Ex Parte Ronchi et al

Board of Patent Appeals and Interferences

Oct 31, 2011

10971231 (B.P.A.I. Oct. 31, 2011)

UNITED STATES PATENT AND TRADEMARKOFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/971,231 10/22/2004 Celestino Ronchi RONCHI ET AL 1 6950
25889 7590 11/01/2011
COLLARD & ROE, P.C.
1077 NORTHERN BOULEVARD
ROSLYN, NY 11576
EXAMINER
HOLT, ANDRIAE M
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
11/01/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CELESTINO RONCHI and GIANCARLO CESCHEL
____________

Appeal 2011-009665
Application 10/971,231
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1, 3-7, 9-14, 16,
and 18-22 (App. Br. 3).1 We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a process for preparing sterile suspensions
for inhalation for pharmaceutical use. The claims are not separately argued
and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is

1 “Claims 23-26 have been withdrawn from consideration” (App. Br. 3).
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representative and is reproduced in the “CLAIMS APPENDIX” of
Appellants’ Brief (App. Br. APPENDIX A).
Claims 1, 3-7, 9-14, 16, and 18-22 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kipp.2
We affirm.
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Kipp teaches “processes to produce stable particles of an organic
compound that are suitable for delivery intravenously” (Kipp, col. 4, ll. 24-
26; Ans. 4).
FF 2. Kipp’s process comprises “(1) dissolving the organic compound in a
water-miscible first solvent to form a solution, (2) mixing the solution with a
second solvent to define a pre-suspension, and (3) adding energy to the pre-
suspension to form particles” (Kipp, col. 4, ll. 30-34; Ans. 4).
FF 3. Kipp suggests
the first solvent is a solvent or mixture of solvents in which the
organic compound of interest is relatively soluble and which is
miscible with the second solvent. Examples of such solvents
include, but are not limited to: ethanol (alcohol, ethanol),
isopropanol, 3-pentanol, n-propanol, glycerol, butylene glycol
(butanediol), ethylene glycol, and propylene glycol (polyol,
propylene glycol).

(Ans. 4-5; see also Kipp, col. 6, ll. 8-20.)

2 Kipp et al., US 6,607,784 B2, August 19, 2003.
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FF 4. Kipp suggests that “the organic compound (‘drug’) is first dissolved
in the first solvent to define a first solution. The organic compound can be
added from about 0.1% (w/v) to about 50% (w/v) depending on the
solubility of the organic compound in the first solvent” (Ans. 5; see also
Kipp, col. 6, ll. 33-37).
FF 5. Kipp suggests providing a second aqueous solution “with one or
more optional surface modifiers such as an anionic surfactant, a cationic
surfactant or a nonionic surfactant” (id.; see also Kipp, col. 6, ll. 40-43).
FF 6. Kipp suggests that “[s]terilization may be accomplished by separate
sterilization of the drug concentrate (drug, solvent, and optional surfactant)
and the diluent medium (water, and optional buffers and surfactants) prior to
mixing to form the pre-suspension” (Kipp, col. 9, ll. 35-39; Ans. 6).
FF 7. Kipp suggests that “[s]terilization methods would include pre-
filtration first through a 3.0 micron filter followed by filtration through a
0.45-micron particle filter, followed by steam or heat sterilization or sterile
filtration through two redundant 0.2-micron membrane filters” (Kipp, col. 9,
ll. 39-43; Ans. 6).
FF 8. Kipp teaches that the suspension is sonicated “(10,000 to 25,000 Hz,
at least 400W) for 15 to 20 minute in 5-minute intervals” (Kipp, col. 12, ll.
42-46; Ans. 6; see also Kipp, col. 13, ll. 60-61).
FF 9. The Examiner finds that “[a]t least 400W would read on 500 to 3000
Watts” (Ans. 6).
FF 10. While Kipp prefers a particle size “from about 400 nm to about 2 µm
. . . [i]t should be understood [that Kipp’s] . . . invention further
contemplates making particles having an average effective particle size in
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other size ranges such as less than about 7 µm, more preferably less than
about 3 µm” (Kipp, col. 4, ll. 45-52; see also Ans. 7).
ANALYSIS
Appellants contend that Kipp’s “[p]articles must be less than seven
microns in diameter to safely pass through capillaries without causing
emboli” (App. Br. 8-9 (emphasis removed); see also Reply Br. 2-3). Kipp
suggests particle sizes between 400 nm and less than about 7 µm (FF 10).
Appellants’ claim 1 requires that at least 80% of the particles have a
diameter between 3 and 5 µm (Claim 1). “[W]here there is a range disclosed
in the prior art, and the claimed invention falls within that range, there is a
presumption of obviousness.” Iron Grip Barbell Co. v. USA Sports, Inc.,
392 F.3d 1317, 1322 (Fed. Cir. 2004). Accordingly we find no error in the
Examiner’s conclusion that Kipp suggests particle sizes that fall with the
range set forth in Appellants’ claim 1 (see Ans. 8).
Since Kipp suggests particles having a diameter between 3 and 5 µm,
we are not persuaded by Appellants’ contention that Kipp is inapplicable to
their claimed invention because Kipp intends to deliver the particles
intravenously, whereas Appellants intend to deliver the particles through
inhalation (App. Br. 10; see also Reply Br. 3-4). Further since Kipp is
interested in a process for producing particles of defined size for drug
delivery, we are not persuaded by Appellants’ contention that Kipp is
directed toward a different field of endeavor and is not relevant to
Appellants’ claimed invention (App. Br. 10; see also Ans. 7-9).
Appellants’ contend that their sonication step, which has a duration of
3-6 minutes, is not suggested by Kipp (App. Br. 13; see also Reply Br. 4-5;
Cf. FF 8 (Kipp teaches that the suspension is sonicated . . . “for 15 to 20
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5
minute in 5-minute intervals”)). We are not persuaded. Notwithstanding
Appellants’ intimation to the contrary, Appellants’ claim 1 is not limited to a
single sonication step having a duration of 3-6 minutes. To the contrary,
Appellants’ claim 18 depends from and further limits claim 1 to require the
sonication be repeated n times, wherein n is an integer ranging from 1 to 50.
Accordingly, we interpret Appellants’ claim 1 to read on a sonication step,
wherein the solution is sonicated any number of times for a duration of 3-6
minutes. Therefore, Kipp suggests the sonication step set forth in
Appellants’ claim 1 (FF 8; see also Ans. 9-10).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 1 under 35 U.S.C. § 103(a) as
unpatentable over Kipp is affirmed. Because they are not separately argued
claims 3-7, 9-14, 16, and 18-22 fall together with claim 1.
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

cdc