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 13 July 2023; and claims benefit of provisional application 63/388,777, filed 13 July 2022.
Claims 1-30 are pending in the current application. Claims 15-30, drawn to non-elected inventions, are withdrawn. Claims 1-14 are examined on the merits herein.
Election/Restrictions
Applicant’s election of Group I, claims 1-14, in the reply filed on 09 April 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In this case applicant’s response does not distinctly and specifically point out the error as to why there would be no undue burden to search and examine the claims together, where the Restriction requirement mailed 09 Jan 2026 at pages 4-5 details that there would be a serious search and/or examination burden because one or more of the reasons (a), (b), and (c) apply.
Claims 15-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 09 April 2026.
Applicant’s election of species of the carbohydrate backbone of formula (I) and the therapeutic agent of paclitaxel in the reply filed on 09 April 2026 is acknowledged.
Search and examination has expanded to the species of the compound wherein the linker is -O(CH2)3S(CH2)2NH2 and the therapeutic agent is doxorubicin.
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 (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 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 1, 4, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cope (US 2018/0015187, published 18 Jan 2018, provided by Applicant in IDS filed 31 July 2025).
Cope discloses a compound comprising 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 3), meeting limitations of claim 1. In some embodiments, the mannose-binding C-type lectin receptor targeting moiety is selected from, but not limited to, mannose, fucose, and n-acetylglucosamine (page 8, paragraph 95), meeting limitations of claim 4. Therapeutic agents include, but are not limited to, chemotherapeutic agents, such as doxorubicin (page 9, paragraph 116; page 12, paragraph 139 and scheme 3), meeting limitations of claim 8. The structure of doxorubicin contains free hydroxyl groups (page 12, paragraph 139 and scheme 3), interpreted as reactive hydroxyl groups and meeting limitations of claim 1. In some embodiments, the one or more therapeutic agent is attached via a biodegradable linker (page 8, paragraph 97), meeting limitations of claim 1. In one aspect, the invention relates to pharmaceutical compositions comprising a pharmaceutically acceptable carrier and an effective amount of at least one disclosed compound; or a pharmaceutically acceptable salt, hydrate, solvate, or polymorph thereof (page 13, paragraph 143), meeting limitations of claim 10.
Regarding claim 1, the claim language is interpreted to not limit the linker to be coupled specifically to the reactive hydroxyl group, and encompasses the doxorubicin embodiment disclosed in Cope. For example, compare to the claim language found in claim 12 which specifies the degradable linker is coupled to the reactive hydroxyl group of the therapeutic agent.
Claims 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al. (Langmuir, 2013, 29, p734-743, cited in PTO-892).
Yuan et al. discloses a novel controlled drug-delivery system (CDDS) based on fluorescent mesoporous silica nanoparticles (FMSN) covalently linked with paclitaxel (PTX) via a disulfide linker was designed and characterized (page 734, abstract). Paclitaxel (PTX) is an effective and widely applied anticancer therapeutic agent for the treatment of a variety of cancers. The conversion of PTX into a water-soluble prodrug is an attractive alternative available for delivering PTX, which could be further refined by the application of novel drug carriers such as liposomes, soluble polymers, nanoparticles, micelles, and antibody conjugates for delivery via the “leaky” vasculature into tumors (page 734, paragraph spanning left and right columns), meeting limitations of claim 14. The paclitaxel contains a reactive hydroxyl group, for example at the 2’ position, to which the linker is attached (page 736, Scheme 1). This linker is degradable in order to deliver the drug (page 737, Scheme 2). This PTX-linker is coupled to a primary amine of a second compound which is the FMSN (page 738, Scheme 3), meeting limitations of claim 12.
Claims 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Satyam (US 2006/0046967, published 02 March 2006, cited in PTO-892).
Satyam discloses prodrugs containing bio-cleavable linkers (page 1, paragraph 2). The invention relates to the general formula (I)
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(page 2, paragraph 19 to page 4, paragraph page 4, paragraph 37). Satyam discloses the embodiments of compounds I-AH-MPD17 and I-AH-MPD18 (page 64), comprising on the left side of the structure the therapeutic agent of paclitaxel linked at the reactive hydroxyl group at the 2’ position, in the middle of the structure a bio-degradable linker comprising a disulfide and a carbonate moiety, and at the right side of the structure a second compound linked via a primary amine to form a carbamate functional group, each of which is a compound of claimed formula (II) and meeting limitations of claims 12-14. Satyam discloses the general procedures for making the prodrugs including the linkers (page 107 to page 129) and particularly prodrugs of paclitaxel (pages 126-129).
Claim Rejections - 35 USC § 103
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 2-3, 5, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cope (US 2018/0015187, published 18 Jan 2018, provided by Applicant in IDS filed 31 July 2025) in view of Rowinsky et al. (New England Journal of Medicine, 1995, 332, p1004-1014, cited in PTO-892) and Yuan et al. (Langmuir, 2013, 29, p734-743, cited in PTO-892).
Cope teaches above regarding claims 1, 4, 8, and 10. Cope further teaches various other leashes known to those skilled in the art or subsequently discovered may be used in place of (or in addition to) -O(CH2)3S(CH2)2NH2 (page 8, paragraph 98). Cope further teaches in still further embodiments, the therapeutic agent is selected from the group including taxol and taxane (page 9, paragraph 120).
Cope does not specifically disclose the compound wherein comprising a degradable linker comprising one or more carbonate and/or disulfide moieties (claims 2-3, 11). Cope does not specifically disclose the compound wherein the therapeutic agent comprises paclitaxel (elected species, claim 9).
Rowinsky et al. teaches taxanes are an important new class of anticancer agents that exert their cytotoxic effects through a unique mechanism. Paclitaxel (Taxol), the first taxane in clinical trials, is active against a broad range of cancers that are generally considered to be refractory to conventional chemotherapy (page 1004, left column, paragraph 1).
Yuan et al. teaches as above. Yuan et al. further teaches disulfide bonds, which are stable in the mildly oxidizing extracellular milieu, may be prone to rapid cleavage through thiol-disulfide exchange reactions with intracellular reducing molecules, especially with glutathione (GSH). It has been demonstrated that the concentration of GSH in tumor cells is much higher than that in blood plasma. The unique intracellular redox potential has provided an inbuilt different release mechanism for controlled drug delivery (page 735, left column, paragraph 2).
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 Rowinsky et al. and Yuan et al. in order to select the degradable linker to comprise a disulfide bond, and to select the therapeutic agent to comprise paclitaxel. One of ordinary skill in the art would have been motivated to combine Cope in view of Rowinsky et al. and Yuan et al. with a reasonable expectation of success because Cope teaches various other leashes known to those skilled in the art may be used in may be used in place of or in addition to the disclosed linkers and teaches the therapeutic agent may be taxol, Rowinsky et al. teaches taxol was used in the art as synonymous with paclitaxel, and Yuan et al. teaches a known linker for use to link paclitaxel to a primary amine and teaches the disulfide bond provides the advantage of an inbuilt different release mechanism for controlled drug delivery, suggesting it would have been obvious to select the therapeutic agent to be paclitaxel because Cope describes it to be an alternative embodiment, and to select the leash or linker to be the known linker of Yuan et al. in order to provide the same advantage or improvement.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cope (US 2018/0015187, published 18 Jan 2018, provided by Applicant in IDS filed 31 July 2025) in view of Rowinsky et al. (New England Journal of Medicine, 1995, 332, p1004-1014, cited in PTO-892) and Satyam (US 2006/0046967, published 02 March 2006, cited in PTO-892).
Cope teaches above regarding claims 1, 4, 8, and 10. Cope further teaches various other leashes known to those skilled in the art or subsequently discovered may be used in place of (or in addition to) -O(CH2)3S(CH2)2NH2 (page 8, paragraph 98). Cope further teaches in still further embodiments, the therapeutic agent is selected from the group including taxol and taxane (page 9, paragraph 120).
Cope does not specifically disclose the compound wherein comprising a degradable linker comprising one or more carbonate and/or disulfide moieties (claims 2-3, 11). Cope does not specifically disclose the compound wherein the therapeutic agent comprises paclitaxel (elected species, claim 9).
Rowinsky et al. teaches taxanes are an important new class of anticancer agents that exert their cytotoxic effects through a unique mechanism. Paclitaxel (Taxol), the first taxane in clinical trials, is active against a broad range of cancers that are generally considered to be refractory to conventional chemotherapy (page 1004, left column, paragraph 1).
Satyam teaches as above. Satyam further teaches invention relates to the general formula (I) (page 2, paragraph 19 to page 4, paragraph page 4, paragraph 37), in which a therapeutic agent D1 which can comprise an -OH functional group is linked to a group D2 which may be R4 or a polymer (page 3, paragraphs 25-26), and where R4 may be an amino-functionalized water-soluble polymer or an amino-modified dextran (paragraph 36 spanning pages 3-4). Satyam teaches the advantages of prodrug forms is known in the art (page 1, paragraphs 3-6).
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 Rowinsky et al. and Satyam in order to select the degradable linker having the structure of claimed formula (II), and to select the therapeutic agent to comprise paclitaxel. One of ordinary skill in the art would have been motivated to combine Cope in view of Rowinsky et al. and Satyam with a reasonable expectation of success because Cope teaches various other leashes known to those skilled in the art may be used in may be used in place of or in addition to the disclosed linkers, and teaches the therapeutic agent may be taxol; Rowinsky et al. teaches taxol was used in the art as synonymous with paclitaxel; and Satyam teaches a known bio-degradable linker for use to link paclitaxel to a compound having a primary amine, teaches the scope of the invention encompasses the compound having a primary amine to be a polymer such as an amino-modified dextran, and teaches the advantages of prodrug forms is known in the art; suggesting it would have been obvious to select the therapeutic agent to be paclitaxel because Cope describes it to be an alternative embodiment, and to select the leash or linker to be the known linker of Satyam in order to provide the same advantage or improvement. Further Satyam provides additional guidance to select the therapeutic agent to be paclitaxel within the scope of the teachings of Cope.
Regarding claim 6, Cope in view of Rowinsky et al. and Satyam does not teach the degradable linker having the recited structure prior to being conjugated to the therapeutic agent and the polymeric carbohydrate backbone. However, what is claimed is the compound after the degradable linker has been coupled to the therapeutic agent and the polymeric carbohydrate backbone, not the intermediate compounds or reactants prior to being conjugated. See the language of claim 1 at lines 4-5, which is incorporated into dependent claim 6. Claim 6 is interpreted as limiting the compound to the resultant structure that is produced from the recited structure after being conjugated to the therapeutic agent and the polymeric carbohydrate backbone, and in this case the combined teachings of Cope in view of Rowinsky et al. and Satyam teach the compound having the resultant structure which is claimed. The structure of intermediate compounds or reactants that are no longer present in the resultant product are not required.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 09 April 2026, request that if the Examiner feels the application is not now in condition for allowance that an interview be arranged. Attempts to contact the Applicant’s representative telephonically in order to schedule an interview were made on 30 April 2026 and 06 May 2026.
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.
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, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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