DETAILED CORRESPONDENCE
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 .
Response to Amendment
Based on the claim amendments filed on 11/24/25, the previous claim objections are withdrawn.
As to the remarks filed on 11/24/25, the examiner appreciates applicants clarifying remarks towards the previous 112(b) rejection. In light of applicants remarks, the previous 112(b) rejection is withdrawn.
In regards to applicants amendments to the claims and remarks, the previous prior art rejection is withdrawn and a new ground of rejection has been provided to address the claim amendments.
Claim Status
Claims 1-9 are pending.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kornilovich et al (US 20210322992; hereinafter “Kornilovich”; already of record) in view of Isoshima et al (US 20240033741; hereinafter “Isoshima”) in view of Son, J (US 20200114363; hereinafter “Son”; already of record) in view of Gubatayao et al (US 20140045186; hereinafter “Gubatayao”; already of record).
As to claims 1 and 9, Kornilovich teaches a temperature detection device and method for loop mediated isothermal amplification (LAMP) (Kornilovich; Figs. 2-3, [11]), comprising a temperature measurement mechanism (Kornilovich teaches a temperature feedback sensor; [27]), a heat conduction pad, a heating layer, and a thermal insulation layer which are disposed in sequence from top to bottom (Kornilovich teaches a heating layer 150 which can be recessed in, and therefore under, substrate 120; [27, 28, 29]. Kornilovich teaches the substrate 120 as the heat conduction pad which is thermally conductive and can be copper or aluminum; [17]. Kornilovich teaches insulator 160 as zirconia; [20].), wherein the temperature measurement mechanism is electrically connected to the heating layer (Kornilovich teaches the heater layer 150 connected to temperature feedback sensors; [27]); at least two heating sources are arranged on the heating layer; heating regions corresponding to various heating sources are formed on a surface of the heat conduction pad; various working chambers in a microfluidic chip are aligned with the corresponding heating regions and placed on the heat conduction pad; each working chamber is evaluated by the temperature measurement mechanism to collect corresponding working chamber temperature data, that is, the heating layer adjusts, according to the corresponding working chamber temperature data, heat generated by the corresponding heating source (Kornilovich teaches multiple heating elements; [27]. Each region of space corresponding to the different heaters would be the corresponding heating region. Additionally, Kornilovich teaches that there can be multiple chambers in series and/or parallel with the same configuration of heating elements; [2], Fig. 3. Kornilovich teaches the heater layer 150, which includes multiple heaters, connected to temperature feedback sensors; [27]. Further, the additional chambers in parallel and/or series would mean that each chamber has the corresponding heater as shown in figure 2); the thermal insulation layer prevents the heating layer from downwards transmitting the heat such that the heats generated by the heating sources in the heating layer are all transmitted to the corresponding heating regions through the heat conduction pad (This limitation is related to intended use. Kornilovich teaches thermal insulation layer 160 which would perform this function); the heating layer comprises a microprocessor and circuit, a first heating plate, and a second heating plate; the first heating plate and the second heating plate respectively form different temperature heating sources, so as to heat the corresponding working chambers in the microfluidic chip placed on the heat conduction pad (Kornilovich teaches a temperature controller which would include some type of circuit and processor; [34]. Kornilovich teaches multiple heating elements/plates; [27]. Each region of space corresponding to the different heater plates would be the corresponding heating region. Additionally, Kornilovich teaches that there can be multiple chambers in series and/or parallel with the same configuration of heating elements/plates; [32], Fig. 3. Kornilovich teaches the heater layer 150, which includes multiple heaters, connected to temperature feedback sensors; [27]. Further, the additional chambers in parallel and/or series would mean that each chamber has the corresponding heater plate as shown in figure 2).
Note: The instant Claims 1-8 contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Kornilovich does not specifically teach wherein the heat conduction pad and the thermal insulation layer are disposed on opposite surfaces of the heating layer. However, Isoshima teaches the analogous art of a sample amplification device and method for amplification of a sample, with a heat conduction pad, a heating layer, and a thermal insulation layer which are disposed in sequence from top to bottom, and wherein heat conduction pad and the thermal insulation layer are disposed on opposite surfaces of the heating layer where the sample chamber is aligned with the heating region of the heating pad (Ishoshima teaches a heat conduction pad 2, a heating layer 3, and a thermal insulation layer 4, where the sample chambers 101 are aligned with the heating pad; Fig. 2, 14, [1, 32, 34]). Without some statement of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art to rearrange the heat pad, heating layer and thermal insulation layer of Kornilovich to be arranged such the heat conduction pad and the thermal insulation layer are disposed on opposite surfaces of the heating layer as in the heater of Isoshima because Isoshima teaches that configuring the heater in this manner enables samples to be heated for amplification (Isoshima; [32]) and also because this configuration enables switching between heating and cooling (Isoshima; [32]) helping to provide the advantage of rapid and efficient amplification and improving device lifespan (Isoshima; [9, 11]) since it has been generally recognized that to shift location of parts when the operation of the device is not otherwise changed is within the level of ordinary skill in the art, In re Japikse, 86 USPQ 70; In re Gazda, 104 USPQ 400.' Alternatively, it would have been obvious to one of ordinary skill in the art to substitute the amplification heater for samples in chambers of Kornilovich to be the heater with the heat conduction pad and the thermal insulation layer disposed on opposite surfaces of the heating layer as in Isoshima because Isoshima teaches that the heater provides the advantage of rapid and efficient amplification and improving device lifespan (Isoshima; [9, 11]), and that the heater enables samples to be heated for amplification (Isoshima; [32]) and also because this configuration enables switching between heating and cooling (Isoshima; [32]). This modification would have been obvious to one of ordinary skill in the art since Kornilovich and Isoshima both teach heating configurations for amplification of samples.
Modified Kornilovich does not specifically teach each working chamber provided with a corresponding temperature measurement chamber in parallel such that temperature measurement mechanism enters the corresponding temperature measurement chamber to measure the corresponding temperature measurement chamber to collect corresponding working chamber temperature data, that is, the heating layer adjusts, according to the corresponding working chamber temperature data, heat generated by the corresponding heating source. However, Son teaches the analogous art of a multichamber reaction vessel that is heated, where there is a working chamber provided with a corresponding temperature measurement chamber in parallel such that temperature measurement mechanism enters the corresponding temperature measurement chamber to measure the corresponding temperature measurement chamber to collect corresponding working chamber temperature data, that is, the heating layer adjusts, according to the corresponding working chamber temperature data, heat generated by the corresponding heating source (Son teaches working chamber 104 and a corresponding measurement chamber 805 that includes a temperature sensor 158; Fig. 8, [100]. Son teaches monitoring feedback from the sensor to provide temperature control to the working chamber; [20, 26, 113]). It would have been obvious to one of ordinary skill in the art to have modified the multiple working chambers that have their temperature controlled by feedback from a temperature sensor of Kornilovich to have each included a corresponding temperature measurement chamber with a temperature sensor as in Son because Son teaches that using the temperature measurement chamber provides the advantage of accurate measurement of the working reaction chamber, and provide advantages of quick feedback, and also help provide a more effective and accurate measurement system than with sensors outside the reaction chamber (Son; [100]), and also because Son teaches that using a sensor inside a measurement chamber helps approximate and determine the temperature of the nearby working chamber in real-time (Son; [100]).
Modified Kornilovich does not teach that the heating layer comprises the microprocessor or a pulse width modulation (PWM) driving circuit. However, Gubatayao teaches the analogous art of an amplification module with heaters controlled by a pulse width modulation (PWM) driving circuit electrically connected to the microprocessor (Gubatayao; [84-87, 150]). It would have been obvious to one of ordinary skill in the art to have modified the temperature control for the heaters of modified Kornilovich to have included PWM and corresponding microprocessor circuitry because Gubatayao teaches that a processor and microprocessor are known synonyms and would be present in any control (Gubatayao; [150]) and because Gubatayao teaches that PWM help to control different heaters and that PWM are known to control the on/off of multiple various heaters (Gubatayao; [84-87]).
As to claim 2, modified Kornilovich teaches the temperature detection device for LAMP according to claim 1, wherein the microprocessor drives, through the PWM driving circuit, the first heating plate and the second heating plate to perform heating such that the first heating plate and the second heating plate respectively form a 70° C heating source and a 95° C heating source, that is, a 70° C heating region and a 95° C heating region are formed at corresponding positions on the surface of the heat conduction pad, so as to heat the corresponding working chambers in the microfluidic chip on the heat conduction pad (Kornilovich teaches the heater layer 150 can include multiple elements, each at a corresponding reaction/working chamber region, and connected to temperature feedback sensors to provide temperature control; [27]. See also the modification of claim 1 above. Kornilovich teaches that the chambers can each be controlled to various temperatures including temperatures encompassing 70 and 95 degrees; [30, 11]).
As to claim 3, modified Kornilovich teaches the temperature detection device for LAMP according to claim 2, wherein the first heating plate and the second heating plate are both ceramic heating plates (Kornilovich teaches the multiple heaters above, and teaches that the heaters can be various forms [27] including ceramic such as tantalum nitride [28].
As to claim 4, modified Kornilovich teaches the temperature detection device for LAMP according to claim 2, wherein the temperature measurement mechanism comprises a first temperature sensor and a second temperature sensor which are electrically connected to the microprocessor; and a first probe of the first temperature sensor and a second probe of the second temperature sensor respectively extend into the corresponding temperature measurement chambers to collect the corresponding working chamber temperature data (The modification of the multiple working chambers of Kornilovich to each include a corresponding measurement chamber with a temperature sensor as in Son has already been discussed in claim 1 above).
As to claim 5, modified Kornilovich teaches the temperature detection device for LAMP according to claim 4, wherein the heat generated by the heating source=heat loss+ ambient temperature loss+ heat resistance (The limitations recited here are related to intended use and do not further define the temperature detection device. Further, the recited heat generated appears to be a property that all heating sources would exhibit, and therefore Kornilovich teaches the limitations).
As to claim 6, modified Kornilovich teaches the temperature detection device for LAMP according to claim 5, wherein the ambient temperature loss is Q=cmΔT, where c is specific heat capacity; m is air mass; and ΔT is an air temperature rise (The limitations recited here are related to intended use and do not further define the temperature detection device. Further, the recited heat generated appears to be a property that all heating sources would exhibit, and therefore Kornilovich teaches the limitations).
As to claim 7, modified Kornilovich teaches the temperature detection device for LAMP according to claim 1, wherein the heat conduction pad comprises a low-heat-resistance heat conduction pad; and the low-heat-resistance heat conduction pad transmits the heat generated by each heating source (Kornilovich teaches the substrate 120 as the heat conduction pad which is thermally conductive and can be aluminum or copper, where aluminum has low heat resistance; [17]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kornilovich et al (US 20210322992; hereinafter “Kornilovich”; already of record) in view of Isoshima et al (US 20240033741; hereinafter “Isoshima”) in view of Son, J (US 20200114363; hereinafter “Son”; already of record) in view of Gubatayao et al (US 20140045186; hereinafter “Gubatayao”; already of record) and in view of NASA (https://web.archive.org/web/20210317035412/https://technology.nasa.gov/patent/LEW-TOPS-133; published online 3/17/21; hereinafter “NASA”; already of record).
As to claim 8, modified Kornilovich teaches the temperature detection device for LAMP according to claim 1, with the thermal insulation layer that prevents the heating layer from downwards transmitting the heat such that the heats generated by the various heating sources in the heating layer are all transmitted to the corresponding heating regions through the heat conduction pad.
Modified Kornilovich does not specifically teach that the thermal insulation layer comprises an aerogel thermal insulation thin film. However, NASA teaches the analogous art materials used in sensors, power, insulation, and biotechnology (NASA; p. 2-3) where aerogels are used and known to be used in each of these fields, and where aerogels are thin films (NASA; p. 4). It would have been obvious to one of ordinary skill in the art to have modified the insulator on the sensor of modified Kornilovich to have been a thin film aerogel as in NASA because NASA teaches that aerogels are commonly used in sensors (NASA; p. 2-3) and because NASA teaches that aerogels have low thermal conductivity, are extremely strong, and are flexible and lightweight, and have robust chemical and mechanical properties for any insulative environment (NASA; p. 2).
Response to Arguments
Applicant’s arguments filed on 11/24/25 have been considered, but are moot because the arguments are towards the claim amendments and not the current ground of rejection.
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 Benjamin R Whatley whose telephone number is (571)272-9892. The examiner can normally be reached on Mon- Fri 8am-5pm.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798