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 .
Election/Restrictions
1. Applicant’s election without traverse of the invention of Group I and the species of Compound 1 in the reply filed on 01/15/2026 is acknowledged.
Upon further considerations the restriction requirement between the inventions of Groups I-II and between the different compound species, as set forth in the Office action mailed on 11/17/2025 is withdrawn.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-13 and 15-18 are under examination.
Claim Objections
2. Claim 1 is objected to because of the recitation “each independently selected from absence” in line 10. Correction to “each is independently absent or selected from” is suggested.
3. Claim 1 is objected to because of the recitations “C1-C24alkylene, C2-C24alkenylene, C3-C8cycloalkylene, C3-C8cycloalkenylene”; and “branched C6-C24alkyl or a branched C6-C24alkenyl”.
Correction to “C1-C24 alkylene, C2-C24 alkenylene, C3-C8 cycloalkylene, C3-C8 cycloalkenylene”; and “branched C6-C24 alkyl or a branched C6-C24 alkenyl” wherever these recitations appear in the claim is required.
4. Claim 2 is objected to because of the recitation “m and n, identical or different, each independently is an integral number from 1 to 13”. Correction to “wherein m and n are identical or different and each is independently an integer from 1 to 13” is suggested.
5. Claim 3 is objected to because of the recitation “wherein x, y, m, and n, identical or different, each independently is an integral number from 0 to 13”. Correction to “wherein x, y, m, and n are identical or different and each is independently an integer from 0 to 13” is suggested.
6. Claim 4 is objected to because of the recitations “C1-C12alkylene, C2-C12alkenylene, C3-C8cycloalkylene, and C3-C8cycloalkenylene”.
Correction to “C1-C12 alkylene, C2-C12 alkenylene, C3-C8 cycloalkylene, and C3-C8 cycloalkenylene” is required.
7. Claim 5 is objected to because of the recitation “wherein x, y, m, and n, identical or different, each independently is an integral number from 1 to 12”. Correction to “wherein x, y, m, and n are identical or different and each is independently an integer from 1 to 12” is suggested.
8. Claim 8 is objected to because of the recitation “or represents” in line 5. Correction to “or is” is suggested.
9. Claim 8 is objected to because of the recitations “C1-C13alkylene or C4-C6cycloalkyl”; “C1-C12alkyl”; and “C6-C24alkyl” in line 5 and the last two lines. Correction to “C1-C13 alkylene or C4-C6 cycloalkyl”; “C1-C12 alkyl”; and “C6-C24 alkyl” is required.
10. Claim 9 is objected to because of the recitations “C6-C24alkyl”; and “C1-C24alkyl” in the last two lines. Correction to“C6-C24 alkyl”; and “C1-C24 alkyl” is required.
11. Claim 10 is objected to because of the recitations “C4-C13alkylene”; “L4 is absent or represents C1-C3alkylene”; and “C2-C8alkylene” in lines 6-8. Correction to “C4-C13alkylene”; “L4 is absent or C1-C3alkylene”; and “C2-C8alkylene” is required.
Claim Rejections - 35 USC § 101
12. 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.
13. Claims 15-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim do not fall within at least one of the four categories of patent eligible subject matter because the claims do not recite any method step, and thus, they are not drawn to a proper process claim under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112(b)
14. 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.
15. Claims 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 15-18 are indefinite because they merely recite a “use” without setting forth any active, positive step delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
16. Claims 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim 15 recites the broad recitations “gene therapy” and “gene vaccination”; the claim also recites “preferably the gene therapy is useful for the treatment of cancer and genetic diseases”, “more preferably the cancer is”, “preferably, the gene vaccination is used for the treatment of”, and “more preferably the pathogen is”, which are the narrower statements of the range/limitation.
Claim 16 recites the broad recitation “nucleic acid”; the claim also recites “preferably the nucleic acid is”, which is the narrower statement of the range/limitation.
Claim 17 recites the broad recitation “nucleic acid”; the claim also recites “preferably the nucleic acid is”, which is the narrower statement of the range/limitation.
Claim 18 recites the broad recitations “gene therapy” and “gene vaccination”; the claim also recites “preferably the gene therapy is useful for the treatment of cancer and genetic diseases”, “more preferably the cancer is”, “preferably, the gene vaccination is used for the treatment of”, and “more preferably the pathogen is”, which are the narrower statements of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim Rejections - 35 USC § 103
17. 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.
18. Claims 1-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (WO 20/061367), in view of both Fletcher et al. (J. Med. Chem., 2006, 49: 349-357) and Qiao et al. (Eur. J. Lipid Sci. Technol., 2013, 115: 483-489).
For examination under 35 U.S.C. 103, claims 15-18 are reasonably interpreted as being drawn to lipid nanoparticles carrying nucleic acids, with the wherein clause representing an intended use.
Benenato et al. teach nanoparticles comprising an ionizable cationic lipid, phospholipids, cholesterol, and a PEG lipid, where the nanoparticles encapsulate an mRNA. Benenato et al. exemplifies delivering EPO to the liver with nanoparticles comprising Compounds 3, 18, 24, 25, or 30 as the ionizable cationic lipid, with lipid MC3 serving as a control. Compound 25 provided the higher luciferase expression, followed by Compounds 3, 30, and 24 (see Abstract; [0059]; [0076]-[0078]; [0281], Compound 24; [0340]; [0343]; [0347]-[0348]; [0558]-0559]; p. 461, Table 3G; Example 11, [0573]-[0574], see especially Table 13). However, compound 24 has a double bond in one of its tails and has the structure
PNG
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72
230
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Greyscale
(see the Table in [0281]). Fletcher et al. teach that replacing the double bond with a triple bond doubles the transfection level in vivo with less associated toxicity (see Abstract; p. 352, column 2, first full paragraph; paragraph bridging p. 352 and 353). Based on these teachings, one of skill in the art would have found obvious to modify Compound 24 by replacing the double bond with a triple bond with the reasonable expectation that doing so would reduce toxicity and enhance its transfection efficiency in vivo. By doing so, one of skill in the art would have obtained a compound as recited in claims 1-10 and would have obtained nanoparticles as recited in claims 12, 13, and 15-18. The intended use recited in claims 15-18 is not given patentable weight because it does not state any distinct definition of any of the claimed limitations differentiating the claimed composition from the composition taught by the cited prior art. Thus, the intended use is of no significance to the composition structure and therefore, it is of no significance in claim construction.
Compound taught by the cited prior art is similar in structure with claimed compound 3 recited in claim 11, except that the head group is hydroxyethanolamine instead of hydroxypropylamine. However, one of skill in the art would have readily recognized that hydroxyethanolamine and hydroxypropylamine are homologs differing by one CH2 group. In searching for new ionizable cationic lipids, one of skill in the art would have found obvious to modify the headgroup taught by the cited prior art with the reasonable expectation that doing so would result in a compound suitable to be used as a transfection agent (see MPEP 2144.09). One of skill in the art would have reasonably expected to be successful in doing so because Qiao et al. teach that increasing the headgroup length from hydroxyethyl to hydroxypropyl enhances transfection efficiency (see Abstract; p. 486, Scheme 1; p. 488, column 1, last paragraph). By doing so, one of skill in the art would have obtained compound 3 (claim 11).
The compound cited by the prior art has a C9 linear alkynyl tail, while the elected compound 1 has a C7 linear alkynyl tail. However, there is no evidence of record indicating that using compound 1 leads in unexpected results over the prior art. Benenato et al. teach varying the linear tail (see [0281]). One of skill in the art would have found obvious to use routine experimentation and vary the length of the linear tail with the reasonable expectation that doing so would identify the length mediating optimal transfection. As held In re Peterson, 315 F.3d 1325, 1329-30, there is “a normal desire of scientists or artisans to improve upon what is already generally known”.
Routine optimization is not considered inventive and no evidence has been presented that the selection the claimed tails was other than routine or that the results should be considered unexpected in any way as compared to the closest prior art (see MPEP 2144.05 II).
It is noted that a sufficient showing of a secondary consideration (e.g. unexpected results) would obviate this and any further rejection of this type. Submission of a secondary consideration such as latent properties must be supported by objective evidence of a probative value (see MPEP 716.01).
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
19. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/Primary Examiner, Art Unit 1633
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