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
The preliminary amendment filed October 23, 2024, is acknowledged and has been entered. Claims 1-69 have been canceled. Claims 70-88 have been newly added.
Claims 70-88 are pending in the application and are under examination.
Information Disclosure Statement
The information disclosure statements have been considered.
Claim Rejections - 35 USC § 112
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 81 and 82 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. In this case, claim 81 recites “A composition comprising a first polynucleotide encoding the iCAR polypeptide in the composition of claim 79”, such that neither claim 81 or 82 which depends from claim 81 comprise the composition of claim 79, so that they fail to include all the limitations of the claim upon which it depends
It is suggested that claim 81 and 82 be canceled to obviate the rejection.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 70-88 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Federov et al (US 2015/0376296 A1).
With respect to claims 70-71, 74, 76-80, Federov et al disclose compositions for treating cancer comprising recombinant T cells that express a first chimeric antigen receptor (CAR) polypeptide and a second chimeric antigen receptor (CAR) polypeptide, wherein the first CAR (aCAR) polypeptide comprises:
1 a) a first extracellular ligand-binding domain having a binding affinity for a first ligand expressed on a cancer cell;
1 b) a first transmembrane domain; and
1c) a first intracellular signaling domain, wherein the second CAR (iCAR) polypeptide comprises:
2a) a second extracellular ligand-binding domain having a binding affinity for a second ligand on the surface of a non-cancerous cells;
2b) a second transmembrane domain; and
2c) a second intracellular signaling domain, wherein binding of the first ligand to the first extracellular ligand-binding domain activates the first CAR polypeptide, and leads to activation of the recombinant cell to inhibit growth or kill a first cancer cell expressing a sufficient amount of the first ligand but not the second ligand, and wherein binding of the second ligand to the second extracellular ligand-binding domain activates the second CAR polypeptide, and leads to reduction of the activation of the first CAR polypeptide, thereby reducing the capability of the recombinant cell to inhibit growth or kill a second non-cancer cell expressing a sufficient amount of the second ligand (see entire document, e.g., ¶ [0008]-[0022] and [0146], Figures and claims).
With respect to claims 72-73, Federov et al disclose HER2 (erbb2) as the first ligand or AML as the first cancer cell (see entire document, e.g., ¶ [0011], [0019] and [0188] and claims).
With respect to claim 75, Federov et al disclose that the second antigen on the non-cancerous cell can be on endothelial cells such a blood-brain barrier specific antigen, etc (see entire document, e.g., ¶ [0020] and claims).
With respect to claim 81-84, Federov et al disclose compositions comprising first and second polynucleotides encoding the iCAR and aCAR respectively, wherein the first and second polynucleotides are incorporated onto the same vector such as a bicistronic vector or different vectors (see entire document, e.g., ¶ [0084] and [0157]-[0163]) and claims).
With respect to claims 85-88, Federov et al disclose treating patients by administering compositions comprising effective amounts of such recombinant T cells to cancer patients (see entire document, e.g., ¶ [0168]-[0189]) and claims), which contact a recombinant cell with the first ligand on a cancer cell but not the second ligand, when contacting the cancer cell and which kill the first cancer cell, but not the second cell.
Therefore, Federov et al is deemed to anticipate the instant claims absent a showing otherwise.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 70-88 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 102 and 107-108 of copending Application No 18/547,652 in view Federov et al (US 2015/0376296 A1). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The claims of the copending application recite a composition comprising:(a) a first chimeric antigen receptor (CAR) polypeptide comprising: i) a first extracellular ligand-binding domain having a binding affinity for a first ligand; ii) a first transmembrane domain; and iii) a first intracellular signaling domain, and (b)) a second chimeric antigen receptor (CAR) polypeptide comprising: i) a second extracellular ligand-binding domain having a binding affinity for a second ligand different from the first ligand; ii) a second transmembrane domain; and iii) a second intracellular signaling domain, wherein neither of the first and the second intracellular signaling domain comprises an ITAM. The claims of the copending application also recite nucleic acids encoding the CARs and cells comprising such nucleic acids.
Federov et al disclose compositions for treating cancer comprising recombinant T cells that express a first chimeric antigen receptor (CAR) polypeptide and a second chimeric antigen receptor (CAR) polypeptide, wherein the first CAR (aCAR) polypeptide comprises:
1 a) a first extracellular ligand-binding domain having a binding affinity for a first ligand expressed on a cancer cell;
1 b) a first transmembrane domain; and
1c) a first intracellular signaling domain, wherein the second CAR (iCAR) polypeptide comprises:
2a) a second extracellular ligand-binding domain having a binding affinity for a second ligand on the surface of a non-cancerous cells;
2b) a second transmembrane domain; and
2c) a second intracellular signaling domain, wherein binding of the first ligand to the first extracellular ligand-binding domain activates the first CAR polypeptide, and leads to activation of the recombinant cell to inhibit growth or kill a first cancer cell expressing a sufficient amount of the first ligand but not the second ligand, and wherein binding of the second ligand to the second extracellular ligand-binding domain activates the second CAR polypeptide, and leads to reduction of the activation of the first CAR polypeptide, thereby reducing the capability of the recombinant cell to inhibit growth or kill a second non-cancer cell expressing a sufficient amount of the second ligand (see entire document, e.g., ¶ [0008]-[0022] and [0146], Figures and claims).
Federov et al disclose HER2 (erbb2) as the first ligand or AML as the first cancer cell (see entire document, e.g., ¶ [0011], [0019] and [0188] and claims).
Federov et al disclose that the second antigen on the non-cancerous cell can be on endothelial cells such a blood-brain barrier specific antigen, etc (see entire document, e.g., ¶ [0020] and claims).
With respect to claim 81-84, Federov et al disclose compositions comprising first and second polynucleotides encoding the iCAR and aCAR respectively, wherein the first and second polynucleotides are incorporated onto the same vector such as a bicistronic vector or different vectors (see entire document, e.g., ¶ [0084] and [0157]-[0163]) and claims).
Federov et al disclose treating patients by administering compositions comprising effective amounts of such recombinant T cells to cancer patients (see entire document, e.g., ¶ [0168]-[0189]) and claims), which contact a recombinant cell with the first ligand on a cancer cell but not the second ligand, when contacting the cancer cell and which kill the first cancer cell, but not the second cell.
Accordingly, in view of the copending claims and the reference, it would have obvious to one of ordinary skill in the art to make compositions comprising recombinant T cells that comprise the CARs of the copending claims, nucleic acids encoding the CARs cells comprising expression vectors comprising the nucleic acids and use the cells to treat cancer because Federov et al disclose that recombinant T cells comprising a first chimeric antigen receptor (CAR) polypeptide comprising: i) a first extracellular ligand-binding domain having a binding affinity for a first ligand; ii) a first transmembrane domain; and iii) a first intracellular signaling domain, and (b)) a second chimeric antigen receptor (CAR) polypeptide comprising: i) a second extracellular ligand-binding domain having a binding affinity for a second ligand different from the first ligand; ii) a second transmembrane domain; and iii) a second intracellular signaling domain (these cells would comprise either one or two vectors encoding the CARs) are desirable and can be predictably used in methods of treating cancer. In this case, the instant claims do not require that the first and the second intracellular signaling domain comprises an ITAM, so the genus of CARs in the instant claims include those that do not comprise ITAMs as required by the copending claims. Accordingly, based on the copending claims and the prior art, the constructs encompassed by the instant claims would be seen as combining elements according to known methods to yield predictable results.
Therefore, the conflicting claims 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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The Examiner works a flexible schedule and can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
July 16, 2026
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