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
Acknowledgement is made of the response filed on July 24, 2026. In that response, claims 258 and 276 were amended. Claims 258, 261-269, 276, and 277 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection
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 258, 261-26, 276, and 277 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,258,578.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to methods of preparing a crosslinked biodegradable particle, comprising: dissolving polyester backbones, a multifunctional thiol, and a photoinitiator in at least one solvent to form a solution; emulsifying the solution in an aqueous phase to form an emulsion; irradiating the emulsion with UV light to react the multifunctional thiol with allyl groups to form a crosslink; evaporating at least a portion of the solvent from the emulsion; and isolating the crosslinked biodegradable particle, wherein the crosslinked biodegradable particle has a diameter of between about 5 um and about 100 um and is configured to release a drug dispersed therein over a period of at least one month in an aqueous environment. The ‘578 patent’s claims recite polyester backbones comprising polycaprolactone, polylactic acid, polyglycolic acid, and/or polyallyllactide in claim 2 and the 1,6-hexanedithiol and 2,2-dimethoxy-2-phenylacetophenone of claim 276 in claims 3 and 4.
Claims 258, 261-269, 276, and 277 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,426,356 in view of Lowe (Lowe, A.B., Thiol–ene “click” reactions and recent applications in polymer and materials synthesis: a first update, Polym. Chem., 2014, 5, 4820-4870)..
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to crosslinked biodegradable particle, comprising a polyester backbone and a thiol-allyl crosslinks wherein the crosslinked biodegradable particle has a diameter of between about 5 um and about 100 um and is configured to release a drug dispersed therein over a period of at least one month in an aqueous environment, which particle is prepared by the process of the present claims. The ‘356 patent’s claims recite polyester backbones comprising polycaprolactone, polylactic acid, polyglycolic acid, and/or polyallyllactide in claims 8-10. The ‘356 patent does not recite 1,6-hexanedithiol and 2,2-dimethoxy-2-phenylacetophenone. However Lowe reviews application of thiol-ene reactions in preparing polymeric material (title; abstract), and Lowe refers to reaction of pendent allylic groups using 1,6-hexanedithiol to yield an “insoluble crosslinked polymer” (p.4844 left col.). Lowe also teaches 2,2-dimethoxy-2-phenyl acetophenone (DMPA) as a suitable and efficient photoinitiator for various allyl-comprising groups (see, e.g., p.4823 rt. col., p.4824 left col., p.4827 left col.). Therefore it would have been prima facie obvious for one having ordinary skill in the art to use 1,6-hexanedithiol and 2,2-dimethoxy-2-phenylacetophenone in preparing the particles of the ‘356 patent.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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