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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/13/23, 10/30/25, 6/17/26 is being considered by the examiner.
Election/Restrictions
Claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (method), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/17/26.
Applicant's election with traverse of claims 1-10 in the reply filed on 6/17/26 is acknowledged. The traversal is on the ground(s) that the methods 11-14 uses the device of claim 1. This is not found persuasive because the claims directed to the method require the methods steps whereas the device claims only require enabling the method steps.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-10 are pending and are examined. Claims 11-14 are withdrawn and are not examined.
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 1, 3, 7, 8, 9, and 10 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 Claims 1 and 7, “the measurement chamber” is unclear and indefinite. Please clarify this limitation to “the at least one measurement chamber”.
Regarding Claim 1, the limitation “on the one hand…on the other hand” is an indefinite expression. Please clarify what the applicant intends by this limitation.
Regarding Claim 3, the limitation “called distributions below” is an indefinite expression. Please clarify what the applicant intends by this limitation.
Regarding Claim 7, the limitation “in particular” is an indefinite expression. Please clarify what applicant intends by this limitation.
Regarding Claims 8, 9, and 10, the limitation “advantageously” is an indefinite expression. Please clarify what the applicant intends by this limitation.
Claims 2, 4, 5, 6, and 10 are rejected by virtue of being dependent on a rejected base claim.
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 patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ymeti (2012/0214707).
Regarding Claim 1, Ymeti teaches an electronic device (1) for analyzing an analyte (2) present in a fluid, characterized in that it comprises: -
a consumable and interchangeable sensor (10) comprising i) a photonic chip (12) comprising at least one measurement chamber (11) comprising a light guide (13) in which temporary receptors (14) capable of interacting with the analyte present in the fluid are arranged, the interaction causing a local property change, the light guide (13) comprising a light inlet (135) and a light outlet (136) ([0138] The (bio-)sensor device comprises a (portable) measurement system POD and a lab-on-a-chip (LOC) system. The LOC, an embodiment of which being depicted in FIG. 10A, comprises an inlet INL, a fluid supply (in this example comprising a (micro-)fluidic cuvette FCV), a sensing part SRG comprising the measurement and reference regions and in most instances completed by an outlet OTL for disposing the fluid or disposing air or other gas as a result of a supply of the sample into the sensing part. The (micro-)fluidic part may also in part or in full be comprised in the portable measurement system.), and
ii) a cap (15) integral with the photonic chip and comprising an opening (16a, 16b) suitable for admitting fluid into the measurement chamber and for discharging fluid from the measurement chamber (cover COV layer (see the side view of the waveguide structure WGS depicted in FIG. 1B, COV in Fig. 1, inlet and out in Fig. 10A);
a sensor support (50) comprising a housing (51) in which the sensor is intended to be placed in a reversible manner (Fig. 9);
a closing element (60) cooperating with the sensor support to encapsulate the sensor (See Fig. 9);
a local property change transducer, the change being caused by the interaction between the receptors and the analyte, capable of converting the local property change into an electronic signal expressing the local property change, this transducer comprising: - a coherent light source (130 ([0084] FIG. 1A depicts a top view of a general schematic of an interferometric based sensor. In an interferometric based sensor, light beam from a (monochromatic) light source LSO, e.g. a laser), on the one hand, capable of emitting a coherent light beam (129) into the light guide of the photonic chip, and, on the other hand, positioned on the cap of the sensor or on the closing element;
an optical detector (131) arranged facing the light outlet of the light guide and capable of measuring an optical parameter of the light beam according to the local property change, at the outlet of the light guide (In a waveguide structure WGS, usually consisting of three layers, i.e. substrate SUB, core COR and cover COV layer (see the side view of the waveguide structure WGS depicted in FIG. 1B), guiding of the light is performed due to appropriate refractive index contrast between the core layer and the cladding (substrate SUB and cover COV layers indicated in FIG. 1B).
Regarding Claim 2, Ymeti teaches the device according to claim 1, wherein the light guide (13) comprises at least one branch (137) comprising a reference arm (132) in which a part of the light beam emitted by the light source is intended to be guided by total internal reflection, and a measurement arm (133) in which another part of the light beam emitted by the light source is intended to be guided by total internal reflection and in which the receptors (14) are arranged, the reference arm (132) and the measurement arm (133) being recombined into an interference arm (134) into which a resulting light beam which results from recombining the part of the light beam guided into the reference arm and the other part of the light beam guided into the measurement arm is intended to be guided, and wherein the radiant power of the resulting light beam guided into the interference arm (134) is equal to or greater than 0.2 µW ([0084] Fig. 1A depicts a top view of a general schematic of an interferometric based sensor. In an interferometric based sensor, light beam from a (monochromatic) light source LSO, e.g. a laser, is usually coupled to an optical (channel) waveguide structure WGS. In a waveguide structure WGS, usually consisting of three layers, i.e. substrate SUB, core COR and cover COV layer).
Regarding Claim 3, Ymeti teaches the device according to claim 2, wherein the resulting light beams are issued from interference arms of the branches, these interference arms possibly being divided at least once into sub-arms, producing a matrix of specific light intensity distributions (points) (called "distributions" below), in the optical detector, each distribution preferably being represented by a light spot in grayscale ([0133] Furthermore, the intensity distribution of the interference pattern, e.g. between different excited modes in the multimode structure of a MMI based sensor could be used as extra additional information to monitor binding events occurring on the sensing regions on top of the MMI multimode structure. Upon binding of a specific analyte onto a given sensing region, the intensity distribution will be locally changed. As this change depends on the analyte concentration, imaging of the intensity distribution in the MMI multimode structure could allow on-line monitoring of this intensity change and consequently may enable estimation of the analyte concentration.).
Regarding Claim 4, Ymeti teaches the device according to claim 1, wherein the light source is positioned on the cap of the sensor and comprising - electronic traces (128) etched on the cap on which the light source is arranged, - an electronic circuit (127) on the closing element, and - an electric contactor (126) enabling the electronic traces to be connected to the electronic circuit in order to supply power to the light source ([0147] In the measurement system, different components of the (optical) set-up, which are used to read-out the LOC system, such as the light source, e.g. a laser diode; incoupling optics, e.g. polarizer, lenses, feedback system for automated light coupling into the optical chip, e.g. a piezo system, and/or a fibre-to-chip coupling system; chip holder; fluid supply, whether or not coupled to a (micro-)fluidic pump, to add fluid to the sensing regions/windows of specific chip channels; a detector, e.g. a CCD camera (including components used to obtain an optimal outcoupling of the light from the optical chip to the CCD array chip, such as lenses, filters or matching oil that could be used when the CCD chip can be mounted onto the optical chip endface), single board computer, touchscreen, electronic circuit and power supply can be integrated into the measurement system (see FIG. 11).).
Regarding Claim 5, Ymeti teaches the device according to claim 1, wherein the light source is positioned on the closing element, and comprising an optical system that preferably comprises at least one lens, which is intended to collimate the light beam ([0147] In the measurement system, different components of the (optical) set-up, which are used to read-out the LOC system, such as the light source, e.g. a laser diode; incoupling optics, e.g. polarizer, lenses, feedback system for automated light coupling into the optical chip, e.g. a piezo system, and/or a fibre-to-chip coupling system; chip holder; fluid supply, whether or not coupled to a (micro-)fluidic pump, to add fluid to the sensing regions/windows of specific chip channels; a detector).
Regarding Claim 6, Ymeti teaches the device according to claim 1, wherein the sensor comprises protection for the temporary receptors which is configured to be active before the sensor is placed into the housing of the sensor support and to be deactivated by the placement of the sensor into the housing of the sensor support ([0090] A further embodiment is illustrated with reference to FIG. 2C. In a further measuring scheme, an additional second reference region RRG 2 pre-coated e.g. with Protein A may be further coated with `clean` serum sample. Coating with Protein A here may have a similar purpose as in the case of the measurement region MRG and reference region RRG, such as to reduce the non-specific binding to the sensor surface and/or to proper orientate the receptor molecules.).
Regarding Claim 7, Ymeti teaches the device according to claim 1, wherein the cap 150 defining the measurement chamber 110 is arranged below the photonic chip 120 and, in particular, below its functionally active lower surface 121, which faces the measurement chamber 110 ([0142] The holder may be designed such that, upon positioning of the (micro-)fluidic cuvette on top of the optical chip (see a schematic example of each component of the LOC system and the integrated system in FIG. 10.B), the fluidic channels of the cuvette are properly aligned with respect to the sensing regions/windows that are realized on the optical chip. To do so, the holder can be etched or otherwise configured in such a way that the (micro-)fluidic cuvette can be positioned on it as shown in FIG. 10.B. The optical chip can be positioned at the bottom of the etched structure of the (plastic) holder, e.g. by etching a channel that is slightly wider than the optical chip. In that way, lateral positioning of the optical chip can be obtained. The positioning along the other direction, which may be less critical, can be arranged with respect to the endface of the (plastic) holder.).
Regarding Claim 8, Ymeti teaches the device according to claim 3, equipped with means enabling a 1st calibration method to be carried out, advantageously implemented by computer, at least during the first detection ([0147] A computer board, which may be used for data collection and analysis, is an inexpensive solution that can perform overall sensor device control. In another configuration, a personal digital assistant (PDA) may also be used to perform the device operation, which may result in a more compact measurement system e.g. having lower power consumption. The measurement system can be battery-operated to enable stand-alone operation.)
this 1st method essentially consisting of: (i.1) identifying the light spot having the highest grayscale, on the matrix of distributions (points) made of light spots in grayscale, contained in an image that is formed in the optical detector; (ii.1) taking this light spot as a reference; (iii.1) adjusting the exposure time of the optical detector, i.e. the duration during which the optical detector measures the specific light intensity distributions, such that the referent light spot has a grayscale Ng at least equal to a predetermined grayscale Ng°, or included within a grayscale range [Ngi - Ng2] (the computer of Ymeti would be capable of enabling these method steps).
Regarding Claim 9, Ymeti teaches the device according to claim 3 at least one of claims 3 to 8 equipped with means enabling a 2nd calibration method to be carried out, advantageously implemented by computer, at least during the first detection ([0147] A computer board, which may be used for data collection and analysis, is an inexpensive solution that can perform overall sensor device control. In another configuration, a personal digital assistant (PDA) may also be used to perform the device operation, which may result in a more compact measurement system e.g. having lower power consumption. The measurement system can be battery-operated to enable stand-alone operation.), this 2nd method essentially consisting of: (i.2) identifying the light spot having the highest grayscale, in the matrix of distributions (points) made of light spots in grayscale, contained in an image that is formed in the optical detector; (ii.2) taking this light spot as a reference; (iii.2) adjusting the exposure time of the optical detector, i.e. the duration during which the optical detector measures the specific light intensity distributions, such that the referent light spot has a grayscale Ng at least equal to a predetermined grayscale Ngmax, corresponding to the upper limit of a grayscale range [Ng10-Ng20]; (iv.2) and, when Ng = Ngmax, repeating the same detection, i.e. the same measurement, several times to obtain several matrices of light intensity distributions (points), contained in (x) images; (v.2) measuring Ng in each of these (x) images; (vi.2) if Ng = Ngmax = Ngx, in these (x) images, then the corresponding exposure time is saved for the following measurements (the computer of Ymeti would be capable of enabling these method steps).
Regarding Claim 10, Ymeti teaches the device according to claim 3, equipped with means enabling a 3rd calibration method to be carried out, advantageously implemented by computer, at least during the first detection ([0147] A computer board, which may be used for data collection and analysis, is an inexpensive solution that can perform overall sensor device control. In another configuration, a personal digital assistant (PDA) may also be used to perform the device operation, which may result in a more compact measurement system e.g. having lower power consumption. The measurement system can be battery-operated to enable stand-alone operation.)
this 3rd method essentially consisting of: (i.3) identifying and locating each light spot constituting the matrix contained in an image, preferably rectangular, forming in the optical detector, by means of the center of the light spot, in a coordinate system XY of which the origin is a given point in the image, preferably one of the corners of the image when the image is rectangular, the matrix thus being composed of Xn rows of Ym light spots; (ii.3) identifying the most luminous light spot T1 'of the image, in a row Xn=b*; (iii.3) tracing a scan line passing through the center of this most luminous spot while also being parallel to the Y axis in an image having a rectangular shape; (iv.3) carrying out, at this scan line, angular scanning by rotation around the center of the most luminous spot, according to an +alpha/-alpha angle, forming an angular sector comprising a line parallel to the Y axis; (v.3) obtaining the angle of rotation (alpha C) in which the scan line intersects Ym-1 light spots of row Xn=b*; (vi.3) for each of Xn-1 lines of Y m light spots, __(vi.3.1) identifying the most luminous light spot of the row, in each row Xn≠b*, __(vi.3.2) tracing a scan line passing through the center of this most luminous spot while also being parallel to the Y axis in an image having a rectangular shape, (vi.3.3) carrying out, at this scan line, angular scanning by rotation around the center of the most luminous spot, according to the angle (alpha C), in order to find the line intersecting Ym-1 light spots of row Xn≠b*, and more specifically to find these Ym-1 light spots of row Xn≠b**; (vii.3) obtaining the coordinates (X,Y) of [Xn x Ym] light spots constituting the matrix, and that are contained in the image forming in the optical detector; (viii.3) storing these coordinates in memory; (ix.3) and using these coordinates to read the resulting light beams in the context of the method according to the invention of analyzing an analyte present in a fluid, by means of the device according to the invention (the computer of Ymeti would be capable of enabling these method steps).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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