Ex Parte Levy et al

Patent Trial and Appeal Board

Oct 19, 2018

12296732 (P.T.A.B. Oct. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/296,732 05/18/2009
23557 7590 10/23/2018
SALIW ANCHIK, LLOYD & EISENSCHENK
A PROFESSIONAL ASSOCIATION
PO Box 142950
GAINESVILLE, FL 32614
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Laurent Levy
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.
BKR.129 1200
EXAMINER
LAMBERSKI, JENNIFER A
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
10/23/2018 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):
euspto@slepatents.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LAURENT LEVY, MATTHIEU GERMAIN, and
CORINNE DEV AUX
Appeal2017-001799
Application 12/296,732
Technology Center 1600
Before MICHAEL J. FITZPATRICK, ULRIKE W. JENKS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Laurent Levy, Matthieu Germain, and Corinne Devaux
("Appellants") 1 appeal under 35 U.S.C. § 134(a) from a final decision
rejecting claims 24--38, 47, 48, and 50-52. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.
1 The real party in interest is identified as "Nanobiotix, located at 60 Rue De
Wattignies, F-75012 Paris, France." Appeal Br. 1.
Appeal2017-001799
Application 12/296,732
STATEMENT OF THE CASE
The Specification
According to Appellants, the present invention "relates generally to
the area of activable particles, for cancer therapy and tumor evolution
monitoring" and more particularly to "pharmaceutical compositions
comprising biocompatible magnetic nanoparticles, methods for preparing
said compositions and using them in the treatment of cancer or in imaging,
for the monitoring of tumor evolution, using a non-oscillating magnetic
field." Spec. 1:3-8.
Appellants state that they "have now discovered that nanoparticles
having a core of a therapeutic or diagnostic magnetic, preferably
ferromagnetic, material, optionally surrounded by a shell composed of a
biocompatible material, may be used in a pharmaceutical or diagnostic
composition even when they are deprived of any cell targeting agent." Id.
2:26-30 (emphasis added).
The Rejected Claims
Claims 24--38, 47, 48, and 50-52 stand rejected. Final Act. 1.2 Claim
24 is representative and reproduced below.
24. A method for treating a cancer comprising:
(a) administering to a patient suffering from a cancer of a
composition comprising a biocompatible nanoparticle or
nanoparticle aggregate, wherein said nanoparticle lacks a
targeting means and consists of a ferromagnetic core, a
biocompatible shell surrounding the core and, optionally, a
labelling agent, wherein the outer diameter of the shell is less
than about 100 nm; and
2 Claims 1-23, 39-46, and 49 are cancelled. Appeal Br. 12, 14.
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Application 12/296,732
(b) exposing the patient to an external non-oscillating
magnetic field.
Appeal Br. 12.
The Appealed Rejections
The following rejections are before us for review:
1. claims 24--38, 47, and 48 are rejected under 35 U.S.C. § 103 as
unpatentable over Roy3 and Bergey4 (Final Act. 3);
2. claims 50 and 52 are rejected under 35 U.S.C. § 103 as
unpatentable over Roy, Bergey, and Johannsen5 (Final Act. 4); and
3. claim 51 is rejected under 35 U.S.C. § 103 as unpatentable over
Roy, Bergey, Johannsen, and Gatenby6 (Final Act. 5).
Appellants requested oral argument in this appeal, which was heard
October 11, 2018.
DISCUSSION
Rejection 1
The Examiner rejected claims 24--38, 47, and 48 under 35 U.S.C.
§ 103 as unpatentable over Roy and Bergey. Final Act. 3.
3 Roy, Indrajit et al., Ceramic-Based Nanoparticles Entrapping Water-
Insoluble Photosensitizing Anticancer Drugs: A Novel Drug-Carrier
System/or Photodynamic Therapy, 125(26) J. AM. CHEM. Soc. 7860-65
(2003) ("Roy")
4 Bergey, Earl J. et al., DC Magnetic Field Induced Magnetocytolysis of
Cancer Cells Targeted by LH-RH Magnetic Nanoparticles in vitro, 4(4)
BIOMEDICAL MICRODEVICES 293-99 (2002) ("Bergey").
5 Johannsen, Manfred et al., Evaluation of Magnetic Fluid Hyperthermia In
a Standard Rat Model of Prostate Cancer, 18(5) J. OF ENDOUROLOGY 495-
500 (June 2004) ("Johannsen").
6 US 2003/0125283 Al, published July 3, 2003 ("Gatenby").
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Application 12/296,732
Roy teaches a "nanoparticle-based drug carrier for photodynamic
therapy" for cancer and reports on "in vitro studies using tumor cells to
investigate drug-carrier uptake and destruction of cancer cells by
photodynamic action." Roy 7860 (Abstract). The nanoparticles are silica-
based with a diameter of approximately 30 nm, within which is a
photosensitizing anticancer drug. Id. "The entrapped drug is more
fluorescent in aqueous medium than the free drug, permitting use of
fluorescence bioimaging studies." Additionally, "[i]rradiation of the
photosensitizing drug entrapped in nanoparticles with light of suitable
wavelength [650 nm] results in efficient generation of singlet oxygen,"
which irreversibly damages the tumor cells. Id.
The Examiner relies on Roy as teaching the subject matter of the
rejected claims, save for the nanoparticles having a "ferromagnetic core,"
"administrating [the particles] to a patient," and "exposing the patient to an
external non-oscillating magnetic field." Non-Final Act. 4 (mailed July 9,
2015). 7
Bergey teaches direct current magnetic field-induced magneto-
cytolysis of cancer cells. Bergey 293 (Title). Bergey employs a "nanosized
structure consisting of an iron oxide core, a two-photon optical probe, a
silica shell and luteinizing hormone-releasing hormone (LH-RH) covalently
coupled to the surface of the shell." Id. at 295 (left col.). The LH-RH
functions as a targeting means, providing "the ability to selectively lyse cells
expressing LH-RH receptors upon exposure to a DC magnetic field." Id. at
7 The Final Action refers back to the Non-Final Action mailed July 9, 2015.
See Final Act. 3.
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Application 12/296,732
293 (Abstract). The Bergey nanoparticles have a diameter of about 30 nm.
Id. at 295 (right col.).
The Examiner concluded that it would have been obvious to a person
of ordinary skill in the art to substitute the ferromagnetic core of the silica-
based Bergey nanoparticles for the photosensitizing core of the also silica-
based Roy nanoparticles because doing so would have provided the
equivalent functions (imaging and cell lysis). Non-Final Act. 5. The
Examiner further concluded that it would have been obvious to a person of
ordinary skill in the art "to treat, detect, and visualize human cancer in vivo
using the silica-based Fe20idye nanoparticles of Roy in view of Bergey
(e.g., by administering the nanoparticles to a patient having cancer, imaging
the nanoparticle uptake into the cancer using a fluorescence imager, then
irradiating the patient and exposing the patient to a DC magnetic field)." Id.
"The person of ordinary skill in the art would have been motivated to make
these modifications and reasonably would have expected success because
the nanoparticles and methods of Roy and Bergey are clearly intended for
treating, detecting, and visualizing human cancer in patients (in vivo) rather
than in petri dishes (in vitro)." Id.
Appellants argue that, in view of Roy and Bergey, a person of
ordinary skill in the art would not have been motivated to administer such
nanoparticles to a patient unless they included a targeting means. Appeal
Br. 7. Similarly, Appellants argue that a person of ordinary skill in the art
would not have had a reasonable expectation of success in treating a cancer
patient with nanoparticles that lacked a targeting means. Id.
Appellants' arguments in this regard are premised on Roy teaching
"that to deliver the nanoparticles to the target cells in vivo, the nanoparticles
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need to be functionalized with a targeting molecule." Id. But that premise is
unpersuasive.
Although Roy contemplates that nanoparticles "can be attached to a
variety of monoclonal antibodies or other ligands to target them to desired
sites in vivo" (see Roy 7861 (left col.)), it does not teach that a targeting
means is required. Further, in actual experiments, Roy found that
its "nanoparticles [ which lack a targeting means] are efficiently taken up by
tumor cells in vitro, and light irradiation of such impregnated cells results in
significant cell death." Roy 7865 (right col.).
It is true, as Appellants point out, that Bergey considered its targeting
means (LH-RH) to be critical to the uptake of its nanoparticles by the target
cells. Appeal Br. 6 ("Bergey et al. indicate that 'No magnetocytolysis of
[. .. ]cells compared to control (no treatment) was observed using LH-RH
negative nanoclinics (Figure 5B)"') ( quoting Bergey 297 (right col.)). It is
also true, as Appellants argue, that Roy acknowledges Bergey's findings and
states: "we are working on functionalizing the silica surface with different
ligands to target our particles to tumor cells containing such ligand-specific
receptors." Roy 7865 (right col.); Appeal Br. 5---6. However, none of this
evidence is probative of Appellants' assertion that Roy's "nanoparticles need
to be functionalized with a targeting molecule" in order to be taken up by
cancer cells. Appeal Br. 7.
In in vitro tests, Roy observed that its nanoparticles were "efficiently
taken up by tumor cells" despite lacking a targeting means. Roy 7865 (right
col.). Roy's statement that it nonetheless was working on targeting means
was in regard to subset of tumor cells, those "containing such ligand-specific
receptors." Roy 7865.
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In short, the fact that Bergey observed that its nanoparticles required
targeted means does not negate the fact that Roy observed that its
nanoparticles did not.
Finally, Appellants argue the following:
Simply substituting the silica-based magnetic nanoparticles
without a targeting agent (i.e., the LH-RH peptides disclosed
in Roy et al.) would have been expected to result in no
magnetocytolysis of the target cells since no magnetocytolysis
was observed using LH-RH negative nanoclinics of Bergey et
al.
Appeal Br. 8 (Appellants' emphasis). This argument is not persuasive
because it is not commensurate with the rejection.
The Examiner concluded that the claims were obvious, in part,
because a person of ordinary skill in the art would have substituted, not the
silica-based magnetic nanoparticles of Bergey, but rather only their
ferromagnetic core. Critically, the asserted combination retains Roy's
nanoparticle shell.
We affirm Rejection 1.
Rejections 2 and 3
The Examiner rejected claims 50 and 52 under 35 U.S.C. § 103 as
unpatentable over Roy, Bergey, and Johannsen and claim 51 additionally
over Gatenby.
Appellants arguments against these rejections are based on their
arguments against Rejection 1. As discussed above, those arguments are not
persuasive.
We affirm Rejections 2 and 3.
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SUMMARY
For the reasons discussed, we affirm the Examiner's rejection of
claims 24--38, 47, 48, and 50-52.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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