Prosecution Insights
Last updated: August 17, 2026
Application No. 18/287,690

MULTIFACETED APPROACH TO NOVEL INTERLEUKIN-6 INHIBITORS

Non-Final OA §102§112§DP
Filed
Oct 20, 2023
Priority
Apr 21, 2021 — provisional 63/177,779 +2 more
Examiner
BARSKY, JARED
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
University of Florida Research Foundation Inc.
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
73%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
469 granted / 933 resolved
-9.7% vs TC avg
Strong +23% interview lift
Without
With
+23.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
75 currently pending
Career history
1015
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
49.3%
+9.3% vs TC avg
§102
8.5%
-31.5% vs TC avg
§112
16.6%
-23.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 933 resolved cases

Office Action

§102 §112 §DP
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 . Claim of Foreign Priority Applicant has not claimed foreign priority. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Election/Restrictions Applicant’s election of Group I, corresponding to claims 1, 39, 74, 89, 98, 122, 125, 128, and 131, and Formula (F) as well as compound LLM418-MCBu, in the reply filed on June 16, 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant submits that claims 1 and 98 encompass the elected species. The examiner notes that the elected species is also known as STN CAS RN: 2854300-83-5. It was entered in the STN database on November 17, 2022. The examiner has expanded his search to a single additional compounds species. The following compounds are taught in U.S. Pat. No. 11,530,181, which is applied in a Double Patenting rejection and a §102 rejection below. See page 30. PNG media_image1.png 216 389 media_image1.png Greyscale , wherein RA2 is halogen. Similarly, there are compounds in which R2 is substituted. See p30. PNG media_image2.png 299 792 media_image2.png Greyscale As such, the examiner applies these compounds in a rejection below. Status of the Claims Claims 1, 74, 89, 94, 98, 100, 110, 122-133 are pending. Claims 74, 89, 94, 98, 100, 110, and 122-133 are withdrawn. Claims 1 and 98 are examined. 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 1 and 98 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the 18 compound species set forth in Specification, are not considered enabled for the all polymorphs, co-crystals, isotopically labeled derivatives, prodrugs and compounds with “optionally substituted” variables claimed in claims 1 and 98. The Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Optionally substituted means with anything. See p23-25 of the Specification. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.” In the instant case, the claimed invention pertains to compounds of Formula (I), which are alleged by the Specification to act as inhibitors of IL-6 signaling or inhibiting IL-6/gp130. The Specification provides examples of the synthesis of 18 compounds. See pp147-179. The State of the Prior Art and the Relative Skill of those in the Art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.” The examiner cites: Lemli et al., “Prioritizing Computational Cocrystal Prediction Methods for Experimental Researchers: A Review to Find Efficient, Cost-Effective, and User-Friendly Approaches,” Int J Mol Sci. 2024 Nov 9;25(22): 12045, in describing the extensive process required to make a co-crystal. Lemli explains: The prediction of cocrystals involves using computational and theoretical methods to identify potential cocrystal formers and understand the interactions between the active pharmaceutical ingredient and coformers. This process aims to predict whether two or more molecules can form a stable cocrystal structure before performing experimental synthesis, thus saving time and resources. A conventional screening process takes into account C solvent evaporation, solution crystallization, dry, liquid-assisted grinding, and melt crystallization, and others, have been foundational in the discovery and development of new cocrystals. More importantly, “However, as practical as they may be, these approaches require extensive laboratory work and are trial-and-error-based, often yielding inefficiencies.” The examiner also cites: Sailaja et al., “Enhancing prodrug development, strategies and challenges,” Int J. Pharm. Drug. Anal, Vol: 13, Issue: 4, 2025; 4-13. Sailaja explains, “Prodrug creation, despite its potential, is a complicated process that involves factors like membrane permeability, enzymatic activation, and chemical stability.” Abstract. As discussed above, the instantly claimed invention pertains to compounds of Formula (F), which are alleged by the Specification to act as inhibitors of IL-6 signaling or inhibiting IL-6/gp130. At the time the instant application was filed, it would have been known by those of ordinary skill in the art that - due in large part to the strict requirement of complementarity between a compound and its corresponding binding site on a target receptor or enzyme - compounds, in the vast majority of cases, demonstrate a remarkably high correlation between their structure, specificity and ability to produce a pharmacological effect. At the same time, it would have also been generally assumed that two compounds with similar chemical properties would exhibit similar biological effects. Thus, given a series of compounds that are shown to exert an activity of interest (or given a target of interest), the ordinarily skilled artisan would have expected that a limited genus of related compounds (e.g., compounds exhibiting near equal molecular shapes and volumes, approximately the same distribution of electrons, and similar physical properties such as hydrophobicity, etc.) would interact with the given target to elicit a related biological response. The Level of Predictability in the Art: Once a compound has been identified by ligand based and/or structure based drug design methods as potentially binding to the target molecule, it must be evaluated. Usually, several molecules which scored well during the docking run are evaluated in further tests since even the top scoring molecule could fail in vitro assays… Finally, leads are brought into the wet lab for biochemical evaluation. A low level of predictability is not surprising considering that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. Indeed, modifying even a single atom in a compound can dramatically change the compound’s overall structure and - even though complementarity in one portion of the compound might be improved by the chemical revision - the overall binding or activity might be severely compromised. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification discloses few examples of polymorphs, co-crystals, isotopically labeled derivatives, prodrugs and compounds with “optionally substituted” variables. While examples of isotopes are discussed, there are limited to specific fluorine isotopes, deuterium or tritium, or carbon. See par.’s 42 and 43. Examples 1-18 provide for the synthesis of solid forms through specific conditions and there does not appear to be any XRPD data. Specific conditions, include solvents, ratios of solvents, temperatures, purification techniques and other factors that were presumably required to yield a synthesized product or form of product. It is not clear that if any of these conditions were to be varied that the described product would be the same. Thus, providing examples may allow applicant to claim those specific examples, it does not provide for a POSA to understand how to make and use all permutations of those compounds that are claimed, including all polymorphs, e.g. There are no examples of a specific polymorph, co-crystal, or prodrug. The Specification explains: “Various polymorphs of a compound can be prepared by crystallization under different conditions.” See par. 104. It is not clear what these “different conditions” entail. Polymorph formulation requires a specific set of conditions, which can each impact a formulated polymorph. There is no direction or guidance in the Specification. Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use” (emphasis added). Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification 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 (Fed. Cir. 1993) (emphasis added). At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims". Amgen, Inc., v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation.” As to the first inquiry, as discussed above, the claims are drawn to compounds of Formula (I), which are alleged by the Specification to as inhibitors of IL-6 signaling or inhibiting IL-6/gp130. Considering that each polymorph, even when using identical solvents and/or solvent combinations can yield a distinct polymorph, the claimed of all polymorphs is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below. Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to compounds of Formula (F), and all polymorphs, co-crystals, isotopically labeled derivatives, prodrugs and compounds with “optionally substituted” variables thereof. Since identifying any compound which is capable of modulating the activity of a specific receptor, ion channel, or enzyme is extremely complex, the nature of the instant invention considered to be one of extreme complexity. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan (armed with screening techniques including computer assisted virtual screening techniques such as ligand-based and structure-based design methods) could not reasonably predict which of the polymorphs, co-crystals, isotopically labeled derivatives, and prodrugs and compounds with “optionally substituted” variables would exert the alleged activity based on the limited disclosure showing not a single specific polymorph, co-crystal, or prodrug, e.g. Although the skilled artisan would have known that certain chemical modifications to the disclosed compounds may predictably provide structurally related compounds having similarly activity, the skilled artisan would have also known that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. Thus, in order to identify polymorphs, co-crystals, isotopically labeled derivatives, and prodrugs and compounds with “optionally substituted” variables of Formula (F), the skilled artisan (at minimum) would have to carry out ligand based drug design methods using compounds of Formula (F) as a starting point and, assuming the structure of the target receptor was known, combine the findings with data derived from structure based drug design methods to arrive at a small library of “lead” compounds believed to possess the activity of interest. The skilled artisan would then synthesize lead compounds that are within Formula (F) for in vitro testing. Given the unpredictability of the chemical arts, it is highly unpredictable whether any compound within the subgenus of compounds of Formula (F) identified by rational drug design based on the instant disclosure would, in fact, be usable. Whether the other compounds of Formula (I) (i.e., those not identified by rational drug design based on the instant disclosure) would be usable is even less predictable. As such, the only way to ascertain which of the hundreds of millions, and potentially billions, of claimed compounds encompassed by Formula (I) are usable based on the limited disclosure would require undue experimentation. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure. Claim Rejections - 35 USC § 112 (Written Description) Claims 1 and 98 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. 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. Following reasons apply: Claimed compounds include all polymorphs, co-crystals, isotopically labeled derivatives, and prodrugs and “optionally substituted” of compounds of Formula (F). It is not entirely clear which polymorphs, co-crystals, isotopically labeled derivatives, and prodrugs and “optionally substituted,” etc., were contemplated as not a single example of any of these categories of agents, have necessarily been identified nor described in the Specification. The instant Specification tests synthesizes approximately 18 total compounds. See pp147-179. None of these are co-crystals, prodrugs, or polymorphs. It is not clear what solvents and conditions are required to yield each. The Specification does not describe other nor test nor contemplate any other specific compounds. Claimed invention is not fully described in the specification. The written description requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of claimed invention. 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, and demonstrate that by disclosure in the specification of the patent. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003). Written description requirement, serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void. See MPEP 2163.01-02) for General principles governing compliance with the written description requirement applications. 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention The written description requirement has several policy objectives. “[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed.” In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term. Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable". Whenever the issue of written description arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). MPEP 2163.02). Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed. The written description requirement is not satisfied by the appearance of mere indistinct words in a specification or a claim, even an original claim. . A description of what a material does, rather than of what it is, usually does not suffice." Enzo, 323 F.3d at 968 (citing Eli Lilly, 119 F.3d at 1568); see Rochester, 358 F.3d at 926 ("[G]eneralized language may not suffice if it does not convey the detailed identity of an invention."). The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genentech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999). Written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate written support. Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. Where the specification provides only constructive examples in lieu of working examples, it must still "describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all of the elements and limitations. It is suggested to amend the claims to represent the embodiments in the Specification that were possessed at the time of filing. Claim Rejections - 35 USC § 102 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1 and 98 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Li et al., (WO2019/165158). Li teaches compounds for treating IL-6 mediated conditions. See Abstract. Compounds include those of a generic formula (I) in addition to pharmaceutically acceptable salts, solvates, hydrate, or prodrugs thereof. PNG media_image3.png 167 279 media_image3.png Greyscale . Further, a more specific formula includes: PNG media_image4.png 230 395 media_image4.png Greyscale (col. 16), wherein D is oxygen, Y is a bond, p is 2, and o is 0. See col. 7, lines 43-50. Compositions are contemplated comprising pharmaceutically acceptable carriers. See, e.g., prior art claim 6. PNG media_image5.png 285 413 media_image5.png Greyscale . See col. 30, lines 20-40. Other compounds that are included in the claim 1 are: PNG media_image6.png 269 444 media_image6.png Greyscale , wherein RA2 is halogen. See p32. As such, claims 1 and 98 are anticipated by the prior art. 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 and 98 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,530,181. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘181 patent include compounds that fall within the scope of the instant claims. For example, compound LLM18 is claimed in claim 4 of the ‘181 patent. Significant overlap exists and as such, the claims are each drawn to identical products. As such, no claim is allowed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 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 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://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JARED BARSKY/Primary Examiner, Art Unit 1628
Read full office action

Prosecution Timeline

Oct 20, 2023
Application Filed
Jul 28, 2026
Non-Final Rejection mailed — §102, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
73%
With Interview (+23.1%)
2y 7m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 933 resolved cases by this examiner. Grant probability derived from career allowance rate.

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