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 .
Acknowledgement of Receipt
Applicant’s Response, filed 3/25/2026, in reply to the Office Action mailed 12/31/2025, is acknowledged and has been entered. Claim 1 has been amended. Claims 1-6 and 9-20 are pending, of which claims 13-20 are withdrawn from consideration at this time as being drawn to a non-elected invention. Claims 1-6 and 9-12 encompass the elected invention and are examined herein on the merits for patentability.
Response to Arguments
Applicant’s arguments have been fully considered. Any rejection not reiterated herein has been withdrawn. The Examiner’s response to Applicant’s arguments is incorporated herein.
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.
Claim(s) 1-6 and 9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Basilion et al. (US 2018/0064831) in view of Dwivedi et al. (ACS Appl. Mater. Interfaces, 2020, 12, p. 23737-23751), for reasons set forth in the previous Office Action.
Claim(s) 1-6 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Basilion et al. (US 2018/0064831) in view of Dwivedi et al. (ACS Appl. Mater. Interfaces, 2020, 12, p. 23737-23751), in further view of Wheatley et al. (US 5,352,436), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that neither Basilion nor Dwivedi, alone or in combination, discloses or suggests the specific amended limitations now recited in claim 1, namely: (i) relative to 1 mol of the lipid, the content of surfactant B is 0.2 mol to 0.5 mol, and the content of the magnetic nanoparticle is 0.1 mol to 0.3 mol; and (ii) the molar ratio of the magnetic particle to the surfactant B is 1:0.6 to 1:2.5. Applicant asserts that Basilion does not disclose any amount of a citric-acid-based compound relative to lipid, does not disclose any amount of a magnetic nanoparticle relative to lipid, and does not disclose any molar ratio between a magnetic particle and a citric-acid-based compound. Applicant contends that Basilion's disclosure of a poloxamer:lipid molar ratio does not fill these gaps; and that Dwivedi likewise does not disclose the claimed molar relationships. Dwivedi states only that the quantity of magnetic nanoparticles was optimized to obtain maximal loading of magnetic nanoparticles in magnetoliposomes. Applicant argues that at most, Dwivedi describes a loading or formulation effort directed to maximizing nanoparticle loading, not the specific quantitative composition now claimed. Applicant asserts that the amended claim is therefore directed to more than the mere optimization of a known result-effective variable; rather amended claim 1 now requires a specific quantitative composition architecture that is absent from the cited references.
Applicant’s arguments have been fully considered but are not found to be persuasive. It is noted that Basilion teaches that Pluronic L10 (MW 3200, PPO/PEO units of 49.7/7.3), at three Pluronic:lipid molar ratios (0.02, 0.2, and 0.4), was incorporated into the lipid film composed of a mixture of DPPC, DPPE, DPPA and DSPE-PEG (paragraph 0121). The incorporation of Pluronic L10 significantly decreased the surface tension, especially at a ratio of 0.2 (paragraph 0122), which is consistent with the instantly claimed ratio of surfactant A to lipid. While Basilion does not specifically teach the amount of (citrate stabilized) iron oxide nanoparticles which are incorporated, it is considered that one of ordinary skill in the art would have been capable of optimizing the amounts and ratio of citrate, magnetic nanoparticle and lipid as a means of incorporating the desired amount of magnetic nanoparticle into echogenic lipid particle, e.g. as in optimized loading, as taught by Dwivedi. For example, citrate stabilized nanoparticles having the following ratios were prepared in the Supporting Information of Dwivedi, FeCl3•6H2O (5 mmol) and FeSO4•4H2O (2.5 mmol) was dissolved in deionized water (15 mL). The reactor was connected to a thermostat and immersed additionally in an ultrasonic bath. The resulting solution was heated to 70°C and ammonia solution (4 mL, 28 wt %) was added drop wise. The resulting MN was stabilized using sodium citrate (2 mmol, 0.5 g/mL) solution.
On page 23738 of Dwivedi, DSPC, cholesterol, and DSPE-PEG2000-maleimide (molar ratio 60:20:20) was prepared by dissolving the lipids in pure chloroform and drying them as a thin film by rotavopour. Further, the dry film was hydrated with the aliquot of MNs in 250 mM ammonium sulfate solution using a rotary evaporator for 30 min while rotating at 90 rpm followed by a freeze−thaw cycle. The size of the obtained magneto-liposomes (MLs) was further reduced using a mini extruder and a Whatman 200 nm pore size polycarbonate membrane. The quantity of MNs was optimized to obtain the maximal loading of MNs in MLs. DOX-MLs were prepared by incubating 5 mL suspension of MLs with 10 mg/mL DOX solution at 50−60 °C for 4 h.
As such, one of ordinary skill in the art could have readily adapted the synthetic methods as by adjusting ratios of surfactants with the result of optimizing magnetic nanoparticle loading. Furthermore, differences in concentration or temperature will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; or In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Conclusion
No claims are allowed at this time.
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.
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/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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