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 the Claims
Claims 1 – 4, 7, 10, 12, 14 – 15, 17 – 18, 27 – 28, 30 – 38 and 46 are pending.
Claims 1 – 2, 7, 10, 14, 17, 28, 30, 35 – 38 and 46 are rejected.
Claims 3 – 4, 12, 15, 18, 27 and 31 – 34 are withdrawn.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1 – 4, 7, 10, 12, 14 – 15, 17 – 18, 27 – 28, 30 – 38 and 46, in the reply filed on December 15, 2025 is acknowledged. Applicant specifically elected the compound depicted in Example 6-1:
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.
The compound reads on the structure of Formula I’:
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, wherein:
L is C1 alkylenyl, and R is C8 aliphatic, or alternatively, L is C2 alkylenyl, and R is C7 aliphatic, or L is C3 alkylenyl, and R is C6 aliphatic;
One L2 is C6 alkylenyl, and the other is C7 alkylenyl;
L1 is C2 alkylenyl;
R1 is OR2, and R2 is H;
X is -C(O)O;
L3 is C1-10 alkylenyl; and
R is C6-20 aliphatic.
Examination: Applicant’s elected species is not allowable over the prior art. Examination of the Markush-type claim has not been extended. Pursuant to Federal Register, Vol. 76, No. 27, dated February 9, 2011, page 7166 (middle column):
“Under principles of compact prosecution, the examiner should also require the applicant to elect a species or group of indistinct species for search and examination (i.e., an election of species). If the examiner does not find the species or group of indistinct species in the prior art, then the examiner should extend the search to those additional species that fall within the scope of a permissible Markush claim. In other words, the examiner should extend the search to the species that share a single structural similarity and a common use. The improper Markush claim should be examined for patentability over the prior art with respect to the elected species or group of indistinct species…within the scope of a proper Markush claim.”
Subject matter not embraced by the elected embodiment or the scope searched is therefore withdrawn from further consideration. Claims 3 – 4, 12, 15, 18, 27 and 31 – 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
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Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 7, 2023, September 10, 2025 and December 15, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The specification amendment filed on June 22, 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. Specifically, the following new phrase is not supported by the application (as filed on June 22, 2023): “the entirety of each of which is herein incorporated by reference”. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. See MPEP 211.02 and MPEP 201.06(c)(IV). PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to 371 applications. When a benefit claim is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. In order to overcome the objection, Applicant may amend by deleting the phrase “the entirety of each of which is herein incorporated by reference”.
Claim Objections
Claims 1 – 2 are objected to because of the following informalities:
Claim 1, page 2, line 11: The phrase “… 7- to 12-membered bridged bicyclic” is grammatically incorrect because it does not recite the complete limitation. In order to overcome the objection, Applicant may amend the phrase as follows: “… 7- to 12-membered bridged bicyclic ring”.
Claim 1, page 2, line 12: The limitation “… 0.4 heteroatoms independently selected from nitrogen, oxygen, or sulfur” (emphasis added) is grammatically incorrect because it does not recite proper Markush group language for the group of alternatives. In order to overcome the objection, Applicant may amend the limitation as follows: “… 0.4 heteroatoms independently selected from nitrogen, oxygen, [[or]] and sulfur”.
Claim 2, line 1 of the claim: The phrase “… compound is of Formula I-a” is grammatically incorrect. In order to overcome the objection, Applicant may amend the phase as follows: “… compound of Formula I’ is a compound of Formula I-a”.
Appropriate correction is required.
Improper Markush Group Rejection
Claims 1 – 2, 7, 10, 14, 17, 28, 30, 35, 37 – 38 and 46 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the compound of Formula I’ is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Claim 1 is directed to a compound of Formula I’:
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, wherein (for example):
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The structures associated with each of the variables (R1, L2, X, L3 and R) above in the Formula I’ do not share a substantial feature to each other. The compounds of Formula I’ as claimed in claim 1 do not belong to the same art-recognized class or chemical class of compounds because there is no common core structure shared among all of the compounds that would enable them to be categorized the same. For example, in atleast R1, L2, L3 and R, the alternatives for “C6-20 aliphatic, 3- to 12-membered cycloaliphatic, 7- to 12-membered bridged bicyclic comprising 0-4 heteroatoms independently selected from nitrogen, oxygen, or sulfur”, “5- to 6-membered monocyclic heteroaryl comprising 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur”, “8- to 10-membered bicyclic heteroaryl comprising 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur” groups can be classified as phenylenes (e.g., CPC class C07C17), thiophenes (e.g., CPC C07D333 and C07D495), pyrrole (e.g., CPC C07D207 and C07D487), or as selenophenes (e.g., CPC C07D345 and C07D517). Further, the alternatives for “phenyl” and “5-6 membered heteroaryl” groups can also be classified in different CPC classes as noted above. Besides the tertiary amine (-N(-)-) connected to the carbonate (-O-C(=O)-O-) moiety via the variable L2, there is no shared structure amongst all of the alternatives as claimed by the variables R1, L2, X, L3 and R in the structure of Formulae I’ (claim 1), and I-a (claim 2). The compounds do not belong to the same recognized physical or chemical class or to the same art-recognized class and each compound would possess different physical and chemical properties in view of the functional and cyclic groups such that they would not be expected to have the necessary common use. Thus, the compounds of the Markush grouping cannot be considered to share a “single structural similarity” that is essential from which a common use flows.
In order to overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. For example, the following is a proper Markush group of structure of Formula I’:
R1 is OR2, and R2 is H;
Each L2 is C2-15 alkylenyl;
X is -OC(O), -C(O)O, or -OC(O)O-;
L3 is C1-10 alkylenyl; and
R is C6-20 aliphatic.
or a single grouping of patentably indistinct species such that the variables R1, L2, X, L3 and R are conserved across all species of Formulae I’ and I-a.
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)(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 – 2, 7, 10, 14, 17, 28, 30, 35 – 38 and 46 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Benenato et al. US 2022/0411361 (effectively filed September 19, 2019).
Benenato et al. teach Compound 6 (see, e.g., page 8, Table 1) as shown below:
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The prior art anticipates the present claims as presented below:
Claims 1, 7, 10, 14, 17, 28, 30 and 35, directed to a compound of Formula I’:
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, wherein:
L is C1 alkylenyl, and R is C8 aliphatic, or alternatively, L is C2 alkylenyl, and R is C7 aliphatic, or L is C3 alkylenyl, and R is C6 aliphatic;
One L2 is C6 alkylenyl, and the other is C7 alkylenyl;
L1 is C2 alkylenyl;
R1 is OR2, and R2 is H;
X is -C(O)O;
L3 is C1-10 alkylenyl; and
R is C6-20 aliphatic.
Claim 2, directed to the compound of Formula I’ is a compound of Formula I-a:
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, wherein:
L is C1 alkylenyl, and R is C8 aliphatic, or alternatively, L is C2 alkylenyl, and R is C7 aliphatic, or L is C3 alkylenyl, and R is C6 aliphatic;
One L2 is C6 alkylenyl, and the other is C7 alkylenyl;
L1 is C2 alkylenyl;
R1 is OR2, and R2 is H;
L3 is C1-10 alkylenyl; and
R is C6-20 aliphatic.
Claim 36, wherein the compound is compound 6-1 as presented below:
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.
With respect to claims 37 – 38, Benenato et al. teach a lipid nanoparticle (LNP) preparation comprising the ionizable Lipid Compound 6. See, e.g., Table 2.
With respect to claim 46, Benenato et al. teach Embodiment 119, wherein a pharmaceutical composition comprising the loaded LNP and a pharmaceutically acceptable excipient. See, e.g., paragraphs [0797].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626