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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/11/2026 has been entered.
Response to Amendment
The Amendment filed 06/11/2026 has been entered. Claims 1, 3-4, 6-7, 9-10, 12-17, and 19-20 remain pending in the application.
Claim Objections
Applicant is advised that should claim 9 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1, 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Shartle et al. (US 20200030797 A1; cited in the Office Action filed 04/19/2024) in view of Andeshmandet al. (US 10820847 B1; effectively filed 08/15/2019) and Ohtsuka et al. (US 20060159591 A1).
Regarding claim 1, Shartle teaches a cartridge (Figs. 1A-1B), comprising:
an elongated body (Figs. 1A-1B, second layer 112) having a first longitudinal axis (Figs. 1A-1B, longitudinal axis 102) and a substantially rectangular shape (Figs. 1A-1B; paragraph [0036]) with a longer side (Figs. 1A-1B) and a shorter side (Figs. 1A-1B), a top side (Figs. 1A-1B), and a bottom side (Figs. 1A-1B), wherein the body accommodates only a single elongated central chamber along the first longitudinal axis (Figs. 1A-1B, microfluidic channel 120);
wherein the single elongated central chamber within the body has a first end (Figs. 1A-1B, interpreted as the end of channel 120 towards element 130) and a second end (Figs. 1A-1B, interpreted as the end of channel 120 towards element 140), and spans a substantial length of the longer side of the body (Figs. 1A-1B);
a fill port (Figs. 1A-1B, first opening 130) positioned on the top side of the elongated body above the first end of the single elongated central chamber (Figs. 1A-1B, first opening 130 is on the top of layer 112 above the end of channel 120) and adapted to introduce fluid into the first end (interpreted as an intended use of the fill port, see MPEP 2114; paragraph [0041] teaches the first opening 130 is configured to receive a sample), the fill port having a second longitudinal axis that is perpendicular to the first longitudinal axis of the elongated body (Figs. 1A-1B, interpreted as the vertical axis of the opening 130 which is perpendicular to the longitudinal axis 102);
a port (Figs. 1A-1B, second opening 140) positioned on the top side of the elongated body above the second end of the central chamber (Figs. 1A-1B teaches the second opening is on the top of the layer 112 above the end of channel 120), the port having a third longitudinal axis that is parallel to the second longitudinal axis (Figs. 1A-1B, interpreted as the vertical axis of the opening 140 which is parallel the axis of opening 130);
a first transparent film (Figs. 1A-1B and paragraph [0036], transparent first layer 110) attached to the top side of the elongated body between the fill port and the port (Figs. 1A-1B teach the first layer 110 is attached to layer 112 and is structurally between the openings 130 and 140) and defining a top portion of the single elongated central chamber (Figs. 1A-1B); and
a second transparent film (Figs. 1A-1B and paragraph [0037], transparent third layer 114) attached to the bottom side of the elongated body and defining a bottom portion of the single elongated central chamber (Figs. 1A-1B).
Shartle fails to teach: the port (Figs. 1A-1B, second opening 140) positioned on the top side of the elongated body above the second end of the central chamber is a hydrophobic filter port, wherein the hydrophobic filter port is adapted to allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled; and a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first transparent film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system.
Shartle teaches an outlet may be provided at an end of a microchannel and configured to vent air out air as the microchannel is filled with a sample (paragraphs [0034],[0042],[0047]). Shartle teaches a scratch-resistant coating may be applied to the layers (paragraph [0193]).
Andeshmandet teaches systems for point-of-care nucleic acid amplification and detection, including a cartridge that can accept a biological sample (abstract). Andeshmand teaches the input and/or output may comprise one or more filter plugs for filtering a fluid and a filter plug is configured to be hydrophobic to vent gasses while retaining liquids (column 60, lines 24-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port of Shartle to incorporate the teachings of a hydrophobic filter of Andeshmand (column 60, lines 24-33) and the teachings of venting out air as the microchannel is filled of Shartle (paragraphs [0034],[0042],[0047]) to provide: the port positioned on the top side of the elongated body above the second end of the central chamber is a hydrophobic filter port, wherein the hydrophobic filter port is adapted to allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled. Doing so would have a reasonable expectation of successfully improving venting of the chamber while retaining liquids as taught by Andeshmand (column 60, lines 24-33).
Modified Shartle fails to teach: a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first transparent film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system.
Shartle teaches the device includes a transparent portion along the length of the microfluidic channel, i.e. between the ports, for detection by an optical sensor, and the entire device is transparent (paragraph [0037]). Shartle teaches a scratch-resistant coating may be applied to the layers (paragraph [0193]). Shartle teaches the device is inserted into an analyzing system (Figs. 10A-10B).
Ohtsuka teaches an assay apparatus loaded with a sensor unit and a sensing surfacing that detects reaction of a sample (abstract), such as a sample fluid in a flow channel (paragraph [0018]). Ohtsuka teaches a protection layer in a transparent form is overlaid on the outer surfaces of the sensor unit to prevent scratches, dirt, and the like (paragraphs [0080],[0081]). Ohtsuka teaches a transparent protection tape is fitted on outer surfaces of a prism in a peelable manner, where the protection tape is peeled from the outer surfaces before start of an assay (paragraph [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate Shartle’s teachings of optical detection along the length of the microchannel, a scratch-resistant coating may be applied to the layers, and inserting the device into an analyzing system (paragraphs [0037],[0193]; Figs. 10A-10B) and Ohtsuka’s teachings of a transparent protection layer overlaid on outer surfaces of a sensor unit and a transparent protection tape that is peeled before start of an assay (paragraphs [0080]-[0082]) to provide: a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first transparent film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system. Doing so would have a reasonable expectation of successfully protecting the first transparent film between the ports of the device prior to optical analysis by protecting the first transparent film from scratches, dirt, and the like as taught by Ohtsuka.
Note that the air and the sample are not positively recited structurally and is interpreted as a functional limitation of the claimed cartridge. A claim is only limited by positively recited elements; thus, inclusion of the material or article (air; sample) worked upon by a structure (cartridge) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that the functional recitations that describe the hydrophobic filter are interpreted as a function limitation of the claimed cartridge and are given patentable weight to the extent which effects the structure of the claimed cartridge. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitation, then it meets the claim. See MPEP 2114. The cartridge of modified Shartle is identical to the presently claimed structure. Modified Shartle discloses the hydrophobic filter port as claimed and therefore, would have the ability to perform the function recited in the claim (i.e. “allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled”). See MPEP 2112.01(I).
Regarding claim 3, Shartle further teaches wherein the central chamber holds a minimum of 250 uL of sample (paragraph [0007] teaches the microfluidic channel defines a volume of between 1 ul to 1mL, which is a range that overlaps with the claimed range with sufficient specificity).
If it is determined that modified Shartle fails to teach the central chamber holds a minimum of 250 uL of sample, 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 central chamber of modified Shartle to incorporate the teachings of a volume range of 1 ul to 1 mL of Shartle (paragraph [0007]) to provide: wherein the central chamber holds a minimum of 250 uL of sample. i.e. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 6, Shartle further teaches wherein a viewing area of the central chamber is a minimum of 250 mm2 (note that “viewing area” is an arbitrary area of the device that is interpreted as part of an intended use of the device; paragraph [0040] teaches the channel may have a length of 1mm-50mm and width of 50um-5mm, therefore Shartle teaches a channel area of 50mm x5mm, which is 250mm2).
If it is determined that modified Shartle fails to teach a viewing area of the central chamber is a minimum of 250 mm2, 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 central chamber of modified Shartle to incorporate the teachings of length and width dimensions of a channel and length and width dimensions of the device of Shartle (paragraphs [0036], [0040]) to provide: a viewing area of the central chamber is a minimum of 250 mm2. Doing so would have a reasonable expectation of successfully improving the desired size of optical analysis of the chamber. i.e. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet and Ohtsuka as applied to claim 3 above, and further in view of Rinker et al. (US 20140274739 A1).
Regarding claim 4, modified Shartle fails to explicitly teach: wherein the central chamber is at least 62.5 mm long, 4 mm wide, and 1 mm deep.
Shartle teaches the microfluidic channel of the second layer may have a length of between about 1 mm and about 50 mm, a depth of between about 50 um and about 5 mm, and a width of between about 50 um and about 5 mm (paragraph [0040]).
Since Shartle teaches a depth and width range that overlaps with the claimed range, 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 central chamber of modified Shartle to incorporate the teachings of a width of 50 um-5mm and depth of 50um - 5 mm (paragraph [0040]) to provide: wherein the central chamber is at least 4 mm wide and 1 mm deep. i.e. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Modified Shartle fails to teach: wherein the central chamber is at least 62.5 mm long.
Rinker teaches flow chambers comprising an inlet, outlet, and ports (abstract). Rinker teaches the central chamber has a width of about 1-20mm, length of about 5-80mm, and height of about 0.025-2.5 mm (paragraph [0052]).
Since Rinker teaches a length of about 5-80mm (paragraph [0052]) which encompasses the claimed ranges of at least 62.5 mm long, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the central chamber of modified Shartle to provide wherein the central chamber is at least 62.5 mm long. I.e., it would have been prima facia obvious to have selected the claimed dimensions that lie within the disclosed dimension ranges (an upper range of the taught length and height ranges [0052]) (see MPEP 2144.05 (I); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)) to optimize the size and thus the volume of the central chamber with a reasonable expectation of success.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet and Ohtsuka as applied to claim 1 above, and further in view of Samsoondar (US 20080180658 A1).
Regarding claim 7, modified Shartle fails to teach: the cartridge in claim 1, further comprising a tethered cap for connecting to the fill port and sealing any sample within the central chamber.
Samsoondar teaches a sample holder for collection and measurement of a sample (abstract). Samsoondar teaches the sample holder comprises a tethered cap (Fig. 1F, tethered cap 145) for connecting to the fill port (105) and sealing any sample within holder (paragraph [0079]). Samsoondar teaches the cap prevents contamination of a user and an analyzer (paragraph [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of a tethered cap of Samsoondar (Fig. 1F; paragraphs [0079]) to provide the cartridge in claim 1, further comprising a tethered cap for connecting to the fill port and sealing any sample within the central chamber. Doing so would utilize known structures for caps as taught by Samsoondar, which would have a reasonable expectation of successfully improving protection of the cartridge and preventing contamination of a user and analyzer when utilized (Samsoondar, paragraph [0079]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet and Ohtsuka as applied to claim 1 above, and further in view of Lemoine et al. (US 20190299210 A1; cited in the Office Action filed 04/18/2025).
Regarding claim 9, modified Shartle fails to teach the cartridge in claim 1, further comprising geometric features adapted to provide capability for interfacing with an instrument to align the cartridge consistently, retain the cartridge during centrifuge, move the cartridge through the instrument for processing, and hold the cartridge flat during optical scanning; wherein the geometric features include asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into an instrument.
Shartle teaches notifying a user of improper placement or insertion of the microfluidic device into a microfluidic device assembly, which may prevent harm to the system (paragraph [0174]). Shartle teaches inserting the microfluidic device into an analysis system (paragraphs [0183],[0186]).
Lemoine et al. (US 20190299210 A1) teaches a cartridge assembly (abstract). Lemoine teaches standoffs 914, i.e. geometric features, may be shaped and dimensioned as alignment keying features to prevent the flow cell cartridge 900 from being inserted incorrectly into the cartridge assembly 100 (e.g. backwards) (Fig. 9; paragraph [0184]). Lemoine teaches the standoffs 914 include asymmetry between a first edge and a second edge of the shorter side of the cartridge assembly (Fig. 9C). Lemoine teaches additional geometric features (elements 927, 923, 925) which include asymmetry between a first end and a second end of the longer side of the cartridge assembly and asymmetry between a first edge and a second edge of the shorter side of the cartridge assembly (Fig. 9C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of ensuring proper insertion the microfluidic device into an analysis system of Shartle (paragraphs [0174],[0183],[0186]) and the teachings of various geometric features of a flow cell cartridge asymmetrically positioned around the cartridge of Lemoine (paragraph [0184]; Figs. 9A-9C) to provide: the cartridge in claim 1, further comprising geometric features adapted to provide capability for interfacing with an instrument to align the cartridge consistently, retain the cartridge during centrifuge, move the cartridge through the instrument for processing, and hold the cartridge flat during optical scanning; wherein the geometric features include asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into an instrument. Doing so would have a reasonable expectation of successfully improving and ensuring correct insertion of the cartridge into an instrument for analysis as discussed by Lemoine (paragraph [0184]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet, Ohtsuka, and Lemoine as applied to claim 9 above, and further in view of Liebel et al. (US 20060216211 A1).
Regarding claim 10, while Shartle teaches the device may be analyzed using microscopy (paragraph [0187]), modified Shartle fails to teach wherein the geometric features include optical Z hold down pads to control cartridge flatness when under a microscope.
Liebel teaches a sample holder for holding samples under a microscope (abstract). Liebel teaches a coupling area can be formed by a recess, groove, or channel (i.e. structural pads) on side walls, with which recess, groove, or channel a functional element for secure coupling to the sample holder can engage (paragraph [0010]). Liebel teaches secure fixing of samples in a sample holder with a spring that presses the sample or samples onto the base frame or onto the adapter (paragraph [0013]). Liebel teaches a secure overall assembly consisting of the base frame, adapter, and fixing element; and to ensure a secure overall assembly at least of the fixing element and base frame the fixing element could be latched or clamped to the base frame (paragraph [0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the geometric features of Shartle to incorporate the teaching of structural elements for securing a sample holder for a microscope of Liebel (paragraphs [0010],[0013]) to provide: wherein the geometric features include optical Z hold down pads to control cartridge flatness when under a microscope. Doing so would have a reasonable expectation for successfully improving securing and alignment of the device for microscopy.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet and Ohtsuka as applied to claim 1 above, and further in view of Lehto (US 20060233670 A1).
Regarding claim 12, modified Shartle fails to teach the cartridge in claim 1, further comprising a push pillar positioned on the top side of the elongated body adjacent to the hydrophobic filter port and having a fourth longitudinal axis that is parallel to the second longitudinal axis and the third longitudinal axis, the push pillar allowing an instrument stage to move the cartridge into and out of a centrifuge and through the instrument.
Lehto teaches a microplate (abstract). Lehto teaches the microplate (Fig. 2) comprises alignment features, such as a push pillar, i.e. a pin, can provide for improved alignment with a fixture or equipment (Fig. 2, element 58; paragraph [0168]). Lehto teaches the alignment features are placed such that they do not interfere with a sealing cover or wells (paragraph [0168]). Lehto teaches the alignment feature allows for proper alignment of each staging capillaries relative to each well (paragraph [0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of alignment features such as a pin of Lehto (Fig. 2; paragraph [0168]) to provide the cartridge in claim 1, further comprising a push pillar positioned on the top side of the elongated body adjacent to the hydrophobic filter port and having a fourth longitudinal axis that is parallel to the second longitudinal axis and the third longitudinal axis, the push pillar allowing an instrument stage to move the cartridge into and out of a centrifuge and through the instrument. Doing so would have a reasonable expectation of successfully improving alignment of the cartridge during use (Lehto, paragraphs [0168],[0232]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet, Ohtsuka, and Lemoine as applied to claim 9 above, and further in view of Rawlings et al. (US 20160281150 A1).
Regarding claim 13, while Shartle teaches the device may be analyzed using microscopy (paragraph [0187]), modified Shartle fails to teach wherein the geometric features include a X-datum spring to control lateral movement and hold against an optical datum during inspection.
Rawlings teaches a cartridge (Fig. 8) comprising a holding mechanism (418; paragraph [0116]) including a datum block that is spring loaded (paragraph [0116]). Rawlings teaches the holding mechanism allows a substrate to be held in a fixed position (paragraph [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of spring loaded datum block of Rawlings (Fig. 8; paragraph [0116]) to provide the geometric features include a X- datum spring to control lateral movement and hold against an optical datum during inspection. Doing so would have a reasonable expectation of successfully improving positioning and holding of the cartridge during use.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet, Ohtsuka, and Lemoine as applied to claim 9 above, and further in view of Shah et al. (WO 2011147421 A1).
Regarding claim 14, while Shartle teaches the microfluidic device may be centrifuged (paragraph [0185]), modified Shartle fails to teach wherein the geometric features include a centrifuge Z hold down springs which retain the cartridge when being spun in a centrifuge.
Shah teaches a socket for microchips (abstract). Shah teaches a chip holder for ensuring more accurate positioning of a chip (page 10, lines 10-19), wherein the chip holder comprises springs (page 10, lines 10-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of a chip holder with springs of Shah (page 10, lines 10-31) to provide wherein the geometric features include a centrifuge Z hold down springs which retain the cartridge when being spun in a centrifuge. Doing so would have a reasonable expectation of successfully improving positioning of the cartridge as taught by Shah (page 10, lines 10-31).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet and Ohtsuka as applied to claim 1 above, and further in view of Clemens et al. (US 20130137591 A1).
Regarding claim 15, modified Shartle fails to teach the cartridge in claim 1, further comprising a handle positioned beyond the second end of the central chamber, having width and height that are greater than the central chamber, and no corresponding symmetrical structure at the first end of the central chamber.
Clemens teaches a fluidic device for purifying, abstracting, filtering, detecting and/or measuring analytes in liquid samples (abstract). Clemens teaches the device comprising a handle for easy manipulation and features to ensure appropriate orientation to an instrument (paragraph [0235]), wherein the handle (Fig. 1A, element 43) is beyond an end of a central chamber (16) and no corresponding symmetrical structure at the other end of the chamber (Fig. 1A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of a handle of Clemens (Fig 1A; paragraph [0235]) to provide the cartridge in claim 1, further comprising a handle positioned beyond the second end of the central chamber, having width and height that are greater than the central chamber, and no corresponding symmetrical structure at the first end of the central chamber. Doing so would have a reasonable expectation of successfully improving manipulation of the overall device (Clemens, paragraph [0235]). Furthermore it would have been obvious to one of ordinary skill in the art to provide the handle having a width and height that are greater than the central chamber in view of Clemens to provide a structure that improves user manipulation of the device.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle in view of Andeshmandet and Ohtsuka as applied to claim 1 above, and further in view of Rullison et al. (US 20060227325 A1).
Regarding claim 16, while Shartle teaches the device may be analyzed using microscopy (paragraph [0187]), modified Shartle fails to teach the cartridge in claim 1, further comprising laser etched microscopic features on the first transparent film or second transparent film for improved optical calibration and object identification accuracy.
Rullison teaches a microfluidic device (abstract). Rullison teaches optical alignment marks formed by etching, wherein the device is positioned relative to optics of an optical system in relation to the alignment marks (paragraph [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of optical alignment marks of Rullison (paragraph [0052]) to provide the cartridge further comprising laser etched microscopic features on the first transparent film or second transparent film for improved optical calibration and object identification accuracy. Doing so would utilize known features of microfluidic cartridges, as taught by Rullison, which would have a reasonable expectation of successfully improving alignment of the cartridge during use (Rullison, paragraph [0052]).
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shartle et al. (US 20200030797 A1; cited in the Office Action filed 04/19/2024) in view of Andeshmandet al. (US 10820847 B1; effectively filed 08/15/2019), Ohtsuka et al. (US 20060159591 A1), Lemoine et al. (US 20190299210 A1; cited in the Office Action filed 04/18/2025), and Lehto (US 20060233670 A1).
Regarding claim 17, Shartle teaches a cartridge (Figs. 1A-1B), comprising:
an elongated body (Figs. 1A-1B, second layer 112) having a first longitudinal axis (Figs. 1A-1B, longitudinal axis 102) and a substantially rectangular shape (Figs. 1A-1B; paragraph [0036]) with a longer side (Figs. 1A-1B) and a shorter side (Figs. 1A-1B), a top side (Figs. 1A-1B), and a bottom side (Figs. 1A-1B), wherein the body accommodates only a single elongated central chamber along the first longitudinal axis (Figs. 1A-1B, microfluidic channel 120);
wherein the single elongated central chamber within the body has a first end (Figs. 1A-1B, interpreted as the end of channel 120 towards element 130) and a second end (Figs. 1A-1B, interpreted as the end of channel 120 towards element 140) spanning a substantial length of the longer side of the body (Figs. 1A-1B);
a fill port (Figs. 1A-1B, first opening 130) positioned on the top side of the elongated body above the first end of the single elongated central chamber (Figs. 1A-1B, first opening 130 is on the top of layer 112 above the end of channel 120) and adapted to introduce fluid into the first end (interpreted as an intended use of the fill port, see MPEP 2114; paragraph [0041] teaches the first opening 130 is configured to receive a sample), the fill port having a second longitudinal axis that is perpendicular to the first longitudinal axis of the elongated body (Figs. 1A-1B, interpreted as the vertical axis of the opening 130 which is perpendicular to the longitudinal axis 102);
a port (Figs. 1A-1B, second opening 140) positioned on the top side of the elongated body above the second end of the central chamber (Figs. 1A-1B teaches the second opening is on the top of the layer 112 above the end of channel 120), the port having a third longitudinal axis that is parallel to the second longitudinal axis (Figs. 1A-1B, interpreted as the vertical axis of the opening 140 which is parallel the axis of opening 130);
a first transparent film (Figs. 1A-1B and paragraph [0036], transparent first layer 110) attached to the top side of the elongated body between the fill port and the port (Figs. 1A-1B teach the first layer 110 is attached to layer 112 and is structurally between the openings 130 and 140) and defining a top portion of the single elongated central chamber (Figs. 1A-1B); and
a second transparent film (Figs. 1A-1B and paragraph [0037], transparent third layer 114) attached to the bottom side of the elongated body and defining a bottom portion of the single elongated central chamber (Figs. 1A-1B).
Shartle fails to teach the port (Figs. 1A-1B, second opening 140) positioned on the top side of the elongated body above the second end of the central chamber is a hydrophobic filter port, wherein the hydrophobic filter port is adapted to allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled; and a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first transparent film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system; and geometric features comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into an instrument; and a push pillar positioned on the top side of the elongated body adjacent to the hydrophobic filter port and having a fourth longitudinal axis that is parallel to the second longitudinal axis and the third longitudinal axis, the push pillar allowing an instrument stage to move the cartridge into and out of a centrifuge and through the instrument.
Shartle teaches an outlet may be provided at an end of a microchannel and configured to vent air out air as the microchannel is filled with a sample (paragraphs [0034],[0042],[0047]). Shartle teaches a scratch-resistant coating may be applied to the layers (paragraph [0193]).
Andeshmandet teaches systems for point-of-care nucleic acid amplification and detection, including a cartridge that can accept a biological sample (abstract). Andeshmand teaches the input and/or output may comprise one or more filter plugs for filtering a fluid and a filter plug is configured to be hydrophobic to vent gasses while retaining liquids (column 60, lines 24-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port of Shartle to incorporate the teachings of a hydrophobic filter of Andeshmand (column 60, lines 24-33) and the teachings of venting out air as the microchannel is filled of Shartle (paragraphs [0034],[0042],[0047]) to provide: the port positioned on the top side of the elongated body above the second end of the central chamber is a hydrophobic filter port, wherein the hydrophobic filter port is adapted to allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled. Doing so would have a reasonable expectation of successfully improving venting of the chamber while retaining liquids as taught by Andeshmand (column 60, lines 24-33).
Modified Shartle fails to teach: a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system; and geometric features comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into an instrument; and a push pillar positioned on the top side of the elongated body adjacent to the hydrophobic filter port and having a fourth longitudinal axis that is parallel to the second longitudinal axis and the third longitudinal axis, the push pillar allowing an instrument stage to move the cartridge into and out of a centrifuge and through the instrument.
Shartle teaches the device includes a transparent portion along the length of the microfluidic channel, i.e. between the ports, for detection by an optical sensor, and the entire device is transparent (paragraph [0037]). Shartle teaches a scratch-resistant coating may be applied to the layers (paragraph [0193]). Shartle teaches the device is inserted into an analyzing system (Figs. 10A-10B).
Ohtsuka teaches an assay apparatus loaded with a sensor unit and a sensing surfacing that detects reaction of a sample (abstract), such as a sample fluid in a flow channel (paragraph [0018]). Ohtsuka teaches a protection layer in a transparent form is overlaid on the outer surfaces of the sensor unit to prevent scratches, dirt, and the like (paragraphs [0080],[0081]). Ohtsuka teaches a transparent protection tape is fitted on outer surfaces of a prism in a peelable manner, where the protection tape is peeled from the outer surfaces before start of an assay (paragraph [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate Shartle’s teachings of optical detection along the length of the microchannel, a scratch-resistant coating may be applied to the layers, and inserting the device into an analyzing system (paragraphs [0037],[0193]; Figs. 10A-10B) and Ohtsuka’s teachings of a transparent protection layer overlaid on outer surfaces of a sensor unit and a transparent protection tape that is peeled before start of an assay (paragraphs [0080]-[0082]) to provide: a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first transparent film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system. Doing so would have a reasonable expectation of successfully protecting the first transparent film between the ports of the device prior to optical analysis by protecting the first transparent film from scratches, dirt, and the like as taught by Ohtsuka.
Modified Shartle fails to teach: geometric features comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into an instrument; and a push pillar positioned on the top side of the elongated body adjacent to the hydrophobic filter port and having a fourth longitudinal axis that is parallel to the second longitudinal axis and the third longitudinal axis, the push pillar allowing an instrument stage to move the cartridge into and out of a centrifuge and through the instrument.
Shartle teaches notifying a user of improper placement or insertion of the microfluidic device into a microfluidic device assembly, which may prevent harm to the system (paragraph [0174]). Shartle teaches inserting the microfluidic device into an analysis system (paragraphs [0183],[0186]).
Lemoine teaches a cartridge assembly (abstract). Lemoine teaches standoffs 914, i.e. geometric features, may be shaped and dimensioned as alignment keying features to prevent the flow cell cartridge 900 from being inserted incorrectly into the cartridge assembly 100 (e.g. backwards) (Fig. 9; paragraph [0184]). Lemoine teaches the standoffs 914 include asymmetry between a first edge and a second edge of the shorter side of the cartridge assembly (Fig. 9C). Lemoine teaches additional geometric features (elements 927, 923, 925) which include asymmetry between a first end and a second end of the longer side of the cartridge assembly and asymmetry between a first edge and a second edge of the shorter side of the cartridge assembly (Fig. 9C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of ensuring proper insertion the microfluidic device into an analysis system of Shartle (paragraphs [0174],[0183],[0186]) and the teachings of various geometric features of a flow cell cartridge asymmetrically positioned around the cartridge of Lemoine (paragraph [0184]; Figs. 9A-9C) to provide: geometric features comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into an instrument. Doing so would have a reasonable expectation of successfully improving and ensuring correct insertion of the cartridge into an instrument for analysis as discussed by Lemoine (paragraph [0184]).
Modified Shartle fails to teach: a push pillar positioned on the top side of the elongated body adjacent to the hydrophobic filter port and having a fourth longitudinal axis that is parallel to the second longitudinal axis and the third longitudinal axis, the push pillar allowing an instrument stage to move the cartridge into and out of a centrifuge and through the instrument.
Lehto teaches a microplate (abstract). Lehto teaches the microplate (Fig. 2) comprises alignment features, such as a push pillar, i.e. a pin, can provide for improved alignment with a fixture or equipment (Fig. 2, element 58; paragraph [0168]). Lehto teaches the alignment features are placed such that they do not interfere with a sealing cover or wells (paragraph [0168]). Lehto teaches the alignment feature allows for proper alignment of each staging capillaries relative to each well (paragraph [0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of alignment features such as a pin of Lehto (Fig. 2; paragraph [0168]) to provide a push pillar positioned on the top side of the elongated body adjacent to the hydrophobic filter port and having a fourth longitudinal axis that is parallel to the second longitudinal axis and the third longitudinal axis, the push pillar allowing an instrument stage to move the cartridge into and out of a centrifuge and through the instrument. Doing so would have a reasonable expectation of successfully improving alignment of the cartridge during use (Lehto, paragraphs [0168],[0232]).
Note that the air and the sample are not positively recited structurally and is interpreted as a functional limitation of the claimed cartridge. A claim is only limited by positively recited elements; thus, inclusion of the material or article (air; sample) worked upon by a structure (cartridge) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that the functional recitations that describe the hydrophobic filter are interpreted as a function limitation of the claimed cartridge and are given patentable weight to the extent which effects the structure of the claimed cartridge. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitation, then it meets the claim. See MPEP 2114. The cartridge of modified Shartle is identical to the presently claimed structure. Modified Shartle discloses the hydrophobic filter port as claimed and therefore, would have the ability to perform the function recited in the claim (i.e. “allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled”). See MPEP 2112.01(I).
Regarding claim 19, modified Shartle further teaches wherein the geometric features are adapted to provide capability for interfacing with the instrument to align the cartridge consistently, retain the cartridge during centrifuge, move the cartridge through the instrument for processing, and hold the cartridge flat during optical scanning (interpreted as functional limitations of the geometric features, see MPEP 2114; see above claim 17, modified Shartle teaches the claimed geometric features, which are identical to the presently claimed structure and therefore would have the ability to perform the function recited in the claim. See MPEP 2112.01(I)).
Note that the functional recitations that describe the geometric features are interpreted as a function limitation of the claimed cartridge and are given patentable weight to the extent which effects the structure of the claimed cartridge. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitation, then it meets the claim. See MPEP 2114. The cartridge of modified Shartle is identical to the presently claimed structure. Modified Shartle discloses the geometric features as claimed and therefore, would have the ability to perform the function recited in the claim. See MPEP 2112.01(I).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shartle et al. (US 20200030797 A1; cited in the Office Action filed 04/19/2024) in view of Andeshmandet al. (US 10820847 B1; effectively filed 08/15/2019), Ohtsuka et al. (US 20060159591 A1) and Lemoine et al. (US 20190299210 A1; cited in the Office Action filed 04/18/2025).
Regarding claim 20, Shartle teaches a cartridge (Figs. 1A-1B), comprising:
an elongated body (Figs. 1A-1B, second layer 112) having a first longitudinal axis (Figs. 1A-1B, longitudinal axis 102) and a substantially rectangular shape (Figs. 1A-1B; paragraph [0036]) with a longer side (Figs. 1A-1B) and a shorter side (Figs. 1A-1B), a top side (Figs. 1A-1B), and a bottom side (Figs. 1A-1B), wherein the body accommodates only a single elongated central chamber along the first longitudinal axis (Figs. 1A-1B, microfluidic channel 120);
wherein the single elongated central chamber within the body has a first end (Figs. 1A-1B, interpreted as the end of channel 120 towards element 130) and a second end (Figs. 1A-1B, interpreted as the end of channel 120 towards element 140) spanning a substantial length of the longer side of the body (Figs. 1A-1B);
a fill port (Figs. 1A-1B, first opening 130) positioned on the top side of the elongated body above the first end of the single elongated central chamber (Figs. 1A-1B, first opening 130 is on the top of layer 112 above the end of channel 120) and adapted to introduce fluid into the first end (interpreted as an intended use of the fill port, see MPEP 2114; paragraph [0041] teaches the first opening 130 is configured to receive a sample), the fill port having a second longitudinal axis that is perpendicular to the first longitudinal axis of the elongated body (Figs. 1A-1B, interpreted as the vertical axis of the opening 130 which is perpendicular to the longitudinal axis 102);
a port (Figs. 1A-1B, second opening 140) positioned on the top side of the elongated body above the second end of the central chamber (Figs. 1A-1B teaches the second opening is on the top of the layer 112 above the end of channel 120), the port having a third longitudinal axis that is parallel to the second longitudinal axis (Figs. 1A-1B, interpreted as the vertical axis of the opening 140 which is parallel the axis of opening 130);
a first transparent film (Figs. 1A-1B and paragraph [0036], transparent first layer 110) attached to the top side of the elongated body between the fill port and the port (Figs. 1A-1B teach the first layer 110 is attached to layer 112 and is structurally between the openings 130 and 140) and defining a top portion of the single elongated central chamber (Figs. 1A-1B);
a second transparent film (Figs. 1A-1B and paragraph [0037], transparent third layer 114) attached to the bottom side of the elongated body and defining a bottom portion of the single elongated central chamber (Figs. 1A-1B).
Shartle fails to teach the port (Figs. 1A-1B, second opening 140) positioned on the top side of the elongated body above the second end of the central chamber is a hydrophobic filter port, wherein the hydrophobic filter port is adapted to allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled; a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first transparent film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system; and geometric features adapted to provide capability for interfacing with an instrument to align the cartridge consistently, retain the cartridge during centrifuge, move the cartridge through the instrument for processing, and hold the cartridge flat during optical scanning, the geometric features further comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into the instrument.
Shartle teaches an outlet may be provided at an end of a microchannel and configured to vent air out air as the microchannel is filled with a sample (paragraphs [0034],[0042],[0047]). Shartle teaches a scratch-resistant coating may be applied to the layers (paragraph [0193]).
Andeshmandet teaches systems for point-of-care nucleic acid amplification and detection, including a cartridge that can accept a biological sample (abstract). Andeshmand teaches the input and/or output may comprise one or more filter plugs for filtering a fluid and a filter plug is configured to be hydrophobic to vent gasses while retaining liquids (column 60, lines 24-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port of Shartle to incorporate the teachings of a hydrophobic filter of Andeshmand (column 60, lines 24-33) and the teachings of venting out air as the microchannel is filled of Shartle (paragraphs [0034],[0042],[0047]) to provide: the port positioned on the top side of the elongated body above the second end of the central chamber is a hydrophobic filter port, wherein the hydrophobic filter port is adapted to allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled. Doing so would have a reasonable expectation of successfully improving venting of the chamber while retaining liquids as taught by Andeshmand (column 60, lines 24-33).
Modified Shartle fails to teach: a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system; and geometric features adapted to provide capability for interfacing with an instrument to align the cartridge consistently, retain the cartridge during centrifuge, move the cartridge through the instrument for processing, and hold the cartridge flat during optical scanning, the geometric features further comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into the instrument.
Shartle teaches the device includes a transparent portion along the length of the microfluidic channel, i.e. between the ports, for detection by an optical sensor, and the entire device is transparent (paragraph [0037]). Shartle teaches a scratch-resistant coating may be applied to the layers (paragraph [0193]). Shartle teaches the device is inserted into an analyzing system (Figs. 10A-10B).
Ohtsuka teaches an assay apparatus loaded with a sensor unit and a sensing surfacing that detects reaction of a sample (abstract), such as a sample fluid in a flow channel (paragraph [0018]). Ohtsuka teaches a protection layer in a transparent form is overlaid on the outer surfaces of the sensor unit to prevent scratches, dirt, and the like (paragraphs [0080],[0081]). Ohtsuka teaches a transparent protection tape is fitted on outer surfaces of a prism in a peelable manner, where the protection tape is peeled from the outer surfaces before start of an assay (paragraph [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate Shartle’s teachings of optical detection along the length of the microchannel, a scratch-resistant coating may be applied to the layers, and inserting the device into an analyzing system (paragraphs [0037],[0193]; Figs. 10A-10B) and Ohtsuka’s teachings of a transparent protection layer overlaid on outer surfaces of a sensor unit and a transparent protection tape that is peeled before start of an assay (paragraphs [0080]-[0082]) to provide: a peel off transparent protective film positioned atop the first transparent film between the fill port and the hydrophobic filter port, the peel off transparent protective film protecting the first transparent film from contamination during use of the fill port, the peel off transparent protective film being removed before the sample cartridge is inserted into an analyzing system. Doing so would have a reasonable expectation of successfully protecting the first transparent film between the ports of the device prior to optical analysis by protecting the first transparent film from scratches, dirt, and the like as taught by Ohtsuka.
Modified Shartle fails to teach: geometric features adapted to provide capability for interfacing with an instrument to align the cartridge consistently, retain the cartridge during centrifuge, move the cartridge through the instrument for processing, and hold the cartridge flat during optical scanning, the geometric features further comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into the instrument.
Shartle teaches notifying a user of improper placement or insertion of the microfluidic device into a microfluidic device assembly, which may prevent harm to the system (paragraph [0174]). Shartle teaches inserting the microfluidic device into an analysis system (paragraphs [0183],[0186]).
Lemoine teaches a cartridge assembly (abstract). Lemoine teaches standoffs 914, i.e. geometric features, may be shaped and dimensioned as alignment keying features to prevent the flow cell cartridge 900 from being inserted incorrectly into the cartridge assembly 100 (e.g. backwards) (Fig. 9; paragraph [0184]). Lemoine teaches the standoffs 914 include asymmetry between a first edge and a second edge of the shorter side of the cartridge assembly (Fig. 9C). Lemoine teaches additional geometric features (elements 927, 923, 925) which include asymmetry between a first end and a second end of the longer side of the cartridge assembly and asymmetry between a first edge and a second edge of the shorter side of the cartridge assembly (Fig. 9C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of modified Shartle to incorporate the teachings of ensuring proper insertion the microfluidic device into an analysis system of Shartle (paragraphs [0174],[0183],[0186]) and the teachings of various geometric features of a flow cell cartridge asymmetrically positioned around the cartridge of Lemoine (paragraph [0184]; Figs. 9A-9C) to provide: geometric features adapted to provide capability for interfacing with an instrument to align the cartridge consistently, retain the cartridge during centrifuge, move the cartridge through the instrument for processing, and hold the cartridge flat during optical scanning, the geometric features further comprising asymmetry between a first end and a second end of the longer side of the body and asymmetry between a first edge and a second edge of the shorter side of the body to prevent the cartridge from being inserted backwards into the instrument. Doing so would have a reasonable expectation of successfully improving and ensuring correct insertion of the cartridge into an instrument for analysis as discussed by Lemoine (paragraph [0184]).
Note that the air and the sample are not positively recited structurally and is interpreted as a functional limitation of the claimed cartridge. A claim is only limited by positively recited elements; thus, inclusion of the material or article (air; sample) worked upon by a structure (cartridge) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that the functional recitations that describe the hydrophobic filter are interpreted as a function limitation of the claimed cartridge and are given patentable weight to the extent which effects the structure of the claimed cartridge. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitation, then it meets the claim. See MPEP 2114. The cartridge of modified Shartle is identical to the presently claimed structure. Modified Shartle discloses the hydrophobic filter port as claimed and therefore, would have the ability to perform the function recited in the claim (i.e. “allow air to escape the central chamber while a sample is being loaded and provides a positive pressure feedback to a user indicating the central chamber is fully filled”). See MPEP 2112.01(I).
Response to Arguments
Applicant’s arguments, see page 7, filed 06/11/2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 03/11/2026 have been withdrawn.
Applicant’s arguments with respect to claims 1, 17, and 20, specifically regarding Neff, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument (i.e. Neff). However, upon further consideration, a new ground(s) of rejection is made in view of: Shartle et al. (US 20200030797 A1; cited in the Office Action filed 04/19/2024) in view of Andeshmandet al. (US 10820847 B1; effectively filed 08/15/2019) and Ohtsuka et al. (US 20060159591 A1); Shartle et al. (US 20200030797 A1; cited in the Office Action filed 04/19/2024) in view of Andeshmandet al. (US 10820847 B1; effectively filed 08/15/2019), Ohtsuka et al. (US 20060159591 A1), Lemoine et al. (US 20190299210 A1; cited in the Office Action filed 04/18/2025), and Lehto (US 20060233670 A1); and Shartle et al. (US 20200030797 A1; cited in the Office Action filed 04/19/2024) in view of Andeshmandet al. (US 10820847 B1; effectively filed 08/15/2019), Ohtsuka et al. (US 20060159591 A1) and Lemoine et al. (US 20190299210 A1; cited in the Office Action filed 04/18/2025).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Houck et al. (US 20190370447 A1) teaches a device including a sensor window (abstract). Houck teaches the sensor windows include layers, such as a protective layer (e.g., a coating disposed on top of optical filter coating portion 510), an anti-reflectance layer, an out of band blocker layer (e.g., to block a particular spectral range), and/or the like (paragraph [0048]).
Baker et al. (US 20210339245 A1; effectively filed 10/12/2018) teaches a protective cover prevents damage to the IRE or the addition of material to the second surface of the IRE such as fingerprints (paragraph [0060]), wherein the protective cover comprise a removable film (paragraph [0060]).
Letourneau et al. (US 20200197928 A1; effectively filed 05/12/2017) teaches an apparatus for detecting a target substance (abstract). Letourneau teaches the apparatus includes a removable layer 702 is disposed over the protective layer 722; and the protective layer 722 includes a window 728 aligned over a portion of the detection unit 716 for viewing an indicator that demonstrates presence or absence of a target substance in a tested liquid (paragraph [0074]). Letourneau teaches the protective layer 924 includes an opening 926, which can provide an opening through which liquid or other medium can travel to the lateral flow assay 946 for testing (paragraph [0093]). Letourneau teaches a protective layer includes an opening that may be an entry port through which a fluid can enter the cavity; and the protective layer may include vents (paragraph [0054]). Letourneau teaches the protective layer may help seal and secure the detection unit within the apparatus (paragraph [0056]).
Neff et al. (US 20130298641 A1) teaches a sample collection unit for microbiological analysis comprising an optical window (abstract). Neff teaches it is advantageous that an optical window has a film which is removable before use (paragraph [0023]); in this way, the sample collection unit is protected, prior to use, against contamination and damage to the listed areas (paragraph [0023]). Neff teaches the sample collection unit is transported to a place of analysis and the protective film on the optical window is removed (paragraph [0049]). Neff teaches an analysis unit has a sensor device aligned with the optical window of the sample collection unit for analysis (paragraph [0043]).
Kondo et al. (US 4270920 A) teaches an integrated material for chemical analysis of a liquid sample (abstract). Kondo teaches supports or other supports (e.g., translucent or opaque supports such as of paper, plastic, metal foil, etc.) coated with a very thin film of a release agent such as silicone resin, etc., are used as the support, it provides the protection and it can be removed by peel-off just before the analysis measurement (column 4, lines 61-68).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
Prosecution Insights