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 .
Priority
This application, filed 1 September, 2023, is a national stage application of PCT/JP2022/009003, filed 2 March, 2022, which claims foreign benefit of applications JP2021-146833, filed 9 September, 2021 and JP2021-034026, filed 4 March, 2021.
Information Disclosure Statement
Three information disclosure statements (IDS) submitted on 1 September 2023, 6 September 2024, and 7 July 2025, are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 1 September 2023, in the matter of Application N° 18/548,716. Said documents have been entered on the record.
Claims 3-7, 9-10, and 12-13 have been amended. No new matter was introduced. Therefore, Claims 1-14 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I – Compounds, compositions and methods of Formula I (Claims 1-7 and 10-14), and, Species “PSMA-NAT-DA1” in the reply filed on 5 March, 2026 is acknowledged.
Claims 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5 March, 2026.
Thus, Claims 1-7 and 10-14 represent all claims currently under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for specific compounds to include the elected species (PSMA-NAT-DA1, Para 0289) and describes certain chelating moieties (A1) in detail, does not reasonably provide enablement for (i) any chelating part capable of coordinating with a radioactive metal ion, (ii) any atomic group containing an albumin-binding part, and (iii) any atomic group containing a PSMA molecule-binding part, optionally connected through linker structures at variable positions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Regarding Claims 1-2, with respect to the factors set forth in In re Wands, the breadth of the claims is extensive, encompassing numerous possible combinations of independently variable structural components. Although the specification provides detailed disclosure of certain chelating moieties, it fails to provide a commensurate disclosure of albumin-binding moieties or PSMA-binding moieties, which are defined primarily by function. Additionally, the specification does not provide guidance regarding the compatibility of these components within a single compound or demonstrate operability across the breadth of possible combinations, despite the fact that each component significantly affects the overall biological and chemical performance of the compound. The limited experimental data are restricted to a narrow subset of compounds and do not represent the full scope of the claimed genus. Further, the nature of the invention involves radiopharmaceutical compounds and biologically active targeting moieties, which are recognized as unpredictable.
Accordingly, one of ordinary skill in the art would be required to engage in extensive trial-and-error experimentation to identify operable combinations across the full scope of the claimed genus, including determining compatibility among chelating groups, targeting moieties, and linker structures. Such experimentation would be undue. Therefore, the full scope of the claimed invention is not enabled.
Claims 3-7, 10-14, which depend or rely upon Claim 1, do not cure the deficiencies stated above, as they continue to rely on components defined by functional language and do not provide structural limitations commensurate with the breadth of the claims.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2 are directed to a broad genus of compounds comprising (i) a chelating part capable of coordinating with a radioactive metal ion, (ii) an atomic group containing an albumin-binding part, and (iii) an atomic group containing a PSMA molecule-binding part, optionally connected through linker structures. However, the specification does not reasonably convey to one of ordinary skill in the art that the inventor had possession of the full scope of the claimed genus at the time of filing.
While the specification describes certain chelating moieties in detail and provides specific example compounds, including the elected species, the disclosure does not provide a representative number of species or a structural description commensurate in scope with the claimed genus of albumin-binding moieties and PSMA-binding moieties. In particular, these components are defined primarily by their functional properties, without sufficient disclosure of the structural features common to such binding moieties across the full scope of the claims. Further, although certain chelating moieties are enumerated, the specification does not demonstrate possession of their use across the full range of combinations with albumin-binding and PSMA-binding moieties encompassed by the claims.
Additionally, the specification does not identify structural features or provide guidance sufficient to allow one of ordinary skill in the art to recognize which compounds within the claimed genus would possess the recited binding functions. The limited disclosure, including the experimental data, is directed to a narrow subset of compounds and does not represent the full breadth of the claimed genus. Accordingly, the specification does not demonstrate possession of the claimed invention, and the written description requirement is not satisfied.
Claims 3-7, 10-14, which depend or rely upon Claim 1, do not cure the deficiencies stated above.
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 1-7 and 10-14 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 1, the phrase “a compound comprising a structure having…,” renders the scope of the claim unclear. A compound is itself a chemical structure, and it is therefore unclear what additional elements the compound is intended to “comprise” beyond the recited structure. The claim does not clearly indicate whether the recited structure defines the entirety of the compound or only a portion thereof.
Furthermore, the limitation “a chelating part capable of coordinating with a radioactive metal ion,” “an albumin-binding part,” and “a PSMA molecule-binding part,” define portions of the claimed compound primarily by intended capability or binding function, without setting forth reasonably clear structural boundaries for what is encompassed by each “part”. Further, the terms “first atomic group” and “second atomic group,” each merely “including” the respective binding part, fail to clearly delimit the extent of each claimed group, including what additional atoms or linkers are included. Moreover, the recitation that the first atomic group and the second atomic group are “bonded with each other through the chelating part” does not clearly define the required structural connectivity of the compound. Accordingly, the metes and bounds of the claimed subject matter cannot be determined with reasonable certainty.
Regarding Claim 2, although the claim introduces a general formula, the key components “A1,” “B,” and “C” are defined primarily by functional language, namely “a chelating part capable of coordinating with a radioactive metal ion,” “an atomic group including an albumin-binding part,” and “an atomic group including a PSMA molecule-binding part,” respectively, without reciting reasonably clear structural limitations for these components. In particular, the phrase “containing a…binding part” fails to define the boundaries of the claimed atomic groups, leaving it unclear what additional structure is encompassed. Further, the recitation that components are bonded to “an arbitrary position” of A1 does not provide a definite structural limitation. Additionally, the alternative bonding language (“B or La” and “C or Lb”) in combination with variables m and n equal to 0 or 1 renders the connectivity of the claimed compound unclear. According, one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed invention.
Regarding Claim 6, in addition to not curing the deficiencies of Claim 1 from which it depends, also recites the phrase “derived from” which does not provide clear structural boundaries, and the inclusion of both small molecules and macromolecules (e.g., antibodies and peptides) renders the scope of the claimed “albumin-binding part” unclear.
Regarding Claim 10, in addition to not curing the deficiencies of Claim 1 from which it relies, it is also unclear how the radioactive metal ion relates structurally to the compound, i.e., whether it is coordinated, complexed, or merely present, rendering the scope of the claim unclear.
Regarding Claim 12, the phrase “the radiolabeled compound according to Claim 1” lacks proper antecedent basis and renders the scope of the claim unclear. Claim 1 recites a compound capable of coordinating with a radioactive metal ion but does not define or recite a “radiolabeled compound.” Accordingly, it is unclear whether the claimed composition requires the compound of claim 1 to be coordinated with a radioactive metal ion, and if so, under what conditions or structural limitations. Therefore, the metes and bounds of the claim cannot be determined with reasonable certainty.
Claims 3-5, 7, 11, and 13-14 which depend or rely upon Claim 1, do not cure the deficiencies stated above, as they continue to rely on components defined by functional language and do not provide structural limitations commensurate with the breadth of the claims.
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.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kung et al. (WO 2020/220023 A1, cited in IDS), hereinafter Kung.
Regarding Claims 1-7, Kung teaches Compound 7 (‘023, Pg 23, Structure 2, Pg 41, Scheme 10, and Pg 65, Table 1), shown below top, which is fully encompassed by the genus of Claim 1 and formula 1 of Claim 2, wherein the chelating part A1 is DOTA (as in instant Claims 1-2 and 4-5), the albumin-binding part B is B1 (as in instant Claims 1-2 and 6-7), the PSMA molecule-binding part C is C1 (as in instant Claims 1-3), wherein m and n are each independently 1, and wherein A1 is bonded to La and at a different position Lb, by different linker structures (as in instant Claim 2).
PNG
media_image1.png
580
1000
media_image1.png
Greyscale
‘023 Compound 7
PNG
media_image2.png
158
666
media_image2.png
Greyscale
Instant PSMA-NAT-DA1
Examiner notes Kung’s Compound 7 differs from the elected species only in the optional linkers connecting the identical A1, B1, and C1 moieties.
Regarding Claims 10-11, Kung teaches a complex comprising the compound and a radioactive metal ion coordinated to the chelating moiety. Such a complex corresponds to the claimed “radiolabeled compound,” as coordination of a radioactive metal ion to the chelating portion of the compound results in a radiolabeled form of the compound. Kung teaches that the compound forms stable chelating complexes with various radioactive metals, including but not limited to 68Ga (for diagnostic) as well as 177Lu (for radionuclide therapy) (‘023, Abstract, Pg. 4-5, Schemes 4-5, and Pg. 10, Para 0022).
Regarding Claim 12, Kung teaches pharmaceutical compositions comprising a pharmaceutical acceptable carrier and a compound or complex as above (‘023, Pg. 33, Para 0076).
Regarding Claim 13, Kung teaches radiolabeled complexes formed by coordination of a radioactive metal ion to the chelating moiety of the disclosed compounds (‘023, Pg. 4-5 and 9-10, Schemes 4-6). The formation of such complexes inherently requires coordinating the compound to a radioactive metal ion as recited in the claim.
Regarding Claim 14, as set forth above with respect to Claims 1-7, Kung teaches Compound 7, which is encompassed by and anticipates the claimed compounds, including those corresponding to the structure of Formula 1S. Because Kung discloses Compound 7 having the same structural framework as formula 1S, and further discloses complexes of such compounds with radioactive metal ions coordinated to the chelating moiety (‘023, Pg. 4-5 and 9-10, Schemes 4-6), Kung necessarily teaches coordinating such compounds with radioactive metal ions.
As such, Kung anticipates the instant Claim 1-7 and 10-14.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-7 and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4-5, and 8-19 of copending Application No. 17/904,792 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application includes claims drawn to compounds having the same general structural framework, including the chelating moiety, PSMA-binding moiety, and albumin-binding moiety, as well as radiolabeled compounds thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights