Prosecution Insights
Last updated: August 06, 2026
Application No. 18/556,299

LIPID COMPOUNDS AND LIPID NANOPARTICLE COMPOSITIONS

Non-Final OA §102§112§DP
Filed
Oct 19, 2023
Priority
Oct 08, 2021 — CN PCT/CN2021/122690 +2 more
Examiner
VYAS, KEYUR ANILKUMAR
Art Unit
1637
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Suzhou Abogen Biosciences Co., Ltd.
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
10m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
38 granted / 73 resolved
-7.9% vs TC avg
Strong +64% interview lift
Without
With
+64.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
38 currently pending
Career history
119
Total Applications
across all art units

Statute-Specific Performance

§101
5.6%
-34.4% vs TC avg
§103
34.0%
-6.0% vs TC avg
§102
18.1%
-21.9% vs TC avg
§112
26.7%
-13.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 73 resolved cases

Office Action

§102 §112 §DP
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 without traverse of Group I and of cationic species of formula 01-1 in the reply filed on 06/05/2026 is acknowledged. Claims 1-2, 4, 6, 8, 10, 12, 14, 16, 20, 22, 26 and 27 are pending and examined here. Priority The claim to priority to foreign applications PCT/CN2021/122690 and PCT/CN2022/117968, filed on 10/08/2021 and 09/09/2022, respectively, via its PCT/CN2022/123721, filed on 10/07/2022, is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. All claims will receive priority to ‘690 filing of 10/08/2021. Information Disclosure Statement The information disclosure statement (IDS) submitted on 01/24/2024 and 06/05/2026 were filed before the mailing date of this first Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 112 35 U.S.C. 112(a) The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 20, 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 20 recites: “nanoparticle composition of claim 1, wherein the nucleic acid encodes a RNA or protein; and wherein the amount of RNA or protein expressed from the nucleic acid in a mammalian cell or tissue of a mammal is more than the amount of RNA or protein expressed from the nucleic acid formulated in a reference nanoparticle composition that does not comprise sphingomyelin of about 10 to 40 mol percent of the total lipid present in the reference nanoparticle composition; optionally wherein the reference nanoparticle composition contains 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) instead of sphingomyelin.” When claim 20 is analyzed in light of the specification, instant invention encompasses a nanoparticle (NP) composition of claim 1, which can be interpreted as a NP comprising 1) any cationic lipid, 2) any steroid, 3) any polymer conjugated lipid, 4) each lipid at any concentration, 5) as long as sphingomyelin is of about 5 to 40 mol percent of the total lipid present in the NP composition, and wherein the amount of RNA or protein expressed from the nucleic acid delivered via claimed NP to any mammalian cell or any tissue of any mammal is more than the amount of RNA or protein expressed from the nucleic acid formulated in a reference nanoparticle composition that does not comprise sphingomyelin of about 10 to 40 mol percent ratio (it is understood for this action by stating mol percent ratio as of the total lipid present in the reference NP or the NP composition). The genera for cationic lipid is provided in par. 240 of Formula (01-I, see below, also see, e.g., par. 239-283 for numerous cationic lipids), for polymer conjugated lipids the formula below (see, e.g., par. 284-291, and uses the “not limited to those described” but as understood in the art, see par. 284), and for steroid (see, e.g., par. 292-295, but the specification notes “is not limited to those described” within the specification). Cationic lipid PNG media_image1.png 136 178 media_image1.png Greyscale Polymer conjugated lipid PNG media_image2.png 88 210 media_image2.png Greyscale Thus, briefly, the recited NP expresses more RNA/protein than the reference NP without SM of 10-40% mol ratio. In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, only NP with certain types of cationic lipid (of Table Y, par. 406) and with SM percentage from only 10-20%, cholesterol, DMG-PEG2k are the only species whose complete structure is disclosed for which the functional limitation of increased expression compared to reference NP comprising only 10% molar ratio of DSPC instead of SM of 10-20% ratio applies. While the genus encompasses a large number of variants and molecules that have the same activity as the NP of claim 1, and the genus encompasses a large number of variants and molecules that have a different structure, the specification does not describe the complete structure of a representative number of species of the large genus of NP with any type of cationic lipid, steroid, and polymer conjugated lipid and the respective concentration of noted lipid. The application of functional limitation relationship between the structure and the function is best illustrated by the results in Fig. 6 and 10 (excerpts copied below; Table 6.6 provides representation of Formulation designation (par. 400, also provided below): Fig. 6: PNG media_image3.png 518 481 media_image3.png Greyscale The Formulation-19-SM (F-19-SM) through F-22-SM’s expression is less than F-1-control, which comprises DSPC at 10% mol ratio (see Fig. 6 above). F-19, F-20, F-21, and F-22 have SM of 30, 35, 40, and 45% mol ratio. F-19-SM, F-20-SM, and F-21-SM have SM within the limits noted in claim 20, but do not express more EPO than 10% DSPC (i.e. only one concentration of DSPC is shown here in Fig. 6). Thus in NPs for only certain SM concentrations (10-20% mol ratio) is the expression greater than NP with 10% of DSPC. Similar results are noted in Fig. 10, Formulation 1B-Control, which substituted DSPC at 10% mol ratio instead of SM, and is administered in vivo (see Fig. below along with Formulations Table, par. 413) PNG media_image4.png 567 726 media_image4.png Greyscale In all tissues, Formulation-5-SM, which has NP with 30% SM, has less luciferase expression (“Total Flux”) than Formulation-1B-control (DSPC at 10% mol ratio). Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics, specific features and functional attributes that would distinguish different members of the claimed genus. Here, Fig. 9 provides demonstration of other cationic lipids of Although various other cationic lipids, polymer conjugated lipid, and steroids are known and described in the specification, it is not clear based on the results of Fig. 6, 9, and 10, and other data, whether nucleic acid expression delivered in a NP of any cationic lipid, any steroid, and any polymer conjugated lipid along with SM of 5-40% molar ratio of total lipid of nanoparticle composition in any mammalian cell or tissue of mammal is more than the amount of RNA in a reference nanoparticle, i.e. without SM of about 10-40 mol percent or with equal molar percentage of SM in the NP compared to DSPC in the reference NP will result in increased expression compared to a reference nanoparticle. The invention of claim 22 suffers from similar issue as claim 20, and there is not sufficient results of “wherein the molar percentage of sphingomyelin. . . is the same as the molar percentage of DSPC” and due to the results noted that are very specific for the NP composition with specific concentrations of the lipids used and the consequential properties (e.g., size, lipid permeability) that it acquires, claim 22 is rejected. Further, the inventions of claim 22 requires the use of the inventions of Claim 20 and therefore are likewise rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. Applicant’s attention is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement (MPEP2163). In conclusion, Applicant’s disclosure of a few species of NPs with certain types of cationic lipid (of Table Y, par. 406) and, more importantly, with SM percentage from only 10-20%, cholesterol, DMG-PEG2k are the only species of the claimed broad genus is not deemed sufficient to reasonably convey to one skilled in the art that Applicant was in possession of the claimed broad genus at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus. 35 U.S.C. 112(b) 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 1-2, 4, 6, 8, 10, 12, 14, 16, 20, 22, 26 and 27 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 26 recites “lipid nanoparticle has a semi-lamellar morphology”. Par. 149 defines the term: “semi-lamellar morphology” of “a particle means that the microscopic structure of the particle contains a lamellar (unilamellar or multilamellar) portion (see FIG. 2B area pointed by Arrow A) and an electron dense portion (see FIG. 2B area pointed by Arrow B), where the lamellar portion surrounds less than the entire electron dense core. In some embodiments, a particle having the semi-lamellar morphology can comprise two or more lamellar portions that collectively surround less than the entire electron dense core.” The definition and term “semi-lamellar morphology” is a subjective term and lacks definiteness; a skilled artisan is not certain since the metes and bounds of “semi-lamellar” is not clear. Here, a skilled artisan requires the use of electron microscope to identify characteristics that are not clear or definite; the definition points to Fig. to identify “an electron dense portion” and different lamellar portions, i.e. unilamellar or multilamellar layer. The scope of “unilamellar or multilamellar layer” would encompass any embodiment of lamellar LNP and a skilled artisan is not sure what is and what is not within the scope of a “semi-lamellar” LNP. Further, the “portions” is a relative term and lacks definiteness. The term “about” in claims 1, 2, 4, 6, 8, 10, 12, 14, 20, 26 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification, which does provide for the definition of “about” in par. 141, does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The issue with the relative term “about” is that, here, the NP composition comprises different lipid components that need to add up to 100% mol ratio. Under BRI, the term about, which can be a deviation of 20% of a given value (par. 141, thus for a sphingomyelin of 40%, a deviation of 20% is a deviation of a value of 8). With an “about” for each lipid component, modification to one lipid component would require modification to one or all of the other lipid components of the claim or dependent claims; thus introducing lack of clarity for the public and a skilled artisan. Thus the claims reciting “about” and its dependent claims are rejected. Here, claim 16 incorporate by reference to a table or figure, specifically Table X (line 3) and Tables 1 to 5 (line 8). Since incorporation by reference is a necessity doctrine, not for applicant’s convenience, the claims are indefinite per MPEP 2173.05(s). MPEP 2173.05 is related to “Specific Topics Related to Issues Under 35 U.S.C.112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph” MPEP 2173.05(s) “Reference to Figures or Tables” states: Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). (Emphasis added). The amendment may be overcome by eliminating the incorporation by reference. Claim 26 is also rejected for reciting “and sub-formulas thereof;” a) “sub-formulas” is not defined in the claim or specification, and b) “sub-formulas” is a relative term and the metes and bounds of the scope it encompasses is uncertain. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-2, 4, 6, 8, 10, 12, 14, 16, 20, 22, 26 and 27 are rejected under pre-AIA 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by DeRosa et al. (US2021019633, pub. 07/01/2021, “DeRosa,” of record). Regarding instant cl. 1, DeRosa discloses methods and compositions of effective delivery of mRNA to CNS by administering a composition comprising an mRNA encapsulated in liposomes or lipid nanoparticle (LNP) (abstract and par. 110). DeRosa tested various formulations of LNP to deliver mRNA to the brain (see Table 6, par. 222): out of the 13 exemplary formulations tested, 2 comprises sphingomyelin and were designated as formulations 2 and 13 (see excerpt of Fig. 6 below, left column). The formulated compositions were administered intrathecally to rats and then the tissue was analyzed for formulation delivery (Par. 223, 224, 235) and the studies demonstrated that LNP with the mRNA can be delivered successfully to various tissues of the CNS (par. 231, see Figs. noted in right column below of respective formulation). PNG media_image5.png 185 467 media_image5.png Greyscale Fig. 3A-C, par. 60 PNG media_image6.png 96 484 media_image6.png Greyscale Fig. 14A-C, par. 71 DeRosa discloses multiple formulations that comprise sphingomyelin at 15% molar ratio, a cationic lipid (either C12-200 or cKK-EE12 (par. 180)), a steroid, cholesterol, a DMG-PEG-2K, i.e. a polymer conjugated lipid) and a mRNA, along with neutral/helper (aka non-cationic) lipid DOPE (par. 183) (see Table 6 above). Regarding instant cl. 2, DeRosa discloses LNPs comprising sphingomyelin at 15% molar ratio (see Table 6 above), which is within the range of at least instant cl. 2(a). Regarding instant cl. 4, DeRosa discloses the formulation of LNP comprising cationic lipid (cKK-EE12, C12-200) is 40% mol ratio (see Table 6 above), which is within the range of instant cl. 4(a, b, c, e). Regarding instant cl. 6, DeRosa discloses the formulation of LNP with sphingomyelin at 15% mol ratio and cationic lipid at 40% mol ratio (see Table 6 above), which is within the ranges noted at least in cl. 6(a). Regarding instant cl. 8, DeRosa discloses the formulation of LNP comprising cholesterol, a steroid, at 20% molar ratio, which is within the range of at least in cl. 8(a). Regarding instant cl. 10, DeRosa discloses the formulation of LNP comprising sphingomyelin (15% mol. Ratio), cationic lipid (40%), and cholesterol (a steroid, 20% mol ratio), within range of at least cl. 10(a). Regarding instant cl. 12, DeRosa discloses a LNP comprising DMG-PEG-2K, a polymer conjugated lipid, can be within the range of 1-10% and discloses the specific species of 1, 2, or 3% molar ratio (par. 21). Regarding instant cl. 14, DeRosa discloses a LNP with sphingomyelin (15%), cationic lipid (40%), cholesterol (20%) and DMG-PEG-2K (5%) (Table 6), but discloses species of DMG-PEG that is suitable within the LNP, including 3% mol ratio (par. 21), thus is within the range of at least 14(a). Regarding instant cl. 16, DeRosa discloses LNP comprising a steroid is cholesterol and polymer conjugated lipid is DMG-PEG-2000 (see Table 6 above). Regarding instant cl. 20,22 since the prior art discloses LNP comprising the structural elements of cl. 1, then the recited functional limitation will naturally follow. Regarding instant cl. 26, since DeRosa discloses that liposome of the invention “refers to any lamellar, multilamellar or solid lipid nanoparticle vesicle” (par. 110) and that DeRosa discloses the LNP with formulation of cl. 1 the semi-lamellar property of the formulation will naturally follow. Regarding instant cl. 27, the Z average of formulation 2 and 13 are 90 nm and 74 nm, respectively, thus is within the mean average size of cl. 27(a). 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. App: 17/801477: Claims 1, 14 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 1, 2, 4, 8, 10, 11, 13, 15, 16-19, 21, 50 of copending Application No. 17/801,477 in view of DeRosa et al. (US2021019633, pub. 07/01/2021, “DeRosa,” of record). This is a provisional nonstatutory double patenting rejection. Instant cl. 16 recites cationic lipid of Tables 1 to 5. A few compounds of instant Table 3 are illustrated below (left column). Instant cl. 16: from Table 3, par. 264. Various compounds of Table 1 of ‘477; a few are illustrated below (and are same as instant spec. Table 3). PNG media_image7.png 89 271 media_image7.png Greyscale PNG media_image8.png 100 269 media_image8.png Greyscale PNG media_image9.png 138 293 media_image9.png Greyscale PNG media_image10.png 121 276 media_image10.png Greyscale Regarding instant cl. 1, 14 and 16, DeRosa discloses methods and compositions of effective delivery of mRNA to CNS by administering a composition comprising an mRNA encapsulated in liposomes or lipid nanoparticle (LNP) (abstract and par. 110). DeRosa tested various formulations of LNP to deliver mRNA to the brain (see Table 6, par. 222): out of the 13 exemplary formulations tested, 2 comprises sphingomyelin and were designated as formulations 2 and 13 (see excerpt of Fig. 6 below, left column). The formulated compositions were administered intrathecally to rats and then the tissue was analyzed for formulation delivery (Par. 223, 224, 235) and the studies demonstrated that LNP with the mRNA can be delivered successfully to various tissues of the CNS (par. 231, see Figs. noted in right column below of respective formulation). PNG media_image5.png 185 467 media_image5.png Greyscale Fig. 3A-C, par. 60 PNG media_image6.png 96 484 media_image6.png Greyscale Fig. 14A-C, par. 71 DeRosa discloses multiple formulations that comprise sphingomyelin at 15% molar ratio, a cationic lipid (either C12-200 or cKK-EE12 (par. 180)), a steroid, cholesterol, a DMG-PEG-2K, i.e. a polymer conjugated lipid) and a mRNA, along with neutral/helper (aka non-cationic) lipid DOPE (par. 183) (see Table 6 above). DeRosa does not disclose Compound 209 of Table 3 (cl. 16). Claims 30, 1, 2, 4, 8, 10, 11, 13, 15, 16-19, 21, 50 of ‘477 read on instant compounds of Table 3. Claim 30 teaches a compound of Table 1 or Table 1A, claim 50 teaches lipid nanoparticle of the compound of claim 1. Claims 1, 2, 4, 8, 10, 11, 13, 15, 16-19, 21, teach a generic formula of compounds in Table 1 (see par. 194, at least compounds 1-247), some of which are the same as instant compounds of Table 3 (see pg. 83, par. 264). See Table above for some compounds that are the same. One of the KSR rationale that may be used to support a conclusion of obviousness is that there is some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cationic lipid of DeRosa in view of ‘477 and arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to substitute cationic lipid of DeRosa with any cationic lipids of ‘477 of Table 1, specifically at least compounds 140 and 209, and would yield predictable results. App: 18/163,117 Claims 1, 14 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 81, 68, 69, 70, 72, 75, 76, 77, 82, 83 of copending Application No. 17/163,117 in view of DeRosa et al. (US2021019633, pub. 07/01/2021, “DeRosa,” of record). This is a provisional nonstatutory double patenting rejection. Disclosure of DeRosa is noted above. DeRosa does not teach a cationic lipid of instant Table 4 of cl. 16. Claim 81 of ‘117 teaches at least the following compounds Compound 1 and 2 (see illustration below; there maybe others (see Compound 70) , the claim teaches some 30 cationic lipid structures), which are the same as instant cationic lipids of Table 4, specifically Compound 04-1 and 04-2 (see par. 272, pg. 86). Claim 83 teaches lipid nanoparticle comprising compound of cl. 68. Claims 68, 69, 70, 72, 75, 76, 77 teach the generic formulas of compound 1, 2 and 70 of cl. 81. PNG media_image11.png 79 508 media_image11.png Greyscale Thus, instant claims 1, 14 and 16 would be prima facie obvious, since it would be obvious to substitute cationic lipids of DeRosa for the cationic lipid of cl. 83 of ‘117, including Compound 1, 2 or 70, of ‘117, and a skilled artisan would reasonably expect success in substituting the cationic lipid. App: 17/586,488 Claims 1, 14 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43, 1, 6, 7, 9, 10, 11, 15, 17, 19, 20, 21, 26-28, 30, 31, 33, 36-42, 44, 62 of copending Application No. 17/586,488 in view of DeRosa et al. (US2021019633, pub. 07/01/2021, “DeRosa,” of record). This is a provisional nonstatutory double patenting rejection. Disclosure of DeRosa is noted above. Claim 43 of ‘488 teaches various compounds, including Compounds 1-155; see illustration of Compounds 1 and 2 (see illustration below), which are the same as instant compounds of Table 1, Compounds 01-1, Compound 01-2, respectively (see par. 246, pg. 73). There are additional ones also. PNG media_image12.png 114 509 media_image12.png Greyscale Claim 62 teaches lipid nanoparticle comprising the compound of claim 1. Claims 1, 6, 7, 9, 10, 11, 15, 17, 19, 20, 21, 26-28, 30, 31, 33, 36-42 teach the generic formula of the species of cl. 43 of ‘488. Thus, instant claims 1, 14 and 16 would be prima facie obvious, since it would be obvious to substitute cationic lipids of DeRosa with the cationic lipids of claim 43 of ‘488 and a skilled artisan would reasonably expect success in substituting the cationic lipids. Allowable Subject Matter No claim allowed. Closing Paragraph Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keyur Vyas whose telephone number is 571-272-0924. The examiner can normally be reached M-F, 9am-4pm (EST). 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, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KEYUR A VYAS/Examiner, Art Unit 1637 /Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
Read full office action

Prosecution Timeline

Oct 19, 2023
Application Filed
Jul 15, 2026
Non-Final Rejection mailed — §102, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
52%
Grant Probability
99%
With Interview (+64.0%)
3y 7m (~10m remaining)
Median Time to Grant
Low
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