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 .
Election/Restrictions
Claims 1-4, 6-8 and 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 25, 2026.
Claims 25-34 have been examined on the merits.
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 25-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.12083242 B2.
Claim 25 is representative of the present invention and is directed to a method of inducing a self-degrading embolism in a subject in need thereof, comprising administering a plurality of the alginate microspheres capable of self-degradation upon rehydration into a blood vessel of the subject, an alginate microsphere comprising: an alginate lyase enzyme pre-treated by varying temperature, by varying pH, and/or with a metal-ion enzyme inhibitor; alginate molecules having one or both of (i) a predetermined molecular weight, and (ii) a predetermined ratio of B-D-Mannuronic acid (M) blocks to a-L-Guluronic acid (G) blocks; and a divalent metal-ion crosslinking the alginate molecules, wherein the alginate microspheres are substantially free of water and/or sterilized and upon rehydration.
The reference claim 15 discloses a method of administering the alginate microsphere that has been dehydrated by lyophilization to a subject, wherein the alginate microsphere is self-degradable upon rehydration, and comprises an alginate lyase enzyme pre-treated by varying temperature, by varying pH, and/or with a metal-ion enzyme inhibitor; and alginate molecules having one or both of (a) a predetermined molecular weight, and (b) a predetermined ratio of β-D-Mannuronic acid (M) blocks to α-L-Guluronic acid (G) blocks and a divalent metal-ion crosslinking the alginate molecules, as defined in the reference claim 9.
The administration method is defined to include administering a plurality of the disclosed alginate microspheres into a blood vessel of the subject to induce a self-degrading embolism in the subject. See ‘242, col, 40, lines 9-13.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of the claims are directed to the same method steps of using the same alginate microspheres.
Regarding claim 26, the reference claim 17 teaches that the degradation of alginate microsphere is controlled by one or more of the pre-treatment of the alginate lyase enzyme, an amount of the alginate enzyme in the microsphere, the predetermined molecular weight of the alginate molecule, and the predetermined ratio of M:G blocks of the alginate molecules, and a composition of gelling bath, including an amount and or charge of one or more ions in the gelling bath.
Regarding claims 27-31, the conditions of the claimed method are disclosed in the reference claims 10, 11, 13, 15, 16, and 18-21.
Regarding claims 32-34, the period “less than about 5 days” is defined to include 50 minutes, 100 minutes and after about 2 hours. See Examples 14 and 15.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
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