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
1. The Amendment filed July 2, 2026, in response to the Office Action of March 04, 2026, is acknowledged and has been entered. Claims 1, 2, 6, 7, 12, and 13 have been amended.
2. Claims 1-24 are pending.
3. Claims 3, 4, 8, 9 and 14-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim.
4. Claims 1, 2, 5-7 and 10-13 are currently under consideration as drawn to the elected species.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
5. 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 specification at p. 10-line 21, p. 15-line 8, p.17-line 27, and p20-lines 4-5 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, 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.
Priority
6. The Examiner has established a priority date of October 23, 2020, for claims 1, 2, 5-7 and 10-13 of the instant application because the priority of the instantly claimed invention is based on the prior filed application JP2019-193830 which is written Japanese. The prior filed applications have not been translated, and the Examiner is unable to determine the information in the document.
If Applicant disagrees with any rejection set forth in this action based on examiner's establishment of a priority date of October 23, 2020, for claims 1, 2, 5-7 and 10-13. Applicant is invited to submit a proper translation of the priority document and to point to page and line where support can be found establishing an earlier priority date. If Applicants choose to file a translation, then the translation must be filed together with a statement that the translation of the certified copy is accurate. See 35 U.S.C. 119 (b)(3), 37 C.F.R. 1.55(g)(3)(4), 37 C.F.R. 1.78(d)(7), and MPEP 1895.01.
Specification
7. The disclosure is objected to because of the following informalities: Table 3 on p. 49 is not fully legible.
Appropriate correction is required.
New 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)(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.
8. Claim(s) 1, 2, and 5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0390425 (Kawatani et al. Dec. 7, 2023, effectively filed Oct. 16, 2020), “Kawatani” evidenced by Herceptin® (Trastuzumab) Package Insert (Genentech, Inc. Sep. 26, 2003).
Kawatani teaches a method of production of conjugate with trastuzumab. See Example 1.
Kawatani teaches contacting trastuzumab (an Fc molecule) with a 17 amino acid peptide (P3) (GPDCAYHKGELVWCTFH), which comprises the SEQ ID NO: 2, Fc-IgBP of the instant specification. Kawatani the peptide-modified antibody has an Fc region of the antibody site-specifically modified by the above-mentioned peptide. See ¶¶ 0184-0186.
Kawatani teaches the solution comprising peptide-modified antibody was then passed through the IgG-BP column to separate into the first antibody composition containing relatively large amounts of the unlabeled antibody and the monovalent antibody and the second antibody composition containing a relatively large amount of the divalent antibody. See ¶¶ 0187-0188.
Kawatani teaches an IgG-BP column is a column in which an IgG-binding peptide is immobilized and bound to a carrier. Divalent antibody cannot bind to the column because the binding sites are already occupied by IgG-binding peptides, and only monovalent antibodies show affinity for the column. Using the IgG-BP column and utilizing the difference in the interaction with respective antibody-modification peptides, the first antibody composition containing relatively large amounts of the unmodified antibody and the monovalent antibody and the second antibody composition containing a relatively large amount of the divalent antibody can be respectively separated and purified. In one preferred embodiment, the molar ratio of unmodified antibody to monovalent antibody in the first antibody composition is 4-47:53-96, preferably 4-30:70-96, more preferably 4-20:80-96, further preferably 4-10:90-96. See ¶¶ 0132- 0133.
Kawatani teaches that the monovalent antibody is antibody in which one molecule of antibody-modification peptide is bound to one molecule of human anti-HER2 antibody, and the divalent antibody is an antibody in which two molecules of antibody-modification peptide are bound to one molecule of human anti-HER2 antibody. See ¶¶ 0131.
Regarding claim 2, trastuzumab is an IgG1 antibody. See Herceptin® (Trastuzumab) Package Insert-Description.
New 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.
9. Claim(s) 1, 2, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0390425 (Kawatani et al. Dec. 7, 2023, effectively filed Oct. 16, 2020), “Kawatani” evidenced by Herceptin® (Trastuzumab) Package Insert (Genentech, Inc. Sep. 26, 2003).
Kawatani teaches as set forth above, but does not explicitly teach that the proportion of an Fc molecule where one Fc-binding IgBP, per Fc molecule, is bound, relative to a total amount of the Fc molecule is 55% or more.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Kawatani an obtain the proportion of an Fc molecule where one Fc-binding IgBP, per Fc molecule, is bound, relative to a total amount of the Fc molecule is 55% or more Kawatani because the molar ratio of unmodified antibody to monovalent antibody in the first antibody composition is 4-47:53-96, preferably 4-30:70-96, more preferably 4-20:80-96, and further preferably 4-10:90-96. One would have been motivated to obtain a high proportion of the monovalent trastuzumab in the composition to obtain the highest purity composition for further use of the monovalent trastuzumab as taught by Kawatani in Example 1.
10. Claim(s) 7 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0390425 (Kawatani et al. Dec. 7, 2023, effectively filed Oct. 16, 2020), “Kawatani” evidenced by Herceptin® (Trastuzumab) Package Insert (Genentech, Inc. Sep. 26, 2003) as applied to claims 1, 2, 5, and 6 above, and further in view of US 2010/0297606 A1 (Ito, Y. Nov. 25, 2010, IDS), “Ito”.
Kawatani teaches as set forth above but does not explicitly teach cutting a bond between the Carrier-binding IgBP and the Fc molecule to recover the bound product of the Fc-binding IgBP and the Fc molecule from the carrier or injecting an Fc molecule to a column to which a Carrier-binding IgBP is bound.
Ito teaches as set forth in the Office Action of March 04, 2026.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Kawatani teaches and Ito inject an Fc molecule (trastuzumab) to a column to which a Carrier-binding IgBP is bound to bind the Fc molecule to Fc binding peptide with a cleavable linker that could be enzymatically cleaved to recover the bound product of the Fc-binding IgBP and the Fc molecule (trastuzumab) from the carrier because Ito teaches using column injection techniques and cleavable linkers for purification of Fc containing fragments. One would have been motivated with a reasonable expectation to use column injection techniques and cleavable linkers for purification of Fc containing fragments because these are routine protein purification methods in the art as exemplified by the teachings of Ito. One would have been motivated to obtain a high proportion of the monovalent trastuzumab in the composition to obtain the highest purity composition for further use of the monovalent trastuzumab as taught by Kawatani in Example 1.
Conclusion
11. All other objections and rejections recited in the Office Action of March 04, 2026, are withdrawn in view of Applicant’s amendments and arguments.
12. No claims allowed.
13. 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch, can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Peter J Reddig/
Primary Examiner, Art Unit 1646
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