DETAILED ACTION
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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 6/25/2026 in response to the Non-Final Rejection mailed on 4/2/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-6, 8-20 are pending.
Claims 9-10, 18-20 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-6, 8, 11-17 are pending and examined on the merits.
Applicant’s remarks filed on 6/25/2026 in response to the Non-Final Rejection mailed on 4/2/2026 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Priority
Acknowledgement is made of this national stage entry of PCT/CN2022/140536 filed on 12/21/2022, which claims foreign priority to Chinese Patent Application Number CN202211064221,6, filed on 9/1/2022. The certified copy has been filed in the present application on 2/10/2026.
Withdrawn Rejections
The rejection of claims 7, 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicant’s cancellation of claim 7. It is noted that claim 8 was invertedly included in the rejection dated 4/2/2026, therefore the rejection over claim 8 is withdrawn.
The rejection of claim 4 under 35 U.S.C. 102a1 as being anticipated by JP2006304633A (Date of Publication: 2006-11-09, cited on IDS dated 3/5/2025) {herein ‘633A} is withdrawn in view of Applicant’s amendment of claim 4 to recite ‘and at least one functional polypeptide FLD, wherein the at least one functional polypeptide FLD satisfies any of the following conditions: A. having an amino acid sequence shown in SEQ ID NO.5; and B. having an amino acid sequence of at least 80% sequence identity to the amino acid sequence as shown in SEQ ID NO.5 in A.’
Maintained 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.
The rejection of claims 4-6, 14-17 are newly 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 is maintained. The rejection has been modified to add claims 4-6, 17 due to amendment of claim 4 to recite ‘and at least one functional polypeptide FLD, wherein the at least one functional polypeptide FLD satisfies any of the following conditions: A. having an amino acid sequence shown in SEQ ID NO.5; and B. having an amino acid sequence of at least 80% sequence identity to the amino acid sequence as shown in SEQ ID NO.5 in A’ and cancellation of claim 7.
Regarding claims 4-6, 14-17, the phrase "at least one functional polypeptide FLD, wherein the at least one functional polypeptide FLD satisfies any of the following conditions: A. having an amino acid sequence shown in SEQ ID NO.5; and B. having an amino acid sequence of at least 80% sequence identity to the amino acid sequence as shown in SEQ ID NO.5 in A " renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. It is unclear if Applicant is referencing the polypeptide of claim 1, upon which claim 4 depends, or a separate polypeptide. It is suggested that Applicant amend the claim to recite ‘and further comprising at least one functional polypeptide FLD, wherein the at least one functional polypeptide FLD satisfies any of the following conditions: A. having an amino acid sequence shown in SEQ ID NO.5; and B. having an amino acid sequence of at least 80% sequence identity to the amino acid sequence as shown in SEQ ID NO.5.’ Appropriate correction is suggested.
RESPONSE TO REMARKS: Applicants remarks filed on 6/25/2026 have been fully considered; however, they are rendered not persuasive in view of the modified rejection set forth above, which is necessitated by Applicants’ amendment to the claim 4 to recite ‘and at least one functional polypeptide FLD, wherein the at least one functional polypeptide FLD satisfies any of the following conditions: A. having an amino acid sequence shown in SEQ ID NO.5; and B. having an amino acid sequence of at least 80% sequence identity to the amino acid sequence as shown in SEQ ID NO.5 in A.’ Examiner contends that the claim language is indefinite as it is unclear if Applicant is referencing the polypeptide of claim 1, upon which claim 4 depends, or a separate polypeptide. It is recommended that Applicant amend the claim to recite ‘and further comprising at least one functional…’
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The rejection of claims 1, 2, 3, 5, 6, 8, 11, 12, 13, 14, 17 under 35 U.S.C. 102a1 as being anticipated by JP2006304633A (Date of Publication: 2006-11-09, cited on IDS dated 3/5/2025) {herein ‘633A} is maintained. The rejection has been modified in view of Applicant’s amendment of claim 1 to remove the recitation ‘alanine’ in claim 1, line 8 of the instant application, amendment of claim 4 to recite ‘and at least one functional polypeptide FLD, wherein the at least one functional polypeptide FLD satisfies any of the following conditions: A. having an amino acid sequence shown in SEQ ID NO.5; and B. having an amino acid sequence of at least 80% sequence identity to the amino acid sequence as shown in SEQ ID NO.5 in A,’ and cancellation of claim 7.
Claims 1, 2, 3, 5, 6, 8, 11, 12, 13, 14, 17 are drawn to a polypeptide Cm, wherein the polypeptide Cm is selected from: (1) a polypeptide Cm having a substitution mutation in at least one position selected from the group consisting of positions 16, 25, 29, 49 and 58, as compared with a natural C structural domain of a protein A as shown in SEQ ID NO.1; wherein, the position 16 is subjected to a substitution mutation into leucine or valine; the position 25 is subjected to a substitution mutation into lysine, arginine, histidine or tryptophan; the position 29 is subjected to a substitution mutation into leucine or threonine; the position 49 is subjected to a substitution mutation into arginine or histidine; and the position 58 is subjected to a substitution mutation into glycine, isoleucine or alanine; or (2) a polypeptide Cm having at least 80% of sequence identity to the polypeptide in (1) and retaining substitution mutation in at least one position selected from the group consisting of positions 16, 25, 29, 49 and 58.
With respect to claims 1, 2, 3, 5, 6, 8, 11, 12, 13, 14, 17, ‘633A teaches a C domain multimeric polypeptide of Staphylococcus protein A that is modified with a substitution at G29A (appendix A; page 3, para 5; page 4, para 1) and position 16 (page 3, para 4), which is the same as the recitation of ‘a polypeptide Cm having at least 80% of sequence identity to the polypeptide in (1) and retaining substitution mutation in at least one position selected from the group consisting of positions 16, 25, 29, 49 and 58’ of the instant application claim 1 since ‘633A teaches a polypeptide with at least 80% sequence identity to SEQ ID NO: 1 AND a substitution mutation at position 29 (appendix A). Said polypeptide is encoded by a nucleic acid (page 4, para 1) of which can be utilized within an affinity column for characterization of samples via the multimeric protein (page 4, para 1), of which is comprised of 2 or more immunoglobulin-binding domains that are linked (page 7, para 3). It is noted that ‘633 also teaches a mutation of E25, which also reads on the instant application claim 1, line 14 limitation of ‘positions 16, 25, 29, 49 and 58’ (page 11, para 1). Absent evidence otherwise, it is the Examiner’s position that the affinity column of which contains the multimeric protein encoded by nucleic acid is a biomaterial as it utilizes immobilized biological molecules to bind and purify target biomolecules. Additionally, it is the Examiner’s position that said multimeric domain taught by ‘633A is the designated polypeptide Cm as Applicant defines polypeptide Cm as being comprised of polypeptide B (instant application SEQ ID NO: 2; appendix B) fusion-type multimeric protein (instant application claims 6, 14). Furthermore, ‘633A teaches the G29A polypeptide (appendix A) is cloned into a pET vector for synthesis of a C-G29A fusion protein (page 9, para 3). The C-G29A fusion protein immunoglobulin binding domain portion corresponds to SEQ ID NO: 2, which is the same as the instant application SEQ ID NO: 1 (appendix A). Furthermore, ‘633A teaches an equifunctional variant of the Z domain (Z domain in which the 1-position of the Z domain was replaced with Ala; Z-V1A) was cloned into a pET vector, effectively resulting in a Z-VIA fusion protein which is the same as SEQ ID NO: 2 of the instant application (page 9, para 2 and para 3; appendix B).
For the reasons stated herein, the teachings of ‘633A anticipates claims 1, 2, 3, 5, 6, 8, 11, 12, 13, 14, 17.
RESPONSE TO REMARKS: Beginning on p. 3 of Applicant’s remarks, in summary, Applicant contends that amending claim 1 to ‘a polypeptide Cm’ overcomes the anticipation rejection over ‘633. Applicant contends that SEQ ID NO: 1 of the present application does not correspond to the polypeptide Cm defined in claim 1. Rather, it serves as the mutational scaffold basis for the polypeptide Cm defined in claim 1. Applicant contends that it can be seen that D1 only discloses the case in which position 29 is mutated to alanine in claim 1 of the present application. Therefore, amended claim 1 differs from D1 at least with respect to the following distinguishing features:
1) a polypeptide Cm having a substitution mutation in at least one position selected from the group consisting of positions 16, 25, 29, 49 and 58, as compared with a natural C structural domain of a protein A as shown in SEQ ID NO.1; wherein,
the position 16 is subjected to a substitution mutation into leucine or valine;
the position 25 is subjected to a substitution mutation into lysine, arginine, histidine or tryptophan;
The position 29 is subjected to a substitution mutation into leucine or threonine;
the position 49 is subjected to a substitution mutation into arginine or histidine; and
the position 58 is subjected to a substitution mutation into glycine, isoleucine or alanine; or
2) a polypeptide Cm having at least 80% of sequence identity to the polypeptide in (1) and retaining substitution mutation in at least on
The arguments are not persuasive. Examiner appreciates Applicant’s Response to Arguments dated 6/25/2026. However, Examiner contends that ‘633 teaches the recitation ‘…(2) a polypeptide Cm having at least 80% of sequence identity to the polypeptide in (1) and retaining substitution mutation in at least one position selected from the group consisting of positions 16, 25, 29, 49 and 58.’ Examiner contends that SEQ ID NO: 1 of the instant application (1ADNKFNKEQQNAFYEILHLPNLTEEQRNGFIQSLKDDPSVSKEILAEAKK LNDAQAPK 58) is at least 80% identical to SEQ ID NO: 2 of ‘633 (1ADNKFNKEQQNAFYEILHLPNLTEEQRNAFIQSLKDDPSVSKEILAEAKKLNDAQAPK 58). It is also noted that the comparison of SEQ ID NO: 1 of the instant application with SEQ ID NO: 2 of ‘633 yields a substitution at position 29 of G to A (appendix A). It is noted that ‘633 also teaches ‘the position 25 is subjected to a substitution mutation, as recited in the instant application claim 1, line 14 (‘633: page 11, para 1). Examiner appreciates Applicants amendment of claim 1 to remove the recitation ‘alanine’ in line 8. However, amending the claim to remove said limitation does not render the claim patentable over ‘633 as ‘633 anticipates the recitation ‘(2) a polypeptide Cm having at least 80% of sequence identity to the polypeptide in (1) and retaining substitution mutation in at least one position selected from the group consisting of positions 16, 25, 29, 49 and 58’ as said recitation only requires 80% sequence similarity and a substitution mutation at any one of amino acid positions 16, 25, 29, 49 and 58.
Conclusion
Status of Claims
Claims 1-6, 8, 11-17 are pending and examined on the merits.
Claims 9-10, 18-20 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-6, 8, 11-17 are rejected.
No claims are in condition for allowance.
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 replying 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656 (nr)
Appendix A
‘633A SEQ ID NO: 2 vs Instant application seq id no: 1 (G29A)
Query Match 98.0%; Score 290; Length 58;
Best Local Similarity 98.3%;
Matches 57; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 ADNKFNKEQQNAFYEILHLPNLTEEQRNGFIQSLKDDPSVSKEILAEAKKLNDAQAPK 58
Db 1 ADNKFNKEQQNAFYEILHLPNLTEEQRNAFIQSLKDDPSVSKEILAEAKKLNDAQAPK 58
Appendix B
‘633A SEQ ID NO: 1 (polypeptide B) vs Instant application SEQ ID NO: 2
Query Match 98.0%; Score 292; Length 58;
Best Local Similarity 98.3%;
Matches 57; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 ADNKFNKEQQNAFYEILHLPNLNEEQRNGFIQSLKDDPSQSANLLAEAKKLNDAQAPK 58
Db 1 ADNKFNKEQQNAFYEILHLPNLNEEQRNAFIQSLKDDPSQSANLLAEAKKLNDAQAPK 58
Prosecution Insights