Ex Parte Chinea et al

Board of Patent Appeals and Interferences

Apr 27, 2010

11189582 (B.P.A.I. Apr. 27, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte VANESSA I. CHINEA, KEVIN MICHAEL KANE, and
ORLANDO RUIZ
____________

Appeal 2010-000089
Application 11/189,582
Technology Center 1700
____________

Decided: April 27, 2010
____________

Before EDWARD C. KIMLIN, BRADLEY R. GARRIS, and
CHARLES R. WARREN, Administrative Patent Judges.

KIMLIN, Administrative Patent Judge.

Appeal 2010-000089
Application 11/189,582

DECISION ON APPEAL

This is an appeal from the final rejection of claims 1, 4, 6, 14, 16, and
18-25. Claims 5, 7-13 and 15 have been withdrawn from consideration.
Claim 1 is illustrative:
1. A method of preparing a deposited bioactive agent having a
selected morphology, the method comprising:
selecting one or more application parameters based on a target particle
morphology, wherein the target particle morphology includes a target
particle size of less than about 1 µm;
preparing a solution of the bioactive agent according to the application
parameters; and
applying the bioactive agent solution to a substrate as a plurality of
droplets according to the selected application parameters;
wherein evaporation of the applied bioactive agent solution produces
particles of the bioactive agent having the target morphology.

The Examiner relies upon the following reference as evidence of
obviousness:
Voss 4,322,449 Mar. 30, 1982
The present application is a continuation-in-part of U.S. Patent
Applications No. 10/801,379 (SN ‘379) and 10/801,381 (SN ‘381). Both
parent applications were before this board and the appealed claims in both
applications were directed to a method of controlling a dissolution rate of a
bioactive agent. The Board affirmed the Examiner’s rejection under 35
U.S.C. § 103(a) in both appeals over the same Voss reference applied in the
instant appeal. The Board agreed with the Examiner in both prior appeals
that it was known in the art that the topography, surface texture or size of a
dot is a result effective variable which determines the dissolution rate of the
bioactive agent within the dot, and it would have been obvious for one of
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ordinary skill in the art to optimize the dissolution rate of the bioactive agent
by optimizing the topography of the deposited dot.1
The claims of the present appeal are directed to a method of preparing
a deposited bioactive agent having a selected morphology, including a target
particle size of less than about 1 micron. The particle size is achieved by
selecting 1 or more application parameters, such as nozzle geometry,
ejection element firing chamber geometry, ejected drop volume,
etc(Spec.20, 18-25).
Appealed claims 1, 4, 6, 14, 16 and 18-25 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Voss.
Appellant argues claims 1, 4, 6, and 14 as a group, and claims 16 and
18-25 as a group. Accordingly, claims 1, 4, 6, and 14 stand or fall together,
as do claims 16 and 18-25.
We have thoroughly reviewed each of Appellants’ arguments for
patentability. However, we are in complete agreement with the Examiner
that the claimed subject matter would have been obvious to one of ordinary
skill in the art within the meaning of § 103 in view of the applied prior art.
Accordingly, we will sustain the Examiner’s rejection for essentially those
reasons expressed in the Answer.
Appellant does not dispute the Examiner’s factual determination that
Voss, like Appellants, discloses a method of applying a bioactive agent in a
solvent, or in suspension, by a dosing system which applies precisely
controlled droplets, which droplets’ volume and weight are controlled in the
application process. There is also no dispute that Voss teaches that the

1 SN ‘379 corresponds to appeal number 2008-2802, and SN ‘381
corresponds to appeal number 2008-2962.
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Application 11/189,582

droplets have a diameter of 20 microns, and that the droplets can be made
even smaller by the application of a strong electrical field during the
deposition (col. 3, l. 64-col. 4, l. 2). Voss further teaches that particles
comprising the bioactive agent are formed on the substrate when the solvent
evaporates. While the reference does not expressly disclose the size of the
particles formed on the substrate, we agree with the Examiner that it is
reasonable to conclude that the reference particles have a size of less than
about 1 micron, as presently claimed.
It is well settled that when a claimed process or product reasonably
appears to be substantially the same as a process or product disclosed by the
prior art, the burden is on the applicant to prove that the prior art process or
product does not necessarily or inherently posse’s characteristics attributed
to the claimed process or product. In re Spada, 911 F.2d 705,708 (Fed. Cir.
1990); In re Best, 562 F.2d 1252, 1255 (CCPA 1977). In the present case,
we find that the Examiner has presented sufficient evidence to shift to
Appellants the burden of demonstrating that the method of Voss does not
produce particles of the claimed size. Also, inasmuch as Appellants
acknowledge at page 2 of the specification that it was known in the art to
make particles comprising bioactive agents having a size less than 1 micron
(page 2, first full para.), we find that it would have been obvious for one of
ordinary skill in the art to operate the Voss system to produce particles of the
claimed size. Also, it would appear from Appellants’ specification that
known apparatus and methods are employed to form the claimed particles.
Voss discloses that “an extremely precise dosing of active
pharmaceutical ingredients onto pharmaceutical carriers can be achieved if
the liquid, dissolved or suspended active substance is dotted onto the
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Application 11/189,582

pharmaceutical carrier in a specific quantity in the form of discrete droplets
of specific volume” (col. 1, ll. 62-67). The reference further teaches that the
liquid comprising the bioactive agent can be “divided into discrete droplets
of specific volume after application of a high pressure during passage
through a narrow nozzle, whereby the individual droplets are successively
charged electrically and are intermittently deflected electrostatically towards
the pharmaceutical carriers” (col. 2, ll. 1-8). Hence, it is clear that Voss
teaches the selection of application parameters to control the size of the
droplets and dosing of the bioactive agent. Since we agree with the
Examiner that there is a direct correlation between the droplet size and the
particle size after the solvent of the droplet is evaporated, we find no error in
the Examiner’s finding that Voss teaches selecting one or more application
parameters based on a target particle morphology, i.e., particle size.
Appellants maintain that they “have consistently argued throughout
prosecution that droplet size does not disclose particle size” (Reply Br. 6,
second para.). However, although it is true that a disclosure of droplet size
is not a disclosure of particle size, Appellants have not refuted the
Examiner’s position that it is reasonable to conclude that the micron-sized
droplets produced by the Voss method would produce particles having the
claimed size. To the extent Appellants argue that there is no correlation
between droplet size and particle size, their own specification teaches the
contrary. In particular, the specification discloses that “drop size can be
very small, and small drop size can facilitate small dot size” (sentence
bridging pages 11-12). The specification further discloses that “the dot size
of the applied bioactive agent can be kept relatively small by applying
relatively small drops to a delivery substrate” (page 13, second full para.).
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Application 11/189,582

The specification further discloses that “current application systems can
apply drops ranging from nanoliters to femtoliters, and even smaller drop
sizes may be possible” (id). Accordingly, we are not persuaded by
Appellants’ argument that Voss’s teaching of controlling droplet size would
not have been understood by one of ordinary skill in the art as controlling
particle size of the deposited bioactive agent.
As a final point, we note that Appellants based no argument upon
objective evidence of nonobviousness, such as unexpected results.
In conclusion, based on the foregoing and the reasons well stated by
the Examiner, the Examiner’s decision rejecting the appealed claims is
affirmed.
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

tc

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