Ex Parte Paillard et al

Patent Trial and Appeal Board

May 10, 2018

12681225 (P.T.A.B. May. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/681,225 08/23/2010 Alexandra Paillard
21888 7590 05/14/2018
THOMPSON COBURN LLP
ONE US BANK PLAZA
SUITE 3500
ST LOUIS, MO 63101
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
51585-89207 2790
EXAMINER
SINGH, RANDEEP
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
05/14/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
IPDOCKET@THOMPSONCOBURN.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEXANDRA P AILLARD, MARIE-CLAIRE VENIER, and
JEAN-PIERRE BENOIT
Appeal 2017-004110
Application 12/681,225
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
Appeal 2017-004110
Application 12/681,225
STATEMENT OF CASE
The following claim is representative.
1. A method for preparing a dispersion of poloxamer-
protein particles, said method comprising the steps of:
i) preparing an aqueous solution comprising a protein and
a poloxamer; and
ii) contacting the obtained solution with a water-miscible
protein non-solvent in a sufficient amount to form a dispersion
of poloxamer-protein particles,
wherein the water-miscible protein non-solvent is
glycofurol and wherein said poloxamer-protein particles are
solid.
Cited References
Fessi et al.
(hereinafter "Fessi")
Goldman
Kipp et al.
(hereinafter "Kipp 1 ")
J oabsson et al.
(hereinafter "J oabsson")
Ground of Rejection
us 5,118,528
US 2005/0181041 Al
US 2005/0276861 Al
US 2007 /0080323 Al
June 2, 1992
Aug. 18, 2005
Dec. 15, 2005
Apr. 12, 2007
Claims 1-7, 9-21, and 24--26 are rejected under 35 U.S.C. § I03(a) as
being unpatentable over Kipp 1, Fessi, Goldman, and Joabsson.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 2-11 and Answer, pages 2-7.
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Application 12/681,225
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"Obviousness requires a suggestion of all limitations in a claim."
CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
( citing In re Royka, 490 F .2d 981, 985 ( CCP A 197 4) ).
Obviousness requires more than a mere showing that the prior
art includes separate references covering each separate limitation in a
claim under examination. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). Rather, obviousness
requires the additional showing that a person of ordinary skill at the
time of the invention would have selected and combined those prior
art elements in the normal course of research and development to
yield the claimed invention. Id. at 421, 127 S.Ct. 1727.
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011).
An invention "composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418
(2007). "Often, it will be necessary ... to look to interrelated teachings of
multiple [references] ... and the background knowledge possessed by a
person having ordinary skill in the art, all in order to determine whether
there was an apparent reason to combine the known elements in the fashion
claimed[.]" Id. "[T]his analysis should be made explicit" (id.), and it "can
be important to identify a reason that would have prompted a person of
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Application 12/681,225
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does" (id.).
Obviousness Rejection
According to the Examiner
Kipp 1 discloses methods for preparing a dispersion of solid
poloxamer-protein particles comprising preparing an aqueous
solution comprising a peptide and a poloxamer ( such as
poloxamer 188), contacting the obtained solution with a water-
miscible protein non solvent in a sufficient amount to form a
dispersion of poloxamer-protein particles, and recovering the
particles ( see paragraphs [0052], [O 109], and paragraphs
[0167]-[173]). Kipp 1 cites Fessi et al. (U.S. Patent No.
5,118,528) for teaching a solvent anti-solvent precipitation
technique for preparing small particle dispersions (see
paragraph [0109] of Kipp 1 ).
Final Act. 2-3. The Examiner relies on Fessi for the disclosure of processes
for preparing small particle dispersions, which include:
(1) the preparation of a liquid phase consisting essentially of a
solution of the substance in a solvent or in a mixture of solvents
to which may be added one or more surfactants, (2) the
preparation of a second liquid phase consisting essentially of a
non-solvent or a mixture of non-solvents for the substance and
to which may be added one or more surfactants, the non-solvent
or the mixture of non-solvents for the substance being miscible
in all proportions with the solvent or the mixture of solvents for
the substance, (3) the addition of one of the liquid phases
prepared in (1) or (2) to the other with moderate stirring so as to
produce a colloidal suspension of nanoparticles of the
substance, and ( 4) if desired, the removal of all or part of the
solvent or the mixture of solvents for the substance and of the
non-solvent or the mixture of non-solvents for the substance so
as to produce a colloidal suspension of nanoparticles of the
desired concentration or to produce a powder of nanoparticles
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Application 12/681,225
(see Abstract). Fessi et al. state that in step (3), nanoparticles
are formed practically instantaneously, producing a colloidal
dispersion (see column 2, lines 52-55).
Final Act. 3.
Appellants contend, among other things, that
Goldman et al. does not teach or suggest that glycofurol
is a water-miscible protein non-solvent as opposed to a solvent.
Simply finding all the elements of a claim in the various
references to allege obviousness is not sufficient to maintain an
obviousness rejection. The Office must still present specific
rationale for combining elements to arrive at the claimed
invention.
Reply Br. 7.
Appellants further argue that
A Solvent Anti-Solvent Precipitation method involves
both a solvent and an anti-solvent. A solvent can be a solvent
for some compounds and an anti-solvent for other compounds.
Thus, the disclosure of a group of solvent or anti-solvents does
not provide any guidance at to which anti-solvent to use in a
particular Solvent Anti-Solvent Precipitation method. Nothing
in Joabsson et al. or Goldman et al. would guide one of
ordinary skill in the art to select glycofurol as the water-
miscible protein non-solvent out of the numerous possibilities.
Reply Br. 7-8.
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness. We agree with Appellants and do not find
that the Examiner has explained why one of ordinary skill in the art would
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Application 12/681,225
have specifically selected glycofurol as a water miscible protein non-solvent
to be used in the method of Kipp 1 in combination with Fessi, Goldman, and
Joabsson.
In particular, Kipp 1 generally describes an aqueous nanoparticle
suspension for use in the formulation of pharmaceutical agents that include
biologics, such as proteins, peptides, polypeptides, etc. as well as a large
group of pharmaceutical compounds. ,r,r 52, 55-59. The method may
comprise suitable solvent anti-solvent precipitation techniques. ,r 109. Fessi
contains similar disclosure of the use of solvent anti-solvent precipitation
techniques, primarily with biologically active substances. Col. 2, 11. 52-58;
Final Act. 3. What is missing from the Examiner's analysis is why one of
ordinary skill in the art would have specifically selected glycofurol as a
water miscible protein non-solvent for making poloxamer-protein particles,
as claimed, in view of the generic solvent disclosures of Goldman and
Joabsson.
Goldman discloses the production of mixed phase co-crystals
containing pharmaceutical active agents. The production method of mixed
phase co-crystals involves the use of a solvent and anti-solvent. ,r 25.
Goldman discloses that many pharmaceutical compounds, as well as some
antibiotic polypeptides may be formulated as mixed phase co-crystals.
,r,r 33-173. Glycofurol is specifically listed in Goldman to be one of a long
list of solvents and anti-solvents for the preparation of mixed phase co-
crystals. ,r,r 17 5-180.
Appellants argue that
The "solvents" of Joabsson et al.- whether being the "at least
one solvent" of the composition of paragraphs [0025] and [0026] or
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Application 12/681,225
the "oxygen containing organic solvent" of paragraphs [0085] and
[0086] - would not be considered by one of ordinary skill in the art
combining the teachings of the cited references as a "non-solvent." As
defined in Fessi et al. (column 4, lines 1-3), a non-solvent is a liquid
that does not dissolve the substance while being miscible with the
solvent used. While Goldman et al. teaches a method involving a
solvent and anti-solvent (Goldman et al., paragraph [0010]) and
provides numerous examples of solvents and anti-solvents (Goldman
et al., paragraph [0175]) ... Goldman et al. does not teach or suggest
that glycofurol is a water-miscible protein non-solvent as opposed to a
solvent.
.Reply Br. 6-7. Appellants additionally argue that
A solvent can be a solvent for some compounds and an anti-
solvent for other compounds. Thus, the disclosure of a group of
solvent or anti-solvents does not provide any guidance [as] to which
anti-solvent to use in a particular Solvent Anti-Solvent Precipitation
method. Nothing in Joabsson et al. or Goldman et al. would guide one
of ordinary skill in the art to select glycofurol as the water-miscible
protein non-solvent out of the numerous possibilities. The Office's
conclusion is the result of ex post facto analysis based on knowledge
of the non-solvent of the claimed invention.
Reply Br. 7-8 [bold emphasis added].
We agree with Appellants that the Examiner has pointed to no
disclosure in Goldman that suggests that glycofurol should be used
specifically in making protein/poloxamer particles, or as a non-solvent for
proteins. Nor does Joabsson make up for this deficiency in the primary
combination of references. On this record, we do not find that the Examiner
has identified a sufficient reason that would have prompted a person of
ordinary skill in the relevant field to combine the specifically claimed
glycofurol non-solvent with protein/poloxamer combinations in making
polaxamer/protein particles, as claimed.
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In view of the above, the obviousness rejection is reversed.
CONCLUSION OF LAW
The cited references do not support the Examiner's obviousness
rejection, which is reversed.
REVERSED
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