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 1/23/2025 and 2/1/2024 have been 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 17, 18, 20, 21, 23, 24, 26, 27, 29, 30, 32, 33, 35 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benenato et al. (US 2019/0314292; of record).
Benenato is directed to nanoparticle compositions for intracellular delivery of therapeutic agents (e.g. mRNA; see claim 21) (see instant claims 20, 21, 32 and 33), the nanoparticle comprising novel lipids having the generic structure:
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(see Formula 1A, [0284]) wherein l is from 1-5, m is from 5-9, M1 and M are -C(O)O-, R’ is a C3-15 alkyl, R2 and R3 are C1-14 alkyl and R4 is –(CH2)nQ wherein n is 2, 3 or 4 and Q is -OH (see [0260, 0284, 0286]). An exemplified lipid according to the formula/substituents is
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(Compound 25, [0512]). Compound 25 anticipates the lipid of claims 17 and 18:
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where R1 is C8.
Benenato’s nanoparticle composition is to comprise additional lipids such as phospholipids (e.g. DSPC, DOPE; see [0578] and claim 6) (see instant claims 23, 24, 26 and 27), structural lipids (e.g. cholesterol; see [0576] and claim 8) (see instant claims 23, 24, 26 and 27) and PEG lipids (e.g. PEG-DMG; see [0575, 0710]) (see instant claims 23, 24, 29 and 30).
Benenato discloses that their lipid nanoparticle compositions may be administered to a subject, e.g. a mammal (see [0293]) (see instant claims 35 and 36).
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 17-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (US 2019/0314292; of record).
Benenato is relied upon for disclosure described in the rejection of claims 17, 18, 20, 21, 23, 24, 26, 27, 29, 30, 32, 33, 35 and 36 under 35 U.S.C. 102(a)(1).
Benenato fails to disclose a lipid according to claim 19:
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, e.g.
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wherein R1 is C7.
Although not explicitly disclosed by Benenato, the claimed lipid structure is obvious as Formula 1A
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(see 102(a)(1) discussion above) R2 and R3 are C1-14 alkyl (see [0284]). An exemplified lipid within the generic structure of Formula 1A is a lipid having the following structure:
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which corresponds to an R2 of C8 and a R3 of C8. R3 of Benenato is understood to correspond with R1 of the instant claim. It would have been obvious to vary the alkyl chain length from C1-14 as prescribed by Benenato. Modifying the above structure such that the R3 is C7 rather than C8 would have been obvious as it is within the general framework described by the reference and it would have been obvious to use the lipid in a nanoparticle comprising a phospholipid, structural lipid and PEG lipid. See MPEP 2143(I)(G).
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611
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