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 .
DETAILED ACTION
Claim Status
The amended claim set of 05 Aug 2024 has been entered and reviewed
Claims 1-35, 39-43, 46, 47, 49, 51, 53, 55, 59, 60, 62, 64, 65, 67, 69-105, 108-175, 178-209, 212-214, and 216-238 are cancelled.
Claims 38, 44, 45, 48, 50, 52, 54, 56, 57, 58, 61, 63, 66, 68, 107, 177, 210, and 215 have been amended.
Claims 36-38, 44, 45, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, 106, 107, 176, 177, 210, 211, and 215 are pending and under consideration.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 36-38, 44, 45, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, 211, and 215, directed to a high throughput method for optimizing the process for manufacturing lipid nanoparticles, in the reply filed on 26 May 2026 is acknowledged. Applicants also elected that the payload is an antisense molecule in response to the species election requirement.
Claims 44, 45, 106, 107, 176, 177, and 210 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 36-38, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, 211, and 215 are under consideration to the extent of the elected species, i.e., that the payload is an antisense molecule.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 22 Apr 2024, 30 Jul 2025, and 19 Feb 2026 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: [0063] indicates blue arrows in Figure 7 but the figures are not in color to distinguish blue arrows.
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.
Claims 36-38, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, and 215 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.
Claims 36 (line e.), 37, 48, 61, 68 recite the limitation "the payload" or “said payload.” There is insufficient antecedent basis for this limitation in the claims. Base claim 36 (line c.) recites “at least one payload molecule”, which encompasses multiple payload molecules, and it is unclear whether “the payload” or “said payload” includes just one or more than one payload molecule. Amending the claims to recite “the at least one payload molecule” or “said at least one payload molecule” would overcome this rejection. Claims 38, 50, 52, 54, 56-58, 63, 66, and 215 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 36.
Claim 36 recites in the first line “the process for manufacturing a lipid nanoparticle (LNP) preparation.” This lacks proper antecedent basis as the definite article “the” refers back to a previous process for manufacturing a lipid nanoparticle but a process was not previously recited and it is unclear what process is intended by this limitation. Claims 37, 38, 44, 45, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, and 215 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 36.
Claim 58 is indefinite in reciting “lipids that are PEGylated are varied between about 0.5% to about 5% of the total lipid composition.” The claims are unclear because no units for the percent concentration are given (e.g. wgt/wgt or mol%) and one skilled in the art, therefore, would not be reasonably apprised of the metes and bounds of the claims.
Claim 61 is indefinite in the recitation that the N:P ratio is varied between about 0.5 to about 5. The limitation “0.5 to about 5” is not a standard form for a ratio and it is unclear what is meant by this limitation. For example, it is unclear if this is intended to cover a ratio of 0.5:1 to 5:1 or 1:0.5 to 1:5 or 0.5:5.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 48 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 48 recites ‘the payload is dissolved in the first solution or in the second solution.” Claim 36, from which claim 48 depends, has the limitation in line c. of “dissolving at least one payload molecule into either the first or second solution.” Thus, claim 48 fails to furth limit the subject matter of claim 36. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 36-38, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, 211, and 215 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan et al. (International Journal of Pharmaceutics 599 (2021) 120392, available online 25 February 2021, listed on IDS filed 22 Apr 2024).
Fan teaches automated high-throughput preparation and characterization of lipid nanoparticles loaded with antisense oligonucleotides (ASOs) in a full 96 well plate within 3 hours (title, abstract) (anticipating claims 37 and 38). Fan teaches that the ASO-loaded LNPs were formulated by an automated solvent-injection method using a robotic liquid handler, and assessed for particle size distribution, encapsulation efficiency, and stability with different formulation compositions and ASO loadings (abstract). Fan teaches that the ASO loaded MC3 LNPs were prepared with ASO dissolved in citrate buffer at concentration corresponding to N/P ratio of 5, 2, 1, and 0.5 (anticipating claim 61) and dispensed into a 96 well plate using a robotic liquid handler and that the lipid mixture with varying total lipid amounts and DSPE-PEG2000 (at 0, 1.5, 3 or 5 mol% of total lipids) was prepared in ethanol and dispensed into the ASO plate, followed by mixing, resulting in the plate with 32 distinct conditions in parallel (page 2 section 2.2, page 3 section 3.1) (anticipating lines a-e of claim 36 and claims 50, 52, 54, 56, 57, 58, and 66). Fan teaches other experiments where the MC3 lipid was replaced with DOTAP and the reverse dispensing sequence (injection of ASO solution into lipid mixtures) and different mixing speeds and cycles were also explored to optimize the phase mixing process (page 2 section 2.2). Fan teaches measuring particle size distributions using a DynaPro plate reader III (page 2 section 2.3), and teaches a streamlined workflow to screen formulation variables, including total lipid concentration, lipid composition, and ASO loading amount for optimal quality attributes of ASO-loaded LNPs and measuring with high-throughput DLS and OD260 (page 7 right column) and teaches the workflow determining optimal lipid formulations and supporting scaleup formulations (Fig 2, page4 section 3.3, page 8 left column), anticipating claims 36 and 211. Fan teaches liposomes (page 7 left column) and the process of forming lipid nanoparticles taught by Fan page 2 right column) renders obvious liposomes as in claim 63. Fan teaches that the N/P ratio governed ASO encapsulation (page 4 right column, page 8 left column, Conclusion) and teaches encapsulation efficiency is related to the N/P ratio (Figure 3E, 4E), anticipating claim 215. Thus, the claims are anticipated by the prior art.
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.
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 36-38, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, and 211 are rejected under 35 U.S.C. 103 as being unpatentable over Horhota et al. (WO 2020/061457, published 26 Mar 2020) in view of Yang et al. (Journal of Liposome Research, 2012, 22(1): 31-41, listed on IDS filed 22 Apr 2024).
Horhota teaches a method of producing a lipid nanoparticle composition comprising mixing an aqueous buffer solution and an organic solution to form a lipid nanoparticle formulation comprising an LNP encapsulating a nucleic acid ([0005]). Horhota teaches dissolving mRNA in the organic solvent phase ([0098]) and combining the oligonucleotide with the lipid components in the organic solvent phase prior to mixing with the aqueous phase ([0094, 0096]). These process steps render obvious steps a-c of instant claim 36 and claim 48. Horhota teaches that the lipid nanoparticles may include one or more therapeutics such as a nucleic acid ([00379]) which can include antisense RNA ([00398], [00383]), rendering obvious claims 37 and 38. The aqueous buffer taught by Horhota (e.g. [0005]) renders obvious claim 50. Horhota teaches the organic solvent may be ethanol ([00135]), rendering obvious claim 52. Horhota teaches including cationic lipids, helper lipids, PEGylated lipids and other lipids such as phospholipids as part of generating an organic solution with lipids suitable for LNP production ([00109], [00119], [00254), rendering obvious claims 54 and 56. Horhota teaches that the PEG lipid in the lipid nanoparticle may be from about 0-10 mol% ([00213]), thus rendering obvious that the percentage of lipids that are PEGylated may be varied as in claims 57 and 58. Horhota teaches that the organic feed solutions of lipid compositions may be prepared with a lipid concentration of 5-25 mM and the organic feed solution is combined with an aqueous solution in ratios such as 1:1 ([00694-00695]) which would give lipid concentrations of about 2.5-12.5 mM, thus indicating that the lipid concentration is variable and further rendering obvious claim 58. Horhota teaches varying N:P ratios including from about 2:1 to about 8:1 ([00216]), rendering obvious claim 61. Horhota teaches that the lipid nanoparticles of the invention include liposomes ([00259]), rendering obvious claim 63. Horhota teaches an ethanol solution manually pipetted into an aqueous solution to form the LNPs ([00703]), rendering obvious the injection of claim 66.
Horhota teaches that organic soluble mRNA reduces the need for stringent mixing environments and that rapid parallel mixing and purification could significantly increase formulation screening bandwidth ([00702]). Horhota teaches high-throughput mixing to generate particles where formulations may be prepared in a simple mixing in a 96 well format ([00702, [00711]]). Horhota teaches preparation of a LNP composition where collected nanoparticles were tested for accessible mRNA and particle sizing was performed and the size and PDI was were assessed and particles were formed with a size between 96-110 nm and a PDI between 0.07-0.11 with an encapsulation efficiency of 93-94% were assessed as having good encapsulation ([00712-00713] Table 4), and teaches the encapsulation efficiency may be at least 80% ([00225]), rendering it obvious to assess parameters for the LNPs such as the encapsulation efficiency and particle size distribution as in claim 36 (line f) and claim 68. Horhata teaches that LNP diameter was determined by dynamic light scattering ([00220]), rendering obvious use of an instrument capable of measuring desired LNP characteristics as in claim 211. Horhata teaches an example where the behavior of the lipid nanoparticle formulations on particle formation was assessed when prepared in various buffer and pH conditions from the organic or aqueous phases where the particles were assessed based on their size, PDI and encapsulation efficiency (see example 5 [00720] Table 5), thus rendering obvious varying the selection of phase and buffer and pH as in claim 36 line e. Horhota teaches that the mixing may be automated (claim 12).
Horhata does not teach optimizing with a robotic liquid handler as in claims 36 and 211. This deficiency is made up for in the teachings of Yang.
Yang teaches fast high-throughput screening of temoporfin loaded liposome formulation prepared by ethanol injection method (title). Yang teaches that numerous liposomal formulations were efficiently prepared using a pipetting robot followed by automated size characterization using a dynamic light scattering plate reader (abstract). Yang teaches that that incorporation efficiency and zeta potential were also detected (abstract). Yang teaches that there are many factors that directly affect the formation and final properties of liposomes, such as the lipid concentration in ethanol, ratio of ethanol to aqueous solution, choice of lipids, addition of stabilizers, and ratio of drug to lipid (page 32 left column). Yang teaches that the composition of liposomes is critical to determine the structure and performance attributes and the relationship between these factors and the resulting liposomes is complex and not readily predictable ab initio and that the relationship between the factors and properties of the liposome system must be studied empirically in detail and that the rigorous development of an optimal formulation is complex and time-consuming (page 32 left column). Yang teaches that while traditionally large numbers of samples are prepared and characterized manually and often sequentially, this work is labor intensive and often exhibits a high degree of sample variability because of human faults and thus they sought a solution to automate the process to allow for more controlled, uniform preparation of samples in a systemic, programmable, standardized, and miniaturized format (page 32 left column-page 33 right column). Yang teaches developing a fast, convenient method for high-throughput screening of temoporfin-loaded liposomal formulations where a large number of formulations were prepared quickly and systematically using a pipetting robot, followed by a high-throughput characterization of liposomes to investigate, step-by-step, the interplay between different parameters relating to the optimization of new formulations and that finally, one optimal formulation for each lipid was selected for further study of morphology and stability (page 33 left column). Yang teaches the robot was equipped with tips and used to prepare liposomes in a 96 well plate by the ethanol injection method (page 33 right column). Yang teaches that the robot took multiple solutions including PBS solution, pure ethanol, and ethanolic lipid stock solutions (with and without temoporfin) and dispensed the solutions into target wells (page 34 left column), meeting the limitation of claim 211 of injecting a plurality of solutions into each of the microwells. Yang teaches that to optimize the formulation, different parameters were investigated, including lipid types, lipid concentration in injected ethanol, ratio of ethanol to aqueous solution, ratio of drug to lipid, and the addition of functional phospholipid (abstract). Yang teaches that the results illustrate the approach to be promising for fast high-throughput screening of liposomal formulations (abstract). Yang teaches that the high throughput screening strategy is fast, automated, materially efficient, labor-saving, time-saving, economic, facile, and highly reproducible and promising for development of new formulations (page 40 conclusions).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used a high throughput method with a pipetting robot for producing the lipid nanoparticles obvious from Horhota as part of a method of screening parameters for optimal liposomal formulations and to form liposomes based on the optimal parameters. It is known from Horhata that organic and aqueous buffers may combined to form lipid nanoparticles encapsulating nucleic acid compounds (such as antisense RNA) and that parameters such as lipid types may be varied and that conditions such as encapsulation efficiency depend on how the nanoparticle is formed. It is further known from Horhata that such nanoparticles may be formed in a high throughput manner with 96 well plates and the mixing may be automated. It is additionally known from Yang that the composition of liposomes is critical to determine the structure and performance attributes and the relationship between these factors and the resulting liposomes is complex and not readily predictable ab initio and that the relationship between the factors and properties of the liposome system must be studied empirically in detail and that the rigorous development of an optimal formulation is complex and time-consuming and that pipetting robots with 96 well plates may be used to quickly and systematically prepare liposomal formulations and analyzed for various attributes such as particle size as part of determining optimal parameters for the liposome formulation, rendering it obvious to use a robot as part of a method of optimizing lipid nanoparticle formulations. One would have a reasonable expectation of success as it is known from Yang that the pipetting robot offers a high throughput screening strategy that is fast, automated, materially efficient, labor-saving, time-saving, economic, facile, and highly reproducible and promising for development of new formulations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 215 is rejected under 35 U.S.C. 103 as being unpatentable over Horhota et al. (WO 2020/061457, published 26 Mar 2020) in view of Yang et al. (Journal of Liposome Research, 2012, 22(1): 31-41, listed on IDS filed 22 Apr 2024) as applied to claims 36-38, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, and 211 above and further in view of Karmali et al. (WO 2017/048770, published 23 Mar 2017).
The teachings of Horhota and Yang are described supra.
Horhota and Yang do not teach optimizing encapsulation efficiency by measuring the charge ratio of ionizable lipid/oligonucleotide. This deficiency is made up for in the teachings of Karmali.
Karmali teaches systems, compositions, and methods for formulation nucleic acid compositions (title). Karmali teaches encapsulating a nucleic acid into a lipid nanoparticle (page 2 lines 10-11). Karmali teaches that a cationic lipid and a nucleic acid have a nitrogen/phosphate ratio (page 3 line 15, page 11 line 9). Karmali teaches the effect to nitrogen to phosphorous (N/P) ratio on the lipid particle formation and the relationship of the N/P ratio to encapsulation efficiency and teaches that the encapsulation efficiency changed from 100% to 95.4% as the N/P ratio went from 2.50 to 1.00 (page 29 lines 3-4, lines 19-21, Table 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have measured the N/P ratio as part of optimizing the encapsulation efficiency. The N/P ratio is known for Horhota to be variable and it is further known that the encapsulation efficiency is an obvious parameter to measure and it is known from Karmali that the N/P ratio is related to the encapsulation efficiency of lipid particles. Thus it would have been obvious to measure the N/P ratio as part of optimizing the encapsulation efficiency as there is a known relationship between the parameters. The N/P ratio represents the ratio of the cationic lipid to the nucleic acid and thus measuring the N/P ratio meets the limitation of measuring the charge ratio of ionizable lipid/oligonucleotide.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 36-38, 48, 50, 52, 54, 56-58, 61, 63, 66, 68, 211, and 215 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, 13-17, 19-28, 33, and 34 of copending Application No. 18/332,324 in view of Yang et al. (Journal of Liposome Research, 2012, 22(1): 31-41, listed on IDS filed 22 Apr 2024) and Karmali et al. (WO 2017/048770, published 23 Mar 2017).
The reference application recites
PNG
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The application further recites the payload is an antisense molecule, an aqueous buffer, the organic phase is methanol or ethanol, lipid species of cationic, ionizable, non-cationic, phospholipid, and non-phospholipid species, that the total lipid concentration is varied between 0.4-4 mM, the PEGylated lipids are varied between 0.5-5%, the N:P ratio is varied between 0.5-5, and the LNP is a polymer lipid nanoparticle, liposome or lipoprotein.
The reference application does not recite that the high-throughput method is for optimizing the process for manufacturing the LNP, an instrument capable of measuring the LNP characteristics, and the encapsulation is optimized by measuring the charge ratio of ionizable lipid/oligonucleotide. These deficiencies are made up for in the teachings of Yang and Karmali.
The teachings of Yang and Karmali are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used the high-throughput method for manufacturing a plurality of lipid nanoparticles as part of optimizing the production of the LNPs and to incorporated instruments such as DLS readers for particle sizing and to optimize encapsulation efficiency based on the N/P ratio (i.e. the ratio of the cationic lipid to the nucleic acid). It is known from Yang that the composition of liposomes is critical to determine the structure and performance attributes and the relationship between these factors and the resulting liposomes is complex and not readily predictable ab initio and that the relationship between the factors and properties of the liposome system must be studied empirically in detail and that the rigorous development of an optimal formulation is complex and time-consuming and that pipetting robots with 96 well plates may be used to quickly and systematically prepare liposomal formulations and analyzed for various attributes such as particle size with dynamic light scattering plate readers as part of determining optimal parameters for the liposome formulation, rendering it obvious to use the robot as part of a method of optimizing lipid nanoparticle formulations. Further, it is known from Karmali that the N/P ratio is related to the encapsulation efficiency of lipid particles it thus would have been obvious to measure the N/P ratio as part of optimizing the encapsulation efficiency as there is a known relationship between the parameters.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Correspondence
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
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