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 § 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.
Claims 11 and 14 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.
Regarding claim 11, ll. 3-4 recite “the indicator region”. There is insufficient antecedent basis for this limitation in the claim. “The indicator region” is not present in claims 1 or 6 from which claim 11 depends, but rather is first introduced in claim 2. Applicant may amend the claim by changing dependency from claim 6 to another claim with the limitation or replacing “the indicator region” with “an indicator region” followed by the appropriate definition of the term.
Regarding claim 14, ll. 5-6 recite “the indicator region”. There is insufficient antecedent basis for this limitation in the claim. “The indicator region” is not present in claims 1 or 13 from which claim 14 depends, but rather is first introduced in claim 2. Applicant may amend the claim by changing dependency from claim 13 to another claim with the limitation or replacing “the indicator region” with “an indicator region” followed by the appropriate definition of the term.
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 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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verhoeckx et. al (US 20170120241 A1).
Regarding claim 1, Verhoeckx teaches a liquid handling device (a cartridge (10) for processing of a liquid sample; Abstract; Fig. 1), comprising:
an inlet conduit configured to receive a liquid sample (Sample liquid…is taken up…via a funnel-shaped sample intake port 12; [0108]; Fig. 1);
a first flow path comprising a sample adequacy control chamber in fluidic communication with the inlet conduit (“This intake port 12 is connected via a first or “intake capillary channel” 13 to a storage chamber 14,” wherein the intake capillary channel 13 is the first flow path and the storage chamber 14 is the sample adequacy control chamber; [0109]; Fig. 1), wherein the sample adequacy control chamber is configured to allow the presence or absence of a volume of liquid within the sample adequacy control chamber to be determined (The storage chamber 14 comprises at least two sets of pinning structures 21 that prevent premature liquid flow along the ribs of the storage to ensure that the liquid front is properly shaped and can be used for reliable reading of the sample adequacy indicator (SAI), i.e. a user can verify that a sufficient amount of sample has been drawn if the level of the sample is between these structures; [0109]; Fig. 1); and
a second flow path in fluidic communication with the inlet conduit (A second or “feeding capillary channel” 15 is provided that branches from the intake capillary channel 13; [0110]; Fig. 1),
wherein the second flow path is configured to provide a higher hydraulic resistance than the first flow path (“The cross sections of the channels 13 and 15 are designed in such a way to give the fastest filling,” wherein paragraphs [0031]-[0034] teach minimizing the hydraulic flow resistance of the intake capillary channel to achieve rapid filling of the storage chamber, while the narrower feeding capillary channel is used to control downstream forwarding of the sample; [0110]).
Regarding claim 2, Verhoeckx teaches the liquid handling device according to claim 1, wherein the liquid handling device comprises an indicator region through which the sample adequacy control chamber is viewable, such that a user can determine the presence or absence of the volume of liquid within the sample adequacy control chamber (“The user can see the liquid inside the storage chamber 14 through a window, which is preferably located at the position corresponding with the minimum required amount of sample (“sample adequacy indicator” SAI),” wherein the region between the two sets of pinning structures 21 is the indicator region; [0136];[0109]; Fig. 1).
Regarding claim 3, Verhoeckx teaches the liquid handling device according to claim 2, wherein the indicator region through which the sample adequacy control chamber is viewable is downstream from a sample adequacy control chamber inlet port in the first flow path (Fig. 3 shows pinning structures 21 to be within the storage chamber 14, between which the sample fluid level is read by the user ([0109]). The sample adequacy control chamber inlet port is where the intake capillary channel 13 ends and the storage chamber 14 begins).
Regarding claim 4, Verhoeckx teaches the liquid handling device according to claim 1, wherein the second flow path comprises an outlet conduit (The outlet conduit is the end feeding capillary channel 15 that connects to the processing/detection chamber 16 as shown in Fig. 1),
wherein the outlet conduit has a smaller cross-sectional area than the inlet conduit (As shown in Fig. 1 and described in paragraphs [0031]-[0034], Verhoeckx teaches a relatively large “funnel-shaped sample intake port 12” ([0108]) and a narrow feeding capillary channel 15 with micrometer dimensions).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeckx et. al (US 20170120241 A1), in view of Blankenstein et al. (US 20050249641 A1).
Regarding claim 5, Verhoeckx teaches the liquid handling device according to claim 2, wherein the sample adequacy control chamber comprises:
a sample adequacy control chamber inlet port (See junction at the end of the intake capillary channel 13 and the opening of the storage chamber 14 in Fig. 1) configured to receive liquid from the inlet conduit (during sample intake the sample flows via the sample intake port and the capillary intake channel into the storage chamber; [0030]).
Verhoeckx fails to teach a sample adequacy control chamber outlet port in fluidic connection with the second flow path; wherein the distance between the sample adequacy control chamber outlet port and the indicator region is less than the distance between the sample adequacy control chamber inlet port and the indicator region.
Blankenstein teaches a sample adequacy control chamber outlet port in fluidic connection with the second flow path (“The capillary (42) leading out of cavity (41),” wherein the sample adequacy control chamber is the cavity (41) which visually displays the sample ([0242]), the outlet port is the connection between 42 and 41, and the second flow path is capillary 42 leading to cavity 43; [0220]; Fig. 2a).
Blankenstein is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Verhoeckx teaches that the feeding capillary channel 15 (second flow path) may branch from the intake capillary channel 13 (first flow path) to achieve a LIFO (Last In, First Out) principle ([0034]); however, Verhoeckx describes this arrangement as merely “another embodiment” rather than a required feature of the device. Verhoeckx’s broader objective is to collect a sufficient sample volume and reliably control forwarding of the sample for downstream processing. Blankenstein teaches a chamber architecture in which liquid enters a chamber through an inlet and exits the chamber through an outlet connected to a downstream flow path. The sample collection and adequacy determination objectives of Verhoeckx could likewise be achieved using a through-flow chamber arrangement rather than the optional LIFO arrangement. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Verhoeckx’s liquid handling device to provide a chamber outlet in fluid communication with the second flow path as taught by Blankenstein because this would improve controlled transfer of sample liquid from the chamber to downstream processing regions while still permitting sample adequacy determination prior to further processing, and this involves the substitution of one known chamber-flow architecture for another to obtain predictable results (See MPEP 2143(I)(B)).
Modified Verhoeckx fails to teach the distance between the sample adequacy control chamber outlet port and the indicator region is less than the distance between the sample adequacy control chamber inlet port and the indicator region.
However, Modified Verhoeckx teaches using the region between pinning structures 21 to reliably determine whether a sufficient sample volume has entered the storage chamber (Verhoeckx , [0109]), and therefore, the location of the indicator region affects the amount of liquid progression required before sample adequacy is indicated, and is thus a result-effective variable. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx in view of Blankenstein by optimizing the location of the indicator region within the chamber by positioning the pinning structures closer to the outlet port than the inlet port because a greater portion of the chamber would be filled before the indication occurs, thereby improving the reliability of sample adequacy determination and downstream sample processing, and this involves the routine optimization of a result-effective variable to yield predictable results (See MPEP 2144.05(II)(A)).
Regarding claim 6, Verhoeckx teaches the liquid handling device according to claim 1.
Verhoeckx fails to teach the first flow path further comprises a metering chamber configured to store a specific volume of liquid, wherein the metering chamber comprises:
a metering chamber inlet port configured to receive liquid from the inlet conduit; and
a metering chamber outlet port in fluidic connection with the second flow path.
Blankenstein teaches a first flow path (Fluid path extending from feed chamber (31) to cavity (41) in Fig. 2a) further comprising a metering chamber configured to store a specific volume of liquid (“Introduction of a metered aliquot of the filled liquid via capillary (34) into the chamber (35),” wherein chamber (35) is the metering chamber; [0232]; Fig. 2a), wherein the metering chamber comprises:
a metering chamber inlet port configured to receive liquid from the inlet conduit (fluid entrance into chamber 35 from upstream capillary 34; See Fig. 2a); and
a metering chamber outlet port (fluid exit from chamber 35 toward downstream capillary path leading to chamber 41; See Fig. 2a) in fluidic connection with the second flow path (Chamber 35 communicates with the downstream capillary path ultimately supplying chamber 41; See Fig. 2a).
Blankenstein is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Verhoeckx teaches confirming sample adequacy before transporting the sample to a detection area for analysis ([0116]-[0124]) while Blankenstein teaches that chemical and biochemical analyses often require metering a sample and treating the sample under predefined reproducible conditions ([0006]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Verhoeckx’s liquid handling device by incorporating the metering chamber within the first flow path as taught by Blankenstein because this would provide a predetermined volume of sample for downstream analysis for improved reproducibility, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 7, Modified Verhoeckx teaches the liquid handling device according to claim 6, wherein the first flow path comprises a connector conduit (transition of capillaries 36-40 in Fig. 2a of Blankenstein) providing a fluidic connection between the metering chamber (chamber (35); Blankenstein, [0219]; Fig. 2a) and the sample adequacy control chamber (Blankenstein’s sample adequacy control chamber is the cavity (41) which visually displays the sample ([0242])(However, as modified by the incorporation of metering chamber 35 into the device of Verhoeckx, capillaries 36-40 transfer the metered sample volume from chamber 35 of Blankenstein to storage chamber 14 of Verhoeckx for sample adequacy determination).
Regarding claim 8, Modified Verhoeckx teaches the liquid handling device according to claim 7, wherein the cross-sectional area of the connector conduit is smaller than the cross-sectional area of the metering chamber (Fig. 2a of Blankenstein shows that capillaries 36-40 are narrower than chamber 35).
Regarding claim 9, Modified Verhoeckx teaches the liquid handling device according to claim 7, wherein the second flow path comprises an outlet conduit (The outlet conduit is the end feeding capillary channel 15 that connects to the processing/detection chamber 16 as shown in Fig. 1 of Verhoeckx)
Modified Verhoeckx fails to teach the cross-sectional area of the connector conduit is greater than or equal to the cross-sectional area of the outlet conduit.
However Verhoeckx teaches that capillary suction pressure, flow direction, and hydraulic resistance are controlled by selecting the dimensions of the channel cross-sections ([0029]-[0031]). Therefore, the relative cross-sectional areas of the connector conduit and outlet conduit constitute result-effective variables. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx in view of Blankenstein by optimizing the relative conduit dimensions, including providing a connector conduit having a cross-sectional area greater than or equal to the outlet conduit, in order to achieve the desired fluid flow and filling characteristics (See MPEP 2144.05(II)(A)).
Regarding claim 10, Modified Verhoeckx teaches the liquid handling device according to claim 6, wherein the sample adequacy control chamber is downstream from the metering chamber (Blankenstein’s sample adequacy control chamber is the cavity (41) which visually displays the sample ([0242]) and is downstream from the metering chamber 35 in Fig. 2a)(However, following incorporation of metering chamber 35 into the device of Verhoeckx, the metered sample volume is transferred from chamber 35 to storage chamber 14 where sample adequacy is determined. Accordingly, sample adequacy control chamber 14 is downstream from metering chamber 35).
Regarding claim 11, Modified Verhoeckx teaches the liquid handling device according to claim 6.
Modified Verhoeckx fails to teach the distance between the metering chamber outlet port and the indicator region is less than the distance between the metering chamber inlet port and the indicator region.
However Verhoeckx teaches that the sample adequacy indicator is read when the liquid front reaches the region between pinning structures 21 (See paragraph [0109]). The location of the indicator region affects the amount of liquid progression required before sample adequacy is indicated, and is thus a result-effective variable. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx in view of Blankenstein by optimizing the location of the indicator region so that it is closer to the metering chamber outlet than the metering chamber inlet, thereby ensuring that liquid traverses a greater portion of the fluidic path before indication occurs and improving confidence that a sufficient sample has been collected (See MPEP 2144.05(II)(A)).
Regarding claim 12, Verhoeckx teaches the liquid handling device according to claim 2.
Verhoeckx fails to teach the second flow path comprises an outlet conduit section extending in the direction of the indicator region.
Blankenstein teaches a second flow path comprising an outlet conduit section extending in the direction of a sample adequacy control chamber (“The capillary (42) leading out of cavity (41),” wherein the sample adequacy control chamber is the cavity (41) which visually displays the sample ([0242]), the outlet conduit section is the connection between 42 and 41, and the second flow path is capillary 42 leading to cavity 43; [0220]; Fig. 2a).
Blankenstein is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Verhoeckx teaches that the feeding capillary channel 15 (second flow path) may branch from the intake capillary channel 13 (first flow path) to achieve a LIFO (Last In, First Out) principle ([0034]); however, Verhoeckx describes this arrangement as merely “another embodiment” rather than a required feature of the device. Verhoeckx’s broader objective is to collect a sufficient sample volume and reliably control forwarding of the sample for downstream processing. Blankenstein teaches a chamber architecture in which liquid enters a chamber through an inlet and exits the chamber through an outlet connected to a downstream flow path. The sample collection and adequacy determination objectives of Verhoeckx could likewise be achieved using a through-flow chamber arrangement rather than the optional LIFO arrangement. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Verhoeckx’s liquid handling device to provide a chamber outlet extending in the direction of the indicator region of the sample adequacy control chamber as taught by Blankenstein because this would improve controlled transfer of sample liquid from the chamber to downstream processing regions while still permitting sample adequacy determination prior to further processing, and this involves the substitution of one known chamber-flow architecture for another to obtain predictable results (See MPEP 2143(I)(B)).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeckx et. al (US 20170120241 A1), in view of Floriano et al. (WO 2007134191 A1, see attached English translation).
Regarding claim 13, Verhoeckx teaches the liquid handling device according to claim 1.
Verhoeckx fails to teach the first flow path comprises a vented waste chamber in fluidic communication with the sample adequacy control chamber.
Floriano teaches a vented waste chamber (Excess introduced sample will enter overflow reservoir 132 if the metered volume portion is filled. In some embodiments, overflow region 132 is coupled a waste region. Overflow reservoir 132 includes vent 140 to promote fluid flow; [00144]).
Floriano is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Floriano teaches that allowing excess amount of sample to flow into the overflow reservoir may inhibit overfilling the collection region and release of potentially hazardous material ([00123]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx by coupling the overflow reservoir taught by Floriano to the sample adequacy control chamber because it would improve reproducible sample collection and prevent excess sample from interfering with sample adequacy determination and downstream analysis, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 14, Modified Verhoeckx teaches the liquid handling device according to claim 13, wherein the sample adequacy control chamber (storage chamber 14; Verhoeckx, [0109]; Fig. 1) comprises a waste outlet providing a fluidic connection to the waste chamber (overflow region 132 is coupled a waste region; Floriano, [00114]),
wherein the waste outlet is located between an upper end and a lower end of the sample adequacy control chamber (Floriano teaches the overflow channel is positioned at a predetermined height within the collection region and it therefore located between the top and bottom of the chamber ([00116]). Floriano’s collection region is similar to Verhoeckx’s sample adequacy control chamber or storage chamber 14).
Modified Verhoeckx fails to teach the distance between the upper end of the sample adequacy control chamber and the indicator region is less than the distance between the lower end of the sample adequacy control chamber and the indicator region.
However, the indicator’s position (region in between the pinning structures 21 within storage chamber 14 of Verhoeckx ([0109], Fig. 1) relative to the overflow level is a result-effective variable and is used to determine whether a sufficient sample volume has been collected. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the indicator location taught by Verhoeckx in view of Floriano by positioning the indicator region closer to the upper end of the chamber than to the lower end to provide a clearer indication that the desired sample volume has been reached (See MPEP 2144.05(II)(A)).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeckx et. al (US 20170120241 A1), in view of Van Workum et al. (US 20220143608 A1, EFD 2020-02-28).
Regarding claim 15, Verhoeckx teaches the liquid handling device according to claim 1.
Verhoeckx fails to teach a pad of porous material, wherein the pad is configured to contact liquid within the sample adequacy control chamber.
Van Workum teaches a pad of porous material, wherein the pad is configured to contact liquid within the sample adequacy control chamber (the sample collection device may further comprise a pad of material. The material may be porous such that the sample can move through the pores to exit the pad, whereas particulate contaminants will be retained in the pad; [0015]).
Van Workum is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Verhoeckx’s storage chamber 14 (sample adequacy control chamber) is configured to receive and temporarily store a sufficient volume of sample so that sample adequacy can be visually verified before the sample is transferred to downstream processing chambers for analysis ([0109],[0122]). Similarly, Van Workum teaches a sample collection location 14 that receives and temporarily holds the collected sample within porous pad 24 before the sample is transferred to the decoupling zone and downstream analysis components ([0015],[0058]-[0061]). Van Workum discloses that the pad absorbs and retains sample liquid while also providing a visual indication of sample collection through a colour change or a transparency change of the pad ([0018],[0020]). Paragraph [0019] of Van Workum even states that “This provision of a positive indication that sufficient sample has been collected gives confidence to the user and also reduces the failure rate in connection with insufficient sample”. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx by incorporating the porous pad taught by Van Workum into the sample adequacy chamber because it would improve sample retention, reduce leakage, and enhance visual confirmation that a sufficient sample volume has been collected, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 16, Verhoeckx teaches the liquid handling device according to claim 1.
Verhoeckx fails to teach a pad of absorbent material, wherein the pad is configured to absorb liquid within the sample adequacy control chamber.
Van Workum teaches a pad of absorbent material, wherein the pad is configured to absorb liquid within the sample adequacy control chamber (the sample collection device may further comprise a pad of material…The porous material may absorb the sample and holds the sample in the sample collection device; [0015]).
Van Workum is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Verhoeckx’s storage chamber (sample adequacy control chamber) is configured to receive and temporarily store a sufficient volume of sample so that sample adequacy can be visually verified before the sample is transferred to downstream processing chambers for analysis ([0109],[0122]). Similarly, Van Workum teaches a sample collection location 14 that receives and temporarily holds the collected sample within porous pad 24 before the sample is transferred to the decoupling zone and downstream analysis components ([0015],[0058]-[0061]). Van Workum discloses that the pad absorbs and retains sample liquid while also providing a visual indication of sample collection through a colour change or a transparency change of the pad ([0018],[0020]). Paragraph [0019] of Van Workum even states that “This provision of a positive indication that sufficient sample has been collected gives confidence to the user and also reduces the failure rate in connection with insufficient sample”. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx by incorporating the porous pad taught by Van Workum into the sample adequacy chamber because it would improve sample retention, reduce leakage, and enhance visual confirmation that a sufficient sample volume has been collected, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 17, Verhoeckx teaches the liquid handling device according to claim 1.
Verhoeckx fails to teach an occluding material provided in a wall of the liquid handling device through which the sample adequacy control chamber is viewable, wherein the occluding material is configured to occlude at least a portion of the sample adequacy control chamber until the occluding material is in contact with a quantity of liquid.
Van Workum teaches an occluding material provided in a wall of the liquid handling device through which the sample adequacy control chamber is viewable, wherein the occluding material is configured to occlude at least a portion of the sample adequacy control chamber until the occluding material is in contact with a quantity of liquid (“the sample collection device may further comprise a pad of material,” wherein “the transparency of the pad changes when sufficient sample has been collected and this increase in transparency allows a coloured backing to become visible to the user”; [0015],[0020]).
Van Workum is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Verhoeckx’s storage chamber (sample adequacy control chamber) is configured to receive and temporarily store a sufficient volume of sample so that sample adequacy can be visually verified before the sample is transferred to downstream processing chambers for analysis ([0109],[0122]). Similarly, Van Workum teaches a sample collection location 14 that receives and temporarily holds the collected sample within porous pad 24 before the sample is transferred to the decoupling zone and downstream analysis components ([0015],[0058]-[0061]). Van Workum discloses that the pad absorbs and retains sample liquid while also providing a visual indication of sample collection through a colour change or a transparency change of the pad ([0018],[0020]). Paragraph [0019] of Van Workum even states that “This provision of a positive indication that sufficient sample has been collected gives confidence to the user and also reduces the failure rate in connection with insufficient sample”. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx by incorporating the porous pad taught by Van Workum into the sample adequacy chamber because it would improve sample retention, reduce leakage, and enhance visual confirmation that a sufficient sample volume has been collected, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeckx et. al (US 20170120241 A1), in view of Montagu (US 20100093551 A1).
Regarding claim 18, Verhoeckx teaches the liquid handling device according to claim 1.
Verhoeckx fails to teach a liquid storage container interface configured to provide a fluidic connection to a volume of liquid within a pierceable liquid storage container,
the liquid storage container interface comprising a liquid extraction outlet configured to allow liquid to be extracted from the liquid storage container;
wherein the liquid extraction outlet is in fluidic communication with the inlet conduit such that liquid extracted from the liquid storage container is received in the inlet conduit.
Montagu teaches a liquid storage container interface configured to provide a fluidic connection to a volume of liquid within a pierceable liquid storage container (the device comprises a tube-shaped main body closed at one end by a screwed-on small filtrate receptacle. The other end is open, exposing within the main body, a free sliding piston-like member, e.g., a short "poppet," which is sealed to the inside wall of the main body. The piston is traversed through its center by a fixed, sharp hypodermic needle which protrudes outwardly. The needle is exposed to pierce the end seal of an evacuated collection tube. In the region of the main body of the device, between the poppet and the sample receptacle, is a filter assembly, the "cage", through which the liquid is forced to pass, e.g., for removing blood cells.; [0021]),
the liquid storage container interface comprising a liquid extraction outlet configured to allow liquid to be extracted from the liquid storage container (a pump constructed to transfer liquid out of a partially filled, predetermined portable sealed container; [0023]),
wherein the liquid extraction outlet is in fluidic communication with the inlet conduit such that liquid extracted from the liquid storage container is received in the inlet conduit (the piston carrying a fixed, hollow penetrating needle having a protruding end exposed to penetrate the end seal during the first movement in the first direction, to enable the coupling of the piston with the predetermined container and to provide the fluid passage between the closed volume and the interior of the container; [0032]).
Montagu is considered to be analogous to the claimed invention because it is in the same field of endeavor for microfluidic analytical testing devices. Verhoeckx’s testing cartridge requires a collected blood sample for sample adequacy determination and downstream analysis (Abstract), and Montagu provides a structure for extracting a blood sample from a standard tube and transferring it to a processing system ([0036], Abstract). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid handling device taught by Verhoeckx by incorporating the liquid storage container interface taught by Montagu because it would provide a reliable mechanism for transferring the required sample into the testing cartridge “and with minimum danger of exposure of the operator or contamination of the sample while enabling standard evacuated collection tubes to be used” (Montagu, Abstract), and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 19, Modified Verhoeckx teaches the liquid handling device according to claim 18, further comprising a liquid extraction mechanism actuatable from a first configuration to a second configuration,
wherein the liquid extraction mechanism is configured to provide a pressure difference between a volume of gas in the liquid storage container and the liquid extraction outlet, when the liquid extraction mechanism is actuated from the first configuration to the second configuration (the piston including a passage for enabling fluid communication between the closed volume and the portable container, whereby, forcing the movable assembly in a first direction toward the liquid receptacle can force compressed air captured in the closed volume into the portable container in a first action tending to equilibrate fluid pressures between the closed volume and the sealed container, and releasing the movable assembly enables compressed air captured in the closed volume to move the assembly in pressure-relieving direction opposite to the first direction, so that residual air pressure above liquid within the portable container is effective to force liquid in the portable container to move through the passage into the closed volume in a second action tending to equilibrate fluid pressures between the sealed container and the closed volume; Montagu, [0023]).
Conclusion
No claims are allowed.
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/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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