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 was filed 03/20/2024 and is a CON of 18/482912 (10/08/2023, US Pat 11964948) which is a CON of PCT/US2023/068062 (06/07/2023) which has PRO 63/487789 (03/01/2023) and PRO 63/408970 (09/22/2022) and PRO 63/349833 (06/07/2022). Claims 1-9 have been canceled. Claims 10-30 are before the Examiner.
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 10-16 and 20-30 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 compounds wherein R is a reactive group chosen from formula IIID, IIIE and IIIF and M is a chelator moiety chosen from formulas IIIA, IIIB and IIIC, does not reasonably provide enablement for any reactive group that can mediate conjugation to a protein or a peptide, a benzyl group, at least one amino acid or amino acid derivative, a chelator moiety, a PEG spacer, a non-aromatic cyclic hydrocarbon or other group (see paragraph 7) or a synthetic peptide or any M which is any possible chelator moiety. 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 or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is a bifunctional chelator compound and a conjugate of a bifunctional chelator compound.
The state of the prior art: The state of the prior art is that it involves identifying and screening possible chelators and reactive groups to determine which would work in the instant linker grouping to conjugate them with antibodies or antigen binding fragments of monoclonal antibodies as targeting agents for therapeutics or diagnostic use. There is no predictability of which compounds will combine to make conjugates that would work as therapeutic or diagnostic agents. Without this predictability, the ordinary artisan would not accept that any chelator or reactive moiety would work without testing.
The predictability in the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to the therapeutic effects of mixing various reactive groups with any chelator moiety and the linker to have a therapeutic or diagnostic utility. Hence, in the absence of a showing of a nexus between any and all known chelators and/or reactive moieties and the possible diagnostic and/or therapeutic possibilities, one of ordinary skill in the art is unable to fully predict possible results from the administration of the compound of claim 1 due to the unpredictability of the identity of M (chelator moiety)and R (reactive group).
The presence or absence of working examples: The examples in the specification have one of three reactive groups (IIID, IIIE and IIIF) and one of three chelators (IIIA, IIIB and IIIC). Only three specific compounds have been depicted in the claims.
The amount of direction or guidance present: The guidance present in the specification is that any reactive group and any chelator will work as claimed. However, only three reactive groups and three chelators have been depicted in the specification. Guidance of how to choose others from the general teachings is lacking. The specification does not seem to enable a correlation between the generalities of “reactive group” and “chelator” and a working bifunctional chelator compound that has activity as a therapeutic or as a diagnostic means.
The breadth of the claims: The claims are drawn to generally any bifunctional chelator compound or composition that can be used as a therapeutic or diagnostic agent.
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine what specific reactive group would work along with a specific chelator would work for the treatment or diagnosis or an unspecified condition.
The level of the skill in the art: The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which bifunctional chelator compounds would work for therapeutic or diagnostic purposes.
Thus, the specification fails to provide sufficient support of the broad use of R as “reactive group” and M as “chelator moiety” outside those of formulas IIIA – IIIF.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds of the instant claims, with no assurance of success.
This rejection can be overcome by limiting R to formulas IIID, IIIE and IIIF and M to IIIA, IIIB and IIIC.
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 10, 11 and 23-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stenberg. Stenberg teaches compound (C) (page 131) and a method of preparation of alpha-emitting prostate-specific membrane antigen targeted radioligands (page 132 first full paragraph) such as compounds B and C as well as methods of making them that anticipate the instant claims.
Claims 10-13, 20 and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat 10377778 Larsen. Larsen teaches compounds such as col 11 line 5 and methods of making them that anticipate the instant claims. Bifunctional chelators Col 9-11. Claim 11 formulas IIIA and IIIB on Col 12. Claims 12-13 and 20 on Col 11 l1-30. Claim 22 in abstract, Field of Invention, C2l8, 3l67 and C4l13-14. Claims 23-25 paragraph 21 teaches peptides, Cl5-10 proteins, C6l3 antibodies. This anticipates the instant claims.
Claims 10-13, 20 and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPGPub 20200297877 Larsen. Larsen teaches compounds such as page 6 as well as methods of making them that anticipate the instant claims. Claim 10 on page 5 paragraph 0111. Claims 11-13 and 20 on page 7. Claim 22 in the abstract. Claims 23-25 paragraph 0024, 0042, 0072 and paragraph 0092. This anticipates the instant claims.
Claims 10-12, 20 and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPGPub 20210393809 Haberkorn. Haberkorn teaches compounds such as CA002 and CA028 as well as methods of making them that anticipate the instant claims. Claim 10 abstract formula (I). Claim 11 on page 2-3. Claims 12 an 20 on page 4. Claim 1 on page 2. Claim 22 on end of page 6 to page 7. Claim 23-24 peptide on paragraph 0228. Proteins in paragraphs 0005 and 0308. Claim 25 in paragraphs 0006 and 0343. This anticipates the instant claims.
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.
Claims 10-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11975081 and claims 1-23 of US Patent No 11964948. Although the claims at issue are not identical, they are not patentably distinct from each other because the patents claims a smaller Markush of compounds and method of making that fall within the instant claims. The specifics of the L1, M and R instantly claimed are the sameL1, M and R claimed in the patents. Further, the compound claimed in the instant claim 17 is the same compound claimed in 11964948 claim 8.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
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