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 .
Remark
The amendment filed on March 02, 2026 are noted.
Claims 1, 19, 20, 22, 25-27 have been amended.
New claims 28-29 have bene added.
Claims 2-5, 14, 17-18, 21 and 23-24 have been canceled.
Claims 1, 6-13, 15-16, 19-20, 22 and 25-29 are pending.
Election/Restrictions
Applicant’s election without traverse of group I , species of IL-12 the reply filed on 3/02/2026 is acknowledged.
However, Applicants elected SEQ ID NO: 50 with traverse in the reply filed on 3/02/2026 is acknowledged. Applicants’ argument has been respectably considered. However, it is found persuasive partially to rejoin the SEQ ID NO: 52 as the parent bale case the SEQ ID NO: 52 was considered.
However, other non-elected species are not considered and a rejoinder practice will be considered upon the elected the elected generic claims are in a condition for allowance.
Hence, Claims 1, 10, 15-16, 19-20, 22, 25-26, and 27-29 with the elected species of SEQ IDNO: 50 and 52 and IL-12 are considered.
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, 6-13, 15-16, 20, 22, 26-27 and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,220,459. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and rejected claims are considered to be either as conflict claims with an overlapping scope or obvious each from other rather than patentable distinct subject matter for any person ordinarily skilled in the art.
In particular, the rejection product claims 1, 6-10, 20, 22, 26, 27, 28 and 29 are directed to an immune-stimulating composition comprising a pharmacologically acceptable excipient or an expression construct encoding same of a mutated constitutively active pro-inflammatory human caspase-1 as well as a method for using the same, wherein the mutated constitutively active pro-inflammatory is human caspase-1 comprises swapped p10 and p20 domains, but lacks a caspase-recruitment domain (CARD) and a p20-p10 interdomain linker (IDL) The human caspase-1 further comprises a glycine corresponding to G403 of SEQ ID NO: 52 located at a distance from 0 to 40 amino acids residues from a cysteine corresponding to C136 of SEQ ID NO: 52. Furthermore, the swapped p10 and p20 domains are connected by a protease cleavable site, and it is also the one comprising at least one antigen or at least one RNA or DNA nucleic acid sequence encoding an antigen as well as accessory molecule in combination with an accessory gene encoding an antigen and/or interleukin-12 (IL-12) combination thereof. It is worth to note that genetic vaccine is defined by the specification as it was ordinally filed (see column 17 of the specification ) as an expression construct that can express said one or more antigens from an RNA or DNA expression construct and may further comprise a nucleic acid encoding another immune stimulating molecule such as a cytokine . Hence the issues reference claims are obviously to the rejected claim 8 that cites the claimed immune-stimulation composition further comprising a genetic vaccine. The rejected method claims 11-13, 15-16 and 27 are drawn to a method for using the same in an individual to induce an immune response against a tumor or infection in general.
The reference claims are also drawn to a structurally truncated constitutively active pro-inflammatory caspase-1, a composition comprising the same as well as the method of using the same, which is also directed to a human constitutively active pro-inflammatory caspase-1 comprising swapped p10 and p20 domains, but lacking either caspase-recruitment domain (CARD) and/or a p20-p10 interdomain linker (IDL). Because the claims are cited with an open language “comprising”, it would have been obviously rather than distinct from the one cited in the rejected claims for any person ordinarily skill in the art to think they are not distinct but obvious to make the same. Moreover, the swapped p10 and p20 domains are also cited to comprise a protease cleavable sit cited in reference claim 16 as well as the one comprising 1) an accessary gene and 2). at least one immune-stimulating factor, which is also directed to IL-2. Moreover, the reference claim also cites that claimed biological molecule can be prepared in a composition and a pharmacologically acceptable excipient that can be presented as an recombinant protein or polypeptide molecules in combination or it can be presented as a RNA or DNA molecule encoding the at least one antigen or the entire recombinant molecule can be presented or carried by an expression vector.
. Furthermore, the reference claims are also directed to a method for using the same for a patient in need for induce an immune response against tumor or infection, which meet the same limitations cited in the rejected claims 11-13, 15-16 and 27.
Therefore, the reference claims and rejected claims are considered to not considered patentable distinct rather than obvious each from other for any person ordinarily skill in the art.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
Prosecution Insights