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 .
Restrictions/Elections
Applicant’s election of the following invention/species without traverse, as set forth in the Reply filed 13 August 2025, is acknowledged:
Group 1: claims 63-65, 70-71 and 83-87.
Status of the Claims
Claims 63-65, 70-77, and 79-87 are currently pending. Claims 63-65, 70-77, and 79-82 are withdrawn. Claims 63-65, 70-71 and 83-87 are subject to this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record.
Claim Rejections - 35 USC § 112(a)
Claims 70, 84, and 86 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating B cell malignancies, does not reasonably provide enablement for treating any and all cancers. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Nature of the invention/Breadth of the claims.
The claims require treating cancer in a subject comprising administering to a subject having a cancer the population of engineered cells, wherein the first population of engineered cells are directed to CD19 and the second population is directed to BCMA, and wherein cancer encompasses hematological, solid, B cell associated and non- B cell associated cancers.
State of the prior art/Predictability of the art.
The prior art demonstrates that CD19 and BCMA are known B cell and/or B cell malignancy associated antigens1, and that BCMA upregulation is primarily associated with malignant plasma cells in multiple myeloma (MM) (see abstract and introduction sections of Tai2).
Working examples.
No working examples are provided that demonstrate treatment of cancer with the present invention. Furthermore, the in vitro and in vivo examples set forth in the present application ate merely prophetic.
Guidance in the specification.
The specification defines various B cell malignancies, but does not provide guidance on non-B cell malignancies.
Amount of experimentation necessary.
Undue additional research is required in order to determine if embodiments of the instant invention are operable. Additional research would be undue because there is no reasonable expectation that the proposed invention will be operable in treating non-B cell related cancers. Thus, there is insufficient information provided in order for an artisan to design and execute an experiment to test non-B cell related cancers, if any, will respond to the instant invention as claimed.
For the reasons discussed above, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with this claim and it would require undue experimentation for one skilled in the art to use the claimed methods.
Priority
The earliest effective U.S. filing date afforded the instantly claimed invention has been
determined to be 13 January 2020, the filing date of Provisional Application No. 62/960,285, to
which Int. Application No. PCT/US2021/012977 claims priority to.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 63-65, 70-71 and 83-87 are rejected under 35 U.S.C. 103 as being unpatentable over Novartis3 in view of Trager4, Pulé5, and Hinrichs6.
The applied reference, Trager, has a common assignee and some common inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Novartis discloses a combination immunotherapy composition comprising a BCMA CAR-expressing NK cell population and a CD19 CAR-expressing NK cell population to treat BCMA associated cancer, and that the purpose of the CD19 CAR-expressing NK cell population acts on neoplastic cells and/or neoplastic-supporting cells (see, e.g., abstract, specification, and claims; in particular at p. 166-167; see also the Written Opinion of the ISA for Int. Application No. PCT/US2021/012977).
The prior art of Novartis differs from the instantly claimed invention as follows: Novartis does not expressly disclose the claimed sequences set forth in instant claim 63.
Trager discloses a method comprising CD19-directed chimeric antigen receptor comprised by immune cells wherein the anti-CD19 binding moiety is an scFv, wherein the VL domain comprises SEQ ID NO: 120 (see claim 3; compare id. with instant SEQ ID NO: 120) and the VL domain comprises SEQ ID NO: 118 (see claim 4; compare id. with instant SEQ ID NO: 118). Trager further discloses that this anti-CD19 CAR is useful as an anti-CD19 binding domain for a method of treating cancer using immunotherapy (see claim 1), wherein the CAR is comprised by NK cells (see claim 2).
Pulé discloses an anti-CD19 CAR of SEQ ID NO: 11, which is a “CAT19 CAR with an OX40-Zeta endodomain”, and comprises a CD8a hinge of SEQ ID NO: 2, an OX-40 subdomain of SEQ ID NO: 6, and a CD3zeta subdomain of SEQ ID NO: 8 (compare id. with instant SEQ ID NOs: 2, 6, and 8). Pulé further discloses: cells comprising the CAR, and the use of the CAR in the treatment of cancer (see, e.g., Abstract); that the CAR induces T cell signaling (see, e.g., [29]); and that the cell which comprises the CAR may be an NK cell (see, e.g., [33, 105, 111-113], Claim 19).
Hinrichs discloses a nucleotide sequence encoding an amino acid comprising an Il-15, a linker peptide, and a transmembrane amino acid sequence, and host cells expressing the nucleic acid (Abstract). Hinrichs further discloses the use of this nucleic acid to treat cancer and enhance immune response of a mammal to a vaccine. Hinrichs further discloses an embodiment comprising SEQ ID NO: 20, which comprises a sequence 100% identical to instant SEQ ID NO: 12 (see Example 1).
Obviousness Analysis: In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than:
the simple substitution of one known element for another (e.g., the CAR construct of Trager for those of Novartis) to obtain predictable results (e.g., treating a B cell malignancy, e.g., a BCMA associated cancer such as multiple myeloma);
combining prior art elements (e.g., combining the following known CAR construct elements: the anti-CD19 scFv VH and VL sequences of Trager and the intracellular signaling domain sequences of Pulé) to obtain predictable results;
and applying a known technique to a known method ready for improvement to yield predictable results (e.g., co-expressing the CAR with mbIL15, as mbIL15 is known to enhance immune response when treating cancer). See MPEP 2143(I) (A), (B), (D), (G).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, the instant claims are rejected.
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.
Patent No. 11,253,547
Claims 63-65, 70-71 and 83-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of Patent No. 11,253,547 (reference patent) in view of Novartis (supra).
The disclosures/teachings of Novartis are set forth above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analyses.
Obviousness analysis: Regarding instant claims 63-65, 70-71 and 83-87, claims 1-17 of the reference patent claims a polynucleotide encoding a CD19-directed CAR comprising sequences identical to instantly claimed sequences set forth in instant SEQ ID NO: 120, 118, 6, 8, 12 (see reference claims and SEQ ID NOs: 120, 118, 6, 8, 12; compare id. with instant SEQ ID NOs: 120, 118, 6, 8, 12). Although the reference patent doesn’t expressly claim the sequence set forth in instant SEQ ID NO: 2, the identical sequence is disclosed and is therefore an obvious variant7 of “a hinge, wherein the hinge is a CD8 alpha hinge”, as set forth in claim 1 (see reference claim 1 and SEQ ID NO: 2; compare id. with instant SEQ ID NO: 2).
The reference patent claims differ from that of the instant application as follows: the reference patent does not expressly claim the combined population of engineered cells and associated methods.
However, the disclosures of Novartis remedy these deficiencies, as set forth above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to simply substitute one known element for another (e.g., the reference CAR constructs for those of Novartis) to obtain predictable results (e.g., treating a B cell malignancy, e.g., a BCMA associated cancer such as multiple myeloma). Furthermore, it amounts to no more than combining the prior art elements set forth in the reference patent with Novartis (e.g., combining a cell population expressing the reference CD19 CAR construct with a second cell population expressing the same construct, except with a BCMA binding moiety instead of one that binds to CD19, as instantly claimed) to obtain predictable results (e.g., developing a combination therapy comprising two engineered cell populations, wherein the first population is directed to BCMA and the second is directed to CD19, for the treatment of a B cell malignancy). One would have been motivated to do so, particularly in the context of treating a B cell malignancy, as the CD19 CAR-expressing cell population is known to act on neoplastic cells and/or neoplastic-supporting cells (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, the instant claims not patentably distinct relative to the reference claims.
Patent No. 11,154,575
Claims 63-65, 70-71 and 83-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of Patent No. 11,154,575 (reference patent) in view of Novartis (supra).
The disclosures/teachings of Novartis are set forth above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analyses.
Obviousness analysis: Regarding instant claims 63-65, 70-71 and 83-87, claims 1-25 of the reference patent claims methods of treating cancer comprising administering NK cells expressing a CD19-directed CAR and mbIL15, wherein the CAR and mbIL15 comprises sequences that are identical to instantly claimed sequences set forth in instant SEQ ID NO: 120, 118, 6, 8, 12 (see reference claims and SEQ ID NOs: 120, 118, 6, 8, 12; compare id. with instant SEQ ID NOs: 120, 118, 6, 8, 12). Although the reference patent doesn’t expressly claim the sequence set forth in instant SEQ ID NO: 2, the identical sequence is disclosed and is therefore an obvious variant8 of “a hinge, wherein the hinge is a CD8 alpha hinge”, as set forth in claim 1 (see reference claim 1 and SEQ ID NO: 2; compare id. with instant SEQ ID NO: 2).
The reference patent claims differ from that of the instant application as follows: the reference patent does not expressly claim the combined population of engineered cells and associated methods.
However, the disclosures of Novartis remedy these deficiencies, as set forth above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to simply substitute one known element for another (e.g., the reference CAR constructs for those of Novartis) to obtain predictable results (e.g., treating a B cell malignancy, e.g., a BCMA associated cancer such as multiple myeloma). Furthermore, it amounts to no more than combining the prior art elements set forth in the reference patent with Novartis (e.g., combining a cell population expressing the reference CD19 CAR construct with a second cell population expressing the same construct, except with a BCMA binding moiety instead of one that binds to CD19, as instantly claimed) to obtain predictable results (e.g., developing a combination therapy comprising two engineered cell populations, wherein the first population is directed to BCMA and the second is directed to CD19, for the treatment of a B cell malignancy). One would have been motivated to do so, particularly in the context of treating a B cell malignancy, as the CD19 CAR-expressing cell population is known to act on neoplastic cells and/or neoplastic-supporting cells (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, the instant claims not patentably distinct relative to the reference claims.
Patent No. 11,141,436
Claims 63-65, 70-71 and 83-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of Patent No. 11,141,436 (reference patent) in view of Novartis (supra).
The disclosures/teachings of Novartis are set forth above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analyses.
Obviousness analysis: Regarding instant claims 63-65, 70-71 and 83-87, claims 1-16 of the reference patent claims NK cells expressing a CD19-directed CAR and mbIL15, wherein the CAR and mbIL15 comprise sequences that are identical to instantly claimed sequences set forth in instant SEQ ID NO: 120, 118, 6, 8, 12 (see reference claims and SEQ ID NOs: 120, 118, 6, 8, 12; compare id. with instant SEQ ID NOs: 120, 118, 6, 8, 12). Although the reference patent doesn’t expressly claim the sequence set forth in instant SEQ ID NO: 2, the identical sequence is disclosed and is therefore an obvious variant9 of “a hinge, wherein the hinge is a CD8 alpha hinge”, as set forth in claim 1 (see reference claim 1 and SEQ ID NO: 2; compare id. with instant SEQ ID NO: 2).
The reference patent claims differ from that of the instant application as follows: the reference patent does not expressly claim the combined population of engineered cells and associated methods.
However, the disclosures of Novartis remedy these deficiencies, as set forth above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to simply substitute one known element for another (e.g., the reference CAR constructs for those of Novartis) to obtain predictable results (e.g., treating a B cell malignancy, e.g., a BCMA associated cancer such as multiple myeloma). Furthermore, it amounts to no more than combining the prior art elements set forth in the reference patent with Novartis (e.g., combining a cell population expressing the reference CD19 CAR construct with a second cell population expressing the same construct, except with a BCMA binding moiety instead of one that binds to CD19, as instantly claimed) to obtain predictable results (e.g., developing a combination therapy comprising two engineered cell populations, wherein the first population is directed to BCMA and the second is directed to CD19, for the treatment of a B cell malignancy). One would have been motivated to do so, particularly in the context of treating a B cell malignancy, as the CD19 CAR-expressing cell population is known to act on neoplastic cells and/or neoplastic-supporting cells (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, the instant claims not patentably distinct relative to the reference claims.
Patent No. 12,398,187
Claims 63-65, 70-71 and 83-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of Patent No. 12,398,187 (reference patent) in view of Novartis (supra).
The disclosures/teachings of Novartis are set forth above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analyses.
Obviousness analysis: Regarding instant claims 63-65, 70-71 and 83-87, claims 1-24 of the reference patent claims polypeptides encoding a CD19-directed CAR and NK cells expressing the CAR and mbIL15, wherein the CAR and mbIL15 comprise sequences that are identical to instantly claimed sequences set forth in instant SEQ ID NO: 120, 118, 6, 8, 12 (see reference claims and SEQ ID NOs: 120, 118, 6, 8, 12; compare id. with instant SEQ ID NOs: 120, 118, 6, 8, 12). Although the reference patent doesn’t expressly claim the sequence set forth in instant SEQ ID NO: 2, the identical sequence is disclosed and is therefore an obvious variant10 of “a CD8 alpha hinge domain”, as set forth in claim 1 (see reference claim 1 and SEQ ID NO: 2; compare id. with instant SEQ ID NO: 2).
The reference patent claims differ from that of the instant application as follows: the reference patent does not expressly claim the combined population of engineered cells and associated methods.
However, the disclosures of Novartis remedy these deficiencies, as set forth above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to simply substitute one known element for another (e.g., the reference CAR constructs for those of Novartis) to obtain predictable results (e.g., treating a B cell malignancy, e.g., a BCMA associated cancer such as multiple myeloma). Furthermore, it amounts to no more than combining the prior art elements set forth in the reference patent with Novartis (e.g., combining a cell population expressing the reference CD19 CAR construct with a second cell population expressing the same construct, except with a BCMA binding moiety instead of one that binds to CD19, as instantly claimed) to obtain predictable results (e.g., developing a combination therapy comprising two engineered cell populations, wherein the first population is directed to BCMA and the second is directed to CD19, for the treatment of a B cell malignancy). One would have been motivated to do so, particularly in the context of treating a B cell malignancy, as the CD19 CAR-expressing cell population is known to act on neoplastic cells and/or neoplastic-supporting cells (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, the instant claims not patentably distinct relative to the reference claims.
Copending Application No. 19/080,060 (US20250296970)
Claims 63-65, 70-71 and 83-87 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 of Copending Application No. 19/080,060 (reference application) in view of Novartis (supra).
This is a provisional nonstatutory double patenting rejection.
The disclosures/teachings of Novartis are set forth above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analyses.
Obviousness analysis: Regarding instant claims 63-65, 70-71 and 83-87, claims 2-21 of the reference application claims a population of NK cells expressing a CD19-directed CAR and mbIL15, wherein the CAR and mbIL15 comprise sequences that are identical to instantly claimed sequences set forth in instant SEQ ID NO: 120, 118, 2, 6, 8, 12 (see reference claims and SEQ ID NOs: 120, 118, 6, 8, 60; compare id. with instant SEQ ID NOs: 120, 118, 6, 8, 12; note that reference SEQ ID NO: 60, at the amino acid residues noted in claim 1, comprises 100% of instant SEQ ID NO: 12). Although the reference patent doesn’t expressly claim a the CAR comprising a CD8 alpha hinge domain or the sequence set forth in instant SEQ ID NO: 2, the identical sequence is disclosed (see SEQ ID NO: 2; compare id. with instant SEQ ID NO: 2) along with embodiments wherein the CAR comprises a CD8 alpha hinge domain (see, e.g., at [0006] to [0009] of the specification), and therefore, is an obvious variant11 of the claimed CAR.
The reference application claims differ from that of the instant application as follows: the reference application does not expressly claim the combined population of engineered cells and associated methods.
However, the disclosures of Novartis remedy these deficiencies, as set forth above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to simply substitute one known element for another (e.g., the reference CAR constructs for those of Novartis) to obtain predictable results (e.g., treating a B cell malignancy, e.g., a BCMA associated cancer such as multiple myeloma). Furthermore, it amounts to no more than combining the prior art elements set forth in the reference patent with Novartis (e.g., combining a cell population expressing the reference CD19 CAR construct with a second cell population expressing the same construct, except with a BCMA binding moiety instead of one that binds to CD19, as instantly claimed) to obtain predictable results (e.g., developing a combination therapy comprising two engineered cell populations, wherein the first population is directed to BCMA and the second is directed to CD19, for the treatment of a B cell malignancy). One would have been motivated to do so, particularly in the context of treating a B cell malignancy, as the CD19 CAR-expressing cell population is known to act on neoplastic cells and/or neoplastic-supporting cells (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, the instant claims not patentably distinct relative to the reference claims.
Conclusion
Claims 63-65, 70-71 and 83-87 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Friday 9:00AM - 5PM PT.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 See, e.g., Novartis at p. 1, 30 and 39.
2 Tai, Yu-Tzu et al. “Novel anti-B-cell maturation antigen antibody-drug conjugate (GSK2857916) selectively induces killing of multiple myeloma.” Blood vol. 123,20 (2014): 3128-38.
3 WO2019241426A1; cited on the IDS filed 24 March 2025
4 US20210060073; effectively filed 5 March 2019; discloses instant SEQ ID NOs: 118 and 120
5 U.S. Patent No. 10,457,730; published 29 October 2019; discloses instant SEQ ID NOs: 2, 6, 8
6 WO2019157130; published 15 August 2019 and effectively filed 9 February 2018; discloses instant SEQ ID NO: 12
7 See, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”
8 See, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”
9 See, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”
10 See, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”
11 See, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”