DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed July 16, 2025.
Claims 1-21 are pending
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(s)
The information disclosure statement (IDS) submitted on 02/19/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejection - 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 1-21 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter the grounds set out in detail below:
Independent Claim 1:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent claim 1 falls within the statutory category of machine.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claim 1 claimed invention are directed to a judicial exception.
The claim elements in the independent claim 1 which set forth the abstract idea are:
A system for determining medical treatment parameters based on a desired appearance for a body part of a subject, comprising:
capture one or more digital images of the body part of the subject;
display the one or more digital images captured by the camera system;
receive one or more inputs that alter a characteristic of the body part of the subject based on the desired appearance for the body part
calculate a medical treatment based on the one or more inputs to achieve the desired appearance for the body part.
which falls within “certain methods of organizing human activity” as following rules or instructions to calculate a medical treatment for a body part based on desired appearance for the body part. See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent Claim 1 this judicial exception is not integrated into a practical application.
In Claim 1 the additional elements are:
a camera system
a display
a processing system
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
No additional element is recited as executing the abstract idea.
The additional element, a camera system, is recited as a tool or equivalent to apply the abstract idea as “apply-it” (e.g. configured to) to gather data
The additional element, a display, is stated as a tool or equivalent to apply the abstract idea as “apply-it” (e.g. configured to) to output data
The additional element, a processing system, is stated as a tool or equivalent to apply the abstract idea as “apply-it” (e.g. configured to) to analyze data
Accordingly, claim 1 does not integrate the abstract idea into a practical application.
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claim 1 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than applying the abstract idea thus insufficient to provide “significantly more”. Therefore, the claims do not amount to significantly more and the claims are ineligible.
Dependent Claims 2-21:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
The dependent claims 2-21 falls within the statutory category of machine.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2-21 claimed invention are directed to a judicial exception.
Dependent claims 2-21 continue to limit the abstract idea in the independent claims by (1) further limiting analyzing the images, (2) further limiting altering images and characteristics of body part, (3) further limiting the medical treatment, (4) further limiting injection parameters, and (5) further limiting the medical treatment thus, inheriting the same abstract idea which falls within “certain methods of organizing human activity” as following rules or instructions to calculate a medical treatment for a body part based on desired appearance for the body part. See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): In Claims 2-21 this judicial exception is not integrated into a practical application.
In Claims 2-21 the additional elements not already recited in the independent claim are:
wired or wireless communication
a touchscreen user interface comprising an array of controls
a projection device
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (a), is used as a tool or equivalent as “apply-it” to communicate data
The additional element, (b), is used as a tool or equivalent as “apply-it” to gather and output data
The additional element (c), is used as a tool or equivalent as “apply-it” (e.g. configured to) to apply the abstract idea of illuminating injections sites.
Eligibility Step 2B (Does the claim amount to significantly more?): Dependent claims 2-21 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than “apply-it” and thus insufficient to provide “significantly more”. Therefore, the claims do not amount to significantly more and the claims are ineligible.
Claim interpretation - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “a processing system configured to receive one or more inputs that alter a characteristic of the body part of the subject based on the desired appearance for the body part and to calculate a medical treatment based on the one or more inputs to achieve the desired appearance for the body part.” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-14 and 20-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tufail et. al (hereinafter Tufail) (US12277707B2)
As per claim 1, Tufail teaches:
A system for determining medical treatment parameters based on a desired appearance for a body part of a subject, comprising: (Col. 8 lines 45-60 discloses, “The inventive method and system may even be used following surgery affecting the appearance of the facial region, including plastic or cosmetic surgery, to monitor the healing process and to detect adverse complications at an early stage. Preferably, the additional information comprises indications on a desired outcome of the treatment provided by the human subject and/or an attending professional of the human subject. This allows for assessing whether the treatment has the desired effect and whether the treatment may be stopped because its goal has been attained. Indications on a desired outcome are particularly advantageous if the desired outcome is not basically the same in all treatments of the condition ( clear skin, remission of blepharitis or a chalazion, complete opening of the eye lid, etc.). This applies in particular to cosmetic treatments.”)
a camera system configured to capture one or more digital images of the body part of the subject; (Col. 3 lines 1-13 discloses, “The at least one image is acquired by suitable means, in particular by a digital camera, which may be a standalone device or integrated into another device (such as a desktop or notebook computer, webcam, smartphone, tablet computer, digital mirror, etc.). A digital camera generates digital image data representing the image. This image data may be processed in further steps of the method. The step of processing the image data may include known image processing steps to improve the image quality ( e. g. for reducing noise, sharpening the image, correcting imag- ing errors, etc.), to identify and/or measuring certain structures (e.g. facial structures, wrinkles, spots, etc.) and/or to generate statistical data (e. g. on the colour distribution).” And see Col. 5 lines 35-40 discloses, “Preferably, the acquiring step includes acquiring a plurality of images of the facial region. Accordingly, the camera of the inventive system is operated to acquire a plurality of images and to forward the image data representing the plurality of images to the processor. This allows for improving the image data and/or data derived from the image data.”)
a display configured to display the one or more digital images captured by the camera system; (Col. 9 lines 40-53 discloses, “The FIG. 1 is a block diagram of an embodiment of an inventive system for generating treatment recommendations. The system includes a user terminal 1, in the described example this is a smartphone, including inter alia a display 2 and a front camera 3. The user terminal 1 further includes a communication interface for communicating over a mobile network. The front camera 3 is on the same face of the user terminal 1 as the display. This allows for acquiring images of the user, while at the same time displaying information (such as a real-time display of the acquired image or instructions). The display 2 features a touchscreen, such that the user is enabled to operate most of the functions of the user terminal 1 by appropriately touching regions of the touch screen.”)
and a processing system configured to receive one or more inputs that alter a characteristic of the body part of the subject based on the desired appearance for the body part and to calculate a medical treatment based on the one or more inputs to achieve the desired appearance for the body part. (see figs. 2E-3B and see Col. 12 lines 13-51 discloses, “The corresponding image data is fed to a machine learning process for classifying the image with respect to the treatment recommendation to be obtained, taking into account additional information provided, including indications about a desired outcome ( or a default indication, if no user-specific information is available). In particular, a multilabel classification method is employed that allows for providing multi-dimensional treatment recommendations. In the given example, only the subregions of the facial region chosen by the user will be processed, i. e. the forehead lines area 51. The machine learning process has access to input information relating to a considerable number of BoNT treatments of this area, including information on the visual appearance before and after the treatment as well as on the treatment itself, including in particular injection positions and dosage. All information is anonymized and pooled and delivered to the server in a HIP AA compliant encrypted way. The datasets may be complemented by further information, e. g. on the patient (gender, age, skin type, etc.) or on the treatment (follow-up treatment steps, treatment interval, specific composition used, etc.). All this information may be taken into account in the machine learning process. The process may include the generation of heatmaps representing the change over time ( e. g. before/after a certain kind of treatment or the actual treatment provided to the user in the past). The machine learning process may be complemented by an optimization step, in particular if several areas are treated and/or if several kinds of treatment are combined. The overall expected result of the treatment, represented by a score, may be optimized based on a numerical optimization process. Both the optimization as well as the machine learning process may be based on scales (metrics) that have been developed, e. g. scales measuring the degree of ageing and the severity of facial wrinkles in the field of non-surgical cosmetic procedures. The scales provide an objectified framework for evaluating the level of improvement resulting from cosmetic procedures.”)
As per claim 2, Tufail teaches:
The system of claim 1, wherein the camera system, the processing system, and the display are coupled in wired or wireless communication for transferring the one or more digital images associated with the medical treatment there between. (Col. 9 lines 40-67 and Col. 10 lines 1-2 discloses, “The FIG. 1 is a block diagram of an embodiment of an inventive system for generating treatment recommendations. The system includes a user terminal 1, in the described example this is a smartphone, including inter alia a display 2 and a front camera 3. The user terminal 1 further includes a communication interface for communicating over a mobile network. The front camera 3 is on the same face of the user terminal 1 as the display. This allows for acquiring images of the user, while at the same time displaying information (such as a real-time display of the acquired image or instructions). The display 2 features a touchscreen, such that the user is enabled to operate most of the functions of the user terminal 1 by appropriately touching regions of the touch screen. The user terminal 1 communicates with a server 10 over the mobile network. For that purpose, the server 10 comprises a mobile network communication interface 11. The server 10 further comprises a processor including a comparison module 12 and a classifying module 13. It is to be noted that in the described example the comparison module 12 and the classifying module 13 are software modules running on the server computer. Data is exchanged between the communication interface 11, the comparison module 12 and the classifying module 13. The server 10 further comprises a second communication module 14 for accessing a cloud storage 20 and a third communication module 15 for communicating with a computer system 30 of an attending professional. Both the second communication module 14 and the third communication module 15 exchange data with the processor of the server 10.”)
As per claim 3, Tufail teaches:
The system of claim 2, wherein the camera system is configured to store and transfer the one or more digital images to the processing system, the display, or a combination thereof. (see col. 9 and see Col. 10 lines 25-58 discloses, “The user may select areas to be treated by activating the respective area by operating the touchscreen at the respective place(s). In the described example, the user selects the forehead lines area 51. The choice is confirmed by displaying the chosen area(s) by dashing (see FIG. 2B). In a next step, the user is guided to acquire those images that are needed to assess the present state of the condition to be treated. This may include the taking of detail images of the areas to be treated. For that purpose, a frame 61 denoting the area to be imaged is overlaid the real-time image of the user (see FIG. 2C), and the user repositions the user terminal 1 until the frame roughly corresponds with the display. As soon as this is the case, a still image is automatically acquired (see FIG. 2D). If the entire facial region relevant for BoNTs treatments shall be covered, usually about 5-8 images will be required ( e. g. forehead both sides, lower face just below the eyes to below the chin, right and left side of the face). In order to enhance relevant structures of the facial region, the user may be asked to assume a certain facial expression. In the described case, the user is asked to raise his eyebrows as high as possible by displaying a corresponding instruction 62 (see FIG. 2D). Both the still image of the user with a relaxed facial expression and of the user with raised eyebrows (FIG. 2E) are stored in the memory of the user terminal 1. …[…]….The acquired images are sent to the server 10 over the mobile network. In the server 10, the images are processed to generate an initial proposal for a treatment recommendation as described in more detail below.”)
As per claim 4, Tufail teaches:
The system of claim 1, wherein the processing system is further configured to divide at least one of the one or more digital images displayed on the display into a plurality of demarcated regions on the display. (see Fig. 2B and see Col. 10 lines 11-29 discloses, “In a first step, the treatment areas are defined. For that purpose, possible treatment areas are marked by oval areas overlaid on an acquired still image of the facial area of the user. The correct locations for the areas is determined based on an image recognition process, identifying marked features of the facial region. In the described example, the marked possible treatment areas are the following: forehead lines (area 51); eyebrows (areas 52a, 52b); frown lines (area 53); crow's feet (areas 54a, 54b); bunny lines (area 55); comers of the mouth ( areas 56a, 56b ); and chin (area 57). The user may select areas to be treated by activating the respective area by operating the touchscreen at the respective place(s). In the described example, the user selects the forehead lines area 51. The choice is confirmed by displaying the chosen area(s) by dashing (see FIG. 2B).”)
As per claim 5, Tufail teaches:
The system of claim 4, wherein the plurality of demarcated regions are transposed over the at least one of the one or more digital images displayed on the display. (see Fig. 2B and see Col. 10 lines 11-50 discloses, “In a first step, the treatment areas are defined. For that purpose, possible treatment areas are marked by oval areas overlaid on an acquired still image of the facial area of the user. The correct locations for the areas is determined based on an image recognition process, identifying marked features of the facial region. In the described example, the marked possible treatment areas are the following: forehead lines (area 51); eyebrows (areas 52a, 52b); frown lines (area 53); crow's feet (areas 54a, 54b); bunny lines (area 55); comers of the mouth ( areas 56a, 56b ); and chin (area 57). The user may select areas to be treated by activating the respective area by operating the touchscreen at the respective place(s). In the described example, the user selects the forehead lines area 51. The choice is confirmed by displaying the chosen area(s) by dashing (see FIG. 2B). In a next step, the user is guided to acquire those images that are needed to assess the present state of the condition to be treated. This may include the taking of detail images of the areas to be treated. For that purpose, a frame 61 denoting the area to be imaged is overlaid the real-time image of the user (see FIG. 2C), and the user repositions the user terminal 1 until the frame roughly corresponds with the display. As soon as this is the case, a still image is automatically acquired (see FIG. 2D). If the entire facial region relevant for BoNTs treatments 40 shall be covered, usually about 5-8 images will be required ( e. g. forehead both sides, lower face just below the eyes to below the chin, right and left side of the face). In order to enhance relevant structures of the facial region, the user may be asked to assume a certain facial expression. In the described case, the user is asked to raise his eyebrows as high as possible by displaying a corresponding instruction 62 (see FIG. 2D). Both the still image of the user with a relaxed facial expression and of the user with raised eyebrows (FIG. 2E) are stored in the memory of the user terminal 1.”)
As per claim 6, Tufail teaches:
The system of claim 5, wherein each of the plurality of demarcated regions is associated with a particular area of the body part of the subject. (see Fig. 2B and see Col. 10 lines 11-50 discloses, “In a first step, the treatment areas are defined. For that purpose, possible treatment areas are marked by oval areas overlaid on an acquired still image of the facial area of the user. The correct locations for the areas is determined based on an image recognition process, identifying marked features of the facial region. In the described example, the marked possible treatment areas are the following: forehead lines (area 51); eyebrows (areas 52a, 52b); frown lines (area 53); crow's feet (areas 54a, 54b); bunny lines (area 55); comers of the mouth ( areas 56a, 56b ); and chin (area 57). The user may select areas to be treated by activating the respective area by operating the touchscreen at the respective place(s). In the described example, the user selects the forehead lines area 51. The choice is confirmed by displaying the chosen area(s) by dashing (see FIG. 2B). In a next step, the user is guided to acquire those images that are needed to assess the present state of the condition to be treated. This may include the taking of detail images of the areas to be treated. For that purpose, a frame 61 denoting the area to be imaged is overlaid the real-time image of the user (see FIG. 2C), and the user repositions the user terminal 1 until the frame roughly corresponds with the display. As soon as this is the case, a still image is automatically acquired (see FIG. 2D). If the entire facial region relevant for BoNTs treatments 40 shall be covered, usually about 5-8 images will be required ( e. g. forehead both sides, lower face just below the eyes to below the chin, right and left side of the face). In order to enhance relevant structures of the facial region, the user may be asked to assume a certain facial expression. In the described case, the user is asked to raise his eyebrows as high as possible by displaying a corresponding instruction 62 (see FIG. 2D). Both the still image of the user with a relaxed facial expression and of the user with raised eyebrows (FIG. 2E) are stored in the memory of the user terminal 1.”)
As per claim 7, Tufail teaches:
The system of claim 1, wherein the display comprises a touchscreen user interface that accepts at least one of the one or more inputs that are received by the processing system. (see Fig. 2B and see Col. 10 lines 11-50 discloses, “In a first step, the treatment areas are defined. For that purpose, possible treatment areas are marked by oval areas overlaid on an acquired still image of the facial area of the user. The correct locations for the areas is determined based on an image recognition process, identifying marked features of the facial region. In the described example, the marked possible treatment areas are the following: forehead lines (area 51); eyebrows (areas 52a, 52b); frown lines (area 53); crow's feet (areas 54a, 54b); bunny lines (area 55); comers of the mouth ( areas 56a, 56b ); and chin (area 57). The user may select areas to be treated by activating the respective area by operating the touchscreen at the respective place(s). In the described example, the user selects the forehead lines area 51. The choice is confirmed by displaying the chosen area(s) by dashing (see FIG. 2B). In a next step, the user is guided to acquire those images that are needed to assess the present state of the condition to be treated. This may include the taking of detail images of the areas to be treated. For that purpose, a frame 61 denoting the area to be imaged is overlaid the real-time image of the user (see FIG. 2C), and the user repositions the user terminal 1 until the frame roughly corresponds with the display. As soon as this is the case, a still image is automatically acquired (see FIG. 2D). If the entire facial region relevant for BoNTs treatments 40 shall be covered, usually about 5-8 images will be required ( e. g. forehead both sides, lower face just below the eyes to below the chin, right and left side of the face). In order to enhance relevant structures of the facial region, the user may be asked to assume a certain facial expression. In the described case, the user is asked to raise his eyebrows as high as possible by displaying a corresponding instruction 62 (see FIG. 2D). Both the still image of the user with a relaxed facial expression and of the user with raised eyebrows (FIG. 2E) are stored in the memory of the user terminal 1.”)
As per claim 8, Tufail teaches:
The system of claim 7, wherein the processing system is configured to divide at least one of the one or more digital images displayed on the display into a plurality of demarcated regions transposed over the at least one of the one or more digital images displayed on the display; wherein each of the plurality of demarcated regions is associated with a distinct area of the body part of the subject; wherein the touchscreen user interface comprises an array of controls that accept at least one of the one or more inputs from a user or the subject; and wherein each of the array of controls is associated with one of the plurality of demarcated regions. (see Fig. 2B and see Col. 10 lines 11-67 and Col. 11 lines 1-13 discloses, “In a first step, the treatment areas are defined. For that purpose, possible treatment areas are marked by oval areas overlaid on an acquired still image of the facial area of the user. The correct locations for the areas is determined based on an image recognition process, identifying marked features of the facial region. In the described example, the marked possible treatment areas are the following: forehead lines (area 51); eyebrows (areas 52a, 52b); frown lines (area 53); crow's feet (areas 54a, 54b); bunny lines (area 55); comers of the mouth ( areas 56a, 56b ); and chin (area 57). The user may select areas to be treated by activating the respective area by operating the touchscreen at the respective place(s). In the described example, the user selects the forehead lines area 51. The choice is confirmed by displaying the chosen area(s) by dashing (see FIG. 2B). In a next step, the user is guided to acquire those images that are needed to assess the present state of the condition to be treated. This may include the taking of detail images of the areas to be treated. For that purpose, a frame 61 denoting the area to be imaged is overlaid the real-time image of the user (see FIG. 2C), and the user repositions the user terminal 1 until the frame roughly corresponds with the display. As soon as this is the case, a still image is automatically acquired (see FIG. 2D). If the entire facial region relevant for BoNTs treatments 40 shall be covered, usually about 5-8 images will be required ( e. g. forehead both sides, lower face just below the eyes to below the chin, right and left side of the face). In order to enhance relevant structures of the facial region, the user may be asked to assume a certain facial expression. In the described case, the user is asked to raise his eyebrows as high as possible by displaying a corresponding instruction 62 (see FIG. 2D). Both the still image of the user with a relaxed facial expression and of the user with raised eyebrows (FIG. 2E) are stored in the memory of the user terminal 1….[…]…The acquired images are sent to the server 10 over the mobile network. In the server 10, the images are processed to generate an initial proposal for a treatment recommendation as described in more detail below. The treatment recommendation is submitted back to the user terminal 1 as well as to the computer system 30 of the attending professional. On the user terminal 1, the proposed treatment recommendations, BoNT injections in the described case, as well as a preview of the look of the facial region after treatment are displayed. The treatment recommendations include the position 63.1 ... 8 and dosage 64.1 ... 8 of several BoNT injections. In the shown example, each dosage 64.1 ... 8 may be individually adjusted by using sliders 65.1 ... 8 (see FIG. 2F). The preview is dynamically adjusted, essentially in real-time, such that the user may iteratively adjust the dosages until the previewed result matches with his or her aims. As soon as all adjustments have been made, the choice is accepted. Next, the final treatment recommendation is displayed for information purposes (see FIG. 2G). The treatment recommendations include the position 66.1 ... 8 and dosage 67.1 ... 8 of several BoNT injections. The attending professional is provided by the same information; it may be complemented by further information that is relevant for an optimum treatment but that is of little interest for the user.”)
As per claim 9, Tufail teaches:
The system of claim 8, wherein the processing system is configured to modify at least one of the one or more digital images into an altered image comprising one or more appearance-related alterations caused by the one or more inputs to show how the medical treatment calculated by the processing system would alter the appearance of the body part and to display the altered image on the display. (Col. 8 lines 61-67 and Col. 9 lines 1-3 discloses, “Preferredly, a preview image representing an expected look of the facial region after treatment according to the obtained treatment recommendation is generated and displayed. This allows in particular for choosing between 65 different treatment regimes or between treatment and nontreatment. Preferably, the preview image is displayed directly to the patient, e. g. on his or her computing device. The preview image may be a still and/or video image. The effects may be simulated in real-time by augmented reality techniques.” And see Col. 10 lines 61-67 and Col. 11 lines 1-5 discloses, “On the user terminal 1, the proposed treatment recommendations, BoNT injections in the described case, as well as a preview of the look of the facial region after treatment are displayed. The treatment recommendations include the position 63.1 ... 8 and dosage 64.1 ... 8 of several BoNT injections. In the shown example, each dosage 64.1 ... 8 may be individually adjusted by using sliders. 65.1 ... 8 (see FIG. 2F). The preview is dynamically adjusted, essentially in real-time, such that the user may iteratively adjust the dosages until the previewed result matches with his or her aims. As soon as all adjustments have been made, the choice is accepted.”)
As per claim 10, Tufail teaches:
The system of claim 9, wherein the processing system is configured to generate in real time the altered image based on each of the one or more inputs received and to display the altered image in real time to allow the user or the subject to visualize how each of the one or more inputs changes the appearance of the body part. (Col. 8 lines 61-67 and Col. 9 lines 1-3 discloses, “Preferredly, a preview image representing an expected look of the facial region after treatment according to the obtained treatment recommendation is generated and displayed. This allows in particular for choosing between 65 different treatment regimes or between treatment and nontreatment. Preferably, the preview image is displayed directly to the patient, e. g. on his or her computing device. The preview image may be a still and/or video image. The effects may be simulated in real-time by augmented reality techniques.” And see Col. 10 lines 61-67 and Col. 11 lines 1-5 discloses, “On the user terminal 1, the proposed treatment recommendations, BoNT injections in the described case, as well as a preview of the look of the facial region after treatment are displayed. The treatment recommendations include the position 63.1 ... 8 and dosage 64.1 ... 8 of several BoNT injections. In the shown example, each dosage 64.1 ... 8 may be individually adjusted by using sliders. 65.1 ... 8 (see FIG. 2F). The preview is dynamically adjusted, essentially in real-time, such that the user may iteratively adjust the dosages until the previewed result matches with his or her aims. As soon as all adjustments have been made, the choice is accepted.”)
As per claim 11, Tufail teaches:
The system of claim 1, wherein the processing system is configured to control the camera system, the display, or a combination thereof. (Col. 9 lines 40-53 discloses, “The FIG. 1 is a block diagram of an embodiment of an inventive system for generating treatment recommendations. The system includes a user terminal 1, in the described example this is a smartphone, including inter alia a display 2 and a front camera 3. The user terminal 1 further includes a communication interface for communicating over a mobile network. The front camera 3 is on the same face of the user terminal 1 as the display. This allows for acquiring images of the user, while at the same time displaying information (such as a real-time display of the acquired image or instructions). The display 2 features a touchscreen, such that the user is enabled to operate most of the functions of the user terminal 1 by appropriately touching regions of the touch screen.”)
As per claim 12, Tufail teaches:
The system of claim 1, wherein the processing system is configured to receive the one or more inputs that alter the characteristic of the body part of the subject from a touchscreen user interface of the display and analyze the one or more inputs, compare the desired appearance to the displayed digital image, or a combination thereof to calculate the medical treatment to achieve the desired appearance in the subject. (see figs. 2E-3B and see Col. 12 lines 13-51 discloses, “The corresponding image data is fed to a machine learning process for classifying the image with respect to the treatment recommendation to be obtained, taking into account additional information provided, including indications about a desired outcome ( or a default indication, if no user-specific information is available). In particular, a multilabel classification method is employed that allows for providing multi-dimensional treatment recommendations. In the given example, only the subregions of the facial region chosen by the user will be processed, i. e. the forehead lines area 51. The machine learning process has access to input information relating to a considerable number of BoNT treatments of this area, including information on the visual appearance before and after the treatment as well as on the treatment itself, including in particular injection positions and dosage. All information is anonymized and pooled and delivered to the server in a HIP AA compliant encrypted way. The datasets may be complemented by further information, e. g. on the patient (gender, age, skin type, etc.) or on the treatment (follow-up treatment steps, treatment interval, specific composition used, etc.). All this information may be taken into account in the machine learning process. The process may include the generation of heatmaps representing the change over time ( e. g. before/after a certain kind of treatment or the actual treatment provided to the user in the past). The machine learning process may be complemented by an optimization step, in particular if several areas are treated and/or if several kinds of treatment are combined. The overall expected result of the treatment, represented by a score, may be optimized based on a numerical optimization process. Both the optimization as well as the machine learning process may be based on scales (metrics) that have been developed, e. g. scales measuring the degree of ageing and the severity of facial wrinkles in the field of non-surgical cosmetic procedures. The scales provide an objectified framework for evaluating the level of improvement resulting from cosmetic procedures.” And see Col. 4 lines 8-19 discloses, “The classifying substep is based on the reference measure and yields the treatment recommendation. In this substep, the examined case is assigned to one or several classes based on the reference measure. An example of a set of possible classes is "treatment", "no treatment", "delayed treatment", "suggested face-to-face examination". Another example of such a set is "treatment with substance A, dosage 1/d", "treatment with substance A, dosage 2/d" "treatment with substance B, dosage 1/d", etc. The treatment recommendation is the totality of assigned classes (such as "delayed treatment", "treatment with substance A, dosage 1/d") or information derived from this totality of assigned classes.”)
As per claim 13, Tufail teaches:
The system of claim 12, wherein the medical treatment comprises injection parameters associated with each of a plurality of demarcated regions that are transposed over the at least one of the one or more digital images displayed on the display and associated with a particular area of the body part of the subject. (see Col. 4 lines 8-19 discloses, “The classifying substep is based on the reference measure and yields the treatment recommendation. In this substep, the examined case is assigned to one or several classes based on the reference measure. An example of a set of possible classes is "treatment", "no treatment", "delayed treatment", "suggested face-to-face examination". Another example of such a set is "treatment with substance A, dosage 1/d", "treatment with substance A, dosage 2/d" "treatment with substance B, dosage 1/d", etc. The treatment recommendation is the totality of assigned classes (such as "delayed treatment", "treatment with substance A, dosage 1/d") or information derived from this totality of assigned classes.” And see Col. 11 lines 5-13 discloses, “Next, the final treatment recommendation is displayed for information purposes(see FIG. 2G). The treatment recommendations include the position 66.1 ... 8 and dosage 67.1 ... 8 of several BoNT injections. The attending professional is provided by the same information; it may be complemented by further information that is relevant for an optimum treatment but that is of little interest for the user.”)
As per claim 14, Tufail teaches:
The system of claim 13, wherein the injection parameters comprise one or more of an injection location, an injection depth, an injection location, an injection angle, a medicine or pharmaceutical preparation an injection, or a dosage amount for the medicine or pharmaceutical preparation. (see Col. 11 lines 5-13 discloses, “Next, the final treatment recommendation is displayed for information purposes(see FIG. 2G). The treatment recommendations include the position 66.1 ... 8 and dosage 67.1 ... 8 of several BoNT injections. The attending professional is provided by the same information; it may be complemented by further information that is relevant for an optimum treatment but that is of little interest for the user.”)
As per claim 20, Tufail teaches:
The system of claim 1, wherein the processing system is configured to (1) modify at least one of the one or more digital images into an altered image comprising one or more appearance- related alterations based on the one or more inputs, (2) display the altered image on the display in real time to allow a user or the subject to visualize how each of the one or more inputs changes the appearance of the body part, and (3) calculate the medical treatment once the altered image corresponds to the desired appearance for the body part. (Col. 8 lines 61-67 and Col. 9 lines 1-3 discloses, “Preferredly, a preview image representing an expected look of the facial region after treatment according to the obtained treatment recommendation is generated and displayed. This allows in particular for choosing between 65 different treatment regimes or between treatment and nontreatment. Preferably, the preview image is displayed directly to the patient, e. g. on his or her computing device. The preview image may be a still and/or video image. The effects may be simulated in real-time by augmented reality techniques.” And see Col. 10 lines 61-67 and Col. 11 lines 1-5 discloses, “On the user terminal 1, the proposed treatment recommendations, BoNT injections in the described case, as well as a preview of the look of the facial region after treatment are displayed. The treatment recommendations include the position 63.1 ... 8 and dosage 64.1 ... 8 of several BoNT injections. In the shown example, each dosage 64.1 ... 8 may be individually adjusted by using sliders. 65.1 ... 8 (see FIG. 2F). The preview is dynamically adjusted, essentially in real-time, such that the user may iteratively adjust the dosages until the previewed result matches with his or her aims. As soon as all adjustments have been made, the choice is accepted. Next, the final treatment recommendation is displayed for information purposes (see FIG. 2G). The treatment recommendations include the position 66.1 ... 8 and dosage 67.1 ... 8 of several BoNT injections.” And see col. 12 lines 13-15 and lines 39-51)
As per claim 21, Tufail teaches:
The system of claim 20, wherein the medical treatment calculated by the processing system comprises injection parameters comprising one or more of an injection location, an injection depth, an injection location, an injection angle, a medicine or pharmaceutical preparation an injection, or a dosage amount for the medicine or pharmaceutical preparation. (see Col. 11 lines 5-13 discloses, “Next, the final treatment recommendation is displayed for information purposes(see FIG. 2G). The treatment recommendations include the position 66.1 ... 8 and dosage 67.1 ... 8 of several BoNT injections. The attending professional is provided by the same information; it may be complemented by further information that is relevant for an optimum treatment but that is of little interest for the user.”)
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.
Claims 15-19 are rejected under 35 U.S.C.103 as being unpatentable over Tufail et. al (hereinafter Tufail) (US12277707B2) in view of Boyden et. al (hereinafter Boyden) (US20170151394A1)
As per claim 15, Tufail does not teach:
The system of claim 13, wherein the injection parameters comprise one or more injection locations, an injection depth for each of the one or more injection locations, an injection dosage amount for each of the one or more injection locations, and an injection angle for each of the one or more injection locations.
However, Boyden does teach:
The system of claim 13, wherein the injection parameters comprise one or more injection locations, an injection depth for each of the one or more injection locations, an injection dosage amount for each of the one or more injection locations, and an injection angle for each of the one or more injection locations. (see Fig. 14 discloses, “1440 Wherein the at least one injection-treatment parameter Comprises at least one of an injection site, a type of injectable agent, a type of injector, a dosage of an injectable agent, a sequence of dosing an injectable agent, a timing of dosing an injectable agent, an injection depth, or an injection angle.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Tufail’s teachings as previously cited with Boyden’s explicit teachings as previously cited, the motivation being Tufail teaches the final treatment recommendation having parameters for the injection and the need for precision in planning for treatments (e.g. see Col. 8 and 11) thus Boyden’s additional choice data in totality would further increase the precision of treatments to improve the outcome for the patients.
As per claim 16, Tufail further teaches:
The system of claim 14, wherein the injection parameters further comprise a frequency or time interval for a subsequent medical treatment when the processing system determines more than one of the medical treatment is needed to achieve the desired appearance for the body part. (Col. 3 lines 47-51 discloses, “Ultimately, the treatment recommendation may be displayed in several ways. Preferably, the recommendation is displayed in the form of a graphical chart to support the patient and attending professionals in optimising retreatment intervals, dose and position of treatment if applicable.” And see Col. 5 lines 29-31 discloses, “In a preferred embodiment, a message will notify both the patient and the attending professional at a likely optimum time to retreat, including information on specific parameters of the suggested treatment.”)
As per claim 17, Tufail further teaches:
The system of claim 16, wherein the injection parameters are stored by the processing system, communicated to the display, displayed on the display, or a combination thereof. (Col. 3 lines 47-51 discloses, “Ultimately, the treatment recommendation may be displayed in several ways. Preferably, the recommendation is displayed in the form of a graphical chart to support the patient and attending professionals in optimising retreatment intervals, dose and position of treatment if applicable.” And see Col. 5 lines 29-31 discloses, “In a preferred embodiment, a message will notify both the patient and the attending professional at a likely optimum time to retreat, including information on specific parameters of the suggested treatment.”)
As per claim 18, Tufail does not teach:
The system of claim 1, further comprising: a projection device configured to illuminate one or more injection locations on the body part based on the medical treatment calculated by the processing system.
However, Boyden does teach:
The system of claim 1, further comprising: a projection device configured to illuminate one or more injection locations on the body part based on the medical treatment calculated by the processing system. (see fig. 13 discloses, “2OO Illuminating one or more injection sites in an injection-treatment pattern on a surface of a body region of the individual in accordance with an injection-treatment plan 1300 Illuminating the one or more injection sites on the surface of a face, torso, abdomen, head, neck, upper extremity, lower extremity, or buttocks region of the individual Illuminating the one or more injection sites on the surface of the body region of the individual with one or more controllable light emitting elements configured to emit non-destructive light. Wherein the one or more Controllable light emitting elements Configured to emit non-destructive light comprise one or more of a controllable light emitting diode, laser, laser diode, Collimated light source, projector, or focused light source configured to emit non-destructive light” and see [0138] discloses, “In one embodiment, the injector-tracking device includes a processor operable to calculate a distance between the tip of the injector, e.g., the tip of a needle attached to the injector, and the surface of skin at the illuminated injection site.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Tufail’s teachings as previously cited with Boyden’s explicit teachings as previously cited, the motivation being for the same reasons as given for claim 15 to increase precision.
As per claim 19, Tufail does not teach:
The system of claim 18, wherein the projection device is configured to illuminate a sequence of injections based on the medical treatment calculated by the processing system.
However, Boyden does teach:
The system of claim 18, wherein the projection device is configured to illuminate a sequence of injections based on the medical treatment calculated by the processing system. ([0151] discloses, “FIG. 15 shows further aspects of the method of FIG. 12 for guiding injection in an individual. FIG. 15 includes block 1500. Block 1500 depicts optionally illuminating the one or more projected injection sites in the injection-treatment pattern simultaneously on the Surface of the body region of the individual. In one embodiment, all of the one or more injection sites are illuminated at the same time. In one embodiment, each injection site is illuminated with light emitted from a single controllable light-emitting element. In one embodiment, all of the one or more injection sites are illuminated simultaneously with light emitted from a projector, projecting an image onto the body Surface that includes the entirety of the illuminated injection sites. FIG. 15 further includes block 1510. Block 1510 depicts option ally illuminating the one or more injection sites in the injection-treatment pattern sequentially on the Surface of the body region of the individual. In one embodiment, sequentially illuminating the one or more injection sites is accomplished using a single controllable light-emitting element that alters the beam of emitted light so as to alter the location of illumination on the surface of the body region. In one embodiment, a sequence of illuminated injection sites is generated by sequentially activating a series of controllable light-emitting elements that sequentially illuminate different locations on the Surface of the body region. In one embodiment, a sequence of illuminated injection sites is generated by projecting onto the Surface of the body region a sequentially changing image, e.g., a series of images in which digitally registered injection sites associated with the images sequentially appear and disappear according to an injection treatment plan. Block 1510 of FIG. 15 further includes optional block 1520. Block 1520 illustrates optionally illuminating the one or more injection sites in the injection treatment pattern sequentially on the Surface of the body region of the individual contingent on completing one or more injections at one or more previously illuminated injection sites. In one embodiment, completion of one or more injections at a specific illuminated injection site is monitored with an image capture device. The injector itself may include a sensor, e.g., a photo-sensor, which activates when the injector is in the vicinity of the beam of light illuminating an injection site. Once the system determines that an injection has occurred at a given illuminated injection site, the next injection site in the sequence is illuminated and available for injection.” And see [0138] discloses, “In one embodiment, the injector-tracking device includes a processor operable to calculate a distance between the tip of the injector, e.g., the tip of a needle attached to the injector, and the surface of skin at the illuminated injection site.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Tufail’s teachings as previously cited with Boyden’s explicit teachings as previously cited, the motivation being for the same reasons as given for claim 15 to increase precision.
Prior Art Cited But Not Relied Upon
MCCLELLAN (US20160136363A1)
Systems and method of targeted injection are provided. A method includes: capturing an image of a subject; displaying the image on a touch screen display; providing input to the touch screen display, wherein the input generates at least one mark Superimposed on the image; Saving the image and the at modified image onto the Subject; and administering an injection to the Subject where the at least one mark is projected on the Subject.
Slayton et. al (US20170020610A1)
Systems and methods provide visualization of the projected results of an aesthetic treatment, such as facial skin therapy, using an image display device and a plurality of stored transformation instructions. The system receives an input image of a Subject, Such as a recent portrait photograph. The system determines the aesthetic treatment to apply, retrieves the associated transformation instructions, and transforms the input image with the transformation instructions to produce a modified image that represents changes to the subject’s face that are expected to occur after the selected treatment. The system may include or access a virtual treatment visualization engine that stores transformation parameters describing changes to make to the input image based on the selected treatment and other input parameters. The transformation parameters may be obtained from a model that received the selected treatment. The system may determine similarities of the subject to the model.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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