DETAILED ACTION
Claims 1-15 are currently pending and have been examined.
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 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 1-12 & 14-15 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-13 are directed to a system (i.e., a machine); Claims 14-15 are directed to a method (i.e., a process). Accordingly, claims 1-15 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. (Currently Amended) A device for guidance in spatial setups of a room in a medical facility, the device comprising:
a data input;
a data processor; and
an output interface;
wherein the data input is configured: to provide procedure data about a current executed medical procedure; and to provide spatial data of at least one of the group of staff and equipment relating to the currently executed medical procedure;
wherein the data processor is configured: to calculate upcoming physical movement of at least one of the group of the staff and the equipment based on the procedure data and the spatial data procedure data; and to determine, based on the calculated upcoming physical movement, at least one of the group of equipment movement instructions and staff spatial guidance; and
wherein the output interface is configured: to provide at least one of the group of the equipment movement instructions and the staff spatial guidance.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because provide procedure and spatial data, calculating upcoming physical movement of staff and equipment, determine and output instructions and spatial guidance based on the movement are associated with managing personal behavior or relationships or interactions between people. For example, but for the system, this claim encompasses a person facilitating data access, receiving data, and outputting data in the manner described in the identified abstract idea. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Accordingly, independent claim 1 and analogous independent claim 14 recite at least one abstract idea.
Furthermore, dependent claims 2-10, 12, & 15 further narrow the abstract idea described in the independent claims. Claims 2-3 recite tracking type and phase of a medical procedure, Claim 4 recites tracking objects and marker data, Claim 5 recites calculating possible target positions, Claim 6 recites determining radiation dose exposure, Claim 7 recites determining a score, Claim 8 recites determining a room layout, Claim 9 recites proposing changes to room layout, Claim 10 recites determining alternative positions, . These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 1 and analogous independent claim 14, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
1. (Currently Amended) A device for guidance in spatial setups of a room in a medical facility, the device comprising:
a data input;
a data processor; and
an output interface;
wherein the data input is configured: to provide procedure data about a current executed medical procedure; and to provide spatial data of at least one of the group of staff and equipment relating to the currently executed medical procedure;
wherein the data processor is configured: to calculate upcoming physical movement of at least one of the group of the staff and the equipment based on the procedure data and the spatial data procedure data; and to determine, based on the calculated upcoming physical movement, at least one of the group of equipment movement instructions and staff spatial guidance; and
wherein the output interface is configured: to provide at least one of the group of the equipment movement instructions and the staff spatial guidance.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the data input, data processor, output interface; the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 14 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recites at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 11-12: These claims recite a capturing arrangement comprising at least one of a camera, radar sensor, microphone, and position/orientation tracking devices; do no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the at least one abstract idea is performed (see MPEP § 2106.05(h)).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitations of the data input, data processor, output interface; the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-12 & 14-15 are ineligible under 35 USC §101.
Claim 15 recites step limitations that are not integrated with the computer program comprising instructions mentioned in the preamble. The broadest reasonable interpretation of a claim drawn to a computer program comprising instructions typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent, or open-ended. See MPEP 2111.01. Therefore, given the broadest reasonable interpretation of the claim, the recited computer readable medium could be interpreted as a transitory propagating signal per se. As such, the claim is rejected as covering a signal per se, which is not directed towards statutory subject matter.
In order to overcome this rejection under 35 U.S.C. 101, a claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments by adding the limitation "non-transitory" in the claim to recite a “non-transitory computer readable medium.” Cf Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multicellular organism to avoid a rejection under 35 US.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding the claimed feature of calculate, based on the provide procedure data, the spatial data and the calculated upcoming physical movement, alternative positions under the doctrine that at least a part of the group of staff and equipment is organized according to a flock-of-birds concept and to assess if any of the alternative positions provides benefits for upcoming stage; the as-filed Specification does not describe this feature with sufficient detail such that one of ordinary skill in the art could reasonably conclude that the inventor was in possession of the invention at the time of filing, e.g. see MPEP 2163(I). Examiner notes that an applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention, e.g. see MPEP 2163(I). In the present case, pg. 13 of the as-filed Specification discloses staff member and the equipment, are provided with its own algorithm running on a processor to optimize its position in the flock. However, this merely discloses the inputs (i.e. staff member and the equipment) and outputs (i.e. optimize its position in the flock) without disclosing how the outputs are obtained from the inputs, for example a particular algorithm/formula/equation, and hence does not demonstrate that the inventor had possession of the feature of calculate, based on the provide procedure data, the spatial data and the calculated upcoming physical movement, alternative positions under the doctrine that at least a part of the group of staff and equipment is organized according to a flock-of-birds concept and to assess if any of the alternative positions provides benefits for upcoming stage at the time of filing. Appropriate clarification and correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 7-9, 11-12, & 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Masson (US20220223268) in view of Scholl (US20230207110).
As per claim 1, Masson teaches a device for guidance in spatial setups of a room in a medical facility, the device comprising:
a data input (para. 16: setup module receives data input);
a data processor (para. 27: processor); and
an output interface (para. 23: output interface);
wherein the data input is configured: to provide procedure data about a current executed medical procedure; and to provide spatial data of at least one of the group of staff and equipment relating to the currently executed medical procedure (para. 17: input module receives data regarding medical procedure type and data associated with one or more of item, equipment, and personnel in the medical procedure room set up via the one or more mixed reality devices).
Masson does not expressly teach wherein the data processor is configured: to calculate upcoming physical movement of at least one of the group of the staff and the equipment based on the procedure data and the spatial data procedure data; and to determine, based on the calculated upcoming physical movement, at least one of the group of equipment movement instructions and staff spatial guidance; and
wherein the output interface is configured: to provide at least one of the group of the equipment movement instructions and the staff spatial guidance.
Scholl, however, teaches to optimizing medical procedure ergonomics where a model is created of medical procedures that may later be used to, for example, predict a difficulty level of a procedure (para. 30). Scholl also teaches to using the model to output recommend positions of medical staff, technicians, and support staff, and of various equipment and fixtures in the medical suite (para. 32).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Scholl with Masson based on the motivation of evaluating medical personnel ergonomics during a medical procedure and providing alerts and feedback to the medical personnel (Scholl - para. 2).
As per claim 2, Masson and Scholl teach the device according to claim 1. Masson teaches wherein, for the provision of the procedure data about the current executed medical procedure, the data processor is configured to track type and phase of the current executed medical procedure (para. 17, 95: input module receives data regarding medical procedure type and data associated with one or more of item, equipment, and personnel in the medical procedure room set up via the one or more mixed reality devices; receive information about medical procedure resources in visual mixed reality format, including quantities and tracking of these resources, use, patterns for use, sequence of use, percentage and priority of use).
As per claim 3, Masson and Scholl teach the device according to claim 2. Masson teaches wherein, for the tracking of the type and phase of the current executed medical procedure, the data processor is configured to provide at least one of the group of: procedure analysis based on image data of a current scenario; procedure analysis based on acoustic data comprising at least parts of a conversation by the staff of a current scenario; and patient related data (para. 53-54: various sensors used to capture data including image and medical sensors; sensors provide monitoring of the various devices and equipment associated with the medical procedure room).
As per claim 4, Masson and Scholl teach the device according to claim 1. Masson teaches wherein, for the provision of the spatial data, the data processor is configured to provide at least one of the following group of: optical tracking of physical objects in a predetermined space of the room based on optical image data; and marker tracking of at least one of the group of the staff and the equipment, wherein the markers are provided as at least one of the group of optical markers, electromagnetic markers and acoustic markers (para. 53-54: various sensors used to capture data including image and medical sensors; sensors provide monitoring of the various devices and equipment associated with the medical procedure room).
As per claim 7, Masson and Scholl teach the device according to claim 1. Masson does not expressly teach wherein, for determining the equipment instructions and the staff spatial guidance, the data processor is configured to provide a parameter weighting to achieve an overall optimal score.
Scholl, however, teaches to calculating ergonomic “safe zones” for a range of motion (ROM) of a shoulder of medical staff during the medical procedure to determine high, medium, or low ergonomic risk (para. 54). The calculation may be based on multiple ROM criteria including, for example, a ROM zone, a percentage of time in the ROM zone, a number of repetitions, and a sustained time in a ROM position (para. 54). These parameters contribute more or less based on the criteria hitting a certain threshold (para. 54).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 8, Masson and Scholl teach the device according to claim 1. Masson teaches wherein the data processor is configured to generate a specific procedure room layout configuration based on a plurality of generic room layout configurations; and to apply the generic room layout configurations to a model of a specific room stored in a room model store (para. 16: provide recommendation to the procedure room setup module for optimizing the medical procedure room set up based on the comparison with reference medical procedure room setups).
As per claim 9, Masson and Scholl teach the device according to claim 1. Masson teaches wherein the data processor is configured to detect: i) based on changes and/or input by the user, deviations from at least one of the group of the provided equipment movement instructions and the staff spatial guidance; and to propose changes to stored room settings to the user providing a learning update (para. 100: machine learning module compare the acquired data with the analyzed prestored data by determining whether the acquired data associated with the one or more of item, equipment, and personnel in the medical procedure room set up correspond to the determined optimal relationship); and/or ii) based on tracked patient vital parameters, changes above a predetermined threshold indicating a possible upcoming emergency scenario; and to provide emergency equipment movement instructions and emergency staff spatial guidance.
As per claim 11, Masson and Scholl teach a system for guidance in spatial setups of a room in a medical facility. Masson teaches the system comprising:
a device according to claim 1 (para. 17: input module receives data regarding medical procedure type and data associated with one or more of item, equipment, and personnel in the medical procedure room set up via the one or more mixed reality devices); and
a capturing arrangement (para. 53-54: various sensors used to capture data including image and medical sensors; sensors provide monitoring of the various devices and equipment associated with the medical procedure room);
wherein the capturing arrangement is configured to capture a current executed medical procedure and to detect spatial location and arrangement of at least one of the group of staff and equipment (para. 53-54: various sensors used to capture data including image and medical sensors; sensors provide monitoring of the various devices and equipment associated with the medical procedure room); and wherein the device for guidance is configured to determine the procedure data based on the captured current executed medical procedure (para. 17: input module receives data regarding medical procedure type and data associated with one or more of item, equipment, and personnel in the medical procedure room set up via the one or more mixed reality devices); and to determine the spatial data of the staff and/or equipment based on the detected spatial location and arrangement of at least one of the group of staff and equipment (para. 53-54: various sensors used to capture data including image and medical sensors; sensors provide monitoring of the various devices and equipment associated with the medical procedure room).
As per claim 12, Masson and Scholl teach the system according to claim 10. Masson teaches wherein the capturing arrangement comprises at least one of the group of: optical cameras; time of flight cameras; radar sensors; and position and orientation tracking devices (para. 53-54: various sensors used to capture data including image and medical sensors; sensors provide monitoring of the various devices and equipment associated with the medical procedure room).
Claims 14-15 recite substantially similar limitations as those already addressed in claim 1, and, as such, are rejected for similar reasons as given above.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Masson (US20220223268) in view of Scholl (US20230207110) as applied to claim 1 above, and in further view of Rodas “Pose optimization of a C-arm imaging device to reduce intraoperative radiation exposure of staff and patient during interventional procedures”.
As per claim 6, Masson and Scholl teach the device according to claim1, but do not expressly teach wherein, as further input, the data input is configured to provide radiation dose information for at least a part of the staff members, and wherein, based on the respective location, the data processor is configured to compute a dose exposure probability and to determine an adjusted position information to reduce radiation exposure of the staff.
Rodas, however, teaches to recommend an x-ray device’s C-arm imaging device to reduce intraoperative radiation exposure of staff and patient during interventional procedures (abstract). Rodas further teaches to input the position of staff and computing dose exposure and generating a recommendation for positioning of the x-ray C-arm (abstract; pg. 4204).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Rodas with Masson and Scholl based on the motivation of lower the probability of appearance and severity of long-term negative effects due to radiation exposure and improve overall radiation safety (Rodas – abstract).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Masson (US20220223268) in view of Scholl (US20230207110) as applied to claim 12 above, and in further view of Shelton (US20220384019).
As per claim 13, Masson and Scholl teach the system according to claim 12, but do not expressly teach further comprising equipment; and wherein at least a part of the equipment is provided with at least one of the group of:
i) a drivable base, wherein the equipment movement instructions are provided to operate the base to move the equipment accordingly;
ii) an actuatable boom, wherein the equipment movement instructions are provided to actuate the boom to reposition the equipment accordingly; and
iii) an actuatable pan-tilt mechanism, wherein the equipment movement instructions are provided to actuate the pan-tilt mechanism to adjust the equipment accordingly;
wherein at least a part of the equipment is configured to be moved automatically according to the movement instructions.
Shelton, however, teaches to obtaining monitored data associated with movement of various surgical instruments and staff in an operating room (para. 10). Shelton also teaches to adjusting a display using a mechanism that can adjust the position and orientation of the display based on adjustment parameters (Fig. 35; para. 45, 641, 649).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Shelton with Masson and Scholl based on the motivation of improving performance for surgical procedure(s) and/or maintenance of operating room(s). (Shelton – para. 41).
Prior Art Rejection
All of the cited references fail to expressly teach or suggest, either alone or in combination, the features found within dependent claims 5 &10. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: calculation of the upcoming physical movement, the data processor is configured to determine possible upcoming target positions of at least one of the group of the staff and the equipment based on the procedure data and the spatial data procedure data; to calculate possible movement trajectories; and to provide a plausibility check to select a target position and a trajectory; and wherein the data processor is configured to calculate the upcoming physical movement comprising at least one of the group of from-to routes for at least one of the group of the staff and the equipment and an order for the movements of at least one of the group of the staff and the equipment; calculate, based on the provide procedure data, the spatial data and the calculated upcoming physical movement, alternative positions under the doctrine that at least a part of the group of staff and equipment is organized according to a flock-of-birds concept; to assess if any of the alternative positions provides benefits for upcoming stages; and to provide at least one of the group of adjusted equipment movement instructions and adjusted staff spatial guidance.
The most relevant prior art of record includes:
Masson (US20220223268) teaches to a method for optimizing a medical procedure room set up comprises obtaining a medical procedure room setup input associated with a medical practitioner identifier, a medical procedure identifier, and a medical procedure room identifier for the medical procedure room set up. Scholl (US20230207110) teaches to determine whether the determined current medical staff ergonomics exceed any of the determined one or more ergonomic safe zones, and upon determining that the determined current medical staff ergonomics exceed any of the determined one or more ergonomic safe zones, providing ergonomic feedback to the medical staff. Shelton (US20220384019) teaches to a surgical computing system may obtain monitored data associated with healthcare professionals (HCPs), surgical instruments and/or environments in one or more operating rooms (ORs). The surgical computing system may utilize the monitored data to enable improving movement or motion efficiency for surgical procedures and/or performing ergonomic monitoring and analysis for Ors.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bailey (US 20160379504 A1) teaches to a method of setting up a medical care area, such as an operating room, and in particular to a method of arranging medical or surgical devices in an operating room.
Tiwary (US 20240207626 A1) teaches to one or more images depicting a medical environment and a medical workflow performed in the medical environment may be received. Contextual information associated with the medical workflow may be determined, and a stage of the medical workflow may be identified, based on the one or more images.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/Primary Examiner, Art Unit 3619
