Ex Parte Yagi et al

Patent Trials and Appeals Board

Apr 25, 2019

13565078 - (D) (P.T.A.B. Apr. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/565,078 08/02/2012
513 7590 04/29/2019
WENDEROTH, LIND & PONACK, L.L.P.
1030 15th Street, N.W.,
Suite 400 East
Washington, DC 20005-1503
FIRST NAMED INVENTOR
Nobuhiro Yagi
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
2012_1068 3095
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
04/29/2019 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):
eoa@wenderoth.com
kmiller@wenderoth.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NOBUHIRO YAGI, TAKUY A TOKUDA,
MASASHI NAKAKURA, and YASUKI KATO
Appeal2017-010545
Application 13/565,078 1
Technology Center 1600
Before FRANCISCO C. PRATS, ELIZABETH A. LA VIER, and
DAVID COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of producing coated fine particles. The Examiner rejected the claims on
appeal as obvious under 35 U.S.C. § 103(a) and on the ground ofnon-
statutory obviousness-type double patenting.
We affirm.
1 According to Appellants, the real party in interest is Kyowa Hakko Kirin
Co., Ltd. App. Br. 2.
Appeal2017-010545
Application 13/565,078
STATEMENT OF THE CASE
The Specification discloses that "[ t ]he present invention relates to a
method of producing coated fine particles, and the like." Spec. ,r 1.
Claims 32-35 are on appeal. Claim 32 is illustrative and reads as
follows:
32. A method of producing coated fine particles in which
core fine particles are coated with a coating layer component,
which comprises the steps of:
preparing a liquid A comprising one or more coating
layer components dissolved therein and one or more polar
organic solvent[ s] selected from the group consisting of
alcohols, glycols, and polyalkylene glycols;
preparing a liquid B mixable with liquid A, in which the
core fine particles are dispersed and wherein liquid B does not
contain one or more polar organic solvents selected from the
group consisting of alcohols, glycols, and polyalkylene glycols
or contains said one or more polar organic solvents in a ratio
lower than that in the liquid A; and
mixing the liquid A with the liquid B to prepare a liquid
C so that the concentration of the polar organic solvent in the
liquid C is 30 to 60 vol%, the core fine particles are not
dissolved in the liquid C and the coating layer component or
components is/ are in the dispersed state in the liquid C; and
leaving or mixing the liquid C for 3 seconds to 30
minutes.
App. Br. 16.
The claims stand rejected as follows:
Claims 32-35 were rejected on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 2-13
of the U.S. Patent No. 7,678,415.
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Application 13/565,078
Claims 32-35 were provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 20-40 of
copending Application No. 14/683,674.2
Claims 32-35 were rejected under 35 U.S.C. § I03(a) as being
obvious over Kato. 3
OBVIOUSNESS
Appellants argue claims 32-35 together. We designate claim 32 as
representative.
In rejecting claim 32 as obvious, the Examiner found that Kato
disclosed a method of coating fine particles comprising:
(i) preparing liquid A by dissolving lipids ( coating layer
components) in a polar solvent or in an aqueous solution
comprising a polar solvent; (ii) preparing liquid B comprising a
dispersion of liposomes ( fine particles) in an aqueous solution
comprising a polar solvent; (iii) mixing liquids A and B to
obtain liquid C wherein the liposomes are dispersed and the
coating layer components are dissolved; and (iv) adding water
to liquid C to reduce the amount of polar solvent to 50% or less
( dilution), rendering the coating layer components insoluble
( dispersed state) and thus, able to coat the dispersed liposomes
by accumulating on their surface.
Ans. 9. The Examiner found that the only difference between the method
disclosed in Kato and the claimed method was that "Kato et al. perform
dilution after preparing liquid C, while in the instant invention dilution takes
place at the time of obtaining liquid C." Id. The Examiner explained,
however, that both methods "achieve the same goal: rendering the coating
2 This application was abandoned on September 21, 2018. Because this
rejection is now moot, it is no longer a part of this appeal.
3 Kato et al., EP 1 323 415 Al, published July 2, 2003 ("Kato").
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Application 13/565,078
layer components insoluble and thus, able to coat the dispersed fine particles
by accumulating on their surface." Id. at 10.
The Examiner found that the ordinary artisan would have understood
that the dilution step could be performed using Kato's liquid B (rather than
Kato's liquid D) because Kato teaches that the "liposomes are in a dispersed
state even after reducing the polar solvent concentration to 50% or lower"
and thus the liposomes in liquid B would remain dispersed even liquid be
were more dilute. Id. at 6-7. The Examiner concluded that it would have
been obvious to vary the timing of the dilution step in order to optimize the
process of coating the liposomes. Id. at 7.
We agree with the Examiner that claim 32 would have been obvious
over Kato. We address the Appellants' arguments below.
Appellants argue that the claimed method differs from Kato in that
"the step of adding water for adjusting the concentration of ethanol cannot
be excluded from the method disclosed in the Kato reference" while the
"invention recited in present Claim 32 does NOT require 'the step of adding
water for adjusting the concentration of ethanol." App. Br. 6. We are not
persuaded because claim 32 uses the transitional phrase "comprising" and
thus does not exclude the addition of water. Invitrogen Corp. v. Biocrest
Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) ("The transition
'comprising' in a method claim indicates that the claim is open-ended and
allows for additional steps."). Accordingly, replacing liquid Bin Kato with
a diluted liquid B - as proposed by the Examiner - does not contravene the
method of claim 32.
Moreover, because the Appellants used the transitional phrase
"comprising," the method described in Kato reads on the claimed method
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even without the modification suggested by the Examiner. Put another way,
the claims read on a method, like that described in Kato, where an
intermediary step - diluting with water - occurs after mixing liquid A and
liquid B to arrive at a final liquid (liquid C) having the claimed
concentration of polar organic solvent.
Appellants argue that "as long as the Kato reference does not mention
the reducing method recited in the present claims, the Appellants submits
that the Examiner's assertion is only arrived at through improper hindsight
reconstruction after reviewing the present specification and claims." App.
Br. 7. We are not persuaded.
As our reviewing court's predecessor stated in In re McLaughlin, 443
F.2d 1392, 1395 (CCPA 1971):
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
Here, we find no evidence that the Examiner gleaned anything from
Appellants' disclosure in reaching the conclusion that claim 32 would have
been obvious. It is clear from the Examiner's discussion of Kato that the
Examiner relied only on what was known to one skilled in the art prior to the
time the invention was made.
Appellants argue that the Examiner has failed to provide "some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." App. Br. 8. We are not persuaded.
The Examiner's rationale for finding claim 32 obvious is premised on
changing the timing of the dilution step described in Kato such that it occurs
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when liquids A and B are mixed rather than after they are mixed. Ans. 6-7,
12-13. The Examiner found a sound evidentiary basis for this modification
in Kato' s teaching that the liposomes dispersed in liquid B would remain
dispersed even if liquid B were diluted by adding water. Id. at 6-7. The
Examiner found motivation to make this change in the desire to optimize the
claimed method. Id. at 7. Appellants have not identified, and we do not
find, any deficiency in the Examiner's reasoning. Moreover, for the reasons
discussed above, we find that Kato discloses the method of claim 32, even
without the modification proposed by the Examiner.
Appellants argue:
If water is added to liquid B of the method of the present claims
in advance, the desired fine particles could not be obtained. In
other words, when the liquid B contains a lot of water, the
water ratio in the mixed solution (liquid C) also increases. This
increase of water in liquid B causes the fine particles to
aggregate in the mixed solution (liquid C). The aggregation
occurs because the lipids are dispersed in the solution ( the
lipids are insoluble into water). As a result, adding water to
liquid B of the subject invention produces coated fine particles
which have a larger particle size.
Reply Br. 4 ( emphasis omitted). We are not persuaded because Appellants
have not provided evidence to support these assertions. See Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) ("Attorneys' argument is
no substitute for evidence."); In re Pearson, 494 F.2d 1399, 1405 (CCPA
197 4). In addition, we note that claim 3 2 does not require that the fine
particles produced by the claimed method have any particular size.
Appellants argue that the unexpected results exhibited by the
invention of the present claims obviate any prima facie case of obviousness.
App. Br. 9. We are not persuaded. As Appellants concede, the coated fine
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particles produced by the claimed methods are "similar to the ones obtained
[by] conventional methods." App. Br. 10, 11, and 12; see also Spec.
,r,r 106, 112, and 127. To the extent Appellants contend that the claimed
process produces smaller particles than are produced by "conventional
methods," we are not persuaded for the reasons discussed by the Examiner.
Ans. 14--17. To the extent that Appellants contend that the claimed method
produces similar particles using a simpler method, we are not persuaded
because the Appellants have not identified persuasive evidence suggesting
that this result was unexpected. In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972) ("[I]t is not enough to show that results are obtained which differ from
those obtained in the prior art: that difference must be shown to be an
unexpected difference").
Accordingly, we affirm the Examiner's rejection of claim 32 as
obvious over Kato. Because they were not argued separately, claims 33-35
fall with claim 32.
DOUBLE PATENTING
The Examiner rejected claims 32-35 over claims 2-13 of US Patent
No. 7,678,415 ("the '415 patent). The '415 patent and Kato are derived
from the same international application, PCT/JPOI/08759. Appellants argue
that their arguments with respect to Kato are "equally applicable" to the
double patenting and that "U.S. Patent No. 7,678,415 does not disclose the
above technical feature[s] of present claims 32-35 for the same reasons that
Kato et al. (EP1323415) does not disclose every element of the amended
claims." App. Br. 14. We are not persuaded for the reasons discussed in
connection with the obviousness rejection over Kato. Accordingly, we
affirm the Examiner's rejection of claims 32-35 as obvious over claims
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2-13 of the '415 patent.
SUMMARY
For the reasons set forth herein, and those set forth in the Examiner's
Answer and Final Office Action, we affirm the Examiner's rejection of
claims 32-35 under 35 U.S.C § 103(a) as obvious over Kato and the
Examiner's rejection of claims 32-35 on the ground of obviousness-type
non-statutory double patenting over claims 2-13 of US Patent No.
7,678,415.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED
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