Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
1. Claims 1-21 are the original claims filed 1/17/2024. In the preliminary amendment of 5/10/2024, Claims 1-8, 12-13, 15-16 and 18 are amended, claims 9-11, 14, 17 and 19-21 are cancelled, and new claims 22-28 are added. Claims 1-8, 12-13, 15-16, 18 and 22-28 are pending.
Priority
2. USAN 18/414,892, filed 01/17/2024, is a Continuation of 17/215,479, filed 03/29/2021, now U.S. Patent # 11912782, 17/215,479 is a Divisional of 16/050,944, filed 07/31/2018, now U.S. Patent # 10988546, 16/050,944 Claims Priority from Provisional Application 62/59,6194, filed 12/08/2017, 16/050,944 Claims Priority from Provisional Application 62/539,825, filed 08/01/2017. The claimed invention is granted the effective filing date of 08/01/2017.
Information Disclosure Statement
3. AS of 8/4/2026, a total of two (2) IDS are filed: 2/8/2024; and 5/14/2026. The corresponding initialed and dated 1449 form is considered and of record.
Objections
Drawings
4. The drawing sheets for Figures 8 and 13-15 are objected to because the series of graphs in each of the figures is not identified alphabetically and the figures do not comport with those for the other drawing sheets. 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.
Specification
5. The disclosure is objected to because of the following informalities:
a) The use of the term Tris, Alexa, Octet, Horizon Brilliant, Ultra Comp, eBEADS, BiTE, GraphPad, Mass Hunter, Ablexis, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
b) The figure legends are inconsistent in the alphabetical identification of the graphs for each of the figures. Compare the figure legend for Fig. 1 to Fig. 2-3, 8-10 and 13-15.
Appropriate correction is required.
Claim Objections
6. Claims 1-8, 12-13, 15-16, 18 and 22-28 are objected to because of the following informalities:
a) Claims 1-8, 12-13, 15-16, 18 and 22-28 contain improper punctuation throughout, e.g., a semi-colon (;) follows a colon (:).
b) Amend claim 1 to recite “contacting multiple myeloma cells that express BCMA with an antibody-drug conjugate (ADC),” to comport with claim 1 and the dependent claims.
c) Amend claims 8 and 25 to recite “of formula” to reduce verbiage without surrendering claim scope.
d) Amend claim 15 to recite “an antibody-drug conjugate (ADC)” that will correct a minor typographical error.
e) Claims 7-8 and 24-25 are objected to because: it is redundant to use the full name pyrrolobenzodiazepine and the abbreviation “PBD” (Claims 7 and 24); and inconsistent to use the full name if the abbreviation is already provided (Claims 8 and 25).
f) Claim 18 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 16, when “and” language is applied in the construction of claim 16. Claim 16 recites “and/or” language for the VH and VL domains of the same corresponding sequences to claim 18. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
7. Claims 1-8, 12-13, 22-25, and 28 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.
a) Claims 1-8, 12-13 are indefinite for the phrase “preferentially binds”. The phrase renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
b) Claims 22-25 recites the limitation "the cytotoxin". There is insufficient antecedent basis for this limitation in the claims. Claim 15 does not mention “a cytotoxin” to provide the proper antecedent basis for the limitation of Claims 22-25.
c) Claim 28 is indefinite for the phrase “preferentially binds”. The phrase renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
8. Claims 1-8, 12-13, 15-16, 18, and 22-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10988546 (16/050,944) in view of claims 1-19 of U.S. Patent No. 11912782.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate or render obvious the instant claimed an antibody-drug conjugate (ADC) comprising a monoclonal antibody, or an antigen-binding fragment thereof, directed against B-cell maturation antigen (BCMA) conjugated to a cytotoxin, compositions comprising the antibody-drug conjugate, and a monoclonal antibody directed against B-cell maturation antigen (BCMA).
As regards the clams of U.S. Patent No. 10988546 comprising the inventive 15B2 (15B2GL) or MEDI2228 clone in an ADC format with a cytotoxin:
Ref 1. An antibody-drug conjugate (ADC) comprising a monoclonal antibody or an antigen-binding fragment thereof, conjugated to a cytotoxin, wherein the monoclonal antibody or antigen-binding fragment thereof is capable of binding to human B-cell maturation antigen (BCMA) and comprises (a) a heavy chain variable region comprising a complementarity determining region 1 (HCDR1) amino acid sequence of SEQ ID NO: 1, an HCDR2 amino acid sequence of SEQ ID NO: 2, and an HCDR3 amino acid sequence of SEQ ID NO: 3 and (b) a light chain variable region comprising a complementarity determining region 1 (LCDR1) amino acid sequence of SEQ ID NO: 4, an LCDR2 amino acid sequence of SEQ ID NO: 5, and an LCDR3 amino acid sequence of SEQ ID NO: 6. See instant Claims 1 and 15.
Ref 2. The antibody-drug conjugate of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7. See instant Claims 2 and 16.
Ref 3. The antibody-drug conjugate of claim 1, wherein the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8. See instant Claims 3 and 16.
Ref 4. The antibody-drug conjugate of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7 and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8. See instant Claims 4, 16 and 18.
Ref 5. The antibody-drug conjugate of claim 1, wherein the cytotoxin is an anti-microtubule agent, a pyrrolobenzodiazepine (PBD), an RNA polymerase II inhibitor, or a DNA alkylating agent. See instant Claims 5 and 22.
Ref 6. The antibody-drug conjugate of claim 5, wherein the cytotoxin is an anti-microtubule agent selected from the group consisting of a maytansinoid, an auristatin, and a tubulysin. See instant Claims 6 and 23.
Ref 7. The antibody-drug conjugate of claim 5, wherein the cytotoxin is a pyrrolobenzodiazepine (PBD). See instant Claims 7 and 24.
Ref 8. The antibody-drug conjugate of claim 7, wherein the pyrrolobenzodiapezine (PBD) is SG3249 having the following formula:
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See instant Claims 8 and 25.
Ref 9. A composition comprising the antibody-drug conjugate of claim 1 and a pharmaceutically-acceptable carrier. See instant Claim 15.
Ref 10. A monoclonal antibody or an antigen-binding fragment thereof, wherein the monoclonal antibody or antigen-binding fragment thereof is capable of binding to human B-cell maturation antigen (BCMA) and comprises (a) a heavy chain variable region comprising a complementarity determining region 1 (HCDR1) amino acid sequence of SEQ ID NO: 1, an HCDR2 amino acid sequence of SEQ ID NO: 2, and an HCDR3 amino acid sequence of SEQ ID NO: 3 and (b) a light chain variable region comprising a complementarity determining region 1 (LCDR1) amino acid sequence of SEQ ID NO: 4, an LCDR2 amino acid sequence of SEQ ID NO: 5, and an LCDR3 amino acid sequence of SEQ ID NO: 6. See instant Claim 28.
As regards the claims of U.S. Patent No. 11912782, using the inventive 15B2 (15B2GL) or MEDI2228 clone in an ADC cytotoxin format in a method of treating multiple myeloma cells:
Ref 3. The method of claim 1, wherein the multiple myeloma cells are in a human. See instant claims 12 and 26.
Ref 4. The method of claim 1, wherein the multiple myeloma cells are in vitro. See instant claims 13 and 27.
The species in the ref claims are identical and therefore render obvious the instant claimed invention.
9. Claims 1-5, 7-8, 15-16, 18, 22, 24-25 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4, 7, 11, 17-19 and 24 of copending Application No. 17/595,671 (reference application US 20220218835).
The reference application is not afforded safe harbor protection under 35 USC 121 because it shares neither continuity nor a restriction/speciation with the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim sets relate to methods and compositions for the treatment of a B-cell malignancy with a composition, comprising: (a) an antibody-drug conjugate (ADC) comprising an antibody or antigen-binding fragment thereof that binds to B-cell maturation antigen (BCMA), conjugated to a nucleic acid cross-linking agent. The species of anti-BCMA antibody are specifically recited in both sets of claims being identical and for the inventive 15B2 (15B2GL) or MEDI2228 clone.
Ref claims 3-4
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See instant claims 1 and 15 for the ADC comprising a cytotoxin to treat MM.
Ref 7
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See instant claims 1 and 15 for a MM expressing BCMA.
Ref 11
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See instant claims 2-4, 16 and 18.
Ref 17-19
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See instant claims 5, 7-8, 22, and 24-25.
Ref 24
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See claims 1 and 15 where cell killing of MM is equated with reduction in tumor size or tumor growth.
Because of the status of the application being unrelated in continuity, instant claim 28 is included in the rejection for reciting the method of using the inventive 15B2 (15B2GL) or MEDI2228 clone in the killing of multiple myeloma cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 1-8, 12-13, 15-16, 18 and 22-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11912782. The instant application is a bona fide continuation of U.S. Patent No. 11912782 therefore the safe harbor provision under 35 USC 121 does not apply.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate or render obvious the instant claimed an antibody-drug conjugate (ADC) comprising a monoclonal antibody, or an antigen-binding fragment thereof, directed against B-cell maturation antigen (BCMA) conjugated to a cytotoxin, compositions comprising the antibody-drug conjugate, and a monoclonal antibody directed against B-cell maturation antigen (BCMA) for the inventive 15B2 (15B2GL) or MEDI2228 clone used in a method of killing multiple myeloma cells.
Ref 1. A method of killing multiple myeloma cells comprising: contacting multiple myeloma cells that express B-cell maturation antigen (BCMA) with an antibody-drug conjugate (ADC) comprising a monoclonal antibody, or an antigen-binding fragment thereof, directed against BCMA conjugated to a cytotoxin, wherein the monoclonal antibody comprises (a) a heavy chain variable region comprising a complementarity determining region 1 (HCDR1) amino acid sequence of SEQ ID NO: 1, an HCDR2 amino acid sequence of SEQ ID NO: 2, and an HCDR3 amino acid sequence of SEQ ID NO: 3; and (b) a light chain variable region comprising a complementarity determining region 1 (LCDR1) amino acid sequence of SEQ ID NO: 4, an LCDR2 amino acid sequence of SEQ ID NO: 5, and an LCDR3 amino acid sequence of SEQ ID NO: 6; wherein the ADC binds to BCMA on the multiple myeloma cells and kills the multiple myeloma cells. See instant claims 1 and 15.
Ref 2. The method of claim 1, wherein the ADC is in a composition with a pharmaceutically acceptable carrier. See instant claim 15.
Ref 3. The method of claim 1, wherein the multiple myeloma cells are in a human. See instant claims 12 and 26.
Ref 4. The method of claim 1, wherein the multiple myeloma cells are in vitro. See instant claims 13 and 27.
Ref 5. The method of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7. See instant claims 2 and 16.
Ref 6. The method of claim 1, wherein the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8. See instant claims 3 and 16.
Ref 7. The method of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7 and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8. See instant claims 4, 16 and 18.
Ref 8. The method of claim 1, wherein the cytotoxin is an anti-microtubule agent, a pyrrolobenzodiazepine (PBD), an RNA polymerase II inhibitor, or a DNA alkylating agent. See instant claims 5 and 22.
Ref 9. The method of claim 8, wherein the cytotoxin is an anti-microtubule agent selected from the group consisting of a maytansinoid, an auristatin, and a tubulysin. See instant claims 6 and 23.
Ref 10. The method of claim 8, wherein the cytotoxin is a pyrrolobenzodiazepine (PBD). See instant claims 7 and 24.
Ref 11. The method of claim 10, wherein the pyrrolobenzodiazepine is SG3249 having the following formula.... See instant claims 8 and 25.
Ref 12. The method of claim 3, wherein the human has multiple myeloma and wherein a therapeutically effective amount of the ADC is administered to the human. See instant claims 12 and 26.
Because of the continuation status of the application, instant claim 28 is included in the rejection for reciting the method of using the inventive 15B2 (15B2GL) or MEDI2228 clone in the killing of multiple myeloma cells.
The species in the ref claims are identical and therefore render obvious the instant claimed invention.
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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