7 Id. Thus, if anything, the NIPPON Document supports that a
broader range of ΔYI values, which includes those reported in the Sugimoto
Declaration for PE, PP and PET, are generally viewed as equivalent. It
certainly does not support Appellant’s argument that a 1.1 “difference in
ΔYI value for medicinal discoloration indicates a change in the
composition.” See Reply Br. 8.
We are also not persuaded by Appellant’s arguments concerning the
teachings in Iyakuhin and Ganka regarding oxygen permeability. See App.
Br. 6–8; Reply Br. 1–4. While Iyakuhin states that “a container, which can
minimize . . . oxygen gas permeation, is preferable” and rates the oxygen
permeability of PE and PP as “slightly inferior” to other materials like PVC
and PET, such teachings do not teach away from the use of PE and PP or
otherwise evidence that such materials would be unacceptable for
pharmaceutical preparation in Appellant’s claims. See Iyakuhin 1. As our
reviewing court has explained, “[a] known or obvious composition does not
become patentable simply because it has been described as somewhat
inferior to some other product for the same use.” In re Gurley, 27 F.3d 551,
553 (Fed. Cir. 1994). Here, the prior art (Ganka) teaches that PE and PP,

6 Appellant does not explain how, if at all, the “ΔE*” values in the NIPPON
document relate to the ΔYI in the Sugimoto Declaration.
7 The NIPPON Document further qualifies that “clients concerning paints
and inks industry will make complaints about the color difference.” Id.
There is no suggestion, much less evidence, that clients in the “paints and
inks industry” would be considered persons of ordinary skill in the art at
issue here.
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like PET and PC, are “commonly used” materials for eye bottle containers.
FF2. Even if, as Appellant argues, Iyakuhin and Table 3 of Ganka teach that
PVC and PET are preferable with respect to oxygen permeability, that
teaching does not render the use of other commonly used, but perhaps less
desirable, materials like PE and PP patentable. See In re Mouttet, 686 F.3d
1322, 1334 (Fed. Cir. 2012) (“[J]ust because better alternatives exist in the
prior art does not mean that an inferior combination is inapt for obviousness
purposes.”) (citing Gurley, 27 F.3d at 553). Nor is there evidence that a
skilled artisan would expect the recited “compound of Formula (1)” to be
particularly susceptible to degradation by oxygen gas such that generally-
accepted materials with higher permeability should be avoided here.
Accordingly, Appellant’s argument that “the skilled person would have
understood that the stability of a medicinal content would not be acceptable
in a container made of PE or PP” is not supported by the evidence before us.
Reply Br. 9.
Finally, even if Appellant’s evidence were probative of unexpected
results, we determine that evidence is insufficient to overcome Examiner’s
prima facie showing of obviousness. As explained above, Examiner has
presented a strong prima facie showing of obviousness. Weighing that
showing together with Appellant’s evidence of purportedly unexpected
results, which on balance is weak at best, we determine that the
preponderance of the evidence supports Examiner’s obviousness rejection.
See, e.g., Bayer Pharma AG v. Watson Labs., Inc., 874 F.3d 1316, 1329
(Fed. Cir. 2017) (weighing evidence of unexpected results and copying
together with other evidence, including “strong evidence of a motivation to
make the claimed combination” in the cited prior art, to conclude that
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combination was obvious); Bayer Healthcare, 713 F.3d at 1377 (finding that
secondary indicia evidence did not “overcome[] the plain disclosures and
express motivation to combine those disclosures in the prior art”).
For all these reasons, Appellant’s arguments fail to persuade us that
Examiner erred in rejecting claims 1–12 as obvious over Hidaka and Ganka.
Accordingly, we affirm.
SUMMARY
We affirm the rejection of claims 1–12 under 35 U.S.C. § 103 as
unpatentable over Hidaka and Ganka.

TIME PERIOD FOR RESPONSE
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