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 12/31/2025 in which claims 1-6, 10-12, 16 were amended, has been entered. Claims 19-29 were previously cancelled. Claim 31 was previously withdrawn.
Claims 1-18, 30 are under examination on the merits.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 12/31/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 10/01/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 12/31/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 10/01/2025.
Claim Objections
(Previous objections, withdrawn as to claims 1, 3). Applicant’s amendments to claims 1, 3 have overcome previous objections to those claims.
(New objection as to claims 2-18) Claims 2-18 are objected to because of the following informalities: On claims 2-18 the recitation of “The device of claim 1,” should read “The immunoassay device of claim 1,” to maintain consistency of claim language with claim 1, which claims 2-18 depend on.
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.
(Previous rejection, withdrawn as to claims 10, 11, and 16) Claims 10, 11, and 16 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for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.
See claims 10, 11 and 16 as submitted on 12/31/2025.
Applicant’s amendment to the instant claims filed on 12/31/2025 has overcome previous rejection to claims 10, 11, 16.
(New rejection, necessitated by amendment as to claims 1-18, 30) Claims 1-18, 30 are 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.
See claims 1-18, 30 as submitted on 12/31/2025.
Amended claim 1 recites “wherein the SARS CoV-2 N protein or peptide of the detectable reagent and/or the SARS CoV-2 N protein or peptide on the N-test line is selected from the group of sequences of SEQ ID NOS: 25-27 and any sequence having at least 90% sequence identity thereto”. Similarly amended claims 10 and 11 recite “the SARS CoV-2 N protein or peptide selected from the group of sequences of SEQ ID NOS: 25-27”. According to the Specification (pages 13 and 14) SEQ ID NOs: 26 and 27 correspond to S1 and S2 sequences, respectively not to an N protein. This is inconsistent with the claim recitation indicated above which refers to an N protein or peptide. Only SEQ ID NO: 25 corresponds to a SARS CoV-2 N protein. Therefore, the claims are indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claims 1, 10 and 11 were interpreted herein to refer to a SARS-CoV-2 N protein or peptide.
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.
(previous rejection, maintained and modified as necessitated by amendment as to claims 10-12, expanded as to claims 1-9, 13-18, 30) Claims 1-18, 30 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.
See claims 1-18, 30 as submitted on 12/31/2025.
It is noted that amended claim 1 recites a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27 or any sequence having 90% identity thereto; amended claims 10 and 11 recite a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27 or any sequence having 95% identity thereto; and amended claim 12 recites the full length SARS-CoV-2 N protein or any sequence having 95% identity thereto. However, as explained in detail below the amended limitations still correspond to a massive genus comprising innumerable of sequences, with respect to SEQ ID NOs: 25-27 and a full length SARS-CoV-2 N protein. It is noted that claim 1 which recites SEQ ID NOs: 25-27 is being interpreted herein to refer to a SARS-CoV-2 N protein or peptide (see rejections under 35 USC § 112(b) above).
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.”
Amended claim 1 recites a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27 or any sequence having 90% identity thereto. Amended claims 10 and 11 require a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27; while amended claim 12 requires the full length SARS-CoV-2 N protein. It is noted that claims 10 and 11 were interpreted herein consistent with the Specification to refer to a SARS-CoV-2 S protein or peptide and/or a SARS-CoV-2 N protein or peptide (see rejections under 35 USC § 112 (b) above). The amended claims require the associated function of having binding specificity for human antibodies against SARS CoV-2 N proteins or peptides for capturing in an immunoassay. The amended claims alternatively require a SARS CoV-2 N protein or peptide wherein sequence alterations can be made anywhere in the amino acid sequences of SEQ ID NOs: 25-27 or the full length N protein, including in the antibody binding regions, provided that a SARS CoV-2 N protein or peptide bear at least 95% sequence homology to SEQ ID NOs: 25-27 or the full length N protein and having binding specificity for human antibodies against SARS CoV-2 N proteins or peptides for capturing in an immunoassay. It is noted that instant claims also encompass peptides with the same associated function, having binding specificity for human antibodies against SARS CoV-2 N proteins for capturing in an immunoassay. However, the Specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genus as to establish a structure-function relationship with respect to having binding specificity for human antibodies against SARS CoV-2 N proteins.
SEQ ID NOs: 25-27 are of various amino acid residues lengths, for instance the longest is SEQ ID NO: 26 which is 679 amino acids residues long. In the case of SEQ ID NO: 26, the instant claims encompass any sequence having at least 95% sequence identity to SEQ ID NO: 26. An amino acid sequence sharing only 95% identity relative to SEQ ID NO: 26 could have anywhere from 1 to 34 substitutions, deletions, or additions in any combination along any length of SEQ ID NO: 26 which corresponds to a massive genus (2034 = 1.7 x 1044) comprising trillions upon trillions of sequences, with respect to SEQ ID NO: 26 alone.
However, while the claims are drawn to a genus that comprises innumerable
sequences, the Specification has only adequately described and successfully reduced to practice (1) a recombinant N protein 419 amino acid residues long derived from instant SEQ ID NO: 25, expressed in E. coli (Specification, Example 7, page 32); (2) an S1 protein 669 amino acid residues long derived from instant SEQ ID NO: 26, expressed in HEK293 cells (Specification, Example 7, page 32); and (3) an S2 protein 539 amino acid residues long derived from instant SEQ ID NO: 27, expressed in baculovirus-insect cells (Specification, Example 7, page 32). This is not representative of the extremely large genus of sequences claimed, since no variants, mutants, etc. of SEQ ID NO: 25-27 are demonstrated to have binding specificity for human antibodies against SARS CoV-2 N protein.
At best, the Specification contemplates the use of BLAST to identify functional homologs based on sequence homology. However, this is not sufficient to describe members of the claimed genus because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Thus, one of skill in the art would readily appreciate that relying on a non-patent source that is continuously subject to change as a means to identify members of the claimed genus does not sufficiently meet the written description requirement.
Moreover, Friedberg (“Automated protein function prediction--the genomic challenge”. Brief Bioinform. 2006;7(3):225-242.) teaches that homology-based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub-regions is critical to functional annotation, and that often addition, deletion, or re-shuffling of domains can lead to errors in annotation (page 227, second column; page 228, first paragraph). Furthermore, Friedberg teaches that sequence-based tools are just not sensitive enough to identify functional protein similarity as databases get larger, and diversity of sequences gets larger (page 228, first full paragraph).
Thorton (“Structural genomics takes off.” Trends Biochem Sci. 2001;26(2):88-89.) teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thorton further describes examples of little correlation between specific binding function and overall protein structure (page 992, right column, at lines 2-10). Thus, when taken with the teachings of Friedberg and Thorton, one of skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function.
In the absence of a representative number of examples, the Specification must at least describe the structural features that are required for the claimed function, in this case binding specificity for human antibodies against SARS CoV-2 N protein. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to binding specificity for human antibodies against SARS CoV-2 N protein.
Accordingly, it is herein maintained that 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.
(previous rejection, maintained and modified as necessitated by amendment as to claims 1-18 and 30) Claims 1-18 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al., in view of Skraba et al. Prior art of record., further in view of US PGPub 20210347858 A1 to Starzl effectively filed on 04/03/2020 (See PTO-892: Notice of References Cited.)
See claims 1-18, 30 as submitted on 12/31/2025.
Regarding claims 1 and 2, It is noted that amended claim 1 recites a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27 or any sequence having 90% identity thereto. Amended claim 1 is being interpreted herein to refer to a SARS-CoV-2 SARS-CoV-2 N protein or peptide (see rejections under 35 USC § 112 (b) above). However, it is noted that only SEQ ID NO: 25 refers to the SARS-CoV-2 N protein sequence, and such sequence was known in the art before the effective filing date of instant application; for example Starzl teaches a SARS-CoV-2 N protein sequence (SEQ ID NO: 8) which shares 100% identity with instant SEQ ID NO: 25 (see alignment below). As previously explained, Chen et al. teach an immunoassay device for detection of an anti-SARS-CoV-2 immunoglobulin comprising a lateral flow assay (LFA) (Abstract; Fig. 1), wherein the immunoassay device comprises:
a sample pad or receiving zone where a serum sample can be received (page 3, Fig. 1).
a detectable reagent comprising a SARS-CoV-2 recombinant nucleocapsid (N) protein (Abstract, page 3, Fig. 1).
and the sample is said to be positive for comprising an anti-SARS-CoV-2 antibody or immunoglobulin when the detectable reagent is detected at the test lines (Abstract, page 3, Fig. 1).
Chen et al. do not explicitly teach a SARS-CoV-2 N protein or peptide as part of the detectable reagent.
However, Skraba et al. teach an immunoassay device for detection of a target substance comprising a lateral flow assay (LFA) (Abstract; ¶¶ [0008], [0010], [0191]; Figs. 24A-D), wherein the immunoassay device comprises a detectable reagent to comprising multiple substrates such as viral proteins including SARS-CoV-2 N and spike (S) proteins. Skraba et al. further teach that a pair of substrates can be spatially arranged in the assay to provide specific identification of the virus and to achieve low cross-reactivity (¶¶ [0018], [0010], [0191].)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the teachings of Skraba et al. about a detectable reagent to comprising multiple substrates including the SARS-CoV-2 N protein, into the immunoassay device of Chen et al. for the benefit of providing specific identification of the virus and achieving low cross-reactivity. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had a reasonable expectation of success in incorporating the teachings of Skraba et al. into the immunoassay device of Chen et al. given that the methods of immunoassay device assembly comprising multiple viral substrates are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Sequence alignment of SEQ ID NO: 25 (Qy is instant SEQ ID NO: 25; Db is Starzl’s SEQ ID NO: 8 sequence)
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519
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Regarding claims 3 and 4, it is noted that no new limitations were introduced to claims 3 and 4 in the amendment filed on 12/31/2025. As previously explained, Skraba et al. further teach an immunoassay device comprising multiple, for example two, conjugation regions (or capture zones, as recited in claim 4) and multiple test lines, wherein a first capture zone comprises a test line for a substrate for example SARS-CoV-2 S protein and a test line for another substrate for example SARS-CoV-2 N protein (¶¶ [0019]-[0021], [0163]). Skraba et al. further teach the first and the second conjugation regions are capable of capturing the detectable reagent comprising secondary monoclonal antibodies that bind human primary antibodies (a non-human anti-human antibody, as recited in claims 3 and 4), wherein the secondary antibodies are monoclonal antibodies that allow for comparable detection of specific substrates, for example IgG and IgM antibodies (¶¶ [0019]-[0021], [0167], [0191]). It is noted that neither claim 3 nor claim 4 recite specific antibodies, accordingly, absent evidence to the contrary, the teachings of Skraba et al. encompass the limitations of claims 3 and 4.
Regarding claims 5 and 6, it is noted that no new limitations were introduced to claims 5 and 6 in the amendment filed on 12/31/2025. As indicated above Skraba et al. teach detectable reagent comprising secondary monoclonal antibodies that bind human primary antibodies (a non-human anti-human antibody, as recited in claim 4), wherein the secondary antibodies are monoclonal antibodies that allow for comparable detection of specific substrates, for example IgG and IgM antibodies (¶¶ [0019]-[0021], [0167], [0191]). Further, Chen et al. teach a detectable reagent comprising a mouse-anti human IgG antibody (page 2, fig. 1).
Regarding claim 7, it is noted that no new limitations were introduced to claim 7 in the amendment filed on 12/31/2025. As indicated above, Skraba et al. teach an immunoassay device comprising multiple, for example two, conjugation regions (or capture zones, as recited in claim 7) and multiple fluid paths and a single inlet (or receiving zone) may feed into the multiple fluid paths (¶¶ [0019]-[0021]. Skraba et al. further teach each fluid path can comprise a test line for a substrate for example SARS-CoV-2 S protein and a second fluid path can comprise a test line for another substrate for example SARS-CoV-2 N protein (¶¶ [0019]-[0021], [0163]).
Regarding claim 8, it is noted that no new limitations were introduced to claim 8 in the amendment filed on 12/31/2025. As previously explained, the recitation of “wherein the detectable reagent is deposited on the device in conjunction with a test sample” does not impart any additional structural features to the immunoassay device as recited in claim 1, therefore this recitation is considered to flow from the features already present in the immunoassay device as recited in claim 1. Further, the recitation of “wherein the detectable reagent is deposited on the device in conjunction with a test sample” in claim 8 merely states intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, therefore the indicated recitation is not considered a limitation and is of no significance to the claim construction, See MPEP 2111.02. Further, given that instant claims are directed to an immunoassay device and not to a method of using the immunoassay device, the recitations with respect to the manner in which the claimed immunoassay device is indented to be employed do not differentiate the claimed immunoassay device from any prior art immunoassay devices that meet the structural limitations as recited in claim 1. See also MPEP 2111.04 (II). Therefore, any immunoassay device in the prior art having the all of the structural limitations recited in claim 1 would be capable of receiving the detectable reagent in conjunction with a test sample. Accordingly, the teachings of Chen et al. and Skraba et al. explained above meet the limitations of claim 8.
Regarding claim 9, it is noted that no new limitations were introduced to claim 9 in the amendment filed on 12/31/2025. As previously explained, Chen et al. teach wherein the detectable reagent is in a reagent zone downstream of the sample receiving zone (page 2, fig. 1). Further, Skraba et al. further teach wherein the detectable reagent is in a reagent zone downstream of the sample receiving zone (¶¶ [0019]-[0021], Figs. 24A-D).
Regarding claims 10 and 11, the amended claims recite “the SARS CoV-2 N protein or peptide selected from the group of sequences of SEQ ID NOS: 25-27”. As indicated above, claims 10 and 11 were interpreted herein to refer to a SARS-CoV-2 S protein or peptide and/or a SARS-CoV-2 N protein or peptide (see rejections under 35 USC § 112 (b) above). Further, as noted above only SEQ ID NO: 25 refers to the SARS-CoV-2 N protein sequence, and such sequence was known in the art before the effective filing date of instant application; for example Starzl teaches a SARS-CoV-2 N protein sequence (SEQ ID NO: 8) which shares 100% identity with instant SEQ ID NO: 25 (see alignment above). As previously explained, Skraba et al. teach a detectable reagent comprising multiple substrates such as viral proteins including SARS-CoV-2 N and spike (S) proteins. Skraba et al. further teach that a pair of substrates can be spatially arranged in the assay to provide specific identification of the virus and to achieve low cross-reactivity (¶¶ [0018], [0010], [0191], [0163].)
Regarding claim 12, the amended claim no longer recites an S protein or peptide. However, as indicated previously, Skraba et al. already teach a detectable reagent comprising multiple substrates such as viral proteins including SARS-CoV-2 N (¶¶ [0018], [0010], [0191], [0163].)
Regarding claims 13-15, it is noted that no new limitations were introduced to claims 13-15 in the amendment filed on 12/31/2025. As previously explained, Skraba et al. teach an immunoassay device comprising multiple, for example two or ten, conjugation regions (or capture zones, as recited in claims 13-15) and multiple fluid paths and a single inlet (or receiving zone) may feed fluid into the multiple fluid paths (¶¶ [0019]-[0021]. Skraba et al. further teach each fluid path can comprise a test line for an immobilized substrate for example SARS-CoV-2 S protein and a second fluid path can comprise a test line for another immobilized substrate for example SARS-CoV-2 N protein (¶¶ [0019]-[0023], [0163]). Further, Skraba et al. also teach a kit used to identify multiple bacteria or viruses as well as multiple bacterial strains (¶¶ [0039]-[0062]). Accordingly, one of ordinary skill in the art would have been motivated and had reasonable expectation of success to include both, a test line comprising a SARS-CoV-2 S protein and a second test line comprising a SARS-CoV-2 N protein for the benefit of detecting different strains of SARS-CoV-2.
Regarding claim 16, the amended claim recites “the detectable reagent”. As indicated previously, Skraba et al. teach a detectable reagent comprising multiple substrates such as viral proteins including SARS-CoV-2 N and spike (S) proteins (¶¶ [0018], [0010], [0191], [0163]). Skraba et al. further teach wherein each fluid path can comprise a capture zone comprising an immobilized substrate for example SARS-CoV-2 S protein and a second fluid path can comprise a capture zone comprising another immobilized substrate for example SARS-CoV-2 N protein (¶¶ [0019]-[0023], [0163]).
Regarding claims 17 and 18, it is noted that no new limitations were introduced to claims 17 and 18 in the amendment filed on 12/31/2025. As previously explained, Chen et al. teach wherein a detectable reagent comprises a detection moiety comprising a chelated lanthanide comprising europium (page 2).
Regarding claim 30, it is noted that no new limitations were introduced to claim 30 in the amendment filed on 12/31/2025. As previously explained, Chen et al. and Skraba et al, in combination teach the immunoassay device of claim 1. Skraba et al. further teaches a kit comprising an immunoassay device (¶ [0008]).
Accordingly, it is herein maintained that claims 1-18 and 30 were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
Applicant contends on page 9 of the Remarks submitted on 12/31/2025:
“Applicant respectfully submits that production and testing of the recited variant sequences are well within the ordinarily skilled artisan's capabilities. One of ordinary skill in the art would understand that sequences having at most only 5% variance from the recited N protein sequences of SEQ ID NOS: 25, 26 and 27 were well within the possession of the inventors at the time of filing the present application. Applicant respectfully submits that the recited sequences of SEQ ID NOS: 25, 26, and 27 are thus representative of the variants recited in the claims containing only modest modifications of 5% or less. Accordingly, Applicant respectfully requests reconsideration and withdrawal of the written description rejection.”
In response:
The amended claims encompass a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27 or any sequence having 90% identity thereto, per claim 1; a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27 or any sequence having 95% identity thereto, in claims 10 and 11; and the full length SARS-CoV-2 N protein or any sequence having 95% identity thereto, in claim 12 and having binding specificity for human antibodies against SARS CoV-2 N proteins in a sample. However, as noted above only SEQ ID NO: 25 refers to the SARS-CoV-2 N protein sequence, and such sequence was known in the art before the effective filing date of instant application; for example Starzl teaches a SARS-CoV-2 N protein sequence (SEQ ID NO: 8) which shares 100% identity with instant SEQ ID NO: 25 (see alignment above). As explained in detail above the amended limitations still correspond to a massive genus (2034 = 1.7 x 1044 with respect to SEQ ID NO: 26 alone) comprising innumerable of sequences, with respect to SEQ ID NOs: 25 and a full length SARS-CoV-2 N protein. Further, it is noted that the instant claim encompass peptides. However, as discussed above, the Specification fails to describe any substantive structural limitations that such peptides must retain as to establish a structure-function relationship with respect to binding specificity for human antibodies against SARS CoV-2 N protein. Accordingly, it is herein maintained that 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.
Applicant contends on page 9 of the Remarks submitted on 12/31/2025:
“Applicant respectfully submits that neither Chen, Skraba, nor the combination thereof discloses or suggests an N protein or peptide as specifically defined in the presently amended claims. A person of ordinary skill in the art reading the Office's cited art references would have had no reason to select any of the claimed N protein or peptide sequences or variants thereof without the benefit of the present claims or specification to use as a blueprint. Indeed, the Office points to no disclosure in either of its cited references which suggests, let alone describes, any specific amino acid sequences. Rather, the Office merely refers to Skraba for its general disclosure of using SARS-CoV-2 N or S proteins.”
In response:
The instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant claims recite “a SARS-CoV-2 N protein or peptide selected from SEQ ID NOs: 25-27 or any sequence having 90% identity thereto.” That instant claims were interpreted herein consistent with the Specification to refer to a SARS-CoV-2 N protein or peptide (see rejections under 35 USC § 112 (b) above). Skraba et al. teach that exact limitation. However, as noted above only SEQ ID NO: 25 refers to the SARS-CoV-2 N protein sequence, and such sequence was known in the art before the effective filing date of instant application; for example Starzl teaches a SARS-CoV-2 N protein sequence (SEQ ID NO: 8) which shares 100% identity with instant SEQ ID NO: 25 (see alignment above). The teachings of Skraba et al., Chen et al., and Starzl in combination teach the exact embodiment instantly claimed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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