DETAILED ACTION
Election/Restrictions
Applicant’s election of selected species, filed September 12, 2026, is acknowledged. The elected species are: 5’ UTR is a leader sequence represented by SEQ ID NO: 2, and regulatory sequence is represented by SEQ ID NO: 19. Claims 2, 3,
Claims Summary
Claim 1 is directed to a gene construct comprising:
A coding region for expressing mRNA of a target gene;
A 5’ UTR located upstream of the coding region, wherein the 5’ UTR comprises a leader sequence of SEQ ID NO: 2 (76-nt from SARS-CoV-2, elected species (claim 4)); and
A 3’ UTR located downstream of the coding region, wherein the 3’ UTR comprises SEQ ID NO: 5 (196-nt) (claim 5).
The gene construct further comprises a promoter and/or poly(A) sequence (claim 6). The promoter is located upstream of the 5’ UTR (claim 7). The poly(A) sequence is located downstream of the 3’ UTR (claim 8). The gene construct comprises SEQ ID NO: 19 (364-nt). SEQ ID NO: 19 contains SEQ ID NO: 2 and SEQ ID NO: 5. Also claimed is a vector (claim 10), pharmaceutical composition (claim 11), vaccine composition (claim 12), and a composition for the intended use of gene therapy (claim 13), each comprising the gene construct.
Claim Objections
Claims 2 and 9 are objected to because of the following informalities:
It appears that the parentheses are misplaced in claim 2. Suggested language: “a leader sequence of the coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2)”.
Claim 9 recites, “The gene construct of claim 1, further comprising a sequence of SEQ ID NO: 18 or 19”. It appears that SEQ ID NO: 19 represents the gene construct itself, and is not an additional sequence in the gene construct. Clarification 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 1, 5, 6, 8 and 10-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature without significantly more. The claims are directed to a gene construct comprising:
A coding region for expressing mRNA of a target gene;
A 5’ UTR located upstream of the coding region, wherein the 5’ UTR comprises a leader sequence a coronavirus; and
A 3’ UTR located downstream of the coding region, wherein the 3’ UTR comprises SEQ ID NO: 5 (196-nt) (claim 5).
The gene construct further comprises a promoter and/or poly(A) sequence (claim 6). The promoter is located upstream of the 5’ UTR (claim 7). The poly(A) sequence is located downstream of the 3’ UTR (claim 8). Also claimed is a vector (claim 10), pharmaceutical composition (claim 11), vaccine composition (claim 12), and a composition for the intended use of gene therapy (claim 13), each comprising the gene construct.
The gene construct reads on a product of nature because the recited components are not markedly different from the product’s naturally occurring counterpart in its natural state because it conveys the same genetic information. The sequence of the genome of the SARS-CoV-2 Wuhan-Hu-1 isolate, as disclosed in Wu et al. (Nature, March 12, 2020, published online February 3, 2020, 579(7798):265-269, cited in the IDS filed 5/21/2025, “Wu”) evidenced by NCBI Reference Sequence NC_045512.2 (July 18, 2020), qualifies as a gene construct because it is a viral genome. The genome of the Wuhan-Hu-1 isolate has a coding region expressing mRNA of a target gene. Note that a “target gene” is not defined or limited by the specification or claims such that it excludes a gene or all genes from the Wuhan-Hu-1 isolate. The genome of the Wuhan-Hu-1 isolate has a 5’ UTR (nt 1-265) upstream of its gene coding regions and it comprises a leader sequence within the 5’ UTR (nt 1-72) which is from a coronavirus since the Wuhan-Hu-1 strain is a SARS-CoV-2 strain. The genome of the Wuhan-Hu-1 isolate comprises a 3’ UTR (nt 29675-29903) downstream of its coding regions, which is identical in content and length with Applicant’s SEQ ID NO: 5, including a poly(A) tail downstream of the 3’ UTR.
Claim 10 is directed to a vector comprising the gene construct. The genome of the Wuhan-Hu-1 isolate qualifies as a vector, since no particular definition or limitation is provided for the vector, and the genome comprises the gene construct.
Claims 11-13 are directed to a pharmaceutical composition, a vaccine composition, and a composition for gene therapy, each comprising the gene construct. The additional element of a composition for the intended uses of a pharmaceutical, a vaccine and gene therapy, fails to integrate the judicial exception into a practical application. Merely placing the product of nature into a generic composition 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.
Compositions, separately or in combination with the product of nature, do not add significantly more to the product of nature exception. Compositions comprising viral gene constructs are well-understood, routine and conventional in the biotech art, as seen in US 2019/0351048 A1 (see abstract).
Therefore, the claims are directed to a judicial exception without significantly more and are thus patent ineligible.
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.
Claims 1, 5, 6, 8, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (Nature, March 12, 2020, published online February 3, 2020, 579(7798):265-269, and supplemental pages, “Wu”) evidenced by NCBI Reference Sequence NC_045512.2 (July 18, 2020). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Wu discloses the sequence of the genome of the SARS-CoV-2 Wuhan-Hu-1 isolate, qualifies as a gene construct because it is a viral genome (claim 1, aspect of gene construct). The genome of the Wuhan-Hu-1 isolate has a coding region expressing mRNA of a target gene (claim 1, aspect of mRNA of a target gene). Note that a “target gene” is not defined or limited by the specification or claims such that it excludes a gene or all genes from the Wuhan-Hu-1 isolate. The genome of the Wuhan-Hu-1 isolate has a 5’ UTR (nt 1-265) upstream of its gene coding regions and it comprises a leader sequence within the 5’ UTR (nt 1-72) which is from a coronavirus since the Wuhan-Hu-1 strain is a SARS-CoV-2 strain (claim 1, aspects of 5’ UTR, coronavirus leader sequence, and claim 5, aspect of SEQ ID NO: 5). The genome of the Wuhan-Hu-1 isolate comprises a 3’ UTR (nt 29675-29903) downstream of its coding regions, which is identical in content and length with Applicant’s SEQ ID NO: 5, including a poly(A) tail downstream of the 3’ UTR (claim 1, aspect of 3’UTR, and claims 6 and 8, aspect of poly(A)). The genome of the Wuhan-Hu-1 isolate qualifies as a vector, since no particular definition or limitation is provided for the vector, and the genome comprises the gene construct (claim 10). Wu discloses the presence of the viral genome in a composition, which is reasonably considered a pharmaceutical composition since it is useful in the laboratory (see “Methods” section on supplementary pages) (claim 11). Therefore, the claimed embodiments are anticipated by the prior art.
Claims 1, 5, 6, 8, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yao et al. (PeerJ, July 1,2021, 1:9:e11686, 14 pages, “Yao”) evidenced by GenBank Accession number MW250350.1 (November 29, 2020). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Yao discloses synthetic defective interfering SARS-CoV-2 constructs (see abstract). The construct comprises select portions of the wildtype Wuhan-Hu-1 isolate, the construct being represented in NCBI Reference Sequence NC_045512.2. Figure 1A shows that the wildtype 5’UTR (nt 1-265) and wildtype 3’ UTR (nt 572-800, an exact match for Applicant’s SEQ ID NO: 5) are part of the construct, which include the leader sequence (nt 1-72) and poly(A) sequence downstream of the 3’ UTR (claims 1, 5, 6 and 8, aspects of 5’ and 3’ UTRs, SEQ ID NO: 5, coronavirus leader sequence, and poly(A)). The construct includes coding regions for expressing mRNA of a target gene (see Figure 1A). Although Yao selected coding regions that do not code for functional protein, the regions enable genome replication and packaging (see abstract) (claim 1, aspect of coding region). Yao’s construct qualifies as a vector since no particular definition or limitation is provided for the vector, and the defective genome comprises the gene construct (claim 10). Yao’s constructs are in a composition (see page 3, “In vitro transcription” section). The composition is reasonably considered a pharmaceutical composition since it is useful in the context of antiviral therapy (see abstract). Therefore, the claimed embodiments are anticipated by the prior art.
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, 4-8 and 10-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-7 of copending Application No. 19/582,058 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Copending claim 4 is directed to a composition for preventing or treating bladder cancer comprising a coding region comprising a nucleic acid encoding a proenkephalin protein, a 5’ UTR upstream of the coding region, a 3’ UTR downstream of the coding region, wherein the 5’ UTR comprises a coronavirus leader sequence. In copending claim 5, the 5’ UTR comprises SEQ ID NO: 2, which is identical to Applicant’s SEQ ID NO: 2. In copending claim 6, the 3’ UTR comprises SEQ ID NO: 3, which is identical to Applicant’s SEQ ID NO: 5. In copending claim 7, the gene construct comprises a promoter and/or a poly(A) sequence. In copending claim 9, there is a pharmaceutically acceptable carrier, thus rendering obvious the vector of claim 10, and the compositions of claims 11-13.
The copending claims differ from the instant claims in that the instant claims specify that the coding region expresses mRNA. Copending claim 3 indicates that the nucleic acid is RNA. It would have been obvious to have claimed mRNA with a reasonable expectation of success since it is the form of RNA that is read by the ribosome, thus mRNA is ready to be processed once administered.
The copending claims do not specify that the promoter is located upstream of the 5’ UTR. However, it would have been obvious to have claimed this embodiment with a reasonable expectation of success since the promoter would have to be positionally located before the 5’ UTR.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
SEQ ID NO: 2 and SEQ ID NO: 19 are free of the prior art of record.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
