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 .
Election Acknowledged
Applicants’ election without traverse the invention of Group I and the species 306-012B having the structure:
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encompassing claims 1-3, 5, 10, 13-15, 18, 21, 22, 24, 26, 29, 69 and 85 is acknowledged. The restriction is made final without traverse.
It is noted that claims 41 and 57 is directed to an amide containing lipids rather than the esters as claimed and so are withdrawn from consideration as being directed to nonelected species.
Claims 1-3, 5, 10, 13-15, 18, 21, 22, 24, 26, 29, 41, 57, 65, 69, 85 and 93 are pending, claims 41, 57, 65 and 93 are withdrawn as being directed to nonelected subject matter and claims 1-3 5, 10, 13-15, 18, 21, 22, 24, 26, 29, 69 and 85 are presented for examination on the merits.
The following rejections are made.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/23/2023, 1/22/2024, 5/30/2024, 7/30/2024 and 12/4/2024 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 1-3, 5, 10, 13-15, 18, 21, 22, 24, 26, 29, 69 and 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xi et al. (WO 2019/152848), evidenced by Wang et al. (PNAS, 113(11), 2016, 2868-2873) and Croda Pharma: DSPE PEG2000 (2026, 1 page).
Xi describes a lipid like complex having the generic structure:
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(see page 2) wherein A includes
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(see page 14), B is
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, (see page 2), R1 and R2 are C1-20 alkyl (inclusive of C2/ethyl; see pages 2 and 5). X is linker having the structure:
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wherein G is O and L2 is O, W is S, m is zero, V is S (see page 3) and R5 is a C1-20 alkyl (see page 2) which is inclusive to dodecyl (C12 alkyl chain) (see page 5) (see instant claims 1-3, 5, 10, 13-15, 18, 69 and 85).
The lipid is made according to the following process:
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(see page 22) wherein the amine compound (see A above) reacts with the vinyl carbonyl compound to produce the final lipid product. It’s noted that the amine is ultimately substituted so as to possess two of the vinyl carbonyl units on the amine nitrogen. The resulting lipid where A is
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would be modified such that the flanking amines would be reacted so as to possess two of the vinyl carbonyl units as outlined/described above resulting in a lipid structure identical with that of the elected species.
The lipid is to be used to prepare lipid nanoparticles that encapsulate cargo molecules of various physical properties such as pharmaceutically active agents such as proteins and/or nucleic acids (see pages 23 and 54; see instant claim 29). The lipid concentration in such composition is taught to be 3.3 mg/L (see pages 30). Regarding instant claim 21, although Xi is silent regarding the ‘molar percentage’ of the lipid in the resulting composition, such is considered obvious because 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).
Lipid nanoparticles for delivering encapsulated mRNA to target cells are described wherein the nanoparticle composition includes the lipid, cholesterol, DOPE and DSPE-PEG2k (see page 31). It is noted that cholesterol is a steroid (see instant claim 22). DOPE is 1,2-diolcoyl-sn-glycero-3-phosphoethanolamine (see evidence to Wang, page 2869) which is a phospholipid (see instant claim 26) and DSPE-PEG2k is 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethylene glycol)-2000] which is a polymer-conjugated lipid (see evidence to Croda Pharma) (see instant claim 24).
The only difference between Xi and the instant claims is that Xi does not teach the specific combination of components as claimed in a single embodiment, or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Xi, but ‘such ‘picking and choosing’ within several variable does not necessarily give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 85 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 85 is dependent from “claim 0”. However, there is no “claim 0” and so claim 85 is unclear. Correction is required. For examination purposes, the Examiner will assume that the claim intended to depend on claim 1.
Although withdrawn, it’s noted that claim 57 also depends on “claim 0”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 5, 10, 13-15, 18, 21, 22, 24, 26, 29, 69 and 85 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 10, 12, 17, 22-26, 28, 50, 51, 56, 58, 59, 67, 84, 88 and 116 of copending Application No. 18/265561.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims in all the applications are drawn to a lipid composition comprising a lipidoids having an amine head (
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) and a hydrophobic tail (
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) where n4 is from 4-30. Moreover, both applications require the composition include an active agent such as a nucleic acid or protein. The scope of the claims in the cited applications are overlapping and the differences are considered to be obvious over each other. For example, the major difference between the two applications is the reference application describes antigens and the composition being in the form of a kit but such limitations are contemplated by the present application (see [0096, 0103]). Thus, the claims of the copending application are not patentably distinct over the instantly claimed subject matter.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-3, 5, 10, 13-15, 18, 21, 22, 24, 26, 29, 69 and 85 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 10, 12-16, 18, 21 and 24-27 of copending Application No. 18/845749.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims in all the applications are drawn to a lipid composition comprising a lipidoids having an amine head
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wherein Rb1, Rb2, Rb3 and Rb4 are
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. Thus, the claims of the copending application are not patentably distinct over the instantly claimed subject matter.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented
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
Prosecution Insights