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 with traverse of Group I in the reply filed on 11/21/ 2025 is acknowledged. The traversal is on the ground(s) that Group I and amended claim 35 now reads on the compounds of formula I. This was found to be persuasive and amended claim 35 was added to Group I. Applicant’s elected with traverse Group I and elect the compound shown below, claims 1-8 and 35- 36 encompass the elected group and the elected species, in the reply filed on 11/21/2025 is acknowledged. The elected species has been searched and found to be free of the prior art. Thus the scope of the search was expanded to the scope of claim 1. Claim 1 and thus all claims that are dependent from claim 1 were found to be free of the prior art and thus rejoined. The scope of the search was then expanded to claim 28 . Claim 28 was found to be anticipated by the prior art and the search was halted. E xamination has been limited to claims directed to the elected species, the claims dependent from claim 1 and claim 1, and claim 28 . The examined claims are claims 1-10, 28 , 35-39 . Since the claim 28 has been found not allowable, subject matter not embraced by the elected embodiment (claims 1-10, 28 , 35-39) is therefore withdrawn from further consideration. Claims 11- 27, 29- 34 are withdrawn. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S .C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. FILLIN "Insert the appropriate statutory section(s)." 120 as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc. , 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. FILLIN "Enter prior application number." 63/068,898 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. FILLIN "Enter explanation of lack of support or enablement." A claim by claim analysis indicated a lack of support for formula I in the PRO application thus claims 1-10 and 35-39 have been given a priority date of 08/20/2021. Claim 28 has been given a priority date of 08/21/2020. Information Disclosure Statement The information disclosure statement (IDS) submitted on 04/04/2023 is being considered by the examiner. Claim Interpretation The following chemical variables were interpretated in view of basic chemical knowledge. The chemical groups -C=O- and -CH2OCO- were interpretated in view of oxygen generally limited to two bonds and thus these groups are both bound to the rest of the molecule through the carbons. Claim Objections Claim s 1-10, 28 , 35-39 are objected to because of the following informalities: FILLIN "Enter appropriate explanation" \* MERGEFORMAT heterocycylene is misspelled . Appropriate correction is required. Claim Rejections - 35 USC § 112 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 FILLIN "Enter claim identification information" \* MERGEFORMAT 37 and 39 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 FILLIN "Identify claimed subject matter for which the specification is enabling" \* MERGEFORMAT treating specific diseases , does not reasonably provide enablement for FILLIN "Identify aspects of claims for which the specification is not enabling" \* MERGEFORMAT any related disease or any disease or disorder . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to FILLIN "Enter --make-- or --use-- or --make and use--" \* MERGEFORMAT use the invention commensurate in scope with these claims. To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated: The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely , or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).[1] The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 ( BdApls 1986) at 547 the court recited eight factors: 1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention, 5) the state of the prior art, 6) the relative skill of those in the art, 7) the predictability of the art, and 8) the breadth of the claims. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons: 1. The nature of the invention, state and predictability of the art, and relative skill level The invention relates to a method for treating a disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of claim 1. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites the fact that while Applicant demonstrated the use of several triptolides conjugates for antitumor activity , nowhere in the specification did applicant demonstrate the use in treating all diseases . Given that such compounds would have contrasting chemical and/or physical reactivity and given the nature of the invention, the examiner maintains that applicant has yet to enable the use of various compounds encompassed by formula ( I ) to treat any disease or disorder . Further, the predictability of treating any disease is relatively low given that the various types of diseases and disorders have different causative agents, involve different cellular mechanisms, and consequently, differ in treatment protocol. It is known (see I yengar et al., Science & Society series on drugs and science , EMBO reports VOL 14 | NO 12 | 2013 ) in the current art that different drugs have different targets in the human body and treat different diseases . Thus, given that applicant has failed to demonstrate treatment of various diseases and disorders utilizing various compounds encompassed by formula ( I ) and in light of the challenge in treating various types of diseases and disorders , the examiner maintains that applicant has not enabled the breadth of the claims. 2. The breadth of the claims The claims are thus very broad insofar as they recite the “ a method for treating a disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of claim 1. ”. While such “treatment” might theoretically be possible for the specific diseases listed utilizing compound s of formula (I) , as a practical matter it is nearly impossible to achieve a treatment for all possible disease s or disorder s with the same compounds of formula ( I ) especially given the divergent structures of said compounds. 3. The amount of direction or guidance provided and the presence or absence of working examples The specification provides no direction or guidance for the use of all compounds of Formula ( I ) for all disease s or disorder s. No reasonably specific guidance is provided concerning useful therapeutic protocols for all of the disclosed compounds of formula ( I ), other than tumor examples . The latter is corroborated by the working examples on pages 139-140 and the drawings of the instant invention . 4. The quantity of experimentation necessary Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that every instantly claimed compound of formula (I) could be predictably used for the treatment of every single diseases or disorders as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success. [1] As pointed out by the court in In re Angstadt , 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”. 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 appl icant regards as his invention. Claim FILLIN "Enter claim indentification information" \* MERGEFORMAT s 1-10 and 36-39 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. The scope of claims 1-10 and 3 6 -39 is unclear because the chemical groups -C=O- and -CH2OCO- are indicated that the rest of the formula is bound to the oxygen group, however, one of ordinary skill in chemistry knows that chemically these groups would be attached through the carbon. Thus it is unclear if the meaning is the general chemical understanding or as written. 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(s) 28 is/are rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1) as being FILLIN "Insert either—clearly anticipated—or—anticipated—with an explanation at the end of the paragraph." \d "[ 3 ]" anticipated by FILLIN "Insert the prior art relied upon." \d "[ 4 ]" STN( STN, CAS 2121516-29-6 REGISTRY, Entered STN: 28 Aug 2017). 762000 832485 The reference STN teaches the following compound, wherein R2=R1=H,n1=1, X1=bond, n2=1, X2=CO, X3=O, A=substituted heterocyclyl . This anticipates claim 28 . . Conclusion Claims 1-10, 28 , 35-39 are rejected. Claims 11-27 and 29-34 are withdrawn . Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ALISON AZAR SALAMATIAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4584 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off) . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney Klinkel can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5239 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /A.A.S./ Examiner, Art Unit 1627 /Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627