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 .
Status of Claims
Claims 1-2, 6, 10, 13, 15-18, 21, 23, 26, 31, 33, 35, 37, 39-41 and 47 are pending. This is the first office action on the merits.
Information Disclosure Statement
The IDSs filed 6/5/2024, 11/04/2024 and 12/10/2025 have been reviewed.
Election/Restrictions
Applicant’s election of Group I (claims 1-2, 6, 10,13, 15-18, 21 and 23) without traverse in the reply dated May 12, 2026 is acknowledged. Applicant’s election of a single compound of formula I, a sterol and a phospholipid as additional components, a nucleic acid as the therapeutic agent, and cancer as the disease or disorder without traverse in the reply dated June 26, 2026 is also noted.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-2, 6, 10,13, 15-18, 21 and 23 have been examined on their merits in light of the elected species of a single compound of formula I, a sterol and a phospholipid, a nucleic acid, and cancer.
The elected species of a single compound of formula I has been searched and is not taught or suggested by the prior art. Therefore, all claims reciting and limited to the elected species of compound formula I are allowable.
The next species of compound formula I chosen to be examined is Phenyl-N-(2-(didodecylamino)ethyl)-N-nonylglycinate wherein in formula I X is O, R2 is unsubstituted C1 alkyl, R3 is unsubstituted C2 alkyl; R4, R5 and R6 are each C9 alkyl, R7 is unsubstituted C1 alkyl and there is a terminal phenyl ring wherein R8, R9, R10, R11 and R12 are each H.
Claims 2, 10, 16-18, 21, 23 and 47 are withdrawn as being drawn to a non-elected invention or species, there being no linking or generic claim.
Therefore, claims 1, 6, 13, 15, 26, 31, 33, 35, 37, 39-41 are examined in light of Phenyl-N-(2-(didodecylamino)ethyl)-N-nonylglycinate, a sterol and a phospholipid, a nucleic acid, and cancer.
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 of this title, 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, 6, 13, 15, 26, 31, 33, 35, 37 and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. US 2021/0161829 (8/12/2020)(6/5/2024 IDS).
Benenato et al. (Benenato) teaches amino lipids and compositions involving the same. Nanoparticle compositions further including therapeutic agents such as RNA are useful in the delivery of therapeutic agents to mammalian cells. (See Abstract). Benenato teaches that there exists a need to develop methods and compositions to facilitate the delivery of therapeutic agents such as nucleic acids to cells. (See [0003]).
Benenato teaches a method of treating a disease or disorder in a human and this disease can be cancer. (See [0275]). Benenato also teaches a method of delivering a therapeutic agent by administering to a subject a nanoparticle composition including a lipid component including a phospholipid, a PEG lipid, a structural lipid and a compound according to formulas I-IV and a therapeutic agent which may be mRNA in which administering involves contacting a mammalian cell with the nanoparticle composition. (See [0277]). mRNA as a nucleic acid is called for in instant claim 40. (See [0004], [0261]). The nanoparticle composition can contain a therapeutic agent which can be a nucleic acid as called for in claim 41. (See [0261]). The therapeutic agent can be an anticancer agent as called for in instant claim 37. (See [0275] and [0802]). The nucleic acid can encode a cytokine as called for in instant claim 41. (See [02202]). Benenato teaches that that its nanoparticle composition encapsulates the drug as called for in instant claim 35. (See [0778]).
The nanoparticle composition can contain other components (as called for in instant claim 31) such as a sterol as called for in instant claims 33. (See [0742]). The lipid component can be a phospholipid as called for in claim 33. (See [0755]). Benenato teaches that the therapeutic agent and additional components can be selected for use based on the condition of the subject and the selection of the appropriate therapeutic agent and additional components is within the skill of the skilled artisan. (See [02230] and [0882]).
Benenato teaches a compound Methyl-N-(2-(didodecylamino)ethyl)-N-nonylglycinate. (See [0975-0976]).
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Methyl-N-(2-(didodecylamino)ethyl)-N-nonylglycinate has all of the features of Formula I (wherein X is O (the oxygen atom is the glycinate moiety). R2 is unsubstituted C1 alkyl, R3 is unsubstituted C2 alkyl; R4, R5 and R6 are each C9 alkyl (the nonyl residues are attached to their respective amino groups), R7 is unsubstituted C1 alkyl (the terminal methyl group is attached to the carboxy moiety). (See [0975-0976]).
X can be O according to claims 1 and 15. R3 as unsubstituted C2 alkyl falls within the C1-C5 alkyl called for in claim 1 and also falls within the C2-C4 alkyl of claim 6. R4, R5 and R6 as C9 alkyl fall within the unsubstituted C6-C20 alkyl of claim 1. They are all the same as called for in instant claim 13. R7 as unsubstituted C1 alkyl falls with in the unsubstituted C1 alkyl of claim 1.
In another embodiment Benenato teaches the compound comprising the terminal phenyl ring, wherein R8, R9, R10, R11 and R12 are each H. (See [2091]-[2093]). R8, R9, R10, R11 and R12 being each H on a phenyl ring fall within the R8, R9, R10, R11 and R12 each being H as called for in instant claim 1.
It would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date to have modified the composition in order to have provided for the compound comprising terminal phenyl ring, to adjust the properties of the amino lipids in delivery of prophylactic agents such as RNA to the mammalian cells to regulate gene expression and treat cancer. (See Abstract, [0975]-[0976], [2091-[2093]). The modification of providing for the compound comprising a terminal phenyl ring, wherein R8, R9, R10, R11 and R12 are each H, would provide the benefit of extending the terminal methyl oxy group of the compound with the unsubstituted phenyl ring to adjust the properties of the amino lipids in delivery of therapeutic agents such as RNA to regulate gene expression and treat cancer. There is additional motivation in light of Benenato’s teaching that there exists a need to develop methods and compositions to facilitate the delivery of therapeutic agents such as nucleic acids to cells. (See [0003]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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SARAH CHICKOS
Examiner
Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
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