COMPOUNDS AND THEIR USE IN TREATING CANCER

FINAL REJECTION Receipt is acknowledged of Applicants' Amendments and Remarks, filed Jun. 2, 2026. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims. STATUS OF THE CLAIMS Claims 6-15, 18-21, and 23-71 have been canceled. Claims 1, 3, and 16 have been amended and incorporate no new matter. No new claims have been added. Claims 17 and 72 stand withdrawn as drawn to nonelected inventions and/or species. Thus, claims 1-5, 16, and 22 now represent all claims currently pending and under consideration. INFORMATION DISCLOSURE STATEMENT The information disclosure statement (IDS) submitted on Mar. 17, 2026 was filed after the mailing date of the non-final action on Dec. 2, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. MAINTAINED REJECTIONS The following rejection is maintained from the previous Office Action dated Dec. 2, 2025, on the ground that the references cited therein continue to read on the limitations of the amended claims. Claim Rejections - 35 U.S.C. § 112(b) – Indefiniteness Claims 1-5, 16, and 22 stand 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 pre-AIA the applicant regards as the invention. As recognized by MPEP § 2173.05(g), a claim term is merely functional descriptive language when it recites a feature "by what it does rather than by what it is" (e.g., as evidenced by its specific structure). In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971). The following factors are considered when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention, or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise. Here, the claims recite compounds of formula (I), having the structural formula, PNG media_image1.png 136 280 media_image1.png Greyscale wherein A is a "BRD4 binding unit." However, the term describes only the result achieved by A, not its structure. The specification provides no definition for the term, which also has no clear-cut, commonly understood definition in the art. Those skilled in the art understand that, functionally, a BRD4 binding unit is a chemical moiety that binds to BRD4 (Bromodomain and Extraterminal domain protein 4) to some degree. However, the structures encompassed by the term “BRD4 binding unit” have no clear boundary. The instant specification fails to disclose any BRD4 binding units. Only a "protein binding unit" is disclosed in embodiment A (specification page 9, lines 1-2), having the structural formula, PNG media_image2.png 200 153 media_image2.png Greyscale . Beyond this, neither the claims nor the specification further define or describe the chemical structure(s), formula(s), or structural moieties encompassed by a "BRD4 binding unit." In the absence of a structural definition set forth in the specification, a "BRD4 binding unit" encompasses any substance capable of binding to any BRD4 protein, e.g., small molecule ligands, functional groups, antibodies, etc., which bind to any BRD4 protein at any site, to any degree, and in any way, e.g., covalently or non-covalently. While methods of assaying for BRD4 binding activity are known in the art, the term "BRD4 binding unit" includes substances with levels of BRD4-binding activity which are detectable but too low to have any therapeutic utility, as well as substances which have not yet been identified. Thus, the exact set of substances encompassed by formula (I) and excluded therefrom, cannot be unambiguously determined by one of ordinary skill in the art. Substances encompassed by the term "BRD4 binding unit" cannot be readily distinguished from substances which are excluded. Therefore, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite. Claim Rejections - 35 U.S.C. § 112(a) - Written Description Claims 1-5, 16, and 22 stand 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. The claim(s) contains 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims are drawn to compounds of formula (I), encompassing compounds of unknown structure, such that one of ordinary skill in the art could not reasonably conclude that the applicant was in possession of the claimed genus as of the filing date. The description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). This matter is of particular importance in the evaluation of claims drawn to a chemical genus which identifies a core compound bearing variable substituents. "A generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification . . . demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010). An adequate written description requires a precise definition, such as by structure, formula, chemical name, or properties of species falling within the genus, sufficient to distinguish the genus from other materials. Id., quoting Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). A sufficient disclosure is one which reasonably conveys to one having ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date. Vas-Cath, 935 F.2d at 1563. The description must reasonably describe the invention, not simply indicate a result which one might achieve if one actually made the invention. Eli Lilly, 119 F.3d at 1568. To properly evaluate whether an applicant has complied with the written description requirement therefore requires an analysis of whether the skilled artisan would recognize, from the description provided, the applicants were in possession of sufficient compounds representing the full breadth of diversity of the genus claimed. Here, amended claim 1 recites compounds of formula (I), wherein the structures of variable groups Z and Y are clearly defined. However, variable group A is any undefined “BRD4-binding unit.” The specification provides no definition of “BRD4-binding unit,” no examples, and no structure-function correlation. While methods of assaying for BRD4 binding activity are known in the art, the term "BRD4 binding unit" includes substances with levels of BRD4-binding activity which are detectable but too low to have any therapeutic utility, as well as substances which have not yet been identified. Thus, the scope of formula (I) is structurally undefined, against which the specification exemplifies only THREE (3) compounds falling within the genus: Examples 127, 128, and 129. While PROTAC (proteolysis targeting chimera) compounds are known in the art, comprising an E3 ubiquitin ligase binding domain and a protein-binding domain connected by a linker of variable length, those skilled in the art would not recognize that the unknown scope of claimed formula (I) was actually in the applicants’ possession as of the filing date. "[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1173-74 (Fed. Cir. 2010), quoting University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 930 (Fed. Cir. 2004). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention” – that is, conceive of the complete and final invention with all its claimed limitations – and disclose the fruits of that effort to the public. Id. RESPONSE TO ARGUMENTS The claim amendments filed Jun. 2, 2026 overcome the rejections under 35 U.S.C. § 103 and on the ground of nonstatutory obviousness-type double patenting. With respect to the rejections under 35 U.S.C. §§ 112(a) and 112(b), Applicant's arguments filed Jun. 2, 2026 have been fully considered but they are not persuasive. Regarding the rejection under 35 U.S.C. § 112(b), Applicant argues that the claims have been amended to replace “protein binding unit” with "BRD4 binding unit,” which is a specific, well-characterized bromodomain protein target, with support for "BRD4 binding unit" found on at least pages 8, 34, 35, and 156-158 of the as-filed Specification (Remarks, p. 7). Regarding the rejection under 35 U.S.C. § 112(a), Applicant argues that claim 1 is amended to limit A to a "BRD4 protein binding unit". Support for "BRD4 binding unit" is found on at least pages 8, 34, 35, and 156-158 of the as-filed Specification, where BDR4 is the sole target disclosed as it pertains to bifunctional degraders comprising a BDR4-binding unit coupled to a defined cereblon-recruiting moiety and linker (Remarks, p. 9). It is acknowledged that BRD4 (Bromodomain and Extraterminal domain protein 4) is a specific, well-characterized bromodomain protein target. However, because there is no objective, art-recognized way to determine which chemical moieties are encompassed by the term "BRD4 binding unit," versus which are excluded, the structure of compounds of formula (I) remain open-ended and undefined. Both “protein binder unit” and “BRD4 binding unit” suffer from the same defect, in that they attempt to define compounds of formula (I) by their function (what they do), rather than by their structure (what they are). Substances and chemical moieties that bind to BRD4 are structurally diverse. Nowhere in the specification is the “BRD4 binding unit” of formula (I) defined in structural terms, nor does the term draw any structural boundary. As a result of this ambiguity, an accurate, comprehensive structure search of compounds of formula (I) cannot be carried out. Because formula (I) remains an open-ended functional genus of undefined scope and with no clear boundary, the rejections under 35 U.S.C. §§ 112(a) and 112(b) are maintained. CONCLUSION No claims are allowed. 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. CORRESPONDENCE Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /SARA E. TOWNSLEY/Examiner, Art Unit 1629