Ex Parte Ogawa et al

Patent Trial and Appeal Board

Aug 17, 2016

13358025 (P.T.A.B. Aug. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/358,025 01125/2012
513 7590 08/19/2016
WENDEROTH, LIND & PONACK, LLP,
1030 15th Street, N.W.,
Suite 400 East
Washington, DC 20005-1503
FIRST NAMED INVENTOR
Yasuaki OGAWA
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_0050 1128
EXAMINER
ROGERS, JAMES WILLIAM
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/19/2016 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):
ddalecki@wenderoth.com
eoa@wenderoth.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte Y ASUAKI OGAWA, SHOKO NAGASAKI, YOSHIHIKO
NOGAT A, KA TSUHIKO SAGA WA, and CHIEKO TSUCHIYA
Appeal2014-009161
Application 13/358,025 1
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for reconstituting a lyophilized drug-encapsulating polymer micelle
preparation in an aqueous medium. The Examiner rejected the claims on
appeal as obvious under 35 U.S.C. § 103(a).
We affirm.
1 According to Appellants, the real party in interest is NanoCarrier Co., Ltd.
App. Br. 2.
Appeal 2014-009161
Application 13/358,025
STATEMENT OF THE CASE
Claims 18-20 and 22-27 are on appeal. Claim 18, the only
independent claim, is illustrative and reads as follows:
18. A method for reconstituting a lyophilized drug-
encapsulating polymer micelle preparation in an aqueous
medium, comprising:
providing a lyophilized drug-encapsulating polymer
micelle preparation, and
mixing the lyophilized drug-encapsulating polymer
micelle preparation in water to homogeneously disperse or
solubilize the preparation in the water,
wherein:
(a) the preparation comprises a drug, the drug is
paclitaxel, and a saccharide selected from the group
consisting of trehalose, maltose and sucrose and/or
homopolymeric polyethylene glycol having a molecular
weight of about 1000 Dato about 35000 Da as a stabilizing
agent,
(b) the drug-encapsulating polymer micelle is formed
from a biock copoiymer having a hydrophiiic poiymer
segment and a polymer segment which is hydrophobic or
capable of containing a charge or which has the repetitive
units of both of them, and it is a core-shell type micelle in
which the drug is carried principally in a core part and in
which a shell part is constituted by the above hydrophilic
polymer segment, and wherein the block copolymer of (b) is
represented by Formula (I) or (II):
R1iOCH2CH2T;;-L1-+(COCHNH)x · (COCHNH)y}-R2
I I (I)
CH2COOH CH2COO-R5
or
2
Appeal 2014-009161
Application 13/358,025
wherein
R1 and R3 each represent independently a hydrogen atom or a
methyl group substituted or not substituted with a functional group
which may be protected;
R2 represents a hydrogen atom, a saturated or unsaturated C1 to
C29 aliphatic carbonyl group or an arylcarbonyl group;
Ri represents a hydroxyl group, a saturated or unsaturated C1 to
C10 aliphatic oxy group or an aryl-methyloxy group;
Rs represents a phenyl group, a C1 to C4 alkyl group or a benzyl
group;
Li and L2 each represent independently a linkage group;
n is an integer of 10 to 2500;
x and y are different or the same and are an integer in which the
total of them is 10 to 300; and x toy falls in a range of 7:3 to 1:3
and wherein said drug-encapsulating polymer micelle preparation
is homogeneously dispersed or solubilized in said medium.
The following grounds of rejection by the Examiner are before us on
review:
Ciaims 18----20 and 22----27 under 35 U.S.C. § 103 as being unpatentabie
over JP 11-3352672 in view ofMilton3;
Claims 18-20 and 22-27 under 35 U.S.C. § 103 as being unpatentable
over JP 11-335267 in view of Milton, Gref4, and Mamoru5;
Claims 18-20 and 22-27 under 35 U.S.C. § 103 as being unpatentable
over Sakurai6 in view of Milton and JP 11-335267; and
2 Japanese Patent Publication No. 11-335267, published Dec. 7, 1999.
3 Milton et al., U.S. Patent No. 6,960,564 B2, issued Nov. 1, 2005
("Milton").
4 Gref et al., U.S. Patent No. 5,543, 158, issued Aug. 6, 1996 ("Gref').
5 Mamoru et al., Japanese Patent Abstract Publication No 03-061859,
published Mar. 18, 1991.
6 Sakurai et al., U.S. Patent No. 5,693,751, issued Dec. 2, 1997 ("Sakurai").
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Appeal 2014-009161
Application 13/358,025
Claims 18-20 and 22-27 under 35 U.S.C. § 103 as being unpatentable
over Sakurai in view of Milton, JP 11-335267, Gref, and Mamoru.
ANALYSIS
We agree with the Examiner that the challenged claims would have
been obvious over the cited art. Appellants do not challenge the Examiner's
prima facie showing of obviousness, instead arguing that unexpected results
show the claimed invention to be non-obvious. Because the issues are
substantially the same with respect to all of the Examiner's obviousness
rejections, we will consider them all together.
Appellants rely principally upon the declaration of Tatsuyuki Hayashi
(filed Sept. 10, 2012) to demonstrate unexpected results. The Hayashi
Declaration includes data comparing the redissolvability of 15 lyophilized
micellar compositions prepared according to the claimed invention with 1 7
preparations prepared according to the prior art. App. Br. 5. Mr. Hayashi
redissoived each of these preparations and then measured the absorbency of
light having a wavelength of 420 nm. Id. According to the Appellants,
"[t]he absorbency values show the redissolvability of the preparation ... the
lower the absorbency, the better the redissolvability." Id.
The results for Mr. Hayashi's testing are set forth below, with
compositions E 1-E 15 reflecting the compositions prepared according to the
claimed invention and compositions C 1---C 1 7 reflecting compositions of the
prior art.
4
Appeal 2014-009161
Application 13/358,025
_?\.~fa_~n ~
~
~
~
~
oor:nponent Qf »~Q'»»»»»»
i Mat.~ro.~o l 401),.'1 ! 40
0:2269 I FJ
0.1939
l Trebalose 40 ;
!""":"""""""""'~~:~-------~:--- """""""':""""""""l 0,2421
i Ma\::·rugol ,,.,.J(}(}\) '-1-0 ~ r------------------------------------------- ---------------------------------t--------------------------------
Su~~~)j\(~ 40 l 0.5210
............ sti~;:;-;·--w-·-----~r-··········t·············---·--------·······
~--¥"""""""""'""""'""·''"' """"'""~¥~"'''''''''' ~ 0.2489
____ M~£I2St!L'!Q}!Q _________________ :LQ___________ f --~-----·····················--
i St.K':~~".l~">e l . 40 ... l ...................... .
I . . . . l · t o ., ~3".I
L.~'.!~~~g~!J~ 00 .. _.L, .. , ...... ~~:2 .......... w.-l-,:=~·----=---··········
~ Sucrose ~ 40 ~~
r":"""""""""""""":«"" "'"'""W"«««««««.WN·1 0.23:34
! Macro in 1 2!X}00 40 !
Bl2
E13
5
Appeal 2014-009161
Application 13/358,025
6
Appeal 2014-009161
Application 13/358,025
Hayashi Deel. 7-8.
Appellants contend that the Hayashi Declaration shows that "it was
unpredictable from the cited references that the specific selection of the
claimed stabilizing agent and the claimed micelle-forming block copolymer
would result in such unexpected superior redissolvability of the lyophilized
preparations." App. Br. 5. We are not persuaded.
As the Federal Circuit explained in In re Huai-Hung Kao:
Evidence of secondary considerations must be reasonably
commensurate with the scope of the claims. See In re
Tiffin, 58 CCPA 1420, 448 F.2d 791, 792 (1971); In re
Hiniker, 150 F.3d 1362, 1369 (Fed. Cir.1998). This does
not mean that an applicant is required to test every
embodiment within the scope of his or her claims. If an
applicant demonstrates that an embodiment has an
unexpected result and provides an adequate basis to
support the conclusion that other embodiments falling
within the claim will behave in the same manner, this
will generally establish that the evidence is
commensurate with scope of the claims. See In re
Greenfield, 571F.2d1185, 1189 (CCPA 1978)
(concluding that evidence of secondary considerations
was not commensurate with the scope of the claims
where that evidence related to a single compound and
there was no adequate basis to conclude that other
compounds included within the scope of the claims
would exhibit the same behavior); In re Cescon, 474 F.2d
1331, 1334 (CCPA 1973) (concluding that, although not
every compound within the scope of the claims was
tested, the evidence of secondary considerations was
sufficient where evidence showed a correlation and there
was no factual basis to expect the compounds to behave
differently in different environments).
In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).
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Appeal 2014-009161
Application 13/358,025
Here, the evidence presented by Appellants does not demonstrate
unexpected results that are commensurate with the scope of the claims. The
claims encompass composition EIO, which comprises polyethylene glycol-
co-polybenzyl aspartate (PEG-PBLA) and sucrose. The absorbency value
for composition EIO is 0.52. The absorbency value for composition C5,
which comprises just PEG-PB LA, and thus falls outside the scope of the
claims, is 0.67. To put the reduction from 0.67 to 0.52 in context, we note
that it is smaller than the reductions achieved by adding maltose to
composition C9 (cf composition C7) or adding either maltose or Macrogol
4000 to composition C13 (cf compositions Cl I and C12). See, Hayashi
Deel. 8. In view of these results, we agree with the Examiner that, at least
with respect to the species represented by EIO, the reduction achieved by
including an additive represents "a difference in degree and not in kind."
Ans. 3. As E 10 falls within the scope of the claims, Appellants have not
shown unexpected results commensurate with the scope of the claims. In re
Clemens, 622 F.2d 1029i 1036 (CCPA 1980) (finding no unexpected results
for claims directed to process for removing con-osion at "elevated
temperatures'~ where the clairns encompassed performing the method at a
temperature where the prior art ion exchange resin was known to perform
well).
In addition, the Hayashi Declaration provides data only for one
specific polymer within the scope of the claims, PEG-PB LA. As the
Examiner explained:
[T]he polymer example in the declaration is clearly
narrower in scope then the claimed invention since only
one specific example of a polymer within the scope of
the claims, PEG-PBLA of specific MW is used. The
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Appeal 2014-009161
Application 13/358,025
claims recite a broader genus that includes more types of
polymers (R5=benzyl, C 1-C4 alkyl group or benzyl) with
a large lower and upper limit for MW (repeat unit n=l0-
2500, x and w [sic, y] together are 10-300) than the
specific copolymer exemplified. Given the variance with
regard to MW and functional groups on this polymer it
would be expected that the properties of the polymer
would have a large variance.
Ans. 4. We agree with the Examiner that the claims encompass more than
just the polymer exemplified in the Hayashi Declaration. Because the
Appellants provide no evidence that other embodiments falling within the
claim will behave in the same manner as compositions El-E15, the results
set forth in the Hayashi Declaration are not commensurate with the scope of
the claims. See In re Greenfield, 571F.2d 1185.
In sum, for the reasons discussed, Appellants' arguments do not
persuade us that a preponderance of the evidence fails to support the
obviousness of claim 18. Because they were not argued separately, claims
19, 20 and 22-27 fall with claim 18. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
For these reasons and those set forth in the Examiner's Answer, the
Examiner's final decision to reject claims 18-20 and 22-27 is affirmed.
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
9