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 .
Applicant’s reply to the April 07, 2026 Office action, filed July 07, 2026, is acknowledged. Applicant canceled claims 3-4 and 8-9. Claims 1-2, 5-7 and 10-15 are currently pending and under examination. Any objection or rejection of record in the previous Office Action, which is not addressed in this action has been withdrawn in light of applicant’s amendments and/or arguments. This action is Final.
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.
Claims 1, 5-7 and 10-12 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Hodgkiss et al. (U.S. Patent Application Publication US 2017/0115281 A1, published April 27, 2017). This is a new rejection as necessitated by amendments.
Regarding claim 1, Hodgkiss teaches a method for selecting a single-stranded nucleic acid having an ability of being bound to a target substance (Page 1, [0005]-[0006], Page 3, [0024] and [0026], Page 4, [0041] and Page 8, [0128] and [0130]-[0131]). Hodgkiss teaches preparing a gold nanoparticle-single-stranded nucleic acid library (Page 1, [0005]-[0006], Page 3, [0024] and [0026], Page 4, [0041] and [0044], Page 8, [0128] and [0130]-[0131] and Page 9, [0143]-[0150]). Hodgkiss teaches reacting the gold nanoparticle-single-stranded nucleic acid library with a target substance (Page 1, [0005]-[0006], Page 4, [0044], Page 8, [0128] and [0130]-[0131] and Page 9, [0143]-[0150]). Hodgkiss teaches separating the single-stranded nucleic acid bound to the target substance from the reaction mixture by centrifuging the reaction mixture to obtain a supernatant containing the single-stranded nucleic acid bound to the target substance (Page 12, [0222], Page 13, [0228] and Pages 13-14, [0240]). Hodgkiss teaches inducing the gold nanoparticles to aggregate by adding a salt to the reaction mixture (Page 3, [0024], Pages 8-9, [0138]-[0140], Page 9, [0143]-[0145] and Page 11, [0184]-[0186]). Hodgkiss teaches measuring a color index (colorimetric readout/response/assay) of the reaction mixture (Page 3, [0033], Page 6, [0102], Page 10, [0157] and [0160], Page 14, [0242] and Page 9, [0140]-[0145]). Hodgkiss teaches visually determining a colorimetric change indicates the presence of the target (Page 3, [0024] and [0033], Page 4, [0046]-[0051] and Claims 10-11). Hodgkiss teaches determining whether to proceed with an additional reaction based on the color index of the reaction mixture (Page 3, [0024]-[0025], Page 4, [0046]-[0051], Pages 7-8, [0127]-[0128] and Pages 8-9, [0136]-[0145]). Hodgkiss teaches isolating the single-stranded nucleic acid from the target substance (Page 1, [0005] and Page 13, [0228]). Hodgkiss teaches the methods disclosed allows for selecting aptamers for small molecule targets in a reduced amount of time as well as higher binding affinity (Pages 2-3, [0017], Page 7, [0119] and Page 8, [0131]).
Regarding claim 5, Hodgkiss teaches the isolating the single-stranded nucleic is acid is performed by ethanol precipitation (Page 13, [0228]).
Regarding claim 6, Hodgkiss teaches amplifying the single-stranded nucleic acid after separating the single-stranded nucleic acid bound to the target substance (Page 1, [0006] and Page 8, [0131]).
Regarding claim 7, Hodgkiss teaches determining whether to proceed with an additional reaction based on the color index of the reaction mixture comprising measuring a color index of the reaction mixture and comparing the color index of the reaction mixture to a standard color index (Page 3, [0024]-[0025], Page 4, [0046]-[0051], Pages 7-8, [0127]-[0128], Pages 8-9, [0136]-[0145] and Pages 10-11, [0160]).
Regarding claim 10, Hodgkiss teaches the color index of the reaction mixture is quantified as the ratio of the absorbance values measured at two wavelengths before the gold nanoparticles are aggregated and the absorbance values measured at the same two wavelengths after the gold nanoparticles are aggregated (Page 8, [0139]-[0140], Page 9, [0145], Page 14, [0242] and Pages 10-11, [0160]).
Regarding claim 11, Hodgkiss teaches performing sequentially separating the single-stranded nucleic acid bound to the target substance from the reaction mixture after determining whether to proceed with an additional reaction through the color index of the reaction mixture. (Page 13, [0228]).
Regarding claim 12, Hodgkiss teaches the target substance comprises a small molecule material capable of inducing aggregation of gold nanoparticles including proteins, bisphenol and nucleic acids (Page 2, [0014], Pages 3-4, [0039]-[0040] and Pages 4-5, [0063]).
Hodgkiss teaches each and every claim limitation of claims 1, 5-7 and 10-12, therefore Hodgkiss anticipates claims 1, 5-7 and 10-12.
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 2 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hodgkiss et al. (U.S. Patent Application Publication US 2017/0115281 A1, published April 27, 2017), as applied to claims 1, 5-7 and 10-12 above, in view of Lee et al. (U.S. Patent Application Publication US 2018/0216158 A1, published August 02, 2018), previously cited in the May 29, 2025 Office Action. This is a new rejection as necessitated by amendments.
Regarding claim 2, Hodgkiss teaches preparing the gold nanoparticle-single-stranded nucleic acid library (Page 1, [0005]-[0006], Page 4, [0044], Page 8, [0128] and [0130]-[0131] and Page 9, [0143]-[0150]). Hodgkiss teaches reacting the gold nanoparticles with the single-stranded nucleic acid library (Page 1, [0005]-[0006], Page 4, [0044], Page 8, [0128] and [0130]-[0131] and Page 9, [0143]-[0150]). Hodgkiss teaches reduction and stabilization with citrate (Page 8, [0138]).
Regarding claim 13, Hodgkiss teaches preparing a gold nanoparticle-single-stranded nucleic acid library of single-stranded nucleic acids bound to the target substance (Page 1, [0005]-[0006], Page 3, [0024] and [0026], Page 4, [0041] and [0044], Page 8, [0128] and [0130]-[0131] and Page 9, [0143]-[0150]).
Hodgkiss does not specifically teach or suggest preparing gold nanoparticles having an average diameter of 15 nm to 50 nm. Hodgkiss does not teach or suggest removing the single-stranded nucleic acid not bound to the gold nanoparticles. Hodgkiss does not teach or suggest reacting the gold nanoparticle-single-stranded nucleic acid library with a non-target substance. Hodgkiss does not teach or suggest separating the single-stranded nucleic acids that are not bound to the non-target substance from the reaction mixture. Hodgkiss does not teach or suggest the target substance and the non-target substance are different.
Lee teaches aggregation schemes using gold nanoparticles that are functionalized with single-stranded DNA (Page 2, [0012]). Lee teaches aggregation inducing detectable change in peak absorption and peak shift by measuring wavelength changes and colorimetric detection (Abstract and Page 2, [0012]). Lee teaches salt induced aggregation (Page 5, [0057]). Lee teaches the gold nanoparticles are produced by citrate reduction method and an average gold nanoparticle diameter ranging from 15nm to 50nm (Page 4, [0045]). Lee teaches removing the single-stranded nucleic acid not bound to the gold nanoparticles after centrifuging the nanoparticles (Page 6, [0073]). Lee teaches using a color index to determine the presence of a target in the sample (Page 5, [0058]-[0059], Figs. 2-3 and 5B). Lee teaches preparing a gold nanoparticle-single-stranded nucleic acid library of single-stranded nucleic acids bound to the target substance (Page 2, [0012], Page 4, [0051]-[0052] and Page 5, [0056] and [0062]). Lee teaches reacting the gold nanoparticle-single-stranded nucleic acid library with a non-target substance (Page 4, [0048] and [0052] and Page 5, [0058]-[0059]). Lee teaches separating the single-stranded nucleic acids that are not bound to the non-target substance from the reaction mixture (Page 6, [0073]). Lee teaches the target substance and the non-target substance are different (Page 8, [0081]). Lee teaches using this size range for the gold nanoparticle is optimal because if the nanoparticle is too small, then performance is reduced because surface-plasmon resonance would be reduced and completely abolished for small particles and the color change will not be observed and when it is too large, then performance is reduced because the aggregation affinity of the nanoparticles would be higher leading to false positive results (Page 4, [0045]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified Hodgkiss with the teachings of Lee to produce a gold nanoparticle by citrate reduction method with an average diameter ranging from 15nm to 50nm and reacting the gold nanoparticle single stranded nucleic acid library with a non-target substance. Using this size range is optimal for gold nanoparticles because if the nanoparticle is too small, then performance is reduced because surface-plasmon resonance would be reduced and completely abolished for small particles and the color change will not be observed and when it is too large, then performance is reduced because the aggregation affinity of the nanoparticles would be higher leading to false positive results, as taught by Lee (Page 4, [0045]).
Allowable Subject Matter
Claims 14 and 15 remain allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art fails to teach or suggest alone or in combination a single-stranded nucleic acid consisting of one nucleotide sequence selected from SEQ ID NOs: 1, 17 and 18.
Although single-stranded nucleic acids are known, the prior art fails to disclose or suggest a single-stranded nucleic acid consisting of one nucleotide sequence selected from SEQ ID NOs: 1, 17 and 18 as disclosed and claimed by the instant application.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments and amendments filed July 07, 2026, with respect to the
rejections under U.S.C. § 103 have been fully considered and are persuasive, therefore these rejections have been withdrawn.
However, upon further consideration, new grounds of rejection are made in view of applicant’s amendments, which include new rejections under U.S.C. § 102 and 103.
As discussed above, newly cited Hodgkiss discloses a method for selecting a single-stranded nucleic acid having an ability of being bound to a target substance. Hodgkiss discloses preparing a gold nanoparticle-single-stranded nucleic acid library. Hodgkiss discloses reacting the gold nanoparticle-single-stranded nucleic acid library with a target substance. Hodgkiss discloses separating the single-stranded nucleic acid bound to the target substance from the reaction mixture by centrifuging the reaction mixture to obtain a supernatant containing the single-stranded nucleic acid bound to the target substance. Hodgkiss discloses inducing the gold nanoparticles to aggregate by adding a salt to the reaction mixture. Hodgkiss teaches measuring a color index (colorimetric assay) of the reaction mixture and visually determining a colorimetric change indicates the presence of the target, as well as determining whether to proceed with an additional reaction based on the color index of the reaction mixture. Hodgkiss discloses selecting aptamers for small molecule targets for biosensing applications in a reduced amount of time as well as enhanced binding affinity.
Therefore, for all these reasons and those listed above, Hodgkiss as well as Hodgkiss in view of Lee render the instant invention of claims 1-2, 5-7 and 10-13 anticipated/obvious.
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 JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
