DETAILED ACTION
Applicant's arguments, filed 06/25/2026, 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 canceled claim 21 and 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/25/2026 has been entered.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3, line 2 should read “from one of the plurality of unused, disposable swabs …”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 12, it is unclear how the biosensor generates IgA presence data indicative of an allergic reaction to the user to an allergen. Is any amount of IgA in the sweat indicative of an allergic reaction? Is there a range or threshold of IgA that is indicative of an allergic reaction? Per claim 12, it appears that a threshold level of IgA is determined to be present; however, it remains unclear if this threshold results in an allergic reaction as they are not directly related. Is the threshold level of IgA related to the allergic reaction? Is the threshold universal or user-dependent? For examination purposes, claim 1 will be interpreted such that any amount of IgA present is indicative of an allergic reaction of the user. Claim 12 will be interpreted such that detecting IgA is due to an allergic reaction to the allergen. Claims 2-11, 13-20, and 22 are also rejected due to their dependence on claims 1 and 12.
Regarding claims 1 and 12, it is unclear how the allergen sensor is specially configured to detect the presence of the user-specific allergen that the user is known to be allergic to. Without any structural limitation that modifies the allergen sensor, the allergen remains the same structure specially “configured to” detect a user-specific allergen. Has the allergen sensor changed in some way? How is it specially configured to detect the presence of a user-specific allergen?
Further, it is unclear how the allergen sensor detects a presence of the allergen in a substance sample. Applicant provides examples of types of substances the allergen sensor may detect allergens from: peanut oil, gluten, topical ointments, chemicals (Paragraph 00041), pollen, smoke from wild fires, inversions, and presence of a pet (Paragraph 00047). How does the allergen sensor detect allergens from all of these sample types? Can the allergen sensor detect all allergen types? Or is it specially configured to detect one type of user-specific allergen? Is the allergen presence data a simple yes/no or positive/negative on if the allergen is present, or does it measure some quantity of the allergen?
Applicant should clarify how the allergen sensor detects a presence of the allergen, what the allergen presence data refers to, and what the allergen is (i.e., all allergen types or a user-specific type). For examination purposes, the claims will be interpreted such that the presence of an allergen is detected. Claims 2-11, 13-20, and 22 are also rejected due to their dependence on claims 1 and 12.
Regarding claim 1, it is unclear what action is performed with the IgA presence data and the allergen presence data. Are they compared? Is there a further calculation or equation to determine that the user is allergic to the allergen based on the IgA data? Does the allergy test kit display or output the result of the user being allergic to a detected allergen? For examination purposes, the data will not be required to be used for further analysis. However, Applicant should clarify what occurs with the allergen and IgA presence data after the processor and memory receives said data. Claims 2-11 are also rejected due to their dependence on claim 1.
Regarding claim 12, it is unclear how it is determined that a portion of detected allergen data corresponds to a portion of known allergen data. What is a portion of detected allergen data and what is a portion of known allergen data? Does “a portion of detected allergen data” refer to a certain amount of one allergen or one allergen of many allergens? Does “a portion of known allergen data” refer to a certain amount of a known allergen or one known allergen of many known allergens? Applicant should clarify what “a portion” refers to. For examination purposes, the claim will be interpreted such that “a portion of detected allergen data” is one detected allergen and “ a portion of known allergen data” is one known allergen. Claims 13-20 and 22 are also rejected due to their dependence on claim 12.
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), Cronin (US 20180070873), and Pugh (US 6908008).
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 this 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.”),
a plurality of unused, disposable swabs, each of the unused, disposable swabs configured to collect the sample of sweat (Paragraph 1373, wherein a sample collection module includes sample collection methods such as one or more of a swab; Paragraph 0329, a bodily fluid may be drawn in a variety of ways including via swabs); and
a compartment in the housing in which swabs are stored (Paragraph 1373, the sample collection module).
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. Holmes further fails to explicitly disclose a compartment for storing unused swabs in the housing.
Holmes and Cronin are in the same field of detecting allergens. Cronin teaches an apparatus for providing health information relating to allergic reactions, wherein sensors (Fig. 2, wearable sensors 264(1) – 264 (N)) detect known allergens to the user (Paragraph 0042, “For 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 the device of Holmes to incorporate detecting a user-specific allergen of Cronin, the benefit being conservation of processing power. 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.
Holmes, Cronin, and Pugh are in the same field of testing devices. Pugh teaches an apparatus for dispensing a plurality of diagnostic test strips and testing a biological fluid dispensed onto the strip (Abstract). The test strips are retained in a chamber 36 of the housing 22, which provides a convenient means of storing the test strips for use with the device (Fig. 1; Col 2, lines 45-65). As Homes modified by Cronin discloses a housing for receiving test swabs, Pugh teaches a housing for testing that holds the test strips within the housing. One of ordinary skill would have been motivated in applying the known improvement of storing test swabs within the same housing as the testing device, and the results of storing the swabs for convenient use would have been predictable to one of ordinary skill in the art. Therefore, 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 the device of Holmes and Cronin to incorporate the stored test strips taught by Pugh, and the result of storing swabs in the same housing as the testing device would have been predictable to one of ordinary skill in the art.
Regarding claim 2, Holmes as modified 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 as modified 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 as modified 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 as modified 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 as modified 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 (US 20130079599), Cronin (US 20180070873), and Pugh (US 6908008) as applied to claim 1 above, and further in view of Kurani (US 11490852).
Regarding claim 7, Holmes as modified further discloses that the test kit comprises a user interface operably coupled to the processor (Fig. 2, display/user interface 260). Holmes as modified fails to explicitly 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.
Holmes, Cronin, Pugh, and Kurani are in the same field of detecting an allergic reaction. 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). Displaying a detected allergen/allergic reaction is detected is recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been motivated in applying this known technique to the device of Holmes that was ready for improvement, and displaying a detected result would have been predictable to one of ordinary skill in the art. 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 and Cronin to incorporate the displaying a detected allergen/allergic reaction taught by Kurani, and the results would have been predictable to one of ordinary skill in the art.
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 (US 20130079599), Cronin (US 20180070873), Pugh (US 6908008), and Kurani (US 11490852) applied to claim 7 above, and further in view of Cronin (US 20180070873).
Regarding claims 10-11, 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, and 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.
Holmes, Cronin, and Kurani are in the same field of detecting an allergic reaction. Cronin further teaches wherein the memory stores a record of allergens, wherein the user has set up the wearable device to check for and be responsive to a certain allergic reaction, such as a peanut allergy (Paragraph 0038). The device and method of Cronin includes software that receives an allergy database and prompts for and receives from a user preferred allergy information such that the wearable device will monitor the user for the occurrence of an allergic reaction to a particular allergen (Paragraph 0056 and Fig. 6). An alert may be sent to the user when an allergic reaction is detected (Fig. 14, alert 1420, “peanut exposure detected”. As Holmes, Cronin, and Kurani disclose detecting allergens and a user’s response via IgA, Cronin discusses that detecting an allergen that a user is known to be allergic to can notify the user to a level of risk and advise them to seek treatment (See Fig. 14, remedy 1424 “Use Epinephrine Pen Immediately!”). 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, Cronin, and Kurani to incorporate the storing allergen data specific to the user and notifying the user upon a detected, stored allergen as taught by Cronin, the benefit of notifying the user of their risk and to seek treatment.
Claims 12-17, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (US 20130079599), Cronin (US 20180070873), and Pugh (US 6908008), and Ray (US 9000933).
Regarding claim 12-17, 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 the 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:
the 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.”);
the biosensor 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);
a plurality of unused, disposable swabs, each of the unused, disposable swabs configured to collect the sample of sweat (Paragraph 1373, wherein a sample collection module includes sample collection methods such as one or more of a swab; Paragraph 0329, a bodily fluid may be drawn in a variety of ways including via swabs); and
a compartment in the housing in which swabs are stored (Paragraph 1373, the sample collection module).
Holmes fails to teach recording detected allergen and allergic response data, determining and providing notification if at least a portion of the detected allergen data corresponds to at least a portion of known allergen data, and providing notification when the threshold level of IgA is present in the sample of sweat. Lastly, 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. Holmes further fails to disclose the limitations of claims 13-17.
Holmes and Cronin are in the same field of detecting allergens. Cronin teaches an apparatus for providing health information relating to allergic reactions, wherein sensors (Fig. 2, wearable sensors 264(1) – 264 (N)) detect known allergens to the user (Paragraph 0042, “For 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 further teaches wherein the memory stores a record of allergens and allergic reactions, wherein the user has set up the wearable device to check for and be responsive to a certain allergic reaction, such as a peanut allergy (Paragraph 0038). The device and method of Cronin includes software that receives an allergy database and prompts for and receives from a user preferred allergy information such that the wearable device will monitor the user for the occurrence of an allergic reaction to a particular allergen (Paragraph 0056 and Fig. 6). An alert may be sent to the user when an allergic reaction is detected (Fig. 14, alert 1420, “peanut exposure detected”).
Cronin discusses this method of storing allergen data that the user is allergic to 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 the device of Holmes to incorporate detecting a user-specific allergen of Cronin, the benefit being conservation of processing power. 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.
Holmes, Cronin, and Pugh are in the same field of testing devices. Pugh teaches an apparatus for dispensing a plurality of diagnostic test strips and testing a biological fluid dispensed onto the strip (Abstract). The test strips are retained in a chamber 36 of the housing 22, which provides a convenient means of storing the test strips for use with the device (Fig. 1; Col 2, lines 45-65). As Homes modified by Cronin discloses a housing for receiving test swabs, Pugh teaches a housing for testing that holds the test strips within the housing. One of ordinary skill would have been motivated in applying the known improvement of storing test swabs within the same housing as the testing device, and the results of storing the swabs for convenient use would have been predictable to one of ordinary skill in the art. Therefore, 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 the device of Holmes and Cronin to incorporate the stored test strips taught by Pugh, and the result of storing swabs in the same housing as the testing device would have been predictable to one of ordinary skill in the art.
Holmes, Cronin, Pugh, and Ray are in the same field of testing devices. Ray teaches a device containing an allergy profile for the user (Abstract). The device updates known allergen data to include new allergen data (Fig. 5; Col 1, lines 55-57; Col 5, lines 53-56), wherein the known allergen data may include a level of sensitivity (Col 11, lines 19-23). When an allergen is detected, it is compared to the known allergen data and the level of sensitivity (Col 5, lines 53-56; Col 8, line 64 - Col 9, line 5), providing a notification if the detected allergen is above a threshold level of sensitivity (Col 8, lines 64 - Col 9, line 5; Holmes discloses the IgA threshold in the sample of sweat as set forth above and thus the modification would necessarily result in a notification being provided when a threshold level of IgA is present in the sample of sweat). The data is synced to the device, wherein the synced data includes allergen exposure data (Col 5, lines 12-16), the allergen exposure data provided by input from a smart phone device that is carried by a user (Fig 5; Col 4, lines 49-58). Allergen exposure data (Col 5, lines 19-32) may be received from food logging and health databases (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 (Col 5, lines 19-32, shops), restaurant order databases (Col 5, lines 19-32, restaurant), food label databases (Col 5, line 45, vending machine), and geolocation databases (Col 5, lines 19-32, GPS coordinate set).
As Holmes modified by Cronin and Pugh are concerned with detecting allergens, Ray discloses a method of notifying the user to allergen exposure data and updating the allergen data to new allergen data. The mobile phone alerting system is useful to prevent inadvertent exposure to allergens from sources for potential exposures (Col 1, lines 39-42). 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, Cronin, and Pugh to incorporate the teachings of updating an allergen database and notifying the user of allergen exposure data as taught by Ray. This is useful to prevent inadvertent exposure to allergens from sources for potential exposures.
Regarding claim 19, Holmes as modified further 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 (US 20130079599), Cronin (US 20180070873), and Pugh (US 6908008), and Ray (US 9000933) as applied to claim 17 above, and in further view of Calman (US 20140074675).
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.
Holmes, Cronin, Pugh, Ray, and Calman are in the same field of allergen detection. 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”). As the combination with Holmes is concerned with detecting allergens and notifying of allergen exposure, Calman introduces an additional method of allergen exposure by updating the data based on a receipt and ingredient list. 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, Cronin, Pugh, and Ray to incorporate taking a picture a receipt and determine if there is an allergen risk as taught by Calman, the benefit in allowing 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 (US 20130079599), Cronin (US 20180070873), and Pugh (US 6908008), and Ray (US 9000933) as applied to claim 12 above, and in further view of Manautou (US 20130256097)
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
Holmes, Cronin, Pugh, Ray, and Manautou are in the same field of allergen detection. 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). As the combination with Holmes is concerned with detecting allergens and notifying of allergen exposure, Manautou introduces an additional step of tracking detected allergens by providing a timestamp detected allergen data and allergic response data. 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, Cronin, Pugh, and Ray to incorporate timestamping detected data as taught by 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, see pages 1-2, filed 06/25/2026, with respect to the 35 U.S.C. §103 rejections have been fully considered and are persuasive. Applicant has amended the claim to include that the unused, disposable swabs are stored in a compartment of the housing. Examiner agrees the cited references fail to explicitly disclose this limitation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Pugh, as described above.
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights