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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/9/2026 has been entered.
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 1-53, 55-58 and 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Li (Journal of Controlled Release, 2001) in view of Xia (Journal of Materials Chemistry B, 2014) in further view of Sah (Recent Trends in Preparation of Poly(lactide-co-glycolide) Nanoparticles by Mixing Polymeric Organic Solution with Antisolvent, Journal of Nanomaterials Volume 2015, Article ID 794601, 22 pages). Li teaches a mesoscale nanoparticle comprising a core comprising poly(lactic-co-glycolic acid) (PLGA) and a surface coating comprising polyethylene glycol (methoxy PEG) with a zeta potential of -16.1 mV (a surface charge between -40 mV to +40 mV), wherein the composition has a particle size of about 200 nm (abstract; Materials and methods). The mesoscale nanoparticle is used to encapsulate bovine serum albumin for administration to a patient (Materials and methods). The molecular weight of the PLGA is 45 kDa (from 7 kDa to 54 kDa ) (Materials and methods). The molecular weight of the PEG is 5 kDa (Materials and methods). The nanoparticles are monitored in vivo using 125I (a method for monitoring a patient, the method comprising administering the mesoscale nanoparticle composition to the patient, wherein the mesoscale nanoparticle composition comprises an imaging agent, and imaging the administered mesoscale nanoparticle composition) (Materials and methods).
Li fails to teach the presently recited diameters, a diameter of 400 nm +/- 25% or a diameter of 400 +/- 10%, and further fails to teach at least one therapeutic agent, and the doses required by claim 61.
Xia teaches a nanoparticle comprising doxorubicin encapsulated with bovine albumin for delivery of the doxorubicin (a therapeutic agent; an anti-cancer agent) to a patient (abstract). The composition has long-term stability and provides localized release of doxorubicin which enhances the efficiency of killing cancer cells (Conclusions).
Sah is directed to poly(lactide-co-glycolide)-PEG nanoparticles used as carriers of therapeutic agents into the body (Abstract; Introduction). Sah teaches a nanoparticle diameter range of 252 to 330 nm with encapsulation efficiencies of almost 100% (Section 6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to encapsulate doxorubicin in the bovine serum albumin of the mesoscale nanoparticles of Li. The motivation for this is that Xia teaches nanoparticles comprising doxorubicin encapsulated with bovine albumin may be used for delivery of doxorubicin. By incorporating doxorubicin in the bovine serum albumin of the mesoscale nanoparticles of Li, the nanoparticles could be used for the treatment of cancer. The expectation of success is high, as Xia teaches that its composition has long-term stability and provides localized release of doxorubicin which enhances the efficiency of killing cancer cells. It would have been obvious to administer the doxyrubicin-containing nanoparticle thus made to a patient for the treatment of cancer. It would have been further obvious to optimize the dose of the composition for effective treatment of cancer, and find the claimed dose of 25 mg per kg or 50 mg per kg through routine experimentation, and obvious to optimize the particle diameter for delivery of agents into the body, and in this way, the artisan would find the present range through routine experimentation. Sah gives sufficient guidance to this end, as it teaches diameters ranging from 252 to 300 nm, which overlap with the present ranges 400 nm +/- 25% and 400 nm +/- 10%.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s arguments regarding the particle diameter, the examiner’s response is that the rejection, as presently presented, relies on Sah. It would have been obvious to find applicant’s range through routine experimentation based on Sah for the reasons given above. Regarding applicant’s reference to the previously filed declarations, the examiner’s response is that these have already been addressed in the record. The examiner appreciates the previous declaration of Ryan M. Williams filed on 6/14/2024, and agrees with applicant that the results presented in the declaration are unexpected. However, the results are not sufficient to overcome the rejection because they are not commensurate in scope with the claimed invention for the following reasons. The results are limited to a nanoparticle composition comprising: a core comprising 50:50 poly(lactic-co-glycolic acid) (PLGA) having a molecular weight of 38-54 kDA; a surface coating comprising PEG having a molecular weight of 5 kDa); a diameter of 386.7 nm or 402.8 nm, and a surface charge of -19.5 mV or 18.3 mV, respectively; and DEDC (a fluorescent molecule) associated with the nanoparticle. By contrast, the claims are open to a mesoscale nanoparticle composition comprising: a core comprising poly(actic-co-glycolic acid) (PLGA); and a surface coating comprising one or more of polyethylene glycol (PEG), PEG- carboxylic acid, PEG-carboxylic acid-DMAB, and methoxy PEG, the surface coating having a surface charge between -40 mV to +40 mV, wherein the composition is in the form of a nanoparticle having an intensity- weighted average diameter as determined by dynamic light scattering of 400 nm +/- 25% (and the narrower embodiment 400 nm +/- 10%). The results are not representative of the claimed invention. The results for a single dye associated with a nanoparticle is not representative of the genus of “at least one of a therapeutic agent bound to the nanoparticle wherein the mesoscale nanoparticle composition demonstrates selective targeting of kidneys of the patient such that [the] concentration of the mesoscale nanoparticle composition in the kidneys is at least 1.5 times greater than the concentration of the mesoscale nanoparticle composition in any of the heart, lung, liver, or spleen of the patient from 3 days to 2 months following administration.” The scope of “at least one therapeutic agent” is vast, including several thousand agents, and applicant has not shown that the results hold across the scope of at least one of a therapeutic agent bound to the nanoparticle wherein the mesoscale nanoparticle composition demonstrates selective targeting of kidneys of the patient such that [the] concentration of the mesoscale nanoparticle composition in the kidneys is at least 1.5 times greater than the concentration of the mesoscale nanoparticle composition in any of the heart, lung, liver, or spleen of the patient from 3 days to 2 months following administration. Table 1 presented in applicant’s arguments including DEDC, ODN2088, Edaravone, dsDNA, NBP, RNLS peptide, PDL-1 siRNA, and IL1beta siRNA, also do not repent the scope of “therapeutic agent” over the scope of “at least one therapeutic agent,” which encompasses several thousand agents.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
March 7, 2026
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