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
Applicant’s arguments, filed xxx, have been fully considered but they are not deemed to be fully persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Objections
Claim 56 is objected to on the grounds that the claim contains a status modifier of “Canceled),” yet the text still appears in the claim stricken through. A properly cancelled claim cannot contain text other than the claim number and status modifier. Applicant is required in response to this action to delete the text from claim 56.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 57-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The application does not describe how to treat a patient suffering from or susceptible to a disease or condition affecting the kidney, by administration of the mesoscale composition of claim 41, as there are no therapeutic agents present in the formulation. The artisan would understand that treatment of a disease or condition of the kidney requires an agent that treats a disease or condition of the kidney. As there is no such agent present in the present composition, nor disclosure in the application of how to use the present composition to treat diseases or conditions of the kidney, the artisan would not accept that the application provides sufficient description to carry out the claimed method.
Allowed Claims
Claims 41-53, 55, and 61-62 are allowed. The following is the examiner’s reasons for allowance. The closest prior art is Li (Journal of Controlled Release, 2001) in view of Xia (Journal of Materials Chemistry B, 2014). Although 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), it fails to teach or fairly suggest a diameter of 400 nm +/- 25% or a diameter of 400 +/- 10%, and further fails to teach at least one imaging agent, and the doses required by claim 61. Further, applicant’s affidavits filed 6/14/2024 and 1/13/2025, which disclose data showing an unexpected accumulation of the imaging agent in the kidneys, further distinguish applicant’s invention over the prior art.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection. THIS ACTION IS THEREFOR MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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
July 9, 2026
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