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 .
Priority
Applicant’s claim for the benefit of a prior-filed application 63/664,059, filed 06/25/2024, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 5 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 5 recites “the plurality of instruments used in the surgical procedure in the storage tray…” Claim 5 is dependent on claim 3, which is dependent on claim 1. Claim 1 recites “a storage device,” but there is no recitation of “a storage tray.” Therefore, this recitation lacks sufficient antecedent basis in the claims.
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 an abstract idea without significantly more.
Step 2A Prong One
Claims 1 recites obtaining at least one post-surgery image of a plurality of instruments used in a surgical procedure; processing the at least one post-surgery image to identify the instruments of the plurality; and outputting data relating to a position of at least one of the instruments in a storage device to assist a user in storing the at least one instrument.
These limitations, as drafted, given the broadest reasonable interpretation, encompass managing personal behavior or interactions between people, which is a subgrouping of Certain Methods of Organizing Human Activity. For example, the claim encompasses assisting a user with post-surgical handling of surgical instruments by obtaining an image of the instruments used in surgery, identifying the instruments in the image, and providing a user with a position of at least one of the instruments where it should be stored. Such manual steps encompass Certain Methods of Organizing Human Activity.
Claims 2-20 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 2-5 further encompass obtaining a list of the instruments, comparing instruments, and providing a user with any discrepancies found in the comparison. Claims 6-7 additionally recite outputting data related to instrument position and an instruction for robotic storage. Simply outputting an instruction does not require operation by the robot and is, therefore, part of the abstract idea. Claims 8-9 further recite obtaining and processing video at a time related to the post-surgery image. This encompasses a user observing and evaluating video. Claims 10-13 further expand on the storage device to be a sterilization tray. Claims 14-15 further expand on obtaining the image. Claim16 further expands on identifying the surgical instrument. Claim 17 further expands on comparing images to identify an instrument. Claim 18 further identifies the timing of obtaining the image of instruments. Claims 19-20 further expand on outputting instrument information. As explained above, these manual steps encompass Certain Methods of Organizing Human Activity.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with adding elements similar to adding the words “apply it” to the abstract idea, and generally linking the abstract idea to a particular technological environment, along with insignificant, extra-solution data gathering activity.
Claims 1-20, directly or indirectly, recite the following additional elements at a high level of generality and merely utilized as tools to implement the abstract idea:
Claims 1:
a processing unit; anda non-transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit.
Claims 2-20:
the computer-readable program instructions are executable by the processing unit.
Claim 15
imaging the plurality of instruments with a non-radiographic digital camera.
The written description discloses that the recited computer components encompass generic components including “CAS controller 50 may be part of any suitable processor unit(s), such as a personal computer or computers including laptops and desktops, tablets, server, cloud, etc” (see page 3, lines 9-11). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 2 and 16, directly or indirectly, recite the following additional elements at a high level of generality, involving no more that extra-solution data gathering and transmitting activity:
Claim 2:
obtaining a list…from a computer-assisted surgery system operating a surgical workflow (i.e. obtaining data from a computer).
Claim 16:
recognizing an optical code…and retrieving the identify of the instrument from the optical code (i.e. obtaining data from a barcode or QR code).
These additional elements are recited at a high degree of generality and are merely involved in insignificant extra solution data gathering using generic computer components. As set forth in MPEP 2106.05(g) insignificant, extra-solution activity, such as insignificant acquisition and data transmission, is an example of when an abstract idea has not been integrated into a practical application.
Claims 6-7, recite the following additional elements at a high level of generality, generally linking the abstract idea to a particular technological environment:
Claims 6:
a robot configured to store the at least one instrument in the storage device.
Claim 7:
driving the robot to store the at least one instrument in the storage device.
The robot is broadly recited and is only recited as a destination of output instructions for “driving” the robot to perform a function. There is no indication that the combination of the robot and the other recited limitations provides any type of technical improvement or an improvement to another technical field. The robot simply links the abstract idea to a particular technological environment.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Insignificant, extra solution, data gathering activity (e.g. obtaining data using generic computer components) has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)).
Generally linking the abstract idea to a particular technological environment (e.g. a robot) does not amount to significantly more than the abstract idea (see MPEP 2016.05(h) and Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 120 USPQ2d 1201 (Fed. Cir. 2016)).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. These additional elements merely carry out the abstract idea through data collection, data processing, data communication, and data storage. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 8-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Caprara, US Patent Application Publication No. 2024/0074814.
As per claim 1, Caprara teaches a system for managing surgical hardware in computer-assisted surgery, comprising: a processing unit (see paragraph 0068; processor comprising a processing device); and a non-transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit (see paragraph 0068; storage device with a management and tracking program installed) for: obtaining at least one post-surgery image of a plurality of instruments used in a surgical procedure (see paragraphs 0024 and 0026; recognition of surgical instruments to detect the images); processing the at least one post-surgery image to identify the instruments of the plurality (see paragraph 0050; perform image and data processing relating to the surgical instruments and generate visual content from the images and data); and outputting data relating to a position of at least one of the instruments in a storage device to assist a user in storing the at least one instrument (see paragraph 0052; outputs data related to surgical instrument positioning and placement within a kit for post surgery sterilization).
As per claim 2, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining a list of the plurality of instruments from a computer-assisted surgery system operating a surgical workflow during the surgical procedure (see paragraph 0049; detect and obtain images and identification codes of surgical instruments).
As per claim 8, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining a video feed when obtaining the at least one post-surgery image of the plurality of instruments (see paragraphs 0054 and 0079; acquired data may be from video camerates and may be used to produce video content).
As per claim 9, Caprara teaches the system of claim 8 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for processing the video feed when processing the at least one post-surgery image (see paragraphs 0054 and 0079; acquired data may be from video camerates and may be used to produce video content).
As per claim 10, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining the at least one post- surgery image of the plurality of instruments in a sterilization tray (see paragraph 0052; images include surgical instruments and surgical kits of the sterilization unit).
As per claim 11, Caprara teaches the system of claim 10 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining the at least one post- surgery image of the plurality of instruments in the sterilization tray prior to sterilization (see paragraph 0052; images include surgical instruments and surgical kits of the sterilization unit; data relating to surgical instrument includes history of sterilization procedures for the surgical instrument, which indicates an images being before or after a sterilization).
As per claim 12, Caprara teaches the system of claim 10 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining the at least one post- surgery image of the plurality of instruments in the sterilization tray after sterilization(see paragraph 0052; images include surgical instruments and surgical kits of the sterilization unit; data relating to surgical instrument includes history of sterilization procedures for the surgical instrument, which indicates an images being before or after a sterilization).
As per claim 13, Caprara teaches the system of claim 10 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining the at least one post- surgery image of the plurality of instruments in the sterilization tray, the sterilization tray being the storage device (see paragraph 0052; images include surgical instruments and surgical kits of the sterilization unit).
As per claim 14, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for imaging the plurality of instruments to obtain the at least one post-surgery image (see paragraphs 0024 and 0026; recognition of surgical instruments to detect the images).
As per claim 15, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for imaging the plurality of instruments with a non-radiographic digital camera (see paragraphs 0048 and; image acquisition means 0079 include video cameras and thermal imaging cameras).
As per claim 16, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for recognizing an optical code on at least one of the instruments when processing the at least one post-surgery image to identify the instruments of the plurality, and for retrieving the identity of the instrument from the optical code (see paragraph 0113; optical identification code uniquely associated with a surgical instrument).
As per claim 18, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining at least one post-surgery image of a plurality of instruments used in the surgical procedure after the surgical procedure is completed and before the plurality of instruments are stored in a storage device (see paragraph 0052; images include surgical instruments; data relating to surgical instrument includes history of sterilization procedures for the surgical instrument, which indicates an images being before or after being in a surgical kit).
As per claim 19, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for outputting an image of the at least one instrument when outputting said data (see paragraph 0052; outputs data related to surgical instrument positioning and placement within a kit for post surgery sterilization).
As per claim 20, Caprara teaches the system of claim 1 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for outputting an image of the storage device with a visual marker on said position when outputting said data (see paragraph 0062; outputs surgical kit with arrow-shaped indications related to surgical instruments that have been placed wrongly or the container in which the surgical instrument is to be placed).
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.
Claim(s) 3-5 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caprara, US Patent Application Publication No. 2024/0074814 in view of Hanajima, US Patent Application Publication No. 2019/0206560.
As per claim 3, Caprara teaches the system of claim 2 as described above. Caprara does not explicitly teach the computer-readable program instructions are executable by the processing unit for comparing the identified instruments from the plurality to the list of instruments used during the surgical procedure. Hanajima teaches comparing identified instruments from a plurality to a list of instruments used during a surgical procedure (see paragraphs 0301-0302; count logs of surgical instruments from before and after a medical surgery are compared to identify any lost instruments). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to compare instruments in the system of Capara as described in Hanajima with the motivation of improving the accuracy of managing medical instruments before and after procedures (see paragraph 0189 of Hanajima).
As per claim 4, Caprara and Hanajima teaches the system of claim 3 as described above. Caprara does not explicitly teach the computer-readable program instructions are executable by the processing unit for outputting data relating to any discrepancy between the list and the plurality of instruments. Hanajima further teaches outputting data relating to any discrepancy between the list and the plurality of instruments (see paragraphs 0301-0302; count logs of surgical instruments from before and after a medical surgery are compared to identify any lost instruments). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate this feature in the system of Caprara for the reasons given above with respect to claim 3.
As per claim 5, Caprara and Hanajima teaches the system of claim 3 as described above. Caprara further teaches the computer-readable program instructions are executable by the processing unit for obtaining the at least one post- surgery image of the plurality of instruments used in the surgical procedure in the storage tray (see paragraph 0050; perform image and data processing relating to the surgical instruments and generate visual content from the images and data; paragraph 0052; data related to surgical instrument positioning and placement within a kit for post surgery sterilization; Figure 2 shows surgical kit in the form of a storage tray). Caprara does not explicitly teach outputting data relating to any discrepancy between a current position and a set position of at least one of the plurality of instruments. Hanajima further teaches outputting data relating to any discrepancy between a current position and a set position of at least one of the plurality of instruments (see paragraphs 0301-0302; count logs of surgical instruments from before and after a medical surgery are compared to identify any lost instruments). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate this feature in the system of Caprara for the reasons given above with respect to claim 3.
As per claim 17, Caprara teaches the system of claim 2 as described above. Caprara does not explicitly teach the computer-readable program instructions are executable by the processing unit for comparing images of the instruments to images of instruments in a database of instrument images when processing the at least one post-surgery image to identify the instruments of the plurality. Hanajima teaches comparing images of instruments to images of instruments in a database of instrument images when processing at least one post-surgery image to identify the instruments of the plurality (see paragraphs 0301-0302; count logs of surgical instruments from before and after a medical surgery are compared to identify any lost instruments). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to compare instruments in the system of Capara as described in Hanajima with the motivation of improving the accuracy of managing medical instruments before and after procedures (see paragraph 0189 of Hanajima).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caprara, US Patent Application Publication No. 2024/0074814 in view of Gerstner, US Patent Application Publication No. 2025/0331945.
As per claim 6, Caprara teaches the system of claim 1 as described above. Caprara does not explicitly teach the computer-readable program instructions are executable by the processing unit for outputting said data relating to the position of at least one of the instruments in the storage device as instructions for driving a robot configured to store the at least one instrument in the storage device. Gerstner teaches outputting data relating to the position of at least one instrument in a storage device as instructions for driving a robot configured to store the at least one instrument in the storage device (see paragraphs 0209 and 0212; describes outputting instructions for a robotic device to move a surgical instrument to a tray). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to include robotic operation for surgical device moving in the system of Caprara with the motivation of improving organization of surgical instruments (see paragraph 0029 of Gerstner).
As per claim 7, Caprara and Gerstner teaches the system of claim 6 as described above. Caprara does not explicitly teach the computer-readable program instructions are executable by the processing unit for driving the robot to store the at least one instrument in the storage device. Gerstner further teaches driving the robot to store the at least one instrument in the storage device. (see paragraphs 0209 and 0212; describes outputting instructions for a robotic device to move a surgical instrument to a tray). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate this feature in the system of Caprara for the reasons given above with respect to claim 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Canton, International Publication No. WO 2022/087015, discloses tracking and monitoring surgical tools throughout use from captured images and displaying augmented reality to assist a user.
Barnett, US Patent Application Publication No. 2018/0338801, discloses capturing images of surgical instruments and displaying movement and positioning of the instruments.
Stewart, US Patent Application Publication No. 2018/0353256, discloses displaying data related to surgical instruments including positioning within a surgical tray.
Yang, US Patent Application Publication No. 2022/0164576, discloses a global identification module to recognize images of surgical instruments.
Pfanner, US Patent Application Publication No. 2016/0045276, discloses projecting images of surgical instruments onto surgical trays.
Ma, US Patent Application Publication No. 2021/0193307, discloses capturing images of surgical instruments and determining actions to perform with the instruments.
Foster, US Patent No. 9,847,044, discloses displaying images of surgical instruments correctly arranged in instrument trays to assist sterilization staff in positioning the instruments.
Wolter, US Patent Application Publication No. 2018/0011722, discloses displaying a predetermined arrangement of surgical instruments in a cleaning basket.
Oka et al., An efficient annotation method for image recognition of dental instruments, discloses recognizing dental instruments to label the instruments within a tray.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached Monday through Friday 9:00 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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