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
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application
No. PCT/US2021/017716, filed September 10, 2021.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 158 – 164, 166 – 170, and 175 – 178, and species (a) SEQ ID NO. 402, 566, 740, 597, 470, 364 (reading on claims 158, 159, 166, 167 and 175) and (b) SEQ ID NO. 245-251 (reading on claim 160), in the reply filed on 11/20/2025 is acknowledged.
Claims withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 with traverse in the reply filed on 11/20/2025.
Applicant's election with traverse of the species election in the reply filed on 11/20/2025 is acknowledged. Grounds for the traversal was not given by the applicant. As there are no grounds for traversal, the traversal was not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 158 – 164, 166 – 170, and 175 – 178 are under consideration.
Claim Objections
Claims 158 – 164, 166 – 170, and 175 – 178 are objected to because of the following informalities:
Claim 158 recites “A composition comprising monomers or multimers of: one or more peptides or proteins comprising, consisting of, or consisting essentially of: one or more SARS-CoV-2 amino acid sequences selected from SEQ ID NO: 1 to 1126, concatemers, subsequences, portions, homologues, variants or derivatives thereof; a fusion protein comprising one or more amino acid sequences selected from SEQ ID NO: 1to 1126.” There is a missing coordinating conjunction after “derivatives thereof;”. The claim should be amended to “derivatives thereof; or”. Appropriate correction is required.
Claim 159 recites “comprises, 22, 3, 4”. Compared to the specification, this appears to be an error. The claim should be amended to recite “comprises, 2, 3, 4”. Appropriate correction is required.
Claim Interpretation
Claim 158 recites “comprising, consisting of, or consisting essentially of”. For purposes of examination, the claim will be broadly interpreted as encompassing “comprising”.
As discussed above, claim 159 recites “comprises, 22, 3, 4”. For purposes of examination, the claim will be interpreted, consistent with the Specification, as reciting “comprises, 2, 3, 4”.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
Claims 158 – 164, 166 – 170, and 175 – 178 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.
As discussed above, claim 158 lacks the conjunction “or”. The lack of conjunction after a semicolon makes the metes and bounds unclear because it is unclear if the composition comprises of one or more SARS-CoV-2 peptides or proteins and a fusion protein or either one or more SARS-CoV-2 peptides or proteins or a fusion protein.
For purposes of examination, claim 158 is interpreted as “A composition comprising monomers or multimers of: one or more peptides or proteins comprising, consisting of, or consisting essentially of: one or more SARS-CoV-2 amino acid sequences selected from SEQ ID NO: 1 to 1126, concatemers, subsequences, portions, homologues, variants or derivatives thereof; or a fusion protein comprising one or more amino acid sequences selected from SEQ ID NO: 1 to 1126.”
Additionally, regarding claim 158, it is unclear what constitutes homologues, variants or derivatives of SARS-CoV-2 amino acid sequences selected from SEQ ID NO: 1 to 1126. For example, it is unclear if tyrosine would seem to be a derivative of SEQ ID NO: 1 (Tyr Arg Ile Asn Trp Ile Thr Gly Gly Ile Ala Ile Ala Met Ala). The Specifications fail to define the terms “homologues”, “variants” or “derivatives” nor are any working examples given that would allow one of ordinary skill of the art to draw a meaningful definition from these terms. Therefore, the inclusion of “homologues”, “variants” and/or “derivatives” makes the metes and bounds of the claim unclear.
The dependent claims state and/or fail to limit the independent claim and therefore are also rejected.
Trademark
Claim 163 contains the trademark/trade name MF59®, Quil A®, and montanide™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe adjuvants and, accordingly, the identification/description is indefinite.
Relative Term
The term “about” in claims 162 and 167 are a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 162 recites “about 9-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-75 or 75-100 amino acids”
Claim 167 recites “about 9-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-75 or 75-100 amino acids”
Claim Rejections - 35 USC § 112 – Written Description
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 158 – 164, 166 – 170, and 175 – 178 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.”
I. Lack of W/D for an innumerable combination of amino acids (All claims)
The claims are broadly drawn to a genus comprising: “A composition comprising monomers or multimers of: one or more peptides or proteins comprising, consisting of, or consisting essentially of: one or more SARS-CoV-2 amino acid sequences selected from SEQ ID NO: 1 to 1126, concatemers, subsequences, portions, homologues, variants or derivatives thereof; a fusion protein comprising one or more amino acid sequences selected from SEQ ID NO: 1 to 1126.” 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 SARS-CoV-2 function.
The broadest reasonable interpretation of the claims encompasses innumerable permeations of concatemers, subsequences, portions, homologues, variants or derivatives of the SARS-CoV-2 peptide/proteins of SEQ ID NOs: 1 to 1126. The Specification fails to disclose which regions of SEQ ID NOs: 1 to 1126 can be mutated deleted, truncated, etc., or which regions of SEQ ID NOs: 1 to 1126 must be retained to constitute concatemers, homologues, variants or derivatives of the claimed sequences defined only be a nebulous “SARS-CoV-2” function.
Likewise, the Specification fails to disclose which regions, key amino acids, etc. must be must be retained to constitute a subsequence or portion of the claimed SARS-CoV-2 peptides/protein. For example, tyrosine would seem to be a subsequence of SEQ ID NO: 1 (Tyr Arg Ile Asn Trp Ile Thr Gly Gly Ile Ala Ile Ala Met Ala), yet it is unclear if this constitutes a functional SARS-CoV-2 amino acid sequence since the Specification fails to describe any
substantive structural limitations as to establish a structure-function relationship with respect to “SARS-CoV-2” function. The claims improperly define the genus based on what it does—not what it is.
While the claims are drawn to a nebulous genus of ill-defined subsequences, portions, homologues, variants, and derivatives, the Specification has only adequately described and successfully reduced to practice specific a few wild type SARS-CoV-2 sequences, such as S, N, and nsp3, can bind to T-cells (Figure 1A, Figure 4B). Furthermore, SEQ ID NO: 1 to 1154 are drawn to wild type sequences and portions thereof.
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 (Brief Bioinformatics, 7:225-242 (2006)) 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 et al. (Nature Struct. Biol, Struct. Genom. Suppl. Nov., 991-994 (2000), hereinafter “Thorton”) 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 enzyme 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 “SARS-CoV-2” function. However, as discussed above, the Specification fails to describe any
substantive structural limitations as to establish a structure-function relationship with respect to “SARS-CoV-2” function. Applicant merely offers a cursory statement that any “concatemers, subsequences, portions, homologues, variants or derivatives” of SEQ ID NOs: 1 to 1126 will work.
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 before the effective filing date of the claimed invention.
II. Lack of W/D for elicit, stimulate, induce, promote, increase or enhance an immune response (claims 160, 162-163)
The claims are broadly drawn to genus comprising a composition of monomers or multimers related to SARS-CoV-2 or a variant, homologue, derivative or subsequence thereof that can elicit, stimulate, induce, promote, increase or enhance an immune response. The claims define the amino acid sequences based on function and not structure. Additionally, the Specification and the claims have 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 eliciting, stimulating, inducing, promoting, increasing or enhancing an immune response.
The Specification fails to disclose which regions of SEQ ID NOs: 1 to 1126 can be mutated deleted, truncated, etc., or which regions of SEQ ID NOs: 1 to 1126 must be retained to constitute homologues, variants or derivatives of the claimed sequences defined only be a nebulous function of eliciting, stimulating, inducing, promoting, increasing or enhancing an immune response. Furthermore, the claims improperly define the genus based on what it does—not what it is.
While the claims are drawn to a nebulous genus of compositions of monomers or multimers related to SARS-CoV-2 that can elicit, stimulate, induce, promote, increase or enhance an immune response, the Specification has only adequately described and successfully reduced to practice SARS-CoV-2-specific T cell, such as CD4+ and CD8+, reactivity to wild type SARS-CoV-2 proteins. This was done through large scale screens and bioinformatic pipelines to determine the activity of T-cells. The Specification recites a vague range of amino acids that that can elicit, stimulate, induce, promote, increase or enhance an immune response without defining which sequences would satisfy the claim. This is not sufficient to describe members of the claimed genus because such the amount of sequence combinations is innumerable.
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 eliciting, stimulating, inducing, promoting, increasing or enhancing an immune response. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to eliciting, stimulating, inducing, promoting, increasing or enhancing an immune response as a function. Applicant merely offers a cursory statement that any sequence related to SARS-CoV-2 will work.
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 before the effective filing date of the claimed invention.
III. Lack of W/D for the various modulators (Claim 164)
The claims are broadly drawn to the composition of claim 158 and agonist or antagonist of modulator of an immune response, an innate immune response or IL-6, IL-10, IFN-g, or TGF-B. Similar to the combinations of amino acid sequences, the recitation of “agonist or antagonist” of a modulator of an immune response or an innate immune response results in an innumerable quantity of compositions. “Modulator of an immune response” alone results in an unmeasurable amount of components that can satisfy the claim. Furthermore, 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 modulating an immune response function.
The broadest reasonable interpretation of the claims encompasses innumerable number of modulators of an immune response. Although the claims recite specific immune modulators such as Interleukin-6 (IL-6), Interferon-gamma (IFN-y), Transforming growth factor beta (TGF-β), and Interleukin-10 (IL-10), the inclusion of “a modulator of an immune response, an innate immune response”, and “an agonist or antagonist thereof” broaden the claim to an innumerable amount of immune modulators. Additionally, the recitation of “agonist or antagonist” renders the listed modulators as vague suggestions rather than concrete claims. Likewise, the Specification has not adequately described and/or successfully reduced to practice any use case of modulators of immune response. Furthermore, the claims improperly define the genus based on what it does—not what it is.
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 eliciting, stimulating, inducing, promoting, increasing or enhancing an immune response. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to modulating an immune response as a function. Applicant merely offers a cursory statement that any modulator of an immune response will work.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 158 – 162, 164, 166 – 167, 169 – 170 and 175 – 178 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the reasons set forth below. See MPEP § 2106 for analysis parameters.
The instant claims are drawn to a composition of peptides or cells, which is a statutory category of invention (Step 1: YES).
The instant claims are directed to the natural phenomenon of a peptides of a virus, a viral vector with viral genes, cells comprised of the viral vector, and cells that can detect peptides. The broadest reasonable interpretation of the sequences of the claims would encompass the naturally occurring genome of SARS-CoV-2. Therefore, in regards to claim 176 to 178, the broadest reasonable interpretation also includes SARS-CoV-2 as a vector and a host cell as any cell infected with SARS-CoV-2. In regards to claim 166, a naturally occurring T-cell that detects the presence of SARS-CoV-2 would also be included as a reasonable interpretation of the claim. As evidenced by Wu et al (Nature, Feb 2020, hereinafter, “Wu”), SARS-CoV-2 is a naturally occurring virus that can infect cells and there for a viral vector that can be found in host cells (Abstract). As evidence by Wu, the sequences of the instant claim are naturally incurring in cells infected by SARS-CoV-2 (Section: Data availability). As evidenced by Thevarajan et al (medrxiv, February 2020), T cells can naturally detect epitopes of Sars-Cov-2 (Abstract, Figure 2). Similarly, in regards to claim 164, IL-6 is a modulator of an immune response and is found naturally occurring in nature as evidenced by Tanaka et al (Cold Spring Harb Perspect Biol. 2014; ¶1) As such recite judicial exceptions (JE) in the form of a natural phenomenon (STEP 2A, Prong One: YES).
The claims are limited to the JE, and not a method of, e.g., using the JE for a particular treatment or prophylaxis. As such, the claims do not recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Since the claims are limited to solely the JE, the claims do not recite any additional that amount to significantly more than the JE itself. (STEP2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C 101.
Claim Rejections - 35 USC § 102
(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.
Claim(s) 158 – 162 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheung et al (Vaccine, 2007, hereinafter, “Cheung”).
Cheung discloses the induction of T-cell response by a DNA vaccine encoding an HLA-A0201 severe acute respiratory syndrome coronavirus epitope (Title). The vaccine targets the SARS-CoV nucleocapsid protein due to its effectiveness in triggering an immune response (Abstract). Through bioinformatics, Cheung discloses the discovery of several peptides including the HLAA0201 restricted peptide, GMSRIGMEV which is identical to SEQ ID NO:740 (Section: 2.1. Bioinformatic analysis of the SARS N-protein HLA-A*0201 restricted peptide, Table 1, alignment reproduced below). Cheung discloses that GMSRIGMEV is T cell epitope for SARS-CoV-1.
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Regarding claim 158, as discussed above, Cheung discloses the T cell epitope GMSRIGMEV which is identical to SEQ ID NO:740.
Regarding claims 159 and 161, Cheung discloses GMSRIGMEV is 9 amino acids long.
Cheung does not disclose GMSRIGMEV is an epitope for SARS-CoV-2. This, however, would be an inherent property of the epitope taught by Cheung. The epitope taught by Cheung is identical to the claimed epitope and, therefore, absent evidence to the contrary, would be also function as an epitope for SARS-CoV-2. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See also MPEP 2112.01(II).
Regarding claim 160 and 162, Cheung discloses GMSRIGMEV is a T cell epitope for SARS-CoV-1.
Accordingly, Cheung anticipates the claimed invention.
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.
Claims 163 – 164 and 166 – 170 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung as applied to claims 158 - 162 above, and further in view of Zhao et al (Vaccine, 2010, hereinafter, “Zhao”), as evidenced by Mena et al (Immunology, 2003, hereinafter, “Mena”).
As discussed above, claims 158 – 162 were anticipated by Cheung.
The reference does not disclose a composition of GMSRIGMEV with an adjuvant or modulator of an immune response, nor do they teach of a kit comprising of T-cells and reagents.
However, Zhao teaches the mechanism and properties of CD8 T cell response in human HLA-A0201 transgenic mice when challenged with HLA-A0201 epitopes from SARS-CoV-1 (Abstract, Section 2.4 Immunization). The mice are given SARS-CoV-S DNA with HLA-A0201 restricted peptides (Abstract). The immune response is assessed with ELISA, ELISPOT, and FACS to understand the effects of SARS-CoV-1 on CD8 T cells (Abstract).
Regarding, claims 163 and 164, Zhao teaches the coadministration of HLA-A0201 epitopes with CpG ODN (Section 2.4 Immunization). As evidenced by Mena, CpG ODN is a modulator of the immune system, stimulating innate immune responses (Abstract).
Cheung and Zhao are considered to be analogous to the claim invention because they describe properties of coronaviridae. Cheung teaches that the HLA-A0201 epitope GMSRIGMEV is T cell epitope for SARS-CoV-1 (Table 1). Zhao teaches the use of GpG ODN in combination with HLA-A0201 epitopes (Section 2.4 Immunization).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to formulate GMSRIGMEV, as taught by Cheung, with CpG ODN, as taught by Zhao, because doing so would increase the immune response when challenged by SARS-CoV-2. One of ordinary skill in the art would have had a reasonable expectation of success increasing the effectiveness of GMSRIGMEV by formulating with CpG ODN given that the formulation of CpG ODN with other HLA-A0201 epitopes is well known, has been successfully demonstrated, and commonly used in the prior art.
Regarding claims 166 and 167, both Cheung and Zhao teach that T-cells can detect SARS-CoV epitopes. As discussed above, SEQ ID NO: 740, GMSRIGMEV, is identical in both SARS-CoV-1 and SARS-CoV-2. Cheung teaches that the HLA-A0201 epitope GMSRIGMEV is T cell epitope for SARS-CoV-1 (Table 1). Zhao teaches the mechanism and properties of CD8 T cell response in human HLA-A0201 transgenic mice when challenged with HLA-A0201 epitopes from SARS-CoV-1 (Abstract, Section 2.4 Immunization). Therefore, both Cheung and Zhao, because the amino acid sequence GMSRIGMEV is found in SARS-CoV-1 and SAR-CoV-2 and T cells can detect this epitope, it would have been prima facie obvious before the effective filing date of the claimed invention to use the T cell of Cheung and Zhao to detect the amino acid sequence GMSRIGMEV for SARS-CoV-2.
Regarding claim 168 including instructions for a diagnostic method is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.").
Regarding claims 169 and 170, Zhao teaches the combination of PBS as a reagent delivered with the epitopes (Section: 2.4 Immunization).
Cheung and Zhao are considered to be analogous to the claim invention because they describe properties of coronaviridae. Cheung teaches that the HLA-A0201 epitope GMSRIGMEV is a T cell epitope for SARS-CoV-1 (Table 1). Zhao teaches the use of GpG ODN in combination with HLA-A0201 epitopes (Section 2.4 Immunization).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to create a kit for the detection of SARS-CoV-2 or an immune response to SARS-CoV-2 using a T-cell that specifically detects GMSRIGMEV, as taught by Cheung, with a reagent like PBS, as taught by Zhao, because it is known that T cells bind to GMSRIGMEV and therefore if there is binding or a change in T-cell in detected one could be reasonably certain that SARS-CoV-2 has been detected. One of ordinary skill in the art would have had a reasonable expectation of success in using a T cell to probe for SARS-CoV-2 given that GMSRIGMEV as a SARS-CoV-2 epitope is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claims 175 – 178 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung as applied to claims 158 - 162 above, and further in view of Meulen et al (WO2004111081A2, hereinafter, “Meulen”).
As discussed above, claims 158 – 162 was disclosed by Cheung.
The reference failed to disclose the amino acid sequence GMSRIGMEV in a viral vector or a host cell.
However, Meulen teaches antigenic peptides of SARS-CoV spike protein and the use of these peptides in diagnostic test methods (Abstract). Meulen also teaches antibodies that are capable of recognizing the antigenic peptides for the purpose of diagnosis and treatment of SARS-CoV infection (Abstract).
Regarding claim 175, Cheung teaches the sequence of the T cell epitope GMSRIGMEV (Table 1).
Regarding claims 176 and 177, Meulen teaches antigenic epitopes can be expressed in viral vectors (Claim 11; Specification: “Preferred gene therapy vehicles of the present invention will generally be viral vectors, such as comprised within a recombinant retrovirus, herpes simplex virus (HSV), adenovirus, adeno-associated virus (AAV), cytomegalovirus (CMV), and the like”)
Regarding claim 178, Meulen teaches that a host cell can comprise at least one vector (Claim 12 and 13).
Cheung and Meulen are considered to be analogous to the claim invention because they describe properties of coronaviridae. Cheung teaches that the HLA-A0201 epitope GMSRIGMEV is T cell epitope for SARS-CoV-1 (Table 1). Meulen teaches that host cells can be comprised of viral vector encoding antigenic peptides (Claims 11 – 13).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to create a composition comprising a host cell comprised of a viral vector, as taught by Meulen, encoding GMSRIGMEV, as taught by Cheung, because doing so would enable the production of recombinant antigenic peptides, thereby increasing the amount of peptides without the need of harvesting and processing virus. One of ordinary skill in the art would have had a reasonable expectation of success in using a host cell comprising of a viral vector encoding GMSRIGMEV given that GMSRIGMEV as a SARS-CoV-2 epitope and production of recombinant peptide using host cells is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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, 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.
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.
/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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