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 .
Applicant’s preliminary amendment filed 10/12/2023, is acknowledged. Claims 1-3, 10, 13, 17, 20, 26-28, 39, 40, 42, 47, 115, 117, 138, 142, 145 and 174 are pending.
Claim Objections
Claim 10 is objected to because of the following informalities: The claim recites Pullalun in parenthesis. It is not clear whether Pullulan is a trademark however, the use of parathesis raises the question of whether Pullulan is a limitation or not. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The claim recites "bismuth-231" not "bismuth-213". Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 142 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 142 recites the limitation "the modified RNA". There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 13, 26-28, 39, 40, 42 and 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kübelbeck (WO 2021/229015A1).
Regarding claim 1, Kübelbeck “relates to a composition of nanoparticles as carrier for pharmaceutically acceptable compounds.” Abstract. The nanoparticle “has functionalities on its surface which function as recognition points for antigens ultimately to be bound or adsorbed. The surface here encompasses all areas, i.e. besides the outer surface, also the inner surface of cavities (pores) in the particle. The functionalities may be directly or indirectly bound to the surface.” Page 7, lines 16-19. The nanoparticles may also have a core-shell structure. See page 7, lines 37-40. “According to the invention pharmaceutically acceptable compounds are RIG-I agonists such as oligonucleotides bearing free, uncapped 5' phosphate.” Page 22, lines 38-39. “Other RIG-I agonists are 5' triphosphate oligonucleotides.” Page 23, lines 2-3.
Regarding claim 13, the nanoparticle may also comprise metals. See page 7, lines 32-35.
Regarding claim 26, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the disclosed pharmaceutical composition “can be employed in the prophylaxis, therapy, control or post-treatment of patients” including cancer patients. Page 27, lines 38-41. As such, the composition would be capable of performing the intended use.
Regarding claim 27, the pharmaceutical composition may be in the form of solid or liquid compositions and comprise a carrier like water. See page 28, lines 5-8.
Regarding claim 28, the pharmaceutical composition may be injected. See page 28, line 21.
Regarding claims 39, 40 and 42, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the disclosed pharmaceutical composition “can be employed in the prophylaxis, therapy, control or post-treatment of patients” including cancer patients. Page 27, lines 38-41. As such, the composition would be capable of performing the intended use.
Regarding claim 47, the composition may comprise an adjuvant. See page 28, line 8.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kübelbeck (WO 2021/229015A1) as applied to claims 1, 13, 26-28, 39, 40, 42 and 47 above, and further in view Aprikyan et al. (US 2021/0154323).
Teachings of Kübelbeck are discussed above.
Regarding claim 10, Kübelbeck does not teach “wherein the shell comprises an aminated polysaccharide coating.”
Aprikyan et al. teaches “functionalized nanoparticles for penetrating through a mammalian cell membrane and delivering intracellularly one or more biologically active molecules comprising a nanoparticle core, one or more cell membrane-penetrating molecule(s) and one or more biologically active molecules(s) for introducing or affecting one or more cellular functions(s).” Abstract. More particularly, Aprikyan et al. “provides functionalized nanoparticles having (a) a nanoparticle core; (b) a polymer coating or lipid bilayer that encapsulates the nanoparticle; (c) one or more functional group(s) that are associated with and/or attached directly to the nanoparticle and/or to the polymer coating.” Para. [0033]. The coatings “provide a surface that can be modified with one or more functional groups for attachment to one or more crosslinking agents, biologically active molecules, and/or cell membrane-penetrating molecules” Para. [0036]. Exemplary polymers include dextran and pullulan. See para. [0180].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to arrive at the claimed invention in view of the combination of Kübelbeck and Aprikyan et al. In this instance, one of ordinary skill in the art would find motivation to combine the references and have a reasonable expectation of success in combination because both references teach using core-shell nanoparticles for delivery of pharmaceutically acceptable compounds. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”) Further, in this regard, it is prima facie obviousness to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Here
Here, one of ordinary skill in the art would have been motivated to incorporate a polymer shell as taught by Aprikyan et al. to obtain the functionalities it is taught to provide.
Regarding claim 17, Aprikyan et al. also teaches that “[f]unctionalized nanoparticles of the present disclosure can also further include one or more chelators, radioisotopes, and/or contrast agents.” Para. [0168].
Regarding claim 20, Aprikyan et al. discloses representative radioisotopes such as bismuth-213 and copper-67. See para. [0169].
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 2, 3, 115, 117, 138, 142, 145 and 174 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 52, 80-82, 101-105, 109, 119-121, and 135 of copending Application No. 18/270,361 (“the ‘361 reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious modification of the claims of the ‘361 application as demonstrated below.
Claims 115 and 117 of the instant application require administering to a subject “a nanoparticle comprising a nanoparticle core; a radiolabel; and a single-stranded 5' uncapped triphosphate or biphosphate modified RNA oligonucleotide that is linked to the nanoparticle core, wherein said oligonucleotide is complementary to a miRNA which is highly expressed in a solid tumor or solid tumor microenvironment in comparison to a non-solid tumor or non-solid tumor microenvironment thereby generating a localized immune response.”
The ‘361 reference application claims “[a] method for treating cancer comprising administering to a subject a therapeutically effective amount of a single-stranded 5' uncapped triphosphate or biphosphate modified RNA oligonucleotide, wherein said oligonucleotide is complementary to a miRNA, which is highly expressed in a tumor or tumor microenvironment in comparison to a non-tumor or non-tumor microenvironment.” See claim 1. The modified oligonucleotide is further linked to a nanoparticle. See claim 101.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to arrive at the claimed invention, the instant claims being an obvious modification of the claims of the ‘361 application.
Regarding claims 2, 3 and 138 of the instant application, the ‘361 reference application claims that the nanoparticle may be have a polymer coating such as dextran functionalized with one or more amine groups. See claims 101-105. Further, the miRNA may be miR10b, for instance.
Regarding claim 142, the ‘361 reference application describes “wherein the modified RNA oligonucleotide is capable of forming a duplex with the said miRNA and the duplex activate RIG-I.”
Regarding claims 145 and 174, the wherein clauses are not considered limitations because they merely express the intended results of a process step positively recited. MPEP 2111.04 (“Claim scope is not limited by claim language that . . . does not limit a claim to a particular structure.”).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/ROBERT S CABRAL/ Primary Examiner, Art Unit 1614