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 .
Response to Amendment
The amendment filed February 12, 2026 has been entered. Claims 1 and 6 remain pending in the application. Claims 1 and 6 are noted as amended. Applicant’s amendments to the claims and specification have overcome the previous objections and 35 U.S.C. 112(a) rejections set forth in the Non-Final Office Action mailed November 19, 2025 and all objections and 112(a) rejections therein have been withdrawn.
Claim Interpretation
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(s) is/are: “a creating module” in claim 1; “a training module” in claim 1; and “a supporting module” 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.
“a creating module” interpreted as a software module executed on the host computer system for performing the functions of loading a searched surgical image and creating the VR surgical environment based on the image using 3D reconstruction such as optical measure, geometry, or deep learning algorithm per paragraphs 0024 and 0027.
“a training module” interpreted as a software module executed on the host computer system for performing the functions of performing surgical training including monitoring surgical operation behavior via the user inputs and generating a time point message if the behavior is interrupted or delayed per paragraphs 0025 and 0027.
“a supporting module” interpreted as a software module executed on the host computer system for performing the functions of displaying the 2D surgical images and synchronously displaying the operation step, time point, and reference message based on the generated time point message per paragraphs 0026 and 0027.
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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-3 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nesichi et al. (US PGPub 20180098813), hereinafter referred to as Nesichi in view of Avisar (US PGPub 20190222635), further in view of Samosky et al. (US PGPub 20150194066), hereinafter referred to as Samosky, and further in view of Kubota et al. (US PGPub 20120081367), hereinafter referred to as Kubota.
In regards to claims 1 and 6, Nesichi teaches a surgical teaching auxiliary system using virtual reality (Abstract; Paragraph 0034; “a system for simulating medical procedures in a virtual reality”), comprising:
a surgical image database (Paragraphs 0076, 0088 teach the system includes databases for storing information which would include the simulation information including images), configured to store two-dimensional surgical images, wherein each of the two-dimensional surgical images corresponds to a surgical method name (Paragraph 0070 teach the system and method include simulating a type of medical procedure which can be selected by the trainee), an operation step (Paragraph 0063; “guidance can be a step-by-step tutorial”), a time point of using an instrument (Paragraph 0031, 0041, 0046, 0063 teach the guidance can be given by a nurse bot/avatar which can pass virtual tools to the trainee based on the progress of the operation as the surgical tools are determined based on the selected medical procedure), and a reference message (Paragraphs 0044, 0063 teach the system can present messages and visual effects to the user for guidance within the simulated procedure); and
a host, linked to the surgical image database, wherein the host (Paragraph 0034-0035 teaches the system includes a medical simulation system and VR simulation system connected by a connection module) comprises:
a non-transitory computer-readable storage medium, configured to store computer- readable program instructions (Paragraph 0028); and
a hardware processor, electrically connected to the non-transitory computer-readable storage medium, and configured to execute the computer-readable program instructions (Paragraphs 0080, 0083-0084) to execute:
a creating module (Paragraph 0059; “medical procedure simulation module 110”), linked to the surgical image database (Paragraph 0035 teaches the systems and modules are connected via the connection module), wherein before a surgical training is performed, the creating module is configured to receive the surgical method name (Paragraph 0070 teaches the trainee can specify the medical procedure type (surgical method name) that is to be performed);
a training module (Paragraph 0059; “medical procedure simulation module”), linked to the creating module (Paragraph 0035 teaches the systems and modules are connected via the connection module), wherein after the virtual-reality surgical environment is created completely, the training module is configured to perform the surgical training (Paragraphs 0030, 0044, 0071 teach the system can simulate the VR environment and perform the simulated procedure to train the trainee including tracking trainee progress and performance), wherein when the surgical training is performed, the training module is configured to continuously acquire motion signals from at least one of a motion sensor (Paragraphs 0037, 0073; “the medical tool can be a device that can sense motion”), a wrist-worn device (Paragraph 0043; “VR/AR glove(s)”), and a hand motion input device (Paragraph 0043; “VR/AR glove(s)”) during the surgical training (Paragraphs 0030, 0037, 0042-0044, 0071 teach the system includes various input devices that can detect and receive user inputs including receiving haptic input from the trainee via the input device to perform the simulated procedures (surgical operation behavior)); and
a supporting module (Paragraph 0076, “surface sharing module”), linked to the training module (Paragraph 0035 teaches the systems and modules are connected via the connection module), and configured to display the corresponding two-dimensional surgical image, and synchronously display the operation step, the time point of using instrument, and the reference message to provide an auxiliary support and guidance (Paragraphs 0063, 0079 teach the system can display a two-dimensional screen showing a two-dimensional view of the simulation which can include the simulated elements/effects including the step-by-step tutorial/guidance messages which would include the current procedure step the trainee is performing including the tool being displayed and used).
Nesichi further teaches the rendering can be two-dimensional amounting to a two-dimensional surgical images of the selected procedure (Paragraph 0059). Nesichi may not explicitly teach store two-dimensional surgical images, wherein each of the two-dimensional surgical images corresponds to a surgical method name, an operation step, a time point of using an instrument, and a reference message; load one of the two-dimensional surgical images that corresponds to the received surgical method name; and reconstruct a three-dimensional virtual surgical environment. However, Avisar teaches a system and method for generating a surgical simulation by converting static/still medical images into three-dimensional images/models including generating user tools that interact with the surgical simulation wherein the medical images are stored in a database including the performed surgical procedure (Paragraphs 0014-0021, 0037, 0046, 0131).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nesichi to incorporate the teachings of Avisar by including storing medical images in the database and using the images to generate the 3D medical procedure simulation, as the references and the claimed invention are directed to surgical/medical procedure training systems including virtual reality. One of ordinary skill in the art would modify Nesichi by including real medical images in the database and associating the medical images with the patients corresponding medical/surgical procedure such that, when a trainee selects a surgical procedure type, the system can retrieve the corresponding images and procedure guidance/tutorials and steps and generate the 3D surgical simulation based on the procedure type and images. Upon such modification, the method and system of Nesichi would include store two-dimensional surgical images, wherein each of the two-dimensional surgical images corresponds to a surgical method name, an operation step, a time point of using an instrument, and a reference message; load one of the two-dimensional surgical images that corresponds to the received surgical method name; and reconstruct a three-dimensional virtual surgical environment. Further it would have been obvious to one of ordinary skill in the art to apply the method of generating 3D models/dynamic images based on medical images of Avisar to the system of Nesichi in order to improve the system in the same way by generating more realistic surgical models and helping surgeons better prepare (Avisar Paragraphs 0014, 0037). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Avisar with Nesichi’s system and method in order to create more realistic simulations based on real medical images and better train surgical/medical trainees.
Nesichi in view of Avisar may not explicitly teach input the acquired motion signals into a machine learning model which has been trained completely to recognize whether a surgical operation behavior represented by the motion signals is abnormally interrupted or delayed relative to a reference operation sequence, wherein the machine learning model is trained by continuously inputting surgical operation behavior data that has no abnormally interrupted or delayed condition, and generate a feedback signal when the machine learning model recognizes that the surgical operation behavior is abnormally interrupted or delayed. However, Samosky teaches a system and method for medical training and learner performance assessment including providing guidance to a user through a sequence of steps wherein the system detects if an appropriate action has been performed by the user at each stage and provides “just-in-time guidance” (feedback signal) based on detecting user error or hesitation (abnormal delay) compared to a response time threshold or expert performance wherein the performance data can be used in and mined by (training) clustering algorithms (machine learning) that can determine novice and expert performance including the speed, accuracy, and nature of user’s actions and can create customized, learner-adaptive tutorial feedback such as the “just-in-time guidance” if a user hesitates or makes an error (slow speed or accuracy actions) in the procedure and thereby training the algorithms and models on the behavior of the users (Paragraphs 0002, 0048, 0061).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nesichi in view of Avisar to incorporate the teachings of Samosky by applying the technique of providing just-in-time guidance based on user/trainee hesitation and the metrics of the clustering algorithm of Samosky to the guidance/tutorial of Nesichi, as the references and the claimed invention are directed to surgical/medical procedure training systems including step-by-step surgical procedure guidance. One of ordinary skill in the art would modify Nesichi by providing messages/guidance to the trainee if the trainee makes an error or hesitates (abnormally delayed) compared to an expert performance or pre-set threshold wherein criteria and metrics are based on clustering algorithms analysis of the performance data and wherein the user performance is used to train/develop clustering algorithms and models of the user behavior as taught by Samosky in order to improve Nesichi in the same way by providing targeted guidance and improving user performance and training (Samosky Paragraph 0033). Upon such modification, the method and system of Nesichi in view of Avisar would include input the acquired motion signals into a machine learning model which has been trained completely to recognize whether a surgical operation behavior represented by the motion signals is abnormally interrupted or delayed relative to a reference operation sequence, wherein the machine learning model is trained by continuously inputting surgical operation behavior data that has no abnormally interrupted or delayed condition, and generate a feedback signal when the machine learning model recognizes that the surgical operation behavior is abnormally interrupted or delayed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Samosky with Nesichi in view of Avisar’s system and method in order to improve trainee performance and understanding by providing real-time guidance and assistance based on user behavior (Samosky Paragraph 0033).
Nesichi in view of Avisar and Samosky may not explicitly teach reconstruct a three-dimensional virtual surgical environment by performing at least one of optical measure, geometry, and deep learning algorithm from the loaded two-dimensional surgical images and transform the loaded two-dimensional surgical image into three-dimensional information of virtual reality. However, Kubota teaches a surgical simulation model generation method and system that generates the models through geometrical analysis of medical images stored in a storage unit by determining relative positions and volume data for the body part/image (Abstract; Paragraphs 0013, 0037, 0042).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nesichi in view of Avisar and Samosky to incorporate the teachings of Kubota by applying the technique of using geometrical information to generate three-dimensional models based on medical images of Kubota to the simulation generation of Avisar, as the references and the claimed invention are directed to surgical/medical procedure training systems including virtual-reality/simulated anatomy. One of ordinary skill in the art would modify Nesichi in view of Avisar and Samosky by using geometrical analysis/information of the medical images of Avisar to generate the simulated anatomy and surgical procedure as the technique is well-known method (Kubota paragraph 0037) and improves Avisar in the same way by generating anatomy that is more realistically reactive (Kubota Paragraphs 0005, 0052). Upon such modification, the method and system of Nesichi in view of Avisar and Samosky would include reconstruct a three-dimensional virtual surgical environment by performing at least one of optical measure, geometry, and deep learning algorithm from the loaded two-dimensional surgical images and transform the loaded two-dimensional surgical image into three-dimensional information of virtual reality. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Kubota with Nesichi in view of Avisar and Samosky’s system and method in order to improve simulation realism and generate better reactions to user manipulation.
Response to Arguments
Applicant's arguments, see Remarks/Arguments, filed February 12, 2026, with respect to the rejection(s) of claims 1 and 6 under 35 U.S.C. 103, have been fully considered, but they are not persuasive. With regard to Applicant’s arguments, see pages 9-12, Applicant argues the following: A) the instant application claims a supervised training method that requires only correct (uninterrupted) data; B) Samosky fails to teach “establishing a single, continuous, time-ordered reference operation sequence…”; and C) Samosky does not teach how to establish a single “reference operation sequence” for detecting deviations. Overall, Applicant’s arguments are not commensurate with the claim language and rely on piecemeal analysis of the cited references. Specifically, with regard to argument A, Applicant argues Samosky fails to teach the limitation because it does not teach “only data without abnormalities” but the claim language does not include such an exclusionary proviso and is preamble with the transitional phrase “comprising” meaning the claim is open-ended. Therefore, the reference can teach training with both novice (error data) and expert (gold standard) data as taught by Samosky. Therefore, this argument is not commensurate with the claim language as the claim does not explicitly exclude other training data and Samosky does teach training with expert data for determining the thresholds for hesitation/delay in user performance including training data with “no abnormally interrupted or delayed condition”. With regard to arguments B and C, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant states Samosky fails to teach limitations that, as discussed above, are taught by the combination of Nesichi, Avisar, Samosky, and Kubota as combined above. Samosky failing to teach the specific cited limitations does not make the combination non-obvious as the limitations are taught by the combination of the references. Further Samosky does teach a specific sequence for which the deviations can be detected as Samosky Paragraph 0048 teaches the process is a sequence of operations including visual displays, feedback, and guidance that can be provided to guide the user through the sequence of steps while providing specific feedback/guidance based on performance of certain tasks in the sequence. Therefore, the claims stand rejected under 35 U.S.C. 103.
Conclusion
Accordingly, claims 1 and 6 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached on (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CORRELL T FRENCH/Examiner, Art Unit 3715
/KANG HU/Supervisory Patent Examiner, Art Unit 3715
Prosecution Insights