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
Status of Application, Amendments, and/or Claims
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/12/2025 has been entered.
Claims 1, 3-6, 10, 13, 16-19, 34, 49, 53-55, and 60 are pending. Claims 1, 3-6, 10, 13, 16-17, 34, and 60 are currently under consideration. Claims 18-19, 49, and 53-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or nonelected species.
In the reply filed on 12/23/2024, Applicant elected the following species: (i). an engineered antibody containing at least one epitope binding domain; (ii) an engineered Wnt agonist that binds FZD1, FZD2, FZD5, FZD7, and FZD8, and which also binds LRP6; and (iii) the R2M3-26 heavy chain sequence of SEQ ID No: 1, and the R2M3-26 light chain sequence of SEQ ID No: 2.
Withdrawn Objections and/or Rejections
The provisional rejection of claims 1, 3-6, 16-17, and 60 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 6-7, 9-10, and 27-28 of co-pending Application No. 17/623,006 is withdrawn in view of amended claims and Applicant’s argument.
The provisional rejection of claims 1, 3-6, 16-17, and 60 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4-8, and 19 co-pending Application No.18/281,253 is withdrawn in view of amended claims and Applicant’s argument.
The rejection of claims 1, 3-6, 8, 10, 13, 16-17, 34, and 60 under 35 U.S.C. 112(a) is withdrawn in view of amended claims.
Information Disclosure Statement
The information disclosure statement filed on 11/12/2025 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to the office action.
Claim Rejections under 35 USC § 112 (b)
(i). The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
(ii). Claims 10 and 60 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(a). A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, part a) of claim 60 recites the broad recitation, “wherein the methods result in: a. reduced inflammation”, and the claim also recites “optionally inflammation in a gastrointestinal tract tissue, optionally small intestine, large intestine, or colon tissue”, which is the narrower statement of the range/limitation.
Likewise, claim 60, part c)-d), also recite a broad limitation together with a narrow limitation that falls within the broad limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
(b). Claim 60 is indefinite because it recites “c. reduced disease activity index”. It is unclear what the metes and bounds of the limitation are.
(c). Claim 10 recites “wherein the engineered WNT agonist comprises a tissue targeting molecule”. The claim is indefinite because the engineered WNT antibody agonist of claim 1 does not comprise a tissue targeting molecule.
Claim Rejections under 35 USC § 112 (d)
(i). The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(ii). Claims 3-6 and 60 are rejected under 35 U.S.C. 112 (d), 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.
Specifically, claim 1 recites “wherein the engineered WNT agonist comprises a variable heavy chain (VH)sequence and a variable light chain (VL sequence selected from the following: a) a VH comprising SEO ID NO: 1 and a VL comprising SEO ID NO: 2; …”. The engineered WNT agonist is inherently an antibody. On the other hand, claim 3 recites “wherein the engineered WNT agonist is an engineered polypeptide or an engineered antibody”. Thus, claim 3 does not further limit claim 1.
Likewise, the properties recited in claims 4-6 are inherent to the engineered WNT agonist. Thus, Thus, claims 4-6 do not further limit claim 1.
Claim 60 recites biological outcomes of the treatment of claim 1. However, such biological outcomes are necessarily result from the method of claim 1. Thus, claim 60 does not properly further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Objections
Claims 1, 3-6, 10, 13, 16-17, 34, and 60 are objected to because they recite non-elected subject matter (WNT agonists recited in claim 1).
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674 November 17, 2025