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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/27/24, 10/23/25 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, 9-13, 15, 18, 20, 21, 22 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Suzuki et al (US 2017/0334852 A1 hereafter Suzuki).
Suzuki teaches a compound
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meeting the limitations of claims 1, 3-6. A lipid nanoparticle comprising the lipid compound comprising this compound [0068], meeting the limitations of claim 9. The lipid nanoparticle further comprises at least a neutral lipid such as DOPE, DMPC or DSPC , meeting the limitations of claims 10 and 11 [0045]. The formulation further comprises structural lipid such as cholesterol, meeting the limitations of claim 12 [0051]. The lipid nanoparticle can further comprise PEGylated lipids such as PEG-modified diakylglycerols meeting the limitations of claim 13 [0047-0048]. The formulation comprises polynucleotide meeting the limitations of claims 15 [0042]. The polynucleotides are conventional such as siRNA, miRNA, shRNA [0042], meeting the limitations of claim 15 and 18. The formulation comprises a plurality of lipid nanoparticles and a carrier meeting the limitations of claims 20 [0066]. The formulation is delivered via injection so as to introduce the polynucleotide in a cell [0069], meeting the limitations of claim 21. These disclosures render the claims anticipated.
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.
Claim(s) 1, 3-6, 9-15, 18-22, 24, 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Suzuki et al (US 2017/0334852 A2 hereafter Suzuki) in view of Jain et al (WO 2020/252589 A1 hereafter Jain).
As discussed above, Suzuki discloses a formulation comprising a cationic lipid comprising a polynucleotide and it present in a lipid nanoparticle formulation that is delivered into a cell. The formulation comprises a cationic lipid, a neutral lipid, a structural lipid or a PEGylated lipid. The cationic lipid is present from 40-70 % by mole, with the neutral lipid present about 0-30% by mole, the structural lipid is present about 20-50% by mole and a PEGylated lipid from 0-10% by mole [0041, 0043, 0050, 0052, 0056], meeting some of the limitations of claim 14. Further the cationic lipid formulation is present as an injectable lipid nanoparticles formulation where the average nanoparticle diameter is from 30 to 200 nm [0068]. The ranges meet the general conditions of the claims and while they overlap, the optimization of these ranges is well within the level of skill in the art. Where 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
Suzuki discloses a cationic lipid formulation comprising a polynucleotide however not the same polynucleotide as the instant claims. The use of such polynucleotides are known in the art as seen in the Jain patent.
Jain discloses a cation lipid formulation in the form of a lipid nanoparticle formulation [abstract]. The formulation comprises a cationic lipid, a neutral lipid and a structural lipid [00136, 00141]. The cholesterol is present about 30% by mole [00141]. The cationic lipid is present about 40-49 % by mol [00144]. The neutral lipid comprises DSPC, SPP and DOPE [00168, 00176]. The cationic lipids further comprise polynucleotides including self-amplifying RNA [00183, 00184, 00213]. The formulation is present as a lipid nanoparticle where the nanoparticles have a diameter from 15-50 nm [00193]. The lipid nanoparticle formulation is present as a human vaccine for a coronavirus or cancer [00147]. It would have been obvious to apply the polynucleotide into the formulation of Suzuki as they solve the same problem.
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable cationic lipid formulation useful as a vaccine formulation. It would have been obvious to combine the disclosures of Jain with the disclosures of Suzuki as they solve the same problem and use the same collection of components. One of ordinary sill in the art would have been motivated to combine the prior art with an expected result of a stable vaccine formulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618
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