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 .
Election/Restrictions
Applicant's election without traverse of Group I in the reply filed 6/30/2026 in the reply filed is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The following terms recited in claim 1 and the dependent claims are relative terms which render the claims indefinite “rapid” in “rapid renal clearance,” “uniform,” “uniformly,” “weakly” in “weakly polar solvent,” are relative terms that render the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further regarding claim 1, as what constitutes “rapid” verses “not rapid” is not clear in the application, it is also unclear what is encompassed by the claimed “achieving the rapid renal clearance,” and what needs to be “achieved” to produce “rapid renal clearance” within the boundaries of the claims. Further regarding the dependent claims, it’s unclear how “one or a combination of more than two of” limits the claim, and how this is different than simply reciting “one or more than two of.”
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 1-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (Ultrasmall Near-Infrared Fluorescent Quantum Dots for In Vivo Imaging, Journal of Nanomedicine & Nanotechnolgoy, Vol 14, pages 245-252, 2022) in view of Wagner (Quantum Dots in Biomedical Applications, Acta Biomater. 2019 August ; 94: 44–63. doi:10.1016/j.actbio.2019.05.022). Gao teaches the synthesis of ultrasmall near-infrared (NIR) meting quantum dots optimized to have hydrodynamic diameters under 5.5. nm which permits rapid renal filtration and clearance from the body (Results and Discussion ). Gao further teaches a method where a hydrophobic core quantum dot precursor (corresponding to applicant’s probe) uniformly dissolved and heated in a weakly polar solvent, such as a mixture of octadecene and olyamine (Results and discussion; Experimental section). Solvothermal treatment sizes down and uniformizes the quantum dots to an average core size of 3.8 (less than 5 nm) (Results and discussion; Experimental Section)). Gao further teaches a phase transfer process using a ligand exchange reaction wherein in one embodiment the ligand exchange uses a phase-transfer catalyst at 50 degrees C for 120 minutes to exchange native hydrophobic chains with hydrophilic thiol-terminated molecules (Results ad discussion; Experimental Section). This is a preparation method of a near-infrared fluorescent quantum dot for achieving a rapid renal clearance, comprising: carrying out a solvothermal reaction on a first uniformly mixed reaction system comprising a first probe of the near-infrared fluorescent quantum dot and a weakly polar solvent to prepare a second probe of the near-infrared fluorescent quantum dot with a particle size of less than 5 nm and uniform size; and carrying out a ligand exchange reaction on a second uniformly mixed reaction system comprising the second probe of the near-infrared fluorescent quantum dot and a hydrophilic ligand to obtain the near-infrared fluorescent quantum dot for achieving the rapid renal clearance. Gao teaches performing the solvothermal reaction inside an autoclave at 180 degrees C for 4 hours, which anticipates the presently claimed 0-300 degrees C and 0.5-24 h (Results and Discussion). The reaction solution of Gao provides for a radio of 2.5:100, which anticipates the present range of 1-10: and 10:-1000 (Results and Discusion).
Gao fails to teach a temperature and time range of 0-100°C for 1-6000 minutes.
It would have been obvious to one of ordinary skill in the art at the time the invention as filed to optimize the reaction time and temperature of Gao with the motivation to improve renal clearance, and in this way, and the artisan would find the present values through routine laboratory experimentation. “[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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP § 2144.05, II.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
September 15, 2026
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