DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed 7/23/2026 with respect to the rejection of Claims 1, 11, 12, 18, and 20, and Claims 2-10, 13-17, and 19 by dependency, under 35 U.S.C. 112(b) have been fully considered and are persuasive. The Examiner agrees that the amendments to Claims 1, 11, 12, 18 and 20 are sufficient to overcome the cited indefiniteness issues. Therefore, the rejection has been withdrawn.
Applicant’s arguments regarding the rejection of Independent Claim 1 under 35 USC 102(a)(1) as being anticipated by US 2019/0000556 A1 to Sela et al. (“Sela”) have been fully considered and are persuasive. Claim1 has been amended to require that the recited plurality of spatial regions are “separate from one another.” The Examiner agrees that Sela’s “first tracking region 207” and “second tracking region 209” are not “separate from one another” as required by Claim 1. Therefore, the rejection is withdrawn. However, new grounds of rejection is made in view of Sela wherein Sela’s “tracking markers 16” are considered such “spatial regions” as claimed.
Applicant’s arguments regarding Independent Claims 18 and 20 are similar to Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive as explained above. Therefore, the rejection is withdrawn. However, new grounds of rejection is made in view of Sela wherein Sela’s “tracking markers 16” are considered such “spatial regions” as claimed.
Applicant’s arguments regarding dependent Claims 2-17 and 19 are based on Applicant’s arguments regarding the Independent Claims from which each respectively depends. Applicant’s arguments have been fully considered and are persuasive as explained above. Therefore, the rejection is withdrawn. However, new grounds of rejection is made in view of Sela wherein Sela’s “tracking markers 16” are considered such “spatial regions” as claimed.
Applicant’s arguments regarding the rejection of Claims 6 and 7 in view of US 2017/0312035 A1 to May et al. (“May”) are moot in view of the foregoing interpretation of Sela. As Sela’s “tracking markers 16” rather than Sela’s “first tracking region 207” and “second tracking region 209” are equated herein to the claimed “spatial regions,” Applicant’s argument that the proposed modification of Sela with May would obtain spatial information indicative of only a single rather than a plurality of spatial regions is moot.
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.
Claims 1, 2, 18 and 20, and Claims 3-17 and 19 by dependency, are 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 claims 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 Independent Claim 1:
Claim 1 recites “obtaining spatial information indicative of a plurality of spatial regions….” The Present Specification does not describe what the recited “spatial information” entails in such a way as would apprise a person of ordinary skill in the art of what information is being obtained. The Present Specification states “[t]he spatial information may indicate, for at least two or all of the spatial regions, at least one property selected from a size, a shape, an outline, a border, a position and an orientation” (Present Specification at Pg. 8, Fourth Paragraph). However, this statement appears to describe in what sense the “spatial information” is “indicative of a plurality of spatial regions” rather than what the “spatial information” itself entails. One of ordinary skill in the art would be unable to discern what information (e.g., coordinates of each spatial region, distance information relative to a reference which defines each spatial region, an output from the robot, etc.) is obtained. No examples of such “spatial information” are provided, and no details are included regarding the information itself. Accordingly, the Present Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Claim 1 recites “each of the plurality of spatial regions being associated with one or more feedback parameters.” The Present Specification does not describe the term “feedback parameters” in a manner sufficient to apprise a person of ordinary skill in the art of what it entails. That is, were a person of ordinary skill in the art to read Claim 1 in view of the Present Specification, he would be unable to discern what “each of the plurality of spatial regions” is contemplated to be “associated with.” No specific examples of “feedback parameters” are listed, and no definition of the term is provided. One of ordinary skill in the art would be unable to decipher whether any particular prior “spatial region” is “associated with one or more feedback parameters” in the manner contemplated by Claim 1. Accordingly, the Present Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Claim 1 recites “obtaining tracking information indicative of tracked poses….” The Present Specification does not describe what such “tracking information” entails in a manner sufficient to apprise a person ordinarily skilled in the art of what information is being obtained. No examples of “tracking information” are provided, nor are any details regarding what “tracking information” is contemplated to include. Accordingly, the Present Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Claim 1 recites “associating, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions.” In view of the above-explained deficiencies regarding the terms “spatial information” and “tracking information,” one of ordinary skill in the art would be unable to discern what “each of the plurality of medical instruments” is associated to “a respective at least one of the plurality of spatial regions” based on.
Regarding Claim 2, Claim 2 recites “wherein the one or more feedback parameters are region-specific and/or differ between two or more of the plurality of spatial regions.” As explained above with respect to Claim 1, the Present Specification does not explain what the recited “feedback parameters” entail in a manner sufficient to apprise a person of ordinary skill in the art to their meaning. As such, the Present Specification does not detail what “differ[s] between two or more of the plurality of spatial regions” or in what sense these unidentified “feedback parameters” are “region-specific.” Furthermore, the Present Specification does not describe the term “region-specific” in such a manner as would enable a person of ordinary skill in the art to understand how the term “region-specific” modifies the unidentified “feedback parameters.” Accordingly, the Present Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Regarding Claims 18 and 20, Claims 18 and 20 contain similar limitations to those addressed above with respect to Claim 1, and stand rejected for the same reasons.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 1-20 each fall within one of the four categories of statutory subject matter.
Eligibility Step 2A, Prong One: Claims 1-20 recite abstract ideas:
Regarding Independent Claim 1:
“associating, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions” recites a mental process when afforded its broadest reasonable interpretation. Such associating as claimed is able to practically be performed in the human mind, as it is a judgment. For example, a human could observe the recited spatial information, observe the recited tracking information and observe the spatial regions, and exercise judgment to associate each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions.
Regarding Claims 2-17, Claims 2-17 depend from and further limit Claim 1, and recite a mental process for the same reasons as does Claim 1.
Regarding Claim 18:
“associate, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions” recites a mental process when afforded its broadest reasonable interpretation for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claim 19, Claim 19 depends from and further limits Claim 18, and recites a mental process for the same reasons as does Claim 18.
Regarding Claim 20:
“associate, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions” recites a mental process when afforded its broadest reasonable interpretation for the same reasons as explained above with respect to the similar limitation of Claim 1.
Eligibility Step 2A, Prong Two: Claims 1-20 do not amount to significantly more than the abstract ideas recited therein.
Regarding Independent Claim 1:
“the method being performed by at least one processor” recites a generic computer structure for performing a generic computer function, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
“obtaining spatial information indicative of a plurality of spatial regions separate from one another in the operating room, each of the plurality of spatial regions being associated with one or more feedback parameters” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“obtaining tracking information indicative of tracked poses of a plurality of medical instruments in the operating room” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“triggering feedback, for each of the medical instruments, according to the one or more feedback parameters associated with the respective at least one of the plurality of spatial regions” amounts to mere data outputting in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Regarding Claims 2-8, Claims 2-8 do not recite any additional elements.
Regarding Claim 9:
“obtaining information indicative of the spatial regions in a coordinate system of the patient image data” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“obtaining a transformation between the coordinate system of the patient image data and a real-world coordinate system” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“and determining the spatial information by transforming the information indicative of the spatial regions from the coordinate system of the patient image data into the real-world coordinate system based on the obtained transformation” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
That is, the “determin[ed] spatial information” is the data (i.e., it is the same “spatial information”) which is used to accomplish the mental process of “associating.”
Regarding Claims 10-17, Claims 10-17 do not recite any additional elements.
Regarding Independent Claim 18:
“A system comprising at least one processor” recites a generic computer structure for performing a generic computer function, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
“obtain spatial information indicative of a plurality of spatial regions separate from one another in an operating room, each of the plurality of spatial regions being associated with one or more feedback parameters” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above with respect to the similar limitation of Claim 1.
“obtain tracking information indicative of tracked poses of a plurality of medical instruments in the operating room” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above with respect to the similar limitation of Claim 1.
“trigger feedback, for each of the plurality of medical instruments according to the one or more feedback parameters associated with the respective at least one of the plurality of spatial regions.” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claim 19:
“a tracking system configured to track the poses of the plurality of medical instruments in the operating room” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“a feedback unit configured to provide the feedback to at least one user in the operating room” amounts to mere data outputting in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“a robot configured to handle a medical tool” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Regarding Claim 20:
“A computer program product comprising non-transitory computer storage medium storing instructions which, when executed on at least one processor, cause the at least one processor to” recites a generic computer structure for performing a generic computer function, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
“obtain spatial information indicative of a plurality of spatial regions separate from one another in the operating room, each of the plurality of spatial regions being associated with one or more feedback parameters” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above with respect to the similar limitation of Claim 1.
“obtain tracking information indicative of tracked poses of a plurality of medical instruments in an operating room” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above with respect to the similar limitation of Claim 1.
“trigger feedback, for each of the plurality of medical instruments, according to the one or more feedback parameters associated with the respective at least one of the plurality of spatial regions” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above with respect to the similar limitation of Claim 1.
Eligibility Step 2B: Claims 1-20 do not recite additional elements that integrate the recited judicial exception into a practical application.
Regarding Independent Claim 1:
“the method being performed by at least one processor” does not contribute an inventive concept. The “at least one processor” is recited at a high level of generality, and such a processor is well-understood, routine and conventional in the art. See, e.g., US 2014/0219548 A1 at Para. [0016].
“obtaining spatial information indicative of a plurality of spatial regions separate from one another in the operating room, each of the plurality of spatial regions being associated with one or more feedback parameters” obtaining such spatial information is recited at a high level of generality, and is well understood, routine and conventional in the art. See, e.g., US 2004/0013240 A1 at Para. [0022]; US 2005/0182316 A1 at Para. [0044].
“obtaining tracking information indicative of tracked poses of a plurality of medical instruments in the operating room” does not contribute an inventive concept. Such tracking information is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2005/0182316 A1 at Para. [0044].
“triggering feedback, for each of the medical instruments, according to the one or more feedback parameters associated with the respective at least one of the plurality of spatial regions” does not contribute an inventive concept. Such feedback is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2010/0004558 A1 at Para. [0109].
Regarding Claims 2-8, Claims 2-8 do not recite any additional elements.
Regarding Claim 9:
“obtaining information indicative of the spatial regions in a coordinate system of the patient image data” does not contribute an inventive concept. The recited information is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2023/0079638 A1 at Para. [0054]; US 5,142,930 A at Col. 3, Ln. 37-40.
“obtaining a transformation between the coordinate system of the patient image data and a real-world coordinate system” does not contribute an inventive concept. The recited transformation is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2023/0079638 A1 at Para. [0054]; US 2020/0093397 A1 at Para. [0078]; US 5,142,930 A at Col. 3, Ln. 37-40.
“and determining the spatial information by transforming the information indicative of the spatial regions from the coordinate system of the patient image data into the real-world coordinate system based on the obtained transformation” does not contribute an inventive concept. The recited transformation is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2023/0079638 A1 at Para. [0054]; US 2020/0093397 A1 at Para. [0078]; US 5,142,930 A at Col. 3, Ln. 37-40.
Regarding Claims 10-17, Claims 10-17 do not recite any additional elements.
Regarding Independent Claim 18:
“A system comprising at least one processor” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
“obtain spatial information indicative of a plurality of spatial regions separate from one another in an operating room, each of the plurality of spatial regions being associated with one or more feedback parameters” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
“obtain tracking information indicative of tracked poses of a plurality of medical instruments in the operating room” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
“trigger feedback, for each of the plurality of medical instruments according to the one or more feedback parameters associated with the respective at least one of the plurality of spatial regions” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claim 19:
“a tracking system configured to track the poses of the plurality of medical instruments in the operating room” does not contribute an inventive concept. Such a tracking system is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2004/0013240 A1 at Para. [0022].
“a feedback unit configured to provide the feedback to at least one user in the operating room” does not contribute an inventive concept. Such feedback is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2010/0004558 A1 at Para. [0109].
“a robot configured to handle a medical tool” does not contribute an inventive concept. Such a robot is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 2015/0257838 A1 at Paras. [0106] and [0107].
Regarding Claim 20:
“A computer program product comprising non-transitory computer storage medium storing instructions which, when executed on at least one processor, cause the at least one processor to” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
“obtain spatial information indicative of a plurality of spatial regions separate from one another in the operating room, each of the plurality of spatial regions being associated with one or more feedback parameters” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
“obtain tracking information indicative of tracked poses of a plurality of medical instruments in an operating room” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
“trigger feedback, for each of the plurality of medical instruments, according to the one or more feedback parameters associated with the respective at least one of the plurality of spatial regions” does not contribute an inventive concept for the same reasons as explained above with respect to the similar limitation of Claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 8-13, 15, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by previously cited US 2019/0000556 A1 to Sela et al. (“Sela”).
Regarding Independent Claim 1, Sela discloses:
A method for supporting users in an operating room by triggering feedback regarding one or more medical instruments, the method being performed by at least one processor and comprising: (Title, “Medical electronic device with multi-tracking cameras;” Para. [0010], “FIG. 2 is a perspective view of a medical procedure room in which a medical electronic device in accordance with example embodiments of the present disclosure is used;” Para. [0053], “Exemplary aspects of the disclosure can be implemented via processor(s) (such as the processor 311 of the medical tracking system 302 and/or a processor of the control and processing unit 304)) coupled with memory;” Abstract, “The processor is configured to determine, based on data received from the first tracking system and data received from the second tracking system, transposition information to map data received from the first tracking system and data received from the second tracking system into a common space.”);
Sela’s “determin[ing] … transposition information…” is such “triggering feedback” as claimed.
obtaining spatial information indicative of a plurality of spatial regions separate from one another in the operating room, (Para. [0031], “…the tracked instrument includes a plurality of tracking markers 16. The tracking markers are, in the example, tracking spheres. In the example embodiment, the tracked instrument includes four reflective tracking spheres;” Para. [0057], “At operation 402, the first tracking system and the second tracking system acquire data, which is then provided to and received by the processor. That is, the tracking systems attempt to track tracking markers such as tracking markers provided on a tracked instrument;” Fig. 1, “tracking markers 16;” see Annotated Fig. 1);
Sela’s “data” that “the first tracking system and the second tracking system acquire” is such “spatial information” as claimed.
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each of the plurality of spatial regions being associated with one or more feedback parameters; (Para. [0045], “The tracking systems may track the tracking markers and, more particularly, the tracked instrument, based on light reflected. That is, the tracked instrument may be tracked based on the light reflected from the tracking markers on the tracked instrument.”);
Sela’s “the light reflected from the tracking markers” is such a feedback parameter as claimed.
obtaining tracking information indicative of tracked poses of a plurality of medical instruments in the operating room; (Para. [0032], “… the optical tracking system knows the position in space of a tip of a medical instrument relative to the tracking markers being tracked;” Para. [0031]; Para. [0038], “The medical tracking system 302 may be employed to track one or more of medical instruments 310 …”);
associating, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions; (Para. [0031], “…the tracking markers are provided on the tracked instrument in a configuration that is known to a medical electronic device which tracks the tracked instrument. Using this known geometry, the medical electronic device can determine the location of other features of the tracked instrument, such as the tip of the tracked instrument;” Para. [0038], “The medical tracking system 302 may be employed to track one or more of medical instruments 310 …”);
and triggering feedback, for each of the medical instruments, according to the one or more feedback parameters of the associated respective at least one of the plurality of spatial regions. (Para. [0033], “A medical navigation system 205 comprising an equipment tower, tracking system (which is an optical tracking system in the embodiment of FIG. 2), displays and tracked instruments 211 assist the surgeon 201 during his procedure.”).
Regarding Claim 2, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the one or more feedback parameters are region-specific and/or differ between two or more of the plurality of spatial regions. (Para. [0034], “…the first tracking region 207 is an area that is represented in data generated by the first tracking system 206. The first tracking system 206 is configured to track the tracked instrument within the first tracking region;” Para. [0041], “The second tracking system 208 is configured to track the tracked instrument within the second tracking region.”).
Sela’s “feedback parameters are region-specific” in that each tracking region tracks only markers in that region, which markers reflect light whose detection is such a feedback parameter as claimed.
Sela’s “feedback parameters … differ between two or more of the plurality of spatial regions” in that differing “tracking markers 16” indicate differing positions.
Regarding Claim 8, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the spatial information is determined or defined based on patient image data comprising one or more medical images of at least a portion of a patient’s body (Para. [0037], “By observing the tracked instrument 211 during the patient registration procedure, the medical electronic device may determine the location of the patient 202 in space. This allows the medical electronic device to map the physical coordinate space of the operating room to the image space of the magnetic resonance imaging (MRI) image, computerized tomography (CT) image, or image of another type;” Para. [0032], “ccordingly, optical tracking systems, which may be used in the medical procedure, track the position of a part of the tracked instrument that is within line-of-site of the optical tracking system. These optical tracking systems may use a reference to the patient to know where the instrument is relative to the target (e.g., a tumor) of the medical procedure;” Para. [0052], “…the transposition information 315 may map a viewspace of the second tracking system to a patient reference space, which is a space defined based on a location of a patient;” Paras. [0064] through [0065]);
Sela’s “spatial information” is “defined based on patient image data” in that the patient is used a reference point for defining location of Sela’s markers.
Regarding Claim 9, Sela discloses the entirety of Claim 8 as explained above.
Sela additionally discloses:
further comprising: obtaining information indicative of the spatial regions in a coordinate system of the patient image data; obtaining a transformation between the coordinate system of the patient image data and a real-world coordinate system; (Para. [0037], “…fiducial points may be identified on images and then the tracked instrument may be used to touch the associated locations. By observing the tracked instrument 211 during the patient registration procedure, the medical electronic device may determine the location of the patient 202 in space. This allows the medical electronic device to map the physical coordinate space of the operating room to the image space of the magnetic resonance imaging (MRI) image, computerized tomography (CT) image, or image of another type.”);
and determining the spatial information by transforming the information indicative of the spatial regions from the coordinate system of the patient image data into the real-world coordinate system based on the obtained transformation. (Para [0059], “In such embodiments, a coordinate system may be defined with reference to the first tracking system and data associated with the second camera may be mapped to that coordinate system;” Para. [0061], “For example, the transposition information may represent a transposition that may be applied to the position of a tracking marker in a second space (such as a coordinate system associated with the second tracking system) to transpose it to a first space (such as a coordinate system associated with the first tracking system);” Para. [0052]).
Regarding Claim 10, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein at least one of the spatial information and the tracking information is obtained for multiple points in time and the feedback is iteratively triggered for two or more of the multiple points in time. (Para. [0002], “ The tracking system may track tracking markers that are provided on a medical instrument, for example. By tracking the tracking markers, the medical electronic device can determine the location, in space, of the tracked tool or instrument. This location information may be used, for example, to facilitate a medical procedure. For example, in some embodiments, the location of the tracked tool or instrument may be used to automatically reposition a robotic arm associated with the medical electronic device;” Para. [0062], “The data from the first tracking system and the data from the second tracking system that are used to determine the position of the tracked instrument are received at substantially the same time to reduce errors from movements of the tracked instrument. In at least some embodiments, the data from the first tracking system and the data from the second tracking system may include respective time stamps or other timing information which indicates the time that such data was acquired;” Para. [0068]; Para. [0033]).
Regarding Claim 11, Sela discloses the entirety of Claim 10 as explained above.
Sela additionally discloses:
wherein one or more of the respective at least one of the plurality of spatial regions are updated based on a movement of one or more of the plurality of medical instruments as indicated by the tracking information obtained for multiple points in time. (Paras. [0071] through [0073]; Fig. 4, “Detect Repositioning 408” and “Re-Calibrate 410”).
Regarding Claim 12, Sela discloses the entirety of Claim 11 as explained above.
Sela additionally discloses:
wherein: the one or more of the respective at least one of the plurality of spatial regions are updated such that the medical instrument associated with said one or more of the respective at least one of the plurality of spatial regions remains within said one or more of the at least one of the plurality of spatial regions; and/or the one or more of the respective at least one of the plurality of spatial regions is updated such that a medical instrument not associated with said one or more of the respective at least one of the plurality of spatial regions remains outside said one or more of the at least one of the plurality of spatial regions. (Para. [0063], “…a plurality of reference tracking markers may be fixedly positioned in a medical procedure room within the first tracking region associated with the first tracking system and the second tracking region associated with the second tracking system;” Para. [0068], “…when the tracked instrument is visible to both tracking systems, data from both tracking systems may be used to determine the position of the tracked instrument. In some embodiments, when the tracked instrument is visible to both tracking systems, the processor determines a position of a tracked instrument within the first tracking region using data from the first tracking system and determines the position of the tracked instrument within the first tracking region using data from the second tracking system.”).
Regarding Claim 13, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the plurality of medical instruments comprises instruments handled simultaneously (Para. [0048], “The medical tracking system 302 may be employed to track one or more of medical instruments 310 (such as the tracked instruments described above) and spatially register the one or more tracked instruments to an intraoperative reference frame.”).
Regarding Claim 15, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the one or more feedback parameters define at least one of an auditory feedback, a haptic feedback and a visual feedback (Para. [0033], “A medical navigation system 205 comprising an equipment tower, tracking system (which is an optical tracking system in the embodiment of FIG. 2), displays and tracked instruments 211 assist the surgeon 201 during his procedure.”).
Regarding Independent Claim 18, Sela discloses:
A system comprising at least one processor configured to: (Para. [0053]; Abstract);
obtain spatial information indicative of a plurality of spatial regions separate from one another in an operating room, each of the plurality of spatial regions being associated with one or more feedback parameters; (Para. [0031]; Para. [0057]; Para. [0045]; Fig. 1, “tracking markers 16;” see Annotated Fig. 1);
obtain tracking information indicative of tracked poses of a plurality of medical instruments in the operating room; (Para. [0050]; Para. [0032]; Para. [0031]);
associate, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions; (Para. [0045]; Para. [0031]; Para. [0038]);
and trigger feedback, for each of the plurality of medical instruments, according to the one or more feedback parameters associated with the respective at least one of the plurality of spatial regions. (Para. [0033]).
Regarding Claim 19, Sela discloses the entirety of Claim 18 as explained above.
Sela additionally discloses:
further comprising at least one of the following components: a tracking system configured to track the poses of the plurality of medical instruments in the operating room; (Fig. 2, “first tracking system 206” and “second tracking system 208”);
a feedback unit configured to provide the feedback to at least one user in the operating room; (Para. [0047], “The control and processing unit 304 may be interfaced with other external devices, such as the medical tracking system 302 and other devices 306. The other devices 306 may include, for example, data storage, and external user input and output devices, which may include, for example, one or more of a display…;” see also Para. [0033], with reference to “medical navigation system 205” of Fig. 2, noting it to contain the display elaborated upon at Para. [0047])
and a robot configured to handle a medical tool (Para. [0002], “…in some embodiments, the location of the tracked tool or instrument may be used to automatically reposition a robotic arm associated with the medical electronic device.”).
Regarding Independent Claim 20, Sela discloses:
A computer program product comprising non-transitory computer storage medium storing instructions which, when executed on at least one processor, cause the at least one processor to: (Para. [0053]; Abstract);
obtain spatial information indicative of a plurality of spatial regions separate from one another in the operating room, each of the plurality of spatial regions being associated with one or more feedback parameters; (Para. [0031]; Para. [0057]; Para. [0045]; Fig. 1, “tracking markers 16;” see Annotated Fig. 1)
obtain tracking information indicative of tracked poses of a plurality of medical instruments in an operating room; (Para. [0050]; Para. [0032]; Para. [0031]);
associate, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions; (Para. [0045]; Para. [0031]; Para. [0038]);
and trigger feedback, for each of the plurality of medical instruments, according to the one or more feedback parameters of the associated respective at least one of the plurality of spatial regions. (Para. [0033]).
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.
Claims 3-5, 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2019/0000556 A1 to Sela et al. (“Sela”) as applied to Claims 1 and 15 above, and further in view of previously cited WO 2021003401 A1 to Malackowski et al. (“Malackowski”).
Regarding Claim 3, Sela discloses the entirety of Claim 1 as explained above.
Sela does not disclose:
wherein the plurality of spatial regions are defined based on a pose of at least one reference object in the operating room
Malackowski describes “[s]ystems and methods … wherein a localizer is configured to detect a position of a first object and a vision device is configured to generate a depth map of surfaces near the first object.” Malackowski is analogous art.
Malackowski teaches:
wherein the plurality of spatial regions are defined based on a pose of at least one reference object in the operating room (Para. [0100], “ During an initial phase of a surgical procedure, the trackers 34, 36 may be firmly affixed to the femur F and tibia T of the patient respectively. The position of coordinate systems FBONE and TBONE may then be mapped to the coordinate systems BTRK1 and BTRK2, respectively. For instance, a pointer instrument P (FIG. 1) … having its own tracker PT, may be used to register the femur coordinate system FBONE and tibia coordinate system TBONE to the bone tracker coordinate systems BTRK1 and BTRK2, respectively. The fixed positional relationship between the femur coordinate system FBONE and the bone tracker coordinate system BTRK1, and the fixed positional relationship between the tibia coordinate system TBONE and the bone tracker coordinate system BTRK2, may be stored on the navigation controller 22 as transformation data 83.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sela with the teachings of Malackowski (i.e., to define Sela’s spatial regions based on a pose of at least one reference object in the operating room in the manner of Malackowski) in order to facilitate maneuvering of a surgical instrument in proximity to sensitive anatomical structures while avoiding other objects adjacent the target volume, such as other medical tools and adjacent anatomical structures (Malackowski at Paras. [0003] and [0042]).
Regarding Claim 4, the combination of Sela and Malackowski renders obvious the entirety of Claim 3 as explained above.
Malackowski additionally teaches:
wherein the at least one reference object comprises at least a portion of a patient’s body and/or at least a portion of a medical tool and/or at least a portion of a medical instrument. (Para. [0100], “ During an initial phase of a surgical procedure, the trackers 34, 36 may be firmly affixed to the femur F and tibia T of the patient respectively. The position of coordinate systems FBONE and TBONE may then be mapped to the coordinate systems BTRK1 and BTRK2, respectively.”).
Regarding Claim 5, the combination of Sela and Malackowski renders obvious the entirety of Claim 4 as explained above.
Malackowski additionally teaches:
wherein different ones of the plurality of spatial regions comprise different portions of the patient’s body. (Para. [0100], “ During an initial phase of a surgical procedure, the trackers 34, 36 may be firmly affixed to the femur F and tibia T of the patient respectively. The position of coordinate systems FBONE and TBONE may then be mapped to the coordinate systems BTRK1 and BTRK2, respectively. For instance, a pointer instrument P (FIG. 1) … having its own tracker PT, may be used to register the femur coordinate system FBONE and tibia coordinate system TBONE to the bone tracker coordinate systems BTRK1 and BTRK2, respectively.”).
Regarding Claim 14, Sela discloses the entirety of Claim 1 as explained above.
Sela does not disclose:
wherein different subsets of the plurality of spatial regions are associated with different surgeons
Malackowski is analogous art, as explained above.
Malackowski teaches:
wherein different subsets of the plurality of spatial regions are associated with different surgeons (Para. [0042], “ During a surgical procedure, the surgical navigation system 12 may track the position (location and orientation) of objects of interest within a surgical workspace using a combination of tracker-based localization and machine vision. … The tracked objects may include, but are not limited to … anatomical structures of surgical personal such as a surgeon’s hand or fingers.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sela with the teachings of Malackowski (i.e., to associate different spatial regions with different surgeons in the manner of Malackowski) in order to “provide an accurate and efficient mechanism for the surgical navigation system … to determine the position of such objects in the surgical workspace” (Malackowski at Para. [0043]).
Regarding Claim 16, Sela discloses the entirety of Claim 15 as explained above.
Sela does not disclose:
wherein the visual feedback includes display of a navigation view visualizing the pose of the respective medical instrument
Malackowski is analogous art, as explained above.
Malackowski teaches:
wherein the visual feedback includes display of a navigation view visualizing the pose of the respective medical instrument (Para. [0143], “During a surgical procedure, the navigation controller 22, such as via the surgical navigator 81, may be configured to display the illustration of FIG. 14 along with an image or virtual model for the surgical instrument 16 at the current position of the surgical instrument 16 in the common coordinate system, such as tracked with the localizer 18, to aid a surgeon in guiding the surgical instrument 16 to the target volume 202.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sela with the teachings of Malackowski (i.e., to include display of a navigation view visualizing the pose of the respective medical instrument in the manner of Malackowski) in order to “aid a surgeon in guiding the surgical instrument … to the target volume….” (Malackowski at Para. [0143]).
Regarding Claim 17, Sela discloses the entirety of Claim 16 as explained above.
Malackowski additionally teaches:
wherein the one or more feedback parameters define at least one setting of the navigation view, the at least one setting comprising: a type of medical image data used for rendering the navigation view; a criterion for highlighting structures in the navigation view; a criterion for indicating planned objects in the navigation view; an orientation of the navigation view; and/or a perspective of the navigation view. (Para. [0133], “The model data 82 may also define predetermined profiles for various objects potentially present in the target site, each profile setting forth one or more features specific to the object that aid the navigation controller 22 in identifying the object from the actual depth map. For example, a profile for a given object may include, without limitation, one or more of a color palate, wavelength range, signal intensity range, distance or depth range, area, volume, shape, polarization, and deep metrics output from a learned or statistical model corresponding to the object;” Para. [0135], “… a user may interact with the user interface 24 to manually select an object of the identified portion segmented by the navigation controller 22, and/or to select a predefined profile for the selected object.”).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2019/0000556 A1 to Sela et al. (“Sela”) in view of previously cited WO 2021003401 A1 to Malackowski et al. (“Malackowski”) as applied to Claim 5 above, and further in view of previously cited US 2017/0312035 A1 to May et al. (“May”).
Regarding Claim 6, the combination of Sela and Malackowski renders obvious the entirety of Claim 5 as explained above.
The combination of Sela and Malackowski does not disclose:
wherein at least some of the plurality of spatial regions are separated from one another by one or more virtual planes that are optionally defined relative to the patient?s body.
May describes a “SURGICAL SYSTEM HAVING ASSISTED NAVIGATION” (Title). May is analogous art.
May teaches:
wherein at least some of the plurality of spatial regions are separated from one another by one or more virtual planes that are optionally defined relative to the patient’s body (Para. [0029], “FIG. 2 is a block diagram of an exemplary surgical navigation system embodiment in accordance with the present teachings, such as an Acumen™ Surgical Navigation System…. The Acumen™ Surgical Navigation System can operate in a variety of imaging modes such as a fluoroscopy mode creating a two-dimensional x-ray image, a computer-tomography (CT) mode creating a three-dimensional image, and an imageless mode creating a virtual image or planes and axes by defining anatomical points of the patient's anatomy.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Sela and Malackowski with the teachings of May (i.e., to separate the spatial regions of combined Sela and Malackowski with such a virtual plane as taught by May) in order to simplify the required setup by reducing the number of devices required to construct spatial regions (May at Para. [0029]).
Regarding Claim 7, the combination of Sela, Malackowski and May renders obvious the entirety of Claim 6 as explained above.
May additionally teaches:
wherein the one or more virtual planes comprise at least one anatomical plane, at least one user-defined plane and/or at least one plane associated with an anatomical element of the patient’s body. (Para. [0029], “FIG. 2 is a block diagram of an exemplary surgical navigation system embodiment in accordance with the present teachings, such as an Acumen™ Surgical Navigation System…. The Acumen™ Surgical Navigation System can operate in a variety of imaging modes such as a fluoroscopy mode creating a two-dimensional x-ray image, a computer-tomography (CT) mode creating a three-dimensional image, and an imageless mode creating a virtual image or planes and axes by defining anatomical points of the patient's anatomy.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
