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 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) 1-3, 6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinz et al (US PGPub 2017/0022549) discloses a POCT microfluidic chip (see [0182] and Figures 1-5), comprising an upper casing (referred to as front portion 120) and a lower casing (referred to as door assembly 200), characterized by further comprising
a sample pool (shown as chamber C16; see [0315]-[0316]), for collecting a sample to be tested and lysing the sample to be tested (see [0290]-[0291]);
a mixed liquid pool (referred to as chamber C26, see [0315]-[0316]), which is connected to the sample pool through a microchannel for extracting target fragments from the lysed sample to be tested (see [0315]-[0316]);
a waste liquid pool (referred to as chamber C36, see [0315]-[0316]), which is connected to the mixed liquid pool for collecting waste liquid produced during the extraction process of the target fragments (see [0246] and [0315]-[0316]; and
a reaction pool, which is connected to the mixed liquid pool through a
microchannel, wherein the reaction pool comprises at least two constant temperature chambers, wherein a bottom of each constant temperature chamber is embedded with a superconducting thermal body (i.e. a heat transfer element constructed from a thermally conductive material) and each constant temperature chamber has a different temperature, wherein the constant temperature chambers communicate with each other through microchannels, wherein each constant temperature chamber is equipped with an airbag pool (referred to as a flexible portion of each chamber),which communicates with a corresponding constant temperature chamber through a microchannel ([0072], [0085], [0094], [0108]-[0125], [0289], [0353]-[0360] and [0387]);
wherein the sample pool, the mixed liquid pool, the waste liquid pool and the reaction pool are all located on the lower casing, and on the upper casing a
number of sample inlets are provided, which correspond to the sample pool, the
mixed liquid pool and the reaction pool, respectively (see Figures 1-5; [0109], and [0360]);
wherein a soft insert (i.e. a PTFE coating, an elastomeric shield or thermoplastic layers) is provided on a surface of the upper casing, and the soft insert is used to cut off the connection between the reaction pool, the mixed liquid pool and the external environment (see [0260], [0350], [0401] and [0409]);
wherein the airbag pool comprises a pool body and a pressure airbag (referred ti as a bladder), wherein the pool body is located in the lower casing, wherein the pressure airbag is embedded in the upper casing and corresponds to the pool body, wherein by pressing the pressure airbag, a liquid in a corresponding constant temperature chamber is driven to flow ([0072], [0109]-[0125], [0289], [0342]-[0344], [0353]-[0360] and [0399]-[0400]).
Regarding Claim 2, Heinz et al teaches that a material of the superconducting thermal body is selected from metal, single crystal silicon or ceramics (see [0109] and [0253]).
Regarding Claim 3, Heinz et al teaches that the sample pool is provided with a lysis absorbing and releasing piece for absorbing and releasing the sample to be tested (since the receptacle may be pre-loaded with an agent )and a lysis buffer to fully contact and lyse the same (see [0290]-[0292]).
Regarding Claim 6, Heinz et al teaches that the POCT microfluidic chip of claim 1, wherein the material of the soft insert is selected from TPE, TPR, PU or silicone combination (specifically, using thermoplastic materials such as polypropylene (e.g., Reflex® polyolefins available from the Rexene Corporation, Dallas, Tex.), polyester, polyethylene (e.g., polyethylene teraphthalate (“PET”) and polyethylene naphthalate (“PAN”)), polyvinyl chloride, polyvinylidene chloride, polycarbonate resins (e.g., polyvinyl fluoride films) and polyurethane) (see [0254] or [0401]).
Regarding Claim 8, Heinz et al teaches A POCT detection system (referred to as system 700), comprising a POCT detection equipment (referred to as detector system 712), further comprising the POCT microfluidic chip according to claim 1 (see Figure 2 and [0344]-[0346]).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Heinz et al as applied to claim 1 above, and further in view of Yamagata et al (US PGPub 2019/0160466).
Regarding Claim 4, Heinz et al teaches that the sample inlet of the sample pool is sealed by a seal (see [0006] and [0372]).
Heinz et al does not explicitly disclose that the sample inlet of the sample pool is sealed with an antifouling part.
However, in the analogous art of analysis devices, apparatus and systems, Yamagata et al teaches an analysis cell 9, which is a laminate of the upper substrate 901 and the lower substrate 902, the gas outlets 941 and 942 communicating with the flow path 15 communicate with the gas outlet paths 951 and 952 via the space and the communication paths 961 and 962. The gas outlet paths 951 and 952 communicate with the gas outlet 943 of the protruding portion 932 in the upstream end portion. On the downstream side of the analysis cell 9, the gas outlets 941 and 942 are covered with the gas outlet cover member 92, and besides, the space above the gas outlets 941 and 942 is covered with the antifouling member 97. Therefore, by providing the liquid-tight and gas-tight antifouling member 97, exhaust gas from the flow path 15 passes through the gas outlets 941 and 942 and moves inside the gas outlet paths 951 and 952 via the communication paths 961 and 962 toward the gas outlet 943 on the upstream side. Accordingly, if the liquid-tight and gas-tight inlet cover member is used, by attaching the inlet cover member, both the inlet 93 and the gas outlet 943 are covered in a liquid-tight and gas-tight manner, and therefore, it is possible to prevent a sample and the exhaust gas from leaking to the outside (see [0199]). It would have been obvious to one of ordinary skill in the art to modify the POCT microfluidic chip by incorporating an antifouling part to seal the sample inlet (as taught by Yamagata et al) for the benefit of preventing sample and exhaust gas from leaking to the outside of the chip while providing a liquid-tight and gas-tight to the sample inlet.
Allowable Subject Matter
Claim 9 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.
Regarding Claim 9, Heinz et al (nor any other prior art) teaches or fairly suggests that the POCT microfluidic chip runs a POCT detection method: said detection method comprising: adding the sample to be tested and a lysis buffer to the sample pool to lyse the sample to be tested; guiding the lysed sample mixture to be tested into the mixed liquid pool, and extracting the target fragments from the sample to be tested with magnetic bead method; guiding an extracted target fragments into the reaction pool, and at the same time, adding diagnostic reagents to the reaction pool, and the sample mixture to be tested entering each of the constant temperature chambers to perform cyclic reactions at various stages according to a temperature required for a reaction and driven by respective airbag pools; and collecting a reaction signal of the constant temperature chamber of a final reaction in the reaction pool, performing calculation analysis and outputting a result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
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