Prosecution Insights
Last updated: April 19, 2026
Application No. 17/788,916

Acylsulfamide Compound and Pharmaceutical Use Therefor

Non-Final OA §112
Filed
May 24, 2023
Examiner
ANDERSON, REBECCA L
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Japan Tobacco Inc.
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
2y 5m
To Grant
97%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
749 granted / 1022 resolved
+13.3% vs TC avg
Strong +24% interview lift
Without
With
+24.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
44 currently pending
Career history
1066
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
17.0%
-23.0% vs TC avg
§102
25.0%
-15.0% vs TC avg
§112
31.8%
-8.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1022 resolved cases

Office Action

§112
DETAILED ACTION Claims 1-15, and 18-20 are currently pending in the instant application. Claims 1-12, 14, 15, and 18-20 are rejected. Claim 13 is objected. 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 . Specification The disclosure is objected to because of the following informalities: The Preliminary Amendment filed 24 May 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “The contents of each of these applications are incorporated herein by reference in their entirety.” MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications: MPEP 211.02, in-part For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p). When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(b). MPEP 201.06(c)(IV), in-part 201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-07.2015] IV. INCORPORATION BY REFERENCE An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). 20.6 Confirmation of Incorporation by Reference of Elements and Parts (a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7 , a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18 , accompanied by: (i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned; (ii) where the applicant has not already complied with Rule 17.1(a) , (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed; (iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a) , a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and (iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii). (b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office. (c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i) , 20.5(b) , 20.5(c) , 20.5bis(b) or 20.5bis(c) , as the case may be. 20.7 Time Limit (a) The applicable time limit referred to in Rules 20.3(a) and (b) , 20.4 , 20.5(a) , (b) and (c) , 20.5bis(a) , (b) and (c) , and 20.6(a) shall be: (i) where an invitation under Rule 20.3(a) , 20.5(a) or 20.5bis(a) , as applicable, was sent to the applicant, two months from the date of the invitation; (ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office. (b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit. 4.18 Statement of Incorporation by Reference Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) , or a part of the description, claims or drawings referred to in Rule 20.5(a) , or an element or part of the description, claims or drawings referred to in Rule 20.5bis(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6 , incorporated by reference in the international application for the purposes of Rule 20.6 . Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date. The instant application is a 371 application which has an International filing date of 25 December 2020. The incorporation by reference statement is being added by way of a Preliminary Amendment filed 24 May 2023, which is after the instant application's International filing date of 25 December 2020. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter. Applicant is required to cancel the new matter in the reply to this Office Action. The disclosure is objected to because of the following informalities: Page 50 of the specification has part of the names of some haloalkyl substituents highlighted. This highlighting makes the words illegible. Page 62 appears to be missing text before and after the “or”: PNG media_image1.png 216 482 media_image1.png Greyscale . Additionally, pate 89 appears to be missing text as the majority of the page is blank and ends with an “or”. Text appears to be missing before and after the “or”. PNG media_image2.png 120 610 media_image2.png Greyscale It is unclear if the bottom of page 46 is missing text or if the formula found on page 47 are the only formula required. It is suggested that applicant check the specification for missing text. Appropriate correction is required. Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because it is more than one paragraph. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Objections Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 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 1-3, 5-9 and their dependent claims 4, 10-12, 14, 15, and 18-20 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. The instant claims 1-3, and 5-9 have multiple instances of the term “comprising” in the definition of the compound, for example: Regarding claim 1, the claim recites the following phrases: PNG media_image3.png 36 620 media_image3.png Greyscale (above from page 3/27 amendment filed 5/24/2023) PNG media_image4.png 40 654 media_image4.png Greyscale PNG media_image5.png 32 642 media_image5.png Greyscale PNG media_image6.png 32 618 media_image6.png Greyscale PNG media_image7.png 26 636 media_image7.png Greyscale PNG media_image8.png 26 556 media_image8.png Greyscale PNG media_image9.png 30 550 media_image9.png Greyscale PNG media_image10.png 36 558 media_image10.png Greyscale ( above from page 4/27) PNG media_image11.png 34 560 media_image11.png Greyscale PNG media_image12.png 26 642 media_image12.png Greyscale (above from page 5/27) PNG media_image13.png 34 636 media_image13.png Greyscale PNG media_image14.png 30 670 media_image14.png Greyscale PNG media_image15.png 28 636 media_image15.png Greyscale PNG media_image16.png 36 660 media_image16.png Greyscale (above from page 6/27) PNG media_image17.png 54 656 media_image17.png Greyscale (above from page 7/27) PNG media_image18.png 26 662 media_image18.png Greyscale PNG media_image19.png 32 690 media_image19.png Greyscale (above from page 8/27) PNG media_image20.png 34 662 media_image20.png Greyscale (above from page 9/27) PNG media_image21.png 54 654 media_image21.png Greyscale PNG media_image22.png 30 648 media_image22.png Greyscale (above from page 10/27) PNG media_image23.png 34 668 media_image23.png Greyscale (above from page 11/27) PNG media_image24.png 54 650 media_image24.png Greyscale PNG media_image25.png 50 636 media_image25.png Greyscale PNG media_image26.png 36 654 media_image26.png Greyscale PNG media_image27.png 32 652 media_image27.png Greyscale (above from page 12/27) PNG media_image28.png 28 498 media_image28.png Greyscale PNG media_image29.png 18 652 media_image29.png Greyscale (above from page 13/27) Regarding claim 2, the claim recites the following phrases: PNG media_image30.png 36 646 media_image30.png Greyscale PNG media_image31.png 34 640 media_image31.png Greyscale PNG media_image32.png 30 674 media_image32.png Greyscale PNG media_image33.png 26 638 media_image33.png Greyscale PNG media_image34.png 26 606 media_image34.png Greyscale PNG media_image35.png 18 626 media_image35.png Greyscale PNG media_image36.png 30 612 media_image36.png Greyscale (above from page 14/27) PNG media_image37.png 32 654 media_image37.png Greyscale PNG media_image38.png 32 678 media_image38.png Greyscale (above from page 15/27) PNG media_image39.png 22 642 media_image39.png Greyscale (above from page 16/27) PNG media_image40.png 24 598 media_image40.png Greyscale PNG media_image41.png 24 628 media_image41.png Greyscale (above from page 17/27) PNG media_image42.png 22 656 media_image42.png Greyscale PNG media_image43.png 28 652 media_image43.png Greyscale PNG media_image44.png 30 500 media_image44.png Greyscale (above from page 18/27) In regards to claim 3, the following phrases: PNG media_image45.png 32 640 media_image45.png Greyscale PNG media_image46.png 28 626 media_image46.png Greyscale (above from page 19/27) PNG media_image47.png 24 690 media_image47.png Greyscale (above from page 20/27) In regards to claim 5, the following phrases: PNG media_image48.png 30 658 media_image48.png Greyscale PNG media_image49.png 40 642 media_image49.png Greyscale PNG media_image50.png 34 638 media_image50.png Greyscale PNG media_image51.png 24 660 media_image51.png Greyscale (above from page 21/27) In regards to claim 6, the following phrases: PNG media_image52.png 30 644 media_image52.png Greyscale PNG media_image53.png 22 670 media_image53.png Greyscale (above from page 21/27) In regards to claim 7, the following phrases: PNG media_image54.png 32 616 media_image54.png Greyscale PNG media_image55.png 36 650 media_image55.png Greyscale PNG media_image56.png 30 610 media_image56.png Greyscale (above from page 22/27) In regards to claim 8, the following phrases: PNG media_image57.png 32 600 media_image57.png Greyscale (above from page 23/27) In regards to claim 9, the following phrases: PNG media_image58.png 42 602 media_image58.png Greyscale (above from page 23/27) In the abovementioned phrases, the term, “comprising”, is open-ended and thus, does not exclude additional, unrecited elements, according to MPEP 2111.03(I). Subsequently, it is unclear to the Examiner whether the above mentioned partial structure, heterocycloalkyl, heteroaromatic, heteroaryl, heterocycloalkyl, etc. contain heteroatom(s) outside of the abovementioned recited heteroatoms (e.g. N, O, and S), such as phosphorus (P) or if a larger number of heteroatoms could be present and would read on the abovementioned limitations. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite. The term “comprising” or forms of the term are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed. The term “compound” contradicts the open language "comprising." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148. By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules. The transitional term "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). Thus, a contradiction arises within the definition of instant discussed variables in claims 1-3, 5-9 and their dependent claims 4, 10-12, 14, 15, and 18-20 because a "compound" requires a definite chemical formula, and the open-ended term "comprising" does not exclude unrecited elements. Furthermore, "comprising", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope of compounds, thereby rendering the scope of claims 1-12, 14, 15, and 18-20 indefinite. It is suggested that an amendment to change “comprising” to a form such as “with”, for example. Regarding claims 4, 10-12, 14, 15, and 18-20, these claims are dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered these claims indefinite. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm. 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, Joseph McKane can be reached on 571-272-0699. 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. /REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 11 September 2025 Rebecca Anderson Primary Examiner Art Unit 1626, Group 1620 Technology Center 1600
Read full office action

Prosecution Timeline

May 24, 2023
Application Filed
Sep 11, 2025
Non-Final Rejection — §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
73%
Grant Probability
97%
With Interview (+24.0%)
2y 5m
Median Time to Grant
Low
PTA Risk
Based on 1022 resolved cases by this examiner. Grant probability derived from career allow rate.

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