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 .
2. Applicant’s response filed on 04/27/2026 is acknowledged.
3. Claims 1, 3 and 8-21 are pending.
4. Claim 21 stands withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/07/2025.
5. Claims 1, 3 and 8-20 are under consideration for their full scope.
6. The following rejections are necessitated by Applicant’s amendment filed on 04/27/2026.
7. Claim 20 is objected to because of the following informalities: Claim 20 depends on canceled claim 2.
Appropriate correction is required.
8. 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.
9. Claims 3, 8, 13, 15-16 and 19-20 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.
Claim 3 recites the limitations “the population” and "an antibody structural isoform" in lines 1-2. There is insufficient antecedent basis for these limitations in the claim. It is noted that claim 1 recites two structural isoforms
Claim 8 recites the limitations "said antibody " in line 1. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 1 recites two antibodies.
Claim 13 recites the limitations "the produced antibody " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 1 recites two antibodies.
Claim 15 recites the limitations "the antibody " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 1 recites two antibodies.
Claim 16 recites the limitations "said antibody " in lines 1. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 1 recites two antibodies.
Claim 19 recites the limitations "the produced antibodies " in line 2. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 1 recites two antibodies.
Claim 20 recites the limitations "the structural antibody isoforms" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Correction is required.
10. 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.
11. Claims 1, 3 and 8-21 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 is a New Matter Rejection.
Applicant’s amendment asserts that no New Matter has been added and points to the specification at Examples 4-6 of the specification for support for the newly added limitation “A method for producing an antibody preparation, said method comprising contacting an antibody solution with a reducing agent, and then re-oxidizing the antibody, wherein the antibody solution comprises a first antigen-binding domain and a second antigen-binding domain which are linked with each other via at least one disulfide bond, wherein said first antigen-binding domain and said second antigen-binding domain comprises a CHI region, a CL region, a VL region, a VH region and/or a VHH region, wherein said at least one disulfide bond is formed between the amino acid residues at position 191 according to EU numbering in the respective CHI regions of the first antigen-binding domain and the second antigen-binding domain, and wherein said antibody solution comprises two structural isoforms which differ by said at least one disulfide bond.” of claim 1; and “further comprising a step of removing or chemically inactivating the reducing agent, prior to said step of re-oxidizing the antibody” of claim 15. At best the specification provides support for a method which is limited to incubating the antibody samples with 2-MEA or TCEP, changing the buffer to remove the 2-MEA or TCEP and then incubating the samples overnight at room temperature. However, the specification does not appear to provide an adequate written description for the methods as recited in claims 1, 3 and 8-21 which include “re-oxidizing the antibody” and doing so without removing the reducing agent and re-oxidizing the antibody by any other means than incubating at room temperature overnight without reducing agent. The instant claims now recite limitations which were not clearly disclosed in the specification and claims as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in the present claims, which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C. 112.
Obviousness is not the standard for the addition of new limitations to the disclosure as filed. It is noted that entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977). New Matter is a written description issue.
12. No claim is 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 NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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July 14, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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