DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 03/24/2025, are acknowledged.
Claims 1-2, 4-5, 10, 13, 20, 29, 34-35, 40-41, 50, 55-56, 61-63, 65-66 are pending in this application. Claims 3, 6-9, 11-12, 14-19, 21-28, 30-33, 36-39, 42-49, 51-54, 57-60, 64, 67-142 have been cancelled. Claims 1-2, 4-5, 10, 13, 20, 29, 34-35, 40-41, 50, 55-56, 61-63, 65-66 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application is a continuation of U.S. Patent Application No. 17/402,077, filed August 13, 2021 and now issued as U.S. Patent No. 12,178,921, which claims benefit of provisional U.S. Application No. 63/158,761, filed March 9, 2021, and U.S. Application No. 63/066,051, filed August 14, 2020.
Inventorship
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.
Specification
The lengthy specification (86 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification comprises multiple acronyms without proper definition (e.g., Para. 0036, 0050, 00130, 00141, 00192, 0236). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The specification comprises typographic errors, e.g., “Poloxamer”, “Cationic lipids” that need to be corrected to “poloxamer”, “cationic lipids”, respectively (e.g., Para. 0039, 0071). Appropriate correction is required.
The use of the trademarks/trade names/product names has been noted in this application (e.g., Para. 0039, 0051, 0072, 00195). It should be capitalized wherever it appears and be accompanied by generic terminology. Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The specification comprises references on foreign applications and/or publications (e.g., Para. 0003, 0055, 0066, 0070, 0073, 0075, 0086, 0088, 0097, 0173, 0177). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Information Disclosure Statement
The information disclosure statements (209 references), filed 03/04/2025 and 09/03/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Applicant has submitted oversized information disclosure statements without specifically pointing out where relevant material can be found in each of the references. As a result, the examiner has considered said information disclosure statements to the extent permitted by the allotted time for such consideration and consistent with the MPEP. For the record, the legible copies of cited foreign patent documents and/or non-patent literature documents have been submitted in parent application 17/402,077.
The information disclosure statement, filed 09/03/026, does not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or does not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Objections
Claims 1, 5, 10, 35, 41, 50, 56, 61, 63, 65, 66 are objected to because of the following informalities:
Claims 1, 56 comprise acronyms. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed.
Claim 1 comprises the typographic error “medium comprises about 4% w/v to” that needs to be corrected to “medium comprises from about 4% w/v to”. Similar is applied to other constituents and/or steps recited in claim 1 as well as to claims 5, 10, 35, 41, 50, 56, 61, 63, 65.
Claims 66 comprises the typographic error “Poloxamer” that needs to be corrected to “poloxamer”.
Appropriate correction is required.
Claim Rejections - 35 USC § 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, 4-5, 10, 13, 20, 29, 34-35, 40-41, 50, 55-56, 61-63, 65-66 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 pre-AIA the applicant regards as the invention.
Claim 1 discloses a method of lyophilizing a composition comprising nanoparticles comprising a ribonucleic acid (RNA) that is unclear and indefinite, because the lyophilization steps are not clearly delineated. First, it is unclear what lipid nanoparticles should be used in step (a) – with or without RNA. Second, it is unclear what the term “adjusting the liquid medium” recited in step (b) does imply. Third, it is unclear when and/or how the lyophilization should be performed. Clarification is required.
Claim 1 recites the term "about" that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, but teaches that “the terms “about,” “substantially,” and “approximately” may provide an industry-accepted tolerance for their corresponding terms and/or relativity between items, such as from less than one percent to five percent” (Para.00246). Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 2, 5, 10, 35, 41, 50, 56, 61, 63, 65. clarification is required.
Claim 66 recites the limitation "Poloxamer 188" that is a product name. Neither the claims nor the instant specification provides a clear description/definition for the compounds identified as poloxamer 188 to be used in the claimed composition. The claim scope is uncertain since the product name cannot be used properly to identify any particular material. The formula or characteristics of the product may change and yet it may continue to be sold under the same name. Clarification is required.
Claims 4, 13, 20, 29, 34, 40, 55, 62 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter. The prior art teaches a large variety of compositions that prior to lyophilization include lipid nanoparticles encapsulating RNA and may include saccharide/sucrose, poloxamer (e.g., poloxamer 188), polyvinyl alcohol, NaCl, and wherein said pre-lyophilized compositions are subjected to an initial freezing step and drying steps (e.g., US 2017/0020819A1, US 2020/0069599A1, US 2018/0243219A1). The prior art does not teach the use of pre-lyophilized compositions as instantly claimed, i.e., comprising at least one compound selected from potassium sorbate, thiosulfate, sodium benzoate, and iodixanol. Applicant teaches that said approach result in a preservation of lipid nanoparticle integrity, integrity of the encapsulated nucleic acid, the particle size of the lipid nanoparticles within an acceptable degree of pre-lyophilized particle size, and good polydispersity of the nanoparticles.
Conclusion
Claims 1-2, 4-5, 10, 13, 20, 29, 34-35, 40-41, 50, 55-56, 61-63, 65-66 are rejected, but would be allowable if rewritten or amended to overcome objections and the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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