DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election with traverse of group I, claims 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, and 74, in the reply filed on 5/13/26 is acknowledged. Applicant has further has elected NKG2D as the species of antigen binding domain, SEQ ID NO: 6 as the species from claim 3, TPOR as the JAK-binding domain, an intracellular domain comprising IL-15RB-2 and IL21R-2 corresponding to SEQ ID NO: 16 and 21, a CAR as an exogenous receptor targeting GPC3 and having SEQ ID NO; 29, SEQ ID NO: 98 as the species of sequence in claim 28, and T cell as the species of immune effector cell. Applicant’s traversal is on the grounds that groups I and II are directed to a product and process of use of said product and thus belong to a single general inventive concept under PCT 13.1. As noted in the restriction requirement, groups I and II are not so linked as to from a single inventive concept under PCT 13.1 because the claims lack a special technical feature that defines the contribution over US 20200276238.
The requirement is still deemed proper and is therefore made FINAL.
Claims 75 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, and 74, are being acted upon.
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.
Claim 28 is 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.
Claim 28 is unclear in the recitation that the immune effector cell “comprises” SEQ ID NO; 30, for example. A cell can express polypeptides which comprise amino acid sequences, but the recitation that he cell “comprises” an amino acid sequence is unclear and indefinite. For example, do the limitations of claim 28 further limit the chimeric cytokine receptor or the functional exogenous receptor, or both? Does the claim mean that the amino acid sequences in claim 28 are expressed by the immune effector cell?
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.
Claims 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, and 74 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
NK2D, antibodies, TIGIT and SIRP-alpha are completely structurally unrelated, and also functionally unrelated. For example, NKG2D and TIGIT bind to different ligands and have different signaling pathways. Antibodies have CDRs and are structurally unrelated to NKG2D or TIGIT receptors.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, and 74 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of extracellular antigen binding domains “derived from NKG2D, truncated NKG2D, or “variants thereof”, or sequences having at least 75%-99% identity to the claimed SEQ ID Nos.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP 2163.
The instant claims are directed to a chimeric cytokine receptor comprising an “antigen binding domain” that is “derived from NKG2D, truncated NKG2D” or a “variant thereof”. The claims encompass an extremely large genus of structurally distinct antigen binding domains. For example, the claims would encompass anything that could be “derived” from NKG2D, and include “variants”, i.e. polypeptides with numerous amino acids additions, deletions, or substitutions. See also claim 3 which encompass variants having 75% identity to, for example SEQ ID NO: 6, i.e. variants different by up to 25% of amino acid residues. Furthermore, the claims encompass variants/derivatives of any “truncated” NKD2D. The claims require that the extracellular domain functions in “antigen binding”, which would encompass functionality to bind to NKG2D ligands. The state of the art is such that “deriving” antigen binding domains from NKG2D or truncated NKG2D or variants thereof is complex and unpredictable. For example, Karimi teaches that truncated NKG2D splice isoform lacks a ligand binding domain. Therefore, deriving antigen binding domains from truncated NKG2D would be highly complex and unpredictable. Furthermore, as taught by Zingoni, NKG2D recognizes a genus of diverse ligands and interactions with NKG2D is highly complex with different ligands inducing selective signaling pathways resulting in different outcomes (See page 6, in particular). Additionally, the state of the art is such that protein chemistry is one of the most unpredictable areas of biotechnology. Whisstock et al (Quarterly Review of Biophysics, 2003, 36, pp307-340) teach that the prediction of protein function from sequence and structure is a difficult problem, because homologous proteins often have different functions. The instant application does not disclose a correlation between structure and “antigen binding” function. The instant specification discloses three species which represent extracellular NKG2D domains comprising residues 81-216 of human NKG2D (i.e. SEQ ID NO; 6), residues 98-216 of human NKG2D (i.e. SEQ ID NO: 156), and residues 89-216 of human NKG2D (i.e. SEQ ID NO: 157). These are not sufficiently representative of the broad genus of different antigen binding domains “derived” from NK2D, truncated NKG2D, or variants thereof. The claims also encompass variants of JAK-STAT binding domain having at least 75-99% identity to SEQ ID NO: 7 or to numerous cytokine signaling domains and variants thereof, which encompass numerous amino acid substitutions. The instant specification does not disclose any species nor does it disclose a correlation between said structure and function.
The claims also encompass sequences having at least 75% identity or 99% identity to sequences having a CAR, for example, to SEQ ID NO: 29 or 98, This encompasses sequences having an antibody antigen binding domain of a CAR and sequence variants thereof, including in the CDR sequences. The state of the art is such that the 6 CDRs of an antibody are critically involved in antigen binding, that even single amino acid changes can alter antigen specificity of binding, and that CDR mutations are unpredictable in terms of affinity, specificity, and solubility, and are also context dependent (see Hall, 1992, and Rabia, 2018). The specification does not disclose a correlation between structure and function, nor a representative number of species to support the genus of sequence having at least 75-99% identity to the claimed sequences, including to antigen binding domains of a CAR.
The instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of antibodies and inhibitors encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 11, 13, 18, 32-33, 34, 69, 71, and 74 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019118885.
WO2019118885 teaches an immune cell expressing a first and second chimeric polypeptide, wherein the first polypeptide contains FRB polypeptide (i.e. an “antigen binding domain), a transmembrane domain, and an intracellular signaling domain, and wherein the second polypeptide comprises a NKG2D ligand binding domain, a transmembrane domain, and an intracellular signaling domain of a costimulatory domain, wherein such as TNF receptor, i.e. a cytokine receptor intracellular domain (see pages 44-49 and Fig. 14, in particular). Said first polypeptide is within the scope of a “functional exogenous receptor” and said second chimeric polypeptide is within the scope of the “chimeric cytokine receptor” recited in the instant claims. WO2019118885 teaches that the NKG2D domain of SEQ ID NO: 10 or 11. WO2019118885 teaches expressing said first and second polypeptide from a nucleic acid molecule (see pages 71-78), and, wherein the two polypeptides are linked by one or more self-cleaving polypeptides (see pages 67-70, in particular). WO2019118885 teaches vectors comprising said nucleic acid molecule and expressing said first and second polypeptides in a T cell such as a helper T cell or a cytotoxic T cell (see pages 93-94, in particular). NKD2D ligands are inherently expressed on the surface of a tumor cell. WO2019118885 teaches that the intracellular signaling domain of the first polypeptide comprises a primary intracellular signaling domain of CD3 and a costimulatory signaling domain (see Fig. 14, in particular). WO2019118885 teaches pharmaceutical compositions comprising said immune cells (See page 100, in particular). WO2019118885 also teaches that the immune cell further express an engineered chimeric antigen receptor (CAR) that binds to GPC3, which also would be within the scope of the “functional exogenous receptor” of the instant claims (See pages 54-57, in particular).
Claim 1-9, 11, 18, 28, 32-34, 69, 71, 74 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2020/0276238
The ’238 publication teaches immune cells engineered to express a CAR (i.e. a functional exogenous receptor comprising a extracellular antigen binding domain, a transmembrane domain, and an intracellular signaling domain) and a chimeric cytokine receptor (See abstract, in particular). The ‘238 publication teaches that said chimeric cytokine receptor comprises an extracellular domain of SEQ ID NO: 2, a transmembrane domain comprising a JAK binding domain and a cytoplasmic domain from a cytokine receptor (see paragraph 35, Table 1 in particular). The ‘238 publication teaches that the immune cell is an ab T cell (see paragraph 11, 97 in particular). The ‘238 publication teaches that the transmembrane domain can comprise SEQ ID NO: 16, which is identical to SEQ ID NO: 7 of the instant application. The ‘238 publication teaches that the cytoplasmic domain is from a cytokine receptor can be IL-15 receptor and IL-21 receptor, and teaches an IL-21R cytoplasmic domain of SEQ ID NO: 53, which comprises SEQ ID NO: 21 of the instant application (see page 10 and Table 6a, in particular). Said antigen binding domain of SEQ ID NO: 2 is a PD-1 domain and shares overall 38% similarity to the NKG2D of SEQ ID NO: 6 of the instant application (see attached alignment). Therefore, said PD-1 domain can be considered a “derivative” or “variant” of NKG2D. Tumor cells can express PD-1 ligands, and therefore the extracellular domain of the chimeric cytokine receptors of the ‘238 publication would bind to an antigen expressed on the surface of a tumor cell. The ‘238 publication teaches that the CAR has a primary intracellular signaling domain of an immune effector cell (CD3) and a co-stimulator signaling domain (see Fig. 1D, in particular). The ‘238 publication teach a polypeptide comprising said CAR and said chimeric cytokine receptor linked via a P2A self-cleaving peptide, and nucleic acids encoding said polypeptide and vectors comprising said nucleic acid (see Fig. 1D and paragarph10, in particular). The ‘238 publication teaches pharmaceutical compositions (see paragraph 11, in particular).
Regarding claim 28, the claim encompass “an amino acid sequence” at least 75% identical to SEQ ID NO: 98. For example, the cited reference teaches SEQ ID NO: 21 of the instant application, which is found within SEQ ID NO: 98 and represents “an amino acid sequence” having 100% identity to SEQ ID NO: 98.
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.
Claims 1-3, 11, 18, 32-33, and 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170107491, in view of US 20170283500.
The ‘491 publication teaches a chimeric receptor comprising an NKG2D extracellular ligand binding domain of SEQ ID NO: 12, a transmembrane domain, and a CD3zeta signal domain, nucleic acids encoding said receptor, and T lymphocytes expressing said chimeric receptor (See paragraphs 1-17, 92-95, and 100, in particular). The ‘491 publication teaches that the signaling domain can be combined with any other desired cytoplasmic domains (see paragraph 94, in particular). The ‘491 publication further teaches that said NKG2D binds to NKG2D ligands expressed by tumor cells. Regarding the limitation of a functional exogenous receptor, such as a TCR, it is noted that T lymphocytes inherently express numerous functional exogenous receptors comprising extracellular ligand binding domains, transmembrane domains, and intracellular domains, such as cytokine receptors or a TCR. The limitation of “exogenous” would refer to a product by process limitation explaining how the receptors is introduced. However, the receptors or TCRs of the T lymphocytes of the ‘491 publication are structurally and functionally identical, and therefore meet the limitation of a functional exogenous receptor, i.e. TCR. The ‘491 publication teaches pharmaceutical compositions. The ‘491 publication teaches T cells can be ab T cells (see paragraph 126, in particular).
The reference differs from the claimed invention in that it does not explicitly teach a cytokine receptor intracellular domain.
The ‘500 publication teaches that chimeric receptors comprising intracellular CD3 signaling domains can further comprise a costimulatory molecule signaling domain (see paragraphs 1-17, in particular). The ‘500 publication teaches that the costimulatory signaling domain include cytokine receptor signaling domains (See paragraph 22, in particular). The ‘500 publication teaches that including a costimulatory signaling domain provides for additional signals with induce T cell activation and can increases potency (See paragraph 78 and 106-107, in particular). The ‘500 publication also teaches that T cells can be engineered to possess specificity to one or more desired targets, and teaches T cells can express more than one different chimeric antigen receptor (see paragraphs 12, 226, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to include a cytokine receptor costimulatory domain, as taught by the ‘500 publication, in the intracellular signaling domain of the NKG2D chimeric receptor of the ‘491 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because ‘500 publication teaches that doing so provides additional signals which induce T cell activation and can increases potency. Even though the limitation of a functional exogenous receptor is met by the teachings of the ‘491 publication, it is noted that it would also be obvious to further engineer the T cells of the ‘491 publication to express a second chimeric antigen receptor, since the ‘500 publication teaches that T cells can be engineered to express more than one different chimeric antigen receptor. The ordinary artisan would be motivated to do so to provide for additional antigen specificities or signals to the T cells.
Claim 1-3, 11, 13, 18, 27-28, 32-33, 34, 69, 71, and 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019118885, in view of WO2020/097346.
The teachings of WO 2019118885 are described above.
The reference differs from the claimed invention in that it does not explicitly teach a CAR comprising an amino acid sequence at least 99% identical to SEQ ID NO: 29.
WO2020/097346 teaches a GPC3 CAR of SEQ ID NO: 1, which is 99.3% identical to SEQ ID NO: 29 of the instant application. WO2020/097346 teaches co-expressing said CAR in T cells with other co-stimulatory polypeptides for cell based immunotherapy (see page 1-2, in particular). WO2020/097346 teaches that the CAR targets the T cells toward GPC3 tumor antigen that is expressed on solid tumor (see page 9, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the GPC3 CAR of WO2020/097346, as the GPC3 CAR in the immune cells of WO2019118885. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because WO2020/097346 that the CAR targets GPC3 and can be co-expressed in T cells with other co-stimulatory polypeptides for cell based immunotherapy to target solid tumors
Regarding claim 28, the claim encompass “an amino acid sequence” at least 75% identical to SEQ ID NO: 98. For example, the cited reference render obvious SEQ ID NO: 29 of the instant application, which is found within SEQ ID NO: 98 and represents “an amino acid sequence” having 99% identity to SEQ ID NO: 98.
Claim 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2020/0276238, in view of WO2020/097346.
The teachings of the ‘238 publication are described above.
The reference differs from the claimed invention in that it does not explicitly teach a CAR comprising an amino acid sequence at least 99% identical to SEQ ID NO: 29.
WO2020/097346 teaches a GPC3 CAR of SEQ ID NO: 1, which is 99.3% identical to SEQ ID NO: 29 of the instant application. WO2020/097346 teaches co-expressing said CAR in T cells with other co-stimulatory polypeptides for cell based immunotherapy (see page 1-2, in particular). WO2020/097346 teaches that the CAR targets the T cells toward GPC3 tumor antigen that is expressed on solid tumor (see page 9, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the GPC3 CAR of WO2020/097346, as the CAR in the immune cells of the ‘238 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because WO2020/097346 that the CAR targets GPC3 and can be co-expressed in T cells with other co-stimulatory polypeptides for cell based immunotherapy to target solid tumors.
Claim 13, 27-28, 34, 69, 71 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 20170107491 and US 20170283500, as applied to claim 1 above, and further in view of WO2020/097346.
The combined teachings of the ‘491 and ‘500 publications are discussed above.
They do not teach explicitly teach a GPC3 CAR.
WO2020/097346 teaches a GPC3 CAR of SEQ ID NO: 1, which is 99.3% identical to SEQ ID NO: 29 of the instant application.
WO2020/097346 teaches co-expressing said CAR in T cells with other co-stimulatory polypeptides for cell based immunotherapy (see page 1-2, in particular). WO2020/097346 teaches that the CAR and the other co-stimulatory polypeptide can be expressed from a nucleic acid as a single polypeptide with an intervening P2A peptide S(see page 5 and 50-51, in particular). WO2020/097346 teaches that the CAR targets the T cells toward GPC3 tumor antigen that is expressed on solid tumor (see page 9, in particular).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to apply the teachings of WO2020/097346, to the immune cells made obvious by the ‘491 and ‘500 publication. One of ordinary skill in the art at the time the invention was made would have been motivated to do so, and have a reasonable expectation of success, because WO2020/097346 that the CAR targets GPC3 and can be co-expressed in T cells with other co-stimulatory polypeptides for cell based immunotherapy to target solid tumors. Furthermore, expressing both polypeptides from a single expression vector via a P2A peptide would be obvious and well withing the purview of the ordinary artisan.
Regarding claim 28, the claim encompass “an amino acid sequence” at least 75% identical to SEQ ID NO: 98. For example, the cited reference render obvious SEQ ID NO: 29 of the instant application, which is found within SEQ ID NO: 98 and represents “an amino acid sequence” having 99% identity to SEQ ID NO: 98.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, and 74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of copending Application No. 19/480,131, in view of WO2020/09734.
The ‘131 application claims a chimeric cytokine receptor comprising a first extracellular antigen binding domain, a transmembrane domain, a TPOR motif, and a cytokine receptor intracellular domain. The ‘131 application claims that said transmembrane domain is TPOR, that the intracellular domain is IL-21R and IL-15R and identical sequences to SEQ ID NO: 16 and 21 of the instant claims. The ‘131 application claims that the extracellular domain is an extracellular domain of NKG2D identical to SEQ ID NO: 6 the instant claims. The ‘131 application claims a cell comprising said chimeric cytokine receptor and further comprising a GPC3 CAR, wherein the CAR comprises sequences identical to those of the instant claims, and wherein the chimeric cytokine receptor and the CAR are linked via a P2A peptide linker. Alternatively, a GPC3 CAR within the scope of the instant claims is obvious based on the teachings of WO2020/09734 for the same reasons set forth above. The ‘131 application claims that the cell is an ab T cell and nucleic acids encoding said receptors. The cells would comprise “an amino acid sequence” having identity to SEQ ID NO: 98.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, and 74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-22, 24, 26-28, 32, 41-42, 44-46, and 49 copending Application No. 18/687,617, in view of US2020/0276238.
The ‘617 application claims a GPC3 CAR, said CAR comprising SEQ ID NO: 54 which is at least 97% identical to SEQ ID NO: 29 of the instant application. The ‘617 application claims a polynucleotide encoding said CAR and ab T cells expressing said CAR.
Although the ‘617 application does not explicitly claim that said T cells further express a chimeric cytokine receptor, doing so would be obvious based on the teachings of the ‘238 publication above. For example, once could further express the chimeric cytokine receptor of the ‘238 publication to achieve the advantages disclosed in the reference. This would be a chimeric cytokine receptor having an extracellular antigen binding domain that is derived from or is a “variant” of NKG2D for the reasons set forth above.
Claims 1-9, 11, 13, 18, 27-28, 32-34, 69, 71, and 74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-38, 65-69 copending Application No. 19/512,007, in view of WO2020/097346, US 20170107491, US 20170283500, and WO2020/097346.
The ‘007 application claims a dual CAR system comprising a first and second chimeric receptor, nucleic acids encoding and T cells (such as ab T cells) expressing said first and second CAR. It would be obvious to employ the CAR and/or chimeric cytokine receptors made obvious by the cited references as the first and/or second chimeric receptor in the dual CAR system claimed in the ‘007application. For example, once could further express the chimeric cytokine receptor of the ‘238 publication to achieve the advantages disclosed in the reference. This would be a chimeric cytokine receptor having an extracellular antigen binding domain that is a “variant” of NKG2D for the reasons set forth above. Additionally, one could use the chimeric receptor made obvious by the ‘491 publication and the ‘500 publication. as one of the first and second receptor. It would also be obvious to use the GPC33 CAR of WO2020/097346 as one of the CAR for the same reasons set forth above.
No claim is allowed.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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