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 .
Priority
This application claims benefit of priority to Republic of Korea Application No. KR10-2020-0038530 filed on 03/30/2020. This application is also a CON of PCT/KR2021/001233 filed on 01/29/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 filed on 09/29/2025. However, an English translation of the foreign priority documents was not provided. Therefore, for the purposes of applying prior art, the effective filing date of the instant application remains 01/29/2021.
Amendments and Claim Status
In the reply filed on 09/25/2025, Applicant amended claims 1, 3-12 and 14-20. Claim 2 was previously canceled.
Claims 1 and 3-20 are currently pending.
Claims 5, 7 and 9-20 are withdrawn as not being encompassed by the elected group/species.
Claims 1, 3-4, 6 and 8 are under examination.
Withdrawn Rejections
The 35 USC § 112(b) rejection over claims 1, 3-4, 6 and 8 is withdrawn due to Applicant’s amendments.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 3-4, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR 2017069452 A, 06/21/2017) (IDS Reference of 09/29/2022, 17 Pages) (Of Record) in view of Leung et al. (WO 2019228510 A1, 12/05/2019) (Of Record) and Fujii et al. (Somatic Cell and Molecular Genetics, 1990) (Of Record).
Regarding claims 1, 3-4, 6 and 8, Kim et al. disclose a Z-domain-calsequestrin fusion protein for antibody isolation (Title). Further, the Z-domain and calsequestrin of the fusion protein can be fused through a linker (Page 2, Paragraph 14). Regarding the calsequestrin, Kim et al. disclose the fusion protein may include the amino acid sequence of SEQ ID NO: 7 (Page 2, Paragraph 15). SEQ ID NO: 7 of Kim et al. has 100% sequence identity to instant SEQ ID NO: 1.
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Kim et al. does not disclose the calsequestrin in the fusion protein consists of an amino acid sequence of instant SEQ ID NO: 5.
However, Fujii et al. disclose a calsequestrin gene that shares 100% sequence identity with instant SEQ ID NO:5 (Page 187).
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Exemplary rationales that may support a conclusion of obviousness include simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B). As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the calsequestrin gene disclosed by Fujii et al. in the fusion protein of Kim et al. as the fusion protein does not require a specific calsequestrin gene and the calsequestrin gene disclosed by Fujii et al. was a calsequestrin gene known in the prior art as it amounts to simple substitution of one known element for another to obtain predictable results.
Kim et al. does not disclose the linker of the fusion protein consists of an amino acid sequence of SEQ ID NO: 8.
However, Leung et al. disclose a fusion protein comprising two polypeptides (Claim 1). Further, the fusion protein comprises a peptide linker that connects the two polypeptides, wherein the polypeptide is a linear polypeptide between 1-20 amino acids in length (Paragraph [0015]). More specifically, the peptide linker is identical to SEQ ID NO: 74 (Paragraph [00168]). SEQ ID NO: 74 of Leung et al. shares 100% sequence identity to instant SEQ ID NO: 8.
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Exemplary rationales that may support a conclusion of obviousness include simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B). As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the peptide linker disclosed by Leung et al. in the fusion protein of Kim et al. as the fusion protein does not require a specific linker and the peptide linker disclosed by Leung et al. was a peptide linker known in the prior art as it amounts to simple substitution of one known element for another to obtain predictable results.
Regarding the amended limitation wherein the linker consists of the amino acid sequence of SEQ ID NO: 8, it is noted the linker of Leung et al. shares 100% identity to SEQ ID NO: 8. However, the linker of Leung et al. does comprise 7 more amino acids than instant SEQ ID NO: 8. Even so, Leung et al. disclose, as discussed above, that the linker can be 1-20 amino acids in length. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a linker between 1-20 amino acids in length, including the 6 amino acids within the disclosed SEQ ID NO: 74 of Leung et al. that shares 100% sequence identity to instant SEQ ID NO: 8 as the linker in the fusion protein of Kim et al./Fujii et al. with a reasonable expectation of success.
35 USC § 103 – Response to Arguments
Applicant's arguments filed on 09/25/2025 have been fully considered but they are not persuasive.
Applicant argued the claimed fusion protein exhibits a significant increase and unexpected remarkable effects in reactivity with calcium, stability, recovery yield and purity of antibodies obtained by use thereof, and points to preparation Examples 1 and 2 (Page 9, First Paragraph and Page 10, Paragraph 4).
Applicant’s arguments have been fully considered, but are not persuasive. It is noted Preparation Example 1 is not encompassed by the election of species and is not being examined at this time. Further, it is the Examiner’s position that Preparation Example 2, fully encompassed by the election of species, does not show a significant increase or an unexpected effect. When looking at Figures 4 and 5, the CSQ1(4N) fusion protein, which contains the linker GSNNNN, is slightly more stable in CHO Cell Culture at 50 hours than the other fusion proteins, however, it is not more stable in 0.1 M NaOH at 50 hours than the other fusion proteins. It is noted Applicant compares multiple fusion proteins of the instant invention, all of which comprise different linkers, with CSQ1(8N) comprising the linker GSNNNNNNNN and CSQ1(LE8N) comprising the linker LENNNNNNNN, to CSQ2, a fusion protein Applicant indicates is from Korean Patent No. 10-1774354. Thus, while the claimed fusion protein may be slightly more stable in specific conditions, the instant disclosure does not provide for a significant increase or unexpected effect. Further, the examiner cannot reasonably conclude the data is statistically significant effect since Figures 4 and 5 do not show the standard deviation. Assuming arguendo there is some unexpected property of the claimed fusion protein, the claims should be commensurate in scope with the unexpected results, i.e. the claimed embodiment.
Applicant further argued there is no motivation for one of ordinary skill in the art to combine Kim et al. and Fujii et al. to reach the claimed invention (Page 9, Paragraph 2), or to combine Kim et al., Fujii et al. and Leung et al. (Page 10, Paragraph 3).
Applicant’s arguments have been fully considered, but are not persuasive. As discussed above, Kim et al. disclose a Z-domain-calsequestrin fusion protein for antibody isolation. Therefore, as it is the desire of scientists and artisans to improve upon what is already generally know, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized any known Z-domain, linker and calsequestrin to create a fusion protein to determine the best fusion protein for antibody isolation. Thus, as the Z-domain, linker and calsequestrin were all known in the art, it would have been obvious to substitute the known components into the fusion protein disclosed by Kim et al.
Applicant additionally argued Leung et al. do not disclose the linker of SEQ ID NO: 8, but a linker of SEQ ID NO: 74 consisting of the sequence SGSNNNNNNNGSGG, of which instant SEQ ID NO: 8 is in bold (Page 10, Paragraph 2).
The Examiner agrees the linker disclosed by Leung et al. contains more amino acids than instant SEQ ID NO: 8. This is new limitation is addressed above in the modified rejection set forth above as necessitated by amendment.
Conclusion
Claims 1, 3-4, 6 and 8 are rejected.
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 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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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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