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 the Claims
Claims 1, 4, 10, 12-13, 16-19, 29, 35, 87 and 90 are pending. Claims 12-13, 16-19, 29 and 87 are withdrawn. Claims 1, 4, 10, 35 and 90 are rejected.
Election/Restrictions
Applicant's election of Group I (originally claims 1, 4, 10-13, 16-20, 29, 35 and 90) and species
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(cl. 35, p. 16) without traverse in the reply filed on 8/25/2026 is acknowledged. Claims 1, 4, 10, 35 and 90 read on Applicant’s species election of Formula I,
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, wherein X is O, Y is H, Z is a bond, R is R4, R4 is
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and R2 and R3 are absent.
Examination of the elected invention was conducted in accordance with the MPEP 803.02. The elected species is allowable in view of the prior art; therefore, examination of the Markush-type claim has been extended to the scope of Formula (I) wherein, X is O,
Y is H, Z is a bond, R is R4, R4 is
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or
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,
Since art was found on a nonelected species, subject matter not embraced by the elected embodiment or the above-identified non-elected species is, therefore, withdrawn from further consideration. Claims 12-13, 16-19, 29 and 87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
This application is a 371 of PCT/US2022/028193, filed 05/06/2022, which claims benefit of PRO 63/321,187, filed 03/18/2022, PRO 63/248,705, filed 09/27/2021, and PRO 63/185,736, filed 05/07/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/8/2024 is in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. Accordingly, the IDS has been considered
by the examiner and a signed copy is enclosed herewith.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, page 4, line 3 recites “R30 is 5-6 membered heteroaryl”, which is grammatically incorrect. The following is suggested: “R30 is 5- to 6-membered heteroaryl”.
Claim 1, page 5, the Markush group Rz ends with a semicolon followed by a period. The semicolon is improper.
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, 4, 10, 35 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. US 2021/0353764 A1 (earliest priority date: 9/26/2018).
Xu teaches antitumor drug compounds of formula (D),
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, which can be prepared as a ligand-drug conjugate for treating tumors. See, e.g., Xu para. 163 and 209-211. Compounds 5 and 6 are among the lead compounds of formula (D) identified in Table 1 as having highly selective antitumor properties against U87 glioblastoma cells. Xu para. 733.
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(5)
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(6)
These compounds have structure of Formula (D) wherein Y is -O-(CRaRb)m-CR1R2-C(O)-, m is 1, Ra and Rb are H, and R1 and R2 form a cycloalkyl ring. Xu para. 165-172. According to Xu, “m is an integer from 0 to 4”. Xu para. 172.
Compounds 5 and 6 are adjacent methylene (-CH2-) homologs of the claimed compounds
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and
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, respectively, corresponding to m being 2 (i.e., -CH2-CH2-) instead of being 1 (i.e., -CH2-) in Y of Formula D.
According to MPEP 2144.09, “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. ‘An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.’ In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990)… Compounds which are... homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.”
In this case, the claimed compounds and Xu’s compounds are derivatives of exatecan and have antitumor properties. Xu’s compounds, like the claimed compounds, are “useful as payloads in drug conjugates” (specification para. 7). Since Xu’s compounds have antitumor properties and uses as drug conjugates, a PHOSITA would have expected that the ethylene homologs of compounds 5 and 6 would have similar properties, which properties are the same as those reported for the claimed compounds. Therefore, a PHOSITA wishing to make new antitumor agents within the scope of Xu’s Formula (D) would have found it obvious to make the claimed antitumor homologs, starting with lead compounds 5 and 6 and modifying “m”, by extending the methylene chain (m is 1) to an ethylene chain (m is 2), given Xu’s teaching that m is an integer between 0 and 4. Xu para. 172.
The ethylene homologs of Xu’s compounds 5,
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,
and 6,
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, have the structure of instant compounds
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and
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, respectively. Thereby rendering obvious the claimed homologs of instant Formula (I),
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, wherein X is O,
Y is H, Z is a bond, R is R4, R4 is
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or
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, which compounds are
embraced by claims 1, 4, 10 and 35 (p. 22, lines 1-2).
Regarding claim 90, drawn to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient, Xu teaches “a pharmaceutical composition comprising the compound of formula (D)… and one or more pharmaceutically acceptable carrier(s), diluent(s) or excipient(s)” (para. 207). Since a PHOSITA would have found it obvious to make antitumor homologs of Xu’s compounds 5 and 6, which homologs are embraced by formula (D), the PHOSITA would have been motivated to prepare pharmaceutical compositions thereof, further comprising an acceptable excipient, for treating tumors.
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 1, 4, 10, 35 and 90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/126,763 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘763 application teaches therapeutic payload moieties and pharmaceutical compositions thereof. See, e.g., claim 24. The ‘763 application teaches the payloads have a structure of Formula (II),
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, which compounds can be conjugated/linked to a targeting moiety. See, e.g., claim 1. Claim 12 lists several species of drug conjugates, including
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(p. 211), which comprises the payload moiety
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, Applicant’s elected species. Therefore, the claimed elected species and its pharmaceutical composition would have been obvious in view of the copending claims. Accordingly, claims 1, 4, 10, 35 and 90 are rejected for obvious-type double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L AGUIRRE whose telephone number is (571)272-5592. The examiner can normally be reached 10 am-6 pm MST.
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, JEFFREY H MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA L. AGUIRRE/ Primary Examiner, Art Unit 1626
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