DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after July 03, 2025, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 07/03/2025 in the matter of Application N° 18/861,755. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-21 represent all claims currently under consideration.
Claim Rejections - 35 USC § 101
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 21 is rejected under 35 U.S.C. 101 because a “use” claim is not directed to one of the four statutory classes of invention.
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 21 is 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.
With respect to claim 21, the phrase “Use” renders the scope of the claims indefinite because it introduces exemplary language without clearly defining whether the recited subject matter is required or merely illustrative. As a result, the metes and bounds of the claimed invention cannot be determined with reasonable certainty.
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.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhenhua et al. (CN112843019A).
Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle comprising a nucleic acid therapeutic and a lipid carrier. The lipid carrier includes one or more cationic lipids, neutral lipids, cholesterol, PEG-modified lipids, and amphiphilic lipids. The nucleic acid may be selected from DNA, siRNA, miRNA, or mRNA, and suitable cationic lipids include Dlin-MC3-DMA, DLinDMA, DODMA, Dlin-MC2-MPZ, DLinKC2-DMA, DOTAP, DC-Chol, and DOTMA (See claim 1, claim 2, and the “Means for solving the problems,” paragraphs 1-3). Zhenhua et al. further disclose calcium-containing additives, including calcium chloride and calcium carbonate (See claim 2, and “Means for solving the problems,” paragraph 5). Calcium chloride provides calcium ions in association with chloride counterions, rather than phosphate, hydrogen phosphate, or dihydrogen phosphate anions, thereby meeting the claimed limitation requiring a non-phosphate counterion.
Zhenhua et al. additionally teach that the neutral lipids are modified by anion modification groups and then modified by partial cation groups to keep neutral (See Detailed Description paragraph 14). Zhenhua et al. disclose that the lipid carrier may be selected from at least one of a cationic lipid, neutral lipid, anionic lipid, cholesterol, and amphiphilic lipid (See claim 1). Thus, although Zhenhua et al. identify anionic lipids as one possible lipid component, the reference does not require the presence of an anionic lipid in every disclosed lipid nanoparticle formulation. Rather, the anionic lipid is presented as an optional component among alternative lipid constituents. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to formulate the nucleic acid-loaded lipid nanoparticle using the disclosed cationic lipid, neutral lipid, cholesterol, and PEGylated/amphiphilic lipid components without including a non-PEG-group-modified negatively charged lipid, particularly where Zhenhua et al. does not identify such an anionic lipid as necessary for formation or function of the nanoparticle. Such selection would have represented the predictable choice of a formulation expressly permitted by Zhenhua’ s disclosure. Zhenhua et al. further disclose an exemplary nucleic acid-loaded lipid nanoparticle formulation prepared using DOTAP, DSPC, cholesterol, and PEG-DMG as the lipid components. In this disclosed formulation, DOTAP functions as the cationic lipid, DSPC as the neutral phospholipid, cholesterol as the cholesterol lipid and PEG-DMG as the PEGylated lipid (See claim 2). The exemplified lipid composition does not include a non-PEG group-modified negatively charged lipid, thereby satisfying the claimed limitation that the cationic lipid nanoparticle is free of such lipid.
Regarding claim 2, Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle comprising calcium-containing additives, including calcium chloride and calcium carbonate, incorporated into the lipid nanoparticle formulation (See claims 1 and 2). The reference describes a stable nanoparticle composition suitable for delivery of nucleic acid therapeutics. Zhenhua et al. disclose the use of calcium chloride as a calcium-containing component of the nucleic acid lipid nanoparticle formulation. As defined in paragraph 56 of the present specification, calcium ions in a “non-precipitated state” include calcium ions provided by soluble calcium salts Accordingly, it would have been obvious that the calcium ions are maintained in a non-precipitated state” include calcium ions provided by soluble calcium salts. Calcium chloride is a soluble calcium salt and, therefore, provides calcium ions in a non-precipitated state as defined by the present specification. Accordingly, Zhenhua et al.’s disclosure of calcium chloride satisfies the claimed limitation requiring the cationic lipid nanoparticle to contain calcium ions in a non-precipitated state.
Regarding claim 3, Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle composition comprising calcium-containing auxiliary materials, including calcium chloride and calcium carbonate (See claims 1 and 2). The reference further teaches specified mass ratios between the drug-loaded lipid nanoparticles and the auxiliary materials, as well as between the auxiliary materials and water, thereby recognizing that the amount of calcium-containing additive is a formulation parameter that may be varied to produce the desired nanoparticle composition (See Claim 7).
Zhenhua et al. disclose preparing an aqueous auxiliary-material solution by dissolving 0.3 g of calcium chloride in 46 mL of water and mixing the resulting solution with 1 mL of the lipid-containing ethanol solution by a thin-film hydration method (See Example 4). Using the molecular weight of anhydrous calcium chloride of approximately 110.98 g/mol, 0.3 g of calcium chloride corresponds to approximately 2.70 mmol of calcium chloride and, consequently, approximately 2.70 mmol of calcium ions. Based on an approximate total formulation volume of 47 mL following mixing, the resulting calcium concentration is approximately 57.5 mmol/L. This concentration falls within the claimed calcium concentration range of 0.01-150 mmol/L. Accordingly, Zhenhua et al. disclose a calcium concentration encompassed by the range recited in claim 3.
Regarding claim 4, Zhenhua et al. discloses for the reasons set forth with respect to claim 3. The recited calcium concentration relative to the total volume represents a further optimization of the amount of calcium incorporated into the lipid nanoparticle formulation. Because Zhenhua et al. recognize the amount of calcium-containing auxiliary material as a formulation parameter, selecting a concentration within the claimed micromolar ranges would have been an obvious matter of routine optimization of a result effective variable to achieve predictable formulation properties.
Regarding Claim 5, Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle comprising a lipid carrier that includes cationic lipids, neutral lipids, PEGylated lipids, and cholesterol, together with calcium containing auxiliary materials, including calcium chloride and calcium carbonate (See Abstract, and claims 1 and 2). The reference further teaches varying the relative amounts of the lipid nanoparticles, auxiliary materials, and aqueous medium through disclosed mass ratios, thereby recognizing that the relative proportions of the formulation components may be adjusted to obtain the desired nanoparticle properties. Although Zhenhua et al. do not expressly disclose a molar ratio of calcium to lipid of 1:(0.01-20), 1:(0.1-10), 1:(1-10), 1:(0.1-1), or 1:(2-18), it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to optimize the relative amount of calcium with respect to the lipid components through routine experimentation in order to achieve predictable formulation characteristics, including nanoparticle stability, nucleic acid encapsulation efficiency, particle formation, and delivery performance. Selecting an operable molar ratio within the claimed ranges amounts to the routine optimization of a recognized result-effective variable.
Regarding claim 6, Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle comprising a lipid carrier including cationic lipids, neutral lipids, cholesterol, PEGylated lipids, and calcium containing auxiliary materials, including calcium chloride and calcium carbonate. Although Zhenhua et al. do not expressly disclose a molar ratio of calcium to the total amount of cholesterol and/or cholesterol ester of (0.01:1) -(0.8:1), (0.02:1) -(0.6:1), or (0.03:1) -(0.4:1), the reference recognizes both calcium and cholesterol as formulation components whose relative amounts may be adjusted during preparation of the lipid nanoparticle. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date to optimize the relative molar ratio of calcium to cholesterol and/or cholesterol ester through routine experimentation to achieve predictable formulation characteristics, including nanoparticle stability, structural integrity, nucleic acid encapsulation efficiency, and delivery performance. Selecting a ratio within the claimed ranges would have constituted nothing more than the routine optimization of a recognized result effective variable.
Regarding claim 7, Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle comprising calcium ions derived from calcium-containing compounds, including calcium chloride and calcium carbonate (See claims 1 and 2). Although Zhenhua et al. do not expressly disclose that the calcium ions are derived from a calcium salt solution having a concentration of 50-1000 mmol/L, 50-150 mmol/L, 150-300 mmol/L, or 300-500 mmol/L, the reference recognizes calcium salts as formulation components used to prepare the lipid nanoparticle composition. Given the recognized desirability of incorporating a calcium salt into the formulation, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to select a suitable calcium salt source with a reasonable expectation that the selected compound would provide calcium ions for the intended purpose.
Regarding claim 8, Zhenhua et al. disclose that the drug-loaded lipid nanoparticle comprises a nucleic acid drug and a lipid carrier, wherein the nucleic acid drug is preferably selected from DNA, siRNA, miRNA, and mRNA (See “Means for Solving the Problems,” paragraph 1, and claim 1). These disclosed nucleic acids fall within the scope of the claimed substances to be delivered by the calcium-containing cationic lipid nanoparticle, including DNA, siRNA, miRNA, and mRNA.
Regarding claim 9, Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle comprising a nucleic acid drug and a lipid carrier including one or more cationic lipids, and further teach a mass ratio of the nucleic acid drug to the lipid carrier of 1:(2-30) (See claim 1). Although Zhenhua et al. do not expressly discloses a molar ratio of phosphate groups in the nucleic acid to the positively charged groups of the cationic lipid of 1:(0.5-20), 1:(1-10), 1:(1.5-6), or 1:(1.5-3). Zhenhua et al. disclose that the drug-loaded lipid nanoparticle comprises a nucleic acid drug and a lipid carrier, wherein the mass ratio of the nucleic acid drug and lipid carrier may vary within a disclosed range. Although Zhenhua et al. do not expressly disclose the claimed molar ratio of phosphate groups in the nucleic acid to positive charges in the cationic lipid, the disclosed nucleic acid to lipid mass-ratio range provides a quantitative starting point for varying the relative amounts of these components. It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to determine an appropriate relative amount of nucleic acid and cationic lipid through routine experimentation to achieve suitable complexation and encapsulation of the nucleic acid within the lipid nanoparticle. Zhenhua et al. further disclose a lipid modified with an anionic modifying group, wherein the anionic modifying group is preferably a phosphate group (See paragraph 13). Accordingly, Zhenhua et al. recognize the presence of phosphate functionalities within the lipid nanoparticle system in combination with cationic lipids and nucleic acid cargo. Although Zhenhua et al. do not expressly disclose the claimed molar ratio of phosphate groups in the nucleic acid to the positively charged groups of the cationic lipid, the reference recognizes the relative amounts of these interacting components as formulation parameters that may be adjusted during preparation of the lipid nanoparticle. It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to optimize the relative proportions of the nucleic and cationic lipid, including the corresponding phosphate-to-cationic charge ratio, through routine experimentation to achieve predictable nanoparticle formation, encapsulation efficiency, stability, and nucleic acid delivery.
Regarding claim 10, Zhenhua et al. disclose a nucleic acid-loaded lipid nanoparticle comprising a nucleic acid drug and a lipid carrier, wherein the mass ratio of the nucleic acid drug to the lipid carrier is 1:(2-30) (See claim 1 and the “Means for Solving the problems,” paragraph 1). The disclosed mass ratio overlaps the claimed ranges of 1:(-100), 1(5-90), 1(10-70), and 1:(10-30). It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to employ a mass ratio falling within the claimed ranges because Zhenhua et al. expressly teach values encompassed by, and overlapping with, the claimed ranges. selecting a value within an overlapping range would have been an obvious matter of routine choice and is presumed to yield the same or similar properties absent evidence of criticality or unexpected results.
Regarding claim 11, Zhenhua et al. disclose calcium-containing cationic lipid nanoparticles for delivering nucleic acid drugs and teach that nucleic acid drugs include nucleic acids (including nucleotides and deoxynucleotides) extracted from cells or prepared by artificial synthesis having nucleic acid structures and pharmacological effects. Zhenhua et al. further disclose that, in certain embodiments, the nucleic acid drug is selected from at least one of DNA, siRNA, miRNA, and mRNA, and explain that the pharmacological actions of nucleic acid drugs include use as antiviral agents, antitumor agents, interferon inducers, immunopotentiators, and functional agents (See Description, paragraph 9). Although Zhenhua et al. do not expressly disclose a substance to be delivered having a length of about 15-30,000, 15-60, 60-120, 120-250, 250-500, 500-1,000, 1000-2,000, 2,000-4,000, 4,000-8,000, etc., one of ordinary skill in the art, prior to the instant effective filing date would have understood that different therapeutic applications employ nucleic acid molecules of different lengths depending on the intended target and biological function. Accordingly, it would have been obvious to select a nucleic acid having a length within the claimed ranges through routine design and optimization to achieve the desired therapeutic effect, with a reasonable expectation of success.
Regarding claim 12, Zhenhua et al. teach the development of lipid nanoparticles encapsulating nucleic acid drugs and disclose drug-loaded lipid nanoparticles comprising a nucleic acid drug and a lipid carrier, wherein the mass ratio of the nucleic acid drug to the lipid carrier is 1:(2-30) (See Abstract and claim 1). Zhenhua et al. further disclose that the nucleic acid drug is preferably selected from at least one of DNA, siRNA, miRNA, and mRNA, thereby recognizing that the amount of nucleic acid incorporated into the lipid nanoparticle is a formulation parameter (See claim 1). Although Zhenhua et al. do not expressly disclose a loaded nucleic acid amount of 5 µg/mL to 10mg/mL, 5-10 µg/mL, 10-20 µg/mL, 20-40 µg/mL, or 40-80 µg/mL, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date to determine an appropriate nucleic acid loading concentration through routine formulation optimization in order to achieve desired encapsulation efficiency, therapeutic dosage, particle stability, and delivery performance. Selecting a loading amount within the claimed ranges would have constituted no more than the routine optimization of a recognized result-effective variable and would have predictably affected the performance of the lipid nanoparticle formulation.
Regarding claim 13, Zhenhua et al. disclose a calcium-containing cationic lipid nanoparticle comprising lipid components including ionizable cationic lipids, cholesterol and/or cholesterol esters, neutral lipids, and PEGylated lipids (See claim 1, “Means for solving the problems,” paragraph 2, and claim 2). Zhenhua et al. further teach that the lipid carrier may comprise one or more cationic lipids, cholesterol or cholesterol esters, neutral lipids, and optional PEGylated lipids. Zhenhua et al. further disclose that suitable PEGylated lipids include PEG-DMG, PEG-c-DMA, PEG-DSPE, PEG-PE, PEG-modified ceramide, PEG-modified dialkylamine, PEG-modified diacylglycerol, PEG-DPG, and PEG-DSG (See “Means for solving the problems,” paragraph 3, and claim 2). Accordingly, Zhenhua et al. teach the recited lipid components, including an ionizable cationic lipid, cholesterol and/or a cholesterol ester, a neutral lipid, and an optional PEGylated lipid.
Regarding claim 14, Zhenhua et al. disclose drug-loaded lipid nanoparticles comprising a nucleic acid drug and a lipid carrier, wherein the lipid carrier is selected from lipid components including cationic lipids and cholesterol and/or cholesterol esters, a neutral lipid, and a PEGylated lipid. Zhenhua et al. further disclose a representative formulation comprising 50 mol% DOTAP, 38.5 mol% cholesterol, 10 mol% DSPC, and 1.5 mol% PEG-DMG. The disclosed formulation falls within the claimed ranges of 1-90 mol% cationic lipid and/or 1-90 mol% cholesterol lipid, 10-60 mol% cationic lipid and/or 25-75 mol% cholesterol lipid. To the extent the narrower claimed ranges are not expressly disclosed, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to adjust the relative molar proportions of the cationic lipid and cholesterol through routine formulation optimization to achieve desired nanoparticle properties, including stability, encapsulation efficiency, and nucleic acid delivery. Selecting molar percentages within the claimed ranges would have been an obvious matter of routine optimization of recognized result-effective variables.
Regarding claim 15, Zhenhua et al. disclose drug-loaded lipid nanoparticles comprising a lipid carrier including a cationic lipid, cholesterol, a neutral phospholipid, and a PEGylated lipid. Zhenhua et al. further disclose a representative lipid formulation comprising approximately 50 mol% DOTAP (cationic lipid), 38.5 mol% cholesterol, 10 mol% DSPC (neutral phospholipid), and 1.5 mol% PEG-DMG (PEGylated lipid). The disclosed formulation falls within the claimed ranges of (a)1-90 mol% cationic lipid, 1-90 mol% cholesterol lipid, 1-90 mol% neutral lipid, and 0.1-20 mol% PEGylated lipid, and (b) 10-60 mol% cationic lipid, 25-75 mol% cholesterol lipid, 1-30 mol% neutral lipid, and 0.5-10 mol% PEGylated lipid. The disclosed neutral lipid and PEGylated lipid contents also fall within the narrower ranges recited in (C). To the extent the narrower ranges of 20-40 mol% cationic lipid and 40-60 mol% cholesterol lipid are not expressly disclosed, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to adjust the relative molar proportions of these lipid components through routine formulation optimization to achieve desired nanoparticle stability, encapsulation efficiency, and nucleic acid delivery. Such adjustments would have represented no more than the routine optimization of recognized result-effective variables and would have produced predictable results.
Regarding claim 16, Zhenhua et al. expressly disclose lipid nanoparticle formulations comprising lipid components selected from DLinDMA, DODMA, and Dlin-MC3-DMA as suitable cationic lipids. Zhenhua et al. further disclose PEG-DMG and PEG-DPG as suitable amphiphilic/PEGylated lipids and disclose lecithin and soybean lecithin as suitable adjuvant lipid components (See claim 2, and “Means for solving the problems,” paragraph 5).
Regarding claim 17, Zhenhua et al. expressly disclose that, in certain embodiments, the hydrodynamic (fluid mechanical) diameter of the drug-loaded lipid nanoparticles is 30-800 nm, as measured by dynamic light scattering (DLS) (See “Second aspect,” paragraph 6). The disclosed particle-size range overlaps the claimed particle size ranges of 25-1000 nm, 25-500 nm, 500-1000 nm, 25-75 nm, 75-125 nm, 125-175 nm, 175-115 nm, 225-275 nm, and 350-500 nm. Because the prior art teaches a particle-size range that overlaps the claimed ranges, it would have been obvious to one of ordinary skill in the art to employ a particle size with in the claimed ranges. Zhenhua et al. further disclose lipid nanoparticles as a solid colloidal drug delivery system having a particle size of 50-1000 nm, prepared by wrapping or embedding a drug within a lipid or lipid core using natural or synthetic lipids or lipoids as the matrix (See Background, paragraph 1). The disclosed particle size range overlaps the claimed particle size ranges of 25-1000 nm, 25-500 nm, 500-1000 nm, 25-75 nm, 75-125 nm, 125-175 nm, 175-225 nm, 225-275 nm, and 350-500 nm. Because the prior art teaches particle sizes that overlap the claimed ranges.
Regarding claim 18, Zhenhua et al. expressly disclose calcium containing cationic lipid nanoparticles loaded with nucleic acid cargos, including siRNA, mRNA, and DNA, and further disclose formulations comprising Dlin-MC3-DMA as the cationic lipid, cholesterol, DSPC as the neutral phospholipid, and PEG-DMG (PEG2000-DMG) as the PEGylated lipid. Zhenhua et al. further teach incorporating calcium ions into the lipid nanoparticle formulation using calcium salts, including calcium chloride. Although Zhenhua et al. do not expressly disclose calcium acetate as the calcium ion source, it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to substitute calcium acetate for another pharmaceutically acceptable calcium salt because both function as sources of calcium ions for incorporation into the lipid nanoparticle formulation, and such a substitution would have been expected to produce predictable results absent evidence that the particular choice of calcium salts imparts unexpected properties or criticality.
Regarding claim 19, Zhenhua et al. disclose a nucleic acid lipid nanoparticle dry-powder formulation having an aerodynamic particle size of 0.5-15 µm, which permits the particles to be inhaled into the deep lung (See “Second aspect,” paragraph 4). Zhenhua et al. further teach that, following pulmonary administration, the medicine can enter the bloodstream through the lungs, providing a rapid therapeutic response and high bioavailability (See “Advantageous effects of invention,” paragraph 2).
Regarding claim 20, Zhenhua et al. disclose preparing nucleic acid-loaded lipid nanoparticles by dissolving DOTAP, DSPC, cholesterol, and PEG-DMG in ethanol, dissolving mRNA in a 50mM citrate buffer at pH 4.0. The lipid solution and mRNA solution are rapidly mixed using microfluidic mixing to form lipid nanoparticles, and the resulting formulation is dialyzed to remove ethanol, thereby producing an mRNA-entrapped lipid nanoparticle solution. Zhenhua et al. thus teach preparing lipid nanoparticle compositions through mixing and post-formation processing. Although Zhenhua et al. do not expressly disclose adjusting the pH of the formulation to neutrality after mixing, pH control is recognized as a conventional formulation parameter in lipid nanoparticle preparation. It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to adjust the pH, as appropriate, to a physiologically acceptable or neutral value to improve formulation stability and compatibility for administration, absent evidence that the claimed pH adjustment produces unexpected results.
Regarding claim 21, Zhenhua et al. disclose that the nucleic acid lipid nanoparticle dry powder may be redissolved in physiological saline to form an injectable composition and administered by intramuscular injection, intravenous injection, or local injection. Zhenhua et al. further disclose, in Example 15, redissolving the nucleic acid lipid nanoparticle dry powder in water and administering the formulation to mice by pulmonary inhalation and intramuscular injection, followed by evaluation of mRNA expression through fluorescence detection and in vivo imaging. Zhenhua et al. additionally teach that the disclosed lipid nanoparticle technology has significant potential for loading biological drugs, vaccine preparation, anticancer therapy, and overcoming biological barriers (See background, paragraph 2). These teachings demonstrate the suitability of the disclosed nucleic acid-loaded lipid nanoparticle compositions for delivering nucleic acids to cells and tissues through local or systemic administration. It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to use the disclosed composition gene transfection, cell modification, and local or systemic administration to achieve nucleic acid delivery and vaccine immunization, as recited in claim 21, because these represent predictable applications of the disclosed nucleic acid delivery platform.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
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.
/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights