DETAILED ACTION
Election/Restrictions
Applicant’s response to the requirement for election of species, filed August 6, 2025, is acknowledged. The elected species are a polypeptide and SEQ ID NO: 67.
Claims Summary
Claims 59, 61 and 63 are directed to a polypeptide comprising SEQ ID NO: 67, and/or fragment and variants thereof having at least 80% homology thereto, wherein the fragments or variants retain MHC binding propensity and the same TCR specificity, and/or retains African Swine Fever Virus (ASFV) activity (claim 67). The published application, US 20230192777 A1, notes that retaining MHC binding propensity refers to retaining the ability to bind to a same HLA molecule (see paragraph [0010]). (Please note that “homology” appears to have the same as “identity”, according to paragraph [0093]. Thus, “at least 80% homology” is the same as “at least 80% identity”. See claim objections below requesting clarification on this issue.) SEQ ID NO: 67 is 399 amino acids in length. The polypeptide further comprises a pharmaceutically acceptable excipient, carrier or adjuvant (claim 73). Also claimed is a method for inducing an immune response against ASFV and/or a related disease caused by ASFV infection in a subject in need thereof, by administering a therapeutically effective amount of the polypeptide (claim 74), wherein the polypeptide further comprises a pharmaceutically acceptable excipient, carrier or adjuvant (claim 75). The method further comprises administering an ASFV that is live attenuated or inactivated (claim 76). Claims 77 and 78 are directed to a chimeric or fusion polypeptide as described above that is joined, linked or inserted into a heterologous polypeptide.
Claim Objections
Claims 59, 63, 67 and 73-77 are objected to for minor informalities.
Claims 59, 63 and 77 recite, “having at least 80% homology to” SEQ ID NO: 67. The published application provides a definition of homology that appears to be the same as “sequence identity” in paragraph [0093], reproduced below with emphasis added in underscore.
[0093] As used herein, two polypeptides (or a region of the polypeptides) are substantially homologous or identical when the amino acid sequences are at least about 45-55%, typically at least about 70-75%, more typically at least about 80-85%, more typically greater than about 90%, and more typically greater than 95% or more homologous or identical. To determine the percent homology or identity of two amino acid sequences, or of two nucleic acid sequences, the sequences are aligned for optimal comparison purposes (e.g., gaps can be introduced in the sequence of one polypeptide or nucleic acid molecule for optimal alignment with the other polypeptide or nucleic acid molecule). The amino acid residues or nucleotides at corresponding amino acid positions or nucleotide positions are then compared. When a position in one sequence is occupied by the same amino acid residue or nucleotide as the corresponding position in the other sequence, then the molecules are homologous at that position. As is known in the art, the percent identity between the two sequences is a function of the number of identical positions shared by the sequences, taking into account the number of gaps, and the length of each gap, which need to be introduced for optimal alignment of the two sequences. Sequence homology for polypeptides is typically measured using sequence analysis software.
Clarification is required as to the difference, if any, between sequence homology and sequence identity.
Claims 73 and 75 refer to a polypeptide comprising a pharmaceutically acceptable excipient, carrier or adjuvant. Clarification is requested. If Applicant intends that the excipient, carrier and adjuvant be a separate entity from the polypeptide and present in the same composition as the polypeptide, then a composition claim/context would be more appropriate.
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.
Claims 59, 61, 63, 67 and 73-78 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.
According to the published application, US 20230192777 A1, a “variant” is defined as following (relevant portions underscored):
[0071] A “variant” polypeptide (including a variant T-cell epitope) can differ in amino acid sequence by one or more substitutions, deletions, insertions, inversions, fusions, and truncations or a combination of any of these. In aspects, a variant T-cell epitope can differ in amino acid sequence by one or more substitutions, deletions, insertions, inversions, fusions, and truncations or a combination of any of these provided said variants retain MHC binding propensity and/or TCR specificity.
It is not clear what portion of the original polypeptide is retained in the variant. Thus, the metes and bounds of the polypeptides cannot be determined.
Similarly, it is not clear what “retains ASFV activity” encompasses. The activities that are encompassed by this term are not provided in the claims. The specification does not provide a definition of these activities such that they can be measured or observed. The metes and bounds of the claims cannot be determined.
Claim 74 is directed to, in part, a method of inducing an immune response against a related disease caused by ASFV infection. It is not clear how the claimed polypeptide would induce an immune response against a related diseased caused by ASFV infection. An immune response is induced against a pathogen, not a disease. Correction is required.
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 59, 61, 63, 67 and 73-78 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.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The claims are directed to a large genus of polypeptide fragments and variants having at least 80% homology (understood to be the same as at least 80% sequence identity) to SEQ ID NO: 67, wherein MHC binding propensity is retained, TCR specificity is the same, and ASFV activity is retained. The structure provided in the claims is a base sequence, SEQ ID NO: 67, which is 399 amino acids in length. The structure is a fragment or a variant of the 399-mer. A fragment is a portion of the sequence. A fragment that retains at least 80% homology must have at least 320 contiguous amino acids from the 399-mer. A variant encompasses one or more amino acid substitutions, deletions, insertions, inversions, fusions, and truncations or a combination thereof. A variant that retains at least 80% sequence homology retains at least 320 amino acids from anywhere along the 399-mer, allowing for 79 amino acid changes. The function of the fragments and variants is MHC binding propensity is retained, TCR specificity is the same, and ASFV activity is retained.
The missing factor needed to provide sufficient distinguishing identifying characteristics of the genus is a nexus between the structure and function. There is no identification of any particular portion of the structure that must be conserved from SEQ ID NO: 67 such that the functions are retained. The specification does not provide fragments or variants of SEQ ID NO: 67 that have the claimed functions. SEQ ID NO: 67 is comprised of a series of epitopes. If the structure of the epitope is changed, the functions may not be present. Without the nexus between the structure and function, the process of obtaining fragments and variants having the necessary function is the process of discovery. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Conclusion
No claim is allowed. SEQ ID NO: 67 is free of the prior art of record.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1671