DETAILED ACTION
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 Objections
Claim 1 is objected to because of the following informalities: It appears the term “scoring value” was cancelled in error when only the element number was intended to be cancelled. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-14 are drawn to a device and a method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites obtaining visual information associated with a skin of the patient; detecting an anomaly on the skin of the patient based at least in part on the obtained visual information; assigning a scoring value to the detected anomaly, wherein the scoring value is associated with the health risk for the patient.
Independent claim 3 recites obtaining visual information associated with a skin of the patient; receiving a scoring value to be assigned to an anomaly on the skin of the patient based at least in part on the obtained visual information, wherein the scoring value is associated with the health risk for the patient.
Independent claim 13 recites obtaining a first visual information associated with a first part of a skin of the patient; detecting a first anomaly on the skin of the patient based at least in part on the obtained first visual information; assigning a first scoring value to the detected first anomaly, wherein the first scoring value is associated with the health risk for the patient.
The respective dependent claims 2, 4-12, and 14, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
Said above recited limitations, as drafted, under their broadest reasonable interpretation, cover mental processes, as reflected in the specification, which states the invention is to “monitoring a health risk for a patient” (see: specification page 2, lines 1, and independent claims 1, 3, and 13 preambles). If a claim, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. The present claims cover mental processes because they address abstract problems with abstract solutions involving observation, evaluation, judgment, and opinion. For instance, the specification states that “[e]ven though[] many noninvasive methods have been developed to at least support the diagnosis of PVDs and PADs, the currently existing methods for diagnosing and curing PVDs and PADs are not yet satisfying…since they may require many manual and thus time-intensive diagnosis steps” (see: specification page2, lines 2-5). To address such deficiencies, the present invention provides for “to track and recognize existing symptoms of the patient or as a tracking tool for physicians to gain access to the progressive symptoms of a potentially prevalent disease” (see: specification page 3, lines 17-20). Accordingly, the claims recite an abstract idea(s). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
Step 2A Prong Two
These judicial exceptions are not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including an “means for detecting…means for assigning…” (claim 1), “means for receiving a scoring value…” (claim 3), “the means for detecting…” (claim 6), “the means for detecting an anomaly…the means for assigning a scoring value…the device further comprising: means for making a comparison…means for assigning a comparison scoring value…” (claim 7), “the means for detecting an anomaly…the means for assigning a scoring value…the device further comprising: means for making a first comparison…means for assigning a first comparison scoring value…” (claim 8), “the means for detecting an anomaly…the means for assigning a scoring value…the means for making the first comparison…the means for assigning the first comparison scoring value…” (claim 9), “wherein the means for detecting an anomaly on the skin of the patient comprise an artificial intelligence engine” (claim 10), “means for weighting the received at least one answer and/or the scoring value…” (claim 12), and “to a trained artificial intelligence engine, wherein the trained AI engine has been trained on previously obtained visual data…through the trained AI engine…by an autoencoder of the trained AI engine…” (claim 14), which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer elements. The “means for detecting an anomaly” corresponds to a trained artificial intelligence engine or model and is configured through no more than a statement than that said means is “for” detected said anomaly, and further, the “autoencoder” of said trained artificial intelligence engine is configured through no more than a statement that that deriving a first anomaly is performed “by” said autoencoder of the trained artificial intelligence engine; the “means for receiving a scoring value” corresponds to a server and is configured through no more than a statement than that said means is “for” receiving said scoring value; and the “means for assigning a scoring value”, “means for making a comparison”, “means for assigning a comparison scoring value”, “means for means for making a first comparison”, “means for means for assigning a first comparison”, and “means for weighting” each correspond to a server and/or smartphone and are each configured through no more than a statement than that said means is “for” its respective function. See: MPEP 2106.05(f).
The claims recite the additional elements of “means for obtaining…” (claim 1), “wherein the means for obtaining comprise means for receiving the visual information from a local device” (claim 2), “means for obtaining…” (claim 3), “the means for obtaining visual information…” (claim 8), “the means for obtaining visual information…” (claim 9), and “means for providing the patient with at least one question…means for receiving at least one answer…” (claim 11), which are nominal or tangential addition to the abstract idea(s) and amount to extra-solution activity concerning mere data gathering. The addition of an insignificant extra-solution activity limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of the recited abstract idea(s) as outlined in the recitations above. See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer elements and limitations directed toward extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea(s) into a practical application because they do not impose any meaningful limits on practicing the abstract idea(s). Accordingly, the claims are directed to an abstract idea(s) (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea(s) into a practical application, using the additional elements to perform the abstract idea(s) amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. See MPEP 2106.05(f).
The claimed additional elements directed toward extra-solution activity, identified above, are not sufficient to amount to significantly more than the judicial exception because they are understood by the courts to perform well-understood, routine, and conventional activities previously known to the industry. The claimed limitations of a “means for obtaining…” (claim 1), “wherein the means for obtaining comprise means for receiving the visual information from a local device” (claim 2), a “means for obtaining…” (claim 3), “the means for obtaining visual information…” (claim 8), “the means for obtaining visual information…” (claim 9), and “means for providing the patient with at least one question…means for receiving at least one answer…” (claim 11), are representative of concepts to electronic recordkeeping, receiving or transmitting data over a network, such as using the Internet to gather data or send messages over a network, and storing and retrieving information in memory. Said representative concepts have been identified by the courts as well-understood, routine, and conventional activities; therefore, the corresponding claimed limitations are shown to be well-understood, routine, and conventional activities. See: MPEP 2106.05(d)(II) and MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea(s) with routine, conventional activity specified at a high level of generality in a particular technological environment. Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea(s) (Step 2B: NO).
Dependent claim(s) 2, 4-12, and 14, when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea(s) without significantly more. These claims fail to remedy the deficiencies of their parent claims above and are therefore rejected for at least the same rationale as applied to their parent claims above and incorporated herein.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention appears to be directed to a computer program per se (Gottschalk v. Benson, 409 U.S. at 72). Specifically, Applicant directly claims “computer program comprising code”, where the specification merely describes as “[a]nother aspect of the present invention relates to a computer program comprising code, which when executed on a computer, performs the method as outlined above” (see: specification, page 20, lines 4-5). A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter (see: MPEP, Chapter 2106, Section I, “The Four Categories of Statutory Subject Matter”).
CLAIM INTERPRETATION IN VIEW OF 35 USC § 112
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
The claim limitations of that have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, correspond to structure described in the specification as follows:
Sensor chip (originally filed specification paragraph page 4, lines 8-10) corresponds to claim 1 “means for obtaining visual information”.
Artificial intelligence, AI, engine or model (originally filed specification page 10, lines 18-19) corresponds to claims 1 “means for detecting an anomaly”.
The device itself (originally filed specification page 4, lines 16-17) corresponds to claim 2 “the means for obtaining comprise means for receiving the visual information from a local device”.
Server (originally filed specification page 4, lines 13-15) corresponds to claim 3 “means for receiving a scoring value”.
Graphical display or at least one loudspeaker (originally filed specification page 11, lines 11-16) corresponds to claim 11 “means for providing the patient with at least one question”.
Touch-sensitive display or microphone (originally filed specification page 11, lines 18-29) corresponds to claim 11 “means for receiving at least one answer”.
The specification states on page 2, lines 17-18, that the “device may be implemented as a remote entity such as, e.g., a server, but also as a local entity, such as a smartphone, for example”, and provides further evidence for the analysis of the invention being performed by a server at page 7, lines 8-18, and the local device being a smartphone at page 15, lines 16-18, which are considered to correspond to the following:
The claim 1 “means for assigning a scoring value”;
The claim 7 “means for making a comparison”;
The claim 7 “means for assigning a comparison scoring value”;
The claim 8 “means for means for making a first comparison”;
The claim 8 “means for means for assigning a first comparison”; and
The claim 12 “means for weighting”.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claim 2-3 is 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 pre-AIA the applicant regards as the invention.
As per claim 2, the claim teaches a device comprising “the means for obtaining comprise means for receiving the visual information from a local device”, but in originally filed specification page 4, lines 16-17, it is stated that such means may be “the device itself.” That the device may comprise a means for obtaining that comprises a means for receiving that is the device itself represents circular logic and renders it unclear as to what is considered the means for obtaining/receiving.
As per claim 3, the claim rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps/elements/structural relationships, such omission amounting to a gap between the steps/elements/structural relationships. See MPEP § 2172.01. The omitted steps/elements/structural relationships are: the means for detecting an anomaly. The claim teaches that visual information is obtained and a scoring value is assigned to an anomaly which was never detected; hence, the omittance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Application Publication 2015/0230712 to Aarabi.
As per claim 3, Aarabi teaches a device for monitoring a health risk for a patient, comprising:
means for obtaining visual information associated with a skin of the patient (see: Aarabi, paragraph 48, 54, 58, 60-61, and 81-83, is met by an image or video may be captured by a camera, such as a camera available on a smart phone, or any other device capable of capturing an image or a video showing skin);
means for receiving a scoring value to be assigned to an anomaly on the skin of the patient based at least in part on the obtained visual information, wherein the scoring value is associated with the health risk for the patient (see: Aarabi, paragraph 25, 55-57, 70-72, 154, 158, and 184, is met by identifying aspects of skin determinable from either an image or video, as well as user responses to certain queries, to highlight the existence of skin health conditions or potential skin health conditions of a subject, where user responses to queries provided to the user relating to skin health may be utilized to determine skin health information relating to specific skin conditions, and the user responses may further be utilized to generate skin health results and an overall skin health determination, and an overall health index score display provides a measurement of the overall level of health of skin shown in the image or video).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2020/0193597 to Fan in view of U.S. Application Publication 2015/0230712 to Aarabi.
As per claim 1, Fan teaches a device for monitoring a health risk for a patient, comprising:
means for obtaining visual information associated with a skin of the patient (see: Fan, Fig. 16; and paragraph 138, is met by the multispectral multi-aperture imaging system can capture image data representing physical points on an object such as a lesion);
means for detecting an anomaly on the skin of the patient based at least in part on the obtained visual information (see: Fan, Fig. 16; and paragraph 138, 140-143, and 145-146, is met by to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue);
Fan teaches the analysis may be further generated based on at least one patient health metric including textual information such as the area of the lesion, health history variables, and the health status of a lesion (see: Fan, Fig. 25; Table 1; and paragraph 8, 144, and 163), but Fan fails to specifically teach the following limitations met by Aarabi as cited:
means for assigning a scoring value to the detected anomaly, wherein the scoring value is associated with the health risk for the patient (see: Aarabi, paragraph 25, 56-57, 70-72, 154, 158, and 184, is met by identifying aspects of skin determinable from either an image or video, as well as user responses to certain queries, to highlight the existence of skin health conditions or potential skin health conditions of a subject, where user responses to queries provided to the user relating to skin health may be utilized to determine skin health information relating to specific skin conditions, and the user responses may further be utilized to generate skin health results and an overall skin health determination, and an overall health index score display provides a measurement of the overall level of health of skin shown in the image or video).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the analysis as taught by Fan to include user responses to queries provided to the user relating to skin health being utilized in a determination of specific skin conditions and overall skin health for display as an overall health index score measurement of the overall level of health of skin in an image or video as taught by Aarabi with the motivation of allowing a diagnosis of multiple skin conditions to be performed by a skin health professional located remotely from the user or the subject (see: Aarabi, paragraph 79).
As per claim 2, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the means for obtaining comprise means for receiving the visual information from a local device (see: Fan, Fig. 10A; Fig. 16; and paragraph 138, is met by mobile device such as smartphones equipped with imaging sensors such that the multispectral multi-aperture imaging system can capture image data representing physical points on an object such as a lesion).
As per claim 4, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the health risk is a prevalence, presence and/or progression of a peripheral arterial disease, PAD, and/or a peripheral vascular disease, PVD, and/or a diabetes (see: Fan, Fig. 16; and paragraph 138, 140-143, and 145-146, is met by to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue).
As per claim 5, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the visual information is a video sequence (see: Fan, paragraph 62, 81, and 113, is met by a device such as cell phone, digital camera, tablet computer, personal digital assistant to capture of still images and video).
As per claim 6, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the means for detecting detects a lesion at least one location on the skin of the patient and an appearance of the lesion (see: Fan, Fig. 16; and paragraph 138, is met by the multispectral multi-aperture imaging system can capture image data representing physical points on an object such as a lesion).
As per claim 7, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
wherein visual information comprises a first visual information and a second visual information, wherein the first visual information and the second visual information are associated with a part of the skin of the patient and the second visual information is obtained later in time than the first visual information (see: Fan, Fig. 16; and paragraph 7-8, 12, 56, and 138, is met by the multispectral multi-aperture imaging system can capture image data representing physical points on an object such as a lesion, an assessed healing parameter over a predetermined time interval such as 30 days);
the means for detecting an anomaly are configured to detect a first anomaly on the part of the skin at least in part on the obtained first visual information, and a second anomaly on the part of the skin at least in part on the obtained second visual information (see: Fan, Fig. 16; and paragraph 7-8, 12, 56, 138, 140-143, and 145-146, is met by an assessed healing parameter over a predetermined time interval such as 30 days, including to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue);
Fan teaches the analysis may be further generated based on at least one patient health metric including textual information such as the area of the lesion, health history variables, and the health status of a lesion (see: Fan, Table 1; and paragraph 8, 144, and 163), but Fan fails to specifically teach the following limitations met by Aarabi as cited:
the means for assigning a scoring value are configured to assign a first scoring value to the first anomaly and a second scoring value to the second anomaly (see: Aarabi, paragraph 25, 56-57, 70-72, 154, 158, 184, and 194, is met by information generated or received in relation to previous images or videos may be stored with the images or videos, including any responses by a user to queries, and can be utilized to conduct an assessment, and identifying aspects of skin determinable from either an image or video, as well as user responses to certain queries, to highlight the existence of skin health conditions or potential skin health conditions of a subject, where user responses to queries provided to the user relating to skin health may be utilized to determine skin health information relating to specific skin conditions, and the user responses may further be utilized to generate skin health results and an overall skin health determination, and an overall health index score display provides a measurement of the overall level of health of skin shown in the image or video); and
the device further comprising: means for making a comparison between the first scoring value and the second scoring value (see: Fan, Fig. 16; and paragraph 194-197, is met by information generated or received in relation to previous images or videos may be stored with the images or videos, including any responses by a user to queries, detailed health score reports, skin health results and scores, overall skin health and scores, which can be utilized to conduct an assessment of improvement or deterioration of skin of the same subject over time); and
means for assigning a comparison scoring value to the second anomaly based on the comparison (see: Fan, Fig. 16; and paragraph 194-197, is met by a review of changes in the skin health - including related skin health results and scores, and overall skin health and scores - of a subject over time).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the analysis, as taught by Fan, to include user responses to queries provided to the user relating to skin health being utilized in a determination of specific skin conditions and overall skin health for display as the score for each skin condition and an overall health index score measurement of the overall level of health of skin in an image or video, where information generated or received in relation to previous images or videos, including any responses by a user to queries, can be utilized to conduct an assessment of improvement or deterioration of skin of the same subject over time including related skin health results and scores, and overall skin health and scores of the subject over time, as taught by Aarabi, with the motivation of allowing a diagnosis and/or monitoring of multiple skin conditions to be performed by a skin health professional located remotely from the user or the subject (see: Aarabi, paragraph 79).
As per claim 8, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the means for obtaining visual information are configured to obtain a first visual information associated with a first part of the skin and a second visual information associated with a second part of the skin (see: Fan, Fig. 16; and paragraph 7-8, 12, 56, 133, 138, and 146, is met by the multispectral multi-aperture imaging system can capture image data representing physical points on an object such as a lesion, and allow for the identification of healthy tissue adjacent to wounded tissue);
the means for detecting an anomaly are configured to detect a first anomaly on the first part of the skin at least in part on the obtained first visual information, and a second anomaly on the second part of the skin at least in part on the obtained second visual information (see: Fan, Fig. 16; and paragraph 7-8, 12, 56, 138, 140-143, and 145-146, is met by the comparing of healthy tissue surrounding the wound bed to the wound bed, including to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue); and
Fan teaches the analysis may be further generated based on at least one patient health metric including textual information such as the area of the lesion, health history variables, and the health status of a lesion (see: Fan, Table 1; and paragraph 8, 144, and 163), but Fan fails to specifically teach the following limitations met by Aarabi as cited:
the means for assigning a scoring value are configured to assign a first scoring value to the first anomaly and a second scoring value to the second anomaly (see: Aarabi, paragraph 25, 56-57, 70-72, 94-96, 154, 158, and 184, is met by determinations of average skin patch or average skin colour may each be utilized as a baseline from which deviations of skin shown in the image or video from an average can be analyzed and otherwise investigated, and identifying aspects of skin determinable from either an image or video, as well as user responses to certain queries, to highlight the existence of skin health conditions or potential skin health conditions of a subject, where user responses to queries provided to the user relating to skin health may be utilized to determine skin health information relating to specific skin conditions, and the user responses may further be utilized to generate skin health results and an overall skin health determination, and an overall health index score display provides a measurement of the overall level of health of skin shown in the image or video); and
the device further comprising: means for making a first comparison between the first scoring value and the second scoring value (see: Fan, Fig. 16; and paragraph 154-158 and 182-184, is met by identify aspects of skin determinable from either an image or video and user responses to certain queries to highlight the existence of skin conditions or potential skin conditions of a subject, where an overall health index score is determined as well as the score for each skin condition to indicate to the user the severity of each skin condition in relation to the skin shown in the image or video); and
means for assigning a first comparison scoring value to the first anomaly based on the first comparison (see: Fan, Fig. 16; and paragraph 25, 56, 154-158, and 182, is met by provide the user a determination of skin health information to highlight the existence of skin conditions or potential skin conditions of a subject, where the score is provided for each skin condition may indicate to the user the severity of each skin condition in relation to the skin shown in the image or video).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the analysis, as taught by Fan, to include user responses to queries provided to the user relating to skin health being utilized in a determination of specific skin conditions and overall skin health for display as the score for each skin condition and an overall health index score measurement of the overall level of health of skin in an image or video, where the determinations of average skin patch or average skin colour may each be utilized as a baseline from which deviations of skin shown in the image or video from an average can be analyzed and used to identify aspects of skin determinable from either an image or video, as well as user responses to certain queries, to highlight the existence of skin health conditions or potential skin health conditions of a subject, as taught by Aarabi, with the motivation of allowing a diagnosis and/or monitoring of multiple skin conditions to be performed by a skin health professional located remotely from the user or the subject (see: Aarabi, paragraph 79).
As per claim 9, Fan and Aarabi teach the invention as claimed, see discussion of claim 8, and further teach:
the means for obtaining visual information are further configured to obtain a third visual information associated with the first part of the skin and a fourth visual information associated with the second part of the skin, wherein the third visual information and the fourth visual information are obtained later in time than the first visual information, respectively, the second visual information (see: Fan, Fig. 16; and paragraph 7-8, 12, 56, and 138, is met by the multispectral multi-aperture imaging system can capture image data representing physical points on an object such as a lesion, an assessed healing parameter over a predetermined time interval such as 30 days);
the means for detecting an anomaly are further configured to detect a third anomaly on the first part of the skin at least in part on the obtained third visual information, and a fourth anomaly on the second part of the skin at least in part on the obtained fourth visual information (see: Fan, Fig. 16; and paragraph 7-8, 12, 56, 138, 140-143, and 145-146, is met by an assessed healing parameter over a predetermined time interval such as 30 days, including to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue);
Fan teaches the analysis may be further generated based on at least one patient health metric including textual information such as the area of the lesion, health history variables, and the health status of a lesion (see: Fan, Table 1; and paragraph 8, 144, and 163), but Fan fails to specifically teach the following limitations met by Aarabi as cited:
the means for assigning a scoring value are configured to assign a third scoring value to the third anomaly and a fourth scoring value to the fourth anomaly (see: Aarabi, paragraph 25, 56-57, 70-72, 154, 158, 184, and 194, is met by information generated or received in relation to previous images or videos may be stored with the images or videos, including any responses by a user to queries, and can be utilized to conduct an assessment, and identifying aspects of skin determinable from either an image or video, as well as user responses to certain queries, to highlight the existence of skin health conditions or potential skin health conditions of a subject, where user responses to queries provided to the user relating to skin health may be utilized to determine skin health information relating to specific skin conditions, and the user responses may further be utilized to generate skin health results and an overall skin health determination, and an overall health index score display provides a measurement of the overall level of health of skin shown in the image or video);
the means for making the first comparison are further configured to make a second comparison between the first scoring value and the third scoring value, and a third comparison between the second scoring value and the fourth scoring value, and/or a fourth comparison between the third scoring value and the fourth scoring value (see: Fan, Fig. 16; and paragraph 194-197, is met by information generated or received in relation to previous images or videos may be stored with the images or videos, including any responses by a user to queries, detailed health score reports, skin health results and scores, overall skin health and scores, which can be utilized to conduct an assessment of improvement or deterioration of skin of the same subject over time); and
the means for assigning the first comparison scoring value are further configured to assign a second comparison scoring value to the third anomaly based on the second comparison and the third comparison and/or the first comparison and/or the fourth comparison (see: Fan, Fig. 16; and paragraph 194-197, is met by a review of changes in the skin health - including related skin health results and scores, and overall skin health and scores - of a subject over time).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the analysis, as taught by Fan, to include user responses to queries provided to the user relating to skin health being utilized in a determination of specific skin conditions and overall skin health for display as the score for each skin condition and an overall health index score measurement of the overall level of health of skin in an image or video, where information generated or received in relation to previous images or videos, including any responses by a user to queries, can be utilized to conduct an assessment of improvement or deterioration of skin of the same subject over time including related skin health results and scores, and overall skin health and scores of the subject over time, as taught by Aarabi, with the motivation of allowing a diagnosis and/or monitoring of multiple skin conditions to be performed by a skin health professional located remotely from the user or the subject (see: Aarabi, paragraph 79).
As per claim 10, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the means for detecting an anomaly on the skin of the patient comprise an artificial intelligence engine (see: Fan, Fig. 16; and paragraph 138, 140-143, and 145-146, is met by to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue).
As per claim 11, Fan and Aarabi teach the invention as claimed, see discussion of claim 1, and further teach:
means for providing the patient with at least one question associated with the health state of the patient, wherein the at least one question is associated with an extent of a pain experienced by the patient and/or a location of the pain experienced by the patient (see: Aarabi, paragraph 2, 56-57, 70-72, 84, 154, 172, and 195, is met by questions being posed to a user via the display unit of the system);
means for receiving at least one answer from the patient in response to the at
least one question (see: Aarabi, paragraph 85, 154, and 172, is met by keyboard, mouse, and/or other communication means, may be connected either wirelessly or via a wired connection to the system, including to the computer processor element of the system, whereby a user may respond to queries posed to said user).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system as taught by Fan to include questions being posed to a user via the display unit of the system and a keyboard, mouse, and/or other communication means whereby a user may respond to queries posed to said user as taught by Aarabi with the motivation of allowing a diagnosis of multiple skin conditions to be performed by a skin health professional located remotely from the user or the subject (see: Aarabi, paragraph 79).
As per claim 12, Fan and Aarabi teach the invention as claimed, see discussion of claim 11, and further teach:
to provide an estimation of the prevalence of PAD, PVD and/or diabetes (see: Fan, Fig. 16; and paragraph 138, 140-143, and 145-146, is met by to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue)
Fan fails to specifically teach the following limitations met by Aarabi as cited:
means for weighting the received at least one answer and/or the scoring value, respectively, the first scoring value and/or the second scoring value and/or the third scoring value and/or the fourth scoring value and/or the first comparison scoring value and/or the second comparison scoring value (see: Aarabi, paragraph 56 and 68-72, user responses to questions provided by the user via the response means may be combined with the parameters and utilized to generate overall skin health, where a weighted averaging of each parameter, as well as each user response to the questions posed, may be utilized, so that the parameters and user responses are processed and combined to determine skin health results and the overall skin health, or alternatively any other statistical combination of the parameters and user responses may be utilized).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the analysis as taught by Fan to include a weighted averaging of each parameter, as well as each user response to the questions posed, may be utilized, so that the parameters and user responses are processed and combined to determine skin health results and the overall skin health as taught by Aarabi with the motivation of allowing a diagnosis of multiple skin conditions to be performed by a skin health professional located remotely from the user or the subject (see: Aarabi, paragraph 79).
As per claim 13, Fan teaches a method for monitoring a health risk for a patient, comprising:
obtaining a first visual information associated with a first part of a skin of the patient (see: Fan, Fig. 16; and paragraph 138, is met by the multispectral multi-aperture imaging system can capture image data representing physical points on an object such as a lesion);
detecting a first anomaly on the skin of the patient based at least in part on the obtained first visual information (see: Fan, Fig. 16; and paragraph 138, 140-143, and 145-146, is met by to assess pathologies involving changes to tissue blood flow and pulse rate including peripheral arterial disease or a diabetic ulcer, where image data is analyzed as input data into a machine learning model to generate a classified mapping of the imaged tissue);
Fan teaches the analysis may be further generated based on at least one patient health metric including textual information such as the area of the lesion, health history variables, and the health status of a lesion (see: Fan, Fig. 25; Table 1; and paragraph 8, 144, and 163), but Fan fails to specifically teach the following limitations met by Aarabi as cited:
assigning a first scoring value to the detected first anomaly, wherein the first scoring value is associated with the health risk for the patient (see: Aarabi, paragraph 25, 56-57, 70-72, 154, 158, and 184, is met by identifying aspects of skin determinable from either an image or video, as well as user responses to certain queries, to highlight the existence of skin health conditions or potential skin health conditions of a subject, where user responses to queries provided to the user relating to skin health may be utilized to determine skin health information relating to specific skin conditions, and the user responses may further be utilized to generate skin health results and an overall skin health determination, and an overall health index score display provides a measurement of the overall level of health of skin shown in the image or video).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the analysis as taught by Fan to include user responses to queries provided to the user relating to skin health being utilized in a determination of specific skin conditions and overall skin health for display as an overall health index score measurement of the overall level of health of skin in an image or video as taught by Aarabi with the motivation of allowing a diagnosis of multiple skin conditions to be performed by a skin health professional located remotely from the user or the subject (see: Aarabi, paragraph 79).
As per claim 14, Fan and Aarabi teach the invention as claimed, see discussion of claim 13, and further teach:
providing the obtained first visual information to a trained artificial intelligence engine, wherein the trained AI engine has been trained on previously obtained visual data considered as healthy and based on a skin type of the patient (see: Fan, paragraph 12, 118, 144, and 146, is met by training data including actual provided data used for training an artificial neural network based on patient metrics to train different instances of the machine learning model for use with other patients having those same patient metrics, where patient metrics can include textual information or medical history or aspects thereof describing characteristics of the patient or the patient's health status such as the area of a wound, lesion, or ulcer, the diabetic status of the patient, the existence of peripheral vascular disease, and a machine learning model trained to classify according to a certain wound states including healthy skin category); and/or
deriving a first anomaly in the obtained first visual information through the trained AI engine by reconstructing the obtained first visual information by an autoencoder of the trained AI engine and comparing the reconstructed information to the obtained first visual information (see: Fan, paragraph 161 and 169, is met by an autoencoder neural network to compress the input data with the encoder such that the output is a good/perfect reconstruction of the original input data with reduced feature representation of the input).
As per claim 16, Fan and Aarabi teach the invention as claimed, see discussion of claim 13, and further teach:
A computer program comprising code, which when executed on a computer, performs the method of claim 13 (see: Fan, paragraph 234 and 238, is met by a processor (or multiple processors) that executes program instructions or modules stored in a memory or other non-transitory computer-readable storage medium or device, including solid state storage devices and disk drives, where the various functions disclosed herein may be embodied in such program instructions, or may be implemented in application-specific circuitry of the computer system).
Conclusion
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/ROBERT A SOREY/Primary Examiner, Art Unit 3682
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