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/Restriction
Applicant’s election without traverse of Group I, claims 91-99 in response filed on December 29, 2025 is acknowledged. Claims 1-90 and 100-102 are canceled. Claims 91-99 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 31, 2023, March 6, 2024 and February 28, 2024 have been considered by the examiner.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 91-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.11,654,188. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to A compound for the induction of antigen-specific immune tolerance in a subject, the compound comprising: an antigen to which tolerance is desired; wherein the antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer comprising a first acrylyl unit and a second acrylyl unit, the first acrylyl unit comprising a first C-amido or C-carboxy functionality and the second acrylyl unit comprising a second C-amido or C-carboxy functionality; wherein the second C-amido or C-carboxy functionality is conjugated to an aliphatic group, an alcohol, or an aliphatic alcohol; wherein the polymeric linker is bonded to the antigen to which tolerance is desired via a disulfide bond or a disulfanyl ethyl ester; wherein the polymeric linker comprises a terminal end unit lacking each of a dithioester and a dithiobenzoate (DTB) and wherein the terminal end unit confers improved stability to the compound when in solution; and a liver-targeting moiety; and wherein the liver targeting moiety is connected to the first acrylyl unit through the first C-amido or C-carboxy functionality and a polyether.
The claims of the U.S. Patent No.11,654,188 are drawn to A composition for the induction of antigen-specific immune tolerance in a subject, the composition comprising: an antigen to which tolerance is desired, wherein the antigen to which tolerance is desired is capable of inducing an unwanted immune response in the subject; a polymeric linker prepared by methacrylating a galactosylating moiety to provide a methacrylate and polymerizing the methacrylate: wherein the polymeric linker is bonded to the antigen via a disulfide bond or a disulfanyl ethyl ester; wherein the disulfide bond or the disulfanyl ethyl ester are each configured to be cleaved after administration of the composition to the subject and to release the antigen from the polymeric linker; and a liver targeting moiety.
The present claims would have been obvious over the claims of the U.S. Patent No.11,654,188 because both the present claims and the claims of the U.S. Patent No.11,654,188 are drawn to compounds comprising an antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer. The only difference between the present claims and the claims of the U.S. Patent No.11,654,188 is that the claims of the U.S. Patent No.11,654,188 recite the process of making the composition that involves preparing it by methacrylating a galactosylating moiety to provide a methacrylate and polymerizing the methacrylate.
Claim 91-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.11,801,305. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to A compound for the induction of antigen-specific immune tolerance in a subject, the compound comprising: an antigen to which tolerance is desired; wherein the antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer comprising a first acrylyl unit and a second acrylyl unit, the first acrylyl unit comprising a first C-amido or C-carboxy functionality and the second acrylyl unit comprising a second C-amido or C-carboxy functionality; wherein the second C-amido or C-carboxy functionality is conjugated to an aliphatic group, an alcohol, or an aliphatic alcohol; wherein the polymeric linker is bonded to the antigen to which tolerance is desired via a disulfide bond or a disulfanyl ethyl ester; wherein the polymeric linker comprises a terminal end unit lacking each of a dithioester and a dithiobenzoate (DTB) and wherein the terminal end unit confers improved stability to the compound when in solution; and a liver-targeting moiety; and wherein the liver targeting moiety is connected to the first acrylyl unit through the first C-amido or C-carboxy functionality and a polyether.
The claims of the U.S. Patent No.11,801,305 are drawn to A composition for the induction of antigen-specific immune tolerance in a subject, the composition comprising: an antigen to which tolerance is desired; wherein the antigen to which tolerance is desired is capable of inducing an unwanted immune response in the subject; a liver targeting moiety; and a polymeric linker comprising: ##STR00086## where the right bracket “)” indicates a bond between the linker and a corresponding reversible addition-fragmentation chain transfer (RAFT) polymerization agent; the bottom bracket “custom character” indicates a bond between the linker and the liver targeting moiety; W is a copolymer or a random copolymer of the W.sup.1 and W.sup.2 having p repeat units, where: ##STR00087## where: p is an integer from 2 to 150; R.sup.9 is a direct bond, —C(O)—NH—CH.sub.2—CH.sub.2—, or —C(O)—NH—(CH.sub.2—CH.sub.2—O—).sub.t—CH.sub.2—CH.sub.2—; t is an integer from 1 to 5; R.sup.10 is an aliphatic group, an alcohol or an aliphatic alcohol; Y′ comprises: ##STR00088## where n is an integer from 1 to 100; and the left bracket “(” of Y′ indicates the bond between the antigen and linker; the right bracket “)” of Y′ indicates a bond between Y′ and the remainder of the polymeric linker; wherein the polymeric linker is bonded to the antigen to which tolerance is desired via a disulfide bond or a disulfanyl ethyl ester, wherein the disulfide bond or the disulfanyl ethyl ester are each configured to cleave after administration of the composition to the subject and to release the antigen to which tolerance is desired from the polymeric linker; and wherein the liver-targeting moiety comprises a galactosylating moiety.
The present claims would have been obvious over the claims of the U.S. Patent No.11,801,305 because both the present claims and the claims of the U.S. Patent No.11, 801,305 are drawn to compounds comprising an antigen to which tolerance is desired; wherein the antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer. The only difference between the present claims and the claims of the U.S. Patent No.11, 801,305 is that the claims of the U.S. Patent No.11,801,305 recite different species of polymers.
Claims 91-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.11,666,638. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to A compound for the induction of antigen-specific immune tolerance in a subject, the compound comprising: an antigen to which tolerance is desired; wherein the antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer comprising a first acrylyl unit and a second acrylyl unit, the first acrylyl unit comprising a first C-amido or C-carboxy functionality and the second acrylyl unit comprising a second C-amido or C-carboxy functionality; wherein the second C-amido or C-carboxy functionality is conjugated to an aliphatic group, an alcohol, or an aliphatic alcohol; wherein the polymeric linker is bonded to the antigen to which tolerance is desired via a disulfide bond or a disulfanyl ethyl ester; wherein the polymeric linker comprises a terminal end unit lacking each of a dithioester and a dithiobenzoate (DTB) and wherein the terminal end unit confers improved stability to the compound when in solution; and a liver-targeting moiety; and wherein the liver targeting moiety is connected to the first acrylyl unit through the first C-amido or C-carboxy functionality and a polyether.
The claims of the U.S. Patent No.11,666,638 are drawn to A composition for the induction of antigen-specific immune tolerance in a subject, the composition comprising: an antigen to which tolerance is desired; wherein the antigen to which tolerance is desired is capable of inducing an unwanted immune response in the subject; a polymeric linker; wherein the polymeric linker is coupled to the antigen to which tolerance is desired via a disulfide bond or a disulfanyl ethyl ester; wherein the disulfide bond or the disulfanyl ethyl ester are each configured to be cleaved after administration of the composition to the subject and to release the antigen to which tolerance is desired from the polymeric linker; a liver-targeting moiety; wherein the polymeric linker comprises the following structure: ##STR00048## where the right bracket “)” indicates a bond between the linker and a corresponding reversible addition-fragmentation chain transfer (RAFT) polymerization agent; p is an integer from 2 to 150; R.sup.9 comprises —C(O)—NH—CH.sub.2—CH.sub.2—; and the bottom bracket “)” indicates a bond between the linker and the liver targeting moiety; Y′ comprises: ##STR00049## where n is an integer from 1 to 100; the left bracket “(indicates the bond between the antigen and linker; and the right bracket “)” of Y′ indicates a bond between Y′ and the remainder of the polymeric linker; wherein the liver-targeting moiety comprises a galactosylating moiety.
The present claims would have been obvious over the claims of the U.S. Patent No. 11,666,638 because both the present claims and the claims of the U.S. Patent No. 11,666,638 are drawn to compounds comprising an antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer. The only difference between the present claims and the claims of the U.S. Patent No. 11,666,638 is that the claims of the U.S. Patent No. 11,666,638 recite different species of polymers.
Claims 91-99 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/056,135.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to A compound for the induction of antigen-specific immune tolerance in a subject, the compound comprising: an antigen to which tolerance is desired; wherein the antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer comprising a first acrylyl unit and a second acrylyl unit, the first acrylyl unit comprising a first C-amido or C-carboxy functionality and the second acrylyl unit comprising a second C-amido or C-carboxy functionality; wherein the second C-amido or C-carboxy functionality is conjugated to an aliphatic group, an alcohol, or an aliphatic alcohol; wherein the polymeric linker is bonded to the antigen to which tolerance is desired via a disulfide bond or a disulfanyl ethyl ester; wherein the polymeric linker comprises a terminal end unit lacking each of a dithioester and a dithiobenzoate (DTB) and wherein the terminal end unit confers improved stability to the compound when in solution; and a liver-targeting moiety; and wherein the liver targeting moiety is connected to the first acrylyl unit through the first C-amido or C-carboxy functionality and a polyether.
Claim 1 of the copending Application No. 19/056,135 is drawn to A compound for the induction of antigen-specific immune tolerance in a subject, the compound comprising: a peptide to which tolerance is desired;wherein the peptide to which tolerance is desired, when presented to the subject alone, is capable of inducing an unwanted immuneresponse in the subject; a polymeric linker; wherein the polymeric linker is coupled to the peptide to which tolerance is desired via a disulfide bond or a disulfanyl ethyl ester;wherein the disulfide bond or the disulfanyl ethyl ester are each configured to be cleaved upon administration of the compound to the subject and torelease the peptide to which tolerance is desired from the polymeric linker; wherein the polymeric linker comprises a 1-cyano-1-methyl-propyi group and methacrylic units comprising an ethylacetamido functionality; anda liver-targeting moiety;wherein the liver-targeting moiety comprises a galactosylating moiety;wherein the liver-targeting moiety is coupled to the polymeric linker through the ethylacetamido functionality.
The present claims would have been obvious over the claims of the copending Application No. 19/056,135 because both the present claims and the claims of the copending Application No. 19/056,135 are drawn to compounds comprising an antigen to which tolerance is desired, when presented alone to the subject is capable of inducing an unwanted immune response in the subject; a polymeric linker comprising: a copolymer. The only difference between the present claims and the claims of the copending Application No. 19/056,135 is that the claims of the copending Application No. 19/056,135 recite different species of polymers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pertinent references
Hubbell et al. (WO2018/232176) discloses compounds for the induction of antigen-specific immune tolerance wherein an antigen to which immune tolerance is desired is bonded to an acrylyl copolymer wherein some of the acrylyl units carry a liver targeting unit and wherein the acrylyl copolymer is bonded to a thioester terminal end unit (see claims 1, 23 and 54). In the precursor compounds of Ex. 3, the copolymer carries at one end a pyridyl dithiol unit which can react with the thiol group of an antigen to form a disulfide linkage and which is bonded to the acrylyl units via a disulfide bond and at the other end a dithiobenzoate unit which is a remnant of the reversible addition-fragmentation chain transfer (RAFT) polymerization preparation; the liver targeting unit is N-acetylgalactosamine or N-acetylglucosamine. Hubbell et al. (WO2018/232176) does not teach dithioester and a dithiobenzoate present within the linker.
Hubbell et al (WO 2015/140648) discloses compounds for the induction of antigen-specific immune tolerance wherein an antigen to which immune tolerance is desired is bonded to an acrylyl copolymer wherein some of the acrylyl units carry a liver targeting unit and wherein the acrylyl copolymer is bonded to a thioester terminal end unit. Hubbell et al. (WO2015/140648) does not teach dithioester and a dithiobenzoate present within the linker.
Contact Information
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648