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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 – 4, 8 – 19, and 28 – 29 in the reply filed on 17 April 2026 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 169, 173, 176, 177, and 269
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 157
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “104” has been used to designate both “reagent cartridge” and “drive assembly”; “456” has been used to designate both “curved outer portion” and “upper portion.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 3, 19, and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stanwood et al (US 20170151564 A1).
With regards to claim 1, Stanwood et al teaches;
The claimed “a system” has been read on the taught ([0044], “…an instrument 1400…”);
The claimed “a reagent cartridge receptacle” has been read on the taught ([0044], “The cartridge 10 is loaded into an instrument 1400…”; A cartridge which can be loaded into an instrument reads on the instrument having a reagent cartridge receptacle.);
The claimed “an illumination assembly comprising an illumination source to emit an illumination light” has been read on the taught ([0106], “The instrument 1400 provides […] optical excitation of the assay elements (GNRs) 850 (FIG. 8A) in the cartridge 10.”; Providing optical excitation reads on an illumination source emitting an illumination light.);
The claimed “a sensor” has been read on the taught ([0050], “…the optical sensing system of the instrument 1400…”);
The claimed “a processor” has been read on the taught ([0124], “The instrument 1400 described herein and shown in FIG. 14 may be a computer-controlled device having the necessary electronics, computer processing power, interfaces, memory, hardware, software, firmware, logic/state machines, databases, microprocessors…”);
The claimed “a reagent cartridge receivable within the reagent cartridge receptacle” has been read on the taught ([0033], “…the multi-use assay cartridge 10 of the present disclosure…”);
The claimed “a well assembly, comprising: a body defining a well and having an opening, an aperture” has been read on the taught ([0036], “The top side of the reservoir layer 14 (FIG. 1) has wells or reservoirs for holding liquids of the assay… The bottom side also has through-holes (or vias) which allow liquids in the wells (on the opposite side) to pass through to the fluidic layer 20 below…”; The opening of the well reads on an aperture. The through-holes or vias read on an opening);
The claimed “a field of view (FOV) enabling optical access from the aperture to the well” and “wherein the illumination assembly is positioned to direct the illumination light through the aperture and the sensor is positioned to capture light” has been read on the taught ([0059], “The glass slide layer 22 (FIGS. 1,2) gives the fluidic layer 20 structural support and seals the lower side of the fluidic layer channels from the outside providing the bottom of the fluidic channels 800. It also provides an optical “window” for the measurement instrument to view the fluidic channels and to view the assay elements or GNRs and measure the fluorescence therefrom and determine the assay results.”);
The claimed “reagent contained within the well” has been read on the taught ([0035], “It also provides access holes for dispensing fluids into the cartridge, such as sample fluid and buffer fluid, to sample wells and buffer wells, as discussed more hereinafter.”; Sample fluid and buffer and fluid read on reagents contained within the well.);
The claimed “a cover coupled to the body and covering the opening” has been read on the taught ([0106], “The user then closes the instrument cover and presses a “GO” button on the instrument 1400”; the instrument cover reads on a cover coupled to the body.).
With regards to claim 2, the apparatus of claim 1 is anticipated by Stanwood et al.
The claimed “wherein a membrane is coupled to a surface of the body and a fluidic line is defined between the membrane and the body, further comprising a membrane valve that selectively controls a flow liquid between the well and the fluidic line” has been read on the taught ([0037], “The membrane layer 18, is a flexible sheet which acts as a diaphragm for the valves and pistons, and which has holes that allow liquids to pass between the reservoir layer 14 and the fluidic layer 20.”).
With regards to claim 3, the apparatus of claim 2 is anticipated by Stanwood et al.
The claimed “wherein the membrane defines an opening aligned with the aperture” has been read on the taught ([0037], “The membrane layer 18, is a flexible sheet which acts as a diaphragm for the valves and pistons, and which has holes that allow liquids to pass between the reservoir layer 14 and the fluidic layer 20.”).
With regards to claim 19, the apparatus of claim 1 is anticipated by Stanwood et al.
The claimed “wherein the sensor generates illumination data using the light captured and the processor processes the illumination data to determine a parameter value associated with the reagent contained within the well and wherein the parameter value comprises at least one of a moisture content value, an oxygen content value, or a concentration value of at least one component of the reagent” has been read on the taught ([0065], “The assay cartridge of the present disclosure may be used for quantifying antibody concentrations of the desired fluid samples.”; Quantifying antibody concentrations reads on a concentration value of at least one component of the regant.).
With regards to claim 28, Stanwood et al teaches;
The claimed “an apparatus” has been read on the taught ([0044], “…an instrument 1400…”);
The claimed “a body defining a well and having an opening, an aperture” has been read on the taught ([0036], “The top side of the reservoir layer 14 (FIG. 1) has wells or reservoirs for holding liquids of the assay… The bottom side also has through-holes (or vias) which allow liquids in the wells (on the opposite side) to pass through to the fluidic layer 20 below…”; The opening of the well reads on an aperture. The through-holes or vias read on an opening);
The claimed “a field of view (FOV) enabling optical access from the aperture to the well” and “wherein the illumination assembly is positioned to direct the illumination light through the aperture and the sensor is positioned to capture light” has been read on the taught ([0059], “The glass slide layer 22 (FIGS. 1,2) gives the fluidic layer 20 structural support and seals the lower side of the fluidic layer channels from the outside providing the bottom of the fluidic channels 800. It also provides an optical “window” for the measurement instrument to view the fluidic channels and to view the assay elements or GNRs and measure the fluorescence therefrom and determine the assay results.”);
The claimed “dry reagent contained within the well” has been read on the taught ([0065], “For example, for each assay within the assay strip 310, the detect analyte (DA) well 424 holds dehydrated detect analyte (DA), and the dye well 426 holds dehydrated dye (e.g., streptavidin)…”);
The claimed “a cover coupled to the body and covering the opening” has been read on the taught ([0106], “The user then closes the instrument cover and presses a “GO” button on the instrument 1400…”; The instrument cover reads on a cover.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4, 8, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Stanwood et al (US 20170151564 A1) in view of Giehring (US 20170016890 A1, cited on the IDS provided 06 January 2025).
With regards to claim 4, the apparatus of claim 1 is anticipated by Stanwood et al.
Stanwood et al further teaches the desirability of transparent portions of the device, as read on the taught ([0099], “If the rigid backing is not removed, it should be made of a material that is transparent to the wavelengths of light used by the instrument, to permit the instrument to perform the assay and read the assay results.”).
However, Stanwood et al does not explicitly disclose wherein the body comprises an inner portion and an outer portion and wherein the inner portion is substantially transparent and comprises the aperture, and the outer portion is substantially opaque.
In the analogous art of well assemblies, Giehring teaches;
The claimed “wherein the body comprises an inner portion and an outer portion and wherein the inner portion is substantially transparent and comprises the aperture, and the outer portion is substantially opaque” has been read on the taught ([0066], “…at least one well of the microplate a device which has an at least partly transparent structural element […] and wherein the base of the device, apart from the base area of the structural element, is opaque…”. The inner portion reads on the structural element. The outer portion reads on the base of the device.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microplate as taught by Stanwood et al with the two piece construction having different opacities as taught by Giehring. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Stanwood et al teaches a “base” device of a system including a well assembly. The prior art of Giehring teaches a “comparable” device of a well assembly with a transparent inner portion and an opaque outer portion, which has been improved in the same way as the claimed invention. One of ordinary skill in the art could have applied the known improvement technique of a two-part construction with different opacities for the predictable result of creating a well assembly with different inner and outer surface features and which controlled the transmission of light within the well assembly.
With regards to claim 8, the apparatus of claim 4 is obvious over Stanwood et al in view of Giehring.
Stanwood et al does not explicitly disclose wherein the inner portion comprises a flange and the outer portion is overmolded over the flange.
Giehring et al further teaches;
The claimed “wherein the inner portion comprises a flange” has been read on the taught ([0066], “…at least one well of the microplate a device which has an at least partly transparent structural element which is in the form of an upwardly tapering protrusion and the cross section of which can have any desired geometry…”; An upwardly tapering protrusion reads on a flange.);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the well assembly that is obvious over Stanwood et al in view of Giehring with the flange as taught by Giehring, for the predictable benefit of creating a device which prevents particles from interfering with excitation and emission light (Giehring, “[0064], “When selecting a suitable shape for the structural element, it must be ensured that particles do not interfere with the excitation and emission light. It is therefore particularly advantageous if the end of the structural element has a convex shape and the structural element is in the form of a protrusion which tapers upwards.”).
Regarding the limitation “the outer portion is overmolded over the flange,” this is held to be a product-by-process limitation. According to MPEP 2113(I), product-by-process claims are limited only by the structure implied by the steps.
In the case of the instant invention, Giehring et al teaches that a variety of joining methods are suitable for joining the base (read on the outer portion) to the structural element (read on the inner portion), including molding techniques ([0073], “The connection of the base to the microplate and the application of an opaque layer take place as described below in the same context.”; [0074], “The one-piece base having structural elements can be produced by shaping methods, for example by injection moulding methods, additive production methods (for example 3D printing) or thermoforming (hot forming, deep drawing or vacuum forming).”).
Giehring et al further teaches that the base may overlap the bottom portion of the structural element, as read on the taught ([0206], “The base (112) is connected to the side walls (108) and to the magnetic element (113) removably or non-removably.”; Figure 1c shows the bottom portion of the structural element being covered by the base).
Accordingly, the structure implied by “the outer portion is overmolded over the flange” is obvious over Stanwood et al in view of Giehring et al.
With regards to claim 15, the apparatus of claim 4 is obvious over Stanwood et al in view of Giehring.
Stanwood et al does not explicitly disclose wherein the inner portion and the outer portion are concentric.
Giehring et al further teaches the claimed “wherein the inner portion and the outer portion are concentric,” as read on the taught (See annotated figure 2a, below, showing concentric arrangement of parts)
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring with the concentric inner and outer portions as taught by Giehring. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Stanwood et al in view of Giehring teaches a “base” device of a well assembly. The prior art of Giehring further teaches a “comparable” device which has been improved in the same way by having a concentric inner and outer portion. One of ordinary skill in the art could have applied the known improvement technique to the well assembly of Stanwood et al in view of Giehring for the predictable benefit of allowing one camera device to align with both apertures.
With regards to claim 18, the apparatus of claim 4 is obvious over Stanwood et al in view of Giehring.
Stanwood et al does not explicitly disclose wherein the inner portion comprises a second aperture and the outer portion comprises a second tapered surface that redirects the FOV toward the second aperture.
Giehring further teaches;
The claimed “wherein the inner portion comprises a second aperture” has been read on the taught ([0202], “…a structural element (103) which has a measuring window (104) through which excitation light (105) passes into the detection region (106)…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring with the inner portion comprising an aperture as taught by Giehring, for the predictable result of allowing the excitation light to pass into the device as taught by Giehring ([0202], “…a structural element (103) which has a measuring window (104) through which excitation light (105) passes into the detection region (106)…”).
Regarding the limitation wherein “the outer portion comprises a second tapered surface that redirects the FOV toward the second aperture, this is held to be mere duplication of parts. According to MPEP 2144.04(VI)(B), “mere duplication of parts has no patentable significance unless a new and unexpected result is produced.”—see In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring with a second tapered surface to further control the light environment inside of the well.
Claims 9 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Stanwood et al (US 20170151564 A1) in view of Giehring (US 20170016890 A1, cited on the IDS provided 06 January 2025) as applied to claim 4 above, and further in view of Mar et al (US 20220168737 A1, effectively filed 01 December 2020).
With regards to claim 9, the apparatus of claim 4 is obvious over Stanwood et al in view of Giehring.
Stanwood et al does not explicitly disclose wherein the outer portion comprises a tapered surface that redirects the FOV toward the well.
Giehring et al further teaches that the side walls of the device (reading on the outer portion) may be curved or straight ([0193], “The measuring chamber can have round or straight side walls.”).
However, neither Stanwood et al nor Giehring explicitly disclose wherein the outer portion comprises a tapered surface that redirects the FOV toward the well.
In the analogous art of reagent well design, Mar et al teaches;
A well assembly, as read on the taught ([0090], “FIG. 3 is a partial cross-sectional isometric view of an implementation of the well assembly 124…”);
The claimed “wherein the outer portion comprises a tapered surface that redirects the FOV toward the well” has been read on the taught ([0092], “The body 126 also includes an inward tapered surface 218 that extends toward the port 134 and defines the well 128. The inward tapered surface 218 encourages fluid to flow toward the port 134.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the well assembly of Stanwood et al in view of Giehring with the tapered outer section as taught by Mar et al, for the predictable benefit of allowing fluid to settle at the lowest point of the tapered region.
With regards to claim 10, the apparatus of claim 9 is obvious over Stanwood et al in view of Giehring and further in view of Mar et al.
Stanwood et al further teaches;
The claimed “wherein the reagent within the well is within the FOV” has been read on the taught ([0106], “The instrument 1400 locates the fluidic channels and the GNRs 850 and optically scans the GNRs 850 and measures the fluorescence and provides the assay results to the user.”).
With regards to claim 11, the apparatus of claim 9 is obvious over Stanwood et al in view of Giehring and further in view of Mar et al.
Neither Stanwood et al nor Mar et al explicitly disclose wherein the inner portion comprises a second aperture and the outer portion comprises a second tapered surface that redirects the FOV toward the second aperture.
Giehring further teaches;
The claimed “wherein the inner portion comprises a second aperture” has been read on the taught ([0202], “…a structural element (103) which has a measuring window (104) through which excitation light (105) passes into the detection region (106)…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring in view of Mar et al with the inner portion comprising an aperture as taught by Giehring, for the predictable result of allowing the excitation light to pass into the device as taught by Giehring ([0202], “…a structural element (103) which has a measuring window (104) through which excitation light (105) passes into the detection region (106)…”).
Regarding the limitation wherein “the outer portion comprises a second tapered surface that redirects the FOV toward the second aperture, this is held to be mere duplication of parts. According to MPEP 2144.04(VI)(B), “mere duplication of parts has no patentable significance unless a new and unexpected result is produced.”—see In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring in view of Mar et al with a second tapered surface to further control the light environment inside of the well.
With regards to claim 12, the apparatus of claim 11 is obvious over Stanwood et al in view of Giehring and further in view of Mar et al.
Neither Stanwood et al in nor Mar et al explicitly disclose wherein a headspace within the well is within the FOV.
Giehring further discloses;
The claimed “wherein a headspace within the well is within the FOV” has been read on the taught (See annotated figure 2a below, which shows a headspace within the well aligned with the window);
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring and further in view of Mar et al with the headspace located within a field of view as taught by Giehring, for the predictable benefit of allowing different volumes of liquid to be view and accommodated within the well according to different applications.
With regards to claim 13, the apparatus of claim 11 is obvious over Stanwood et al in view of Giehring and further in view of Mar et al.
Regarding the limitation “wherein the body comprises a base that includes the aperture and the second aperture,” this limitation is held to be a case of making components integral with one another. According to MPEP 2144.04(V)(B), making components integral may be prima facie obvious when there is an obvious matter of engineering choice; please see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring and further in view of Mar et al to have a base comprising the aperture and second aperture, for the predictable benefit of a uniform and stable platform on which to include the tapering outer portions.
With regards to claim 14, the apparatus of claim 11 is obvious over Stanwood et al in view of Giehring and further in view of Mar et al.
Neither Stanwood et al nor Mar et al explicitly disclose wherein a central axis of the aperture and a central axis of the second aperture are substantially parallel.
Giehring further teaches;
The claimed “wherein a central axis of the aperture and a central axis of the second aperture are substantially parallel” has been read on the taught (See annotated figure 2a below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Stanwood et al in view of Giehring and further in view of Mar et al with the apertures aligned according to their central axis as taught by Giehring. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Stanwood et al in view of Giehring and further in view of Mar et al teaches a “base” device having two apertures. The prior art of Giehring further teaches a “comparable” device which has been improved in the same way by having substantially aligned apertures. One of ordinary skill in the art could have applied the known improvement technique to the well assembly of Stanwood et al in view of Giehring and further in view of Mar et al for the predictable benefit of allowing one camera device to align with both apertures.
Allowable Subject Matter
Claims 16, 17, and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art teaches both stacked openings/apertures. In the case of prior art Eom In Yong, the well teaches apertures positioned in the sides of the well. Webster et al teaches the use of fiber optic sensors that are inserted in the well.
In the case of claims 16 and 17, there is no teaching wherein two tapered surfaces direct light between two apertures within the construction of a well. In the case of claim 29, there is no teaching of a second orthogonal aperture, or a tapered surface directing a field of view between the first and second aperture.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eom In Yong (KR 102211398 B1, cited on the IDS provided 09 September 2023) teaches a reagent well which has a window with two apertures located on the sides of the well.
Webster et al (US 20140011266 A1) teaches the use of fiber-optic sensing within well assemblies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
Prosecution Insights