Prosecution Insights
Last updated: October 04, 2026
Application No. 18/558,810

NLRP3 INFLAMMASOME-INHIBITING COMPOUNDS AND THE USE THEREOF

Final Rejection §102§103§112
Filed
Nov 03, 2023
Priority
May 03, 2021 — IT 102021000011237 +1 more
Examiner
HERNANDEZ, JACKSON J
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
UNIVERSITA' DI PISA (40%)
OA Round
2 (Final)
51%
Grant Probability
Moderate
3-4
OA Rounds
4m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allowance Rate
36 granted / 70 resolved
-8.6% vs TC avg
Strong +45% interview lift
Without
With
+45.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
50 currently pending
Career history
126
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
39.3%
-0.7% vs TC avg
§102
9.5%
-30.5% vs TC avg
§112
22.7%
-17.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 70 resolved cases

Office Action

§102 §103 §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 . Drawings In view of amendments to the spec., which define the acronyms used in the Drawings, Drawings filed 11/03/2023 have been accepted. The drawings filed 07/24/2026 have worse quality and have not been entered. Status of the Claims Claims 1-2, 5-11, and 14-19 are pending in this application. Claims 3-4 and 12-13 have been cancelled by applicant. Claim Objections Claims 6 and 15 are objected to because of the following informalities: In claims 6 and 15, the structures provided are blurry and difficult to read in some cases. New clear structures are required. Appropriate correction is required. 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 1-2, 5-9, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of diseases mediated by NLRP3 inflammasome, does not reasonably provide enablement for prevention of the same. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make use of the invention commensurate in scope with these claims. The applicant’s attention is drawn to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), where the court set forth eight factors to considers when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the examples; and (8) the quantity of experimentation necessary. Breadth of Claims Claims 1 and 8 broadly encompasses a method of treating and/or preventing any condition or disorder mediated by the NLRP3 inflammasome (any inflammatory, autoimmune, cardiovascular, metabolic, and neoplastic disease and/or disorder, etc.), in any individual in need thereof, comprising administration of any of the compounds of Formula Ia, or pharmaceutically acceptable derivatives thereof. Claim 9 slightly narrows the scope of claim 1 by referring to the treatment or prevention of cryopyrin-associated periodic syndromes (CAPS), asthma, arthritis, inflammation induced by viral infections, Alzheimer’s disease (AD), cardiovascular diseases, non-alcoholic steatohepatitis (NASH), obesity, type 1 diabetes, and cancers, like stomach, lung, head/neck cancers, and melanoma. The term “individual in need” was not defined in the specification. Accordingly, the broadest reasonable interpretation of the term is taken to be any animal (humans, other primates, dogs, cats, squid, etc.). The term “prevention” is not defined in the specification. The Oxford English Dictionary (2024) defines “prevent” as to “preclude the occurrence” and thus claim 1 encompasses embodiments in which the claimed compounds can preclude the many diseases mediated by NLRP3 inflammasome. See definition II.9.a. Obtained from oed.com [retrieved on 2025-03-05] URL:httos://www.oed.convdictionary/prevent_y?t=true). Nature of the invention/ State of the Prior Art/ Predictability in the Art The CDC reports that currently, type 1 diabetes cannot be prevented, however, it can be treated effectively. Obtained from cdc.gov [retrieved on 02/02/2026] <URL: https://www.cdc.gov/diabetes/about/about-type-1-diabetes.html>) Pub. Date: May 15, 2024. The NHS reports that there is no certain way to prevent Alzheimer’s disease. Obtained from nhs.uk [retrieved on 02/02/2026] <URL: https://www.nhs.uk/conditions/alzheimers-disease/prevention/>) Pub. Date: July 04 2024. The American Cancer Society reports there is no sure way to prevent stomach cancer (gastric cancer), and there are only things we can do to lowers risks. Obtained from cancer.org [retrieved on 02/02/2026] <URL: https://www.cancer.org/cancer/types/stomach-cancer/causes-risks-prevention/prevention.html>) Pub. Date: April 30, 2025. Finally, the medical arts are also generally considered to be unpredictable making the goal of achieving prevention in this case even less likely. See Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involve.”). Level of One of Ordinary Skill The level of one of ordinary skill in the art would be high, likely an M.D. or Ph.D. in the medical arts (e.g., studying treatment of cancers, neurological, and metabolic conditions). See Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 at 1381–82 (Fed. Cir. 1983) (Factors that may be considered in determining level of ordinary skill in the art include: … type of problems encountered in the art …”). Guidance/Working Examples In page 100, applicant discloses cytotoxicity studies of THP-1 cells (monocytic leukemia cell line) with “test compounds” at different concentrations – unclear which compounds were actually tested, though from page 98, last para. line 24, it appears that only compounds INF176 and 177 (shown below) were tested. In page 101, Applicant shows compound INF176 is able to inhibit NLRP3-dependent cell pyroptosis induced by LPS/ATP in a dose dependent manner; and that compound INF176 inhibits IL-1β release from human macrophages (Figures 1A and B). Applicant states in vivo experiments with INF176 in mice improved the systemic tissue parameters associated with colitis in DSS induced colitis (Example 50 of spec. and Figures 2-3). Applicant notes that INF176 improves slowing of colon transit, and that in vitro studies demonstrate improvement in colon contractions. In page 102, Applicant discloses in vivo mice models with INF176, starting chronic administration in the earliest stages of the disease, before the appearance of the first symptoms, and notes a counteraction in cognitive decline and reduced expression of p-tau protein with results comparable to donepezil, a medicament approved for treatment (not prevention) of AD (Figures 4A-C). Lastly, Applicant discloses molecular docking studies of INF177 – a metabolite of INF176 – in Table 3 (page 103). PNG media_image1.png 128 355 media_image1.png Greyscale PNG media_image2.png 127 352 media_image2.png Greyscale Therefore, the specification provides no working examples for the prevention of type 1 diabetes, Alzheimer’s, or any cancers. Particularly, the specification does not enable one of ordinary skill to treat or prevent the many diseases claimed with all of the many compounds encompassed by instant Formula I, since the activity of only INF176 and 177 was actually tested. Degree of Experimentation To practice the invention as claimed, the skilled artisan would have to screen each of the many compounds encompassed by the broad genus in instant Formula I in order to determine whether the compounds meet the functional limitations of the claim for the treatment and/or prevention of any of the many diseases encompassed by the claims (cryopyrin-associated periodic syndromes (CAPS), asthma, arthritis, inflammation induced by viral infections, Alzheimer’s disease (AD), cardiovascular diseases, non-alcoholic steatohepatitis (NASH), obesity, type 1 diabetes, and cancers, like stomach, lung, head/neck cancers, and melanoma). In addition, the skilled artisan would need to determine which subjects would benefit from treatment and prevention of these diseases (humans, other primates, cats, dogs, squid, etc.) by administering the instantly claimed compounds to a statistically significant pool of subjects from each species. Prevention the many aforementioned conditions would require long-term monitoring of each patient for appearance of any new cryopyrin-associated periodic syndromes (CAPS), asthma, arthritis, inflammation induced by viral infections, Alzheimer’s disease (AD), cardiovascular diseases, non-alcoholic steatohepatitis (NASH), obesity, type 1 diabetes, and cancers, like stomach, lung, head/neck cancers, and melanoma, etc. Thus, the quantity of experimentation in this area would be extremely large, since there are a significant number of parameters that would have to be studied beyond the preliminary studies provided. Furthermore, the ultimate outcome of such experimentation is completely unpredictable. In sum, taking into consideration the Wands factors outlined above, an undue amount of experimentation would be required here to make and use the full scope of the claimed invention. 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 1-2, 5-11, and 14-19 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. In claim 1, the following limitation lacks antecedent basis within the claims, since there are no R6-7 groups in the amended claims: PNG media_image3.png 22 401 media_image3.png Greyscale Further regarding claim 1, the claim reads: “Method of … with compounds of general Formula (I) … and their enantiomers, diastereomers, rotamers, or mixtures thereof; and the pharmaceutically acceptable salts or solvates thereof, said method comprising administering a therapeutically effective amount of said compound to said individual”. As written, it is unclear if the “said compound” refers only to administration of the “compounds of Formula I” or to the administration of the “compounds of Formula I, enantiomers, diastereomers, rotamers, or mixtures thereof; and the pharmaceutically acceptable salts or solvates thereof.” Claims 2, 5-9, and 18 are rejected for depending upon the limitations of claim 1 without resolving the deficiencies thereof. Claims 2 and 11 recites the limitation "R6 and R7 form a substituted piperidine or pyrrolidine with the N atom". There is insufficient antecedent basis for this limitation in the claim, since there are no R6-7 variables in Formula Ia – see claim interpretation in 112(d) section. In claim 10, the terms “preferably” (line 1 of page 20, for example), is a relative term which render the claims indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 10 recites the limitation "R6 and R7 do not form a ring”. There is insufficient antecedent basis for this limitation in the claim. Furthermore, since this proviso requires that “R6 and R7 do not form a ring” and Formula Ia requires a ring in the position which used to be R6-7, then this proviso should be removed, as it does not make sense in the amended claims. Also in claim 10, there is insufficient antecedent basis for the following limitation in the claim: PNG media_image4.png 62 482 media_image4.png Greyscale Regarding claims 9 and 10, the phrase "including" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Specifically, for claim 10, Examiner suggests using the same language for claim 1, when Applicant states: “a halide selected from F, Cl…” or something to that effect. Claims 11 and 14-17 are rejected for depending upon the limitations of claim 10 without resolving the deficiencies thereof. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitations: “viral infections”, “ALS correlated symptoms”, “cardiovascular diseases”; and the claim also recites “including (those caused by the SARS-CoV-2 (COVID-19) virus)”, “including (gastrointestinal disorders)”, “including (hypertension…)” which are the narrower statements of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Examiner suggests removing the parentheses and information therein. Further regarding claim 9, the limitation “tumors comprising stomach cancer, head/neck cancers, lung cancer, melanoma, and myelodysplastic syndromes” is indefinite because it is unclear if Applicant intends a single tumor comprising all of “stomach cancer, head/neck cancers, lung cancer, melanoma, and myelodysplastic syndromes” or if Applicant intends “a tumor selected from the group consisting of stomach cancer, head/neck cancers, lung cancer, melanoma, and myelodysplastic syndromes”. On a related note, the claim is indefinite for being an improper Markush – does applicant intend “tumors selected from the group consisting of …”? Claim 18 is unclear, because it is impossible for Formula Ia to be a phenyl. First of all, ‘phenyl’ is not a compound, but a mono- or poly-valent group for substitution. Thus, it is unclear what Applicant intended. For the purposes of applying art, it will be assumed Applicant intended “the method according to claim 1, wherein A is phenyl” – as stated in claim 19. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 2 and 11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2, as written, fails to further limit claim 1, from which it depends, since it is drawn to the same method of treatment comprising administration of the same compound of Formula Ia, without any further limitation. Examiner believes Applicant intended to claim the method comprising administration of the compound of Formula Ia wherein m and n are independently 1 or 2, so as to form piperidines or pyrrolidines – claim will be interpreted as such for the purposes of applying art. Claim 11, as written, fails to further limit claim 1, from which it depends, since it is drawn to the same compounds of Formula Ia, without any further limitation. Examiner believes Applicant intended to claim the compounds of Formula Ia wherein m and n are independently 1 or 2, so as to form piperidines or pyrrolidines – claim will be interpreted as such for the purposes of applying art. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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. Claims 1-2, 7-9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Spyrakis et al. (Eur. J. Med. Chem., 42, 2007, 921-933 – previously cited) (“Spyrakis”); in view of Mihara et al. (Endocrinology, 2010, 151(2):513–519 – previously cited) (“Mihara”). Regarding claims 1-2, 7-9, and 18, Spyrakis discloses the compound 7 below (scheme 1), which anticipates the instant compounds when A is substituted phenyl, with R1-2 being substituted alkyl; R3 is H; X is SO2; R4 is substituted phenyl; Y is N; and m = 0; n = 2; and R8 is H. Spyrakis discloses their compound as a thrombin inhibitor (see 1ett entry, table 1, page 923). PNG media_image5.png 257 177 media_image5.png Greyscale While Spyrakis does not specifically teach their compound for the treatment of inflammatory diseases associated with NLRP3 inflammasome; the teachings of Mihara are relied upon for these disclosures. Mihara teaches that the binding of thrombin to its receptor stimulates inflammatory cytokines including IL-6 and MCP-1, leading to the development of insulin resistance and type 2 diabetes (abstract). Thus, Mihara suggests that thrombin inhibition ameliorates insulin resistance in obese, diabetic mice (abstract). Therefore, regarding instant claims 1-2, 7-9, and 18, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to administer Spyrakis’ compound 7 for the treatment of inflammatory diseases such as type 2 diabetes in view of Mihara. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Spyrakis teaches their compound as a thrombin inhibitor (ΔG of -8 kcal/mol for binding – indicating a favorable, exergonic process); further because Mihara teaches thrombin inhibition ameliorates insulin resistance in obese, diabetic mice by blocking stimulation of inflammatory cytokines. Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)). Further regarding claims 1 and 7, Applicant is advised that a recitation of the intended use of the claimed invention, such as the limitation: “wherein the compound is an NLRP3 inflammasome medicament” or “disorders mediated by the NLRP3 inflammasome” in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Applicant is further reminded that products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Response to Arguments Specification/ Drawings Amendments to the specification are acknowledged and have been entered. No new matter has been introduced. Objections to the specification have been withdrawn. Amendments to the Drawings have not been entered, as new drawings were of poorer quality than those filed 11/03/2023. Drawings from 11/03/2023 have been accepted in view of amendments to the spec, which clarified information contained in the drawings. Objections to the drawings are withdrawn. Claims Amendments to the claims are acknowledged and have been entered. No new matter has been introduced. As a result, most claim objections have been withdrawn. The objections to claims 6 and 15 have been maintained, as applicant has failed to resolve deficiencies indicated with these objections. Claim Rejections - 35 USC § 112(a) Applicant's arguments filed 07/24/2026 have been fully considered but they are not persuasive. Applicant argues the spec. provides working examples of prophylactic administration, citing Example 51 in page 102, which allegedly describes ‘administration of INF176 to SAMP8 mice starting at the earliest stages of the disease, before appearance of symptoms, and reports counteraction of cognitive decline and reduction of p-tau protein in brain tissue.’ Applicant further argues that their general statement of ‘prevention of diseases mediated by NLRP3 inflammasome provides a limited scope which reduces the degree of experimentation needed. This is not persuasive. Example 51, from the spec. is shown below: PNG media_image6.png 452 612 media_image6.png Greyscale As applicant admits, they begin treatment starting at the earliest stages of the disease, meaning that the disease/ condition has already been contracted/ presented, and therefore, no ‘prevention’ or ‘prophylaxes’ of anything is demonstrated by this example. Furthermore, Applicant admits results are comparable to approved treatments for AD. As stated in the 112(a)-rejection presented herein, there are no known methods for the prophylaxis of AD. Thus, Applicant’s example demonstrates a potential treatment for AD, not a prophylactic. In response to Applicant’s argument that their general statement of ‘prevention of diseases mediated by NLRP3 inflammasome provides a limited scope which reduces the degree of experimentation needed; NLRP3 inflammasome pertains to an extremely broad range of diseases and conditions with significantly different mechanisms. As outlined in the Wands factors herein, undue experimentation would be required to reduce the instant claims to practice. This rejection is maintained. Claim Rejections - 35 USC § 112(b) In view of claim amendments, most of the 35 USC § 112(b) rejections have been withdrawn or rendered moot. Some 35 USC § 112(b) rejections have been maintained (specifically, use of ‘preferably’ in claim 10 and broad/ narrow issues in claim 9), and some new 35 USC § 112(b) rejections have been raised in view of claim amendments. Claim Rejections - 35 USC § 112(d) In view of claim amendments, the 35 USC § 112(d) rejections have been withdrawn or rendered moot. However, in view of claim amendments, a new ground of 35 USC § 112(d) rejections have been raised herein. Claim Rejections - 35 USC § 102 In view of claim amendments, the 35 USC § 102 rejections have been withdrawn or rendered moot. Claim Rejections - 35 USC § 103 In view of claim amendments, most of the 35 USC § 103 rejections have been withdrawn or rendered moot. The 35 USC § 103 rejections over Spyrakis et al. in view of Mihara et al. has been maintained. Applicant argues neither reference teach or suggest arriving at a compound of Formula Ia, as required by narrower claims; and does Mihara provides no motivation to modify Syrakis’ compound to arrive at the specific structural features of the amended claims. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Spyrakis discloses the compound 7 below (scheme 1), which anticipates the instant compounds when A is substituted phenyl, with R1-2 being substituted alkyl; R3 is H; X is SO2; R4 is substituted phenyl; Y is N; and m = 0; n = 2; and R8 is H. Spyrakis discloses their compound as a thrombin inhibitor (see 1ett entry, table 1, page 923). PNG media_image5.png 257 177 media_image5.png Greyscale Mihara teaches that the binding of thrombin to its receptor stimulates inflammatory cytokines including IL-6 and MCP-1, leading to the development of insulin resistance and type 2 diabetes (abstract). Thus, Mihara suggests that thrombin inhibition ameliorates insulin resistance in obese, diabetic mice (abstract). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to administer Spyrakis’ compound 7 for the treatment of inflammatory diseases such as type 2 diabetes in view of Mihara. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Spyrakis teaches their compound as a thrombin inhibitor (ΔG of -8 kcal/mol for binding – indicating a favorable, exergonic process); further because Mihara teaches thrombin inhibition ameliorates insulin resistance in obese, diabetic mice by blocking stimulation of inflammatory cytokines. Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5. Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. 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. /JACKSON J HERNANDEZ/Examiner, Art Unit 1627 /SARAH PIHONAK/Primary Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Nov 03, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection mailed — §102, §103, §112
Jul 24, 2026
Response Filed
Sep 01, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
51%
Grant Probability
96%
With Interview (+45.0%)
3y 3m (~4m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 70 resolved cases by this examiner. Grant probability derived from career allowance rate.

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