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
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional application 63/111,781 (filed on 11/10/2020).
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-3, 5-7, 13, 17-18, 70, and 74, in the reply filed on 04 February, 2026 is acknowledged.
Claims 22-25, 38, 30, 32, 36, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 February, 2026.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
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.
Claims 1-3, 5-7, 13, 18, 70, and 74 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.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Instant claims 1-3, 5-7, 13, 18, 70, and 74 broadly encompass a fusion protein comprising a cellulose binding domain and a protein which binds an antibody to SARS-CoV-2.
Instant claims 5-7 further recite that the antibody binding protein comprises a SARS-CoV-2 protein, a SARS-CoV-2 nucleoprotein or fragment thereof or a SARS-CoV-2 spike protein or fragment thereof. Instant claim 13 further recites that the antibody-binding protein comprises at least 85% sequence identity of the amino acid sequence of SEQ ID NO: 3 (SARS-CoV-2 nucleocapsid) or 4 (SARS-CoV-2 spike protein).
The Specification has failed to sufficiently describe the structural features that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the antibody-binding protein to bind a SARS-CoV-2 antibody. The claims define the protein based on it does—not what it is.
“[A] protein which binds an antibody to SARS-CoV-2” encompasses a large pool of proteins when accounting for both the constant and variable region of the antibody. For example, Shpigel, et al. (Biotechnol Appl Biochem. 2000 Jun;31(3):197-203., NPL-IDS, filed, 02/04/2026) discloses a fusion protein comprising a CBD and a protein (staphylococcal Protein A) which binds the Fc region of IgG, this would include IgG antibodies to SARS-CoV-2. “[A]t least 85% sequence identity of the amino acid sequence of SEQ ID NO: 3 or 4” also encompasses a large pool of sequences, as allowing for changes to 15% of the amino acid residues allows for many proteins. SEQ ID NO: 3 is 416 amino acids in length while SEQ ID NO: 4 is 202 amino acids in length. A variant sharing only 85% identity to SEQ ID NOs: 3 or 4 can have anywhere from 1 to 62 (SEQ ID NO: 3) or 1 to 30 (SEQ ID NO:4) substitutions, deletions, or additions in any combination, along any length of the sequence. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genius (SEQ ID NO: 3 – 2062 = 4.61 x 1080; SEQ ID NO: 4 – 2030 = 1.07 x 1039) comprising trillions upon trillions of sequences.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences the Specification has only adequately described and successfully reduced to practice specific antibody-binding proteins (SEQ ID NOs: 3 and 4). As such, the Specification reasonably demonstrates that Applicant was in possession of fusion proteins with a CBD and SEQ ID NOs: 3 or 4. However, this is not representative of the extremely large genus of sequences claimed since these sequences only encompass SARS-CoV-2 nucleocapsid and spike glycoprotein and not the innumerable sequences contained within a genus of sequences comprising all protein which bind to an antibody to SARS-CoV-2 or an antibody binding protein with at least 85% identity to the amino acid sequences of SEQ ID NOs: 3 or 4..
The data generated for SEQ ID NOs: 3 and 4 described in the Specification cannot reasonably be extrapolated and applied to support possession of the entire claimed genus of variants and fragments because no one species, combination, or variant accounts for the variability amongst the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Burbelo, et al. (medRxiv [Preprint]. 2020 Apr 24:2020.04.20.20071423., hereinafter “Burbelo”) provides a review SARS-CoV-2 proteins that can be used for the detection of SARS-CoV-2 antibodies, these include the spike glycoprotein and nucleocapsid, and not portions of these proteins (Abstract). While Applicant may have possession of portions of these proteins, as the portions have not been shown to bind to SARS-CoV-2 antibodies.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
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, 5-7, 18, 70, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Sikes, et al. (WO 2019/075306 A1, FOR-IDS, filed, 02/04/2026, hereinafter “Sikes”) and further in view of Burbelo.
Regarding claims 1 and 5-7, 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.
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.
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sikes and Burbelo as applied to claims 1-3, 5-7, 18, 70, and 74 above and further in view of GEN BANK: QHD43423.2 (https://www.ncbi.nlm.nih.gov/protein/1798172432, nucleocapsid phosphoprotein [Severe acute respiratory syndrome coronavirus 2], GenBank: QHD43423.2 published 18 March 2020, accessed 17 Feb 2026, hereinafter “NCBI”).
Regarding claims 13 and 17, Sike and Burbelo teach a fusion protein comprising a CBD and the nucleocapsid or spike proteins of SARS-CoV-2 which bind SARS-CoV-2 antibodies (see claim 1 above). 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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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.
Conclusion
NO CLAIMS ARE ALLOWED
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672