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 .
This application is a domestic application, filed 29 Dec 2022; and claims benefit of provisional application 63/294,996, filed 30 Dec 2021.
Claims 1-31 are pending in the current application. Claims 1-26, drawn to non-elected inventions, are withdrawn. Claims 27-31 are examined on the merits herein.
Election/Restrictions
Applicant's election with traverse of Group II, claims 27-31, in the reply filed on 05 Jan 2026 is acknowledged. The traversal is on the ground(s) that there is no serious burden to search and/or examine the claims together. This is not found persuasive because the different inventions would require searching divergent subject matter or employing different search queries for method steps or the structure of a compound made by any method as detailed in the restriction mailed 04 Nov 2025. Therefore there would be a serious burden to search and/or examine the claims together.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05 Jan 2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cope (US 2016/0206763, published 21 July 2016, provided by Applicant in IDS filed 12 Dec 2023) in view of Ganivada et al. (Macromolecules, 2014, 47, p2703-2711, cited in PTO-892).
Cope teaches compounds and compositions for targeting macrophages and other mannose-binding c-type lectin receptor high expressing cells (abstract). In one aspect is a compound comprising a dextran backbone having one or more mannose-binding C-type lectin receptor targeting moieties and one or more therapeutic agents attached thereto (page 1, paragraph 5). In some embodiments, the mannose-binding C-type lectin receptor targeting moiety is selected from mannose, fucose, and n-acetylglucosamine. (page 8, paragraph 91). In some embodiments, the targeting moiety and therapeutic agents are attached via linkers that comprise -O(CH2)3S(CH2)2NH-. The linker may also be substituted with groups including alkynyl groups and -NH-C(O)- groups. Other suitable linkers would be known to one of ordinary skill in the art (page 8, paragraph 92). In some embodiments the therapeutic agent is attached via a biodegradable linker that comprises an acid sensitive moiety such as a hydrazone (page 8, paragraph 93). Various other leashes may be used in place of or in addition to the linker -O(CH2)3S(CH2)2NH-, such as -S-CH2-C(O)-NH-CH2-CH2-NH- (page 8, paragraph 94 to page 9, paragraph 110). In some embodiments, the dextran-based moiety is about 50-100 kD (page 8, paragraph 89), addressing limitations of claim 29. Working example 7 teaches the embodiment of conjugation of a hydrazone-linked doxorubicin to modified tilmanocept (page 22, paragraph 198), addressing limitations of claim 30. Cope teaches the general structure of tilmanocept (paragraph 76 at page 6), providing examples of linkers used in the compound.
Cope does not specifically teach the embodiment wherein the linker or leash comprises a terminal alkyne moiety, and the doxorubicin therapeutic agent comprises a hydrazone azide moiety (claim 27). Cope does not specifically teach the compound wherein each X is specifically the second and fourth structures of claim 28.
Ganivada et al. teaches biocompatible nanocarriers having a doxorubicin and poly(ethylene oxide) (PEG) motif have been designed. Acylhydrazine linker is used to release the drug exactly at the mild acidic conditions resembling the pH of the cancerous cells (page 2703, abstract). The application of polymeric nanocarriers to oncology explores the use of macromolecules to enhance delivery of therapeutic agents. Polymeric nanocarriers, due to the enhanced permeability and retention (EPR) effect, provide increased drug solubility, extended drug half-life, and effective targeting to solid tumors (page 2703, left column, paragraph 1). The azide-containing doxorubicin with an acylhydrazine linker (DOXI-N3)
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was synthesized for attaching the DOXI motif to the carrier (page 2706, paragraph spanning left and right columns). Click chemistry between azide of the DOXI-N3 and acetylene of the carrier was used to couple the doxorubicin to the carrier by formation of the triazole linker (paragraph spanning pages 2706-2707; scheme 1 at page 2704). The DOXI release from the copolymer carrier at pH 7.4 was observed less than 10%, while 60% drug was released at pH 6.0 compared to pH 7.4, suggesting the importance of having the acid-labile acylhydrazine linker (paragraph spanning pages 2707-2708).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Cope in view of Ganivada et al. in order to select the linker or leash that attach the targeting moiety and therapeutic agents to the dextran backbone. It would have been obvious to one of ordinary skill in the art to combined Cope in view of Ganivada et al. with a reasonable expectation of success because Cope teaches the examples of linkers or leashes used in tilmanocept, teaches suitable linkers would be known to one of ordinary skill in the art, and teaches the linker may be substituted with alkynyl groups and -NH-C(O)- groups; and Ganivada et al. teaches azide-containing doxorubicin with an acylhydrazine linker coupled to a polymeric carrier having a terminal alkynyl group using click chemistry; suggesting it would have been obvious to one of ordinary skill in the art to vary the linkers starting from the examples in Cope and Ganivada et al. One of ordinary skill in the art would have been motivated to combined Cope in view of Ganivada et al. because Cope teaches in embodiments therapeutic agent is attached via a biodegradable linker that comprises an acid sensitive moiety such as a hydrazone, and Ganivada et al. teaches the importance of having the acid-labile acylhydrazine linker, and teaches structures for using click chemistry which one of ordinary skill in the art would understand to be a simple and efficient approach to coupling molecules together.
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 27-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,404,349 (reference patent) in view of Cope (US 2016/0206763, published 21 July 2016, provided by Applicant in IDS filed 12 Dec 2023) and Ganivada et al. (Macromolecules, 2014, 47, p2703-2711, cited in PTO-892).
Reference claims 1-15 of the reference patent are drawn to a compound comprising: a polymeric carbohydrate backbone comprising at least one amine terminated leash attached thereto, and one or more mannose-binding C-type lectin receptor targeting moieties, wherein the one or more mannose-binding C-type lectin receptor targeting moieties is attached to the at least one amine terminated leash as an amide linkage. Reference claim 3 recites the compound comprising a subunit of a formula (I) and wherein A encompasses therapeutic agent, overlapping in scope with the structure of claim 27. Reference claims 9-10 recite substituent structures corresponding to the first and second structures of claim 28. Reference claim 12 recites the backbone has a molecular weight of between about 1 kD to about 150 kD, overlapping in scope with claim 29. Reference claims 16-19 are drawn to a method of making said compound, making obvious possession of the compound so made.
Reference claims 1-19 do not specifically teach the embodiment wherein the linker or leash comprises a terminal alkyne moiety, and the therapeutic agent being an anthracycline comprising a hydrazone azide moiety (claim 27). Cope does not specifically teach the compound wherein each X is specifically the fourth structure of claim 28.
Cope teaches as above.
Ganivada et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-19 in view of Cope and Ganivada et al. in order to select the linker or leash connecting the therapeutic agent to backbone, and to select the therapeutic agent to be doxorubicin. One of ordinary skill in the art would have been motivated to combine Reference claims 1-19 in view of Cope and Ganivada et al. with a reasonable expectation of success for the same reasoning applied above to the combined teachings of Cope and Ganivada et al. Further, Reference claims 1-19 provide additional guidance for selecting the structure of the linker or leash, and Cope teaches suitable linkers would be known to one of ordinary skill in the art.
Claims 27-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/314,445 (reference application) in view of Cope (US 2016/0206763, published 21 July 2016, provided by Applicant in IDS filed 12 Dec 2023) and Ganivada et al. (Macromolecules, 2014, 47, p2703-2711, cited in PTO-892).
Reference claim 1 of the reference application is drawn to a compound comprising: a polymeric carbohydrate backbone comprising at least one amine terminated leash attached thereto; and one or more mannose-binding C-type lectin receptor targeting moieties; wherein the one or more mannose-binding C-type lectin receptor targeting moieties is attached to the amine terminated leash via an amide linker.
Reference claim 1 does not specifically teach the polymeric carbohydrate backbone having a structure of formula (II) wherein the linker or leash comprises a terminal alkyne moiety, a therapeutic agent being an anthracycline comprising a hydrazone azide moiety (claim 27).
Cope teaches as above.
Ganivada et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1 in view of Cope and Ganivada et al. in order to select structure of the polymeric carbohydrate backbone, the linker or leash connecting the therapeutic agent to backbone, and to select compound to comprise a therapeutic agent of doxorubicin. One of ordinary skill in the art would have been motivated to combine Reference claim 1 in view of Cope and Ganivada et al. with a reasonable expectation of success for the same reasoning applied above to the combined teachings of Cope and Ganivada et al. Further, Reference claim 1 provide additional guidance for selecting the structure of the linker or leash, and Cope teaches suitable linkers would be known to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 27-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,007,272 (reference patent) in view of Cope (US 2016/0206763, published 21 July 2016, provided by Applicant in IDS filed 12 Dec 2023) and Ganivada et al. (Macromolecules, 2014, 47, p2703-2711, cited in PTO-892).
Reference claims 1-12 are drawn to methods of treatment comprising administering the compound of formula (II) wherein each X is independently H, L1-A, or L2-R; each L1 and L2 are independently linkers; each A independently comprises a therapeutic agent or a detection label or H; each R independently comprises a CD206 targeting moiety or H; and n is an integer greater than zero; and wherein at least one R is a CD206 targeting moiety and at least one A is a chemotherapeutic agent, corresponding to the claimed formula (II). Reference claims 8, 11 and 12 encompass the chemotherapeutic agent being doxorubicin, which is an anthracycline agent. Reference claim 5 recites at least one L1 comprises an acid-sensitive linker. Reference claims 1-12 make obvious possession of the compound administered in the claimed method.
Reference claims 1-12 do not specifically teach the polymeric carbohydrate backbone having a structure of formula (II) wherein the linker or leash comprises a terminal alkyne moiety, and a therapeutic agent being an anthracycline comprising a hydrazone azide moiety (claim 27).
Cope teaches as above.
Ganivada et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-12 in view of Cope and Ganivada et al. in order to select the linker or leash connecting the therapeutic agent to backbone, and to select compound to comprise a therapeutic agent of doxorubicin comprising a hydrazone azide moiety. One of ordinary skill in the art would have been motivated to combine Reference claims 1-12 in view of Cope and Ganivada et al. with a reasonable expectation of success for the same reasoning applied above to the combined teachings of Cope and Ganivada et al.
Claims 27-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,005,122 (reference patent) in view of Cope (US 2016/0206763, published 21 July 2016, provided by Applicant in IDS filed 12 Dec 2023) and Ganivada et al. (Macromolecules, 2014, 47, p2703-2711, cited in PTO-892).
Reference claims 1-20 are drawn to methods of treatment comprising administering the compound of formula (II) wherein each X is independently H, L1-A, or L2-R; each L1 and L2 are independently linkers; each A independently comprises a therapeutic agent or a detection label or H; each R independently comprises a CD206 targeting moiety or H; and n is an integer greater than zero; and wherein at least one R is a CD206 targeting moiety and at least one A is a chemotherapeutic agent, corresponding to the claimed formula (II). Reference claim 14 encompass the chemotherapeutic agent being an anthracycline drug that is not doxorubicin, implying that reference claims 1-13 and 15-20 encompass the anthracycline drug doxorubicin. Reference claim 5 recites at least one L1 comprises an acid-sensitive linker. Reference claims 1-20 make obvious possession of the compound administered in the claimed method.
Reference claims 1-20 do not specifically teach the polymeric carbohydrate backbone having a structure of formula (II) wherein the linker or leash comprises a terminal alkyne moiety, and a therapeutic agent being an anthracycline comprising a hydrazone azide moiety (claim 27).
Cope teaches as above.
Ganivada et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-20 in view of Cope and Ganivada et al. in order to select the linker or leash connecting the therapeutic agent to backbone, and to select compound to comprise a therapeutic agent of doxorubicin comprising a hydrazone azide moiety. One of ordinary skill in the art would have been motivated to combine Reference claims 1-20 in view of Cope and Ganivada et al. with a reasonable expectation of success for the same reasoning applied above to the combined teachings of Cope and Ganivada et al.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693