DETAILED ACTION
Claims 1-17, 27, 52, and 54 are pending in the instant application.
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 .
Priority
The instant application claims priority to the U.S. Provisional Application Serial No. 63/443,675 filed February 6, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted May 14, 2024 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-17, 27 and 52 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Jiang et al. (CN 105056251, 2015).
Jiang discloses an environment-responsive peptide-containing dendrite lipid material (Abstract). The environment-responsive peptide-containing dendrimer lipid material according to claim 1, wherein its structural formula is as follows: Formula 1 - Among them, K is the repeating unit of dendrimers, G1 and Gn represent the first generation and n generation dendrimers respectively, n is 2 or 3 or 4 or 5, X-X is the connection molecule with reduction response function, X is S or Se, R is a hydrophobic group. The environment-responsive peptide-containing dendrimer lipid material according to claim 1, wherein the hydrophilic end of the dendrimer is also connected with a hydrophilic group with a pH response function. The above-mentioned hydrophilic group with pH response function is connected to the amino group or guanidinium group at the end of the dendrimer (claims 2-3).
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(Exemplary compounds) (pg 4). Jiang discloses compounds listed in claim 16 of instant application, which would also read on claim 1 of instant application. Jiang discloses that the amphiphilic lipid material can self-assemble into nanometer-sized liposomes or micelles or vesicles through hydrophilic and hydrophobic interactions, and wrapping drugs or genes in them can form a drug or gene carrier system. When the carrier system enters a high-concentration reducing substance environment, the reduction-sensitive bonds are broken, disassembly occurs, and drugs or genes can be released (Abstract). The present invention also provides a gene carrier system, including genes (such as plasmid DNA, RNA, etc.) (pg 4, 13th paragraph). Jiang discloses that more and more gene-related diseases are considered to be curable by gene therapy, which usually requires the delivery of nucleic acid drugs to target cells to treat some tumors, asthma and cardiovascular diseases (pg 2, 2nd paragraph).
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 1-17, 27, 52, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (CN 105056251, 2015) and Liang et al. (Integration of Indocyanine Green Analogs as Near-Infrared Fluorescent Carrier for Precise Imaging-Guided Gene Delivery, Nano Micro, 2020) as further evidenced by Cambridge medchem (Ester and Amide Bioisosteres).
Jiang discloses an environment-responsive peptide-containing dendrite lipid material (Abstract). The environment-responsive peptide-containing dendrimer lipid material according to claim 1, wherein its structural formula is as follows: Formula 1 - Among them, K is the repeating unit of dendrimers, G1 and Gn represent the first generation and n generation dendrimers respectively, n is 2 or 3 or 4 or 5, X-X is the connection molecule with reduction response function, X is S or Se, R is a hydrophobic group. The environment-responsive peptide-containing dendrimer lipid material according to claim 1, wherein the hydrophilic end of the dendrimer is also connected with a hydrophilic group with a pH response function. The above-mentioned hydrophilic group with pH response function is connected to the amino group or guanidinium group at the end of the dendrimer (claims 2-3).
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(Exemplary compounds) (pg 4). Jiang discloses compounds listed in claim 16 of instant application, which would also read on claim 1 of instant application. Jiang discloses that the amphiphilic lipid material can self-assemble into nanometer-sized liposomes or micelles or vesicles through hydrophilic and hydrophobic interactions, and wrapping drugs or genes in them can form a drug or gene carrier system. When the carrier system enters a high-concentration reducing substance environment, the reduction-sensitive bonds are broken, disassembly occurs, and drugs or genes can be released (Abstract). The present invention also provides a gene carrier system, including genes (such as plasmid DNA, RNA, etc.) (pg 4, 13th paragraph). Jiang discloses that more and more gene-related diseases are considered to be curable by gene therapy, which usually requires the delivery of nucleic acid drugs to target cells to treat some tumors, asthma and cardiovascular diseases (pg 2, 2nd paragraph).
Liang discloses that codelivery of diagnostic probes and therapeutic molecules often suffers from intrinsic complexity and premature leakage from or degradation of the nanocarrier (Abstract). Liang discloses the arginine-rich and oleic-acid-containing amphiphilic dendritic lipopeptide (RLS) (pg 3, right col).
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(pg 2).
Both Jiang and Liang disclose the compound of Formula I. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a lipopeptide molecule that can deliver DNA. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, compound of Formula 1A is taught above.
Regarding claims 3-4, compound of formula II and IIA is taught above.
Regarding claim 5, Cambridge medchem teaches that ester and amide groups can be bioisosteres (pages 3-4). One of ordinary skill in the art would contemplate replacing an amide group in Formula III with an ester group as they are routinely used bioisosteres.
Regarding claim 6, alkylene group is taught above.
Regarding claim 7, butylene group is taught above.
Regarding claims 8-10, R1 and R2 being alkyl groups are taught above.
Regarding claims 11-12, R3 and R4 groups having ionizable functional groups is taught above.
Regarding claim 13, ionizable functional group is taught above.
Regarding claims 14-15, guanidine is taught above.
Regarding claim 16, compounds of claim 16 are taught above.
Regarding claim 17, Jiang discloses that the invention includes nanoparticles (pg 2, 4th paragraph).
Regarding claim 27, a payload such as DNA is taught above.
Regarding claim 52, delivering a payload is taught by Jiang above.
Regarding claim 54, one of ordinary skill in the art would recognize that a lipopeptide containing a therapeutic agent or DNA would be useful for treating a condition or disorder that requires such a therapeutic agent or DNA.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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