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
The present application claims the priority of U.S. Provisional Application 63/407,507, filed September 16, 2022, and U.S. Provisional Application USSN: 63/422,340, filed November 3, 2022. There is no support for the claimed compounds in the U.S. Provisional Application 63/407,507 and therefore the effective filing date is considered to be filed November 3, 2022.
Requirement for Election/Restriction
In the Restriction Requirement, claims 1-3, 5-7, 9-12, 15-20, 22, 25, and 27-28 are
subject to the requirement for restriction/election under 35 U.S.C. § 121 as follows:
Group I: claims 1-3, 11, 12, 15-20, and 22 drawn to compounds of Formulas (I-IV);
Group II: claim 5, drawn to a compound of Formula (II); and
Group III: claims 6-7, 9, 10, 25, 27, and 28, drawn to compounds of Formula (V and
VI) that include metal chelates and radioisotopes.
In response to the requirement for election/restriction set forth in the Restriction
Requirement, Applicant hereby elects Group I without traverse. Applicant believes claims 1-3,
11, 12, 15-20, and 22 to read on the elected invention.
In response to the Election of Species requirement, Applicant respectfully elects HAPH-2
as the single disclosed species for examination. Applicant identifies at least claims 1-3, 11, 12,
15-20, and 22 as encompassing the elected invention and/or being readable on the elected
HAPH-2 species, to the extent applicable.
The Examiner notes that in the Applicant’s Election of Species, that Applicant has elected HAPH-2, that reads on Formula (II) as the species that is a subgenus of Formula (I). The species of claim 5 also reads on the elected species of Formula II so the restriction between Groups I and II is withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/18//2024 (12 references. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
Claims 1-3, 5, 11, 12, 15-20, and 22 are pending and are the subject of the Office Action below.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schor, et.al., Structural studies on the inactivation of γ-glutamylcysteine synthetase by the disulfide analogs of radioprotective cysteamine derivatives. Effects of aminoalkyl and hydroxyalkyl chain length, and ββ-bis-dimethylation, Biochemical Journal (1990), 267(2), pages 291-6.
Schor, structure SAPH3
Claim 1 of the instant claims
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141
511
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Greyscale
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423
419
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R1 is H
R1 is H
R3 is -SH
R3 is -SH
R2 is H
R2 is H
m is 0
n is 0
R4 is H
Claim 1 is drawn to the compound as detailed above where the variables listed as variables R1-R4, m, n are anticipated by the compound of Schor, et.al., SAPH3.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lomis et.al., Iron(II) and Copper(II) Complexes of HAPH, 1 a Bleomycin Metal Binding Site Analogue with Apical Imidazole Coordination, Inorganic Chemistry, Vol. 28, No. 12, 1989, pages 2369-2377.
Loomis, et. al.,
Formula I instant applicaton
Formula II Instant Application
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330
384
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423
419
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309
249
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Greyscale
Claims 1 and 2 are drawn to compounds of Formula I and Formula II respectively, as detailed in the table above. Therefore, the compound of Loomis, et.al., anticipates the Applicant’s compounds of Formula I and Formula II.
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 1-3, 5, 11, 12, 15-20, and 22 are obvious variants of 19/111,996:
Claims 1-3, 5, 11, 12, 15-20, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-14, 17, 20, 22, 25 and 27-29 of copending U.S. Provisional Application 19/111,996 filed on March 14, 2025 (hereinafter “the ‘996 application”). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘996 teaches the same compounds. Specifically, claims 1, 3, 5, 6, 7 9, 10 and 22 are identical “word for word” to the claims 1, 3, 5, 6, 7 9, 10 and 22 of ‘996.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffery Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.R.G./ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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