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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on January 29, 2026 has been entered.
Status of Claims
Claims 1- 6 and 8-22 are pending. Claim 7 is cancelled.
Response to Amendments
In light of Applicant’s amendments/remarks, the objections of record with respect to claim 1 is withdrawn.
Response to Arguments
Applicant’s amendments of independent claims 1 and 13, which has altered the scope of the claims of the instant application, has necessitated the new ground(s) of rejection presented in this office action with respect to claims of the instant application. Accordingly, in response to Applicant’s arguments that are merely directed to the amended portion of the claims, new analyses have been presented below, which make Applicant’s arguments moot.
Double Patenting
Non-statutory
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 1-6 and 8-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of Patent No. 12,308,109 B2 in view of Divine et al. (US 10,991,461 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader in every aspect than the claims in the above-listed reference application and are therefore obvious variants thereof.
This is a nonstatutory obviousness-type double patenting rejection because the patentably indistinct claims have in fact been patented.
For example, the following is a chart comparing claim 1 of the instant application to the claim 1 and 7 of US Patent 12,308,109 B2 in view of Divine:
Instant Application 18/352,122
US Patent No. 12,308,109 B2
Although the U.S Patent 12,308,109 B2 discloses a system and method for optimizing a medical procedure, the U.S Patent 12,308,109 B2 does not explicitly disclose “[[an]] a dedicated imaging device for a predefined area of the medical procedure room, the dedicated imaging device is configured to: obtain one or more data associated with one or more medical items present in [[a]] the predefined area of the medical procedure room, wherein the predefined area corresponds to a portion of the area of the medical procedure room defined by the presence of the one or more medical ”.
However, Divine teaches “[[an]] a dedicated imaging device for a predefined area (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional") of the medical procedure room (Divine column 11 lines 31-34 ""For example, one or more cameras can be located at different positions in an operating room, examination room, laboratory room, at different positions throughout a hospital, etc"), the dedicated imaging device (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional") is configured to:
obtain one or more data associated with one or more medical items present in [[a]] the predefined area of the medical procedure room (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional"), wherein the predefined area corresponds to a portion of the area of the medical procedure room defined by the presence of the one or more medical items (Divine Figure 3 and column 25 lines 12-23 "assess the procedural environment prior to beginning the procedure, at various points throughout the procedure, and upon completion of the procedure, to determine whether the procedural environment is on par with the required guidelines. For example, the procedure assessment component 116 can determine if certain supplies or equipment is missing from the procedure environment, if certain supplies or equipment is functioning improperly, if supplies/tools were unused when they should have been, whether certain supplies/tools that were used were not disposed correctly ( e.g., a sponge was left in the patient), and the like
It would have been obvious to a person having ordinary skill in the art before
effective filing date of the claimed invention of the instant application to combine a system and method for optimizing a medical procedure as taught by claim 1 and 7 of U.S Patent 12,308,109 B2 to include a system and method for minimizing human error during medical procedure as taught by Divine.
The suggestion/motivation for doing so would have been that there is a need in
the field of medical procedures to decrease human error, "systems provide mechanisms to improve human behavior through AR guidance. For example, the subject AR systems and methods contemplated herein can help guide staff to complete the correct procedure steps based on which procedure is correct based on many factors discussed herein, and including which government and/or insurance agency may be paying for the activity. Further, in some implementations, the subject AR systems can detect when human behavior may be an improvement over current procedures and methods and propose those improvements to leadership" as noted by the Divine disclosure in column 4 lines 37-47.
Therefore, it would have been obvious to combine the disclosure of U.S Patent 12,308,109 B2 with the Divine disclosure to obtain the invention as specified in instant application claim 1 as there is a reasonable expectation of success and/or because doing so merely combines prior art elements according to known methods to yield predictable results. Claims 2-6 and 8-22 are similarly rejected under nonstaturory obviousness-type double patenting as being unpatentable over U.S Patent 12,308,109 B2 in view of Divine.
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 8-22 are rejected under 35 U.S.C. 103 as being unpatentable over Divine et al. (US 10,991,461 B2) in view of Masson et al. (US 12,308,109 B2).
Regarding claim 1, Divine teaches “A system for optimizing a medical procedure performed by a medical practitioner in a medical procedure room (Divine Figure 1 and column 4 lines 30-34 "computer processing systems, computer-implemented methods, apparatus and/or computer program products that facilitate preventing or minimizing human error associated with performance of healthcare related procedures by a healthcare professional"), the system comprising:
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Divine Figure 1
[[an]] a dedicated imaging device for a predefined area (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional") of the medical procedure room (Divine column 11 lines 31-34 ""For example, one or more cameras can be located at different positions in an operating room, examination room, laboratory room, at different positions throughout a hospital, etc"), the dedicated imaging device (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional") is configured to:
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Divine Figure 3
obtain one or more data associated with one or more medical items present in [[a]] the predefined area of the medical procedure room (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional"), wherein the predefined area corresponds to a portion of the area of the medical procedure room defined by the presence of the one or more medical items (Divine Figure 3 and column 25 lines 12-23 "assess the procedural environment prior to beginning the procedure, at various points throughout the procedure, and upon completion of the procedure, to determine whether the procedural environment is on par with the required guidelines. For example, the procedure assessment component 116 can determine if certain supplies or equipment is missing from the procedure environment, if certain supplies or equipment is functioning improperly, if supplies/tools were unused when they should have been, whether certain supplies/tools that were used were not disposed correctly ( e.g., a sponge was left in the patient), and the like") in which the one or more medical items are present ;
a server communicatively coupled to the dedicated imaging device , the server configured to: receive the one or more data associated with the one or more medical items present in the predefined area of the medical procedure room from the dedicated imaging device (Divine column 11 lines 11-16 "live video can be rendered via the display 106 and/or provided to the server device 108 for processing by the AR assistance module in association with monitoring the healthcare professional's performance of the healthcare procedure and providing real-time feedback to the healthcare professional regarding the performance");
(Divine column 18 column 32-40 "The procedure identification component 112 can further determine the type of procedure being performed by comparing the one or more descriptive parameters with predefined information (e.g., in memory 130, at one or more external information sources 138, or at another device) that associates the one or more descriptive parameters (e.g., the identified objects, people, words, actions or event, characteristics of those actions or events, etc.) or patterns in the descriptive parameters with a defined type of procedure");
;
provide one or more recommendations associated with the one or more medical items corresponding to the predefined area for optimizing the medical procedure (Divine column 25 lines 12-23 "assess the procedural environment prior to beginning the procedure, at various points throughout the procedure, and upon completion of the procedure, to determine whether the procedural environment is on par with the required guidelines. For example, the procedure assessment component 116 can determine if certain supplies or equipment is missing from the procedure environment, if certain supplies or equipment is functioning improperly, if supplies/tools were unused when they should have been, whether certain supplies/tools that were used were not disposed correctly ( e.g., a sponge was left in the patient), and the like") based on the comparison; and
an augmented reality device communicatively coupled to the server (Divine column 10 lines 21-26 "the server device 108 includes ( or is otherwise operatively coupled to) at least one memory 130 that stores computer-executable components. In one or more embodiments, these computer executable components include the augmented reality (AR) assistance module 110 and associated components"), the augmented reality device configured to: receive the one or more recommendations from the server (Divine column 55 lines 3-7 "Relevant recommendation information (e.g., relevant to a current area being viewed by a user and a current context of the user) can further be selected by the selection component 1016 and provided to a user as overlay data in an AR or VR experience"); and
display the one or more recommendations on the augmented reality device for the optimization of the medical procedure, wherein the displaying comprises providing a mixed reality interface having at least one virtual representation of information associated with at least one medical item of the one or more medical items (Divine column 53 lines 41-50 “AR visualization 1500 including auxiliary information regarding various aspects of an operating room environment in accordance with one or more embodiments described herein. One or more aspects of the example AR visualization 1500 demonstrate the features and functionalities of systems 1000 and 1300 (and additional systems described herein) with respect to equipment/supplies assessment component 1008 and employee assessment component 1302”) corresponding to a real-world view of the predefined area of the medical procedure room for the upcoming phase (Divine Figure 3 and column 55 lines 3-7 "Relevant recommendation information (e.g., relevant to a current area being viewed by a user and a current context of the user) can further be selected by the selection component 1016 and provided to a user as overlay data in an AR or VR experience" – note, for clarity, as shown in Figure 3 the overlay for the needle can be interpreted as an item required for the upcoming phase of the procedure).”
However, Divine is not relied on to teach “identify an upcoming phase of the medical procedure” and “obtain one or more reference data for a plurality of reference medical items required for the upcoming phase of the medical procedure corresponding to the predefined area from one or more reference medical procedures performed prior to the medical procedure, wherein the one or more reference data for the plurality of reference medical items is associated with a phase identifier of the upcoming phase and a combination of a medical practitioner identifier identifying the medical practitioner performing the medical procedure, a medical procedure identifier identifying the medical procedure being performed, and a medical procedure room identifier identifying the medical procedure room for execution of the medical procedure; compare the one or more reference data for the plurality of reference medical items with the one or more received data associated with the one or more medical items present in the medical procedure room corresponding to the predefined area”.
Masson teaches “identify an upcoming phase of the medical procedure (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures")” and
“obtain one or more reference data for a plurality of reference medical items required for the upcoming phase of the medical procedure corresponding to the predefined area from one or more reference medical procedures performed prior to the medical procedure, wherein the one or more reference data for the plurality of reference medical items is associated with a phase identifier of the upcoming phase (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures") and a combination of a medical practitioner identifier identifying the medical practitioner performing the medical procedure, a medical procedure identifier identifying the medical procedure being performed, and a medical procedure room identifier identifying the medical procedure room for execution of the medical procedure (Masson column 22 lines 53-65 "the data module 810 is configured to store one or more steps of one or more previously executed medical procedures (herein interchangeably referred to as reference medical procedures) associated with each of the medical practitioner identifier, a medical procedure identifier, and a medical procedure room identifier for execution of the medical procedure. For example, one or more medical procedures previously performed by a medical practitioner is recorded and associated with the medical practitioner identifier and stored in the data module 810. Similarly, one or more medical procedures performed in a medical procedure room is recorded and associated with the medical procedure room identifier and stored in the data module 810");
compare the one or more reference data for the plurality of reference medical items with the one or more received data associated with the one or more medical items present in the medical procedure room corresponding to the predefined area (Masson column 24 line 67 and column 25 lines 1-7 "the machine learning module 812 is configured to compare the acquired data with the analyzed prestored data by determining whether the acquired data associated with usage of at least one of the item and the equipment during the medical procedure correspond to the determined optimal relationship for the one or more of the medical practitioner identifier, the medical procedure identifier, and the medical procedure room identifier")”.
It would have been obvious to a person having ordinary skill in the art before
effective filing date of the claimed invention of the instant application to combine a system for minimizing human error during medical procedure as taught by Divine to include comparison of reference information with information of the current medical procedure to identify next stage and deviations in the medical procedure as taught by Masson.
The suggestion/motivation for doing so would have been that there is a need in
the field of medical procedures to decrease human error, "During a medical procedure that demands the full attention of the medical practitioner and other medical personnel, the tracking of such equipment can easily be ignored or incorrectly logged. Further, information about the number and type of supplies used during the procedure may be useful to the medical practitioner, medical personnel, and/or medical facility for efficiency evaluation, practitioner success rates, cost per procedure, patient variation and response, procedure improvement, and/or other characteristics over time. Finally, most medical procedures demand that the steps be performed in a specific order, at a specific speed, with correctly sized implants and/or tools, and the like. Regardless
of how well trained the medical practitioner is, human error can occur, especially when performing new or complex procedures. Therefore, a medical practitioner must pay careful attention to the sequence of medical procedure steps, the number and characteristics of all tools and supplies used, the medical procedure room setup, and patient needs, to name a few" as noted by the Masson disclosure in column 1 lines 41-60.
Therefore, it would have been obvious to combine the disclosure of Divine with
the Masson disclosure to obtain the invention as specified in claim 1 as there is a
reasonable expectation of success and/or because doing so merely combines prior art
elements according to known methods to yield predictable results.
Regarding claim 13, it recites a method with steps corresponding to the elements of the system recited in claim 1. Therefore, the recited steps of claim 13 are mapped to the proposed combination in the same manner as the corresponding elements of the apparatus claim 1. Additionally, the rationale and motivation to combine Divine and Masson presented in rejection of claim 1, apply to this claim.
Regarding claim 2 (similarly claim 14), the combination of Divine and Masson teaches “The system of claim 1, wherein the one or more reference data includes identification of the plurality of reference medical items required for the upcoming phase (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures"), wherein the server is further configured to provide a recommendation of the one or more recommendations including removal of a medical item of the one or more medical items present in the predefined area of the medical procedure room (Divine column 8 lines 25-33 "equipment information regarding utilization and/or performance of equipment associated with the area, employee information regarding utilization and/or performance of the employees associated with the area, and recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)"), and wherein to remove the medical item, the server is configured to:
identify the medical item present in the predefined area of the medical procedure room based on the one or more data obtained from the dedicated imaging device (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional"), the medical item uniquely identified by a medical item identifier (Divine column 8 lines 19-23 "The computing system can further identify objects, equipment, supplies, people, etc., included in the area (or associated with the area), and further determine auxiliary information associated with the objects, equipment, supplies, people, etc.");
compare the reference data with the medical item identifier (Masson column 24 line 67 and column 25 lines 1-7 "the machine learning module 812 is configured to compare the acquired data with the analyzed prestored data by determining whether the acquired data associated with usage of at least one of the item and the equipment during the medical procedure correspond to the determined optimal relationship for the one or more of the medical practitioner identifier, the medical procedure identifier, and the medical procedure room identifier") corresponding to the medical item (Divine column 56 lines 9-14 "the system determines by whether an aspect of one of the actions currently being performed by the user deviates from a defined protocol for the healthcare related procedure based on comparison of the descriptive information with reference descriptive parameters for the healthcare related procedure (e.g., via procedure assessment component 116)"):
determine whether the medical item is required (Divine column 8 lines 25-33 "equipment information regarding utilization and/or performance of equipment associated with the area, employee information regarding utilization and/or performance of the employees associated with the area, and recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)") for the upcoming phase of the medical procedure based on the comparison (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures"): and
provide the recommendation for removing the medical item from the predefined area of the medical procedure room for the upcoming phase when the medical item is not required for the upcoming phase (Divine column 8 lines 25-33 "recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 2. Finally the system recited in claim 2 is met by Divine and Masson.
Regarding claim 3 (similarly claim 15), the combination of Divine and Masson teaches “The system of claim 1, wherein the one or more reference data includes identification of the plurality of reference medical items required for the upcoming phase (Masson column 24 line 67 and column 25 lines 1-7 "the machine learning module 812 is configured to compare the acquired data with the analyzed prestored data by determining whether the acquired data associated with usage of at least one of the item and the equipment during the medical procedure correspond to the determined optimal relationship for the one or more of the medical practitioner identifier, the medical procedure identifier, and the medical procedure room identifier"), wherein the server is configured to provide a recommendation of the one or more recommendations including addition of a medical item in the predefined area of the medical procedure room (Divine column 8 lines 25-33 "equipment information regarding utilization and/or performance of equipment associated with the area, employee information regarding utilization and/or performance of the employees associated with the area, and recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)"), and wherein to add the medical item, the server is configured to:
identify the one or more medical items present in the predefined area of the medical procedure room based on the one or more data obtained from the dedicated imaging device (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional"), each medical item uniquely identified by a medical item identifier (Divine column 8 lines 19-23 "The computing system can further identify objects, equipment, supplies, people, etc., included in the area (or associated with the area), and further determine auxiliary information associated with the objects, equipment, supplies, people, etc.");
compare the one or more reference data with the medical item identifiers (Masson column 24 line 67 and column 25 lines 1-7 "the machine learning module 812 is configured to compare the acquired data with the analyzed prestored data by determining whether the acquired data associated with usage of at least one of the item and the equipment during the medical procedure correspond to the determined optimal relationship for the one or more of the medical practitioner identifier, the medical procedure identifier, and the medical procedure room identifier") corresponding to the one or more medical items present in the predefined area (Divine column 56 lines 9-14 "the system determines by whether an aspect of one of the actions currently being performed by the user deviates from a defined protocol for the healthcare related procedure based on comparison of the descriptive information with reference descriptive parameters for the healthcare related procedure (e.g., via procedure assessment component 116)");
determine an absence of the medical item in the predefined area of the medical procedure room (Divine column 8 lines 25-33 "equipment information regarding utilization and/or performance of equipment associated with the area, employee information regarding utilization and/or performance of the employees associated with the area, and recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)") for the upcoming phase of the medical procedure based on the comparison (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures"); and
provide the recommendation for adding the medical item in the predefined area of the medical procedure room for the upcoming phase based on the determination (Divine Figure 3 and column 8 lines 25-33 "recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 3. Finally the system recited in claim 3 is met by Divine and Masson.
Regarding claim 4 (similarly claim 16), the combination of Divine and Talmor teaches “The system of claim 1, wherein the one or more reference data includes position information of the plurality of reference medical items required for the upcoming phase (Masson column 4 lines 46-56 "each practitioner's preferred medical procedure room layout for each procedure may be stored in the optimization system 104 as a default setup and suggested to a user and/or the practitioner when planning a new setup for the same or similar medical procedure. As the medical practitioner, medical personnel 130, and/or other user of the optimization system 104 performs each step of the procedure and uses, moves, or removes each item of equipment and/or inventory, such activity is logged by the optimization system 104 for later analysis, inventory replenishment, education, procedural support, or other purposes"), wherein the server is further configured to provide a recommendation of the one or more recommendations including change in an arrangement of a medical item of the one or more medical items present in the predefined area of the medical procedure room (Masson column 16 lines 53-57 "the edit to the medical procedure room includes one or more of change in the available room layout and dimensions, change in position of the items corresponding to one or more of the medical devices, consumables, general tray, and equipment in the medical procedure room"), and wherein to recommend change in the arrangement of the medical item, the server is configured to:
identify one or more data associated with the arrangement of the medical item present in the predefined area of the medical procedure room (Divine column 8 lines 19-23 "The computing system can further identify objects, equipment, supplies, people, etc., included in the area (or associated with the area), and further determine auxiliary information associated with the objects, equipment, supplies, people, etc.");
compare the one or more data associated with the arrangement of the medical item with the position information of the plurality of reference medical items (Divine column 56 lines 9-14 "the system determines by whether an aspect of one of the actions currently being performed by the user deviates from a defined protocol for the healthcare related procedure based on comparison of the descriptive information with reference descriptive parameters for the healthcare related procedure (e.g., via procedure assessment component 116)");
determine a change in the arrangement of the medical item present in the predefined area of the medical procedure room based on the comparison (Divine column 56 lines 9-14 "the system determines by whether an aspect of one of the actions currently being performed by the user deviates from a defined protocol for the healthcare related procedure based on comparison of the descriptive information with reference descriptive parameters for the healthcare related procedure (e.g., via procedure assessment component 116)"); and
provide the recommendation for changing the arrangement of the medical item present in the predefined area of the medical procedure room for the upcoming phase based on the determination (Masson column 4 lines 26-31 "the layout of the preferred medical procedure room setup 106 may be uploaded or input into the optimization system 104 and may be displayed to a medical practitioner and/or medical personnel 130 through one or more mixed reality devices 132 of the optimization system 104" and Masson column 4 lines 35-40 "the optimization system 104 may suggest,or at least partially suggest, to the medical practitioner and/or medical personnel 130 an optimized medical procedure room setup 106, amount and type of inventory and items of medical equipment, and other characteristics to enhance efficiency of the medical procedure").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 4. Finally the system recited in claim 4 is met by Divine and Masson.
Regarding claim 5 (similarly claim 17), the combination of Divine and Masson teaches “The system of claim 1, wherein to identify the upcoming phase of the medical procedure, the server is further configured to: receive data associated with usage of the one or more medical items in the predefined area of the medical procedure room from the dedicated imaging device (Divine column 8 lines 34-40 "the user can be automatically provided with auxiliary information associated with performance of the healthcare organization based on utilization of the room, including but not limited to: information identifying medical supplies and equipment included in the room, information regarding usage of the medical supplies and equipment" and Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional");
compare the data associated with the usage of the one or more medical items with one or more prestored reference data corresponding to the one or more reference data associated with the usage of the one or more medical items in a plurality of phases of the one or more reference medical procedures performed prior to the medical procedure (Masson column 24 lines 61-67 "the machine learning module 812 is configured to compare the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures");
identify, based on the comparison, an ongoing phase associated with the medical procedure in the medical procedure room (Masson column 25 lines 38-45 "the machine learning module 812 is configured to compare the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures"); and
determine the upcoming phase of the medical procedure with reference to the ongoing phase (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures […] the machine learning module 812 is configured to identify the current step, as discussed above, to determine the next steps for execution of the medical procedure").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 5. Finally the system recited in claim 5 is met by Divine and Masson.
Regarding claim 6, the combination of Divine and Masson teaches “The system of claim 1,wherein the server is further configured to identify the upcoming phase of the medical procedure (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures") based on a user input (Masson column 19 lines 17-24 "Next, in operation 712, a medical practitioner identifier (for example a medical practitioner) is selected from a list of medical practitioner identifiers. Next, in operation 714 a procedure identifier is selected from a list of procedure identifiers. Once the medical practitioner identifier and the procedure identifier have been selected, a medical procedure room 102 is identified").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 6. Finally the system recited in claim 6 is met by Divine and Masson.
Regarding claim 8 (similarly claim 18), the combination of Divine and Masson teaches “The system of claim 1, wherein displaying the one or more recommendations on the augmented reality device includes displaying a virtual representation of a medical item at a location in the predefined area of the medical procedure room (Divine Figure 3 and column 31 lines 7-12 "the AR device 306 can include or be communicatively coupled to the AR assistance module 110 to facilitate monitoring the performance of the procedure by the clinician 302 in real-time and providing the clinician 302 with overlay data that guides or assists the clinician 302 with performing the procedure")..
Regarding claim 9 (similarly claim 19), the combination of Divine and Masson teaches “The system of claim 1, wherein the server is further configured to provide a recommendation of the one or more recommendations (Divine Figure 3 and column 8 lines 25-33 "recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)") including providing one or more data associated with a usage of a medical item in the predefined area of the medical procedure room (Divine column 8 lines 34-40 "the user can be automatically provided with auxiliary information associated with performance of the healthcare organization based on utilization of the room, including but not limited to: information identifying medical supplies and equipment included in the room, information regarding usage of the medical supplies and equipment"), wherein to provide the one or more data, the server is configured to:
receive data associated with a usage of a medical item of the one or more medical items in the predefined area of the medical procedure room from the dedicated imaging device (Divine Figure 3 and column 11 lines 7-9 "the camera 104 can capture live video of a healthcare professional's environment in association with performance of a healthcare procedure by the healthcare professional"),
wherein the medical item is associated with a medical item identifier (Divine column 8 lines 19-23 "The computing system can further identify objects, equipment, supplies, people, etc., included in the area (or associated with the area), and further determine auxiliary information associated with the objects, equipment, supplies, people, etc.");
compare the data associated with the usage of the medical item associated with the medical item identifier with one or more prestored reference data corresponding to the one or more reference data associated with a usage of a reference medical item associated with the medical item identifier from the one or more refence medical procedures performed prior to the medical procedure (Masson column 24 lines 61-67 "the machine learning module 812 is configured to compare the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures");
determine a deviation in the data associated with the usage of the medical item with respect to the reference data associated with the usage of the reference medical item (Masson column 27 lines 20-24 "the machine learning module 812 is configured to generate an alert when the data associated with the usage of at least one of an item and an equipment during the medical procedure is not consistent with the received medical procedure"); and
provide the recommendation associated with the usage of the medical item based on the deviation (Divine Figure 3 and column 8 lines 25-33 "recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 9. Finally the system recited in claim 9 is met by Divine and Masson.
Regarding claim 10, the combination of Divine and Masson teaches “The system of claim 1, wherein displaying the one or more recommendations on the augmented reality device includes displaying a virtual representation of a medical item at a location in the predefined area of the medical procedure room (Divine Figure 3 and column 31 lines 7-12 "the AR device 306 can include or be communicatively coupled to the AR assistance module 110 to facilitate monitoring the performance of the procedure by the clinician 302 in real-time and providing the clinician 302 with overlay data that guides or assists the clinician 302 with performing the procedure").”
Regarding claim 11, the combination of Divine and Masson teaches “The system of claim 1, wherein displaying the one or more recommendations on the augmented reality device includes displaying superimposition of a digital identification mark on a medical item present in the predefined area of the medical procedure room (Divine Figure 3 and column 31 lines 10-12 "providing the clinician 302 with overlay data that guides or assists the clinician 302 with performing the procedure").”
Regarding claim 12 (similarly claim 20), the combination of Divine and Masson teaches “The system of claim 1, wherein the server is configured to compare the one or more reference data for the plurality of reference medical items with the one or more received data associated with the one or more medical items present in the medical procedure room (Masson column 24 line 67 and column 25 lines 1-7 "the machine learning module 812 is configured to compare the acquired data with the analyzed prestored data by determining whether the acquired data associated with usage of at least one of the item and the equipment during the medical procedure correspond to the determined optimal relationship for the one or more of the medical practitioner identifier, the medical procedure identifier, and the medical procedure room identifier") by:
analyzing the one or more reference data associated with the one or more reference medical procedures (Masson column 3 lines 8-12 "obtaining, by a procedure module, at least one medical procedure input associated with a medical practitioner identifier, a medical procedure identifier, and a medical procedure room identifier for execution of the medical procedure");
determining an optimal reference data corresponding to each phase of the medical procedure based on the analyzed one or more reference data, the optimal reference data corresponding to one or more of an identification, a setup, and a usage of the plurality of reference medical items required for each phase of the medical procedure (Masson column 3 lines 16-25 "acquiring, by a procedure input module, via the one or more mixed reality devices, data associated with usage of at least one of an item and an equipment during the medical procedure. Further, the method comprises analyzing, by a machine learning module, prestored data associated with usage of at least one of the items and the equipment in one or more reference medical procedures corresponding to the one or more of the medical practitioner identifier, the medical procedure identifier, and the medical procedure room identifier"), wherein the optimal reference data is determined by comparing a number of instances of the one or more reference data in the corresponding phases of the one or more reference medical procedures with a predefined threshold number (Divine column 35 lines 7-19 "optimization component 604 can examine the entirety or a subset of the data to which it is granted access and can provide for reasoning about or infer states of the system (e.g., system 600 and the like), environment, etc., from a set of observations as captured via events and/or data. An inference can be employed to identify a specific context or action, or can generate a probability distribution over states, for example. The inference can be probabilistic ( e.g., the computation of a probability distribution over states of interest can be based on a consideration of data and events). An inference can also refer to techniques employed for composing higher-level events from a set of events and/or data"); and
comparing the received one or more data associated with the one or more medical items with the optimal reference data to provide recommendations (Masson column 3 lines 25-33 "The method further comprises comparing, by the machine learning module, the acquired data associated with usage of at least one of the items and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures, and providing recommendation for optimizing the execution of the medical procedure based on the comparison").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 12. Finally the system recited in claim 12 is met by Divine and Masson.
Regarding claim 21, the combination of Divine and Masson teaches “The system of claim 1, wherein the server is further configured to:
determine an optimal reference data for a plurality of reference medical items required (Divine column 8 lines 25-33 "equipment information regarding utilization and/or performance of equipment associated with the area, employee information regarding utilization and/or performance of the employees associated with the area, and recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)") for the upcoming phase (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures") by:
determining an optimal relationship (Masson column 23 lines 9-12 "The data stored in the data module 810 may provide medical personnel 130 with the ability to search for instruments to provide information for unfamiliar tools and give feedback of optimal placement") between the obtained reference data (Divine column 8 lines 25-33 "equipment information regarding utilization and/or performance of equipment associated with the area, employee information regarding utilization and/or performance of the employees associated with the area, and recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)") and one or more pre-determined performance parameters associated with the upcoming phase (Masson column 25 lines 57-64 "the machine learning module 812 is configured to identify a next step for execution of the medical procedure based on the comparison of the acquired data associated with usage of at least one of the item and the equipment during the medical procedure with the analyzed prestored data associated with the respective at least one of the item and the equipment in one or more reference medical procedures"); and
update the one or more displayed recommendations (Divine column 53 lines 1-5 "the AR device 1104 can include or be communicatively coupled to the AR assistance module 110 to facilitate providing the user with auxiliary information regarding usage and/or performance of a healthcare system equipment in association with viewing the equipment") in real-time based on the updated optimal relationship (Divine column 20 lines 21-28 "The procedure characterization component 114 can further generate descriptive information that describes various aspects of a procedure over the course of the procedure. In one or more embodiments, in addition to facilitating identifying a procedure being performed, this descriptive information can be used by the procedure assessment component to evaluate the performance of the procedure in real time over the course of the procedure").”
The proposed combination as well as the motivation for combining Divine and Masson references presented in the rejection of claim 1, applies to claim 21. Finally the system recited in claim 21 is met by Divine and Masson.
Regarding claim 22, the combination of Divine and Masson teaches “The system of claim 1, wherein the at least one virtual representation of information associated with at least one medical item comprises an indication associated with an addition, removal, arrangement (Divine Figure 15 and column 8 lines 25-33 "equipment information regarding utilization and/or performance of equipment associated with the area, employee information regarding utilization and/or performance of the employees associated with the area, and recommendation information regarding recommendations for improving the performance of the healthcare organization in association with changing an aspect of the equipment and/or employee utilization and/or performance associated with the area ( e.g., addition or removal of resources)" – for clarity the needle misplaced as overlayed in Figure 15 shows indication of an arrangement of a medical item), or any combination of, of the at least one medical item in the predefined area of the medical procedure room (Divine Figure 3 and column 55 lines 3-7 "Relevant recommendation information (e.g., relevant to a current area being viewed by a user and a current context of the user) can further be selected by the selection component 1016 and provided to a user as overlay data in an AR or VR experience" – for clarity the missing needle shows the requirement of an additional item in the predefined space)”.
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Divine Figure 15
Conclusion
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/JASPREET KAUR/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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