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 2. Applicant’s election without traverse of Group I, claims 1, 3, 7, 32, 45, 78 and 148, drawn to a compound of Formula (I’) in the reply filed on March 6, 2026 is acknowledged with appreciation. 3. Claims 49, 50, 76, 77, 89, 90, 96, 104, 110, 111, 117, 122, 124, 125, 128, 133, 136, 140, 141, 150, 152, and 166 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to the nonelected inventions of Groups II-VIII, without traverse, there being no allowable generic or linking claim. 4. Applicant additionally elected the species of compound I-1: which is readable on claims 1, 3, 7, 32, 45, 78 and 148. 5. The non-elected species are withdrawn from consideration as directed to nonelected subject matter, without traverse. Application Status 6. Applicants’ elected species of the compound of formula ( I ’) was found to be free of the prior art. A ccord ingly, the search is extended to include the full genus of compounds of Formula (I’). 7 . Claims 1, 3, 7, 32, 45, 78 and 148 are under examination and are the subject of this office action. Information Disclosure Statement 8 . The information disclosure statement s (IDS) submitted on October 16, 2023 (two IDS’s) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement s have been considered by the examiner , please refer to the signed copies of Applicant’s PTO-1449 forms, attached herewith. Claim Rejections - 35 USC § 112(b) 9 . 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. 10 . Claim s 1, 3, 7, 32, 45, and 78 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. 1 1 . Claim 1 recites a compound according to Formula (I’) , and in line 3 , the claim also recites “or a …composition .” The preamble of claim 1 is drawn to a compound, therefore it is not clear if Applicant is attempting to expand the claim to additionally comprise a composition according to Fo rmula (I’). Clarification is requested. Claim Rejections - 35 USC § 112(a) 1 2 . 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. 1 3 . Claim s 1, 3, 7, 32, 45, 78 and 148 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement regarding the scope of compounds and alternatives according to the genus of Formula (I’) . The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In particular, support cannot be found for the full scope of compounds of Formula (I’) , or their solvates, hydrates, polymorphs, co-crystals, tautomers, stereoisomers, isotopically labeled derivatives, prodrugs, compositions, or mixture thereof as instantly recited by the claims . 1 4 . The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co. , 119 F.3d 1559 (Fed. Cir. 1997), cert. denied , 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” ( Id. ), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar , 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus ( i.e ., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that uses open-ended language such as “or an isotop ically labeled derivative thereof . ” In such a case, the claim simply recites the generic “derivative,” and may do so without describing species that achieve that result. But the specification must demonstrate that the Applicant has made a generic invention that achieves the claimed result and do so by showing that the Applicant has invented sufficient alternative species to support the claim to the generically-defined genus. 1 5 . The factors considered in the Written Description requirement are: (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and (5) the method of making the claimed invention. 1 6 . Level of skill and knowledge in the art : The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks. 1 7 . Partial structure; Physical and/or chemical properties; and Functional characteristics: The claims are drawn to a compound according to the vast genus of Formula (I’) : , or a pharmaceutically acceptable salt, solvate, hydrate, polymorph, co-crystal, tautomer, stereoisomer, isotopically labeled derivative, prodrug, composition, or mixture thereo f, and its pharmaceutical composition thereof. In the instant case, it is evident that the genus of compounds embraced by formula (I ’ ) has substantial variance. T he claimed genus of formula (I’) is virtually without limit, embracing hundreds of thousands of compounds , and potentially millions, which bear little structural overlap with one another , i.e. , presently the genus of compounds according to formula (I’) embraces compound species wherein each of the variables R, R 1 , R 2 , R 3 and R 4 can be any carbocycle, heterocycle, aryl or heteroaryl , without limit , which can be optionally substituted with any substituent without limit . 1 8 . The Specification defines the term “solvate” and states that “r epresentative solvates include hydrates, ethanolates, and methanolates ” but fails to provide examples of such (paragraph [0092]). The Specification defines the term “tautomer,” and states that “[e] xemplary tautomerizations include keto-to-enol, amide-to-imide, lactam-to-lactim, enamine-to-imine, and enamine-to-(a different enamine) tautomerizations ,” but fails to provide examples of such (paragraph [0094]). Regarding stereoisomers, the Specification defines the terms isomer and stereoisomer (paragraph [0095]) but fails to define the preparation of any such stereoisomers other than the chirality indicated in Formula (I’) of claim 1. The Specification defines t he term "polymorph" : “ refers to a crystalline form of a compound (or a salt, hydrate, or solvate thereof). All polymorphs have the same elemental composition. Different crystalline forms usually have different X-ray diffraction patterns, infrared spectra, melting points, density, hardness, crystal shape, optical and electrical properties, stability, and solubility ,” but fails to disclose the preparation of any such polymorphic forms or co-crystals thereof (paragraph [0096]). Regarding “prodrug ,” the Specification describes types of prodrugs: “[p] rodrugs include acid derivatives well known to practitioners of the art, such as, for example, esters prepared by reaction of the parent acid with a suitable alcohol, or amides prepared by reaction of the parent acid compound with a substituted or unsubstituted amine, or acid anhydrides, or mixed anhydrides. Simple aliphatic or aromatic esters, amides, and anhydrides derived from acidic groups pendant on the compounds described herein are particular prodrugs. In some cases it is desirable to prepare double ester type prodrugs such as (acyloxy)alkyl esters or ((alkoxycarbonyl)oxy)alkylesters , C 1 -C 5 alkyl, C2-C 5 alkenyl, C2-C 6 alkynyl, aryl, C7-C12 substituted aryl, and C7-C12 arylalkyl esters of the compounds described herein ,” (paragraph [0097]), however, the Specification fails to disclose any examples or alternatives thereof of said polymorphs . The Specification states that the compounds may include one or more isotopically enriched atoms : “[f] or example, compounds having the present structures except for the replacement of hydrogen by deuterium or tritium, replacement of 19 F with 18 F, or the replacement of 12 C with 13 C or 1 C are within the scope of the disclosure. Such compounds are useful, for example, as analytical tools or probes in biological assays ,” (paragraph [0033]), but fail to provide examples of such. 19. The instant compounds are alleged by the Specification to be transcriptional enhanced associate domain (TEAD) transcription factor inhibitors, which may be useful as therapeutics for the treatment of diseases associated with overexpression activity of a transcription factor (paragraph [004]). 20. Method of making : I t is evident that the genus of compounds embraced by the claims has substantial variance , for example, each of the variables R, R 1 , R 2 , R 3 and R 4 can be any unsubstituted or substituted carbocycle, heterocycle, aryl or heteroaryl , without limit, such that the scope of compounds of Formula (I’) recited by claim 1 embraces hundreds of thousands of compound species, and potentially millions of compound species , as well as their salts, solvates, hydrates, polymorphs, co-crystals, tautomers, stereoisomers, isotopically labeled derivatives, prodrugs, compositions, or mixtures thereof. Yet, the instant Specification discloses the preparation of only four compound species according to Formula (I’) as broadly recited by the claims : see Table 10 (page 151) and the Syntheses of compounds I-1, I-6, I-7 and I-9 ( pages 152-158 ) . 21 . While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad gene ric claim . For example, in In re Gostelli , the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli , 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of the preparation of just four compounds ( i.e ., I-1, I-6, I-7, and I-9) does not adequately describe a genus embracing hundreds of millions of possible compounds. T hat is, the Specification does not disclose a sufficient variety of species to reflect the breadth of the possible compound selections recited in the claims . 2 2 . The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Ariad , 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. Eshhar , 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir. 2005). The fields of biology and chemistry are considered “unpredictable” because the complexity and unpredictability of chemical and biological interactions can make it difficult to understand the exact properties of an invention. A person of ordinary skill in the art from the specification or from the prior art cannot predict the pharmacological effects of administration of the instant formulation in subjects in regards to prevention of pain . The pharmaceutical industry is the prototypical example of a highly unpredictable field. Pfizer v. Teva Pharm ., 482 F.Supp.2d 390, 413 (D.N.J. 2007 ); 2 Chisum on Patents § 5.04. 2 3 . Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure to use the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester , 358 F 3d at 923; Eli Lilly , 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.” Vas-Cath Inc. v. Mahurkar , 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). 2 4 . The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder , 736, F.2d 1516, 1521,222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). 2 5 . Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of compounds of Formula (I’) and their salts, solvates, hydrates, polymorphs, co-crystals, tautomers, stereoisomers, isotopically labeled derivatives, prodrugs, compositions, or mixtures thereof as recited in the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. As such, claim s 1, 3, 7, 32, 45, 78 and 148 are rejected. Conclusion 2 6 . Claims 1, 3, 7 ,32, 45, 49-50, 76-78, 89-90, 96, 104, 110-111, 117, 122, 124-125, 128, 133, 136, 140-141, 148, 150, 152, and 166 are p resent in the application . Claims 49, 50, 76, 77, 89, 90, 96, 104, 110, 111, 117, 122, 124, 125, 128, 133, 136, 140, 141, 150, 152, and 166 are currently withdrawn . Claims 1, 3, 7, 32, 45, 78 and 148 are rejected. No claim is presently allowable. 2 7 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JANET L COPPINS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0680 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8:30AM-5PM 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, FILLIN "SPE Name?" \* MERGEFORMAT Amy L Clark can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-1310 . 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. /JANET L COPPINS/ Examiner, Art Unit 1628 /Rayna Rodriguez/ Primary Examiner, Art Unit 1628