DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6 are withdrawn.
Claims 7-15 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 11/21/2025 has been entered.
Claims 7 and 10-15 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the specification and rejections of the claims under 35 U.S.C. 112(b).
Claims 13-14 are newly objected to due to the amendment.
The rejection of claims 7-15 under 35 U.S.C. 103 has been modified to address the amendment and maintained.
Response to Arguments
Applicant’s arguments, see Remarks (pages 6-9), filed 11/21/2025, with respect to the rejection of claims under 7-15 have been fully considered and are persuasive due to the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Weigandt, Priestley, and Lovell.
Arguments directed to the claims as newly amended (Remarks, pages 6-7) are not persuasive in view of the new rejections presented below wherein the new limitation of equilibrating for at least two minutes is addressed.
Applicant argues that Weigandt, even when combined with Lovell, does not suggest or otherwise contemplate forming monodisperse polymer micelles with DLS size polydispersities less than about 0.2 in aqueous conditions following single-step dialysis or evaporation (Remarks, page 7). This argument is not persuasive, because as stated previously, Weigandt teaches a polydispersity index is calculated for each sample (Weigandt, page 7, paragraph 0076) and teaches an example with a polydispersity index of 0.120 (Weigandt, page 7, paragraph 0077, 1st sample), which lies within the claimed range of less than about 0.2. As evidenced by Lovell, a polydispersity index of less than 0.5 corresponds to a monodisperse sample (Lovell, page 7, paragraph 0080).
Applicant argues that Weigandt describes directly dialyzing, which does not lead to monodisperse micelles (Remarks, pages 7-9). This argument is not persuasive, because as stated above, Weigandt teaches a polydispersity index which lies within the claimed range, and as evidenced by Lovell, corresponds to a monodisperse sample.
Information Disclosure Statement
The information disclosure statement filed 11/24/2025 has been considered.
New Claim Objections
Claims 13-14 are objected to because of the following informalities. Appropriate correction is required.
Regarding claims 13-14, “ wherein the conducting a single-step” should read “wherein the single-step” as stated in claim 15.
New 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.
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.
Claims 7-15 are rejected under 35 U.S.C. 103 as being unpatentable over Weigandt (US 20150051181 A1; IDS reference, 11/17/2022), further in view of Priestley (WO 2018067469 A1) and Lovell (US 20170135955 A1; IDS reference, 11/17/2022). Weigandt and Lovell were cited previously by the Examiner.
Regarding claim 7, Weigandt teaches a process for the production of nanoparticles (Weigandt, claim 1) from amphiphilic block copolymers (Weigandt, claim 5), wherein the nanoparticle can be a micellar formulation (Weigandt, page 6, paragraph 0074) and wherein the polymer is dissolved in an organic solvent and an aqueous phase (i.e., a mixed solvent comprising water and a non-aqueous co-solvent) with constant stirring/agitation, followed by removal of the organic solvent in vacuo (i.e., an evaporation process for removal of the non-aqueous solvent; Weigandt, page 1, paragraph 0009). Weigandt further teaches dialysis of a polymer solution against water (Weigandt, page 1, paragraph 0015) and teaches the composition can be freeze-dried (Weigandt, page 3, paragraph 0032).
Weigandt teaches the method as stated above, with preferably mixing the solutions (i.e., the aqueous and non-aqueous solvent) with constant stirring, shaking, or optionally with the use of ultrasound (Weigandt, page 2, paragraph 0023), but does not specify how long the mixing (i.e., equilibration) should last. Priestley teaches a preparation of kinetically frozen nanoparticles (Priestley, page 21, paragraph 0058), wherein the nanoparticles are prepared by mixing a polymer with THF (i.e., a non-aqueous solvent) and water and stirring for 5 minutes before removing the solvents (Priestley, page 45, paragraph 00126).
Weigandt teaches a polydispersity index is calculated for each sample (Weigandt, page 7, paragraph 0076) and teaches an example with a polydispersity index of 0.120 (Weigandt, page 7, paragraph 0077, 1st sample), which corresponds to a monodisperse sample due to the polydispersity index of less than 0.5 as evidenced by Lovell (Lovell, page 7, paragraph 0080). Weigandt does not specify that freeze drying results in kinetically frozen micelles. Lovell, however, teaches a kinetically frozen micelles (Lovell, page 4, paragraph 0037), which can be monodisperse (Lovell, page 7, paragraph 0080) and teaches freeze drying as a step “c” (Lovell, claim 13) with micelles determined as kinetically frozen in a step “d” (Lovell, page 4, paragraph 0037).
Weigandt, Priestley, and Lovell are considered to be analogous to the claimed invention, because all are in the same field of polymer micelle formulations. 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 optimized the process taught by Weigandt to stir the solution during the dissolving step for the 5 minutes taught by Priestley, because both references teach the dissolution of a polymer in THF, adding water, then evaporating the solvent (Weigandt, page 6, paragraph 0072; Priestley, page 45, paragraph 00126), and because Weigandt does not specify a time required for this mixing, it would have been obvious to optimize the mixing time based on what is known in the art. It also would have been prima facie obvious to one of ordinary skill in the art to have expected the freeze drying of the micelles taught by Weigandt to have resulted in stable, tunable, and non-toxic kinetically frozen micelles as taught by Lovell (Lovell, page 19, paragraph 0167).
Regarding claim 8, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches the block copolymer can contain polystyrene (i.e., comprised of styrene monomer units; Weigandt, claim 6).
Regarding claim 9, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches the block copolymer can be polyethylene glycol-polystyrene (i.e., comprised of polystyrene and polyethylene glycol blocks; Weigandt, claim 7).
Regarding claim 10, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches the block copolymer can be polyethylene glycol-polystyrene (i.e., “PS-PEG” block copolymer; Weigandt, claim 7) and teaches the polymer is dissolved in organic solvent and water (Weigandt, claim 1) and the organic solvent can be acetone (Weigandt, claim 9).
Regarding claim 11, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches constant stirring or shaking optionally with the use of ultrasound (i.e., sonication) during the mixing (i.e., equilibration) of the solution (Weigandt, page 2, paragraph 0023).
Regarding claim 12, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches constant stirring or shaking optionally with the use of ultrasound (i.e., a method of mechanical agitation) during the mixing (i.e., equilibration) of the solution (Weigandt, page 2, paragraph 0023).
Regarding claim 13, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches direct (i.e., single-step) dialysis against water or buffer in a dialysis device, such as dialysis membranes (Weigandt, page 1, paragraph 0015), and exemplifies a dialysis for 24 hours (i.e., greater than 10 minutes; Weigandt, page 6, paragraph 0068).
Regarding claim 14, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches a direct (i.e., single-step) dialysis in which the dialysis is carried out against water and wherein the water is replaced once (i.e., the aqueous reservoir is replaced with fresh water once; Weigandt, page 6, paragraph 0068).
Regarding claim 15, Weigandt, Priestley, and Lovell together teach all the elements of the current invention as applied to claim 7. Weigandt teaches a single-step in which a 2 mL nanoparticle solution is dialyzed against 5 liters of saline (i.e., a larger volume than the solution being dialyzed; Weigandt, page 8, paragraph 0079).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613