DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. Applicant’s amendments received 07/07/2026 are acknowledged.
3. Claims 39-44 are new.
4. Claims 1-2, 4, 6, 10-11, 14, 18, 20-24, 31, and 39-44 are pending and currently under consideration in the instant application.
5. The following new ground of rejection are necessitated by the amendment submitted 07/07/2026.
Priority
6. The instant application claims foreign priority to European Application No. EP22306067.4, filed 07/18/2022. Applicant’s claim for the benefit of prior-filed application is acknowledged.
Response to Arguments
Rejections under 35 U.S.C. 112(a)
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.
7. Claims 1-2, 4, 6, 10-11,14, 18, 20-24, and 31 stand rejected and newly added claims 39-44 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention, for the same reasons set forth in the previous office action mailed 04/07/2026.
Claim 39-44 encompass a genus of ISVD comprising 3 CDRs but lacking antigen-specificity and frameworks. Additionally, independent claim 41 does not explicitly recite target antigen specificity and lacks specific FR1-4.
8. Applicant’s arguments, filed 07/07/2026, have been fully considered, but have not been found convincing.
9. Regarding Enablement –
Applicant argues that one having ordinary skill in the art could – in view of the Specification – make and use the claimed polypeptides (and compositions) without undue experimentation. This is not possible. As stated in the previous Office Action, “base claim 1 and dependent claims thereof encompass a genus of ISVD comprising three CDRs but lacking antigen-specificity and frameworks, as well as a genus of up to 2 amino acid modifications in the ISVD comprising the CDR 1(c) of SEQ ID NO: 53, 55, and 57” (see page 3, second paragraph). As evidenced by the reference Rudikoff et al. (Proc Natl Acad Sci USA 1982 Vol 79(6), page 1979-1983), even the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function. Further, as stated in the previous Office Action, “[t]he specification provides no direction or guidance regarding how to produce Immunoglobulin Single Variable Domain (ISVD) fusion proteins as broadly defined by the claims. For example, claim 1(c) having ‘2 or 1 amino acid differences with SEQ ID NO: 57’ creates an undue burden of experimentation. Also, an artisan would not know how to screen for missing elements (i.e., framework and substitutions). Undue experimentation would be required to produce the invention commensurate with the scope of the claims from the written disclosure alone.” (see previous Office Action page 4).
The previous rejection for Enablement under 35 U.S.C. 112(a) is maintained.
10. Claims 1-2, 4, 6, 10-11,14, 18, 20-24, and 31 stand rejected and the newly added claims 39-44 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention, for the same reasons set forth in the previous office action mailed 04/07/2026.
11. Applicant’s arguments, filed 07/07/2026, have been fully considered, but have not been found convincing.
12. Regarding Written Description – Applicant argues that Examiner misunderstands the instant invention in terms of ISVDs requiring only 3 intact CDRs rather than 6 CDRs. However, the previous Office Action clearly notes “[w]ith respect to the recitation of an antibody which does not comprise all 6 CDRs of the antibody or VHH which does not comprise all 3 CDRs of the VHH/nanobody recited in the claims, the Examiner directs Applicant’s attention to the training material…” It is understood that ISVDs only require 3 intact CDRs, however the requirement that claims explicitly recite the binding antigen still remains (see previous Office Action page 9). Base claim 1 and dependent claims thereof fail to establish ‘a reasonable structure-function correlation’ since no binding antigen is explicitly recited for any of the three ISVDs in claim 1. Furthermore, as noted in the previous Office Action, “[p]ossession is not shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895” (See previous Office Action page 8).
The previous rejection for Written Description under 35 U.S.C. 112(a) is maintained.
Rejections under 35 U.S.C. 112(b)
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.
13. Claim 6 stands rejected and newly added claim 41 is rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
14. Regarding instant claim 6 – applicant’s argument filed 07/07/2026 has been fully considered and has not been found persuasive. Applicant argues that “[o]ne having ordinary skill in the art understands these numbering schemes. Moreover, one having ordinary skill in the art can readily and conclusively identify CDRs of an ISVD according to the AbM numbering scheme (e.g., as recited in the claim 1) and identify individual residues in framework positions of the same ISVD according to the Kabat numbering scheme (e.g., as recited in claim 6).” Examiner asserts that AbM and Kabat numbering schemes should not be mixed within the same polypeptide analysis because they use different residue assignments and boundary definitions for complementarity-determining regions (CDRs). The previous rejection of instant claim 6 under 35 U.S.C. 112(b) is maintained.
15. The recitation “correspond to” in claim 41 is indefinite because the term “corresponding” indicates analogous/equivalent /form /comparable to.
Conclusion
16. No claims are allowed.
17. 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.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN ALFANO whose telephone number is (571)272-3092. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALAN ALFANO/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641
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