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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/15/2026 has been entered.
Priority
This application claims benefit of priority to Republic of Korea Application No. KR10-2020-0038530 filed 03/30/2020 and is also a Continuation of PCT/KR2021/001233 filed 01/29/2021.
Drawings
The Drawings filed 09/29/2022 are accepted by the Examiner.
Claim Status
Applicant’s election of Group I, claims 1 and 3-10, in the Response to Election/Restriction filed 06/04/2025 is reiterated. Applicant further elected SEQ ID NO: 5 as the specific calsequestrin, SEQ ID NO: 1 as the specific Z-domain and SEQ ID NO: 8 as the specific linker. Claims 5, 7 and 9-20 were withdrawn by the Examiner as they were not encompassed by the elected Group/Species.
In the response filed 02/17/2026, Applicant amended claims 1, 14-17 and 20.
Claims 1 and 3-20 are currently pending.
Claims 5, 7 and 9-20 remain withdrawn.
Claims 1, 3-4, 6 and 8 are under examination.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 is missing the word “the” before “calsequestrin” in line 2 of the claim. Appropriate correction is required.
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) (Of Record) in view of Leonetti et al. (US 20130195908 A1, 08/01/2013), Rosen et al. (US 20230357754 A1, 11/09/2023, with priority to 03/20/2020) and Leung et al. (WO 2019228510 A1, 12/02/2019) (Of Record).
Regarding claims 1, 3-4, 6 and 8, it is noted that the claims do not utilize a transition word after “a fusion protein” in the preamble, meaning “comprising,” “consisting of” or “consisting essentially of.” Therefore, the claims are interpreted as utilizing open language in regard to what can be included in the fusion protein, that is, the claims are interpreted as a fusion protein comprising a calsequestrin consisting of the amino acid sequence of SEQ ID NO: 5 linked to a Z-domain consisting of the amino acid sequence of SEQ ID NO: 1 wherein the linker consists of the amino acid sequence of SEQ ID NO: 8. However, the fusion protein as a whole can comprise other amino acids as only the specific constituents, the calsequestrin, Z-domain and linker themselves ‘consist of’ the noted sequences.
Kim et al. disclose a fusion protein comprising of a Z-domain and a calsequestrin for the isolation and purification of antibodies (See entire document, Abstract). The Z-domain and calsequestrin can be fused through a linker (Page 2, Paragraph 14).
Kim et al. do not disclose a calsequestrin consisting of the amino acid sequence of SEQ ID NO: 5, a Z-domain consisting of the amino acid sequence of SEQ ID NO: 1 or a linker consisting of the amino acid sequence of SEQ ID NO: 8.
However, Leonetti et al. disclose Protein A and the Z domain which is derived therefrom can bind to the Fc region of various classes of antibodies (Paragraph [0140]). Immunoglobulin-binding elements include particular S. aureus protein A and the ZZ derivative thereof (Paragraph [0031]). Leonetti et al. disclose a specific ZZ derivative, SEQ ID NO: 3 that binds the Fc region (Paragraph [0031]). SEQ ID NO: 3 of Leonetti et al. shares 100% sequence identity to instant SEQ ID NO: 1. A sequence alignment is provided below wherein Qy is instant SEQ ID NO: 1 and Db is SEQ ID NO: 3 disclosed by Leonetti et al.
PNG
media_image1.png
250
640
media_image1.png
Greyscale
Additionally, Rosen et al. disclose methods for sensitive and high-throughput detection of various antibodies and targets (See entire document, Abstract). Rosen et al. further disclose protein sequences amplified for their library which includes SEQ ID NO: 2192 encoding CASQ1 (UniProt ID) (Table 1 and Paragraph [0424]). CASQ1 is calsequestrin-1 from Homo sapiens. SEQ ID NO: 2192 of Rosen et al. shares 100% sequence identity to instant SEQ ID NO: 5. A sequence alignment is provided below wherein Qy is instant SEQ ID NO: 5 and Db is SEQ ID NO: 2192 disclosed by Rosen et al.
PNG
media_image2.png
672
648
media_image2.png
Greyscale
Finally, Leung et al. disclose fusion proteins, methods of preparing fusion proteins and uses thereof (See entire document, Abstract). The fusion protein comprises a peptide linker that connects the two polypeptides wherein the peptide linker is a linear polypeptide having 1-20 amino acids (Paragraph [0015]). Leung et al. disclose SEQ ID NO: 73, a specific peptide linker (Paragraph [0016]). SEQ ID NO: 73 of Leung et al. shares 100% sequence identity to instant SEQ ID NO: 8. An alignment is provided below wherein Qy is instant SEQ ID NO: 8 and Db is SEQ ID NO: 73 disclosed by Leung et al.
PNG
media_image3.png
156
622
media_image3.png
Greyscale
Thus, 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 the Z-domain disclosed by Leonetti et al. in the fusion protein of Kim et al. because it was a known and effective Z-domain with the ability to bind to the Fc region of various antibodies as taught by Leonetti et al. It would have been further obvious to utilize the calsequestrin disclosed by Rosen et al. in the fusion protein of Kim et al. because it was a calsequestrin known in art as taught by Rosen et al. and the fusion protein of Kim et al. does not require a specific calsequestrin. It would have also been obvious to utilize the linker of Leung et al. in the fusion protein of Kim et al. because it was a known and effective linker for linking two polypeptides when creating fusion proteins as taught by Leung et al. Overall, it would have been obvious to utilize the Z-domain disclosed by Leonetti et al., the calsequestrin disclosed by Rosen et al. and the linker of Leung et al. in the fusion protein of Kim et al. motivated by the desire to create an effective fusion protein for isolating antibodies as it amounts to simple substitution of one known element for another to obtain predictable results. Examples of rationales that may support a conclusion of obviousness includes simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B).
Reiterating the claim interpretation discussed above, the fusion protein as a whole can comprise other amino acids other than the specific sequences of the Z-domain, calsequestrin and linker as-claimed. Therefore, even though the linker of Leung et al. has 6 more amino acids than the claimed linker of SEQ ID NO: 8, as the linker of Leung et al. shares 100% sequence identity to the claimed linker, utilizing the linker of Leung et al. as the linker in the fusion protein of Kim et al. would read on a fusion protein with the Z-domain and calsequestrin linked by the linker of instant SEQ ID NO: 8 because even though there are additional amino acids on the C-terminus in Leung’s linker, the calsequestrin and Z-domain are still linked by the claimed amino acid sequence.
Response to Arguments from the Declaration under 37 C.F.R. § 1.132
Applicant's arguments filed 04/15/2026 have been fully considered but they are not persuasive.
Applicant’s arguments regarding an unexpected results are not persuasive because the claims are not commensurate in scope with the showing. While it appears the results shown in Figures 4 and 5 could potentially show an unexpected result, the claims are not commensurate in scope with what is shown in the Figures. Figures 4 and 5 show the stability of specific fusion proteins, meaning fusion proteins with a specific calsequestrin sequence, a specific Z-domain sequence and a specific linker sequence, yet claim 1 is drawn to a fusion protein that can comprise multiple different sequences for the calsequestrin, multiple different sequences for the Z-domain and multiple different sequences for the linker. Therefore, the claims are not commensurate in scope with the showing.
Conclusion
Claims 1, 3-4, 6 and 8 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights