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(s) (IDS) submitted on 05/24/2023 has been considered and the listed references were noted.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: ⑫, 904, S316, S322, and S3354.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 is over 150 words (180 words). 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).
The disclosure is objected to because of the following informalities:
In Paragraphs [0013], [0017], [00124], and [00125] "Surgical" should read "surgical"
In Paragraph [00101]:
"transmitted S309 and, generates…." should read "…transmitted S309, generates…"
"…second 3D image, using software…" should read "…second 3D image using software…"
"…transmits 315 it…" should read "…transmits it (315) …
Minor inconsistencies are present for when parentheses are used around reference numbers throughout the disclosure (Ex. In Paragraph [00100], reference numbers S305, S307, and S309 have parenthesis, while another instance of 307 does not have parenthesis). Examiner recommends that applicant use parenthesis on reference numbers when appropriate for clarity purposes.
The numbering for the paragraphs [00100] - [00126] should renumbered to read [0100]-[0126]
Appropriate correction is required.
Claim Objections
Claim 2 objected to because of the following informalities:
"…to the first terminal, further includes…" should be revised to say "…to the first terminal, the method further includes…"for clarity
Appropriate correction is required.
Claim 4 objected to because of the following informalities:
"…wherein the designing, by said server, the implant…" should read either "…wherein the designing, by said server, of the implant…" OR “…wherein designing, by said server, the implant…”
Appropriate correction is required.
Claim 7 objected to because of the following informalities:
The claim language for “..allow the second terminal..” is incomplete from what was described from the independent claim 6 and could also be revised for clarity (…comprises requesting designing the implant to the server…” should read “…comprises requesting the designing of the implant to the server…”). The examiner recommends the following revision:
The method of claim 6, wherein the confirming, by the first terminal, the third image to allow the second terminal to design the implant comprises: requesting the designing of the implant to the server, by the second terminal.
Appropriate correction is required.
Claim 10 objected to because of the following informalities:
The claim is verbose and could be revised for clarity. The examiner recommends the following revision:
"The method of claim 6, wherein before the generating, by the first terminal, of the at least one modified 3D image corresponding to the surgical plan initially designed by the patient, the method further comprises:
Providing to the first terminal software capable of modifying the 3D image, wherein the modified 3D image is generated using software.”
Appropriate correction is required.
Claims 13 objected to because of the following informalities:
The claim is verbose and could be revised for clarity. The examiner recommends the following revision:
"The method of claim 12, wherein before the generating, by the first terminal, of the at least one modified 3D image corresponding to the surgical plan initially designed by the patient, the method further comprises:
Providing to the first terminal software capable of modifying the 3D image, wherein the modified 3D image is generated using software.”
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Jeon (KR 101968758 B1).
Regarding Claim 1, Jeon discloses “A method for fabricating a surgical implant, based on a system for a first terminal for initially designing a surgical plan by a patient, a second terminal for finalizing a surgical plan by a surgeon, and a server for communicating with the first terminal and the second terminal and further designing an implant according to the surgical plan, the method comprising:” (Jeon, Abstract, discloses: “a plastic surgery consultation method using diagnostic data of a plastic surgery applicant. According to the present invention, a plastic consultation method comprises the steps of: (a) registering an image obtained by photographing a plastic portion as plastic data; (b) displaying an estimated amount and evaluation content for each plastic portion as self-diagnosis data based on the registered plastic data; and (c) registering plastic surgery consultation data based on plastic data of a plastic subject by a plastic specialist of the corresponding plastic portion when a consultation with a plastic specialist is desired, and the plastic subject who has confirmed the registration registers the plastic surgery consultation data based on the plastic data of the plastic subject, and performs consultation and actual surgery by the plastic subject who has confirmed the registration. therefore, the plastic consultation method can not only receive an automatic estimate of the plastic portion before visiting a hospital, but also receive a specific estimate and opinion of the plastic specialist.”); “obtaining, by the server, a first 3D image based on a patient medical image data including at least one of a surgical part” (Jeon, Paragraphs [0043]-[0045], discloses the following:
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As shown in the above paragraphs, the patient has the ability to self-diagnose themselves for the plastic surgeon by taking a photo of themselves around the desired body part that they would like to enhance through plastic surgery, thus counting as the first 3D image.
); “transmitting, by the server, the first 3D image to the first terminal to obtain at least one modified second 3D image corresponding to the surgical plan initially designed by the patient, from the first terminal” (Jeon, Paragraphs [0047]-[0049], disclose the following:
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Here, after the first 3D image is acquired, we see that it gets transmitted by the server to the next terminal (plastic subject terminal) where the image is modified through applying the face recognition library to let the plastic surgeon have the ability to modify the patient’s 3D image to adjust it to their liking while being able to show the cost of how much the implant would be overall.); “transmitting, by the server, the at least one modified second 3D image to the second terminal to obtain a final third 3D image corresponding to the surgical plan designed by the surgeon, from said second terminal” (Jeon, Paragraph [0027], discloses “as shown in fig. 1, the plastic surgery consultation device of the present invention is configured to transmit a plastic surgery site image to a web server 200 through the internet, automatically receive an estimated estimate for each plastic surgery site, review the received result, receive plastic surgery consultation data from a plastic surgery specialist terminal 300 when a specific plastic surgery consultation estimate is desired after reviewing the received result, and perform actual plastic surgery through consultation if necessary.”; Paragraph [0028] discloses: “That is, the present invention comprises: one or more molding target terminals (100) for transmitting an image obtained by photographing a molding portion of a molding target person by using a photographing means; a web server (200) for automatically calculating an expected molding cost by analyzing the molding portion in the image transmitted from the molding target terminal (100)”); and “designing, by said server, the implant based on the patient medical image data, the first 3D image, the second 3D image, and/or the third 3D image” (Jeon, Paragraph [0062], discloses: “the web server 200 registers the molding data information transmitted from the terminal of the recipient requesting the “self-diagnosis consultation” in the order in which the molding data information is received in the “self-diagnosis consultation item and transmits the registered information to the molding specialist to the registered specialist terminal 300 receives the registered information, terminal 300 of the molding specialist registered as the molding specialist of the corresponding molding part, the terminal 300 of the molding specialist automatically executes an application and displays the registered information on the terminal display unit 330 when the registered information is received.”; Paragraph [0063] discloses “In addition, the terminal 300 of the plastic specialist may simulate the image after plastic surgery based on the plastic data of the plastic subject and register the plastic surgery consultation data for each plastic portion together with the contact information as the plastic surgery consultation data.”). Therefore, it would have been obvious for one of ordinary skill in the art to use the techniques of having specific terminals to obtain the first, second, and third 3D images for designing a surgical implant seen in Jeon to have an improved method for providing the surgical implant. By using the image acquisition and design techniques seen in Jeon, one of ordinary skill in the art can intuitively gain a clearer picture of the structure around the desired surgical site for the patient before proceeding with any type of cosmetic surgery (i.e., rhinoplasty). Therefore, it would have been obvious for one of ordinary skill in the art to use the Jeon reference to achieve the same method described in Claim 1.
Regarding Claim 6, “A method for fabricating a surgical implant based on a system for a first terminal for initially designing a surgical plan by a patient, a second terminal for finalizing a surgical plan by a surgeon, and a server for communicating with the first terminal and the second terminal and further designing an implant according to the surgical plan, comprising:” (Jeon, Abstract, discloses “a plastic surgery consultation method using diagnostic data of a plastic surgery applicant. According to the present invention, a plastic consultation method comprises the steps of: (a) registering an image obtained by photographing a plastic portion as plastic data; (b) displaying an estimated amount and evaluation content for each plastic portion as self-diagnosis data based on the registered plastic data; and (c) registering plastic surgery consultation data based on plastic data of a plastic subject by a plastic specialist of the corresponding plastic portion when a consultation with a plastic specialist is desired, and the plastic subject who has confirmed the registration registers the plastic surgery consultation data based on the plastic data of the plastic subject, and performs consultation and actual surgery by the plastic subject who has confirmed the registration. therefore, the plastic consultation method can not only receive an automatic estimate of the plastic portion before visiting a hospital, but also receive a specific estimate and opinion of the plastic specialist.”); “acquiring, by the first terminal, a first 3D image based on patient medical image data, including at least a surgical part” (Jeon, Paragraphs [0043]-[0045], discloses the following:
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Here, we can see that the terminal actively prompts the user to take a 3D image of themselves in order to get a consultation from a plastic surgeon. Thus, the terminal is acquiring the image from the prospective patient.); “generating, by the first terminal, at least one modified second 3D image corresponding to the surgical plan initially designed by the patient based on the acquired first 3D image” (Jeon, Paragraph [0106] and Figure 4, discloses: “Fig. 4 is a flowchart for explaining a process of registering a plastic surgery review. as shown in fig. 4, the plastic subject terminal 100 executes an application to create a pre-operative face image and a pre-operative face image after surgery, a surgical site, a surgical cost, a surgical schedule, and a face image according to the lapse of a schedule after surgery (s131), and applies for registration to the web server 200 as a plastic surgery review (s132).”
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As shown, the image is being generated to show the applicant images of how they would look before and after surgery before the procedure takes place to see the initial surgical plan); “transmitting, by the first terminal, the at least one modified second 3D image to the server and/or the second terminal” (Jeon, Paragraph [0106], discloses: “That is, the present invention comprises: one or more molding target terminals (100) for transmitting an image obtained by photographing a molding portion of a molding target person by using a photographing means; a web server (200) for automatically calculating an expected molding cost by analyzing the molding portion in the image transmitted from the molding target terminal (100); one or more molding-specialized terminals (300) for registering molding data information on the molding target person who has requested self-molding consultation; and one or more general terminals (400) preparing molding with reference to a molding review.”); “receiving, by the first terminal, a third 3D image that is a final 3D image corresponding to the surgical plan finalized by the surgeon based on the at least one modified second 3D image generated” (Jeon, Paragraph [0030], discloses “the terminal 100 includes a storage unit 190 that stores the self-diagnosis data received from the web server 200 and the plastic surgery consultation data received from the plastic surgery specialist terminal 300 as a table in a db, and a user application unit 150 that stores an application related to the plastic surgery consultation device of the present invention.”; Jeon, Paragraph [0063], discloses “the terminal 300 of the plastic specialist may simulate the image after plastic surgery based on the plastic data of the plastic subject and register the plastic surgery consultation data for each plastic portion together with the contact information as the plastic surgery consultation data.”; Paragraph [0063] discloses “In addition, the terminal 100 includes a storage unit 190 that stores the self-diagnosis data received from the web server 200 and the plastic surgery consultation data received from the plastic surgery specialist terminal 300 as a table in a db, and a user application unit 150 that stores an application related to the plastic surgery consultation device of the present invention.”); and “confirming, by the first terminal, the third 3D image to allow the second terminal to design the implant based on the patient medical image data, the first 3D image, the second 3D image, and/or the third 3D image” (Jeon, Paragraph [0068] discloses “That is, the plastic surgery subject who has undergone the plastic surgery executes the application using the terminal 100 to register his or her pre-operative face image, surgical site, surgical cost, surgical schedule, and facial image that has elapsed after the surgery in the web server 200 as a plastic later stage, and is operated so that the terminal 400 in which the application is executed can check the status of replies for each plastic later stage registered in the web server 200.”). Therefore, it would have been obvious for one of ordinary skill in the art to use the techniques of having specific terminals to acquire and generate the first, second, and third 3D images for designing a surgical implant as well as the confirmation of the third 3D image by the first terminal seen in Jeon to have an improved second method for providing the surgical implant. By using the image acquisition and design techniques seen in Jeon, one of ordinary skill in the art can intuitively gain a clearer picture of the structure around the desired surgical site for the patient before proceeding with any type of cosmetic surgery (i.e., rhinoplasty). By further confirming the design of the third image with the patient operating the first terminal, one of ordinary skill in the art allows the patient to decide whether the implant is the right fit before the surgical plan is executed. Thus, it would have been obvious for one of ordinary skill in the art to use the Jeon reference to achieve the same method described in Claim 6.
Regarding Claim 12, “A method for fabricating a surgical implant based on a system for a first terminal for initially designing a surgical plan by a patient, a second terminal for finalizing a surgical plan by a surgeon, and a server for communicating with the first terminal and the second terminal and further designing an implant according to the surgical plan, the method comprising:” (Jeon, Abstract, discloses “a plastic surgery consultation method using diagnostic data of a plastic surgery applicant. According to the present invention, a plastic consultation method comprises the steps of: (a) registering an image obtained by photographing a plastic portion as plastic data; (b) displaying an estimated amount and evaluation content for each plastic portion as self-diagnosis data based on the registered plastic data; and (c) registering plastic surgery consultation data based on plastic data of a plastic subject by a plastic specialist of the corresponding plastic portion when a consultation with a plastic specialist is desired, and the plastic subject who has confirmed the registration registers the plastic surgery consultation data based on the plastic data of the plastic subject, and performs consultation and actual surgery by the plastic subject who has confirmed the registration. therefore, the plastic consultation method can not only receive an automatic estimate of the plastic portion before visiting a hospital, but also receive a specific estimate and opinion of the plastic specialist.”); “acquiring a 3D image, by the first terminal, based on a patient's medical image data including at least a surgical site” (Jeon, Paragraph [0014], discloses: “executing an application in the molding applicant terminal and registering an image obtained by photographing a molding site in the web server as molding data”; Paragraph [0015] discloses “In addition, the plastic subject terminal may execute an application to register a pre-operative face image of the user after surgery, a surgical site, a surgical cost, a surgical schedule, and a face image according to the elapse of a schedule after surgery in the web server as a plastic reviewer, and may operate such that a current state in which comments are replied for each plastic reviewer registered in the web server can be confirmed in a terminal in which the application is executed.”; Paragraph [0045] discloses “It is preferable that the face image includes one or more representative pictures, a front picture, a left side picture, and a right side picture so that the face image can be analyzed in three dimensions.”); “generating, by the first terminal, at least one modified 3D image corresponding to the surgical plan initially designed by the patient based on the acquired 3D image” (Jeon, Paragraph [0106] and Figure 4, discloses: “Fig. 4 is a flowchart for explaining a process of registering a plastic surgery review. as shown in fig. 4, the plastic subject terminal 100 executes an application to create a pre-operative face image and a pre-operative face image after surgery, a surgical site, a surgical cost, a surgical schedule, and a face image according to the lapse of a schedule after surgery (s131), and applies for registration to the web server 200 as a plastic surgery review (s132).”
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As shown and discussed previously in the analysis of Claim 6, the image is being generated to show the applicant images of how they would look before and after surgery before the procedure takes place to see the initial surgical plan); “acquiring, by the first terminal, a final 3D image corresponding to the surgical plan finalized by the surgeon based on the at least one modified 3D image” (Jeon, Paragraphs [0051], [0100], [0101], and [0068] disclose the following:
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As we can see from the aforementioned paragraphs, when the patient in the first terminal applies for “self-diagnosis counseling” in terminal 100, the plastic surgery specialist in the other terminal starts designing the implant virtually based on the information (in terms of images and specific surgical site they want to enhance) that the patient provides. After this process, the patient receives the final image that they can observe before the surgical plan is performed on them); and “confirming, by the first terminal, the final 3D image to allow the server to design the implant based on the patient medical image data, the 3D image, and the final 3D image” (Jeon, Paragraph [0068], discloses “That is, the plastic surgery subject who has undergone the plastic surgery executes the application using the terminal 100 to register his or her pre-operative face image, surgical site, surgical cost, surgical schedule, and facial image that has elapsed after the surgery in the web server 200 as a plastic later stage, and is operated so that the terminal 400 in which the application is executed can check the status of replies for each plastic later stage registered in the web server 200.”; In this same paragraph, we can see that the patient confirms with the surgeon whether the implant suits them by having the ability to monitor each stage of the manufacturing process.) Therefore, it would have been obvious for one of ordinary skill in the art to use the techniques of having specific terminals to acquire and generate 3D images for designing a surgical implant as well as the confirmation of the final 3D image by the first terminal seen in Jeon to have an improved third method for providing the surgical implant. By using the image acquisition and design techniques seen in Jeon, one of ordinary skill in the art can intuitively gain a clearer picture of the structure around the desired surgical site for the patient before proceeding with any type of cosmetic surgery (i.e., rhinoplasty). By further confirming the design of the third image with the patient operating the first terminal, one of ordinary skill in the art allows the patient to decide whether the implant is the right fit before the surgical plan is executed. Thus, it would have been obvious for one of ordinary skill in the art to use the Jeon reference to achieve the same method described in Claim 12.
Claims 2, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Jeon in view of Choi (KR 20040075672 A).
Regarding Claim 2, Jeon discloses “The method of Claim 1, wherein before or at a time of transmitting the first 3D image to the first terminal, further includes:” (Please refer to the above-described analysis for Claim 1) (Choi, Paragraph [0026]). As shown in Paragraph [0026], the virtual molding simulation method transforms the image of the 3D face model that the patient into an image that has the desired surgical part at the surgical site modified accordingly to the patient’s opinion and the surgeon’s recommendation. As such, this can only be done via software as the image modification is done virtually. Choi further discloses that “As shown in the drawing, the online virtual molding simulation system according to an embodiment of the present invention allows a user for performing molding simulation to access a molding server constructed on a website or the like by using a client 600 such as a computer or the like, receive a simulation means 603, convert a user face image input by an image input device 601 such as a digital camera, a scanner or the like into a desired shape through the simulation means 603, and then store the user face image in a storage device or output the user face image by using an output device 604 such as a monitor, a printer or the like to generate and check a virtually molded image” (Choi, Paragraph [0153]). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method for providing a surgical implant seen in Jeon with the technique of transforming the first 3D image into a second modified 3D image seen in Choi to achieve a more complete method of adjusting the proposed implant before surgery. By combining the method seen in Jeon with the modification technique seen in Choi, one of ordinary skill in the art can allow the surgeon to ensure the implant suits the patient’s needs whilst assessing the safety of the surgical plan to mitigate risk. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon and Choi references to achieve the same method described in Claim 2.
Regarding Claim 10, Jeon discloses “The method of Claim 6, further comprising: before the generating, by the first terminal, at least one modified second 3D image corresponding to the surgical plan initially designed by the patient” (Please refer to the above-described analysis for Claim 6) the present invention for solving the above-described problems in the related art is to provide a hierarchical virtual molding simulation method, in which a 3d face model composed of a plurality of polygons is hierarchically divided to have a molding object having feature points set for deformation and a molding type defining a deformation method for transforming the molding object to generate a face 3d model capable of transforming an image, a face image of a user who wants to perform molding simulation is matched with the face 3d model, a molding object and a molding type of a desired molding portion are selected from the matched face 3d model and a displacement value is input to transform the selected molding object, the face 3d model is transformed by correcting such deformation to be reflected in an inner or outer area of the molding object, and the transformed face 3d model is subjected to 3d texture mapping with a face image to be a simulation target selected by the user to allow the user to check a face shape after molding as a 3d stereoscopic image.” (Choi, Paragraph [0026]). As shown in Paragraph [0026], the virtual molding simulation method transforms the image of the 3D face model that the patient into an image that has the desired surgical part at the surgical site modified accordingly to the patient’s opinion and the surgeon’s recommendation. As such, this can only be done via software as the image modification is done virtually. Choi further discloses that “As shown in the drawing, the online virtual molding simulation system according to an embodiment of the present invention allows a user for performing molding simulation to access a molding server constructed on a website or the like by using a client 600 such as a computer or the like, receive a simulation means 603, convert a user face image input by an image input device 601 such as a digital camera, a scanner or the like into a desired shape through the simulation means 603, and then store the user face image in a storage device or output the user face image by using an output device 604 such as a monitor, a printer or the like to generate and check a virtually molded image” (Choi, Paragraph [0153]). From this, we can assume that the output device is the first terminal, as that is where they are able to modify and adjust the image to their liking depending on the current mold. Finally, Choi additionally discloses “In step s3, when the face 3d model is changed according to the feature point moved by the user or the displacement value directly input through the displacement value input window (the molding object adjustment unit of fig. 18) according to the molding type, the modified 3d face image is generated by 3d texture mapping the changed face 3d model and the face image to be molded simulation, and when correction is required, the processing process of the hierarchical virtual molding simulation method of the present invention is terminated by repeatedly performing the processing process of the present invention from step s3 (s4).” (Choi, Paragraph [0053]). Here, the changed face model constitutes as a second 3D image as it has been changed from the initial image acquired, and the software, in the form of the online virtual molding simulation system, modifies the second image further to create a second modified 3D face image. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method for providing a surgical implant seen in Jeon with the technique of transforming the second 3D image into a second modified 3D image seen in Choi to achieve a more complete method of adjusting the proposed implant before surgery. By combining the method seen in Jeon with the modification technique seen in Choi, one of ordinary skill in the art can allow the surgeon to ensure the implant suits the patient’s needs whilst assessing the safety of the surgical plan to mitigate risk. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon and Choi references to achieve the same method described in Claim 10.
Regarding Claim 13, Jeon discloses “The method of Claim 12, further comprising: before the generating, by the first terminal, at least one modified 3D image corresponding to the surgical plan initially designed by the patient” (Please refer to the above-described analysis for Claim 12)(Choi, Paragraph [0026]). As shown in Paragraph [0026], the virtual molding simulation method transforms the image of the 3D face model that the patient into an image that has the desired surgical part at the surgical site modified accordingly to the patient’s opinion and the surgeon’s recommendation. As such, this can only be done via software as the image modification is done virtually. Choi further discloses that “As shown in the drawing, the online virtual molding simulation system according to an embodiment of the present invention allows a user for performing molding simulation to access a molding server constructed on a website or the like by using a client 600 such as a computer or the like, receive a simulation means 603, convert a user face image input by an image input device 601 such as a digital camera, a scanner or the like into a desired shape through the simulation means 603, and then store the user face image in a storage device or output the user face image by using an output device 604 such as a monitor, a printer or the like to generate and check a virtually molded image” (Choi, Paragraph [0153]). From this, we can assume that the output device is the first terminal, as that is where they are able to modify and adjust the image to their liking depending on the current mold. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method for providing a surgical implant seen in Jeon with the technique of transforming a 3D image into a modified 3D image seen in Choi to achieve a more complete method of adjusting the proposed implant before surgery. By combining the method seen in Jeon with the modification technique seen in Choi, one of ordinary skill in the art can allow the surgeon to ensure the implant suits the patient’s needs whilst assessing the safety of the surgical plan to mitigate risk. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon and Choi references to achieve the same method described in Claim 13.
Claims 3, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jeon in view of Choi and Zaldivar (US 20130018276 A1).
Regarding Claim 3, the combination of Jeon and Choi discloses “The method of claim 2 wherein the modified second 3D image is generated” (Please refer to the above-described analysis for Claim 2) (Zaldivar, Paragraph [0016] and Figures 1A-1C).
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As shown in Paragraph [0016] and Figures 1A-1C above, Zaldivar creates a modified image through clicking and dragging the mouse to adjust the axes of there the corneal topographic image to allow for careful observation. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method seen in the combination of Jeon and Choi with the click-and-drag technique seen in Zaldivar to create a modified second 3D image and achieve an improved method for providing a surgical implant. By combining the method seen in the combination of Jeon and Choi with the Zaldivar technique using a click-and-drag method to create a new second 3D image, one of ordinary skill in the art can permit surgeons to virtually adjust the surgical site where the implant will be inserted to fine tune the image to get the appropriate structure that both the surgeon and the patient are in agreement with. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon, Choi, and Zaldivar references to achieve the same method described in Claim 3.
Regarding Claim 11, the combination of Jeon and Choi discloses “The method of claim 10 wherein the modified second 3D image is generated” (Please refer to the above-described analysis for Claim 10) (Zaldivar, Paragraph [0016] and Figures 1A-1C).
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As shown in Paragraph [0016] and Figures 1A-1C above, Zaldivar creates a modified image through clicking and dragging the mouse to adjust the axes of there the corneal topographic image to allow for careful observation. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method seen in the combination of Jeon and Choi with the click-and-drag technique seen in Zaldivar to create a modified second 3D image and achieve an improved method for providing a surgical implant. By combining the method seen in the combination of Jeon and Choi with the Zaldivar technique using a click-and-drag method to create a new second 3D image, one of ordinary skill in the art can permit surgeons to virtually adjust the surgical site where the implant will be inserted to fine tune the image to get the appropriate structure that both the surgeon and the patient are in agreement with. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon, Choi, and Zaldivar references to achieve the same method described in Claim 11.
Regarding Claim 14, the combination of Jeon and Choi discloses “The method of claim 13 wherein the modified second 3D image is generated” (Please refer to the above-described analysis for Claim 13) (Zaldivar, Paragraph [0016] and Figures 1A-1C).
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As shown in Paragraph [0016] and Figures 1A-1C above, Zaldivar creates a modified image through clicking and dragging the mouse to adjust the axes of there the corneal topographic image to allow for careful observation. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method seen in the combination of Jeon and Choi with the click-and-drag technique seen in Zaldivar to create a modified 3D image and achieve an improved method for providing a surgical implant. By combining the method seen in the combination of Jeon and Choi with the Zaldivar technique using a click-and-drag method to create a new modified 3D image, one of ordinary skill in the art can permit surgeons to virtually adjust the surgical site where the implant will be inserted to fine tune the image to get the appropriate structure that both the surgeon and the patient are in agreement with. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon, Choi, and Zaldivar references to achieve the same method described in Claim 14.
Claims 4-5, 7-8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Jeon in view of Choi 2 (KR 20160024894 A)
Regarding Claim 4, Jeon discloses “The method of claim 1” (Please refer to the above-described analysis for Claim 1), silicone implant is manufactured by using this” (Choi 2, Paragraph [0007]). Choi 2 also discloses the following in Paragraphs [0027]-[0030]:
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In the aforementioned paragraphs, we can see that the manufacturing process from Choi 2’s invention is designed at a particular shape and height that is optimized for each patient to allow the surgeon to perform the surgery comfortably while monitoring the satisfaction of the procedure overall once it has been done. Although the source does not mention the designing of the implant by a server, it is assumed that the reconstructed image would be stored in a server before it is handed off to the surgeon to be designed on. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method seen in Jeon with the Choi 2 technique of using a placing surface and determining a shape and height of the implant based on the difference between the images taken of the patient to achieve an improved method for aligning with the patient’s opinion when providing a surgical implant. By combining the method seen in Jeon with the surfacing and molding techniques found in Choi 2, one of ordinary skill in the art can enable a surgeon to intuitively design the implant to functionally and aesthetically suit the patient’s needs, while ensuring that the implant has a solid surface to be built on when 3D printing or injecting molding the implant using biologically compatible materials (such as silicone). Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon and Choi 2 references to achieve the same method described in Claim 4.
Regarding Claim 5, Jeon discloses “The method of claim 4, further comprising” (Please refer to the above-described analysis for Claim 4) implant may be performed by at least one of 3D printing, cutting, injection, mold, and vacuum forming”. However, in an analogous field of endeavor, Choi 2 discloses “The designed nose prosthesis 3d model of the present invention can be output in a format applicable to various processing systems such as cnc machines and 3d printing, and there is an advantage in that it is easy to manufacture a clinical nose prosthesis through drawings or prototypes even in a method for manufacturing a clinically approved nose prosthesis” (Choi 2, Paragraph [0027]). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method seen in Jeon with the technique of manufacturing the designed implant through 3D printing seen in Choi 2 to achieve a more improved method for designing the surgical implant for the patient. By combining the Choi 2 technique of designing the implant on a placing surface and using 3D printing to construct the implant, one of ordinary skill in the art allows for careful manufacturing to be performed for the implant to mitigate errors since the implant will be placed and built upon a solid surface. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon and Choi 2 references to achieve the same method described in Claim 5.
Regarding Claim 7, Jeon discloses “The method of Claim 6” (Please refer to the above-described analysis for Claim 6) wherein the confirming, by the first terminal, the third 3D image to allow the second terminal comprises requesting designing the implant to the server, by the second terminal. Jeon does not explicitly disclose “wherein the confirming, by the first terminal, the third 3D image to allow the second terminal comprises requesting designing the implant to the server, by the second terminal”. However, in an analogous field of endeavor, Choi 2 discloses “In addition, the prosthesis design means may include a test algorithm for designing an optimal prosthesis by correcting a treatment error between a treatment site and the prosthesis by repeatedly performing a simulation for inserting the prosthesis into the treatment site of the patient with respect to the three-dimensional image so as to be treatable based on the three-dimensional image of the patient.” (Choi 2, Paragraph [0016]). Here, the test algorithm designs the implant on the surgeon’s terminal to correct errors seen between the treatment site and prosthesis while simulating the implant multiple times to ensure the design is functional and optimal for the patient before proceeding with surgery. Therefore, it would have been obvious for one of ordinary skill in the art to combine the method seen in Jeon with the Choi 2 technique of requesting the designing of the implant by the second terminal to achieve an improved method for providing the surgical implant. By combining the technique of allowing the second terminal to design the implant seen in Choi 2 with the method seen in Jeon, one of ordinary skill in the art can allow the surgeon to finalize the surgical plan effectively (as seen by the repetitive “stress” tests from Paragraph [0016]) before performing the surgery on the patient. Therefore, it would have been obvious for one of ordinary skill in the art to combine the Jeon and Choi 2 references to achieve the same method described in Claim 7.
Regarding Claim 8, the combination of Jeon and Choi 2 discloses “The method of claim 7, further comprising” (Please refer to the above-described analysis for Claim 7) and “transmitting a message for confirming the third 3D image to the second terminal and/or the server, by the first terminal.” (Choi, Paragraph [0016], discloses: “In addition, the prosthesis design means may include a test algorithm for designing an optimal prosthesis by correcting a treatment error between a treatment site and the prosthesis by repeatedly performing a simulation for inserting the prosthesis into the treatment site of the patient with respect to the three dimensional image so as to be treatable based on the three-dimensional image of the patient.”; As shown, Paragraph [0016] also demonstrates this limitation through the implant being simulated multiple times to ensure that the prosthesis is optimal enough for testing).
Regarding Claim 9, the combination of Jeon and Choi 2 discloses “The method of claim 8” (Please refer to the above-described analysis for Claim 8) and “wherein the transmitting, by the first terminal, the confirmed message for the third 3D image comprises transmitting a patient's opinion based on comparing the second 3D image with the third 3D image” (Choi 2, Paragraph [0035], discloses “On-site doctors should be able to use it without prior education, the driving speed that can be implemented during actual treatment time should be within 30 seconds, and the patient should be able to intuitively recognize the treatment results. In addition, it should be possible to secure compatibility with various image information and diagnostic programs and price competitiveness with ready made products.”; Choi 2, Paragraph [0100] and Figure 12, discloses “Fig. 12 is a schematic image of a platform for the technology related to the present invention, and when a program starts, an implant library is loaded to select patient data, thereby automatically changing bones in 3d. After that, the cartilage is changed in 3d and the length of the nose is automatically measured to select and apply an implant suitable for the patient. Detailed adjustments of front view, side view, and warm's view are made. After that, the implant can be checked and stored, and the mold can be automatically generated. When the software part is formed in this way, the software part is connected to the server as a hardware part to form an authentication module, and an implant library is loaded through a 3d scanner, and the software part is connected by 3d printing while passing through a mold file storage module to complete the implant manufacturing process.”; Please note that the patient data are the images of the surgical part and surgical site that the patient provides, where it is assumed that the patient has discussed prior to method being used of their opinion before the 3D printing takes place to effectively model the implant).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee (KR 20190108923 A) teaches a plastic surgery medical consultation/operation support system using the augmented reality (AR), which 3D models an operation part of a patient by collected patient data to use the 3D-modelled operation part in a medical consultation, and through the AR, provides operation information of the patient to improve the operation success rate.
McCombs (US 20190070010 A1) teaches systems and methods for planning surgical procedures involving custom medical implants that can involve the selection, design and/or creation of custom medical implants and/or the selection, modification, and/or design of custom surgical procedures related to those implants.
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/SORIE I KOROMA JR/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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