DETAILED ACTION
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
Applicant's election with traverse of Group II, claims 78-96, 99-101 in the reply filed on 03/26/2026 is acknowledged. The traversal is on the ground(s) that the claimed compounds are novel and prior art fails to motivate one to make the structure. This is not found persuasive because the restriction was based on lack of unity. The core formula of the claimed structures was shown in the prior art, breaking unity of invention. Since the common technical feature of the claims was shown in the prior art, it was not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claim 77, 102 and 103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112—4th paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 99-101 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 99-101 are improper insofar as they depend from cancelled claim 98. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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) 78-96, 99-101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song et al., (CN114044741, cited in IDS).
Song et al. teaches compounds of the following formula:
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90
138
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(Abstract). The claimed compound YK-108
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141
309
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is a compound of the formula of Song et al. where G3 is C2 alkylene; G2 is C6 alkylene; G1 is C3 alkylene; L1 is C11 linear alkyl and L2 is C12-25 branched alkyl or
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104
304
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(see p. 6 paras. [0007]-[0013]). The prior art teaches a specific embodiment:
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223
474
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(p. 4, para. [0025]), which is close enough to the claimed compound to reasonably expect the same properties.
The prior art teaches:
The present disclosure is based on at least the following discovery: structure of cationic lipid compound and intracellular transfection efficiency, toxicity generated by the cell and no obvious corresponding relation between high expression and continuous expression in the animal body. small structure difference of the compound, the transfection efficiency and/or toxicity of the cell, high expression in the cell difference is very large, such as the compound YK-009 and YK-010, cell transfection efficiency difference is nearly 60 times, the toxicity difference of the transfection cell is more than 25 %; the expression of the compound YK-003 and YK-010 in the mouse body and the continuous expression difference can reach 50 times. (see 4th page, 3rd paragraph).
The compounds of Song et al., including the claimed YK 108, are “capable of simultaneously having high transfection efficiency and low toxicity to the cell” (Id. 4th paragraph)
The compounds of Song et al. are taught to be formulated in compositions requiring a carrier comprising the cationic lipids or pharmaceutically acceptable salts thereof (Abstract: clm. 78), wherein the molar ratio of cationic lipid to carrier is 30% to 70% (5th page, line 5 of translation; clm. 79). The carrier can further comprise a “neutral lipid” (Id. line 8; clm. 80), e.g., “phosphatidylcholine” (Id. lines 8-22; clm. 82), “DLPC” (Id.; clm. 83), wherein the molar ratio of cationic lipid to neutral lipid is “1:1 to 10:1” (Id. lines 6-7;clm. 81); a “structured lipid” (6th page, line 7; clm. 84), e.g., “cholesterol” (Id. line 9; clm. 86), wherein the molar ratio of cationic lipid to structured lipid is “1:1 to 5:1” (Id. lines 7-8; clm. 85); a “polymer-conjugated lipid” (6th page, 5th paragraph; clm. 87), e.g., “PEG” modified compounds (Id. 6th paragraph; clm. 89) or “DSPE-PEG2000” (Id. clm. 90), wherein the mol ratio amount of polymer-conjugated lipid is present from “0.5% to 5%” (Id. 5th paragraph; clm. 88); “other ionizable lipid compound” (Id. paragraph 10; clm. 93); “therapeutic agents” (Id. paragraph 11;clm. 94), wherein the mass ratio of carrier to agent is “15:1 to 25:1, preferably 16:1” (clm. 95; Id), e.g., nucleic acids molecules (clm. 96; Id at paragraph 12), such as DNA (clm. 99, 101; Id. paragraph 15) and RNA, e.g. “small interfering RNA (siRNA)” (clm. 100; 7th page, 1st and 2nd paragraphs).
In regard to claim 91, the prior art teaches an embodiment where the carrier comprises “the cationic lipid, the neutral lipid, the structural lipid, and the mol ratio of the polymer conjugated lipid is (25-65): (5-25): (25-45); (0.5-5), preferably 50:10:38:5:1.5” (6th page paragraph 8).
In regard to claim 92, the lipid particles have an average particle diameter of “10nm to 205 nm” (6th page paragraph 8) and multi-dispersion coefficient not more than 50% (Id.).
The prior art is not anticipatory insofar as it does not teach the exact formula of YK108;however, it would have been obvious to a person having ordinary skill in the art to make YK108 given that its core structure and option for variables in the structure are taught by Song et al. The artisan would have been further motivated to modify the core structure since small changes can have a big impact on efficacy. Song et al. teaches “small structure difference of the compound, the transfection efficiency and/or toxicity of the cell, high expression in the cell difference is large, such as the compound YK-009 and YK-010, cell transfection efficiency difference is nearly 60 times, the toxicity of the transfection cell is more than 25%; the expression of the compound YK-003 and YK-010 in the mouse body and the continuous expression difference can reach 50 times” (p. p. 11, 1st paragraph).
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
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