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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 05/08/2026 has been entered.
Claims 1, 3, 8-9, 22, 27, 39, 46 and 53 are pending and under consideration.
Applicant’s IDS documents filed on 05/08/2026 and 05/12/2026 have been considered.
Claim Objections
Claims 3, 8-9, 22, 27, 39 and 53 are objected to because of the following informalities: Claims 3, 8-9, 22, 27, 39 and 53 recited ‘Fzd’ instead of FZD as recited in independent claim 1. Appropriate correction is required.
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, 3, 8-9, 22, 27, 39, 46 and 53 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “one” FZD binding region of (i) and (ii) which binds to “a FZD receptor”
In claim 3 the claim recites “one Fzd binding region” and “the second FZD binding region”
In claim 8 the claim recites “the two Fzd binding regions”, “(i) a first Fzd binding region” and “(ii) a second Fzd binding region”
In claim 9 the claim recites “(a) the first Fzd binding region” and “(b) the second Fzd binding region” and
In claim 39 the claim recites “the first heavy chain of the first FZD binding region”; “the second heavy chain of the second FZD binding region”; “the first FZD binding region” and “the second FZD binding region”
It is unclear what the first and second FZD/Fzd binding regions are referring to and the terms lack antecedent basis in claim 1. It is noted that binding region (i) in claim 1 is directed to FZD4 and binding region (ii) in claim 1 is directed to FZD9, though the binding region which binds to FZD4 is referred to as the “second FZD binding region” and the binding region which binds to FZD9 is referred to as “one Fzd binding region” in the claim 3. It is suggested by the Examiner to amend claim 1 to include reference to a first and second binding region and first and second FZD receptors and to amend the dependent claims to correspond to the language chosen in claim 1.
Correction is required.
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.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the Wnt surrogate of claim 8 wherein: a) the first and second Fzd binding regions binds to at least one Fzd receptor that induces canonical Wnt signaling., does not reasonably provide enablement for the Wnt surrogate of claim 8 wherein: a) the first Fzd binding region binds to at least one Fzd receptor that induces non- canonical Wnt signaling; and b) the second Fzd binding region binds to at least one Fzd receptor that induces canonical Wnt signaling. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The art of Post et al. (PTO-892; Reference U) teaches “[f]our FZD subfamilies, FZD1,2,7, FZD5,8, FZD4, and FZD9,10, mediate WNT/β-catenin (canonical) signaling, whereas FZD3,6 is involved primarily in non-canonical signaling independent of β-catenin.5,6 (In particular, ‘introduction’, whole document). Since the multispecific Wnt surrogate molecule is directed to FZD4 and FZD9 binding regions, then claim 1 is not directed to any binding regions which bind to a FZD receptor that induces non-canonical Wnt signaling.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (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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June 1, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights