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.
Claim Objections
Claims 16-17 are objected to because of the following informalities: On line 9 of claim 16. the phrase “a plurality of microscopic objects” should be changed to –the plurality of microscopic objects—so as to positively refer to the plurality of microscopic objects recited on line 5 of claim 16.
Appropriate correction is required.
Inventorship
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 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.
Claim(s) 1, 3-5, 7, 12-13, 16-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tokonami et al (WO 2017/195872, English-language translation is US 2020/0182770) in view of Trivedi (US 2019/0032114, submitted in the IDS filed on June 23, 2025).
With regards to claims 1, 16 and 19, Tokonami et al teach of a method, a collecting kit for collecting microscopic objects such as bacteria in a liquid sample, and a method for manufacturing the detection kit. The collecting kit comprises a substrate 11, a polymer film in the form of a honeycomb structure 12 having a plurality of pores therein, and a thin film 13 located over the pores of the honeycomb structure, wherein the film forms a photothermal conversion region. See Figure 3(a) and 3(b), and paragraphs 0056-0059 in Tokonami et al (US 2020/0182770). The photothermal conversion film 13 converts light energy into heat energy by absorbing light from a laser beam L1 from a light source 50. See paragraph 0059 and Figures 1, 3(a) and 3(b) in Tokonami et al. Each of the pores in the honeycomb structure has an opening and a depth, the opening being larger than a size of an analyte (i.e. bacteria) to be detected in a sample. A method of using the collecting kit comprises introducing a liquid sample containing an analyte (i.e. bacteria) to the plurality of pores in the honeycomb structure 12 of the photothermal conversion region, irradiating the photothermal conversion region with light from light source 50 to heat the liquid sample to generate thermal convection in the liquid sample, wherein the light has a wavelength within an absorption range of the photothermal conversion region, and detecting the analyte (i.e. bacteria) by monitoring the detection kit after irradiation with the light 50, wherein the detecting comprises illuminating the liquid sample on the photothermal conversion region with light from an illumination light source 80, collecting the light which passes through the sample with an imaging device 80, and analyzing an image of the sample containing the bacteria with a control unit. See Figure 1 in Tokonami et al. The bacteria in the sample are introduced into the pores of the honeycomb structure 12 such that the bacteria are trapped inside the plurality of pores so as to be held in the pores. Tokonami et also teach that the bacteria held and trapped within each pore of the honeycomb structure can be fixed to an inner wall or a bottom of the pores using an antibody or the like contained within or adhered to the inner wall or bottom of the pores (see paragraph 0122 in Tokonami et al). A method for manufacturing the detection kit comprises preparing a substrate 11 including a photothermal conversion region 12 in which a plurality of pores are disposed, each of the pores having an opening and a depth, the opening being larger than a size of an analyte (i.e. bacteria) and the depth being deeper than a size of each of the bacteria, and introducing a sample containing bacteria into the plurality of pores so that the bacteria are held in the pores in an unfixed manner but with stability. See Figures 1, 3(a), 3(b), 11(a)-11(c) and 21, and paragraphs 0042-0050, 0056-0059, 0071-0079, 0084-0088 and 0122 in Tokonami et al.
Tokonami et al fail to teach that the method, collection kit and method for manufacturing the collection kit comprises introducing a plurality of microscopic objects having a surface modified by a host substance capable of being specifically bound to the analyte (i.e. bacteria) into the pores of the photothermal conversion region prior to heating the sample with light from light source 50, wherein the depth of the pores is deeper than the size of the microscopic objects, and the introducing of the plurality of microscopic objects into the pores allows the objects to be held in the pores in an unfixed manner with stability.
Trivedi teaches of a detection device and a method for detecting an analyte (i.e. a nucleic acid) in a liquid sample. The method comprises introducing a plurality of microscopic objects, such as magnetic beads (see paragraph 0454 in Trivedi), into a plurality of pores formed in a 3D pattern layer 517 located on a substrate 501, wherein a heat generation layer 503 is deposited over a surface of both the inside and outside of the pores (see Figure 5A in Trivedi). A linker layer 527 containing intermediate chemical molecules for immobilization of nucleic acid primers is located over the heat generation layer 503. In the embodiment depicted in Figure 5E, a surface of magnetic beads 535 is modified by a host substance comprising a linking molecule 531 that links to a nucleic acid primer 529. When the magnetic beads 535 are introduced to the plurality of pores in the detection device, the linking molecules 531 on the beads covalently bind to the intermediate chemical molecules on the linker layer 527 to become stably trapped in the pores so as to be held in the pores. Each of the pores in the 3D pattern layer 517 has an opening and a depth, wherein a size of the opening and a depth of the pores is larger and deeper than a size of the magnetic beads 535 so that the beads are trapped within the pores after being introduced to the pores. In a method of using the device taught by Trivedi, the magnetic beads 535 containing the linking molecules 531 are introduced to the device so that the beads become stably trapped in the pores, a liquid sample 507 containing nucleic acids to be detected is introduced to the device, the liquid sample is heated to generate thermal convection by irradiating the heat generation layer 503 with light having a wavelength within an absorption wavelength of the heat generation layer 503, and binding between nucleic acids in the sample and the nucleic acid primers 529 on the beads is detected. See Figures 5A, 5E and 5F, and paragraphs 0453-0455, and the claims in Trivedi.
Based upon a combination of Tokonami et al and Trivedi, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to introduce a plurality of microscopic objects having a surface modified by a host substance capable of being specifically bound to the analyte (i.e. bacteria) into the pores of the photothermal conversion region of the device taught by Tokonami et al prior to heating the sample with light from the light source 50, wherein the depth of the pores is deeper than the size of the microscopic objects, and the introducing of the plurality of microscopic objects into the pores allows the objects to be trapped in the pores so as to be held in the pores, because Tokonami et al teach that the bacteria held and trapped within each pore of the honeycomb structure can be fixed to an inner wall or a bottom of the pores using an antibody or the like contained within or adhered to the inner wall or bottom of the pores (see paragraph 0122 in Tokonami et al), and Trivedi teaches that another known and equivalent method of trapping an analyte in pores of a photothermal conversion region is to first introduce microscopic objects such as magnetic beads having a surface modified by a host substance capable of being specifically bound to an analyte into the pores so that the microscopic beads are stably held in the pores in an unfixed manner.
With regards to claim 3, the photothermal conversion region taught by Tokonami et al includes a thin film 13 that converts light into heat, and the magnetic beads taught by Trivedi comprise a core having a thermal conductivity lower than a thermal conductivity of the thin film 13.
With regards to claim 4, the plurality of pores in the photothermal conversion region 13 taught by Tokonami et al are arranged in a honeycomb pattern. See Figure 3(a) of Tokonami et al.
With regards to claim 5, the combination of Tokonami et al and Trivedi teaches that the plurality of microscopic objects are magnetic particles or beads, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an external magnetic field to introduce the magnetic particles into the plurality of the pores in the photothermal conversion region taught by Tokonami et al because an external magnetic field is widely known to move magnetic materials from one location to the another location.
With regards to claim 7, when combining the teachings of Tokonami et al and Trivedi, the plurality of magnetic beads taught by Trivedi would be introduced into the pores of the photothermal conversion region 13 taught by Tokonami et al as a result of the irradiation of the photothermal conversion region with light.
With regards to claims 12-13, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively detect an analyte, such as a bacteria, in a sample from a plurality of other substances or impurities present in the sample in the method and device taught by the combination of Tokonami and Trivedi because the host substance on the surface of the plurality of microscopic objects (i.e. magnetic particles) taught by Trivedi can be specifically selected to target binding with a desired analyte over any other substances or impurities in the sample.
With regards to claim 17, Tokonami et al teach of a detection system that comprises the components of the detection system recited in claim 16 (see explanation above), as well as a light source 50 that emits light having a wavelength within an absorption wavelength range of the photothermal conversion region 13, and a detector 90 that detects the analyte by monitoring the detection kit after irradiation with light from the light source 50. See Figure 1 in Tokonami et al.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tokonami et al (WO 2017/195872, English-language translation is US 2020/0182770) in view of Trivedi (US 2019/0032114, submitted in the IDS filed on June 23, 2025) as applied to claims 1, 3-5, 7, 12-13, 16-17 and 19 above, and further in view of Iida et al (WO 2018/207937, submitted in the IDS filed on November 7, 2023). For a teaching of Tokonami et al and Trivedi, see previous paragraphs in this Office action.
With regards to claim 15, the combination of Tokonami and Trivedi fails to teach or fairly suggest that the detection kit further comprises first and second electrodes located apart from each other with the photothermal conversion region interposed between the electrodes, and detecting an analyte such as bacteria in a sample on a basis of a change of an electric resistance between the first and second electrodes.
Iida et al (WO 2018/207937) teach of a detection kit and a method for detecting an analyte in a sample. The detection kit comprises a substrate 11, a photothermal heating element
110 located on the substrate, and electrodes 111 and 112 arranged apart from each other on the substrate 11, wherein the photothermal heating element 110 is interposed between the electrodes 111 and 112. See Figures 2 and 17 in Iida et al. Iida et al teach that in a method for detecting an analyte in a sample, the sample is introduced to the substrate 11 in the region of the photothermal heating element 110, a light source is used to irradiate the photothermal heating element 110 to cause the sample to be heated, and an electric resistance between the electrodes 111 and 112 is measured to detect the presence of the analyte in the sample. See Figures 2 and 17, and pages 7, 9-11, 33-37 and 81 of the English-language translation of Iida et al provided with this Office action.
Based upon a combination of Tokonami et al, Trivedi and Iida et al (WO 2018/207937), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the detection kit taught by the combination of Tokonami and Trivedi first and second electrodes located apart from each other on the substrate of the device with the photothermal conversion region interposed between the electrodes, and to detect an analyte such as bacteria in a sample on a basis of a change in an electric resistance between the first and second electrodes because the detection system and kit taught by the combination of Tokonami et al and Trivedi uses a photothermal conversion region to perform an analysis of an analyte in a sample, and Iida et al teach that an electrical resistance between electrodes positioned on a substrate between a photothermal conversion region also allows analyte to be detected in a sample.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tokonami et al (WO 2017/195872, English-language translation is US 2020/0182770) in view of Trivedi (US 2019/0032114, submitted in the IDS filed on June 23, 2025) as applied to claims 1, 3-5, 7, 12-13, 16-17 and 19 above, and further in view of Iida et al (WO 2020/218347, submitted in the IDS filed on November 7, 2023). For a teaching of Tokonami et al and Trivedi, see previous paragraphs in this Office action.
With regards to claims 9-11, the combination of Tokonami et al and Trivedi fails to teach that an analyte such as bacteria is detected in the sample by detecting light from the liquid sample after irradiation, calculating a fluorescence accumulation area of the analyte from an image captured by the imaging device, and calculating a concentration of the analyte from the calculated fluorescence accumulation area by referring to a correlation between the concentration of the analyte and an accumulation area of the analyte.
Iida et al teach of a micro-object collection method and system that comprises introducing a sample containing particles such as resin beads into pores of a polymer film 22 located on a substrate 21, wherein the polymer film 22 is in the form of a honeycomb structure. A photothermal conversion film 13 is located over the pores of the honeycomb structure, wherein the film forms a photothermal conversion region. A method of using the collection system comprises introducing a sample containing resin beads to the plurality of pores in the honeycomb structure of the photothermal conversion region, irradiating the photothermal conversion region with light from a light source to heat and generate thermal convection in the sample, and detecting the resin beads accumulated in an accumulation area of the substrate by illuminating the liquid sample on the photothermal conversion region with light from an illumination light source, collecting the light which passes through the sample with an imaging device, calculating a fluorescence accumulation area of the analyte from an image captured by the imaging device, and calculating a concentration of the analyte from the calculated fluorescence accumulation area by referring to a correlation between the concentration of the analyte and an accumulation area of the analyte. See Figures 19-20, the abstract, and pages 15-18 of the English-language translation of Iida et al.
Based upon a combination of Tokonami et al, Trivedi and Iida et al (WO 2020/218347), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to detect an analyte such as bacteria in the sample with the system and method taught by the combination of Tokonami et al and Trivedi by detecting light from the liquid sample after irradiation, calculating a fluorescence accumulation area of the analyte from an image captured by the imaging device, and calculating a concentration of the analyte from the calculated fluorescence accumulation area by referring to a correlation between the concentration of the analyte and an accumulation area of the analyte because Iida et al (WO 2020/218347) teach that objects in a sample analyzed using a porous photothermal conversion region on a substrate can be detected using such steps since the objects accumulate in an area close to the photothermal conversion region and can be easily viewed with an imaging device.
Allowable Subject Matter
Claims 6, 8 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims because the closest prior art references to Tokonami et al and Trivedi, described above, fail to teach or fairly suggest that the plurality of microscopic objects (i.e. magnetic beads) can be introduced into the plurality of pores in the photothermal conversion region by irradiation with ultrasonic waves or by natural sedimentation, and that a spectroscope measures a spectrum of light from the liquid sample and calculates a concentration of the analyte on a basis of the spectrum measured by the spectroscope.
Response to Arguments
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive.
The previous rejections of the claims under 35 USC 112(a) and 35 USC 112(b) made in the last Office action mailed on May 6, 2026 have been withdrawn in view of the amendments made to the claims and Applicant’s persuasive arguments. However, claims 16-17 are objected to for the reasons set forth above.
Applicant argues the rejection of the claims under 35 USC 103 as being obvious over Tokonami et al (WO 2017/195872, English-language translation is US 2020/0182770) in view of Trivedi (US 2019/0032114, submitted in the IDS filed on June 23, 2025), and further in view of either Iida et al (WO 2018/207937, submitted in the IDS filed on November 7, 2023) or Iida et al (WO 2020/218347, submitted in the IDS filed on November 7, 2023) by first stating that no combination of Tokonami et and Trivedi et al discloses or suggests microscopic objects having a surface modified by a host substance capable of being specifically bound to an analyte since the beads 535 taught by Trivedi et al are disclosed in the context of solid phase PCR, and the linking molecules 531 on the beads 535 serve to covalently bind the beads to the linker layer 527 in the pores of the solid surface of the detection device and to immobilize nucleic acids primers 529 designed for PCR amplification of nucleic acids, not for specifically binding to and detecting an analyte in the manner recited by the instant claims. This argument is not found persuasive since the nucleic acid primer molecules 529 immobilized on the beads 535 taught by Trivedi et al are short single-stranded DNA or RNA sequences that bind to a specific region of a template DNA or RNA strand via complementary base pairing. Therefore, these nucleic acid primers 529 attached to the linking molecules 531 on the beads 535 taught by Trivedi et al would constitute a host substance capable of being bound to an analyte, as recited in the instant claims, since the analyte in this case would comprise the template DNA or RNA strands complementary to the DNA or RNA primer molecules 529 immobilized to the beads 535 located in the pores of the photothermal conversion layer of the detection device taught by Trivedi et al. During the PCR process taught by Trivedi et al, the template DNA or RNA strands complementary to the DNA or RNA primer molecules 529 immobilized to the beads 535 are both amplified and detected in the method.
Applicant also argues that no combination of Tokonami et al and Trivedi et al discloses or suggest microscopic objects trapped inside pores of a photothermal conversion layer so as to be held in the pores since the beads 535 taught by Trivedi et al are immobilized in the pores of the photothermal conversion layer via covalent binding, which is a permanent chemical fixation as opposed to the physical trapping of the microscopic objects recited in the instant claims inside the pores of the photothermal conversion region without being chemically bonded to any surface. This argument is not found persuasive since the claims do not recite that the microscopic objects are trapped inside the pores without being chemically bonded to any surface. Rather, the instant claims only recite that the microscopic objects are “trapped inside the plurality of pores so as to be held in the plurality of pores”. Similarly, the covalent binding of the microscopic beads 535 taught by Trivedi et al to the inside of the pores in the photothermal conversion layer of the device would also trap the beads 535 in the pores so as be held in the pores.
Applicant also argues that a person of ordinary skill in the art would not combine Tokonami et al and Trivedi et al since Tokonami et al teach of fixing an analyte (i.e. bacteria) to the pore walls of pores in a photothermal conversion region instead of to separate microscopic objects modified with a host substance, and Trivedi’s bead-based approach is designed for the purpose of nucleic acid amplification rather than analyte detection. Therefore, Applicant argues that a person of ordinary skill in the art would not look to Trivedi’s PCR primer immobilization technique to modify Tokonami’s bacteria collection and detection device because the two references address fundamentally different problems and employ different mechanisms. This argument is not persuasive since both references to Tokonami et al and Trivedi et al teach of using a photothermal conversion region in a device for detecting an analyte such as bacteria or a nucleic acid in a sample. The primary reference to Tokonami et al provides the teaching and suggestion to trap an analyte such as bacteria in pores of a photothermal conversion region of a detection device by immobilizing a host substance capable of being specifically bound to the analyte in the pores. The secondary reference to Trivedi et al provides the teaching and suggestion that another known way to trap an analyte in pores of a photothermal conversion region of a detection device is to add microscopic beads to the pores along with a sample containing the analyte to be detected, wherein the microscopic beads are modified by a host substance capable of being specifically bound to the analyte since the microscopic beads 535 taught by Trivedi et al having nucleic acid primers attached thereto specifically bind to and amplify complementary nucleic acids present in a sample added to the pores of the photothermal conversion region along with the beads 535. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to introduce a plurality of microscopic objects having a surface modified by a host substance capable of being specifically bound to the analyte (i.e. bacteria) into the pores of the photothermal conversion region of the device taught by Tokonami et al prior to heating the sample with light from the light source 50 because Tokonami et al teach that the bacteria held and trapped within each pore of the honeycomb structure can be fixed to an inner wall or a bottom of the pores using an antibody or the like contained within or adhered to the inner wall or bottom of the pores (see paragraph 0122 in Tokonami et al), and Trivedi teaches that another known and equivalent method of trapping an analyte in pores of a photothermal conversion region is to introduce microscopic objects such as magnetic beads having a surface modified by a host substance capable of being specifically bound to an analyte into the pores so that the microscopic beads are trapped inside the pores.
For all of the above reasons, Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 August 24, 2026
Prosecution Insights