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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 04/30/2026 is acknowledged.
Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/30/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/28/2023 and 02/27/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities:
Line 4 of claim 4 reads… and liquid coolant outlet on the side of the apparatus... However, it should read as…and a liquid coolant outlet on the side of the apparatus...
Appropriate correction is required.
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 1-2, 4, 6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ward et al. (hereinafter Ward) US 2010/0203595 cited in the IDS filed 02/27/2024.
Regarding claim 1, Ward discloses an apparatus (thermal cycling apparatus 9), comprising: an amplification chamber (thermally conductive receiving cup 13) to contain a biochemical reaction associated with amplification of a biologic sample including a nucleic acid; a heater (TEC 12) thermally coupled to the amplification chamber; and a thermally conductive substrate (thermally conductive heat removal module (HRM) 10) in contact with the heater and including a liquid coolant passage (coolant channels 11) to pass a liquid coolant through the thermally conductive substrate, as shown in Figs. 1, 2 and 6 and discussed in at least [0058-0059]. Also see whole document.
Regarding claim 2, Ward discloses wherein the thermally conductive substrate includes a first conductive layer upon which the heater is deposited, and a second conductive layer which is a support substrate for the apparatus, and wherein the first conductive layer and the second conductive layer define the liquid coolant passage, as shown in Fig. 2 reproduced below.
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Regarding claim 4, Ward discloses wherein the liquid coolant passage (alternative cooling system 120) includes a liquid coolant inlet (conduit 122) on a side of the apparatus opposite of the amplification chamber for the liquid coolant to enter the liquid coolant passage, and a liquid coolant outlet (conduit 122) on a side of the apparatus opposite of the amplification chamber for the liquid coolant to exit the liquid coolant passage, as shown in at least Fig. 8 and discussed in at least [0071]. Also see Fig. 3.
Regarding claim 6, Ward discloses an apparatus (thermal cycling apparatus 9), comprising: an amplification chamber (thermally conductive receiving cup 13) to contain a biochemical reaction associated with amplification of a biologic sample including a nucleic acid; a series of heaters (TEC 12) thermally coupled to the amplification chamber; and a thermally conductive substrate (thermally conductive heat removal module (HRM) 10) in contact with the series of heaters and including a liquid coolant passage (coolant channels 11) to pass a liquid coolant through the thermally conductive substrate, as shown in Fig. 6 and discussed in [0058-0059].Also see whole document.
Regarding claim 8, Ward discloses wherein the thermally conductive substrate further defines a liquid coolant inlet trough (inlet manifold 20) disposed parallel to the series of heaters and a liquid coolant outlet (outlet manifold 21) trough disposed parallel to the series of heaters such that the liquid coolant flows in a direction orthogonal to the series of heaters, as shown in Fig. 3 and discussed in at least [0070].
Regarding claim 9, Ward discloses wherein each of the series of heaters is independently pulsed for an amount of time for the biochemical reaction, discussed in at least [0059 and 0067-0068].
Regarding claim 10, Ward discloses wherein the thermally conductive substrate includes channel separators to direct the liquid coolant flow in a serpentine direction from a liquid coolant inlet to a liquid coolant outlet, as shown in Fig. 3 and discussed in [0070].
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.
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.
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ward US 2010/0203595.
Regarding claim 3, Ward discloses wherein the amplification chamber includes a lid (lid 15) [0064].
However, Ward does not disclose the lid comprising the thermally conductive substrate, and the thermally conductive substrate includes silicon.
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide a lid comprising the thermally conductive substrate, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP §2144.04 (V-B).
While Ward does not disclose that the thermally conductive substrate includes silicon, Ward does disclose in paragraph [0060] that the HRM 10 (the thermally conductive substrate includes silicon) is formed of a low specific heat capacity, highly thermally conductive material with a high resistance to oxidation. Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide a thermally conductive substrate that includes silicon, 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 7, Ward discloses wherein the thermally conductive substrate further defines a liquid coolant inlet (inlet manifold 20) on a side of the apparatus and a liquid coolant outlet (outlet manifold 21), such that the liquid coolant flows in a direction parallel to the series of heaters from the liquid coolant inlet to the liquid coolant outlet as shown in at least Figs. 4 and 6. [0026 and 0069-0070].
Ward does not disclose that the coolant inlet is on a side of the apparatus opposite of the series of heaters and the liquid coolant outlet is on the side of the apparatus opposite of the series of heaters.
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide a coolant inlet on a side of the apparatus opposite of the series of heaters and liquid coolant outlet on a side of the apparatus opposite of the series of heaters, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ward US 2010/0203595 as applied to claims 1-4 and 6-10 above, and further in view of Hanagata et al. (hereinafter Hanagata) US 2017/0136466 cited in the IDS filed 11/28/2023.
Regarding claim 5, Ward does not disclose wherein the heater is a thin-film resistor.
Hanagata discloses a microfluidic device 200 including heater elements in the form of thin film resistive heaters 212. In one embodiment, a heater element 212 is associated with each microfluidic channel 202 and may be located beneath the microfluidic channel 202. Each heater element 212 comprises two heater sections: a PCR heater 212a section in the PCR zone 204 and a thermal melt heater section 212b in the thermal melt zone 206 [0053].
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to modify Ward with a thin-film resistor as taught by Hanagata, since thin-film resistive heaters are known to provide uniform heat distribution and rapid temperature response. Thereby providing excellent thermal efficiencies.
Conclusion
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-Wednesday 08:00-18:00 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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