The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 17-36 are pending and currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 6-11-2025 has been considered. An initialed copy is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Double Patenting
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.
Claims 17-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,246,915. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix polypeptide and heterologous therapeutic cargo. Given that there is no structural limitations on the Cholix polypeptide or any limitation as to the claimed therapeutic cargo, the patented claims encompass all the limitations of the rejected claims.
Claims 17-22 and 26-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,160,869. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload”. Specifically, SEQ ID NO:5 and SEQ ID NO:13 of the patented claims are drawn to fusion proteins comprising a cholix variant and an IL-10 molecule. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo”, the patented claims encompass all the limitations of the rejected claims. Moreover, with regard to the additional “elements” recited in the patented claims, said limitations do not preclude the fusion proteins of the rejected claims due to the use of the term “comprising”.
Claims 17-22 and 26-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,479,593. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload”. Specifically, SEQ ID NO:5 and SEQ ID NO:13 of the patented claims are drawn to fusion proteins comprising a cholix variant and an IL-10 molecule. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo”, the patented claims encompass all the limitations of the rejected claims. Moreover, with regard to the additional “elements” recited in the patented claims, said limitations do not preclude the fusion proteins of the rejected claims due to the use of the term “comprising”.
Claims 17-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-13 of U.S. Patent No. 11,324,833. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix polypeptide and heterologous therapeutic cargo. Given that SEQ ID NO:2 of the patented claims is a cholix molecule and there is no structural limitation on the Cholix polypeptide (claimed) or any limitation as to the claimed therapeutic cargo, the patented claims encompass all the limitations of the rejected claims.
Claims 17-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,504,433. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix polypeptide and heterologous therapeutic cargo. Given that SEQ ID NO:2 of the patented claims is a cholix molecule and there is no structural limitation on the Cholix polypeptide (claimed) or any limitation as to the claimed therapeutic cargo, the patented claims encompass all the limitations of the rejected claims.
Claims 17-22 and 26-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,479,593. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload”. Specifically, SEQ ID NO:17 of the patented claims are drawn to fusion proteins comprising a cholix variant and an IL-22 molecule. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo”, the patented claims encompass all the limitations of the rejected claims.
Claims 17-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,130,688. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix polypeptide and heterologous therapeutic cargo. Given that there is no structural limitations on the Cholix polypeptide or any limitation as to the claimed therapeutic cargo, the patented claims encompass all the limitations of the rejected claims.
Claims 26-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,786.556. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload” comprising an IL-10 molecule. Given that there is no structural limitations on the structure of the claimed cholix polypeptide or the “therapeutic cargo”, the patented claims encompass all the limitations of the rejected claims. Moreover, with regard to the additional “elements” recited in the patented claims, said limitations do not preclude the fusion proteins of the rejected claims due to the use of the term “comprising”.
Claims 17-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,090,691. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix polypeptide and heterologous therapeutic cargo. Given that there is no structural limitations on the Cholix polypeptide or any limitation as to the claimed therapeutic cargo, the patented claims encompass all the limitations of the rejected claims.
Claims 17-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,617,767. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix polypeptide and heterologous therapeutic cargo. Given that there is no structural limitations on the Cholix polypeptide or any limitation as to the claimed therapeutic cargo, the patented claims encompass all the limitations of the rejected claims.
Claims 17-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,799,565. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix polypeptide and heterologous therapeutic cargo. Given that there is no structural limitations on the Cholix polypeptide or any limitation as to the claimed therapeutic cargo, the patented claims encompass all the limitations of the rejected claims.
Claim 17-22 and 26-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 64 of copending Application No. 18/906,129 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload”. Specifically, SEQ ID NO:4 of the patented claim is drawn to fusion proteins comprising a cholix variant and an IL-10 molecule. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo”, the reference application encompasses all the limitations of the rejected claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 17-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 59-74 of copending Application No. 18/777,927 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a mMART (e.g. Cholix molecule) and heterologous “payload”. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo” of the reference application, the reference application encompasses all the limitations of the rejected claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 17-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 146, 152,154-158 and 163-165 of copending Application No. 18/774,008 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a. Cholix molecule and heterologous “payload”. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo” of the reference application, the reference application encompasses all the limitations of the rejected claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 17-22 and 27-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6-25 of copending Application No. 19/042,438 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload”. Specifically the reference application are drawn to a fusion comprising a Cholix molecule and a protein (e.g. IL-10). Given there is no structural limitations on the cholix structure of the rejected claims or the “therapeutic cargo” of the reference application, the reference application encompasses all the limitations of the rejected claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 17-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-10 of copending Application No. 18/807,300 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload”. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo” of the rejected claims, the reference application encompasses all the limitations of the rejected claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 17-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 15/837,256 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to constructs comprising a Cholix molecule and heterologous “payload”. Given that there is no structural limitations on the structure of the cholix polypeptide or the “therapeutic cargo” of the rejected claims, the reference application encompasses all the limitations of the rejected claims. Moreover, with regard to the additional “elements” recited in the patented claims, said limitations do not preclude the fusion proteins of the rejected claims due to the use of the term “comprising”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 17-21 and 26-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sarnovsky et al. (Cancer Immunology Immunotherapy Vol. 59, pages 737-746 – IDS filed on 6-11-2025).
Sarnovsky et al. disclose immunotoxins comprising a cholix toxin coupled to a single chain antibody (see page 738, left column). Sarnovsky et al. further disclose that said antibody is directed to the human transferrin receptor and could be used as a first line therapeutic agent. Consequently, Sarnovsky et al. anticipates all the limitations of the rejected claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-36 are rejected under 35 U.S.C. 103 as being unpatentable over Sarnovsky et al. (Cancer Immunology Immunotherapy Vol. 59, pages 737-746 – IDS filed on 6-11-2025).
Sarnovsky et al. disclose immunotoxins comprising a cholix toxin coupled to a single chain antibody (see page 738, left column). Sarnovsky et al. further disclose that said antibody is directed to the human transferrin receptor and could be used as a first line therapeutic agent.
Sarnovsky et al. differs from the rejected claims in that they don’t explicitly disclose coupling cytokines, hormones, growth factors or clotting factors to their cholix toxin.
Given the reduce immunogenicity of the cholix toxin fusions of Sarnovsky et al., it would have been obvious for one of ordinary skill in the art to utilize their cholix toxin for the delivery of other types of heterologous molecules including cytokines, hormones, growth factors or clotting factors. Moreover, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Sarnovsky et al. demonstrate the effective use of a cholix toxin as a carrier protein and the use of bacterial toxins as carrier proteins for a variety of macromolecules is well established in the art, the use of the cholix toxin of Sarnovsky et al. as a carrier protein for cytokines, hormones, growth factors and clotting factors is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 June 8, 2026
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