USE OF HPK1 INHIBITOR IN TREATMENT OF INTERFERON-RELATED DISEASES

§101 §102 §103 §112

DETAILED ACTION Claims 1-15 are pending in the present application. Claims 8-12 and 15 are withdrawn. Claims 1-7 and 13-14 are rejected for the reasons set forth below. No claim is allowed. 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 Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. 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. Priority Claim Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Applicant cannot rely upon the certified copy of the foreign priority application to overcome the rejections below because an English-language translation has not been made of record in accordance with 37 CFR 1.55. When an English translation of a non-English foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP1 §§ 215 and 216. No such statement or translation is found in the record. Election/Restrictions Applicant’s election with traverse of Group I, drawn to use of a HPK1 inhibitor in the prep-aration of a drug, in the reply filed on August 10, 2026 is acknowledged. No particular reason is given for the traversal, so it is deemed proper and is therefore made FINAL. Claim 15 is with-drawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on August 10, 2026. As explained below, a “use” is not patentable subject matter in the United States. The examiner therefore presumes that Group I is drawn to a “process” (or “method”) within the meaning of 35 U.S.C. 101. Claim 15 will not be eligible for rejoinder for the reasons discussed in MPEP 821.04, so the examiner suggests that this claim be cancelled. Applicant’s election with traverse of Compound “C1” (see instant claim 13) as the species for initial examination is also acknowledged. No specific reason is given for traversal, so the requirement is deemed proper and is therefore made FINAL. Claims 8-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. As explained below, the elected species is not allow-able, so the provisional election is given effect and examination is limited to claims to the elected species, with claims drawn to species patentably distinct from the elected species held with-drawn from further consideration. See MPEP 803.02. Applicant timely traversed the election requirement. Objection to The Specification The specification is objected to because certain chemical structures are illegible. See, e.g., pp. 6-12 and 54. Appropriate correction is required. Claim Objections Claim 7 is objected to because the chemical structures are illegible. Appropriate correc-tion is required. Improper Markush Grouping Claims 1-3 and 14 are rejected2 on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these require-ments in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, they and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117. The Markush grouping of claims 1-3 and 14 (especially claim 3) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the claims are drawn to isoquinolines (see, e.g., claims 8-12), classifiable in C07D 215/00, as well as quinazolines (see, e.g., claims 4-7), classifiable in C07D 239/72. The dissimilarity in the chemical structures of isoquinolines and quinazolines are self-evident; a search of the prior art in respect of one group of compounds will not necessarily produce the relevant prior art for consideration of patentability of the other group. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independ-ent or dependent claims or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. This is a rejection on the merits and is appealable. Claim Rejections – 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufac-ture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-7 and 13-14 are rejected under 35 U.S.C. 101 because they are drawn to non-statutory subject matter. The claims are drawn to a “use,” which is not a “process, machine, manufacture, or composition of matter” within the meaning of § 101. The examiner understands that in certain foreign jurisdictions “use” claims may be permitted. They are not statutory subject matter in the United States. It is the examiner’s impression, however, that applicant intends the claimed subject matter to be a “process” (or “method”) for treating certain diseases. Claim Rejections – 35 USC § 112(b) 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. Claims 1-7 and 13-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The claims are drawn to a “use” of HPK1 inhibitors. Attempts to claim a process without setting forth any steps involved in the process raises an issue of indefiniteness under 35 U.S.C. 112(b) because it is unclear what steps one must perform in order to meet the limitations of the claims. See MPEP 2173.05(q). The examiner suggests that the “use” claims be amended to “process” (or “method”) claims. In addition, the claimed “solvate,” “prodrug,” “metabolite,” and “derivative” (see, e.g., instant claim 3) are undefined and therefore indefinite. Claim Rejections – 35 USC § 112(a) 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. Claims 1-7 and 13-14 rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter that 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, at the time the application was filed, had possession of the claimed invention. At issue here are the claimed “solvate,” “prodrug,” “metabolite,” and “derivative” (see, e.g., instant claim 3). In general, an application may show that the inventor was in 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. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See MPEP 2163. Applicant’s specification includes no data, structures, figures, diagrams, formulas, and so forth for any of the claimed solvates, prodrugs, metabolites, and derivatives. The search of the prior art reveals that there are no known solvates, prodrugs, metabolites, or derivatives known for the compounds at issue. 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. Claims 1-2 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2021/254118 A1 by Lin et al. For convenience, this discussion refers to US 2023/0241050 A1, which is the English-language equivalent of this reference. The actual basis for rejection, however, is the original Chinese-language publication. Lin et al. discloses “use of an HPK1 kinase inhibitor in the preparation of a medicament for preventing and/or treating a disease or condition caused by or associated with pathogen infection in an animal” (para. 0005). Specifically, the pathogen is a virus (para. 0062-63), includ-ing many of the very same viruses recited in instant claim 14 (see para. 0064 of the reference). 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are explained in MPEP 2141 et seq. They are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1-7 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over CN 114315798 A by Jin et al. in view of WO 2020/255022 A1 by Horton et al. Jin (cited in applicant’s IDS3) discloses (pp. 5-8) the same compounds recited in instant claim 7. It also discloses applicant’s elected species, compound “C1” (see the first compound at p. 30 of the reference; it is implicit that the chemical structure in the reference includes all stereoisomers). This reference further discloses (para. 0003) as follows: 本申请的一个目的是提供一种喹唑啉类化合物及其药物组合物，本申请的化合物 可高效抑制HPK1激酶的活性，具备极高的成药性。 The foregoing paragraph is translated4 as follows: An object of the present application is to provide a quinazoline compound and a pharmaceutical composition thereof; the compound of the present application can highly effectively inhibit HPK1 kinase activity and possesses excellent druggability. The difference between the prior art and the claims at issue is that Jin does not specifically disclose treating or preventing a viral infection. Horton (also cited in applicant’s IDS), however, discloses (pp. 40-41) that “inhibitors of hematopoietic protein kinase 1 (HPK1) … can be useful in the treatment or prevention, particu-larly the treatment, of diseases that are susceptible to the effects of the immune system,” such as viral infection. “HPK1 inhibitors can enhance an immune response, increase T cell activity,” and are “useful for treating or preventing, in particular treating, infectious diseases, … particularly viral infections.” Especially “chronic viral infection, e.g., chronic HBV infection,” i.e., hepatitis B infection. It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to use the HPK1 inhibitors of Jin in the treatment of viral disease, such as hepatitis B infection, as taught by Horton and thereby arrive at subject matter within the scope of the instant claims. In general, it is prima facie obvious to use an existing compound in accordance with its known or expected pharmaceutical properties and thereby arrive at a readily predictable outcome. See, e.g., MPEP 2144.07, which explains that the “selection of a known material based on its suitability for its intended use” is generally prima facie obvious. Apprised of the utility of HPK1 inhibitors in the treatment of viral infection as taught by Horton, it would have been apparent that the compounds of Jin would be useful in methods of treating viral disease. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (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. THEODORE R. HOWELL Primary Examiner Art Unit 1628 /THEODORE R. HOWELL/Primary Examiner, Art Unit 1628 October 14, 2026 1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024] 2 It appears that claims 8-12 would also be rejectable, although they are withdrawn. 3 See the information disclosure statement (IDS) submitted on August 23, 2024. 4 Translations obtained from Google Translate (https://translate.google.com).