Ex Parte Snyder et al

Board of Patent Appeals and Interferences

Jan 5, 2012

10284960 (B.P.A.I. Jan. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
10/284,960 10/31/2002 Herman E. Snyder 53272-US-CNT 1833
1095 7590 01/06/2012
NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
01/06/2012 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 HERMAN E. SNYDER, MICHAEL J. VOSBERG, and
CHRISTOPHER M. VARGA
__________

Appeal 2011-007527
Application 10/284,960
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for making a powder. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses a spray drying method using “a gas
assisted liquid atomizer compris[ing] … a plurality of atomizing nozzles.
Each of the atomizing nozzles includes a liquid nozzle adapted to disperse a
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liquid and a gas nozzle adapted to disperse a gas.” (Spec. 6, ¶ 19.) Figure 4
of the Specification is shown below:

Figure 4 shows “a schematic illustration of the operation of an individual
nozzle of a multi-nozzle atomizer” (id. at 8, ¶ 30); specifically, the “inner
conduit 100 carries the solution feed and terminates in an orifice 104.… The
outer conduit 102 is disposed coaxially about the inner conduit 100 and
carries the atomizing gas.” (Id. at 19, ¶ 59.)
Claims 1, 3-5, 7-10 and 37-42 are on appeal. The claims have not
been argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 1 is representative and reads as follows:
1. A method for making a powder batch, comprising:
providing a feedstock containing an active agent in a liquid vehicle;
providing a multi-nozzle atomizer comprising a housing supporting a
plurality of atomization nozzles, wherein each atomization nozzle comprises
a liquid nozzle and a gas nozzle;
atomizing the feedstock from the multi-nozzle atomizer to produce a
droplet spray, wherein the feedstock is from a single source and is fed
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through the housing to the liquid nozzles in each of the atomization nozzles;
and
flowing the droplet spray in a heated gas stream to evaporate the
liquid vehicle of the feedstock and produce a powder batch of dry
particulates comprising the active agent, wherein the dry particulates have an
average particle size of less than 50 microns.

Issue
The Examiner has rejected claims 1, 3-5, 7-10, and 37-39 under 35
U.S.C. § 103(a) as being obvious in view of Platz1 and Brandenberger.2 The
Examiner has also rejected claims 1, 3-5, 7-10, and 37-42 under 35 U.S.C.
§ 103(a) as being obvious in view of Platz, Brandenberger, and Prube.3
Since Appellants have waived any argument based on Prube (Appeal Br. 8),
we will consider the rejections together.
The Examiner finds that Platz discloses a method meeting most of the
limitations of claim 1, but that Platz “does not teach using a plurality of
atomization nozzles” (Answer 4-5). The Examiner finds that Brandenberger
discloses “a multinozzle system for the production of uniform particles” (id.
at 5). The Examiner concludes that it “would have been obvious to the
person of ordinary skill in the art … to incorporate a plurality of atomization
nozzles … into PLATZ’s method … because BRANDENBERGER teaches
the additional nozzles would increase … productivity” (id.).

1 Platz et al., US 6,051,256, Apr. 18, 2000
2 H. Brandenberger et al., A new multinozzle encapsulation/immobilisation
system to produce uniform beads of alginate, 63 J. BIOTEHNOLOGY 73-80
(1998)
3 Prube et al., Production of Spherical Beads by JetCutting, 23 CHEMICAL
ENGINEERING AND TECHNOLOGY 1105-1110 (2002)
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Appellants contend that the cited references would not have made
obvious the limitations of “a plurality of atomization nozzles, wherein each
atomization nozzle comprises a liquid nozzle and a gas nozzle” (Appeal Br.
5) or a housing supporting the nozzles such that feedstock “is fed through
the housing to the liquid nozzles in each of the atomization nozzles” (id.).
Appellants also argue that unexpected results have overcome any prima
facie case of obviousness (id. at 7).
The issues presented are: Does the evidence of record support the
Examiner’s conclusion that the cited references would have made it obvious
to modify Platz’s method to include “a plurality of atomization nozzles,
wherein each atomization nozzle comprises a liquid nozzle and a gas nozzle”
and a housing supporting the nozzles such that feedstock “is fed through the
housing to the liquid nozzles in each of the atomization nozzles?”
If so, have Appellants provided evidence of unexpected results
sufficient to overcome the prima case of obviousness?
Findings of Fact
1. Platz discloses a “process for preparing ultrafine powders of
biological macromolecules [that] comprises atomizing liquid solutions of the
macromolecules, drying the droplets formed in the atomization step, and
collecting the particles which result from drying” (Platz, abstract).
2. Platz discloses that “[u]sually, the ultrafine dry powders will have
a size distribution where at least 90% of the powder by weight will comprise
particles having an average size in the range from 0.1 μm to 7 μm” (id. at
col. 8, ll. 10-13).
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3. Platz discloses that “the use of two fluid atomizers where the liquid
medium is delivered through a nozzle concurrently with a high pressure gas
stream” is preferred (id. at col. 11, ll. 14-16).
4. Figure 3 of Platz is shown below:

Figure 3 shows “an exemplary two-fluid nozzle.… The inner conduit 100
carries the solution feed and terminates in an orifice 104.… The outer
conduit 102 is disposed coaxially about the inner conduit 100 and carries the
atomizing gas.” (Id. at col. 13, l. 64 to col. 14, l. 4.)
5. Brandenberger discloses a “new multinozzle system with 13
nozzles for the encapsulation and immobilisation of micro-organisms,
enzymes or cells ... [in] monodisperse beads … in the range of 0.2-1 mm”
(Brandenberger, abstract).
6. Brandenberger discloses that the system is based on a laminar jet
break-up technique (id. at 73, right col.).
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7. Brandenberger discloses that devices based on laminar jet break-up
technology “usually have small work rates.... So a multinozzle apparatus has
been developed to produce particles … in large quantities.” (Id.)
8. Figure 2 of Brandenberger, in relevant part, is shown below:

Figure 2 shows a “[s]chematic representation of the multinozzle
system” (id. at 75).
Analysis
Platz discloses a process for making ultrafine powders that includes
most of the limitations of claim 1 on appeal, but Platz’s process does not use
a multi-nozzle atomizer. Brandenberger discloses that using a multinozzle
system for encapsulation allows producing particles in large quantities. In
view of these disclosures, it would have been obvious to one of skill in the
art to modify the Platz spray drying method by increasing the number of
nozzles to produce more product particles because Brandenberger teaches
that increasing the number of nozzles in a particle production system is an
effective way to achieve greater particle production.
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Appellants argue that one of ordinary skill in the art would not have
been motivated to modify Platz to use a plurality of atomization nozzles
based on Brandenberger because Platz and Brandenberger “each make their
droplets in entirely different manners utilizing entirely different
technologies” (Appeal Br. 5-6). Appellants argue that Platz “uses a gas
atomization technique and Brandenberger et al uses a vibrating pulse that
forces liquid through a nozzle plate” (id. at 6).
This argument is not persuasive. Brandenberger discloses scaling up
a particle production process by using multiple nozzles to form droplets
prior to drying. One of ordinary skill in the art would understand that this
approach would also apply to the Platz system (which uses nozzles to form
droplets prior to drying), even if the nozzles in the two processes generate
particles differently.
Appellants also argue that Platz teaches away from increasing the
number of atomizing nozzles as proposed by the Examiner because Platz
“states that it is ‘difficult to control particle size and particle size distribution
in compositions produced by spray drying.’” (Appeal Br. 7, citing Platz at
col. 2, ll. 38-40). Appellants argue that “[i]n view of this known difficulty,
one of ordinary skill in the art would not have been motivated to complicate
a system by adding multiple atomization nozzles, thereby seemingly making
the size and distribution more difficult to control since there would be
stream and droplet interaction in the drying chamber” (id.).
This argument is not persuasive. Although Platz states that in spray
drying methods in general, it can difficult to control particle size and
distribution (see Platz, col. 2, ll. 38-40), Platz also discloses that its spray
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drying method overcomes such problems (see id. at col. 3, ll. 40-44). Platz
therefore does not teach away from modifying he spray drying method of
Platz to include multiple nozzles.
Appellants also contend that the cited references would not have made
obvious the limitation of a housing supporting the plurality of nozzles such
that feedstock “is fed through the housing to the liquid nozzles in each of the
atomization nozzles” (Appeal Br. 4-5).
The Examiner responds that Brandenberger discloses “a housing
supporting a plurality of atomization nozzles (see around number 7 at Figure
2 [of Brandenberger]). It would have been obvious to the person of ordinary
skill in the art … to incorporate a housing supporting a plurality of
atomization nozzles into PLATZ, especially at 57 in figure 2.” (Answer 11-
12.)
We agree with the Examiner’s reasoning. The Specification does not
define the term “housing,” and claim 1 specifies that the housing supports
the plurality of atomization nozzles. Figure 2 of Brandenberger shows a
nozzle plate 8 in the area indicated by the Examiner, supporting the nozzles.
Thus, in view of the cited references, it would have been obvious to attach
the nozzles to a plate, or housing, that would support the nozzles when they
were being used to produce particles.
Appellants also argue that unexpected results have overcome any
prima facie case of obviousness because those of skill in the art would not
have expected that a multi-nozzle spray drying system could “produce
acceptably small particles within an acceptably small distribution” (Appeal
Br. 7; citing the Specification at ¶¶ 8, 10, and 16).
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This argument is not persuasive. Unexpected results must be
supported by factual evidence, and attorney argument is not evidence. See
In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). The cited paragraphs of
the Specification detail benefits of the claimed method but do not state that
unexpected results were obtained. Thus, Appellants have not provided
evidence that unexpectedly superior results were obtained with the claimed
method. “Mere improvement in properties does not always suffice to show
unexpected results.” In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited references would have made it obvious to modify Platz’s method to
include “a plurality of atomization nozzles, wherein each atomization nozzle
comprises a liquid nozzle and a gas nozzle” and a housing supporting the
nozzles such that feedstock “is fed through the housing to the liquid nozzles
in each of the atomization nozzles.” Appellants have not provided evidence
of unexpected results sufficient to overcome the prima case of obviousness.
SUMMARY
We affirm the rejection of claims 1, 3-5, 7-10, and 37-42 under 35
U.S.C. § 103(a).

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Application 10/284,960

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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

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