DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-12 in the reply filed on 05/05/2026 is acknowledged.
Claims 13-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected set of apparatus and method claims, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/05/2026.
Drawings
Per 37 CFR 1.84(b)(1) and MPEP 608.02.VII.B, "Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention." Because the instant drawings do not illustrate one of the exempted types of images described in 37 CFR 1.84(b)(1) and MPEP 608.02.VII.B, a photograph or grayscale image is not the only practical medium for illustrating the claimed invention and thus the photograph or grayscale image within the instant drawings should be replaced by a line drawing.
Claim Objections
Claim 6 is objected to because of the following informalities:
Regarding claim 6, “lutetium” and “strontium” are both listed twice.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9, 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ingber et al. (US 20150147276 A1) (hereon referred as Ingber).
Regarding claim 1, Ingber teaches a micro-bead (“invention provides a method for delivering a therapeutic agent or an imaging or contrast agent…administering to a subject in need thereof an aggregate”, paragraph [0007]) comprising:
A matrix (“the aggregate can comprise a matrix material for aggregating nanoparticles”, paragraph [0035])
A plurality of nano-beads (“invention provides an aggregate, comprising a plurality of nanoparticles”, paragraph [0027])
Wherein the nano-beads comprise at least one of a polymer (“nanoparticles formed from a polymer”, paragraph [0061]), a radionuclide, radionuclide chelator (“imaging agent can be selected from a group consisting of…radionuclides”, paragraph [0172], “radionuclide is bound to a chelating agent”, paragraph [0171]), a ligand (“nanoparticles formed from…a ligand”, paragraph [0061]), a chemotherapeutic agent (“nanoparticles formed from…a therapeutic agent”, paragraph [0061], “therapeutic agents include…chemotherapy agents”, paragraph [0138]), a metal (“a non-polymer nanoparticle can be a metal nanoparticle”, paragraph [0077]), and a cell-penetrating peptide (“a wide variety of compounds can be associated with aggregates…peptides”, paragraph [0123]).
Regarding claim 2, Ingber teaches the matrix comprising a polymer consisting of polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), collagen, gelatin, polymethylmethacrylate (PMMA) (“suitable biodegradable polymers include…polycaprolactones, copolymers of polylactic acid and polyglycolic acid…polymethyl methacrylate…gelatin, collagen”, paragraph [0073]), and polystyrene (“suitable non-biodegradable biocompatible polymers include…polystyrene”, paragraph [0074]).
Regarding claim 3, Ingber teaches the polymer consisting of polymethylmethacrylate (PMMA), polystyrene (“the aggregate…wherein the nanoparticles comprises a polymer selected from the group of…polymethylmethacrylate…polystyrene”, paragraph [0355]) and PLGA (“PLGA based nanoparticles”, paragraph [0227]).
Regarding claims 4, Ingber teaches the nano-beads comprising a biodegradable polymer (“nanoparticle comprises a polymer, e.g. a biocompatible polymer”, paragraph [0070], “biocompatible polymer refers to polymers…either non-biodegradable or preferably biodegradable”, paragraph [0072]).
Regarding claim 5, Ingber teaches the nano-beads comprising a non-biodegradable polymer (“nanoparticle comprises a polymer, e.g. a biocompatible polymer”, paragraph [0070], “biocompatible polymer refers to polymers…either non-biodegradable or preferably biodegradable”, paragraph [0072]).
Regarding claim 6, Ingber teaches the nano-beads comprising a radionuclide that is a radioactive isotope of an element consisting of actinium, astatine, bismuth, chromium, cobalt, dysprosium, erbium, holmium, iridium, lead, lutetium, molybdenum, palladium, potassium, radium, rhenium, samarium, selenium, sodium, strontium, technetium, ytterbium, yttrium, copper, gallium, germanium, indium, rubidium, and thallium (“a wide variety of compounds can be associated with aggregates…selected from the group consisting of small or large organic or inorganic molecules…”, all listed in paragraph [0123]).
Regarding claim 7, Ingber teaches the radionuclide chelator consisting of triethylenetetramine (TETA) and 10-tetraacetic acid (DOTA) (“suitable chelating agents include…DOTA…TETA”, paragraph [0171]).
Regarding claim 8, Ingber teaches the ligand consisting of [123I]Ioflupane and [123I]Altropane (“imaging agent can be selected from a group consisting of…123I-Iofluplane…altropane”, paragraph [0172]).
Regarding claim 9, Ingber teaches the nano-beads comprising an MRI contrast agent (“imaging agent can be selected from the group consisting of…MRI contrast agents”, paragraph [0172]) or gold nanoparticles (“in one embodiment, the nanoparticle is a gold nanoparticle”, paragraph [0077]).
Regarding claim 11, Ingber teaches the chemotherapeutic agent consisting of doxorubicin, cisplatin, taxol, vinblastine, vincristine, fluorouracil, and methotrexate (“pharmaceutically active agent…include…taxol…fluorouracil, doxorubicin…cisplatin, vinblastine, vincristine…methotrexate”, paragraph [0153]).
Regarding claim 12, Ingber teaches the cell-penetrating peptide being transportan (“ligand is a peptide selected from the group consisting of…transportan”, paragraph [0193]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10 is rejected under 35 U.S.C. 103 as being obvious over Ingber in view of Barnett et al. (US 20110104052 A1) (hereon referred as Barnett).
Regarding claim 10, Ingber teaches all the limitations of claim 1, but does not teach the nano-beads further comprising boron-10 or gadolinium-157.
However, Barnett teaches a micro-bead comprising of nano-beads further comprising boron-10 or gadolinium-157 (“potentially radioactive isotope is an isotope possessing a high absorption cross-section…selected from the group consisting of boron-10…gadolinium-157”, paragraph [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the micro-bead of Ingber with Barnett and have the nano-beads further comprise boron-100 or gadolinium-157 in order to further provide a noninvasive method of treating cancer cells, due to the non-radioactive isotopes having the ability to capture slow neutrons (“potentially radioactive isotope is an isotope possessing a high absorption cross-section to neutrons”, paragraph [0030]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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