DETAILED ACTION
Claim Rejections - 35 USC § 102/103
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed 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 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, 2 and 5-13 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fasching (US 20240326048)1.
With respect to claim 1, Fasching discloses a nucleic acid amplification system comprising a fluidic consumable (see Fig. 120) configured to contain a test sample including target nucleic acids. At least paragraph [0164] states that the fluidic device is disposable. A temperature sensor (Figure 128A:12805) is configured to measure a temperature of the test sample in the fluidic consumable (“A second temperature probe (12805) was used to measure fluid temperature inside the sample chamber”). Paragraphs [0195] and [0200] teach that a computer device and a detection system are also provided to detect target nucleic acids and regulate device operations. Fasching further states in paragraphs [0011]-[0014], [0439]-[0442], [0445] and [0457]-[0460] that a single use chemical heater and a multi-use heater are used to heat the fluidic consumable. Fasching states that the single use chemical heater may take a variety of forms, including a pouch containing sodium acetate configured to undergo an exothermic chemical reaction. The multi-use heater may take a variety of forms, including a resistive heating element, an induction heater and a Peltier element. It is believed that Fasching teaches that both the chemical heater and the multi-use heater are provided such that the chemical heater and multi-use heater each heat the same fluidic consumable when the fluidic consumable is on the chemical heater. In the event that Fasching instead discusses the multi-use heater and chemical heater as alternative options, it would have nonetheless been obvious to use them together in the same embodiment to collectively heat the fluidic consumable. The chemical and multi-use heaters each operate in a highly predictable manner and the provision of both types of heaters would produce an expected cumulative and/or redundant result. The chemical and multi-use heaters may also be located at different portions of the same fluidic consumable to controllably heat selected areas at different temperatures.
With respect to claim 2, Fasching discloses the system as described above. P, PI and PID feedback controllers are considered to be notoriously well known in the art.
With respect to claim 5, Fasching discloses the system as described above. Fasching further states in paragraphs [0228], [0438], [0445] and [0459] that the multi-use heater may be a resistive heater or an inductive heater.
With respect to claim 6, Fasching discloses the system as described above. Fasching teaches in paragraphs [0438] and [0445] that the system may include a Peltier device.
With respect to claim 7, Fasching discloses the system as described above. Fasching shows that the fluidic consumable includes at least one chip plate and microfluidic channel. See Fig. 120.
With respect to claims 8-12, Fasching discloses the system as described above. Fasching additionally teaches that the test sample includes a target nucleic acid and that an additive is mixed with the test sample. The additive includes BSA, PEG (e.g., TEG), a chaotrope/denaturant, and Triton-X 100 as a detergent. This is taught in paragraphs [0225], [0302], [0307], [0396], [0468] and [0518]-[0520]. It would have been within the ability of one of ordinary skill to select specific additives at varying amounts to improve operation of the Fasching amplification system. Absent a showing of criticality, it would have been obvious to select an additive concentration through routine experimentation.
With respect to claim 13, Fasching discloses the system as described above. Fasching states in paragraphs [0260]-[0263] and [0294] that a light source and a camera are provided for detecting an optical signal.
Allowable Subject Matter
Claims 3 and 4 are allowed.
The Seip (US 20030092173) reference is believed to be the closest prior art by disclosing a porous bag containing iron oxide powder and configured to produce an exothermic reaction. Seip, however, is directed to an anaerobic culture operation, as opposed to nucleic acid amplification.
Response to Arguments
Applicant's arguments filed 21 August 2026 have been fully considered but they are not persuasive.
Applicant primarily argues that Fasching describes chemical and multi-use heaters as alternative options and does not teach that the multi-use heater is configured to heat both the chemical, single-use heater and the fluidic consumable. However, it would have been obvious to use a multi-use heater and a single-use heater together in the same embodiment to collectively heat the fluidic consumable. Chemical and resistive heaters, for example, each operate in a highly predictable manner and the provision of both types of heaters would produce an expected cumulative and/or redundant result. Furthermore, one heater may be used as a “backup” for the other in the case of operational error. Fasching does not appear to describe the different heaters as mutually exclusive or include any concern or warning that would discourage one from utilizing more than one of the many enumerated heating options.
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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
1 The previous office action incorrectly identified this reference using the related WIPO publication WO 2021243308 with Ching as the first-named inventor
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