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 .
Status of Application
Applicant’s election without traverse of List (applicant elected claims 1, 4-6, and 14) in the reply filed on 12/15/2025 is acknowledged.
Claims 2-3 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/15/2025.
Applicant’s cancellation of claims 8-13 in the reply filed on 12/15/2025 is acknowledged.
Applicant’s amendments of claims 1, 4-5, and 14 in the reply filed on 12/15/2025 is acknowledged.
Applicant’s addition of new claims 15-18 in the reply filed on 12/15/2025 is acknowledged.
Claims 1, 4-6, and 14-18 are under examination.
Specification
The disclosure is objected to because of the following informalities: compound figure
Appropriate correction is required.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities: compound images are blurry and difficult to read.
Appropriate correction is required.
Claim Interpretation
Claims 6 and 17-18 recite an intended use of the composition.
See MPEP 2111.02: PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). A claim where the preamble only states the purpose or intended use for the invention, the preamble is not a claim limitation. The preamble for claims 6 and 17-18 recited a composition was “for diagnosing cancer cells overexpressing PSMA”. This statement is of no significance to the structure of the composition.
Claims 14-16 recite the intended use of the claimed kit.
See MPEP 2114.II: MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble recited in claim 14 and by dependency claims 15 and 16 states, "[a] kit for diagnosing cancer cells overexpressing PSMA” and the body of the claim recites a compound comprising a radioisotope, a chelator, and a PSMA-targeting moiety…”. The examiner interprets this as intended use of the kit and will not be interpreted as limiting the kit.
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.
Claim(s) 1, 4-6, and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weinessen, et al. (Weineisen et al. EJNMMI Research 2014, 4:63, disclosed in IDS dated 12/13/2023) in further view of Ray, et al. (WO 2017/165473 A1).
Weineisen et al. (hereafter referred to as Weineisen) is drawn to a cancer targeting compound for treatment and diagnosis of PSMA-type cancer as of title, abstract, and body of the paper.
As to claim 1, Weineisen teaches a radioisotope (abstract, lines 20-21), a chelator (abstract, lines 4-6), and a PSMA-targeting moiety (abstract, lines 20-21).
Weineisen does not teach the 203Pb and 212Pb isotopes.
Weineisen does not teach the DOTAM chelator.
Weineisen does not teach the same stereochemistry throughout the same molecule as compound 1.
Ray et al. (hereafter referred to as Ray) is also drawn to a cancer targeting compound for treatment and diagnosis of PSMA-type cancer (title, abstract, specification, and claims). Ray teaches radioisotopes (pg 61, claims 4-5; pg 73, claim 10) and chelators (pg 61, claim 3; pg 61-71, claim 6; and pg 72, claim 9; pg 73-82, claim 11), PSMA-targeting moiety (pg 61-71, claim 6; and pg 73-82, claim 11), and kits (pg 29, lines 25-27). Since both Weineisen and Ray are drawn to similar works, a person of ordinary skill in the art would be motivated to combine elements from each publication.
Regarding the radioisotopes of claim 1, Weineisen teaches that a wide variety of radioisotopes can be used with chelating molecules such as 131I, 90Y, and 177Lu (pg 2, col 2, line 6).
Weineisen does not teach 203Pb or 212Pb.
Ray teaches 203Pb and 212Pb (pg 60, claim 5) to be used with PSMA-targeting compounds. Given the similarity of scope between Weineisen and Ray, it would have been obvious to a person of ordinary skill in the art to substitute any of the radioisotopes of Weineisen with the radioisotopes (such as 203Pb or 212Pb) of Ray. The prior art contained a compound which differed from the claimed device by substitution of some radioisotopes with other radioisotopes. And, the substituted radioisotopes and their functions were known in the art. Therefore, one of ordinary skill in the art could have substituted one radioisotope for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding the chelator of the compound of claim 1, Weineisen teaches that chelators may be substituted to improve desired features (pg 3, lines 1-10). Furthermore, Weineisen specifically teaches the chelator DOTA (pg 3, Fig 2, DOTA-FFK(Sub-KuE)).
Weineisen does not teach the chelator DOTAM.
Ray teaches the chelator DOTAM (pg 80-82, claim 11). Given that Weineisen teaches the interchangeability of chelators on PSMA-targeting compounds (Weineisen, pg 3, col 1, lines 3-5) and the similarity of scope between Weineisen and Ray, it would have been obvious to a person or ordinary skill in the art to substitute the DOTAM chelator of Ray with the chelators or Weineisen. Particularly, Weineisen contained a DOTA chelator which differed from the claimed chelator by the substitution of the DOTA chelator with the DOTAM chelator of Ray. The substituted chelators and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding the PSMA-targeting moiety of claim 1, Weineisen teaches PSMA-targeting moiety of the compound from claim 1 (pg 9, Fig 4, compound 12) attached to DOTAGA chelating moiety.
As discussed above, Weineisen teaches substitution of chelators and Ray teaches DOTAM on compounds for PSMA expressing tumors or cells (Ray, pg 80-82, claim 11). Given that Weineisen teaches the same PSMA-targeting moiety of the compound from claim 1 and that the chelator may be substituted as desired, and that Ray teaches the DOTAM chelator, it would have been obvious to a person having ordinary skill in the art to have substituted known elements of Ray with known elements of Weineisen to achieve predictable results. See MPEP 2143(I)(B).
As to claims 4 and 5, Ray teaches the radioisotopes 203Pb and 212Pb (pg 60, claim 5).
As to claim 6, Weineisen teaches a composition for diagnosing cancer cells (pg 12, Fig 8).
As to claim 14, Ray teaches a kit including compounds of the class of the compound from claim 14 (pg 29, lines 25-27). The compound described in claim 14 is the same as the compound of claim 1.
Weineisen teaches a radioisotope (abstract, lines 20-21), a chelator (abstract, lines 4-6), and a PSMA-targeting moiety (abstract, lines 20-21).
Weineisen does not teach the 203Pb and 212Pb isotopes.
Weineisen does not teach the DOTAM chelator.
Weineisen does not teach the same stereochemistry throughout the same molecule as compound 1.
Ray is also drawn to a cancer targeting compound for treatment and diagnosis of PSMA-type cancer (title, abstract, specification, and claims). Ray teaches radioisotopes (pg 61, claims 4-5; pg 73, claim 10), chelators (pg 61, claim 3; pg 61-71, claim 6; and pg 72, claim 9; pg 73-82, claim 11), PSMA-targeting moiety (pg 61-71, claim 6; and pg 73-82, claim 11), and kits (pg 29, lines 25-27). Since both Weineisen and Ray are drawn to similar works, a person of ordinary skill in the art would be motivated to combine elements from each publication.
Regarding the radioisotopes of claim 14, Weineisen teaches that a wide variety of radioisotopes can be used with chelating molecules such as 131I, 90Y, and 177Lu (pg 2, col 2, line 6).
Weineisen does not teach 203Pb or 212Pb.
Ray teaches 203Pb and 212Pb (pg 60, claim 5) to be used with PSMA-targeting compounds. Given the similarity of scope between Weineisen and Ray, it would have been obvious to a person of ordinary skilled in the art to substitute any of the radioisotopes of Weineisen with the radioisotopes (such as 203Pb or 212Pb) of Ray. The prior art contained a compound which differed from the claimed device by substitution of some radioisotopes with other radioisotopes. And, the substituted radioisotopes and their functions were known in the art. Therefore, one of ordinary skill in the art could have substituted one radioisotope for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding the chelator of the compound of claim 14, Weineisen teaches that chelators may be substituted to improve desired features (pg 3, lines 1-10). Furthermore, Weineisen specifically teaches the chelator DOTA (pg 3, Fig 2, DOTA-FFK(Sub-KuE)).
Weineisen does not teach the chelator DOTAM.
Ray teaches the chelator DOTAM (pg 80-82, claim 11). Given that Weineisen teaches the interchangeability of chelators on PSMA-targeting compounds (Weineisen, pg 3, col 1, lines 3-5) and the similarity of scope between Weineisen and Ray, it would have been obvious to a person or ordinary skill in the art to substitute the DOTAM chelator of Ray with the chelators or Weineisen. Particularly, Weineisen contained a DOTA chelator which differed from the claimed chelator by the substitution of the DOTA chelator with the DOTAM chelator of Ray. The substituted chelators and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B)
Regarding the PSMA-targeting moiety of claim 14, Weineisen teaches PSMA-targeting moiety of the compound from claim 1 (pg 9, Fig 4, compound 12) attached to DOTAGA chelating moiety.
As discussed above, Weineisen teaches substitution of chelators and Ray teaches DOTAM on compounds for PSMA expressing tumors or cells (Ray, pg 80-82, claim 11). Given that Weineisen teaches the same PSMA-targeting moiety of the compound from claim 14 and that the chelator may be substituted as desired, and that Ray teaches the DOTAM chelator, it would have been obvious to a person having ordinary skill in the art to have substituted known elements of Ray with known elements of Weineisen to achieve predictable results. See MPEP 2143(I)(B).
As to claims 15 and 16, Ray teaches the radioisotopes 203Pb and 212Pb (pg 60, claim 5).
As to claim 17 and 18, Ray teaches compositions of compounds containing either 203Pb or 212Pb in the class of the compound from claim 1 (pg 30, lines 9-13).
Non-Statutory 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.
Co-pending Application No. 16/477,623
Claims 1, 4-6, and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-10 of co-pending application No. 17/477,623 in view of Weineisen and Ray.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims 1, 4-6, and 14-18 are taught by conflicting claims in co-pending application No. 16/477,623 claims 1 and 3-10.
Instant claim 1 and 14 are drawn to a cancer targeting compound for treatment of cancer cells overexpressing PSMA comprising a radioisotope, a chelator, and a PSMA-targeting moiety where the radioisotopes are selected from 203Pb and 212Pb. The instant claim teaches cancer targeting through a peptide-based targeting moiety attached to the chelator.
Conflicting claims 1 and 14 teach the general structure of a chelator which allows for DOTAM and radioisotopes that may be selected from 203Pb and 212Pb. The instant claim uses DOTAM and 203Pb and 212Pb in the compound.
However, while conflicting claims 8-12 teach the use of a peptide-based cell targeting moiety,
the conflicting patent application does not expressly teach the PSMA-targeting moiety.
As noted in the current rejections above, the combined teachings of Weineisen and Ray render obvious the PSMA-targeting moiety of claims 1 and 14.
Instant claim 4 is drawn to a compound where the radioisotope is 203Pb.
Conflicting claims 1, 3, 4, 5, 6, 8, 9, 10, 11, 12, 20, and 26 teach the use of 203Pb.
Instant claim 5 is drawn to a compound where the radioisotope is 212Pb.
Conflicting claims 1, 3, 4, 5, 6, 8, 9, 10, 11, 12, 20, and 26 teach the use of 212Pb.
Instant claims 6, 17 and 18 are drawn to compositions for diagnosing cancel cells overexpressing PSMA comprising the compound of claim 1 with 203Pb or 212Pb as the radioisotope.
Conflicting claims 1-12 teach a composition for treating cancer cells using either 203Pb or 212Pb.
However, conflicting claims do not teach treating cancer cells overexpressing in PSMA.
As noted in the current rejections above, the combined teachings of Weineisen and Ray render obvious the PSMA-targeting moiety of instant claim 6.
Instant claim 15 and 16 are drawn to a kit comprising the compound of claim 14 using either 203Pb or 212Pb respectively.
Conflicting claims 13-17 teach a kit using a cancer targeting composition with DOTAM, radioisotopes, and a peptide-based cancer targeting moiety where the radioisotopes are selected from either 203Pb or 212Pb.
The conflicting claims do not teach a kit using the PSMA-targeting moiety of claim 14.
As noted in the current rejections above, the combined teachings of Weineisen and Ray render obvious the PSMA-targeting moiety of instant claims 15 and 16.
As claims 1 and 3-10 of the co-pending application No. 16/477,623 and the teachings of Weineisen and Ray all teach cancer targeting compounds, compositions, and kits, it would have been obvious to combine the claims 1 and 3-10 of co-pending application No. 16/477,623 with Weineisen and Ray because the elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the claimed radiopharmaceutical composition.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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, Sahana Kaup can be reached at (571) 272-6897. 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.
/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612