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 02/18/2025 was 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.
Claims 1, 2, 7, 17, 31, 38, 44, 54, 55, 62, 63, 72, 76 and 79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansson et al. (US 2020/0338004).
Hansson discloses a lipid nanoparticle composition comprising from about 30-60mol% of the lipid:
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which comprises a tertiary amine and at least one C14-42 alkyl ester, between about 18-5-48.5mol% of a structural lipid (e.g. cholesterol which is a steroid), between 0-30 mol% a phophoslipid and between 0-10mol% a PEG lipid such as PEG-diacylglycerol (see claim 3) (a polymer conjugated lipid), with 1.5 mol% PEG lipid being disclosed (see [0141]) and mRNA (a nucleic acid), which may be modified (see Table 1 and claim 1) wherein the lipid to nucleic acid ratio is from about 10:1 to about 100:1 (e.g. 20:1, 10:1, etc) (see [0036-0038] and claims 35-37). The lipid nanoparticle composition that comprises 0 mol% would read on the limitation of “the lipid nanoparticle comprises no more than 0.5 mole percent phospholipid” set forth by instant claim 1.
In all, Hansson discloses a composition which comprises:
60mol% cationic lipid having i) a tertiary amine and ii) an at least one C14-42 alkyl ester;
48.5mol% of a steroid (cholesterol);
1.5 mol% of a polymer conjugated lipid (PEG lipid);
0 mol % phospholipid; and
a modified nucleic acid (e.g. mRNA), wherein the composition has a lipid to nucleic acid ratio of 10:1.
The outlined composition above anticipates the composition described by instant clams 1, 2, 7, 17, 54, 55, 62.
Hansson’s lipid nanoparticle is to have a mean diameter of about 50-100 nm (see [0024] and claim 22) (see instant claim 63).
The lipid of Hansson:
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anticipates instant claims 31, 38 and 44.
Pharmaceutical compositions comprising the lipid nanoparticles together with an excipient (e.g. solvent, surface active agent, dispersion media, etc.) are disclosed (see [0025, 0044, 0090] and claim 12) (see instant claim 72).
Methods of administering the lipid nanoparticles to a subject (e.g. a human) via intradermal administration are contemplated (see [0063, 0111], Examples 2 and 3 and claim 28) (see instant claims 76 and 79).
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.
Claim 1, 2, 7, 17, 31, 38, 42, 44, 54-56 62, 63, 66, 72, 76 and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansson et al. (US 2020/0338004) in view of Smith et al. (US 2022/0062175).
Hansson is relied upon for disclosure described in the rejection of claims 1, 2, 7, 17, 31, 38, 44, 54, 55, 62, 63, 72, 76 and 79 under 35 U.S.C. 102(a)(1).
As noted above, Hansson teaches a particle size ranging from about 50-100 nm. Although this particle size is below about 110-130 nm as set forth by instant claim 66, it is considered sufficiently close to be considered obvious. See MPEP 2144.05(I) which states that obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, such as here. In the present case, the proportions are so close that one of ordinary skill would expect the nanoparticles of the art and those clamed to exhibit similar properties. It is also noteworthy that ‘about’ encompasses values above those of the prior art and below the stated numerical values claimed.
Hansson fails to teach a lipid having a structure:
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as defined by instant claim 42. Hansson also fails to teach the encapsulated mRNA as encoding for an antigen or antigenic fragment as set forth by instant claim 56.
Smith, like Hansson, is directed to lipid nanoparticles. The lipid nanoparticles are useful in the delivery of nucleic acids such as RNA encoding at least one cancer antigenic polypeptide (see [0719, 0720]; see instant claim ). The lipid of Smith is to have the generic structure:
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(see [0320]) wherein M and M1 may be -C(O)O- or -OC(O)- (see [0285]), R1, R2 and R3 are C5-30 alkyl groups (see [0281]) and l and m are respectively integers between 1-5 and 5-9 (see [0320]). R4 may be (CH2)n-oQ where Q is OH or N(R)R8 (see [0282, 0320]) wherein R is a C1-3 alkyl (see [0290]) and R8 is C3-6 carbocycle (i.e. cycloalkyl) (see [0287]). The alkyl of substituent R may be modified so as to possess a hydroxy group (see [0233]). A more narrow embodiment of Smith’s lipid is:
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(see [0403]) where R4 is defined as above. The structure where R4 is (CH2)n-oQ, Q is N(R)R8, R is a OH modified C1-3 alkyl and R8 is a C3-6 cycloalkyl would read on the structures of present claim 42. Smith teaches that their inventive lipids are useful in nanoparticle formulations as they exhibit decreased polydispersity and improved structural homogeneity (see Fig 10 and [0035]). Thus, it would have been obvious to identify lipids from within the broad framework of Smith for use in lipid nanoparticle compositions. If such an undertaking identified lipids such as those claimed, then this outcome would have been the product of ordinary skill and common sense, rather than one of innovation.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 1, 2, 7, 17, 31, 38, 44, 45, 50, 52, 54, 55, 62, 63, 72, 76 and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansson et al. (US 2020/0338004) in view of Ying et al. (WO 2022/152109; of record per IDS filed 02/18/2025).
Hansson is relied upon for disclosure described in the rejection of claims 1, 2, 7, 17, 31, 38, 44, 54, 55, 62, 63, 72, 76 and 79 under 35 U.S.C. 102(a)(1).
Hansson fails to teach a lipid as possessing a structure:
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as defined by instant claims 45, 50 and 52.
Ying, like Hansson, is directed to lipid nanoparticles for the delivery of genetic material.
The lipid nanoparticle has the following generic structure:
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(see claim 1), such as
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wherein
L1 and L2 may be -C(O)OR1- or -OC(O)R1- wherein R1 is a C6-24 alkyl;
n and m are 1 or 2;
G1, G2, and G3 are a C2-12 alkylene;
R3 is optionally substituted C1-12 alkylene; and
R4 is a C3-8 cycloalkyl (see claim 1).
An exemplified lipid described by Ying is
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(see compound 135, [0569]) (see instant claims 45, 50 and 52). Ying’s compounds 135 is comparable to the structure instant claim 52:
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except the ester linkage of Ying is -C(O)O- rather than the -OC(O)- claimed. However, Ying teaches that both esters linkages are suitable for their lipid compounds (see definitions for L1 and L2 above), and the manipulation of Ying to use the other ester linkage would have been an obvious modification. Moreover, one would have been motivated to modify Hansson’s lipid nanoparticle composition with Ying’s lipids as Ying teaches that their lipids provide improvements in structural homogeneity and polydispersity for the resulting nanoparticles (see [0034, 0035]).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
