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
Applicant’s election without traverse of Group II, claims 54-67, in the reply filed on 05/18/2026 is acknowledged.
Claims 34-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 54-57, 60-67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panicker et al (WO 2020/183239, September 2020, of record).
Claim(s) 54-57, 60-67 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Panicker et al (WO 2020/183239, September 2020).
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Concerning claim 54 Panicker teach treatment of cancer and metastases (see paragraphs [0018, 0034]) by administering chitosan-based polyplexes comprising cationic polymer and therapeutic nucleic acid encoding IL-12 and nucleic acid encoding RIG-1 agonist (see paragraphs [0010-0011, 0022]).
Concerning claims 55-57 Panicker teach treatment of bladder cancer (see paragraph [00238, 00260]).
Concerning claim 60 Panicker teach that RIG-1 agonist can be eRNA11a (see paragraph [0019]).
Concerning claims 61-65 Panicker teach that chitosan-based polyplex comprises amino-functionalized chitosan and further comprises a reversible coating comprising one or more polyanion-containing block co-polymers having at least one polyanionic anchor region and at least one hydrophilic tail region (see paragraph [0011]). Amino-functionalized chitosan further comprises arginine and comprises a hydrophilic polyol such as glucose or gluconic acid (see paragraph [0012]).
Concerning claim 66 Panicker teach that nucleic acid encoding IL-12 is of SEQ ID NO: 7 (see paragraph [0016]), which is identical to instant SEQ ID NO: 8.
Concerning claim 67 Panicker teach that administration can be oral (see paragraph [0219]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 54-65, 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ullman et al (WO 2019/199994, October 2019) and in further view of Giesing (US 2019/0060344, February 2019), Chan et al (US 2019/0184006, June 2019), Gao et al (WO 2013/138930, September 2013), Lachelt et al (Chemical Reviews, 2015, 115: 11043-11078).
Ullman teach methods of treatment of cancer and metastases comprising administering to the subject in need thereof a nucleic acid construct encoding IL-12 (see paragraphs [0003, 0008-0010]) and other genes such as PAMP and DAMP, which function through activation of RIG-1 like receptors (see paragraph [0105]). Such nucleic acid construct can be formulated with cationic polymer (see paragraph [0013]) such as polylysine or chitosan (see paragraph [0077]). The cancer to treat can be breast cancer, colon cancer, pancreatic cancer, melanoma, bladder cancer (see paragraphs [0014, 0119]). Metastases can be in the lung (see paragraph [0147]). Administration of the treatment can be oral (see paragraph [0058]).
Ullman do not teach treatment of metastasis at two different sites, or specific RIG-1 agonists such as SLR10 and SLR14, or using amino-functionalized chitosan comprising arginine and gluconic acid, or polyplexes comprising reversible coating comprising polyanion containing block co-polymers having polyanionic anchor region and hydrophilic tail region.
Giesing teaches that bladder cancer can metastasize to two different sites including liver, lung, bone and brain (see paragraph [0050]).
Chan teach methods of treatment of variety of cancers including metastatic cancers (see paragraphs [0141-0143]) by administering RIG-1 agonists (see paragraphs [0028, 0034]) such as SLR10 and SLR14 (see Table 1 on page 7).
Gao teach amino-functionalized chitosan comprising arginine and gluconic acid for gene delivery in vivo (see Abstract), which has increased transfection efficiency (see paragraph [0005]). Gao teach such modified chitosan-nucleic acid polyplexes formation for nucleic acid delivery (see paragraph [0010]).
Lächelt teach that for efficient intracellular delivery, several barriers are faced and have to be overcome by polymer-based nucleic acid carriers (see page 11047; Figure 3). Acute toxicity triggered by partial dissociation and aggregation of nanoparticles and blood cells, unspecific interactions with complement and other blood components, or nontarget cells can be reduced by providing polyplexes with a coat of hydrophilic macromolecules, which shield the surface potential from the exterior environment (see Figure 14). The most common shielding agent has been PEG. PEG-polylysine/ pDNA polyplexes were the first polymer-based formulations which were evaluated in human clinical in vivo gene therapy studies in epithelia of cystic fibrosis patients (see page 11054). Lächelt teach that reversible coatings have been incorporated into polyplexes, and block-co-polymers have been used, including PEG-pLys, pHPMA-pTMAEM, or PEG-pAsp(DET) (see page 11054).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to improve methods of cancer treatment taught by Ullman by including elements taught by Chan, Gao and Lachelt, above, and to treat metastases at different sites as taught by Gieseng, arriving at instant invention. One of the ordinary skill in the art would be motivated to use RIG-1 agonists taught by Chan together with IL-12 cytokines taught by Ullman, because they are both intended for the treatment of the same disease, making it obvious to include such nucleic acids of RIG-1 agonists taught by Chan to express together with nucleic acids encoding IL-12 taught by Ullman and because Ullman suggest such drug combination. Further, one of the art would be motivated to deliver such nucleic acids using polyplexes described by Gao and Lachelt, because Gao suggest improvement to chitosan delivery agent also suggested by Ullman, which improves transfection efficiency. Lachelt further suggest improvements to polyplexes to protect delivered nucleic acids from unspecific interactions and reduce their toxicity. One of the art would be motivated to treat metastases at different sites, because Ullman suggest treatment of metastatic cancers and Gieseng teach that cancer can metastasize to more than one site.
Claim(s) 54 and 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ullman et al, above, and in further view of Panicker, above.
Teachings of Ullman are discussed above.
Ullman do not teach expression of IL-12 of instant SEQ ID NO: 8.
Panicker teach expression of IL-12 of SEQ ID NO: 7 (see paragraph [00362]), which is 100% identical to instant SEQ ID NO: 8 for cancer treatment (see Abstract). Such expression can be done in combination with RIG-1 agonist (see paragraph [0010]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to treat metastatic cancers by administering nucleic acid encoding IL-12 of instant SEQ ID NO: 8 in combination with RIG-1 agonist based on teachings of Ullman and Panicker. One of the ordinary skill in the art would be motivated to do so, because Ullman suggest treatment of metastatic cancers by administering nucleic acids encoding IL-12 and RIG-1 agonists, while Panicker teach specific nucleic acid encoding IL-12 and intended for cancer treatment, identical to instant SEQ ID NO: 8, which can be administered in combination with RIG-1 agonist.
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 54-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23-24, 33-53, 55-56 of copending Application No. 17/438,922 in view of Giesing, above. Claims from ‘922 teach methods of treatment of bladder cancer by administering chitosan-based polyplex comprising therapeutic nucleic acid encoding IL-12 and nucleic acid encoding RIG-1 agonist, same as in instant invention. Teachings of Giesing are discussed above. It would have been obvious to treat metastases of bladder cancer taught by Giesing using methods from ‘922, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Claims 54-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,623,011 in view of Ullman, Giesing and Chan, above. Claims from ‘011 recite method of delivery of nucleic acids to a subject using chitosan nucleic acid polyplex, wherein chitosan is coupled with gluconic acid and arginine. Teachings of Ullman, Giesing and Chan are discussed above. It would have been obvious to treat cancer and metastases by delivering nucleic acids encoding IL-12 and RIG-1 agonist using polyplex from ‘011, arriving at instant invention.
Claims 54-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15-44, 46 of copending Application No. 17/438,921 in view of Ullman, Giesing and Chan, above. Claims from ‘921 recite chitosan-derived nanoparticle for nucleic acids delivery, wherein chitosan is amino-functionalized and coupled with arginine. Teachings of Ullman, Giesing and Chan are discussed above. It would have been obvious to treat cancer and metastases by delivering nucleic acids encoding IL-12 and RIG-1 agonist using polyplex from ‘921, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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