Ex Parte Bamba et al

Board of Patent Appeals and Interferences

Apr 22, 2011

10182908 (B.P.A.I. Apr. 22, 2011)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.
10/182,908 08/02/2002 KENZO BAMBA

EXAMINER
OBLON, SPIVAK, McCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314

VERA AFREMOVA
ART UNIT PAPER NUMBER
1653
MAIL DATE DELIVERY MODE

04/26/2011 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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KENZO BAMBA,
YASUYUKI KUROIWA, and TERUAKI SEKINE
__________

Appeal 2010-003016
Application 10/182,908
Technology Center 1600
__________

Before LORA M. GREEN, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition and its use in a cell preservation method. The Examiner has
rejected the claims as anticipated and/or obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 1-12, 15-17, and 22-24 are on appeal (App. Br.
1
4). The
claims have not been argued separately and therefore stand or fall together
for each ground of rejection. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is
representative and reads as follows:
1. A liquid composition comprising:
refined albumin,
dimethyl sulfoxide (DMSO),
0.1% to 5% (w/w) calcium and magnesium ions,
at least one divalent or tervalent metal ion other than calcium or
magnesium, and
an aqueous phosphate buffer containing phosphoric ion.
Claims 1-12, 15-17, 22, and 23 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Harcuch
2
in light of Freshney
3
(Ans.
4
3).
Claims 1-12, 15-17, and 22-24 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Harcuch in view of Freshney, Price,
5
and
Demetriou
6
(Ans. 5).
ANTICIPATION
The Examiner finds that Harcuch discloses “a preservation liquid
comprising albumin, DMSO, sugar including glucose and the DMEM
culture medium basic ingredients including phosphate ion and divalent or

1
Response to Notice of Non-Compliant Appeal Brief dated May 15, 2009.
2
Kuri Harcuch et al., WO 96/14738 A2, May 23, 1996.
3
R. Ian Freshney, Culture of Animal Cells: A Manual of Basic Technique,
pp. 74-75 (2d. ed. 1987).
4
Examiner’s Answer dated August 19, 2009.
5
Price et al. US 6,103,529, issued Aug. 15, 2000.
6
Demetriou et al., US 6,485,959 B1, issued Nov. 26, 2002.
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trivalent metal ions such as calcium, magnesium, iron as evidenced by
Freshney” (Ans. 4). The Examiner also finds:
the total dry weight of all solids in the DMEM culture medium
is about 16.2 g for 1 L and the DMEM culture medium contains
400 mg of calcium and magnesium salts combined for 1 L; and,
thus, the DMEM culture medium composition provides for
about 2.5% (w/w) of calcium and magnesium salts in the
preservation composition.
(Id.)
Appellants argue that, as properly construed, “the Harcuch
composition . . . does not contain 0.1% to 5% w/w calcium and magnesium
ions” (App. Br. 12).
Issue
Does the evidence support the Examiner’s conclusion that Harcuch
discloses a composition containing 0.1% to 5% (w/w) calcium and
magnesium ions?
Findings of Fact
1. Harcuch discloses a “preservation medium consisting of
DMEM plus 0.005M to 3.5M glucose, plus 0.1 mg/ml to 40.0 mg/ml serum
albumin plus either 1.0% [-] 10% (v/v) glycerol or 1% - 10% (v/v) DMSO”
(Harcuch 13: 27-28).
2. Freshney discloses that DMEM contains 200 mg/l CaCl2 and
200 mg/l MgSO4·7H2O (Freshney 74-75).
Analysis
The Examiner concludes:
The instant as-filed specification does not provide any specific
definitions for the claimed term “% (w/w)” (pages 4-5). Thus,
in the office action the claimed concentration of composition
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ingredients and, in particular, the concentration 0.1-5% (w/w)
for calcium and magnesium are interpreted as percent dry
weight by dry weight of total solids as it is based on the
evaluation of the appellants’ exemplified compositions
(page[s] 6-7) and conventional usage.
(Ans. 9.) We are not persuaded.
The Examiner has not set forth any basis for the position that, when
referring to a liquid composition, the phrase “% (w/w)” is conventionally
used to refer to the percent dry weight by dry weight of the total solids rather
than by weight of the entire composition. In the absence of such evidence,
we agree with Appellants that claim 1 should be interpreted to require 0.1%
to 5% by weight calcium and magnesium ions as compared to the weight of
the entire composition.
Conclusion
The evidence does not support the Examiner’s conclusion that
Harcuch discloses a composition containing 0.1% to 5% (w/w) calcium and
magnesium ions. We therefore reverse the anticipation rejection.
OBVIOUSNESS
The Examiner relies on Harcuch as discussed above (Ans. 6). The
Examiner finds:
The DMEM basic culture medium used in the preservation
liquid of [Harcuch] provides calcium and magnesium at
amounts 0.02 % each (weigh[t] by volume) or 2.5% (dry w/dry
w) in the light of Fres[h]ney. . . . [I]f the amounts of calcium
and magnesium in the cited reference are less than it might be
encompassed by the claims, it is well known that the liquid
animal cell culture compositions are commonly provided as
concentrates, for example: [Price] teaches lx, 10x, 25x, 50x and
100x formulations (col. 11, lines 49-60). Thus, the presently
claimed concentrations of divalent and/or trivalent metal ions
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would fall within the ranges of metal ions in culture medium
concentrates.
(Ans. 6-7.) The Examiner concludes that it would have been obvious “to
obtain the preservation liquid composition with the ingredients and at
amounts as required for the claimed invention . . . because the claimed
amounts are within the ranges that are employed in the routine compositions
either as complete ready-to-use formulations or as concentrated
formulations” (id. at 8).
Issue
Does the evidence support the Examiner’s conclusion that a
composition containing refined albumin and 0.1% to 5% (w/w) calcium and
magnesium ions would have been obvious?
Additional Findings of Fact
3. Price relates to cell culture medium formulations (Price, col. 1,
ll. 14-15).
4. Price discloses: “Preferably, the solutions comprising
ingredients are more concentrated than the concentration of the same
ingredients in a 1x media formulation. The ingredients can be 10-fold more
concentrated (10x formulation), 20-fold more concentrated (20x
formulation), 25-fold more concentrated (25x formulation), 50-fold more
concentrated (50x concentration), or 100-fold more concentrated (100x
formulation).” (Id. at col. 11, ll. 49-56.)
5. Price also discloses: “If the media ingredients are prepared as
separate concentrated solutions, an appropriate (sufficient) amount of each
concentrate is combined with a diluent to produce a 1x medium formulation.
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Typically the diluent used is water but other solutions . . . may be used.” (Id.
at col. 11, ll. 61-67.)
Analysis
With regard to the refined albumin, the Examiner finds:
[T]he cell preservation liquid taught by [Harcuch] contains the
same albumin as encompassed by the instant specification and
claims. The cited reference teaches the use [of] commercially
available “serum albumin” which is the same product as the
serum albumin or BSA as disclosed for the appellants’
exemplified compositions, for example see page 7, par. 2.
Moreover, the appellants’ generic disclosure states that any
kind of albumin might be used regardless [of the] method of
refining (page 4, par. 3).
(Ans. 9.) Appellants have not adequately explained why Harcuch fails to
teach refined albumin.
With regard to the amount of calcium and magnesium ions, it is
undisputed that Harcuch discloses a composition comprising each of calcium
and magnesium at an amount of 0.02 % (w/v) (Ans. 6; App. Br. 13). We
agree with the Examiner that it would have been obvious to prepare
Harcuch’s medium as a concentrate, as described in Price. Thus, we agree
with the Examiner that it would have been obvious to form a composition
comprising 0.1% to 5% (w/w) calcium and magnesium ions.
Appellants argue:
[O]ne of ordinary skill in the art would not have contemplated
replacing the (1x) DMEM in the Harcuch compositions with
Price’s 10x, 20x or even more concentrated DMEM preparation
solutions. It is common sense to those of ordinary skill in the
art that a cell culture medium would be used at a 1x
concentration and that concentrated solutions used to prepare
culture media are not used without dilution because
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concentrated media preparation solutions would osmotically
damage cells or inhibit their growth. In this respect, Price is
non-analogous art, and its concentrated solutions are not
equivalents of the DMEM used by Harcuch, but are used as
intermediate products for a different purpose: as concentrated
stock solutions for media preparation. Furthermore, none of the
prior art suggests that such concentrated solutions (e.g. 10X or
100X) would have been considered as suitable for cell
preservation as required by the claims.
(App. Br. 15.) However, the Examiner’s position is not that the
concentrated solution would be suitable for use without dilution. Instead,
the Examiner is merely arguing, and we agree, that it would have been prima
facie obvious to form a concentrate within the scope of claim 1.
Appellants also argue that they “demonstrated that selection of a metal
ion concentration ranging 0.1-5% provides unique value for cell preservation
which is not described by the prior art and for which no reasonable
expectation exists” (App. Br. 16). However, we agree with the Examiner
that the data is not commensurate with the scope of the claims. In particular,
although the Rule 132 Declaration may demonstrate superior results for
compositions containing between 0.1% and 5% (w/w) magnesium ion, it
does not demonstrate that similar results would be obtained using
corresponding amounts of calcium, which are also encompassed by claim 1.
In addition, like the Examiner, we are troubled by the apparent
inconsistency between the data presented in the Rule 132 Declaration and
the data presented in the Specification. Appellants argue:
[A]t a concentration of 0.01% of Mg and Ca the cell
preservation rate is variable, possibly due to influences of
uncontrolled factors like the different cell densities used in the
specification and declaration prior to freezing or other
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uncontrolled divergent experimental conditions. . . . As
apparent from the Declaration, at the higher 0.1% to 5%
concentrations of di- and ter-valent metal ions required by the
claims, no variability in preservation rates over the 0.1% to 5%
range was observed for either P3U1 or K562 cell lines or the
numerous other cell types shown in the Declaration.
(App. Br. 19.) However, there is no evidence supporting this attorney
argument. Moreover, this argument raises questions as to whether the data
presented in the Rule 132 Declaration would be reproducible.
Conclusion
The evidence supports the Examiner’s conclusion that a composition
containing refined albumin and 0.1% to 5% (w/w) calcium and magnesium
ions would have been obvious. We therefore affirm the obviousness
rejection of claim 1 and of claims 2-12, 15-17, and 22-24, which fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We reverse the anticipation rejection of claims 1-12, 15-17, 22, and
23, but affirm the obviousness rejection of claims 1-12, 15-17, and 22-24.
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

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