DETAILED ACTION
Applicant's arguments, filed 03/02/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 03/02/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant added claim 22. Claims 1-20 and 22 are the current claims hereby under examination.
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 .
Claim Rejections - 35 USC § 103
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (US 20130079599 – previously cited) and Cronin (US 20180070873 – previously cited).
Regarding claim 1, Holmes discloses an allergy test kit comprising:
a housing (Fig. 2, device 200 with housing 240);
a biosensor supported by the housing (Fig. 3; Paragraph 0323, “The device may include one or more support structure 220, which may support one or more module 230a, 230b”; Paragraph 0363, “Devices may comprise one or more module. A module may be capable of performing one or more, two or more, or all three of a sample preparation step, assay step, and/or detection step. FIG. 3 shows an example of a module 300. A module may comprise one or more, two or more, or three or more of a sample preparation station 310, and/or an assay station 320”), the biosensor operable to detect a presence of immunoglobulin A (IgA) (Paragraph 0991, “An assay unit may be configured to perform a biological or chemical reaction that yields a detectable signal indicative of the presence or absence of one or more analyte; Paragraph 1540, wherein the analyte is an antigen, one of which is immunoglobin A) in a sample of sweat of a user (Paragraph 0342, “wherein the sample may be a biological sample, one of which is sweat”) and to generate IgA presence data (Paragraph 1021, “assay station, or any other portion of a module or device, may include one or more processing units. A processing unit may be configured to prepare a sample for the performance and/or to perform a biological or chemical reaction that yields a detectable signal indicative of the presence or absence of one or more analyte”, wherein the analyte is IgA as stated above). Examiner notes that the limitation “indicative of an allergic reaction of the user to an allergen” does not impart structural difference to the test kit; rather, it is intended use of the test kit. Thus, Holmes meets the limitation.);
an allergen sensor (Fig. 3, assay station 320; Paragraph 0363, “In accordance with an embodiment of the invention, an assay station, or any other portion of a module or device, may include one or more assay units.”), the allergen sensor operable to detect a presence of an allergen in a substance sample provided by the user (Paragraph 1563, “in some embodiments, the analyte is a foreign antigen. Foreign antigens include... allergens.”) and to generate allergen presence data (Paragraph 1021, “assay station, or any other portion of a module or device, may include one or more processing units. A processing unit may be configured to prepare a sample for the performance and/or to perform a biological or chemical reaction that yields a detectable signal indicative of the presence or absence of one or more analyte” wherein the analyte is an allergen as stated above).
a processor (Paragraph 1259, “A controller [250] may be or use a processor”) operable to receive the IgA presence data from the biosensor and the allergen presence data from the allergen sensor (Fig. 2, controller 250; Paragraph 1259, the controller may receive signals that may be detected from one or more sensors”; Paragraph 0370, “A detection station may include one or more sensors”; Paragraph 0370, “Alternatively, the detection station may be located in an integrated manner with the sample preparation and/or assay station”); and
a memory (Paragraph 1259, “A controller [250] may comprise a local memory) operable to store the IgA presence data and the allergen presence data (Paragraph 1262, “The memory may also store data collected from a detection unit of the device. The data may be stored for analysis of detected signals.”), and
a compartment in the housing configured to hold disposable swabs (Paragraph 1373, wherein a sample collection module includes sample collection methods such as a swab) each configured to collect the sample of sweat (Paragraph 0329, a bodily fluid may be drawn in a variety of ways including via swabs).
Holmes fails to explicitly state wherein the allergen is a user-specific allergen, such that the allergen sensor is specially configured to detect the presence of user-specific allergen that the user is known to be allergic to.
However, Cronin discloses an apparatus for providing health information relating to allergic reactions wherein sensors (Fig. 2, wearable sensors 264(1) – 264 (N)) that detect known allergens to the user (Paragraph 0042, “or instance, imaging data may be used in combination with image recognition software residing in the wearable device 204 (or the results of image capture and recognition residing elsewhere and communicated to the wearable device 204) to detect certain foods that are known allergens and/or detect physiological conditions of the user known to be suspected manifestations of an allergic reaction”). Cronin discusses this is useful to conserve resources by avoiding unnecessary processing (Paragraph 0008). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Holmes to incorporate the teachings of Cronin.
Examiner notes that the limitation “wherein the allergen is a user-specific allergen …” does not impart new structure to the test kit or system to differentiate itself over the prior art. The allergen sensor does not include any specific structural limitations to be “specially configured” to detect one allergen over another.
Regarding claim 2, Holmes further discloses wherein the biosensor is operable to detect a concentration of IgA in the sample of sweat (Paragraph 1021, “assay station, or any other portion of a module or device, may include one or more processing units. A processing unit may be configured to prepare a sample for the performance and/or to perform a biological or chemical reaction that yields a detectable signal indicative of the presence or absence of one or more analyte, and/or a concentration of a one or more analyte” wherein the analyte is IgA and the sample is sweat as stated above.).
Regarding claim 3, Holmes further discloses the biosensor is operable to receive the sample of sweat from a swab used to collect the sample of sweat from the user (Paragraph 0076, “In some cases, the sample includes blood or other bodily fluid”; Paragraph 0329, “the bodily fluid may be collected by various means, including a swab”; Paragraph 0342, “wherein the sample may be a biological sample, one of which is sweat”).
Regarding claim 4, Holmes further discloses wherein the biosensor is operable to be placed in direct contact with the user to receive the sample of sweat directly from the user (Paragraph 0345, “A sample may be collected from the subject by puncturing the skin of the subject, or without puncturing the skin of the subject”; Paragraph 1290, “For example, the device may contact a subject, be worn by the subject”).
Regarding claim 5, Holmes further discloses wherein the housing is operable to be selectively worn by the user, wherein when the housing is worn by the user, the biosensor is positioned against a portion of an epidermis of the user (Paragraph 0345, “A sample may be collected from the subject by puncturing the skin of the subject, or without puncturing the skin of the subject.”; Paragraph 1290, “For example, the device may contact a subject, be worn by the subject, if the device may contact (by way of puncturing the skin or not) or be worn by the subject, it implies the device is operable to be placed against the epidermis).
Regarding claim 6, Holmes further discloses: comprising a removable insert (Fig. 2, sample collection unit 210) supported by the housing proximate the allergen sensor (Fig. 2, the sample collection unit proximate the modules; Fig. 3, an exemplary module containing the assay station), the removable insert operable to support the substance sample (Paragraph 0350, “the sample collection unit may be removable and/or insertable from the device.”; Paragraph 0351, “A sample collection unit may be configured to receive a sample.”)
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes and Cronin as applied to claim 1 above, and further in view of Kurani (US 11490852 – previously cited).
Regarding claim 7, Holmes further discloses that the test kit comprises a user interface operably coupled to the processor (Fig. 2, display/user interface 260). Holmes fails to disclose that the user interface is operable to display at least one of whether an allergic reaction is detected and whether an allergen is detected.
However, Kurani teaches that the user interface is operable to display at least one of whether an allergic reaction is detected and whether an allergen is detected (Figs 39 – 42, wherein the wearable has a user interface screen and displays various detected allergens, for example pollen count).
Holmes and Kurani are both considered to be analogous to the claimed invention because they are in the same field of sensing antigens of a user and/or substance. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Holmes to incorporate the teachings of Kurani and have the user interface operable to display at least one of whether an allergic reaction is detected and whether an allergen is detected. Doing so benefits the user by providing an informative visual of what allergen is detected.
Regarding claim 8, Holmes as modified further discloses wherein the user interface is supported by the housing (Fig. 2, display/user interface 260).
Regarding claim 9, Holmes as modified further discloses a wireless transceiver, wherein the user interface is operably coupled to the processor via the wireless transceiver. (Paragraph 0559, “In some embodiments, the display unit on the device may be detachable. In some embodiments, the display unit may also have a CPU, memory, graphics processor, communication unit, rechargeable battery and other peripherals to enable to operate it as a "tablet computer" or "slate computer" enabling it to communicate wirelessly to the device”; Paragraph 0041, “ the communication unit is configured to send data.”). As stated above, the controller 250 may be or use a processor. Since the display unit may be detachable, and in its detachable form is enabled to communicate wirelessly with the communication unit to the device and its controller, the communication device (read as the wireless transceiver) sends data to the device that read by the processor.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes, Cronin, and Kurani as applied to claim 7 above, and further view of Ray (US 9000933 – previously cited).
Regarding claim 10, Holmes as modified fails to disclose that the memory stores a record of allergens designated by the user which trigger an allergic reaction in the user.
However, Ray teaches that it is known for a memory to store a record of allergens (550) designated by the user which trigger an allergic reaction in the user (Fig. 5 and Page 12, Col 8 lines 34-54; Page 9, Col 1 line 66).
Holmes and Ray are both considered to be analogous to the claimed invention because they are in the same field of sensing and detecting analytes and antigens of a user and/or substance. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Holmes to incorporate the teachings of Ray and store a record of allergens designated by the user which trigger an allergic reaction in the user. Doing so is beneficial to the user of the device if an unknown substance is sampled and contains a known allergen to the user, the stored memory would have that information available and could relay that to the user.
Regarding claim 11, Holmes as modified fails to teach that the user interface notifies the user when the allergen sensor senses an allergen that is listed on the record of allergens designated by the user.
However, Ray further teaches it is known for a user interface to notify the user when an allergen sensor senses an allergen that is listed on the record of allergens designated by the user. (Page 9, Col 1 lines 55-57; Page 11, Col 5 lines 53-56).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Holmes to incorporate the teachings of Ray to alert the user if the user interface in Holmes would notify the user when an allergen is detected by the allergen sensor in Holmes that is listed on the allergy profile of the user in Ray. Doing so immediately alerts the user to an incoming allergic reaction to that allergen.
Claims 12-17, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes, Cronin, Kurani, and Ray.
Regarding claim 12, Holmes discloses a system (Fig. 2, device 200), comprising:
An allergen sensor in a housing (Fig. 3, assay station 320; Paragraph 0363, “In accordance with an embodiment of the invention, an assay station, or any other portion of a module or device, may include one or more assay units.”);
A biosensor in a housing (Fig. 3, assay station 320);
one or more processors (Paragraph 1259, “A controller [250] may be or use a processor”) of at least one computing device (Fig. 2, controller 250); and
one or more memories (Paragraph 1259, “A controller [250] may comprise a local memory”) having non-transitory computer-readable instructions stored thereon that (Paragraph 0323, “memory may be capable of storing one or more instructions”), upon execution by at least one of the one or more processors, cause the at least one computing device to:
Holmes also discloses an allergen sensor operable to detect an allergen in a sample provided to the allergen sensor (Paragraph 1563, “in some embodiments, the analyte is a foreign antigen. Foreign antigens include... allergens.”);
a biosensor (Fig. 3, assay station 320) operable to detect IgA in a sample of sweat (Paragraph 0991, “An assay unit may be configured to perform a biological or chemical reaction that yields a detectable signal indicative of the presence or absence of one or more analyte; Paragraph 1540, wherein the analyte is an antigen, one of which is immunoglobulin A; Paragraph 0342, “wherein the sample may be a biological sample, one of which is sweat”); and a threshold level of IgA presence in sweat (Paragraph 1324, “Such data may include analyte threshold data.” Wherein the analyte is IgA and the sample data is sweat as stated above), and
a compartment in the housing configured to hold disposable swabs (Paragraph 1373, wherein a sample collection module includes sample collection methods such as a swab) each configured to collect the sample of sweat (Paragraph 0329, a bodily fluid may be drawn in a variety of ways including via swabs).
Holmes fails to teach that the stored instructions, when executed by at least one of the one or more processors, cause the at least one computing device to provide data representing at least one of an allergen and an allergic reaction, including: recording detected allergen data received from and generated by the allergen sensor; determining if at least a portion of the detected allergen data corresponds to at least a portion of known allergen data stored on the one or more memories; providing notification when at least the portion of the detected allergen data corresponds to at least the portion of the known allergen data; recording allergic response data received from and generated by the biosensor; and providing notification when the threshold level of IgA is present in the sample of sweat.
Holmes fails to explicitly state wherein the allergen is a user-specific allergen, such that the allergen sensor is specially configured to detect the presence of user-specific allergen that the user is known to be allergic to.
However, Cronin discloses an apparatus for providing health information relating to allergic reactions wherein sensors (Fig. 2, wearable sensors 264(1) – 264 (N)) that detect known allergens to the user (Paragraph 0042, “or instance, imaging data may be used in combination with image recognition software residing in the wearable device 204 (or the results of image capture and recognition residing elsewhere and communicated to the wearable device 204) to detect certain foods that are known allergens and/or detect physiological conditions of the user known to be suspected manifestations of an allergic reaction”). Cronin discusses this is useful to conserve resources by avoiding unnecessary processing (Paragraph 0008). Examiner notes that the limitation “wherein the allergen is a user-specific allergen …” does not impart new structure to the test kit or system to differentiate itself over the prior art.
Holmes and Cronin are considered analogous to the claimed invention because they are in the same field of measuring allergens. This is useful to conserve resources by avoiding unnecessary processing. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Holmes to incorporate the teachings of Cronin.
However, Kurani teaches that stored instructions, when executed by at least one of one or more processors, causes at least one computing device to provide data representing at least one of an allergen and an allergic reaction (Fig 3., computer 350; Figs 39 – 42, wherein the wearable device has a user interface screen and displays various detected allergens, for example pollen count). Kurani further teaches recording detected allergen data received from and generated by an allergen sensor, and recording allergic response data received from and generated by a biosensor (Page 85, Col 69 lines 33-37); Fig. 1, biosensor 310 and enviro sensor 330; Examiner notes that the limitation “due to an allergic reaction to the allergen” does not impart structural difference to the system; rather, it is intended use of the system. Thus, Holmes in view of Kurani meets the limitation.);
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Holmes to incorporate the teachings of Kurani to have a device that records detected allergens and allergic responses to the memory of the device and provide data representing an allergen. Doing so would allow the user of the device to review previously detected allergens and view the allergen data which is beneficial to the user because they can then avoid those allergens in the future.
Holmes as modified fails to disclose determining if at least a portion of the detected allergen data corresponds to at least a portion of known allergen data stored on the one or more memories, providing notification when at least the portion of the detected allergen data corresponds to at least the portion of the known allergen data, and providing notification if a threshold level of IgA is present in the sample of sweat.
However, Ray teaches determining if at least a portion of detected allergen data corresponds to at least a portion of known allergen data stored on one or more memories (Page 9, Col 1 lines 55-57; Page 11, Col 5 lines 53-56), providing notification when at least the portion of the detected allergen data corresponds to at least the portion of the known allergen data (Fig. 5 and Page 12, Col 8 lines 41-42; Page 9, Col 1 line 66) and providing notification (Fig. 5 and Page 12, Col 8 lines 41-42; Page 9, Col 1 line 66) if a threshold level is met (Page 13, Col 9 lines 1-5; Holmes discloses the IgA threshold in the sample of sweat as set forth above and thus the modification results in a notification being provided when a threshold level of IgA is present in the sample of sweat).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Holmes to incorporate the teachings of Ray to have a device that determines if a detected allergen is one of the known allergens stored in the memory and providing notification if a portion of the detected allergen data corresponds to at least the portion of the known allergen data and if a threshold level of IgA is present in the sweat. Doing so would provide the user an alert if the device detects an allergen the user is allergic too and/or if IgA is elevated in sweat, one indicator of an allergic response. This is beneficial to user because they can then know how reactive they may be to an allergen and respond appropriately to the alert.
Regarding claim 13, Ray further discloses that the one or more memories is rewritable to update the known allergen data to include new allergen data (Fig. 5; Page 9, Col 1 lines 55-57; Page 11, Col 5 lines 53-56), and wherein the known allergen data may include a level of sensitivity (Page 14, Col 11 lines 19-23).
Regarding claim 14, Ray further discloses comparing detected allergen data to known allergen data and the level of sensitivity (Page 11, Col 5 lines 53-56; Page 12, Col 8, lines 64-67 through Page 13, Col 9 lines 1-5), wherein the at least of the one or more processors provides notification if the detected allergen data is above a threshold of the level of sensitivity (Page 12, Col 8, lines 64-67 through Page 13, Col 9 lines 1-5), related to the known allergen data.
Regarding claim 15, Ray further discloses that the stored instructions, when executed by the at least one or more processors, cause the at least one computing device to sync data including allergen exposure data (Page 11, Col 5 lines 12-16).
Regarding claim 16, Ray further discloses that the allergen exposure data (Page 11, col 5 lines 19-32) is received from food logging and health databases (Page 13, col 10 lines 32-37, “a parks and recreational facility informing of locations of bee and wasp hives… Health hazards such as the presence of cancer causing substances”), grocery order databases (Page 11, col 5 lines 19-32, shops), restaurant order databases (Page 11, col 5 lines 19-32, restaurant), food label databases (Page 11, col 5 line 45, vending machine), and geolocation databases (Page 11, col 5 lines 19-32, GPS coordinate set).
Regarding claim 17, Ray further discloses that the allergen exposure data provided by input from a smart phone device that is carried by a user (Fig 5, Page 10, Col 4 lines 49-58) and that is one of the one or more computing devices.
Regarding claim 19, Holmes as modified also discloses that the stored instructions, when executed by the at least one or more processors, cause the at least one computing device to switch between an allergen module relating to the data representing allergens and an allergic reaction module relating to the data representing allergic reactions (Paragraphs 1219 and 1220). Here, the sensors are a part of the one or more assay stations of the device which read on the biosensor and allergen sensor as stated above. The instructions may trigger a sensor to sense. Due to there being multiple assay stations, the instructions may switch between sensors being triggered of different assay stations (Paragraph 1244, “A protocol may include one or more set of instructions that may determine which resources to use at which times. The protocol may include instructions to use resources within the same module, within different modules, or external to the module”).
Regarding claim 22, Holmes as modified further discloses wherein the biosensor, the allergen sensor, the processor, and the memory are within a single housing (Fig. 2, housing 240 with modules 230a and 230b, controller 250; Paragraph 0323, wherein the device 200 may have memory).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes, Cronin, Kurani, and Ray as applied to claim 17 above, and in further view of Calman (US 20140074675 – previously cited).
Regarding claim 18, Holmes as modified fails to disclose that the smart phone includes a camera for capturing at least one of a receipt and an ingredient list, wherein the one or more processors determines exposure data based on the at least one of the receipt and the ingredient list.
However, Calman teaches that the smart phone includes a camera for capturing at least one of a receipt and an ingredient list (Paragraph 0015, “A transaction record may be a physical receipt that is captured via a camera”), wherein the one or more processors determines exposure data based on the at least one of the receipt and the ingredient list (Paragraph 0032, “Also, if the transaction record includes SKU level data, the system may determine whether any of the products purchased by the user include potential allergen risks”).
Holmes, Cronin, Ray, Kurani, and Calman are considered to be analogous to the claimed invention because they are in the same field of sensing antigens and/or allergens of a user and/or a substance. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Holmes to incorporate the teachings of Calman and have the smart phone able to take a picture a receipt and determine if there is an allergen risk. Doing so allows the user to quickly gather allergen data from a grocery receipt.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes, Cronin, Kurani, and Ray as applied to claim 12 above, and in further view of Manautou (US 20130256097 – previously cited)
Regarding claim 20, Holmes as modified fails to disclose that the stored instructions, when executed by the at least one or more processors, cause the at least one computing device to timestamp detected allergen data and to timestamp the allergic response data
However, Manautou teaches that the stored instructions, when executed by the at least one or more processors, cause the at least one computing device to timestamp detected allergen data and to timestamp the allergic response data (Paragraph 0062).
Holmes, Cronin, Ray, Kurani, and Manautou are considered to be analogous to the claimed invention because they are in the same field of sensing antigens and/or allergens of a user and/or a substance. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Holmes to incorporate the teachings of Manautou. Doing so would be beneficial to the user to know exact times of their allergic exposure and response to either be informed on the time between the exposure and response and/or remember what the allergen was if they weren’t immediately notified and need to look back when it occurred.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive. Applicant asserts that the prior art of record does not teach the added limitation of a compartment in the housing configured to hold disposable swabs that are configured to collect the sample of sweat. However, as described above, Holmes reads on the limitation.
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 NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791