Prosecution Insights
Last updated: July 17, 2026
Application No. 18/845,718

NOVEL TAFAMIDIS SYNTHESIS METHOD

Non-Final OA §112
Filed
Sep 10, 2024
Priority
Mar 10, 2022 — RE 10-2022-0030262 +1 more
Examiner
SHIM, DAVID M.
Art Unit
Tech Center
Assignee
Korea University Research and Business Foundation
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
1y 0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
51 granted / 88 resolved
-2.0% vs TC avg
Strong +56% interview lift
Without
With
+55.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
63 currently pending
Career history
126
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
59.1%
+19.1% vs TC avg
§102
13.1%
-26.9% vs TC avg
§112
19.7%
-20.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 88 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 Claims 1-15 are pending in the application. Claims 1-15 are rejected. Claims 1-15 are objected to. Priority This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/KR2023/002888, filed on March 2, 2023, which claims priority to Korean Application No. KR10-2022-0030262, filed on March 10, 2022. 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. Information Disclosure Statement The Information Disclosure Statement(s) (IDS) filed on September 10, 2024 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached. Specification The amendment filed on September 10, 2024 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 phrase “...the entire disclosure of which is incorporated herein by reference for all purposes.” 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-08.2017] 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) or 20.5(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), and 20.6(a) shall be: (i) where an invitation under Rule 20.3(a) or 20.5(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) 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 March 2, 2023. Specifically, PCT/KR2023/002888 was filed without an “incorporation by reference” statement to the earlier application filed in the Republic of Korea. Then, Applicant filed a 371 of the PCT and attempted to amend the specification to include the “incorporation by reference” statement via a preliminary amendment filed September 10, 2024, which is after the instant application's International filing date of March 2, 2023. This is considered new matter. MPEP 201.06(c): “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)).” Applicant is required to cancel the new matter in the reply to this Office Action. This objection to the specification can be overcome by deleting the phrase “...the entire disclosure of which is incorporated herein by reference for all purposes” from the instant specification. Claim Objections Claims 1-15 are objected to because of the following informalities: Claim 1 should be amended to recite, “A method for manufacturing compound 1 Claim 1 should be amended to replace “Where M and M’” with -where M and M’- for sake of clarity. Claims 2-15 should each be amended to replace “The method for manufacturing of claim” with -The method of- or -The manufacturing method of- for sake of clarity. Claim 10 should be amended to replace “the base” with -the base containing M- for sake of clarity and consistency. Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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 1-15 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. Claim 1 recites the limitation “[w]here M and M’ are each independently selected from the group consisting of alkali metals, alkaline earth metals, and ammonium” and is rejected as indefinite. It is unclear how M or M’ (i.e., singular entities) can be “alkali metals” or “alkaline earth metals” (i.e., plural entities) at any given point in time. It is suggested Applicant replace “alkali metals” and “alkaline earth metals” with -an alkali metal- and -an alkaline earth metal-, respectively, to overcome this issue of indefiniteness. Dependent claims 2-7 and 9-15 do not correct this issue of indefiniteness and are hence rejected. Claim 1 recites the limitation “the manufacturing method is characterized by being performed in air without using metal catalysts and/or additional oxidizing agents” and is rejected as indefinite. It is unclear whether Applicant intended this limitation to apply to the entire method [i.e., steps (a)-(d)] or to further limit one or more- but not all- of steps (a)-(d). The former seems unlikely considering step (c) potentially involves a metal-containing catalyst. Consequently, it is unclear which recited step(s) of the instantly claimed method Applicant intended the aforementioned limitation to further limit. In addition, the limitation “additional oxidizing agents” implies Applicant intended the claim to recite at least one other oxidizing agent. Therefore, it is unclear whether Applicant intended “additional oxidizing agents” to be in reference to a) unrecited oxidizing agents or b) the oxygen found in air. Applicant should amend claim 1 to clearly indicate how the limitation “the manufacturing method is characterized by being performed in air without using metal catalysts and/or additional oxidizing agents” is limiting the scope of the claim. Dependent claims 2-15 do not correct this issue of indefiniteness and are hence rejected. Allowable Subject Matter Claims 1-15 are free of the prior art and would otherwise be allowable if amended to overcome the claim objection(s) and rejection(s) under 35 U.S.C. § 112(b) as indicated above. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST. 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, RENEE CLAYTOR can be reached at (571)272-8394. 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. /D.M.S./Examiner, Art Unit 1626 /REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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Prosecution Timeline

Sep 10, 2024
Application Filed
Jun 26, 2026
Non-Final Rejection mailed — §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+55.9%)
2y 11m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 88 resolved cases by this examiner. Grant probability derived from career allowance rate.

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