DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6 and 9, and the Wnt species elected in the reply filed on 7/30/2026 is acknowledged.
The species elected is:
(A) the Fzd binding region of the Wnt surrogate molecule, hp4SD1-03-IgG1-AAA, which comprises the light chain of SEQ ID NO: 11 and the heavy chain of SEQ ID NO: 12; (B) the LRP5 and/or LRP6 binding region of the Wnt surrogate molecule, hp4SD1-03- IgG1-AAA, which comprises the light chain of SEQ ID NO: 11 and the heavy chain of SEQ ID NO: 12; and (C) the combination of I253A, H310A, and H435A Fc modification (AAA).
Claims 7-8 and 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/30/2026.
Information Disclosure Statement
The information disclosure statement submitted on 7/30/2026 is acknowledged but has not been fully considered or the form initialed at this time. A number of the documents submitted were not scanned or processed properly. The examiner has requested correction, but this has not occurred at this point in time.
Specification
The substitute specification filed 4/23/2024 has been entered.
The disclosure is objected to because of the following informalities:
The amino acid sequences disclosed on page 28 of the specification do not reference the appropriate sequence identifiers.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-6 and 9 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 is directed to a Wnt surrogate molecule; however, only an Fc region of an immunoglobulin molecule is defined. The claim does not set forth the structure or function of the Wnt surrogate molecule. An Fc region alone has no Wnt surrogate activity as disclosed in the specification. Applicant is reminded that limitations in the specification cannot be read into the claims. See by comparison claim 4 which requires an Fzd binding region and an LRP5/6 binding region. However, claim 4 does not make clear how the Fc region of claim 1 is associated with the Fzd binding region and/or the LRP5/6 binding region.
The parenthetical expressions in claim 4 are confusing. For example, is the Fzd binding region in part (i) limited to one or more regions that specifically binds to one or more Frizzled receptors or does it encompass other structures? For example, is the LRP5/6 binding region part (ii) limited to one or more regions that specifically binds to a Low-density lipoprotein (LDL) receptor-related protein 5 (LRP5) and/or a Low-density lipoprotein (LDL) receptor- related protein 6 (LRP6) or does it encompass other structures.
Claim 9 is confusing in reciting a “therapeutically effective amount.” The claim is directed to a product and not a method. No therapeutic effect is required by the claim. It is not known what amounts would meet the limitations of the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2019/126398, of record, published 27 June 2019, filed 19 December 2018) in view of Regula et al. (U.S. Patent Application Publication 2016/0068613.
The elected species is defined by instant SEQ ID NOS: 11 and 12.
Li et al. discloses the LRP binder of SEQ ID NO: 144 (which contains the VHH that binds LRP5 fused to the N-terminus of the LC for the Fzd binder) has 91% sequence homology to instant SEQ ID NO: 11. See Figure 19 (sheet 43/132, figure starts at sheet 37/132) for SEQ ID NO: 144. There is a GGSGS linker that is underlined. The first 22 amino acids of SEQ ID NO: 144 (in italics) are the leader sequence. The homology to instant SEQ ID NO: 11 is 97% if the leader sequence is not included. Amino acids 145 to 358 of SEQ ID NO: 144 correspond to amino acids 123-336 of instant SEQ ID NO: 11 (i.e. the light chain portion of this sequence). Amino acids 23-472 of SEQ ID NO: 155 have 98% homology to instant SEQ ID NO: 12. See
Figure 19 (sheet 45/132, figure starts at sheet 37/132) The first 22 amino acids of SEQ ID NO: 155 (in italics) are a leader sequence. SEQ ID NO: 155 contains the Fc mutations of instant claim 3. Table 3 at page 173 discloses that SEQ ID NOS: 144 and 155 correspond to the construct 4SD1-3 having FzD binder 004S-D01 (SEQ ID NO: 155, binds Fzd4, see Table 1B) and LRP binder 008S-D01 (SEQ ID NO: 144, binds LRP5, see Table 2A). See pages 169-173. An LRP binder VHH can be fused to the light chain of the FzD binder. Other arrangements of binding domains are also disclosed. See at least pages 3-6; Figures 1, 2A, and 17A; and claims, particularly claims 10-11 and 15-18. The Wnt surrogates can be fused to heterologous Fc portions such as IgG1. See at least page 27, lines 1-15. The domains can be connected by a linker. The linker can comprise or consist of glycine and serine residues and be about 1, 2, 3, 4, 5, 6, or up to 30 amino acids in length. See at least page 29 and page 111, line 29, through page 112, line 17. Mutations in the Fc domain such as P329G, L234A, and L235A are disclosed. See at least pages 31-32. Pharmaceutical compositions are disclosed. See at least claim 55. Modifications resulting in reduced affinity to the neonatal Fc Receptor (FcRn) are not disclosed as recited in instant claims 1-2.
Regula et al. discloses making the combination of IgG1 Fc mutations including I253A, H310A, H435A, L234A, L235A, and P329G to an antibody. These mutations result in reduced affinity to the FcRn. See at least paragraph [0204], second line of the table. Reduced affinity to FcRn modulates half-life. Other mutations to reduce affinity to the FcRn are disclosed. See at least abstract; claims; and paragraphs [0125-0126].
It would have been obvious to make the IgG1 Fc mutations that reduce affinity to the FcRn such as the combination I253A, H310A, and H435A as disclosed by Regula et al. and disclosed by Regula et al. in combination with the Fc mutations L234A, L235A, and P329G to the Fc domains of the 4SD1-3 Wnt surrogate of Li et al. One would have been motivated to do so for the advantages taught by Regula et al. The 4SD1-3 construct meets the Fzd and LRP limitations of claims 1-6 and 9 and Regula et al. discloses the Fc mutations required by instant claims 1-2. The 4SD1-3 construct contains the Fc mutations of instant claim 3.
Claims 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2023/130055, of record, published 6 July 2023, filed 30 December 2022) in view of Regula et al. (U.S. Patent Application Publication 2016/0068613).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). Chen et al. claims priority to 63/398,754 (filed 17 August 2022). This priority document provides basis for the Wnt surrogate of 4DS1-03_LALAPG relied upon in this rejection.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Chen et al. discloses the Wnt surrogate construct 4SD1-03_LALAPG which is formed from SEQ ID NOS: 1 and 2. See abstract and Figure 1. Pharmaceutical compositions are disclosed. SEQ ID NO: 1 corresponds to instant SEQ ID NO: 11. SEQ ID NO: 2 corresponds to instant SEQ ID NO: 12 except for the Fc mutations I253A, H310A, and H435A. (See instant claims 1 and 2.) SEQ ID NO: 2 contains the mutations of instant claim 3. Modifications resulting in reduced affinity to the neonatal Fc Receptor (FcRn) are not disclosed as recited in instant claims 1-2.
Regula et al. is applied as above.
It would have been obvious to make the IgG1 Fc mutations that reduce affinity to the FcRn such as the combination I253A, H310A, and H435A as disclosed by Regula et al. and disclosed by Regula et al. in combination with the Fc mutations L234A, L235A, and P329G to the Fc domains of the 4SD1-03_LALAPG Wnt surrogate of Chen et al. One would have been motivated to do so for the advantages taught by Regula et al. The 4SD1-03 construct meets the Fzd and LRP limitations of claims 1-6 and 9 and Regula et al. discloses the Fc mutations required by instant claims 1-2. The 4SD1-03 construct contains the Fc mutations of instant claim 3.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,773,171 in view of Regula et al. (U.S. Patent Application Publication 2016/0068613).
Issued claim 1 is directed to a soluble, multivalent, multispecific Wnt surrogate molecule, wherein the Wnt surrogate molecule comprises: (i) one or more Fzd binding regions that specifically binds to one or more Frizzled (Fzd) receptors, wherein the one or more Fzd binding regions comprise one or more antibody or antigen-binding fragment of the antibody, wherein the one or more antibody or the antigen-binding fragment comprises: a CDRH1 of SEQ ID NO: 307, a CDRH2 of SEQ ID NO: 501, a CDRH3 of SEQ ID NO: 964, a CDRL1 of SEQ ID NO: 1098, a CDRL2 of SEQ ID NO: 1175, and a CDRL3 of SEQ ID NO: 1372; and (ii) one or more LRP5/6 binding regions that specifically binds to a Low-density lipoprotein (LDL) receptor-related protein 5 (LRP5) and/or a Low-density lipoprotein (LDL) receptor-related protein 6 (LRP6), wherein the one or more LRP5/6 binding regions comprise one or more antibody or antigen-binding fragment of the antibody, wherein the one or more antibody or the antigen-binding fragment comprises: a CDRH1 of SEQ ID NO: 1618, a CDRH2 of SEQ ID NO: 1715, and a CDRH3 of SEQ ID NO: 2012.
Issued claim 3 is directed to the Wnt surrogate molecule of claim 1, wherein the Fzd binding region comprises a full immunoglobulin G (IgG), comprising two light chains and two heavy chains, and the LRP5/6 binding region comprises a VHH.
Issued claim 5 is directed to a pharmaceutical composition.
The issued claims meet the Fzd and LRP structural requirements of the instant claims. The issued claims do not recite modifications resulting in reduced affinity to the neonatal Fc Receptor (FcRn) as recited in instant claims 1-3.
Regula et al. is applied as above.
It would have been obvious to make the IgG1 Fc mutations that reduce affinity to the FcRn such as the combination I253A, H310A, H435A, L234A, L235A, and P329G as disclosed by Regula et al. to the Fc domains of the Wnt surrogates claimed in the ‘171 patent. One would have been motivated to do so for the advantages taught by Regula et al. The antibodies of the claims do not require any particular Fc domain.
Claims 1-6 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,297,278 in view of Regula et al. (U.S. Patent Application Publication 2016/0068613).
Issued claim 1 is directed to a soluble, tetravalent, multispecific Wnt surrogate molecule, wherein the Wnt surrogate molecule comprises: (i) two Fzd binding regions that specifically bind to two Frizzled (Fzd) receptors, wherein each of the two Fzd binding regions comprises an antibody or antigen-binding fragment of the antibody; and (ii) two LRP5/6 binding regions that specifically bind to a Low-density lipoprotein (LDL) receptor-related protein 5 (LRP5) and/or a Low-density lipoprotein (LDL) receptor-related protein 6 (LRP6), wherein each of the two LRP5/6 binding regions comprises an antibody or antigen-binding fragment of the antibody, and wherein each of the two LRP5/6 binding regions is fused to one of the two Fzd binding regions via a linker moiety.
Issued claim 2 is directed to the Wnt surrogate molecule of claim 1, wherein the Fzd binding regions comprise a full immunoglobulin G (IgG), comprising two light chains and two heavy chains, and the LRP5/6 binding regions comprise a VHH.
Issued claim 4 is directed to a pharmaceutical composition.
The issued claims meet the Fzd and LRP structural requirements of the instant claims. The issued claims do not recite modifications resulting in reduced affinity to the neonatal Fc Receptor (FcRn) as recited in instant claims 1-3.
Regula et al. is applied as above.
It would have been obvious to make the IgG1 Fc mutations that reduce affinity to the FcRn such as the combination I253A, H310A, H435A, L234A, L235A, and P329G as disclosed by Regula et al. to the Fc domains of the Wnt surrogates claimed in the ‘278 patent. One would have been motivated to do so for the advantages taught by Regula et al. The antibodies of the claims do not require any particular Fc domain.
Claims 1-6 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 23, and 43-62 of copending Application No. 18/148,448 (9/14/2026 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other.
At least for example, claim 43 is directed to a bispecific antibody formed by SEQ ID NOS: 1 and 2. SEQ ID NO: 1 corresponds to instant SEQ ID NO: 11. SEQ ID NO: 2 corresponds to instant SEQ ID NO: 12 except for the Fc mutations I253A, H310A, and H435A. (See instant claims 1 and 2.) SEQ ID NO: 2 contains the mutations of instant claim 3.
Co-pending claim 1 is directed to a multispecific antibody or antibody fragment comprising at least:
(A) a first antigen-binding region which specifically binds to frizzled class receptor 4 (Fzd4)
and comprises a first heavy chain variable domain (VH1) and a first light chain variable
domain (VL1),
(B) a second antigen-binding region which specifically binds to low density lipoprotein
receptor-related protein 5 and/or 6 (LRP5 and/or LRP6) and comprises at least a second
heavy chain variable domain (VH2),
Co-pending claim 10 recites Fc mutations corresponding to instant claims 1-3. See in particular, claim 10, part (III). The variability permitted by at least co-pending claim 1 (only CDRs defined) and claim 48 would encompass mutations that reduced affinity for the FcRn. Co-pending claim 13 is directed to a pharmaceutical composition.
The co-pending claims encompass and suggest embodiments of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This application is the 371 filing of PCT/US2022/082601 which published as WO 2023/130055.
Claims 1-6 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of Li et al. (U.S. Patent No. 12,606,629, published 21 April 2026, filed 2 July 2020) in view of Regula et al. (U.S. Patent Application Publication 2016/0068613).
Issued claim 1 is directed to an isolated antibody, or an antigen-binding fragment thereof, that binds to Frizzled 1 (Fzd1), comprising a sequence comprising: (i) CDRH1 of SEQ ID NO: 51, CDRH2 of SEQ ID NO: 747 and CDRH3 of SEQ ID NO: 1443; and (ii) CDRL1 of SEQ ID NO: 2139, CDRL2 of SEQ ID NO: 2833 and CDRL3 of SEQ ID NO: 3527.
Issued claim 4 is directed to the isolated antibody, or antigen-binding fragment thereof, of claim 1, wherein the antibody, or antigen-binding fragment thereof, is a fusion protein.
Issued claim 5 is directed to the isolated antibody, or antigen-binding fragment thereof, of claim 4, wherein the antibody, or antigen-binding fragment thereof, is fused to a polypeptide sequence that binds LRP5 or LRP6.
Issued claim 6 is directed to the isolated antibody or antigen binding fragment of claim 1, comprising: a) a variable light chain having at least 90% sequence identity to SEQ ID NO: 22; and b) a variable heavy chain having at least 90% sequence identity to SEQ ID NO: 23. (See certificate of correction and Table 6B for the 033S-B03-35 construct.) SEQ ID NO: 23 contains the mutations of instant claim 3.
Issued claim 8 is directed to a pharmaceutical composition comprising a physiologically acceptable excipient, diluent, or carrier, and a therapeutically effective amount of the isolated antibody, or antigen-binding fragment thereof, according to claim 1.
Issued claim 6 meets the Fzd and LRP structural requirements of the instant claims. The issued claims do not recite modifications resulting in reduced affinity to the neonatal Fc Receptor (FcRn) as recited in instant claims 1-2.
Regula et al. is applied as above.
It would have been obvious to make the IgG1 Fc mutations that reduce affinity to the FcRn such as the combination I253A, H310A, and H435A as disclosed by Regula et al. and disclosed by Regula et al. in combination with the Fc mutations L234A, L235A, and P329G to the Fc domains of the Wnt surrogate in claim 4 of the ‘629 patent One would have been motivated to do so for the advantages taught by Regula et al. The construct comprising SEQ ID NOS: 22 and 23 meets the Fzd and LRP limitations of claims 1-6 and 9 and Regula et al. discloses the Fc mutations required by instant claims 1-2. The construct comprising SEQ ID NOS: 22 and 23 contains the Fc mutations of instant claim 3.
Claims 1-5 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of Li et al. (U.S. Patent No. 11,746,150, of record, published 5 September 2023, filed 19 December 2018) in view of Regula et al. (U.S. Patent Application Publication 2016/0068613).
Issued claim 1 is directed to an isolated antibody, or an antigen-binding fragment thereof, that binds to one or more LRP5 or LRP6 receptor, comprising a sequence comprising: a CDRH1 sequence of SEQ ID NO:107, a CDRH2 sequence of SEQ ID NO:203 and a CDRH3 sequence of SEQ ID NO:452 or any one of SEQ ID NOs: 609-618.
Issued claim 5 is directed to the isolated antibody, or antigen-binding fragment thereof, of claim 1, wherein the antibody, or antigen-binding fragment thereof, comprises a fusion protein.
Issued claim 6 is directed to the isolated antibody, or antigen-binding fragment thereof, of claim 5, wherein the antibody, or antigen-binding fragment thereof, is fused to a polypeptide sequence that binds one or more Frizzled (Fzd) receptors.
Issued claim 11 is directed to a pharmaceutical composition comprising a physiologically acceptable excipient, diluent, or carrier, and a therapeutically effective amount of the isolated antibody, or antigen-binding fragment thereof, according to claim 1.
Issued claim 6 meets the Fzd and LRP structural requirements of the instant claims. The issued claims do not recite modifications resulting in reduced affinity to the neonatal Fc Receptor (FcRn) as recited in instant claims 1-3.
Regula et al. is applied as above.
It would have been obvious to make the IgG1 Fc mutations that reduce affinity to the FcRn such as the combination I253A, H310A, H435A, L234A, L235A, and P329G as disclosed by Regula et al. to the Fc domains of the Wnt surrogates claimed in the ‘150 patent. One would have been motivated to do so for the advantages taught by Regula et al. The antibodies of the claims do not require any particular Fc domain.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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