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 .
Claim Status
Applicants' response to restriction requirement filed June 4, 2026 have been received and entered. Claims 1-17 are pending in this application.
Priority
Acknowledgment is made of applicant's claim for priority on Application PCT: CN2023/082055 filed on March 17, 2023 and Chinese Application CN202210201173.1 filed on March 25, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 24, 2024 and June 10, 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.
Election/Restrictions
Applicant’s provisional elections of claims 1-9 and 16 and 17 (group I), drawn to a a cationic lipid compound of formula (I). Applicant traverses the restriction requirement arguing that as claims 10 and 13 depend from claim 9 which depends from claim 1 there is unity of invention. Applicant’s argument has been fully considered, but not found persuasive because the groups lack unity of invention because even though the inventions of these groups require the technical feature of a cationic lipid compound of formula (I) this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ansell et al. (Pub. No.: WO 2013/086322; Pub. Date: Jun. 13 2013). Ansell discloses a cationic lipid of formula (1)
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(Abstract and pages 2-4 page 28).
Applicant elects the species of Compound for search purposes. Because Applicants did not distinctly and specifically point out the supposed errors in the species election, the species election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Claims 1-9 ad 16-17 are currently under examination.
The election restriction requirement is deemed proper and made FINAL.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to the use of a cationic lipid compound according to claim 1 in the preparation of a delivery system of mRNA. The use claim 16 is not a method, process, machine, or composition of matter and therefore does not fit into a patentable class of subject matter. In the interest of compact prosecution claim 16 will be interpreted as a composition claim. Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: how is the cationic limpid compound of claim 2 used in a the preparation of a delivery system for mRNA or what is the structure and components of the delivery system. The claim merely recites use of the cationic lipid components of claim 1 in the preparation of a delivery system for mRNA of claim 1 without any active positive step or what is the form or in the preparation. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claim(s) 1-7 and 16-17 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ansell et al. (Pub. No.: WO 2013/086322; Pub. Date: Jun. 13, 2013).
Regarding claims 1-7 Ansell discloses a cationic lipid of formula (1)
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(Abstract and pages 2-4).
Wherein specific embodiments include:
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(page 28).
The synthesis of compound:
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page 48
Regarding claims 16 and 17, Applicant should note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this instance the intended use is the use as a delivery system for mRNA. Ansell discloses that the cationic lipid may be incorporated into a lipid particle for delivery of nucleic acids (abstract). As Ansell discloses the cationic lipid compound according to claim 1 utilized in a deliver system of an active (specifically nucleic acids as fully set forth above, it must be capable of delivery of mRNA.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
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 used the cationic lipid compound of formula (I) and salt thereof as a lipid nanoparticle to deliver the mRNA active agent wherein (abstract) wherein n is 1 and p is 2 (claim 1), R1 is:
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as disclosed by Ansell, as instantly claimed, with a reasonable expectation of success at the time of filing as a matter of design choice (Abstract pages 2-4). Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so and have a reasonable expectation of success because Ansell had already disclosed the cationic lipid formula for use in nucleic acid delivery as fully set forth above. It would have only required routine experimentation to modify the composition of Ansell to achieve the structure of the instant claims.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective fling date of the claimed invention.
Claims 1-9 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Brito, et al. (Pub. No.: WO 2015/095340; Pub. Date: June 25 2015).
Applicant has elected the species: Compound 2
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Regarding claims 1-9, Brito discloses a cationic lipid compound of formula (I) and salt thereof, wherein formula (I) is
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(abstract)
Wherein n is 1 and p is 2 (claim 1), R1 is:
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(page 9)
R2 is
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(page 11)
Herein R4 is hydrogen (page 7 bottom) and
L1 is a bond (page 5) and R3 is:
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(page 6) wherein the carbon connected to the oxygen is C1 and tail alkyl is C10.
The difference between Britio and instant Compound 2 is that the R3 alkyl tail of R3 has 11 carbons while Brito discloses a ten carbon alkyl.
Pursuant to MPEP 2144.09 a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril).
Regarding claims 16-17 Brito discloses wherein the lipid composition is for delivery of an active agent (title and abstract) such as RNA (page 4 lines 4-24) including mRNA (page 21 bottom of page, page 43 line 11, and page 62 lines 6-9) wherein the lipid is in nanoparticle form (claim 11).
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 used the cationic lipid compound of formula (I) and salt thereof as a lipid nanoparticle to deliver the mRNA active agent wherein (abstract) wherein n is 1 and p is 2 (claim 1), R1 is:
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(page 9)
R2 is
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(page 11)
Herein R4 is hydrogen (page 7 bottom) and
L1 is a bond (page 5) and R3 is:
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(page 6) wherein the carbon connected to the oxygen is C1 and tail alkyl is C10 as disclosed by Brito, as instantly claimed, with a reasonable expectation of success at the time of filing as a matter of design choice. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so and have a reasonable expectation of success because Brito had already disclosed the cationic lipid formula for use as an mRNA delivery agent as fully set forth above. It would have only required routine experimentation to modify the composition of Brito to achieve instantly elected Compound 2.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective fling date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA R FALKOWITZ whose telephone number is (571)270-3386. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Zachariah Lucas, can be reached at (571) 272-0905. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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