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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/24/2025 has been entered.
Amendments
Applicants’ amendments to the claims filed 9/24/2024 have been entered. Any objection\rejections from the previous office action filed 6/24/2024 not addressed below has been withdrawn.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao, Y., et al., (Sci. Rep., 2016), cited previously, in view of Mendes, J.B.E., et al., (Sci. World J., 2012), cited previously as evidenced by Shah, S., et al., (J. Photochem Photobiol B, 2017), cited previously, in view of Feczko et al. "Comparison of the preparation of PLGA–BSA nano- and microparticles by PVA, poloxamer and PVP",Colloids and Surfaces A: Physicochemical and Engineering Aspects, Volume 319, Issues 1–3, 15 April 2008, Pages 188-195.
Zhao teaches methods of making resveratrol containing polyester polymer nanoparticles comprising the steps of dissolving the polymer (PLGA) in a first solvent (dichloromethane) and resveratrol (second emulsifier) in a second solvent (ethanol) along with doxorubicin (therapeutic/biologically active agent) and then emulsifying this solution with PVA (first emulsifier) in water and drying to form particles. See entire disclosure, especially page 3, paragraph 7. Regarding claims 22-23, the solution of PVA in water of Zhao reads on applicant’s “second aqueous phase comprising the first emulsifier” as a broadest reasonable interpretation of the claims includes wherein the first and second aqueous phase may be the same chemical composition.
Zhao does not teach modifying the ratio of resveratrol in the compositions nor its effects on the particles.
Mendes teaches methods of making polyester polymer nanoparticles comprising the steps of mixing the polymers PHBV/PCL in the first and second solvents chloroform and methylene chloride and emulsifying the organic phase into an aqueous phase with PVA, drying to form particles, and modifying the amount of resveratrol in the compositions. See page 2, paragraph 6 and table 1. Mendes teaches that the particles have a smooth surface at low concentrations of resveratrol in PCL and a rough surface when high levels of resveratrol are used solidifying it on the surface and providing for a burst release of the drug as well as changes the size of the particles, drug loading, and the drug encapsulation efficiency. See figure 2, page 5, paragraph 6, and table 3. Regarding claims 7 and 17, Mendes teaches changing the concentration from 0-0.4 g/40 mL organic phase or 0-10 mg/mL. See table 1.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of the drug resveratrol in the PLGA nanoparticles in order to adjust the release rate, drug loading, encapsulation efficiency, and morphology of the particles in order to control the drug release from the particles. One of ordinary skill in the art at the time of the invention would have had a predictable expectation of success in making this combination as the prior art already encapsulates resveratrol and other drugs in PLGA nanoparticles using emulsification and Mendes teaches that you can control the drug loading and release as well as particle morphology by altering the drug loading in the particles.
Zhao and Shah do not state that doxorubicin is a detectable label.
Shah provides evidence that doxorubicin is fluorescent and can provide for information on changes in the local environment which is useful when synthesizing nano-particles for doxorubicin entrapment. See abstract.
Zhao while teaching use of PVA emulsifier is silent with respect to a specific molecular weight for the emulsifier.
Feczko is used for its teaching on emulsifiers such as PLGA (MW 8,000) and PVA (MW includes data point of 30,000) were well known at the time of the claimed invention to be useful in emulsion techniques to form particles. See entire disclosure, especially abstract and page 189 left col 2nd full ¶.
Since Zhao already teaches use of polymer emulsifiers one of ordinary skill would have a high expectation of success of using emulsifiers within the claimed molecular weight range such as those of Feczko with predictable results. Obviousness stems from the notion that Zhao already teaches the genus of the emulsifiers claimed and Feczko teaches the use of PLGA and PVA within the recited weight range. The artisan would recognize that, based on the disclosure of Zhao that numerous emulsifiers, including PLGA and PVA within the recited weight range could be substituted into the composition with similar results. Thus the claimed invention would have been prima facie obvious since 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Response to Arguments
Applicant's arguments filed 9/24/2025 have been fully considered but they are not persuasive. Applicants assert Zhao and Mendes do not teach an emulsifier with the required molecular weight now recited in claims 1 and 12. As noted in the modified rejection above such a limitation would be obvious when the secondary reference Feczko is considered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618