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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I of claims (1-3, 5 and 7-20) and of species ((a) the SARS-CoV-2 antigen comprises a S1 subunit or a S2 subunit of the spike protein of the SARS-CoV-2, or a fragment/variant thereof) in the reply filed on 04/23/2026 is acknowledged. Upon further consideration and review, the election of species is withdrawn.
Claims 4 and 21-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/23/2026.
Claims 6 and 28 are cancelled at the Applicant request.
Thus, claims 1-3, 5 and 7-20 are under examination.
Priority
This application is a U.S. National Stage (371) application of PCT/US2021/036745 filed on 06/10/2021 which claims priority to U.S. Provisional Application No. 63/037,303 filed on 06/10/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/14/2023 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and all references are considered except where they were lined through.
Claim Objections
Claim 11 is objected to because of the following informalities: the claim recites “or wherein the subject has been treated with an anti-inflammatory agent or an antiviral agent or therapy”. There is an overuse of the connector “or” and a possible correction is “or wherein the subject has been treated with an anti-inflammatory agent or an antiviral agent”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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, 5 and 7-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using the fusion polypeptide of full length glycoprotein 70 (gp70) fused to full length receptor binding domain (RBD) of spike 1 (S1) subunit of SARS-CoV-2 (Sequence ID No. 5 or gp70-RBD) to detect antibodies to SARS-CoV-2, does not reasonably provide enablement for any fragment of the spike protein (S1 or S2) of the SARS-CoV-2 fused to any fragment/variant of gp70. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with this claim.
Regarding claims 1, 5 and 7-8, the claims recite a method for detecting the antibody or antigen-binding protein that binds to the SARS-CoV-2 antigen or the second SARS-CoV-2 antigen wherein the SARS-CoV-2 antigen or the second SARS-CoV-2 antigen comprises a fusion polypeptide comprising the spike protein of the SARS-CoV-2 or fragment thereof fused to a gp70 polypeptide or fragment/variant. Claim 7 further describes that the SARS-CoV-2 antigen or the second SARS-CoV-2 antigen either comprises a combination of the fusion polypeptide and the S2 subunit or it comprises the spike protein or fragment fused to the C-terminus of the gp70 polypeptide or fragment/variant. The specification does not provide enough support for an artisan to perform the assay without undue additional experimentation as described in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998) as appropriate. See also MPEP § 2164.01(a) and § 2164.04.
The breadth of the claims:
Claims 1 and 5 are recited at a high level of generality in which an antibody or an antigen-binding protein is detected with any SARS-CoV-2 antigen (claims 1 and 5) or any second SARS-CoV-2 antigen (claim 5). Claim 7 is also recited at a high level of generality in which an antibody or an antigen-binding protein is detected with the SARS-CoV-2 antigen or the second SARS-CoV-2 antigen that comprises a fusion polypeptide comprising the spike protein of the SARS-CoV-2 or any fragment thereof fused to a gp70 polypeptide or any fragment/variant thereof. Claim 7 further describes that the SARS-CoV-2 antigen or the second SARS-CoV-2 antigen either comprises a combination of the fusion polypeptide and the S2 subunit or it comprises the spike protein or any fragment fused to the C-terminus of the gp70 polypeptide or any fragment/variant thereof. Claim 8 is further recited at a high level of generality in which the fusion polypeptide has at least 90% sequence identity to SEQ ID No. 5 of gp70-RBD. Thus, the claims are recited at a high level of generality.
The nature of the invention:
The invention is about a method for detecting an antibody or antigen-binding protein in a sample that specifically binds to a SARS-CoV-2 antigen or to a second SARS-CoV-2 antigen. And the SARS-CoV-2 antigen or the second SARS-CoV-2 antigen comprises a fusion polypeptide comprising the spike protein of the SARS-CoV-2 or any fragment thereof fused to a gp70 polypeptide or any fragment/variant thereof. Claim 7 further describes that the SARS-CoV-2 antigen or the second SARS-CoV-2 antigen either comprises a combination of the fusion polypeptide and the S2 subunit or it comprises the spike protein or any fragment fused to the C-terminus of the gp70 polypeptide or any fragment/variant thereof. Claim 8 also describes that the RBD comprises the amino acids 316-542 of the spike protein of SARS-CoV-2 or the fusion polypeptide comprises either an amino acid sequence of SEQ ID No. 5 of gp70-RBD or an amino acid sequence having at least 90% sequence identity to SEQ ID No. 5 of gp70-RBD.
The state of the prior art:
Although there has been an early report about making fusion polypeptides between gp70 and human superoxide dismutase (SOD) to detect antibodies to Simian retrovirus-D serotype 1 (SRV-1) as noted by Kwang et al. (Journal of Virology, May 1988, p. 1774-1780), there is no prior art before the effective filing date of the instant application of 06/10/2020 that teaches or suggests a fusion polypeptide comprising the spike protein of the SARS-CoV-2 fused to a gp70 polypeptide. Also, while Lapointe et al. (US 2021/0389308 A1, priority to Apr. 3rd, 2020) teaches a method of detecting an antibody or antigen-binding protein that specifically binds to a SARS-CoV-2 antigen in a sample from a subject (Abstract; [0014]; [0017]), Lapointe does not teach a fusion polypeptide comprising the spike protein of the SARS-CoV-2 fused to a gp70 polypeptide. And similarly, Buch et al. (US 2023/0341392 A1, priority to Jun. 8th, 2020) teaches that the RBD comprises the amino acids 319-591 of the SARS-COV-2 Full length spike and how to specifically detect anti-spike-RBD antibodies in human saliva ([0130]), but Buch does not teach a fusion polypeptide comprising the spike protein of the SARS-CoV-2 fused to a gp70 polypeptide.
Furthermore, in re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims of the instant application.
The level of one of ordinary skill:
Based on the absence of prior art that describes making a fusion polypeptide between gp70 and SARS-Cov-2 antigen, the level of a person having ordinary skill in the art is not high enough to make fusion polypeptides with any fragment of the S protein of SARSCoV-2 fused with any fragment or variant of gp70.
The level of predictability in the art:
There is a high level of unpredictability in designing fusion polypeptides to detect antibodies to SARS-CoV-2 because of the degree of folding instability of fusion proteins as noted by Challener et al. (BioPharm International, 05-01-2017, Volume 30, Issue 5, page 4, “Achieving and maintaining proper folding for each of the components in fusion proteins is a major challenge in the molecular design of these products”). Also, while Lapointe and Buch teaches how to detect antibodies to SARS-CoV-2, Lapointe and Buch do not teach using fusion proteins of gp70 for detecting antibodies to SARS-CoV-2 antibodies. Thus, it cannot be predicted which fusion protein of any fragment of gp70 fused to any fragment of the spike protein of SARS-Co-V-2 will attain the proper conformation for recognition by SARS-CoV-2 antibodies before testing.
The amount of direction provided by the inventor:
As discussed above, the art does not teach making or using a fusion polypeptide between gp70 and SARS-Cov-2 antigen. The specification provides seven examples and only discusses gp70-RBD fusion protein (full length gp70 fused to full length RBD). Specifically, Example 1 teaches using a fusion protein of full length gp70 fused to full length RBD (gp70-RBD) (Example 1, pages 57-61). Example 2 teaches the advantages of using gp70-RBD antigen over standard forms in seroprevalence assays (Example 2, pages 61-62). Example 3 teaches the use of RBD as a marker to detect the ability of antibodies in patient sera to block the interaction between an RBD antigen and soluble angiotensin-converting enzyme (ACE) to establish immunity to SARS-Cov-2 in a patient (Example 3, Pages 63-64). Example 4 teaches comparing the binding of antibodies to different recombinant antigens of SARS-CoV-2 and to the fusion polypeptide of gp70-RBD (Example 4, Pages 64-66). Example 5 teaches venue-based approaches to seroprevalence studies of SARS-CoV-2 Infection in the U.S. state of New Jersey (Example 5, pages 66-69). Example 6 teaches convalescent plasma therapy and characterizing serum samples from convalescent donors (Example 6, pages 69-72). Example 7 teaches the development of more specific binding assays for antibodies induced by SARS-CoV-2 infection and vaccination (Example 7, pages 72-76).
Examples 1-7 do not provide a plan or a method for how to design and test the functionality and structure of any combination of the SARS-Cov-2 fragments with gp70 fragments to make the fusion polypeptide for SARS-Cov-2 antibody testing. The specification only discusses the fusion polypeptide of gp70-RBD (full length gp70 fused to full length RBD). Thus, the specification of the instant application fails to address a method that uses a fusion polypeptide comprising any fragment of the spike protein (S1 or S2) of the SARS-CoV-2 virus fused to any fragment/variant of gp70 polypeptide and is not commensurate in scope with the broad claim of the instant application.
The existence of working examples:
The examples of the specification only teach using gp70-RBD (full length gp70 fused to full length RBD) as noted above (Example 1, pages 57-61; Example 2, pages 61-62; Example 4, Pages 64-66)). Example 1 of the specification is about how to use a fusion protein of full length gp70 fused to full length RBD (gp70-RBD) (Example 1, pages 57-61). Example 2 of the specification cites the advantages of using gp70-RBD antigen over standard forms in seroprevalence assays (Example 2, pages 61-62). Example 4 of the specification compares the binding of antibodies to different recombinant antigens of SARS-CoV-2 and to the fusion polypeptide of gp70-RBD (Example 4, Pages 64-66).
The examples are directed only to using recombinant antigens of SARS-CoV-2 and to the fusion polypeptide of gp70-RBD. The examples do not teach using a fusion polypeptide comprising any fragment of the spike protein (S1 or S2) of the SARS-CoV-2 virus fused to any fragment/variant of gp70 polypeptide.
Furthermore, there is no indication from the examples that the broadly claimed method would work in any type of assay with any diagnostic platform and with any fragment combination of gp70 with RBD.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
With the lack of teaching in prior art in regards to using a fusion polypeptide comprising any fragment of the spike protein (S1 or S2) of the SARS-CoV-2 fused to any fragment/variant of gp70 polypeptide, the PHOSITA is expected to face an unreasonable amount of experimentation. Furthermore, the emergence of SARS-CoV-2 as a viral infection at the time the application was filed adds another challenge to a PHOSITA or to a clinician.
Thus, the specification of the instant application does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with claims 1, 5 and 7-8 of the instant application. Consequently, claims 1, 5 and 7-8 are rejected under 35 U.S.C. 112(a) because the specification while being enabling for using the fusion polypeptide of full length glycoprotein 70 (gp70) fused to full length receptor binding domain (RBD) of spike 1 (S1) subunit of SARS-CoV-2 (Sequence ID No. 5 or gp70-RBD) to detect antibodies to SARS-CoV-2, does not reasonably provide enablement for any fragment of the spike protein (S1 or S2) of the SARS-CoV-2 fused to any fragment/variant of gp70.
Claim Rejections - 35 USC § 112(b)
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.
Claim 8 is 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.
Claim 8 recites the limitation "the fusion polypeptide" in line 4. There is insufficient antecedent basis for this limitation in the claim.
To move the prosecution, the claim is interpreted to read on the fusion polypeptide of gp70-RBD to use in the method of detecting SARS-CoV-2 antibodies.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5 and 9-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being unpatentable by Lapointe et al. (US 2021/0389308 A1, priority to Apr. 3rd, 2020).
Claim 1 recites:
“A method of detecting an antibody or antigen-binding protein that specifically binds to a SARS-CoV-2 antigen in a sample from a subject, comprising:
contacting the sample with a SARS-CoV-2 antigen, under conditions suitable for binding the
antibody or antigen-binding protein to the SARS-CoV-2 antigen; and
detecting the binding of the antibody or antigen-binding protein to the SARS-CoV-2 antigen.,_
wherein:
(a) the SARS-CoV-2 antigen comprises a S1 subunit or a S2 subunit of the spike protein
of the SARS-CoV-2, or a fragment/variant thereof;
(b) the SARS-CoV-2 antigen comprises a receptor-binding domain (RBD) in the SI
subunit of the spike protein of the SARS-CoV-2 or fragment/variant thereof; or
(c) the SARS-CoV-2 antigen comprises an amino acid sequence of SEO ID NO: 5 or an
amino acid sequence having at least 75% sequence identity to SEO ID NO: 5”.
Regarding claim 1, Lapointe teaches a method of detecting an antibody or antigen-binding protein that specifically binds to a SARS-CoV-2 antigen in a sample from a subject (Abstract; [0014]; [0017]). Lapointe further teaches contacting the sample with a SARS-CoV-2 antigen, under conditions suitable for binding the antibody or antigen-binding protein to the SARS-CoV-2 antigen [0017]. And Lapointe teaches detecting the binding of the antibody or antigen-binding protein to the SARS-CoV-2 antigen [0017]. Lapointe also teaches that the SARS-CoV-2 antigen comprises a S1 subunit of the spike protein of the SARS-CoV-2 or a receptor-binding domain (RBD) in the S1 subunit of the spike protein of the SARS-CoV-2 [0095]; [0341-0342]; [0407-0408].
Regarding claim 2, Lapointe teaches that the SARS-CoV-2 antigen is immobilized on a solid phase substrate either directly or through binding to a capture antibody (Sheet 8 of 19, Fig. 8A and 8B, “Neutralizing antibodies against RBD”, “Receptor Binding Domain (RBD)”;[0148]). Lapointe further teaches contacting the sample with the solid phase substrate under conditions suitable for binding the antibody or antigen-binding protein to the SARS-CoV-2 antigen ((Sheet 8 of 19, Fig. 8A and 8B, “Neutralizing antibodies against RBD”, “Receptor Binding Domain (RBD)”; [0016-0017]). Lapointe also teaches detecting the binding of the antibody or antigen-binding protein to the solid phase substrate [0016-0017]. And Lapointe teaches that the binding of the antibody or antigen-binding protein to the solid phase substrate is indicative of the subject having the antibody or antigen-binding protein that specifically binds the SARS-CoV-2 antigen [0016-0017]; [0149]; [0847].
Regarding claim 3, Lapointe teaches identifying the antibody or antigen-binding protein after the step of detecting [0249].
Regarding claim 5, Lapointe teaches that the step of detecting comprises detecting the antibody or antigen-binding protein bound to the SARS-CoV-2 antigen or the solid phase substrate using a second SARS-CoV-2 antigen that interacts with the antibody or antigen-binding protein (Sheet 9 of 19, Fig. 8C, Fig. 8D, “RBD1”, “RBD2”, “Neutralizing antibodies against RBD1”, “Neutralizing antibodies against RBD2”; [0052]; [0056]; [0127]). Lapointe further teaches that the second SARS-CoV-2 antigen comprises a S1 subunit of the spike protein of the SARS-CoV-2, or a receptor-binding domain (RBD) in the S1 subunit of the spike protein of the SARS-Co V-2 (Sheet 9 of 19, Fig. 8C, Fig. 8D, “RBD1”, “RBD2”, “Neutralizing antibodies against RBD1”, “Neutralizing antibodies against RBD2”; [0052]; [0056]; [0127]).
Regarding claim 9, Lapointe teaches that the SARS-CoV-2 is a human or an animal SARS-CoV-2 [0340].
Regarding claim 10, Lapointe teaches that the sample comprises a saliva, blood, serum, plasma, cerebrospinal fluid (CSF) or peritoneal fluid [0074].
Regarding claim 11, Lapointe teaches that the subject is asymptomatic [0850].
Regarding claim 12, Lapointe teaches that the antiviral agent or therapy comprises a convalescent plasma therapy [0231].
Regarding claim 13, Lapointe teaches that the solid phase substrate is selected from the group consisting of microparticles, microbeads or magnetic beads [0119]; [0335], [0401].
Regarding claim 14, Lapointe teaches that the step of detecting comprises detecting fluorescence or chemiluminescence or comprises a competitive binding assay, a direct ELISA or a capture ELISA ([0116]; [0148]; [0307]; [0346]).
Regarding claim 15, Lapointe teaches that the competitive binding assay comprises detecting the binding of the antibody to the SARS-CoV-2 antigen in the presence of an angiotensin converting enzyme 2 (ACE2) polypeptide, and wherein the ACE2 polypeptide thereof is capable of binding to the SARS-Co V-2 antigen ((Sheet 8 of 19, Fig. 8A and 8B, “Neutralizing antibodies against RBD”, “Receptor Binding Domain (RBD)”; [0016-0017]).
Regarding claim 16, Lapointe teaches that the second SARS-CoV-2 antigen comprises a detection agent [0103]; [0240]. Regarding claim 17, Lapointe teaches that the detection agent comprises a biotin moiety [0148]. Regarding claim 18, Lapointe teaches that the second SARS-CoV-2 antigen is biotinylated [0148].
Regarding claim 19, Lapointe teaches that the step of detecting comprises contacting one or more secondary antibodies with the sample, and wherein each of the one or more secondary antibodies comprises a label [0149]. Regarding claim 20, Lapointe teaches that the label is an enzyme [0150].
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 (PHOSITA) 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lapointe et al. (US 2021/0389308 A1, priority to Apr. 3rd, 2020) as applied to claim 1 above, and further in view of Buch et al. (US 2023/0341392 A1, priority to Jun. 8th, 2020).
Claim 8 recites:
“The method of claim 1, wherein the spike protein or fragment/variant thereof comprises the RBD, optionally wherein:
(a) the RBD comprises the amino acids 316-542 of the spike protein; or
(b) the fusion polypeptide comprises an amino acid sequence of SEQ ID NO: 5 or an
amino acid sequence having at least 90% sequence identity to SEQ ID NO: 5”.
Regarding claim 8, the teachings of Lapointe are previously discussed.
Moreover, regarding claim 8, Lapointe teaches that the spike protein comprises RBD ([0088], “In some embodiments, the peptide or protein is an antibody or antigen-binding fragment that directly or indirectly binds the RBD of the spike protein”; [0095], “In some embodiments, the portion comprises the receptor binding domain (RBD) of subunit 1 of the spike protein”).
Regarding claim 8, Lapointe does not teach that the RBD comprises the amino acids 316-542 of the spike protein.
Regarding claim 8, Buch teaches that the RBD comprises the amino acids 319-591 of the SARS-COV-2 Full length Spike (Sheet 9 of 20, Fig. 6D, “SARS-CoV-2 Full Length Spike, 1-1191”; Sheet 11 of 20, Fig. 6F, “SARS-CoV-2 Spike Receptor Binding Domain, 319-591”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the RBD sequences of Buch with the antibody detection method of Lapointe because Buch taught how to specifically detect anti-Spike-RBD antibodies in human saliva ([0130]). A PHOSITA would have had a reasonable expectation of success in combining the methods of Buch and Lapointe based on the methods being in the field of detecting SARS-CoV-2.
It would have been obvious for a PHOSITA to further specify the detected antibodies by using the RBD sequences of Buch in the antibody detection method of Lapointe to further assess the patient’s immune status to SARS-CoV-2.
Conclusion
No claims are allowed.
Claim 7 is free of prior art because there is no prior art before the effective filing date of the instant application of 06/10/2020 that teaches or suggests a fusion polypeptide comprising the spike protein of the SARS-CoV-2 fused to a gp70 polypeptide.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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