Ex Parte Chinea et al

Board of Patent Appeals and Interferences

Jan 23, 2012

11332131 (B.P.A.I. Jan. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte VANESSA I. CHINEA, KEVIN M. KANE, ISAAC FARR, and
IDDYS D. FIGUEROA
__________

Appeal 2011-007738
Application 11/332,131
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving a claim to a method
of forming nanoparticles, which the Examiner has rejected as anticipated.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claim 5, the only claim on appeal, reads as follows:
5. A method comprising:
dissolving a pharmaceutical ingredient within a solvent; and,
Appeal 2011-007738
Application 11/332,131

2
evaporating the solvent to at least partially form a plurality of
nanoparticles of the pharmaceutical ingredient, without employing a
substrate for the nanoparticles, such that a portion of the solvent remains
within which the nanoparticles are located; and,
at least substantially reducing or stopping evaporation of the solvent
to prevent degradation of the nanoparticles formed,
wherein at least substantially reducing or stopping evaporation of the
solvent comprises sealing the portion of the solvent remaining within which
the pharmaceutical ingredient has been dissolved so that further evaporation
cannot occur.

The Examiner has rejected claim 5 under 35 U.S.C. § 102(b) as
anticipated by Talton.1 The Examiner finds that Talton discloses a “method
of forming drug particles, comprising providing a drug in an initial solution,
agitating said drug in said initial solution …, evaporating a portion of the
initial solution and collecting said drug particles” (Answer 3). The
Examiner finds that Talton discloses an apparatus for forming drug particles
that comprises a chamber fitted with “a gas tight cover 21 with an input port
23 and output port 25… and the gas in and vacuum out ports are opened and
the temperature is set to the desired process temperature” (id.). The
Examiner finds that Talton discloses that “[o]nce the desired particle
suspension is obtained, the gas in[/]vacuum out process has to be stopped
which would close these ports.… The gas tight seal on the vessel covers the
particle suspension and would therefore prevent further evaporation of the
solvent.” (Id. at 5.)
Appellants argue that Talton does not anticipate claim 5 because
“Talton never stops evaporation of the solvent by sealing the portion of the

1 Talton et al., WO 03/090,717 A1, Nov. 6, 2003
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Application 11/332,131

3
solvent remaining within which the pharmaceutical ingredient has been
dissolved so that further evaporation cannot occur” (Appeal Br. 4, emphasis
deleted). Appellants argue that Talton does not disclose “that the gas in-
vacuum out process has to be stopped by closing the ports such that the
solution is sealed.… [I]t is just as likely that the ports remain open after gas
has been introduced into the vessel, such that the solution is not sealed.”
(Reply Br. 2.)
We agree with Appellants that the Examiner has not adequately
shown that Talton discloses “at least substantially reducing or stopping
evaporation of the solvent …, wherein at least substantially reducing or
stopping evaporation of the solvent comprises sealing the portion of the
solvent remaining” as required by claim 5.
Talton discloses “methods of forming drug particles, comprising:
providing a drug in an initial solution; agitating said drug in said initial
solution using low-frequency sonication; evaporating a portion of the initial
solution; and collecting said drug particles” (Talton 9). Talton discloses an
apparatus comprising
a chamber for containing a drug in an initial solution; a low-
frequency vibration source…; at least one input port into said
chamber for adding a second solution and/or a gas; at least one
output port near the top of said chamber for providing a vacuum
and evaporating a portion of the initial and/or second solution;
at least one output port into said chamber for collecting said
drug particles.
(Id. at 10.)
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Appeal 2011-007738
Application 11/332,131

5
remaining” because the term “sealing” is broad enough to “encompass the
sealing of a portion of nanoparticles and solvent by the topmost layer of
the nanoparticles, that would initially dry. Such a sealing by the top layer
of the nanoparticles … would trap certain amount of solvent with the
nanoparticles below it and as such reduce evaporation of the solvent.”
(Answer 8.)
This reasoning is also not persuasive. Even assuming for the sake of
argument that the Examiner’s interpretation of the claim term “sealing” is
correct, the Examiner has not adequately explained why Talton’s process
would inherently – i.e., necessarily – result in a layer of dry nanoparticles on
top of a layer of nanoparticles and solvent, or why dried particles on the top
of a drying suspension of particles would necessarily seal in the solvent.
SUMMARY
We reverse the rejection of claim 5 under 35 U.S.C. § 102(b).

REVERSED

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