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 .
Claim Status
Claims 1-14 are pending.
Claims 1-14 are currently under consideration.
Claims 1-14 are rejected.
Acknowledgement of Receipt
Applicants’ election without traverse of the following final product of Example 135 (paragraph [0342]) (see Spec., bottom of pg. 137, see structure below) in the reply filed on 12/22/2025 is acknowledged. This Office Action is in response to Applicants’ remarks filed 12/22/2025.
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Priority
This application is a CON of PCT/JP2020/042513 filed 11/13/2020 which claims benefit to Japanese Application JAPAN 2019-207118 filed 11/15/2019. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 11/15/2019. It is noted, however, that applicant has not filed a certified copy of the JAPAN 2019-207118 application as required by 37 CFR 1.55. Further, should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The thirteen (13) Information Disclosure Statements (IDSs) submitted on 06/08/2022, 08/03/2022, 01/18/2023, 03/29/2023, 04/20/2023, 08/14/2023, 09/25/2023, 12/06/2023, 05/31/2024, 06/21/2024, 11/22/2024, 02/26/2025, and 04/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these IDSs have been considered by the Examiner.
Claim Objections
Claims 1-14 are objected to because of the following informalities: the structure of the elected species (i.e., final product) does not appear in the claims. Applicants may consider amending with to include, “A compound or a salt thereof selected from the following compounds:”. 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 1 and all dependent claims thereof 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 1 recites “the first lipid” in line 2 of claim 1. There is no recitation of a “second lipid” and how the two lipids relate to each other. For example, dependent claim 3 recites the composition further comprising a lipid having a nonionic hydrophilic polymer structure this limitation does not make clear if this pertains to the first lipid or not. For the purposes of this office action, prior art teaching a lipid, will be considered to be read on the claim limitation.
Thus, claim 1 and all dependent claims thereof are also rejected for being indefinite as they are dependent on an indefinite claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-14 is/are rejected under 35 U.S.C. 103 as being obvious over Tanabe, et al. (WO 2019/235635 A1, pub. 12/12/2019 as cited on IDS 06/08/2022) herein referenced Tanabe ‘635.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Tanabe ‘635 discloses a compound represented by formula (1) (see below) or a salt thereof. In the formula, X represents -NR1- or -O-; R1 represents a hydrogen atom, a hydrocarbon group or the like; each of R2 and R3 independently represents a hydrogen atom, a hydrocarbon group or the like; each of R4, R5, R6, R7, R8, R9, R10, R11 and R12 independently represents a hydrogen atom, an alkyl group or the like; one or more pairs selected from among a pair of R4 and R5, a pair of R10 and R5, a pair of R5 and R12, a pair of R4 and R6, a pair of R5 and R6, a pair of R6 and R7, a pair of R6 and R10, a pair of R12 and R7, and a pair of R7 and R8 may combine with each other and form a 4- to 7-membered ring that may contain an O atom; and each of a, b, c and d independently represents an integer of 0-3, provided that (a + b) is 1 or more and (c + d) is 1 or more (abstract).
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Tanabe ‘635 teaches that the lipid particle wherein the lipid is at least one lipid selected from the group consisting of a neutral lipid and a lipid having a nonionic hydrophilic polymer, further comprising a sterol, further comprising a nucleic acid (claim 26). The compounding amount of sterol is preferably 10 mol% to 60 mol%, more preferably 20 mol% to 55 mol%, and further preferably 25 mol% to 50 mol% with respect to the total lipid amount ([0088]). Tanabe ‘635 provides a structure in claim 67 (see below) that is very similar in structure to of the instantly claimed final product other than the additional carbon highlighted in yellow and where a carbon is missing highlighted in green. It would have been obvious to one of ordinary skill in the art to optimize conventional working conditions to use the appropriate starting materials and reagents to obtain the desired result. This is deemed merely a matter of judicious selection and this type of modification would have been well within the purview of the skilled artisan.
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This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Double Patenting – Nonstatutory, Nonprovisional
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 and 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,370,143 B2 (equivalent Tanabe, et al. US 2024/0315970 cited on IDS 11/22/2024) herein referenced Tanabe ‘143. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4 of Tanabe ‘143 discloses a lipid particles comprising a compound represented by Formula (1) or a salt thereof; and a nucleic acid (claim 1), further comprising a lipid (claim 2) consisting of a lipid having a nonionic hydrophilic polymer (claim 3), further comprising a sterol (claim 4); to overlap with the instant claims 1, 3, 4.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,508,226 B2 (equivalent Endo, et al. US 2022/0096381 A1 cited on IDS 06/08/2022) herein referenced Endo’226 . Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Endo ‘226 discloses a lipid composition comprising a lipid represented by Formula (1) or a salt thereof; a nonionic lipid; a lipid having a nonionic hydrophilic polymer structure; and a nucleic acid, wherein the lipid composition contains or does not contain a zwitterionic lipid, and in a case where (A) represents a molar ratio in percentage of the lipid represented by Formula (1) or a salt thereof to total lipids constituting the lipid composition, and (B) represents a molar ratio in percentage of the zwitterionic lipid to the total lipids constituting the lipid composition, (A) and (B) satisfy 40<(A)−(B)≤90; wherein the nonionic lipid is sterols wherein the nonionic lipid is sterols (claim 2); wherein the sterols are cholesterol (claim 3); wherein the lipid having a nonionic hydrophilic polymer structure is a lipid having a polyethylene glycol structure (claim 5); wherein the lipid having a polyethylene glycol structure is a lipid having a diacylglycerol structure and a polyethylene glycol structure (claim 6); wherein a content of the lipid represented by Formula (1) or a salt thereof is more than 40 mol % and 90 mol % or less, a content of the nonionic lipid is 20 to 60 mol %, a content of the lipid having a nonionic hydrophilic polymer structure is 0.5 to 10 mol %, and a content of the zwitterionic lipid is 0 to 30 mol % (claim 7); wherein the compound represented by Formula (1) is a compound represented by Formula (2) (claims 8-9); wherein in Formula (2), at least one of R2 or R3 represents a hydrocarbon group with 3 to 24 carbon atoms containing one or more unsaturated bonds; wherein a content of the nucleic acid with respect to the total lipids is 1% to 25% by mass (claim 10); further comprising: a pharmaceutically acceptable carrier (claim 11); which is a composition for introducing nucleic acids into cells (claim 12); which is a composition for in vivo delivery of nucleic acids (claim 13) to overlap with instant claims 1-14.
Conclusion
Claims 1-14 are rejected. No claims are allowable at this time. The Examiner asks that Applicant provides support for the amendments in the application by referencing page numbers, paragraphs, figures, etc.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is 571-270-5896. The examiner can normally be reached 0930-1730 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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