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 .
Response to Restriction
Applicant’s election without traverse of Group I (i.e., claims 1-4, 8-13, 15-21, 24, and 46-60), Species A (i.e., emibetuzumab), and Species B (i.e., MYT4849, also Seq ID Nos: 146 and 284) in the reply filed on 6 May 2025 is acknowledged (see Response to Restriction received 05/06/2025 pg. 26, 1st para).
Status of the Claims
Claims 1-45 were originally filed 27 January 2022. The preliminary amendment filed 26 July 2022 has been entered. Claims 42-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group (i.e., Group II), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 May 2025 (see Response to Restriction received 05/06/2025 pg. 26, 1st para). Claims 1-4, 8-13, 15-21, 24, 41, and 46-60 are under consideration.
Information Disclosure Statement
The application has 2 IDSs filed 23 January 2026 which are duplicates of each other; therefore, the second one has not been considered.
Priority
The priority date for the instant claims 1-4, 8-13, 15-21, 24, 41, and 46-60 will be 30 July 2020 (i.e., PCT/US2020/044263) for the reasons made of record.
Claim Interpretation
Claims 1, 4, 21, and 24 are drawn to antibodies comprising CDRs in particular Seq ID Nos. The specification does not provide a limiting definition for CDRs; however, discloses CDRs were determined from methods described by Kabat et al. and IMGT (see specification pg. 533, 2nd para, 2nd sentence, see IDS dated 01/10/2023 #63). It is noted the Kabat et al. reference is not cited on any of the IDSs provided by Applicant nor was a copy provided. The specification teaches residues falling under either or both Kabat and IMGT CDR definitions were called as CDR residues. Therefore, the language of claims 1, 4, 21, and 24 regarding “the heavy chain CDRs” or “the light chain CDRs” in a particular Seq ID No encompass CDRs defined using Kabat, IMGT, or both numbering systems (see MPEP § 2111).
Withdrawn Claim Objections
In view of Applicant’s amendments to claims 11 and 52 the claim objections are hereby withdrawn.
Withdrawn Rejections
In view of Applicant amending claims 1, 4, 21, and 24 to remove “about” (i.e., relative term) the 35 USC 112(b) rejection is hereby withdrawn.
In view of Applicant amending claims 8 and 49 to clarify the wherein clauses the 35 USC 112(b) rejection is hereby withdrawn.
In view of Applicant amending claims 16 and 57 to remove recitation of a VH domain, VHH domain, or a VNAR domain the 35 USC 112(b) and 35 USC 112(d) rejections are hereby withdrawn.
In view of Applicant amending claims 50-52 to remove recitation of a composition the 35 USC 112(b) rejection is hereby withdrawn.
In view of Applicant filing terminal disclaimers over copending Applications 18/535713 and 18/273078 the non-statutory double patenting rejections are hereby withdrawn.
Maintained Claim Rejections - 35 USC § 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.
Scope Enablement
Claims 1-4, 8-13, 15-21, 24, 41, and 46-60 are 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 anti-MET antibodies with particular VH and VL sequences (i.e., CDRs with specific substitutions or specific combinations of substitutions), does not reasonably provide enablement for the following:
A MET ABPC or MET epitope binding ABPC comprising a heavy chain variable region and light chain variable region with particular histidine substitution combinations (i.e., i. either a VH or VL paired with a corresponding domain comprising “a tolerated histidine CDR substitution variant thereof” or ii. antibodies comprising the particular histidine substitutions paired with the light chain CDRs of SEQ ID No: 2 and any framework region) with the functional properties recited in claims 1, 2, 4, 8-11, 19, 21, 24, 46, 47, 49-52, and 55
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 the invention commensurate in scope with these claims.
Applicant's arguments filed 23 January 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues in view of claim amendments to eliminate VH, VHH, and VNAR structures as well as disclosure of Exhibits A and B are sufficient to overcome the 35 USC 112(a) (i.e., scope of enablement) (see Remarks pg. 38 last para, pg. 40, 1st full para, Exhibits A and B).
First, claims 1, 4, 8, 21, 24, and 49 remain drawn to broad genera of antibodies. Specifically, claim 1 is drawn to antigen binding domains that specifically bind MET or a MET epitope comprising VH domains with histidine substitutions at particular positions (up to 4) paired with either i. the light chain CDRs in Seq ID NO: 2 or ii. a tolerated histidine substitution variant thereof. This is a genus of antibodies wherein the VL can comprise CDRs derived from any art recognized numbering scheme with any framework region. In addition, the VH can be paired with a VL wherein there are any number of histidine substitutions in the CDR regions so long as they are “tolerated”. It is unclear what substitutions are or are not considered tolerated. In so far as Applicant intends to encompass any combination of histidine substitutions while maintaining binding and possessing the claimed functional properties as a result of the substitutions in the VH domain this is a broad genus of antibodies. Likewise claim 1 is drawn to limitations in the inverse wherein the VL has histidine substitutions in particular positions (up to 3). It is noted the language of claim 1 encompasses wherein the VH comprises a tolerated “histidine or alanine CDR substitution”. These alternatives extend to 4 independent parent antibodies across all claims. Claims 4, 21, and 24 are drawn to identical limitations in the particular genera of antigen binding domains while differentiating based on what the binding domain is conjugated to or the composition. Claims 8 and 49 are drawn to a genera of antibodies wherein a particular VH or VL is paired with any one of the corresponding variable region selected from a group. Thus, the claims remain drawn to a genera of unpredictable antibodies which extends beyond what is disclosed in Exhibits A and B.
Second, Tables I and II are drawn to particular combinations of VH and VL Seq ID Nos. with various antigen binding properties (see Remarks pg. 38 last para, Exhibits A and B). Even if the claims were limited to those particular antibodies disclosed in Exhibits A and B it would not be enabled for the breadth of antibodies disclosed. For example, claim 1b is drawn to emibetuzumab variants wherein Applicant discloses at least half the antibodies are scored as a 5 (i.e., “variant exhibited significantly lower affinity as compared to its parent, but it did not appear to exhibit pH-dependent binding” (see Remarks pg. 39, 1st para) which means these antibodies do not meet the corresponding functional limitations (i.e., pH sensitive binding). In addition, several claimed antibodies do not exhibit antigen binding at all (i.e., “obliterated MET binding” (see Remarks pg. 38 last para) such as antibodies comprising i. Seq ID Nos. 146 and 299 (MYT 4341), 146 and 302 (MYT 4344), or 146 and 303 (MYT4345) (see Exhibit A pg. 6 middle). Further, Applicant provides evidence that even among the disclosed structures in Exhibits A and B that further combinations are highly unpredictable. For example, a histidine substitution in the VH at position 31 (i.e., see Exhibit A pg. 4, MYT2319 comprising Seq ID Nos: 159 and 147)) and in the VL at position 92 (i.e., see Exhibit A pg. 5 first line, MYT3979 comprising Seq ID Nos: 146 and 210) had no antigen binding (i.e., a score of 2) (see Exhibit B pg. 3, MYT4021 comprising Seq ID Nos: 159 and 210) while the respective single variants had favorable properties (i.e., scores of 3). Therefore, Applicant’s Exhibits demonstrate that a substantial number of claimed antibodies are not enabled for the claimed functional properties and supports the unpredictability of combining even favorable variants.
Therefore, given the claims are drawn to large genera of MET antigen binding domains or MET epitope binding that extends beyond what is disclosed in the exhibits, the breadth of disclosed/claimed antibodies in Exhibits A and B which do not meet the functional limitations of the claims, the unpredictability in combining variants, and the reasons made of record the 35 USC 112(a) rejection is hereby maintained.
Examiner suggests amending the claims to recite particular pairs of VH and VL sequences which have the functional properties claimed as set forth in Exhibits A and B (i.e., a score of 3 from Exhibits A and B).
Written Description
Claims 1-4, 8-13, 15-21, 24, 41, and 46-60 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 claims contain 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.
Applicant's arguments filed 23 January 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues in view of claim amendments to eliminate VH, VHH, and VNAR structures as well as disclosure of Exhibits A and B are sufficient to overcome the 35 USC 112(a) (i.e., written description) (see Remarks pg. 40 middle para, Exhibits A and B).
Therefore, for the reasons set for above and the reasons made of record the 35 USC 112(a) (i.e., written description) rejection is hereby maintained.
Maintained Claim Rejections - 35 USC § 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.
Claims 4, 9-11, 19, 21, 24, 49, 50-52, and 57 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.
Claims 21, and 24 are drawn to ABPC with a faster or greater (e.g., 1 fold) dissociation rate or KD, respectively. It is unclear how the “control ABPC” can be both the measure by which ABPC are determined as within the scope (i.e., faster or greater than the “control APBC”) implying the control ABPC is not within the scope of claims yet the definition of “a control ABPC” with a dissociation rate or a KD between 0.1-3 fold faster or greater at a pH of about 4-6.5 than a pH of about 7-8 is within the scope of claims.
Claims 4, 9-11, 19, 24, and 50-52 are drawn to functional properties compared to “a control ABPC”. As stated above the specification defines “a control ABPC” as capable of binding MET or an epitope of MET on the surface and either a dissociation rate or a KD between 0.1-3 fold faster or greater at a pH of about 4-6.5 than a pH of about 7-8 or the parental antibody (no substitutions) of those disclosed in the working examples (e.g., emibetuzumab) (see specification para spanning pgs. 20-21).
Applicant's arguments filed 23 January 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the definition in the specification and the examples of control ABPCs describe in the specification are sufficient to make “a control ABPC” clear and definite. However, while the specification uses the particular parent antibodies as a control ABPC the definition of a “control ABPC” provided in the specification is much broader and non-limiting:
“means (i) an ABPC that is capable of specifically binding to MET or and epitope of MET presented on the surface of a mammalian cell (e.g., a target mammalian cell), where one or both of the following is true: (a) the dissociation rate of the first antigen binding domain at a pH of about 4.0 to about 6.5 (e.g., any of the subranges of this range described herein) is no more than 3-fold... faster than the dissociation rate at a pH of about 7.0 to about 8.0 (e.g., any of the subranges of this range described herein...); or (b) the dissociation constant (KD) of the first antigen-binding domain at a pH of about 4.0 to about 6.5 (e.g., any of the subranges of this range described herein) is no more than 3-fold... greater than the KD at a pH of about 7.0 to about 8.0 (e.g., any of the subranges of this range described herein); and/or (ii) Telisotuzumab; and/or (iii) Emibetuzumab; and/or (iv) hucMET27Gv1.3; and/or (v) P3D12 (Tanabe)” (see specification para spanning pgs. 20-21).
Therefore, the 35 USC 112(b) rejection of “a control ABPC” is hereby maintained. Examiner suggest amending the claims to recite wherein the control ABPC is a particular set of Seq ID Nos.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Improper Markush Group
Claims 1, 4, 8, 21, 24, and 49 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
Applicant's arguments filed 23 January 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the claims have been amended to remove Markush language and therefore the rejection should be withdrawn (see Remarks pg. 41 last para).
Pursuant to MPEP § 2117(I, second para), treatment of claims reciting alternatives is not governed by the particular format used (e.g., alternatives may be set forth as "a material selected from the group consisting of A, B, and C" or "wherein the material is A, B, or C"). See, e.g., the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications ("Supplementary Guidelines"), 76 Fed. Reg. 7162 (February 9, 2011). Claims that set forth a list of alternatives from which a selection is to be made are typically referred to as Markush claims, after the appellant in Ex parte Markush, 1925 Dec. Comm’r Pat. 126, 127 (1924). Although the term "Markush claim" is used throughout the MPEP, any claim that recites alternatively usable members, regardless of format, should be treated as a Markush claim.
Therefore, removal of Markush language from the claims does not overcome the Markush group rejection. Given the claims are a large list of alternatives and the reasons made of record the 35 USC 112(d) (i.e., Markush group) rejection is hereby maintained.
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 1-4, 8-13, 18-21, 24, 41, 46-55, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9, and 10 of U.S. Patent No. 12,331,125 B2 (referred to herein as the ‘125 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 17, 21, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9, and 10 of U.S. Patent No. 12,331,125 B2 (referred to herein as the ‘125 patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 15, 16, 21, 56, and 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9, and 10 of U.S. Patent No. 12,331,125 B2 (referred to herein as the ‘125 patent) and U.S. Patent No. 10,383,948 (referred to herein as Allan, as cited on the IDS 03/15/2024 #2) as evidenced by Murtaugh. Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed 23 January 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant wishes to hold these non-statutory double patenting rejections in abeyance until otherwise allowable subject matter has been identified (see Remarks pg. 42, 2nd-4th para).
As no allowable subject matter has been identified the non-statutory double patenting rejections are maintained for the reasons made of record.
The following rejections are necessitated by amendment.
Claim Rejections - 35 USC § 112(a)
See above for statue.
New Matter
Claims 1-4, 8-13, 15-21, 24, 41, 46-60 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.
Claims 1, 4, 21, and 24 are drawn to “a tolerated histidine CDR substitution variant thereof” or “a tolerated histidine or alanine substitution variant thereof” (e.g., see claim 1, pg. 3 lines 1-2 and 3-4, pg. 4 lines 5-6 and 7-8, pg. 5 lines 8-9 and 10-11). Applicant has pointed to previous claims 18 and 59 and the last paragraph on pg. 16 (see Remarks pg. 38, 2nd para). However, previous claims 18 and 59 are drawn to the overall structure of the antibody (i.e., comprising a VH and VL) and the last paragraph on page 16 is drawn to assays that can be used isolating targets from the endosome and lysosomal pathways (see specification last para on pg. 16). Therefore, the claim amendments are drawn to a genus of VH and VL sequences that reaches beyond the specification as originally filed.
Claim Rejections - 35 USC 112(b)
See above for the statue.
Claims 1-4, 9-13, 15-21, 24, 41, 46-48, and 50-60 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.
Claims 1, 4, 21, and 24 are drawn to “a tolerated histidine CDR substitution variant thereof” or “a tolerated histidine or alanine substitution variant thereof”. It is unclear when a histidine or alanine substation is tolerated. For example, is the substitution tolerated when the claimed functional outcomes are met or alternatively as long as antigen binding is maintained.
Conclusion
No claim allowed.
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.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644
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