Prosecution Insights
Last updated: October 21, 2026
Application No. 18/710,312

HETEROCYCLIC AMIDES AND METHODS OF USING THE SAME

Non-Final OA §112
Filed
May 15, 2024
Priority
Nov 18, 2021 — provisional 63/280,939 +1 more
Examiner
MCDOWELL, BRIAN E
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Rgenta Therapeutics Inc.
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
843 granted / 1139 resolved
+14.0% vs TC avg
Strong +31% interview lift
Without
With
+31.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 2m
Avg Prosecution
68 currently pending
Career history
1193
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
16.6%
-23.4% vs TC avg
§102
20.1%
-19.9% vs TC avg
§112
49.8%
+9.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1139 resolved cases

Office Action

§112
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . DETAILED ACTION RESPONSE TO ELECTION/RESTRICTION Applicant’s election without traverse of the elected species: PNG media_image1.png 152 246 media_image1.png Greyscale in the reply filed on 8/24/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL. Claims 8,20-21,30, and 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. An action on the merits of claims 1,6,9,17-19,22-23,26,28,31-33,42 and 54 is contained herein. Applicant’s elected species was found free of the art and the search extended to cover a proper Markush grouping as described herein. Priority This application claims priority to U.S. Provisional Application No. 63/280,939, filed November 18, 2021. Benefit for the provisional application is not accorded since subject matter disclosed within the instant application is not supported (e.g. full scope of variable A embodiments in claim 1). The claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawaiv.Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). Information Disclosure Statement The examiner has considered the references cited in the information disclosure statement filed of record. Specification Applicant is reminded of the proper content of an Abstract of the Disclosure, see MPEP 608.01(b). In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., "The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics." Exemplification of a species could be illustrative of members of the class. For processes, the type reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary. It is recommended that the structure of Formula I be inserted into the abstract to accurately illustrate the claimed invention. Additionally, the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. Claim Objections Claim 54 is objected to because of the following informalities: The preamble of claim 54 should more appropriately incorporate alternative language such as “selected from the group consisting of ..” or something similar thereof. Additionally, there should be commas between each recited species. Correction is required. Claim Rejections - 35 USC § 112 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 1,6,9,17-19,22-23,26,28,31-33, and 42 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 pre-AIA the applicant regards as the invention. In the instant claim 1 and other claims the embodiment “C1-6cycloalkyl” is indefinite since it takes a minimum of 3 carbon atoms to make a cycloalkyl ring. Thus any carbon atoms below this threshold is unclear with regard to chemical structure. Thus the claim and claims dependent on it which do not rectify the issue are indefinite. Additionally the scope of “any one of claims 31” in claim 33 is unclear since there is only one claim 31 presented. See In re Zletz, 13 USPQ2d 1320, 1322, “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.” Claim Rejections - 35 USC § 112 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 35 U.S.C. 112 (pre-AIA ), fourth paragraph: Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 28, 31-33, and 54 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 28 does not further limit claim 1 with respect to variable R12 (recited in claim 28 as variable R13) having alkyl, alkenyl, and alkynyl being optionally substituted with “methoxy” since claim 1 does not set forth the latter. Additionally claim 54 does not limit claim 1 with species such as: PNG media_image2.png 178 676 media_image2.png Greyscale wherein variable B is substituted with “-C(O)OalkylOC(O)alkyl” since this limitation is not supported by claim 1. Correction is required where necessary. 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 – Improper Markush Grouping Rejection Claims 1, 9,17-19,22-23,26,28,31-33,42 and 54 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y). In re Harnish, 206 USPQ 300, 305, says, “ …we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification (see claim 1 below for pictorial example): PNG media_image3.png 605 882 media_image3.png Greyscale . Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371. Indeed, as was stated in Ex parte Haas, 188 USPQ 374, “The rejection of a claim as containing an improper Markush grouping has a relatively long history in Office practice. The Court of Customs and Patent Appeals, at least as far back as 1942, has recognized that a rejection may be based upon the Examiner's holding that the claim has an improper Markush group. See In re Swenson, 30 CCPA 764, 132 F.2d 336, 56 USPQ 180 , citing Ex parte Palmer, 398 OG 707, 1930 CD 3.” It should be noted that in Harnish, there was a substantial structural feature from which the common use flowed and that the claimed compounds all belong to a subgenus. That is exactly what is lacking in this case, as there is no substantial structural feature when viewing the compound as a whole. The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: For example the following chemical class of compounds as a whole may be obtained: 1) wherein X = CR, Y = Z = N: (classified as substituted diazines, C07D 237/02+); 2) wherein X = Y = Z = N: (classified as substituted triazines, C07D 253/06+); This list is not exhaustive and clearly classifying the above groups as one subgeneric group would be repugnant to scientific classification. Thus, the first requirement is not met as described above. Secondly, there is little evidence provided that the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. The examiner recommends that the claims should be amended to include only species that share a single structural similarity and a common use (e.g. drawn to compounds of the formula I wherein X = CR, Y = Z = N) to overcome the rejection. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF. 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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Prosecution Timeline

May 15, 2024
Application Filed
Oct 01, 2026
Non-Final Rejection mailed — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+31.0%)
2y 2m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1139 resolved cases by this examiner. Grant probability derived from career allowance rate.

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