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 .
Response to Amendment
Applicant’s remarks and amendments filed 01/12/2026 have been acknowledged. Claim 1 has been amended. Claims 7-9 have been canceled. Claims 15-17 are newly added. The amendments/cancellation of claims overcome claim objections, 35 USC 112(a) written description rejection, prior art rejections not based on Onodera, and the double patenting rejection previously set forth in the Non-Final Rejection of 09/11/2025. The substitute specification and sequence listing overcome objections to the specification.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. In particular, Figure 6-2 discloses light and heavy chain CDR3 sequences of clones NT-108 and NT-193 without sequence identifiers. Figure 6-10 discloses heavy and light chain sequences of clones NT-108 and NT-193 without sequence identifiers.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claims 3, 4, and 17 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.
Claims 3 and 4 recite amino acid residues present in the receptor binding domain of a coronavirus, each identified by residue number. However, the claim does not identify the reference sequence against which these residue numbers are defined. In the absence of a specified sequence (e.g. SEQ ID NO: 2), it is unclear what residues are being referred to, since residue numbering can vary depending on the sequence used. Accordingly, the metes and bounds of the claims cannot be reasonably ascertained, and the claims are indefinite.
Claim 17 recites “The method for detecting coronavirus according to claim 1”. Claim 1 is not a method, but a product. As such, there is insufficient antecedent basis for the limitation “the method” 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.
(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 1-6, 10-13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Onodera et al (Onodera, Taishi et al. “A SARS-CoV-2 antibody broadly neutralizes SARS-related coronaviruses and variants by coordinated recognition of a virus-vulnerable site.” Immunity vol. 54,10 (2021): 2385-2398.e10. doi:10.1016/j.immuni.2021.08.025, of record), hereinafter Onodera.
Onodera discloses the SARS-CoV-2 neutralizing human antibody clones NT-108 and NT-193 which specifically bind to the receptor binding domain (RBD) of the spike protein of SARS-CoV-2 (Page 2836, first paragraph under “Results” section and Figure 1). Clone NT-108 has the VH and VL chain amino acid sequences of SEQ ID NOs: 14 and 16 (see Para. 0036 and 0038 of instant specification). Clone NT-193 has the VH/VL chain amino acid sequences of SEQ ID NOs: 18 and 20 (see Para. 0040 and 0042 of instant specification). Both antibodies were highly potent neutralizers of CoV2-pseudotyped and CoV2-authentic viruses, with a half-maximal inhibitory concentration (IC50) < 100 ng/mL (Page 2388, left column). The clone NT-193, in particular, targets residues R403 and K417 of the RBD ( “Structure of the NT-193 Fab-RBD complex reveals a distinct binding mode” section, particularly on Page 2391). The NT-193 antibody was administered at a >4 mg/kg dosage to mice to assess its therapeutic efficacy against CoV2 infection (Page 2393). As such, a pharmaceutical composition comprising the anti-SARS-CoV2 for the treatment of CoV2 infection is necessarily disclosed. Lastly, per instant claim 13, the minimal structure required for a “reagent for detecting coronavirus” is the antibody of instant claim 1, which binds to the spike protein of coronavirus. Therefore, the anti-SARS-CoV-2 antibody NT-193 or NT-108 meets the minimal structure required to be considered a reagent for detecting coronavirus.
Thus, Onodera meets the limitations of instant claims 1-6, 10-13, 15, and 16.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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.
Claims 14 and 17 are rejected under 35 U.S.C. 103 as being obvious over Onodera, as applied to claims 1-6, 10-13, 15, and 16 above, and further in view of Marasco et al (US20050249739A1, of record), hereinafter Marasco.
The teachings of Onodera have been discussed above and differ from the instantly claimed invention in that a method for detecting coronavirus comprising a step of contacting the anti-SARS-CoV-2 antibody disclosed by Onodera with a biological sample.
However, Marasco teaches methods of detecting the presence of a coronavirus in a biological sample (e.g. blood, hair, saliva, etc.) comprising contacting the sample with the antibodies that bind to SARS-CoV (Para. 0021). In vitro techniques for detection of an analyte protein include enzyme linked immunosorbent assays (ELISAs), Western blots, immunoprecipitations, and immunofluorescence. In vitro techniques for detection of an analyte genomic DNA include Southern hybridizations (Para. 0136).
It would have been obvious to one of ordinary skill in the art to modify the methods of detecting the presence of a coronavirus in a biological sample disclosed by Marasco such that the anti-SARS-CoV-2 antibodies of Onodera are used as the detecting reagents. One of ordinary skill in the art would have been motivated to do so in order to detect the presence of SARS-CoV-2 antigen in a biological sample. Additionally, it would have been obvious to artisans to substitute anti-SARS-CoV antibody disclosed by the Marasco with the antibody disclosed by Onodera since they have the same function and can be used for the same purpose (i.e. detection of a coronavirus in a sample). An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213USPQ 532 (CCPA 1982). Therefore, one of ordinary skill in the art would reasonably expect that the anti-SARS-CoV-2 antibodies of Onodera can be used in methods of detecting a coronavirus disclosed by Marasco in order to determine the presence of SARS-CoV-2 antigen in a biological sample
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive.
With respect to the rejection under 35 USC 112(b), Applicant argues that amendments to claim 1 to provide antecedent basis for the epitope recited in claims 3 and 4 as well as the cancellation of claims 7 and 8 overcome this rejection.
In response to Applicant’s arguments, the Examiner notes that claims 3 and 4 still recite amino acid residues present in the receptor binding domain of a coronavirus, each identified by residue number. However, the claim does not identify the reference sequence against which these residue numbers are defined. In the absence of a specified sequence, it is unclear what residues are being referred to, since residue numbering can vary depending on the sequence used. Accordingly, the metes and bounds of the claims cannot be reasonably ascertained, and the claims are indefinite. Therefore, the rejection of claims 3 and 4 under 35 USC 112(b) is maintained.
With respect to the rejection made under 35 USC 102 (based on Onodera et al), Applicant states that the e-publication date of Onodera is August 23, 2021, about one month before the date of the PCT application filed on September 16, 2021 but after the foreign priority date. It is noted by Applicant that Onodera lists the following co-authors: Taishi Onodera, Yu Adachi, Yasuhiro Kazuki, Mitsuo Oshimura, Hiroyuki Satofuka, Takao Hashiguchi, Katsumi Maenaka, and Yoshimasa Takahashi. All the inventors of the present application are listed as co-authors of Onodera. Because all the inventors of the present application are listed as co-authors on the Onodera publication, Applicant submits that the exceptions to the prior art set forth in 35 USC 102(b) should apply. Applicant states that “if necessary and if required by the Examiner, the undersigned will attempt to provide more information regarding the exceptions to the prior art.”.
Additionally, Applicant notes that surprising technical effects can be found throughout the specification. For example, as shown in Figure 4, with regard to the IC50 of the neutralizing activity of each antibody against SARS-coV2, NTCOV2-1 had an IC50 value of 1.3 ng/mL, NTCOV2-2 had an Ic50 value of 0.56 ng/mL. Moreover, the neutralizing activity of the NTCOV-2-2 antibody against SARS-CoV had an IC50 value of 13 ng/mL. Applicant contends that these results show superior effects of the antibody of the present invention, and for these additional reasons argues that the prior art rejections should be withdrawn.
In response to Applicant’s arguments over the teachings of Onodera, MPEP 2153.01 states that a disclosure made within the grace period is not prior art under AIA 35 U.S.C. 102(a)(1) if it is apparent from the disclosure itself that it is an inventor-originated disclosure. Specifically, Office personnel may not apply a disclosure as prior art under AIA 35 U.S.C. 102(a)(1) if the disclosure: (1) was made one year or less before the effective filing date of the claimed invention; (2) names the inventor or a joint inventor as an author or an inventor; and (3) does not name additional persons as authors on a printed publication or joint inventors on a patent. This means that in circumstances where an application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies (emphasis added).
In this case, the present application names fewer joint inventors than the grace period publication. The entire author list for the Onodera publication is as follows: Taishi Onodera, Shunsuke Kita, Yu Adachi, Saya Moriyama, Akihiko Sato, Takao Nomura, Shuhei Sakakibara, Takeshi Inoue, Takashi Tadokoro, Yuki Anraku, Kohei Yumoto, Cong Tian, Hideo Fukuhara, Michihito Sasaki, Yasuko Orba, Nozomi Shiwa, Naoko Iwata. Noriyo Nagata, Tateki Suzuki, Jiei Sasaki, Tsuyoshi Sekizuka, Keisuke Tonouchi, Lin Sun, Shuetsu Fukushi, Hiroyuki Satofuka, Yasuhiro Kazuki, Mitsuo Oshimura, Tomohiro Kurosaki, Makoto Kuroda, Yoshiharu Matsuura, Tadaki Suzuki, Hirofumi Sawa, Takao Hashiguchi, Katsumi Maenaka, and Yoshimasa Takahashi.
The Office has provided a mechanism in 37 CFR 1.130 for filing an affidavit or declaration to establish that a disclosure is not prior art under AIA 35 U.S.C. 102(a) due to an exception in AIA 35 U.S.C. 102(b). Under 37 CFR 1.130(a), an affidavit or declaration of attribution may be submitted to except a disclosure as prior art because it was made by the inventor or a joint inventor, or the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor. Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an unequivocal statement from the inventor or a joint inventor that the inventor or joint inventor (or some combination of named inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982). When any claim of an application or a patent under reexamination is rejected, the applicant or patent owner may submit an appropriate affidavit or declaration to except a disclosure as prior art by establishing that the disclosure was made by the inventor or a joint inventor, or the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor. However, an affidavit or declaration under 37 CFR 1.130(a) that is only a naked assertion of inventorship and that fails to provide any context, explanation or evidence to support that assertion is insufficient. See EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 123 USPQ2d 1146 (Fed. Cir. 2017). See also Ex parte Kroger, 219 USPQ 370 (Bd. App. 1982) (affirming rejection notwithstanding declarations by the alleged actual inventors as to their inventorship in view of a nonapplicant author submitting a letter declaring the nonapplicant author's inventorship) (see MPEP 2155.01).
Alternatively, an English translation of any relevant certified copy of a foreign application as filed can be submitted together with a statement that the translation of the certified copy is accurate for the purpose of determining the applicant’s right to rely on the foreign filing date. If the applicant is found to be entitled to the priority date, the reference (Onodera et al) will not be relied upon as prior art and the rejection withdrawn. Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. (see MPEP §§ 215 and 216).
Lastly, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973) (see MPEP 2131.04).
In the absence of either an affidavit/declaration to establish that the disclosure of Onodera is not prior art under AIA 35 U.S.C. 102(a) due to an exception in AIA 35 U.S.C. 102(b) or an English translation of any relevant certified copy of a foreign application as filed submitted together with a statement that the translation of the certified copy is accurate for the purpose of determining the applicant’s right to rely on the foreign filing date, the rejection under 35 USC 102(a)(1) over the Onodera reference is maintained.
Applicant’s arguments with respect to claim and specification objections, prior art rejections not based on Onodera, and double patenting rejections have been fully considered and are persuasive. These objections and rejections have been withdrawn.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641