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 and Response to Restriction Requirement
Claims 1-3, 5-6, 10, 13, 17-18, 21, 37-39, 41, 48, 54, 62, 77 and 87-88 are pending as of the response filed 02/04/2026. Claims 4, 7-9, 11-12, 14-16, 19-20, 22-36, 40, 42-47, 49-53, 55-61, 63-76, 78-86 and 89-91 are cancelled. Applicant’s election of group I claims 1-3, 5-6, 10, 13, 17-18, 21, 37-39, 77 and 87-88 without traverse is acknowledged. Claims 41, 48, 54 and 62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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’s election of a species of the compound shown below without traverse is acknowledged.
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Claims 1-3, 5-6, 10, 13, 17, 21, 37-39 encompass the elected species. Claims 18, 77 and 87-88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Therefore, claims 1-3, 5-6, 10, 13, 17, 21, 37-39 have been examined to the extent to which they are readable on the above identified elected species.
Because Applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants right for examination of additional species if the elected species is found to be free of prior art in accordance with MPEP 803.02 (III)(C)(2) is acknowledged.
Prior art that renders the elected species prima facie obvious was found, as discussed below. In view of the pending claims, the following rejections are made.
Response to Remarks
Applicants argue on page 22 of the remarks dated 02/04/2026 that
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Applicant’s remarks are acknowledged. However, while the R3a, R3b, R3c and R3d groups of claim 77 may be different, the examiner notes that claims 77 and 87-88 share the same core structure, i.e., a phenyl attached to a thiadiazolidinone ring via an optional methylene linker, as that of claim 1, which is taught by compound BSK-1-40 of Ponder. Therefore, claims 77 and 87-88 have been appropriately withdrawn as not encompassing the elected species.
Priority
This application is a 371 of PCT/US2021/017970 filed 02/12/2021, which claims priority to PRO 62/976,604 filed 02/14/2020.
The subject matter of claims 1-3, 5-6, 10, 13, 17, 21, 37-39 are supported by PRO 62/976,604 filed 02/14/2020 and accordingly, have an effective filing date of 02/14/2020.
Information Disclosure Statement
The information disclosure statement submitted on 02/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in Para. [00413] of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Claim 1 recites various options for the variable R1 that includes Cy1. However, claim 10, does not require Cy1 to actually be present in the compound, they simply define what Cy1 must be if present in the compound. As such, a compound lacking Cy1 as a functional group for R1 still falls within the scope of dependent claim 10.
Claim Rejections - 35 USC § 112
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, 3, 5-6, 10, 13, 37, 39 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 claim recites “wherein R11, when present, is a carboxylate residue of a chemotherapeutic agent or a carbamide residue of a chemotherapeutic agent”. The term “carboxylate residue “ is generally understood in the art to relate to a R-(C=O)-O- group. However, dependent claims 2 and 17 encompass compounds wherein the R11 group includes a R-O-(C=O)O- group (i.e., a carbonate ester group when X is O). The term “carbamide residue” is generally understood in the art to relate to a R-NH-C=O-NH- group. However, dependent claims 2 and 17 encompass compounds wherein the R11 group includes a R-C=O-NH- group (i.e., a carboxamide group when X is NH). The instant specification does not specifically define a “carboxylate residue” or a “carboxamide residue” other than listing the specific examples. The causes ambiguity regarding the scope of the claim. Therefore, the metes and bounds of the claim are indefinite.
Claims 3, 5-6, 10, 13, 39 depend from the rejected base claim and are similarly rejected.
For the purpose of applying prior art, the claims have been searched with respect to the recited residue of the elected species.
Regarding claim 37, the claim depends from cancelled claim 31 and therefore, lacks sufficient antecedent basis.
For the purpose of applying prior art, claim 37 been interpreted as depending from claim 21 to provide sufficient antecedent basis.
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 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 1-3, 5-6, 10, 13, 17, 21, 37-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ponder, Dissertation (Phenotypic Screening of Parthenolide Derivatives reveals the Chemotherapeutic Role of Galectin-1 in Acute Myeloid Leukemia, 18 May 2018, in the IDS) as evidenced by the list of FDA approved solvents (Q3C — Tables and List, Guidance for Industry, June 2017).
Regarding instant claim 1, Ponder teaches compound BSK 1-40 (EC50 of 1.3 µM) and BSK 1-87 (EC50 of 1.2 µM) as a potent thiadiazolidinone (TDZD) analogues of chemotherapeutic agents (Pg. 199, Batch 23.2; Pg. 203, Batch 25.1b) having efficacy against acute myeloid leukemia (AML) cell lines (Abstract). BSK 1-40 and BSK 1-87 have the following structure (Pg. 199, first compound; Pg. 203, first compound of second column).
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Compound BSK 1-40 and compound BSK 1-87 fall within the scope of formula of instant claim 1, wherein
m is 1;
R1 is C2 haloalkyl (chloroethyl – BSK 1-40; iodoethyl – BSK 1-87);
R2a, R2b, R2d and R2e are each hydrogen;
R2c is
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; R11 is a carbamide residue of a chemotherapeutic agent (Pg. 13, Figure 1 teaches MMB to be a chemotherapeutic agent in a leukemia cell line).
Compound BSK 1-40 and compound BSK 1-87 satisfy the requirement that when m is 1 and R1 is C1-C10 haloalkyl as an option, one of R2a, R2b, R2c, R2d and R2e is
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, then R11 is not -OC(O)2(C1-C8 alkyl), -NHC(O)2(C1-C8 alkyl), or -N(C1-C4 alkyl)C(O)2(C1-C8 alkyl).
The compounds of Ponder anticipate a compound of instant claim 38 (Pg. 11, sixth compound’ Pg. 12, first compound). The compounds of Ponder further read on the limitations of claims 2-3, 5-6, 10, 13, 17, 21, 37.
Ponder teaches the compounds/drugs were diluted from a DMSO stock solution into PBS (phosphate-buffered saline) such that the final concentration of DMSO was constant and did not exceed 0.5% (Pg. 31, first paragraph). The list of FDA approved solvents evidences that DMSO is a Class 3 solvent that can be used in pharmaceutical products in amounts under 0.5 % (Pg. 7, first paragraph, Table 3), thus showing that the disclosure in Ponder meets the instant limitation drawn to a pharmaceutical composition. Therefore, Ponder anticipates the limitation of instant claim 39.
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 1-3, 5-6, 10, 13, 17, 21, 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Ponder, Dissertation (Phenotypic Screening of Parthenolide Derivatives reveals the Chemotherapeutic Role of Galectin-1 in Acute Myeloid Leukemia, 18 May 2018, in the IDS) as evidenced by the list of FDA approved solvents (Q3C — Tables and List, Guidance for Industry, June 2017).
Regarding the instantly elected species of compound, the teachings of Ponder are set forth in the anticipation rejection above and incorporated herein by reference.
Compound BSK 1-87 of Ponder differs from the instantly elected species of compound with respect to the number of intervening -CH2- groups in the haloalkyl group of R1 (drawn side-by-side for comparison).
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Instantly elected species of compound BSK 1-87
According to MPEP 2144.09 (II), “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or 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 re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Absent any criticality, the simple addition of -CH2- groups would be prima facie obvious.
Further, according to MPEP 2144.09 (III), Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the length of the haloalkyl group of R1 of Ponder, by varying the number of -CH2- groups to obtain the instantly elected species of compound, with a reasonable expectation of success that it will result in a compound having similar properties. Doing so would have been well within the skill of one of ordinary skill in the pharmaceutical arts. The motivation being to provide additional candidates for further pharmacological and/or commercial development.
Conclusion
Claims 1-3, 5-6, 10, 13, 17, 21, 37-39 are rejected.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627