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
Claims 1, 57, 60-63, 66-70 and 74-82 are pending. Applicant has withdrawn (Remarks, page 12, second para) claims 66-69, 74, 75 and new claims 79-82 due to the restriction requirement which was mailed on 08/14/2025. Claims 79 and 80 which are dependent on the elected claim 62, are under examination in the current office action, since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. However, the newly submitted claims 81 and 82 which are dependent on a non-elected claim 67, are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
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, 60-63, 70 and 76-80 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.
Claims 1, 60 and 62 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.
Regarding claims 1, 60 and 62, the "non-existence" of p2 when r1=0 raises ambiguity for alternatives. It is unclear that when r1=0, which results in absence of p2, would satisfy the alternative: wherein each of p1 to p3 independently is an integer of 1 to 5; and wherein p1, p3, or both are greater than p2. Appropriate correction or clarification is required.
Claim 79 is 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 claim is ambiguous, it is unclear if the all the elements after the term “optionally” are optional, or only a guide nucleic acid and/or donor nucleic acids are optional. Similarly, it is unclear if the use of “or” between an siRNA, or dsRNA is meant to as choice between the two RNAs or for all the elements before the two RNAs. Appropriate correction or clarification is required.
Claim Interpretation
For Claims 1, 60 and 62, the absence of p2 when r1=0, is interpreted to satisfy: wherein each of p1 to p3 independently is an integer of 1 to 5; and wherein p1, p3, or both are greater than p2.
For claim 78, the instant inventive examples are utilized to interpret BuNH- moiety as butyl-NH group to form the amide end group.
For claim 79, it is interpreted that only nucleic acid and/or peptide are required features of the claim, and all the elements after “optionally” are not required features but are optional.
Claim Objections
Claim 79 is objected to because of the following informalities: the requirement “transcription activator-like effector nuclease” is repeated twice. Appropriate correction is required.
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 1, 57, 61-63, 70 and 76-80 are rejected under 35 U.S.C. 103 as being unpatentable over Satchi-Fainaro et al. US2018/0318428.
Regarding claims 1, 57, 59, 61 and 70, Satchi-Fainaro teaches copolyamide (which is hydrolysable) structure (reference claim 79), where the backbone units can be selected to be structural units Formula BU(5) and Formula BU(6), as shown below.
[AltContent: textbox (BU(5))]
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[AltContent: textbox (BU(6))]
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For BU(5), where R9 can be H, and L5 and R10 can be together a pentyl group and corresponds to the required hydrophobic side chain (Satchi-Fainaro paras [0262] and [0263]). For BU(6), the 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 BU(6) structure as depicted below.
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The obvious polyamine structure as taught by Satchi-Fainaro complies with the second polyamine structure, where r1 is 0, p2 is absent, p1 and p3 are 2, and where p1 and p3 are greater than p2, and where R2 is combined with a second R2 to form a heterocyclic group.
Regarding claims 62 and 63, as discussed when addressing claim 1, Satchi-Fainaro renders the required hydrolysable backbone with hydrophobic pentyl side chain and cationic side chain with polyamine, obvious. Satchi-Fainaro notes that the repeat units can be linked as a block copolymer (reference claim 80). Satchi-Fairnaro further notes that the repeat unit BU(5) can be at least 40 mol% and BU(6) can be at least 20 mol% (reference claims 70 and 73, u mol% for BU(5) and v mol% for BU(6), also see paras [0307] and [0308]). In Satchi-Fainaro’s copolyamide composed of 100 backbone units, the BU(5) with pentyl hydrophobic side chain corresponds to applicant’s n1 repeat units, with R3b as ethylene, X1 as -C(O)NR11-, with R11 as hydrogen, and X2 as C5 alkyl group, such that n2=0 and n1 is at least 40. BU(6) structure as presented when addressing claim 1, reads on the required m1, with R3b ethylene, R11 as hydrogen and A1 as the second required polyamine, such that m2=0, and m1 is at least 20.
Regarding claims 76 and 77, Satchi-Fainaro teaches copolyamide (which is hydrolysable) structure (reference claim 79, Formula I*), where the backbone units can be selected to be structural units Formula BU(5) and Formula BU(6), which have a Ra N-terminus and a Rb C-terminus group. As discussed, when addressing claim 62, Satchi-Fainaro renders Formula 1 obvious. Satchi-Fainaro adds (para [0298]) that the Ra can be hydrogen such that N-terminus is an amine, and (para [0299]) Rb can be amine such that C-terminus is an amide group, where amine can be -NR’R’’ with R’ and R’’ are both hydrogen (para [0620]), which meets Q with R6 as hydrogen, c=0, -(CH2-)0, and Y is cleavable -NH- linker, and R1 is hydrogen, and reads on Formulae 1A and 1B.
Regarding claim 78, as discussed when addressing claims 76 and 77, Satchi-Fainaro notes that (para [0299]) Rb can be amine such that C-terminus is an amide group. Satchi-Fainaro further adds that amine describes a -NR’R’’ where R’ and R’’ can be independently hydrogen and an alkyl (para [0620]). The required butyl amine would be at once envisaged by one of ordinary skilled in the art to create the required C-terminus amide, per Satchi-Fainaro’s disclosure. See MPEP 2131.02 III.
Regarding claims 79-80, the polymer structure of claim 62 is rendered obvious Satchi-Fainaro, as discussed when addressing the claim. Satchi-Fainaro (reference claims 82 and 101) discloses creation of a conjugate comprising the inventive polyamide copolymer and an oligonucleotide, and a method of delivering an oligonucleotide to a cell, by contacting the cell with the conjugate.
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, 60-63, 70 and 76-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-8, 14, 18-21, 23 and 26 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, 60-63, 70 and 76-78 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 1 and 62:
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Where p1 =2, r1=0, p3 =2, and where both R2 is C1 alkyl.
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.
Additionally, reference claims 20-21, 23 and 36 read on instant claims 79-80.
Claims 1, 57, 61-63, 70 and 76-78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18, 48, 51-55, 57-62 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, which corresponds to applicant’s hydrophobic sidechain and polyamine structure which can form cationic side chains, as required by instant claim 1. Reference application’s Claim 62, polymer structure 40, reads on instant claims 1, 62 and 76-78 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, 60-63, 70 and 76-78 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). Claim 17’s, fifth structure of the copending application renders the first structure of the instant claim 60 obvious. Claim 28’s polymer structure 75 of the copending application, reads on instant claims 76-78.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on 07/02/2026 have been fully considered, please see the response below.
The amended claim 1, overcomes the 112(b) rejection of the non-final office action mailed in 01/02/2026. However, the claim amendment raises new 112(b) issues as discussed above.
Applicant submits (pages 15 and 16, remarks) that the reference Satchi-Fainaro does not disclose or suggest the required structure amended claim 1, with side chain with at least one tertiary amine and only a single nucleophilic center (i.e., a primary or
secondary amine) at the terminus, as defined by the pending claims, wherein each of p 1 to p3 independently is an integer of 1 to 5, and wherein p1, p3, or both are greater than p2 and/or p1, p3, or both are integers of 3 to 5, much less in combination with hydrophobic side chains, as presently claimed.
In response, while it is acknowledged that Satchi-Fainaro (structure X) no longer anticipates the required claim 1 features, the limitations of claim 1 are rendered obvious by the reference, as discussed when addressing claim 1. Satchi-Fainaro disclosure of BU(5) repeat units correspond to applicant’s hydrophobic side chains, while the BU(6) repeat units with nitrogen containing heterocyclic moiety complies with the required polyamine side chain with at least one tertiary amine and only a single nucleophilic center which is a secondary amine at the terminus. Since applicant recites the r1=0 as one of the limitation, the p1 and p3 both =2, where p1 and p3 are greater than p2 (which is 0 when r1=0), meet the claimed requirements.
Applicant’s arguments against Satchi-Fainaro are found to be unpersuasive and the reference continues to provide the support for maintaining the rejection of the amended claims.
Applicant traverses the obviousness-type double patenting rejection over U.S. Patent 12,344,709. Applicant notes that the ‘709 patent does not disclose or suggest a polymer comprising a hydrolysable polymer backbone, wherein the polymer backbone comprises monomer units comprising a hydrophobic side chain and monomer units comprising a polyamine side chain with at least one tertiary amine and only a single nucleophilic center (i.e., a primary or secondary amine) at the terminus, as defined by the pending claims, and that variables p1 and p3 of Polymer 20 of the '709 patent, are not encompassed by the amended claims. Since the amended claim 1 recites r1=0 as one of the limitation, the p1 and p3 both =2, where p1 and p3 are greater than p2 (which is 0 when r1=0), meet the claimed requirements. Polymer 20 of the ‘709 patent meets the requirement of claim 1, and since the backbone of Polymer 20 is a polyamide, the backbone would be hydrolysable. Applicant’s argument against the obviousness-type double patenting rejection over U.S. Patent 12,344,709, is not convincing and the rejection is maintained.
Applicant further argues that provisional obviousness-type double patenting rejections based on the '981 and '307 are not proper since the applications ‘981 and ‘307 were filed later. In response, it is highlighted that applications ‘981 and ‘307 were filed earlier on 10/22/2021 and 11/24/2021 respectively, while the instant application was filed on 10/24/2022. The claims of copending applications '981 and '307 teach the required hydrolysable backbone with the hydrophobic and polyamine side chains, and therefore the rejections are maintained.
Applicant’s amended claim 1, overcomes the provisional obviousness-type double patenting rejection based on the copending '539 application.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/S.M.D./
Examiner
Art Unit 1765
/JOHN M COONEY/Primary Examiner, Art Unit 1765
Prosecution Insights