DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 11 is objected to because of the following informalities:
In claim 11, line 2, “via a sensor” should read “via the at least one sensor”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 2 of copending Application No. 19/067,519 (US PGPub 20250285546) in view of Sloat (US PGPub 20230237929).
The claims are taught as mapped below:
Application 19/072,808
Application 19/067,519
Claim 1: a dialysis device training system, comprising:
an augmented reality (AR) device; and
a control device configured to:
select a training task with respect to a dialysis device;
compute user instructions for guiding a user through the training task;
monitor, via at least one sensor, activities of the user while operating the dialysis device; and
provide assistance for carrying out the training task based on the computed user instructions and the monitored activities, wherein providing the assistance comprises causing an output of indications via the AR device.
Claim 1: a medical system for providing assistance to a user on an augmented reality device comprising:
the AR device;
a control device configured to: determine a task to be executed by the user;
determine an assistance scheme for providing assistance to the user for carrying out the determined task;
monitor activities of the user based on the data captured by the sensor; and
provide assistance according to the determined assistance scheme, wherein providing the assistance comprises causing output of indications via the AR device.
Claim 3: an augmented reality (AR) device, comprising:
an output device configured to provide indications based on determined assistance for training a user with respect to a dialysis device; and/or
a sensor interface to a sensor configured to capture data related to the dialysis device and/or an activity of the user operating the dialysis device.
Claim 1: a medical system for providing assistance to a user on an augmented reality device comprising:
the AR device (output device); provide assistance according to the determined assistance scheme, wherein providing the assistance comprises causing output of indications via the AR device; and
monitor activities of the user based on the data captured by the sensor;
Claim 4: a method for operating a dialysis device training system which employs an augmented reality (AR) device, the method comprising:
selecting, by a control device, a training task with respect to a dialysis device;
computing, by the control device, user instructions for guiding a user through the training task;
monitoring, via at least one sensor, activities of the user while operating the dialysis device; and
providing, by the control device, assistance for carrying out the training task based on the computed user instructions and the monitored activities, wherein providing the assistance comprises causing an output of indications on the AR device.
Claim 2: a method for providing assistance on an augmented reality (AR) device for operating a medical device, comprising:
determining, by the control device, a task to be executed on the medical device;
determining, by the control device, an assistance scheme for providing assistance for carrying out the determined task;
monitoring, by the control device, activities of a user based on the data captured by the at least one sensor; and
providing, by the AR device, assistance according to the determined assistance scheme, wherein providing the assistance comprises outputting indications via the AR device.
While the cited claims are not identical to the instant claims, the limitations are anticipated as the cited claims are more specific than the instant claims and therefore anticipate the broader claim limitations such as “determining an assistance scheme for providing assistance to the user for carrying out the determined task” of cited claim 1 anticipates “compute user instructions for guiding a user through the training task”. Regarding claims 1, 3, and 4, the ’519 Application is silent on the teachings of a dialysis device. However, the Sloat reference provides a teaching for a system and method for dialysis training using augmented reality including a dialysis machine (Abstract; Paragraphs 0038, 0052-0053). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ‘519 Application with the teachings of Sloat to include the medical device being a dialysis device. One of ordinary skill would make such modification in order to provide more comprehensive training and as a dialysis device is a known type of medical device.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, and 4 of copending Application No. 19/072,787 (US PGPub 20250285547) in view of Sloat (US PGPub 20230237929).
The claims are taught as mapped below:
Application 19/072,808
Application 19/072,787
Claim 1: a dialysis device training system, comprising:
an augmented reality (AR) device; and
a control device configured to:
select a training task with respect to a dialysis device;
compute user instructions for guiding a user through the training task;
provide assistance for carrying out the training task based on the computed user instructions and the monitored activities, wherein providing the assistance comprises causing an output of indications via the AR device.
monitor, via at least one sensor, activities of the user while operating the dialysis device; and
Claim 1: an augmented reality (AR) system, comprising:
an AR device; and
a control device configured to:
compute an assistance scheme for carrying out a task to be executed by a user; and
generate an output via the AR device by applying the computed assistance scheme, wherein the generated output comprises a representation of a virtual character or person.
Claim 2: further comprising: a sensor configured to capture data related to the dialysis device and/or data related to an operation of the user.
Claim 3: an augmented reality (AR) device, comprising:
an output device configured to provide indications based on determined assistance for training a user with respect to a dialysis device; and/or
a sensor interface to a sensor configured to capture data related to the dialysis device and/or an activity of the user operating the dialysis device.
Claim 1: an augmented reality (AR) system, comprising:
an AR device; and
a control device configured to:
generate an output via the AR device by applying the computed assistance scheme, wherein the generated output comprises a representation of a virtual character or person
Claim 2: further comprising: a sensor configured to capture data related to the dialysis device and/or data related to an operation of the user..
Claim 4: a method for operating a dialysis device training system which employs an augmented reality (AR) device, the method comprising:
selecting, by a control device, a training task with respect to a dialysis device;
computing, by the control device, user instructions for guiding a user through the training task;
monitoring, via at least one sensor, activities of the user while operating the dialysis device; and
providing, by the control device, assistance for carrying out the training task based on the computed user instructions and the monitored activities, wherein providing the assistance comprises causing an output of indications on the AR device.
Claim 4: a method for controlling an augmented reality (AR) device for operating a dialysis device, the method comprising:
computing, by an AR system, an assistance scheme for carrying out a task to be executed by the user with regard to the dialysis device; and
generating, by the AR system, an output via the AR device by applying the computed assistance scheme, wherein the generated output comprises a representation of a virtual character or person.
While the cited claims are not identical to the instant claims, the limitations are anticipated as the cited claims are more specific than the instant claims and therefore anticipate the broader claim limitations such as “generate an output via the AR device by applying the computed assistance scheme, wherein the generated output comprises a representation of a virtual character or person” of cited claim 1 anticipates “provide assistance for carrying out the training task based on the computed user instructions and the monitored activities, wherein providing the assistance comprises causing an output of indications via the AR device”. Regarding claims 1, 3, and 4, the ’808 Application is silent on the teachings of selecting, by a control device, a training task with respect to a dialysis device; and monitoring, via at least one sensor, activities of the user while operating the dialysis device [instant claim 4]. However, the Sloat reference provides a teaching for dialysis training using augmented reality wherein the user can select a simulated dialysis treatment (task) and level for the training, and the system can score a user’s performance based on the simulated activities of the user (Abstract; Paragraphs 0063-0064, 0110). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ‘519 Application with the teachings of Sloat to include having a user select the level/task to be carried out and monitoring user activities. One of ordinary skill would make such modification in order to improve user interaction and performance by allowing a user to select a difficulty level of the training and evaluating user performance to further user training and performance.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 3-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 4 recite a system/machine for performing a process and the process, the process including the steps of selecting a training task with respect to a dialysis device; computing user instructions for guiding a user through the training task; monitoring activities of the user while operating the dialysis device; and providing assistance for carrying out the training task based on the computed user instructions and the monitored activities. The recited steps, as drafted, under their broadest reasonable interpretation, are a process that is a method of applying an abstract idea, specifically mental processes (evaluation (computing user instructions; providing assistance), judgement (selecting a training task), observation (monitoring activities of the user)) and/or certain methods of organizing human activity in the form of teaching (selecting a training task; computing user instructions; monitoring activities of the user; providing assistance). If claim limitations, under their broadest reasonable interpretation, include a mental process and/or certain methods of organizing human activity, the limitations fall under the abstract ideas judicial exception and therefore recite ineligible subject matter. Accordingly, claims 1 and 4 recite abstract ideas.
The judicial exception is not integrated into a practical application because the claims do not recite additional elements that are significantly more than the judicial exception or meaningfully limit the practice of the judicial exception. The additional elements are an augmented reality (AR) device; a control device; at least one sensor; and wherein providing the assistance comprises causing an output of indications via the AR device. The additional elements are insignificant extra-solution activity and instructions for applying the judicial exception with a generic computing device as, under their broadest reasonable interpretation, the additional step(s) is/are merely outputting/displaying results of the process (assistance indications). The other additional elements of an augmented reality device, a control device, and at least one sensor are generic computer components for performing the above method, per MPEP 2106.05(f). Under their broadest reasonable interpretation, the additional elements are generic components of a computing device used to apply the abstract idea. Further, paragraphs 0029, 0043, and 0071 of the specification state the device may be a handheld device such as a table computer or smartphone. As such, these additional elements are interpreted as merely instructions to apply the judicial exception. Accordingly, the additional elements and steps do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above, the additional step(s) of providing the assistance comprises causing an output of indications via the AR device is/are insignificant extra-solution activity performed during the abstract idea. The additional elements of an augmented reality (AR) device, a control device, and at least one sensor used to perform the process are generic computing components/device used to apply the judicial exception and therefore fall under the “apply it” limitation of the judicial exception and do not amount to significantly more per MPEP 2106.05(f). Further, the limitations, taken in combination, add nothing that is not already present when looking at the elements taken individually. As such, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, under their broadest reasonable interpretation, the additional elements do not meaningfully limit the practice of the abstract idea and do not amount to significantly more than the judicial exceptions. Therefore, claims 1 and 4 are not directed to eligible subject matter as they are directed to abstract ideas without significantly more.
Claims 5-18 are dependent from claim 4 and include all the limitations of the independent claims. Therefore, the dependent claims recite the same abstract idea. The limitations of the dependent claims fail to amount to significantly more than the judicial exception. For example:
The limitations of claims 5, 8-13, 15, and 17 recite further abstract ideas including detecting an operation of the user (evaluation/observation MP), calculating a training progress score (evaluation MP; CMOHA), computing the user instructions based on the score (judgement MP; CMOHA), computing new user instructions based on the score deviating from a threshold (judgement MP; CMOHA), determining a viewing direction of the user (observation MP), configuring a speed for carrying out the training task (judgement MP), detecting a predefined user input (observation MP), adapting the provided assistance (evaluation MP), jumping to a specific position in the instructions (judgement MP), skipping one or more instructions (judgement MP), adapting a level of detail (judgement MP), selecting a new task (judgement MP), receiving an input message from a trainer (observation MP; CMOHA), and adapting the instruction or assistance based on the message (judgement MP; CMOHA). As the limitations are further abstract ideas, the limitations cannot meaningfully limit or amount to significantly more than the abstract ideas of the independent claims. The additional elements of the dependent claims are further insignificant extra-solution activities including data gathering (sensor data detected by a sensor) and displaying data on the AR device including virtual representations. The limitations fail to provide any teaching that integrates the judicial exceptions into a practical application or amounts to significantly more than the judicial exceptions. For this reason, the analysis performed on the independent claims is also applicable on these claims.
The limitations of claims 6, 7, and 16 recite further outputs and displayed content including virtual representations, notifications, and a virtual character or person in order to provide guidance/assistance to the user. Therefore, the limitations are insignificant extra-solution activity including displaying results of the process on a generic computing device and generally linking the judicial exceptions with the field of augmented reality. The limitations fail to provide any teaching that integrates the judicial exceptions into a practical application or amounts to significantly more than the judicial exceptions. For this reason, the analysis performed on the independent claims is also applicable on these claims.
The limitation of claim 14 recites clarification of the type of user input being a user gesture. Under its broadest reasonable interpretation, the limitation is insignificant extra solution activity as it is merely defining the type of data being receive/manipulated. The limitations fail to provide any teaching that integrates the judicial exceptions into a practical application or amounts to significantly more than the judicial exceptions. For this reason, the analysis performed on the independent claims is also applicable on these claims.
The limitation of claim 18 recites further instructions for applying the judicial exceptions with a generic computing device as the additional elements are using pattern recognition and/or machine learning to determine user actions. The pattern recognition and machine learning are recited at a high level of generality amounting to a computer algorithm or instructions for performing the judicial exceptions with a generic computing device and generally linking the judicial exceptions with machine learning. The limitations fail to provide any teaching that integrates the judicial exceptions into a practical application or amounts to significantly more than the judicial exceptions. For this reason, the analysis performed on the independent claims is also applicable on these claims.
Accordingly, claims 5-181 are directed to abstract ideas without significantly more and are not drawn to eligible subject matter.
Claims 3 recites a system/machine for performing a process, the process including the steps of provide indications based on determined assistance for training a user with respect to a dialysis device; or capture data related to an activity of the user operating the dialysis device. The recited steps, as drafted, under their broadest reasonable interpretation, are a process that is a method of applying an abstract idea, specifically mental processes (evaluation (provide indications based on determined assistance), observation (capture data related to an activity of the user)) and/or certain methods of organizing human activity in the form of teaching (provide indications based on determined assistance; capture data related to an activity of the user). If claim limitations, under their broadest reasonable interpretation, include a mental process and/or certain methods of organizing human activity, the limitations fall under the abstract ideas judicial exception and therefore recite ineligible subject matter. Accordingly, claim 3 recites an abstract idea.
The judicial exception is not integrated into a practical application because the claim does not recite additional elements that are significantly more than the judicial exception or meaningfully limit the practice of the judicial exception. The additional elements are an augmented reality device; an output device; and/or a sensor interface to a sensor. The additional elements are instructions for applying the judicial exception with a generic computing device as, under their broadest reasonable interpretation, the additional elements of an AR device, an output device, and a sensor and sensor interface are generic computer components for performing the above method, per MPEP 2106.05(f). Under their broadest reasonable interpretation, the additional elements are generic components of a computing device used to apply the abstract idea. Further, paragraphs 0029, 0043, and 0071 of the specification state the device may be a handheld device such as a table computer or smartphone. As such, these additional elements are interpreted as merely instructions to apply the judicial exception. Accordingly, the additional elements and steps do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Therefore, the claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above, the additional elements of an AR device, an output device, and/or a sensor and sensor interface used to perform the process are generic computing components/device used to apply the judicial exception and therefore fall under the “apply it” limitation of the judicial exception and do not amount to significantly more per MPEP 2106.05(f). Further, the limitations, taken in combination, add nothing that is not already present when looking at the elements taken individually. As such, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, under their broadest reasonable interpretation, the additional elements do not meaningfully limit the practice of the abstract idea and do not amount to significantly more than the judicial exceptions. Therefore, claim 3 is not directed to eligible subject matter as it is directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 3 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Adi (US PGPub 20230274659).
Regarding claim 3, Adi teaches an augmented reality (AR) device (Paragraphs 0046, 0052, 0065 teach an augmented reality system using a mobile phone, smartphone, tablet, or AR goggles), comprising: an output device (Paragraphs 0046, 0052, 0065 teach an augmented reality system using a mobile phone, smartphone, tablet, or AR goggles) configured to provide indications based on determined assistance for training a user with respect to a dialysis device (Paragraphs 0040, 0063-0065 teach the system can provide and display guidance including instructions and virtual objects and avatar for completing a dialysis step and path); and/or a sensor interface to a sensor configured to capture data related to the dialysis device and/or an activity of the user operating the dialysis device (Paragraphs 0041-0042, 0058 teach the system includes an imaging input/camera (sensor) for capturing images of the user and the dialysis device).
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.
Claim(s) 1-2, 4-5, 7-9, 12-13, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sloat (US PGPub 20230237929) in view of Chiu et al. (US PGPub 20220336100), hereinafter referred to as Chiu.
Regarding claim 1, Sloat teaches a dialysis device training system (Abstract; Paragraphs 0031, 0035, 0059 teach a system for providing training for dialysis treatment), comprising: an augmented reality (AR) device (Paragraphs 0056, 0059, 0115 teach a user device for providing the training using augmented reality wherein the device can be a smartphone, tablet, or other mobile device); and a control device (Paragraphs 0050, 0053, 0054 teach a back-end computing system (control device)) configured to: select a training task with respect to a dialysis device (Paragraphs 0059, 0063-0065 teach the user can use the device to train using an AR environment by mimicking a task and/or selecting a training simulation including a level of difficulty of the simulated training); monitor, via at least one sensor, activities of the user while operating the dialysis device (Paragraphs 0038, 0063, 0088, 0110 teach the system can include a touch screen (sensor) receiving user inputs and feedback that can be evaluated to score user performance for operating the machine); and provide assistance for carrying out the training task based on the computed user instructions and the monitored activities, wherein providing the assistance comprises causing an output of indications via the AR device (Paragraphs 0059, 0063, 0081, 0083, 0115 teach the system can display an augmented reality environment for the user to train in wherein the simulated training includes dialysis events which can be outputted to the user including prompts and indicia related to the events and user performance (monitored activities)).
Sloat may not explicitly teach compute user instructions for guiding a user through the training task. However, Chiu teaches a system and method for providing augmented reality guidance to a user operator a medical device wherein the system can determine guidance information (user instructions) to provide to the user based on the determined objective (task) and current settings (Paragraphs 0095-0097).
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 Sloat to incorporate the teachings of Chiu by applying the technique of determining guidance for a user to achieve an objective of Chiu to the simulated training of Sloat, as both references and the claimed invention are directed to augmented reality training systems for training users on medical devices. One of ordinary skill in the art would modify Sloat by coding the system to include generating guidance instructions based on the steps of the simulated dialysis treatment training and providing the guidance to the user. Upon such modification, the method and system of Sloat would include compute user instructions for guiding a user through the training task. 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 Chiu with Sloat’s system and method in order to provide further guidance to the user and assist the user in completing the training by providing instructions as needed.
Regarding claim 2, Sloat further teaches further comprising: the dialysis device (Paragraphs 0035, 0038, 0052; a dialysis/hemodialysis machine).
Regarding claim 4, Sloat teaches a method for operating a dialysis device training system which employs an augmented reality (AR) device (Abstract; Paragraphs 0031, 0033, 0059, 0061, 0115 teach a method for providing training for dialysis treatment using augmented reality), the method comprising: selecting, by a control device, a training task with respect to a dialysis device (Paragraphs 0059, 0063-0065 teach the user can use the device to train using an AR environment by mimicking a task and/or selecting a training simulation including a level of difficulty of the simulated training); monitoring, via at least one sensor, activities of the user while operating the dialysis device (Paragraphs 0038, 0063, 0088, 0110 teach the system can include a touch screen (sensor) receiving user inputs and feedback that can be evaluated to score user performance for operating the machine); and providing, by the control device, assistance for carrying out the training task based on the computed user instructions and the monitored activities, wherein providing the assistance comprises causing an output of indications on the AR device (Paragraphs 0059, 0063, 0081, 0083, 0115 teach the system can display an augmented reality environment for the user to train in wherein the simulated training includes dialysis events which can be outputted to the user including prompts and indicia related to the events and user performance (monitored activities)).
Sloat may not explicitly teach computing, by the control device, user instructions for guiding a user through the training task. However, Chiu teaches a system and method for providing augmented reality guidance to a user operator a medical device wherein the system can determine guidance information (user instructions) to provide to the user based on the determined objective (task) and current settings (Paragraphs 0095-0097).
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 Sloat to incorporate the teachings of Chiu by applying the technique of determining guidance for a user to achieve an objective of Chiu to the simulated training of Sloat, as both references and the claimed invention are directed to augmented reality training systems for training users on medical devices. One of ordinary skill in the art would modify Sloat by coding the system to include generating guidance instructions based on the steps of the simulated dialysis treatment training and providing the guidance to the user. Upon such modification, the method and system of Sloat would include computing, by the control device, user instructions for guiding a user through the training task. 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 Chiu with Sloat’s system and method in order to provide further guidance to the user and assist the user in completing the training by providing instructions as needed.
Regarding claim 5, Sloat further teaches wherein the selected task is a mock task comprising a mock operation for setting at least one operational parameter and/or entering at least one input on the dialysis device (Paragraphs 0033, 0053, 0057-0059, 0088-0089 teach the system allows the user to mimic (mock operation) and simulate the dialysis treatment including the user inputting a user input such as adjusting conditions (parameters)); and wherein the method further comprises detecting an operation of the user based on the monitored activities of the user (Paragraphs 0057, 0069, 0088, 0091 teach the system can detect user inputs (operation) in response to the simulated treatment and training); computing a virtual result state of the dialysis device in response to the detected operation of the user (Paragraphs 0057, 0069, 0092, 0094 teach the system will update the simulation based on the user input (operation) including the simulated patient and dialysis machine (virtual result state)); and virtually overlaying the computed virtual result state of the dialysis device without actually carrying out the operation on the dialysis device (Paragraphs 0033, 0057, 0059, 0069, 0092, 0094, 0105, 0115 teach the system includes displaying a simulated dialysis machine and patient such that the user can mimic the operations and dialysis treatment wherein the simulation includes updating the patient condition and parameters based on the user inputs (operation) such that the displayed simulation in an AR environment (virtual overlay) would include the updated parameters (virtual result state)).
Regarding claim 7, Sloat further teaches further comprising: outputting a notification via the AR device based on the monitored activities of the user deviating from prestored target activities for the training task (Paragraphs 0063, 0105, 0110-0111 teach the system can output and display prompts (notification) based on the user performance including prompts indicating a goal (target activity) has been missed (deviating) based on the user inputs).
Regarding claim 8, Sloat further teaches further comprising: calculating a training progress score (Paragraphs 0063, 0070, 0110 teach the system can calculate and determine a score for the user’s performance), wherein the training progress score is computed based on a measured time for carrying out the task to be trained (Paragraphs 0063, 0107, 0110 teach the score can be determined in part based on getting a patient on/off their treatment on time, reaching a patient’s EDW within an allotted time, and time thresholds for the steps), and/or a level of difficulty assigned to the task to be trained (Paragraphs 0070, 0072, 0110 teach the treatments have difficulty levels and the score is determined for a completed level and much exceed a threshold to advance to a next level such that the score is based in part on the difficulty level of the task/training).
Regarding claim 9, Sloat, as modified, further teaches wherein the user instructions are computed based on the calculated training progress score (Paragraphs 0070, 0072, 0110 teach the determined score is used to determine whether to unlock a next level of training (user instructions) for the user which would include the guidance for the task of Chiu (see prior art rejection of claim 4 above)).
Regarding claim 12, Sloat further teaches further comprising: configuring a speed for carrying out the training task, wherein the assistance is provided according to the configured speed (Paragraphs 0034, 0063, 0080, 0082, 0090, 0107 teach the system may include the training simulations being time specific (configuring a speed) wherein the simulation and/or level may last a certain amount of time and include time steps of set increments (speed) during which the process can be performed including triggering dialysis events and providing the prompts and indicia).
Regarding claim 13, Sloat, as modified, further teaches further comprising: detecting a predefined user input (Paragraphs 0057, 0069, 0088, 0091 teach the system can detect user inputs (operation) in response to the simulated treatment and training); wherein the provided assistance for carrying out the task to be trained is adapted based on the detected user input (Paragraphs 0057, 0069, 0092, 0094 teach the system will update (adapt) the simulation based on the user input (detected input) including the prompts and the guidance as taught by Chi (see prior art rejection of claim 4 above)).
Regarding claim 15, Sloat further teaches wherein: a level of detail for providing the assistance is adapted based on the detected user input (Paragraphs 0064-0065, 0072, 0075 teach the user input can be selecting a difficult level (level of detail) for the training wherein different difficulties have different events, complications, and tasks), and/or a new task to be carried out is selected based on the detected user input (Paragraphs 0064-0065, 0072, 0075 teach the user input can be selecting a difficult level for the training wherein different difficulties have different events, complications, and tasks thereby carrying out different/new tasks as higher levels are selected).
Regarding claim 16, Sloat further teaches further comprising: computing a virtual character or person, wherein the virtual character or person provides at least part of the assistance (Paragraphs 0059, 0105, 0115 teach the simulated AR environment can include displaying a simulated patient (character/person) wherein the patient is used for simulating the dialysis treatment thereby being part of the training (assistance)), and wherein the virtual character or person is provided via the AR device (Paragraphs 0059, 0105, 0114-0115 teach the simulated AR environment can include displaying a simulated patient (character/person) wherein the display is via the user device using augmented reality).
Claim(s) 6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sloat in view of Chiu as applied to claim 4 above, and further in view of Adi.
Regarding claim 6, Sloat in view of Chiu may not explicitly teach wherein the selected task comprises operations for mounting or demounting an accessory and/or filling a medium; and wherein the method comprises: computing a virtual representation of the medium and/or a virtual representation of the accessory; and providing the computed virtual representation(s) via the AR device. However, Adi teaches a system and method for providing guided dialysis training using augmented reality wherein the guidance includes virtual objects corresponding to dialysis supplies and accessories including clamps, tubes, and fluids wherein the guidance can include placing (filling) the fluids and other overlays and instructions relating to the supplies (Abstract; Paragraphs 0037, 0041, 0059).
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 Sloat in view of Chiu to incorporate the teachings of Adi by including the virtual/simulated supplies and corresponding guidance of Adi as part of the simulated training of Sloat, as both references and the claimed invention are directed to augmented reality training systems for training users on dialysis devices/treatment. One of ordinary skill in the art would modify Sloat in view of Chiu by coding the system to include simulated accessories including fluids and tubing wherein the accessories are virtual objects within the augmented/simulated environment and wherein the task/dialysis event can include attaching accessories or filling fluids into the machine in part as Sloat already teaches ensuring proper placement of parts such as needles and providing fluids such as saline (Sloat paragraphs 0059, 0085). Upon such modification, the method and system of Sloat in view of Chiu would include wherein the selected task comprises operations for mounting or demounting an accessory and/or filling a medium; and wherein the method comprises: computing a virtual representation of the medium and/or a virtual representation of the accessory; and providing the computed virtual representation(s) via the AR device. 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 Adi with Sloat in view of Chiu’s system and method in order to provide further guidance to the user and provide more comprehensive training to ensure proper usage of a dialysis machine.
Regarding claim 17, Sloat in view of Chiu may not explicitly teach further comprising: receiving an input message from a trainer; wherein computing the user instructions and/or providing the assistance is adapted based on the received input message. However, Adi further teaches the training may be monitored by a coach wherein the coach can provide additional guidance through voice, text, video, or virtual avatar (Paragraphs 0040, 0063, 0070, 0073).
As discussed above, 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 Sloat in view of Chiu to incorporate the teachings of Adi by including a coach being able to provide text and other guidance that is included in the simulated training of Adi as part of the simulated training of Sloat, as both references and the claimed invention are directed to augmented reality training systems for training users on dialysis devices/treatment. One of ordinary skill in the art would modify Sloat in view of Chiu by coding the system to include receiving feedback and guidance from a coach (trainer) wherein the guidance can be provided to the user via text, video, or other overlay to the training simulation (adapted). Upon such modification, the method and system of Sloat in view of Chiu would include further comprising: receiving an input message from a trainer; wherein computing the user instructions and/or providing the assistance is adapted based on the received input message. 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 Adi with Sloat in view of Chiu’s system and method in order to provide further guidance to the user and allow coaches/trainers to monitor user performance and provide additional guidance to improve user performance.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sloat in view of Chiu as applied to claim 9 above, and further in view of Allen et al. (US PGPub 20190237083), hereinafter referred to as Allen.
Regarding claim 10, Sloat in view of Chiu may not explicitly teach wherein new user instructions are computed based on the training progress score deviating from a predefined threshold or range. However, Allen teaches a system and method for providing real-time assistance for trainees during training exercises wherein the system scores a user performance/interaction and if the user’s score is within an unacceptable score threshold range (deviating from an acceptable range) the system outputs additional instructions to the user (Paragraphs 0048-0049, 0093-0094, 0110-0112).
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 Sloat in view of Chiu to incorporate the teachings of Allen by applying the technique of providing additional guidance to a user if their performance/interaction score is outside an acceptable range of Allen to the training guidance of Sloat in view of Chiu, as the references and the claimed invention are directed to augmented reality training systems for training users on performing exercises/tasks. One of ordinary skill in the art would modify Sloat in view of Chiu by coding the system to include acceptable and unacceptable threshold score ranges for the scores of Sloat wherein if a user’s score is within an unacceptable range or outside an acceptable range additional guidance and instructions can be given to the user to correct the user’s performance. Upon such modification, the method and system of Sloat in view of Chiu would include wherein new user instructions are computed based on the training progress score deviating from a predefined threshold or range. 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 Allen with Sloat in view of Chiu’s system and method in order to provide further guidance to the user and efficiently provide assistance to the user (Allen Paragraph 0112).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sloat in view of Chiu as applied to claim 4 above, and further in view of Cork et al. (US PGPub 20170039423), hereinafter referred to as Cork.
Regarding claim 11, Sloat in view of Chiu may not explicitly teach further comprising: determining a viewing direction of the user based on sensor data detected via a sensor; wherein the provided assistance is adapted to direct the viewing direction of the user to a target viewing direction. However, Cork teaches a head mounted display device for use in a medical facility including detecting eye movements or other characteristics of the eyes using a camera (sensor) including a location of the user’s gaze (viewing direction) and providing instructions to direct the person’s gaze to a suitable (target) area or icon (Paragraphs 0019, 0039, 0041).
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 Sloat in view of Chiu to incorporate the teachings of Cork by applying the technique of detecting a user’s eye movements and gaze direction using a camera and providing instructions to direct the user’s gaze of Cork to the simulation and training guidance of Sloat in view of Chiu, as the references and the claimed invention are directed to augmented reality training systems for training users on using dialysis devices. One of ordinary skill in the art would modify Sloat in view of Chiu by coding the system to include using the camera/imaging device to capture a user’s eye movement and determine a gaze direction of the user and providing guidance to direct the user’s gaze based on the current task/step. Upon such modification, the method and system of Sloat in view of Chiu would include further comprising: determining a viewing direction of the user based on sensor data detected via a sensor; wherein the provided assistance is adapted to direct the viewing direction of the user to a target viewing direction. 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 Cork with Sloat in view of Chiu’s system and method in order to provide assist user’s in finding the appropriate buttons and controls and improve user performance.
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sloat in view of Chiu as applied to claim 13 above, and further in view of Buras et al. (US PGPub 20210327303), hereinafter referred to as Buras.
Regarding claim 14, Sloat in view of Chiu may not explicitly teach wherein the predefined user input is a predefined user gesture. However, Buras teaches a system and method for augmented reality guidance for use of medical equipment wherein the system can receive user inputs including gestures (Abstract; Paragraphs 0081, 0083, 0094, 0257).
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 Sloat in view of Chiu to incorporate the teachings of Buras by including the device receiving user hand motions/gestures as an input of Buras for the user input/selection of Sloat, as both references and the claimed invention are directed to augmented reality training systems for training users on medical equipment. One of ordinary skill in the art would modify Sloat in view of Chiu by coding the system to include receiving user gestures and hand motions as inputs via the camera of the augmented reality device. Upon such modification, the method and system of Sloat in view of Chiu would include wherein the predefined user input is a predefined user gesture. 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 Buras with Sloat in view of Chiu’s system and method in order to improve user interaction as gesture recognition for input into augmented reality devices is well-known in the art and one of ordinary skill in the art would expect applying the technique to Sloat in view of Chiu would achieve the expected result of allowing a user to interact with the system in a hands-free manner.
Regarding claim 18, Sloat in view of Chiu may not explicitly teach wherein based on the monitored activities of the user, actions are determined based on pattern recognition and/or based on machine learning applied to data obtained from the at least one sensor. However, Buras teaches a system and method for augmented reality guidance for use of medical equipment wherein the system includes a machine learning model that can perform pattern recognition and monitor user actions based on data captured by cameras (sensor) (Abstract; Paragraphs 0018, 0081, 0083, 0089, 0095, 0241, 0243-0244).
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 Sloat in view of Chiu to incorporate the teachings of Buras by applying the technique of using machine learning models to monitor user actions and performance of Buras for training simulations of Sloat, as both references and the claimed invention are directed to augmented reality training systems for training users on medical equipment. One of ordinary skill in the art would modify Sloat in view of Chiu by coding the system to machine learning models to analyze the camera/imaging device data and determine user actions and performance. Upon such modification, the method and system of Sloat in view of Chiu would include wherein based on the monitored activities of the user, actions are determined based on pattern recognition and/or based on machine learning applied to data obtained from the at least one sensor. 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 Buras with Sloat in view of Chiu’s system and method in order to improve system performance and better identify user actions as machine learning analysis of images/videos is well-known in the art and one of ordinary skill in the art would expect applying the technique to Sloat in view of Chiu would achieve the expected result of identifying user actions and performance.
Conclusion
Accordingly, claims 1-18 are rejected.
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/CORRELL T FRENCH/Examiner, Art Unit 3715
1 Examiner notes claim 2, which depends from claim 1, is not rejected under 35 U.S.C. 101 as claim 2 positively recites the dialysis device which amounts to a practical application of the judicial exceptions as the recitation implements the judicial exception with a particular machine that is integral to the claim (see MPEP 2106.05(b)).
