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 .
Status of the Claims
Claims 60-63 and 68-71 are pending. Claims 60-63 and 68-71 are rejected.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 10/21/2024 was considered by the Examiner.
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 60-63 and 68-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12098141. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 60 and 68, US12098141 claim 17 recites identical compounds, with identical stereochemistry:
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. While US12098141 claims recite multiple species in addition to those of the instant claims, US12098141 claim 17 is solely drawn to the instantly claimed species. Additionally, the instant claims are drawn to pharmaceutical compositions, wherein US12098141 claim 24 recites the following:
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Regarding instant claims 61 and 69, which are drawn to “treating a disorder or condition through modulating a glucocorticoid receptor”, US12098141 claim 25 is drawn to the following:
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. While the patent is drawn to administering a compound vs. the instant claims drawn to administering a pharmaceutical composition, a skilled artisan would have rendered the instant claims obvious. The patent claims identical compounds and also pharmaceutical compositions thereof.
Regarding instant claims 62 and 70, which are drawn to “treating a disorder or condition through antagonizing a glucocorticoid receptor”, US12098141 claim 26 is drawn to the following:
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. While the patent is drawn to administering a compound vs. the instant claims drawn to administering a pharmaceutical composition, a skilled artisan would have rendered the instant claims obvious. The patent claims identical compounds and also pharmaceutical compositions thereof.
Regarding instant claims 63 and 71, which are drawn to specific disorders or conditions, US12098141 claim 27 are drawn to identical disorders and conditions:
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.
Closest Prior Art
The closest prior art is US20190185470. US20190185470 is drawn to the following genus, taught ad modulators of the glucocorticoid receptor (arrow added by Examiner):
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. The prior art differs from the instant claims in multiple locations, including that of the added arrow. By the added arrow, the prior art has a
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group whereas the instant species have a
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group. The prior art does not provide motivation for, nor render obvious the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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, Amy Clark can be reached at 571-272-1310. 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.
/MEGHAN C HEASLEY/Examiner, Art Unit 1626
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