DETAILED ACTION
This office action is in response to the Applicant’s filing dated June 15th, 2026.
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 .
Priority
This application is a 371 of PCT/KR2022/006174 filed on April 29th, 2022; and claims benefit of foreign priority of KR10-2021-0056374 filed on April 30th, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 1-9 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on June 15th, 2026. Acknowledgment is made of Applicant’s amendment of claims 1, 3-6 and 9.
Notice of Change of Examiner
Please note that the Examiner prosecuting this application has been changed to Examiner Christopher Johnson of Art Unit 1691. Please address all future correspondences to Examiner Johnson.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
New Objections and/or Rejections
Necessitated by Claim Amendment
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.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ayad et al (Pharmaceutics, (2021), 13(3), 377, 1-18); in view of Lee et al (WO 2019/212288 A1); further in view of Goepferich et al (US 9,579,394 B2), cited in a previous Office action.
Regarding claims 1-6 and 9, Ayad teaches polylactic acid (herein referred to as PLA) nanoparticles comprising a cationic lipid for delivery of nucleic acids. Ayad further teaches PLA nanoparticles further comprise the cationic lipid DOTAP and teaches the use of the nanoparticles for delivery of mRNA and plasmid DNA (page 1, Abstract). Notably, Ayad’s disclosed PLA nanoparticle formulation does not comprise an amphiphilic polymer (page 3, Sections 2.1-2.2.3). Ayad reports nanoparticles having a mean hydrodynamic diameter of 245nm (page 6, Table 1). Ayad reports effective intracellular delivery of nucleic acids, demonstrating transfection of HeLa and DC2.4 cells with mRNA and plasmid with the nanoparticle formulation (pages 11-12, Sections 3.2-3.3 and Figure 6).
Ayad does not teach that the PLA is present in salt form or a kit wherein the nanoparticles and drug are contained in respective first and second chambers.
Lee teaches a composition for mRNA delivery wherein the mRNA forms a complex with a cationic compound through electrostatic interaction, and the resulting complex is encapsulated within a nanoparticle structure comprising PLA (page 3, paragraph [0013]; page 4, paragraph [0023]). Lee further teaches nanoparticles comprising a salt of a PLA, specifically sodium PLA (herein referred to as NaPLA), in the nanoparticle core; and expressly states the PLA salt is a separate component from the amphiphilic block copolymer (page 11, paragraphs [0069-0070]). Lee teaches that the PLA salt enhances hydrophobicity of the nanoparticle core and stabilizes the nanoparticles; further explaining that the carboxylate anion of the PLA salt binds more effectively to the cationic complex than PLA itself, thereby reducing the positive surface potential of the nanoparticles, decreasing capture/uptake by the reticuloendothelial system, and increasing delivery efficiency to target sites (page 11, paragraph [0069]). Lee discloses in Comparative Example 1 that water is an acceptable solvent for the mRNA, and pH is adjusted with 100mM sodium acetate buffer at pH 4.2; and the prepared nanoparticle composition is filtered through a 0.22 μm hydrophilic filter (page 18, paragraph [0121]).
Goepferich teaches that complexes of a polyanion, including a nucleic acid, and a cationic component may be formed spontaneously upon mixing two separately prepared solutions, wherein each component is dissolved in a solvent, e.g. water. Goepferich further expressly teaches that the separate solutions may be mixed during administration using a dual chamber syringe, and teaches that physicochemical parameters including pH, ionic strength and osmotic pressure may be adjusted before or after mixing (column 6, lines 14-16).
It would have been prima facie obvious to a person of ordinary skill in the art to modify the nanoparticle system of Ayad by employing the PLA salt, such as NaPLA as taught by Lee, and providing the resulting nanoparticle system in the dual chamber configuration as taught by Goepferich. Lee expressly teaches that the PLA salt is a nanoparticle component separate from the amphiphilic block copolymer, and that use of the PLA salt enhances hydrophobicity and stability of the nanoparticle, promotes more effective interactions with the cationic complex than PLA itself, reduces surface potential and reticuloendothelial uptake, and improves delivery efficiency to target sites. Goepferich further teaches that the components of a cationic/nucleic acid delivery system may be maintained in separate solutions and mixed upon administration using a dual chamber syringe. Accordingly, one of ordinary skill in the art would have had reason to employ the PLA salt of Lee in Ayad’s cationic lipid containing PLA nanoparticles to obtain the expressly taught stability and drug delivery benefits, and to contain the nanoparticles and nucleic acid drug in respective chambers according to Goepferich’s known dual chamber delivery configuration with a reasonable expectation of successfully preparing the desired drug containing nanoparticles upon mixing. Because the PLA salt is expressly disclosed by Lee as a component separate from the amphiphilic block copolymer, incorporation of the PLA salt into Ayad would not require incorporation of Lee’s amphiphilic block copolymer. The resulting nanoparticles drug delivery system represents no more than the use of prior art elements according to their established functions, yielding no more than predictable results.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Regarding claims 7-8, Ayad, Lee and Goepferich render obvious the kit of claims 1-6 and 9 as described in the above rejection.
Lee further teaches a preferred embodiment wherein cationic lipid is present in 2-14 parts, and PLA salt is present in 2-50 parts, per 1 part mRNA (page 12, paragraph [0073]); which mathematically corresponds to PLA salt:cationic lipid ratios of 0.14:1 – 25:1 as shown below.
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MPEP § 2144.05 states:
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all of this would result in the kit of instant claims 1-9 with a reasonable expectation of success.
Conclusion
Claims 1-9 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L JOHNSON whose telephone number is (571)272-1672. The examiner can normally be reached Monday - Friday 08:00AM - 5:00PM EST with Flex on Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights