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 .
Claim Status
Claims 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 15 are pending and are examined. Claims 2, 14, and 16-20 are cancelled.
Claim Rejections - 35 USC § 112
Claims 1 and 3-13 are 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.
Claim 1 recites “a heat sink in thermal contact with the heater and the heat spreading layer in the consumable amplification module”. It is unclear whether “a heat sink” is referring to “a heat sink in the reader module” previously recited in claim 1, or a different heat sink. In the instant application, the examiner notes that Fig. 1 shows a heat sink 104. For the purposes of examination, the examiner interprets the limitation to recite a single heat sink.
Claims 3-13 are rejected by being dependent on a rejected base claim.
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Knight (US Pub 2012/0052560; previously cited) in view Ogg (WO 2015/073999; previously cited).
Regarding Claim 15, Knight teaches a consumable amplification module for insertion into a reader module of a system for thermal cycling in nucleic acid amplification testing ([0337] The present invention has the capability of rapidly processing very small aliquots of a nucleic acid sample solution and then subsequently running another assay on another small aliquot from the same sample. [0053] Fig. 6A is a perspective view of a microfluidic device according to one embodiment. [0054] FIG. 6B is a perspective view of a heat sink assembly of a microfluidic device according to one embodiment.), the amplification module comprising: a reactor vessel for containing a test sample ([0134] According to one embodiment, the wells and inlet ports of the microfluidic device 322 are accessible from above); a heater comprising a heater element in thermal contact with the reactor vessel and being adapted to receive a control signal ([0134] Figs. 6A and 6B The microfluidic device 322 may include heater elements, which may be in the form of thin film resistive thermal detectors (RTDs) or thermistors. One or more heater elements may be associated with each microfluidic channel and may be located adjacent to the microfluidic channel.), from an external controller, to add heat to the reactor vessel to heat the test sample; a temperature sensor (356a, 356b) for determining the temperature of at least one of the heater element and the test sample.
Modified Knight is silent to a heat spreading layer in thermal contact with the heater, wherein the heat spreading layer being adapted for thermal contact with a thermal interface of a heat sink of the reader module when the amplification module is received by the reader module, for removing heat from the heater and from the reactor vessel to cool the test sample.
Ogg teaches in the related art of cartridges and processing sample for nucleic acids. [0034] FIGS. 15A and 15B show cartridge 1501. The reaction chamber 1521 can be covered with a seal and/or can have a separate heat spreader layer 1521. [0054] (3) an optional thermal control assembly (e.g., thermal cycler) configured to place a heat spreader in thermal contact with a thermal cycling chamber of an engaged cartridge and to regulate temperature of the thermal cycling chamber, when the engagement assembly is the second position. [00151] PCR can be carried out using a thermal cycler assembly. This assembly can include thermal controller, such as a Peltier device, infrared radiation source, resistive heating element, circulating water or other fluids, circulating air, movement of constant temperature blocks, or other material, which can be configured to heat and cool for thermal cycling and can be comprised in the cartridge module which can be configured to move the thermal controller into thermal contact with the thermal cycling chambers, for example, through a heat spreader (or thermoconductor that can spread/distribute heat and cooling) disposed over each of the reaction chambers.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a heat spreader, as taught by Ogg, a heat spreader in thermal contact with the heater, the heat spreader being adapted for thermal contact with a thermal interface of a heat sink in the device of Knight, to allow for distributing heat across an area for a PCR reaction, as taught by Ogg, in [0151].
Allowable Subject Matter
Claims 1 and 3-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Reasons for Indicating Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or suggest a heat spreading layer in thermal contact with the heater and adapted to transmit heat from the heater and from the reactor vessel in the amplification module to a heat sink in the reader module and a heat sink in thermal contact with the heater and the heat spreading layer in the consumable amplification module through the thermal interface when the amplification module is inserted into the reader module, for removing heat from the heater and from the reactor vessel to cool the test sample.
Response to Arguments
Applicant’s arguments, see pages 6-top of page 14, filed 12/17/25, with respect to the 103 rejection have been fully considered and are persuasive. The 103 rejection of claims 1 and 3-13 has been withdrawn.
Applicant's arguments, see pages 14 and 15, filed 12/17/25 regarding the 103 rejection over independent claim 15 have been fully considered but they are not persuasive.
Applicant argues on page 14 that claim 15 requires the heat sink to be located in the reader module.
In response, the examiner notes that claim 15 reads as follows regarding the term “reader module”- “for insertion in a reader module”. The examiner notes that the reader module is not part of the claimed amplification module recited in independent claim 15. Therefore, “the heat sink” which is “of the reader module” is also not part of the claimed device (amplification module). The examiner notes that in contrast claim 1 is directed to a system and comprised both the amplification module and the reader module. Therefore, claim 15 remains rejected over the prior art.
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 JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798