Ex Parte Nagasaki et al

Patent Trial and Appeal Board

Jun 11, 2018

11187621 (P.T.A.B. Jun. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/187,621 07/21/2005
23900 7590 06/11/2018
JC PATENTS
4 VENTURE, SUITE 250
IRVINE, CA 92618
FIRST NAMED INVENTOR
Takeshi Nagasaki
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.
JCLA17009 6497
EXAMINER
HOBBS, MICHAEL L
ART UNIT PAPER NUMBER
1799
MAIL DATE DELIVERY MODE
06/11/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TAKES HI NAGASAKI,
SEIJI SHINKAI, and ATSUSHI UNO
Appeal2017-009231
Application 11/187,621 1
Technology Center 1700
Before ADRIENE LEPIANE HANLON, KAREN M. HASTINGS, and
GEORGE C. BEST, Administrative Patent Judges.
HANLON, Administrative Patent Judge.
DECISION ON APPEAL
A. STATEMENT OF THE CASE
The Appellants filed an appeal under 35 U.S.C. § 134(a) from an Examiner's
decision finally rejecting claims 1, 2, and 4--13 under 35 U.S.C. § 103(a) as
1 According to the Appellants, JNC Corporation is the real party in interest.
Appeal Brief dated February 15, 2017 ("App. Br."), at 1.
Appeal2017-009231
Application 11/187,621
unpatentable over Kobayashi et al. 2 in view of Shinto et al., 3 Satake et al., 4 and
Hubbell et al. 5 We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
The appealed claims are directed to a cell culture device ( claims 1, 2, 4, and
5) and a method of manufacturing a cell culture device ( claims 6-13) wherein the
substrate surface of the device is coated with at least one of further polymerized
derivatives of E-poly-L-lysine and salts of further polymerized derivatives of E-
poly-L-lysine in an amount of 10 ng/cm2 to 140 ng/cm2. The Appellants disclose
that E-polylysine may be further polymerized according to "the method described
in Japan unexamined patent publication No. 2003-171463 [Satake], wherein E-
polylysine undergoes dehydration-condensation by heat treatment at 150QC or
higher in an inert gas or vacuum." Spec. ,r 28; see also App. Br. 1 (citing Spec.
i128).
Representative claim 1 is reproduced below from the Claims Appendix of
the Appeal Brief. The limitation at issue is italicized.
1. A cell culture device wherein the surface of substrate is coated
with at least one of further polymerized derivatives of E-poly-L-lysine
and salts of further polymerized derivatives of E-poly-L-lysine,
wherein the further polymerized derivatives of E-poly-L-lysine are
derived from dehydration-condensation of E-poly-L-lysine,
wherein the amount coated of at least one of further
polymerized derivatives of E-poly-L-lysine and salts of further
2 US 6,528,514 Bl, issued March 4, 2003.
3 US 5,674,726, issued October 7, 1997.
4 JP 2003-171463 A, published June 20, 2003. In this Decision on Appeal, we
refer to the English translation of JP 2003-171463 A, which is of record in the
instant Application.
5 US 2002/0128234 Al, published September 12, 2002.
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Application 11/187,621
polymerized derivatives of E-poly-L-lysine is in a range 10 nglcm2 to
140 nglcm2 .
App. Br. 8.
B. DISCUSSION
Based on the teachings in Shinto and Satake, the Examiner concludes that it
would have been prima facie obvious to substitute the E-poly-L-lysine used to coat
Kobayashi's culture device (i.e., a 96-well plate) with the further polymerized
derivatives of E-poly-L-lysine or salts of further polymerized derivatives of E-poly-
L-lysine recited in the claims on appeal. Final Act. 3-5. 6 The Appellants do not
direct us to any error in the Examiner's conclusion. See App. Br. 2 (identifying the
issue on appeal as relating to the claimed amount of further polymerized
derivatives of E-poly-L-lysine ).
The Examiner, however, finds Kobayashi, Shinto, and Satake do not
disclose the claimed amount of further polymerized derivatives of E-poly-L-lysine
or salts of further polymerized derivatives of E-poly-L-lysine. Final Act. 6.
Therefore, the Examiner turns to Hubbell. Final Act. 6. Hubbell discloses coating
a surface with a-poly-L-lysine grafted polyethylene glycol ("a-PLL-g-PEG"). See,
e.g., Hubbell ,r 16. The Examiner finds Hubbell "discloses that the coating can be
applied with an areal density of 120 ng/cm2 ... which is within the claimed range."
Final Act. 6 (citing Hubbell ,r 274). 7 The Examiner concludes that it would have
been obvious to one of ordinary skill in the art to employ the coating amount
disclosed in Hubbell for coating Kobayashi's modified culture device to "yield the
6 Final Office Action dated May 10, 2016.
7 The Examiner also relies on Hubbell's paragraph 275 to teach an amount between
150 and 250 ng/cm2. Final Act. 6. Hubbell's paragraph 275, however, discloses
an amount of adsorbed protein, not an amount of a-PLL-g-PEG as disclosed in
Hubbell's paragraph 274.
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Appeal2017-009231
Application 11/187,621
desired degree of binding to the surface of the analytical device." Final Act. 6
( citing Hubbell ,r 43).
The Appellants argue that the a-PLL-g-PEG disclosed in Hubbell differs
from the further polymerized derivatives of E-poly-L-lysine ("[ E-PLL ]m") coated on
Kobayashi's modified culture device because:
a) only a-amino group but no E-amino group are used in the
polymerization of poly-L-lysine, b) its branches are PEG grafts rather
than E-PLL chains, and c) it branches only once, compared to [ E-
PLL ]m that has further branches on branches to provide a fully 3D
environment that is more close to the natural environment of cell
growth.
App. Br. 4 ( emphasis omitted).
The Appellants also argue that Hubbell coats metal oxide surfaces which are
different from the material of Kobayashi's culture device. 8 App. Br. 4. Based on
those differences, the Appellants argue there is no reason to believe that the
8 Additionally, the Appellants argue that "the purpose of Hubbell coating a-PLL-g-
PEG is to reduce protein absorption to the surface." App. Br. 4 (emphasis
omitted). The Appellants' argument is not completely accurate. Hubbell discloses
that PEG decreases cellular adhesion. Hubbell ,r 12. However, Hubbell also
discloses that:
The polymers must ... have sufficient PLL character to adequately
bind to a chip surface. Polymers with insufficient PLL character fail
to bind adequately. The polycationic polymer [(e.g., PLL)] can be
any polycation that provides a sufficient amount and density of
cationic charges to be effective at adhering to the analytical or sensing
substrate.
Hubbell ,r 49 ( emphasis added). Hubbell discloses that the resulting amount
of a-PLL-g-PEG adsorbed to the surface varies for different metal oxides
and depends on the characteristic isoelectric point of the particular metal
oxide. Hubbell ,r 27 4; see also Hubbell Fig. 4.
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Application 11/187,621
amount of a-PLL-g-PEG disclosed in Hubbell would be suitable for coating the
surface of Kobayashi's culture device with [E-PLL]m. App. Br. 5; Reply Br. 1. 9
Significantly, the Examiner does not address (1) the differences between the
a-PLL-g-PEG disclosed in Hubbell and the claimed [E-PLL]m and (2) the
differences between the surfaces coated in Hubbell and Kobayashi. The Examiner
finds Hubbell discloses coating polymer surfaces "which are not dissimilar to the
well plate of Kobayashi." Ans. 4 (citing Hubbell ,r 14); see also Ans. 6. 10 The
Examiner, however, does not direct us to any portion of Hubbell disclosing the
amount of a-PLL-g-PEG to be coated on those similar surfaces. 11
Based on the foregoing, a preponderance of the evidence of record does not
support a finding that one of ordinary skill in the art would have expected to
successfully bind [ E-PLL ]m to the surface of Kobayashi's culture device using the
amount of a-PLL-g-PEG coated on the metal oxide surface in Hubbell. See Final
Act. 6 (finding that the reason to use the coating amount disclosed in Hubbell is to
yield a desired degree of binding to the surface of Kobayashi's analytical device).
For that reason the§ 103(a) rejection on appeal is not sustained.
C. DECISION
The Examiner's decision is reversed.
REVERSED
9 Reply Brief dated June 15, 2017.
10 Examiner's Answer dated April 18, 2017.
11 Hubbell paragraph 14 does not disclose a coating amount for a polymer surface.
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