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 1-18 are pending.
Priority
Instant application 18/578,361, filed 01/11/2024 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 05/31/2024 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2 and 6-16; and the elected species Lipid 2AEOAP2 in the reply filed on 05/27/2026 is acknowledged. However, in the course of the search, the elected species was identified as free of the prior art. The search was therefore expanded to non-elected Group I and Group III. In view of the foregoing, the restriction requirement between inventions I-III, as set forth in the Office action mailed on 03/27/2026, is hereby withdrawn and claims 3-5 and 17-18 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Claim Objections
Claim 3 is objected to because of the following informalities: claim 3 contains a typographical error. The structure of Formula (II) is cut off such that the oxo group at the bottom of the structure is missing. Formula (II) in claim 3 is being interpreted according to para. [0083] in the Specification:
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Appropriate correction is required.
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.
Claim 10 is 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.
Claim 10 recites “cholesterol or a derivative thereof”. The term “derivative” expresses only a relationship to a parent compound; it does not, by itself, fix any limit on the kind or degree of structural modification a compound may have while remaining within the claim. The specification supplies no definition that establishes such a limit. At [00104], the specification states only that “[n]on-limiting examples of cholesterol derivatives include” an enumerated list of compounds “or combinations thereof.” This expressly non-limiting, exemplary language does not establish the metes and bounds of the term; it names certain species but leaves the outer scope of the genus undefined and dependent on the unbounded word “derivative.”
Furthermore, the enumerated examples cannot be reconciled under any single structural category, and therefore do not permit one of ordinary skill in the art to ascertain what additional compounds are encompassed. The list includes 5a-cholestane, which lacks the 3-hydroxyl group and any oxygen-containing functionality. The list also includes the phytosterols sitosterol, stigmasterol, campesterol, and brassicasterol, whose carbon skeletons differ from that of cholesterol. The examples thus encompass removal of functional groups, addition of functional groups, ring saturation, esterification and etherification, and structurally distinct classes of sterols, without disclosing any common characteristic by which the boundary of the claimed genus may be determined.
Accordingly, the claim is open to at least two reasonable interpretations: (i) a narrower construction limited to direct structural modifications of the cholesterol molecule; and (ii) a broader construction reaching any compound bearing a sterol nucleus and resembling cholesterol. It cannot be determined whether, for example, bile acids, steroid hormones, or vitamin D compounds, each derivable from cholesterol, fall within the claim. Where a claim is amenable to two or more plausible reasonable interpretations and the scope of those interpretations differs, the claim is indefinite. See MPEP 2173.
In the interest of compact prosecution, applicant is encouraged to amend claim 10 to remove the phrase “or a derivative thereof” in order to overcome the rejection. If protection for additional sterols is sought, applicant is encouraged to amend claim 10 to recite a closed group of the disclosed compounds from para. [00104] (e.g., “wherein the sterol is selected from the group consisting of cholesterol, ergosterol, campesterol…”).
Claims 12-13 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.
Claim 12 recites “wherein the lipid nanoparticle at least partially encapsulates a nucleic acid.” It cannot be determined from this language whether: (i) a nucleic acid is a required component of the claimed composition; or (ii) whether the recitation instead sets forth only a functional capability or intended use of the lipid nanoparticle, such that no nucleic acid need be present.
On the one hand, the limitation employs the active verb “encapsulates”, which could be interpreted as meaning that a nucleic acid is in fact present and is at least partially enclosed by the lipid nanoparticle, because a nucleic acid that is absent cannot be encapsulated. Under this interpretation, the nucleic acid is a positively required element of the composition. On the other hand, claim 6, from which claim 12 depends, is directed to a lipid nanoparticle composition defined by its constituents (ionizable lipid, helper lipid, sterol, PEGylated lipid conjugate) and does not recite a nucleic acid as a component of the composition. Read in that context, the phrase at issue could be interpreted to characterize the lipid nanoparticle by a property or intended use (i.e., a lipid nanoparticle of the type that encapsulates nucleic acids) which would not require that a nucleic acid actually be present.
Because the claim is open to at least two reasonable interpretations, the metes and bounds of the claim cannot be determined. In particular, it cannot be determined whether a lipid nanoparticle containing no nucleic acid falls within the scope of the claim. Where a claim is amenable to two or more plausible reasonable interpretations and the scope of those interpretations differs, the claim is indefinite. See MPEP 2173. Claim 13 is also rejected because it depends from claim 12 and fails to resolve the issue.
Clarification is required. If a nucleic acid is intended to be a required component, applicant is encouraged to amend the claim to positively recite it (e.g., “the composition of claim 6, further comprising a nucleic acid, wherein the lipid nanoparticle at least partially encapsulates the nucleic acid”). Alternatively, if only a capability is intended, the claim should be amended to state that (e.g., “wherein the lipid nanoparticle is capable of at least partially encapsulating a nucleic acid”).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the instant claims are drawn to compositions comprising ionizable lipids according to Formula (I) (claim 1):
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;
Formula (II) (claim 3):
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; or
Lipid 20B (claim 5):
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.
Formula (I) is novel. Close prior art to Formula (I) compounds is ESSLER (US 20050164963 A1). Essler discloses the compound (Essler, [0089], page 7):
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.
Essler’s compound comprises alkyl chains reading on R2 in instant formula (I). However, the orientation of the linking ester group is flipped; the central linker is a carbon atom rather than an amine; and the piperidinyl R1 group required by instant formula (I) is absent. The prior art fails to teach, suggest, or otherwise provide any motivation to modify Essler’s compounds to arrive at instant formula (I).
Formula (II) is also novel. Close prior art to Formula (II) compounds is DENG (WO 2012162210 A1). Deng discloses the compound (page 18, compound 15):
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Deng’s compound comprises alkyl chains reading on R2 in instant formula (I). However, the difference between Formula (II) and Deng’s compound is the group
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instead of the piperidinyl R1 group required by instant Formula (II). The prior art fails to teach, suggest, or otherwise provide any motivation to modify Deng’s compounds to arrive at instant formula (I).
Lipid 20B in claim 5 is novel. Close prior art to Lipid 20B is DU (US 20160376224 A1). Du discloses the compound (Table 3, page 36):
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. Du’s compound comprises the same alkyl chains present in Lipid 20B. However, the difference between Lipid 20B and Du’s compound is the group
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instead of the piperidinyl group required by Lipid 20B. The prior art fails to teach, suggest, or otherwise provide any motivation to modify Du’s compounds to arrive at instant Lipid 20B.
Claims depending from allowable claims 1, 3, and 5 require all the limitations of those claims and are therefore allowable. Accordingly, claims 1-9, 11, and 14-18 are allowable.
Conclusion
Claims 1-2, 4-9, 11, and 14-18 are allowed. Claim 3 is objected to for minor informalities but is otherwise allowable. Claims 10 and 12-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights