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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Mar. 09, 2026. Claims 1 and 5-14 are pending and are currently examined.
Claim Objection
(Previous objection- withdrawn) The claims 1-8, and 12-13 are objected to because of the following informalities:
This objection is withdrawn in view of the amendment filed on Mar. 09, 2026.
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.
(Previous rejection- withdrawn) Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
This rejection is withdrawn in view of the amendment filed on Mar. 09, 2026.
(New Rejection-necessitated by amendment) Claim 8 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.
The amended claim 8 recites a phrase “the one or more thymine modified with the modifying group are the underlined thymine bases in the base sequences of SEQ ID Nos: 1 to 13” that renders the claim indefinite because it is not clear which underlined thymine base is under modification. A cited position of the modified thymine is needed. In addition, it is unclear what the bold “T” means in the claimed SEQ ID NOs: 1-13 in the claim 8.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Claim Rejections - 35 USC § 112 (Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(Previous rejection- withdrawn) Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is withdrawn in view of the amendment filed on Mar. 09, 2026.
(New Rejection-necessitated by amendment) Claims 1 and 5-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended base claim 1 is directed to a SARS-CoV-2 spike glycoprotein-binding nucleic acid molecule, comprising any of the following polynucleotides (a) and (b), where (b) is a polynucleotide consisting of a sequence complementary to a polynucleotide that hybridizes to a polynucleotide consisting of any sequence of the polynucleotide (a) under a stringent condition, and binding to a SARS-CoV-2 spike glycoprotein.
The written description rejection is made because the claims are interpreted as being drawn to “a polynucleotide consisting of a sequence complementary to a polynucleotide that hybridizes to a polynucleotide consisting of any sequence of the polynucleotide (a) under a stringent condition, and binding to a SARS-CoV-2 spike glycoprotein”. The instant specification discloses that the expression polynucleotide that hybridizes to" is not particularly limited as long as, for example, the polynucleotide (b) is a polynucleotide perfectly or partially complementary to the polynucleotide (a) and it allows the polynucleotide (b) to bind to the SARS-CoV-2 spike glycoprotein (See Instant specification, [0068]). Here it indicates that the hybridized polynucleotide can vary although a stringent condition is limited in the amended base claim 1. Thus, the instant specification does not provide support if the claimed polynucleotide in the base claim (b) is hybridize to the SEQ ID NOs: 1-13, and it can hybridize to a polynucleotide consisting of any base sequence of the polynucleotide (a) under a stringent condition, and binding to a SARS-CoV-2 spike glycoprotein (See instant specification, [0067]). Therefore, the claimed polynucleotide in the base claim 1 (b) cannot be determined.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004).
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.).
Accordingly, the specification does not provide sufficient written description to support for the invention as claimed in the base claims 1 and 5-14. The skilled artisan cannot envision the detailed sequences of the claimed “a polynucleotide consisting of a sequence complementary to a polynucleotide that hybridizes to a polynucleotide consisting of any sequence of the polynucleotide (a) under a stringent condition, and binding to a SARS-CoV-2 spike glycoprotein”. Therefore, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
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.
(Previous rejection- withdrawn) Claims 1, 2 and 9 -11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (Anal Chem. 2020 Jul 21;92(14):9895-9900; Supporting information).
This rejection is withdrawn in view of the amendment filed on Mar. 09, 2026.
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.
(Previous rejection- withdrawn) Claims 5, 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tolley et al. (US 2023/0228751 A1, published on July 20, 2023; Priority Date: Jun. 18, 2020).
This rejection is withdrawn in view of the amendment filed on Mar. 09, 2026.
Allowable Subject Matter
The nucleic acid sequences of SEQ ID Nos: 1-13 are free of the prior art. The formula (1) is free of the prior art.
Responses to Applicant’s Remarks
Applicant’s arguments filed on Mar. 09, 2026 has been received and fully considered.
1). Applicant’s amendment on claim objection is considered and the objection is withdrawn.
2). Applicant’s argument and amendment on rejections under 35 U.S.C. § 112 (b) is considered and the rejection is withdrawn.
3). Applicant’s argument and amendment on rejections under 35 U.S.C. § 112 (a) is considered and the rejection is withdrawn.
4). Applicant’s argument and amendment on rejections under 35 U.S.C. § 102 is considered and the rejection is withdrawn.
5). Applicant’s argument and amendment on rejections under 35 U.S.C. § 103 is considered and the rejection is withdrawn.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/RUIXUE WANG/ Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672
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