Ex Parte Schmidt

Patent Trial and Appeal Board

Feb 23, 2016

10549631 (P.T.A.B. Feb. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/549,631 11/07/2005
34375 7590 02/25/2016
NATH, GOLDBERG & MEYER
Joshua Goldberg
112 South West Street
Alexandria, VA 22314
FIRST NAMED INVENTOR
Beate Schmidt
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.
26964U 6178
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
02/25/2016 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):
USPTO@nathlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte Beate Schmidt, 1
Appeal2013-005231
Application 10/549,631
Technology Center 1600
Before DEMETRA J. MILLS, JOHN G. NEW, and
ROBERT A. POLLOCK, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the final rejection of
claims 1-9, 11-15, 17, and 18. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Appellant's invention relates to a process of preparing crystalline
ciclesonide having particles sizes suitable for inhalation therapy. Spec.,
Abstract, 1, 2-3. "To carry out the process of the invention, the compound
of the formula 1 dissolved in a suitable water-miscible organic solvent." Id.
at 3--4. "The subsequent addition of this solution to water expediently takes
1 Appellants identify the Real Party in Interest as NYCOMED GmbH. App.
Br. 3.
Appeal2013-005231
Application 10/549,631
place with stirring and .... particularly preferably takes place by dropwise
addition." Id. "The amount of water employed In the process of the
invention is expediently to be chosen so that the dissolved compound of the
formula 1 is precipitated in quantitative form after addition to the water." Id.
"The ratio of the water to the water-miscible organic solvent by volume is
preferably in the range between 0.1-1 [ v/v ], in particular between 0.25-0. 75
[v/v]." Id. at 7. Independent claim 1 is illustrative and reads as follows:
1. A process for preparing a compound of the formula I
q. '
~'-.. ~:·
:;~;~,t~:~: <;;~,
.· ,.
~ ~\'
~
in crystalline form, with defined particle size, comprising the
steps of
a) preparing a solution of the compound of the formula I in a
suitable water-miscible organic solvent;
b) adding the solution obtained in a) to water and
c) isolating a precipitate with a particle diameter for 50% of
the total volume of all particles (Xso) of less than or equal to
3 µm of the compound of the formula I which is formed.
The claims on appeal stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Amschler2 and the Merck Index. 3
2 Amschler and Flockerzi, WO 98/09982, published March 12, 1998.
3 The Merck Index (121h ed., 1996).
2
Appeal2013-005231
Application 10/549,631
ANALYSIS
We have reviewed Appellant's argument in the Briefs, the Examiner's
rejection, the Examiner's response to Appellant's arguments, and have also
considered Appellant's oral arguments before the Board on February 2,
2016. We concur with Appellant's conclusion that the Examiner erred in
finding that there is insufficient evidence of record to support a finding of
unexpected results relevant to the order of addition required by independent
claim 1.
As set forth on page 4 of the Answer, Amschler describes a process of
R-epimer enrichment of ciclesonide4 by
dissolving the ciclesonide in a suitable water miscible solvent
such as acetone or ethanol, "expediently" at elevated
temperature .... Water is then added to the solution and then
cooled with vigorous stirring .... the precipitate is [then]
collected in a manner known to the skilled artisan, such as by
filtration.
Ans. 4. Consistent with this description, the Examiner finds that "Amschler
does not describe the order of steps taken in the recrystallization as put forth
in the instant application," and as described in claim 1. Ans. 5. 5 The
Examiner finds, however, that one of ordinary skill in the art would have
been motivated to change the order taught by Amschler (adding water to a
ciclesonide/solvent solution) to that of claim 1 (adding a ciclesonide/solvent
solution to water) "because MPEP § 2144.04(IV)(C) indicates that the
4 We find no dispute on this record that the methods set forth in Amschler,
related to ciclesonide, which has the chemical structure set forth in formula 1
of the claims on appeal.
5 The Examiner relies on the Merck Index solely for the boiling points of
acetone and ethanol. Id. at 5.
3
Appeal2013-005231
Application 10/549,631
selection of any order of mixing ingredients known in the prior art is prima
facie obvious." Id. Altering the order of performing process steps is, in fact,
prima facie obvious-absent evidence of new or unexpected results. See In
re Burhans 154 F.2d 690, 692 (C.C.P.A. 1946).
As set forth in Appellant's briefs, Example 1 of the Specification
demonstrates that ciclesonide prepared according to the teachings of the
invention results in particles "of less than or equal to 3 µm," as required by
claim 1, whereas in Example 3, ciclesonide prepared using the same solvent
system (ethanol and water), but according to the process set forth in
Amschler, results in particle of roughly 10-fold greater size. See App. Br.
16-21; Reply Br. 4-9; cf Spec. 9 (Example 1) and 11 (Example 3). As
emphasized by Appellant at oral argument, a principle difference between
the two data sets is the order of addition of the ciclesonide/drug solution and
water. Tr. 4:8-5:2; 7: 11-8:6 see eg., id. at 5:6-8 "There's a big difference
between adding the solution to water versus adding water to the solution.").
This comparison is reasonably interpreted as demonstrating unexpected
results from altering the order of addition of reactants as compared to that
described in Amschler.
The Examiner argues that Appellant's comparative data is not a
comparison with the closest prior art and is limited to a single solvent
system, not the full breadth of the solvent systems within the scope of the
claim. Ans. 8. Appellant replies that the data in Example 3 of the
Specification is directly comparable to the solvent system of Amschler.
Reply Br. 8. The Examiner has failed to establish that the comparative
evidence provided by Appellant would not have been understood by one of
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Appeal2013-005231
Application 10/549,631
ordinary skill in the art to be representative of closely related or similar
solvent systems to those set forth in the Examples.
"After a prima facie case of obviousness has been made and rebuttal
evidence submitted, all the evidence must be considered anew." In re Eli
Lilly & Co., 902 F.2d 943, 945 (Fed. Cir. 1990). On the current record, we
find that the Examiner erred in failing to fully consider Appellant's evidence
of unexpected results and, accordingly, we do not sustain the rejection.
SUMMARY
We reverse the rejection of claims 1-9, 11-15, 17, and 18 under§ 35
U.S.C. 103(a) as unpatentable over the combination of Amschler and the
Merck Index.
REVERSED
5