Prosecution Insights
Last updated: July 17, 2026
Application No. 18/568,591

FLUORESCENT PROBES

Non-Final OA §101§103§112§DP
Filed
Dec 08, 2023
Priority
Jun 24, 2021 — JP 2021-105163 +1 more
Examiner
SAMSELL, RILLA MARIE
Art Unit
1653
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Senju Pharmaceutical Co., Ltd.
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
7m
Est. Remaining
87%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allowance Rate
55 granted / 76 resolved
+12.4% vs TC avg
Moderate +15% lift
Without
With
+14.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
38 currently pending
Career history
113
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
35.3%
-4.7% vs TC avg
§102
13.4%
-26.6% vs TC avg
§112
25.0%
-15.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 76 resolved cases

Office Action

§101 §103 §112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Status of the Claims Claims 1-25 are pending. Priority Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Instant application is a U.S. National Stage Entry of PCT/JP2022/025205, filed 06/23/2022. PCT/JP2022/025205 claims priority of foreign application JP2021-105163, filed 06/24/2021. Therefore, the effective filing date is 06/24/2021. Information Disclosure Statement The information disclosure statement filed 12/08/2023 and 11/21/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because references JP 2004520850 A, JP 2014505685 A, Dyson et al., and Belikov et al. have no direct English translation provided. It has been placed in the application file, but the information referred to in these references only has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). Election/Restriction Requirement Applicant's election with traverse of Group I, compounds of formula (I), directed to claims 1-10, 12-16, and 20-24, in the reply filed on 04/06/2026 is acknowledged. The traversal is on the ground(s) that there is not a serious search burden on the examiner. This is not found persuasive because the unity of invention has been broken, which is a requirement under 37 CFR 1.475(e). Additionally, the inventions lack a corresponding special technical feature under PCT Rule 13.2. The searching of a pharmaceutical composition comprising a calpain inhibitor would not overlap in scope with the search of the compounds of formula (I), since the intended use of the pharmaceutical composition of Group VI (claim 25) “is not considered a limitation and is of no significance to claim construction” (MPEP 2111.02 II). The requirement is still deemed proper and is therefore made FINAL. Applicant further elected the species with formula (III), shown below, which reads on instant claims 1-3, 6-10, 12-16, and 20-24. Claims 1-3, 6-10, 12-16, and 20-24 are currently under examination. PNG media_image1.png 133 304 media_image1.png Greyscale Claims 4, 5, 11, 17-19, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/06/2026. Objections – Drawings 37 C.F.R. 1.84 (p) Numbers, letters, and reference characters. (1) Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet. Reference characters should be arranged to follow the profile of the object depicted. (u) Numbering of views. (1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear. (2) Numbers and letters identifying the views must be simple and clear and must not be used in association with brackets, circles, or inverted commas. The view numbers must be larger than the numbers used for reference characters. The drawings are objected to because some references are not oriented in the same direction as the view (e.g., FIG. 3, FIG. 4, FIG. 26). The partial views are labeled incorrectly. For example, FIG. 1 should be split into FIG. 1A and FIG. 1B. Some views are labeled “FIGS.” rather than “FIG.”. Some view numbers are not larger than numbers used in reference characters (e.g., FIG. 20 – FIG. 24). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Interpretation Claims 12-16 are interpreted as being directed to a diagnostic composition comprising a compound of claim 1. The preamble “for a calpain activity-associated disease” is an intended use and is not given patentable weight. Similarly, claim 24 is interpreted as a kit comprising a compound of claim 1. The “for pancreatic juice detection” is an intended use. MPEP 2111.02 II states: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. Claim Objections Applicant is advised that should claim 12 be found allowable, claims 13-16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. The preambles of claims 12-16 are not given patentable weight. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 10 and 20-23 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). 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 1-3, 6, 7, 9, 10, 12-16, and 20-24 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 compounds of formula (I) where R1-R9 are H; p is 0; X is CH2; R10 and R11 are H, Me, or taken together to form an unsubstituted C3-5 cycloalkyl; R12 is H, C1-4 alkyl, C1-3 alkyl-OH, C1-3 alkyl-C(O)OH, C1-4 alkyl-NH2, C1-4 alkyl-NMe2, or C1-3 alkyl-(3- to 5-membered heterocycloalkyl) containing O as the only heteroatom, wherein the alkyl and heterocycloalkyl groups are unsubstituted; and L is a bond or (-O-CH2-CH2-)1-8, does not reasonably provide enablement for compounds of formula (I). 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 the invention commensurate in scope with these claims. To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that: The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation". The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors: 1- the quantity of experimentation necessary, 2- the amount of direction or guidance provided, 3- the presence or absence of working examples, 4- the nature of the invention, 5- the state of the prior art, 6- the relative skill of those in the art, 7- the predictability of the art, and 8- the breadth of the claims These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons: The nature of the invention The nature of the invention relates to compounds of formula (I) in claim 1. Such compounds are useful in fluorescent probes to measure calpain activity. This invention is also directed to compositions comprising said compounds. Predictability of the art The hypothetical compounds in claim 1 would be unpredictable in terms of one skilled in the art being able to synthesize every possible compound claimed in instant claim 1. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657. Level of skill in the art An ordinary artisan in the area of drug development would have experience in synthesizing and screening chemical compounds for particular activities, such as a medical doctor or chemist. Screening of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems. 4. The breadth of the claims The scope of the claims involves compounds of formula (I), shown below. PNG media_image2.png 242 582 media_image2.png Greyscale Claim 1 is very broad in the number of variables and the options of substituents for each variable. There is an indefinite amount of hypothetical compounds included in claim 1. 5. The amount of direction provided, the presence or absence of working examples, and the quantity of experimentation necessary The specification only provides the synthesis of about 40 compounds that read on formula (I). In all of the compounds synthesized, R1-R9 are H; p is 0; X is CH2; R10 and R11 are H, Me, or taken together to form an unsubstituted C3 cycloalkyl; R12 is H, C1-2 alkyl, C1-3 alkyl-OH, C1-3 alkyl-C(O)OH, C1-3 alkyl-NH2, C1-3 alkyl-NMe2, or C1-3 alkyl-(4-membered heterocycloalkyl) containing O as the only heteroatom, wherein the alkyl and heterocycloalkyl groups are unsubstituted; and L is a bond or (-O-CH2-CH2-)1-6. However, it would be assumed that the inventors are also enabled for compounds where R10 and R11 are C4-5 cycloalkyl; R12 is C3-4 alkyl, C4 alkyl-NH2, C4 alkyl-NMe2, or C1-3 alkyl-(3- to 5-membered heterocycloalkyl); and L is (-O-CH2-CH2-)7-8, since these substituents are similar in size and reactivity. Synthesis methods are not taught in the specification to provide for the aforementioned variables to include all of the possible substituents listed in the claims. It would be expected that the optional substituents on all variables, the alkyl and cyclic alkyl groups of R1-9, and heteroatoms in R12, would change the reactivity of the compounds, and therefore would require alternate synthesis methods. It could also be possible that some combinations of compounds may not be able to be synthesized due to their instability (e.g., where all of R1-9 are bulky cyclic groups). It would require one skilled in the art, such as a chemist, to perform thousands of reactions to determine which compounds of formula (I) can be prepared and would require synthesis methods other than those provided in the specification. This is undue experimentation given the limited guidance and direction provided by Applicants. Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success. 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 1-3, 6, 7, 9, 10, 12-16, and 20-24 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, the phrase "substituted" renders the claims indefinite because the claims include elements not actually disclosed (those encompassed by "substituted"), thereby rendering the scope of the claims unascertainable. The specification on pages 6-7, provides non-limiting examples of optional substituents, wherein, as in paragraph [0014], the optional substituents may then be further optionally substituted, by undefined substituents. Therefore, the non-limiting optional substituents in the compounds of formula (I) results in an indefinite number of compounds falling under formula (I). Claims 2, 3, 6, 7, 9, 10, 12-16, and 20-24 are rejected as being dependent upon a rejected claim and failing to define the optional substituents. Claims 10 and 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: a step of administering the probe or pharmaceutical composition. For the sake of compact prosecution, the claims will be interpreted as a fluorescent probe and not a method of administering said fluorescent probe. 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. Claims 1-3, 6-10, 12-16, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Urano et al. (WO 2016137004 A1) cited by Applicant, English translation provided, as evidenced by Iwai et al. (Turn-on mode fluorescent diarylethenes: effect of electron-donating and electron-withdrawing substituents on photoswitching performance, Photochem. Photobiol. Sci. ,2020, Vol. 19, pages 783–789) and Meng et al. (Electron‑donating methoxy group enhances the stability and efficiency of indole‑based fluorescent probe for detecting Cu2+, Research on Chemical Intermediates, 2020, Vol. 46, pages 5517–5533). Urano et al. teaches, in claim 4, compound (3), shown below. The compound is taught, in claims 6 and 7 and throughout the document, to be used in a fluorescent probe for detecting and measuring calpain and intracellular calpain activity. PNG media_image3.png 170 354 media_image3.png Greyscale It is taught, in paragraph [0008], that the fluorescence of the resulting fluorescent probe, using compound (3), “increases when it reacts with calpain in a cell by amide bonding a peptide chain serving as a calpain substrate with HMRG as a basic skeleton”. The HMRG skeleton is shown below in formula (I). PNG media_image4.png 198 312 media_image4.png Greyscale Urano et al. teaches, in paragraph [0029], that the calpain activity-associated disease is an eye disease, “especially normal-tension glaucoma”. Urano et al. fails to teach the elected species compound (III), shown below. PNG media_image1.png 133 304 media_image1.png Greyscale It can be seen that the elected species differs from the prior art species only by the addition of a methoxy group. MPEP 2144.09 I states: “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979)”. Additionally, the MPEP states that the presumption of obvious based on structural similarity is not valid if the compounds do not have similar properties, or if the instant compound has unexpected properties compared to the prior art compound. MPEP 2144.09 V: “The presumption of obviousness based on a reference disclosing structurally similar compounds may be overcome where there is evidence showing there is no reasonable expectation of similar properties in structurally similar compounds. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)”. MPEP 2144.09 VII: “A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)”. Since the instant elected species is so structurally similar to the prior art species, only differing by the presence of a methoxy group, and since the properties of the elected species are the same as those taught in the prior art, for use in a fluorescent probe to determine calpain activity, the elected species is rendered prima facie obvious in view of the prior art compound. Additionally, as evidenced by Iwai et al. (cited above) and Meng et al. (cited above), it is common in the art to add electron-donating substituents to fluorescent probes, such as a methoxy group. In both of these studies on fluorescent probes, it was shown that adding a methoxy group improved the performance of the fluorescence probes. In Iwai et al., the methoxy substituted improved the “fatigue resistance”, and in Meng et al., the methoxy substituent enhanced the stability and efficiency of the fluorescent probe. One would be motivated to make derivatives of prior art compounds in order to use them for the same purpose and to test the biological efficacy of the derivatives, as this is common practice in the art. One would be especially motivated to add electron-donating groups, specifically a methoxy group, when testing the efficacy of fluorescent probes, in view of Meng et al. and Iwai et al. as discussed above. One would have a reasonable expectation of success using an almost identical compound as a prior art compound for the same purpose, since compounds similar in structure would be presumed to have similar properties. Nonstatutory Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-3, 6-10, 12-16, and 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4-7 of U.S. Patent No. 10,294,240, in view of Iwai et al. (cited above) and Meng et al. (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other. Patent ‘240 teaches, in claim 2, the compound shown below. Claims 4-8 teach a fluorescent probe consisting of said compound, a method for measuring calpain, and a method of treating retinal diseases. PNG media_image5.png 192 384 media_image5.png Greyscale The compound above differs from the instant claims by the absence of a methoxy group. Therefore, the instant claims are rendered prima facie obvious over Patent ‘240 in view of Iwai et al. and Meng et al. See above 35 U.S.C. 103 rejection for reasoning. Claims 1-3, 6-10, 12-16, and 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4-8 of U.S. Patent No. RE49,518 E, in view of Iwai et al. (cited above) and Meng et al. (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other. Patent ‘518 teaches, in claim 2, the compound shown below. Claims 4-8 teach a fluorescent probe consisting of said compound, a method for measuring calpain, and a method of treating retinal diseases. PNG media_image5.png 192 384 media_image5.png Greyscale The compound above differs from the instant claims by the absence of a methoxy group. Therefore, the instant claims are rendered prima facie obvious over Patent ‘518 in view of Iwai et al. and Meng et al. See above 35 U.S.C. 103 rejection for reasoning. Conclusion Claims 1-3, 6-10, 12-16, and 20-24 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3. 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 Murray can be reached at (571) 272-9023. 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. /R.M.S./Examiner, Art Unit 1624 /JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Dec 08, 2023
Application Filed
Jun 04, 2026
Non-Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
87%
With Interview (+14.7%)
3y 2m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 76 resolved cases by this examiner. Grant probability derived from career allowance rate.

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