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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 10, 13-15, 20-21, 23-27, 29-32 and 34 are rejected under 35 U.S.C. 102 as being anticipated by Wu (Bioorganic & Medicinal Chemistry Letters, 1994) (IDS filed 2/16/2026). Wu teaches Wu teaches a dendrimer radiolabeled with an alpha particle emitter (abstract: "Polyamidoamine dendrimers were modified chemically by reaction with DOTA and DTPA type bifunctional metal chelators and were coupled to monoclonal antibody 2E4 ... [b]oth the DTPA- and DOTA-dendrimer-antibody constructs were easily labeled with ... 212Bi. .. "( page 452 para 2; bismuth-212 is an alpha emitter, ( instant specification page 1 lines 19-20). Wu further discloses wherein the alpha particle emitter is selected from actinium 225, astatine-211, lead-212, terbium-149, thorium-227, radium-223, radium-224, bismuth-212, and bismuth-213 (abstract: "Polyamidoamine dendrimers were modified chemically by reaction with DOTA and DTPA type bifunctional metal chelators and were coupled to monoclonal antibody 2E4 ... [b]oth the DTPA- and DOTA-dendrimer-antibody constructs were easily labeled with ... 212Bi..."( page 452 para 2). Wu fteaches comprises a G1- G1 O generation dendrimer (page 449 para 3: "Herein we report the successful coupling with minimal loss of immunoreactivity of a single mAb molecule to a polyamidoamine (PAMAM) dendrimer (Generation 2, i.e., G=2) with 10.2 of the available 12 surface primary amines coated with the
DOTA chelator''). Wu further discloseswherein the dendrimer comprises a G2-G1 O generation dendrimer (page 449 para 3: "Herein we report the successful coupling with minimal loss of immunoreactivity of a single mAb molecule to a polyamidoamine (PAMAM) dendrimer (Generation 2, i.e., G=2) with 10.2 of the available 12 surface primary amines coated with the DOTA
chelator"). Wu further discloses the, wherein the dendrimer is selected from a G2 to G6 dendrimer, a G4 to GS dendrimer, and mixtures thereof (page 449 para 3: "Herein we report the successful coupling with minimal loss of immunoreactivity of a single mAb molecule to a polyamidoamine (PAMAM) dendrimer (Generation 2, i.e., G=2) with 10.2 of the available 12 surface primary amines coated with the DOTA chelator'').
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3,6,10,13-15,20-21,23-27,29-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022094327A1 to Ashvatha (IDS filed 2/16/2026). Ashvattha discloses a dendrimer radiolabeled with a radionuclide, which can be an alpha particle emitter (para [008]: "In some aspects, the disclosure provides compositions of hydroxyl-terminated dendrimers conjugated to one or more imaging agents ... where imaging agents can include radionuclide ... "; para [0012]: "In some embodiments, the radionuclide is selected from ... 212Bi, 213Bi. ..
225Ac ... "; bismuth 212, 213, and actinium 225 are alpha emitters, ( instant specification page 1 lines 19-20).
Ashvattha does not disclose a specific example or embodiment wherein the dendrlmer is radiolabeied with an alpha particle emitter.
It would have been obvious to one of ordinary skill in the art at the time the invention was fielded to to radiolabel the dendrimer with an alpha particle emitter, based on the teachings of Ashvattha, since Ashvattha discloses that the dendrimer can be radiolabeled with an alpha particle emitter. Ashvattha further discloses wherein the alpha particle emitter is selected from actinlum-
225, astatine-211, lead-212, terbium-149, thorium-227, radlum-223, radium-224, blsmuth-212, and bismuth-213 (para [0012]: "In some embodiments, the radionuclide is selected from ... 212Bi, 213B1 ... 225Ac ... ").Ashvattha further discloses wherein the dendrimer comprises a G1- G10 generation dendrimer (para [0017]: "In some embodiments, the dendrlmers are generation 4, generation 5, or generation 6 poly(amldoamine) (PAMAM) hydroxyl-terminated dendrlmers"). Ashvattha further discloses, wherein the dendrimer comprises a G2-G10 generation dendrimer (para [0017]: "In some embodiments, the dendrimers are generation 4, generation 5, or generation 6 poly(amidoamine) (PAMAM) hydroxyl-terminated dendrimers"). Ashvattha further discloses wherein the dendrimer is selected from a G2 to G6 dendrimer, a G4 to G5 dendrimer, and mixtures thereof (para [0017]: "In some embodiments, the dendrimers are generation 4, generation 5, or generation 6 poly(amidoamine) (PAMAM) hydroxyl-terminated dendrimers"). Ashvattha further discloses wherein the dendrimer comprises a polyamidoamine (PAMAM) generation four or generation six particle (para [0017]: "In some embodiments, the dendrimers are generation 4, generation 5, or generation 6 poly(amidoamine) {PAMAM) hydroxyl-terminated dendrimers"). Ashvattha further discloses, wherein the polyamidoamine generation four or generation six particle comprises a surface group selected from a hydroxyl surface group, a glucose surface group, and combinations thereof (para [0017]: "In some embodiments, the dendrimers are generation 4, generation 5, or generation 6 poly{amidoamine) {PAMAM) hydroxylterminated dendrimers").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/ Primary Examiner, Art Unit 1618
September 20, 2026
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