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 statements (IDS) submitted on 11/6/2025, 8/21/2025 and 7/22/2025 have been considered by the examiner.
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 1-4, 9-13, 15-20, 22, 23 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergland et al. (WO 2020/131656).
Berglund teaches a lipid nanoparticle composition for use in the treatment of cancer and its method of use (see claim 78; see instant claim 27), the composition comprising 20-70 mol % cationic (i.e. ionizable) lipid, e.g. DODMA (DODMA comprises a lipid headgroup having a tertiary amine) (see pages 35 and 45; see instant claims 16 and 17), 5-45 mol % neutral lipid, e.g. DPPC, DOPE, DSPC (see pages 35 and 45; see instant claim 20), 0.5-15 mol% PEGylated lipid, e.g. PEG-ceramides, PEG-diacylglycerols (see pages 35 and 43-44; see instant claim 22) and an oil component, e.g. squalene (a fusogenic oil having fewer than 3 rings and a C12-C40 alkyl or alkylene chain) (see pages 48 and 51; see instant claims 1, 6 and 9-13) in an amount of between 2-20% (by volume). See MPEP 2144.05 regarding obviousness of overlapping ranges.
It is noted that Berglund teaches the (fusogenic) oil component by volume % rather than mol %. However, if the vol % did not already overlap with that claimed, one of ordinary skill in the art would have been capable of working within the guidance of Berglund to identify concentrations useful for producing lipid nanoparticles. If it were found that a 5-50mol% of fusogenic oil resulted in stable lipid nanoparticles, then this would have been the product of ordinary skill and common sense as the prior art already provided the framework for the claimed invention. Where the general conditions of a claim are described in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). A similar rationale is applied to the claimed ratios of the fusogenic oil (squalene) to the cationic lipid and to the PEGylated lipid as stated by instant claims 18 and 23.
Berglund’s lipid nanoparticles are to encapsulate a therapeutic agent such as an antisense RNA, a PD-L1 antibody and an immune receptor agonist such as a TLR agonist, e.g. TLR7, TLR8, TLR9 (see page 3; see instant claims 1, 2 and 4). It is taught that TLR agonists (in combination with RNA) results in regression of tumors and significant improvement in patient survival. An exemplified TLR agonist is resiquimod (see page 12; see instant claim 3).
The only difference between Berglund and the instant claims is that Berglund does not teach the claimed structure in a single embodiment, or with sufficient specificity to be anticipatory. The specific combination of features claimed is described within Berglund, but ‘such ‘picking and choosing’ does not yield anticipation. However, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP 2141(I).
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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Berglund et al. (WO 2020/131656) as applied to claims 1-4, 9-13, 15-20, 22, 23 and 27 above, and further in view of Yantasee et al. (US 2021/0030679).
Berglund fails to teach the TLR9 agonist as being SD-101. Berglund also fails to teach a composition which comprises a TLR agonist and an antisense oligonucleotide capable of reducing expression of PD-L1.
Yantasee, like Berglund, is directed to compositions and methods for the treatment of cancers by providing nanoparticulate compositions containing TLR agonists and oligonucleotides that act as immune checkpoint inhibitors (see [0129]). Exemplified TLR agonists include SD-101 and resiquimod (see [0070, 0136]). Oligonucleotides include antisense oligonucleotides that act as immune checkpoint inhibitors that target PD-L1 (see [0129-0130]). Thus, it would have been obvious to modify Berglund to include other TLR agonists and immune checkpoint inhibitors, such as SD-101 and an antisense oligonucleotide that targets PD-L1 respectively, as a) these compounds are known as useful in treating cancer and b) they broadly overlap with the compounds (TLR agonists) and immune checkpoint inhibitors (PD-L1 antibodies) contemplated by Berglund. The selection of a known material (e.g. SD-101, antisense oligonucleotide targeting PD-L1) based on its suitability for its intended use (e.g. treating cancer) is supportive of obviousness. See MPEP 2144.07. See also MPEP 2144.06(I).
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
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