DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 6/25/2026 wherein claims 8 and 70 have been amended.
Claims 1, 3-7, 9, 11, 14, 20, 25, 33, 46, 48, 49, 55, 61 and 76 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendment filed 6/25/2026 renders moot the rejection of claim 8 made by the Examiner under 35 USC 112(b). This rejection has been withdrawn.
Applicant’s arguments filed 6/25/2026 regarding the rejection of claims 1, 3-8, 11, 14, 20, 25, 33, 46, 48, 49, 55, 57 and 61 made by the Examiner under 35 USC 103 over Ahmad et al. (US 2022/0296516) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 3/25/2026.
Applicant’s arguments filed 6/25/2026 regarding the rejection of claims 70 and 76 made by the Examiner under 35 USC 103 over Ahmad et al. (US 2022/0296516) further in view of Arbiser et al. (US 2012/0196870) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 3/25/2026.
In regards to the 103 rejections, Applicant asserts the following:
A) Ahmad does not teach the enteric coating being applied to the LNP core but instead to the finished dosage forms, e.g. tablets, dragees, capsules, pills, and granules.
In response to A, Ahmad teaches the delivery vehicles can comprise a coating, the coating being an enteric coating so as to prevent or minimize dissolution in the stomach but allow dissolution in the small intestine. ‘Delivery vehicle’ is defined by Ahmad as comprising i) a cargo and a ii) lipid nanoparticle (see [0004, 0005, 0013, 0043, etc. and claim 111). It is the Examiner’s perspective that the enterically coated delivery vehicle encompasses enterically coated lipid nanoparticles such as that claimed.
The Examiner acknowledges that Ahmad teaches that an enteric coating may be applied to larger dosage forms, e.g. tablets, capsules, etc as alluded to in Applicant’s response but is not persuaded that the enteric coating is to be applied only to these dosage forms. As discussed above in section 7, Ahmad teaches that the delivery vehicle (i.e. lipid nanoparticle) also be capable of receiving the coating. Thus, one of ordinary skill in the art would readily envisage modifying the nanoparticle of Ahmad such as proposed by the Examiner with a reasonable expectation for success.
Maintained Rejections, of Record
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-8, 11, 14, 20, 25, 33, 46, 48, 49, 55, 57 and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (US 2022/0296516).
Ahmad describes a biological delivery vehicle comprising a lipid nanoparticle (see instant claim 1(a)) (see [0004]) comprising a ionizable lipid (cationic), such as DLin-M-C3-DMA and/or DLIN -KC2-DMA, (see [0006]) (a cationic lipid; see instant claims 1(a) and 6), a sterol, e.g. cholesterol (see [0114]) (see instant claims 1(a) and 3), a PEGylated lipid such as DMG-PEG-2000 (see [0011, 0191]) (see instant claims 1(a) and 4) and a phospholipid such as DOPE and/or DSPC (see [0009, 0010]) (see instant claims 1(a) and 5).
The lipid nanoparticle is to encapsulate a cargo material (see [0076]) such as a nucleic acid (e.g. RNA, DNA; see [0014]) (see instant claim 20), drug, protein or a small/large biological molecule (see [0050, 0139]) (see instant claim 1(a).
The lipid nanoparticle is to be coated with an anionic enteric layer, the enteric material being selected from alginate, stearic acid methyl acrylate-methacrylic acid copolymer, HPMC phthalate, etc. ([0184, 0185]) (see instant claims 1(b) and 8). Acrylate copolymers and alginate possess carboxylic acid functionalities (see instant claim 7). These coating materials are not DNA or RNA thereby obviating instant claim 11 nor are they separated by a poly-arginine polymer layer as required by instant claim 14.
The delivery vehicle may possess a targeting moiety such as an antibody specific to the various surface antigens such as CD4 (anti-CD4) and CD19 (anti-CD19) (see instant claim [0118]) (see instant claims 25 and 33).
The nanoparticles may be provided with a pharmaceutically acceptable excipient such as mannitol, lactose, etc. (see [0174]) (see instant claim 46).
Methods of administering the delivery vehicle are described wherein the vehicle is administered to a subject having a disease (e.g. immune disease, proliferative diseases, etc. (see [0137]) in need of treatment (see [0017] and Example 6) (see instant claims 55 and 57). As the delivery vehicle is to be modified with targeting antibodies (see above), the administration of the delivery vehicle would be specific for a target cell (those cells expressing the target antigen) (see instant claims 48 and 49). The delivery vehicle can also be used in method of gene therapy (i.e. gene editing) (see [0003]) (see instant claim 61).
The only difference between Ahmad and the instant claims is that Ahmad does not teach the specific combination of components as claimed in a single embodiment with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Ahmad, but ‘such ‘picking and choosing’ within several variable does not necessarily give rise to anticipation. Where the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, when 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. See MPEP 2141(I). Consistent with this reasoning, it would have been obvious to have identified and selected various combinations of lipids, cargo materials, sterols, anionic materials, etc. from within Ahmad’s disclosure, to arrive at compositions and methods overlapping with those claimed.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 70 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (US 2022/0296516) as applied to claims 1, 3-8, 11, 14, 20, 25, 33, 46, 48, 49, 55, 57 and 61 above, and further in view of Arbiser (US 2012/0196870).
Ahmad fails to teach the enteric outer coating as comprising polyacrylic acid.
Arbiser teaches that enteric coating materials include alginates and polyacrylic acid (see [0039]). It would have been obvious to modify Ahmad’s lipid nanoparticle such that the enteric nanoparticle coating included polyacrylic acid given that polyacrylic acid is a known variant of the enteric materials described by Ahmad. See MPEP 2144.07.
Moreover, Arbiser teaches that pharmaceutical composition can be provided as a packaged product replete with instructions for use and product information (i.e. a kit) (see [0033]) (see instant claim 76). Modifying Ahmad’s teaching so as to package the delivery vehicle as a kit with instructions would have been an obvious modification.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
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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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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