DETAILED ACTION
Status of Claims
The amendments, and arguments, filed July 22, 2026, are acknowledged and have been fully considered. Claims 1 and 3-15 are pending and currently under consideration. Claims 1, 6, 9, 13 and 15 have been amended; and claim 2 has been cancelled. 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 Office Action: Final
Withdrawn Claim Objections & Rejections
The objection to the specification is withdrawn in light of applicant’s 07/22/2026 amendments to the specification. Applicant’s 07/22/2026 remarks at p. 8, par. 4 are acknowledged.
The objections to claims 6 and 9 (items A. and B. at par. 1-2 of the 04/22/2026 Office action) is withdrawn in light of applicant’s 07/22/2026 amendments. Applicant’s 07/22/2026 remarks at p. 8, par. 5 are acknowledged.
The rejection of claims 3 and 5 under 35 U.S.C. § 112 (a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as not being enabling (at par. 3-13 of the 04/22/2026 Office action), is withdrawn in light of applicant’s 07/22/2026 amendments. Applicant’s 07/22/2026 remarks at p. 8, par. 7 are acknowledged.
The rejection of claims 1-15 under 35 U.S.C. § 103 over NISHIO (US 2011/0300223 A1), in view of KOSHI (US 2016/0256543 A1) (at par. 14-29 of the 04/22/2026 Office action), is withdrawn in light of applicant’s 07/22/2026 amendments (in particular, the amendment to independent claim 1 reciting, “wherein the mixture comprises each of the particle and the immuno-stimulating factor in an independent state”). Applicant’s 07/22/2026 remarks at p. 9, par. 1 to p. 14, par. 3 are acknowledged.
The nonstatutory double patenting rejection of claims 1-15 over claims 1-10 of US 10,556,004 B2, matured from US Appl. No. 15/028,266 (at par. 30-32 of the 04/22/2026 Office action), is withdrawn in light of applicant’s 07/22/2026 amendments (in particular, the amendment to independent claim 1 reciting, “wherein the mixture comprises each of the particle and the immuno-stimulating factor in an independent state”).
The nonstatutory double patenting rejection of claims 1-8 and 10-15 over claims 1, 3-7, 10-12 and 14-19 of US copending Appl. No. 18/687,149 (at par. 33-48 of the 04/22/2026 Office action), is withdrawn in light of applicant’s 07/22/2026 amendments (in particular, the amendment to independent claim 1 reciting, “wherein the mixture comprises each of the particle and the immuno-stimulating factor in an independent state”).
The nonstatutory double patenting rejection of claims 1-8 and 10-15 over claims 1, 3-7 and 10-19 of US copending Appl. No. 18/692,396 (at par. 49-64 of the 04/22/2026 Office action), is maintained in modified form, in light of applicant’s 07/22/2026 amendments, which cancel claim 2.
Modified Claim Rejections - Nonstatutory Double Patenting – Necessitated by Amendments
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1 and 3-15 are provisionally rejected on the ground of nonstatutory double patenting over claims 1, 3-7 and 10-19 of copending Application No. 18/692,396 (‘396 Application). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a composition for enhancing immunogenicity, containing, as an active ingredient, a mixture of a particle and an immuno-stimulating factor, wherein the particle comprises an amphiphilic polymer and an antigen.
Claim 1 is obvious per claims 1 and 4 of the ‘396 Application. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Claim 3 is anticipated by claim 5 of the ‘396 Application.
Claim 4 is anticipated by claim 6 of the ‘396 Application.
Claim 5 is anticipated by claim 7 of the ‘396 Application.
Claim 6 is anticipated by claim 10 of the ‘396 Application.
Claim 7 is anticipated by claim 11 of the ‘396 Application.
Claim 9 is anticipated by claim 12 of the ‘396 Application.
Claim 8 is anticipated by claim 12 of the ‘396 Application.
Claim 10 is anticipated by claim 14 of the ‘396 Application.
Claim 11 is anticipated by claim 15 of the ‘396 Application.
Claim 12 is anticipated by claim 16 of the ‘396 Application.
Claim 13 is anticipated by claim 17 of the ‘396 Application.
Claim 14 is anticipated by claim 18 of the ‘396 Application.
Claim 15 is anticipated by claim 19 of the ‘396 Application.
Response to Arguments
Applicant’s arguments filed on July 22, 2026 have been fully considered, and it is acknowledged that applicants will take appropriate action in the event that the claims of one or both of the pending applications are allowed, or determined to have allowable subject matter therein. Remarks, p. 14, par. 5-8. Until such an appropriate event as noted by applicantis taken, the provisional double patenting rejection of record is maintained.
Summary/Conclusion
Claims 1 and 3-15 are rejected. No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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