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 .
Status of Claims
Claims 1, 5, 7-12, 16, 21-28 remain pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 5 recites “to facilitate TIR” where when an acronym appears for the first time, it should be written out fully. Therefore, claim 1 should be amended to recite “to facilitate total internal reflection (TIR)”
Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 ais 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 12 recites “a free flow region of the fluid pathway” on lines 3-4 where it is unclear if the free flow region of the fluid pathway is the same or different from the free flow region of the fluid pathway described in claim 1.
For examination, it will be interpreted that they are the same free flow region of the fluid pathway.
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(s) 1, 8-10, 12, 16, 21-23, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neijzen (US-2011/0005341-A1) in view of Douglas (US-2002/0052050-A1).
Regarding claim 1, Neijzen teaches a lateral to free flow assay device for analysis of a fluid sample, the device comprising:
a sample collection unit (filtering cavity 13) configured to introduce the sample into the device ([0088], Figure 13);
an optical element (please see annotated Figure 8 below which has a dashed box enclosing components of the second part 16 that make up an optical element) configured to facilitate TIR for the analysis of the sample ([0090], [0091] see Figure 8 shows a detection of changes at a surface using the frustrated total internal reflection method where a beam of light reflects on the interface between a medium with a higher refractive index, second part 16, and a lower refractive index, the fluid, there is a certain critical angle of incidence above which there is a situation of total internal reflection, where the present detection configuration is such that there is total internal reflection of the incoming beam. Figure 13 is seen to have a detection cavity 14 that will look the same as the detection cavity 14 seen in Figure 8);
a fluid pathway (see Figure 13 where a fluid pathway will be the path that fluid 3 travels through the device) configured to provide fluid communication between the sample collection unit (13) and a free flow region (the free flow region will be the part of the fluid pathway that occurs after transferring element 11) adjacent the optical element (see annotated Figure 8 below);
a wicking pad (filter element 2) defining a lateral flow section of the fluid pathway ([0088], Figure 13);
wherein at least one surface of the optical element (annotated figure 8 below) defines at least part of the free flow region of the fluid pathway (see annotated Figure 8 below where surface 30 is part of the optical element and also defines a part of the fluid pathway); and
wherein the fluid pathway is configured to enable fluid flow from the lateral flow region to the free flow region of the fluid pathway to facilitate the analysis of the sample (see Figure 13).
The limitations ” a sample collection unit configured to introduce the sample into the device”, “an optical element configured to facilitate TIR for the analysis of the sample”, “a fluid pathway configured to provide fluid communication between the sample collection unit and a free flow region adjacent the optical element”, “wherein the fluid pathway is configured to enable fluid flow from the lateral flow region to the free flow region of the fluid pathway to facilitate the analysis of the sample.” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Neijzen and the apparatus of Neijzen is capable of introducing a sample into the device, facilitating TIR, providing fluid communication between sample collection unit and free flow region adjacent to the optical element, and enabling fluid flow from the lateral flow region to the free flow region to facilitate analysis of the sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Neijzen (see MPEP §2114).
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Neijzen does not teach wherein one or more reagents are provided in the wicking pad;
In the same problem solving area of separating whole blood into red blood cells and relatively clear fluid, Douglas teaches where a capillary wick spreading layer can include separating agents (Douglas; [0044]).
Specifically, Douglas teaches where a capillary wick spreading layer can include separating agents that are impregnated into the capillary wick where the separating agents help to separate whole blood into red blood cells and relatively clear fluid (Douglas; [0045]). [0024]-[0025] of Douglas describes that the apparatus comprises a capillary tube in communication with a hydrophilic capillary wicking or spreading material which is in communication with an absorbent reagent membrane, where a user applies a blood sample to the capillary, and then the fluid passes through the capillary spreading layer/filter onto the membrane and then reading or measuring for the presence/concentration of the analyte being tested is accomplished. It is further described by [0063] of Douglas that a whole blood sample is applied to the capillary and wicks into the matrix material, where, as the sample wicks, the red blood cells adhere to the glass fibers or to other matrix fibers and the clear fluid moves vertically into the membrane test area.
It would have been obvious to one skilled in the art to modify the filter element of Neijzen to include separating agents as taught by Douglas because Douglas teaches that the separating agents help to separate whole blood into red blood cells and clear fluid (Douglas; [0045]).
Regarding claim 8, modified Neijzen teaches the device according to claim 1. Neijzen further teaches wherein one or more of the walls adjacent to the fluid pathway is provided with surface features to optimise fluid flow from the wicking pad (2) into the free flow region of the fluid pathway (Neijzen; [0073] see transferring element 11 may consist of a microfluidic structure (microextrusions of grooves) that increase the capillary forces and effectively guide the fluid into the connecting fluidic channel towards the detection cavity, Figure 13, and where the fluid pathway is the path that fluid 3 travels through the device).
Regarding claim 9, modified Neijzen teaches the device according to claim 8. Neijzen further teaches wherein the surface features are grooves (Neijzen; [0073]).
Regarding claim 10, modified Neijzen teaches the device according to claim 1. Neijzen further teaches wherein the free flow portion tapers along the fluid pathway (Neijzen; Figure 15 that is a top view of the apparatus seen in Figure 13, where there is an area that occurs after transferring element 11 that tapers moving from right to left of the channel).
Regarding claim 12, modified Neijzen teaches the device according to claim 1. Neijzen further teaches wherein at least one wall of the fluid pathway is roughened to optimise fluid flow from the wicking pad (2) into a free flow region of the fluid pathway (Neijzen; [0073] see transferring element 11 may consist of a microfluidic structure (microextrusions of grooves) that increase the capillary forces and effectively guide the fluid into the connecting fluidic channel towards the detection cavity, Figure 13, and where the fluid pathway is the path that fluid 3 travels through the device. The microextrusions of grooves roughen the pathway).
Regarding claim 16, modified Neijzen teaches the device according to claim 1. Neijzen further teaches wherein the free flow region (part of the fluid pathway that occurs after transferring element 11 seen in Figure 13 of Neijzen) of the fluid pathway includes one or more reagents (antibody 26) (Neijzen; [0092] see surface 30 coated with antibody 26 that can couple to a target molecule, where the antibody 26 is a reagent).
Regarding claim 21, modified Neijzen teaches the device according to claim 1. Neijzen further teaches further comprising a flow controller (vent 31) downstream of the free flow region (part of the fluid pathway that occurs after transferring element 11 seen in Figure 13 of Neijzen) of the fluid pathway (Neijzen; [0077], Figure 13).
Regarding claim 22, modified Neijzen teaches the device according to claim 21. Neijzen further teaches wherein the flow controller (31) is a vent (Neijzen; [0077]).
Regarding claim 23, modified Neijzen teaches the device according to claim 1. Neijzen further teaches further comprising a filter (deposition material 617) upstream of the wicking pad (2) (Neijzen; [0036] see filter element may be covered by a coarse capillary structure to keep blood in place, [0086] see pore size of the deposition medium is larger than the pore size of the filter element, [0088], Figure 13. The capillary structure with large pore sizes would be a filter for large particulates).
Regarding claim 28, modified Neijzen teaches the device according to claim 1. Neijzen further teaches wherein the device is enclosed within a housing (first part 615 and second part 16) and wherein the optical element (annotated Figure 8 supra) is configured to facilitate TIR for the analysis of the sample by the provision of an opening in the housing (615 and 16) to enable light to be incident at or above the critical angle (Neijzen; [0088] Figure 13, Figure 8 where light beam 29 entering the second part 16 is an opening in the housing, [0091]).
The limitation “the optical element is configured to facilitate TIR for the analysis of the sample” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Neijzen and the apparatus of Neijzen is capable of facilitating TIR for the analysis of the sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Neijzen (see MPEP §2114).
Claim(s) 5, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neijzen (US-2011/0005341-A1) and Douglas (US-2002/0052050-A1), and in further view of Nieuwenhuis (US-2010/0310423-A1).
Regarding claim 5, modified Neijzen teaches the device according to claim 1. Neijzen does describe where the first and second part are plastic parts that are injection molded and are preferentially transparent for visible light (Neijzen; [0075]), however Neijzen does not teach what the plastic is.
In the analogous art of cartridges for use in a frustrated total internal reflection biosensor, Nieuwenhuis teaches where the bottom part of the cartridge is made of plastics that are preferably moulded (Nieuwenhuis; [0001], [0012]).
Specifically, Nieuwenhuis teaches that a cartridge 11 that has a bottom portion 1 made of a first material is preferably polycarbonate and is injection-moulded (Nieuwenhuis; [0030]).
Neijzen is silent with regards to specific plastic for the first and second parts, therefore, it would have been necessary and thus obvious to look to the prior art for conventional materials used for frustrated total internal reflection methods. Nieuwenhuis provides this conventional teaching showing that it is known in the art to use polycarbonate. Therefore, it would have been obvious to one having ordinary skill in the art to make the first and second parts polycarbonate because it is taught by Nieuwenhuis that polycarbonate is an effective material to use for a cartridge that is used in a frustrated total internal reflection biosensor.
While Nieuwenhuis does not address if the material has a positive wetting coefficient to optimize the fluid flow from the wicking pad into the free flow region of the fluid pathway, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the polycarbonate plastics are different, the prior art is considered to have the same properties with respect to wetting coefficient as that is claimed. MPEP § 2112.01 (I-IV).
Please see page 6 of the instant specification that describes that examples of materials with suitable wetting coefficients include glass and some plastics such as PMMA and PC.
Regarding claim 11, modified Neijzen teaches the device according to claim 1. Neijzen does describe where the first and second part are plastic parts that are injection molded and are preferentially transparent for visible light (Neijzen; [0075]), however Neijzen does not teach what the plastic is.
In the analogous art of cartridges for use in a frustrated total internal reflection biosensor, Nieuwenhuis teaches where the bottom part of the cartridge is made of plastics that are preferably moulded (Nieuwenhuis; [0001], [0012]).
Specifically, Nieuwenhuis teaches that a cartridge 11 that has a bottom portion 1 made of a first material is preferably polycarbonate and is injection-moulded (Nieuwenhuis; [0030]).
Neijzen is silent with regards to specific plastic for the first and second parts, therefore, it would have been necessary and thus obvious to look to the prior art for conventional materials used for frustrated total internal reflection methods. Nieuwenhuis provides this conventional teaching showing that it is known in the art to use polycarbonate. Therefore, it would have been obvious to one having ordinary skill in the art to make the first and second parts polycarbonate because it is taught by Nieuwenhuis that polycarbonate is an effective material to use for a cartridge that is used in a frustrated total internal reflection biosensor.
While Nieuwenhuis does not address if the material has a positive wetting coefficient, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the polycarbonate plastics are different, the prior art is considered to have the same properties with respect to wetting coefficient as that is claimed. MPEP § 2112.01 (I-IV).
Please see page 6 of the instant specification that describes that examples of materials with suitable wetting coefficients include glass and some plastics such as PMMA and PC.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neijzen (US-2011/0005341-A1) and Douglas (US-2002/0052050-A1), and in further view of Babcock (US-2016/0038940-A1).
Regarding claim 7, modified Neijzen teaches the device according to claim 1. Neijzen does not teach wherein the fluid pathway is provided with a plurality of layers of coating.
In the same problem solving area of fluid control in a plurality of fluid passages, Babcock teaches gradient surface energy coatings (Babcock; abstract).
Specifically, Babcock teaches where coating compositions are configured to produce controlled surface energy gradient coatings that are used to provide a controlled, or even constant, fluid velocity over the length of a channel, where coatings can be configured to control liquid flow by providing coating compositions that control the initial contact angle at the beginning of the channel, by providing coating compositions that change the contact angle over the length of the channel, and by providing coating compositions that increase or decrease the rate of change of the contact angle over the length of the channel (Babcock; [0042]). The coating composition can provide a surface energy gradient region on a surface from a proximal location to a distal location where the contact angle formed between water and the surface at a proximal location of the region is different from the contact angle formed between water and the surface at a distal location (Babcock; [0050]).
It would have been obvious to one skilled in the art to modify the channel of Neijzen to include the gradient surface energy coatings as taught by Babcock because Babcock teaches that with the coatings, it can reduce the amount of solution used in the system (Babcock; [0010]).
[0010] of Babcock describes that the gradients can be created utilizing one or more surface energy gradients, where further because the surface energy gradient is different from the proximal area of a channel to a distal area, it is understood that these are different amounts/compositions of coating, and therefore there would be a plurality of coatings being applied as the coating is changing along the length of the channel.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neijzen (US-2011/0005341-A1) and Douglas (US-2002/0052050-A1), and in further view of Chow (US-2002/0187564-A1).
Regarding claim 24, modified Neijzen teaches the device according to claim 1. Neijzen does not teach further comprising an external pressure source configured to control the flow of the sample through the wicking pad and pathway.
In the same problem solving area of fluid transport systems within a microfluidic device, Chow teaches where the fluid transport systems include fluid pressure sources that module fluid pressure in microchannels (Chow; [0082]).
Specifically, Chow teaches where pressure is applied to microscale elements such as a microchannel to achieve fluid movement, where this movement can be accomplished using a piston, a pressure diaphragm, vacuum pump, probe or the like to displace liquid and raise or lower the pressure at a site in the microfluidic system (Chow; [0109]).
It would have been obvious to one skilled in the art to modify the device of Neijzen such that it includes the pressure source as taught by Chow because Chow teaches that applied pressures generate pressure differentials across the lengths of channels to drive fluid flow through them (Chow; [0111]).
The limitation “an external pressure source configured to control the flow of the sample through the wicking pad and pathway.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Neijzen and the apparatus of modified Neijzen is capable of controlling the flow of sample through the wicking pad and pathway. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Neijzen (see MPEP §2114).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neijzen (US-2011/0005341-A1) and Douglas (US-2002/0052050-A1), and in further view of Khattak (US-2014/0336083-A1).
Regarding claim 25, modified Neijzen teaches the device according to claim 1. Neijzen does not teach further comprising a second wicking pad downstream of the free flow region of the fluid pathway to draw the sample through the device.
In the same problem solving area of drawing sample through a microfluidic channel to sensors, Khattak teaches an absorbent pad (Khattak; [0122]).
Specifically, Khattak teaches where the absorbent pad downstream of the sensors that wicks liquid from the microfluidic channel, where the absorbent pad is enough to drain a sample reservoir and wash reservoir but only enough to pull the chemical substrate reservoir into the channel and over the sensors and stop so that there is little to no flow over the sensors so that the detectable signal over the sensors is read (Khattak; [0122]).
It would have been obvious to one skilled in the art to modify the device of Neijzen such that it includes an absorbent pad downstream of the detection chamber because it is taught by Khattak that an absorbent pad draws sample through and stops at a specific point where sample is measured (Khattak; [0122]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neijzen (US-2011/0005341-A1) and Douglas (US-2002/0052050-A1), and in further view of Wang (US-2008/0257438-A1).
Regarding claim 26, modified Neijzen teaches the device according to claim 1. Neijzen does not teach further comprising an electro-wetting element within the free flow region of the fluid pathway.
In the same problem solving area of controlling the flow of a fluid in a capillary or microfluidic channel, Wang teaches a micromachined electrowetting microfluidic valve (Wang; abstract, [0015]).
Specifically, Wang teaches where the micromachined electrowetting microfluidic microvalve is embedded into the microchannel and acts as a start/stop valve for the continuous fluid column (Wang; [0015]).
It would have been obvious to one skilled in the art to modify the device of Neijzen such that it includes the electrowetting microfluidic microvalve as taught by Wang because Wang teaches that the electrowetting microfluidic microvalve is able to control the flow of minute quantities of a fluid (Wang; [0017]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neijzen (US-2011/0005341-A1) and Douglas (US-2002/0052050-A1), and in further view of Bunce (US-5853670-A).
Regarding claim 27, modified Neijzen teaches the device according to claim 1. Neijzen does not teach further comprising an indicator to confirm that a sufficient sample has been provided.
In the same problem solving area of indicating whether or not sufficient first liquid (blood or blood plasma) has been applied, Bunce teaches an indicator that is provided with a visible marker dye able to be entrained in liquid flow (Bunce; column 3 lines 23-25, column 4 lines 62-67).
Specifically, Bunce teaches a blood separation membrane 714 is held in contact with first channel 710 by means of compression member 721 which is part of housing 717, where a line of dye 761 is provided on the top surface of the compressed region of the separator membrane, and the housing has an indicator window 762 (Bunce; column 13 lines 60-67, column 14 lines 1-2, Figure 10). Whole blood 723 is applied by way of application window 702 to the top surface of the separator membrane 714, and when sufficient plasma has filled the first channel 710 with a defined volume, plasma will be drawn to the compressed region 760 and the plasma will entrain the dye indicator and if present in sufficient quantity will transport it past the indicator window 762 (Bunce; column 14 lines 6-15).
It would have been obvious to one skilled in the art to modify the device of Neijzen such that the filter element has a compressed region that has a dye indicator, and the first part has a window as taught by Bunce because Bunce teaches that these allow a user to see whether sufficient plasma has passed through the separator membrane and to apply further whole blood if the dye stain has not appeared in the window (Bunce; column 14 lines 14-19).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796