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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 05/05/2026; and IDS filed on 05/05/2026 and 08/21/2023.
Claims 67 and 72 are drawn to non-elected species.
Claims 58-78 are pending in the instant application.
Claims 67, 72-78 are withdrawn from consideration.
Election/Restrictions
Applicant’s election of Group I (claims 58-72) and specie elections of “spacer comprises one or more alkyl groups…” (claim 66) and “Generation 4” (claim 71) in the reply filed on 05/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Note, claims 67 and 72 are drawn to non-elected species.
Claim Rejections - 35 USC § 112, 2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 58 and 66 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 58, the term “high” in claim 58 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instance, at what amount is the density of surface hydroxyl groups NOT high?
For examination purposes, any amount would read on “high”.
Regarding claim 66, claim 1 recites the spacer “comprises” polyethylene glycol, while claim 66 recites the spacer “comprises” something else, such as one or more alkyl group. Did Applicant meant to recite “further comprises”?
Note, this issue is also in withdrawn claim 67.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 58-62, 66, 68-70 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RANGARAMANUJAM et al (US 2019/0142964).
Regarding claim 58, RANGARAMANUJAM teaches a composition comprised of: dendrimers with functional groups of about 120 hydroxyls groups (see abstract) conjugated to active agents or diagnostic agents (see [0017]), such as radionuclide imaging agents (see [0111]), wherein spacer/linker is conjugated to the dendrimers via one or more of ether (see [0072]), wherein the spacer can include polyethylene glycol (see abstract; and [0071]).
Regarding claims 59-60, actives agents/linkers occur via about 1% of the total available groups of the dendrimers prior to conjugation (see [0146]).
Regarding claim 61 and 62, RANGARAMANUJAM teaches radionuclide imaging agents, such as 111In (see [0111]).
Regarding claim 66, RANGARAMANUJAM teaches spacer groups include alkyl groups, heteroalkyl groups, alkylaryl groups (see [0143]).
Regarding claim 68, RANGARAMANUJAM teaches spacer/liner is conjugated via ether group (see [0072]), for improved stability (see [0072]).
Regarding claims 69-70, RANGARAMANUJAM teaches G4 PAMAM (see [0016]; and [0020]).
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.
Claim(s) 58-66, 68-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over RANGARAMANUJAM et al (US 2019/0142964) in view of ZHAO et al (Radiolabeled Dendrimers for Nuclear Medicine Applications. Molecules 2017, 22, 1350, pg. 1-22).
As discussed above, RANGARAMANUJAM teaches Applicant’s invention.
Regarding claims 63-65, RANGARAMANUJAM does not teach using chelating agents, such as DOTA.
ZHAO teaches the prior art had known of radiolabeled dendrimers for nuclear medicine applications (see title), wherein radionuclides include 111In and 18F (see pg. 3, wherein 18F is the most important PET isotope in clinical use, therefore radiolabeling strategies need to be developed for 18F-labeled dendrimers (see pg. 3). Additional disclosures include: dendrimers are mainly modified with bifunctional chelators (see pg. 3), such as DOTA and NOTA (see pg. 8), wherein PEGylated DOTA have been used for 68Ga radiolabeling (see pg. 13), wherein the PEG length was optimized for highest binding affinity (see pg. 13).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate chelating agents, such as DOTA. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because dendrimers are mainly modified with bifunctional chelators (see pg. 3), such as DOTA and NOTA (see pg. 8) and PEGylated DOTA have been used to link radionuclides.
Regarding claim 71, RANGARAMANUJAM does not teach using a specific radionuclide, such as 18F.
As discussed above, ZHAO teaches the prior art had known of radiolabeled dendrimers for nuclear medicine applications (see title), wherein radionuclides include 111In and 18F (see pg. 3, wherein 18F is the most important PET isotope in clinical use, therefore radiolabeling strategies need to be developed for 18F-labeled dendrimers (see pg. 3).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a specific radionuclide, such as 18F. The person of ordinary skill in the art would have been motivated to make those modifications, because ZHAO teaches18F is the most important PET isotope in clinical use, therefore radiolabeling strategies need to be developed for 18F-labeled dendrimers, and reasonably would have expected success because 18F and 111In are functional equivalents of radionuclides used for imaging.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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