Ex Parte Berndl et al

Board of Patent Appeals and Interferences

Sep 27, 2010

09937313 (B.P.A.I. Sep. 27, 2010)

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.
09/937,313 09/24/2001 Gunther Berndl 0050/49860 8414
26474 7590 09/27/2010
NOVAK DRUCE DELUCA + QUIGG LLP
300 NEW JERSEY AVENUE NW
FIFTH FLOOR
WASHINGTON, DC 20001
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
09/27/2010 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 GUNTHER BERNDL, JORG BREITENBACH,
FOLKER RUCHATZ, AXEL SANNER, and HEINRICH SACK
__________

Appeal 2009-015182
Application 09/937,313
Technology Center 1600
__________

Before ERIC GRIMES, MICHAEL P. COLAIANNI, and
BEVERLY A. FRANKLIN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a process
for producing a pharmaceutical excipient. The Examiner has rejected the

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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Application 09/937,313

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claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
STATEMENT OF THE CASE
Claims 10-12, 14-18, and 20-24 are on appeal. Claims 10 and 22 are
the only independent claims and read as follows:
10. A process for producing an excipient adapted for use in a solid
pharmaceutical dosage form, wherein said excipient is in the form of a free-
flowing powder and consists essentially of:
a pharmaceutically acceptable polymer, wherein the polymer is a
homo- or copolymer of N-vinylpyrrolidone, which is a water-soluble
polymer with Fikentscher K values of from 12 to 100, and
from 10 to 50% by weight, based on the total weight of said excipient,
of a liquid or semisolid solubilizing surface-active substance, comprising
ethoxylated sorbitan fatty acid esters, or the products of the reaction of
ethylene oxide with castor oil, hydrogenated castor oil or with 12-
hydroxystearic acid,
said process comprising either:
spray-drying a solution comprising the surface-active substance and
the pharmaceutically acceptable polymer, or
processing the polymer and the surface-active substance in an
extruder to obtain a homogeneous melt and subsequently converting the melt
into the free-flowing powder.

22. A process for producing a free-flowing powder excipient for use
in a solid pharmaceutical dosage form consisting essentially of:
a pharmaceutically acceptable polymer, and from 10 to 50% by
weight, based on the total weight of the excipient, of a liquid or semisolid
solubilizing surface-active substance, wherein the pharmaceutically
acceptable polymer in the excipient is a homo- or copolymer of N-
vinylpyrrolidone, and is a water-soluble polymer with Fikentscher K values
of from 12 to 100
the process comprising producing the free-flowing powder excipient
by one of:
spray-drying a solution comprising the surface-active substance and
the pharmaceutically acceptable polymer, or
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extruding the polymer and the surface-active substance to obtain a
homogeneous melt and subsequently converting the melt into the free-
flowing powder, wherein
the surface active substance is in a suitable concentration to keep the
excipient free flowing.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 10-12, 14-18, 20, and 22-24 Guzi,2 Staniforth,3 and Zeligs;4
• Claims 10, 15, 16, 18, 20, and 21 in view of Kolter,5 Staniforth, and
Zeligs.
I.
Issue
The Examiner has rejected claims 10-12, 14-18, 20, and 22-24 under
35 U.S.C. § 103(a) as being obvious in view of Guzi, Staniforth, and Zeligs.
The Examiner finds that Guzi discloses “a method of making an
excipient comprising spray-drying a solution comprising 15-40 % by weight
of a nonionic dispersing agent, and a polymer such as N-vinylpyrrolidone”
(Answer 3) and concludes that it would have been obvious to substitute the
surfactant taught by Staniforth or Zeligs in the Guzi composition to improve
the compressibility or stability of the spray dried particles (id. at 5).
Appellants contend that the cited references would not suggest the
claimed invention because substituting the surfactant of Staniforth or Zeligs
for the surfactant of Guzi would not result in an excipient that is suitable for

2 Guzi, Jr. et al., US 4,127,422, issued Nov. 28, 1978.
3 Staniforth et al., US 5,858,412, issued Jan. 12, 1999.
4 Zeligs et al., US 6,086,915, issued July 11, 2000.
5 Kolter et al., US 6,066,334, issued May 23, 2000.
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use in a solid pharmaceutical dosage form, as required by claims 10 and 22
(Appeal Br. 9).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the cited references would
have made obvious the claimed methods of making an excipient suitable for
use in a solid pharmaceutical dosage form?
Findings of Fact
1. Guzi discloses a method of making
a dry water-dispersible pigment composition … comprising the
steps of: forming a homogeneous mixture comprising milled or
homogenized pigment, water and, by weight of the pigment, (a)
from 15 to 45% of a nonionic dispersing agent … (b) from 10
to about 67% of at least one water-dispersible nonionic polymer
selected from the group consisting of (1) an at least partially
hydrolyzed polymer of vinyl acetate and (2) a polymer of an N-
vinyl pyrrolidone and (c) from 0 to about 40% of a nonionic
colloid; and removing the water from said mixture until a dry
composition is obtained.
(Guzi, col. 2, ll. 26-43.)
2. Guzi discloses that its compositions “hav[e] broad compatibility in
latex and other aqueous systems, such as paper coating compositions,
disposable nonwovens, melamine-formaldehyde laminates, ink systems and
universal colorant systems” (id. at col. 1, ll. 61-64).
3. Guzi discloses that
[t]ypical pigments include organic pigments such as diarylide
yellow, the phthalocyanine blues and greens, the quinacridone
reds and violets, dioxazine violet and the like; and inorganic
pigments such as the cadmium reds and yellows, the cadmium
sulfide type pigments, the molybdate oranges, iron oxide
yellow and red, and the like. Also suitable are the hydrophilic
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type pigments such as, for example, titanium dioxide and the
lead chromate colors.
(Id. at col. 2, l. 62 to col. 3, l. 2.)
4. All of Guzi’s working examples describe tinting commercial latex
paint formulations with its dry pigment compositions (id. at col. 5, l. 54 to
col. 10, l. 6).
Principles of Law
If the claim preamble, when read in the context of the entire
claim, recites limitations of the claim, or, if the claim preamble
is “necessary to give life, meaning, and vitality” to the claim,
then the claim preamble should be construed as if in the balance
of the claim. . . . If, however, the body of the claim fully and
intrinsically sets forth the complete invention, including all of
its limitations, and the preamble offers no distinct definition of
any of the claimed invention’s limitations, but rather merely
states, for example, the purpose or intended use of the
invention, then the preamble is of no significance to claim
construction because it cannot be said to constitute or explain a
claim limitation.
Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999).
Analysis
Claim 10 is directed to a “process for producing an excipient adapted
for use in a solid pharmaceutical dosage form,” by either spray-drying or
extruding a defined composition. Claim 22 is similarly directed to a
“process for producing a free-flowing powder excipient for use in a solid
pharmaceutical dosage form,” by either spray-drying or extruding a defined
composition.
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Appellants argue that substituting the surfactant of Staniforth or
Zeligs for the surfactant of Guzi, as suggested by the Examiner, would not
result in an excipient that would be suitable for use in a solid pharmaceutical
dosage form (Appeal Br. 9). Appellants further argue that “a skilled artisan
had no apparent reason to assume that the pigments employed in the Guzi
pigment compositions - intended primarily for use in commercial latex
paints - would be suitable for use in a solid pharmaceutical dosage form”
(id.).
The Examiner responds that the preambles of claims 10 and 22 are
“merely a future intended use limitation,” not claim limitations (Answer 10).
The Examiner further responds that the “ingredients are all generally
recognized as safe and are used in pharmaceutical dosage forms as seen in
the Staniforth and Zeligs patents” (id.).
Appellants’ arguments are persuasive. The preamble of a claim limits
the scope of the claim when it recites limitations or provides meaning
necessary to the body of the claim. Pitney Bowes, 182 F.3d at 1305. Here,
the preambles of claims 10 and 22 state that the claimed process produces an
excipient that is suitable for use in a solid pharmaceutical dosage form. We
agree with Appellants that the preamble language limits the claimed
processes to those producing compositions suitable for pharmaceutical use.
The Examiner’s rejection relies on the substitution of the surfactants
of Staniforth and Zeligs into the process of Guzi. However, Guzi is directed
to the preparation of pigment compositions for use in paints and other non-
pharmaceutical compositions. The Examiner has not adequately shown that
the product of the Guzi process would be suitable for use in a
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pharmaceutical dosage form. The Examiner asserts that all of the
ingredients are generally recognized as safe but has not pointed to any
evidence to establish that the pigments used in Guzi’s process would be
suitable for use in pharmaceutical compositions.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the cited references would have made obvious the claimed methods of
making an excipient suitable for use in a solid pharmaceutical dosage form.
The rejection of claims 10-12, 14-18, 20, and 22-24 as being obvious in
view of Guzi, Staniforth, and Zeligs is reversed.
II.
Issue
The Examiner has rejected claims 10, 15, 16, 18, 20 and 21 under 35
U.S.C. § 103(a) as being obvious in view of Kolter, Staniforth, and Zeligs.
The Examiner finds that Kolter discloses a spray-dried “redispersible
microparticle formulation comprising polyvinylpyrrolidone and up to 10%
of a surfactant” (Answer 6). The Examiner concludes that “[r]egarding the
specific surfactant/emulsifiers, … it would have been well within the level
of skill in the art to simply substitute the emulsifiers/dispersing agents” of
Staniforth and Zeligs into the Kolter process (id. at 7).
Appellants contend that the references do not suggest the claimed
process because Kolter spray-dries a dispersion and does not disclose or
suggest spray-drying a solution, as required by the claims (Appeal Br. 11).
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The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the cited references disclose
or suggest “spray-drying a solution comprising the surface-active substance
and the pharmaceutically acceptable polymer?”
Additional Findings of Fact
5. Kolter discloses “redispersible polymer powders or polymer
granules consisting of polyvinyl acetate and N-vinylpyrrolidone-containing
polymers as binders for producing solid pharmaceutical presentations”
(Kolter, col. 1, ll. 6-9).
6. Kolter discloses that “[p]olyvinylpyrrolidone has excellent
solubility in water” while “[p]olyvinyl acetate is insoluble in water and has
not to date been described as binder” (id. at col. 2, ll. 48-53).
7. Kolter discloses that the “redispersible polymer powders are
produced by initial emulsion polymerization of vinyl acetate, then addition
of the N-vinylpyrrolidone-containing polymer …, to the resulting shear-
stable and fine-particle dispersion, and spray-drying of the mixture” (id. at
col. 2, ll. 63-67).
Analysis
Claim 10 specifies the process step of “either: spray-drying a solution
comprising the surface-active substance and the pharmaceutically acceptable
polymer, or processing the polymer and the surface-active substance in an
extruder to obtain a homogeneous melt and subsequently converting the melt
into the free-flowing powder.”
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The Examiner does not find that the cited references disclose
processing by extrusion, but relies on Kolter as disclosing the process step of
spray-drying a solution containing the polymer and the surface active
substance.
Appellants contend that “Kolter describes spray drying a fine-particle
dispersion not a solution” (Appeal Br. 11) and that Kolter explains that
“polyvinyl acetate is insoluble in water” (id.).
The Examiner responds that “emulsifiers are added to the mixture
creating a homogeneous [ ] mixture of liquids…. This homogeneous mixture
of liquids would effectively function identically to the instant claims.”
(Answer 10.)
Appellants’ arguments are persuasive. Although the Examiner
reasons that Kolter’s mixture would therefore “effectively function
identically to the instant claims” (Answer 10), the claims require spray-
drying a solution not a dispersion, even if the dispersion may be
homogeneous. The Examiner therefore has not shown that the cited prior art
discloses or suggests all of the claim limitations.
The rejection of claims 10, 15, 16, 18, 20 and 21, as obvious in view
of Kolter, Staniforth, and Zeligs is reversed.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the cited references disclose or suggest “spray-drying a solution
comprising the surface-active substance and the pharmaceutically acceptable
polymer.”
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SUMMARY
We reverse the rejection of claims 10-12, 14-18, 20, and 22-24 as
obvious based on Guzi, Staniforth, and Zeligs, and the rejection of claims
10, 15, 16, 18, 20, and 21 as obvious based on Kolter, Staniforth, and Zeligs.

REVERSED

cdc

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