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 .
DETAILED ACTION
This Office Action is responsive to the Response to Election/Restriction filed 08/12/2026. The preliminary Amendment filed 11/01/2024, amended claims 1-2, 4-6, 20, 31, 39, 41-43, 50, 52, and 55-56, cancelled claims 3, 7-19, 21-30, 32-38, 45-49, 51, 53-54, and 57-60, and added claims 61-62.
Claims 1-2, 4-6, 20, 31, 39-44, 50, 52, 55-56, and 61-62 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I and the species:
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, in the reply filed on 08/12/2026, is acknowledged.
The elected species is allowable over the prior art. In the course of the search, the entire genus of instant formula (I) and formula (II) were searched. As such, the election of species requirement is hereby withdrawn.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 41-44, 50, 52, 55-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-2, 4-6, 20, 31, 39-40, and 61-62 are examined on the merits herein.
Claim Objections
Claim 1 is objected to because of the following informalities:
-In claim 1, following the depiction of Formula I on pg. 3 of the claim set, the term “or a,” following “(I),” appears to be a typo or superfluous language and should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 6 and 40 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.
-In claim 6, the definition of L3 and L3’ renders the claim indefinite. In claim 6, L3 and L3’ are defined as “an optionally substituted. . .C1-5 hydrocarbon chain and/or –(CH2)m-CyA-(CH2)m’-; and/or m and/or n is 0 or 1.
Claim 6 depends from claim 1, wherein claim 1 defines L3 and L3’ as “an optionally substituted. . .C1-10 hydrocarbon chain, wherein 1-3 methylene units are optionally and independently replaced with. . . –(CH2)m-CyA-(CH2)m’-.”
Thus, it is not clear if this is a typo and Applicant forgot to add “wherein 1-3 methylene units are replaced with” prior to –(CH2)m-CyA-(CH2)m’-,” or if Applicant is additionally defining L3 and L3’ in claim 6 as –(CH2)m-CyA-(CH2)m’-.
This rejection can be overcome by adding - - wherein 1-3 methylene units are replaced with- - prior to “–(CH2)m-CyA-(CH2)m’-”.
-In the last line of 6, “n” is defined. However, claim 6, and claim 1, from which claim 6 depends, do not recite the variable “n.” As such, it is not clear if this is a typo, or if n should be m’ or if a group that contains variable “n” is missing from the claims.
This rejection can be overcome by replacing “n” with - -m- -.
-Claim 40 recites “A compound selected from Table 1,” which is improper; where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. MPEP 2173.05(s)
This rejection can be overcome by copying the contents of the table into the claim.
Claim Rejections - 35 USC § 112(a)-Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-6, 20, 31, 39, and 61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2163.
Independent claim 1 is directed toward the following generic compounds:
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.
In summary compounds of Formula (I) and (II) contain the following variable groups: R, R1, R2, R2’, L1, L1’, L2, L2’, L3, L3’, L4, L4’, X1, X1’, X2, X2’, Y1, Y1’, wherein these variable groups are defined as multiple generic groups that can be substituted by unlimited generic groups.
The instant specification teaches the following regarding “substituted”:
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.
Paragraph [0085] of the specification provides examples of what suitable monovalent substituents include.
Thus, while the specification provides some examples of what a substituted group may be, the scope is non-limiting, thereby including groups not recited in [0085], such as protein, nucleic acid, metal complexes, etc.
As discussed in MPEP 2163 II.A(3)(a)(ii), the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. . .A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The instant specification provides 24 species similar to the instantly claimed compound of Formula (II),
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and Formula (I)
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, in Table 1 ([0163]) of the specification.
These species include the following R, R1, R2, R2’, L1, L1’, L2, L2’, L3, L3’, L4, L4’, X1, X1’, X2, X2’, Y1, Y1’ groups:
Y1 is CH2
Y1’ is (CH2)2
L1 and L1’ are (CH2)2
L2 and L2’ are (CH2)2
X1 and X1’ are -OC(O)-
X2 and X2’ are absent
L3 is an unsubstituted, saturated C2-3 alkyl chain
L3’ is (CH2)3 or (CH2)2;
L4 and L4’ are absent
L5 is an unsubstituted C8 hydrocarbon chain with one double bond
R1 is H
R is –C(O-L5b-Rb)(O-L5b-Rb), wherein L5b is absent and Rb is an unsubstituted C8 hydrocarbon chain with one double bond,
or a combination of L3’ and R are an unsubstituted hydrocarbon chain with 1 or 2 double bonds,
R2 is CH3.
Thus, the species disclosed in the specification are very limited in scope when compared to the expansive scope of compounds of formula (I) and (II):
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;
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, as recited in the instant claims, such that one of skill in the art would not have recognized that Applicant was in possession of the full scope of the claims.
Specifically, the species have no or limited disclosure of groups such as:
Y1 and Y1’ are C3;
X1 and X1’ are C(O)O- or -OC(O)O-
X2 and X2’ are -OC(O)-, -C(O)O-, or -OC(O)O-
L4 and L4’ are an optionally substituted, bivalent saturated or unsaturated straight or branched, C1-10 hydrocarbon chain, wherein 1-3 methylene units are optionally and independently replaced with -O- or -NRy-
-any of the recited hydrocarbon groups have 1-3 methylene units replaced with -O- or -NRy-.
As a result, there is a vast scope in the claims that has no representation at all or homology to the disclosed species. The disclosure does not adequately reflect the structural diversity of the claimed genus, through the disclosure of sufficient species that are “representative of the full variety or scope of the genus.” In addition, there is no establishment of “a reasonable structure-function correlation” in the disclosure nor was it known in the art. The instant claims are free of the prior art, and the instant specification only provides 24 examples, wherein only two of these species, which are both compounds of instant formula (II), are used as ionizable lipids in lipid nanoparticles ([071], [0377]).
Such a disclosure does not embrace widely variant species given the unpredictable nature of the art both with respect to the synthesis and utility of the claimed compounds as evidenced by Cullis (Lipid Nanoparticle Systems for Enabling Gene Therapies, PTO-892 of 05/12/2026), which teaches that while lipid nanoparticles (LNP) have proven useful for in vitro transfection purposes, their utility in vivo is limited due to their large size, instability, positive surface change, and dose-limiting toxic side effects (pg. 1468, Col. 1, 1st paragraph).
Moreover, the instant specification merely states that “the present disclosure describes that a combination of components may better suite delivery of siRNA. . .mRNA. . .DNA” ([0101]). And the instant specification only exemplifies two species of instant formula (II), i.e., 7-7 and 7-8, for use in LNPs and drug delivery ([0371] and [0377]).
Thus, a representative number of adequately described species are not disclosed for the genus such that one of skill in the art would reasonably conclude that the Applicant had possession of the full scope of the claimed invention.
As such, claims 1-2, 4-6, 20, 31, 39, and 61 are broader than what the specification supports and are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Free of the Prior Art
Claim 40 is free of the prior art.
Claim 62 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The compounds of instant claims 40 and 62 are novel and non-obvious over the prior art.
The closest prior art is WO 2021/195529 to Stanton (published 09/30/2021, IDS of 07/08/2025) which teaches compounds such as:
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(Table 3, beginning on pg. 38).
The reference does not teach
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of instant Formula (II) which is a distinct feature of the instantly claimed compound of Formula (II).
Additional close prior art is WO 2021/102411to Staton (published 05/27/2021, IDS of 07/08/2025), which teaches compounds such as:
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(Table 1, beginning on pg. 41).
The reference does not teach instant X1 or X1’ or teach
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of instant Formula (I), which are distinct features of the instantly claimed compound of Formula (I).
Conclusion
Claims 40 and 62 are free of the prior art.
Claims 1-2, 4-6, 20, 31, 39, and 61 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
