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 .
DETAILED ACTION
Priority
This is a National Stage of PCT Application PCT/US2022/081914 filed on December 19, 2022, which derives priority from U.S. Provisional Application Ser. No. 63/291,577 filed December 20, 2021, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 06/19/2024 is acknowledged. Claims 1, 14, 16, 19, 21, 23, 25, 27, 29, 31, 33, 36, 40-43 and 45-51 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 06/19/2024 are acknowledged and accepted by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation 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.
Claims 1, 14, 16, 19, 21, 23, 25, 27, 29, 31, 33, 36, 40-43 and 45-51 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.11.A.2.(a).i) states, "Whether the specification shows that applicant was in
possession of the claimed invention is not a single, simple determination, but rather is a factual
determination reached by considering a number of factors. Factors to be considered in
determining whether there is sufficient evidence of possession include the level of skill and
knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention".
For claims drawn to a genus, MPEP § 2163 states 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
applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at
1406. A "representative number of species" means that the species which are adequately described arerepresentative of the entire genus. Thus, when there is substantial variation within the genus, onemust describe a sufficient variety of species to reflect the variation within the genus. Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
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 protein comprising, from N- to C- terminus:
a. a sequence that is at least 90% identical, or at least 91% identical, or at least 92% identical, or at least 93% identical, or at least 94% identical, or at least 95% identical, or at least 96% identical, or at least 97% identical, or at least 98% identical, or at least 99% identical, or 100% identical to SEQ ID NO: 34 or SEQ ID NO: 35, and
b. an amino acid sequence that is at least 95%, 96%, 97%, 98%, 99%, or 100% identical to any one of SEQ ID NOs: 25-33, wherein, compared to SEQ ID NO: 1, said protein comprises an internal deletion that is at least four consecutive amino acids long.
The grounds for the rejection is the following: The sequences consisting of a sequence that is at least about 90% to 99% identity thereto; and comprise an internal deletion that is at least four consecutive amino acids long can have any type of mutation (e.g., deletion, insertion, substitution), anywhere along the peptide sequence. Therefore, the written description is not commensurate in scope with the claims drawn to any parts or percentages of the peptide sequence, whereby the sequences have at least 90% identity to SEQ ID NOs: 34 and 35 and at least 95% identity to SEQ ID NOs: 25-33. The same applies to dependent claims 14, 16, 19, 21, 23, 25, 27, 29, 31, 36 and 48.
There is some general teaching in the art that some amino acid variations are tolerated without losing a protein’s tertiary structure, but conservation of structure is not necessarily a surrogate for conservation of function. While one of skill in the art could, with the aid of a computer as suggested, could identify all the peptide sequences that have at least 90% identity to SEQ ID NOs: 34 and 35 and at least 95% identity to SEQ ID NOs: 25-33 (including the dependent claims), this would not tell one the structure of the sequence having the recited functional activity of expression as an antigen. In terms of function of the genus of polypeptides, they must retain the ability to retain their immunogenicity. Applicant has not provided a structure-function nexus. The instant claims encompass a genus of peptides having alterations of any portion of SEQ ID NOs: 4, 5, 7, 11, 12, 25-35, 46 and 48. For example, SEQ ID NO: 35, it’s 499 amino acids (AA) long, so a peptide with even 95% identity can vary up to 25 AA along the sequence, so, for substitutions alone, i.e., each position could be any one of the 20 canonical amino acids, would encompass 2025 = 3.35 x 1032 peptide species, which also need to be immunogenic. This reasoning would also apply to the fragments, which encompass any two, any three, and any four, etc. (e.g., 1-3, 13-20, 46-48, etc.) stretches along any part of the sequence, which need to retain function, so it appears to permutate into an equally large genus. Accordingly, it does not appear applicants were in possession of the claimed sequences having at least 90% identity to SEQ ID NOs: 34 or 35 and at least 95% identity to SEQ ID NOs: 25-33 at the time of filing. Moreover, it is understood that the protein can comprise intermediate regions present along the two identified sequences. Thus, the additional recitation “said protein comprises an internal deletion that is at least four consecutive amino acids long”, increases the exponential variations of said proteins in that it results in a written description that is not commensurate in scope with the claims. Given that there is no identification of any particular portion of the structure that must be conserved, and in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. While it is possible to make antigenic polypeptides, the specification must provide an adequate description of the genus. The provision of a partial structure and a function without a nexus between the two does not put one in possession of the large genus of variants encompassed by the claims. Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Thus, the Applicant has not shown, otherwise, which mutations would retain the functional limitation. The Applicant has not provided adequate written description to support the claimed genus of the construct limited by the function of being immunogenic (i.e. a vaccine comprising the composition for preventing piscine myocarditis virus (PMCV) infection in a salmonid). In view of the lack of disclosure of how to make the composition comprising said peptide and fragments thereof, the claims are rejected as lacking adequate descriptive support for the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
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.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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