The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Specification
The abstract of the disclosure is objected to because the current abstract merely recites claim 1, and states that it is “an example process”. According to MPEP 608.01(b)(I)(B), “A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art… Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; … (5) if a process, the steps. Extensive mechanical and design details of apparatus should not be included in the abstract.” MPEP 608.01(B)(I)(C) states “The abstract should be in narrative form and generally limited to a single paragraph preferably within the range of 50 to 150 words in length. The abstract should not exceed 15 lines of text. Abstracts exceeding 15 lines of text or 150 words should be checked to see that they are as concise as the disclosure permits. The form and legal phraseology often used in patent claims, such as ‘means’ and ‘said,’ should be avoided. The abstract should sufficiently describe the disclosure to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, ‘This disclosure concerns,’ ‘The disclosure defined by this invention,’ ‘This disclosure describes,’ etc.”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 6, 13 and 20 are objected to because of the following informalities:
Claims 6, 13 and 20 are objected to because “wherein the one or assignments” in line 2 of claim 6 should read “wherein the one or more assignments”. Claims 13 and 20 contain the same error in their respective locations.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (US Patent Pub. No. 2020/0281672) in view of Piron et al. (US Patent Pub. No. 2016/0015471).
Regarding claims 1, 8 and 15, Goldberg discloses methods and system for assigning input devices to teleoperated surgical instrument functions (see Title). Specifically, Goldberg teaches that “surgical instruments 102 include a unique identifier encoded at the surgical instruments that identifies the specific surgical instrument and the type of surgical instrument… The unique identifier may be, for example, a unique serial number (see paragraph 68). “The unique identifier may be transmitted from the surgical instrument 102 and sensed by one or more memory structure reader devices (not shown) at the patient side cart 110, for example, in proximity to or associated with each actuation interface assembly” (see paragraph 69). Paragraph 69 also teaches that “memory storage structure reader devices can be proximity-based in that their ability to read the unique information with which an instrument memory storage device is programmed relies on the instrument being in close range, e.g., coupled or engaged, with a respective actuation interface assembly of the patient side cart.” In other words, this teaches that the surgical instrument being identified would be, based on the stated proximity-basis, within a “field of view” of the reader device. Therefore, the discussion of Goldberg this far reads on “detecting and identifier associated with an object” and “identifying the object in a field of view”. Paragraph 71 then discusses that “the unique identifier information may be transmitted to the control system, which may include one or more processors 150 able to analyze the detected type of surgical instrument 102.” Based on the analysis by the one or more processors and detection of the type of surgical instrument (see paragraph 72 for additional detail of “the type of surgical instrument” in that this may be “the instrument type and other information regarding an instrument 102”), foot pedals may be initiated and configured in various ways, with the following providing numerous examples:
“By way of example, if the detected type of surgical instrument is a permanent cautery spatula, foot pedal 124a could automatically be assigned to send a signal to a monopolar energy generator to perform a monopolar cut auxiliary function and foot pedal 124b could be assigned to send a signal to a monopolar energy generator to perform a monopolar coagulation auxiliary function” (see paragraph 80).
“By way of particular example, when foot pedal 124a is assigned to a surgical instrument 102a of a particular auxiliary function type and that is in-following with left gripping mechanism 122a, actuation (e.g., depressing) of the foot pedal 124a will cause the surgical instrument 102a to be activated to deliver monopolar cautery energy. If, however, rather than being a monopolar cautery energy delivery instrument, surgical instrument 102a instead is configured for stapling for example, then actuation of foot pedal 124a would activate the surgical instrument 102a to perform a stapling auxiliary function” (see paragraph 82).
“For example, if the surgical instrument type positionally mapped to the left bank of pedals 124a, 124b is an electrosurgical energy type of instrument, then depressing pedal 124a may activate the surgical instrument to deliver a higher voltage energy than depressing 124b would or vice versa. In other exemplary embodiments, upper and lower pedal pairs in a bank can correspond to differing modalities, such as, for example, monopolar cut and monopolar coagulation; stapler fire and stapler clamping; suction and irrigation; mechanical cutting, and vessel sealing, etc.” (see paragraph 83).
However, it is noted that Goldberg merely teaches that “one or more processors 150 able to analyze the detected type of surgical instrument 102” (see paragraph 71, also see paragraph 73), without providing details of how the analysis occurs, or specifically “comparing the identifier to a list of identifiers to identify a corresponding device linked to the object”.
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Piron teaches a context aware surgical system (see Title). Specifically with regard to the above noted deficiency of Goldberg, Piron teaches a process of identifying medical instruments (see Figure 4 found below). “In step 220, one or more signals associated with the medical instrument are detected” (see paragraph 123). “The identity of the medical instrument is then obtained, as shown in step 230, by comparing the identification measures with pre-selected identification data, where the pre-selected identification data associates the identities of a plurality of medical instruments with various measures. The identification data may be provided in the form of a database, look-up table, or other data structure that may be accessed by control and processing unit 400 to identify the medical instrument” (see paragraph 124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application for the analysis performed by the one or more processors of Goldberg to utilize a look up table within a database, as taught by Piron, because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Specifically with respect to claim 8 adding “one or more pedals”, it is noted that Figure 1 of Goldberg illustrates multiple pedals 124a, 124b, 124c and 124d associated with unit 120. The remainder of the claimed “a detection unit” and “a processor” and their associated configurations are described immediately above in the main descriptions of Goldberg and Piron.
Regarding claims 2, 9 and 16, it is noted that Goldberg teaches that “Instrument identification storage and reader device technology can be via a variety of technologies known to those skilled in the art, such as, for example, any of a variety of optical encoding/reading…” (see paragraph 74), along with multiple other options stated in the same paragraph. Additionally, Piron teaches that the tracking system and fiducials can provide “a dual role of position/alignment sensing and instrument identification” (see paragraph 131), there is also the situation where these can be decoupled, where “In such embodiments, the system may employ one or more additional cameras in order to image the identifying markers, and the system may include an image processing module to process the images to obtain one or more measures associated with the identity of the medical instrument. In such an embodiment, the additional cameras may be spatially registered to the reference frame of the tracking system” (see paragraph 132). It is noted that Piron teaches one or more additional cameras, which thereby teaches “a visualization array”.
Regarding claims 3, 10 and 17, it is noted that both Goldberg and Piron as describes above with regard to claim 1 clearly teach the tracking and determination of a surgical instrument.
Regarding claims 4, 11 and 18, Goldberg teaches that “The unique identifier may be, for example, a unique serial number (see paragraph 68), and also that “Exemplary instrument reader devices can include, but are not limited to, for example, RFID sensors that read a unique RFID tag that is disposed on each surgical instrument; a memory chip (e.g., a SRAM or EEPROM memory chip) reader that can interface with and receive data from a unique memory chip provided on each surgical instrument; a barcode reader; and/or a magnetic medium reader (e.g., magnetic strip reader)” (see paragraph 69 of Goldberg, emphasis added). Additionally, Piron teaches “In step 220, one or more signals associated with the medical instrument are detected. The signals may be, for example, images showing the medical instrument and/or fiducial markers attached to the medical instrument, optical signals emitted from markers attached to the medical instrument (e.g. pulses from an active fiducial marker), and RFID signals emitted from RFID tags attached to the medical instrument. These signals may then be processed to obtain one or more identification measures associated with the identity of the medical instrument, such as an RFID tag value, a code associated with an optical pulse sequence, as shown in step 225” (see paragraph 123 of Piron, also see paragraphs 125-129 for various other means by which identifying information may be gathered, and paragraphs 132-134 with regard to different tracking system options). And with regard to “forwarding…” and “identifying a match…” as recited in claim 4, Piron teaches a process of identifying medical instruments in Figure 4, in which “In step 220, one or more signals associated with the medical instrument are detected” (see paragraph 123). “The identity of the medical instrument is then obtained, as shown in step 230, by comparing the identification measures with pre-selected identification data, where the pre-selected identification data associates the identities of a plurality of medical instruments with various measures. The identification data may be provided in the form of a database, look-up table, or other data structure that may be accessed by control and processing unit 400 to identify the medical instrument” (see paragraph 124).
Regarding claims 5, 12 and 19, it is noted that Goldberg illustrates an exemplary display in Figure 6, in which 608a and 608b show a left instrument identification display and a right instrument identification display, respectively, “which indicate to the user the type of instrument currently responsive to the master input devices” (see paragraph 92). This information must be retrieved before it can be displayed for the user.
Regarding claims 6, 13 and 20, Goldberg teaches auxiliary functions may be modified based on the instrument being used, and states that “The gripping input mechanisms are an example of the latter, master-slave type of control input device, while a foot pedal that is depressed to send a command signal to cause a surgical instrument at the patient side cart to delivery energy, activate a translating cutting blade, and/or fire a stapler, for example, is an example of the latter, auxiliary function input device” (see paragraph 30). It is noted that “activating a translating cutting blade” is a type of movement, as is claimed. In addition to this, Piron teaches an exemplary situation in which a “coarse resection tool is removed from the surgical field and a fine resection tool is brought within the surgical field, the absence of the gross section tool and the presence of the fine resection tool is detected, with the fine resection tool being identified by the system as described above. New customized configuration parameters are obtained, and the optical system 250 is reconfigured as shown in FIG. 5B” (see paragraph 144). Paragraph 144 continues by teaching specific changes that the system undergoes due to the change from the coarse resection tool to the fine resection tool, which teaches a device profile being deactivated for the coarse resection tool and replaced by the fine resection tool. Paragraph 145 then states “Additionally, for example, the system may be further reconfigured by providing configuration parameters for any one or more of… adjustment of speed and/or power of the fine resection tool” (emphasis added).
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Piron as applied to claims 1 and 8 above, and further in view of El-Galley et al. (WO 2008/098085).
Goldberg in combination with Piron was described above with regard to claims 1 and 8. While Goldberg illustrates via 608a, 608b, 708a and 708b in Figures 6 and 7 respectively the name of the devices currently associated with the foot pedals, and also teaches that “Other output units may include a speaker (or other component capable of transmitting sound)” (see paragraph 50), there is no explicit teaching of an audio output to identify information related to the pedals.
El-Galley teaches a universal surgical function control system (see Title). Specifically, El-Galley states that “Using the device select button on the foot pedal, the surgeon may toggle between each of the connected instruments. In various aspects, the operating personnel can be alerted to the device that is selected by a visual screen display and/or by a voice notification” (see paragraph 144 on page 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize voice notifications to alert operating personnel to the instruments currently being used and which pedals are associated with which functions, as taught by El-Galley, and to incorporate this in to the system and methods of Goldberg with Piron because “these rich visual and voice notifications… have significant safety and efficiency implications. … significantly eases the mental burden placed on the surgeon to maintain constant awareness of device selection and left and right foot pedal assignment. In addition to these benefits, the nurses and support staff no longer have to attend to the surgeon's "foot pedal dance". This benefit greatly reduces OR staff fatigue, saves valuable time each time the surgeon changes instruments or requires verification of instrument selection, and allows them to direct their focus toward the patient and not at the surgeon's feet” (see paragraph 145 on page 38 of El-Galley).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792