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 .
Claims 6-11 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/20/2026 has been entered.
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.
Previously presented rejection of claims 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Guo, Nature Chemistry (2019), 11(3), 254-263 and Guo supplementary material; Basilea, WO 200152894 and Aoki, WO20005251 is maintained for reasons of record.
Applicants arguments are not persuasive.
The argument that Basilea and Aoki teachings drawn to antifungal compounds and therefore are not in the same field of endeavor because Guo teaching is drawn to pharmaceutical, is questionable on its face, because, claim 6 is a product claim. While the claims are interpreted in the context of specification, the limitation (alleged pharmaceutical use) does not limit the scope of the claim. Further, the new use (if any) of an old compound, must account for the possibility that the underlying mechanism for the new therapy is the same mechanism that allows for a prior art treatment using the same compound (or its obvious version).
The position taken is that Guo, Basilea and Aoki are all in the same filed which is using inherent properties of chemical compounds and optimizing their chemical structures for example, as pictured at the top of page 3 of previous action 08/22/2025.
Contrary to Applicants argument, there is motivation: Compound of claim 6 and the active ingredient of the method claims 7-11 is a Rapafucin derivative, hybrid macrocyclic compounds inspired by rapamycin, featuring a conserved FKBP-binding domain and a custom tetrapeptide effector domain designed for targeted medicinal use. Key rapafucin analogs include Rapaglutin A (RgA) and Rapaglutin E (RgE) (GLUT inhibitors for cancer) and Rapadocin (an hENT1 inhibitor for ischemia-reperfusion injury) See Abdel-Magid, Rapalogs Potential as Practical Alternatives to Rapamycin, ACS Med. Chem. Lett. 2019, 10, 843−845.
As to the argument that ‘commonsense’ rationale is insufficient”:
The derivatization to make the compound, pictured at page 4 of the office action 08/22/2025, that is attaching an acetic acid moiety to know compounds, is routine in medicinal chemistry gymnastics as the acid group provides an handle to make water soluble salts, prodrugs etc. See Bharate, Carboxylic Acid Counterions in FDA-Approved Pharmaceutical Salts, Pharm Res (2021) 38:1307–1326.
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 6-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent Nos. 11066416. 11945827, US 11708391, US 11555054 and US 10774110 is maintained.
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uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12540144 further in view of Guo, Nature Chemistry (2019), 11(3), 254-263, Basilea, WO 200152894, Aoki, WO20005251 and Das, WO 2017136708.. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
Base claim 1 of 12540144 is drawn to the instantly pictured compound in a genus (12540144)- species (instant) relationship.
Thus even though the specific species of the instant claim is not explicitly taught in the claims of 12540144, there is overlap. The teachings of Guo, Basilea, Aoki and Das, discussed in their entirety in the obviousness analysis (see section under Claim Rejections - 35 USC § 103). See previous actions in this regard.
See specification column 407 and 408 of 12540144.
Also note that reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Motivation to modify can be found in the following:
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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