DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 56, 58, 60, 64 and 66-67 are pending. Claims 1-55, 57, 59, 61-63, 65 and 68-70 are canceled.
3. Claims 56, 58, 60, 64 and 66-67 are under consideration.
Priority
4. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/767,470, filed on 05/27/2020.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 6/29/2023, 9/21/2023, 12/27/2023, 2/28/2024, 7/11/2024, 10/29/2024, 1/28/2026 and 2/17/2026 have been considered by the examiner.
Specification
6. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see pages 1, 2 and 29. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
7. Claims 56, 58, 60, 64 and 66-67 are objected to because of the following informalities:
Claim 56 and its dependent claims are objected to for omitting a subject to be treated and administered with the cell inhibiting agent.
Regarding claim 60, the term “cell” should be added after “CAR-T” in line 4. Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 66 and 67 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 66 recites “wherein said CD33 binding portion comprises an antigen binding fragment of an antibody”.
Claim 67 recites “wherein said CD7 binding portion comprises an antigen binding fragment of an antibody”.
Claims 66 and 67 depend from claim 56. Claim 56 recites “a chimeric antigen receptor T cell or NK cell comprising a bispecific antibody or an antigen binding portion thereof with a CD7 binding portion and a CD33 binding portion”. According to claim 56, the binding portion is an antigen binding fragment of the bispecific antibody. Therefore, claims 66 and 67 do not further limit the subject matter of claim 56.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
10. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
11. Claims 56, 58, 60, 64 and 66-67 are rejected under 35 U.S.C. 103 as being unpatentable over Brogdon et al. (WO2016014576A1, pub. date: 1/28/2016, IDS filed on 9/21/2023), in view of Ossenkoppele et al. (Br J Haematol, 2011, 153:421-36), Bari et al. (WO 2017/213979A1, pub. date: 12/14/2017, effectively filed date: 6/6/2016, IDS filed on 9/29/2023), Schneider et al. (, J Immunother Cancer, May 2017, 5:42; DOI 10.1186/s40425-017-0246-1, IDS filed on 9/21/2023).
Regarding claims 56, 58, 60 and 66-67, Brogdon teaches a method for treating human AML in a subject, comprising administering to the subject having CD33+ AML an effective amount of anti-CD33 CAR T cells, wherein the T cells are autologous or allogenic T cells (Example 6 and claims 49-55, page 24, last para).
In one embodiment, Brogdon teaches that the CAR is bispecific CAR which binds CD33 and another antigen which is expressed on AML cells (page 109 and page 113, lines 1-18).
Regarding claim 64, T cells inherently express the lymphoid marker CD7.
Brogdon does not teach treating AML with anti-CD33/anti-CD7 bispecific CAR-T cell.
Ossenkoppele teaches CD7 is a lymphoid marker that is often aberrantly expressed in AML, and in most publications, associated with a poor prognosis (page 423, column 1).
Bari et al. teaches a method of treating a hematologic cancer comprising delivering to a subject in need of treatment an effective amount of anti-CD7 CAR T cells or anti-CD7 CAR NK cells (claims), wherein the hematologic cancer is acute myelocytic leukemia ([0056]), the T cells are autologous ([0043]).
Schneider teaches that CAR that are bispecific and bind two antigens expressed on leukemic cells can help reduce antigen escape variants and, particularly in higher disease burden setting the bispecific CAR-T cells may be both more effective and less toxic than CAR-T cells specific for the single antigens (Abstract and Discussion). Schneider described methods of producing bispecific CAR by linking a first scFv antibody fragments that binds the first antigen to a second scFv antibody fragment that binds a second antigen via a Gly-Ser linker, (Fig. 1). Schneider teaches the anti-CD19/ anti-CD20 bispecific CAR is capable of activation via binding of either CD19 or CD20 (page 10, column 1, and Figure 11).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have treated CD7+CD33+ hematological cancer in particular AML with anti-CD7/anti-CD33 bispecific CAR T cells or anti-CD7/anti-CD33 bispecific CAR NK cells in view of Brogdon, Ossenkoppele, Bari and Schneider. One of ordinary skill in the art would have been motivated to do so because Brogdon teaches treating CD33+ hematological cancer in particular AML with anti-CD33 CAR T cells, and further teaches that the CAR may be bispecific CAR which binds CD33 and another antigen which is expressed on AML cells (page 109 and page 113, lines 1-18), Ossenkoppele teaches that CD7 is a lymphoid marker that is often aberrantly expressed in AML, Bari et al. teaches a method of treating a hematologic cancer including AML with anti-CD7 CAR T cells or anti-CD7 CAR NK cells (claims), and Schneider teaches that CAR that are bispecific and bind two antigens expressed on leukemic cells can help reduce antigen escape variants and, particularly in higher disease burden setting the bispecific CAR-T cells may be both more effective and less toxic than CAR-T cells specific for the single antigens (Abstract and Discussion). One of ordinary skill in the art would have had a reasonable expectation of success because Brogdon teaches treating human CD33+ AML with anti-CD33 CAR T cells, Bari et al. teaches treating a hematologic cancer including AML with anti-CD7 CAR T cells or anti-CD7 CAR NK cells (claims), and Schneider provide a reasonable expectation that the bispecific CAR-T would be even be more effective in treating cases of high disease burden in AML because it would help avoid antigen escape of AML tumor cells relative to therapy with CD33 monospecific CAR of Brogdon or CD7 monospecific CAR of Bari.
Double Patenting
12. 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.
13. Claims 56, 58, 60, 64 and 66-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-7, 10, 12, 15-16, 19-22, 25, 30-31, 33 and 35-36 of copending Application No. 18/265,781 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-7, 10, 12, 15-16, 19-22, 25, 30-31, 33 and 35-36 of copending application disclose a method of treating a CD7+CD33+ hematological malignancy in a human subject in need thereof, said method comprising administering to the subject a therapeutically effective amount of the antibody or antigen binding fragments thereof binding to CD33 and CD7, wherein the CD33+ and CD7+ cell is an Acute Myeloid Leukemia (AML) cell, wherein the antibody or antigen binding fragments thereof is attached to, or formed with an immune effector cell, optionally wherein the immune effector cell comprises a T cell and/or a NK cell, optionally wherein the T cell is a bispecific anti-CD33 anti-CD7 CAR-T or a CD33+ T cell, a CD7+ T cell, or a combination thereof.
14. Claims 56, 58, 60, 64 and 66-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 20-24, 27-30, 32 and 34-36 of copending Application No. 18/265,783 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 2, 5, 20-24, 27-30, 32 and 34-36 of copending Application No. 18/265,783 (reference application) disclose a method of treating a CD7+CD33+ hematological malignancy in an individual in need therefore, where the method comprises administering the bispecific antibody or antigen binding fragments thereof binding to CD33 and CD7, wherein the CD33+ and CD7+ cell is an AML cell, wherein the bispecific antibody or antigen binding fragments thereof is attached to, or formed with an immune effector cell, optionally wherein the immune effector cell comprises a T cell and/or a NK cell, wherein the immune effector cell is a bispecific anti-CD33 anti-CD7 CAR-T, wherein the T cell comprises a CD33+ T cell, a CD7+ T cell, or a combination thereof.
15. Claims 56, 58, 60, 64 and 66-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,732,040, in view of Brogdon et al. (WO2016014576A1, pub. date: 1/28/2016, IDS filed on 9/21/2023), Bari et al. (WO 2017/213979A1, pub. date: 12/14/2017, effectively filed date: 6/6/2016, IDS filed on 9/21/2023), and Schneider et al. (, J Immunother Cancer, May 2017, 5:42; DOI 10.1186/s40425-017-0246-1, IDS filed on 9/21/2023).
Claims 1-9 of U.S. Patent No. 11,732,040 disclose a method of treating a CD7+CD33+ hematological malignancy by administering a cell inhibiting agent that bispecifically binds to CD33 and CD7, wherein said cell inhibiting agent comprises a cytotoxin linked to a bispecific antibody or antigen binding portion thereof, including a CD7 binding portion and a CD33 binding portion, wherein the CD33+ and CD7+ cell is an AML cell.
Claims 1-9 of U.S. Patent No. 11,732,040 do not disclose a method of treating CD7+CD33+ hematological malignancy by administering CD33 x CD7 bispecific CAR T cells.
The teaches of Brogdon, Bari and Schneider have been set forth above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified the method of the patent to treat CD7+CD33+ hematological cancer in particular AML with anti-CD7/anti-CD33 bispecific CAR T cells or anti-CD7/anti-CD33 bispecific CAR NK cells in view of Brogdon, Bari and Schneider. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Brogdon teaches treating CD33+ AML with anti-CD33 CAR T cells, Bari et al. teaches treating a hematologic cancer including AML with anti-CD7 CAR T cells or anti-CD7 CAR NK cells (claims), and Schneider teaches that CAR that are bispecific and bind two antigens expressed on leukemic cells can help reduce antigen escape variants and, particularly in higher disease burden setting the bispecific CAR-T cells may be both more effective and less toxic than CAR-T cells specific for the single antigens (Abstract and Discussion).
16. Claims 56, 58, 60, 64 and 66-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of copending Application No. 19/511,202 (reference application), in view of Brogdon et al. (WO2016014576A1, pub. date: 1/28/2016, IDS filed on 9/21/2023), Bari et al. (WO 2017/213979A1, pub. date: 12/14/2017, effectively filed date: 6/6/2016), and Schneider et al. (, J Immunother Cancer, May 2017, 5:42; DOI 10.1186/s40425-017-0246-1, IDS filed on 9/21/2023).
The claims of copending application disclose a method of treating a hematological malignancy by administering a cell inhibiting agent that bispecifically binds to CD33 and CD7, wherein said cell inhibiting agent comprises a cytotoxin linked to a bispecific antibody or antigen binding portion thereof, including a CD7 binding portion and a CD33 binding portion, wherein the hematological malignancy is AML cell.
The claims of the copending application do not disclose a method of treating CD7+CD33+ hematological malignancy by administering anti-CD7/anti-CD33 bispecific CAR T cells.
The teaches of Brogdon, Bari and Schneider have been set forth above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified the method of the copending application to treat CD7+CD33+ hematological cancer in particular AML with anti-CD7/anti-CD33 bispecific CAR T cells or anti-7/anti-CD33 bispecific CAR NK cells in view of Brogdon, Bari and Schneider. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Brogdon teaches treating CD33+ AML with anti-CD33 CAR T cells, Bari et al. teaches treating a hematologic cancer including AML with anti-CD7 CAR T cells or anti-CD7 CAR NK cells (claims), and Schneider teaches that CAR that are bispecific and bind two antigens expressed on leukemic cells can help reduce antigen escape variants and, particularly in higher disease burden setting the bispecific CAR-T cells may be both more effective and less toxic than CAR-T cells specific for the single antigens (Abstract and Discussion).
Conclusion
17. No claims are allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646