Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Claims
Claims 58-70 are pending.
Information Disclosure Statement
The listing of references in the specification (p54-56) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Election/Restrictions
Applicants' election of Group I and B4-S5-E7:
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as the elected compound, in the reply filed on 9/24/2026 is acknowledged. The election was made without traverse.
The elected compound is free of prior art, thus examination and search have been extended to the following next species: a compound of formula (I):
wherein R is
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(B4),
R’ is
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(S5), and
R’’ is
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or
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.
Accordingly, claims 66-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 58-65 and 70 are under examination in the instant office action.
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 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.
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 58 and 60-65 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Green et al. (hereafter, Green 2007; Adv. Mater. 2007: 2836-2842; cited in the IDS filed on 8/30/2024).
Green 2007 discloses end-modified poly(β-amino ester)s, which bind and self-assemble with DNA to form stable nanoparticle that effectively enter cells, escape the endosomal compartments and degrade via hydrolytic cleavage of backbone ester groups (abstract and p2836, col 2, para 1).
Green 2007 discloses synthesis of end-modified poly(b-aminoester)s by reaction of acrylate-terminated polymers with primary diamine molecules where n is necessarily at least one (Fig. 1):
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Green 2007 teaches that the molecular weight of the C32-Ac polymer about 8800 Da (8.8 kDa) (p2841, col 1, para 1), which falls within the molecular weight recited in claim 61.
Green 2007 specifically discloses compositions comprising nanoparticles of end-modified C32 polymers such as C32-103 and C32-117 and DNA (nucleic acid) in DMSO (p2839, col 1 para 2, Fig. 2-4, and p2840, col 2, para 2). The C32-103 and C32-117 polymers are the compounds, B4-S5-E1 and B4-S5-E3, as recited in the instant claim 58.
As such, the instant claims 58 and 60-65 are anticipated by Green 2007.
Claims 58-65 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Green et al. (Acc. Chem. Res. June 2008, 41(6): 749–759; cited in the IDS filed on 8/30/2024).
Green et al. discloses end-modified poly(β-amino ester)s, which forms smaller nanoparticle with DNA (see abstract). Specifically, Green et al. discloses compounds of the following structure of:
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, wherein R (corresponding to R’’) can be selected from the following amine capping molecules:
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(when n is 3, corresponding to E1)
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(corresponding to E2),
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(corresponding to E3)
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(corresponding to E4)
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(corresponding to E5),
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(corresponding to E11), and n is necessarily at least one (see Figure 9). The above polymers are species of the claimed genus defined by the formula (I).
Green et al. disclose that the polymers are linear polymers of ~10 kDa (abstract and p758, col 1, para 2).
Green et al. also disclose intraperitoneal injection composition (pharmaceutical composition) comprising the polymer (C32-103 or C32-116) and DNA nanoparticles (p757, col 2, para 2).
As such, the instant claims 58-65 are anticipated by Green et al.
Claims 58-65 are rejected under 35 U.S.C. 102(a)/102(e) as being anticipated by US 20080242626 (hereafter, Zugates; cited in the IDS filed on 8/30/2024).
Zugates teach end-modified poly(β-amino esters)(PBAEs) of the following polymer which are useful in delivery of nucleic acids such as DNA or RNA:
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wherein n is an integer between 5 and 10,000, preferably from 10 to 500 (abstract, claim 2, [0009], [0043], and [0114]). These polymers and their end-modified variants are also useful in the medical and non-medical arts because of the biodegradable nature of the ester linkages in the polymers ([0068]).
Zugates specifically disclose the following acrylate-terminated C32 polymers and their preparation method (Fig. 1 and [0057]):
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The above polymers are species of the claimed genus defined by the formula (I), wherein: R is
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(B4),
R’ is
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(S5), and
R’’ is corresponding to
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or
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.
Also, Zugates discloses that the end-modified polymers may be used to form particles, microparticles, nanoparticles, or other drug delivery device and any agent delivered using the inventive polymer include small molecules, contrast agents, peptides, proteins, polynucleotides, DNA, RNA, RNAi, siRNA, mRNA, tRNA, microRNA, ssDNA, dsDNA, ssRNA, shRNA, metals, organometallic compounds, vitamins, minerals, etc. ([0020] and [0145]).
In addition, Zugates discloses a pharmaceutical composition comprising a polynucleotide such as siRNA and the PBAE polymer (claims 47 and 50). Zugates further discloses that the polymer has a molecular weight between 1,000 and 100,000 g/mol (1-100kDa), more preferably from 1,000 g/mol (1 kDa) to 50,000 g/mol (50 kDa) and the average molecular weight of the polymer is approximately 1,000 g/mol, 2,000 g/mol, 3,000 g/mol, 4,000 g/mol, 5,000 g/mol, 6,000 g/mol, 7,000 g/mol, 8,000 g/mol, 9,000 g/mol, 10,000 g/mol, 11,000 g/mol, 12,000 g/mol, 13,000 g/mol, 14,000 g/mol, 15,000 g/mol, 16,000 g/mol, 17,000 g/mol, 18,000 g/mol, 19,000 g/mol, or 20,000 g/mol ([0070]).
As such, the instant claims 58-65 are anticipated by Zugates.
Non-Statutory Double Patenting Rejection
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 58-65 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,049,530.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a nanoparticle comprising a subgenus of poly(beta-amino ester) (PBAE) compounds defined by the claimed formula (I) wherein R” is
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and species which fall within the claimed genus, which further comprises a therapeutic agent such as a gene, DNA, RNA, siRNA, miRNA, isRNA, agRNA, smRNA, a nucleic acid, a peptide, a protein, a chemotherapeutic agent, a hydrophobic drug, and a small molecule drug peptide. Thus, the instant claims are anticipated by the claims of the patent.
Claim 58-65 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11401380.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘380 patent are drawn to a nanoparticle comprising a nucleic acid molecule and a poly(beta-amino ester) (PBAE) of the same formula (I) as claimed, including the elected compound, B4-S5-E7. Thus, the instant claims are anticipated by the claims of the patent.
Claim 58-65 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11883541.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘541 patent recite a composition comprising a poly(beta-amino ester) (PBAE) of the same formula (I) as claimed, including the elected compound, in a nanoparticle or microparticle with a therapeutic agent such as a nucleic acid, DNA, RNA and mRNA. Thus, the instant claims are anticipated by the claims of the patent.
Claim 58-65 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-17 of U.S. Patent No. 11697804.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘804 patent recite a composition comprising a poly(beta-amino ester) (PBAE) of the same formula (I) as claimed, including the elected compound, in a nanoparticle or microparticle with a therapeutic agent such as a nucleic acid and plasma DNA. Thus, the instant claims are anticipated by the claims of the patent.
Claims 58-61 and 64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,717,694.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a microparticle comprising a subgenus of poly(beta-amino ester) (PBAE) compounds defined by the claimed formula (I), which further comprises peptide. Thus, the instant claims are anticipated by the claims of the patent.
Claim 58-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 14-16, and 25-30 of copending Application No. 17/441188.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘188 application are drawn to a composition comprising a poly(beta-amino ester) (PBAE) compound defined by the claimed formula (I), including the elected compound in nanoparticle. Thus, the instant claims are anticipated by the claims of the co-pending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
Prosecution Insights