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
During a telephone conversation with Michelle Manning on September 8, 2026 a provisional election was made to prosecute the invention of group I and the compound where AR1, AR2, and AR3 are substituted or unsubstituted catechol groups. Affirmation of this election must be made by applicant in replying to this Office action. Claims 4, 5, 7, 8, ans 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention (group and species).
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to an antimony chelate, classified in A61K 51/0474.
II. Claims 20, drawn to a method of treating a subject, classified in A61P 35/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, an antimony chelate of group I can be used for treating a subject as described in group II, or used for in vitro DNA damage analysis, which is a materially different process of using the chelate. Therefore, inventions I and II are distinct because the product can be used in a materially different process of using that product.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Species Election Requirement
This application contains claims directed to the following patentably distinct species an antimony chelate. The species is independent or distinct because different species recite the mutually exclusive characteristics of such species. In addition, this species is not obvious variants of each other based on the current record.
Regardless of the group elected above, Applicant is required to elect one specific structure of an antimony chelate, with all variables completely specified.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-20 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Joint Inventorship
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Notification of Potential Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 14, 16, and 18 are objected to because of the following informalities:
“… via on organic linker…” should read “…via an organic linker….”
Appropriate correction is required.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Joaqui-Joaqui et al. (Inorganic Chemistry, 2020; cited on IDS filed September 12, 2024) in view of Strong et al. (US 2019 0184041; cited on IDS filed September 12, 2024).
Regarding claims 1-3, Joaqui-Joaqui discloses tris-bidentate catecholamide (CAM) ligands (chelating ligand) for radiolabeling of gallium-68 (68Ga ) (abstract). Joaqui-Joaqui discloses the structure of TREN-CAM
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(page 12027, scheme 1), which reads on the elected species, chemical structure of an antimony chelate of instant claims.
Joaqui-Joaqui does not disclose that an antimony (SB(V)) radionuclide such as 119Sb or 118mSb can bind to the chelating ligand (instant claims 1, 12, and 13).
Strong discloses a compound comprising CAM for delivery of radionuclides (abstract; claim 1). Strong discloses that the radionuclides can be 68Ga, 119Sb, or 118mSb (claim 6).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the TREN-CAM of Joaqui-Joaqui for chelating 119Sb or 118mSb instead of 68Ga for specific radiological applications. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Strong teaches that such chelating ligands comprising CAM can bind radionuclides such as 68Ga, 119Sb, or 118mSb. It is obvious to substitute known chemical equivalents based on established functional interchangeability in metal chelation for targeting specific radiological applications. Further, a person of ordinary skill in the art would have been motivated to utilize TREN-CAM for chelating 119Sb or 118mSb in order to achieve therapeutic efficacy specifically for an Auger theranostic application. The substitution of equivalent Sb radionuclides provides an obvious optimization of radiation characteristics while maintaining the core chelating structure taught by Joaqui-Joaqui and Strong. Accordingly, applying the teachings of Strong to the chelate of Joaqui-Joaqui constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
Claims 6, 9-11, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Joaqui-Joaqui and Strong as applied to claims 1-3, 12, and 13 above, and further in view of Neels et al. (Cancers. 2021; cited on PTO-892) and Zalipsky (Bioconjugate chemistry, 1995; cited on PTO-892).
Joaqui-Joaqui and Strong are discussed above.
Neither Joaqui-Joaqui nor Strong discloses the chelate comprising substituted catechol groups comprising a functional group capable of forming a covalent bond to a biological targeting vector such as vipivotide tetraxetan. Neither Joaqui-Joaqui nor Strong discloses an organic linker chain such as a polyether polyol chain and the organic linker chain being bonded to the CAM group via an amide bond and to the biological targeting vector via an amide bond or a thiourea bond.
Neels discloses prostate-specific membrane antigen (PSMA)-targeting radiopharmaceuticals for theranostics of prostate cancer (abstract). Neels discloses that PSMA-617 (vipivotide tetraxetan) can be used as the most prominent ligand for PSMA-targeted endoradiotherapy (page 2, ¶ 2; Table 1). Neels discloses that the use of polyethylene glycol (PEG) linkers of varying lengths had a dramatic impact on PSMA binding affinity as well as blood clearance (page 6, ¶ 3), which reads on the organic linker chain comprising an ether group comprising a polyether polyol chain of instant claims.
Zalipsky discloses that the functionalized derivatives of PEG can be used for the preparation of various bioconjugates as one of the best biocompatible polymers (title; page 150, column 1, ¶ 1). Zalipsky discloses that PEG can be functionalized with amines to be interlinked with drugs or other ligands via amide or thiourea linkages, which are stable in vivo (page 152, column 1, ¶ 2; Scheme 1).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the chelate of Joaqui-Joaqui and Strong to link a biological targeting vector such as vipivotide tetraxetan via an organic linker chain such as PEG to prepare a bioconjugate for targeted radiotherapy. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Neels teaches that vipivotide tetraxetan can be attached to a radionuclide compound for PSMA-targeting radiopharmaceuticals for theranostics of prostate cancer and that a PEG linker can be used for optimizing the efficacy of the bioconjugate. Zalipsky teaches that various functionalized PEGs can be used as biocompatible linkers to link ligands via various bonds such as an amide bond and a thiourea bond. Further, a person of ordinary skill in the art would have been motivated to optimize the structure of the bioconjugate according to the specific requirements of the intended application. Selecting a specific linker and determining the type of linkage bond between the moieties are routine design choices that can be optimized. It would have been within the ordinary skill for an artisan to determine the linkage design in order to best achieve the desired conjugate properties, thereby successfully tailoring the bioconjugate to meet the requisite parameters for specific pharmaceutical applications.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 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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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
