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 I and Enterovirus C, which includes polioviruses, in the reply filed on December 9, 2025 is acknowledged.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim.
Applicant’s request for rejoinder of the method of making and using the elected product upon indication that the product is allowable is acknowledged. Applicant’s attention is directed to the following is a recitation of M.P.E.P. §821.04 regarding the restriction of claims to a product and processes of using the product, Rejoinder:
Where product and process claims drawn to independent and distinct inventions are presented in the same application, applicant may be called upon under 35 U.S.C. 121 to elect claims to either the product or process. See MPEP § 806.05(f) and § 806.05(h). The claims to the nonelected invention will be withdrawn from further consideration under 37 CFR 1.142. See MPEP § 809.02© and § 821 through § 821.03. However, if applicant elects claims directed to the product, and a product claim is subsequently found allowable, withdrawn process claims which depend from or otherwise include all the limitations of the allowable product claim will be rejoined.
Where product and process claims are presented in a single application and that application qualifies under the transitional restriction practice pursuant to 37 CFR 1.129(b), applicant may either (1) elect the invention to be searched and examined and pay the fee set forth in 37 CFR 1.17(s) and have the additional inventions searched and examined under 37 CFR 1.129(b)(2), or (2) elect the invention to be searched and examined and not pay the additional fee (37 CFR 1.129(b)(3)). Where no additional fee is paid, if the elected invention is directed to the product and the claims directed to the product are subsequently found patentable, process claims which either depend from or include all the limitations of the allowable product will be rejoined . If applicant chooses to pay the fees to have the additional inventions searched and examined pursuant to 37 CFR 1.129(b)(2), even if the product is found allowable, applicant would not be entitled to a refund of the fees paid under 37 CFR 1.129(b) by arguing that the process claims could have been rejoined. 37 CFR 1.26 states that "[m]oney paid by actual mistake or in excess will be refunded, but a mere change of purpose after the payment of money...will not entitle a party to demand such a return..." The fees paid under 37 CFR 1.129(b) were not paid by actual mistake nor paid in excess, therefore, applicant would not be entitled to a refund.
In the event of rejoinder, the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104 - 1.106. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. If the application containing the rejoined claims is not in condition for allowance, the subsequent Office action may be made final, or, if the application was already under final rejection, the next Office action may be an advisory action.
The following is a recitation from paragraph five, “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. §103(b)” (1184 TMOG 86(March 26, 1996)):
“However, in the case of an elected product claim, rejoinder will be permitted when a product claim is found allowable and the withdrawn process claim depends from or otherwise includes all the limitations of an allowed product claim. Withdrawn process claims not commensurate in scope with an allowed product claim will not be rejoined.” (emphasis added)
In accordance with M.P.E.P. §821.04 and In re Ochiai, 71 F.3d 1565, 37 USPQ 1127 (Fed. Cir. 1995), rejoinder of product claims with process claims commensurate in scope with the allowed product claims will occur following a finding that the product claims are allowable. Until, such time, a restriction between product claims and process claims is deemed proper. Additionally, in order to retain the right to rejoinder in accordance with the above policy, Applicant is advised that the process claims should be amended during prosecution to maintain either dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder.
Claims 53-72 are pending; claims 54 and 66-71 are withdrawn due to non-elected subject matter; and claims 53, 55-65, and 72 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 9, 2025 has been considered by the examiner.
Claim Objections
Claim 53 is objected to because of the following informalities: the claim lacks a period. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 53, 55-59, 61, 63, 64, and 72 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. Instant claim 53 recites a nucleic acid construct comprising a sequence encoding a modified enterovirus genome devoid of at least a portion of the nucleic acid sequence encoding viral structural proteins. Instant claims 55-58 recite that modified enterovirus genome encoded by the nucleic acid construct is derived from poliovirus 1 (PV1) from Enterovirus C. Instant claim 59 recites a defective interfering (DI) particle comprising the nucleic acid construct. Instant claim 61 recites a recombinant cell comprising: (a) a nucleic acid construct of claim 53, and/or (b) a DI particle comprising the nucleic acid construct of (a). Instant claim 63 recites a DI particle produced by a method. Instant claim 64 recites a pharmaceutical composition comprising a pharmaceutically acceptable excipient and: (a) a nucleic acid construct of claim 53; (b) a DI particle comprising the nucleic acid construct of (a); and/or (c) a recombinant cell comprising the nucleic acid construct of (a) and/or the DI particle of (b). Instant claim 72 recites a kit comprising: (a) a nucleic acid construct according to claim 53; (b) a DI particle comprising the nucleic acid construct of (a); (c) a recombinant cell comprising the nucleic acid construct of (a) and/or the DI particle of (b); and/or (d) a pharmaceutical composition comprising the nucleic acid construct of (a), the DI particle of (b), and/or the recombinant cell of (c).
While instant claims 53, 55-59, 61, 64, and 72 state that the instant nucleic acid is a “construct” encoding a “modified” enterovirus genome and claims 61, 64, and 72 state that the cell is “recombinant”, where quoted terms imply deliberate manipulation of the nucleic acid, enterovirus genome, and cell, by the hand of man. However, the nucleic acid construct encoding a modified enterovirus genome, encompassed in a recombinant cell expressing DI particles of claims 59 and 63, are indistinguishable from naturally-occurring enterovirus DI particles encoded by nucleic acid enterovirus genomes that are devoid of at least a portion of enterovirus structural proteins expressed during poliovirus type 1 natural infection, as evidenced by Morrow (US 5,614,413) and Kuge et al. (Journal of Molecular Biology. 1986; 192:473-487).
Column 5, line 66 to column 6, line 9 of Morrow states (emphasis underlined for convenience):
Previous studies have established that the entire poliovirus genome is not required for RNA replication. Hagino-Yamagishi, K., and Nomoto, A. (1989) J. Virol. 63:5386-5392. Naturally occurring defective interfering particles (DIs) of poliovirus have the capacity for replication. Cole, C. N. (1975) Prog. Med. Virol. 20:180-207; Kuge, S. et al. (1986) J. Mol. Biol. 192:473-487. The common feature of the poliovirus DI genome is a partial deletion of the capsid (P1) region that still maintains the translational reading frame of the single polyprotein through which expression of the entire poliovirus genome occurs.
Kuge et al., cited by Morrow above, state, in the first paragraph on page 474:
Cole et al. (1971) initially reported the generation of DI particles in a preparation of the Mahoney strain of type l poliovirus. The purified DI particles are able to initiate a normal poliovirus replication cycle but fail to synthesize capsid proteins and therefore cannot produce progeny virions. These data suggest that the DI RNAs lack a genome region encoding viral capsid proteins.
Therefore, the instant nucleic acid construct encoding a modified enterovirus genome devoid of at least a portion of the nucleic acid sequence encoding viral structural proteins and the DI and cell comprising the nucleic acid, are indistinguishable from the naturally-occurring enterovirus genomes deficient in at least a portion of the nucleic acid that encodes capsid proteins encompassed by DI particles produced in poliovirus type 1 naturally infected cells, as evidenced by Morrow and Kuge et al. Therefore, the instant claims recite a natural phenomenon according to Step 2A, Prong One of MPEP § 2106.04(II). The comparison between the material claimed and the material of Morrow and Kuge et al. indicate that there are no differences in structure, function, or other characteristics. Therefore, the claimed nucleic acid construct encoding a modified enterovirus genome devoid of at least a portion of a nucleic acid sequence expressing viral structural proteins, encompassed in a DI and poliovirus type 1-infected cells, are a product of nature exceptions. See Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, instant claims recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two requires eligibility analysis to evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Instant claim 64 further requires that the (a) a nucleic acid construct of claim 53; (b) a DI particle comprising the nucleic acid construct of (a); and/or (c) a recombinant cell comprising the nucleic acid construct of (a) and/or the DI particle of (b) is combined with a pharmaceutically acceptable excipient. Paragraph [0167] of the instant published disclosure, USPgPub 2023/0233669, lists water as an acceptable carrier. The combination of water and a nucleic acid encoding an enterovirus genome devoid of at least a portion of a nucleic acid sequence expressing viral structural proteins, encompassed in a DI and a cell, are two products of nature that do not change each other. Therefore, recitation of “a pharmaceutically acceptable carrier” fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. Recitation of “a pharmaceutically acceptable carrier” in instant claim 64 does not integrate the recited judicial exception into a practical application. Instant claim 72 further requires that (a) a nucleic acid construct according to claim 53; (b) a DI particle comprising the nucleic acid construct of (a); (c) a recombinant cell comprising the nucleic acid construct of (a) and/or the DI particle of (b); and/or (d) a pharmaceutical composition comprising the nucleic acid construct of (a), the DI particle of (b), and/or the recombinant cell of (c), are incorporated into a kit. However, recitation of “kit” fails to meaningfully limit the claim because merely placing the product of nature into a generic container does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment. The presence of a container does not change the nature or properties of the naturally-occurring materials. Accordingly, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention is directed to products of nature that are not patent eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. -U.S.—(June 13, 2013).
(Examiner note: this rejection could be overcome if heterologous capsid structural proteins, recited in instant claim 60 (not included in this rejection), is recited, which would distinguish the instant materials from naturally-occurring materials.)
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.
Claims 53 and 55-65 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Morrow (US 5,614,413).
Claims 32, 34-37, 42, and 44 of Morrow anticipate a modified poliovirus genome devoid of at least a portion of P1 capsid nucleic acid sequences encoding viral structural proteins, as required by instant claims 53, 55, and 56. Column 6, lines 24-30 state that the poliovirus type used by Morrow is types 1, 2, and 3, anticipating instant claims 57 and 58.
The Defective interfering (DI) particle phenotype of instant claim 59, is defined in the instant published disclosure, USPgPub 2023/0233669 in paragraphs [0008 and 0098, for example], as an enterovirus nucleic acid genome, devoid of at least a portion of the nucleic acid sequence encoding viral structural proteins. Claims 32, 34-37, 42, and 44 of Morrow anticipate a encapsidated (particle) modified poliovirus genome devoid of at least a portion of P1 capsid nucleic acid sequences encoding viral structural proteins. Since there is no distinction between the claimed DI and the encapsidated enterovirus genome, devoid of at least a portion of the nucleic acids encoding viral structural proteins of Morrow, Morrow anticipates the DI particle of instant claim 59. Claims 38-41, 43, 45, and 46 of Morrow anticipate the structural-protein-deficient-recombinant poliovirus encapsidated by heterologous capsid proteins, as required by instant claim 60. Line 6 of column 14 to line 54 of column 15 of Morrow describes transfecting recombinant poliovirus, devoid of structural protein sequences into HeLa cells infected with vaccinia virus expressing P1 structural proteins and serially passaging the cells to obtain a yield of encapsidated viruses, anticipating instant claims 61 and 62. Also see claims 1-4, 7-10, 16-18, 31, 49, and 50. Claims 23 and 24 of Morrow anticipate encapsidated poliovirus made by the methods of claims 1 and 17, anticipating instant claim 63. Claim 25 of Morrow anticipates an immunogenic composition comprising the encapsidated recombinant poliovirus and a pharmaceutically acceptable carrier, required by instant claim 64. Column 3, lines 37-48 of Morrow anticipate a method of inducing an immune response by administering a composition comprising an encapsidated recombinant poliovirus nucleic acid, anticipating instant claim 65.
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.
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Morrow (US 5,614,413), supra.
See the teachings of Morrow above.
Morrow does not mention a kit comprising an enterovirus nucleic acid sequence devoid of at least a portion of the nucleic acid sequence encoding viral proteins or corresponding encapsidated particles, recited in instant claim 72.
However, it would have been prima facie obvious to one of ordinary skill prior to the instant effective filing date to have incorporated these materials into a kit for ease of transport, storage, and preparation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Choi et al. (Journal of Virology. June 1991; 65 (6): 2875-2883) teach expression of a recombinant poliovirus defective interfering particles with a P1 (capsid) region substituted by the expression of HIV gag, pol, and env, see the abstract and Figures 1 and 5-7.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671