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 application is a Section 371 of International Application No. PCT/GB2021/053351, filed December 17, 2021, which claims priority under 35 U.S.C. § 119(b) to European Application GB2020135.6, filed December 18, 2020 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 01/08/2024 is acknowledged. Claims 1, 7-10, 13, 19-20, 23, 25-27, 29-31, 41-42, 45-46 and 50 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Claim Objections
Claim 8 and 11-12 are objected to for the following informalities:
Claim 8 should contain a period at the end of the sentence.
After claim 10, the claims recite “10. – 12. (Canceled). The claims should recite “11. – 12. (Canceled)”.
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, 7-10, 29, 31, 41-42 and 45-46 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.
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 an immunogenic composition comprising a human herpesvirus immunogenic peptide consisting of SEQ ID NO: 7, SEQ ID NO: 9 or SEQ ID NO: 11, or a sequence having at least 75% identity thereto, or an immunogenic fragment thereof, wherein the immunogenic fragment is about 47 or fewer amino acids in length;
The grounds for the rejection is the following: The sequences consisting of a sequence that is at least about 75% identity thereto can have any type of mutation (e.g., deletion, insertion, substitution), anywhere along the nucleotide sequence. Therefore, the written description is not commensurate in scope with the claims drawn to any parts or percentages of the nucleotide sequence, wherein the sequences have at least 75% identity to SEQ ID NOs: 7, 9 or 11.
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 peptides that have at least 75% identity to SEQ ID NOs: 7, 9 or 11, 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: 7, 9 or 11. For example, SEQ ID NO: 7, it’s 48 amino acids (AA) long, so a peptide with 75% identity can vary up to 12 AA along the sequence, so, for substitutions alone, i.e., each position could be any one of the 20 canonical amino acids, would encompass 2012 = 4,096,000,000,000,000 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 75% identity to SEQ ID NOs: 7, 9 or 11 at the time of filing. 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. 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.
Claims 13, 19-20, 23, 25-27, 30 and 50 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.
The claims are directed to an inhibitor of human herpesvirus glycoprotein-B which is capable of binding to human herpesvirus glycoprotein-B on the surface of a cell, wherein the inhibitor binds within SEQ ID NO: 7, SEQ ID NO: 9, SEQ ID NO: 11, or a sequence having at least 75% identity thereto, or a fragment thereof.
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 grounds for the written description rejection are as follows: (1) the claims read on antibodies and/or antibody fragments, polypeptides, fusion proteins, peptides, polynucleotides, small molecules, aptamers etc. that binds the human herpesvirus glycoprotein-B on the surface of a cell having at least 75% identity to SEQ ID NOs: 7, 9 or 11 or a fragment thereof; however, the claim reads on a class of molecules defined by function and not the inhibitor for which it is claimed, (2) the claim reads on a class of antibodies, antibody fragments, peptides etc. by function; however, there is no evidence that all antibodies, antibody fragments, peptides etc. would have the required functions.
The specification discloses principal features of antibodies of the present invention; however,
the scope of claim 13 and dependent claims are broad encompassing any antibody, antibody fragment, peptide etc. that is capable of binding to human herpesvirus glycoprotein-B on the surface of a cell. The Examiner takes notice that once a structure of an antigenic moiety is known, the technology to produce an antibody to such an antigen is routine experimentation. In this case, the specification contemplates a genus of antibodies and fragments that bind human herpesvirus glycoprotein-B. The specification only broadly discloses generating an inhibitor that is capable of binding human herpesvirus glycoprotein-B. While it is possible to make antibodies and peptides that bind to human herpesvirus glycoprotein-B and test them for the claimed function, specification must provide an adequate description of the genus. 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. There is nothing in the claims that limit the inhibitor to any structural feature that does correlate with the required functions. 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 claim. 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). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision (see page 115). The skilled artisan cannot envision the detailed structures of molecules capable of binding to said human herpesvirus glycoprotein-B. For the written description requirement, an applicant' s specification must reasonably convey to those skilled in the art that the applicant was in possession of the claimed invention as of the date of invention. Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997); Hyatt v. Boone, 146 F.3d 1348, 1354, 47 USPQ2d 1128, 1132 (Fed. Cir.1998).
The present specification fails to demonstrate constructive possession of the claimed invention because it contemplates a genus of antibodies, antibody binding fragments, polypeptide, fusion protein, peptide, polynucleotide, small molecule, aptamer etc. that binds the human herpesvirus glycoprotein-B on the surface of a cell having at least 75% identity to SEQ ID NOs: 7, 9 or 11 or a fragment thereof.
Therefore, it is determined that Applicant was not in possession of a genus of molecules that only needs to bind to the human herpesvirus glycoprotein-B. Thus, in view of the reasons set forth above, one skilled in the art at the time the invention was made would not have recognized that applicant was in possession of the invention as presently claimed.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672