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. Claims 1, 3-6, 8, 12, 17, 19 are amended. New claims 21-23 are added. Claims 9, 11, 13 are canceled.
Claims 1-8, 10, 12, 14-23 are under consideration.
2. It is confirmed that no Restriction Action has been issued in this case. An indication of species initially searched was provided as a courtesy as the SEQ ID NOs: in claim 1 were and are recited in the alternative (“any one of SEQ ID NOs: …”).
Specification
3. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: the specification has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Objections
4. (previous objection, withdrawn) Claim 8 was objected to because of informalities.
Applicant contends: the claim has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 102
5. (previous rejection, withdrawn) Claims 1, 2, 7, 10, 15-18, 20 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knick et al. (WO2018029157; previously cited).
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
6. As indicated in Item #11 of the Non-Final Action issued 8/13/2025, SEQ ID NO: 2 as recited in the instant claims is free of the prior art of record. The art search has thus been extended to SEQ ID NOs: 5, 6, 23, 40-42 as recited in claim 1.
SEQ ID NOs: 5, 6, 23, 40-42 as recited in the instant claims are also free of the prior art of record.
Claim Rejections - 35 USC § 112
7. (previous rejection, withdrawn) Claim 6 was rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant contends: the claim has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
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.
8. (previous rejection, withdrawn as to claims 1-7, 10, 12, 14-20; maintained as to claim 8) Claim 8 is 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.
See claim 8 as submitted 11/13/2025.
Applicant contends: the claims have been amended; with respect to claim 8, the application describes on page 2 that in some embodiments, the binding protein can be fused or conjugated to at least one further molecule, which in some embodiments can be a diagnostically active moiety; the specification discusses diagnostic uses.
In view of applicant’s amendments, the rejection is withdrawn as to claims 1-7, 10, 12, 14-20, but maintained as to claim 8.
See the rejection as recited in the previous Office Action.
Response to Arguments
As to claim 8, it is noted that instant claim does not recite such embodiments or applications. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The rejection is maintained for reasons of record.
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.
9. (previous rejection, maintained; new, necessitated by amendment as to new claims 22, 23) 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 11/13/2025.
Applicant contends: the SEQ ID NOs: claimed are monomeric units that form the basis for all of the binding proteins; these sequences have the requisite binding activity and are highly similar; the sequences are identical with respect to 42/58 amino acid positions and constitute a common structure; the instant binding molecules are not antibodies and do not need to maintain the elaborate three-dimensional structure of antibodies; the SEQ ID NOs: claimed provide a sufficient common core structure to permit one of ordinary skill in the art to conclude that application was in possession of the full scope.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
As to new claims 22, 23, it is noted that said claims depend on rejected claim 3 and claim 1, respectively; further as to claim 23 the claim still recites or reads on “any” amino acid sequence with at least 92% sequence identity to any one of SEQ ID NOs: 2, 5, 6, 23, 40-42; further with one or more substitutions as claimed in (a)-(n), which includes, at a minimum, for example a glutamine (Q) at amino acid position 10 of SEQ ID NO: 2. Such a recitation and scope still reads on sequences with a large genus of possible substitutions with an unpredictable structure-function relationship.
Response to Arguments
Turning to applicant’s arguments, 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 92 % 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.
It is noted that for SEQ ID NO: 2, for example, 92% identity of SEQ ID NO: 2 still reads on at least 53 amino acids of the entire sequence of 58 amino acids. Thus, up to 5 amino acid positions could be still substituted for any one of the canonical 20 amino acids which could lead to unpredictable structure-function relationships, not to mention the cumulative effect of such substitutions. Even if identical with respect to 42/58 amino acid positions as applicant notes and contends with respect to a common structure, up to 16 positions could still be substituted for any one of the 20 amino acids, which could lead to unpredictable structure-function relationships, not to mention the cumulative effect of such substitutions.
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. While the instantly claimed molecules do not explicitly recite antibodies, which were cited as a mere example of a binding protein well known in the art, the instantly claimed molecules actually read on an even broader genus of binding proteins. Further, even beyond antibodies, it is well known in the art that even a mere single amino acid change can affect the function of a peptide. For example, Lucchese et al. (“How a single amino acid change may alter the immunological information of a peptide,” Frontiers in Bioscience E4: 1843-1852 (2012))(See PTO-892: Notice of References 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 92 % 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.
For the reasons above, and in view of the uncertainty as to which binding proteins would comprise an amino acid sequence with at least 92 % sequence identity to any one selected
from the group of SEQ ID NOs: 2, 5, 6, 23, 40-42 and show binding affinity of less than 500 nM for the spike protein or domains thereof, 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.
Conclusion
10. With respect to 35 U.S.C. 101, SEQ ID NOs: 5, 6, 23, 40-42 as claimed do not appear to read on naturally occurring amino acid sequences.
11. Claim 21 is objected to for depending on a rejected claim.
12. No claims are allowed.
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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