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 amendment and remarks filed on 08/10/2026 are acknowledged.
Claims 1-17 are pending.
3. Applicant's election with traverse of the invention of Group III in the reply filed on 08/10/2026 is acknowledged.
The traversal is based on Applicant’s assertion that the reference cited in the Restriction Requirement does not constitute prior art. Applicant’s argument is acknowledged.
All presently pending claims read on the elected invention.
4. Claim 8 is objected to because of an apparent typographical error in the recitation of “IG4,” where it appears that “IgG4” was intended. Appropriate correction or clarification is required.
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 1-2, 4-9 and 11-17 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 1 is indefinite because, in the absence of a conjunction (such as “and” or “or”) in listing of SEQ ID NOS: 41-46, it is unclear whether all six sequences must be present together, or is the presence of any one of these sequences satisfies the claim limitation.
(ii) Claims 2, 4-9 and 11-17 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
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 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.
8. Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Yao et al. (US 20200002400 “Yao ‘400,” cited on IDS).
It is noted that according to Application Data Sheet filed on 07/26/2023, the present application is a 371 of PCT/US2022/013875 (01/26/2022), which is a CIP of USSN 17/352915 (06/21/2021). PCT/US2022/013875 claims benefit of provisional applications USSN 63/154040 (02/26/2021) and USSN 63/142216 (01/27/2021). Accordingly, the earliest priority date of the present application is 01/27/2021.
Yao ‘400 teaches a chimeric antigen receptor of SEQ ID NO: 5 (e.g. claim 5), which is identical to instant SEQ ID NO: 5 (see SCORE), and as such possesses the same structural features and functional properties as recited in instant claims 1-14. Yao ‘400 further teaches T cells expressing the CAR and pharmaceutical composition comprising the T cells (e.g. claims 10-15), thereby anticipating instant claims 15-17.
9. Claims 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yao et al. (US 20210290673 “Yao ‘673,” cited on IDS).
As noted in section 8 above, the earliest priority date of the present application is 01/27/2021. Yao ‘673, filed on 05/18/2020, names another inventor, and as such constitutes prior art under 35 U.S.C. 102(a)(2).
Yao ‘673 teaches chimeric receptor “CAR-T20.19” of SEQ ID NO: 39 (Tables 1 and 2), which is identical to instant SEQ ID NO: 5 (see SCORE), and as such possesses the same structural features and functional properties as recited in instant claims 1-14. Yao ‘673 further teaches T cells expressing the CAR and pharmaceutical composition comprising the T cells (e.g. Example 11), thereby anticipating instant claims 15-17.
10. Claims 1-9 and 11-17 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Press et al. (US 20190106501, cited on IDS).
As noted in section 8 above, the earliest priority date of the present application is 01/27/2021.
The CDR sequences recited in claim 1 and the variable region sequences recited in claim 3 are identical to the corresponding sequences of anti-CD20 antibody ofatumumab (clone 2F2, also known as Arzerra™ and Kesimpta™) (see SCORE).
Press teaches anti-CD20 CARs comprising ofatumumab-based scFv (e.g. [0104]), which is within the scope of instant claims 1, 3 and 4. The CARs further comprise a signal peptide, an IgG4 hinge-CH2-CH3, a CD8 transmembrane domain, and an intracellular domain comprising CD3ζ, 4-1BB, CD28, or any combination thereof (e.g. [0102]-[0104], [0131]), thereby anticipating claims 5-9 and 11-14. Press further teaches CAR-expressing T cells and compositions comprising the cells (e.g. [0268]).
Claim 2 is included in the rejection, because it recites one of only two possible arrangements, and as such would be at once envisaged by a person of ordinary skill in the art.
11. 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.
12. Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of each of U.S. Patents No. 11066457, 11472858, 11618778, 11608369, 12583903, 12747279, 11207349, 11439665, 11633430, 12448432, 12311022, 12458667, 12751973, and 12753221.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of each of the above-listed patents, which recite ofatumumab-based chimeric antigen receptors comprising at least the same CDRs and VRs as instantly recited.
13. Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of each of the following copending applications:
USSN PG Pub. No.
17911502 20230104705
19188511 20250262243
19348065 20260076995
19356595 20260108557
19356548 20260108556
19773860
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of each of the above-listed copending applications, which recite ofatumumab-based chimeric antigen receptors comprising at least the same CDRs and VRs as instantly recited.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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