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 11/26/2025 are acknowledged.
Claims 1-7 and 10-18 are pending.
3. 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.
4. Claim 17 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim contains 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 claimed invention. This is a New Matter rejection.
Applicant does not point out the support for the amendment, and the disclosure as-filed does not appear to provide adequate written description of the following newly added limitation: “wherein the truncated body of IL7Rα comprises the amino acid sequence corresponding to positions 147-226 of SEQ ID NO: 4.”
The specification as-filed contains the following relevant disclosure ([0038] at p. 7): “The fusion protein shown in SEQ ID NO. 4 consists of the anti-CD133 single-chain antibody, a CD28, a truncated body of IL7Rα, and a CD3.” This passage does not specify the amino acid sequence positions of the “truncated body of IL7Rα” within SEQ ID NO: 4, and the examiner was unable to identify support for the newly added recitation elsewhere in the disclosure.
Moreover, since the truncated body of IL7Rα “comprises” the specified amino acid sequence, the “truncated body” may contain other unidentified amino acid sequences, which do not appear to be supported by the disclosure as filed.
The amended claims now recite limitations which were not clearly disclosed in the specification or claims as filed, and change the scope of the instant disclosure as filed. These limitations introduce new concepts and violate the description requirement of 35 U.S.C. 112(a). Applicant is required to cancel the New Matter in the response to this Office Action. Alternatively, Applicant is invited to clearly point out the written support for the newly added limitations.
6. 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.
7. Claims 1-7 and 10-15 stand provisionally rejected, and newly added claims 16-18 are provisionally rejected, on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18/018711, USSN 18/018764, and USSN 18/019010, published as US 20230295294, US 20230322940, and US 20240052014, respectively (all of record).
The grounds of rejection set forth in section 7 of the previous Office action are maintained for the reasons of record, as they apply to the amended and newly added claims, and are incorporated by reference herein as if reiterated in full.
Applicant’s arguments at p. 6-7 of the Remarks have been fully considered but have not been found convincing.
Applicant’s arguments are directed at “core inventive concept,” “core target, technical purpose, logic of the technical solution, and technical effects” of the copending claims.
According to MPEP § 804(II)B, “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).”
In the present case, the instant claims are anticipated by the claims of each of the copending applications, which recite the same anti-CD133 single-chain antibody and fusion proteins as instantly claimed, as explained in section 7 of the previous office action. Applicant’s arguments do not appear to address the fact of anticipation. Accordingly, the grounds of rejection are maintained.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is noted that the present application has the same earliest effective U.S. filing date (as defined in MPEP § 804(I)(B)(1)(a)) as each of the cited copending applications. According to MPEP § 804(I)(B)(1)(b)(ii), if both applications are actually filed on the same day, or are entitled to the same earliest effective filing date taking into account any benefit under 35 U.S.C. 120, 121, 365(c), or 386(c)) with respect to the conflicting claims (see paragraph (a) Effective U.S. filing date) the provisional nonstatutory double patenting rejection made in each application should be maintained until the rejection is overcome. Applicant can overcome a provisional nonstatutory double patenting rejection in an application by either filing a reply showing that the claims subject to the provisional nonstatutory double patenting rejections are patentably distinct or filing a terminal disclaimer in the pending application.
It is further noted that Applicant’s request that the above rejections be held in abeyance 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.
8. Conclusion: no claim is allowed.
9. 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.
10. 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 8:30 AM – 5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. 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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