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 .
Response to Amendment
The amendment filed 26 May 2026 in which claim 1 was amended and claim 13 was cancelled has been entered.
Claims 1-3, 5-7, 17-18, 70, and 74 are under examination on the merits.
Claim Rejections - 35 USC § 112(a)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, maintained as to claims 1-3, 5-7, 18, 70, and 74 and withdrawn as to claim 13 due to cancellation). Claims 1-3, 5-7, 18, 70, and 74 were 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. The rejection as to claim 13 is withdrawn due to the cancellation of the claim in the Applicant response received 26 May 2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 1-3, 5-7, 18, 70, and 74 due to amendment to claim 1). Claims 1-3, 5-7, 18, 70, and 74 were rejected under 35 U.S.C. 103 as being unpatentable over Sikes and further in view of Burbelo.
(New rejection, claims 1-3, 5-7, 118, 70, and 74 necessitated by amendment to claim 1 and previous rejection, maintained and modified as to claim 17 and withdrawn as to claim 13, due to cancellation). Claims 1-3, 5-7, 17-18, 70, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Sikes and in further view of Burbelo and NCBI.
Regarding claims 1, 5-7, and 17, Sikes teaches a fusion protein comprising a cellulose binding domain (CBD) and a protein which can bind an antibody (pg. 2, lines 3-5 and pg. 30, lines 1-9). Sikes does not teach that the antibody is a SARS-CoV-2 antibody. However, Burbelo teaches that antibodies bind to SARS-CoV-2 antigens, specifically nucleocapsid and spike protein antigens, detecting anti-SARS-CoV-2 antibodies allows for the detection of infected subject (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the antigen taught by Sikes for the SARS-CoV-2 antigens that are known to bind SARS-CoV-2 antibodies taught by Burbelo to create a fusion protein with a CBD and a protein which binds SARS-CoV-2 antibodies. Burbelo provides motivation by teaching that detection of SARS-CoV-2 antibodies allows for study of humoral response profiles and detection of SARS-COV-2 infection (lines 304-306). One of ordinary skill would have had a reasonable expectation of success substituting the antigen taught by Sikes for the SARS-CoV-2 antigens taught by Burbelo because both teach protein detection.
Sikes and Burbelo do not teach SEQ ID NO: 3. However, NCBI teaches the amino acid sequence for the SARS-CoV-2 nucleocapsid, which is 100% identical to instant SEQ ID NO: 3 (Origin).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Sikes and Burbelo for a fusion protein comprising a CBD and the nucleocapsid or spike proteins of SARS-CoV-2 which bind SARS-CoV-2 antibodies with the teachings of NCBI for the SARS-CoV-2 nucleocapsid amino acid sequence. Sikes provides motivation by teaching that proteins have amino acid sequences, and the amino acid sequence is required to make the fusion proteins (pg. 32, lines 24-32). One of ordinary skill would have had a reasonable expectation of success of combining the teachings of Sikes, Burbelo, and NCBI because they all teach viral antigens.
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Regarding claim 2, Sikes teaches that the C-terminus of the antigen in linked to the N-terminus of the CBD (pg. 2, lines 6-7).
Regarding claim 3, Sike teaches that the antigen is linked to the CBD through a linker (pg. 2, lines 8-9).
Regarding claim 18, Sikes teaches that the CBD is a type 3a CBD or a type 1 dimerized CBD (pg. 2, lines 17-19).
Regarding claim 70, Sikes teaches a composition comprising a fusion protein bound to a cellulose-containing substrate (pg. 5, lines 4-6).
Regarding claim 74, Sikes teaches a kit for assessing the presence or amount of a protein, comprising a container containing a fusion protein (pg. 5, lines 10-15).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in absence of evidence to the contrary.
Response to Arguments
Applicant contends on pages 6-7 of the Remarks submitted on 26 May 2026 that SEQ ID NOs: 3 and 4 are exceptionally well known in the art including variants that fall within the range of the recited 85% sequence identity.
In response: Variants of the sequences may be well known in the art and well characterized, this does not mean that one could make a predictable change in the sequence and maintained the claimed function of binding to a SARS-CoV-2 antibody. As stated in the Office Action mailed 23 February 2026, 85% sequence identity to SEQ ID NO: 3 allows for up to 4.61 x 1080 different sequences and with no explanation of necessary amino acids to maintain the claimed function, the sequences encompass trillions of sequences that may not bind to an antibody.
Applicant contends on pages 7-8 of the Remarks submitted on 26 May 2026 that claim 1 has been amended to include the limitations of claim 13 which is not rendered prima facie obvious over Sikes and Burbelo.
In response: Applicant’s arguments, with respect to the amendment of claim 1 to include new limitations have been fully considered and are persuasive. The rejection of claims 1-3, 5-7, 18, 70, and 74 has been withdrawn.
Applicant contends on pages 8-10 of the Remarks submitted on 26 May 2026 that there is insufficient motivation to combine the references and that the reason for an alleged reasonable expectation is not sufficiently specific.
In response: Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is sufficient motivation to combine the references or a sufficiently specific reason for a reasonable expectation to combine, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Sikes teaches the SARS-CoV-2 nucleocapsid protein but does explicitly teach the nucleocapsid amino acid sequence, there is motivation to combine these two references as the sequence just further defines and clarifies the protein that was already taught.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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