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 .
Priority
Instant application 17/924,875 filed on 11/11/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-9, 13-44, 52 and 53 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/11/2022 and 06/13/2025 were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 10/11/2025 is acknowledged.
Group I encompasses claims 1-9, 13-44 and 52.
Claims 53 and 38-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/11/2025.
Regarding species election,
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Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of prior art has indicated that elected species is free of prior art. A claim directed to the elected species in independent form would be free of prior art.
Further, the compounds of instant formula (I) do make a contribution over prior art. A claim directed to compounds of formula (I) would be free of prior art.
Examiner expended her search to compounds of formula (II) bearing spiro bicyclic ring of instant formula
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(2’ as B ring) wherein R26 (attached to A ring) is hydrogen.
The subsequent examination is based on this species expansion.
Allowable Subject Matter
Claims 2-4 and 30-34 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
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 (i.e., changing from AIA to pre-AIA ) 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, 5-9, 13-29, 35-37 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over WO-2018115591-A1 in view of Burkhard (Johannes A. Burkhard et al., Angew. Chem. Int. Ed. 2010, 49, 3524 –3527).
WO-2018115591-A1 discloses CYP11A1 inhibitors:
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For, example, WO-2018115591-A1, discloses compound 185:
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The compounds disclosed by WO-2018115591-A1 differ from instant compounds of formula (II), bearing spiro bicyclic ring containing 0-4 heteroatoms, only in the position corresponding to B ring.
It should be noted that instant claims recite “when B is spiro bicyclic ring than R26 can also be hydrogen”.
For example, instant claim 37 recites:
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WO-2018115591-A1 discloses compound 185:
Instant claims recite compound 62:
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WO-2018115591-A1 discloses compound 214:
Instant claims recite compound 42:
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Compound 185, disclosed by WO-2018115591 and instant compound 62 recited in claim 37 differ only in the B ring.
Compound 185, disclosed by WO-2018115591, bears piperidine moiety whereas instant compound 62 bears a spiro bicyclic ring containing 1 heteroatom (azaspiro[3.3]heptane moiety) at the corresponding position.
Burkhard teaches “heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for piperazines, piperidines, morpholines, and thiomorpholines—all of which are common building blocks in medicinal chemistry (see first paragraph)”.
For example, Burkhard teaches compound 34 and compound 13 (see Table 1):
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[…]
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Further, Burkhard teaches that piperidine 34 and homospiropiperidine 13 have identical basicity (page 3525, left column, first paragraph).
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute piperidine moiety present in compounds of WO-2018115591-A1 for a spiro bicyclic ring (homospiropiperidine) because Burkhard teaches “ heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for […] piperidines”.
Based on the teachings of Burkhard, a skilled artisan would consider piperidine and 2-azospiro[3.3] heptane as bioisosteres. One of ordinary skill would have expected retention of activity after the substitution because the core structure of the inhibitor is preserved. The skilled artisan would have been motivated to prepare further examples of CYP11A1 inhibitors for the same purpose.
However, if applicable, Applicant is encouraged to discuss unexpected properties and present data showing that the unexpected properties are results of the substitution of piperidine for spiro bicyclic ring. In addition, if applicable, Applicant is encouraged to discuss/present data showing improvement for the whole scope of instant compounds.
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, 5-9, 13-29, 35-37 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-35 of U.S. Patent 10717726 (based on application 16/427377) in view of Burkhard (Johannes A. Burkhard et al., Angew. Chem. Int. Ed. 2010, 49, 3524 –3527).
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The claims of U.S. Patent 10717726 recite:
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The claims of U.S. Patent US 10717726 recite:
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The claims of U.S. Patent US 10717726 recite:
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The compounds recited in claims of U.S. Patent 10717726 and the instant compounds of formula (II) bearing spiro bicyclic ring differ only in theposition corresponding to B ring.
The compounds recited in claims of U.S. Patent 10717726 bear piperidine moiety whereas instant compounds bear a spiro bicyclic ring containing 1 heteroatom (azaspiro[3.3]heptane moiety) in a corresponding position.
Burkhard teaches “heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for piperazines, piperidines, morpholines, and thiomorpholines—all of which are common building blocks in medicinal chemistry (see first paragraph)”.
For example, Burkhard teaches compound 34 and compound 13 (see Table 1):
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Further, Burkhard teaches that piperidine 34 and homospiropiperidine 13 have identical basicity (page 3525, left column, first paragraph).
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute piperidine moiety present in compounds recited in claims of U.S. Patent 10717726 for a spiro bicyclic ring (homospiropiperidine) because Burkhard teaches “ heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for […] piperidines”. Based on the teachings of Burkhard, a skilled artisan would consider piperidine and 2-azospiro[3.3] heptane as bioisosteres. One of ordinary skill would have expected retention of activity after the substitution because the core structure of the inhibitor is preserved. A skilled artisan would have been motivated to prepare further examples of CYP11A1 inhibitors for the same purpose.
Claims 1, 5-9, 13-29, 35-37 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent 11098032 (based on application 16/895221) in view of Burkhard (Johannes A. Burkhard et al., Angew. Chem. Int. Ed. 2010, 49, 3524 –3527).
The claims of U.S. Patent 11098032 recite:
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The claims of U.S. Patent 11098032 recite:
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The compounds recited in claims of U.S. Patent 11098032 and the instant compounds of formula (I) bearing spiro bicyclic ring differ only in ring B.
The compounds recited in claims of U.S. Patent 11098032 bear piperidine moiety whereas instant compounds bear a spiro bicyclic ring containing 1 heteroatom (azaspiro[3.3]heptane moiety).
Burkhard teaches “heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for piperazines, piperidines, morpholines, and thiomorpholines—all of which are common building blocks in medicinal chemistry (see first paragraph)”.
For example, Burkhard teaches compound 34 and compound 13 (see Table 1):
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Further, Burkhard teaches that piperidine 34 and homospiropiperidine 13 have identical basicity (page 3525, left column, first paragraph).
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute piperidine moiety present in compounds recited in claims of U.S. Patent 11098032 for a spiro bicyclic ring (homospiropiperidine) because Burkhard teaches “ heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for […] piperidines”.
Based on the teachings of Burkhard, a skilled artisan would consider piperidine and 2-azospiro[3.3] heptane as bioisosteres. One of ordinary skill would have expected retention of activity after the substitution because the core structure of the inhibitor is preserved. A skilled artisan would have been motivated to prepare further examples of CYP11A1 inhibitors for the same purpose.
Claims 1, 5-9, 13-29, 35-37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 4, 6-8, 10, 12, 14-20, 22, 26-28, 46 and 52 of copending Application No. 18/696,317 (reference application) in view of Burkhard (Johannes A. Burkhard et al., Angew. Chem. Int. Ed. 2010, 49, 3524 –3527).
The claims of 18/696,317 recite methods for treatments of prostate cancer comprising administering compounds that differ from instant compounds only in ring B.
The claims of 18/696,317 recite:
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The compounds recited in claims of 18/696,317 (wherein R1 is hydrogen) and the instant compounds differ only in the position corresponding to ring B.
For example,
Claims of 18/696,317 recite formula (I) wherein R1 is hydrogen:
Instant claims recite compound 62:
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The compound of formula (I) recited in claims of 18/696,317 (wherein R1 is H) bears piperidine moiety whereas instant compound 62 bears a spiro bicyclic ring containing 1 heteroatom (azaspiro[3.3]heptane moiety).
However, Burkhard teaches “heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for piperazines, piperidines, morpholines, and thiomorpholines—all of which are common building blocks in medicinal chemistry (see first paragraph)”.
For example, Burkhard teaches compound 34 and compound 13 (see Table 1):
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Further, Burkhard teaches that piperidine 34 and homospiropiperidine 13 have identical basicity (page 3525, left column, first paragraph).
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute piperidine moiety present in compounds recited in claims of 18/696,317 for a spiro bicyclic ring (homospiropiperidine) because Burkhard teaches “ heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for […] piperidines”.
Based on the teachings of Burkhard, a skilled artisan would consider piperidine and 2-azospiro[3.3] heptane as bioisosteres.
One of ordinary skill would have expected retention of activity after the substitution because the core structure of the inhibitor is preserved. A skilled artisan would have been motivated to prepare further examples of CYP11A1 inhibitors for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-9, 13-29, 35-37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, 10-11, 13-14, 16-18, 20, 22, 23, 25-28, and 31-33 of copending Application No. 18/704,868 (reference application) in view of in view of Burkhard (Johannes A. Burkhard et al., Angew. Chem. Int. Ed. 2010, 49, 3524 –3527) and in view of WO-2018115591-A1.
It should be noted that instant claims are directed to compounds of formula (I) or (II) or a pharmaceutically acceptable salt thereof.
The claims of application No. 18/704,868 recite salts of:
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The claims of application No. 18/704,868 recite:
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The compound recited in claims of 18/704,868 and the instant compounds of formula (II) bearing spiro bicyclic ring differ in ring B.
In addition, the compound recited in claims of 18/704,868 bear CF3 substituent attached to A ring wherein instant compounds of formula (II), bearing spiro bicyclic ring, bear hydrogen in a corresponding position (R26 variable attached to ring A).
Burkhard teaches “heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for piperazines, piperidines, morpholines, and thiomorpholines—all of which are common building blocks in medicinal chemistry (see first paragraph)”.
For example, Burkhard teaches compound 34 and compound 13 (see Table 1):
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Further, Burkhard teaches that piperidine 34 and homospiropiperidine 13 have identical basicity (page 3525, left column, first paragraph).
Regarding R26 variable, WO-2018115591-A1 discloses CYP11A1 inhibitors bearing hydrogen atom attached to ring A (for example, see compound 185):
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Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute piperidine moiety present in compounds recited in claims of 18/704,868 for a spiro bicyclic ring (homospiropiperidine) because Burkhard teaches “heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for […] piperidines”. Based on the teachings of Burkhard, a skilled artisan would consider piperidine and 2-azospiro[3.3] heptane as bioisosteres.
Further, since WO-2018115591-A1 teaches compounds bearing hydrogen atom attached to ring A - Applying KSR prong (B)- it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute CF3 for H to arrive at the instant compounds with a reasonable expectation of success.
One of ordinary skill would have expected retention of activity after the substitutions because the core structure of the inhibitor is preserved. A skilled artisan would have been motivated to prepare further examples of CYP11A1 inhibitors for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-9, 13-29, 35-37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/730,692 in view of Burkhard (Johannes A. Burkhard et al., Angew. Chem. Int. Ed. 2010, 49, 3524 –3527).
The claims of Application No. 18/730,692 recite:
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The compounds recited in claims of 18/730,692 and the instant compounds of formula II bearing spiro bicyclic ring differ only in B ring.
For example,
Claims of 18/730,692 recite (R1 is hydrogen):
Instant compound 62
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However, Burkhard teaches “heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for piperazines, piperidines, morpholines, and thiomorpholines—all of which are common building blocks in medicinal chemistry (see first paragraph)”.
For example, Burkhard teaches compound 34 and compound 13 (see Table 1):
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Further, Burkhard teaches that piperidine 34 and homospiropiperidine 13 have identical basicity (page 3525, left column, first paragraph).
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute piperidine moiety present in compounds recited in claims of 18/730,692 for a spiro bicyclic ring (homospiropiperidine) because Burkhard teaches “ heteroatom-substituted spiro[3.3]heptanes as viable and promising surrogates for […] piperidines”. Based on the teachings of Burkhard, a skilled artisan would consider piperidine and 2-azospiro[3.3] heptane as bioisosteres. One of ordinary skill would have expected retention of activity after the substitution because the core structure of the inhibitor is preserved. A skilled artisan would have been motivated to prepare further examples of CYP11A1 inhibitors for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621