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 .
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, Applicant recites “wherein the assay surface does not contain electrodes” in line 10. The Examiner has reviewed pages 30-34 and figures 12-15 of the instant specification and has not identified sections that support the limitation.
Examiner notes that although the specification does not explicitly state an electrode it does disclose within page 30 of the specification a TSH assay and exemplary assay processing units (APUs) are disclosed. Both TSH and APUs utilize electrodes. Therefore the present invention does not disclose the newly amended recitation “wherein the assay surface does not contain electrodes”. Barring evidence showing otherwise, the limitation is not supported by the instant disclosure and is considered new matter. Appropriate correction is required.
Claims 2-24 depends on claim 1 and therefore is also rejected.
Claim Rejections - 35 USC § 102
Claims 1-12, 15-17, and 19-24, are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Huff et. al. (US 20180095067 A1).
Regarding claim 1, Huff teaches “An assay surface (AS) for analysis of an analyte of interest in a sample,” (Abstract, Paras [0032] and [0041], Title, Devices and methods for sample analysis. Integrated microfluidic and analyte detection devices are disclosed, along with methods of detecting target analytes. Digital microfluidic and analyte detection devices include a first substrate.); “comprising: a sample processing component configured to process the sample for detection,” (Para [0134], array of wells (where one or more wells of the array are of sufficient size to accommodate the at least one solid support); “wherein the sample processing component comprises a plurality of sample preparation regions, including at least one wash region configured to hold a volume of liquid” (Para [0173], Optionally, the solid support may be contacted with a wash buffer to remove any molecules non-specifically bound to the solid support. Para [0318], Such figures may include chambers for holding sample, wash buffers, binding members, enzyme substrates, waste fluid, etc.); “and at least one storage region configured to hold a plurality of solid supports,” (Paras [0105], [0593- 0595], and FIG. 27B, location of capture microparticles and microparticles. “Bead” and “particle” are used herein interchangeably and refer to a substantially spherical solid support. The microparticles are deposited in the wells by using either gravity (passive loading) or a magnet (active loading).).
The recitation “configured to hold a plurality of solid supports “ is capability of the storage region to hold things. Huff discloses the positively claimed structural elements of the storage region as claimed, such storage region is said to be fully capable of the recited adaption in as much as recited and required herein.
In addition, “wherein the plurality of solid supports is moveable through the plurality of sample preparation regions under a magnetic force;” is capability function of the plurality of solid supports which are not positively claimed. Additionally, this recitation is a capability of the storage region to hold the solid supports. Huff discloses the positively claimed structural elements of the storage region as claimed, such storage region is said to be fully capable of the recited adaption in as much as recited and required herein.
Further taught “and a detection component” (Paras [0547], FIG. 13A illustrates a side view of a sample preparation component positioned adjacent to an analyte detection component. As shown in FIG. 13A, the sample preparation component includes a superstrate 810. The superstrate 810 includes a series of phononic structures 830.). The recitation “configured to receive the plurality of solid supports by the magnetic force and to detect a presence of the analyte or determine a level or concentration of the analyte” is capability of the detection component. Huff discloses the positively claimed structural elements of the detection component as claimed, such detection competent is said to be fully capable of the recited adaption in as much as recited and required herein. In addition Huff teaches the capability with (Paras [0494], [0531], and [0105], The same example, the device includes an analyte detection component configured to receive the propagated liquid and perform analyte detection on the received liquid. The analyte detection component may include an array of wells in which molecules, particles, beads, or cells may be isolated for analyte or biological sample detection purpose. “Bead” and “particle” are used herein interchangeably and refer to a substantially spherical solid support.).
Further taught by Huff is “wherein the assay surface does not contain electrodes” (The assay surface taught within the remaining of claim 1 above does not contain electrodes as taught within Huff above).
Regarding claim 2, Huff teaches all of claim 1 as above. The recitation “wherein the plurality of solid supports comprises magnetic or paramagnetic microparticles or beads.” is not attributed patentable weight as the solid supports are not positively recited. The claimed surface has a storage region configured to hold a plurality of solid supports. Huff teaches this. Huff discloses the positively claimed structural elements of the storage region as claimed, such storage region is said to be fully capable of the recited adaption in as much as recited and required herein. However, Huff also teaches (Paras [0134] and [0593], the capture microparticles consists of a suspension of solid-phase magnetic microparticles. The method includes providing a first liquid droplet containing an analyte of interest, providing a second liquid droplet containing at least one solid support (such as, for example, a magnetic solid support (such as a bead)).
Regarding claim 3, Huff teaches all of claim 1 as above. The recitation “wherein at least one of the plurality of solid supports specifically binds to the analyte of interest or at least one reagent or conjugate.” is a functional recitation which is interpreted as a capability of the plurality of solid supports which are not positively claimed. Applicant positively recites a storage region to hold the solid supports. Huff discloses the positively claimed structural elements of the storage region as claimed, such storage region is said to be fully capable of the recited adaption in as much as recited and required herein. However, taught within para [0593], is that the capture microparticles consist of a suspension of solid-phase magnetic microparticles). Additionally taught within Para [0599], a specific antigen to be analyzed is mixed with magnetic microparticles (2).
Regarding claim 4, Huff teaches all of claim 1 as above in addition to “wherein the sample processing component further comprises the plurality of solid supports in the at least one storage region.” (Para [0134], array of wells (where one or more wells of the array are of sufficient size to accommodate the at least one solid support).
Regarding claim 5, Huff teaches all of claim 1 as above in addition to “wherein the sample processing component further comprises at least one mixing region configured to mix the plurality of solid supports, the analyte of interest, and at least one reagent or conjugate.” (Para [0134], The method includes providing a first liquid droplet containing an analyte of interest, providing a second liquid droplet containing at least one solid support (such as, for example, a magnetic solid support (such as a bead)) which contains a specific binding member that binds to the analyte of interest, using energy to exert a force to manipulate the first liquid droplet (which contains the analyte of interest) with the second liquid (containing the at least one solid support) to create a mixture, moving all or at least a portion of the mixture to an array of wells (where one or more wells of the array are of sufficient size to accommodate the at least one solid support), adding at least one detectable label to the mixture before, after or both before or after moving a portion of the mixture to the array of wells and detecting the analyte of interest in the wells.). Therefore the detectable label teaches to the reagent or conjugate.
Regarding claim 6, Huff teaches all of claim 5 as above in addition to “wherein the sample processing component further comprises the at least one reagent or conjugate in the at least one mixing region.” (Para [0134], The method includes providing a first liquid droplet containing an analyte of interest, providing a second liquid droplet containing at least one solid support (such as, for example, a magnetic solid support (such as a bead)) which contains a specific binding member that binds to the analyte of interest, using energy to exert a force to manipulate the first liquid droplet (which contains the analyte of interest) with the second liquid (containing the at least one solid support) to create a mixture, moving all or at least a portion of the mixture to an array of wells (where one or more wells of the array are of sufficient size to accommodate the at least one solid support), adding at least one detectable label to the mixture before, after or both before or after moving a portion of the mixture to the array of wells and detecting the analyte of interest in the wells.). Therefore the detectable label teaches to the reagent or conjugate in the at least one mixing region.
Regarding claim 7, Huff teaches all of claim 5 as above in addition to “wherein the at least one mixing region has a volume capacity of about 25µL or less.” (Paras [0593-594], addition of the volume solution total µL droplets leading up to the mixing and what is added in the mixing region is less than 25µL). Therefore, the mixing region holds the microliter droplets which are between 0 and 25 µL which would allow them to have a capacity of about 25 µL.
Regarding claim 8, Huff teaches all of claim 5 as above. The recitation “wherein at least one reagent is selected from a group consisting of a detectable label, a binding member, a dye, a surfactant, a diluent, and a combination thereof.” is a recitation that is not part of the analyte surface being claimed. The assay surface includes a mixing region configured to mix . . . at least one reagent. Huff discloses the positively claimed structural elements of the sample processing component as claimed, such sample processing component are said to be fully capable of the recited adaption in as much as recited and required herein. Further, claim 5 claims to have either “at least one reagent or conjugate” so the reagent is not a requirement of the claims. However, Huff does teach a detectable label as a reagent (Claim 11, The device of claim 10, wherein the reagent comprises a detectable label having a cleavable tag.).
Regarding claim 9, Huff teaches all of claim 8 as above. The recitation “wherein the binding member comprises a receptor or an antibody.” is not part of the assay surface claimed. Huff discloses the positively claimed structural elements of the sample processing component as claimed, such sample processing component are said to be fully capable of the recited adaption in as much as recited and required herein. Further, claim 8 claims to the reagent is selected from a group consisting of “detectable label, a binding member, a dye, a surfactant, a diluent, and a combination thereof” which is dependent on claim 5 which does not require a reagent. However, Huff does teach a receptor (Para {0125-0127], receptor) and an antibody (Para [0583], anti-beta TSH capture antibody.).
Regarding claim 10, Huff teaches all of claim 5 as above. The recitation “wherein the at least one wash region is configured to wash off any molecules not bound to any solid supports.” is capability of the wash region. Huff discloses the positively claimed structural elements of the wash region as claimed, such wash region are said to be fully capable of the recited adaption in as much as recited and required herein. However Huff does teach washing off molecules not bound to solid supports (Para [0173], Optionally, the solid support may be contacted with a wash buffer to remove any molecules non-specifically bound to the solid support.).
Regarding claim 11, Huff teaches all of claim 10 as above in addition to “wherein the at least one wash region has a volume capacity of about 10 µL or less.” (Para [0593] volumes leading up to washing and washing are approximately 1-2 μl of sample, 1-2 μl of microparticles, followed by 1-3 washes of 1-2 μl wash buffer (PBS, 0.1% surfactant) from wash buffer 1 reservoir.). Therefore, the total volumes prior to washing and including washing are as low as 3μl and as high as 10 μl which would require the volume capacity of the washing region to be about 10 μl or less.
Regarding claim 12, Huff teaches all of claim 1 as above in addition to “wherein the assay surface comprises a plurality of channels, wherein each of the plurality of channels is in between a first and second sample preparation regions.” (Paras [0306] and [0303], Sample preparation module and the detection module may include a series or plurality of electrodes for moving liquid droplets. The second substrate may extend over the first and second portions of the first substrate. In such an embodiment, the second substrate may be substantially transparent, at least in region overlaying the array of wells. In other cases, the second substrate may be disposed in a spaced apart manner over the first portion of the first substrate and may not be disposed over the second portion of the first substrate. Thus, in certain embodiments, the second substrate may be present in the sample preparation module but not in the detection module.). Therefore, the first sample preparation region is the first part of the first substrate and the second sample preparation region is the second substate within the sample preparation module and the electrodes are the channels.
Regarding claim 15, Huff teaches all of claim 10 as above. The recitation ”wherein after passing the at least one wash region, the plurality of solid supports is moved into the detection component under the magnetic force.” is intended use of the device. Huff discloses the positively claimed structural elements within the claim and the device is to be fully capable of the recited adaption in as much as recited and required herein. However, further taught (Para [471], Following the wash step, a droplet containing the labeled beads which has a complex of the first binding member, analyte of interest and the second binding partner may be moved over to the detection module (such as by removal of the magnetic force if magnetic beads are used). As explained herein, the immunoassay may be carried out in the sample preparation module. The labeled beads may be allowed to settle into the array of wells in the detection module. The beads may settle using gravitational force or by applying electric or magnetic force.).
Regarding claim 16, Huff teaches all of claim 1 as above in addition to “wherein the detection component is configured for optical detection, analog detection, or digital detection.” (Para [0302], In certain cases, the detection module includes the array of wells that are optically interrogated to measure a signal related to the amount of analyte present in the sample.)
Regarding claim 17, Huff teaches all of claim 1 as above in addition to “wherein the detection component comprises an array of element, wherein each of the array of element is dimensioned to hold at least a single one of the plurality of solid supports.” (Para [0300], [0043], [0114], The analyte detection module may include an array of wells in which an analyte related signal is detected. In certain embodiments, the detection module may include an array of wells in a first substrate (e.g., upper substrate) which is disposed over a second substrate (e.g., lower substrate) separated by a gap. In these embodiments, the array of wells is in an upside-down orientation. In certain embodiments, the detection module may include an array of wells in a second substrate (e.g., lower substrate) which is disposed below a first substrate (e.g., upper substrate) separated by a gap. “Microparticle(s)(s)” and “microbead(s)” are used interchangeably herein and refer to a microbead or microparticle that is allowed to occupy or settle in an array of wells, such as, for example, in an array of wells in a detection module.)
Regarding claim 19, Huff teaches all of claim 1 as above in addition to “wherein the detection component further comprises a region comprising a volume of an inert liquid,” (Para [0417] and [0515], The microfluidics device and/or the microfluidics module may include an inert fluid that is immiscible with the sample droplet and the reagent droplets. For example, the inert fluid may be a heavy fluid that is denser than water, such as oil. Exemplary inert fluids include polar liquids, silicone oil, fluorosilicone oil, hydrocarbons, alkanes, mineral oil, and paraffin oil. The device may be filled with a filler fluid which may be air, inert gases, hydrophobic liquids, hydrophilic liquids, oils. The recitation “wherein the inert liquid is configured to seal the array of nanowells.” is capability of the inert liquid. Huff discloses the positively claimed structural elements of the inert liquid as claimed, such inert liquid are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 20, Huff teaches all of claim 19 as above in addition to “wherein the inert liquid comprises an oil.” (Para [0417], The microfluidics device and/or the microfluidics module may include an inert fluid that is immiscible with the sample droplet and the reagent droplets. For example, the inert fluid may be a heavy fluid that is denser than water, such as oil.).
Regarding claim 21, Huff teaches all of claim 1 as above. The recitation “wherein after the plurality of solid supports is moved into the detection component,” is intended use of the device. Huff discloses the positively claimed structural elements within the claim and the device is to be fully capable of the recited adaption in as much as recited and required herein. However, further taught (Para [0114] “Microparticle(s)(s)” and “microbead(s)” are used interchangeably herein and refer to a microbead or microparticle that is allowed to occupy or settle in an array of wells, such as, for example, in an array of wells in a detection module.). The recitation “the detection component is configured to obtain images of the array of elements.” is capability of the detection component. Huff discloses the positively claimed structural elements of the detection component as claimed, such detection component are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 22, Huff teaches all of claim 1 as above. The recitation “wherein the detection component is configured for single-molecule counting.” is capability of the detection component. Huff discloses the positively claimed structural elements of the detection component as claimed, such detection component are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 23, Huff teaches all of claim 1 as above in addition to “wherein the assay surface comprises a hydrophobic material.” (Para [0300], the array of wells including the region in between the wells may be hydrophobic.)
Regarding claim 24, Huff teaches all of claim 1 as above in addition to “wherein the assay surface further comprises a plurality of volumes of liquids,” (Para [0515], the sample preparation component may also include buffer or wash fluids. These buffer or wash fluids may facilitate the propagation of liquids across the sample preparation component and onto the detection component. In other instances, these fluids may be used to wash away any remaining liquid or biological samples once they have being positioned into the well array. Examples of such fluids include air, inert gases, hydrophobic liquids, hydrophilic liquids, oils, organic-based solvents, and high-density aqueous solutions. In certain cases, the device may be filled with a filler fluid which may be air, inert gases, hydrophobic liquids, hydrophilic liquids, oils, organic-based solvents, and high-density aqueous solutions.); “a plurality of solid supports,” (Paras [0105] and [0136], “Bead” and “particle” are used herein interchangeably and refer to a substantially spherical solid support. In certain embodiments, after the at least one solid supports are loaded into the wells, any solid supports that are not loaded into a well can be removed using routine techniques known in the art.); “and at least one reagent or conjugate in the plurality of sample preparation regions.” (Para [0134], The method includes providing a first liquid droplet containing an analyte of interest, providing a second liquid droplet containing at least one solid support (such as, for example, a magnetic solid support (such as a bead)) which contains a specific binding member that binds to the analyte of interest, using energy to exert a force to manipulate the first liquid droplet (which contains the analyte of interest) with the second liquid (containing the at least one solid support) to create a mixture, moving all or at least a portion of the mixture to an array of wells (where one or more wells of the array are of sufficient size to accommodate the at least one solid support), adding at least one detectable label to the mixture before, after or both before or after moving a portion of the mixture to the array of wells and detecting the analyte of interest in the wells.). Therefore the detectable label teaches to the least one reagent or conjugate.
Claim Rejections - 35 USC § 103
Claims 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Huff et. al. (US 20180095067 A1) as applied to claims 12 and 17 above.
Regarding claim 13, Huff teaches all of claim 12 as above in addition to “wherein the assay surface comprises a plurality of stopping elements,” (Paras [0106], [0221], [0492], “Component,” “components,” or “at least one component,” refer generally to a stop solution, and the like that can be included in a kit for assay of a test sample. A solid support may also comprise a protective, blocking, or passivating layer that can eliminate or minimize non-specific attachment of non-capture components (e.g., analyte molecules, binding members) to the binding surface during the assay which may lead to false positive signals during detection or to loss of signal. The methods described herein may use blocking agents to prevent either specific or non-specific binding reactions (e.g., HAMA concern) among assay compounds. Once the agent (and optionally, any controls) is immobilized on the support, the remaining binding sites of the agent may be blocked on the support. Any suitable blocking reagent known to those of ordinary skill in the art may be used.). However Huff does not explicitly teach “wherein at least one of the plurality of stopping elements is between the first and second sample preparation regions.” However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Huff by having the stopping elements between the first and second sample preparation regions, since Huff teaches stopping elements (blocking reagents) thought the kit and including within the solid supports which are within the sample preparation component which the first and second sample preparation regions are within the sample preparation component. In addition, having a stopping element between one region to the next region would provide a distinction between the first and second regions within the sample preparation component which otherwise does not have a distinction of the regions.
Regarding claim 18, Huff teaches all of claim 17 as above but does not explicitly teach “wherein the array of elements comprises an array of nanowells.”. However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Huff by having nanowells within the array of elements since Huff teaches nanoparticles in addition to microfluidics/nanopore device, and nanopore layer within (Paras [0095], [0115], [0134], [0408]). Having nanowells within the array of elements allows for a higher surface to liquid ratio which increases the sensitivity of the assay device.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Huff et. al. (US 20180095067 A1) as applied to claim 13 above, and further in view of Lawson et. al. (US 20080219890 A1).
Regarding claim 14, modified Huff teaches all of claim 13 as above but does not explicitly teach “wherein when the at least one stopping element is removed, a volume of liquid in the first region is fluidically connected to a volume of liquid in the second region.”
Lawson teaches flow cells, particularly multi-channel flow cells, and methods and devices for loading and using flow cells in order to streamline the process of reaction and interrogation of biochemical assays at the microfluidic level. In addition to “wherein when the at least one stopping element is removed, a volume of liquid in the first region is fluidically connected to a volume of liquid in the second region. “ (Para [0098], The user can monitor the loading process visually through the window section 528 and once the channels are filled, the user releases the button 532 to stop the flow of buffer into the channels 12. After waiting a predetermined amount of time, the user actuates the button(s) 532 again to evacuate the buffer from the flow cell 10.)
The recitation “a volume of liquid in the first region is fluidically connected to a volume of liquid in the second region.” is intended use of the stopping element once removed. As intended use the prior art teaches to all of the
positively claimed limitations and can function as intended to by referencing the stopping element removal. However, the above Para [0098] teaches specifically to the indented use.
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 Huff to corporate the teachings of Lawson wherein when the stopping element is removed a volume of liquid is in fluid connection with first and second regions. Doing so allow the device to control the flow between the first and second region which increases the versatility of the device and the mixing and washing steps within the regions.
Response to Amendments
Specification Amendments
The Specification objection set forth in the office action of 08/28/2025 is resolved by applicant’s submission on 2/19/2026.
Response to Arguments
Applicant's arguments filed 2/19/2026 have been fully considered.
Applicant argues that Huff fails to disclose an assay surface that does not contain electrodes as amended claim 1 recites. Examiner highlights that this is new matter however has a made a rejection using the same art showing even with the absence of electrodes Huff teaches to the present amended claims.
Applicant argues that 13, 14, and 18 are not obvious over Huff as Huff fails to teach all elements of the claims. Examiner highlights that the amended claim has new matter however has a made a rejection using the same art showing even with the absence of electrodes modified Huff teaches to the present amended claims.
Applicant states that Lawson does not contain electrodes but one skilled in the art would not be motivated to modify the device of huff to not contain electrodes because the device of Huff would be inoperable for its intended purpose. Examiner disagrees that Huff would be inoperable without electrodes for its intended purpose and has made a art rejection within the use of the electrodes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (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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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights