DETAILED ACTION
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/05/2024, 10/17/2024, 01/10/2025, 04/29/2025 and 11/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant’s arguments filed 11/25/2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that Coursey fails to disclose “four-terminal electrical contacts to the main heater track adapted to provide electrical connection for driving the main heater track and simultaneously sensing a resistance of the main heater track” as recited in claim 1, the examiner disagrees. Coursey ‘605 discloses in paragraph 119 the microfluidic device 2600 includes a plurality of heater electrodes 210 connected to the various thin-film heaters 212a and 212b. Heater electrodes 210 may include PCR section leads 318, one or more PCR section common lead 316a, thermal melt section leads 320, and one or more thermal melt section common lead 316b. That is at least four separate terminal electrical contacts. Further, Coursey ‘605 discloses in paragraph 74 the thin film heaters 212 function as both heaters and temperature detectors. Also see paragraphs 60 and 117-118. Therefore, it is the position of the Office that Coursey ‘605 discloses four-terminal electrical contacts to the main heater track adapted to provide electrical connection for driving the main heater track and simultaneously sensing a resistance of the main heater track as recited in claim 1
In response to applicant’s argument that Coursey does not include a “main heater track” as claimed, but includes multiple separate heater elements, one per microfluidic channel 202 (see paragraph [0060]), given the broadest reasonable interpretation, the term “track” has been taken to mean a course along which something moves or progresses. See https://www.merriam-webster.com/dictionary/track. Further, claim 1 does not specify that the heater track is composed of a singular element. In fact, claim 1 implies that the main heater track comprises four separate elements that correspond to the four-terminal electrical contacts. This is made abundantly clear in the following claim, claim 2 which recites the main heater track comprises a central region comprising a plurality of substantially parallel track sections. New claim 16 also highlights the fact that the main heater track requires a plurality of track sections. Therefore, claim 1 does not require a main heater track composed of a single piece. As such, Coursey ‘605 meets the claim.
In response to applicant’s argument that claim 3 clearly requires specific changes in dimensions of the gap width and/or the track widths depending on different locations within the main heater device, and that concept is not disclosed or even suggested in Coursey, the examiner disagrees. As cited in the previous rejection, Coursey ‘605 discloses in paragraph 68 that other thin film heater dimension can be used. In other words, the thin film heater dimension are not limited to the exemplary embodiments.
As to applicant’s argument that, there is no suggestion within Coursey to modify the disclosed dimensions based on these specific locations (edge vs central region) in a main heater track, the examiner disagrees. Coursey ‘605 discloses that The microfluidic channel and thin film heater can be created having suitable dimensions for performing PCR and high resolution thermal melt reactions. Therefore, the preferred dimensions of the microfluidic channel and thin film heater depend on the intended use of the microfluidic device. That is, the gap width and/or the track widths of the microfluidic channel and thin film heater can be altered in any form including varying the width at specific locations (edge vs central region) in order to achieve accurate PCR and high resolution thermal melt reactions.
Therefore, the examiner maintains absent unexpected results it would have been prima facie obvious to provide a gap width Wgap and/or the width of the track sections Wtrack is lower for a track section near an edge of the main heater track than for a track section in the central region of the main heater track, since such modification would require a mere change in size or dimension of the device, i.e. width, because a mere change in the size (or dimension) of a component is generally recognized as being within the level of ordinary skill in the art. Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A).
In response to applicant’s argument that while Coursey ‘271 refers to the use of a “heat spreader,” there is no indication of how the heat spreader should be arranged with respect to a heater track support layer or diffusion layer.
Coursey ‘271 discloses in one embodiment of the present invention, as depicted in FIG. 3, a thermal heat spreader 313 is affixed to the microfluidic device 101. In one non-limiting embodiment, the heat spreader 313 may be affixed over zone 206 (i.e., zone 2 or the thermal melt zone). A copper plate heat spreader 313 is permanently affixed to the downstream portion of the device in the melt region. In this illustrative embodiment, a film resistor 317 and encapsulated thermistor 316 are included on the heat spreader 313 to provide heat and sense temperature, respectively. In another non-limiting embodiment, a prototype embodying some aspects of the present invention is shown in FIG. 9. In this prototype an aluminum plate heat spreader 313 is permanently affixed to the glass microchip, two film resistors 317 are used for heating and a single resistance temperature detector (RTD) 316 is used for temperature sensing. See paragraphs 73 and 90-91. Therefore, Coursey ‘271, discloses a heat spreader located in contact with a glass microchip (diffusion layer) as shown in Fig. 3.
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 applicant regards as his invention.
Claims 5 is 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.
Regarding claim 5, claim 5 recites “a thermal resistance x area” however, the metes and bounds of the claim cannot be determined. As best as can be understood, the variables are indefinite therefore, it is unclear what the claim is attempting to define.
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.
Claim(s) 1, 2, 10 and 15-16 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Coursey et al. (hereinafter Coursey) US 2016/0341605 cited in the IDS filed 01/26/2023.
Regarding claim 1, Coursey discloses a heater for thermocycling to carry out polymerase chain reaction (PCR) PCR amplification, the heater comprising: a thermal diffusion layer (protective layer 306) having a reaction surface (channel layer 302) for transferring heat to a reaction cell (microfluidic channels 202) discussed in at least [0059]; a heater track support layer (substrate layer 314) having a back surface for cooling; an electrically conductive main heater track (thin film resistive heaters 212) supported between the heater track support layer and the thermal diffusion layer discussed in at least [0067-0068]; and four-terminal electrical contacts to the main heater track configured adapted to provide electrical connection for driving the main heater track (Electrical conductor layer 308 may comprise a plurality of heater electrodes 210 connected to the various thin-film heaters 212a and 212b of thin-film heater layer 310. Heater electrodes 210 may include PCR section leads 318, a PCR section common lead 316a, thermal melt section leads 320, and a thermal melt section common lead 316b. According to one embodiment of the present invention, one of the PCR section leads 318 is connected to one end of each of the thin-film PCR heaters 212a. A PCR common lead 316a is connected to the other end of each of the PCR heaters 212a. Similarly, one of the thermal melt section leads 320 and thermal melt section common lead 316b is connected to either end of each thermal melt heater 212b. [0062])and simultaneously sensing a resistance of the main heater track (A drive system for permitting temperature measurement when the transistor is in both the OFF and ON states according to one embodiment of the present invention is illustrated in FIG. 12. In FIG. 12, a schematic of the PWM driver and measurement circuit 1200 is shown in which the transistor 1206 is connected to R2, which represents the combined resistance of the thin-film heaters 212a or 212b and the leads connected to it (i.e. 316a and 318 or 316b and 320). The voltage drop across R2 can be measured at measurement node 1202. Paragraph [0085]); and wherein lateral dimensions of the reaction surface are greater than a thickness H of the heater, such that reaction surface area A > H2 discussed in at least [0067-0068]. Also see [0082, 0083 and 0090].
Regarding claim 2, Coursey discloses wherein the main heater track comprises a central region comprising a plurality of substantially parallel track sections (212a) having widths Wtrack and separated by gaps of width Wgap as shown in Figs. 2 and 3, wherein the thickness Hp (1-3 μm) of the thermal diffusion layer is less than a minimum width of the track sections Wtrack or less than a minimum gap width Wgap (In one exemplary embodiment, the microfluidic channel 202 dimensions can be approximately 10 μm×180 μm and the thin-film heater 212 beneath the microfluidic channel 202 can be approximately 150 μm wide at the bottom of the channel. Other microfluidic channel dimensions can be used as well such as, for example, approximately 10 μm×300 μm, or more. Other thin film heater dimensions could be used such as, for example, from approximately 30 μm wide to 300 μm wide (i.e. the full width of the channel in one embodiment), or more.[0068]), where Wtrack or Wgap are evaluated in the central region of the main heater track discussed in at least [0067-0068].
Regarding claim 10, Coursey discloses a heat sink (cooling device 516) in contact with the back surface as discussed in at least [0071] and shown in Fig. 5. Also see [0070].
Regarding claim 15, Coursey discloses a control circuit (The control system 550 then applies a constant current to all of the heater electrodes 210 at step 1004. Next, at step 1006, the voltage drop across each of the thin-film heaters 212 can then be measured to determine individual resistance (R) values. Using the individual R values, a nominal heater power (P) can be determined to achieve the required channel temperatures for each microfluidic channel 202 at step 1008. [0078]) configured to drive the main heater track, simultaneously sense a resistance of the main heater track, and calculate a temperature of the main heater track based on the sensed resistance. Also see [0070, 0082, 0083 and 0090].
Regarding claim 16, Coursey discloses wherein the main heater track comprises a plurality of track sections, wherein the plurality of track sections of the main heater track are electrically connected in parallel [0069, 0136, 0141]. Also see Fig. 3.
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Coursey US 2016/0341605 as applied to claims 1-2, 10 and 15-16 above.
Regarding claim 3, Coursey does not explicitly discloses wherein the gap width Wgap and/or the width of the track sections Wtrack is lower for a track section near an edge of the main heater track than for a track section in the central region of the main heater track. However, Coursey does disclose that other thin film heater dimensions could be used. See [0068].
Therefore, absent unexpected results it would have been prima facie obvious to provide a gap width Wgap and/or the width of the track sections Wtrack is lower for a track section near an edge of the main heater track than for a track section in the central region of the main heater track, since such modification would require a mere change in size or dimension of the device, i.e. width, because a mere change in the size (or dimension) of a component is generally recognized as being within the level of ordinary skill in the art. Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Coursey US 2016/0341605 as applied to claims 1-3, 10 and 15-16 above, and further in view of Coursey et al. (hereinafter Coursey ‘689) WO 2015073689 cited in the IDS filed 01/26/2023.
Regarding claim 4, Coursey ‘605 does not explicitly discloses a guard heater track between the heater track support layer and the thermal diffusion layer, the guard heater track substantially surrounding the main heater track; and two further electrical contacts to the guard heater track independent from the four-terminal electrical contacts to the main heater track.
Coursey ‘689 discloses a guard heater track (thermal guard heaters 1504) between the heater track support layer and the thermal diffusion layer, the guard heater track substantially surrounding the main heater track as shown in Figs. 15, 16 and 17; and two further electrical contacts to the guard heater track independent from the four-terminal electrical contacts to the main heater track as discussed in at least [0024, 0123 and 0124].
It would have been obvious to one of ordinary skill in the art to modify Coursey ‘605 with a guard heater track between the heater track support layer and the thermal diffusion layer, the guard heater track substantially surrounding the main heater track; and two further electrical contacts to the guard heater track independent from the four-terminal electrical contacts to the main heater track as taught by Coursey ‘689 in order to improve the thermal uniformity of the microfluidic device by mitigating conduction and/or current imbalance. See Coursey ‘689 [0111 and 0118].
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Coursey US 2016/0341605 as applied to claims 1-3, 10 and 15-16 above, and further in view of Coursey et al. (hereinafter Coursey ‘271) US 2013/0157271 cited in the IDS filed 01/26/2023.
Regarding claim 6, Coursey ‘605 does not explicitly discloses a reaction surface heat spreader layer located in contact with or within one of the thermal diffusion layer or the heater track support layer.
Coursey ‘271 discloses a reaction surface heat spreader layer located in contact with or within one of the thermal diffusion layer or the heater track support layer as discussed in at least [0035 and 0073].
It would have been obvious to one of ordinary skill in the art to modify Coursey ‘605 with a reaction surface heat spreader layer located in contact with or within one of the thermal diffusion layer or the heater track support layer as taught by Coursey ‘271 to provide a more uniform and efficient heating of a reaction zone.
Regarding claim 7, Coursey ‘605 as modified does not explicitly discloses wherein the reaction surface heat spreader layer is more thermally conductive, has a greater lateral thermal conductivity and has a lower heat capacity than the one of the thermal diffusion layer or the heater track support layer.
However, Coursey ‘271 does disclose that suitable heat spreader 313 materials include but are not limited to: copper and its alloys, aluminum and its alloys, silver, ceramics (alumina and beryllium oxide among others), and anisotropic conductive materials such graphite and synthetic diamond (such as chemical vapor deposited (CVD) diamond wafers). See [0019 and 0075].
Therefore, absent unexpected results, it would have been prima facie obvious to provide the reaction surface heat spreader layer with a more thermally conductive material, that has a greater lateral thermal conductivity and has a lower heat capacity than the one of the thermal diffusion layer or the heater track support layer, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07.
Regarding claim 8, Coursey ‘605 as modified does not explicitly discloses wherein the reaction surface heat spreader layer is located within the heater track support layer at a distance Ls from the main heater track, wherein Ls is less than 20% of the minimum of the heater track width Wtrack and heater gap width Wgap evaluated in the central region.
However, absent unexpected results, it would have been prima facie obvious to provide the reaction surface heat spreader layer is located within the heater track support layer at a distance Ls from the main heater track, wherein Ls is less than 20% of the minimum of the heater track width Wtrack and heater gap width Wgap evaluated in the central region, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Regarding claim 9, Coursey ‘605 does not explicitly discloses a back surface heat spreader layer is located on the back surface.
Coursey ‘271 discloses a heat spreader layer located in contact with or within one of the thermal diffusion layer or the heater track support layer as discussed in at least [0035 and 0073].
It would have been obvious to one of ordinary skill in the art to modify Coursey ‘605 with a heat spreader layer located in contact with or within one of the thermal diffusion layer or the heater track support layer as taught by Coursey ‘271 to provide a more uniform and efficient heating of a reaction zone.
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 extension fee 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 LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796