DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's preliminary amendment filed on 02/02/2024 is acknowledged.
Claims 63-80 are pending.
3. 35 U.S.C. § 101 reads as follows:
"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title".
4. Claim 79 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter, because “use” is none of a process, a machine, a manufacture, or a composition of matter.
5. 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.
6. Claims 79-80 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 79 provides for the “use” of a costimulatory domain, but, since the claim does not set forth any steps involved in the “use”, it is unclear what applicant is intending to encompass. A claim is indefinite where it merely recites a “use” without any active, positive steps delimiting how this use is actually practiced.
(ii) Claim 80 is indefinite in the recitation of “a patient in need thereof,” because the target patient population is unknown.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
7. 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.
8. Claim 80 is rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not provide a sufficient enabling description of a method of treating "a patient in need thereof."
The specification does not enable one of skill in the art to make and use the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
A person of ordinary skill in the art would have been aware of the enormous variety of pathological processes in terms of etiology, pathogenesis, and molecular and cellular mechanisms, and so a great majority of diseases would not be treatable by any single therapeutic intervention. In the absence of sufficient guidance, direction, or working examples in the present disclosure, it is at best unpredictable whether a given disease out of a practically infinite number of diseases encompassed by the scope of the generic recitation of "a patient in need thereof" is treatable by administering the recited agent; thus the experimentation left to those skilled in the art would be unnecessarily, and improperly, extensive and undue.
If the claim was limited to a method of treating cancer, it still would not satisfy the enablement requirement of 35 U.S.C. 112(a), because a generically recited “eukaryotic cell” comprising a generically recited “CAR” without a tumor-specific antigen binding domain would not be therapeutically effective.
9. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 63-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,800,833 (cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of US ‘833.
Instant claims are directed to:
a co-stimulatory domain comprising SEQ ID NO: 8; and to
a CAR comprising:
the co-stimulatory domain,
a CD3 zeta intracellular signaling domain,
a CD8 transmembrane domain, and
an scFv specific for a tumor antigen; and to
to genetically-modified T cells and NK cells comprising the CAR; and to
pharmaceutical compositions comprising the cells.
US ‘833 recites:
a co-stimulatory domain comprising SEQ ID NO: 8 (claim 1),
a CAR comprising
the co-stimulatory domain (claim 2),
a CD3 zeta intracellular signaling domain (claim 3),
a CD8 transmembrane domain (claim 16), and
a CD19-specific antigen-binding domain (claim 17);
a genetically-modified T cell comprising the CAR (claims 9 and 19-21); and
a pharmaceutical composition comprising the cell (claim 15).
Claims 67-68 and 71-78 are included in the rejection, because a skilled artisan would have been aware that CD19 is a tumor antigen, that scFv is the most typical format of antigen-binding domain in a CAR, and that CARs are typically incorporated into T cells or NK cells.
Claims 79-80 are included in the rejection, because a skilled artisan would have been aware that CAR-comprising T cells are used for cancer treatment.
11. Claims 63-65 and 67-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,286,291 (cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of US ‘291.
US ‘291 recites:
a co-stimulatory domain comprising SEQ ID NO: 8 (claim 14),
a CAR comprising the co-stimulatory domain (claims 15-16),
a genetically-modified cell comprising the CAR (claims 25-26), and
a pharmaceutical composition comprising the cell (claim 28).
Claim 65 is included in the rejection, because a skilled artisan would have been aware that CARs typically comprise a CD3 ζ intracellular signaling domain.
Claims 67-68 and 71-80 are included in the rejection for the same reason as articulated in section 10 above.
12. Claims 63-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17/782,607 (published as US 20230036065, cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of USSN ‘607.
Specifically, claims 1 and 65 of USSN ‘607 recite a pharmaceutical composition for cancer immunotherapy comprising CAR-T cells, wherein the CAR comprises:
an anti-CD19 scFv,
a CD8 alpha transmembrane domain,
an N6 co-stimulatory domain, and
a CD3 zeta intracellular signaling domain.
The amino acid sequence of Novel 6 (N6) co-stimulatory domain is SEQ ID NO: 12 ([0122] of US 20230036065), which is identical to instant SEQ ID NO: 8 (see SCORE). Accordingly, the subject matter recited in claims 1 and 65 of USSN ‘607 is within the scope of instant claims 63-72, 75-76 and 79-80, thereby anticipating these claims.
Claim 73-74 and 77-78 are included in the rejection, because a skilled artisan would have been aware that CARs expressed by either T cells or NK cells are useful for treating cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. The following documents are cited of record as relating to the state of the art pertinent to the present invention:
US 20200216534 teaches mutating CAR costimulatory domain to increase TRAF binding (e.g. [0249]).
US 20240115608 teaches synthetic CAR costimulatory domains comprising multiple copies of TRAF binding motifs (e.g. [0124]).
14. Conclusion: no claim is allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 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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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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