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 1-20 are pending. Acknowledgment is made of the amendment of claims 1-3, 8, 9, 11, 16, and 20 in the reply filed 04/24/2026.
Withdrawn Objections/Rejections
Applicant’s amendment to the claims, filed 04/24/2026, overcomes the objection to claim 1 for minor informalities. The objection to claim 1 has been withdrawn.
Applicant’s amendment to the claims, filed 04/24/2026, overcomes the rejection of claims 11-20 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 11-20 has been withdrawn.
Applicant’s amendment to the claims, filed 04/24/2026, overcomes the rejection of claim 20 under 35 U.S.C. 112(b) for lack of antecedent basis. The rejection of claim 20 has been withdrawn.
Applicant’s amendment to the claims, filed 04/24/2026, overcomes the rejection of claims 8 and 9 under 35 U.S.C. 112(d) for failing to include the limitations of the claim upon which they depend. The rejection of claims 8 and 9 has been withdrawn.
Maintained Rejections
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 and 10-20 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 claims 1-3, the phrases “targeting ligand” and “affinity tag” render the claims indefinite because the claims include elements not actually disclosed. The specification, on page 12, defines a “targeting ligand” as “well known to those of ordinary skill in the art, with examples including, but not limited to folic acid, mannose, an antibody (e.g., anti-CD22, anti-CD25, anti-EpCAM, etc.), an aptamer (e.g., SYL3C for targeting EpCAM, AptA for targeting Mucin1, etc.), or a polypeptide (e.g., arginine-glycine- aspartic acid (RGD) motif, yclic 9-mer iRGD (CRGDKGPDC), other polypeptides targeting integrins, epidermal growth factor receptor (EGFR), somatostatin receptors (SSTRs), gonadotropin-releasing hormone receptor (GnRH-R), bombesin (Bn) receptors, G protein- coupled receptors (GPCRs), etc.)”. “Affinity tags” are defined in the specification, on pages 12-13, as “well known to those of ordinary skill with examples including, but not limited to, polyhistidine tag, glutathione-S-transferase (GST) tag, Strep-tag (streptavidin-binding tag), almodulin-binding peptide (CBP) tag, chitin-binding domain (CBD), FLAG tag, HA tag, c-Myc tag, etc.”.
Therefore, non-limiting examples are provided for both “targeting ligands” and “affinity tags”, which results in an indefinite number of compounds that would fall under claims 1-3. Claims 10-20 are rejected as being dependent upon a rejected claim and failing to clarify the targeting ligand or affinity tag structure. This rejection would be overcome by including specific targeting ligands or affinity tags to be used in the invention.
Applicant Argues:
Applicant states, in the Remarks filed 04/24/2026, that the terms “targeting ligand” and “affinity tag” are not indefinite, and that the examiner conflates “breadth with indefiniteness”. Applicant states that these terms are part of a well-recognized class of substituents.
Examiner Responds:
Applicant's arguments filed 04/24/2026 have been fully considered but they are not persuasive. For the reasons discussed in the above rejection, the issue is with indefiniteness and not the breadth of the claims, since there are only non-limiting examples provided for these terms and no structure is given to either moiety. This indeed results in an indefinite number of compounds falling under the instant claims. Additionally, under 112(b) this would be viewed as a reach-through claim, since the claim attempts to obtain protection for subject matter that is prophetic and/or has yet to be invented (targeting ligands and affinity tags not yet invented). The metes and bounds of “affinity tag” and “targeting ligand” are not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention.
Nonstatutory 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, 5, 10, 16, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40 and 42 of copending Application No. 18/006,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘889 teaches, in claim 40, a method of increasing mitochondrial respiration in a cell comprising contacting the cell with a compound of formula (II). This compound/method reads on instant claims 1, 5, 10, and 16. It is taught, in claim 42, that the cell is in a subject, as in instant claim 19.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant filed a terminal disclaimer for copending Application No. 18/006,889.
Examiner Responds:
The terminal disclaimer was disapproved by OPLC because “the person who signed the terminal disclaimer is not the applicant, patentee, and/or an attorney of record.”
Allowable Subject Matter
Claims 8 and 9 are allowed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Advisory Notice
Claims 4, 6, and 7 appear allowable if rewritten in independent form.
Conclusion
Claims 8 and 9 are allowed.
Claims 1-3, 5, and 10-20 are rejected.
Claims 4, 6, and 7 are objected to.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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 Murray can be reached at (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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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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