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
Status of Claims
Claims 1-2, 7, 22, 33, 40-41, 43-47, 53, 55, 58-59, and 64-65 are pending.
Election/Restrictions
Applicants’ election of Group I and the following species:
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(Example 7-53), in the reply filed on 6/24/2026 is acknowledged. The election was made without traverse.
Applicant stated that claims 1-2, 7, 22, 33, 40, 43-47, 53, and 64-65 read on the elected compound. However, it is noted that claim 33 is not readable because X1 is not -O- or -NR- in the elected species.
Accordingly, claims 33, 41, 55, and 58-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim. Claims 1-2, 7, 22, 40, 43-47, 53, and 64-65 are under examination in the instant office action.
The elected compound is free of prior art, thus search and examination are extended to the following scope of compounds defined by the formula(I): the compound of formula (I-A),
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wherein,
L2, L2’, and L2” are absent,
L3, L3’, and L3” are absent,
R1, R1’, and R1” are saturated straight or branched C1-20 hydrocarbon chain,
X1 is absent,
X2 is C1-6 hydrocarbon chain wherein one methylene unit is optionally replaced with -NR and R is alkyl; and
X3 is hydrogen.
Claim Rejections - 35 USC § 112
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 43 and 45 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 pre-AIA the applicant regards as the invention.
Claim 43 refers to “Table 1” in the specification. Here the Table 1 contains about 50 compounds and as such can easily be written out and there is no need for “Table 1” in the claim. The claim is not complete in itself.
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. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parteFressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP 2173.05(s).
Claim 45 recites “a conjugate-linker lipid (e.g., polyethylene glycol lipid)”. The recitation of a feature in parenthesis renders a claim indefinite by raising a question or doubt as to whether the feature introduced by the parenthesis is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See MPEP § 2173.05(d).
For examination purpose, the feature introduced by the parenthesis is considered as not required.
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)(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 1-2, 7, 22, 44-47, and 53 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO 2020032184 (hereafter, Matsumoto; its national stage application US 20220098142 cited as English equivalent).
Matsumoto teaches cationic lipid (ionizable lipid) of the following formula (I):
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,
wherein L is -C(O)O- (abstract and claim 1). The compound of formula (I) encompasses the claimed formula (I-A).
Also, Matsumoto specifically discloses the following compound:
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(p27, Table 1, compound 1 and compound 2, and claims 2-6).
The compound is a speices of the claimed formula (I) wherein,
L1, L1’, and L1” are -C(O)-,
L2, L2’, and L2” are absent,
L3, L3’, and L3” are absent,
R1, R1’, and R1” are optionally saturated straight or branched C1-20 hydrocarbon chain,
X1 is absent,
X2 is C4-5 hydrocarbon chain wherein one methylene unit is replaced with -NR and R is methyl (C1 alkyl); and
X3 is hydrogen.
Also, Matsumoto discloses that the cationic lipid may form a complex with a plurality of molecules in a solvent or a dispersion medium and the complex may contain other lipid components and nucleic acids (therapeutic agent) wherein the other lipid components include sterols (e.g., cholesterol, cholesterol ester, and cholesteryl hemisuccinate), phospholipid, and polyethylene glycol lipids (PEG lipids) such as GS-020 ([0083]-[0087]).
Matsumoto teaches that the compound is used for producing the lipid particle and disclose a composition comprising the lipid particle and a nucleic acid (particularly, a nucleic acid which is a substance useful for a pharmaceutical application or an application for a research purpose) ([0090]). Matsumoto specifically disclose siRNA (nucleic acid) encapsulated lipid nanoparticle comprising the cationic lipid, DPPC (phospholipid), cholesterol (sterol), and GS-020 (PEG lipid) (Examples 1-2).
In addition, Matsumoto teaches that the composition as a medicament can be produced by a method known in the field of pharmaceutical formulation techniques using a pharmaceutically acceptable carrier (excipient) ([0109]).
As such, the instant claims are anticipated by Matsumoto.
Allowable Subject Matter
Claims 40 and 64-65 are objected to as being dependent from a rejected base claim (claim 1), but would be allowable if rewritten in independent form to the extent of the scope of the elected invention, including all of the limitations of the base claim and any intervening claims.
The following scope of compounds defined by formula (I-A) appears to be free of prior art:
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wherein,
L2 is absent;
L2’ and L2” are an optionally substituted saturated or unsaturated, straight or branched C1-12 hydrocarbon chain;
L3 is absent;
L3’ and L3” are -C(O)O-;
R1 is –(CH2)p-CyB wherein CyB is 1-adamantyl or 2-adamantyl and p is 1, 2, or 3;
R1’ and R1” are an optionally substituted saturated or unsaturated, straight or branched C1-20 hydrocarbon chain;
X1 is absent; and
X2 -X3 is
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.
Relevant Prior Art
US 2017/0197903, US 20210052646, US 20220273566.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
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
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