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 .
Election/Restrictions
Applicant's election with traverse of the lipid nanoparticles of Claims 1-11 in the reply filed on 13 August 2026 is acknowledged. The traversal is on the ground(s) that the Examiner failed to demonstrate a serious search burden would be imposed should each of the inventions claimed be examined together. This is not found persuasive because search burden has no bearing on restriction in the context of a National Stage entry of an International application. All that is required for restriction in such cases is a determination that the inventions claimed lack a Special Technical Feature per PCT Rule 13.1, which the Examiner set forth in detail in the restriction requirement mailed 18 June 2026.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application is a National Stage entry of International application PCT/IB2022/059217 filed 28 September 2022, which claims the benefit of U.S. Provisional application 63/249,128 filed 28 September 2021.
Status of the Claims
Claims 1-20 are pending.
Claims 12-20 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-11 are presented for examination and rejected as set forth in greater detail below.
Claim Interpretation
Applicants claims are directed to lipid nanoparticles (LNP) combining a messenger RNA and any of 12 different cationic lipid compounds identified as “Compound 1” through “Compound 12.” Claim 2 indicates that any of a neutral, structural, or PEGylated lipid is to be combined with the cationic lipid and the messenger RNA, with each of Claims 3-5 providing Markush-type listings of neutral, structural, and PEGylated lipids, respectively. Claim 6 specifies concentrations of each of the lipid component present in the LNP. 7-9 narrow the identity of the messenger RNA to be contained within the LNP. Claim 11 recites dimensional limitations on the size of the LNP.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki (U.S. PGPub. 2017/0334852), in view of Baumhof (U.S. PGPub. 2020/0163878).
Suzuki describes cationic lipids including the compound “Formula (1)” below, which can be utilized for nucleic acid delivery. (Abs.).
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Suzuki indicates that fine particles containing these cationic lipids can be used to encapsulate nucleic acids including RNA to protect those nucleic acids from degradation in vivo. [0005]. More specifically, Suzuki indicates that by combining these cationic lipids with PEG-modified lipids, problems with particle aggregation may be avoided. [0007]. Suzuki describes compositions combining the cationic lipid with at least one lipid selected from a neutral lipid, PEG-modified lipid, and a sterol, which are then combined with a nucleic acid. [0024; 0044]. Particular neutral lipids described as being useful in these compositions include the DOPE of Claim 3, to be present in a concentration of between 0-50 mol% of the lipids of the composition. [0045-46. Each of PEG2000-DMG and PEG-C-DOMG of Claim 5 are identified as suitable PEG-modified lipids, which may be included in concentrations of 0-30 mol% of the lipids in the composition. [0047-50]. Cholesterol of Claim 4 is identified as a useful sterol to be used in the compositions of Suzuki, in concentrations of between 10-80 mol% of the composition. [0051-52]. The cationic lipid of the compositions of Suzuki should be present in concentrations of 20-90 mol% of the lipids in the composition. [0056]. Suzuki indicates that the average particle diameter of the lipid particles should be within the range of about 30-200nm. [0068]. Concerning the particular lipid concentration ranges and particle sizes recited by the claims, Applicants are reminded that a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
But for the particular description of the nucleic acid to be incorporated into the lipid nanoparticles, the specific combination of features claimed is disclosed within the broad teachings of the Suzuki reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of a cationic lipid of Formula (1) combined with cholesterol, DOPE, and PEG-DMG to provide a nucleic acid LNP with a diameter of between 30-200nm, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected a cationic lipid of Formula (1) combined with cholesterol, DOPE, and PEG-DMG to provide a nucleic acid LNP with a diameter of between 30-200nm from within the Suzuki disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
However, as acknowledged above, Suzuki does not specifically indicate that the nucleic acid to be encapsulated in the cationic lipid/cholesterol/ DOPE/PEG-DMG LNP is a messenger RNA, let alone any of the particular RNA molecules recited by Claims 7-10.
This is cured by the teachings of Baumhof, which describes the use of cationic lipid/PEGylated lipid nanoparticles for the encapsulation of mRNA molecules. (Abs.). Baumhof indicates these complexes have particular utility as mRNA based vaccines. [0001]. Like Suzuki, Baumhof describes advantages associated with formulating nucleic acids such as mRNA in LNP formed from a combination of cationic lipids, sterols, neutral lipids, and PEGylated lipids to both enhance cellular uptake of the nucleotides as well as protect the nucleic acid from degradation in vivo. [0011]. Baumhof indicates that the mRNA may code for an antigenic peptide of Claim 8, more specifically a pathogenic antigen of Claim 9, and even more specifically antigens from pathogenic bacteria, viruses, or protozoa as recited by Claim 10. [0128-131; 0136-39].
As such, it would have been prima facie obvious to have used the cationic lipid/cholesterol/ DOPE/PEG-DMG LNP having a diameter of between 30-200nm as the lipid nanoparticle to encapsulate the bacterial, viral, or protozoal pathogenic antigen-encoding mRNA of Baumhof. This is because Baumhof describes using LNP formed from a combination of cationic lipids, sterols, neutral lipids, and PEGylated lipids to both enhance cellular uptake as well as protect the bacterial, viral, or protozoal pathogenic antigen-encoding mRNA from degradation in vivo, and the Suzuki cationic lipid/cholesterol/ DOPE/PEG-DMG LNP are described as doing precisely that.
Double Patenting
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 9-15, 18, 19, 26, and 27 of copending Application No. 18/695,909. The ‘909 application claims lipid nanoparticles combining a cationic lipid with each of the DOP, Cholesterol, and Pegylated lipids of the instant claims as well as their presence in the composition in concentrations asset forth by the instant claims. Claim 1, from which Claim 9 depends, identifies the compound of “Formula (1)” of the instant application as one of the suitable cationic lipids, which may be configured to contain an mRNA encoding a tumor or viral antigen.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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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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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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