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 .
Specification
The use of the term, “GenBank”, recited in paragraph [0047], “Malvern”, “Ribogreen”, and “Thermo Fisher Scientific”, recited in paragraph [0053] are trade names or a marks used in commerce, noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant is required to properly annotate all trade names and/or marks recited in the instant specification.
In reply to the objection of record, applicant states that the specification will be amended by properly annotating all trade names and/or marks recited in the instant specification.
The objection is maintained for reasons of record.
Claim Interpretation
Claims 1 and 2 remain objected to because of the following informalities: since the mRNA is encapsulated; “with”, recited in lines 1 and 2 of claim 1 and lines 1 and 7 of claim 2 should be replaced with, “in”, for placement accuracy between the mRNA and lipid nanoparticles. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 remain rejected under 35 U.S.C. 103 as being unpatentable over Oostvogels et al. (USPgPub 2022/0211841), SEQ ID NO: 1 alignment with GenEmbl database access no: OK546242 by Wang et al. 2021; and Chen et al. (Virus Research. Available online Dec. 2019; 276: 197834).
In reply to the rejection of record, applicant asserts that Oostvogels et al. do not disclose SEQ ID NO: 1.
In reply, if Oostvogels et al. taught SEQ ID NO: 1, the reference would have been considered under the anticipatory statute.
Applicant argues that the remaining references fail to disclose the specific molar ratio of the instant lipid nanoparticle.
Applicant’s arguments and a review of the references have been fully considered, but are found unpersuasive. Paragraphs [1209, 1210, 1193] and claim 1 of Oostvogels et al. teach that the molar ratio of the lipid nanoparticle components range in approximately (20-60% cationic lipid: 5-25% neutral lipid: 25-55% sterol: 0.5-1.5% PEG-lipid) and or more particularly: 50:10:38.5:1.5 in paragraph [1193] in which quantities of the neutral lipid and sterol of Oostvogels et al. (underlined) are indistinguishable from the quantities of the neutral lipid and sterol instantly required, i.e., 10:38.5. Paragraph [1173] of Oostvogels et al. teach that the PEG-lipid quantity is 1.2, as instantly required.
MPEP § 2144.05 teach:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
In the instant case, Oostvogels et al. teach the range of workable molar ratios of each lipid nanoparticle component with sufficient specificity.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have modified the component ratios of Oostvogels et al. to 55:10:38.5:1.2, as claimed, as applicant appears to have placed no criticality on the neutral lipid: sterol: PEG-lipid since the quantities of these components may range from: (5-15):(30-40):(1-2), taught in paragraph [0016] of the instant published disclosure, USPgPub 2025/0281604, indicating that these components may be within the range taught.
Regarding the requisite quantity of cationic lipid, “55”, Oostvogels et al. teach the molar ratio of the cationic lipid ranges between 20-60%, or more particularly: “50” in paragraph [1193]. It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have optimized the cationic lipid quantity, as evidenced by the teachings of Oostvogels et al., absent teachings of criticality and/or unexpected results to the contrary to arrive at the molar ratio recited in instant claim 1.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet L Andres can be reached at 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671