DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 response filed on 10/16/2025 is acknowledged. Claims 1-299 are canceled. Claims 300-303 are pending. Claims 300 and 301 have been amended.
3. Claims 300-303 are under examination.
Drawings
4. The objection to the drawings for omitting Figs. 95E-H is withdrawn in view of applicant’s submission of a replacement drawing sheet (note: support can be found in parent Application No. 17/109,757).
Specification
5. The amendment to the specification filed on 10/16/2025 is objected to for the following reasons:
(i) The text of paragraph [0982] does not match the text of paragraph [0982] of the original specification, and
(ii) No marked-up copies of Tables 109 and 118 indicating the changes made and no explanation for the support of the changes.
Tables 109 and 118 do not have shadings in the original specification. It appears that applicant added “ ± 1,184” in column 2, row 4 of Table 109. There is no support for this limitation and thus the amendment introduces new matter into the disclosure.
35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. Applicant is required to cancel the new matter in the reply to this Office Action.
Accordingly the amendment to the specification is not entered.
Objections Maintained
6. The objection to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code is maintained because the amendment to the specification is not entered (see above).
Objections Withdrawn
7. The objection to claim 301 for reciting “each cell line” is withdrawn in view of applicant’s amendment.
Rejection Withdrawn
8. The rejection of claims 300-303 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of applicant’s amendment.
9. The rejection of claims 300-303 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,684,659, in view of Link Jr. et al (US 2005/0201993A1, pub date: 9/15/2005) is withdrawn in view of applicant’s amendment.
10. The provisional rejection of claims 300-303 on the ground of nonstatutory double patenting as being unpatentable over Claims 36 and 66 of copending Application No. 19/009,002 (reference application), in view of Link Jr. et al (US 2005/0201993, pub date: 9/15/2005) is withdrawn in view of applicant’s amendment.
Rejections Maintained
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
12. Claims 300-303 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,369,668. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-16 of U.S. Patent No. 11,369,668 disclose a kit comprising at least one vial comprising a first composition comprising NCI-H520 cell line modified in vitro to: 1) knockout expression of CD276 using a zinc-finger nuclease targeting CD276 (SEQ ID NO: 26); and 2) express GM-CSF (SEQ ID NO: 8), membrane bound CD40L (SEQ ID NO: 3), TGFβ1 shRNA (SEQ ID NO: 25), and TGFβ2 shRNA (SEQ ID NO: 24), wherein the first composition comprises approximately 1.0x106-6x107 cells, and the cell line is irradiated.
The amino acid sequences of SEQ ID NOs: 3, 8, 24, 25 and 26 are 100% identical to instant SEQ ID NOs: 3, 8, 24, 25 and 26, respectively.
The claims of the patent disclose every limitation of the instant claims, as such anticipate instant invention.
Response to Applicant’s Arguments
The response states that applicant submitted a terminal disclaimer to obviate the rejection.
The rejection is maintained before the terminal disclaimer is disapproved by the office, see Terminal Disclaimer Review Decision mailed on 10/21/2025.
13. Claims 300-303 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of 14, 67, 118, 119, 130-132, 170, 233, 234, 256, 257, 274, 278 and 287, copending Application No. 19/090,021. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims of 14, 67, 118, 119, 130-132, 170, 233, 234, 256, 257, 274, 278 and 287 of copending Application No. 19/090,021 disclose a vaccine composition comprising NCI-H520 modified to (i) increase expression of GM-CSF (SEQ ID NO:8) and membrane bound CD40L (SEQ ID NO:3), and (ii) decrease expression of TGFβ1, TGFβ2, and CD276, wherein decreased expression of CD276 includes knockout CD276 using a zinc finger nuclease pair that target a CD276 genomic DNA sequence comprising SEQ ID NO:26, decreased expression of TGFβ1 and TGFβ2 comprises knock-down TGFβ1 and TGFβ2 using shRNA comprising SEQ ID NO:25 and 24, respectively, wherein NCI-H520 is irradiated, and the composition comprises approximately 1.0x106-6x107 cells.
The amino acid sequences of SEQ ID NOs: 3, 8, 24, 25 and 26 are 100% identical to instant SEQ ID NOs: 3, 8, 24, 25 and 26, respectively. The claims of the reference application disclose every limitation of the instant claims, as such anticipate instant invention.
Response to Applicant’s Arguments
The response states that applicant submitted a terminal disclaimer to obviate the rejection.
The rejection is maintained before the terminal disclaimer is disapproved by the office, see Terminal Disclaimer Review Decision mailed on 10/21/2025.
14. Claims 300-303 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25, 27, 49, 71, 115, 123, 124 and 132 of copending Application No. 19/089,837. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 25, 27, 49, 56, 71, 115, 123, 124 and 132 of copending Application No. 19/089,837 disclose a composition comprising NCI-H520 cell line modified in vitro to: 1) knockout expression of CD276 using a zinc-finger nuclease targeting CD276 (SEQ ID NO: 52); and 2) express GM-CSF (SEQ ID NO: 8), membrane bound CD40L (SEQ ID NO: 3), TGFβ1 shRNA (SEQ ID NO: 54), and TGFβ2 shRNA (SEQ ID NO: 55), wherein the first composition comprises approximately 1.0x106-6x107 cells.
The amino acid sequences of SEQ ID NOs: 3, 8, 55, 54 and 52 are 100% identical to instant SEQ ID NOs: 3, 8, 24, 25 and 26, respectively. The claims of the reference application disclose every limitation of the instant claims, as such anticipate instant invention.
Response to Applicant’s Arguments
The response states that applicant submitted a terminal disclaimer to obviate the rejection.
The rejection is maintained before the terminal disclaimer is disapproved by the office, see Terminal Disclaimer Review Decision mailed on 10/21/2025.
Conclusion
15. No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Epps-Smith can be reached on 5712720757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG SANG/Primary Examiner, Art Unit 1646