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 .
The previous final rejection dated 5/6/2026 has been obviated herein
DETAILED ACTION
Priority and Status of the Claims
1. This application is a 371 PCT/CN2022/077454 02/23/2022, which claims benefit of the foreign applications: CHINA 202110203800.3 02/23/2021, CHINA 202210095335.0 01/26/2022, and CHINA 202210135655.4 02/14/2022.
2. Amendment of claims 12, 14, 16, 18 and 25, and cancelation of claims 1-11, 13, 17 and 23 in the amendment filed on 7/6/2026 is acknowledged. Claims 12, 14-16, 18-22 and 24-26 are pending in the application.
Responses to Amendments/Arguments
3. Since claims 1 and 3 have been canceled, therefore the rejection of claims 1 and 3 under 35 U.S.C. 103 (a) has been obviated herein.
New Grounds of Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 12, 14-16, 18-22 and 24-26 are rejected under 35 U.S.C. 103(a) as being
obvious over Wehn et al. US 2016/0362390 A1.
Applicants claim a compound, an optical isomer thereof, or a pharmaceutically acceptable salt thereof, wherein the compound is selected from:
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390
1034
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182
560
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, see claim 12. Dependent claims 14-16 further limit the scope of compounds, i.e., methods of use for treatingHIF2α-mediated diseases including renal cancer, breast cancer, Von Hippel-Lindau syndrome, inhibiting HIF2α, or lung cancer.
Applicants claim a compound, an optical isomer thereof, or a pharmaceutically acceptable salt thereof, wherein the compound is
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146
278
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, see claim 18. Dependent claims 19-21 further limit the scope of compounds, i.e., methods of use for treatingHIF2α-mediated diseases including renal cancer, breast cancer, Von Hippel-Lindau syndrome, inhibiting HIF2α, or lung cancer.
Applicants claim a compound of the following formula, or the pharmaceutically acceptable salt thereof, wherein the compound is
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160
238
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, see claim 22. Dependent claims 24-26 further limit the scope of compounds, i.e., methods of use for treatingHIF2α-mediated diseases including renal cancer, breast cancer, Von Hippel-Lindau syndrome, inhibiting HIF2α, or lung cancer.
Determination of the scope and content of the prior art (MPEP §2141.01)
Wehn et al. ‘390 discloses a compound of formula (I),
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218
334
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, or a salt thereof, wherein X and Y are independently selected from C(R3) and N; Z is —O—, —S—, —S(O)—, —S(O).sub.2—, —N(R4)—, C1-C3- alkylene, C1-C3 heteroalkylene, C1-C3 alkenylene, or absent; W1 and W2 are independently C(R5R6), wherein one C(R5R6) or two non-adjacent C(R5R6) may be replaced with a heteroatom independently selected from O, S, and N(R7); W3 is C(R8R9); T is O or N(R10); m is 1, 2, 3, or 4; n is 1, 2, 3, or 4; R1 is selected from alkyl, heteroalkyl, carbocycle (i.e., phenyl) and optionaly substituted with substituted with one or more substituents independently selected from halogen, cyano, alkyl, heteroalkyl, amino, mercapto, hydroxy, and alkoxy, and heterocycle; R2 is selected from hydrogen, halogen, hydroxy, alkoxy, and amino; R3 is independently selected at each occurrence from hydrogen, halogen, hydroxy, cyano, alkyl, and alkoxy; R5, R6, R8, and R9 are independently selected at each occurrence from hydrogen, halogen, hydroxy, mercapto, amino, amido, carboxyl, nitro, phosphonoxy, phosphono, thioxo, formyl, cyano, heteroalkyl, alkyl, alkenyl, alkynyl, alkoxy, carbocycle, heterocycle, and an R5 and R6 attached to the same carbon atom may form ═O, ═CH.sub.2, or ═N(OH), and an R8 and R9 attached to the same carbon atom may form ═O, ═CH2, or ═N(OH); and R4, R7, and R10 are independently selected at each occurrence from hydrogen, hydroxy, alkyl, and cyano, see claim 1 in column 46. When et al. ‘390 compounds are used for inhibiting HIF2α or treating HIF2α-mediated diseases including cancer selected from lung cancer, Von Hippel-Lindau syndrome, head and neck squamous cell carcinoma, pancreatic cancer, breast cancer, ovarian cancer, renal cell carcinoma, prostate cancer, neuroendocrine cancer, gastric cancer, bladder cancer and colon cancer, see claim 42 in column 49 and section [0291] in column 28, thus it reads on the instant methods of use in claims 14-16, and see section [0045] in column 2.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Wehn et al. ‘390 is that the instant claims are embraced within the scope of When et al. ‘390. When et al. ‘390 compounds read on the instant compounds in claims 12, 18 and 22 and their methods of use in claims 14-16, 19-21 and 24-26.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 12, 14-16, 18-22 and 24-26 prima facie obvious because one would be motivated to employ the compound/composition and methods of use of Wehn et al. ‘390 to obtain instant invention.
The motivation to make the claimed compounds/compositions and methods of use derived from the known compound/composition and methods of use of Wehn et al. ‘390 would possess similar activity to that which is claimed in the reference.
Claim Objections
5. Claims 14, 16, 19, 21, 24 and 26 are objected to because of the following informalities:
5.1 Since claims 14, 16, 19, 21, 24 and 26 are drawn to dependent claims on 12, 18 or 22, correction of the beginning term “A” in each claim with a term “The” would obviate the objection.
5.2 Claims 14 and 16 should depend on independent claim 12.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to REI TSANG SHIAO whose telephone number is
(571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 07, 2026
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