Office Action Predictor
Last updated: April 16, 2026
Application No. 17/774,081

GPR52 MODULATOR COMPOUNDS

Final Rejection §112
Filed
May 03, 2022
Examiner
HIRAKIS, SOPHIA P
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nxera Pharma Uk Limited
OA Round
2 (Final)
50%
Grant Probability
Moderate
3-4
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
13 granted / 26 resolved
-10.0% vs TC avg
Strong +65% interview lift
Without
With
+65.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
52 currently pending
Career history
78
Total Applications
across all art units

Statute-Specific Performance

§101
2.8%
-37.2% vs TC avg
§103
32.6%
-7.4% vs TC avg
§102
13.1%
-26.9% vs TC avg
§112
33.1%
-6.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 26 resolved cases

Office Action

§112
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 . Priority The instant application, filed 05/03/2022, is a 371 filing of PCT/GB2020/052832, filed 11/09/2020, which claims foreign priority to GB1918974.5, filed 12/20/2019, GB1918992.7, filed 12/20/2019, and GB1916298.1, filed 11/08/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55. Amendments and Claim Status The following amendment filed on 11/06/2025 is acknowledged and entered. Claims 1, 4-6, 13, 14, 20, and 26 are amended; Claims 2, 3, 12, 17, 19, 21, 22, 24, 27 are cancelled; Claims 28-53 are added; Claims 25 and 26 remain withdrawn according to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species; Claims 1, 4-11, 13-16, 18, 20, 23, 25, 26, and 28-53 are pending. Information Disclosure Statement An Information Disclosure Statement has not been received. Response to arguments Applicant’s arguments filed 11/06/2025 with respect to the objection to the specification, claim objections, and claim rejections under 35 U.S.C. §§ 112(a), and 102 (a) (1) have been fully considered. With respect to the objection to the specification, the amendment to the specification including D in the place of 2H in table 1, is sufficient for withdrawal of the specific grounds of the objection. However, the amended specification presents new grounds for objection on page 47, outlined further below. Therefore the objection is hereby maintained. With respect to the objection to claims 20, the amendment to claim 1 is insufficient to overcome the rejection. Furthermore, new claims have been added which depend on a rejected claim 1. The objection has been amended to include the new dependent claims 28-53 which depend on claim 1. As such, the objection is hereby amended and maintained. With respect to the rejection of claims 1-11, 13-16, 18 and 23 under 35 U.S.C. § 112 (a) as failing to comply with the written description requirement, the cancellation of claims 2 and 3 are sufficient to render the rejection against said claims moot. However, Applicant’s arguments have been fully considered but are not persuasive for the reasons set forth below. The arguments made by Applicant are herein addressed as follows. The following section of the MPEP is relied upon for the response to Applicant’s arguments. According to MPEP § 2163.02, the standard for determining compliance with the written description requirement is as follows, Whenever the issue 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, inventor 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 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. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). 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, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it" Applicant relies on MPEP § 2163 and cited case law for the proposition that well-known information need not be described in detail. Applicant’s argument is found unpersuasive, because written description requires possession, not merely feasibility. The level of skill in the art cannot substitute for written description the demonstrate possession of the claimed compounds. The written description requirement is satisfied only when the specification reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. General statements of feasibility or references to what could be made by a skilled artisan do not establish possession. The disclosure must reasonably convey possession of the full scope of the claimed genus. Within the instant specification, the disclosed compounds are limited to specific structural clusters, and do not represent the breadth of substituent combinations encompassed by the instant claims. As set forth in the rejection, the claims cover numerous combinations across multiple variable positions are not demonstrated by the cited examples. Applicant further argues that the specification discloses a wide variety of substituents at positions R1, R2, Q, A, L, W, and B, thereby demonstrating possession of the claimed structural diversity. Applicant’s argument is found unpersuasive because merely identifying individual substituents at isolated positions does not demonstrate possession of all claimed combinations of a broad range of substituents as instantly claimed. Importantly, the examiner has already acknowledged the specification describes substituents at the positions identified by Applicant. These positions were expressly considered and were not the basis of the written description rejection. The rejection is directed to claimed positional combinations of structural embodiments Applicant has not shown to be described or in possession of, which remain unaddressed in the response. The specification fails to provide representative species, working examples, or structural features that correlate with the full scope of the claimed compounds. Therefore, the cited examples do not map to the claims in a manner that would demonstrate possession of compounds encompassing the claimed substituents. Applicant relies on functional data—including GPR52 agonist activity, cAMP assays, pharmacokinetic profiling, and in vivo rat models—to argue that the inventors were in possession of the claimed genus. Applicant’s argument is unconvincing because, although functional and biological data may demonstrate that certain disclosed compounds are operative, functional results cannot substitute for written description of claimed structural scope, particularly in an unpredictable chemical art. The claims are drawn to chemical structures. As such, the specification must demonstrate possession of the claimed structural embodiments themselves, including those combinations identified as unsupported in the rejection. Applicant cites a court decision and argues that exact disclosure of every claimed embodiment is not required, and thus reasonable clarity is sufficient. Applicant’s argument is unpersuasive because the cited authorities require the disclosure reasonably convey possession of the claimed invention. They do not permit claiming structural scope that is broader than what the specification demonstrates the inventors actually possess. In the instant case, the disclosure fails to show possession of the full claimed genus, particularly with respect to the unsupported positional combinations identified in the rejection. Finally, Applicant argues that amendments narrowing the definitions of R1, R2, V, L, and W align the claims with the working examples, and therefore satisfy the written description requirement. Applicant’s argument is unpersuasive because, while the claims have been narrowed, they still encompass structural embodiments and positional combinations are not described in the specification. Narrowing a claim does not cure a written description deficiency where unsupported subject matter remains within the claims scope, as identified in the rejection. Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent 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”. Accordingly, applicant has not demonstrated the possession of the claimed compounds as required under 35 U.S.C. § 112 (a). The rejection is therefore maintained. Applicant is invited to amend the claims to correspond to subject matter that is adequately supported by the specification, or to provide persuasive evidence demonstrating possession of the claimed compounds as of the effective filing date. With respect to the rejection of claims 1-8, 11, 15, 16 and 23 under 35 U.S.C. § 102(a)(2) as being anticipated by Campbell et al (WO 2019079485 A1, published April 25, 2019, cited in applicant IDS dated 05/24/2022), hereinafter Campbell, the cancellation of claims 2 and 3 sufficiently render the rejection against said claims moot. Applicant has amended claim 1 to strike NH from the limitations of the L, removing the disclosure by Campbell from consideration as a prior art rejection under the premise of anticipation. As such, the rejection is hereby withdrawn. Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein and in the previous non-final rejection. Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Status of Claims Claims 1, 4-11, 13-16, 18, 20, 23, 25, 26, and 28-53 are pending in the instant application. Claims 25 and 26 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and a species to which the search has been extended. Therefore, claims 1, 4-11, 13-16, 18, 20, 23, and 28-53 read on the species to which the search has been extended pursuant to 803.02, and are therefore under consideration in the instant application. Specification The disclosure is objected to because of the following informalities: The amendment to the specification filed 11/06/2025 replacing the compounds of Table 1 features the two-dimensional structure of the compound, and the naming of the example compound (i.e., Example 1). The name of the example compounds 35 and 36 are missing from page 47 (see bottom right). In order to be self-consistent, the specification should be amended to include the names of said compounds below their two-dimensional chemical structure. Appropriate correction is required. Claim Objections Claims 20 and 28-53 are objected to for depending on a rejected claim—claim 1. Claim Rejections - 35 U.S.C. § 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, 4-11, 13-16, 18, and 23 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 claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. § 112, the inventors, at the time the application was filed, had possession of the claimed invention. The cited claims of the instant application are drawn to a compound of Formula (1) having following substituents: R1 is H, C1-6 alkyl optionally substituted with 1 to 6 fluorine atoms, a group —C(R14)2C(R18)2OR17 or a group —C(R14)2C(R19)2OH R14 is H, F or C1-3 alkyl optionally substituted with 1 to 6 fluorine atoms R17 is C1-3 alkyl optionally substituted with 1 to 6 fluorine atoms R18 is H, F or C1-3 alkyl optionally substituted with 1 to 6 fluorine atoms R19 is H or C1-3 alkyl optionally substituted with 1 to 6 fluorine atoms, and wherein R17 and one R14 may be joined to form an oxolane or oxetane ring; R2 is H, halo, CN, C1-6 alkyl optionally substituted with OH or 1 to 6 fluorine atoms, C1-6 alkoxy optionally substituted with OH or 1 to 6 fluorine atoms or C3-6 cycloalkyl optionally substituted with OH or 1 to 6 fluorine atoms, wherein one atom of the C1-6 alkyl, C1-6 alkoxy or C3-6 cycloalkyl group may be optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof; PNG media_image1.png 1 232 media_image1.png Greyscale PNG media_image1.png 1 232 media_image1.png Greyscale R3 is PNG media_image1.png 1 232 media_image1.png Greyscale R4, R5, R6, R7, R8 and R9 are independently selected from H and C1-3 alkyl. The formulas PNG media_image2.png 2 29 media_image2.png Greyscale PNG media_image2.png 2 29 media_image2.png Greyscale PNG media_image2.png 2 29 media_image2.png Greyscale PNG media_image2.png 2 29 media_image2.png Greyscale and PNG media_image2.png 2 29 media_image2.png Greyscale R11, R12, R13, R15 and R16 are H, CN, SF5, halo, a C1-6 saturated hydrocarbon group optionally substituted with 1 to 6 fluorine atoms wherein one atom of the C1-6 saturated hydrocarbon group is optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof, OC1-6 alkyl optionally substituted with 1 to 6 fluorine atoms, SO2C1-6 alkyl optionally substituted with 1 to 6 fluorine atoms and C3-6 cycloalkyl optionally substituted with 1 to 6 fluorine atoms or optionally substituted with CF3, or methyl, isopropyl, cyclopropyl, CF3, CF2H, OCF2H, OCH3 and PNG media_image3.png 75 62 media_image3.png Greyscale 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 ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). 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. 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); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. 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. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). 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 applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention. In the present case, the important factors leading to a conclusion of inadequate written description is the absence of any working example of the invention as claimed, and the lack of predictability in the art. In the instant specification, there is no disclosure of compounds having the following claimed substituents: R1 as C2-6 alkyl optionally substituted with 1 to 6 fluorine atoms R14 as F or C1-3 alkyl optionally substituted with 1 to 6 fluorine atoms R17 as C2-3 alkyl optionally substituted with 1 to 6 fluorine atoms R18 as F or C1-3 alkyl optionally substituted with 1 to 6 fluorine atoms R19 as C1-3 alkyl optionally substituted with 1 to 6 fluorine atoms, and wherein R17 and one R14 may be joined to form an oxolane or oxetane ring; R2 as halo, C2-6 alkyl optionally substituted with or 1, 2, or 4 to 6 fluorine atoms, C1-6 alkoxy optionally substituted with OH or 1 to 6 fluorine atoms or C3-6 cycloalkyl optionally substituted with OH or 1 to 6 fluorine atoms, wherein one atom of the C1-6 alkyl, C1-6 alkoxy or C3-6 cycloalkyl group may be optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof; R3 as PNG media_image1.png 1 232 media_image1.png Greyscale R4 as C2-3 alkyl R5, R6, R7, R8 and R9 as C1-3 alkyl The formula PNG media_image2.png 2 29 media_image2.png Greyscale R11 as CN, SF5, halo, a C1-6 saturated hydrocarbon group optionally substituted with 1 to 6 fluorine atoms wherein one atom of the C1-6 saturated hydrocarbon group is optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof, OC1-6 alkyl optionally substituted with 1 to 6 fluorine atoms, SO2C1-6 alkyl optionally substituted with 1 to 6 fluorine atoms and C3-6 cycloalkyl optionally substituted with 1 to 6 fluorine atoms or optionally substituted with CF3; R12 as CN, SF5, Bromo, Iodo, a C2-6 saturated hydrocarbon group optionally substituted with 1, 2, or 4 to 6 fluorine atoms wherein one atom of the C1-6 saturated hydrocarbon group is optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof, OC1-6 alkyl optionally substituted with 1 to 6 fluorine atoms, SO2C1-6 alkyl optionally substituted with 1 to 6 fluorine atoms and C3-6 cycloalkyl optionally substituted with 1 to 6 fluorine atoms or optionally substituted with CF3 R13 as SF5, Bromo, Iodo, a C2-6 saturated hydrocarbon group optionally substituted with 1, 2, or 4 to 6 fluorine atoms wherein one atom of the C1-6 saturated hydrocarbon group is optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof, OC1-6 alkyl optionally substituted with 1 to 6 fluorine atoms, SO2C1-6 alkyl optionally substituted with 1 to 6 fluorine atoms and C3-6 cycloalkyl optionally substituted with 1 to 6 fluorine atoms or optionally substituted with CF3 R15 as Bromo, Iodo, a C2-6 saturated hydrocarbon group optionally substituted with 2, or 4 to 6 fluorine atoms wherein one atom of the C1-6 saturated hydrocarbon group is optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof, OC2-6 alkyl optionally substituted with 2 to 6 fluorine atoms, SO2C1-6 alkyl optionally substituted with 1 to 6 fluorine atoms and C3-6 cycloalkyl optionally substituted with 1, 2, or 4 to 6 fluorine atoms or optionally substituted with CF3; R16 as CN, SF5, Chloro, Bromo, Iodo, a C1-6 saturated hydrocarbon group optionally substituted with 1 to 6 fluorine atoms wherein one atom of the C1-6 saturated hydrocarbon group is optionally replaced by a heteroatom selected from O, N, S and oxidised forms thereof, OC1-6 alkyl optionally substituted with 1 to 6 fluorine atoms, SO2C1-6 alkyl optionally substituted with 1 to 6 fluorine atoms and C3-6 cycloalkyl optionally substituted with 1 to 6 fluorine atoms or optionally substituted with CF3; The instant specification (pages 45-52) teaches compounds which are characterized as having only the following substituents: R1 is H, CH3, — C(R14)2C(R18)2OR17 , —C(R14)2C(R19)2OH, R14 , R18 , and R19 are H R17 is CH3, R2 is H, CH3, CF3, CH2OH, CN R3 is PNG media_image1.png 1 232 media_image1.png Greyscale PNG media_image1.png 1 232 media_image1.png Greyscale PNG media_image1.png 1 232 media_image1.png Greyscale R4 is H, CH3 R5, R6, R7, R8 and R9 are H The formulas PNG media_image2.png 2 29 media_image2.png Greyscale PNG media_image2.png 2 29 media_image2.png Greyscale PNG media_image2.png 2 29 media_image2.png Greyscale PNG media_image2.png 2 29 media_image2.png Greyscale R11 is H R12 is H, F, Cl, CF3, CN R13 is H, F, Cl, OCH3, OCH2F R15 is H, F, Cl, SF5, CH3, CH2F, CF3, OCH3, OCH2F, CN, and PNG media_image3.png 75 62 media_image3.png Greyscale R16 is H, F Therefore, the compounds described in the instant specification detail only a limited number of the total substituents claimed (see substituents 1-11, above). All working examples presented in the instant specification are related to the compounds containing a fraction of the total claimed substituents (see substituents 28-41, above). There are no working examples in the instant specification for the wide range of substituents claimed, but for which evidence of possession has not been provided (see 12-27). Thus the instant specification does not provide any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021. Thus, since Applicant has not described in adequate detail methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus, claims 1, 2, 4, 5, 7, 8, 13, and 18 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper. Conclusion No claims are allowed. THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday. (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, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (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 +1 (800) 786-9199 (IN USA OR CANADA) or +1 (571) 272-1000. /SOPHIA P HIRAKIS/Examiner, Art Unit 1623 /KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
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Prosecution Timeline

May 03, 2022
Application Filed
Jul 23, 2025
Examiner Interview (Telephonic)
Jul 25, 2025
Non-Final Rejection — §112
Nov 06, 2025
Response Filed
Jan 16, 2026
Final Rejection — §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
50%
Grant Probability
99%
With Interview (+65.0%)
3y 6m
Median Time to Grant
Moderate
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