DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election of the invention of Group II, claims 33-37, in the reply filed on 11/17/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 30-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/17/2025.
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 33, 35-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-6 of U.S. Patent No. 8,916,545,
claims 1-23 of U.S. Patent No. 9,499,461,
claims 1-7 of U.S. Patent No. 9,663,428,
claims 1-9 of U.S. Patent No. 9,987,237,
claims 1-11 of U.S. Patent No. 9,987,271,
claims 1-7 of U.S. Patent No. 9,913,838,
claims 1-8 of U.S. Patent No. 10,092,562,
claims 1-8 of U.S. Patent No. 11,013,804,
claims 1-8 of U.S. Patent No. 11,077,104,
in view of Demierre et al., Nature Reviews Cancer, volume 5, pages 930–942 (2005).
The primary conflicting patents teaches a composition comprising perillyl alcohol carbamate conjugated with either temozolomide, rolipram, and/or dimethyl celecoxib as well as the routes of administration (see the claims). The primary conflicting patents teaches the composition as useful for treating cancer.
The primary conflicting patents do not expressly teach the incorporation of statins.
Demierre et al. teaches statins such as lovastatin and pravastatin as useful in preventing and/or treating various cancers (see page 934, col. 2, Section Statins effects in cancer models; page 936, Table 1, page 938, Table 2).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate both the statins and the herein claimed conjugates into a single composition.
One of ordinary skill in the art would have been motivated to incorporate both the statins and the herein claimed conjugates into a single composition. Combining two agents, which are known to be useful to treat cancer individually, into a single composition useful for the very same purpose is prima facie obvious (See In re Kerkhoven 205 USPQ 1069 (CCPA 1980)).
Claims 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S> Patent no. 11,147,809 (‘809).
‘809 teaches a composition comprising perillyl alcohol carbamate conjugated with either temozolomide, rolipram, and/or dimethyl celecoxib as well as the routes of administration (see the claims 1-8). ‘809 teaches the composition also comprising prostratin (see claim 7).
Since ‘809 teaches every limitations of the instant claims, it reads on the instant invention. This is an anticipatory type of obviousness double patenting rejection.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627