DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions and Claim Status
Applicants’ arguments filed 6/27/25 are acknowledged.
The terminal disclaimer filed on 6/27/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11267896 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Due to the terminal disclaimer, the double patenting rejection based on US 11267896 has been withdrawn.
Previously, Group 2 and the species of SEQ ID NO:308 were elected.
Claims 58-64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/20/24.
Claims 66-70 require additional amino acids or components in addition to SEQ ID NO:308. Applicants did not identify a specific conjugate. As such, claims 66-70 are drawn to non-elected species.
Although applicants argue that the election of species requirement was directed to the genus of CM, the restriction requirement dated 9/23/24 expressly states “Applicant should uniquely identify the polypeptide including any agents conjugated to the polypeptide”. Applicants elected SEQ ID NO:308 which does not include additional components as in claims 66-70.
Claims 66-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/20/24.
Claims 1-57 have been canceled.
Claim 65 is being examined.
Priority
The priority information is found in the filing receipt dated 6/21/24.
Double Patenting
The double patenting rejections set forth below are maintained from the previous office action.
The terminal disclaimer filed on 6/27/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11267896 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Due to the terminal disclaimer, the double patenting rejection based on US 11267896 has been withdrawn.
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.
Claim 65 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,049,505 (505) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
505 teach a polypeptide that comprises SEQ ID NO:78 (claim 2) and suggest as a substrate for urokinase (claim 22).
505 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 505 because 505 teach a polypeptide that comprises SEQ ID NO:78 (claim 2) and suggest as a substrate for urokinase (claim 22). Since 505 suggest a specific use and specifically recites SEQ ID NO:78 (claim 2) one would have been motivated to make a protein comprising SEQ ID NO:78 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 505 recites SEQ ID NO:78 (claim 2) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-58 of U.S. Patent No. 11,046,759 (759) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
759 teach a polypeptide that comprises SEQ ID NO:19 (claims 1 and 7) and suggest as a cleavable moiety (claim 1) and in a composition (claim 54).
759 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 759 because 759 teach a polypeptide that comprises SEQ ID NO:19 (claims 1 and 7) and suggest as a cleavable moiety (claim 1) and in a composition (claim 54). Since 759 suggest a specific use and specifically recites SEQ ID NO:19 (claims 1 and 7) one would have been motivated to make a protein comprising SEQ ID NO:19 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 759 recites SEQ ID NO:19 (claims 1 and 7) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-58 of U.S. Patent No. 10,179,817 (817) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
817 teach a polypeptide that comprises SEQ ID NO:789 (claim 5) and suggest as a cleavable moiety (claim 5) and in a composition (claim 41).
817 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 817 because 817 teach a polypeptide that comprises SEQ ID NO:789 (claim 5) and suggest as a cleavable moiety (claim 5) and in a composition (claim 41). Since 817 suggest a specific use and specifically recites SEQ ID NO:789 (claim 5) one would have been motivated to make a protein comprising SEQ ID NO:789 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 817 recites SEQ ID NO:789 (claim 5) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-88 of U.S. Patent No. 10,745,481 (481) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
481 teach a polypeptide that comprises SEQ ID NO:318 (claim 5) and suggest as a cleavable moiety (claim 5) and in a composition (claim 41).
481 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 481 because 481 teach a polypeptide that comprises SEQ ID NO:318 (claim 5) and suggest as a cleavable moiety (claim 5) and in a composition (claim 41). Since 318 suggest a specific use and specifically recites SEQ ID NO:318 (claim 5) one would have been motivated to make a protein comprising SEQ ID NO:318 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 481 recites SEQ ID NO:318 (claim 5) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-64 of U.S. Patent No. 11,753,466 (466) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
466 teach a polypeptide that comprises SEQ ID NO:318 (claim 1) and suggest as a cleavable moiety (claim 1) and use in a method (claim 1).
466 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 466 because 466 teach a polypeptide that comprises SEQ ID NO:318 (claim 1) and suggest as a cleavable moiety (claim 1) and use in a method (claim 1). Since 466 suggest a specific use and specifically recites SEQ ID NO:318 (claim 1) one would have been motivated to make a protein comprising SEQ ID NO:318 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 466 recites SEQ ID NO:318 (claim 1) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 10,233,244 (244) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
244 teach a polypeptide that comprises SEQ ID NO:276 (claim 6) and suggest as a cleavable moiety (claim 6) and in a composition (claim 41).
244 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 244 because 244 teach a polypeptide that comprises SEQ ID NO:276 (claim 6) and suggest as a cleavable moiety (claim 6) and in a composition (claim 41). Since 244 suggest a specific use and specifically recites SEQ ID NO:276 (claim 6) one would have been motivated to make a protein comprising SEQ ID NO:276 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 244 recites SEQ ID NO:276 (claim 6) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-77 of U.S. Patent No. 10,513,558 (558) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
558 teach a polypeptide that comprises SEQ ID NO:1157 (claim 38) and suggest as a cleavable moiety (claim 38) and in a composition (claim 15).
558 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 558 because 558 teach a polypeptide that comprises SEQ ID NO:1157 (claim 38) and suggest as a cleavable moiety (claim 38) and in a composition (claim 15). Since 558 suggest a specific use and specifically recites SEQ ID NO:1157 (claim 6) one would have been motivated to make a protein comprising SEQ ID NO:1157 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 558 recites SEQ ID NO:1157 (claim 6) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 89, 93, 98-120 of copending Application No. 17/666,898 (898) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
This is a provisional nonstatutory double patenting rejection.
898 teach a polypeptide that comprises SEQ ID NO:789 (claim 101) and suggest as a cleavable moiety (claim 101) and use in a method (claim 89).
898 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 898 because 898 teach a polypeptide that comprises SEQ ID NO:789 (claim 101) and suggest as a cleavable moiety (claim 101) and use in a method (claim 89). Since 898 suggest a specific use and specifically recites SEQ ID NO:789 (claim 101) one would have been motivated to make a protein comprising SEQ ID NO:789 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 898 recites SEQ ID NO:789 (claim 101) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Claim 65 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 101-120 of copending Application No. 18/354,353 (353) in view of Liu et al. (‘Targeting of tumor cells by cell surface urokinase plasminogen activator-dependent anthrax toxin’ The Journal of Biological Chemistry v276(21) May 25 2001 pages 17976-17984; ‘Liu’).
This is a provisional nonstatutory double patenting rejection.
353 teach a polypeptide that comprises SEQ ID NO:318 (claim 113) and suggest as a cleavable moiety (claim 113) and in a composition (claim 116).
353 does not recite a method of manufacturing.
Liu teach proteins that include a cleavage site (abstract). Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 353 because 353 teach a polypeptide that comprises SEQ ID NO:318 (claim 113) and suggest as a cleavable moiety (claim 113) and in a composition (claim 116). Since 353 suggest a specific use and specifically recites SEQ ID NO:318 (claim 113) one would have been motivated to make a protein comprising SEQ ID NO:318 via the known methods as taught by Liu. One would have had a reasonable expectation of success since Liu teach that specific methods of making were known.
In relation to the sequence recited in claim 65, 353 recites SEQ ID NO:318 (claim 113) which is the same as instant SEQ ID NO:308.
In relation to the expressing and recovering of claim 65, Liu teach that proteins were expressed and purified (page 17977 2nd column section ‘Expression and Purification of PrAg Proteins’).
Response to Arguments – Double Patenting
Applicant's arguments filed 6/27/25 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants question whether or not the September 23, 2024 restriction requirement was proper, in reply to the restriction requirement applicants elected Group 2 “without traverse” (12/20/24 page 1). MPEP 818.01(c) recognizes that traverse is required to preserve right of petition. The relevant issue at hand is whether or not the claims are patentable.
Although applicants argue about a restriction requirement in 16/705,124 and refer to a PTO confirmation that ‘method of manufacturing claims are patently distinct from polypeptide claims’, it is first noted that the priority information of record does not show that the instant application claims priority to application 16/705,124. Although 35 USC 121 provides for a shield under certain circumstances, the required fact pattern is not met since the priority information of record does not show that the instant application claims priority to application 16/705,124 nor is there evidence of record that the instant application is a divisional of 16/705,124 or that 16/705,124 is a divisional of the instant application for example.
Further, it appears that applicants are implying that there is some type of per se rule about manufacturing claims. Applicants have provided no evidence that there is in fact some type of per se rule for manufacturing claims.
MPEP 804.02 sets forth ways to avoid a double patenting rejection. None of applicants actions or arguments qualify as a way to overcome the double patenting rejections set forth above. Arguing about a per se rule that does not exist is not adequate to overcome a double patenting rejection.
Although applicants argue that any provisional rejection should be withdrawn under the provisions of MPEP 804(B)(1)(b)(i), such section specifically refers to situations in which the provisional nonstatutory double patenting rejection ‘is the only rejection remaining’. In the instant case, other rejections remain (for example nonstatutory double patenting rejections that are not provisional).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658