DETAILED ACTION
Applicant’s arguments, filed on 10/14/2025, 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.
Applicants have amended their claims, filed on 10/14/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 19-44 and 74 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 § 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 19-44 and 74 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 claim 19, the claim recites the limitation “capture a first test area image” and “capture a second test area image”. The broadest reasonable interpretation of the word “capture” usually involves a camera or other imaging device used to capture the image. There is no support in the claim or the specification for a camera or other imaging device in the allergen teste execution circuit. The limitation should read “retrieve a first test area image” and “retrieve a second test area image” or similar language, as there is no structure in the allergen test execution circuit that is capable of capturing an image. Claims 20-44 and 74 are also rejected due to their dependency on claim 19.
Regarding claim 32, the claim recites the limitation “capture a first test area video”. The broadest reasonable interpretation of the word “capture” usually involves a camera or other imaging device used to capture the video. There is no support in the claim or the specification for a camera or other imaging device in the allergen teste execution circuit. The limitation should read “retrieve a first test area video” or similar language, as there is no structure in the allergen test execution circuit that is capable of capturing a video. Claims 33 and 34 are also rejected due to their dependency on claim 32.
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 19-20, 26, 32, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20170007170) in further view of Adiri (US 20200211697).
Regarding independent claim 19, Smith teaches an apparatus ([0016]: “The present disclosure is directed towards allergy skin test devices and methods for testing a subject for an allergy.”), comprising:
a user introduction circuit structured to provide an allergen patch execution instruction set to a user device ([0045]: “the method can include displaying instructions (e.g., on the mobile device) for the subject to remove the allergy skin test device”);
an allergen test execution circuit structured to:
determine a patch removal event ([0045]: “A display screen of the mobile device can then be used to display an instruction to the subject to remove the allergy skin test device. The allergy skin test device can then be removed from the skin of the subject”);.
However, Smith does not teach providing a user assistance overlay to guide a user to capture a test area image.
Adiri teaches a testing device that uses an image sensor. Specifically, Adiri teaches providing a user assistance overlay to guide a user to capture a test area image ([0171]: “The processing device either directly or through previously transmitted instructions, may cause information to be overlaid on the displayed image, which may guide a user 110 to capture an image of desirable quality (having proper lighting, a proper orientation of an object for analysis, etc.). For example, the processing device may cause an overlay of a colored outline (e.g., a bounding box) of a color board 1202, an analysis region 1212, a dipstick 1206, etc. onto a live image seen by the image sensor”). Smith and Adiri are analogous arts as they are both related to systems that capture images of a user for health analysis.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the overlay from Adiri into the device from Smith as it ensures that the image being captured is of the correct location and assists the user in capturing the image of the desired location.
The Smith/Adiri combination teaches capture a first test area image in response to the patch removal event (Smith, [0037]: “A first image is recorded of the skin of the subject prior to an allergic response 620”);
provide a user notification in response to an elapsed time value determined from the patch removal event (Smith, [0037]: “Next, the method includes waiting a sufficient time to enable an allergic response to occur 630”; [0051]: “Each time the display of the mobile device is used to display an instruction for the subject, the instruction can be accompanied by a sound, vibration, or other notification method to get the attention of the subject or user.”; [0050]: “an instruction can be displayed a short time after applying the allergy skin test device to record an additional image of the skin”); and
capture a second test area image in response to the elapsed time value (Smith, [0037]: “A second image of the skin of the subject viewed through a skin viewing portion of the allergy skin test device is then recorded”); and
a provider interaction circuit structured to transmit the first test area image and the second test area image to a provider device (Smith, [0037]: “The first image is electronically compared with the second image to identify a skin reaction and a corresponding skin reaction factor 650. Finally, the skin reaction factor is electronically compared with a stored reaction parameter to determine an allergic response severity level of the subject”).
Regarding claim 20, the Smith/Adiri combination teaches the apparatus of claim 19, wherein the allergen patch execution instruction set comprises a patch placement instruction (Smith, [0045]: “the mobile or other device can be programmed with instructions to the user on how to administer an allergy test using the allergy test device in conjunction with the mobile device”).
Regarding claim 26, the Smith/Adiri combination teaches the apparatus of claim 19, wherein the allergen patch execution instruction set further comprises a test execution schedule (Smith, [0063]: “The computer system can also be programmed to modify the time schedule for recording additional images in this situation. For example, the time at which another image should be recorded to recalculate the allergic response severity level can be moved forward from the original schedule.”).
Regarding claim 32, the Smith/Adiri combination teaches the apparatus of claim 19.
However, the Smith/Adiri combination does not teach wherein the allergen test execution circuit is further structured to capture a first test area video in response to the patch removal event.
Adiri teaches wherein the allergen test execution circuit is further structured to capture a first test area video in response to the patch removal event ([0044]: “the image data may include pixel data streams, digital images, digital video streams”). Smith and Xu are analogous arts as they are both apparatuses for monitoring the skin of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the video from Adiri into the apparatus of the Smith/Adiri combination as it allows the apparatus to get a video that contains multiple images in it, so there is a suitable amount of images to choose from for the analysis.
Regarding claim 34, the Smith/Adiri combination teaches the apparatus of claim 32, wherein the provider interaction circuit is further structured to transmit the first test area video to the provider device (Smith, [0040]: “the method steps can be performed by a single computer or mobile device. In other embodiments, the method steps can be distributed between multiple computers, mobile devices, servers, clients, and so on. For example, in one embodiment, comparing the first and second images can be performed by a processor of a mobile device such as a smart phone. The stored reaction parameter can be stored in memory of the same mobile device, and the processor the mobile device can also be used to compare the skin reaction factor with the stored reaction parameter to determine an allergic response severity level. In another embodiment, a processor of the mobile device can be used to compare the first and second image and to compare the skin reaction factor with the stored reaction parameter, but the stored reaction parameter can be stored in memory of a server. In yet another embodiment, comparing the first and second images, storing the stored reaction parameter, and comparing the skin reaction factor with the stored reaction parameter can all be performed by a server, and a PC or mobile device can be used as a client for a user to access the server.”; Xu, Page 11: “the management control unit 250 for pre-processing the picture and/or video contained in skin state detection information”).
Regarding claim 35, the Smith/Adiri combination teaches the apparatus of claim 19, further comprising: wherein the provider interaction circuit is further structured to interpret an allergen scoring value from the provider device; wherein the allergen test execution circuit is further structured to generate an allergen report in response to the allergen scoring value; and a user interaction circuit structured to provide the allergen report to the user device (Smith, [0045]: “The method of testing a subject for an allergy can also include warnings to the subject if a very severe allergic reaction occurs … A processor of the mobile device can be used to electronically identify the allergic response severity level; [0061]: “the stored reaction parameter can include a mathematical formula or function that can receive the skin reaction factor as input and then output the allergic response severity level.”; [0057]: “The processor can identify a skin reaction by comparing the first and second images. The skin reaction refers to the physical change in the skin of the patient that signifies an allergic response. The processor can also identify a corresponding skin reaction factor. The skin reaction factor can be any numerical value used by the processor to represent the allergic reaction.”).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri combination as applied to claim 19 above, and further in view of Meltzer (WO 2019165138).
Regarding claim 21, the Smith/Adiri combination teaches the apparatus of claim 19.
However, the Smith/Adiri combination does not teach wherein the user introduction circuit is further structured to provide a test exclusion criteria to the user device, and to determine a test approval value in response to a user response to the test exclusion criteria.
Meltzer discloses a method for managing eosinophilic esophagitis in a patient. Specifically, Meltzer teaches wherein the user introduction circuit is further structured to provide a test exclusion criteria to the user device, and to determine a test approval value in response to a user response to the test exclusion criteria ([00105]: “a patient establishes a baseline mean score in the PRO assessment questionnaire prior to treatment. As discussed above, the baseline mean score indicates which patients are suitable for treatment. That is, if the patient has a baseline mean score that falls within the “treatment range” of from about 2-7, the PRO questionnaire instructs said patient to begin treatment for dysphagia.”). Smith and Meltzer are analogous arts as they are both systems for managing a patient condition by conducting tests and analyzing data using the results and patient input.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the questionnaire from Meltzer into the apparatus from the Smith/Adiri combination as it allows the apparatus to gather important medical information from the patient before conducting the test, and indicate to the user when the test should begin which can provide a more informed examination of the user.
Claims 22-25 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri combination as applied to claim 19 above, and further in view of Flitsch (US 20200146624) and Tversky (US 20170245792).
Regarding claim 22, the Smith/Adiri combination teaches the apparatus of claim 19.
However, the Smith/Adiri combination does not teach wherein the allergen test execution circuit is further structured to: photonically interrogate a test area; to determine a test execution approval in response to the photonically interrogating; and to provide the test execution approval to the user device.
Flitsch discloses methods and apparatuses for monitoring implanted bone healing sensors. Specifically, Flitsch teaches wherein the allergen test execution circuit is further structured to: photonically interrogate a test area ([0076]: “a spectrum of light frequencies may be emitted by QD emitter 810 and may pass thru the sample 830. The sample 830 may absorb light from some of the emitted frequencies if a chemical constituent within the sample is capable of absorbing these frequencies. The remaining frequencies that are not absorbed may continue on to the detector element, where QD receivers 820 may absorb the photons and convert them to electrical signals. These electrical signals may be converted to digital information by a QD detector sensor controller 822. In some examples the sensor controller 822 may be connected to each of the QD receivers 820, or in other examples the electrical signals may be routed to centralized electrical circuits for the sensing. The digital data may be used in analyzing the sample 830 based on pre-determined values for QD wavelength absorbance values.”). Smith and Flitsch are analogous arts as they are both systems for managing a patient condition by conducting tests and analyzing data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the evaluation of the test area from Flitsch into the apparatus from the Smith/Adiri combination as it allows the apparatus to analyze the test area prior to the allergen test, since it will ensure that the test area is in the correct condition to begin testing.
However, the Smith/Adiri/Flitsch combination does not teach to determine a test execution approval in response to the photonically interrogating; and to provide the test execution approval to the user device.
Tversky discloses a skin testing device and method. Specifically, Tversky discloses ensuring the test area is properly visualized before testing ([0094]: “Although visualization of the wheals 904 is clear due to the SWIR detector functionality, further analysis of the SWIR image can be performed.”), therefore the Smith/Adiri/Flitsch/Tversky combination teaches to determine a test execution approval in response to the photonically interrogating; and to provide the test execution approval to the user device. Smith, Flitsch, and Tversky are analogous arts as they all are systems for managing a patient condition by conducting tests and analyzing data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to continue analysis of the image if the image is not clear from Tversky into the apparatus from the Smith/Flitsch combination as it ensures the apparatus can perform the best analysis with the clearest image possible, providing a more accurate determination.
Regarding claim 23, the Smith/Adiri/Flitsch/Tversky combination teaches the apparatus of claim 22, wherein the allergen test execution circuit is further structured to determine the test execution approval in response to at least one of a test area geometry value or a test area clear value (Smith, [0055]: “the size of a spot or weal on the skin can be determined from the image by using edge recognition. Edges of the spot or weal can be found, and then the diameter or area of the spot or weal can be calculated”).
Regarding claim 24, the Smith/Adiri/Flitsch/Tversky combination teaches the apparatus of claim 22, wherein the provider interaction circuit is further structured to provide a third test area image (Smith, [0072]: “After 24 hours, the smartphone application prompts the subject to take another photograph. The smartphone application compares this third photograph with the first photograph in the same way described above.”) to the provider device in response to the photonically interrogating (Tversky, [0076]: “a spectrum of light frequencies may be emitted by QD emitter 810 and may pass thru the sample 830. The sample 830 may absorb light from some of the emitted frequencies if a chemical constituent within the sample is capable of absorbing these frequencies. The remaining frequencies that are not absorbed may continue on to the detector element, where QD receivers 820 may absorb the photons and convert them to electrical signals. These electrical signals may be converted to digital information by a QD detector sensor controller 822. In some examples the sensor controller 822 may be connected to each of the QD receivers 820, or in other examples the electrical signals may be routed to centralized electrical circuits for the sensing. The digital data may be used in analyzing the sample 830 based on pre-determined values for QD wavelength absorbance values.”). Smith discloses capturing a third image, and Tversky discloses photonically interrogating the image. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to provide the third image after the photonically interrogating the first two images, as the apparatus determines whether the image is clear enough after the photonically interrogating the first two images, and if it is not clear enough, it would be obvious to provide another image to get a clearer image.
Regarding claim 25, the Smith/Adiri/Flitsch/Tversky combination teaches the apparatus of claim 22, wherein the provider interaction circuit is further structured to provide the test execution approval to the provider device (Smith, [0050]: “an instruction can be displayed a short time after applying the allergy skin test device to record an additional image of the skin”; [0040]: “the method steps can be performed by a single computer or mobile device. In other embodiments, the method steps can be distributed between multiple computers, mobile devices, servers, clients, and so on. For example, in one embodiment, comparing the first and second images can be performed by a processor of a mobile device such as a smart phone. The stored reaction parameter can be stored in memory of the same mobile device, and the processor the mobile device can also be used to compare the skin reaction factor with the stored reaction parameter to determine an allergic response severity level. In another embodiment, a processor of the mobile device can be used to compare the first and second image and to compare the skin reaction factor with the stored reaction parameter, but the stored reaction parameter can be stored in memory of a server. In yet another embodiment, comparing the first and second images, storing the stored reaction parameter, and comparing the skin reaction factor with the stored reaction parameter can all be performed by a server, and a PC or mobile device can be used as a client for a user to access the server.”).
Regarding claim 30, the Smith/Adiri/Flitsch/Tversky combination teaches the apparatus of claim 19, wherein the allergen test execution circuit is further structured to: photonically interrogate a test area (Flitsch, [0076]: “a spectrum of light frequencies may be emitted by QD emitter 810 and may pass thru the sample 830. The sample 830 may absorb light from some of the emitted frequencies if a chemical constituent within the sample is capable of absorbing these frequencies. The remaining frequencies that are not absorbed may continue on to the detector element, where QD receivers 820 may absorb the photons and convert them to electrical signals. These electrical signals may be converted to digital information by a QD detector sensor controller 822. In some examples the sensor controller 822 may be connected to each of the QD receivers 820, or in other examples the electrical signals may be routed to centralized electrical circuits for the sensing. The digital data may be used in analyzing the sample 830 based on pre-determined values for QD wavelength absorbance values.”); determine that an acceptable image for the first test area image is available in response to the photonically interrogating (Tversky, [0094]: “Although visualization of the wheals 904 is clear due to the SWIR detector functionality, further analysis of the SWIR image can be performed.”); and in response to determining the acceptable image for the first test area image is available, capture the first test area image and provide a user feedback value (Smith, [0037]: “A first image is recorded of the skin of the subject prior to an allergic response 620”; [0037]: “The first image is electronically compared with the second image to identify a skin reaction and a corresponding skin reaction factor 650. Finally, the skin reaction factor is electronically compared with a stored reaction parameter to determine an allergic response severity level of the subject”).
Regarding claim 31, the Smith/Adiri/Flitsch/Tversky combination teaches the apparatus of claim 19, wherein the allergen test execution circuit is further structured to: photonically interrogate a test area (Flitsch, [0076]: “a spectrum of light frequencies may be emitted by QD emitter 810 and may pass thru the sample 830. The sample 830 may absorb light from some of the emitted frequencies if a chemical constituent within the sample is capable of absorbing these frequencies. The remaining frequencies that are not absorbed may continue on to the detector element, where QD receivers 820 may absorb the photons and convert them to electrical signals. These electrical signals may be converted to digital information by a QD detector sensor controller 822. In some examples the sensor controller 822 may be connected to each of the QD receivers 820, or in other examples the electrical signals may be routed to centralized electrical circuits for the sensing. The digital data may be used in analyzing the sample 830 based on pre-determined values for QD wavelength absorbance values.”); determine that the user device is acceptably positioned for capturing the first test area image in response to the photonically interrogating (Tversky, [0094]: “Although visualization of the wheals 904 is clear due to the SWIR detector functionality, further analysis of the SWIR image can be performed.”); and in response to determining the user device is acceptably positioned, capture the first test area image and provide a user feedback value (Smith, [0037]: “A first image is recorded of the skin of the subject prior to an allergic response 620”; [0037]: “The first image is electronically compared with the second image to identify a skin reaction and a corresponding skin reaction factor 650. Finally, the skin reaction factor is electronically compared with a stored reaction parameter to determine an allergic response severity level of the subject”).
Claims 27-29 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri combination as applied to claim 19 above, and further in view of Gillman (US 20150025412).
Regarding claim 27, the Smith/Adiri combination teaches the apparatus of claim 19.
However, the Smith/Adiri combination does not teach wherein the allergen test execution circuit is further structured to perform at least one of a de-skew operation, an orientation operation, or a scaling operation to at least one of the first test area image or the second test area image.
Gillman discloses an allergy testing system. Specifically, Gillman teaches wherein the allergen test execution circuit is further structured to perform at least one of a de-skew operation, an orientation operation, or a scaling operation to at least one of the first test area image or the second test area image ([0088]: “the processing unit 112a performs scaling using a scaling factor that is determined by comparing a size of the reference marker region 1206 to a predetermined size (e.g., length, width, height, and/or diameter) of the reference marker 810 of the template 800.”). Smith and Gillman are analogous arts as they are both allergy testing systems.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the scaling operation from Gillman into the apparatus from the Smith/Adiri combination as it allows the apparatus to compare the images more accurately by ensuring they are the same scale, providing a more accurate result.
Regarding claim 28, the Smith/Adiri/Gillman combination teaches the apparatus of claim 27, wherein the allergen test execution circuit is further structured to interpret at least one of an alignment feature or an orientation feature (Gillman, [0056]: “The reference marker 210 may be of a predetermined size, location, and/or orientation with respect to the panel 20”), and wherein the operation to perform the at least one of the de-skew operation, the orientation operation, or the scaling operation is performed in response to the at least one of the alignment feature or the orientation feature (Gillman, [0088]: “the processing unit 112a performs scaling using a scaling factor that is determined by comparing a size of the reference marker region 1206 to a predetermined size (e.g., length, width, height, and/or diameter) of the reference marker 810 of the template 800.”).
Regarding claim 29, the Smith/Adiri combination teaches the apparatus of claim 19.
However, the Smith/Adiri combination does not teach wherein the allergen test execution circuit is further structured to provide a user assistance overlay, and to capture the first test area image after providing the user assistance overlay.
Gillman teaches wherein the allergen test execution circuit is further structured to provide a user assistance overlay, and to capture the first test area image after providing the user assistance overlay ([0008]: “An allergy testing kit may be summarized as including: a template including a plurality of puncture site indicators arranged at a plurality of predetermined template locations”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the template from Gillman into the apparatus from the Smith/Adiri combination as it allows the apparatus to provide a guide for the user to properly place the allergen patches, ensuring they’re placed correctly and are measuring the correct locations.
Regarding claim 36, the Smith/Adiri combination teaches the apparatus of claim 35.
However, the Smith/Adiri combination does not teach wherein the allergen report includes at least one of: an allergen ingredient value; an allergen chemical description value; or an offset allergen description value.
Gillman teaches wherein the allergen report includes at least one of: an allergen ingredient value; an allergen chemical description value; or an offset allergen description value ([0004]: “the medical professional may assign a score from 0 to 4 to indicate the degree to which the test subject is allergic to the test substance, wherein a score of 0 indicates no reaction and a score of 4 indicates an extremely severe reaction.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the allergen description value from Gillman into the apparatus from the Smith/Adiri combination as it allows the device to provide the user with a numerical value related to their allergies to certain factors, giving the user more information about their allergies and the risks associated with them.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri combination as applied to claims 19 and 35 above, and further in view of Gross (US 20160116340).
Regarding claim 33, the Smith/Adiri combination teaches the apparatus of claim 32.
However, the Smith/Adiri combination does not teach wherein the first test area image comprises a selected image from the first test area video.
Gross discloses an apparatus used to detect skin of a user. Specifically, Gross teaches wherein the first test area image comprises a selected image from the first test area video ([0347]: “apparatus 1600 includes a skin-pixel-identifier 1602 that identifies pixel values that are representative of the skin in two or more images 1604. In some implementations the images 1604 are frames of a video”). Smith, Adiri, and Gross are analogous arts as they are all related to monitoring the skin of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include selecting the test area image from the video as it allows the device to select a specific image from the video, which allows the device to use the collected video for skin analysis.
Claims 37, 43, 44, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri combination as applied to claims 19 and 35 above, and further in view of Eberting (US 20230223126).
Regarding claim 37, the Smith/Adiri combination teaches the apparatus of claim 35.
However, the Smith/Adiri combination does not teach further comprising: wherein the user interaction circuit is further structured to interpret a candidate product description value; wherein the allergen test execution circuit is further structured to determine a product compatibility value in response to the allergen report and the candidate product description value; and wherein the user interaction circuit is further structured to provide the product compatibility value to the user device.
Eberting discloses a digital health platform. Specifically, Eberting teaches further comprising: wherein the user interaction circuit is further structured to interpret a candidate product description value ([0180]: “FIG. 4 illustrates a screenshot of one possible embodiment of a GUI of a healthcare provider 402 utilizing a curated products platform 400 to select a customized product 404. The curated products platform 400 may include a healthcare provider 402, the product 404, and an order form 406. The customized product 404 is developed by populating the order form 406. In some embodiments, the order form 406 may be populated by selecting from a variety of options. In some embodiments, the order form 406 may be populated by providing a product description.”); wherein the allergen test execution circuit is further structured to determine a product compatibility value in response to the allergen report and the candidate product description value ([0186]: “the order form 406 may be prepopulated with personal information about the patient (e.g., name, age, identification information, social security information, medical record identification numbers, and/or other patient demographic information), information regarding the healthcare professional (e.g., personal, entity, and/or other identification information), insurance information, proof of authorization to access medical records, and/or other information for accessing, requesting, and/or transferring medical records.”; [0190]: “the addition of products 404 can include lab tests, pharmaceutical products, or imaging studies and may result in a request for the necessary prescription or consultation from the appropriate healthcare provider 402. The healthcare provider 402 may have the authority to approve, cancel, or change the order for the patient and send any recommendations to the patient.”); and wherein the user interaction circuit is further structured to provide the product compatibility value to the user device ([0334]: “a “PhotoSafe” storage feature may be coupled with the messaging features via the discussion module that allows for photos, videos, audio recordings, images, charts, measurements, etc. to be stored in a HIPPA-compliant manner within an application on a desktop, laptop, tablet, mobile phone, or another personal electronic device.”). Smith and Eberting are analogous arts as they are both systems for managing a patient condition and analyzing data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the product analysis from Eberting into the apparatus from the Smith/Adiri combination as it allows the apparatus to go further than analyzing the allergies, but also determining conditions that are sage and unsafe for the patient.
Regarding claim 43, the Smith/Adiri/Eberting combination teaches the apparatus of claim 19, further comprising a test initiation circuit structured to operate a video conferencing interface between the user device and a support personnel device (Eberting, [0146]: “a physician may meet with a patient and recommend that the patient use a particular soap and lotion combination as a skin treatment for a certain time period. The physician may conduct the visit via a teleconference visit through the preselected product platform 300 associated with the physician and then provide a treatment summary utilizing the discussion module via a secure messaging application.”).
Regarding claim 44, the Smith/Adiri/Eberting combination teaches the apparatus of claim 43, wherein the test initiation circuit is further structured to provide at least a portion of the allergen patch execution instruction set to at least one of the user device or the support personnel device during the operating the video conferencing interface (Smith, [0040]: “the method steps can be performed by a single computer or mobile device. In other embodiments, the method steps can be distributed between multiple computers, mobile devices, servers, clients, and so on. For example, in one embodiment, comparing the first and second images can be performed by a processor of a mobile device such as a smart phone. The stored reaction parameter can be stored in memory of the same mobile device, and the processor the mobile device can also be used to compare the skin reaction factor with the stored reaction parameter to determine an allergic response severity level. In another embodiment, a processor of the mobile device can be used to compare the first and second image and to compare the skin reaction factor with the stored reaction parameter, but the stored reaction parameter can be stored in memory of a server. In yet another embodiment, comparing the first and second images, storing the stored reaction parameter, and comparing the skin reaction factor with the stored reaction parameter can all be performed by a server, and a PC or mobile device can be used as a client for a user to access the server.”).
Regarding claim 74, the Smith/Adiri/Eberting combination teaches the apparatus of claim 44, wherein the portion of the allergen patch execution instruction set is an entirety of the allergen patch execution instruction set (Smith, [0040]: “the method steps can be performed by a single computer or mobile device. In other embodiments, the method steps can be distributed between multiple computers, mobile devices, servers, clients, and so on. For example, in one embodiment, comparing the first and second images can be performed by a processor of a mobile device such as a smart phone. The stored reaction parameter can be stored in memory of the same mobile device, and the processor the mobile device can also be used to compare the skin reaction factor with the stored reaction parameter to determine an allergic response severity level. In another embodiment, a processor of the mobile device can be used to compare the first and second image and to compare the skin reaction factor with the stored reaction parameter, but the stored reaction parameter can be stored in memory of a server. In yet another embodiment, comparing the first and second images, storing the stored reaction parameter, and comparing the skin reaction factor with the stored reaction parameter can all be performed by a server, and a PC or mobile device can be used as a client for a user to access the server.”).
Claims 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri combination as applied to claim 35 above, and further in view of Micieli (US 20140038152).
Regarding claim 38, the Smith/Adiri combination teaches the apparatus of claim 35.
However, the Smith/Adiri combination does not disclose further comprising: wherein the allergen test execution circuit is further structured to determine a medical follow-up description in response to the allergen report; and wherein the user interaction circuit is further structured to provide the medical follow-up description to the user device.
Micieli discloses a medical visualization method and system. Specifically, Micieli teaches further comprising: wherein the allergen test execution circuit is further structured to determine a medical follow-up description in response to the allergen report; and wherein the user interaction circuit is further structured to provide the medical follow-up description to the user device ([0061]: “The selected pages and captured screenshots of the user interface 200 are associated with the patient information to generate a report corresponding to the medical consultation. The report may be comprehensive, and may further include date of consultation, attending physician, reason for consultation, history of present patient condition or illness, past medical history, past surgical history, medications on admission, allergies, social history such as tobacco, alcohol or illegal substance abuse, review of the systems, physical examination, laboratory data, recommendations, treatment options and plan, follow-up visit.”). Smith and Micieli are analogous arts as they are both systems for managing a patient condition and analyzing data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the follow-up description from Micieli in the apparatus from the Smith/Adiri combination as it allows the apparatus to provide recommendations or important information for the patient to know after determining their allergies.
Regarding claim 39, the Smith/Adiri/Micieli combination teaches the apparatus of claim 38, wherein the user interaction circuit is further structured to provide a follow-up notification value to the user device in response to the medical follow-up description (Micieli, [0062]: “the report is added to the existing patient record on the user database 54, otherwise a new patient record is created. The report, or any portion thereof, may be printed and handed to the patient, or it can be forwarded directly to the patient or third party, such as a health insurer or caregiver, via email, snail mail or facsimile. For example, as shown in FIG. 5c, an email message may be sent to the patient directly from the terminal 12 via the messaging server 58 by actuating the email button 246 on the user interface 200. Alternatively, the patient report may be accessible via an FTP or HTTP web portal. Accordingly, the patient is provided a complete record of the medical consultation for future reference.”).
Regarding claim 40, the Smith/Adiri/Micieli combination teaches the apparatus of claim 38, wherein the medical follow-up description comprises at least one of: a follow-up test value; a repeat test value; an allergen panel description value; a treatment plan description value; or a product description value (Micieli, [0061]: “The selected pages and captured screenshots of the user interface 200 are associated with the patient information to generate a report corresponding to the medical consultation. The report may be comprehensive, and may further include date of consultation, attending physician, reason for consultation, history of present patient condition or illness, past medical history, past surgical history, medications on admission, allergies, social history such as tobacco, alcohol or illegal substance abuse, review of the systems, physical examination, laboratory data, recommendations, treatment options and plan, follow-up visit.”).
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri/Micieli combination as applied to claim 38 above, and further in view of Eberting.
Regarding claim 41, the Smith/Adiri/Micieli combination teaches the apparatus of claim 38.
However, the Smith/Adiri/Micieli combination does not teach further comprising: wherein the provider interaction circuit is further structured to provide the allergen report to the provider device, and to interpret a provider command value from the provider device; and wherein the allergen test execution circuit is further structured to determine the medical follow-up description in response to the provider command value.
Eberting teaches further comprising: wherein the provider interaction circuit is further structured to provide the allergen report to the provider device ([0204]: “When the patient selects the healthcare provider 402 and that healthcare provider 402 already has an account, electronic medical records and/or the request for a vaccine may be transmitted to that healthcare provider's 402 vaccination tab on his/her dashboard via the curated products platform 400”), and to interpret a provider command value from the provider device; and wherein the allergen test execution circuit is further structured to determine the medical follow-up description in response to the provider command value ([0035]: “an open house may allow the provider (or another customer of the telemedicine system) to offer remote consultations over the internet and to make a recommendation for appropriate services and specials to the prospective client online.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the interactions with the provider device from Eberting into the apparatus from the Smith/Adiri/Micieli combination as it allows the apparatus to communicate with the patient’s healthcare provider and gather more important information to use during the analysis of the patient.
Regarding claim 42, the Smith/Adiri/Micieli/Eberting combination teaches the apparatus of claim 41, wherein the medical follow-up description comprises at least one of: a follow-up test value; a repeat test value; an allergen panel description value; a treatment plan description value; a treatment initiation value; or a product description value (Micieli, [0061]: “The selected pages and captured screenshots of the user interface 200 are associated with the patient information to generate a report corresponding to the medical consultation. The report may be comprehensive, and may further include date of consultation, attending physician, reason for consultation, history of present patient condition or illness, past medical history, past surgical history, medications on admission, allergies, social history such as tobacco, alcohol or illegal substance abuse, review of the systems, physical examination, laboratory data, recommendations, treatment options and plan, follow-up visit.”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant's arguments with regards to the 112(b) rejections of claims 19 and 32 have been fully considered but they are not persuasive. Applicant argues that the amended limitation in claim 19 of providing a user assistance overlay to guide a user to capture a test area image provides structure capable of capturing a test area image. Examiner disagrees, as simply providing an overlay does not provide a structure capable of capturing an image and is merely a visual cue to the user as where the area being captured should be located. No structure such as a camera or imaging device is recited in the claims, therefore it is unclear how the claimed limitation is capable of capturing an image, when only the structure of a circuit is claimed as the structure capable of capturing the image. Additionally, Applicant cites paragraph [0064] as teaching a camera, however it is noted that the features upon which applicant relies (i.e., the camera) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The same reasoning is applied to claim 32, as there is no structure claimed that is capable of capturing a video.
Applicant’s arguments with respect to the 102 and 103 rejections of claims 19-44 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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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791