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. CONTINUING DATA This application is a 371 of PCT/CN2022/098082 06/10/2022 FOREIGN APPLICATIONS CHINA 202110653130.5 06/11/2021 The claim set under examination is the second preliminary amendment submitted January 5, 2024. Claims 1-19 are pending. Drawings The drawings are objected to because the legends in Figures 1-5 are blurry and illegible. 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 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 appl icant regards as his invention. Claim s 15 and 17-19 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. Claim 15 recites the use of the compound of claim 1 in the manufacture of a medicament for the treatment of tumors and cancers. Claim 15 is unclear because it does not set forth any steps. MPEP 2173.05(q) states that a ttempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) . Claim 17 recites a medicament or formulation, wherein the medicament or formulation is used for the treatment of tumor and cancer diseases in patients. Claim 17 is indefinite because it contains a product and process in the same claim. A single claim which claims both a product and a process in the same claim is indefinite. MPEP 2173.05(p). Claims 18 and 19 each recite a step of applying the product of claim 16, followed by a determining or adjusting step, and then administering the product of claim 16 if certain conditions are met. The claims are indefinite because the meaning of “applying” is unclear. “Applying” could mean the same thing as administering, but then administering is recited separately, which implies that applying is different from administering. Paragraph [0090] of the specification states that a medicament should be applied or administered to reach a therapeutically effective amount, but does not explain the difference between applied and administered. As the claim is written, it is unclear whether the “applying” step is a first administration step or whether applying means something else, such as obtaining or providing the claim 16 composition. Claim 19 recites a step of adjusting an AKR1C3 reductase content or expression level. The claim is indefinite because it is unclear how the adjusting is carried out, or whether the adjusting is a natural outcome of applying (administering?) the claim 16 composition. Paragraph [0087] of the specification states that adjusting is done “through a certain adjustment treatment/administration process.” Paragraph [0087] does not clarify the adjusting step. 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. Claim 2 -9 and 12 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 depends from claim 1. Claim 2 recites formula (II), wherein Y can be CR a R b , NR a , or O, and the position of Y may be changed between the 4 positions excluding 2 carbon atoms shared with the benzene ring. Thus, claim 2 formula (II) includes compounds where the indicated position can be O, NR a , or CR a R b other than CH R 10 . Claims 3-9 and 12 depend from claim 2 and incorporate the same limitation by reference. In claim 1, the indicated position must be CHR 10 . Claim 2 fails to include all the limitations of claim 1. 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 § 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. Claim s 18 -19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) an abstract idea (“determining” step or “adjusting” step). MPEP 2106 provides a flowchart for subject matter eligibility test. Step 1: is the claim to a process, machine, manufacture or composition of matter? The answer is yes, the claim is directed to a process. Step 2A: is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea? The answer is yes, the claim recites a step “ determining an AKR1C3 reductase content ,” which is an abstract idea. Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? The answer is no. The claim recites an additional element step “administering” if the measured AKR1C3 reductase content or level is equal or greater to a predetermined value. MPEP 2106.05 provides guidance for whether a claim amounts to significantly more. Limitations that the courts have found not to be enough to qualify as “significantly more” include mere data gathering in conjunction with an abstract idea. In this instance, “measured” is mere data gathering. The administering step does not amount to significantly more than the abstract idea because step (iii) only requires a treatment step if certain conditions are met (administering to the subject if the measured AKR1C3 reductase content or level is equal or greater to a predetermined value ). If those conditions are not met , the administering step is not required. When administering is not required, it cannot amount to significantly more. The claims are rejected because administering is not necessarily required to be performed. As set forth above, the meaning of “applying” in claim 18 is unclear, so in the event that “applying” only means providing or similar, this rejection is made. Claim 19 also recites a similar contingent limitation and claim 19 is also indefinite, as set forth above. Claim 19 is included in this rejection in the event that the “applying” and “adjusting” steps are not active steps . Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because a “use” is not one of the four statutory classes. Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is Duan (WO 2016/1613432 A1, cited on IDS). Duan teaches the following, which differs from claimed formula (III) because neither of R13 and R14 is hydrogen. Duan does not provide any broader teaching to suggest replacing one of the positions corresponding to R13 or R14 with hydrogen. Conclusion Claims 2-9, 12, 15, and 17-19 are rejected. Claims 1 and 16 are allowed. Claims 10-11 and 13-14 are objected to as depending on a rejected base claim. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LAYLA D BERRY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9572 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 7:00-3:00 CST, M-F . 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, FILLIN "SPE Name?" \* MERGEFORMAT Scarlett Goon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5241 . 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. /LAYLA D BERRY/ Primary Examiner, Art Unit 1693