DETAILED ACTION
This action is pursuant to claims filed on 07/30/2026. Claims 19-21, 23-44, and 74 are pending. An action on the merits of claims 19-21, 23-44, and 74 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/30/2026 has been entered.
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 29-31 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 29, the claim recites the limitation “a user assistance overlay” in line 2. It is unclear if this limitation is meant to refer to the user assistance overlay of claim 19, line 6, or a different user assistance overlay. If it is meant to refer to the user assistance overlay from claim 19, it needs to refer back to it. If it is meant to refer to a different user assistance overlay, it needs to be distinguished from the user assistance overlay from claim 19. For purposes of examination, it is being interpreted as referring to the user assistance overlay from claim 19.
Regarding claim 30, the claim recites the limitation “photonically interrogate a test area” in line 3. It is unclear if this limitation is meant to refer to the photonically interrogating a test area from claim 19, line 16, or a different step of photonically interrogating a test area. If it is meant to refer to the photonically interrogating a test area from claim 19, it needs to refer back to it. If it is meant to refer to a different step of photonically interrogating a test area, it needs to be distinguished from the limitation in claim 19. For purposes of examination, it is being interpreted as referring to the limitation from claim 19.
Regarding claim 31, the claim recites the limitation “photonically interrogate a test area” in line 3. It is unclear if this limitation is meant to refer to the photonically interrogating a test area from claim 19, line 16, or a different step of photonically interrogating a test area. If it is meant to refer to the photonically interrogating a test area from claim 19, it needs to refer back to it. If it is meant to refer to a different step of photonically interrogating a test area, it needs to be distinguished from the limitation in claim 19. For purposes of examination, it is being interpreted as referring to the limitation from claim 19.
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, 23-26, 30-32, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20170007170) in view of Adiri (US 20200211697), Lewinson (US 20230277119), Grass (CN 104470419), and Doronina (“Enhancing the locality of optical interrogation with photonic-crystal fibers”). Citations to CN 104470419 will refer to the English Machine Translation that accompanies this Office Action.
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”; [0041]: “the computer system can include a digital imaging device in communication with one or more processors of the computer system”. The circuit is included in the processors.);
an allergen test execution circuit ([0041]: “the computer system can include a digital imaging device in communication with one or more processors of the computer system”. The circuit is included in the processors.) 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 retrieving a first test area image captured by the user device 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”; [0050]: “the method can include displaying periodic instructions to the subject, such as instructions to record an additional image of the skin. A processor of the mobile device can run a timer and display instructions at certain pre-set times. For example, an instruction can be displayed a short time after applying the allergy skin test device to record an additional image of the skin. If a moderate or severe response is detected after the short time, then an instruction can be displayed that the test result is positive and that the allergy skin test device should be removed. In some examples, the short time can be 5 minutes, 10 minutes, half an hour, or another time that is appropriate for the allergen in question. An instruction to record an additional image of the skin can also be displayed at a normal test end time. For example, the allergy test can be calibrated to end after 5 minutes, 30 minutes, 1 hour, 4 hours, 8 hours, 24 hours, 48 hours, or any other time duration appropriate for the allergen in question. At this point, the processor of the mobile device can display an instruction to record an additional image of the skin so that the processor can evaluate a final test result”; [0052]: “Instructions to record additional images can be displayed at multiple times between the beginning of the test and the end time”. There can be additional images taken after the patch is removed, and the first image taken after the patch is removed is the first image; [0041]: “the computer system can comprise a mobile device such as a smartphone or tablet with an integrated digital camera. Such a digital imaging device can be used to record the first and second images of the skin of the subject”. The digital imaging device is the user device used to capture the image.);
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
retrieve a second test area image captured by the user device 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”; [0050]: “the method can include displaying periodic instructions to the subject, such as instructions to record an additional image of the skin. A processor of the mobile device can run a timer and display instructions at certain pre-set times. For example, an instruction can be displayed a short time after applying the allergy skin test device to record an additional image of the skin. If a moderate or severe response is detected after the short time, then an instruction can be displayed that the test result is positive and that the allergy skin test device should be removed. In some examples, the short time can be 5 minutes, 10 minutes, half an hour, or another time that is appropriate for the allergen in question. An instruction to record an additional image of the skin can also be displayed at a normal test end time. For example, the allergy test can be calibrated to end after 5 minutes, 30 minutes, 1 hour, 4 hours, 8 hours, 24 hours, 48 hours, or any other time duration appropriate for the allergen in question. At this point, the processor of the mobile device can display an instruction to record an additional image of the skin so that the processor can evaluate a final test result”; [0052]: “Instructions to record additional images can be displayed at multiple times between the beginning of the test and the end time”; [0041]: “the computer system can comprise a mobile device such as a smartphone or tablet with an integrated digital camera. Such a digital imaging device can be used to record the first and second images of the skin of the subject”. The digital imaging device is the user device used to capture the image.); 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”; [0041]: “the computer system can include a digital imaging device in communication with one or more processors of the computer system”. The circuit is included in the processors.).
However, the Smith/Adiri combination does not teach wherein the allergen test execution circuit is further structured to: photonically interrogate a test area; determine a test execution approval in response to the photonically interrogating; and provide the test execution approval to the user device.
Lewinson discloses a system for detecting skin allergy reactions. Specifically, Lewinson teaches preprocessing the patch area to determine the orientation of the area before the image-processing steps, therefore teaching the step of determining a test execution approval in response to determining orientation (Abstract: “the system preprocesses the image so that a resulting preprocessed image of the patch area has a prespecified size and orientation. The system then performs image-processing operations on the preprocessed image to identify regions of the patch area corresponding to positive skin contact reactions”. It would be obvious that a teste execution approval is determined in response to determining orientation, as the orientation step occurs before the image analysis steps, therefore requiring the intermediate step of a test execution approval being provided to the user device.). Smith and Lewinson are analogous art as they are both related to devices used for allergen testing.
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 determination of the orientation prior to the image analysis from Lewinson into the Smith/Adiri combination as it ensures that the device is aware of the orientation and in the correct orientation, ensuring that the device only processes the images generated in the correct location. This ensures that the device is capturing the correct location and providing the most accurate information for the allergen testing.
However, the Smith/Adiri/Lewinson combination does not teach the orientation being determined through photonically interrogating the test area.
Grass discloses a system and method for generating imaging data during a procedure. Specifically, Grass teaches determining orientation through optical interrogation (Claim 10: “An external optical sensor (300) for attachment to the patient's body during the medical intervention, and comprising at least one externally oriented fiber core configured to measure the orientation of the external optical sensor relative to a reference point … A display (406) is used to display (522) the orientation of the patient's body using at least a portion of the orientation estimation results from the external sensors”). Lewinson and Grass are analogous art as they are both related to the same field of endeavor of determining the orientation of a test area of a device used to monitor a user’s skin.
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 optical interrogation from Grass into the Smith/Adiri/Lewinson combination as the combination is silent on the specific technique used to determine the orientation, and Grass discloses a suitable method for determination of orientation in an analogous device.
However, the Smith/Adiri/Lewinson/Grass combination does not specify that the fiber optic sensor from Grass is a type of photonic interrogation.
Doronina discloses a type of fiber optic interrogation. Specifically, Doronina teaches fiber optic interrogation being a type of photonic interrogation (Page 101: “With the recently developed photonic-crystal fibers (PCFs),8 fiber dispersion and nonlinearity can be tailored by fiber structure engineering to match a specific optical interrogation protocol”). Grass and Doronina are analogous art as they are both related to fiber optic interrogation.
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 fiber optic interrogation being a type of photonic interrogation from Doronina into the Smith/Adiri/Lewinson/Grass combination as the combination is silent on if the fiber optic interrogation from Grass is a type of photonic interrogation, and Doronina provides suitable evidence that it is a type of photonic interrogation.
Regarding claim 20, the Smith/Adiri/Lewinson/Grass/Doronina 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 23, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19, 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/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19, 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 (Lewinson, Abstract: “the system preprocesses the image so that a resulting preprocessed image of the patch area has a prespecified size and orientation. The system then performs image-processing operations on the preprocessed image to identify regions of the patch area corresponding to positive skin contact reactions”; Grass, Claim 10: “An external optical sensor (300) for attachment to the patient's body during the medical intervention, and comprising at least one externally oriented fiber core configured to measure the orientation of the external optical sensor relative to a reference point … A display (406) is used to display (522) the orientation of the patient's body using at least a portion of the orientation estimation results from the external sensors”; Doronina, Page 101: “With the recently developed photonic-crystal fibers (PCFs),8 fiber dispersion and nonlinearity can be tailored by fiber structure engineering to match a specific optical interrogation protocol”). Smith discloses capturing a third image, and the Lewinson/Grass/Doronina combination discloses photonically interrogating the area to determine the orientation. 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 photonic interrogation, as the apparatus determines the orientation prior to the processing, therefore the third image would be gathered after the photonic interrogation.
Regarding claim 25, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19, 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 26, the Smith/Adiri/Lewinson/Grass/Doronina 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 30, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19, wherein the allergen test execution circuit is further structured to: photonically interrogate a test area (Lewinson, Abstract: “the system preprocesses the image so that a resulting preprocessed image of the patch area has a prespecified size and orientation. The system then performs image-processing operations on the preprocessed image to identify regions of the patch area corresponding to positive skin contact reactions”; Grass, Claim 10: “An external optical sensor (300) for attachment to the patient's body during the medical intervention, and comprising at least one externally oriented fiber core configured to measure the orientation of the external optical sensor relative to a reference point … A display (406) is used to display (522) the orientation of the patient's body using at least a portion of the orientation estimation results from the external sensors”; Doronina, Page 101: “With the recently developed photonic-crystal fibers (PCFs),8 fiber dispersion and nonlinearity can be tailored by fiber structure engineering to match a specific optical interrogation protocol”); determine that an acceptable image for the first test area image is available in response to the photonically interrogating (Lewinson, Abstract: “the system preprocesses the image so that a resulting preprocessed image of the patch area has a prespecified size and orientation. The system then performs image-processing operations on the preprocessed image to identify regions of the patch area corresponding to positive skin contact reactions”. Lewinson ensures that the patch area has a prespecified size and orientation, which is a step of determining that the image is an acceptable image.); and in response to determining the acceptable image for the first test area image is available, retrieve the first test area image captured by the user device 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/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19, wherein the allergen test execution circuit is further structured to: photonically interrogate a test area (Lewinson, Abstract: “the system preprocesses the image so that a resulting preprocessed image of the patch area has a prespecified size and orientation. The system then performs image-processing operations on the preprocessed image to identify regions of the patch area corresponding to positive skin contact reactions”; Grass, Claim 10: “An external optical sensor (300) for attachment to the patient's body during the medical intervention, and comprising at least one externally oriented fiber core configured to measure the orientation of the external optical sensor relative to a reference point … A display (406) is used to display (522) the orientation of the patient's body using at least a portion of the orientation estimation results from the external sensors”; Doronina, Page 101: “With the recently developed photonic-crystal fibers (PCFs),8 fiber dispersion and nonlinearity can be tailored by fiber structure engineering to match a specific optical interrogation protocol”); determine that the user device is acceptably positioned for capturing the first test area image in response to the photonically interrogating (Lewinson, Abstract: “the system preprocesses the image so that a resulting preprocessed image of the patch area has a prespecified size and orientation. The system then performs image-processing operations on the preprocessed image to identify regions of the patch area corresponding to positive skin contact reactions”. Lewinson ensures that the patch area has a prespecified size and orientation, which is a step of determining that the user device is acceptably positioned.); and in response to determining the user device is acceptably positioned, retrieve the first test area image captured by the user device 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 32, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19, wherein the allergen test execution circuit retrieves a recording in response to the patch removal event (Smith, [0050]: “the method can include displaying periodic instructions to the subject, such as instructions to record an additional image of the skin. A processor of the mobile device can run a timer and display instructions at certain pre-set times. For example, an instruction can be displayed a short time after applying the allergy skin test device to record an additional image of the skin. If a moderate or severe response is detected after the short time, then an instruction can be displayed that the test result is positive and that the allergy skin test device should be removed. In some examples, the short time can be 5 minutes, 10 minutes, half an hour, or another time that is appropriate for the allergen in question. An instruction to record an additional image of the skin can also be displayed at a normal test end time. For example, the allergy test can be calibrated to end after 5 minutes, 30 minutes, 1 hour, 4 hours, 8 hours, 24 hours, 48 hours, or any other time duration appropriate for the allergen in question. At this point, the processor of the mobile device can display an instruction to record an additional image of the skin so that the processor can evaluate a final test result”; [0052]: “Instructions to record additional images can be displayed at multiple times between the beginning of the test and the end time”).
However, the Smith/Adiri/Lewinson/Grass/Doronina combination does not teach wherein the recording is a video.
Adiri teaches wherein the allergen test execution circuit is further structured to retrieve a first test area video captured by the user device event ([0044]: “the image data may include pixel data streams, digital images, digital video streams”).
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/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina 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.”; Adiri, [0044]: “the image data may include pixel data streams, digital images, digital video streams”).
Regarding claim 35, the Smith/Adiri/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina combination as applied to claim 19 above, and further in view of Meltzer (WO 2019165138).
Regarding claim 21, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19.
However, the Smith/Adiri/Lewinson/Grass/Doronina 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.”. The treatment range is the test exclusion criteria (such that the values outside of the range are not suitable for treatment and therefore excluded). The user response to the test exclusion criteria is the patient inputting information into the questionnaire, and the test approval value is the baseline mean score used to determine if the patient can begin.). 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/Lewinson/Grass/Doronina 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 27-29 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over the Smith/Adiri/Lewinson/Grass/Doronina combination as applied to claim 19 above, and further in view of Gillman (US 20150025412).
Regarding claim 27, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19.
However, the Smith/Adiri/Lewinson/Grass/Doronina 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, Lewinson, and Gillman are analogous arts as they are all 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/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina/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/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19.
However, the Smith/Adiri/Lewinson/Grass/Doronina 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 retrieve the first test area image captured by the user device 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/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina combination teaches the apparatus of claim 35.
However, the Smith/Adiri/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina combination as applied to claim 32 above, and further in view of Gross (US 20160116340).
Regarding claim 33, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 32.
However, the Smith/Adiri/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina combination as applied to claims 19 and 35 above, and further in view of Eberting (US 20230223126).
Regarding claim 37, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 35.
However, the Smith/Adiri/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina combination as it allows the apparatus to go further than analyzing the allergies, but also determining conditions that are safe and unsafe for the patient.
Regarding claim 43, the Smith/Adiri/Lewinson/Grass/Doronina combination teaches the apparatus of claim 19.
However, the Smith/Adiri/Lewinson/Grass/Doronina combination does not teach the apparatus further comprising a test initiation circuit structured to operate a video conferencing interface between the user device and a support personnel device.
Eberting teaches the apparatus further comprising a test initiation circuit structured to operate a video conferencing interface between the user device and a support personnel device ([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.”).
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 conferencing option from Eberting into the Smith/Adiri/Lewinson/Grass/Doronina combination as it allows the user to communicate with a support personnel, ensuring they are able to receive proper advice and discussion with a professional.
Regarding claim 44, the Smith/Adiri/Lewinson/Grass/Doronina/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/Lewinson/Grass/Doronina/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/Lewinson/Grass/Doronina combination as applied to claim 35 above, and further in view of Micieli (US 20140038152).
Regarding claim 38, the 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.”).
However, the Smith/Adiri/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina 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/Lewinson/Grass/Doronina/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/Lewinson/Grass/Doronina/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/Lewinson/Grass/Doronina/Micieli combination as applied to claim 38 above, and further in view of Eberting.
Regarding claim 41, the Smith/Adiri/Lewinson/Grass/Doronina/Micieli combination teaches the apparatus of claim 38.
However, the Smith/Adiri/Lewinson/Grass/Doronina/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”. The electronic medical records include the allergen report which is transported to the healthcare provider’s tab, which is on 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 ([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.”; [0169]: “a telemedicine visit may be preceded by a direct recommendation for services or products on one dashboard and/or as the direct result of a telemedicine consultation”. The recommendations from the provider are input through a provider command value, and one dashboard created from the recommendation is the determined medical follow-up description, which is determined from the circuits included in the device; [0371]: “Disclosed herein are embodiments of systems, methods, apparatus, circuits, and/or interfaces. As stated above, the embodiments disclosed herein may be embodied as executable instructions stored on a non-transitory machine-readable storage medium. The instructions may comprise computer program code that, when executed and/or interpreted by a computing device, causes the computing device to implement the processing steps and/or operations disclosed herein”.).
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/Lewinson/Grass/Doronina/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. Additionally, including the interface with the provider allows the user to receive information back and forth with their provider, and are capable of providing important recommendations and information about the actions they should take in regards to the test results.
Regarding claim 42, the Smith/Adiri/Lewinson/Grass/Doronina/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 has amended the claims to overcome the 112(b) rejections, however the amendments have introduced new 112(b) rejections.
Applicant’s arguments with respect to claims 19-21, 23-40, 43-44, and 74 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.
Applicant's arguments with respect to claims 41-42 have been fully considered but they are not persuasive. Applicant argues that Eberting does not teach the limitations of claim 41. However, as explained in the 103 rejection above, the electronic records being transmitted to the dashboard is equated with an allergen report transported to a provider device, and the provider inputting recommendation information and providing it to the user through a dashboard is equated with determining a medical follow-up in response to a provider command value, therefore Eberting teaches on this limitation and this argument is not persuasive (Eberting, [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”. The electronic medical records include the allergen report which is transported to the healthcare provider’s tab, which is on the provider device; [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.”; [0169]: “a telemedicine visit may be preceded by a direct recommendation for services or products on one dashboard and/or as the direct result of a telemedicine consultation”; The recommendations from the provider are input through a provider command value, and one dashboard created from the recommendation is the determined medical follow-up description, which is determined from the circuits included in the device; [0371]: “Disclosed herein are embodiments of systems, methods, apparatus, circuits, and/or interfaces. As stated above, the embodiments disclosed herein may be embodied as executable instructions stored on a non-transitory machine-readable storage medium. The instructions may comprise computer program code that, when executed and/or interpreted by a computing device, causes the computing device to implement the processing steps and/or operations disclosed herein). Additionally, the motivation to combine is based in the ability to communicate results back and forth with a provider to receive important health recommendations in regards to the test results would be obvious to a person of ordinary skill in the art, therefore this argument is also not persuasive.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
