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/Restrictions
Applicant’s election without traverse of Group I, claims 1, 57-63 and 70 in the reply filed on 11/14/2025 is acknowledged.
Claims 64-69 and 71-75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected-claims, there being no allowable generic or linking claim.
Claim Objections
Claim 70 (and withdrawn claim 71) is objected to because of the following informalities:
The chemical structures and repeat unit values are not legible. (Similarly, the structures as present in the withdrawn claim 71 are also not legible.)
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 57-63 and 70 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
The structures claimed/exemplified are not cationic. It appears applicant’s intent is ionizable polymers or polymers that can later become cationic.
Claims 59, 60, 62-63 and 70 are rejected 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.
The claimed structures aren’t cationic.
Assuming the claimed subject matter is intended to embrace polymers that are capable of being ionized to form cationic groups, the following rejections apply.
Claim Rejections - 35 USC § 102
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, 57, 61 and 70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Satchi-Fainaro et al. US2018/0318428.
Regarding claims 1, 57, 61 and 70, Satchi-Fainaro discloses structure X (Figure 12) which is a hydrolysable polyamide backbone with 40 mol% monomer units with alkyl side chains which are hydrophobic and 60 mol% of monomer units comprising a cationic side chain, as shown below. The side chain comprises a polyamine with one tertiary amine with a single nucleophilic center (N atom) at the terminus of the polyamine, and where the side chain is capable of becoming cationic. Thus, Satchi-Fainaro anticipates the required polymer.
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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.
Claims 58-59 and 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Satchi-Fainaro et al. US2018/0318428.
Regarding claim 58, Satchi-Fainaro teaches copolyamide structure (reference claim 79), where the backbone units can be selected to be polyamine Formula BU(4), as shown below.
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Where the R5 and R6 can be both H atoms, and thus form a primary amine at the terminus, while the R7 and R8 can be a short chain C1 alkyl (para [0260]), thus making the claimed requirement obvious.
Regarding claims 58 and 59, Satchi-Fainaro additionally teaches copolyamide structure (reference claim 79), where the backbone units can be selected to be polyamine Formula BU(6), as shown below.
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Where L6 is a linear linking moiety and is preferably unsubstituted ethylene (para [0272]) and where Z is a nitrogen containing heterocyclic moiety and can be selected to be piperazine (para [0273]), which when linked via an amine group, would lead to the structure as depicted below.
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The obvious polyamine structure as taught by Satchi-Fainaro complies with the second structure of claim 59 (and additionally meets claim 58), where r1 is 0, p1 and p3 are 2, and where R2 is combined with a second R2 to form a heterocyclic group.
Regarding claim 62, as discussed when addressing claim 1, Satchi-Fainaro provides polyamide structure X (Fig 12), as shown below. However, Satchi-Fainaro does not provide the molecular weight of the copolymer X. Satchi-Fainaro discloses molecular weight of polymer K (Fig 6) of 10560 g/mol (para [0728]), which is substantially identical to polyamide structure X. Satchi-Fainaro adds that various features of the embodiments can be combined in a single embodiment (para [0635]).
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It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have generated polyamide X with similar molecular weight of 10560 g/mol (as that of polymer K) with 60 mol% of repeat units comprising polyamine side chains (with repeat unit MW of 258 g/mol) and 40 mol% of hydrophobic repeat chains (with repeat unit MW of 212 g/mol). This leads to the required repeat units corresponding to m1 of 26 and n1 of 18, with m2 and n2 both being 0. Satchi-Fainaro teaches that the polymer is arranged as a block copolymer (reference claim 80). Satchi-Fainaro’s polyamide X meet the requirements of R3b which is ethylene group, X1 is -C(O)NR11-, R11 are independently hydrogen, X2 is a C6 alkyl hydrophobic side chain, and A1 is a polyamine with one tertiary amine with a single nucleophilic center (N atom) present at the terminus.
Regarding claim 63, as discussed when addressing claim 62, Satchi-Fainaro makes the repeat unit requirements of the hydrophobic and polyamine sidechains obvious. Additionally claim 59, renders the claimed requirement of the polyamine conforming to the second required structure obvious. Satchi-Fainaro adds that various features of the embodiments can be combined in a single embodiment (para [0635]).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have generated polyamide with the required repeat units corresponding to polyamine sidechain units m1 of 26 and hydrophobic sidechain units n1 of 18, with m2 and n2 both being 0, with polyamine A1 where r1 is 0, p1 and p3 are 2, and where R2 is combined with a second R2 to form a heterocyclic group (which corresponds to second structure of instant claim 63).
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 1, 57-63 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-8, 14 and 18-19 of U.S. Patent No. US 12344709. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claim 19, polymer structure 20, read on the required claimed polyamide backbone structures of instant claims 1, 57-59, 61-63 and 70, where the reference polyamine polymer 20 contains both hydrophobic C8 side chains and polyamine side chains which comply with the structure requirement of instant claims 59 and 63:
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Where p1 =2, r1=0, p3 =2, and where both R2 is C1 alkyl.
Additionally, reference patent US 12344709 claims 1 and 18, first structure of B1 and B2, make the instant claim 60’s first structure obvious.
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Where p1=2, r1=0, p3 =2, s1=2; R2 is C1 alkyl, R4 can be -C(O)O- and R5 can be linked to a tissue specific or cell-specific targeting moiety.
Claims 1, 57-59, 61-62 and 70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18, 48 and 50-62 of copending application 17/605,981 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application requires a polymer comprising a hydrolysable polyamide backbone comprising monomers having a hydrophobic side chain X2 and a monomer having a polyamine A1 or A2, which corresponds to applicant’s hydrophobic sidechain and polyamine structure which can form cationic side chains, as required by instant claim 1. Additionally claim 18 of the copending application reads on claim 62 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 57-63 and 70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, 17, 20, 27 and 28 of copending application 17/614,307 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims require a polymer comprising a hydrolysable polyamide backbone comprising monomers having a hydrophobic side chain (i) and a monomer having a polyamine (ii), where R2 can be alkyl group leading to a tertiary amine, as required by instant claim 1. Additionally, claim 17, fifth structure of the copending application renders the first structure of the instant claim 60 obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 57, 61 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8 and 10 of copending application 18/568,539 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application require a polymer comprising a hydrolysable polyamide backbone comprising monomers having a (i) hydrophobic side chain and a monomer having a (ii) polyamine, which reads on the requirement of instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/S.M.D./
Examiner
Art Unit 1765
/DAVID J BUTTNER/Primary Examiner, Art Unit 1765 12/30/25