Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Claims 105-110 are pending and the subject of this NON-FINAL Office Action. This is the first action on the merits.
Claim Rejection - 35 USC § 112 – Written Description
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.
Claims 105-110 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the full scope of the claimed invention.
The specification fails to demonstrate possession of the specific dual CARs of CD7 and CD19, CD7 and BCMA or CD7 and CD5. Section 112 of the Patent Act provides that a patent specification must contain a written description of the invention. 35 U.S.C. § 112(a). To satisfy the written description requirement, a patent’s disclosure must “clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (alteration in original) (citations omitted). That is, the test for sufficiency is whether the disclosure “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. (citations omitted). This test and its concept of possession requires us to determine how a person of ordinary skill in the art would understand the four corners of the specification. Id.
Even more, “the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Id. (emphasis added) (citation omitted). When the technology at issue is “complex” and “highly unpredictable,” as is the case here, the level of detail required to satisfy the written description requirement may be greater. See Ariad, 598 F.3d at 1351. Nonetheless, it is also well-established that working examples or an actual reduction to practice are not necessary to satisfy the written description requirement. Ariad, 598 F.3d at 1352.
Here, the technology is dual CAR vector systems, which are complex and unpredictable. For example, it is well-known in the art, even to this day, that single-CAR (one antigen target) and dual-CAR (two antigen targets) systems, especially those based on CD7 and CD5, yield unpredictable results due to the incredibly complex human response to their administration. See e.g. Dai et al, T cells expressing CD5/CD7 bispecific chimeric antigen receptors with fully human heavy-chain-only domains mitigate tumor antigen escape, Signal Transduct Target Ther. 2022 Mar 25;7:85. doi: 10.1038/s41392-022-00898-z; US20170340705, Background. Yet, Applicants attempt to claim specific antigen targets without ever disclosing their specific combination, much less any specific working examples. The specification is simply silent as to the specific combination of CD7 and CD19, CD7 and CD5 or CD7 and BCMA. Thus, Applicants fail to demonstrate possession of dual-CAR systems with these specific antigen targets.
Double Patenting- Obvious Type
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).
Instant claims 105-110 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-10 of 17/590983, in view of US20170340705 and US 20200281973.
The instant claims are obvious over the conflicting claims because the conflicting claims teach the same basic dual-CAR system using CD5, CD7, CD19 and BCMA, and the use of a self-cleavage peptide between two CARs is a very well-known technique. More specifically, the conflicting claims teach:
1. An engineered cell comprising:
a first polypeptide comprising a chimeric antigen receptor polypeptide; said chimeric antigen receptor polypeptide comprising a first antigen recognition domain, a first signal peptide, a first hinge region, a first transmembrane domain, a co-stimulatory domain, and a signaling domain; and
a second polypeptide comprising a second antigen recognition domain, a second signal peptide, a second hinge region, and a second transmembrane domain, wherein the second polypeptide does not comprise a co-stimulatory domain or a signaling domain.
5. The engineered cell according to claim 1, wherein said first antigen recognition domain and second antigen recognition domain independently comprise a CD2, CD3, CD4, CD5, CD7, CD8, CD19, CD20, CD22, CD30, CD33, CD52, CD123, CS1, BAFF, TACI, or BCMA antigen recognition domain.
6. The engineered cell according to claim 1, wherein the first antigen recognition domain and the second antigen recognition domain are different.
Although the conflicting claims do not explicitly teach the same vector/insert configuration as instant claims, yet a skilled artisan would have very familiar with this familiar dual-CAR setup. For example, US20170340705 teaches use of the same dual-CAR framework as claimed here to allow co-expression of two CARs to address the problems of cancer escape and tumour heterogeneity (Background, Figs. 3 & 13). As does US 20200281973 (Background, Fig. 1, paras. 0033, 0081, 0182-84).
Thus, the conflicting claims render obvious the instant claims.
Instant claims 105-110 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-19 of 17/994787, in view of US20170340705 and US 20200281973.
The instant claims are obvious over the conflicting claims because the conflicting claims teach the same basic dual-CAR system using CD5, CD7, CD19 and BCMA, and the use of a self-cleavage peptide between two CARs is a very well-known technique. More specifically, the conflicting claims teach:
1. A method for treating an autoimmune disorder, the method comprising administering to a patient in need thereof a dual CAR, wherein the dual CAR binds to an antigen expressed on T-cells and an antigen on the surface of B-cells or plasma cells, wherein the antigen expressed on T cells is CD2, CD3, CD4, CD5, or CD7, and wherein the antigen on the surface of B cells or plasma cells is CD19, CD20, CD22, BCMA, CD38, CD138, CS1, or GPRC5D.
2. The method according to claim 1, wherein the autoimmune disorder is T-cell mediated.
3. The method according to claim 1, wherein the autoimmune disorder is T-cell and B-cell mediated.
4. The method according to claim 1, wherein the dual CAR is comprised of CD7CAR, and another CAR unit targeting CD19, CD20, CD22, BCMA, CD38, GPRC5D, or CS1, wherein administration to the patient in need thereof results in depletion of T-cells expressing CD7 surface antigen, or B-cells or plasma cell populations or a combination thereof.
5. The method according to claim 1, wherein the dual CAR binds to cells expressing CD7 or CD19.
6. The method according to claim 1, wherein the dual CAR binds to cells expressing CD7 or CD20.
7. The method according to claim 1, wherein the dual CAR binds to cells expressing CD7 or BCMA.
17. A method for treating a cancer, the method comprising administering a CD7CAR combined with a CAR that requires CAR T-cell expansion to a patient in need thereof, wherein the CD7CAR is combined with a second CAR, wherein the second CAR targets at least one of GD2, GD3, ROR1, PSMA, PSCA (prostate stem cell antigen), MAGE A3, Glycolipid, glypican 3, F77, GD-2, WT1, CEA, HER-2/neu, MAGE-3, MAGE-4, MAGE-5, MAGE- 6, alpha-fetoprotein, CA 19-9, CA 72-4, NY-ESO, FAP, ErbB, c-Met, MART-1, MUC1, MUC2, MUC3, MUC4, MUC5, KIF20A, Survivin, AFP-1, gp100, MUC1, PAP-10, PAP-5, TRP2-1, SART-1, VEGFR1, VEGFR2, NEIL3, MPHOSPH1, DEPDC1, FOXM1, CDH3, TTK, TOMM34, URLC10, KOC1, UBE2T, TOPK, ECT2, MESOTHELIN, NKG2D, P1A, GM2, CD30, MMG49 epitope, EGFRvIII, CD33, CD123, CLL-1, immunoglobin kappa and lambda, CD38, CD52, CD47, CD200, CD70, CD19, CD20, CD22, CD38, BCMA, CS1, NKG2D receptor, April receptor, BAFF receptor, TACI, CD3, CD4, CD8, CD5, CD2, GPRC5D (G protein-coupled receptor, class C, group 5, member D), CD138, and viral or fungal antigens.
Although the conflicting claims do not explicitly teach the same vector/insert configuration as instant claims, yet a skilled artisan would have very familiar with this familiar dual-CAR setup. For example, US20170340705 teaches use of the same dual-CAR framework as claimed here to allow co-expression of two CARs to address the problems of cancer escape and tumour heterogeneity (Background, Figs. 3 & 13). As does US 20200281973 (Background, Fig. 1, paras. 0033, 0081, 0182-84).
Thus, the conflicting claims render obvious the instant claims.
Prior Art
The following prior art also teaches same or similar dual CAR vectors as claimed: US 20160068601; US 20180230225; US8822647; US 20180353588; US 20160207989; WO 2015075470; US 20170340705; US 20190177412; US 20180125892.
Conclusion
No claims are allowed.
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/AARON A PRIEST/ Primary Examiner, Art Unit 1681