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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/16/2024 and 07/11/2024 has/have been considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it has phrases “embodiment provides” and “In certain embodiments”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, line 1, “The method of claim 9” should read -- The method of claim 8 --.
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 1-2 and 4-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding independent claim 1, the claim recites a series of steps. This is a process.
The claim recites processing a medical image to identify a geometric shape and providing an indication of skin irritation. The claim recites several abstract ideas. The claim recites “analyzing”, “identifying” and “determining” steps for detecting geometric shape and skin irritation. The limitations, as drafted, is a product that, under its broadest reasonable interpretation when read in light of the specification, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “medical device” and “one or more processors”, nothing in the claim element precludes the steps from practically being performed in the mind using observation, evaluation, judgment, and opinion. Such mental observations or evaluations fall within the “mental processes” grouping of abstract ideas. Accordingly, the claim recites abstract ideas.
This judicial exception is not integrated into a practical application. In particular, the claim recites additional elements: “obtaining” and “providing” steps. These are data gathering steps. The hardware in these steps is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea, that is no indication of improvement to any other technology or technical field, (see MPEP 2106.05(a)), or applying or by use of, a particular machine (see MPEP 2106.05(b)), or effecting a transformation (see MPEP 2106.05(c)), or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (see MPEP 2106.05(e)).
The claim does 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 into a practical application, the additional element of using a processor to perform prompting and providing steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component or simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (see MPEP 2106.05) cannot provide an inventive concept.
Therefore, the claim is directed to an abstract idea and is not patent eligible.
Claims 14-15 are rejected under 35 U.S.C. 101 with the same analysis as given in claim 1.
The limitations of claims 14 and 15, as drafted, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “non-transitory computer readable medium”, “medical device”, and “one or more processor”, nothing in the claim elements precludes the step from practically being performed in the mind. Mere instructions to apply an exception using a generic computer component or simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (see MPEP 2106.05) cannot provide an inventive concept.
Claim 2 recites “indicating” step that can be performed in the mind. The claim recites additional elements “providing …” and “obtaining …” steps. These are data gathering steps. The additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea, that is no indication of improvement to any other technology or technical field, (see MPEP 2106.05(a)), or applying or by use of, a particular machine (see MPEP 2106.05(b)), or effecting a transformation (see MPEP 2106.05(c)), or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (see MPEP 2106.05(e)).
Claim 4 recites claim limitation “the geometric shape comprises…” that can be performed in the mind.
Claim 5 recites additional element “using a neural network”. However, The claim does not provide any details how the neural network operates or how the analyzing and identifying are accomplished. The neural network is described at a high level such that it amounts to use the network to apply the abstract idea without limiting how the neural network functions. This type of limitation merely confines the use of the abstract idea to a particular technological environment and thus fails to add an inventive concept to the claim. See MPEP 2106.05(f). Accordingly, the claim recites an abstract idea.
Claim 6 recites claim limitation “wherein the subset of image data … geometric shape comprises…” that can be performed in the mind.
Claim 7 recites a “determining” step that can be performed in the mind.
Claims 8 and 9 recite a “selecting” step that can be performed in the mind.
Claim 10 recites additional element “providing” step that is a data gathering step. The additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea, that is no indication of improvement to any other technology or technical field, (see MPEP 2106.05(a)), or applying or by use of, a particular machine (see MPEP 2106.05(b)), or effecting a transformation (see MPEP 2106.05(c)), or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (see MPEP 2106.05(e)).
Claim 11 recites an “indicating” step that can be performed in the mind
Claim 12 recites additional element “obtaining” step that is a data gathering steps. The additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea, that is no indication of improvement to any other technology or technical field, (see MPEP 2106.05(a)), or applying or by use of, a particular machine (see MPEP 2106.05(b)), or effecting a transformation (see MPEP 2106.05(c)), or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (see MPEP 2106.05(e)).
Claim 13 recites “analyzing” and “identifying” steps that can be performed in the mind. The claim recites additional elements “obtaining” and “providing” steps that are data gathering steps. The additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea, that is no indication of improvement to any other technology or technical field, (see MPEP 2106.05(a)), or applying or by use of, a particular machine (see MPEP 2106.05(b)), or effecting a transformation (see MPEP 2106.05(c)), or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (see MPEP 2106.05(e)).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements represent mere instructions to implement an abstract idea or other exception on a generic component or computer and insignificant extra-solution activity, which do not provide an inventive concept.
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, 5-11, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klochko et al (US 20220148172 A1), hereinafter Klochko in view of Lewinson et al (US 20230277119 A1), hereinafter Lewinson.
-Regarding claim 1, Klochko discloses a method, comprising (Abstract; FIGS. 1-4
PNG
media_image1.png
641
502
media_image1.png
Greyscale
): obtaining a medical image comprising a geometric shape (FIG. 3, step 102; [0016], “medical condition … one or more images of an area of interest … body … corresponding to respective anatomical structures of interest”; [0045], “a polygon or other shape”); analyzing, using a set of one or more processors (FIG. 1), the medical image to identify the geometric shape (FIG. 3, step 110; [0045], “a box or other geometric shape around a desired portion of the image, …. as a region of interest”; [0046]); identifying, using the set of one or more processors (FIG. 1), a subset of image data of the medical image associated with the geometric shape (FIG. 3, steps 116, 118; [0057]; [0059]); determining, using the set of one or more processors (FIG. 1), that the subset of image data indicates medical condition; and providing, using the set of one or more processors, an indication of medical condition (FIG. 3, steps 120-122; [0061]; [0067]).
Klochko does not disclose a geometric shape associated with a medical device and a medical condition associated with skin irritation. However, a person of ordinary skills in the art would understand that Klochko’s method can be applied to any kind of geometric shape as a region of interest, and any kind of medical conditions including skin irritation.
In the same field of endeavor, Lewinson teaches a method to detect skin contact reactions to a set of allergens (Lewinson: Abstract; FIGS. 1-5; [0064]). Lewinson further teaches a geometric shape associated with a medical device (Lewinson: FIG. 1A, steps 101-104; [0030], “patch orientation …shape”; [0042], “patch test area”; FIG. 4; FIG. 5, steps 502-504) and a medical condition associated with skin irritation (Lewinson: [0041], “skin … irritant reactions”; [0047], “irritants causing the positive reaction”; FIG. 5, step 506). Lewinson also teaches identifying areas corresponding to positive reactions using machine learning model and labeling positive reactions (Lewinson: FIG. 1A, steps 106-107; FIG. 1B; [0054]; FIG. 5, steps 506-508).
Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to combine the teaching of Klochko with the teaching of Lewinson by identifying a geometric shape associated with a patch and identifying skin irritation in order to provide an application for safe product recommendations.
-Regarding claim 2, Klochko in view of Lewinson teaches the method of claim 1. The combination further teaches providing an instruction to capture the medical image; thereafter indicating the geometric shape within the medical image (Klochko: FIGS. 1, 3); and obtaining a confirmation that the geometric shape has been identified (Klochko: FIG. 1, user interface 26; [0029]; [0030], “allow the user to control one or more operating parameters of the system 10… to receive information or indications from the system 10 relating to … the operation or functionality of the system 10”; [0032]; [0045]; [0063]).
-Regarding claim 5, Klochko in view of Lewinson teaches the method of claim 1. The combination further teaches wherein one or more of the analyzing and the identifying comprises using a neural network to identify one or more of the geometric shape and the subset of image data associated with the geometric shape (Klochko: [0048]; [0078]; See also Lewinson: [0045]).
-Regarding claim 6, Klochko in view of Lewinson teaches the method of claim 1. The combination further teaches wherein the subset of image data associated with the geometric shape comprises one or more of pixel data located within a predetermined distance of the geometric shape and pixel data within the geometric shape (Klochko: [0045], “the coordinates of a polygon or other shape outlining the region of interest, a pixel map that traces the exact border of the anatomy/region of interest, or other suitable coordinates”; [0054]; [0056]).
-Regarding claim 7, Klochko in view of Lewinson teaches the method of claim 1. The combination further teaches wherein the determining comprises comparing one or more pixel values to a set of thresholds indicative of skin irritation (Klochko: [0053], “the score or ratio … pixel intensity of … region of interest”; [0054]; [0062], “the score … compared with one or more predetermined… threshold …”).
-Regarding claim 8, Klochko in view of Lewinson teaches the method of claim 7. The combination further teaches selecting an instruction based on the comparing the one or more pixel values to the set of thresholds (Klochko: FIG. 1; FIG. 3, steps 120-122; [0061], “determine whether that value corresponds to an indication of “condition detected or present” or “condition not detected or not present,” or some variant thereof”; [0062]).
-Regarding claim 9, Klochko in view of Lewinson teaches the method of claim 8. The combination further teaches wherein the instruction is selected based on a threshold from the set of thresholds (Klochko: [0063], “one or more of these thresholds may be selected”; [0064]; FIG. 3, steps 120-122).
-Regarding claim 10, Klochko in view of Lewinson teaches the method of claim 9.
Klochko discloses wherein the providing comprises including the instruction with the indication of medical condition (Klochko: FIG. 3). Klochko does not disclose a medical condition as skin irritation.
Klochko does not disclose a geometric shape associated with a medical device and a medical condition associated with skin irritation. However, a person of ordinary skills in the art would understand that Klochko’s method can be applied to any kind of geometric shape as a region of interest, and any kind of medical conditions including skin irritation.
In the same field of endeavor, Lewinson teaches a method to detect skin contact reactions to a set of allergens (Lewinson: Abstract; FIGS. 1-5; [0064]). Lewinson further teaches a geometric shape associated with a medical device (Lewinson: FIG. 1A, steps 101-104; [0030], “patch orientation …shape”; [0042], “patch test area”; FIG. 4; FIG. 5, steps 502-504) and a medical condition associated with skin irritation (Lewinson: [0041], “skin … irritant reactions”; [0047], “irritants causing the positive reaction”; FIG. 5, step 506). Lewinson also teaches identifying areas corresponding to positive reactions using machine learning model and labeling positive reactions (Lewinson: FIG. 1A, steps 106-107; FIG. 1B; [0054]; FIG. 5, steps 506-508).
-Regarding claim 11, Klochko in view of Lewinson, teaches the method of claim 10. The combination further teaches wherein the instruction comprises one or more of audio data and visual data indicating that the medical device should be repositioned (FIG. 3; [0067], “provide an indication to the user as to whether or not the medical condition was detected … may comprise outputting the electrical signal to a user interface … a visual display … a visual indication … the electrical signal may be output to a speaker …”; A person of ordinary skills in the art would that preventative measures such as repositioning the medical device should be taken based on the indication. See also Rastogi (US 20210137447 A1): [0006]).
-Regarding claim 13, Klochko in view of Lewinson, teaches the method of claim 1. The combination further teaches wherein the obtaining, the analyzing, the identifying, the determining, and the providing are performed locally on a client device (Klochko: FIGS. 1-4; Note: all operations or functions are not involved any server. Thus, Klochko’s method is considered at client side. However, it can be applied to server side as well. See also Baker et al (US 20200261016 A1): FIG. 1).
-Regarding claim 14, Klochko discloses a computer program product, comprising: a non-transitory computer readable medium comprising code executable by a set of one or more processors (FIG. 1; [0019]-[0021]), the code comprising (Abstract; FIGS. 1-4): code that obtains a medical image comprising a geometric shape (FIG. 3, step 102; [0016], “medical condition … one or more images of an area of interest … body … corresponding to respective anatomical structures of interest”; [0045], “a polygon or other shape”); code that analyzes the medical image to identify the geometric shape (FIG. 3, step 110; [0045], “a box or other geometric shape around a desired portion of the image, …. as a region of interest”; [0046]); code that identifies a subset of image data of the medical image associated with the geometric shape (FIG. 3, steps 116, 118; [0057]; [0059]); code that determines that the subset of image data indicates medical condition; and code that provides an indication of medical condition (FIG. 3, steps 120-122; [0061]; [0067]).
Klochko does not disclose a geometric shape associated with a medical device and a medical condition associated with skin irritation. However, a person of ordinary skills in the art would understand that Klochko’s method can be applied to any kind of geometric shape as a region of interest, and any kind of medical conditions including skin irritation.
In the same field of endeavor, Lewinson teaches a method to detect skin contact reactions to a set of allergens (Lewinson: Abstract; FIGS. 1-5; [0064]). Lewinson further teaches a geometric shape associated with a medical device (Lewinson: FIG. 1A, steps 101-104; [0030], “patch orientation …shape”; [0042], “patch test area”; FIG. 4; FIG. 5, steps 502-504) and a medical condition associated with skin irritation (Lewinson: [0041], “skin … irritant reactions”; [0047], “irritants causing the positive reaction”; FIG. 5, step 506). Lewinson also teaches identifying areas corresponding to positive reactions using machine learning model and labeling positive reactions (Lewinson: FIG. 1A, steps 106-107; FIG. 1B; [0054]; FIG. 5, steps 506-508).
Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to combine the teaching of Klochko with the teaching of Lewinson by identifying a geometric shape associated with a patch and identifying skin irritation in order to provide an application for safe product recommendations.
-Regarding claim 15, Klochko discloses a device, comprising (FIG. 1): a set of one or more processors; and a non-transitory computer readable medium comprising code executable by the set of one or more processors (FIG. 1; [0019]-[0021]), the code comprising (Abstract; FIGS. 1-4): code that obtains a medical image comprising a geometric shape (FIG. 3, step 102; [0016], “medical condition … one or more images of an area of interest … body … corresponding to respective anatomical structures of interest”; [0045], “a polygon or other shape”); code that analyzes the medical image to identify the geometric shape (FIG. 3, step 110; [0045], “a box or other geometric shape around a desired portion of the image, …. as a region of interest”; [0046]); code that identifies a subset of image data of the medical image associated with the geometric shape (FIG. 3, steps 116, 118; [0057]; [0059]); code that determines that the subset of image data indicates medical condition; and code that provides an indication of medical condition (FIG. 3, steps 120-122; [0061]; [0067]).
Klochko does not disclose a geometric shape associated with a medical device and a medical condition associated with skin irritation. However, a person of ordinary skills in the art would understand that Klochko’s method can be applied to any kind of geometric shape as a region of interest, and any kind of medical conditions including skin irritation.
In the same field of endeavor, Lewinson teaches a method to detect skin contact reactions to a set of allergens (Lewinson: Abstract; FIGS. 1-5; [0064]). Lewinson further teaches a geometric shape associated with a medical device (Lewinson: FIG. 1A, steps 101-104; [0030], “patch orientation …shape”; [0042], “patch test area”; FIG. 4; FIG. 5, steps 502-504) and a medical condition associated with skin irritation (Lewinson: [0041], “skin … irritant reactions”; [0047], “irritants causing the positive reaction”; FIG. 5, step 506). Lewinson also teaches identifying areas corresponding to positive reactions using machine learning model and labeling positive reactions (Lewinson: FIG. 1A, steps 106-107; FIG. 1B; [0054]; FIG. 5, steps 506-508).
Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to combine the teaching of Klochko with the teaching of Lewinson by identifying a geometric shape associated with a patch and identifying skin irritation in order to provide an application for safe product recommendations.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klochko et al (US 20220148172 A1), hereinafter Klochko in view of Lewinson et al (US 20230277119 A1), hereinafter Lewinson, and further in view of Chi et al (2022 IEEE International Conference on Networking, Sensing and Control (ICNSC)), hereinafter Chi.
-Regarding claim 3, Klochko in view of Lewinson, teaches the method of claim 1.
Klochko in view of Lewinson, does not teach wherein the analyzing comprises performing template matching to identify the geometric shape.
However, Chi is an analogous art pertinent to the problem to be solved in this application and teaches a target detection method (Chi: FIGS. 1-9). Chi further teaches wherein the analyzing comprises performing template matching to identify the geometric shape (Chi: FIGS. 3-4; Page 2, Sec. III.).
Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the teaching of Klochko in view of Lewinson with the teaching of Chi by performing template matching to identify the geometric shape in order to improve accuracy of the identification.
-Regarding claim 4, Klochko in view of Lewinson, and further in view of Chi teaches the method of claim 3.
Klochko does not disclose wherein the geometric shape comprises a predetermined patch shape.
In the same field of endeavor, Lewinson teaches a method to detect skin contact reactions to a set of allergens (Lewinson: Abstract; FIGS. 1-5; [0064]). Lewinson further teaches wherein the geometric shape comprises a predetermined patch shape (Lewinson: FIG. 4; FIG. 5, steps 502-504; [0062]).
Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to combine the teaching of Klochko with the teaching of Lewinson by identifying a geometric shape associated with a patch and identifying skin irritation in order to provide an application for safe product recommendations.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and overcome claim rejections in above section of “Claim Rejections - 35 USC § 101”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAO LIU whose telephone number is (571)272-4539. The examiner can normally be reached Monday-Thursday and Alternate Fridays 8:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Mehmood can be reached at (571) 272-2976. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/XIAO LIU/Primary Examiner, Art Unit 2664