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 3/17/2026 have been entered. Any objection\rejections from the previous office action filed 9/17/2025 not addressed below has been withdrawn.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1,9,11-12,15,23,25-28 is/are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Mohapatra et al. (WO 2018/200829). This new rejection was necessitated by amendment.
Mohapatra discloses method of detecting antigens with a first and second metal nanoparticles (including iron oxide and gold, meeting claim 11) of size 1-100 nm (the data point of 1 nm is within the upper size limit of the claimed hydrodynamic diameter and core diameter) with attached antibody (meeting ligand with three or more amino acids as recited in claim 11) in biological samples including urine and quantifying the concentration of nanoparticle (renal clearance) compared to a standard or control (healthy human subject) for diagnosis of abnormal kidney function including kidney failure and polycystic kidney disease. See entire disclosure, especially abstract, [0045], [0047],[0050]-[0051],[0055]-[0059] and claims, especially 29-31 and 39-42. Regarding the preamble recitation of early diagnosis, Mohapatra discloses that early diagnosis of disease and kidney malfunction is part of the invention. See [0004] and [00148]. Additionally, as the reference discloses the same method to diagnose kidney function for the same patient population it follows it will also pick up early diagnosis of kidney dysfunction as claimed. Regarding claim 15, a fluorescent label could be attached to the nanoparticle of Mohapatra. See [0047].
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.
Claim(s) 1,9,11-12,15-16,23-29 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohapatra et al. (WO 2018/200829) in view of Xu et al. “Dose Dependencies and Biocompatibility of Renal Clearable Gold Nanoparticles: From Mice to Non-human Primates”, Angew. Chem. Int. Ed. 2018, 57, 266 –271, published 12/5/2017, cited previously. This new rejection was necessitated by amendment.
Mohapatra is disclosed above. The reference is silent with respect to glutathione ligand (claim 16), use of ICP-MS or ICP-OES for measurement and the period of time before measurement (claim 37).
Xu teaches methods of evaluating kidney function, renal clearance and structure by injecting glutathione coated (meeting ligand claims 12,16) gold nanoparticles (GsAuNP) (meeting claim 11) in mice and measuring urine using ICP-MS (meeting claim 24), the levels were naturally compared to a standard (no injection of np in CD-1 mice). See entire disclosure, especially abstract, ¶ bridging pages 266 -277, page 277 left col 1st-3rd ¶, page 269 left col 1st full ¶ -right col 1st full ¶. Regarding the limitation in claim 1 on hydrodynamic diameter and size of the core, Xu discloses particle diameters of 2.5 nm, within the claimed range, naturally the core portion (within the coating) of the gold nanoparticle will also be less than 2.5 nm. See page 267 lft col 2nd ¶, page 269 2nd ¶ and Fig 1. Regarding claim 37, samples were collected over a 24-hour period, within the range recited. See Fig. 3a, 4 A,B. Xu also notes AuNPs provide noninvasive fluorescence imaging of kidney dysfunction for long periods of time, thereby rendering obvious applicants claimed method of evaluating kidney function with NPs. See page 266 rt col, 1st full ¶. Xu teaches the GsAuNP have efficient renal clearance and high biocompatibility.
Since the two references are related in their teachings of nanoparticles used in diagnosing kidney function one of ordinary skill would have a very high expectation of success in combining and/or substituting at least one of the nanoparticles of Mohapatra with the GsAuNP of Xu and use ICP-MS for quantification of the nanoparticles in urine over a period of an effective time period, such as within 24 hours, to diagnose kidney dysfunction. Reason to make such a substitution would be the noted advantage of good renal clearance and biocompatibility of GsAuNP. 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.
Response to Arguments
Applicant's arguments filed 3/17/2026 have been fully considered but they are not persuasive. Applicants assert Xu does not teach the claimed method of early diagnosing the more specific kidney dysfunctions listed in claim 1. Xu is not longer relied upon as an anticipatory rejection and is used only as a secondary reference in combination with Mohopatra who teaches applicants claimed early diagnosing steps for the various kidney dysfunctions of claim 1.
Applicants assert the specification shows unexpected results in early detection of kidney dysfunction. Applicants point to Fig 2-6 or a showing of unexpectedness in a statistically significant difference between the control and stage 1.
The allegation is unpersuasive for a number of reasons. The first is applicants result of using nanoparticles to diagnose early kidney disfunction was already known as taught by Mohapatra above. The second is applicants provide no comparison to the closest prior art, considered to be Mohapatra. Lastly applicants’ results are not commensurate with the very broad scope of the claims. Note the examples used to demonstrate fig 2-6 use very specific GsAuNP and this one narrow species does not capture the breath of claim 1. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). “A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference.” In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential. See MPEP 716.02(e). 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.
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.
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 on 9:30-6:00 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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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618