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 .
Applicant’s preliminary amendment filed on November 18, 2024 is acknowledged. Claims 24-45 are under examination in this Office action.
Nucleotide and/or Amino Acid Sequence Disclosures
Claim 26 and 37, lists SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 29, SEQ ID NO: 30, SEQ ID NO: 45, SEQ ID NO: 46, SEQ ID NO: 61, SEQ ID NO: 62, SEQ ID NO: 77, SEQ ID NO: 78, SEQ ID NO: 93, SEQ ID NO: 94, SEQ ID NO: 109, SEQ ID NO: 110, SEQ ID NO: 125, SEQ ID NO: 126, SEQ ID NO: 141, and SEQ ID NO: 142. The sequence listing filed on September 11, 2024 fails to list an amino acid sequence for the above SEQ ID NOs. Examiner has looked through 150 sequences in the sequence listing. Applicant is required to verify all the remaining SEQ ID NO, the total of 594. Table 1 in the present Specification lists antibody designations and the corresponding CDR SEQ ID NOs. The sequences themselves are not listed. Applicant is required to provide a new Sequence listing containing the entire sequence representing the above listed SEQ ID NOs.
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:
via EFS-Web (see Section I.1 of the Legal Framework for EFS-Web (https://www.uspto.gov/patents-application-process/filing-online/legal-framework-efs-web), 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 identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
on compact disc(s) in duplicate according to 37 CFR 1.52(e)(1)(ii) and (4), labeled according to 37 CFR 1.52(e)(6), together with a statement that the duplicate compact discs are identical and an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(5) 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;
via EFS-Web as a PDF (not recommended); or
on paper.
37 CFR 1.821(e) requires that a copy of the "Sequence Listing" must also be submitted in computer readable form (CRF) in accordance with the requirements of 37 CFR 1.824.
If a "Sequence Listing" ASCII text file submitted via EFS-Web on the application filing date complies with the requirements of 37 CFR 1.824(a)(2) - (6) and (b), and applicant has not filed a "Sequence Listing" as a PDF, the text file will serve as both the "Sequence Listing" required by 37 CFR 1.821(c) and the CRF required by 37 CFR 1.821(e), and the statement of identity under the "Legal Framework" is not required.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via EFS-Web as a PDF, then the "Legal Framework" requires submission of a statement that the "Sequence Listing" content of the PDF copy and the ASCII text file copy submitted via EFS-Web are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or compact disc, then 37 CFR 1.821(f) requires submission of a statement that the "Sequence Listing" content of the paper or compact disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.121(b)(3) and 1.125 inserting the required sequence identifiers, 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.
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in any one of items 1) a), b), c), or d); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application;
A statement that the "Sequence Listing" includes no new matter; and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825 and the "Legal Framework."
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A CRF; and
Statement according to item 2) b) or c) above.
If applicant desires the CRF in this application to be identical with the CRF of another application on file in the U.S. Patent and Trademark Office, such request in accordance with 37 CFR 1.821(e) may be submitted in lieu of a new CRF (form PTO/SB/93 may be used for this purpose).
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 24-43 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 pre-AIA the applicant regards as the invention.
Claims 24 and 36 are indefinite because of the recitation of Table 1. The reference to the table in the claims fails to provide clear metes and bounds of the scope of the claimed invention. See MPEP 2173.
Tables within the claims in problematic. See 2173.05(s): Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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