Patent Application 17761863 - NOVEL HEADGROUP LIPID COMPOUNDS AND COMPOSITIONS - Rejection

Patent Application 17761863 - NOVEL HEADGROUP LIPID COMPOUNDS AND COMPOSITIONS

Title: NOVEL HEADGROUP LIPID COMPOUNDS AND COMPOSITIONS FOR INTRACELLULAR DELIVERY OF THERAPEUTIC AGENTS

Application Information

• Invention Title: NOVEL HEADGROUP LIPID COMPOUNDS AND COMPOSITIONS FOR INTRACELLULAR DELIVERY OF THERAPEUTIC AGENTS
• Application Number: 17761863
• Submission Date: 2025-04-07T00:00:00.000Z
• Effective Filing Date: 2022-03-18T00:00:00.000Z
• Filing Date: 2022-03-18T00:00:00.000Z
• National Class: 424
• National Sub-Class: 450000
• Examiner Employee Number: 97293
• Art Unit: 1619
• Tech Center: 1600

Rejection Summary

• 102 Rejections: 0
• 103 Rejections: 2

Cited Patents

No patents were cited in this rejection.

Office Action Text

    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 .
DETAILED ACTION

Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-7, 10-15, 17-20, 24-26, 28 and 29, in the reply filed on 18 Feb 2025 is acknowledged.  Applicants also elected that the compound of Formula (A-1) is compound 66 
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, the phospholipid is DSPC, the structural lipid is cholesterol, the PEG lipid is PEG-1 
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and the therapeutic agent is mRNA in response to the species election requirement.
Claims 10-15, 17, 20, 30, 32 and 33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. It is noted that claim 20 is withdrawn as the elected PEG lipid of PEG-1 does not fit within one of the PEG lipid genus groups listed. 
Claims 1-7, 18, 19, 24-26, 28 and 29 are under consideration to the extent of the elected species, i.e., that the compound of Formula (A-1) is compound 66, the phospholipid is DSPC, the structural lipid is cholesterol, the PEG lipid is PEG-1 and the therapeutic agent is mRNA.

Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 Nov 2022 and 18 Feb 2025 are in compliance with the provisions of 37 CFR 1.97, except where noted.  Accordingly, the information disclosure statement is being considered by the examiner.
Citation number 406 submitted in the IDS filed 15 Nov 2022 was not considered as a copy was not provided. 

Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: in the prior-filed application, Application No. 62/902,928, the applicant failed to provide adequate written description support for claims 1-7, 18, 19, 24-26, 28 and 29. Accordingly, priority cannot be granted at this time, thus claims 1-7, 18, 19, 24-26, 28 and 29 are granted the filing date of PCT/US2020/051629 (18 Sep 2020).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA  35 U.S.C. 112, except for the best mode requirement.  See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/902,928, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA  35 U.S.C. 112, first paragraph for one or more claims of this application.  Application ‘928 fails to provide support for compounds of the instant claims.  For example, the ‘928 application does not disclose the sulfated headgroups (e.g. NRS(O)2RSX) as required per the instant claims. Accordingly, claims 1-7, 18, 19, 24-26, 28 and 29 are not entitled to the benefit of the prior application.
	
	
Specification
The disclosure is objected to because of the following informalities: 
The first sentence of the abstract contains “the disclosure features” which is a phrase that can be implied and is not appropriate for the abstract. 
Appropriate correction is required.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc.  In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.

Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites the functional group “C(O)NR14R14’” and in three lines from the end of the claim it defines “R14’”. The apostrophe is not in superscript in the first recitation (C(O)NR14R14’) but it is superscript in the second recitation (R14’). These should match as either superscripted or non-superscripted for consistency. 
Appropriate correction is required.

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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary.  Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (WO 2017/049245, published 23 Mar 2017, listed in IDS filed 15 Nov 2022).
Benenato teaches lipid nanoparticle compositions ([0004]) and that the nanoparticle compositions include a lipid component such as Formula (II) ([0017]). The structure of Formula (II) is 
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 ([0014]). Benenato teaches options for the variables in the formula where l is 5, M and M1 may be -C(O)O-, and R2 and R3 may be C8 alkyl ([0014]) and R’ may be branched undecan-3-yl ([0092]). Benenato teaches that R4 is –(CH2)nQ where n may be 3 ([0014]) and Q may be -N(H)S(O)2R ([0109]) and R may be C2 alkyl ([00126]). 
When the variables discussed above are selected, the resulting structure is 
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which is the same as the elected species of compound 66 and claims 1-7 and 18.
Benenato does not expressly teach selecting the functional groups for each of the variable of Formula (II) with sufficient specificity to rise to the level of anticipation for compound 66 of the instant claims. 
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have a compound with the structure of compound 66. One of ordinary skill in the art would have been motivated to do so as lipid nanoparticle compositions comprising compounds of Formula (II) are taught by Benenato and functional groups for the l, M, M1, R1, R2, R3 and R4 variables include groups that render the structure of compound 66 when selected. One of ordinary skill in the art would have a reasonable expectation of success in forming the structure described above as each of the functional groups are suitable for the structures of the nanoparticle compositions, as taught by Benenato, and thus the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions. 
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Benenato.
	

Claims 19, 24-26, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (WO 2017/049245, published 23 Mar 2017, listed in IDS filed 15 Nov 2022) as applied to claims 1-7 and 18 above, and further in view of Himansu et al. (WO 2019/136241, published 1 July 2019).
The teachings of Benenato are described supra. 
Benenato further teaches that the nanoparticle compositions may further include phospholipids, PEG lipids, structural lipids ([0002], [0022]) and that the phospholipids may include DSPC ([00193]) and the structural lipids may include cholesterol ([00191]). Benenato thus renders obvious the form of empty lipid nanoparticles comprising a phospholipid a structural lipid and a PEG lipid as in claims 19 and 24. Benenato teaches that the nanoparticle composition may be used for delivering therapeutic and/or prophylactic agents such as mRNA ([0022]), rendering obvious the loaded nanoparticle of claims 25, 26 and 28. Benenato teaches the inclusion of a pharmaceutically acceptable carrier ([00332]), rendering obvious instant claim 29. 
Benenato does not teach the specific PEG-lipid of PEG-1 (i.e. the elected species of PEG lipid). This deficiency is made up for in the teachings of Himansu. 
Himansu teaches the delivery of mRNAs via a lipid nanoparticle delivery system (page 2 lines 28-30). Himansu teaches nanoparticle delivery agents that include ionizable lipids, PEG-modified lipids, phospholipids and structural lipids (page 138 lines 6-8). Himansu teaches that PEG lipids used in the compositions include compounds of Formula (VI) (page 160 lines 6-9) such as compound I 
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(page 161 lines 4-5). Himansu teaches an embodiment where the delivery agent includes the PEG lipid compound I in combination with components such as DSPC and cholesterol (page 211 lines 25-26). 
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a PEG modified lipid such as Compound I (i.e the same compound as PEG-1 of the instant claims) as taught by Himansu as the PEG lipid in the compositions of Benenato. Lipid nanoparticles comprising PEG lipids for delivering mRNA are known, as taught by Benenato, and a PEG lipid such as Compound I is known as a suitable PEG lipid for constructing mRNA delivery nanoparticles, as taught by Himansu, rendering it obvious to have included the compound I PEG lipid in the nanoparticles of Benenato.  The compound I PEG is even taught as suitable in combination with components such as DSPC and cholesterol, which are taught by Benenato and further renders obvious the combination. One would have a reasonable expectation of success as the PEG compound I is known for use in similar mRNA delivery nanoparticle compositions as those of Benenato and thus the use of the PEG lipid compound I of Himansu merely represents using a known prior art element for the same purpose of forming a mRNA delivery nanoparticle. 
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.

	
Conclusion
	No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
	
/ANNA R FALKOWITZ/Primary Examiner,  Art Unit 1600