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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/8/2025 has been entered.
Response to Arguments
Applicant argues that "nowhere in Chang's disclosure is there any mention or even suggestion of fluid flow channels containing angular entrance constriction regions between a common single sample zone and a channel constriction zone as presently claimed. In particular, Applicant submits that Chang fails to teach such an angular entrance constriction region having a projecting portion that expands into the fluid flow channel at an angle that is between about 30- 90°. Further, Chang does not teach the specific geometric shapes of the projecting portion set forth in independent claim 1 i.e., a half-rhombus, half-rectangle, half-square, quarter-rectangle, half-parallelogram, quarter-parallelogram, or half-kite." This argument is not convincing as the rejection is now a 103 rejection where the fluid control features angles and shapes are result effective to control the fluid flow.
Additionally, applicant argues, "the Office asserts that Chang discloses a plurality of discrete fluid flow channels where n is between 2-20 and where each fluid flow channel is identified by an integer between 1 and n, wherein fluid flow channel 1 and fluid flow channel n each comprise an outer channel wall with a width w, and a barrier extension region positioned at the channel entrance region with a width of between about w, and about 10w. As alleged support for the anticipation rejection, the Office points to Chang's Fig. 1L and asserts that this drawing depicts a barrier extension region having an outer wall of outer flow channels with a width equal to the width of the outer channel walls." The argument was convincing, but is now moot in view of the new 103 obviousness rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-8, 12-13, 20-25, 28, 30-31, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (US 2018/0229232A1).
Regarding claims 1, 20, Chang et al teach a device, comprising:
a single, unitary substrate comprising a plurality of discrete fluid flow channels (Para. 0021: single integral substrate and plurality of discrete flow paths),
a single sample zone on the substrate that is common to each fluid flow channel such that each fluid flow channel is in direct fluid communication with the sample zone at a channel entrance region of each fluid flow channel (Para. 0085: single sample receiving zone 20); each fluid flow channel having a length and a width (Fig 29), each fluid flow channel comprising a capture zone downstream from the channel entrance region (Fig. 29 capture zone downstream of the channel entrance) and a channel constriction zone positioned between the channel entrance region and the capture zone (Para. 0085, Fig. 29: fluid flow feature 28 to narrow is positioned between the channel entrance and the capture zone 30), the channel constriction zone having a width and a length, the channel constriction zone width corresponding to a value in the range determined by (i) a minimum value that is equal to or greater than a diameter of a particulate reagent deposited on or to be deposited on the substrate wherein the diameter of the particulate reagent is between about 0.05-10 microns (0.00005-0.1 mm) ii) a maximum value that is less than about 0.825 mm. (Para. 0161-0162 funnel widths of 0.5 and 0.7mm falls within the claimed range). Chang et al teach the plurality of discrete fluid flow channels comprises n fluid flow channels, where n is between 2-20. (Fig 29: 2 fluid flow channels) Chang et al teach each fluid flow channel n is identified by an integer between 1 and n (Fig. 1L (see annotated below): channels 1 through 4), and wherein fluid flow channel 1 (Fig. 1L (see annotated below) Channel 1) and fluid flow channel n (Fig. 1L (see annotated below)channel 4) each comprise an outer channel wall. Chang shows the outer channel wall and continuing to the barrier extension region having a width consistent throughout in Fig. 1L below (Fig. 1L (see annotated below): barrier extension region extends at a right angle from the outer channel wall and has a width equal to the channel wall width; Para. 0123: the wall in the sample receiving zone is the same as the barrier extension region that is perpendicular to the walls in between the channels as shown in the Fig. 1L).
Chang is silent to the description of the Fig. 1L having a specific width and the Figure being drawn to scale for widths of the walls. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a width of the wall is a result effective variable that gives the well known and expected results of providing structural support for the internal components and channels. In the absence of a showing of unexpected results, the Office maintains the width of the wall having the same width would have been within the skill of the art as optimization of a results effective variable and would provide ease of manufacturing to provide an equal width throughout the device.
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Chang teach an angular entrance constriction region in each fluid flow channel positioned between the common single sample zone and the channel constriction zone, wherein the entrance constriction region comprises a projecting portion that expands into the fluid flow channel at an angle in the embodiment in both Fig. 29 and Fig. 31. The angular entrance constriction regions in these embodiments are not defined in the reference, but appear to be about 45 degrees in Fig. 29 and in Fig. 31 more acute than the square shape due to the diamond shape. The fluid control feature is described as "diamond-shaped" (Para. 0062). Chang teach diamond shaped angles appear to fall within the 30-90 degree in Fig. 29 and 31 and the "diamond shape" in Fig. 29 and 31 are sufficiently broad to read on a geometric shape of a half-rhombus or a half-parallelogram as both shapes can be rhombus and parallelograms after having been halved in a parallel cut to the sides. Chang further teaches the geometric shape and angle controls the rate of fluid flow (Para. 0085: geometric shape to control the fluid flow, 0117: angled walls to enhance the pinch point created by the fluid control feature).
In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of an angle between about 30-90° and a geometric shape of a half-rhombus, half-rectangle, half-square, quarter-rectangle, half- parallelogram, quarter-parallelogram, or half-kite is a result effective variable that gives the well known and expected results of providing a desired rate of fluid flow. In the absence of a showing of unexpected results, the Office maintains the choice of the embodiments in Fig. 29 and 31 to use with the device at angles between about 30-90°, wherein the projecting portion has a geometric shape of a half-rhombus, half-rectangle, half-square, quarter-rectangle, half- parallelogram, quarter-parallelogram, or half-kite (read on by the diamond shape in Fig. 29 and 31) would have been within the skill of the art as optimization of a results effective variable.
Regarding claims 3 and 37, Chang et al teach a device, comprising: a single, unitary substrate comprising a plurality of discrete fluid flow channels (Para. 0021: single integral substrate and plurality of discrete flow paths), a single sample zone on the substrate that is common to each fluid flow channel such that each fluid flow channel is in direct fluid communication with the sample zone at a channel entrance region of each fluid flow channel (Para. 0085: single sample receiving zone 20); each fluid flow channel having a length and a width (Fig 29), each fluid flow channel comprising a capture zone downstream from the channel entrance region (Fig. 29 capture zone downstream of the channel entrance) and a channel constriction zone positioned between the channel entrance region and the capture zone (Para. 0085, Fig. 29: fluid flow feature 28 to narrow is positioned between the channel entrance and the capture zone 30), the channel constriction zone having a width and a length, the channel constriction zone width corresponding to a value in the range determined by (i) a minimum value that is equal to or greater than a diameter of a particulate reagent deposited on or to be deposited on the substrate wherein the diameter of the particulate reagent is between about 0.05-10 microns (0.00005-0.1 mm) ii) a maximum value that is less than about 0.825 mm. (Para. 0161-0162 funnel widths of 0.5 and 0.7mm falls within the claimed range). Chang et al teach each fluid flow channel n is identified by an integer between 1 and n (Fig. 1L (see annotated below): channels 1 through 4), and wherein fluid flow channel 1 (Fig. 1L (see annotated below) Channel 1) and fluid flow channel n (Fig. 1L (see annotated below)channel 4) each comprise an outer channel wall with a width w, and a barrier extension region positioned at the channel entrance region with a width of between about w, and about 10w (Fig. 1L (see annotated below): barrier extension region extends at a right angle from the outer channel wall and has a width equal to the channel wall width).
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Chang et al teach an embodiment where the channel fluid control feature 18 length to the length of the fluid flow channel ratio can be 0.1 to 0.5 (Para. 0080: reads on a ratio range of minimum value 10% to maximum value of 50%). Chang further teach the capture pathlength affect the completion time (Par. 0064-0065, 0163; Fig. 31-32). It is well known the lengths of the channel affects the flow completion time (Fig. 32). Chang is silent to the embodiment of the Fig. 29 of the length of the fluid constriction zone is (i) a minimum value that is equal to or greater than about 8% of the fluid flow channel length, and (ii) a maximum value that is equal to or less than about 75% of the fluid flow channel length (claim 3: (i) a minimum value that is equal to or greater than about 10% of the fluid flow channel length, and (ii) a maximum value that is equal to or less than about 65% of the fluid flow channel length). It is desirable to provide a length of the channel constriction zone to provide the adequate time for the desired reaction upstream of the constriction zone. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a minimum and maximum value for the length of the channel constriction zone is a result effective variable that gives the well known and expected results of providing control over the fluid flow upstream of the constriction zone and providing the above advantage of controlling the time for the desired reaction. In the absence of a showing of unexpected results, the Office maintains the choice of a fluid flow channel length and length of the channel constriction such that (i) a minimum value that is equal to or greater than about 8% of the fluid flow channel length, and (ii) a maximum value that is equal to or less than about 75% of the fluid flow channel length (claim 3: (i) a minimum value that is equal to or greater than about 10% of the fluid flow channel length, and (ii) a maximum value that is equal to or less than about 65% of the fluid flow channel length) (taught by the embodiment of the ratio of the lengths of 10% to 50% in Para. 0080) would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 4, Chang et al teach the channel constriction zone width is variable along the channel constriction zone length. (Fig. 29: constriction zone width tapers that reads on variable width)
Regarding claim 5, Chang et al teach the channel constriction zone includes a taper region at an entrance region into the channel constriction zone or at an exit region of the channel constriction zone.(Fig. 29: constriction zone width tapers at both entrance and exit region)
Regarding claim 6, Chang et al teach the taper region extends from the fluid flow channel width to the channel constriction zone width.(Fig. 29: constriction zone width tapers from the channel to the constriction zone width)
Regarding claim 7, Chang et al teach the channel constriction zone is non-angular along its length. (Para. 0085: fluid control feature is non-angular shape)
Regarding claim 8, Chang et al teach the particulate reagent is an optically detectable solid particle. (Para. 0155: europium particle fluorescence)
Regarding claim 12, Chang et al teach the entrance constriction region is positioned at the channel entrance region. (Fig. 29: constriction zone at sample receiving zone)
Regarding claim 13, Chang et al teach the entrance constriction region has a width and a length, wherein the entrance constriction region width is essentially the same as the channel constriction zone. (Fig. 29, Para. 0161: constriction zone at sample receiving zone same width as the second fluid control at the conjugate zone)
Regarding claim 21, Chang et al teach the substrate is nitrocellulose. (Para. 0075)
Regarding claims 22-24, Chang et al teach each capture zone comprises a different capture reagent; capture zone comprises a capture reagent for an infectious agent. (Para. 0139: different flow channels detect RSV, Flu A, Flu B)
Regarding claim 25, Chang et al teach the infectious agent is a Borrelia species. (Para. 0133)
Regarding claim 28, Chang et al teach each capture zone comprises a capture reagent to discriminate bacterial from viral infection. (Para. 0139: different flow channels detect RSV, Flu A, Flu B would indicate a viral infection, thus discriminate from a bacterial infection)
Regarding claim 30, Chang et al teach the capture reagent is a (i) monoclonal or a polyclonal antibody, (ii) a fragment of TRAIL, CRP, IL-10, RSAD2, MX1, MX2, NGAL, PCT or (iii) a fragment of an infectious agent. (Para. 0148 polyclonal antibody)
Regarding claim 31, Chang et al teach the substrate is a laminate comprising a hydrophobic material. (para. 0010: hydrophobic support layer)
Claim(s) 26-27, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (US 2018/0229232A1) in view of Cohen et al (US 2006/0137434).
Regarding claims 26-27, 29 Chang et al teach each capture zone comprises a capture reagent. Chang is silent the capture reagent is for a drug of abuse; the drug of abuse is selected from fentanyl, buprenorphine, oxycodone, and 7-aminoclonazepam; the reagents bind or interact with tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), C-reactive protein (CRP), interferon-gamma-induced protein-10 (IP-10), Radical S-Adenosyl Methionine Domain Containing 2 (RSAD2), MX dynamin like GTPase I (MXI or MxA), MX dynamin like GTPase 2 (MX2 or MxB), neutrophil gelatinase-associated lipocalin (NGAL), and procalcitonin (PCT).
Cohen et al teach a microfluidic device for detecting analytes including virus (influenza virus) or drugs of abuse (fentanyl) or c-reactive protein (Para. 0012). It is desirable to detect analytes that have medically relevant information, such as: viral infections, CRP to detect inflammation in your body, fentanyl to determine if patient is using illicit drugs.
Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the capture reagents of Chang et al for the capture reagents of Cohen to detect analytes such as fentanyl or c-reactive protein to provide the above advantage of providing medically relevant information such as inflammation (CRP) and illicit drug use (fentanyl).
Conclusion
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/Dennis White/Primary Examiner, Art Unit 1758
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