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 1-13 in the reply filed on 26 May 2026 is acknowledged.
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 May 2026.
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.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 recites the limitation "the porous bag" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is believed that claim 4 should be dependent on claim 3.
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 Ching (WO 20240326048).
With respect to claim 1, Ching 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. Ching 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. Ching 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 Ching 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 Ching 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, Ching 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, Ching discloses the system as described above. Ching 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, Ching discloses the system as described above. Ching teaches in paragraphs [0438] and [0445] that the system may include a Peltier device.
With respect to claim 7, Ching discloses the system as described above. Ching shows that the fluidic consumable includes at least one chip plate and microfluidic channel. See Fig. 120.
With respect to claims 8-12, Ching discloses the system as described above. Ching 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 Ching 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, Ching discloses the system as described above. Ching states in paragraphs [0260]-[0263] and [0294] that a light source and a camera are provided for detecting an optical signal.
Allowable Subject Matter
Claim 3 is 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.
Claim 4 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of claim 3.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Lee (KR 102748674) and Shimizu (US 20240416344) references teach the state of the art regarding photothermal heating. The Bearinger (US 20140356874), LaBarre (US 8431387) and Weigl (US 20120115212) references teach the state of the art regarding chemical, inductive and resistive heaters.
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
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