Ex Parte ATAMAN-ONAL et al

Patent Trials and Appeals Board

Mar 12, 2019

13739421 - (D) (P.T.A.B. Mar. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/739,421 01/11/2013
25944 7590 03/14/2019
OLIFF PLC
P.O. BOX 320850
ALEXANDRIA, VA 22320-4850
FIRST NAMED INVENTOR
YASEMIN ATAMAN-ONAL
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.
127097.02 8655
EXAMINER
KINSEY WHITE, NICOLE ERIN
ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
03/14/2019 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):
OfficeAction25944@oliff.com
jarmstrong@oliff.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YASEMIN ATAMAN-ONAL, THIERRY DELAIR,
GENEVIEVE INCHAUSPE, PASCALE JEANNIN,
GLAUCIA PARANHOS-BACCALA, and BERNARD VERRIER,
(APPLICANT: CENTRE NATIONAL DE LA RECHERCHE
SCIENTIFIQUE (C.N.R.S.), PARIS, FRANCE)
Appeal2017-008892 1
Application 13/739,421 2
Technology Center 1600
Before DONALD E. ADAMS, RY ANH. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1 and 3-9
(App. Br. 3). Examiner entered a rejection under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Oral Hearing held March 5, 2018.
2 Appellants identify "CENTRE NATIONAL DE LA RECHERCHE
SCIENTIFIQUE (C.N.R.S.)" as the real party in interest (Appellants'
December 20, 2016 (App. Br.) 1).
Appeal2017-008892
Application 13/739,421
STATEMENT OF THE CASE
Appellants' disclosure "relates to novel bioresorbable particles to
which protein substances are bonded, that are useful in particular in the field
of vaccination" (Spec. 3 1 4). Appellants' claims 1 and 9 are representative
and reproduced below:
1. Bioresorbable nonlamellar microparticles to which protein
substances are
bonded, consisting of poly(lactic acid),
the microparticles being obtained by:
(i) preparing, without stabilizer and without
surfactant, said microparticles by a solvent displacement
method; and
(ii) bonding said protein substances to the
microparticles obtained in step (i) without surfactant;
wherein the microparticles to which are bonded the
protein substances exhibit colloidal stability, and have a
diameter in a range of 150 to 250 nm.
(App. Br. A-1.)
9. Bioresorbable nonlamellar microparticles to which protein
substances are bonded, comprising poly(lactic acid),
wherein the microparticles exhibit colloidal
stability, are devoid of stabilizer and surfactant, and have a
diameter in a range of 150 to 250 nm.
(Id. at A-l-A-2.)
3 Appellants' January 11, 2013 Specification.
4 Appellants' Specification is not paginated. Therefore, all reference to a
page number of the Specification refers to a page number as if the
Specification was number consecutively beginning with the first page.
2
Appeal2017-008892
Application 13/739,421
Grounds of rejection before this Panel for review:
Claims 1 and 3-9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of O 'Hagan, 5 Govender, 6 and Gautier. 7
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. O'Hagan "relates to biodegradable microparticles with adsorbed
polypeptide-containing molecules that are formed without the use of
surfactant, methods for preparing such microparticles, and uses thereof'
(O'Hagan 1: 10-13; see generally Ans. 8 4--5).
FF 2. O'Hagan discloses "microparticles with adsorbed polypeptide-
containing molecules can be formed in the absence of a surfactant"
(O'Hagan 2: 16-17; see also id. 4:25-28; see generally Ans. 5).
FF 3. O'Hagan discloses that "[p ]referred polymers are poly( a-hydroxy
acids), more preferably those selected from the group consisting of poly(L-
lactide ), poly(D,L-lactide) and poly(D,L-lactide-co-glycolide )" (O'Hagan
2:26-28; see also id. at 20:7-24 (noting, inter alia, that useful polymers for
forming microparticles, within the scope of O'Hagan's disclosure, include
5 O'Hagan et al., WO 03/070909 A2, published Aug. 28, 2003.
6 Govender et al., PLGA nanoparticles prepared by nanoprecipitation: drug
loading and release studies of a water soluble drug, 57 J. CONTROLLED
RELEASE 171-185 (1999).
7 Gautier et al., Preparation of poly (D-L-lactide) nanoparticles assisted by
amphiphilic poly(methyl methacrylate-co-methacrylic acid) copolymers, 12
J. BIOMATERIAL SCIENCE 429--450 (2001).
8 Examiner's April 6, 2017 Answer.
3
Appeal2017-008892
Application 13/739,421
"polylactic acid (PLA) (also known as polylactide")); see generally Ans. 4--
5).
FF 4. O'Hagan discloses that "[t]he term 'microparticle' ... refers to a
particle of about 10 nm to about 150 µmin diameter" (O'Hagan 5:28-29;
see generally Ans. 6 and 9).
FF 5. 0 'Hagan discloses that "microparticles are prepared using any of
several methods well known in the art" (O'Hagan 21: 18; see also id. at
21: 19-22: 10 ( exemplifying the preparation of microparticles using: (a)
"double emulsion/solvent evaporation techniques," (b) "spray-drying and
coacervation," and (c) "a modified water-in-oil-in-water (w/o/w) solvent
evaporation technique"); see generally Ans. 5---6).
FF 6. Examiner finds that O'Hagan "does not explicitly recite solvent
displacement as a method for preparing ... [ micro ]particles" and relies on
Govender and Gautier to make up for this deficiency in O'Hagan (Ans. 5;
see also id. at 5---6).
FF 7. Govender discloses the preparation ofpoly(DL-lactide-co-glycolide)
(PLGA) using a nanoprecipitation technique (see Govender, Abstract; see
also Ans. 5 (Examiner finds that Govender discloses "making PLGA
nanoparticles without surfactant or stabilizer via solvent displacement"); cf
App. Br. 28 (PLGA is not PLA)).
FF 8. Gautier discloses:
When co-precipitated with amphiphilic copolymers from
DMSO, poly(D,L-lactide) (PLA) can be readily converted into
stable sub-200 nm nanoparticles by addition of an aqueous
phase, free of any polymeric stabilizers such as poly( vinyl
alcohol) or Poloxamer. In this work, the ability of random
poly(methyl methaciylate-co-methacrylic acid) copolymers
(PMMA-co-MA) to stabilize PLA nanoparticles was
4
Appeal2017-008892
Application 13/739,421
demonstrated, and the properties of PLA/PMMA-co-MA
nanoparticles were investigated.
(Gautier, Abstract; see Ans. 6 (Examiner finds that Gautier discloses
"making PLA particles without surfactant or stabilizer via solvent
displacement[, wherein] ... PLA and PMMA-co-MA were dissolved in
DMSO").)
FF 9. Delair declares, inter alia, that "O'Hagan does not disclose or
suggest a solvent displacement method" (First Delair Deel. 9 ,r 16; Second
Delair10 Deel. ,r 5 ("O'Hagan never specifically teaches implementing
solvent displacement technique"); and Third Delair11 Deel. 1-16
( distinguishing O 'Hagan's double emulsion method from Appellants'
solvent displacement method of preparing microparticles, including, inter
alia, "[a] loss of colloidal stability ... on the particles obtained by
O'Hagan's method" in contrast to the "[c]olloidal stability ... exhibited by
the particles obtained by the process of [Appellants'] application" (see Third
Delair Deel. 14) (emphasis omitted).))
FF 10. Delair declares "Gautier discloses ... that the 'use of amphiphilic
PMMA-co-MA copolymers designed to ensure a durable stabilization of
PLA nanoparticles was investigated' (p.430 and end of p.433)," thus, Delair
declares that Gautier "clearly ... [discloses] that PMMA-co-MA acts as a
stabilizer" (Second Delair Deel. ,r 11; see also Reply Br. 16 ("the PMMA-
co-MA of Gautier ... functions in a similar manner to Poloxamer and thus
would be considered a polymeric stabilizer by one skilled in the art")).
9 Declaration of Thierry Delair, signed Oct. 15, 2014.
10 Declaration of Thierry Delair, signed Sept. 15, 2015.
11 Declaration of Thierry Delair, signed Nov. 13, 2015.
5
Appeal2017-008892
Application 13/739,421
ANALYSIS
Based on the combination of O'Hagan, Govender, and Gautier,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious "to use solvent displacement as one of
the known methods to make the particles of O'Hagan ... (without
surfactant)" (Ans. 6). We are not persuaded.
The bioresorbable nonlamellar microparticles of Appellants' claim 1
consists of poly(lactic acid) and are prepared by a solvent displacement
method, wherein protein substances are bonded to the microparticles, the
microparticles exhibit colloidal stability, and they have a diameter in a range
of 150 to 250 nm (see App. Br. A-1). Appellants' claims 3-8 depend
directly or indirectly from Appellants' claim 1 (see id.). The bioresorbable
nonlamellar microparticles of Appellants' claim 9 comprise poly(lactic
acid), wherein the microparticles exhibit colloidal stability, are devoid of
stabilizer and surfactant, and have a diameter in a range of 150 to 250 nm
(see App. Br. A-l-A-2).
Although O 'Hagan discloses that "microparticles are prepared using
any of several methods well known in the art," the evidence of record makes
clear that O'Hagan does not disclose a solvent displacement method of
preparing microparticles (see FF 5; cf FF 6 and 9). In addition, Delair
declares that microparticles produced by methods disclosed by O 'Hagan,
such as a double emulsion method, differ from microparticles produced by a
solvent displacement method (see FF 9).
There is no dispute on this record that Govender and Gautier disclose
a solvent displacement method of preparing microparticles (see FF 6-8).
The evidence of record, however, supports a conclusion that neither
6
Appeal2017-008892
Application 13/739,421
Govender nor Gautier alone, or in combination, teach or suggest the
preparation of microparticles consisting of poly(lactic acid) (FF 7, 8, and 10;
see also App. Br. 27-30; see generally Reply Br. 12-15).
In sum, although Examiner established that individual components of
Appellants' claim 1 where known in the art at the time of Appellants'
claimed invention, Examiner failed to establish an evidentiary basis on this
record to support a conclusion that a person of ordinary skill in this art
would have found it prima facie obvious to combine the disclosures of
O'Hagan, Govender, and Gautier to produce bioresorbable nonlamellar
microparticles that consist of poly(lactic acid) and are prepared by a solvent
displacement method, wherein the microparticles, to which are bonded
protein substances, exhibit colloidal stability, and have a diameter in a range
of 150 to 250 nm, as required by Appellants' claim 1, with a reasonable
expectation of success (see App. Br. A-1 ).
In addition, although Appellants' claim 9 does not require a particular
method of producing microparticles or exclude polymers in addition to
poly(lactic acid), Examiner failed to establish that: (a) microparticles
comprising poly(lactic acid) produced by methods disclosed by O'Hagan
would have been expected to exhibit colloidal stability (see FF 9) and/or (b)
could have been produced in the absence of a stabilizer (see FF I 0). In this
regard, we note that the evidence of record does not support Examiner's
assertion that "[t]he fact that Gautier ... states that copolymer PMMA-
coMA stabilizes poly(D,L-lactide) nanoparticles, does not in any way mean
that PMMA-coMA is a stabilizer as contemplated and defined by
[Appellants'] [S]pecification" (Ans. 18; cf FF IO (Delair declares that
Gautier "clearly ... [discloses] that PMMA-coMA acts as a stabilizer")).
7
Appeal2017-008892
Application 13/739,421
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 'l Co. v.
Teleflex Inc., 550 U.S. 398,418 ... (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.
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011 ). In this regard, we note that "rejections on obviousness grounds
cannot be sustained by mere conclusory statements; instead, there must be
some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1 and 3-9
under 35 U.S.C. § 103(a) as unpatentable over the combination of O'Hagan,
Govender, and Gautier is reversed.
REVERSED
8