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 .
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timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR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 September 12, 2025 has been entered.
Applicant canceled claims 8 and 9. Claims 1-7 and 10-15 are currently pending and under examination. Any objection or rejection of record in the previous Office Action, mailed December 10, 2025, which is not addressed in this action has been withdrawn in light of Applicants’ amendments and/or arguments.
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 10-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Martin et al. (“A method for selecting structure-switching aptamers applied to a colorimetric gold nanoparticle assay”. J Vis Exp. (96):e52545, published February 28, 2015. This is a new rejection as necessitated by amendments.
Regarding claim 1, Martin teaches a method for selecting a single-stranded nucleic acid having an ability of being bound to a target substance (Abstract and Page 2, Third Paragraph). Martin teaches preparing a gold nanoparticle-single-stranded nucleic acid library (Abstract and Page 2, Second-Third Paragraph). Martin teaches reacting the gold nanoparticle-single-stranded nucleic acid library with a target substance (Abstract and Page 2, First-Third Paragraph). Martin teaches separating the single-stranded nucleic acid bound to the target substance from the reaction mixture (Abstract and Page 2, First-Second Paragraph). Martin teaches inducing the gold nanoparticles to aggregate by adding a salt to the reaction mixture (Page 2, Third Paragraph, and Page 11, Third Paragraph). Martin teaches measuring a color index (colorimetric readout) of the reaction mixture (Title, Abstract, Page 2, Third—Fourth Paragraph and Figs. 3 and 5). Martin teaches visually determining a colorimetric change indicates the presence of the target (Title, Abstract, Page 2, Third—Fourth Paragraph, Page 4, Last Paragraph and Figs. 3 and 5). Martin teaches determining whether to proceed with an additional reaction based on the color index of the reaction mixture (Page 2, Third Paragraph, Page 11, Third Paragraph and Figs. 3 and 5). Martin teaches the methods disclosed allows for selecting aptamers for small molecule targets for biosensing applications in a reduced amount of time as well as enhanced binding affinity (Page 2, Second-Fourth Paragraph and Page 4, 5. Subsequent Rounds of Selection and Sequencing, Step 1).
Regarding claim 2, Martin teaches the gold nanoparticles are produced by citrate reduction method and an average gold nanoparticle diameter ranging from 15nm to 50nm (Page 4, Last Paragraph). Martin teaches preparing a gold nanoparticle-single-stranded nucleic acid library and reacting the gold nanoparticle-single-stranded nucleic acid library with a target substance (Abstract and Page 2, First-Third Paragraph). Martin teaches removing the single-stranded nucleic acid not bound to the gold nanoparticles (Abstract and Page 2, First-Second Paragraph).
Regarding claim 3, Martin teaches separating the single-stranded nucleic acid bound to a target substance from the reaction mixture is performed by obtaining a supernatant after centrifuging the reaction mixture (Page 3, Second Paragraph).
Regarding claim 6, Martin teaches amplifying the single-stranded nucleic acid after separating the single-stranded nucleic acid bound to the target substance (Page 4, 4.Enrichment Monitoring, PCR, and Single-stranded DNA Generation, Step 6 and Page 11, First Paragraph).
Regarding claim 7, Martin teaches measuring a color index of the reaction mixture and comparing the color index of the reaction mixture to a standard color index (Page 4, 4.Enrichment Monitoring, PCR, and Single-stranded DNA Generation, Step 1, Page 5, First Paragraph, Steps 9-10 and Figs. 3 and 5).
Regarding claim 10, Martin 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 4, 4.Enrichment Monitoring, PCR, and Single-stranded DNA Generation, Step 1, Page 5, First Paragraph, Steps 9-10 and Figs. 3 and 5).
Regarding claim 11, Martin 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. (Abstract, Page 2, First-Second Paragraph, Page 5, third Paragraph and Page 11, Fist-Fourth Paragraph).
Regarding claim 12, Martin teaches the target substance comprises a small molecule material capable of inducing aggregation of gold nanoparticles including proteins and nucleic acids (Abstract, Page 2, Fourth Paragraph and Page 4, 5.Subsequent Rounds of Selection and Sequencing, Step 4).
Regarding claim 13, Martin teaches preparing a gold nanoparticle-single-stranded nucleic acid library of single-stranded nucleic acids bound to the target substance (Abstract and Page 2, First-Third Paragraph). Martin teaches reacting the gold nanoparticle-single-stranded nucleic acid library with a non-target substance (Abstract and Page 2, First-Second Paragraph). Lee teaches separating the single-stranded nucleic acids that are not bound to the non-target substance from the reaction mixture (Abstract and Page 2, First-Third Paragraph). Martin teaches the target substance and the non-target substance are different (Abstract and Page 2, First-Third Paragraph).
Martin teaches each and every claim limitation of claims 1-3, 6-7 and 10-13, therefore Martin anticipates claims 1-3, 6-7 and 10-13.
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 4 and 5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Martin et al. (“A method for selecting structure-switching aptamers applied to a colorimetric gold nanoparticle assay”. J Vis Exp. (96):e52545, published February 28, 2015, as applied to claims 1-3, 6-7 and 10-13 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 claims 4 and 5, Martin teaches isolating the single-stranded nucleic acid (Page 2, 1. Library and Primer Design and Synthesis, Step 2).
Martin does not teach or suggest isolating the single-stranded nucleic acid from the target substance after separating the single-stranded nucleic acid bound to the target substance from the reaction mixture. Martin does not teach or suggest isolating the single-stranded nucleic acid is performed by ethanol precipitation.
Kim teaches single-stranded nucleic acid aptamer forming a complex with gold nanoparticles (Abstract). Kim teaches identifying a target biomolecule from the specific binding of the single-stranded nucleic acid and the target biomolecule and wherein the amount of the target biomolecule from the color change of the reaction solution (Abstract). Kim teaches inducing the gold nanoparticles to aggregate by adding a salt to the reaction mixture (Abstract, Page 3, Second-Sixth Paragraph). Kim teaches using ethanol precipitation and isolating the single-stranded nucleic acid from the target substance after separating the single-stranded nucleic acid bound to the target substance from the reaction mixture (Page 6, First—Second Paragraph). Kim teaches using the single-stranded nucleic acid complex with/and forming the gold to the target biomolecule by a color change in the analysis of the reaction solution by the salt based on the dispersion state of the nanoparticles, allows for rapid and safe quantification of target molecules which may further be used in veterinary science, environmental engineering, food engineering, agriculture and medicine (Page 7, Last Paragraph—Page 8, Second Paragraph).
As a common field of endeavor both Martin and Kim disclose methods of aggregating gold nanoparticles using salt to observe a colorimetric change.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Martin with the teachings of Kim, using ethanol precipitation and isolating the single-stranded nucleic acid from the target substance after separating the single-stranded nucleic acid bound to the target substance from the reaction mixture. Using these methods allows for rapid and safe quantification of target molecules which may further be used in veterinary science, environmental engineering, food engineering, agriculture and medicine as taught by Kim (Page 7, Last Paragraph—Page 8, Second Paragraph).
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 March 10, 2026, with respect to the
rejection under U.S.C. § 112 (b), have been fully considered and are persuasive
therefore the rejection has been withdrawn.
Applicant’s arguments and amendments filed March 10, 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 Martin discloses a method for selecting a single-stranded nucleic acid having an ability of being bound to a target substance. Martin discloses preparing a gold nanoparticle-single-stranded nucleic acid library. Martin discloses reacting the gold nanoparticle-single-stranded nucleic acid library with a target substance (Abstract and Page 2, First-Third Paragraph). Martin discloses separating the single-stranded nucleic acid bound to the target substance from the reaction mixture. Martin discloses inducing the gold nanoparticles to aggregate by adding a salt to the reaction mixture. Martin teaches measuring a color index (colorimetric readout) 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. Martin 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, Martin as well as Martin in view of Lee render the instant invention of claims 1-7 and 10-13 obvious.
Conclusion
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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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684