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 .
Amendments
Applicants’ amendments to the claims filed 4/13/2026 have been entered.
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. This modified rejection was necessitated by amendment.
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.
Regarding the new limitation on the ratio of 1st to 2nd solvent in the organic phase, Zhao is silent with respect to a ratio in the claimed range. However, the preparation of emulsion compositions having variable amounts of solvents in each phase is within the level of skill of one having ordinary skill in the art at the time of the invention. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
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 4/13/2026 have been fully considered but they are not persuasive.
Applicants assert the Zhao reference does not teach the claimed ratio and the secondary references do not cure the deficiency. Applicants assert their ratio provides a useful utility in that the particles shown in Fig. 5A-D led to stark changes in morphological characteristics of the resultant polymer particles.
As noted above generally differences in concentration will not support the patentability absent a showing of criticality. Applicants assert the examples seen in Fig 5 A-D show increases in morphological characteristics including increased surface area, however these examples which require specific ingredients including resveratrol and PVP are not commensurate with the generic scope of the pending claims. The claims in their current state are completely generic with respect to the ingredients used to make the particles. Clearly the properties of the particle would change dependent on the type of solvents, polymers and emulsifiers used. The claims are simply too generic in scope to be captured by the very specific examples. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02d. Therefore, applicants have not met their burden to show the criticality of the claimed ratio.
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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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618
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