DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on July 13, 2026 has been entered. The claims pending in this application are claims 240-269 wherein claims 245 and 247-268 have been withdrawn due to the restriction requirement mailed on September 30, 2025. The objection not reiterated from the previous office action is hereby withdrawn in view of applicant’s amendment filed on July 13, 2026. Claims 240-244, 246, and 269 will be examined.
Specification
The amendment filed on July 13, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “The entirety of each of the aforementioned
applications are incorporated herein by reference” because original specification only requires to incorporate U.S. Provisional Patent Application No. 63/051,145 by reference.
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
Claims 240-242, 246, and 269 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Yamamoto et al., (US 2016/0209407 A1, published on July 21, 2016).
Regarding claims 240-242, 246, and 249, since a sample comprising vesicle is not a structural limitation of the platform recited in claim 240, a sample comprising vesicles recited in claim 240 can be considered as a sample containing a target DNA and beads having a catalytic molecular beacon. Thus, Yamamoto et al., teach a platform comprising: an inlet region (ie., a filling channel 46 in Figure 4) operable for receiving a sample comprising vesicle (ie., having an ability for receiving a sample containing a target DNA and beads having a catalytic molecular beacon); a capturing region comprising a first surface (ie., capture region 18 comprising a capturing gel or a sieving matrix for capturing intact probe in Figure 12) operable for capturing the vesicles of the sample (ie., having an ability for capturing beads having a catalytic molecular beacon of the sample); and a plasmonic sensing region comprising a second surface (ie., the surface of the SPFS sensor) for detecting an analyte released from the sample (ie., the fluorescent fragment cleaved from the catalytic molecular beacon), wherein the second surface comprises an analyte detecting agent (ie., capture molecules 33 after the period T23 in Figure 12) for detecting the analyte released from the vesicles (ie., having an ability for detecting the fluorescent fragment cleaved from the catalytic molecular beacon) as recited in claim 240 wherein the first surface comprises a functionalized region and the functionalized region is functionalized with at least one functional group (ie., one of the capture molecules 33) as recited in claim 241, the analyte detecting agent is oligonucleotides as recited in claim 242, the second surface is adjacent or proximal to the first surface as recited in claim 246, and a mixing region for mixing the sample (ie., a region having a sample in a main fluid channel 43 in Figure 4 or a region having a focused sample 15 in Figure 12), wherein the mixing region is upstream of the capturing region (ie., capture region 18 comprising a capturing gel or a sieving matrix for capturing intact probe in Figure 12) as recited in claim 269 (see paragraphs [0004], [0008], [0013], [0033] to [0035], [0048] to [0042], [0051], [0061] and [0062], and Figures 4, 5, 7, and 12).
Therefore, Yamamoto et al., teach all limitations recited in claims 240-242, 246, and 269.
Response to Arguments
In page 9, last paragraph bridging to page 10, third paragraph of applicant’s remarks, applicant argues that “[I]n particular, Yamamoto fails to teach or suggest at least the following elements of amended claim 240: (1) an inlet region operable for receiving a sample comprising vesicles; (2) a capturing region comprising a first surface operable for capturing vesicles; and (3) a plasmonic sensing region comprising a second surface for detecting an analyte released from the vesicles, where the second surface comprises an analyte detecting agent for detecting the analyte released from the vesicles. In fact, Yamamoto fails to teach or suggest any platforms that are operable for processing vesicles. The aforementioned defects in Yamamoto are apparent from the fact that Yamamoto is directed to a combination of surface plasmon field enhanced fluorescencespectroscopy (SPFS) and isotachophoresis (ITP) technologies for directly detecting biomolecules, not analytes released from vesicles. See, e.g., Paragraphs 61-62 and Figure 12 of Yamamoto. In Yamamoto, a sample containing a target DNA, a DNAzyme sensor, and a fluorescent probe is loaded into the microfluidic chip. Id. In the presence of the target DNA, the probe is cleaved to generate a fluorescent fragment. Id. The intact probe is captured on a surface while the fluorescent fragment is allowed to pass through, and the fluorescent fragment is then captured on another location where it is being detected. Id. As such, Yamamoto fails to teach or suggest any platforms configured to capture vesicles and detect their released analytes, as set forth in amended claim 240. The remaining claims depend on and further restrict independent claim 240”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection. Since a sample comprising vesicle is not a structural limitation of the platform recited in claim 240, a sample comprising vesicles recited in claim 240 can be considered as a sample containing a target DNA and beads having a catalytic molecular beacon. Thus, Yamamoto et al., teach a platform comprising: an inlet region (ie., a filling channel 46 in Figure 4) operable for receiving a sample comprising vesicle (ie., having an ability for receiving a sample containing a target DNA and beads having a catalytic molecular beacon); a capturing region comprising a first surface (ie., capture region 18 comprising a capturing gel or a sieving matrix for capturing intact probe in Figure 12) operable for capturing the vesicles of the sample (ie., having an ability for capturing beads having a catalytic molecular beacon of the sample); and a plasmonic sensing region comprising a second surface (ie., the surface of the SPFS sensor) for detecting an analyte released from the sample (ie., the fluorescent fragment cleaved from the catalytic molecular beacon), wherein the second surface comprises an analyte detecting agent (ie., capture molecules 33 after the period T23 in Figure 12) for detecting the analyte released from the vesicles (ie., having an ability for detecting the fluorescent fragment cleaved from the catalytic molecular beacon) as recited in claim 240.
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.
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 243 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al., as applied to claims 240-242, 246, and 269 above, and further in view of Zhao et al., (Scientific Reporters, 8, 3605, 2018) and Yue et al., (Sci. Adv., 2, e1501536, 2016).
The teachings of Yamamoto et al., have been summarized previously, supra.
Yamamoto et al., do not disclose that the second surface comprises plasmonic nanostructures associated with a dielectric surface wherein the plasmonic nanostructures are coupled to the analyte detecting agent as recited in claim 243.
Zhao et al., teach that “[I]n the surface-enhanced fluorescence (SEF) process, it is well known that the plasmonic nanostructure can enhance the light emission of fluorescent emitters” (see abstract).
Yue et al., teach that intrinsically core-shell plasmonic dielectric nanostructures display an ultrahigh refractive index of up to 5.5 in the near-infrared frequency range and enhance light absorption in the ultraviolet and visible ranges when they are applied in advanced optical and plasmonic devices (see abstract and page 6, right column).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have made the platform recited in claims 243 wherein the second surface comprises plasmonic nanostructures associated with a dielectric surface such that the plasmonic nanostructures are coupled to the analyte detecting agent in view of the prior arts of Yamamoto et al., Zhao et al., and Yue et al.. One having ordinary skill in the art would have been motivated to do so because Zhao et al., have shown that “[I]n the surface-enhanced fluorescence (SEF) process, it is well known that the plasmonic nanostructure can enhance the light emission of fluorescent emitters” (see abstract) and Yue et al., have shown that intrinsically core-shell plasmonic dielectric nanostructures display an ultrahigh refractive index of up to 5.5 in the near-infrared frequency range and enhance light absorption in the ultraviolet and visible ranges when they are applied in advanced optical and plasmonic devices (see abstract and page 6, right column). One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to make the platform recited in claims 243 wherein the second surface comprises plasmonic nanostructures associated with a dielectric surface by coupling the intrinsically core-shell plasmonic dielectric nanostructures taught by Yue et al., to the surface of SPFS taught by Yamamoto et al., (ie., the second surface recited in claim 240) such that the plasmonic nanostructures would be coupled to the analyte detecting agent after the period T23 in view of the prior arts of Yamamoto et al., Zhao et al., and Yue et al., in order to enhance light emission of the fluorophore of the degraded probe taught by Yamamoto et al., and enhance light absorption of the surface of SPFS taught by Yamamoto et al., in the ultraviolet and visible ranges.
Response to Arguments
In page 10, last paragraph bridging to page 12, second paragraph of applicant’s remarks, applicant argues that “[A]s set forth in Section II of this Reply, Yamamoto fails to teach or suggest at least the following elements of amended claim 240: (1) an inlet region operable for receiving a sample comprising vesicles; (2) a capturing region comprising a first surface operable for capturing vesicles; and (3) a plasmonic sensing region comprising a second surface for detecting an analyte released from the vesicles, where the second surface comprises an analyte detecting agent for detecting the analyte released from the vesicles. Moreover, the teachings of Yamamoto cannot be modified with the teachings of Zhao and Yue to arrive at the claimed invention because any modification of Yamamoto to incorporate a platform with vesicle-capturing components would render Yamamoto unsuitable for its intended purpose of directly detecting biomolecules. See M.P.E.P. 2143.01 (indicating that a proposed modification cannot render the prior art unsatisfactory for its intended purpose or change the principle of operation of a reference). In particular, any modification of Yamamoto to incorporate vesicle-capturing components would have disrupted Yamamoto's ITP-based transport and detection workflow by interfering with ITP-based electrophoretic focusing and transport of soluble molecular components. Nonetheless, Zhao and Yue fail to cure the aforementioned defects in Yamamoto. In fact, there is no teaching or suggestion in either reference for platforms with vesicle-capturing components. For instance, Zhao merely ‘demonstrated experimentally and theoretically that gold nanoparticles and fluorescent nanodiamonds mutually enhance their light emission when they are coupled for the SEF [(surface-enhanced fluorescence)] process.’ See page 6 (first paragraph) of Zhao. Moreover, Zhao only envisioned that its findings ‘contribute to full and deep understanding of the SEF process.’ Id. Similarly, Yue focused exclusively on a ‘conic plasmonic nanostructure that is made of bulk-insulating topological insulators and has an intrinsic core-shell formation’ without any reference to its incorporation into vesicle-capturing platforms. Accordingly, no rationale or motivation exists in any of the cited art that would lead a person of ordinary skill in the art to arrive at the vesicle-capturing platform of amended claim 240. Particularly, with a lack of guidance in the cited art, and the unsuitability of Yamamoto's biomolecule detection systems for use in vesicle-capturing platforms, a person of ordinary skill in art would not have modified Yamamoto's biomolecule detection system in view of the teachings of Zhao and Yue to arrive at the vesicle-capturing platform of amended claim 240.
As such, Yamamoto, Zhao, and Yue cannot be combined to render independent claim 240 as obvious. Claim 243 depends on and further restricts independent claim 240. Accordingly, Yamamoto, Zhao, and Yue cannot be combined to render claim 243 as obvious for at least the same reasons that they cannot be combined to render independent claim 240 as obvious”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection because Yamamoto et al., teach all limitations recited in claim 240 (see above Response to Arguments related to the rejection under 35 U.S.C 102 (a) (1)).
Claim 244 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al., as applied to claims 240-242, 246, and 269 above, and further in view of Bailey et al., (US 2013/0261010 A1, published on October 3, 2013).
The teachings of Yamamoto et al., have been summarized previously, supra.
Yamamoto et al., do not disclose that the second surface is in a form of an array wherein the array comprises a plurality of different analyte detecting agents that are specific for detecting different analytes as recited in claim 244.
Bailey et al., teach that a surface of an optical sensor has a plurality of the same or different capture probes attached thereto wherein a plurality of the different capture probes attached to the surface of the optical sensor permits multiplex detection of several different analytes of interest (see paragraph [0162]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have made the platform recited in claims 244 wherein the second surface is in a form of an array and the array comprises a plurality of different analyte detecting agents that are specific for detecting different analytes in view of the prior arts of Yamamoto et al., and Bailey et al.. One having ordinary skill in the art would have been motivated to do so because Bailey et al., teach that a surface of an optical sensor has a plurality of the same or different capture probes attached thereto wherein a plurality of the different
capture probes attached to the surface of the optical sensor permits multiplex detection of several different analytes of interest (see paragraph [0162]). One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to make the second surface of the platform in a form of an array comprising a plurality of different analyte detecting agents that are specific for detecting different analytes in view of the prior arts of Yamamoto et al., and Bailey et al., such that the platform recited in claim 244 has an ability to detect different analytes.
Response to Arguments
In page 12, third paragraph bridging to page 13, first paragraph of applicant’s remarks, applicant argues that “[A]s set forth in Sections II and III of this Reply, Yamamoto fails to teach or suggest the vesicle-capturing platforms of amended claim 240. Moreover, as set forth in Section III of this Reply, the teachings of Yamamoto cannot be modified with the teachings of Bailey to arrive at the claimed invention because any modification of Yamamoto to incorporate a platform with vesicle- capturing components would render Yamamoto unsuitable for its intended purpose of directly detecting biomolecules. Nonetheless, Bailey fails to cure the aforementioned defects in Yamamoto. In fact, there is also no teaching or suggestion in Bailey for platforms with vesicle-capturing components. In contrast, Bailey focuses on detection systems for detecting analytes of interest in a solution in the presence of magnetic particles. See, e.g., Abstract of Bailey. As such, Yamamoto and Bailey cannot be combined to render independent claim 240 as obvious. Claim 244 depends on and further restricts independent claim 240. Accordingly, Yamamoto and Bailey cannot be combined to render claim 244 as obvious for at least the same reasons that they cannot be combined to render independent claim 240 as obvious”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection because Yamamoto et al., teach all limitations recited in claim 240 (see above Response to Arguments related to the rejection under 35 U.S.C 102 (a) (1)).
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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
September 11, 2026
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