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
Acknowledgement is hereby made of receipt and entry of the communication filed on Jan. 22, 2024. Claims 1-10, 12-18, 21-22 and 24 are pending and currently examined.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application PCTEP2021055401, filed on 03/03/2021. It is noted, however, that applicant has not filed a certified copy as required by 37 CFR 1.55.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. The file size is expressed in kilobytes instead of bytes. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objection
The base claims 1-3 and 8-13 are objected to because of the following informalities:
These claims recite the phrase “characterized in that… “, where applicant may consider using a wherein clause.
Appropriate correction is required.
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 1-10, 12-18, 21-22 and 24 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.
The base claim 1 and claims 5-6, 15 recite the term “defined” that render these claims indefinite. It is not clear what the term “defined” actually means. For example, it is not clear if “defined” is to be interpreted as to “comprise” the SEQ ID NOs or “consist” of the SEQ ID NOs. Furthermore, it is unclear whether this means two or more nucleic acids, or at least the sequence, or a consensus sequences.
Therefore, one of ordinary skill in the art will not know the metes and bounds of the claims.
The same rejection can also be extended to the term “set forth” in claims 6, 22 and 24. It is not clear if the phrase “set forth” is represented to “comprise” the SEQ ID NOS or “consist” the SEQ ID NOs.
For purposes of compact prosecution and applying prior art, these claims were interpreted herein to comprise the SEQ ID NOS as claimed. For example, it will be interpreted as: Sequence part A comprises the nucleic acid sequence of SEQ ID NO: 50 or a sequence having at least 98.5% sequence identity to the nucleic acid sequence of SEQ ID NO: 50.
In addition, the base claims 1 and 6 recite a phrase “a sequence as defined in SEQ ID NOs”, and the claims 6, 22 and 24 recite a phrase “a sequence as set forth in SEQ ID NOS”, which render the claims indefinite because “a sequence” of nucleic acid can read on any stretch of 2 or more nucleotides sequences. For example, for claim 6, the limitation “an ORF6 sequence as defined in SEQ ID NO 53” is not clear since it may read on a region of SEQ ID NO: 53. Therefore, one of ordinary skill in the art will not know the metes and bounds of the claims.
Regarding claims 2, 13 and 18, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(h). The term “optionally” means "not required or mandatory". For example, a composition comprising A, B, C, and optionally D means that component D can or cannot be present (D is not required to be present). In the rejected claims 2, 13 and 18, however, it appears the use of "optionally" is an attempt to define "preferred" embodiments or limitations. For example, claim 2 states “…optionally at least 20,000 bases”. In this instance, the term optionally does not make sense given the definition of optionally (not required or mandatory). Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Allowable Subject Matter
The SEQ ID NOs: 50 or a sequence having at least 98.5% sequence identity to the sequence as defined in SEQ ID NO: 50 are free of art.
The SEQ ID NOs: 48 or a sequence having at least 98.3% sequence identity to the sequence as defined in SEQ ID NO: 48 are free of art.
The SEQ ID NOs: 49 or a sequence having at least 97.2% sequence identity to the sequence as defined in SEQ ID NO: 49 are free of art.
The SEQ ID NOs: 17 or a sequence having at least 98.5% sequence identity to the sequence as defined in SEQ ID NO: 17 are free of art.
The SEQ ID NOs: 51 or a sequence having at least 98.5% sequence identity to the sequence as defined in SEQ ID NO: 51 are free of art.
The SEQ ID NOs: 59 or a sequence having at least 98.5% sequence identity to the sequence as defined in SEQ ID NO: 59 are free of art.
The SEQ ID NOs: 58 or a sequence having at least 98.6% sequence identity to the sequence as defined in SEQ ID NO: 58 are free of art.
The SEQ ID NOs: 52 or a sequence having at least 99% sequence identity to the sequence as defined in SEQ ID NO: 52 are free of art.
The SEQ ID NOs: 53 or a sequence having at least 94.1% sequence identity to the sequence as defined in SEQ ID NO: 53 are free of art.
The SEQ ID NOs: 55 or a sequence having at least 99% sequence identity to the sequence as defined in SEQ ID NO: 55 are free of art.
The SEQ ID NOs: 19 is free of art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. 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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/RUIXUE WANG/Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672