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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 2, 2026 has been entered.
DETAILED ACTION
3. Claims 87 – 95 are pending in this application. Applicant’s Amendment and Remarks, filed February 2, 2026, is entered, wherein claims 87, 91, and 93 are amended and claims 1 – 86 are canceled.
Claims 87 – 95 are currently examined.
Priority
This application is a national stage application of PCT/EP2020/071145, filed July 27, 2020, which claims benefit of foreign priority document NL2023568, filed July 25, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/02/2026 was filed after the mailing date of the previous Office Action on September 5, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections
6. The objection of claims 87 and 93 in the previous Office Action, mailed September 5, 2025, is withdrawn in view of the amended claims 87 and 93.
Withdrawn Rejections
7. The rejection of claim 91 in the previous Office Action, mailed September 5, 2025, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention has been considered and is withdrawn in view of the amended claim 91.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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 87 – 95 are rejected under 35 U.S.C. 103 as being unpatentable over Kensil (WO93/05789, cited in the previous Office Action) in view of Gilabert-Oriol et al. (Biochemical Pharmacology, 2015, Vol. 97, Issue 3, page 247 – 255, cited in the previous Office Action) and Menjoge et al. (Drug Discovery Today, 2010, Vol. 15, Issues 5 – 6, page 171 – 185, Reference included with PTO-892).
a. Regarding claims 87 – 95, Kensil teaches saponin/antigen conjugates (Abstract), comprising a saponin linked to an antigen, wherein the linkage does not interfere substantially with the ability of the saponin to stimulate an immune response in an animal and the invention also directed to modified saponins which comprise a saponin modified with a linking molecule wherein the modification does not interfere substantially with the ability of the saponin to stimulate an immune response in an animal (page 6, lines 4 – 11). The saponins may be directly linked to the antigen or may be linked via a linking group. “Linker group” can be used to covalently couple the saponin or saponin mixture to the antigen and which do not interfere with the production of antigen-specific antibodies in vivo. The linker group may be attached to any part of the saponin so long as the point of attachment does not interfere with the production of antigen-specific antibodies in vivo and thus interfere with the induction of active immunity (page 15, lines 1 – 9). The examples of linker groups are (page 15, lines 10 – 22):
PNG
media_image1.png
200
400
media_image1.png
Greyscale
.
When a linker group between the saponin and the antigen is desired, the active ester of the saponin glucuronate is prepared as described above and reacted with the linker group e.g. alkylene diamine (page 16, lines 11 – 14).
However, Kensil does not teach that W* moiety is a scaffold comprising poly(amidoamine) and polyethylene glycol and F moiety is an antibody. Kensil also does not teach that the saponin is saponin SO1861.
Gilabert-Oriol et al. teach that the therapeutic antibodies Cetuximab, Panitumumab, and Trastuzumab are chemically conjugated to the toxin dianthin. The cytotoxicity is evaluated in the presence of SO1861 and dianthin-Cetuximab, dianthin-Panitumumab, and dianthin-Trastuzumab and the study concludes that the use of SO1861 in combination with the ADC enhanced the efficacy of the therapeutic antibodies (Abstract).
Menjoge et al. teach that dendrimers are members of a versatile, fourth new class of polymer architecture. Typically, dendrimers are used as well-defined scaffolding to conjugate, complex or encapsulate therapeutic drugs:
PNG
media_image2.png
200
400
media_image2.png
Greyscale
.
As a delivery vector, dendrimer conjugate linker or spacer chemistry plays a crucial part in determining optimum drug delivery to disease sites by conserving active drug efficacy while influencing appropriate release patterns (Abstract). Menjoge et al. disclose the Tomalia-type poly(amidoamine), such as PAMAM (page 172, Left Col., para. 2), wherein PAMAM has been used to conjugate with antibody (page 174, Table 3). Dendrimers confers several structural benefits over linear polymer. Such advantages include rapid cellular entry, reduced macrophage uptake, targetability and more facile passage across biological barriers by transcytosis (page 174, Left Col., para. 1). The dendrimer-drug conjugates are attached directly via linkers or spaces to dendrimer terminal groups and, in some instances, in combination with targeting moieties. A key feature for achieving improved drug delivery and efficacy is the ability to tailor the drug release from the dendrimer conjugate in an active form, at or in very close proximity to the target site and with minimum exposure to healthy collateral tissue (page 175, Left Col., para. 2; Right Col., para. 1). Menjoge et al. also disclose a strategy involved N-acetyl cysteine (NAC), which was linked to PAMAM dendrimers possessing carboxylic acid and amine terminal groups via cleavable disulfide linkages, wherein the NAC-PAMAM conjugates are 16 times more efficacious than the drug alone for the treatment of maternal fetal infections (page 175, Right Col., para. 2; page 176, Left Col., para. 1). Furthermore, Menjoge et al. disclose that Adriamycin (ADR) is conjugated to PEG-grafted G = 4; PAMAM dendrimers by amide and hydrazone linkage revealed that remarkable amounts of ADR (at endosomal pH 5.5) are released from the conjugates possessing hydrazone linkage compared with the amide linkage. The conjugates bearing hydrazone linkages exhibit seven times more efficacy than those with amide linkages (page 176, Left Col., para. 2).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the saponin and the antigen in the saponin/linker/antigen conjugate as taught by Kensil with SO1861 and antibodies, such as Trastuzumab, in view of Gilabert-Oriol et al. because Gilabert-Oriol et al. teach that the efficacy of the therapeutic antibodies will be enhanced when SO1861 is combined with the ADC and Kensil teaches the basic and principle of saponin/linker/antigen conjugates. One would have been motivated to substitute the saponin and the antigen in the saponin/linker/antigen conjugate as taught by Kensil with SO1861 and antibodies, such as Trastuzumab, in view of Gilabert-Oriol et al. because Kensil teaches that the saponin/linker/antigen conjugate will maintain their abilities in vivo even when covalently bonded together. One would have considered the saponin conjugate taught by Kensil and substitute the SO1861 and antibodies in view of Gilabert-Oriol et al. because the function of SO1861 and the antibodies will remain the same after covalently bonded together as Kensil taught. Therefore, such substitution will yield predictable results. Kensil also teaches that the active ester of the saponin glucuronate is prepared as described above and reacted with the linker group e.g. alkylene diamine, thereby, forming an amide bond.
It would been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the linker as taught by Kensil with PEG-grafted PAMAM in view of Menjoge et al. because Menjoge et al. teach that it is known in the art to use dendrimer as a conjugate linker. One would have been motivated to substitute the linker as taught by Kensil with PEG-grafted PAMAM in view of Menjoge et al. because Menjoge et al. teach the benefits of using dendrimer as a conjugate linker, such as rapid cellular entry, reduced macrophage uptake, targetability and more facile passage across biological barriers by transcytosis and improved the amount of drug released and efficacy via hydrazone linkage. Menjoge et al. indicate that a remarkable amounts of ADR has been released at an acidic environment with pH = 5.5, which shows that the bonds are cleaved.
Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to substitute the saponin and the antigen in the saponin/linker/antigen conjugate as taught by Kensil with SO1861 and antibodies, such as Trastuzumab, in view of Gilabert-Oriol et al. and to substitute the linker as taught by Kensil with PEG-grafted PAMAM in view of Menjoge et al. because Kensil teaches the basic and principle of the saponin/linker/antigen as well as that the ability of saponin and antigen remains, Gilabert-Oriol et al. teaches the efficacy of the therapeutic antibodies is enhanced with SO1861 is combined with the ADC, and Menjoge et al. teaches the benefits of incorporating dendrimer with PEG in a drug conjugate, thereby, resulting in an improved form of therapeutic.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed February 2, 2026, have been fully considered and are found to be not persuasive.
Regarding Menjoge et al., Applicant argues that Menjoge et al. do not provide a clear motivation to use PAMAM dendrimers in the claimed manner because Menjoge et al. emphasize significant drawbacks such as cytotoxicity, suboptimal drug release, and safety concerns. However, the argument is not persuasive. Menjoge et al. explicitly teach that dendrimers, including PAMAM, are used as well-defined scaffolds for conjugating therapeutic agents and that linker or spacer chemistry plays a crucial role in drug delivery and release. Menjoge et al. further provide multiple examples of dendrimer-drug conjugates, such as NAC-PAMAM conjugates, which demonstrate enhanced efficacy. Although Menjoge et al. acknowledge certain limitations such as cytotoxicity, Menjoge et al. teach strategies to mitigate these issues, and therefore does not teach away from the use of dendrimers. Menjoge et al. actually reinforce the utility of dendrimer in drug conjugate systems. One of ordinary skill in the art would have been motivated to substitute the linker of Kensil with a PAMAM dendrimer linker in view of Menjoge et al. for improving the drug delivery and release characteristics.
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 87 – 95 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 11, 14, 17 – 19, 23, 26, and 28 – 29 of copending Application No. 17/312,104 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘104 anticipates the present claims.
a. Independent claim 87 is directed to a functionalized glycoside moiety having a molecular structure comprising at least one S moiety and at least one L* moiety with general structure (0):
PNG
media_image3.png
100
116
media_image3.png
Greyscale
,
wherein S moiety is a bisdesmosidic triterpene saponin belonging to the type of a 12, 13-dehydrooleanane with an aldehyde function in position 23, wherein the at least one L* moiety is at least one W* moiety, wherein the W* moiety is a scaffold comprising polyethylene glycol and dendron, wherein if the scaffold comprises primary amine groups, the primary amine groups are blocked or shielded, wherein the scaffold comprises a single reactive group ‘*’ for coupling a single S moiety, or wherein the scaffold comprises more than one reactive group ‘*’, each group for coupling a single S moiety, wherein the at least one S moiety is linked, coupled, or bound to the reactive group ‘*’ on the W* moiety through a covalent bond, wherein said covalent bond is a cleavable bond, wherein the scaffold comprises a single binding site for binding a further moiety F, or wherein the scaffold comprises multiple binding sites for binding multiple further moieties F, wherein moiety F is an antibody or EGF, said binding sites for one or more further moieties F on the scaffold moiety W* being reactive groups ‘*’ on the scaffold moiety W* for provision of a bond with at least one further moiety F, wherein F moieties are the same or different when the functionalized glycoside moiety encompasses more than one F moiety, wherein m = 1. Dependent claim 88 is directed to the functionalized glycoside, wherein if the scaffold comprises primary amine groups, the primary amine groups are blocked or shielded by thiolation or PEGylation. Dependent claim 89 is directed to the functionalized glycoside, wherein the single S moiety is a terminal S moiety. Dependent claims 90 – 91 are directed to the functionalized glycoside, wherein the scaffold comprises or is polyethylene glycol. Dependent claims 92 – 93 are directed to the functionalized glycoside, wherein the cleavable bond is subjected to cleavage under acidic condition, at a pH lower than 5.5. Dependent claim 94 is directed to the functionalized glycoside, wherein the cleavable bond is a hydrazone bond. Dependent claim 95 is directed to the functionalized glycoside, wherein the S moiety is saponin SO1861.
‘104 teaches an effector moiety conjugated with at least one saponin, wherein the saponin is covalently bound to the effector moiety via at least one linker (claim 1). The at least one saponin is a bisdesmosidic triterpene saponin belonging to the type of a 12,13-dehydrooleanane with an aldehyde function in position C-23 (claim 5). The saponin is SO1861 (claim 7). The linker comprises at least one cleavable linker, wherein the linker is subjected to cleavage under acidic condition, at pH ≤ 5.5 and the cleavable bond is a hydrazone bond (claims 11 and 17 – 19). The linker is a scaffold comprising a polymeric structure and a chemical group for covalently coupling of the scaffold to the effector moiety, wherein the saponin is covalently bound to the polymeric structure of the scaffold via a cleavable bond (claim 14), wherein the polymeric structure comprises a poly-ethylene glycol and dendron (claim 23). ‘104 further teaches a therapeutic combination comprising the effector moiety and an antibody-drug conjugate, wherein the antibody is trastuzumab, for binding to tumor-cell receptors (claims 26 and 28 – 29).
For these reasons above, ‘104 anticipates the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 87 – 95 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7 – 8, and 10, of copending Application No. 17/312,193 in view of Menjoge et al. (Drug Discovery Today, 2010, Vol. 15, Issues 5 – 6, page 171 – 185, Reference included with PTO-892).
b. Regarding claims 87 – 95, ‘193 teaches a first proteinaceous molecule comprising a first binding site for binding to a first epitope of a first cell-surface molecule, the first proteinaceous molecule provided with at least one saponin covalently bound via at least one linker and/or via a polymeric scaffold to an amino acid residue of said first proteinaceous molecule, wherein the first binding site is an antibody (claim 1). The at least one saponin is a bisdesmosidic triterpene saponin belonging to the type of a 12,13-dehydrooleanane with an aldehyde function in position C-23, wherein the at least one saponin is SO1861 (claims 4 and 7 – 8). The linker is covalently coupled via am amide bond to an amine group in the proteinaceous molecule (claim 10).
However, ‘193 does not teach the scaffold is polyethylene glycol and dendrimer.
Menjoge et al. teach that dendrimers are members of a versatile, fourth new class of polymer architecture. Typically, dendrimers are used as well-defined scaffolding to conjugate, complex or encapsulate therapeutic drugs:
PNG
media_image2.png
200
400
media_image2.png
Greyscale
.
As a delivery vector, dendrimer conjugate linker or spacer chemistry plays a crucial part in determining optimum drug delivery to disease sites by conserving active drug efficacy while influencing appropriate release patterns (Abstract). Menjoge et al. disclose the Tomalia-type poly(amidoamine), such as PAMAM (page 172, Left Col., para. 2), wherein PAMAM has been used to conjugate with antibody (page 174, Table 3). Dendrimers confers several structural benefits over linear polymer. Such advantages include rapid cellular entry, reduced macrophage uptake, targetability and more facile passage across biological barriers by transcytosis (page 174, Left Col., para. 1). The dendrimer-drug conjugates are attached directly via linkers or spaces to dendrimer terminal groups and, in some instances, in combination with targeting moieties. A key feature for achieving improved drug delivery and efficacy is the ability to tailor the drug release from the dendrimer conjugate in an active form, at or in very close proximity to the target site and with minimum exposure to healthy collateral tissue (page 175, Left Col., para. 2; Right Col., para. 1). Menjoge et al. also disclose a strategy involved N-acetyl cysteine (NAC), which was linked to PAMAM dendrimers possessing carboxylic acid and amine terminal groups via cleavable disulfide linkages, wherein the NAC-PAMAM conjugates are 16 times more efficacious than the drug alone for the treatment of maternal fetal infections (page 175, Right Col., para. 2; page 176, Left Col., para. 1). Furthermore, Menjoge et al. disclose that Adriamycin (ADR) is conjugated to PEG-grafted G = 4; PAMAM dendrimers by amide and hydrazone linkage revealed that remarkable amounts of ADR (at endosomal pH 5.5) are released from the conjugates possessing hydrazone linkage compared with the amide linkage. The conjugates bearing hydrazone linkages exhibit seven times more efficacy than those with amide linkages (page 176, Left Col., para. 2).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the polymeric scaffold as taught by ‘193 with PEG linker in view of Portillo because Portillo teaches the benefits of using a PEG linker and states that PEG linker will overcome the issues of an ADC. One would have been motivated to do such substitution because the benefits of PEG linker may lead to improved ADC characteristics. Therefore, one of the skills in the art would have had a reasonable expectation of success to substitute the polymeric scaffold as taught by ‘193 with PEG linker in view of Portillo because of the PEG benefits.
This is a provisional nonstatutory double patenting rejection.
Claims 87 – 95 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 – 6, 8 – 10, 16, 18, and 22 of copending Application No. 17/312,476 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘476 anticipates the present claims.
c. Independent claim 87 is directed to a functionalized glycoside moiety having a molecular structure comprising at least one S moiety and at least one L* moiety with general structure (0):
PNG
media_image3.png
100
116
media_image3.png
Greyscale
,
wherein S moiety is a bisdesmosidic triterpene saponin belonging to the type of a 12, 13-dehydrooleanane with an aldehyde function in position 23, wherein the at least one L* moiety is at least one W* moiety, wherein the W* moiety is a scaffold comprising polyethylene glycol, wherein if the scaffold comprises primary amine groups, the primary amine groups are blocked or shielded, wherein the scaffold comprises a single reactive group ‘*’ for coupling a single S moiety, or wherein the scaffold comprises more than one reactive group ‘*’, each group for coupling a single S moiety, wherein the at least one S moiety is linked, coupled, or bound to the reactive group ‘*’ on the W* moiety through a covalent bond, wherein said covalent bond is a cleavable bond, wherein the scaffold comprises a single binding site for binding a further moiety F, or wherein the scaffold comprises multiple binding sites for binding multiple further moieties F, wherein moiety F is an antibody or EGF, said binding sites for one or more further moieties F on the scaffold moiety W* being reactive groups ‘*’ on the scaffold moiety W* for provision of a bond with at least one further moiety F, wherein F moieties are the same or different when the functionalized glycoside moiety encompasses more than one F moiety, wherein m = 1. Dependent claim 88 is directed to the functionalized glycoside, wherein if the scaffold comprises primary amine groups, the primary amine groups are blocked or shielded by thiolation or PEGylation. Dependent claim 89 is directed to the functionalized glycoside, wherein the single S moiety is a terminal S moiety. Dependent claims 90 – 91 are directed to the functionalized glycoside, wherein the scaffold comprises or is polyethylene glycol. Dependent claims 92 – 93 are directed to the functionalized glycoside, wherein the cleavable bond is subjected to cleavage under acidic condition, at a pH lower than 5.5. Dependent claim 94 is directed to the functionalized glycoside, wherein the cleavable bond is a hydrazone bond. Dependent claim 95 is directed to the functionalized glycoside, wherein the S moiety is saponin SO1861.
‘476 teaches a scaffold suitable for covalently binding at least one biologically active molecule to a carrier molecule, the scaffold comprising a polymeric structure and at least one of said biologically active molecules covalently bound to said polymeric structure, wherein the scaffold further comprises a first chemical group for covalently coupling of the scaffold to the carrier molecule (claim 1). The at least one biologically active molecule is a bisdesmosidic triterpene saponin belonging to the type of a 12,13-dehydrooleanane with an aldehyde function in position C-23 (claim 5). The saponin is SO1861 (claim 6). ‘476 teaches that the at least one biologically active molecule is covalently bound to the polymeric structure via a cleavable bond, wherein the cleavable bond is subjected to cleavage under acidic condition, pH ≤ 5.5, wherein the cleavable bond is hydrazone bond (claims 8 – 10). The scaffold is a tri-functional linker comprising a second chemical group with at least one biologically active molecule covalently bound thereto, comprising a third chemical group for covalent binding to a molecule and comprising the first chemical group for covalent binding to the carrier (claim 16). The polymeric structure may be a dendron and/or poly-ethylene glycol (claim 18). ‘476 further teaches that the carrier molecule comprises trastuzumab (claim 22).
For the reasons above, ‘476 anticipates the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed February 2, 2026, have been fully considered and are found to be not persuasive.
Regarding the rejections, Applicant requests that the rejections be held in abeyance until indication by the Office of allowable claims in one of the co-pending applications. As Applicant does not file any terminal disclaimer and does not provide other remarks, the double patenting rejections are maintained.
Conclusion
No claim is found to be allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 HOI YAN LEE whose telephone number is 571-270-0265. The examiner can normally be reached Monday - Thursday 7:30 - 17:30.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693