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 .
Status of claims
Claims 20-25, 28 are pending.
Claims 20, 24, and 25 have been amended.
Claims 1-19, 26, 29-60 have been canceled.
Claims 61-66 are new.
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.
Claims 20 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Sundvor et. al. (US 20190257828 A1), English translation.
Regarding claim 20, Sundvor teaches “A colorimetric sensor for detecting an allergen” (Para [0102], suitable sensor(s) configured to detect presence of an analyte based upon one or more of: color change); “comprising a color-changing badge comprising a reaction area” (Para [0124], over time, taking into account kinetics of a reaction at the detection substrate and/or development time of exposed substrate); “and a calibration area” (Para [0032], as well as performing various image processing routines on each captured image (e.g., convolution, averaging, thresholding, peak detection, calibration, etc.) in generating an output.); “wherein the color-changing badge is a lateral-flow assay” (Para [0036], Automating the interpretation of the results of the lateral flow assay can improve the accuracy and repeatability of the analysis,).
Sundvor does not explicitly teach “wherein the reaction area comprises a composite material including a nanofibrous substrate” 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 Iwanaga by having the allergen encapsulated within the nanofibrous substrate, since Sundvor does a fibrous material with antibodies bound to cellulose nanobeads on the substrate within (Para [0068] and [0069], In an example, the detection substrate 150 is a long, narrow, and flat strip of a fibrous material with regions (e.g., bands, lines, spots) of complementary antibodies to an analyte associated with a harmful substance, whereby capillary soaking of the detection substrate 150 distributes the dispersion across the detection substrate 150. Complementary antibodies (e.g., antibodies bound to cellulose nanobeads) at the detection substrate 150). Encapsulating the allergen within the nanofiber substrate would increase the durability of the sensor as the encapsulation would protect the allergen from external factors that could cause degradation.
Further taught by Sundvor “an antibody with specificity for the allergen encapsulated within the nanofibrous substrate,” (Para [0068] and [0042] , complementary antibodies (e.g., antibodies bound to cellulose nanobeads) at the detection substrate 150. The active region(s) can include antibody cocktails for a single analyte associated with a harmful substance, The consumable sample is preferably a food sample potentially containing a harmful substance (e.g., an allergen)); “and a labeling agent conjugated to the antibody” (Para [0068], a color change, fluorescence emission, infrared emission, magnetic response, electrical response, acoustic change, and any other suitable mechanism of indication. The detection substrate 150 is preferably a permeable substrate (e.g., test strip) that soaks up a portion of the dispersion and facilitates binding of one or more analytes in the dispersion with complementary antibodies); “wherein the lateral-flow assay is configured to receive a liquid sample and expose the reaction area and calibration area to said liquid sample” (Paras [0104], In one variation involving data from a photodiode, the analysis can enable identification of absorption peaks detected upon illumination of a detection substrate 150 (e.g., over time, taking into account kinetics of a reaction at the detection substrate), and associate an amount of absorption with an amount (e.g., concentration in parts per million) of an allergen present in the consumable sample. [0032] As shown in FIG. 14, in another example workflow, the system 100 can function to mix the homogenized sample (e.g., where the system 100 is configured to rotate a mixing element located within the sample processing chamber of the test container) with the appropriate processing reagents, to flow the consumable sample to a beginning portion of a detection substrate 150 (e.g., test strip), to perform optical analysis with an optical sensing subsystem 220 of a complementary analysis device 205, and to display results on a user interface 250 (e.g., an indicator of whether or not allergens were detected). In this example workflow, the optical analysis would be performed by the processing module of the analysis device, and can include capturing a plurality of images of the detection substrate at various time points, as well as performing various image processing routines on each captured image (e.g., convolution, averaging, thresholding, peak detection, calibration, etc.) in generating an output.); “wherein, when the liquid sample comprises the allergen” (Para [0047], Additionally or alternatively, components of the system 100 can maintain functionality upon exposure of different components of the system to different types of consumable samples (e.g., of varying viscosity, chemicals, liquid, solid, gas, etc.); “the allergen binds with the antibody, and, upon binding of the allergen with the antibody, the labeling agent is detectable in the reaction area via a color change.” (Para [0068] The detection substrate 150 functions to indicate presence of an analyte, associated with a harmful substance, and in variations, can indicate presence based upon one or more of: a color change, fluorescence emission, infrared emission, magnetic response, electrical response, acoustic change, and any other suitable mechanism of indication. The detection substrate 150 is preferably a permeable substrate (e.g., test strip) that soaks up a portion of the dispersion and facilitates binding of one or more analytes in the dispersion with complementary antibodies (e.g., antibodies bound to cellulose nanobeads) at the detection substrate 150, to provide indication of presence of harmful substances associated with the analyte(s). The detection substrate 150 can include a single active region (e.g., a band, a line, a dot, etc.) for analyte binding, or a set of active regions for analyte binding. The active region(s) can include antibody cocktails for a single analyte associated with a harmful substance, a set of analytes associated with different harmful substances, and/or a control region configured provide a control readout (e.g., in order to enable determination of a baseline signal, in order to establish proper conductance of a test).
Regarding claim 27, modified Iwanaga teaches all of claim 20 as above but does not explicitly teach “wherein the labeling agent comprises a dye.” (Para [0068] The detection substrate 150 functions to indicate presence of an analyte, associated with a harmful substance, and in variations, can indicate presence based upon one or more of: a color change, fluorescence emission, infrared emission, magnetic response, electrical response, acoustic change, and any other suitable mechanism of indication.).
Claims 21, 22-25, 64, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Sundvor et. al. (US 20190257828 A1) as applied to claim 20 above, in further view of Iwanaga (JP 2010014637 A), English translation.
Regarding claim 21, modified Sundvor teaches all of claim 20 as above but does not explicitly teach “wherein the allergen comprises an airborne allergen or an environmental allergen.”. Sundvor does teach an allergen which includes airborne allergen as its an allergen within (Para [0030], the target substances can be a harmful substance, and can include any one or more of: an allergen (e.g., gluten allergen, a dairy-derived allergen, a nut allergen, a fish allergen, an egg-derived allergen, etc.) a toxin, a bacterium, a fungus, a pesticide, a heavy metal, a chemical or biological compound (e.g., a fat, a protein, a sugar, a salt, etc.), and any other suitable harmful substance).
Iwanaga teaches “wherein the allergen comprises an airborne allergen or an environmental allergen” (Page 9, Examples of allergens include pollen, mite allergen, cat allergen and the like.) Therefore, pollen is an airborne allergen which teaches on the claim limitations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sundvor to incorporate the teachings of Iwanaga wherein the allergen comprises an airborne allergen or an environmental allergen. Doing so allows for faster monitoring of the air and increased detection to allergens that cause health concerns.
Regarding claim 22, modified Sundvor teaches all of claim 20 as above but does not explicitly teach “wherein the allergen is selected from Bla g1. Bla g 2. Can f 1, Can f 3. Der f 1, Der f 2, Der p 1. Der p2. Fel d1, Fel d2, Mus m1, and Rat n1.”.
Iwanaga teaches “wherein the allergen is selected from Bla g1. Bla g 2. Can f 1, Can f 3. Der f 1, Der f 2, Der p 1. Der p2. Fel d1, Fel d2, Mus m1, and Rat n1.” (Page 9, Examples of allergens include pollen, mite allergen, cat allergen and the like.) Therefore, the mite allergens include Der f 1, Der f 2, Der p 1, and Der p 2 and the cat allergen is Fel d1, Fel d2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sundvor to incorporate the teachings of Iwanaga wherein the allergen is selected from Bla g1. Bla g 2. Can f 1, Can f 3. Der f 1, Der f 2, Der p 1. Der p2. Fel d1, Fel d2, Mus m1, and Rat n1. Doing so allows for faster monitoring of the environment and increased detection to allergens that cause health concerns.
Regarding claim 23, modified Sundvor teaches all of claim 20 as above but does not explicitly teach “wherein the antibody is selected from 10A4 anti Rat n 1, 10D4 anti Can f 1,10H4 anti Rat n 1, 1A8 anti Fel d 4, 2H6 ant Rat n 1, 3E4 anti Fel d 1, 5B2 anti Fel d 4, 6E9 anti Can f 1, 6F9 anti Fel d 1, 7E6 anti Can f 1, 10A6 anti Bla g 1, 1F3 anti Bla g 2, 1 G9 anti Bla g 5, 2F1 anti Bla g 2, 4B8 anti Bla g 5, 7C11 anti Bla g 2, 10B9 anti Der p 1, 4C1 anti Der p 1/Der f 1, 4D9 anti Blo t 5, 4G9 anti Blo t 5, 5H8 anti Der p 1, 6A8 anti Der f 1, 2C10 anti Alt a 1, and 4A6 anti Asp f 1.
Iwanaga does teach molecules bound to two kinds of molecules that interact with each other and the molecules include a host and a guest (Page 4). In addition, Iwanaga teaches to an allergen (antigen) and an antibody (Page 4). In addition to teaching that the allergen could be mite and cat allergens (Page 4). Therefore, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modify Sundvor and Iwanaga by selecting at least 6A8 anti-Der f 1 as it’s an antibody for a mite allergen which Iwanaga teaches to. Also the relationship would be a host and guest in that the taught allergen is the guest and the antibody is the host which this relationship is also taught within Iwanaga. If the antibody selected was at least 6A8 anti-Der f 1 then the antibody selected has to be from a group which also contains that antibody which teaches to the claimed feature. It would have been a matter of an obviousness to select a antibody from a group consisting of 6A8 anti-Der f 1 if mite allergens was what the sensor was used to detect based on the teachings of Iwanaga and a person skilled in the art knowing that that is an antibody of the mite allergen.
Regarding claim 24, modified Sundvor teaches all of claim 20 as above but does not explicitly teach “wherein the nanofibrous substrate is prepared by electrospinning a mixture of a polymer and the antibody.”
Iwanaga teaches “wherein the nanofibrous substrate is prepared by electrospinning a mixture of a polymer and the antibody.” (Page, 8 The fiber used in the present invention can be produced by a general production method…It is preferable to employ the electrospinning method.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sundvor to incorporate the teachings of Iwanaga wherein the nanofibrous substrate is prepared by electrospinning a mixture of a polymer and the antibody. Doing so increases the surface area which allows increased speed of use.
Regarding claim 25 modified Sundvor teaches all of claim 20 as above but does not explicitly teach “wherein the nanofibrous substrate comprises polyvinylpyrrolidone (-PVP), polyvinylalcohol (PVA), polyethylene glycol (PEG), or polypropylene glycol (PPG).”
Iwanaga teaches “wherein the nanofibrous substrate (Page 7, The polyurethane used in the present invention refers to a fiber composed of a linear synthetic polymer in which the bonding portion between monomers or the bonding portion between basic base polymers is mainly a urethane bond. It is desirable that the polyurethane segment contains 85% or more by mass ratio. It is desirable to be a block copolymer of a segmented polyurethane composed of a soft segment having a low melting point and a soft molecular weight of up to several thousand, and a hard segment having a high melting point and rigidity and high cohesion. Polyethers such as polypropylene glycol and polytetramethylene glycol can be used as the soft segment, and urethane groups formed from 4,4'-diphenylmethane diisocyanate, m-xylene diisocyanate, and the like can be used as the hard segment.).
Regarding claim 64, modified Sundvor teaches all of claim 20 as above but does not explicitly teach “wherein the allergen is from at least one of cockroach, dust mite, mouse, cat, dog, rat, or mold.”.
Iwanaga teaches “wherein the allergen is from at least one of cockroach, dust mite, mouse, cat, dog, rat, or mold.”. (Page 4, When an antigen and an antibody are used as two types of molecules that interact with each other… , Allergens (pollen, mite allergens, mold spores, cat allergens, etc.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sundvor to incorporate the teachings of Iwanaga wherein the allergen is from at least one of cockroach, dust mite, mouse, cat, dog, rat, or mold. Doing gives faster monitoring of the environment and increased detection to allergens that cause health concerns.
Regarding claim 65, modified Sundvor teaches all of claim 20 as above but does not explicitly teach, “wherein the liquid sample is an aqueous solution comprising dust from an indoor environment.”
Iwanaga teaches “wherein the liquid sample is an aqueous solution comprising dust from an indoor environment.” (Page 4, Allergens (pollen, mite allergens, mold spores, cat allergens, etc.), haptens (biotoxins such as verotoxin, mitotoxin, ciguatoxin, penicillin, benzopyrenes and dioxins contained in cigarette smoke, dust, untreated carrier in an antibody aqueous solution and immobilizing the antibody on the carrier by ionic bonding,).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sundvor to incorporate the teachings of Iwanaga wherein the liquid sample is an aqueous solution comprising dust from an indoor environment. Doing so gives faster monitoring of the environment and increased detection to allergens that cause health concerns.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Sundvor et. al. (US 20190257828 A1), English translation as applied to claim 27 as above, in further view of Gee (US 20110159517 A1).
Regarding claim 28, modified Sundvor teaches all of claim 27 as above but does not explicitly teach “wherein the labeling agent comprises a porphyrin.”.
Gee teaches “wherein the labeling agent comprises a porphyrin.” (Para [0119], Dyes of the present invention include… a porphyrin).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Iwanaga to incorporate the teachings of Gee wherein the labeling agent comprises a porphyrin. Doing so allows for a sensor in which is ideal for optical detection as porphyrin has strong light emission and absorption characteristics.
Claims 61-66 are rejected under 35 U.S.C. 103 as being unpatentable over Sundvor et. al. (US 20190257828 A1), English translation as applied to claim 20 above in further view of Zhou et. al. US 20160057413 A1.
Regarding claim 61, modified Sundvor teaches all of claim 20. The recitation “wherein the colorimetric sensor is configured to provide an estimate of a concentration of the allergen in the liquid sample based on a color change ratio between the reaction area and the calibration area after exposure to the liquid sample.” is capability of the sensor. Modified Sundvor discloses the positively claimed structural elements of the sensor as claimed, such sensor is said to be fully capable of the recited adaption in as much as recited and required herein. In addition, Zhou teaches a sensor that varies in color based on concentration of an analyte which is one way to estimate a concentration of an analyte (allergen) within (Paras [0018] and [0034], Reporting the concentration of a test substance analyte based on the calibrated reading in each test area. A signal, color change, or color shade is generated if a specific analyte is present in the test fluid 70; for instance, a color shade or change develops where the color density varies as a result of the concentration of the analyte. The color change or shade can be captured and recorded by an imaging device such as a smart phone or camera phone and can then be processed by an algorithm to calculate the concentration of each analyte based on a calibration curve or color scale 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 have further modified Sundvor to incorporate the teachings of Zhou wherein the colorimetric sensor is configured to provide an estimate of a concentration of the allergen in the liquid sample based on a color change ratio between the reaction area and the calibration area after exposure to the liquid sample. Doing so allows for fast and specific allergy detection.
Regarding claim 62, modified Sundvor teaches all of claim 20 but does not teach “wherein the calibration area of the color-changing badge is a multi-color calibration area.”.
Zhou teaches “wherein the calibration area of the color-changing badge is a multi-color calibration area.”. (Paras [0034], [0039], and [0047], Calibration curve or color scale of the device. A reference or calibration reference color area 126 can include a distinct area and can be directly printed on the device either as part of the channel structure or as an additional pattern. An auxiliary information area 128 can surround the test area 110. Calibration reference area 326 can be separated into multiple sub-areas including separate reference colors associated with each sub-area (not shown). The multiple color reference areas enable use of reagents with different dye colors in test zones 1-5.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sundvor to incorporate the teachings of Zhou wherein the calibration area of the color-changing badge is a multi-color calibration area. Doing so increases the accuracy in color detection and identifying different colors which results in increase accurate identification of the analyte.
Regarding claim 63, modified Sundvor teaches all of claim 62 but Sundvor does not teach “wherein the multi-color calibration area comprises a plurality of regions, each region having a different color, a different tint, or a different shade of the same color.”
Zhou teaches “wherein the multi-color calibration area comprises a plurality of regions, each region having a different color, a different tint, or a different shade of the same color.” (Para [0047], Referring now to FIG. 6, wherein an exemplary Triglyceride paper sensor 300 is therein displayed. Identifying a reference or calibration color area can include a substrate region 328 between the test zones 1, 2, 3, 4, 5 and a calibration color area or region 326. Areas 326, 327, and 328 can be used as reference color areas or contrast color areas. Areas 327 and 328 can be any color to provide contrast (black, color, contrast color, etc.) between the test zones 1-5 and reference areas 326, 327, and 328. It is to be appreciated that the calibration reference area 326 can be separated into multiple sub-areas including separate reference colors associated with each sub-area (not shown). The multiple color reference areas enable use of reagents with different dye colors in test zones 1-5. Alternatively, the reference region can include a first calibration color area including a first predeterminable color for comparing to one or more of the axial test zones. The reference region can further include a second calibration color area including a second predeterminable color for comparing to one or more of the axial test zones. The first and second calibration color areas can each include first and second predeterminable colors.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sundvor to incorporate the teachings of Zhou wherein the multi-color calibration area comprises a plurality of regions, each region having a different color, a different tint, or a different shade of the same color. Doing so increases the quality control of the sensor and allows as the calibration is not a single color but rather multi-colored.
Regarding claim 66, modified Sundvor teaches all of claim 20 as above. The recitation “wherein the colorimetric sensor is configured to be used with a computing device configured to detect and/or quantify the color change of the colorimetric sensor.” is capability of the sensor. Modified Sundvor discloses the positively claimed structural elements of the sensor as claimed, such sensor is said to be fully capable of the recited adaption in as much as recited and required herein.
Response to Amendments
Claim Amendments
Applicant’s amendments independent claim 20 and new claims have overcome the current rejections set forth in the non-final sent on 8/13/2025. Examiner has made new rejections based on new claim amendments.
Response to Arguments
Applicant’s arguments with respect to claim 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798