Prosecution Insights
Last updated: April 19, 2026
Application No. 18/039,740

ALC1 Inhibitors and Synergy with PARPi

Non-Final OA §102§103§112
Filed
Jun 01, 2023
Examiner
DAHLIN, HEATHER RAQUEL
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Eisbach Bio GmbH
OA Round
1 (Non-Final)
46%
Grant Probability
Moderate
1-2
OA Rounds
3y 5m
To Grant
97%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
61 granted / 133 resolved
-14.1% vs TC avg
Strong +51% interview lift
Without
With
+50.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
83 currently pending
Career history
216
Total Applications
across all art units

Statute-Specific Performance

§101
4.6%
-35.4% vs TC avg
§103
33.3%
-6.7% vs TC avg
§102
19.8%
-20.2% vs TC avg
§112
25.7%
-14.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 133 resolved cases

Office Action

§102 §103 §112
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 . Priority This Application is a 371 of PCT/EP2021/084089, filed Dec. 3, 2021 and claims foreign priority to EP20211730.5, filed Dec. 3, 2020 with the European Patent Office. Information Disclosure Statement The information disclosure statements (IDS) submitted on Sept. 8, 2025; Sept. 4, 2025; July 22, 2025; and Feb. 25, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Status Claims 1-19 are currently pending. Applicant’s election without traverse of Group I, claim 1-7 and 15-16, and the compound PNG media_image1.png 172 279 media_image1.png Greyscale , in the reply filed on Dec. 2, 2025 is acknowledged. Claims 1-5, 7, and 15 read on the elected invention. The Applicant indicated that claims 6 and 16 read on the elected invention, however these claims are directed towards a bifunctional compound with an additional E3 ligase ligand moiety, and the elected species is not a bifunctional compound with an additional E3 ligase ligand moiety. Claims 1-5, 7 and 15 are active and subject to examination. Claims 6, 8-14, and 16-19 are withdrawn. Specification The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. 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. 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.” 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 applicant regards as his invention.” Claims 1-5, 7 and 15 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. Regarding claim 1, which is directed towards an allosteric inhibitor of ALC1, wherein the inhibitor specifically binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1, one of ordinary skill in the art cannot determine the metes and bounds of the claim because an ordinary artisan would not know what compounds meet this limitation. The Applicant has demonstrated that certain compounds of formula (I) inhibit ALC1, and the Applicant models the compounds as binding to this pocket in silico, but the Applicant has not shown an ordinary artisan how to actually determine if a compound is an allosteric inhibitor in this pocket. The Applicant has not conducted any mutational screening to demonstrate that the compound actually interacts with the proposed pocket. The Applicant has not solved the crystal structure of the compounds in this pocket. The Applicant cites Abbott et al. (Mol Cancer Ther (2020) 19 (8): 1598–1612)) on page 3 of the specification, where the first inhibitors of ALC1 were identified by a HTS of ALC1 ATPase activity. These compounds could be allosteric inhibitors of ALC1 as claimed and one of ordinary skill in the art would not know if they are allosteric inhibitors of ALC1 as claimed. The Applicant also presents no clear cutoff for the IC50 of these compounds and under what conditions they should bind to the pocket. As such, the metes and bounds of the claim are unclear. Claims 2-3, 7 and 15 depend from claim 1 and do not resolve this ambiguity and are also indefinite. Regarding claims 2-5, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 4 is also indefinite for multiple other reasons. First, it is unclear if N is only nitrogen or if N can be other groups because N is defined as a “hydrogen bond accepting group.” The claim lists the groups RA, R6 and R9 which are not defined. The limitations (i)-(xii) are separated by the conjunction and/or. It is therefore unclear what molecules are encompassed by the claim because the claim reads on molecules wherein e.g. only R5 is defined. Claim 5 is also indefinite because multiple substituents are not defined for each alternative limitation. The first alternative limitation recites: PNG media_image2.png 137 589 media_image2.png Greyscale R6, R7 and RA are not defined. For the second alternative limitation, R6, R7 and R9 are not defined. Claim Rejections – 35 USC § 112(a) – Written Description 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 1-5, 7 and 15 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 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. The written description requirement is distinct from the enablement requirement; this was first pointed out by the court in In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967), and clarified in Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991). The issue of whether the claimed subject matter is adequately supported/described by the specification, is a question of fact. Id. at 1563, 19 USPQ2d at Il 16. When considering whether the claimed subject matter complies with the written description requirement, Applicants' disclosure should be read in light of the knowledge possessed by those skilled in the art. "[T]he disclosure in question must be read in light of the knowledge possessed by those skilled in the art, and that knowledge can be established by affidavits of fact composed by an expert, and by referencing to patents and publications available to the public... " In re Lange, 644 F.2d 856, 863, 209 USPQ 288, 294 (CCPA 1981). see also, In re Alton, 76 F.3d 1168, 37 USPQ2d 1578 (Fed. Cir. 1996). Applicants enjoy the presumption that their patent application is valid and all statements contained therein are accurate; it is the PTO's burden to demonstrate why any of Applicants claims should be rejected or why any of Applicant's statements should be doubted. "it is incumbent upon the Patent Office, whenever a rejection... is made, to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement. Otherwise, there would be no need for the applicant to go to the trouble and expense of supporting his presumptively accurate disclosure. " In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). The court has made it clear that such challenges apply to written description rejections: "we are of the opinion that the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims." In re Wertheim, 191 USPQ 90, 97 (CCPA 1976). If successful in presenting such evidence and argument, the burden then shifts to the Applicant to provide evidence that would convince one to the contrary that the disclosure as a whole provides written description support for the claimed subject matter. The Claimed Invention The Applicant’s invention is directed towards an allosteric inhibitor of ALC1, wherein the inhibitor specifically binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1 (claim 1). The applicant further limits the allosteric inhibitor by the residues of the binding pocket (claim 2) and the function of the allosteric inhibitor in forming non-covalent bond(s) with one or more amino acids of the binding pocket. Claim 4 is dependent on claim 1, and limits the ALC1 allosteric inhibitor to a compound of formula (I): PNG media_image3.png 129 206 media_image3.png Greyscale . Claim 7 is directed towards a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient. Claim 15 is directed towards a kit comprising the compound of claim 1 and a PARP inhibitor. The Supporting Disclosure In the background of the invention, the Applicant summarizes the role of ALC1 in the poly-ADP-ribose polymerase (PARP) pathways and its implication in proliferative diseases (Specification, p. 1-4). In the summary of the invention, the Applicant states that the present invention relates to an allosteric inhibitor of ALC1, which binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1. The Applicant describes that the invention relates to compounds of formula (I): PNG media_image3.png 129 206 media_image3.png Greyscale . The Applicant also states that the invention relates to bifunctional compounds comprising the allosteric inhibitor and an E3 ligase ligand. The Applicant further provides pharmaceutical compositions comprising the ALC1 inhibitor (ALC1i) and a method of treating or ameliorating a proliferative disease in a patient comprising administering an ALC1i (Specification, p. 4-7). The Applicant provides the structures of about 278 ALC1 inhibitors in Figure 10. Not all tested ALC1 inhibitors are shown in Figure 10. For example, ALC1i-117 is not shown in Figure 10. Figure 21 shows the suppliers of each compound employed by the Applicant. In the detailed description of the invention, the Applicant describes certain embodiments and concepts pertaining to the invention, including in silico docking procedures, descriptions of the compounds of formula (I), certain PARP inhibitors, and methods of using the compound in combination with PARP inhibitors (pages 10-50). The Experimental section describes different assays employed by the Applicant to evaluate the ability of the compounds to inhibit ALC1i (pages 50-56). The primary method was a nucleosome sliding assay using purified components from which the IC50 for each compound was estimated. Regarding claim 4, the Applicant only presents a few specific species for R1, for example carboxylic acids or esters or amides, as the hydrogen bond donating group (e.g. p. 21). The Applicant presents only a few specific species for R3, for example, H, =O, -OH, ester groups and alkyls. The Written Description Requirement for Genus Claims The MPEP states that the disclosure must support the full scope of the claimed genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted)."). MPEP § 2161.01. The State of the Art, Relevant facts and Applicants Lacking Disclosure High throughput screening (HTS) is a common strategy in the art to identify enzyme inhibitors. For example, the Applicant cites Abbott et al. (Mol Cancer Ther (2020) 19 (8): 1598–1612)) on page 3 of the specification, where the first inhibitors of ALC1 were identified by a HTS of ALC1 ATPase activity. These inhibitors have varied structures and core features: PNG media_image4.png 1445 1800 media_image4.png Greyscale Abbott, Figure 3. It is unclear what binding pocket these inhibitors act through. The Applicant only describes allosteric inhibitors of formula (I), which have varied potency for inhibition of ALC1. In Fig. 11, the IC50 of the compounds ranges from greater than 250 micromolar, 25 to 250 micromolar, and less than 25 micromolar (Fig. 11; Specification, p. 9). The Applicant does not demonstrate that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. Allosteric inhibitors of ALC1 need not be compounds of formula (I), and could include structurally related or unrelated compounds. For example, allosteric inhibitors of the enzyme fructose 1,6-bisphosphate include structurally diverse compounds: PNG media_image5.png 244 530 media_image5.png Greyscale Heng et al., Bioorganic & Medicinal Chemistry, Volume 17, Issue 11, 1 June 2009, Pages 3916-3922. Regarding claim 4 and the claimed compound of formula (I), the Applicant has not described a sufficient number of species to describe the substituents for R1 and R3. Hydrogen bond donating groups encompass more substituents than the carboxylic acids or esters or amides disclosed for R1 or the H, =O, -OH, ester groups and alkyls disclosed for R3. Alkyls, esters, hydrogen alone, and oxygen alone are also not considered to be H-bond donors. H-bond donors are commonly understood in the are to be groups with an H atom bonded to a strongly electronegative atom such as O or N (see, e.g., “2.14: Organic Functional Groups- H-bond donors and H-bond acceptors”, LibreTexts Chemistry, 2026). 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 1-5 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. Claim 1 is directed towards an allosteric inhibitor of ALC1, wherein the inhibitor specifically binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1. Claims 2-3 further define the binding pocket. Claim 4 is dependent on claim 1, and further limits the allosteric inhibitor to a compound of formula (I): PNG media_image3.png 129 206 media_image3.png Greyscale . Claim 5 further limits the substituents of the compound of claim 4. The Specification gives about 278 examples of compounds of formula (I), some structures of which are presented in Fig. 10. The Applicant identified the compounds as inhibitors of ALC1 from a High Throughput Screen (HTS) that measured ALC1-mediated nucleosomal sliding (Specification, p. 52-53). Each compound used in the assay was purchased from a vendor. Figure 21 shows a table containing the supplier used for each inhibitor (Specification, p. 10). This appears to be an admission of the applicant as to the public availability and sale of the claimed invention prior to the effective filing date of the claimed invention. Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura et al. (US 20180015077 A1). Claim 1 is directed towards an allosteric inhibitor of ALC1, wherein the inhibitor specifically binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1. Claims 2-3 further define the binding pocket. Claim 4 is dependent on claim 1, and further limits the allosteric inhibitor to a compound of formula (I): PNG media_image3.png 129 206 media_image3.png Greyscale . Nakamura teaches compounds of formula (I), for example: PNG media_image6.png 189 208 media_image6.png Greyscale Nakamura, Specification, p. 97; PNG media_image7.png 157 193 media_image7.png Greyscale Nakamura, Specification, p. 104. Nakamura teaches that these compounds are compounds of formula (IIF): PNG media_image8.png 116 242 media_image8.png Greyscale (paragraph [0130]), which can be used in a method of treating HIV infection, comprising administering to a subject in need thereof an effective amount of the compound (paragraph [0460]). While Nakamura does not teach that the compound is an ALC1 allosteric inhibitor, this is an inherent property of the compounds. The specification teaches that these specific compounds are ALC1 allosteric inhibitors (compounds ALCi-58 and ALCi-94) (Figure 10), which have 100% inhibition of ALC at 250 micromolar (Figure 23). Therefore, claims 1-4 are anticipated. Claim 5 reads on the compounds of Nakamura above. Therefore, claim 5 is anticipated. Claim 7 is directed towards a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient. Nakamura teaches a pharmaceutical composition comprising the described compounds and a pharmaceutically acceptable excipient. (Nakamura, Specification, paragraph [0457]). Therefore, claim 7 is anticipated. Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grabowski et al. (Biochemical Pharmacology, Volume 154, August 2018, Pages 148-160) Claim 1 is directed towards an allosteric inhibitor of ALC1, wherein the inhibitor specifically binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1. Claims 2-3 further define the binding pocket. Claim 4 is dependent on claim 1, and further limits the allosteric inhibitor to a compound of formula (I): PNG media_image3.png 129 206 media_image3.png Greyscale . Grabowski teaches a compound of formula (I): PNG media_image9.png 119 132 media_image9.png Greyscale (Grabowski, p. 153, Fig. 5). Grabowski identified this compound as binding to TLR2 through virtual screening (id.). While Grabowski does not teach that the compound is an allosteric inhibitor of ALC1, this is an inherent property of the compound. This compound is compound ALCi-53 which inhibits ALC1 activity by 84.87% at a concentration of 3.91 micromolar (Instant Fig. 23). Therefore, claims 1-4 are anticipated. Claim 5 reads on compound 13 and is therefore also anticipated. Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodinovskaya et al. (Journal of Combinatorial Chemistry, Vol. 10, Issue 2, Feb. 13, 2008, p. 313-322) (of record, IDS 09/04/2025, NPL cite no. 2). Claim 1 is directed towards an allosteric inhibitor of ALC1, wherein the inhibitor specifically binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1. Claims 2-3 further define the binding pocket. Claim 4 is dependent on claim 1, and further limits the allosteric inhibitor to a compound of formula (I): PNG media_image3.png 129 206 media_image3.png Greyscale . Rodinovskaya teaches compounds of formula (I), for example the compounds having structures A or B (34,35), wherein X is Ad, pyridinyl, methyoxyphenyl, fluorophenyl, dimethyoxyphenyl, Benzodioxolyl, benzodioxinyl, methylphenyl, and chlorophenyl are all claimed compounds of formula (I): PNG media_image10.png 648 578 media_image10.png Greyscale Rodinovskaya, p. 319. While Rodinovskaya does not teach that the compound is an allosteric inhibitor of ALC1, this is an inherent property of the compound. The Specification teaches that these compounds are ALC1 inhibitors, for example, the following compounds of the instant Application are some of the compounds disclosed by Rodinovskaya above: PNG media_image11.png 388 584 media_image11.png Greyscale PNG media_image12.png 249 510 media_image12.png Greyscale PNG media_image13.png 113 558 media_image13.png Greyscale PNG media_image14.png 266 548 media_image14.png Greyscale Instant Fig. 10. These compounds are disclosed in Fig. 23 to have ALC1 inhibitory activity. Therefore, claims 1-4 are anticipated. Claim 5 also reads on these compounds so is also anticipated. Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andersson et al. (Journal of Medicinal Chemistry, Vol 55/Issue 17, July 23, 2012, p. 7706-7718). Claim 1 is directed towards an allosteric inhibitor of ALC1, wherein the inhibitor specifically binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1. Claims 2-3 further define the binding pocket. Claim 4 is dependent on claim 1, and further limits the allosteric inhibitor to a compound of formula (I): PNG media_image3.png 129 206 media_image3.png Greyscale . Andersson teaches a compound of formula (I) as a PARP14 (ARTD7) inhibitor: PNG media_image15.png 155 973 media_image15.png Greyscale Andersson, p. 7710; PNG media_image16.png 415 1027 media_image16.png Greyscale Andersson, p. 7711. While Andersson does not teach that the compound is an allosteric inhibitor of ALC1, this is an inherent property of the compound. This compound is disclosed in the specification as ALCi-61 (Figure 10), which is shown to have ALC1 inhibitory activity in Fig. 23. Therefore, claims 1-4 are anticipated. Claim 5 also reads on the compound 3 and is also anticipated. 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 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1-5, 7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. (Journal of Medicinal Chemistry, Vol 55/Issue 17, July 23, 2012, p. 7706-7718), as applied to claims 1-5 above, and further in view of Chang et al. (US 20110097329 A1). The rejection of claims 1-5 above as anticipated by Andersson is incorporated herein by reference. As such, these claims were prima facie obvious at the time of filing. Claim 7 is directed towards a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient. As shown above, Andersson teaches a compound of claim 1 as a PARP14 (ARTD7) inhibitor. While Andersson does not teach a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient, one of ordinary skill in the art would have a reasonable expectation of success to include the compound in a pharmaceutical composition because it is commonly known in the art to include PARP14 inhibitors in pharmaceutical compositions. For example, Chang teaches pharmaceutical compositions comprising one or more PARP inhibitors, including PARP14 inhibitors, and pharmaceutically acceptable excipients (Chang, Specification, paragraphs [0140] and [0146]). Therefore, claim 7 was prima facie obvious at the time of filing. Claim 15 is directed towards a kit of parts comprising separately packaged a PARPi and the ALC1i of claim 1 or a composition comprising a PARPi and the ALC1i of claim 1. As shown above, Andersson teaches a compound of claim 1 as a PARP14 (ARTD7) inhibitor. One of ordinary skill in the art would have a reasonable expectation of success to include this compound in a kit of parts comprising a separately packaged PARPi and the ALC1i because kits comprising one or more PARP inhibitors are commonly known in the art. For example, Chang teaches kits containing one or more PARP inhibitors: The invention further provides kits containing one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) of the pharmaceutical compositions described herein. The kits may further contain materials to aid in the administration of the pharmaceutical agents (e.g., a syringe). The kits may contain one or more doses of a pharmaceutical agent provided by the invention. The kits may further contain instructions for administering the pharmaceutical compositions to a subject having a stress granule-related disorder or cancer, or a subject that has a high probability of developing (a high propensity) for developing a stress granule-related disorder or cancer. Chang, Specification, paragraph [0147]; In each of these methods, compositions, and kits, the one or more PARP inhibitor(s) may selectively decrease (e.g., at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 99%, or even 100% decrease) the expression (e.g., mRNA and/or protein) and/or one or more (e.g., 1, 2, 3, 4, or 5) activities of one or more (e.g., 1, 2, 3, 4, 5, 6, 7, or 8) of PARP1, PARP2, PARP5A, PARP5B, PARP7, PARP8, PARP14, and PARP16. Chang, Specification, paragraph [0014]. Therefore, claim 15 was prima facie obvious at the time of filing. Given the above teachings, the invention as a whole was prima facie obvious at the time of filing. Conclusion No claim is found to be allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5. 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, Jeffrey Lundgren can be reached on (571) 272-5541. 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 86-217-9197 (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. /HEATHER DAHLIN/Examiner, Art Unit 1629
Read full office action

Prosecution Timeline

Jun 01, 2023
Application Filed
Jan 13, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
46%
Grant Probability
97%
With Interview (+50.7%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 133 resolved cases by this examiner. Grant probability derived from career allow rate.

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