--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 .
Applicant’s response dated July 8, 2026 is acknowledged.
Priority
This application is a 371 of PCT/JP2023/003844 filed on 02/06/2023, and claims foreign priority in Japanese application JP2022-060960 filed on 03/31/2022.
Claim Status
Claims 1-16 are pending. Claims 10, 14 are withdrawn. Claims 1-9, 11-13, 15, and 16 are examined.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1-9, 11-13, 15, and 16), drawn to a lipid nanoparticle comprising a pH sensitive cationic lipid of formula I, in the reply filed on July 8, 2026, is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 10 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Response to the restriction requirement of April 8, 2026 was timely filed.
Claims 1-9, 11-13, 15, and 16 are examined on the merits.
Claim Objections
Claim 1 is objected to because it uses two [Chem. 1] and (I) to denote the first chemical
structure, [Chem. 2] and (A) to denote the second chemical structure, and [Chem. 3] and (B) to denote the third chemical structure. It is recommended to amend the claim and use one
designation per chemical compound.
Claim 15 is objected to because it uses two [Chem. 4] and (I) to denote the first chemical
structure, [Chem. 5] and (A) to denote the second chemical structure, and [Chem. 6] and (B) to
denote the third chemical structure. It is recommended to amend the claim and use one
designation per chemical compound.
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 1-9, 11-13, 15, and 16 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.
The entire text of claim 1 immediately after the chemical structure of formula I is enclosed in brackets. The text within the brackets contains two chemical structures, A and B, and each of those chemical structures is followed by text in parentheses. The text in parentheses following structure B also contains three phrases further enclosed in parentheses. The use of brackets and parentheses renders the claim indefinite because their meaning is unknown and it is unclear if the enclosed text is required or optional.
Claim 1 recites five occurrences of “may be” in lines 11, 17-19, and 21. The use of “may be” renders the claim indefinite because it expresses a possibility and it is not clear if the limitations following “may be” are actually required or optional embodiments.
Claim 11 is indefinite because it describes the lipid nanoparticle of claim 1 as an active
ingredient, however the lipid nanoparticle only contains the lipid of formula I, which is not a
known active ingredient and the instant application does not provide evidence that lipid of formula I has properties of an active ingredient. Thus, it is not clear how the lipid nanoparticle of claim 1 is considered an active ingredient. Ground of rejection may be obviated by deleting “is an active ingredient”.
The phrase “wherein the lipid nanoparticle according to claim 1 is an active ingredient” lacks antecedent basis because the pharmaceutical composition is not described by the claim as comprising the lipid nanoparticle according to claim 1. Ground of rejection may be obviated by amending the claim to “A pharmaceutical composition comprising the lipid nanoparticle according to claim.”
Claim 13 recites the limitation "the lipid nanoparticles according to claim 1" in line 2.
There is insufficient antecedent basis for this limitation in the claim. Claim 1 provides support
for lipid nanoparticle (singular).
Claim 13 is further indefinite because the scope of “in which an exogenous gene of
interest to be expressed in liver cells or spleen cells is encapsulated to a subject animal and
expressing the exogenous gene in the liver or spleen of the subject animal” is not clear. It is not
clear if the lipid nanoparticle of claim 1 actually comprises an encapsulated exogenous gene of
interest to be expressed in liver cells or spleen cells, of if the encapsulated exogenous gene is
encapsulated in something else.
The term “gene of interest” in claim 13 is indefinite because it is subjective. The scope of the gene is not clear because it is unknown in the interest of whom the gene is selected.
The entire text of claim 15 immediately after the chemical structure of formula I is enclosed in brackets. The text within the brackets contains two chemical structures, A and B, and each of those chemical structures is followed by text in parentheses. The text in parentheses following structure B also contains three phrases further enclosed in parentheses. The use of brackets and parentheses renders the claim indefinite because their meaning is unknown and it is unclear if the enclosed text is required or optional.
Claim 15 is indefinite because it recites “may be” in lines 10, 16, 17, 18, and 20, which
expresses a possibility and it is not clear if applicant intended to claim an optional embodiment
or an alternative embodiment.
Claims 2-9, 12, and 16 are indefinite because the claims depend from an indefinite base claim.
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 6, 11-13, 15, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 19/339,927 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims are drawn to a compound of formula I that is structurally the same as instantly claimed compound of formula I. Copending claims are further drawn to lipid nanoparticles comprising the compound of formula I and nucleic acids including siRNA, mRNA, and plasmid DNA, which renders the instantly claimed nanoparticles obvious. Copending claim 11 is a method of expressing a foreign gene of interest to be expressed in liver cells, which renders the instantly claimed method in claim 13 obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,458,605 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims are drawn a lipid nanoparticle comprising a compound of formula I, which is structurally the same as instantly claimed compound of formula I, and pharmaceutical compositions comprising said lipid nanoparticle. The lipid nanoparticles of patented claims further comprise nucleic acids including siRNA, mRNA, and plasmid DNA, which renders the instantly claimed nanoparticles obvious. Patented claims 9-11 are methods of expressing a foreign gene of interest to be expressed in liver cells, which renders the instantly claimed method in claim 13 obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The examiner can normally be reached M-F 9:00am-5:00pm.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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