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 § 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.
Claim(s) 184-203 are rejected under 35 U.S.C. 103 as being unpatentable over Bohm eta al (US2003/0007898).
Referring to claim 184. Bohm et al (herein “Bohm”) discloses a “Microfluidic System Including a Virtual Wall Fluid Interface Port For Interfacing With The Microfluidic System”. See Figs. 1-23 and respective portions of the specification. Bohm further discloses a cassette for detecting and sorting target particles and instructions for use thereof in the detection and sorting of target particles, wherein the cassette (73) comprises: a substrate (20) with a first surface and a second surface and a plurality of microchannels (3a-3h) extending from said first surface to second surface (See at least Sect. 0149, Fig. 17) ; a first housing/layer configured to receive said substrate wherein said first housing comprises an internal surface to receive a target particle released from the substrate; a second housing coupled to said first housing in a manner in wherein said first and second housing together encapsulate said substrate and wherein said first or second housing further comprises a fill port (17) (See at least Sects. 0158-0159, Figs. 20); and wherein the cassette further comprises a hydration membrane positioned to contact said substate or positioned adjacent to said substrate. It should be noted Bohm discloses Bohm discloses hydration membranes through the presence of fluid layers applied adjacent to the microchannel surfaces, including wetted surfaces and interface regions used to maintain fluid contact (See at least Sect. 0150-0152). Bohm does not disclose a transmissive portion located in one or each of said first housing and said second housing, wherein said transmissive portion permits transmission of electromagnetic radiation from outside of said cassette to said substrate. However, it should be noted that transmissive windows for optical interrogation/viewing of microfluidic substrates is well known in the art, as optical windows are routinely incorporated into microfluidic cassettes to allow illumination, fluorescence detection, and imaging of samples located within microchannels. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a transmissive portion (window) into the housing to permit electromagnetic radiation to reach the substrate for optical detection.
Referring to claim 185. Bohm doesn’t disclose transmissive portion located in the housing being at least partially transparent to a wavelength in a range of about 250 nm to 1600 nm. Bohm discloses the use of glass plates, which are inherently transmissive to electromagnetic radiation over portions of the range 250 nm to 1600 nm. As noted the use of transparent windows for optical interrogation of microfluidic substrates is well known. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate material transparent at wavelengths between 250 nm – 1600 nm as these ranges correspond to standard excitation/detection wavelengths for optical sensing to aid in sorting target particles.
Referring to claim 186. Bohm as disclosed above discloses encapsulation of the substrate using multiple layers, any of which may be transparent glass plates (See at least Sects. 0155-0158). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a transmissive window in either the upper or lower housing, using transparent glass plates, to allow electromagnetic radiation to reach the substrate.
Referring to claim 187. Bohm discloses wherein the first fill port is configured to receive a sample material mixture into the cassette (See at least Sect. 0034).
Referring to claim 188. Bohm doesn’t explicitly disclose wherein the second housing comprises the fill port. It should be noted that Bohm discloses various ports and wells formed in the sidewalls or layers, and discloses ports in different plates. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the fill port in the second housing as matter of design choice based upon whichever housing was more geometrically favorable.
Referring to claims 189-190. Bohm discloses vent ports, outlet ports, and fluid interface ports formed in the microchannel system to allow liquid movement and removal of fluids (See at least Sects. 0034-0037). Thus, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a release port in the first housing in fluid communication with the internal surface to permit transfer of target particles out of the release port in the cassette, as it is standard to allow outlets to allow fluid to exit.
Referring to claim 191. Bohm discloses substrates and covers are bonded together forming non-removable assemblies (See at least Sect. 0158-0161).
Referring to claim 192. Bohm discloses wherein the substrate comprises glass (See at least Sects. 0154-0157).
Referring to claims 193-194. Bohm discloses a plurality of microchannels (3a-3h) but does not explicitly disclose wherein microchannels are from about 1 million to about 100 billion microchannels or wherein the microchannels have an internal diameter of about 50 nm to 500 µm. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to massively scale the channels into massively parallel arrays to achieve higher throughput operations and to fabricate the microchannels to have an internal diameter within the range of 50 nm to 500 µm, as optimizing the size parameters to this range allows for laminar flow and for efficient transportation and manipulation of particles for a nano-scale separation and cell-level operations.
Referring to claim 195. Bohm discloses using planar substrates from glass plates, in which they are commonly manufactured with a thickness with the 10 µm to 1 mm thickness range. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the substrate thickness so that the distance from the first surface to the second distance was within this range. Likewise, it should be noted that selecting a substate thickness is a design parameter and the claimed range is within the conventional glass/microfabrication thickness ranges.
Referring to claim 196. Bohm discloses the device as described above. Bohm further discloses sample wells (6a) and sample introduction ports (17) (See at least Sects. 0034, 0146). Bohm does not disclose wherein the sample wells ae movable across said first surface of the substrate. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Bohm wherein the sample wells were movable across the first surface of the substrate as an obvious variant to increase sampling flexibility and allow sequential deposition at multiple substrate locations.
Referring to claims 197-199. Bohm discloses a multi-port design, as described in detail above, including multiple sample introduction ports, inlet ports, and wells (See at least Sect. 0034). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an additional fill ports in fluid communication with the internal surface of the first housing to improve loading flexibility.
Referring to claim 200. Bohm discloses fluid layers applied adjacent to the microchannel surfaces, including wetted surfaces and interface regions used to maintain fluid contact (See at least Sect. 0150-0152).
Referring to claim 201. Bohm discloses inlet wells and outlet wells that enable fluid exit from microchannels. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a collection well that interfaces with a release port/outlet well to collect and hold targeted particles.
Referring to claim 202. Bohm doesn’t disclose a metal frame that is affixed to the first or second housing and said first or second surface of said substrate and applies tension across the surface of said substrate. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bohm wherein a metal frame was included that was affixed to the first or second housing and said first or second surface of said substrate with tension applied across the surface of the substrate as a means of improving uniformity and enhancing sealing.
Referring to claim 203. Bohm doesn’t disclose wherein the substrate dimensions are 3 mm x 3mm x 0.3 mm to 5000 mm x 15000 mm x 1000mm. Bohm discloses wherein substrates are made from etched glass or microfabricated materials (See at least Sect. 0155). It should be noted that the claimed range is extremely broad and encompasses known microfluidic chip sizes. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to select substate dimension within this range as a routine engineering consideration.
Conclusion
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/TERRELL H MATTHEWS/Primary Examiner, Art Unit 3653