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 .
Election/Restrictions
Applicant's election of Group I, claims 1, 4, 9 and 12 in the reply filed on November 21, 2025 is acknowledged. The traversal is on the ground(s) that Applicant disagrees with Examiner’s characterization of Parray reference. Applicant did not provide any arguments to support their contention. Thus, the requirement is still deemed proper and is therefore made FINAL. Claims 1, 4, 9 and 12 are under examination in this Office action. Claims 15, 21, 25-26, 28, 30, 36, 38, 40-44, 48-49, and 53-54 are withdrawn as being drawn to non-elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 17, 2024 and March 17, 2023 have been considered by the examiner.
Claim Rejections - 35 USC § 112
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 1, 4, 9 and 12 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.
Claims are drawn to An antibody or antigen binding fragment comprising one or more complementarity-determining regions (CDRs) selected or derived from any cluster or CDRs in any of Tables 1-9, preferably,
wherein the CDRs are selected or derived from the SR1, SR2, SR4, SR6, SR8, SR12, SR15, SR18, SR25, SR30 or SR38 cluster families; or
wherein the antibody or antigen binding fragment comprises CDRs from SR6v15, SR6v7, SR38, SR6c3, SR4t13, or SR2c3.
Claims are rejected because 1) there is a lack structure and function correlation with respect to the claimed antibodies and antigens they bind; 2) the claims recite only a partial structure of an antibody, one or more complementarity-determining regions (CDRs) and 3) the independent claim fails to recite an antigen to which the antibody must bind.
The present claims recite only one CDR region present within the claimed antibody while requiring a function of binding to the N501Y SARS-CoV-2 variant. Tables 1-9 in Applicant’s specification list hundreds of CDR sequences, however the tables do not indicate which 6 CDR sequences, comprise an antigen binning region. It is well known in the art of immunology that a functional antibody is comprises of six CDR regions (see Liu et al. Nature, 2021, Vol. 602, p. 294-320). Applicant’s claims require a function without setting forth a structure required to perform the claimed function.
The claims are thus rejected as failing to comply with the written description requirement as discussed above.
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, 4, 9 and 12 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 are drawn to An antibody or antigen binding fragment comprising one or more complementarity-determining regions (CDRs) selected or derived from any cluster or CDRs in any of Tables 1-9, preferably,
wherein the CDRs are selected or derived from the SR1, SR2, SR4, SR6, SR8, SR12, SR15, SR18, SR25, SR30 or SR38 cluster families; or
wherein the antibody or antigen binding fragment comprises CDRs from SR6v15, SR6v7, SR38, SR6c3, SR4t13, or SR2c3.
Applicant’s Specification states under Table 1 that TABLE-US-00002 TABLE 1 Sequences belonging to cluster SR1. Each line in the table represents one sequence, both segments and full length of the sequence are shown. Shown items are divided by “#” and in the order from start to end of each line is: CDR1 amino acid sequence, CDR2 amino acid sequence, CDR3 amino acid sequence, full-length amino acid sequence with CDRs capitalized, full-length DNA sequence. (SEQ ID NOS: 1-195).
Claims are rejected because of the recitation of the Tables 1-9 listing hundreds of SEQ ID NOs, without specifying which SEQ ID NOs should be present within one antibody. The claims are indefinite because one of skill in the art cannot deduce, from Tables 1-9, which SEQ ID NOs are to be comprised within one antibody. The present claims are deemed indefinite because the boundaries of the present claims are not clearly defined.
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).
Additionally, the recitation of SR1, SR2, SR4, SR6, SR8, SR12, SR15, SR18, SR25, SR30 or SR38 cluster families and CDRs fragments: SR6v15, SR6v7, SR38, SR6c3, SR4t13, or SR2c3 renders the present claims indefinite because the recited designations are arbitrary without defining the exact structures of the antibodies. Applicant is suggested to amend the claims to recite the complete set of six CDR regions, including the SEQ ID NOs representing the CDRs, or alternatively one heavy variable chain and one light variable chain for each of the SR1, SR2, SR4, SR6, SR8, SR12, SR15, SR18, SR25, SR30 or SR38, SR6v15, SR6v7, SR38, SR6c3, SR4t13, or SR2c3.
Also, the recitation of “preferably” is indefinite since the metes and bounds of the claimed antibody cannot be determined. The recitation of “preferably” can be interpreted as “optionally”.
Correction is required.
Pertinent references
Bremel et al. (US Patent US 10,706,955) disclose a Mycobacterium derived sequence identical with present SEQ ID NO: 2 (see SEQ ID NO: 561406 and the sequence alignment below). Bremel et al. does not disclose an antibody comprising present SEQ ID NO: 2.
Query Match 100.0%; Score 28; Length 7;
Best Local Similarity 100.0%;
Matches 5; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RGDDT 5
|||||
Db 1 RGDDT 5
Kapur et al. (US Patent 7,867,704) disclose a sequence derived from Mycobacterium paratuberculosis comprising present SEQ ID NO: 6 (see SEQ ID NO: 1467 and the sequence alignment below).
Query Match 100.0%; Score 33; Length 410;
Best Local Similarity 100.0%;
Matches 7; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 KTGRSVI 7
|||||||
Db 268 KTGRSVI 274
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.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648