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 .
Election/Restrictions
Applicant’s election of the invention of Group I (claims 1 and 4) and a species of Formula A that is Met/Sim in the reply filed on 02/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Examiner has searched the elected species and has further expanded the search scope to encompass the full genus of Formula A. The election of species requirement is withdrawn.
Claims 10, 17, 26-27, 34-39, and 54-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/05/2026.
Priority
Examiner acknowledges that, according to the Filing receipt received 01/02/2024, that the instant application 18/274,549 filed 07/27/2023 is a 371 of PCT/US2022/014658 filed 02/01/2022 which claims domestic benefit of U.S. provisional applications 63/144,161 filed 02/01/2021 and 63/208,807 filed 06/09/2021. Claims 1 and 4 have been awarded the effective filing date of 02/01/2021.
Information Disclosure Statement
The Information Disclosure Statements filed on 08/06/2023 and 09/29/2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Specification
The disclosure is objected to because of the following informalities: par. [0006] "Formulas A" should read "Formula A".
Appropriate correction is required.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1: “formula A” should read “Formula A”;
Claim 1: Examiner additionally suggests amending “comprising formula A” to “comprising a compound of Formula A” for clarity;
Claim 1: “R1a-f” should read “R1a, R1b, R1c, R1d, R1e, or R1f”;
Claim 4: “having the one of the” should read “having one of the”.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 2 contains reference characters 2, 3, 3b, 3a, and 3c. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b)
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 and 4 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.
Claim 1 recites “A composition comprising formula A… and enantiomers, racemates, diastereomers, hydrates, and solvates thereof”. It is unclear if the composition is required to contain enantiomers, racemates, diastereomers, hydrates, and solvates of a compound of Formula A or if enantiomers, racemates, diastereomers, hydrates, and solvates are merely within the scope of Formula A. If the latter is true, Examiner suggests amending “and enantiomers, racemates, diastereomers, hydrates, and solvates thereof” to “or an enantiomer, racemate, diastereomer, hydrate, or solvate thereof”.
Claim 1 is directed toward a composition. A composition necessarily contains two or more components, however, claim 1 does not clearly delineate a second component, nor does the specification appear to contemplate additional components. The scope of the claims is therefore unclear.
Claim 1 recites “the x-y bond is single or double and has an (E)-conformation”. A single bond cannot have an (E)-conformation as the atoms can rotate about the bond. Clarification is required.
Claim 4 recites “The composition of claim 1, having… one of the following structures:”. This limitation is unclear and lacks antecedent basis, as claim 1 is directed toward a composition “comprising formula A” not a composition that is Formula A. Examiner suggests correction to “The composition of claim 1, wherein the compound of Formula A has one of the following structures:”. See additionally Examiner’s suggested correction to claim 1 in the claim objections above.
Claim Rejections - 35 USC § 112(a)
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 1 and 4 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 enantiomers, racemates, and diastereomers of Formula A, does not reasonably provide enablement for hydrates and solvates of Formula A. 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 the invention commensurate in scope with these claims.
The scope of the claims encompasses hydrates and solvates of Formula A. However, the examples presented in the instant specification fail to produce hydrates or solvates of the claimed compounds. Hydrates and solvates cannot be readily predicted and/or willed into existence. The scope of hydrates and solvates is extremely broad. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However...there is no evidence that such compounds exist...the examples of the '881 patent do not produce the postulated compounds...there is...no evidence that such compounds even exist.” Hence, applicants must show that hydrates and solvates of the claimed compounds can be made, or limit the claims accordingly.
Claim Rejections - 35 USC § 103
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 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 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Currie et al. (US 2009/0054450; IDS filed 09/29/2025) in view of Janak et al. (WO 2019/050850; IDS filed 09/29/2025).
Currie et al. discloses compounds for treatment of metabolic disorders and compositions thereof (Abstract). Currie et al. discloses the following core structure of Formula II (p. 1, col. 2).
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In the above structure, Currie et al. teaches that “X is chosen from direct bond, O, NH, and an amino acid residue” (par. [0014]), “R4 is chosen from… guanidine” (par. [0015]), and “R5 is… a residue of a statin” (par. [0017]). Currie et al. additionally discloses the following compounds and reaction schemes.
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The above compounds differ from those of the instant invention in that the moiety in the R2 position is guanidinobutylamino (agmatine) instead of a metformin moiety. This limitation, however, is obvious in view of Janak et al.
Janak et al. discloses biguanide derivatives (p. 7) for treatment of cancers and metabolic diseases (p. 10) comprising a statin residue and a metformin moiety connected via a linker (see, for example, p. 104). Janak et al. discloses that metformin has been clinically studied in combination with statins for treatment of breast cancer, type 2 diabetes, bladder cancer, and prostate carcinoma (p. 6). Janak et al. discloses that combining two drugs by connecting them via linkers can be advantageous for producing synergetic effects, improving solubility, and improving pharmacokinetics of one or both drugs (p. 3).
It would have been prima facie obvious for one of ordinary skill in the art to substitute the agmatine moiety of the compounds of Currie et al. with metformin as in Janak et al. One would have been motivated to do so, with reasonable expectation of success, in view of the reaction schemes of Currie et al. which would guide one of ordinary skill in the art to combine the statin residue with metformin at the primary amine of the biguanide backbone thus creating a bifunctional compound.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/M.E.B./Examiner, Art Unit 1624 02/27/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624