DETAILED ACTION
Claims 1-5 are currently pending in the instant application and are rejected.
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 .
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,065,408 in view of Rautio et al.
Conflicting claims 1-11 are drawn to products of the formula:
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or prodrug thereof (conflicting claims 1-7) and methods of preventing or treating one or more symptoms or conditions of sickle cell disease (conflicting claim 8 and 1) wherein the condition is one of such as vaso-occlusion (conflicting claim 9) and performed orally (conflicting claim 10). Applicant’s instant claims are drawn to products of the formula:
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wherein P is a promoiety such as an imine (instant claims 1 and 2) for to preventing or treating one or more symptoms or conditions of sickle cell disease, such as vaso-occulusion, via oral administration) (instant claims 3-5). Rautio et al. provides that prodrugs can be made at the -OH position or the -C(=O) position, whereas one can at once envisage prodrugs of the formula
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of the conflicting claims to occur at the -OH or -C(=O) position which corresponds to the instant formula:
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wherein the -C(=O) is replaced with a promoiety, see page 256, wherein imines and oximes are shown to be promoieties of C(=O) in Figure 1, which provides drugs with promoiety replacement at the -OH and the -C=O groups.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/130,621 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to prodrug products of the formula:
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(conflicting claim 1) which anticipate applicant’s instantly claimed products:
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wherein P is a promoiety, such as a type of imine (instant claims 1-2). Conflicting claim 6 provides the prodrug:
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which corresponds to applicant’s instantly claimed formula wherein P is a promoiety which is an imine. Conflicting claims 11-15 provide methods of treating or preventing one or more acute symptoms of sickle cell disease (conflicting claim 11), such as respiratory hypoxia (conflicting claim 13) which corresponds to applicant’s instant method claims 3-5 drawn to preventing or treating one or more symptoms or conditions of sickle cell disease. Rautio et al. is provided to show background of prodrug design utilizing promoieties, see page 256, wherein imines and oximes are shown to be promoieties of C(=O).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
See MPEP 804 I.B.1.(b)(ii):
Application under examination has the same patent term filing date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 8 September 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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