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
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/18/2026 has been entered.
2. Claims 1, 5, 6, 8, 19, 23 are amended. Claims 9, 11, 13 are canceled. Claims 1-8, 10, 12, 14-23 are under consideration.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 6/18/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claim 8 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre- AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
Applicant contends: claim 8 has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
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.
5. (previous rejection, maintained and modified in view of applicant’s amendments) Claims 1-8, 10, 12, 14-20, 22, 23 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.
See claims 1-8, 10, 12, 14-20, 22, 23 as submitted 6/18/2026.
Applicant contends: the discussion of antibodies is not particularly relevant; the instantly claimed binding proteins are not antibodies and are not subject to the same degree of sequence rigidity than an immunoglobulin molecule might be; this is not the case with the instantly claimed binding proteins; the issues relevant to antibodies are not present here; the sequences are identical with respect to 42/48 amino acid positions, these 42 amino acids constitute a common structure; substitutions at the recited positions were tolerated, with no evidence that a substitution at any particular position required a compensatory substitution at another particular position or positions; attempt to analogize the instant binding molecules to antibodies does not support the instant rejection; the monomer amino acid sequences presented as SEQ ID NOs: 2, 5, 6, 23, 40-42 provide a sufficient common core structure to conclude applicant was in possession of the full scope of the instant claims; claims 1, 5, 6, 19, 23 have been amended.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
With respect to applicant’s amendments to claims 1, 5, 19, 23, the instant claims still recite or read on binding protein comprising "any" amino acid sequence with at least 96% sequence identity to any one of SEQ ID NOs: 2, 5, 6, 23, 40-42. Such a recitation and scope still read on sequences with a large genus of possible substitutions with an unpredictable structure-function relationship.
Response to Arguments
Turning to applicant’s arguments, as indicated above, it is maintained that
the instant claims read on "any" binding protein for the spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2), comprising wherein the binding protein comprises an (or "any") amino acid sequence with at least 96% sequence identity to any one of SEQ ID NOs: 2, 5, 6, 23, and 40-42, wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or domains thereof, and the application has not provided sufficient written description support for the genus of binding proteins identified in claim 1. The application therefore fails to provide adequate support for methods of using this genus of binding proteins.
The instant rejection is not limited to a discussion of antibodies as applicant contends. Rather, as indicated on page 7 of the Final Rejection issued 3/18/2026, antibodies were cited as a mere example of binding proteins well known in the art and the instantly claimed molecules on the contrary actually read on an even broader genus of binding proteins, which only adds to the importance of the structure-function correlation. Even in view of applicant’s amendments, for SEQ ID NO: 2, for example, 96% identity of SEQ ID NO: 2 still reads on at least 55 amino acids of the entire sequence of 58 amino acids. Thus, up to 2 amino acids could still be substituted for any one of the canonical 20 amino acids which could still lead to unpredictable structure-function relationships, not to mention the cumulative effect of such substitutions. Applicant has not appeared to provide evidence to the contrary, rather arguments of counsel (See MPEP 716.01(c): The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
It is maintained as previously indicated and further noted that it is well known within the
prior art that even the most minor differences can have significant effects on antigen binding
ability, and also function as well. Even Lucchese et al. ("How a single amino acid
change may alter the immunological information of a peptide," Frontiers in Bioscience E4: 1843-
1852 (2012); previously cited) teaches: a single aa change can result in a wide spectrum of outcomes in an immunological context, such a reversing inhibition of host innate immune response pathways, destroying or improving protein immunogenicity, and impairing T-cell activation (p. 1848).
Thus, while the specification as indicated above identifies specific SEQ ID NOs that bind
to spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2), it does not
identify a representative sample of any binding proteins that bind to spike protein of severe acute
respiratory syndrome corona virus 2 (SARS-Cov-2) comprising an amino acid sequence with at
least 96% sequence identity to any one selected from the group of SEQ ID NOs: 2, 5, 6, 23, 40-
42, wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or
domains thereof clearly within the breadth of the claimed genus.
The rejection is maintained for reasons of record.
Conclusion
6. Claim 21 is objected to for depending on a rejected claim.
7. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 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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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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