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 .
Restriction
Applicant's election with traverse of the restriction requirement in the reply filed on February 3, 2026 is acknowledged. The traversal is on the ground(s) that they have amended claims 1, 9, 13, 37, 48, 51 and 76 to recite a peptide epitope selected from the group consisting of CTDDNALAYY (SEQ ID NO:77) and KCYGVSPTK (SEQ ID NO.53). Applicant urges that the recited peptide epitopes share a common technical feature at least in that they are derived from SAR-CoV-2, are not disclosed in Matsui et al and were selected based on their shared ability to bind selected HLA-A*03 or HLA-A*01 types and elicit CD8+T cell responses. See Specification at Table 3 and Example 2. Applicant urges that this demonstrates a functional and technical relationship that unites the peptides under a single general inventive concept, in compliance with PCT Rule 13.1. Applicant further argues that Groups 1-IX should be rejoined.
Applicant’s arguments are not found persuasive because although the newly recited peptides in claim 1 may be derived from SAR-CoV-2 they do not share a common structure. In fact, they differ structurally. They share no common core structure. Groups I-IX lack unity of invention because even though the inventions of these groups require the technical feature of an immunogenic peptide, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Gambotto et al (Pub. NO: US 2023/0241202 A1 published August 3, 2023, effective filing date May 20, 2020). Gambotto et al teach that epitopes SEQ ID NO:26 (CTDDNALAYY) is claimed SEQ ID NO:77 and SEQ ID NO:31 (KCYGVSPTK) is claimed SEQ ID NO: 53 recited in amended claim 1.
The Restriction Requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Applicant’s amendment and response filed February 3, 2026 is acknowledged. Claims 1, 9, 13, 37, 48, 51, 67 and 76 have been amended. Claims 2-5, 7-8, 10-12, 14-18, 26-28, 32-36, 38-47, 49-50, 52-66, 68-75 and 77-81 have been canceled. Claims 20-23,25, 29-31,37, 48, 51, 67 and 76 are withdrawn for considered because they are directed to a nonelected invention. Claims 1, 6, 9, 13, 19 and 24 are under examination.
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.
Claim 1 recites an immunogenic peptide comprising or consisting of a peptide epitope selected from the group consisting of CTDDNALAYY (SEQ ID NO:77) and KCYGVSPTK (SEQ ID NO.53), optionally wherein the immunogenic peptide 1)is derived from a SARS-CoV-2 protein, optionally wherein the SAR-CoV-2 proteins is selected 8, 9, 10, 11, 12, 13, 15 or 15 amino acids in length, optionally wherein the SARS-CoV-2 protein is selected from the group consisting of 1a/b and S protein and/or 2) is capable of eliciting a T cell response in a subject. The claim is indefinite because it recites that the immunogenic peptides comprising or consisting of 8, 11, 12, 13, 14 or 15 amino acids in length. How is this possible when SEQ ID NO:77 comprises 10 amino acids and SEQ ID NO: 53 comprises 9 amino acids?
Claim 1 recites “derived from”. It is unclear as to what that phrase means.
Claims 1 and 6 recites “capable of”. It is unclear as to what that phrase means.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 102
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.
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)(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.
7. Claim 1 is drawn to an immunogenic peptide comprising or consisting of a peptide epitope selected from the group consisting of CTDDNALAYY (SEQ ID NO:77) and KCYGVSPTK (SEQ ID NO.53), optionally wherein the immunogenic peptide 1)is derived from a SARS-CoV-2 protein, optionally wherein the SAR-CoV-2 proteins is selected 8, 9, 10, 11, 12, 13, 15 or 15 amino acids in length, optionally wherein the SARS-CoV-2 protein is selected from the group consisting of 1a/b and S protein and/or 2) is capable of eliciting a T cell response in a subject.
Claim 6 is drawn to an immunogenic composition comprising at least one immunogenic peptide of claim 1, optionally wherein the immunogenic composition 1) further comprises an adjuvant; and/or 2) is capable of eliciting a T cell response in a subject.
Claim 9 is drawn to a composition comprising a peptide epitope selected from the group consisting of CTDDNALAYY (SEQ ID NO: 77) and KCYGVSPTK (SEQ ID NO: 53), and an MHC molecule, optionally wherein the MHC molecule
1) is an MHC multimer, optionally wherein the MHC multimer is a tetramer;
2) is an MHC class I molecule; and/or 3) comprises an MHC alpha chain that is an HLA serotype selected from the group consisting of HLA-A*02, HLA-A*03, HLA-A*01, HLA-A*11, HLA-A*24, and/or HLA-B*07, optionally wherein the HLA allele is selected from the group consisting of HLA-A*0201, HLA- A*0202, HLA-A*0203, HLA-A*0204, HLA-A*0205, HLA-A*0206, HLA-A*0207, HLA-A*0210, HLA-A*0211, HLA-A*0212, HLA-A*0213, HLA-A*0214, HLA-A*0216, HLA-A*0217, HLA- A*0219, HLA-A*0220, HLA-A*0222, HLA-A*0224, HLA-A*0230, HLA-A*0242, HLA-A*0253, HLA-A*0260, HLA-A*0274 allele, HLA-A*0301, HLA-A*0302, HLA-A*0305, HLA-A*0307, HLA-A*0101, HLA-A*0 102, HLA-A*0103, HLA-A*0116 allele, HLA-A* 1101, HLA-A* 1102, HLA-A* 1103, HLA-A* 1104, HLA-A* 1105, HLA-A* 1119 allele, HLA-A*2402, HLA-A*2403, HLA-A*2405, HLA-A*2407, HLA-A*2408, HLA-A*2410, HLA-A*2414, HLA-A*2417, HLA- A*2420, HLA-A*2422, HLA-A*2425, HLA-A*2426, HLA-A*2458 allele, HLA-B*0702, HLA- B*0704, HLA-B*0705, HLA-B*0709, HLA-B*0710, HLA-B*0715, and HLA-B*0721 allele.
Claim 13 is drawn to stable MHC-peptide complex, comprising a peptide epitope selected from the group consisting of CTDDNALAYY (SEQ ID NO: 77) and KCYGVSPTK (SEQ ID NO:53 in the context of an MHC molecule, optionally wherein 1) the MHC molecule a) is an MHC multimer, optionally wherein the MHC multimer is a tetramer; b) is an MHC class I molecule; and/or c) comprises an MHC alpha chain that is an HLA serotype selected from the group consisting of HLA-A*02, HLA-A*03, HLA-A*01, HLA-A* 11, HLA-A*24, and/or HLA- B*07, optionally wherein the HLA allele is selected from the group consisting of HLA- A*0201, HLA-A*0202, HLA-A*0203, HLA-A*0204, HLA-A*0205, HLA-A*0206, HLA- A*0207, HLA-A*0210, HLA-A*0211, HLA-A*0212, HLA-A*0213, HLA-A*0214, HLA- A*0216, HLA-A*0217, HLA-A*0219, HLA-A*0220, HLA-A*0222, HLA-A*0224, HLA- A*0230, HLA-A*0242, HLA-A*0253, HLA-A*0260, HLA-A*0274 allele, HLA-A*0301, HLA-A*0302, HLA-A*0305, HLA-A*0307, HLA-A*0101, HLA-A*0102, HLA-A*0103,HLA-A*0 116 allele, HLA-A* 1101, HLA-A* 1102, HLA-A* 1103, HLA-A* 1104, HLA- A*1105, HLA-A* 1119 allele, HLA-A*2402, HLA-A*2403, HLA-A*2405, HLA-A*2407, HLA-A*2408, HLA-A*2410, HLA-A*2414, HLA-A*2417, HLA-A*2420, HLA-A*2422, HLA-A*2425, HLA-A*2426, HLA-A*2458 allele, HLA-B*0702, HLA-B*0704, HLA- B*0705, HLA-B*0709, HLA-B*0710, HLA-B*0715, and HLA-B*0721 allele; 2) the peptide epitope and the MHC molecule are covalently linked and/or wherein the alpha and beta chains of the MHC molecule are covalently linked; and/or 3) the stable MHC-peptide complex comprises a detectable label, optionally wherein the detectable label is a fluorophore.
Claim 19 is an immunogenic composition comprising the stable MHC-peptide complex of claim 13, and an adjuvant.
Claim 24 is a device or kit comprising one or more immunogenic peptides of claim 1, said device or kit optionally comprising a reagent to detect binding of the one or more immunogenic peptides to a T cell receptor; optionally wherein the immunogenic peptide is expressed by cells and the cells are expanded and/or isolated during one or more steps
8. Claims 1, 6, 9, 13, 19 and 24 are anticipated by Gambotto et al (Pub. No: US 2023/0241202 A1 published August 3, 2023, effective filing date May 20, 2020).
Gambotto et al teach SAR-CoV-2, S1 protein amino acid sequence and one or both of an epitopes of a coronavirus, such as SARS-CoV-2, polypeptide (paragraph [0011 and [0071]). Gambotto et al teach that epitopes SEQ ID NO:26 (CTDDNALAYY) is claimed SEQ ID NO:77 and SEQ ID NO:31 (KCYGVSPTK) is claimed SEQ ID NO: 53. Gambotto et al teach a delivery device for delivering a patient a composition comprising the epitopes of cornonavirus (paragraph [0024]). Gambotto et al teach compositions that include one or more adjuvants or molecules with immune stimulant or adjuvant effect [0182]). Claim limitations “wherein the immunogenic peptide 1) is derived from a SARS-CoV-2 protein, optionally wherein the SAR-CoV-2 proteins is selected 8, 9, 10, 11, 12, 13, 15 or 15 amino acids in length” and “wherein the SARS-CoV-2 protein is selected from the group consisting of 1a/b and S protein and/or 2) is capable of eliciting a T cell response in a subject”, ‘wherein the MHC molecule 1) is an MHC multimer, optionally wherein the MHC multimer is a tetramer; 2) is an MHC class I molecule; and/or 3) comprises an MHC alpha chain that is an HLA serotype selected from the group consisting of HLA-A*02, HLA-A*03, HLA-A*01, HLA-A*11, HLA-A*24, and/or HLA-B*07, optionally wherein the HLA allele is selected from the group consisting of HLA-A*0201, HLA- A*0202, HLA-A*0203, HLA-A*0204, HLA-A*0205, HLA-A*0206, HLA-A*0207, HLA-A*0210, HLA-A*0211, HLA-A*0212, HLA-A*0213, HLA-A*0214, HLA-A*0216, HLA-A*0217, HLA- A*0219, HLA-A*0220, HLA-A*0222, HLA-A*0224, HLA-A*0230, HLA-A*0242, HLA-A*0253, HLA-A*0260, HLA-A*0274 allele, HLA-A*0301, HLA-A*0302, HLA-A*0305, HLA-A*0307, HLA-A*0101, HLA-A*0 102, HLA-A*0103, HLA-A*0116 allele, HLA-A* 1101, HLA-A* 1102, HLA-A* 1103, HLA-A* 1104, HLA-A* 1105, HLA-A* 1119 allele, HLA-A*2402, HLA-A*2403, HLA-A*2405, HLA-A*2407, HLA-A*2408, HLA-A*2410, HLA-A*2414, HLA-A*2417, HLA- A*2420, HLA-A*2422, HLA-A*2425, HLA-A*2426, HLA-A*2458 allele, HLA-B*0702, HLA- B*0704, HLA-B*0705, HLA-B*0709, HLA-B*0710, HLA-B*0715, and HLA-B*0721 allele”, wherein the MHC multimer is a tetramer; b) is an MHC class I molecule; and/or c) comprises an MHC alpha chain that is an HLA serotype selected from the group consisting of HLA-A*02, HLA-A*03, HLA-A*01, HLA-A* 11, HLA-A*24, and/or HLA- B*07, optionally wherein the HLA allele is selected from the group consisting of HLA- A*0201, HLA-A*0202, HLA-A*0203, HLA-A*0204, HLA-A*0205, HLA-A*0206, HLA- A*0207, HLA-A*0210, HLA-A*0211, HLA-A*0212, HLA-A*0213, HLA-A*0214, HLA- A*0216, HLA-A*0217, HLA-A*0219, HLA-A*0220, HLA-A*0222, HLA-A*0224, HLA- A*0230, HLA-A*0242, HLA-A*0253, HLA-A*0260, HLA-A*0274 allele, HLA-A*0301, HLA-A*0302, HLA-A*0305, HLA-A*0307, HLA-A*0101, HLA-A*0102, HLA-A*0103,HLA-A*0 116 allele, HLA-A* 1101, HLA-A* 1102, HLA-A* 1103, HLA-A* 1104, HLA- A*1105, HLA-A* 1119 allele, HLA-A*2402, HLA-A*2403, HLA-A*2405, HLA-A*2407, HLA-A*2408, HLA-A*2410, HLA-A*2414, HLA-A*2417, HLA-A*2420, HLA-A*2422, HLA-A*2425, HLA-A*2426, HLA-A*2458 allele, HLA-B*0702, HLA-B*0704, HLA- B*0705, HLA-B*0709, HLA-B*0710, HLA-B*0715, and HLA-B*0721 allele; 2) the peptide epitope and the MHC molecule are covalently linked and/or wherein the alpha and beta chains of the MHC molecule are covalently linked; and/or 3) the stable MHC-peptide complex comprises a detectable label, optionally wherein the detectable label is a fluorophore” and “comprising a reagent to detect binding of the one or more immunogenic peptides to a T cell receptor; and “wherein the immunogenic peptide is expressed by cells and the cells are expanded and/or isolated during one or more steps are optional. Gambotto et al teach anticipate claimed invention.
9. No claims allowed.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vanessa L Ford whose telephone number is (571)272-0857. The examiner can normally be reached Monday to Friday 9:00 -5:30 EST.
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/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674