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 .
Applicant’s preliminary amendment filed 10/10/2024, are acknowledged. Claims 26-45 are pending and new.
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.
Claim(s) 26-45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karve et al. (US 2018/0153822).
Regarding claim 26, Karve et al. teaches “heating one or more one or more of the solution comprising the pre-formed lipid nanoparticle, the solution comprising the pre-formed lipid nanoparticles, the solution comprising the mRNA and the solution comprising the lipid nanoparticle encapsulated mRNA, during the mixing step” (current claim 44). Para. [0010]. Karve et al. also teaches “[a]ny desired lipids may be mixed at any ratios suitable for encapsulating mRNAs . . . including cationic lipids, helper lipids (e.g., non cationic and/or cholesterol lipids) and/or PEGylated lipids” (current claims 30-33). Para. [0128]. Furhter, “the pre-formed lipid nanoparticles comprising one or more cationic lipids.” Para. [0013].
Regarding claim 27, “preformed lipid nanoparticles are referred to as empty lipid nanoparticles.” Para. [0009].
Regarding claim 28, “the lipid nanoparticles encapsulating the mRNA are prepared with the pre-formed lipid nanoparticles.” Para. [0027].
Regarding claims 35, 36 and 39, “[i]n some embodiments, at least 85% (e.g., at least 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99%) of the lipid nanoparticles are pre-formed.” Para. [0029]. Also, “[i]n some embodiments, greater than about 90%, 95%, 96%, 97%, 98%, or 99% of the purified lipid nanoparticles encapsulate an mRNA within each individual particle. In some embodiments, substantially all of the purified lipid nanoparticles encapsulate an mRNA within each individual particle.” Para. [0030].
Regarding claims 37 and 38, the lipid nanoparticles have an individual size less than about 150 nm
Regarding claim 40, “the term ‘messenger RNA (mRNA)’ refers to a polynucleotide that encodes at least one peptide, polypeptide or protein.” Para. [0089].
Regarding claim 41, Karve et al. teaches “a method of delivering mRNA for in vivo protein production comprising administering into a subject a composition of lipid nanoparticles.” Para. [0036].
Regarding claims 42 and 43, the wherein clause are not considered limitations because they merely express the intended results of a process step positively recited. MPEP 2111.04 (“Claim scope is not limited by claim language that . . . does not limit a claim to a particular structure.”).
Regarding claim 45, “Figure 6 shows immunohistochemical detection of hCFRT protein in rat lungs 24 hours after nebulization.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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, Ali Soroush can be reached at 571-272-9925. 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.
/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
Prosecution Insights