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. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The IDS received on December 7, 2023 is proper and is being considered by the Examiner. Drawings The drawings received on December 7, 2023 is objected to because Figure 21 discloses a nucleotide sequence without reciting a corresponding SEQ ID Number in the figure itself, or in the Brief Description of Drawings. Since the Application contains a Sequence Listing, Applicants are advised to amend the specification or the drawing to identify the disclosed nucleotide sequence(s) with a proper SEQ ID Number(s). In addition, the drawings are objected to because some of the Figures lack clarity the texts therein are not legible. For example, Figure 6 contains miRNA terminal end orientations (5’ and 3’) which are so unclear that it is impossible to determine which is a 5’ and which is a 3’ end. Failure to comply will result in the response being held non-responsive. 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 appl icant regards as his invention. Claim s 19-21, 24, and 28 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. Claims 19-21 and 28 are indefinite because the claim is directed to a system and the system does not actively require the presence of any biological sample nor target nucleic acids. Therefore, further reciting the sample or the target nucleic acid does not further limit the system as currently being claimed, or if further limited, who the system is further limited. Claim 24 is indefinite because the claim is directed to a product ( i.e., system) but contains an active method step of using the system (“collecting and analyzing an optical signal … comprises performing a photoluminescence excitation …”). The Federal Circuit decided an issue of first impression in that Court - whether a patent claim that covers both an apparatus and method of use of that apparatus passes muster under 35 USC §112, para. 2 (indefiniteness). Defending its "1-click system," Amazon won a summary judgment ruling of invalidity, IPXL Holdings, LLC v. Amazon.com, Inc. , 333 F. Supp. 2d 513 (E.D. Va. 2004), which the Federal Circuit affirmed in part, 2005 U.S. App. LEXIS 25120. After upholding the district court's claim constructions and affirming the finding that all but one of the asserted claims were anticipated, the Federal Circuit next affirmed the summary judgment of invalidity (for indefiniteness) for the remaining asserted claim, which read: 25. The system of claim 2 [including an input means] wherein the predicted transaction information comprises both a transaction type and transaction parameters associated with that transaction type, and the user uses the input means to either change the predicted transaction information or accept the displayed transaction type and transaction parameters. Claim 25 on its face is directed to a "system." However, it also recites use steps ("the user uses the input means to ...change the predicted transaction information ... ") This claim was found indefinite by the district court. Thus, for the above reasons, instant claim 24 is indefinite. 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 10-16, 24, and 27 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. This is a Written Description. The written description requirement ensures that, “an applicant invented the subject matter which is claimed. Further, the written description requirement for a claimed genus may be satisfied through a sufficient description of a representative number of species by 1) reduction to practice; 2) reduction to drawing; or 3) disclosure of relevant identifying characteristics ( i.e., structure of other physical and/or chemical properties, functional characteristics coupled with a known or disclosed correlation between function and structure) (MPEP 2163 at II(A)(3)(a)(ii)). Reduction to Practice The Federal Circuit reiterated that mere use of the same words in the specification and the claim (an in ipsis verbis test) is not sufficien to establish written description. The instant specification is clear that the invention is directed toward a “label-free” detection, wherein the label-free detection is achieved by a fluorescence shift in the excitation spectrum of single-walled carbon nanotubes: “ In a non-limiting, exemplary embodiment, the molecular tool and method of the invention combine the advantages of SWCNT-based sensors with those of synthetic biology oligomers, specifically PNA, and show the use of PNA-DNA-SWCNT hybrids to create a platform for the label-free detection of miRNA … it is possible to form stable PNA-DNA-SWCNTs, which demonstrate optically distinct spectra compared to their DNA-SWCNT counterparts … rapid miRNA detection capabilities without a need for additional surfactant molecules during the detection process, making the sensors more applicable for in vivo sensing applications ” (section [0020]) Single Walled Carbon Nanotubes (or SWCNTs) are known in the art to exhibit fluorescent activity in the near infrared spectral region any perturbation at the nanotube surface modulates the fluorescence emission therefrom. The instant application employs this phenomenon, wherein nucleic acid molecules ( i.e., first polymeric molecule comprising nucleic acid) are bound to SWCNTs with a region that is complementary another nucleic acid strand ( i.e ,. second polymeric molecule) comprising nucleic acid analog. When this complex is exposed to a sample containing a target nucleic acid and the target nucleic acid forms a complementarity binding to a region of the second polymeric molecule, the event results in a perturbation on the surface of the SWCNT, inducing a fluorescent shift. While the above-section discloses that the use of SWCNT is a “non-limiting, exemplary embodiment,” the specification does not contain any additional substrate that comprises an optical element that can be employed in a “label-free” method. Some of the potential optical elements recited (for product claims) include quantum dots, and fluorophores, but they are an art recognized “labels” used in a detection means. Therefore, in a context of performing a “label-free” detection utilizing an optical element, the specification fails to disclose any additional species that has been demonstrated to be useful. Therefore, the specification fails to demonstrate possession of a molecular tool comprising any substrate comprising an optical element other than SWCNT that can be used in a label-free detection means. Reduction to Drawing The specification discloses embodiments only directed to the optical element of SWCNT . Disclosure of Relevant Identifying Characteristics While one could argue that a skilled artisan would be able to identify the “representative number of species” of such optical elements that can be used in a label-free method of detection, such would not satisfy description requirement when, “the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art” (MPEP 2163(I)(A)). For the claims at issue, such essential or critical feature is substrate comprising an optical material that can be used in a label-free detection. As stated in University of California v. Eli Lilly and Co. at page 1404: An adequate written description of a DNA ... "requires a precise definition, such as by structure, formula, chemical name, or physical properties ," not a mere wish or plan for obtaining the claimed chemical invention. Fiers v. Revel , 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). Accordingly, "an adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it ; what is required is a description of the DNA itself." Id . at 1170, 25 USPQ2d at 1606. Therefore, for the foregoing reasons, the genus embraced by the claims is not sufficiently described by the number of species disclosed in the specification, and therefore, the specification lacks written description of the claims. Lastly, the Office notes that the product claims have not been rejected herein as the “label-free” detection as required in method claims is not conferred onto a product claim. Claim Rejections - 35 USC § 102 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. Cl aims 1, 2, 5-8, 18-23, 26, and 28 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zavoiura et al. (Bioconjugate Chemistry, 2018, vol. 29, pages 1690-1702) . As pointed out in In re Mott , 190 U.S.P.Q. 536 (CCPA 1975), "Claims must be given broadest reasonable construction their language will permit in ex parte prosecution, and applicant who uses broad language runs the risk that others may be able to support the same claim with a different disclosure." With regard to claim 1, Zavoiura et al. teach a molecular tool comprising: a substrate comprising or consisting of an optical material (semi-conductor quantum dot; a first polymeric molecule comprising a nucleic acid, wherein the first polymeric molecule is coupled with the substrate ( see Fig. 2b, RNA is considered a first nucleic acid and is coupled with the substrate via hybridization to the PNA branch of QD); and a second polymeric molecule coupled to the first polymeric molecule by means of a nucleobase complementarity, wherein the second polymeric molecule comprises a nucleic acid analog ( see Fig. 2b, the PNA of QD can be construed as a second polymeric molecule and this is bound to the first polymeric molecule by means of complementarity). With regard to claim 2, the optical material is quantum dots (“we report an enzyme-free method for fluorometric detection of RNA that relies on target-induced fluorophore transfer onto a semiconductor quantum dot (QD) …”, Abstract). With regard to claim s 5 and 6 , the first polymeric molecule comprises a nucleic acid (RNA, see also “ formation of specific PNA/RNA duplexes on nanoparticle”, page 1697, 1 st column, 2 nd paragraph). With regard to claim 7, the nucleic acid analog is PNA ( see above). With regard to claim 8, the two nucleic acids anneal by complementarity that comprise an overlap (thus partial overlap). With regard to claim 18, the artisans employ a system that comprises the molecular tool, and an electromagnetic radiation source and a detector for collecting and analyzing the optical signal (as evidenced by the analysis of the assay and fluorescence observed). With regard to claims 19-21 and 28, the system does not actively comprise the target nucleic acid ( see above 112b rejection) . With regard to claim 22, the excitation is performed by UV-vis ( see Table 2). With regard to claim 23, the detection is fluorescence detection ( see Table 2). With regard to claim 26, the nucleic acid analog is PNA ( see above). Therefore, Zavoiura et al. anticipate the invention as claimed. Claim Rejections - 35 USC § 103 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. Claim s 17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Zavoiura et al. (Bioconjugate Chemistry, 2018, vol. 29, pages 1690-1702) . The teachings of Zavoiura et al. have already been discussed above. Zavoiura et al. teach a method and employ their disclosure directed to the detection of RNA and explicitly suggest that plasma samples could be analyzed for the presence of DENV RNA in samples (“[o] ur method may prove suitable for the detection of DENV RNA in samples with high viral titer …”, page 1698, 1 st column, 2 nd paragraph), do not teach that the nucleic acid is DNA (claim 25). Zavoiura et al. do not teach a kit (claim 17). However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Zavoiura et al. and arriving at the invention as claimed for the following reasons. In regard to taking the detection tool of Zavoiura et al. and packaging the reagents into a kit, doing so would have been an obvious application for the conventionality of providing a commercially available kit which has been packaged with requisite reagents with concentration/purity for a designed assay. As to employing the molecular tool of Zavoiura et al. for detecting target DNA, doing so would have been obvious to extend the method of Zavoiura et al. for detecting nucleic acid molecules typically assayed in a diagnostic art. Because PNA would have formed complementarity to other nucleic acid types, such as DNA, application of the teachings for detecting DNA would also have been an obvious application, yielding no more than a predictable outcome. The Office notes that the rejection of claim 25 is based on the claim interpretation made for the molecular tool as claimed in claim 1, where the first polymeric nucleic acid can be construed to embrace a target nucleic acid molecule based on BRI. In KSR , the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t] hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” Therefore, the invention as claimed is deemed prima facie obvious over the cited references. Conclusion No claims are allowed. Claims 3, 4, 10-16, 27 are free of prior art. Claims 3 and 4 are objected to for being dependent on a rejected base claim. The closes prior art is by Harvey et al. (National Biome. Eng., 2017, pages 1-25; IDS). Harvey et al. teach a method of detecting the presence of a target nucleic acid molecule comprising a substrate comprising SWCNT that are bound to a nucleic acid ( i.e., DNA), wherein the nucleic acid is bound to SWCNT and comprises a portion which is specific to a target nucleic acid (miRNA, see below from Fig. 1): left 12700 As seen, the blue and orange portion wraps (and bound) to the SWCNT substrate, wherein the orange portion contains a complementary sequence to a target nucleic acid ( i.e., miRNA). When the two portions form a complement structure, the formation produces a perturbation on the surface of the SWCNT and produces a wavelength shift in fluorescence ( see also Fig. 2). This molecular detection complex , as a product, therefore comprises a first polymeric molecule and a second polymeric molecule. However, none of the polymeric molecule is comprised of nucleic acid analog. As well, in a context of using the complex in a method, the second polymeric molecule must form a complementary structure to a target nucleic acid of a sample. This however, cannot be done in the method disclose by Harvey et al. because the second polymeric molecule is the target nucleic acid . The detection of the target nucleic acids from a sample as disclosed by the instant application is effected by a molecular detection complex shown below (from Fig. 1): As seen, the first polymeric molecule (GT) 10 comprises a portion which is complementary to PNA ( i.e., second polymeric molecule) which also anneals by complementarity to a target nucleic acid ( i.e., miRNA). The molecular detection complex of Harvey et al. and that of the instant application is clearly different therefore. Inquiries Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7: 3 0 a.m. to 4:00 p.m (M- F ). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782. Papers related to this application may be submitted to Art Unit 16 81 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. /YOUNG J KIM/ Primary Examiner Art Unit 1637 DATE \@ "MMMM d, yyyy" March 10, 2026 /YJK/