DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14 and 16-19 were Examined. Applicant has amended claims 1, 10-13, 17, and 19; canceled claims 9, 14, and 18, per the reply of 11/20/2025.
Claims 1-8, 10-13, 16-17, and 19 are currently under examination on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/2025 has been entered.
Priority
The instant application filed 11/1/2021 is a Continuation of 15/027387, filed 4/5/2016, now U.S. Patent 11,160,751 and having 2 RCE-type filing therein. 15/027387 is a National Stage entry of PCT/US2014/059443, International Filing Date of 10/7/2014. PCT/US2014/059443 claims Priority from Provisional Application 61/887643, filed 10/7/2013.
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 1-8, 10-13, 16-17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,160,751. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘751 claims are an anticipatory species of the instant claims, claim 1 of ‘751 states a, “method of modulating or controlling a level of hematocrit in blood of a subject, comprising: subcutaneously administering a dose of testosterone or a pharmaceutically acceptable ester or salt thereof in sesame oil with a powered autoinjector configured to inject the dose over an injection time of about 5 seconds to about 20 seconds such that the testosterone or the pharmaceutically acceptable ester or salt thereof in at least one of blood serum or blood plasma of the subject increases from a first concentration to a second concentration greater than the first concentration, the dose of the testosterone or the pharmaceutically acceptable ester or salt thereof comprising a concentration of about 50 milligrams per milliliter to about 400 milligrams per milliliter, wherein following administration of the dose of the testosterone or of the pharmaceutically acceptable ester or salt thereof the concentration of the testosterone or the pharmaceutically acceptable ester or salt thereof in at least one of blood serum or blood plasma of the subject, is maintained at the second concentration at a value from about 300 ng/dl to about 1800 ng/dl for a period of about 2 hours after administration to at least 5 days after administration of the dose of the testosterone or of the pharmaceutically acceptable ester or salt thereof and the level of hematocrit in the blood of the subject does not exceed 70% of a packed cell measurement volume.”
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629