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 09/17/2025 are acknowledged.
Claims 36, 38 and 40-68 are pending.
Claims 64-66 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/28/2025.
Claims 36, 38, 40-63 and 67-68 are presently under consideration.
3. 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.
4. Claim 53 is 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.
Claim 53 is indefinite, because the recitation of “the folate receptor” lacks proper antecedent basis in the base claim.
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.
5. 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.
6. Claims 36, 38 and 40-63 stand rejected, and newly added claim 67 is rejected, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Thompson et al. (US 20180319862; of record).
The grounds of rejection set forth in section 8 of the previous Office action are maintained essentially for the reasons of record, as they apply to the amended claims.
Applicant’s arguments have been fully considered but have not been found convincing.
In response to Applicant’s assertion that Thompson’s “claim 29 alone would comprise thousands if not millions of possible combinations” of elements, is noted that claim 29 recites examples of well-known tumor antigens which may be targeted by the chimeric receptor, and not structural features of the chimeric receptor itself.
Embodiment (a) of instant claim 36 is directed to a chimeric costimulatory receptor comprising:
(i) a disease- or tumour-associated antigen binding domain, linked to
(ii) an extracellular segment of CD28, linked to
(iii) a transmembrane domain, linked to
(iv) a first intracellular segment comprising an intracellular signaling domain of CD28, and linked to
(v) a second intracellular segment comprising an intracellular signaling domain of CD40.
Thompson teaches and claims:
2. A chimeric receptor, comprising: (a) a ligand-binding domain; (b) a transmembrane domain derived from human CD28; and (c) an intracellular signaling domain comprising a signaling domain derived from CD40.
17. The chimeric receptor of any one of claims 1-16, wherein the intracellular signaling domain further comprises a costimulatory signaling domain distinct from the signaling domain derived from the CD40.
19. The chimeric receptor of claim 17 or claim 18, wherein the costimulatory signaling domain comprises a signaling domain derived from CD28, 4-1BB or ICOS or a signaling portion thereof.
Thus, Thompson teaches CD40 signaling domain in combination with one of only three additional domains, i.e. CD28, 4-1BB and ICOS.
Thompson further teaches and claims:
31. The chimeric receptor of any one of claims 1-30, wherein the chimeric receptor comprises further comprises a spacer joining the ligand binding domain and the transmembrane domain.
34. The chimeric receptor of claim 31, wherein the spacer comprises an extracellular portion derived from a CD28, which optionally is a human CD28.
Here, Thompson explicitly teaches extracellular segment of CD28 as a specific embodiment.
Accordingly, Thompson specifically teaches a chimeric receptor within the scope of at least embodiment (a) of claim 36. Therefore, the rejection of claims 36, 38 and 40-63 set forth in section 8 of the previous Office action is maintained, and is incorporated by reference herein as if reiterated in full.
Newly added claim 67 stipulates that the extracellular segment is from CD28 and comprises the amino acids corresponding to residues of 102-152 of SEQ ID NO: 2. This segment constitutes the 50 amino acids adjacent to CD28 transmembrane domain located at residues 153-173 of SEQ ID NO: 2.
As explained above, Thompson teaches a chimeric receptor within the scope of claim 36(a), in particular wherein the transmembrane domain is derived from human CD28 (claim 2). Thompson further teaches that the extracellular portion derived from human CD28 is 1 to 50 amino acids in length (claim 35). The extracellular portion of human CD28 of 50 amino acids in length adjacent to the transmembrane domain corresponds to residues of 102-152 of instant SEQ ID NO: 2. Accordingly, claim 67 is anticipated by Thompson’s teachings.
7. Claims 36, 40-44, 51-52, 57-58, 61, 63 and 68 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Ma et al. (US 20180066034)
Ma teaches chimeric antigen receptors (CARs) comprising an antigen recognition domain, a hinge region, a transmembrane domain, at least one co-stimulatory domain, and a signaling domain (e.g. claim 106).
The antigen recognition domain (i.e. an antigen binding domain) can be an scFv specific to a leukemia antigen such as CD4 (e.g. [0041], claim 111).
The hinge region (i.e. an extracellular segment) can be from human CD9, CD134 (OX40), CD137 (4-1BB), or ICOS (e.g. [0100]).
The transmembrane domain can be from CD4, CD8, CD28 or ICOS (e.g. [0106]).
CARs can include two costimulatory domains from CD137 (4-1BB) and OX40 (e.g. [0039]), and may also include signaling domains from CD2, CD27, CD40, or ICOS (e.g. [0111]).
Ma further teaches T cells comprising polynucleotides encoding the CARs (e.g. claims 111-112).
Accordingly, Ma teaches all of the limitations of instant claims 36 (embodiment (b)), 40-44, 51-52, 57-58, 61, 63 and 68, thereby anticipating these claims.
8. 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.
9. Claims 36, 38, 40-63 and 67-68 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 12187778 and 11945876 (both of record).
Claims 36, 38, 40-63 and 67-68 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications USSN 17/843480, 17/936102, 18/005330, 18/157027, 18/316548, and 18/719985 (all of record).
The grounds of rejection presented in sections 10-12 of the previous Office action are maintained.
Applicant’s request that the above rejections be held in abeyance until all of the pending claims are indicated otherwise allowable is improper, because “[o]nly compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated.” MPEP § 804.
10. Conclusion: no claim is allowed.
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644