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 .
Claim Status
Claims 1-36 have been cancelled; claims 37-39 have been amended; and, claims 49-50 have been newly added, as requested in the amendment filed on 05/08/2026. Following the amendment, claims 37-50 are pending in the instant application.
Claims 41-42 and 45-48 stand as withdrawn, and new claim 50 is also withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions in the Response filed 10/28/2025, there being no allowable generic or linking claim.
Claims 37-40, 43-44, and 49 are under examination in the instant office action.
It is specifically noted that the examined species corresponding to an anti-BCMA antibody comprising: (i) HCDRs1-3 set forth in SEQ ID NOs: 26, 78, and 136, respectively; (ii) a VH comprising SEQ ID NO: 251; and (iii) a heavy chain comprising SEQ ID NO: 319 is allowable, and as a result the additional antibody species corresponding to the additionally recited sequences in claims 37-39 have been rejoined for examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Furthermore, it is noted that an English translation of the foreign priority document has been provided, and as such the claim to foreign priority has been perfected.
Claims 37-40, 43-44, and 49 have an effective filing date of June 30, 2020 corresponding to CN202010618158.0.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/08/2026 and 06/17/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112 Withdrawn
Claims 37, 40, 43, and 44 were 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. Applicant has amended independent claim 37 such that the claim now recites the following language: “HCDR1, HCDR2 and HCDR3 comprising the amino acid sequences of…”. It is noted that this claim language as pertains to the recited CDR sequences is closed sequence claim language, wherein the claims now require the full-length CDR sequences, which are adequately described by the instant specification. As such, the rejection of claims 37, 40, 43, and 44 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 is withdrawn.
Claim Rejections - 35 USC § 102 - Withdrawn
Claims 37, 40, and 43 were rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2016/0046724 A1 (previously cited on PTO-892; herein after referred to as "Brogdon"). Applicant has amended independent claim 37 such that the claim now recites the following language: “HCDR1, HCDR2 and HCDR3 comprising the amino acid sequences of…”. It is noted that this claim language as pertains to the recited CDR sequences is closed sequence claim language, wherein the claims now require the full-length CDR sequences, and in order for a reference to anticipate claim 37 said reference must recite exact matched to the recited CDR sequences. Brogdon does not disclose anti-BCMA antibodies comprising the instantly claimed full-length HCDR sets. As such, the rejection of claims 37, 40, and 43 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Brogdon is withdrawn.
Claim Rejections - 35 USC § 103 - Withdrawn
Claim 44 was rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0046724 A1 (previously cited on PTO-892; herein after referred to as "Brogdon"). As noted above, Applicant has amended independent claim 37 such that the claim now recites the following language: “HCDR1, HCDR2 and HCDR3 comprising the amino acid sequences of…”. It is noted that this claim language as pertains to the recited CDR sequences is closed sequence claim language, wherein the claims now require the full-length CDR sequences. Brogdon does not disclose anti-BCMA antibodies comprising the instantly claimed full-length HCDR sets, and as such does render obvious a combination of kits comprising such anti-BCMA antibodies. As such, the rejection of claim 44 under 35 U.S.C. 103 as being unpatentable over Brogdon is withdrawn.
Double Patenting - Withdrawn
Claims 39-40 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 14, and 28 of copending Application No. 17/764,308 (herein after referred to as "first reference application").
Claims 39-40 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 28, and 64 of copending Application No. 18/256,422 (herein after referred to as "second reference application").
With regard to the above-listed claim rejections under nonstatutory double patenting, it is noted that the copending applications have been amended such that they no longer claim an anti-BCMA antibody that reads on the instantly elected species of anti-BCMA antibody comprising: (i) HCDRs1-3 set forth in SEQ ID NOs: 26, 78, and 136, respectively; (ii) a VH comprising SEQ ID NO: 251; and/or (iii) a heavy chain comprising SEQ ID NO: 319. It is further noted that the copending applications do not claim an anti-BCMA antibody that reads on/comprises the instantly recited full-length VH and/or heavy chain sequences of instant claims 39-40. As such, the above-listed claim rejections under nonstatutory double patenting are withdrawn.
Drawings - Objection Maintained
It is noted that Applicant has filed replacement drawing sheets. However, the drawings stand as objected to because Figure 65A-H still comprises text that is blurry and very difficult to read and/or illegible, specifically with regard to the tables and/or labels of the HPLC chromatograms. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
It is noted that claim 37 has been amended to recites the following language: “HCDR1, HCDR2 and HCDR3 comprising the amino acid sequences of…”. It is noted that this claim language as pertains to the recited CDR sequences is closed sequence claim language, wherein exact matches to the full-length sequences satisfy the sequence limitations.
It is noted that claims 38-39 recite the following the claim language with respect to VH and heavy chain sequences, respectively: “comprises the amino acid sequence of any one of…”. It is noted that this claim language as pertains to the recited VH and heavy chain sequences (claim 38 and 39, respectively) is closed sequence claim language, wherein exact matches to the full-length sequences are required to satisfy the sequence limitations.
Art-Free Subject Matter
It is noted that the sequences of the instantly elected species of anti-BCMA antibody comprising: (i) HCDRs1-3 set forth in SEQ ID NOs: 26, 78, and 136, respectively; (ii) a VH comprising SEQ ID NO: 251; and (iii) a heavy chain comprising SEQ ID NO: 319 has been thoroughly searched. It is specifically noted, that there are no 100% matches to the above-listed sequences disclosed in the prior art. As such, the search has been expanded to include the additionally claimed antibody species of the pending claims (see claims 37-39). It is noted that the additional species have been thoroughly searched, and there are no 100% matches to an anti-BCMA antibody comprising: (i) the additional HCDR sets of instant claim 37; (ii) a VH comprising any one of SEQ ID NOs: 265-280 and 248-250; and (iii) a heavy chain comprising any one of SEQ ID NOs: 330-345 and 316-318. However, it is noted that some of the additional species of the instant claims suffer from deficiencies under nonstatutory double patenting.
Claim Objections - New as Necessitated by Amendment
Claims 39-40 are objected to as being dependent upon a rejected base claim (see the double patenting section below), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Double Patenting - Maintained
The below-listed claim rejections are maintained, updated only to reflect the results of the expanded species search in view of Applicant’s claim amendments.
Claims 37-38 and 43 stand as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 14, and 28 of copending Application No. 17/764,308 (herein after referred to as "first reference application"). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-2 of the first reference application are drawn to a monoclonal antibody or antigen binding fragment thereof targeting BCMA and comprising a heavy chain variable region wherein: (i) the heavy chain variable region comprises HCDRs1-3 comprising the amino acid sequences of SEQ ID NOs: 26, 37, and 41 and (ii) the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 60. It is noted that first reference application SEQ ID NOs: 26, 37, 41, and 60 are 100% matches to instant SEQ ID NOs: 15, 75, 133, and 248, respectively. Claim 14 of the first reference application is drawn to a pharmaceutical composition comprising the monoclonal antibody or antigen binding fragments thereof targeting BCMA of claim 1, and a pharmaceutically acceptable carrier. First reference application claim 28 further limits the monoclonal antibody or antigen binding fragments thereof of targeting BCMA of claim 2, wherein the monoclonal antibody comprises a heavy chain having an amino acid sequence of SEQ ID NO: 7. It is specifically noted that first reference application SEQ ID NO: 7 comprises a 100% match for instant SEQ ID NO: 248. Thus, the claims of the first reference application read on the anti-BCMA antibody of instant claims 37-38 and the pharmaceutical composition of instant claim 43.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 44 stands as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13, 15, and 28 of copending Application No. 17/764,308 (herein after referred to as "first reference application") in view of US 2016/0046724 A1 (previously cited on PTO-892; herein after referred to as “Brogdon”).
The disclosure of claims 1-2, 14, and 28 of the first reference application are detailed above. Additionally, it is noted that first reference application claim 15 is drawn to a method of treating cancer comprising administering an effective amount of the monoclonal antibody or antigen-binding fragments thereof targeting BCMA of claim 1 to a subject. However, it is noted that the first reference application does not claim kits, including a first and second kit comprising an anti-BCMA antibody and additional antibody or pharmaceutical composition for treating cancer, respectively. This deficiency is remedied by Brogdon.
Brogdon discloses compositions and methods for treating diseases associated with BCMA expression and chimeric antigen receptors (CARs) specific to BCMA that comprise a BCMA binding domain (Abstract). It is further noted that the antigen-binding domains of the invention may be a human or humanized antibody or antibody fragment that specifically binds to BCMA (Paragraph 0031); “antibody fragment” refers to at least one portion of an intact antibody, or recombinant variants thereof, and refers to the antigen binding domain, e.g., an antigenic determining variable region of an intact antibody, that is sufficient to confer recognition and specific binding of the antibody fragment to a target, such as an antigen, wherein examples of antibody fragments include, but are not limited to, Fab, Fab′, F(ab′)2, and Fv fragments, scFv antibody fragments, linear antibodies, single domain antibodies such as sdAb (either VL or VH), camelid VHH domains, and multi-specific molecules formed from antibody fragments such as a bivalent fragment comprising two or more, e.g., two, Fab fragments linked by a disulfide bridge at the hinge region, or two or more, e.g., two isolated CDR or other epitope binding fragments of an antibody linked further wherein an antibody fragment can also be incorporated into single domain antibodies, maxibodies, minibodies, nanobodies, intrabodies, diabodies, triabodies, tetrabodies, v-NAR and bis-scFv (Paragraph 0176). In certain embodiments, the BCMA CAR molecules or the anti-BCMA binding domain of the invention include one, two, or three CDRs from the heavy chain variable region as provided in Table 22 (Paragraph 0086). It is specifically noted that, for example, the antibody designated as C9178-G4 from Table 22 comprises: (i) HCDR1 of sequence GFTFSSY; (ii) HCDR2 of sequence SGSGGS; and (iii) HCDR3 of sequence MGWSSGYLCAFDI; the bolded portions of the sequences correspond to sequence fragments comprised within instantly claimed SEQ ID NOs: 26, 78, and 136, respectively. Thus, Brogdon discloses CARs which comprise antigen binding domains, which may be an antibody or antibody fragment, wherein antibody fragments include single domain antibodies only comprising a VH/HCDRs1-3 (i.e., VHH antibody), wherein said antibody or antibody fragment is specific for BCMA and may comprise fragments of the instantly claimed HCDRs. Brogdon further discloses, in one embodiment, the cells expressing a CAR molecule, e.g., a CAR molecule described by the invention, may be administered in combination with an agent that treats the disease associated with BCMA, wherein exemplary diseases to be treated include cancer (i.e., a CAR molecule of the invention may be administered in combination with an agent that treats cancer) (Paragraphs 0073-0076). Brogdon specifically discloses methods for preventing relapse of cancer associated with BCMA-expressing cells, the methods comprising administering to a subject in need thereof an anti-BCMA CAR-expressing cell (e.g., BCMA CART cell or BCMA CAR-expressing NK cell) of the invention that binds to the BCMA-expressing cell wherein, in one aspect, the methods comprise administering to the subject in need thereof an effective amount of an anti-BCMA CAR-expressing cell (e.g., BCMA CAR-T cell or BCMA CAR-expressing NK cell) of the invention that binds to the BCMA-expressing cell in combination with an effective amount of another therapy (Paragraph 0699). It is noted that the term "combination" refers to either a fixed combination in one dosage unit form, or a combined administration where a compound of the present invention and a combination partner (e.g. another drug, also referred to as "therapeutic agent" or "co-agent") may be administered independently at the same time or separately within time intervals, especially where these time intervals allow that the combination partners show a cooperative, e.g. synergistic effect; the single components may be packaged in a kit or separately (Paragraph 0189; emphasis added). It is noted that while Brogdon does not explicitly mention an embodiment wherein the CAR molecule and another therapy are provided in a first and second kit, Brogdon does suggest that single components may be packaged in a kit or separately; thus, one of ordinary skill in the art would recognize that the individual components could be provided in separate kits for the treatment of cancer.
Thus, it would have been obvious to one of ordinary skill in the art that the anti-BCMA antibody, useful for treating cancer, of the first reference application and another therapy (i.e., for treating cancer) could be used in combination, as suggested by Brogdon, wherein said antibody and another therapy could be provided in a first and second kit, respectively, because Brogdon suggests combining BCMA-targeting therapy (i.e., CARs) with another therapy, wherein the single components of such a combination may be packaged in a kit or separately, and one of ordinary skill in the art would recognize that the individual components could be provided in separate kits for the treatment of cancer because combining prior art elements according to known methods would be expected to yield predictable results; one kit providing two active agents, which may be administered separately as suggested by Brogdon, would serve the same purpose as a first and second kit used to provide the same combination of active ingredients useful for the same purpose (i.e., treating cancer, specifically BCMA-expressing cancer).
This is a provisional nonstatutory double patenting rejection.
Claims 37-38 and 43 stand as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 28, and 64 of copending Application No. 18/256,422 (herein after referred to as "second reference application"). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the second reference application is drawn to a protein-drug conjugate generally comprising an antigen-binding protein moiety and a drug conjugate moiety wherein the antigen-binding protein moiety comprises one or more antigen-binding fragments. Second reference application claim 21 further limits the protein-drug conjugate of claim 1, wherein the one or more antigen-binding fragments each independently comprise HCDR1, HCDR2, and HCDR3, and the antigen-binding fragments may comprise amino acid sequences of SEQ ID NOs: 14, 29, and 42, respectively, and/or wherein the one or more antigen-binding fragments each independently comprise a VH comprising an amino acid sequence set forth in, for example, SEQ ID NO: 62. It is specifically noted that second reference application SEQ ID NOs: 14, 29, 42, and 62 are 100% matches to instant SEQ ID NOs: 35, 76, 136, and 272, respectively. Second reference application claim 28 further limits the protein-drug conjugate of claim 1, wherein the protein-drug conjugate further comprises an amino acid sequence set forth in any one of, for example, SEQ ID NOs: 70, 106-129, 148, and 135. It is specifically noted that second reference application SEQ ID NOs: 70, 106-129, 148, and 135 comprise a 100% match to instant SEQ ID NO: 272. Second reference application claim 64 is drawn to a pharmaceutical composition comprising the protein-drug conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus, the claims of the second reference application read on the anti-BCMA antibody of instant claims 37-38 and the pharmaceutical composition of instant claim 43.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 44 stands as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 28, 64-65, and 69 of copending Application No. 18/256,422 (herein after referred to as "second reference application") in view of US 2016/0046724 A1 (previously cited on PTO-892; herein after referred to as “Brogdon”).
The disclosure of claims 1, 21, 28, and 64 of the second reference application are detailed above as pertain to instant claim 37. Additionally, claim 65 and 69 of the second reference application are drawn to a method for treating diseases, comprising administering the protein-drug conjugate according to claim 1, wherein the protein-drug conjugate is optionally in combination with other therapies or drugs and the diseases are tumors or other diseases; wherein the tumors may be selected from, for example, lymphoma, multiple myeloma, and various other types of cancer. However, it is noted that the second reference application does not claim kits, including a first and second kit comprising an anti-BCMA antibody and additional antibody or pharmaceutical composition for treating cancer, respectively. This deficiency is remedied by Brogdon.
Brogdon discloses compositions and methods for treating diseases associated with BCMA expression and chimeric antigen receptors (CARs) specific to BCMA that comprise a BCMA binding domain (Abstract). It is further noted that the antigen-binding domains of the invention may be a human or humanized antibody or antibody fragment that specifically binds to BCMA (Paragraph 0031); “antibody fragment” refers to at least one portion of an intact antibody, or recombinant variants thereof, and refers to the antigen binding domain, e.g., an antigenic determining variable region of an intact antibody, that is sufficient to confer recognition and specific binding of the antibody fragment to a target, such as an antigen, wherein examples of antibody fragments include, but are not limited to, Fab, Fab′, F(ab′)2, and Fv fragments, scFv antibody fragments, linear antibodies, single domain antibodies such as sdAb (either VL or VH), camelid VHH domains, and multi-specific molecules formed from antibody fragments such as a bivalent fragment comprising two or more, e.g., two, Fab fragments linked by a disulfide bridge at the hinge region, or two or more, e.g., two isolated CDR or other epitope binding fragments of an antibody linked further wherein an antibody fragment can also be incorporated into single domain antibodies, maxibodies, minibodies, nanobodies, intrabodies, diabodies, triabodies, tetrabodies, v-NAR and bis-scFv (Paragraph 0176). In certain embodiments, the BCMA CAR molecules or the anti-BCMA binding domain of the invention include one, two, or three CDRs from the heavy chain variable region as provided in Table 22 (Paragraph 0086). It is specifically noted that, for example, the antibody designated as C9178-G4 from Table 22 comprises: (i) HCDR1 of sequence GFTFSSY; (ii) HCDR2 of sequence SGSGGS; and (iii) HCDR3 of sequence MGWSSGYLCAFDI; the bolded portions of the sequences correspond to sequence fragments comprised within instantly claimed SEQ ID NOs: 26, 78, and 136, respectively. Thus, Brogdon discloses CARs which comprise antigen binding domains, which may be an antibody or antibody fragment, wherein antibody fragments include single domain antibodies only comprising a VH/HCDRs1-3 (i.e., VHH antibody), wherein said antibody or antibody fragment is specific for BCMA and may comprise fragments of the instantly claimed HCDRs. Brogdon further discloses, in one embodiment, the cells expressing a CAR molecule, e.g., a CAR molecule described by the invention, may be administered in combination with an agent that treats the disease associated with BCMA, wherein exemplary diseases to be treated include cancer (i.e., a CAR molecule of the invention may be administered in combination with an agent that treats cancer) (Paragraphs 0073-0076). Brogdon specifically discloses methods for preventing relapse of cancer associated with BCMA-expressing cells, the methods comprising administering to a subject in need thereof an anti-BCMA CAR-expressing cell (e.g., BCMA CART cell or BCMA CAR-expressing NK cell) of the invention that binds to the BCMA-expressing cell wherein, in one aspect, the methods comprise administering to the subject in need thereof an effective amount of an anti-BCMA CAR-expressing cell (e.g., BCMA CAR-T cell or BCMA CAR-expressing NK cell) of the invention that binds to the BCMA-expressing cell in combination with an effective amount of another therapy (Paragraph 0699). It is noted that the term "combination" refers to either a fixed combination in one dosage unit form, or a combined administration where a compound of the present invention and a combination partner (e.g. another drug, also referred to as "therapeutic agent" or "co-agent") may be administered independently at the same time or separately within time intervals, especially where these time intervals allow that the combination partners show a cooperative, e.g. synergistic effect; the single components may be packaged in a kit or separately (Paragraph 0189; emphasis added). It is noted that while Brogdon does not explicitly mention an embodiment wherein the CAR molecule and another therapy are provided in a first and second kit, Brogdon does suggest that single components may be packaged in a kit or separately; thus, one of ordinary skill in the art would recognize that the individual components could be provided in separate kits for the treatment of cancer.
Thus, it would have been obvious to one of ordinary skill in the art that the protein-drug conjugate, useful for treating cancer, of the second reference application and another therapy (i.e., for treating cancer) could be used in combination, as suggested by Brogdon, wherein said protein-drug conjugate and another therapy could be provided in a first and second kit, respectively, because Brogdon suggests combining BCMA-targeting therapy (i.e., CARs) with another therapy, wherein the single components of such a combination may be packaged in a kit or separately, and one of ordinary skill in the art would recognize that the individual components could be provided in separate kits for the treatment of cancer because combining prior art elements according to known methods would be expected to yield predictable results; one kit providing two active agents, which may be administered separately as suggested by Brogdon, would serve the same purpose as a first and second kit used to provide the same combination of active ingredients useful for the same purpose (i.e., treating cancer, specifically BCMA-expressing cancer).
This is a provisional nonstatutory double patenting rejection.
Double Patenting - New as Necessitated by Rejoined Species
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.
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).
The below-listed claim rejections are new as required by the expanded species search in view of Applicant’s claim amendments.
Claims 37-38 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-8, and 14 of copending Application No. 18/013,530 (herein after referred to as “third reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Third reference application claim 1 is generally drawn to a binding protein comprising at least two protein functional regions, wherein the binding protein comprises a protein functional region A and a protein functional region B and the protein functional region A and the protein functional region B target different antigens or different epitopes on the same antigen, wherein the protein functional region A is of a Fab structure, the protein functional region B is of a VH structure, and the binding protein further comprises and Fc homodimer. Third reference application claim 2 further limits the binding protein of claim 1, wherein the antigen is selected from one or more of PD-L1, HER2, B7H4, CTLA4, OX40, 4-1 BB and BCMA. Claim 4 of the third reference application further limits the binding protein of claim 3, wherein, for example, the BCMA antibody or the antigen-binding fragment thereof comprises a heavy chain variable region (VH), wherein the VH comprises HCDR1, HCDR2 and HCDR3 with amino acid sequences as set forth in SEQ ID NOs: 17, 39 and 61, respectively. It is specifically noted that third reference application SEQ ID NOs: 17, 39, and 61 are exact matches to instant SEQ ID NOs: 35, 76, and 136, respectively. Third reference application claim 5 further limits the binding protein of claim 3, wherein, for example, the BCMA antibody or antigen-binding fragment thereof comprises a heavy chain variable region (VH), wherein the VH comprises an amino acid sequence as set forth in SEQ ID NO: 115, or the BCMA antibody or the antigen-binding fragment thereof comprises a light chain variable region (VL) and a heavy chain variable region (VH), wherein the VL comprises an amino acid sequence as set forth in SEQ ID NO: 120, and the VH comprises an amino acid sequence as set forth in SEQ ID NO: 110. Claim 7 of the third reference application further limits the binding protein of claim 1, wherein, for example, the protein functional region A comprises a light chain variable region with an amino acid sequence as set forth in SEQ ID NO: 120 and a heavy chain variable region with an amino acid sequence as set forth in SEQ ID NO: 110, and the protein functional region B comprises a heavy chain variable region with an amino acid sequence as set forth in SEQ ID NO: 115. It is specifically noted that third reference application SEQ ID NO: 115 is an exact match to instant SEQ ID NO: 272. Claim 8 of the third reference application further limits the binding protein of claim 1, wherein, for example, the first polypeptide chain comprises an amino acid sequence as set forth in SEQ ID NO: 159; and the second polypeptide chain comprises an amino acid sequence as set forth in SEQ ID NO: 160. It is specifically noted that third reference patent SEQ ID NO: 160 comprises an exact match to instant SEQ ID NO: 272. Third reference application claim 14 is drawn to a pharmaceutical composition comprising the binding protein according to claim 1, and a pharmaceutically acceptable carrier. Thus, the claims of the third reference application read on the anti-BCMA antibody of instant claims 37-38 and the pharmaceutical composition of instant claim 43.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 44 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-8, and 14-16 of copending Application No. 18/013,530 (herein after referred to as “third reference application”) in view of US 2016/0046724 A1 (previously cited on PTO-892; herein after referred to as “Brogdon”).
The disclosure of claims 1, 3-5, 7-8, and 14 of the second reference application are detailed above as pertain to instant claim 37. Additionally, claims 15-16 of the third reference application are drawn to, respectively: (i) a kit comprising the binding protein according to claim 1, wherein the kit further comprises a device for administering the binding protein or instructions for use; and (ii) a combination of kits comprising a kit I and a kit II, wherein the kit I comprises the binding protein according to claim 1, and the kit II comprises an additional antibody or pharmaceutical composition. However, it is noted that the second reference application does not claim a combination of kits, wherein the combination of kits comprises a first and second kit comprising an anti-BCMA antibody and additional antibody or pharmaceutical composition for treating cancer, respectively. This deficiency is remedied by Brogdon.
Brogdon discloses compositions and methods for treating diseases associated with BCMA expression and chimeric antigen receptors (CARs) specific to BCMA that comprise a BCMA binding domain (Abstract). It is further noted that the antigen-binding domains of the invention may be a human or humanized antibody or antibody fragment that specifically binds to BCMA (Paragraph 0031); “antibody fragment” refers to at least one portion of an intact antibody, or recombinant variants thereof, and refers to the antigen binding domain, e.g., an antigenic determining variable region of an intact antibody, that is sufficient to confer recognition and specific binding of the antibody fragment to a target, such as an antigen, wherein examples of antibody fragments include, but are not limited to, Fab, Fab′, F(ab′)2, and Fv fragments, scFv antibody fragments, linear antibodies, single domain antibodies such as sdAb (either VL or VH), camelid VHH domains, and multi-specific molecules formed from antibody fragments such as a bivalent fragment comprising two or more, e.g., two, Fab fragments linked by a disulfide bridge at the hinge region, or two or more, e.g., two isolated CDR or other epitope binding fragments of an antibody linked further wherein an antibody fragment can also be incorporated into single domain antibodies, maxibodies, minibodies, nanobodies, intrabodies, diabodies, triabodies, tetrabodies, v-NAR and bis-scFv (Paragraph 0176). In certain embodiments, the BCMA CAR molecules or the anti-BCMA binding domain of the invention include one, two, or three CDRs from the heavy chain variable region as provided in Table 22 (Paragraph 0086). It is specifically noted that, for example, the antibody designated as C9178-G4 from Table 22 comprises: (i) HCDR1 of sequence GFTFSSY; (ii) HCDR2 of sequence SGSGGS; and (iii) HCDR3 of sequence MGWSSGYLCAFDI; the bolded portions of the sequences correspond to sequence fragments comprised within instantly claimed SEQ ID NOs: 26, 78, and 136, respectively. Thus, Brogdon discloses CARs which comprise antigen binding domains, which may be an antibody or antibody fragment, wherein antibody fragments include single domain antibodies only comprising a VH/HCDRs1-3 (i.e., VHH antibody), wherein said antibody or antibody fragment is specific for BCMA and may comprise fragments of the instantly claimed HCDRs. Brogdon further discloses, in one embodiment, the cells expressing a CAR molecule, e.g., a CAR molecule described by the invention, may be administered in combination with an agent that treats the disease associated with BCMA, wherein exemplary diseases to be treated include cancer (i.e., a CAR molecule of the invention may be administered in combination with an agent that treats cancer) (Paragraphs 0073-0076). Brogdon specifically discloses methods for preventing relapse of cancer associated with BCMA-expressing cells, the methods comprising administering to a subject in need thereof an anti-BCMA CAR-expressing cell (e.g., BCMA CART cell or BCMA CAR-expressing NK cell) of the invention that binds to the BCMA-expressing cell wherein, in one aspect, the methods comprise administering to the subject in need thereof an effective amount of an anti-BCMA CAR-expressing cell (e.g., BCMA CAR-T cell or BCMA CAR-expressing NK cell) of the invention that binds to the BCMA-expressing cell in combination with an effective amount of another therapy (Paragraph 0699). It is noted that the term "combination" refers to either a fixed combination in one dosage unit form, or a combined administration where a compound of the present invention and a combination partner (e.g. another drug, also referred to as "therapeutic agent" or "co-agent") may be administered independently at the same time or separately within time intervals, especially where these time intervals allow that the combination partners show a cooperative, e.g. synergistic effect; the single components may be packaged in a kit or separately (Paragraph 0189; emphasis added). It is noted that while Brogdon does not explicitly mention an embodiment wherein the CAR molecule and another therapy are provided in a first and second kit, Brogdon does suggest that single components may be packaged in a kit or separately; thus, one of ordinary skill in the art would recognize that the individual components could be provided in separate kits for the treatment of cancer.
Thus, it would have been obvious to one of ordinary skill in the art that the binding, useful for treating cancer, of the third reference application and another therapy (i.e., for treating cancer) could be used in combination, as suggested by Brogdon, wherein said binding protein and another therapy could be provided in a first and second kit, respectively, because the third reference application claims a combination of kits, and Brogdon specifically suggests combining BCMA-targeting therapy (i.e., CARs) with another therapy, wherein the single components of such a combination may be packaged in a kit or separately, and one of ordinary skill in the art would recognize that the individual components could be provided in separate kits for the treatment of cancer because combining prior art elements according to known methods would be expected to yield predictable results; one kit providing two active agents, as claimed by the third reference application, which may be administered separately as suggested by Brogdon, would serve the same purpose as a first and second kit used to provide the same combination of active ingredients useful for the same purpose (i.e., treating cancer, specifically BCMA-expressing cancer).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 37-50 are pending in the instant application. Claims 41-42, 45-48, and 50 are withdrawn. Claims 37-38 and 43-44 are rejected. Claims 39-40 are objected to. Claim 49 is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/Laura B Goddard/Primary Examiner, Art Unit 1642
Prosecution Insights