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/Restriction
Applicant’s election without traverse of Invention I and/or species (i.e., clone 5044 and FZD4), in the reply filed on 01AUG2025 is acknowledged.
Upon further consideration, claims 53 and 54 drawn to the antibody of claim 1, wherein the antibody comprises the amino acid sequence set forth in SEQ ID NO: 302 (i.e., HC) or the amino acid sequence set forth in SEQ ID NO: 300 (i.e., LC), which corresponds to claim 1b or clone 5017, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (i.e., not clone 5044). Claims 10 and 27 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species. Election was made without traverse in the reply filed on 01AUG2025.
Claim Status
Claims 1, 8, 12, 19, 21, 26, 36, and 53-55 have been amended.
Claims 2-7, 9, 11, 14-15, 22-23, 28-35, and 37-52 have been canceled.
Claim 56 is new.
Claims 1, 8, 10, 12-13, 16-21, 24-27, 36, and 53-56 are pending in the instant application (i.e., Claim(s) 1 is/are independent).
Claims 10, 27, and 53-54 are withdrawn.
Claims 1, 8, 12-13, 16-21, 24-26, 36, and 55-56 are examined on the merits.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/CA2020/051103, filed 12AUG2020, which claims the benefit of US Provisional Patent Application No. 62/885,781, filed August 12, 2019, and U.S. provisional application 62/886,292, filed August 13, 2019. Applicant’s claim for the benefit of prior-filed application is acknowledged.
Nucleotide and/or Amino Acid Sequence Disclosures
Applicant’s arguments, see p 15-16, Nucleotide and/or amino acid sequence disclosure section, filed 23FEB2026, with respect to sequence deficiencies has been fully considered and said deficiencies have been withdrawn per the outcome of the interview summary dated 12FEB2026.
Specification
Applicant’s arguments, see p 16, Specification section, filed 23FEB2026, with respect to objections to the specification for minor informalities have been fully considered and said objections to the specification have been withdrawn in view of amendments to the specification filed as part of said response.
Claim Objections
Applicant’s arguments, see p 16, Claim objections section, filed 23FEB2026, with respect to objections to claim(s) 1, 8, 21, 26, and 36 for informalities have been fully considered and said objections to claim(s) 1, 8, 21, 26, and 36 have been withdrawn in view of claim amendments filed as part of said response.
Withdrawn Rejections
Indefiniteness
Applicant’s arguments, see p 17, Claim rejection - 35 USC §112(b) section, filed 23FEB2026, with respect to the rejection(s) of claim(s) 36 and 53-54 (i.e., claim(s) 53-54 have been withdrawn as being drawn to a non-elected species) under 35 USC §112(b) have been fully considered and said rejections of claim(s) 36 and 53-54 have been withdrawn in view of the claim amendments filed as part of said response.
Dependency
Applicant’s arguments, see p 17, Claim rejection - 35 USC §112(d) section, filed 23FEB2026, with respect to the rejection(s) of claim(s) 19 under 35 USC §112(d) have been fully considered and said rejections of claim(s) 19 have been withdrawn in view of the claim amendments filed as part of said response.
Scope of Enablement
Applicant’s arguments, see 17-19, Enablement - 35 USC §112(a) section, filed 23FWB2026, with respect to the rejection(s) of claim(s) 1, 8, 12-13, 16-26, 36, and 53-55 (i.e., claim(s) 22-23 have been cancelled and claims 53-54 have been withdrawn as being drawn to a non-elected species) under 35 USC §112(a) - enablement have been fully considered and said rejections of claim(s) 1, 8, 12-13, 16-21, 24-26, 36, and 53-55 have been withdrawn in view of the claim amendments filed as part of said response.
Written Description
Applicant’s arguments, see p 19, Written description - 35 USC §112(a) section, filed 23FEB2026, with respect to the rejection(s) of claim(s) 1, 8, 12-13, 16-20, 22-26, 36, and 53-55 (i.e., claim(s) 22-23 have been cancelled and claims 53-54 have been withdrawn as being drawn to a non-elected species) under 35 USC §112(a) – written description have been fully considered and said rejections of claim(s) 1, 8, 12-13, 16-20, 24-26, 36, and 53-55 have been withdrawn in view of the claim amendments filed as part of said response.
Double Patenting
Applicant’s arguments, see p 19-20, Double patenting section, filed 23FEB2026, with respect to the rejection(s) of claim(s) 1, 8, 12-13, 18-19, 21, 24, and 55 under provisional non-statutory double patenting as being unpatentable over claims 1, 3-4, 8-10, 12, 15-17, 19-21, 23, 26, 31, 41, 43, 53, 55, and 58 of co-pending Application No. 17/801624 have been fully considered and said rejections of claim(s) 1, 8, 12-13, 18-19, 21, 24, and 55 are moot because the Applicant is Surrozen Inc, which is a different entity than AntlerA Therapeutics, Inc of the instant application.
Claim Rejections - 35 USC § 112
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.
Written Description
Claim 21 stands 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.
Claim 21, which recites, “The antibody of claim 1, wherein the antibody is a bispecific antibody that further binds to LRP 5/6” does not require the LRP 5/6 binding moiety of the bispecific antibody to have any function apart from binding LRP 5/6. In this instance, while there is sufficient written description for the function of antibodies having both VH and VL pairs comprised of HCDRs1-3 and LCDRs1-3 consisting of specific SEQ ID NOs, no claims recite any specific or particular structure of the bispecific antibody that gives rise to the specific LRP 5/6 binding functions and the specification does not provide sufficient support of the bispecific antibodies.
Artisans are well aware that knowledge of a given antigen (for instance a specific epitope of LRP 5/6) provides no information concerning the sequence/structure of antibodies that bind the given antigen. For example, Edwards et al. teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences spanning almost the entire heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines, and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well (Edwards, et al., J Mol Biol, 2003, 334, 103-118, see entire document). Goel et al. disclose the synthesis of three monoclonal antibodies that bind to the same short (12-mer) peptide and found that the sequences of these antibodies which bound the same epitope exhibited diverse V gene usage indicating their independent germline origin (Goel, et al., J Immunol, 2004, 173, 7358-7367, see entire document). Further, it should be noted that degenerate binding of the same structural motif by antibodies does not require the existence of sequence homology or identity at any of their CDRs or other chemical similarities at the antigen-binding sites; side chain mobility of epitope residues can confer steric and electrostatic complementarity to differently shaped combining sites, allowing functional mimicry to occur (Lescar et al., J Biol Chem, 1995, 270, 18067-18076, see entire document, in particular Abstract and Discussion). As such, it does not seem possible to predict the sequence/structure of an antibody that binds a given antigen as there does not appear to be any common or core structure present within all antibodies that gives rise to the function of antigen binding. Further, given data such as that of Edwards et al. indicating the diversity of sequence bound in a population of antibodies that bind to a given antigen no number of species appears to reasonably representative of the breadth of the genus of antibodies that bind the given antigen.
Applicant argues that amendment of claim 1 by removing the “/or” limitation resolves the alleged written description deficiency of claim 1 and dependent claims.
RESPONSE
Applicant’s arguments have been fully considered but are found non-persuasive essentially for the reasons of record and as described further below.
As set forth in the rejection of record, the specification provides neither a representative number of the encompassed bispecific anti-FZD x LRP 5/6 structures, nor does it provide a descriptive of structural features that are common to the encompassed bispecific anti-FZD x LRP 5/6 structures.
Therefore, because the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the artisan cannot envision the detailed structure of the encompassed multispecific antigen-binding molecules, antibodies, and non-antibody proteins and therefore Applicant was not in possession of the instant claimed invention.
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, 8, 12-13, 18-21, 24-26, 36, and 55 stand provisionally rejected and claim 56 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of co-pending Application No. 18/267914; herein referred to as the “reference application” in view of Fauteux, et al., (Oncotarget, 2015, 7, 2555-2571); herein referred to as “Fauteux.”
The co-pending claims of the reference application recite: A tetravalent binding antibody molecule comprising: a) an Fc domain or fragment thereof comprising CH3; b) a bivalent low-density LRP binding domain; and c) a bivalent FZD binding domain, wherein the LRP binding domain is attached to one terminus of the Fc domain and the FZD binding domain is attached to the other end of the Fc domain, wherein the LRP binding domain is selected from the group consisting of: a diabody that binds LRP5, etc.; and wherein the FZD binding domain is selected from the group consisting of: a diabody, two scFv, and two Fab that bind one or more of FZD 1-10, wherein the LRP binding domain binds only LRP5, the FZD binding domain binds a FZD selected from FZD1, 2, 3, 5, 6, 7, 8, 9, 10, and combinations thereof (i.e., claim 1). The tetravalent binding antibody molecule of claim 1, wherein the LRP binding domain and/or the FZD binding domain is bispecific; or wherein the LRP binding domain binds LRP6 or binds LRP5 and LRP6, and the FZD binding domain binds a FZD selected from the group consisting of FZD1-10 (i.e., claims 6 or 14). The tetravalent binding antibody of claim 14, wherein the FZD binding domain binds FZD4 or FZD5 (i.e., claim 15). The antibody of claim 15, wherein the FZD binding domain comprises two Fabs that bind FZD4 or FZD5 or multiple FZD (i.e., claim 16). The antibody of claim 16, wherein the FZD-binding Fab comprise a LC CDRs1-3 and HC CDRs1-3 of an antibody of Table 1, 2, or 6 (i.e., see Table 1 antibody ID 5044, p 52 of the originally filed specification) (i.e., claim 17). A pharmaceutical composition comprising a tetravalent binding antibody molecule of claim 1 and a pharmaceutically acceptable carrier (i.e., claim 39).
However they do not claim: an immunoconjugate comprising the antibody that specifically binds one or more of FZD 1, 2, 4, 5, 7, 8, or 9 and a detectable or cytotoxic agent, wherein the agent is selected from maytansinoids, etc., or a pharmaceutical composition thereof.
Nevertheless, Fauteux teaches 50 cell membrane targets which are overexpressed in three major breast cancer subtypes as compared with a range of vital organs and tissues, including FZD7, for developing ADCs which effectively deliver a cytotoxin such as DM1 (i.e., maytansinoids) to the target, and in this instance would be used to treat breast cancer (see entire document, specifically see abstract section, Table 1, and Table 3).
It would have been obvious to artisans to modify the co-pending product of a FZD binding domain which binds FZD 1, 2, 4, 5, 7, 8, or 9 of a tetravalent antibody comprising HCDRs1-3 and LCDRs1-3 of clone 5044 as listed in Table 1, p 53 of the reference application, which are 100% query match to the HCDRs1-3 and LCDRs1-3 of clone 5044 of the instant application (see OA.APPENDIX), by conjugating a drug, such as DM1, and utilize said ADC in a pharmaceutical composition as taught by Fauteux because FZD7 is a target that is overexpressed in three major breast cancer subtypes and provides an effective target for the cytotoxin in treating breast cancer. One would have been motivated to do so, given the direction by Fauteux that FZD7 is a top 50 target for ADC and treating breast cancer. There would have been a reasonable expectation of success, given the knowledge that ADCs with a critical target that is overexpressed in the cancer as compared with other vital organs, such as FZD7, provides optimal candidates for targeting cancer specific targets with a cytotoxin, such as DM1. Additionally, it would be obvious to artisans to simply substitute the anti-FZD antibodies in the co-pending pharmaceutical composition with the anti-FZD immunoconjugate as taught by Fauteux because it would provide a predictable composition of the immunoconjugate and a pharmaceutically acceptable diluent or carrier.
Furthermore, the office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., the FZD binding domain is specific for FZD4, preferentially binds FZD4 compared to other FZD receptors, or blocks binding of Wnt to FZD)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Applicant argues that claims 1-46 of co-pending Application No. 18/267914 does not claim the earliest priority.
RESPONSE
Applicant’s arguments have been fully considered but are found non-persuasive essentially for the reasons of record and as further described supra.
Applicant has asked that the provisional nonstatutory double patenting rejections be withdrawn. Until Applicant has resolved all outstanding rejections and has amended the claims of the instant or co-pending application to provide patentable distinctiveness the provisional nonstatutory double patenting rejections are maintained.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 16-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 16-17 are objected to.
Claims 1, 8, 12-13, 18-21, 24-26, 36, and 55-56 are rejected.
THIS ACTION IS MADE FINAL. 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 SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM 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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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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