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
Election/Restriction
Applicant elected without traverse, Group I invention and compound species, 4-((2-Cyano-4-(isoindolin-2-ylmethyl)phenoxy)methyl)-N,N-dimethylbenzamide (Compound 6), having structure shown below, on July 20, 2026.
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The elected species corresponds to Formula (I), R1 is -X1-C(O)R6, X1 is a bond, R6 is - NR12R13, R12 is C1-7alkyl, R13 is C1-7alkyl, R2 is hydrogen, R3 is cyano, R4 is hydrogen, R5 is hydrogen, B is phenyl, A is a 3-10 membered carbocyclyl.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 22, 34 and 35 read on the elected invention and species.
Claims 29-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim 12-13, 17-20 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The elected species, compound 6 (CAS# 2925557-59-9), entered STN database on June 06, 2023. The search/examination has been expanded to non-elected species wherein moiety B is phenyl, R3 is hydrogen, halogen or OC1-7 alkyl, R4 is hydrogen; moiety A is phenyl or piperidinyl, R1 is C(O)NC1-7 alkyl, R2 is hydrogen; R5 is hydrogen, which are rejected under 35 USC §103 and on the ground of double patenting. Other non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected species, there being no allowable generic or linking claim.
Status of Claims
Claims 1, 2, 4, 6, 7, 9-14, 16-22 and 34-36 are pending in the instant application.
Claims 12-13, 17-20, 29-33 and 36 are withdrawn.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 22, 34 and 35 are under examination in this office action.
Priority
The instant application 18/708,157 filed on May 07, 2024, is 371 of International Application No. PCT/FI2022/050741, filed November 9, 2022, which claims the benefit of Finnish Application No. 20217169, filed November 10, 2021.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of foreign Application No. 20217169 is filed on May 07, 2024.
Information Disclosure Statement
The information disclosure statement dated 12/17/2024 is in compliance with the provisions of 37 CFR 1.97. The reference listed in IDS are being considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 34 and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the full-scope of claimed compound of Formula I. This is a written description rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant is directed to the MPEP 2163 and Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
MPEP 2163.02 states “ Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed.”
Independent claim 1 and dependent claims are drawn to compound of formula I comprising vast variety of moiety A and B. The Applicant is required to provide adequate written description and evidence of possession of the claimed genus that aligns with instantly claimed broad scope.
MPEP 2163 II states; “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above)”. While applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. “A representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus” MPEP 2163 II.
Instant specification discloses about 58 compounds with variety of activities wherein some compounds have high IC50 value over 350nM (See PGPub US 2025/0011285 A1, [0239], Table 1, Examples). The disclosed compounds are not representative for the full scope of compound of Formula I. For example, the disclosed compounds comprise substituted phenyl ring and
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(See Compound 38, 41, 44- 47, 51) as B moiety. Instant specification does not disclose compounds comprising other 8-12 membered heterocyclic and does not commensurate with the broad definition of B moiety as 8-12 membered heterocyclyl.
Instant specification discloses compounds comprising substituted phenyl and piperidinyl ring as A moiety and only one example ( Compound 50) wherein A moiety is a cyclohexyl ring. The disclosure of phenyl ring and one example of cyclohexyl ring as A moiety does not commensurate with the broad definition of A moiety as 3-10 membered carbocyclyl; similarly, the disclosure of piperidinyl ring as A moiety does not commensurate with the broad definition of A moiety as 4-12 membered heterocyclyl.
The only disclosure of other moieties/groups, in addition to the species reduced to practice, is in the form of general formula with lists of possible groups. This kind of disclosure is not representation of any species. A "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species. MPEP 2163.1.A. and Fujikawa v. Wattanasin, 93 ”.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed.Cir. 1996).
Further, claim 1 recites R1 and R2 on A moiety without defined position, wherein R1 and R2 have overlapping definition with proviso that R1 is not hydrogen when B is phenyl. It’s not clear whether the substitute on A moiety is considered as R1 or R2. It’s not clear how to differentiate hydrogen on the A moiety as R2 or R1 to be excluded from the proviso. Instant claimed B moiety comprises R3 and R4 without defined position and R3 and R4 have overlapping definition. It’s not clear whether hydrogen, halogen or nitro group on B moiety is considered as R3 or R4.
There are substantial structural variation within the genus/subgenus embraced by instant claims and instant disclosure of species do not commensurate with the claimed scope of genus/subgenus. One of ordinary skilled in the art would not recognize from the disclosure that the applicant was in possession of full scope of compound of Formula I comprising vast variety of A and B moiety. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 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 for establishing a background for determining obviousness under 35 U.S.C. 103 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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 22, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Din Belle et al. (WO2018/115591 A1, hereafter “ Din Belle’591”, Applicant’s IDS dated 12/17/2024).
Din Belle’591 teaches compound of Formula I, IA to IE, etc. or salt thereof, as CYP11A1 (cytochrome p450 monooxygenase 11A1) inhibitor, pharmaceutical composition and method of treating disease for steroid receptor, particularly androgen receptor dependent diseases and conditions(e.g. cancer) (See abstract; page 3, lines 1-25 ; page 4, lines 1-30; Compounds 1-281; Examples 1-26; claims 1-44).
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Din Belle’591 teaches compound of Formula IC , ID and IE comprising isoindoline moiety(See page 16, lines 4-20),
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Din Belle’591 teaches compound species, e.g. Compound 2-13, 40, 83-85, 120, 126-127, 131, 136-139, 174, 277, 282, etc. (See page 121-, Example 1-15, etc.) that is similar to instant claimed compound of Formula I, except moiety B.
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Regarding claims 4, 6, 7, 9, 10, 11 and 14 , Din Belle’591 discloses variety of A moiety (e.g. phenyl) substituted with variety of R1 and R2 groups, e.g. substituted benzamide wherein X1 is bond (See Compound 120, 127, 174, etc.).
Regarding claim 21, Din Belle’591 discloses embodiments comprising unsubstituted isoindoline (See compound 120, 174, 282, etc.).
Regarding claim 34 and 35, Din Belle’591 discloses pharmaceutical composition comprising pharmaceutically acceptable carrier (See page 9, lines 3-5; claim 43). Din Belle’591 also teaches combination comprising compound of Formula I and at least one additional active ingredient, glucocorticoid, etc.(See page 58, line 23; page 60, lines 6-32; claim 44).
The main difference between Din Belle’591 and instant claimed compound is moiety B.
According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of instant application to explore phenyl ring in place of unsaturated 4H-pyran ring in Din Belle’591 compounds, together with experimentation/optimization based on general knowledge of structure similarity and bioisosteric modification for SAR study. Phenyl ring is one of the most commonly used unsaturated six-member ring in medicinal chemistry/pharmaceutical industry. The substitution of one unsaturated six-membered 4H-pyran ring for another six-membered ring system (phenyl) would have involved predictable selection of a commonly used six-membered phenyl ring which is within the general knowledge and skill of a POSA. Din Belle’591 teaches substituted phenyl ring with variety of R3/R4/R5 group, e.g. hydrogen, halogen, nitro, cyano, C1-7 alkyl, etc. which could have been applied as B moiety. A skilled artisan would be motivated to substitute the six-membered unsaturated pyran ring with six-membered phenyl ring and reasonably expect the phenyl-containing scaffold maintain comparable steric and special characteristics and the resulting phenyl-substituted compounds on B moiety would provide alternative CYP11 inhibitor for treating prostate cancer.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention base on the combined teachings of prior art and further exploration/optimization based on general knowledge of structure similarity and bioisosteric modification for SAR study. Therefore, the invention as a whole is prima facie obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 34 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of 1-35 of U.S. patent No. 10717726.
Reference claims are drawn to compound of formula I, IA, IC and ID, pharmaceutical composition thereof and method of treating a steroid receptor dependent condition or disease, e.g. castration-resistant prostate cancer (CRPC). Reference claims 13 and 14 recite compound of Formula IC and ID comprising substituted phenyl or piperidinyl that read on instant moiety A.
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The main difference between reference compounds and instant compound is moiety B.
According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
It would have been prima facie obvious to one of ordinary skilled in the art to explore phenyl ring in place of unsaturated 4H-pyran ring in reference compounds, together with experimentation/ optimization based on general knowledge of structure similarity and bioisosteric modification for SAR study. Phenyl ring is one of the most commonly used unsaturated six-member ring in medicinal chemistry/pharmaceutical industry. The substitution of one unsaturated six-membered 4H-pyran ring for another six-membered ring system (phenyl) would have involved predictable selection of a commonly used six-membered phenyl ring which is within the general knowledge and skill of a POSA. A skilled artisan would be motivated to substitute the six-membered unsaturated 4H-pyran ring with six-membered phenyl ring and reasonably expect the phenyl-containing scaffold maintain comparable steric and special characteristics and the resulting phenyl-substituted compounds on B moiety would provide alternative CYP11 inhibitor for treating prostate cancer.
The instant application shares at least one common inventor/applicant/assignee with reference patent. Based on the continuity data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 34 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of 1-11 of U.S. patent No. 11098032.
Reference claims are drawn to compound of formula ID, pharmaceutical composition thereof and method of treating a steroid receptor dependent condition or disease, e.g. castration-resistant prostate cancer (CRPC).
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Reference claim 2 recites compound species comprising substituted piperidinyl that read on instant moiety A.
The difference between reference claimed compounds and instant claimed compound is moiety B, 4H-pyran ring .
According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
It would have been prima facie obvious to one of ordinary skilled in the art to explore phenyl ring in place of unsaturated 4H-pyran ring in reference compounds, together with experimentation/optimization based on general knowledge of structure similarity and bioisosteric modification for SAR study. Phenyl ring is one of the most commonly used unsaturated six-member ring in medicinal chemistry/pharmaceutical industry. The substitution of one unsaturated six-membered 4H-pyran ring for another six-membered ring system (phenyl) would have involved predictable selection of a commonly used six-membered phenyl ring which is within the general knowledge and skill of a POSA. A skilled artisan would be motivated to substitute the six-membered unsaturated pyran ring with six-membered phenyl ring and reasonably expect the phenyl-containing scaffold maintain comparable steric and special characteristics and the resulting phenyl-substituted compounds on B moiety would provide alternative CYP11 inhibitor for treating prostate cancer.
The instant application shares at least one common inventor/applicant/assignee with reference patent. Based on the continuity data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 34 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of 1-24 of U.S. patent No. 12030871.
Reference claims are drawn to compound comprising isoindoline moiety, pharmaceutical composition thereof and method of treating a steroid receptor dependent condition or disease, e.g. castration-resistant prostate cancer (CRPC).
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The difference between reference claimed compounds and instant claimed compound is moiety B, 4H-pyran ring.
According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor/applicant/assignee with reference patent. Based on the continuity data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 34 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of 1-34 of U.S. patent No. 12735408 (Application No. 18/255,218).
Reference claims are drawn to compound of formula I , pharmaceutical composition thereof and method of treating a steroid receptor dependent condition or disease, e.g. castration-resistant prostate cancer (CRPC).
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The difference between reference compounds and instant compound is moiety B wherein pyridine ring and phenyl ring are considered as bioisosteric equivalent.
According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor/applicant/assignee with reference patent. Based on the continuity data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Claims 1, 2, 4, 6, 7, 9, 10, 11, 14, 16, 21, 22, 34 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 9,13-23, 27-37 and 52 of copending U.S. Patent application No. 17/924,857. This is a provisional nonstatutory double patenting rejection.
Reference claims are directed to compound of Formula I, IA, IC, and pharmaceutical composition thereof.
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Claim 37 recite compound species comprising substituted phenyl or piperidinyl that read on instant moiety A, for example,
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The main difference between reference compounds and instant claimed compounds is the substituents on phenyl ring of B moiety.
According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor/applicant/assignee with reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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