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 .
Status of the Claims
The office action is in response to the claim amendments and remarks filed on March 26, 2026 for the application filed February 18, 2025 which claims priority to a provisional application filed on September 15, 2022. Claims 1-13, 16-18 and 20-23 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation "the exposure report for the person" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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 1-13, 15-18 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-13 and 21-22 are directed towards a system (i.e. a machine), which is a statutory category. Claims 16-18 are directed towards a method (i.e. a process), which is a statutory category. Claims 20 is directed towards a non-transitory computer-readable storage medium (i.e. a manufacture), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1, 16 and 20 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the representative claim 1 is identified as:
A medical system comprising:
memory; and
processing circuitry communicatively coupled to the memory, the processing circuitry being configured to:
obtain, during performance of a procedure in a medical facility on a patient, data representing a radiation exposure of a person in the medical facility; and
evaluate, at a current location, a hypothetical radiation exposure for the person based on both a candidate location for the person that is different than the current location and a candidate radiation protection equipment;
generate, based on a comparison of the data representing the radiation exposure at the current location and the hypothetical radiation exposure, a combined recommendation for the person to move to the candidate location and utilize the candidate radiation protection equipment to maintain or reduce a radiation dose experienced by the person; and
output, during the performance of the procedure, the combined recommendation; and
generate, based on the data representing the radiation exposure, an exposure report for the person (claims 16 and 20).
The identified limitations of the abstract idea fall within the subject matter grouping of certain methods of organizing human activity related and the sub grouping of managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions). The claims recite the human activity of generating and providing recommendations to maintain or reduce radiation exposure of a person and radiation exposure reports based on obtained data representing a radiation exposure of a person in the medical facility during performance of a procedure. The claimed steps are merely rules or instructions a human should follow in order to provide the recommendations.
The identified limitations of evaluating and generating are directed to the abstract idea grouping of mental processes. The evaluating and generating limitations are recited at a high level of generality and could be practically performed in the human mind using observation, evaluations, judgments and opinions .
Accordingly, claims 1, 16 and 20 recite an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses 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 is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in representative claim 1 are identified in italics as:
A medical system comprising:
memory; and
processing circuitry communicatively coupled to the memory, the processing circuitry being configured to:
obtain, during performance of a procedure in a medical facility on a patient, data representing a radiation exposure of a person in the medical facility; and
evaluate, at a current location, a hypothetical radiation exposure for the person based on both a candidate location for the person that is different than the current location and a candidate radiation protection equipment;
generate, based on a comparison of the data representing the radiation exposure at the current location and the hypothetical radiation exposure, a combined recommendation for the person to move to the candidate location and utilize the candidate radiation protection equipment to maintain or reduce a radiation dose experienced by the person; and
output, during the performance of the procedure, the combined recommendation; and
generate, based on the data representing the radiation exposure, an exposure report for the person (claims 16 and 20).
The additional limitations of “A medical system comprising: memory; and processing circuitry communicatively coupled to the memory, the processing circuitry being configured to:” are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). The memory and processing circuitry are recited at a high level of generality and used in the ordinary capacity to perform the abstract idea. Therefore, these additional elements amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
Accordingly, claims 1, 6 and 20 do not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f), which is do not amount to significantly more than the abstract idea.
Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. None of these limitations are deemed to integrate the claims into a practical application or to amount to significantly more than the abstract idea because, as detailed below.
Regarding claim 2, 5, and 18 the receiving of data from a dosimeter and the receiving of video data from a camera is the insignificant extra-solution activity to the judicial exception of mere necessary data gathering under MPEP §2106.05(g), which is well-understood, routine and convention as evidenced by MPEP §2106.05(d), subsection II.
Claims 3-11 and 17-18, recite steps which are also directed to the abstract idea grouping of certain methods of organizing human activity, such as obtaining and determining data for generating a radiation exposure report. Furthermore, the determining steps are directed to the abstract idea grouping of mental processes as these steps can be performed in the human mind using observations, evaluations, judgments and opinions.
Regarding claims 12-13, the outputting of a live heatmaps and recommendations is the insignificant extra-solution activity to the judicial exception of mere necessary data output under MPEP §2106.05(g) which is well-understood, routine and convention as evidenced by MPEP §2106.05(d), subsection II. Merely defining the outputs and the inherent generation of the outputs (i.e. generating heatmaps and recommendations) is considered to be directed to the abstract idea grouping of certain methods of organizing human activity of generating a radiation exposure report having heatmaps and recommendations. Furthermore the limitation “live” heatmap is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f), as this limitation merely implies the automated, real-time output of data (i.e. via a computer).
Regarding claim 21, representing physical characteristics of the medical facility including locations of one or more objects and radiation reflection properties of the one or more objects; and determine the hypothetical radiation exposure by simulating the candidate location and the candidate radiation protection equipment is determined to be directed to a mental process as this can be performed in the human mind, with or without a physical aid, to determine hypothetical radiation exposure. The generating and use of a digital twin is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f), as the digital twin used to generally apply the abstract idea without placing any limits on how the digital twin functions. Rather, this limitation only recites the outcome of “determine the hypothetical radiation exposure” and does not include any details about how the “determining” is accomplished.
Claim 22 merely defines the recommendation and is encompassed by the abstract ideas of claim 1.
Therefore, whether taken individually or as an ordered combination, 1-13 and 16-22 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim 23 is determined to integrate the abstract idea into a practical application under step 2A, prong 2 by providing meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3-13, 16-18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Padoy et al. (U.S. Pub. No. 2017/0220716) in view of Falt et al. (U.S. Pub. No. 2015/0100290).
Regarding claim 1, Padoy discloses a medical system comprising (Figs. 1 and 6):
Memory (Paragraphs [0090]-[0093]); and
processing circuitry communicatively coupled to the memory, the processing circuitry being configured to (Paragraphs [0090]-[0093]):
obtain, during performance of a procedure in a medical facility on a patient, data representing a radiation exposure of a person in the medical facility (Paragraph [0075], computing a simulation of radiation doses in the obtained three-dimensional model 200 comprising models of individuals 300. Paragraph [0088], a simulation of radiation doses is computed at step 502. Paragraph [0101], recorded evolution of the radiation exposure of a clinician during a surgical intervention.);
evaluate, at a current location, a hypothetical radiation exposure for the person based on Paragraphs [0069]-[0078] discuss using a three dimensional model of an operating room with individuals in the room and unoccupied space represented by three-dimensional volumes (voxels) to simulate radiation does at each voxel and determine the spatial distribution of the hazardousness of these radiation doses. Paragraph [0102], The method may also be used to identify safe locations in an operating room. Paragraph [0104], If…the radiation source is estimated as being hazardous for individuals standing in the operating room, the method may send a warning message and/or may suggest safer positions for these individuals.)
generate, based on a comparison of the data representing the radiation exposure at the current location and the hypothetical radiation exposure, a experienced by the person (Paragraph [0102], The method may also be used to identify safe locations in an operating room, and suggest these locations on an augmented reality image so as to minimize the radiation exposure risk. All this may be performed in real-time as well. Paragraph [0104], If…the radiation source is estimated as being hazardous for individuals standing in the operating room, the method may send a warning message and/or may suggest safer positions for these individuals.); and
output, during the performance of the procedure, the combined recommendation (Paragraph [0102], The method may also be used to identify safe locations in an operating room, and suggest these locations on an augmented reality image so as to minimize the radiation exposure risk. All this may be performed in real-time as well. Also see paragraph [0007], increase the awareness of individuals of their radiation exposure during an intervention.).
Padoy further discloses to using radioprotective equipment such as lead vests and aprons to minimize exposure (Paragraph [0003]), but does not appear to explicitly disclose that the hypothetical radiation exposure is based on a candidate radiation protection equipment or that the recommendation is a combined recommendation for the person to also utilize the candidate radiation protection equipment.
Falt teaches that it was old and well known in the art of simulating radiation exposure at the time of the filing to evaluate a hypothetical radiation exposure for the person based on both a candidate location for the person that is different than the current location and a candidate radiation protection equipment; and generate a recommendation for the person to also utilize the candidate radiation protection equipment (Falt, paragraphs [0159]-[0161] discuss simulating radiation doses at different locations in the operating room based on attenuation factors corresponding to a reduced dose resulting from use of different radiation protection equipment. Paragraph [0038] and [0047], discusses making recommendations as to how a user may reduce radiation exposure and suggesting strategies for improving his or her dose reduction techniques.) to minimize exposure during x-ray guided procedures (Falt, paragraph [0014])
Therefore, it would have been obvious to one of ordinary skill in the art of simulating radiation exposure at the time of the filing to modify hypothetical radiation exposure and recommendation of Padoy, such that the hypothetical radiation exposure is based on a candidate radiation protection equipment and the recommendation is a combined recommendation for the person to also utilize the candidate radiation protection equipment, as taught by Falt, in order to minimize exposure during x-ray guided procedures.
Regarding claim 3, Padoy further discloses wherein the processing circuitry is further configured to:
determine one or more parameters of a radiation emitting device positioned in the medical facility (Paragraph [0076], the energy of the particles emitted by the radiation source 3 can be sampled from simulated X-ray spectra generated for selected peak voltages applied to the source, when the source is drivable with a voltage.),
wherein, to obtain the data representing the radiation exposure of the person, the processing circuitry is configured to obtain the data based on the one or more parameters of the radiation emitting device (Paragraph [0076], The invention may adapt code available from the Geant4 project by providing numerical tools to compute a simulation of radiation doses in the voxels 9, 309 of the three-dimensional model 200. For example, the energy of the particles emitted by the radiation source 3 can be sampled from simulated X-ray spectra generated for selected peak voltages applied to the source, when the source is drivable with a voltage.).
Regarding claim 4, Padoy does not appear to explicitly disclose, but Falt teaches that it was old and well known in the art of simulating radiation exposure at the time of the filing wherein the one or more parameters comprise one or more of a direction of emission, a focus of emission, and an intensity of emission (Falt, paragraphs [0122] and [0131]. Also see figs. 8A-8C and PA-9D.) to minimize health risks to patients and themselves while optimizing image and treatment quality (Falt, paragraph [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art of hazard visualization at the time of the filing to modify the parameters of Padoy to comprise one or more of a direction of emission, a focus of emission, and an intensity of emission, as taught by Falt, in order to generate the model of Padoy and minimize health risks to patients and themselves while optimizing image and treatment quality.
Regarding claim 5, Padoy further discloses wherein, to obtain the data representing the radiation exposure of the person, the processing circuitry is configured to:
receive, from one or more cameras positioned in the medical facility, video data (Paragraph [0066], On the ceiling of the three-dimensional environment 100, a set of cameras 10 may be used, for example an RGB-D system, where RGB stands for red, green, blue and D for depth, adapted for recording the three-dimensional environment 100 from different points of view to recreate a three-dimensional model such as that of FIG. 2. Paragraph [0069], The cameras 10 of FIG. 1 provide information that enables the generation of a three-dimensional model 200, represented on FIG. 2, of the three-dimensional environment 100.); and
determine, based on the video data and the one or more parameters of the radiation emitting device, the data representing the radiation exposure of the person (Paragraph [0075], Once the three-dimensional model 200 including the models 300 of individuals is obtained, the method of the invention comprises the step of computing a simulation of radiation doses in the obtained three-dimensional model 200 comprising models of individuals 300.).
Regarding claim 6, Padoy further discloses wherein the processing circuitry is configured to: determine, based on the video data, a position of the person relative to the radiation emitting device (Paragraph [0069], The cameras 10 of FIG. 1 provide information that enables the generation of a three-dimensional model 200, represented on FIG. 2, of the three-dimensional environment 100. The three-dimensional model 200 appears as a set of objects the boundaries of which are defined by points 8, represented on FIG. 2 by Xs. Paragraph [0070], In addition to the elements described above, defining solid boundaries, individuals 30 evolving in the operating room and air can be included in the three-dimensional model 200 in the form of voxels 9 such as that represented on FIG. 3. Paragraph [0084], update the three-dimensional model 200 by tracking the movements of an individual 30, the change of position of the C-arm 1 and other objects 5, 7 manipulated by machines or individuals. All these movements may have an impact on the spatial distribution of the radiation doses and may require repeatedly implementing the step of obtaining a three-dimensional model 200, computing a simulation of radiation dose values in voxels 9, 309, and generating an image. Also see figs. 2 and 4.).
Regarding claim 7, Padoy further discloses wherein the processing circuitry is configured to:
model, based on the one or more parameters of the radiation emitting device, a radiation field; and determine, based on the modeled radiation field, the data representing the radiation exposure of the person (Abstract, a simulation of radiation doses attributable to ionizing radiation emitted from the source and scattered by the environment is computed in the model. Then, an image indicating the spatial distribution of the hazardousness for an individual of the radiation doses is generated and displayed. Paragraph [0068], provides an accurate estimation of the spatial distribution of the scattered X-rays, thereby providing reliable information on the spatial distribution of the X-ray radiation hazard in the operating room. Paragraph [0078], Once the value of radiation doses at each voxel 9 is computed, the method generates and displays an image of the spatial distribution of the hazardousness of these radiation doses, such as that represented on FIG. 4. Also see paragraphs [0079]-[0080].).
Regarding claim 8, Padoy further discloses wherein, to obtain the data representing the radiation exposure of the person, the processing circuitry is configured to: obtain, for respective body parts of a plurality of body parts of the person, respective data representing radiation exposure of the respective body part (Paragraph [0023], These voxels can be tracked and the radiation dose that they are exposed to recorded, in order to provide a precise record of the radiation exposure, with information relating to which body parts were most exposed. Paragraph [0073], The voxels of a model 300 of an individual can be tracked to keep a record of the radiation dose received by each voxel, thereby providing an accurate picture of the radiation dose received by a specific body part of an individual. By keeping a record of the radiation dose absorbed by the voxels 309 of the model of an individual 30 over time, the method of the invention provides information similar to that of an accurate dosimeter that can be used to identify which body parts were exposed to dangerous radiation doses. The method may also serve to issue warnings when a threshold radiation dose at a specific body part or over the whole body is exceeded on the model 300 of an individual 30. Also see figs. 3-4.).
Regarding claim 9, Padoy further discloses wherein the plurality of body parts include one or more of a left hand of the person, a right hand of the person, and a head of the person (Paragraph [0003], different locations of the body, on the hands, head, torso and feet. Paragraph [0013], hands, limbs or head. Paragraph [0082], On FIG. 4, the feet, head and torso of the image of the individual 430 represented on image 400, are each exposed to different radiation doses. Also see figs. 3-4.).
Regarding claim 10, Padoy further discloses wherein, to generate the exposure report for the person, the processing circuitry is configured to: generate the exposure report to include radiation exposure data for the plurality of body parts of the person (Paragraph [0073], The voxels of a model 300 of an individual can be tracked to keep a record of the radiation dose received by each voxel, thereby providing an accurate picture of the radiation dose received by a specific body part of an individual. By keeping a record of the radiation dose absorbed by the voxels 309 of the model of an individual 30 over time, the method of the invention provides information similar to that of an accurate dosimeter that can be used to identify which body parts were exposed to dangerous radiation doses. Also see paragraph [0023] and figs. 3-4.).
Regarding claim 11, Padoy further discloses wherein: the person is a first person of a plurality of persons, the processing circuitry is configured to obtain, for each respective person of the plurality of persons, respective data representing radiation exposure, and the processing circuitry is configured to generate a respective exposure report for each person of the plurality of persons (Paragraph [0075], Once the three-dimensional model 200 including the models 300 of individuals is obtained, the method of the invention comprises the step of computing a simulation of radiation doses in the obtained three-dimensional model 200 comprising models of individuals 300. Paragraph [0086], The information that is displayed may therefore be more accurate, especially in the presence of several individuals, each of whom absorbs and scatters part of the radiation doses emitted from the radiation source 3 and scattered by the environment. Paragraph [0068], In the case, not represented on FIG. 1, of the presence of several individuals in the operating room, it may be particularly useful to take into account the influence of each individual on the spatial distribution of scattered X-ray radiation. Also see Abstract and paragraph [0014].).
Regarding claim 12, Padoy further discloses wherein the processing circuitry is further configured to: output, during performance of procedure and based on the data representing the radiation exposure of the person, a heatmap of the radiation exposure of the person (Paragraph [0079], One convenient way of generating an image indicating the spatial distribution of the hazardousness of radiation doses may consist in defining a color scale for radiation doses, each color being associated with a level of hazardousness of the corresponding radiation dose. Then, each voxel 9, 309 may be filled with a color corresponding to the level of hazardousness of the radiation dose at that voxel. Paragraph [0013], in the case of a surgical operation during which a source emits radiation, for example ionizing radiation such as X-rays, a clinician or other member of staff or another individual located near the source can look at the displayed image and identify which parts of his body are exposed to hazardous radiation doses. Also see paragraph [0080].)
Regarding claim 13, Padoy further discloses wherein, to output the heatmap, the processing circuitry is configured to: output a live heatmap of the radiation exposure of the person (Paragraph [0021], By repeatedly updating the three-dimensional model, the invention may provide more reliable real-time information regarding the spatial distribution of the hazardousness of radiation doses. Paragraph [0083], the method can be implemented quickly, and in real-time. Also see paragraph [0029].).
Regarding claims 16-18 and 20: all limitations as recited have been analyzed and rejected with respect to claims 1, 3 and 5. Claims 16-18 pertain to a method, corresponding to the system of claims 1, 3 and 5. Claim 20 pertains to a computer readable storage medium, corresponding to the system of claim 1. Claims 16-18 and 20 do not teach or define any new limitations beyond claims 1, 3 and 5 apart from generating, based on the data representing the radiation exposure, an exposure report for the person, disclosed by Padoy at paragraphs [0013] and [0078]; therefore claims 16-18 and 20 are rejected under the same rationale.
Regarding claim 21, Padoy as modified by Falt further discloses wherein, to evaluate the hypothetical radiation exposure for the person, the processing circuitry is configured to: generate a digital twin of the medical facility, the digital twin representing physical characteristics of the medical facility including locations of one or more objects and radiation reflection properties of the one or more objects; and determine the hypothetical radiation exposure by simulating the candidate location and the candidate radiation protection equipment within the digital twin (Paragraphs [0015]-[0016] and [0068]-[0078] discuss generating a three dimensional model of an operating room having objects, individuals and unoccupied space, each represented by locations properties and radiation absorption and scattering properties. The model is used to simulate radiation doses received by the unoccupied space and individuals and determine the spatial distribution of the hazardousness of these radiation doses. The model is construed as a digital twin.)
Claims 2 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Padoy et al. (U.S. Pub. No. 2017/0220716) in view of Falt et al. (U.S. Pub. No. 2015/0100290) and Milner et al. (U.S. Pub. No. 2025/0189684).
Regarding claim 2, Padoy further discloses wherein, to obtain the data representing the radiation exposure of the person, the processing circuitry is configured to: receive, from a dosimeterParagraph [0077], to further improve the accuracy of the simulated radiation doses, the method may use measurements from the wireless dosimeters 6 described above. These measure actual radiation doses at specific locations of the three-dimensional environment 100. Also see paragraph [0067].).
Padoy further discloses that dosimeters can be worn by a person (Paragraph [0003]), but does not appear to explicitly disclose that the processing circuitry is configured to: receive, from a dosimeter worn by the person, the data representing the radiation exposure of the person.
Milner teaches that it was old and well known in the art of hazard visualization at the time of the filing to receive, from a dosimeter worn by the person, the data representing the radiation exposure of the person (Paragraph [0063], the user 105 also wears an orientation tag 540. Paragraph [0053], sensors (e.g., such as the orientation tags 420) may measure actual emissions received (e.g., radiation). The emissions model engine 170 and/or the hazards model engine 405 may train the models based on historical predicted hazards compared to historical actual emissions measured.).
Therefore, it would have been obvious to one of ordinary skill in the art of hazard visualization at the time of the filing to modify the dosimeters of Padoy to be worn by a person, as taught by Milner, in order to train the model of Padoy.
Regarding claim 23, Padoy further discloses to output the candidate location using augmented reality (Paragraph [0102]), but does not appear to explicitly disclose a projector communicatively coupled to the processing circuitry, wherein, to output the combined recommendation, the processing circuitry is configured to cause the projector to project one or more visual indicators onto a floor of the medical facility at the candidate location.
Milner teaches that it was old and well known in the art of hazard visualization at the time of the filing to provide a projector communicatively coupled to the processing circuitry, wherein, to output the combined recommendation, the processing circuitry is configured to cause the projector to project one or more visual indicators onto a floor of the medical facility at the candidate location (Milner, paragraph [0089], In some implementations, the emitter 120 (e.g., as described with reference to FIG. 1 ) of the c-arm radiography machine 110 may also be equipped with a display generator. The display generator may, for example, generate and emit an optical projection. The optical projection may be patterned according to a visualization model. For example, the optical projection may be generated as a function of relative hazard (e.g., corresponding to (expected) concentration of scattered radiation). For example, the optical projection may create visual indicia on the floor. Also see figs. 1-4 and paragraph [0031].) to enable personnel to reduce exposure to hazardous emissions in an environment (Milner, paragraph [0008]).
Therefore, it would have been obvious to one of ordinary skill in the art of hazard visualization at the time of the filing to modify the system of Padoy to include a projector communicatively coupled to the processing circuitry, wherein, to output the combined recommendation, the processing circuitry is configured to cause the projector to project one or more visual indicators onto a floor of the medical facility at the candidate location, as taught by Milner, in order to enable personnel to reduce exposure to hazardous emissions in an environment.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Padoy et al. (U.S. Pub. No. 2017/0220716) in view of Falt et al. (U.S. Pub. No. 2015/0100290), Cornelis et al. (Ergonomics in Interventional Radiology: Awareness Is Mandatory) and Mann et al. (Balancing Dose Reduction from Shielding and the Impact on Workplace Ergonomics).
Regarding claim 22, Padoy as modified by Falt does not appear to explicitly disclose, but Cornelis and Mann teach that it was old and well known in the art of interventional radiology and worker safety at the time of the filing wherein the candidate radiation protection equipment comprises less radiation protection than a current radiation protection equipment worn by the person at the current location (Cornelis, pages 3-4, section 4.2 and page 5.3 discuss balancing the ergonomic disadvantages of shielding and recommending alternatives to traditional lead aprons, such as a two-part coat or one with a suitable belt, lighter weight, composite, or fully lead-free aprons which still provide similar protection and freestanding, suspended, or movable shields, construed a less radiation protection than a current radiation protection equipment worn by the person.), and wherein the combined recommendation is output to optimize a trade-off between a radiation exposure risk and an ergonomic risk to the person (Mann, page 15, last paragraph, discussed that when choosing shielding, a cost-benefit analysis should be performed balancing the dose reduction with the ergonomic detriment. The most optimal analysis would be mock ups in conjunction with calculations.).
Therefore, it would have been obvious to one of ordinary skill in the art of interventional radiology and worker safety at the time of the filing to modify the recommendation of Padoy as modified by Falt such that the candidate radiation protection equipment comprises less radiation protection than a current radiation protection equipment worn by the person at the current location and wherein the combined recommendation is output to optimize a trade-off between a radiation exposure risk and an ergonomic risk to the person, as taught by Cornelis and Mann, in order to optimize the performance and well-being of radiologists (Cornelis, page 1, section 1) and create a unified approach to worker safety (Mann, page 8).
Response to Arguments
Applicant's arguments filed March 26, 2026 regarding claims 1-13, 16-18 and 20-22 being rejected under 35 U.S.C. §101 have been fully considered but they are not persuasive.
Applicant argues under step 2A, prong one that the claims recite evaluating complex, hypothetical physical scenarios regarding radiation scatter, combined with the physical attenuation factors of shielding equipment to generate real-time recommendations during a live medical procedure which goes far beyond a mental process or organizing human activity.
In response, the claims do not provide details as to how the evaluation is performed or how the recommendation is generated and is recited at such a high level that it encompassed both methods of organizing human activity and mental processes, such as a radiation safety worker recommending that physician moves to a different location and uses protective equipment based on observations, evaluations, judgments and opinions.
Applicant argues under step 2A, prong two that the claims integrate an abstract idea into a practical application by effecting the specific prophylaxis of prevention and mitigation of hazardous radiation exposure and improving the technical field of clinical monitoring by evaluation hypothetical combinations of location and equipment.
In response, while moving locations and using protective equipment may reduce the risk of disease, it is no a treatment as specified by MPEP §2106.05(d)(2) and does not affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition, as recommending does not actually provide a treatment or prophylaxis. Evaluation hypothetical combinations of location and equipment cannot be considered an improvement to a technical field as it is identified as part of the abstract idea and not an additional element.
Applicant's arguments filed March 26, 2026 regarding claims 1-13, 16-18 and 20-23 being rejected under 35 U.S.C. §102/103 have been fully considered but they are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Devin C. Hein whose telephone number is (303)297-4305. The examiner can normally be reached 9:00 AM - 5:00 PM M-F MDT.
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/DEVIN C HEIN/Examiner, Art Unit 3686
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