Ex Parte Hirofuji et al

Board of Patent Appeals and Interferences

Feb 17, 2012

10536397 (B.P.A.I. Feb. 17, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HAJIMU HIROFUJI and HOTAKA HASHIMOTO
__________

Appeal 2011-001032
Application 10/536,397
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
Claim 13 is representative of the claims on appeal and reads as
follows:
13. A method for producing a stabilized lyophilized preparation
comprising (1) amrubicin or a salt thereof; and (ii) wherein the water content
within the preparation is 0 to 3.5% by weight based on the weight of the
lyophilized powder, which comprises the following Steps (1) to (4):

(1) preparing an aqueous solution of (a) amrubicin or a salt thereof,
and (b) L-cysteine or a salt thereof by dissolving them in water;
(2) adjusting the pH value of the aqueous solution of the above (1) to
pH 2 to pH 5;
(3) sterilizing the aqueous solution of the above (2) by aseptic
filtration;
(4) lyophilizing the aqueous solution obtained in the above (3) under
conditions for controlling the water content within the preparation so that the
water content is in the range of 0 to 3.5% by weight based on the weight of
the lyophilized powder.

Cited References

Shimago WO 99/28331 June 10, 1999

Grounds of Rejection
Claims 13-23 are rejected under 35 U.S.C. § 103(a) for obviousness
over Shimago.
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at
pages 3-6.

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Discussion
ISSUE
The Examiner concludes that the cited prior art teaches a prima facie
case of obviousness.
Appellants rely on unexpected results to overcome the prima facie
case of the Examiner.
The issue is: Does the cited prior art support the Examiner’s
conclusion that the claimed subject matter is obvious? Is Appellants’
evidence of unexpected results, when weighed with the evidence of
obviousness, sufficient to overcome the prima facie case of obviousness?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

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[I]t is elementary that the mere recitation of a newly discovered
function or property, inherently possessed by things in the prior
art, does not cause a claim drawn to those things to distinguish
over the prior art. Additionally, where the Patent Office has
reason to believe that a functional limitation asserted to be
critical for establishing novelty in the claimed subject matter
may, in fact, be an inherent characteristic of the prior art, it
possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (quoting In re
Swinehart, 439 F.2d 210, 212-13 (CCPA 1971)).
“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
“Mere recognition of latent properties in the prior art does not render
nonobvious an otherwise known invention.” (Id.) Expected beneficial
results are not evidence of nonobviousness. See In re Skoner, 517 F.2d 947,
950 (CCPA 1975).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection,
and responses to Appellants’ arguments as set forth in the Answer. We find
that the Examiner has presented a prima facie case of obviousness on the
evidence before us. We provide the following additional comment.
Appellants argue that the method of Shimago is different from the
freeze-drying of the present invention. (Br. 7-8.)

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Appellants argue that the Examiner states that Shimago teaches:

[S]terilizing said preparation prior to freeze drying
“by subjecting the moistened crystals to a reduced
pressure at 0 to 50 °C, preferably 10 to 30°C. The
pressure in drying may be, for example, less than
200 mmHg, preferably 1 to 50 mmHg. The drying
can be monitored by measuring the amount of
water in crystals. Usually the drying will be
completed in 1 to 24 hours” (page 7, lines 25-29
and page 8, lines 1-2).

(Office Action dated March 24, 2009, pages 2-3.) However, as
a matter of fact, this cited process is provided in Shimago to
describe the removal of residual organic solvents from
amrubicin hydrochloride crystals, which is completely
unrelated to sterilization prior to freeze drying or the freeze-
drying step itself. For example, the cited drying process is
performed on a moistened crystal of amrubicin to yield an
amrubicin hydrochloride crystal, whereas the freeze drying step
of the instant application is typically performed on a frozen
liquid solution of amrubicin, under lyophilizing conditions, e.g.
subliming ice from a frozen aqueous solution in a lyophilization
chamber, to yield a lyophilized powder. The two drying
processes are markedly different.
Shimago discloses, inter alia, a method for preparing
amrubicin hydrochloride crystals. Because the amrubicin
crystals may carry the organic solvent used in the crystallization
step (Shimago, page 7, lines 11-12), the organic solvent is
removed from the crystal by first moistening the crystal and
then drying the moistened crystal (Id. at page 7, lines 13-15).
Details on drying the moistened crystal are disclosed on page 7,
lines 25-29, and page 8, lines 1-2 of Shimago. The preparation
of a freeze-dried composition of amrubicin is mentioned on
page 8, lines 4-29, and page 9, line 1 of Shimago, however no
details of time, temperature, pressure, or water content in
connection with the freeze-drying step are provided in
Shimago. Thus, Appellants respectfully submit that one skilled
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in the art would not have derived any teaching from Shimago,
and certainly not from the text relied upon by the Examiner, to
be applied to the freeze-drying step of the instant application.
(App. Br. 7-8.)
Appellants’ claim 13 does not recite any particular time, temperature
or pressure in the claimed method. On the other hand, the Examiner has
provided evidence of the claimed process steps in the prior art. (Ans. 3-4.)
In particular, the freeze-drying step of Shimago is performed for 1-24 hours.
(Shimago, 8.) In Example 2, page 14 of the Specification, the amrubicin
product was also freeze dried for 24 hours. Therefore, the Examiner has
reason to believe that the prior art products and the claimed products are the
same based on performance of the same process steps. Thus, under the
principles of In re Best, cited above, Appellants have the burden to show that
the prior art product made by a similar method as claimed is not the same as
the product made by the claimed method. Appellants have not met this
burden on the record before us.
Appellants have not compared the properties of the product made by
the claimed method with those of the closest prior art product made by the
similar method of Shimago. Nor is Appellants’ Declaration evidence of
unexpected results convincing, because Appellants have not compared the
water content of the closest prior art product of Shimago and shown that the
water content of the product made by the claimed method is unexpected in
view of the Shimago product. In other words, while the Tanaka Declaration
dated September 26, 2007, Table A, does show that lyophilized preparations
of amrubicin with a water content of 0- 3.5% by weight are superior with
respect to suppression of desaccharified compound, Appellants have not
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shown that the amrubicin made by the claimed method is superior to the
water content of the amrubicin product made by the method of Shimago.
Specifically, we note that in the Declaration of Kazunari Tanaka dated
September 26, 2007 (Tanaka Declaration I), a lyophilized preparation was
made (Lot A-1), in which a water content of 0.5% was obtained (Tanaka
Declaration I, paragraph bridging pp. 2-3). In order to obtain lots having
different water contents, the lyophilized preparation of Lot A-1 was
subjected to humidity conditioning so that water could be added back in to
obtain water contents of over 3.5%. (Tanaka Declaration I, p. 3, ¶¶ 2 and 3.)
Appellants have presented no evidence that the ordinary artisan would have
expected that the freeze-dried preparation of amrubicin hydrochloride as
prepared in Example 6 of Shimago would have had a water content greater
than 3.5%.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection
which is not overcome by Appellants’ evidence of unexpected results.
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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