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 .
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.
Claim 1-2, 4 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Livneh et al. (WO 2011039752 A2 – previously cited), hereinafter “Livneh”.
Regarding claim 1, Livneh teaches a surgical system (Figure 1), comprising: an instrumentation system (Figure 1, receiver 119 and display 122) configured to be disposed external to a body of a patient (Figure 1, mammalian body 100); sensors configured to be placed within the body of the patient (Figure 1, cameras 106, the examiner notes that paragraph 0025 of the specification of the present applicant teaches the sensors may be cameras), each sensor including a first communication device including a first antenna (Figure 1, data transmission 109 indicate some form of a communicating antenna in order to allow for the data to be transmitted to antenna 115); and a surgical instrument (Figure 1, transdermal antenna 110) including a second communication device (Figure 1, second communication device 115+116) including a second antenna disposed at a proximal portion of the surgical instrument (Figure 1, outer antenna 116), wherein the proximal portion of the surgical instrument (Figure 1, outer antenna 116) is configured to be disposed external to the body of the patient in use, the second communication device configured to communicate with the sensors via the first and second antennas (Figure 1, by way of inner antenna 115 and outer antenna 116, Paragraph 0039 “data transmissions received by the inner antenna 115 may be conducted to the outer antenna 116”), the second communication device further configured to communicate messages to or from the instrumentation system when the surgical instrument is placed in the body of the patient, the messages including sensor data from the sensors (Paragraph 0037 lines 2-4; Paragraph 0040).
Regarding claim 2, Livneh teaches wherein the second antenna (Figure 1, outer antenna 116) is configured to act as a master antenna (Paragraphs 0004 lines 1-3 and 0066 lines 7-13).
Regarding claim 4, Livneh teaches wherein the surgical instrument (Figure 1, transdermal antenna 110) is a laparoscope (Paragraphs 0030, 0036 lines 1-3 and 0037 lines 8-11).
Regarding claim 11, Livneh teaches a surgical communication method (Figure 21), comprising: receiving, through a first antenna (Figure 1, outer antenna 116) disposed at a proximal portion of a surgical instrument (Figure 1, transdermal antenna 110), the surgical instrument having a distal portion configured to be disposed within a body of a patient (Figure 1, mammalian body 100) and the proximal portion configured to be disposed external to the body of the patient in use, EM sensor signals from second antennas of sensors placed within the body of the patient (Figure 1, cameras 106, data transmission 109 indicate some form of a communicating antenna in order to allow for the data to be transmitted to antenna 115); and transmitting, from the first antenna of the surgical instrument, an EM signal to an instrumentation system (Figure 1, receiver 119 and display 122) disposed external to the body of the patient (Paragraph 0037 lines 2-4) in use.
Claim Rejections - 35 USC § 103
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 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, 6-10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh as applied to claims 1 and 11 above, and further in view of Weisner et al. (US 20150099458 A1 – previously cited), hereinafter “Weisner”.
Regarding claim 3, Livneh fails to teach wherein the sensors are configured to communicate with each other via the first antennas of the sensors.
Weisner teaches a surgical system (Figure 8, Paragraph 0197) comprising sensors (Figure 8, medical devices 200a-200h, Paragraph 0197) and a surgical instrument (Figure 8, relay modules 30a), wherein the sensors are configured to communicate with each other antennas of the sensors (Paragraph 0200, Figure 8, signal paths 204 indicate some form of a communicating antenna in order to allow for communication between medical devices 200a-200h). Weisner also teaches that doing so would allow for constant data transmission at any point in time (Paragraph 0218).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Livneh to configure the sensors to communicate with each other via the first antennas of the sensors as taught by Weisner in order to allow for constant data transmission at any point in time (Weisner, Paragraph 0218).
Regarding claim 6, Livneh teaches a second surgical instrument (Figure 15A, transdermal antenna 110c) including a third communication device which includes a third antenna (Figure 15A, data transmissions 109 indicate some form of a communicating antenna in order to allow for the data to be transmitted to antenna 115). However, Livneh fails to teach wherein the third communication device includes a second microcontroller which is configured to communicate with the second communication device and the sensors via the first, second, and third antennas.
Weisner teaches a surgical system (Figure 8, Paragraph 0197) comprising sensors (Figure 8, medical devices 200a-200h, Paragraph 0197) including a first antenna (Figure 8, signal paths 202-212 indicate some form of a communicating antenna in order to allow for communication between medical devices 200a-200h and other devices of the network 16a), a surgical instrument surgical instrument (Figure 8, relay modules 30a) including a communication device including an second antenna (Figure 3A, antenna 31a), and a second surgical instrument (Figure 8, relay modules 30a), wherein the second surgical instrument includes a microcontroller (Figures 3A-3D, controller 34) configured to communicate with the communication device and the sensors via the antennas (Figure 8, signal paths 202-212). Weisner also teaches that doing so would allow for constant data transmission at any point in time (Paragraph 0218).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Livneh to provide the third communication device with a second microcontroller which is configured to communicate with the second communication device and the sensors via the first, second, and third antennas as taught by Weisner in order to allow for constant data transmission at any point in time (Weisner, Paragraph 0218).
Regarding claims 7-10 and 12-15, Livneh fails to teach wherein the surgical instrument includes a microcontroller configured to: build a mesh network including the surgical instrument and the sensors; detect a failure event associated with the surgical instrument or one of the sensors; wherein the failure event includes movement external to the body of the patient in use and failures of a battery of at least one of the sensors; and in response to detecting the failure event associated with the surgical instrument or one of the sensors, removing the surgical instrument or one of the sensors from the mesh network and generating a message indicating that not all sensors are at a location external to the body of the patient.
Weisner teaches a surgical system (Figure 8, Paragraph 0197) comprising sensors (Figure 8, medical devices 200a-200h, Paragraph 0197) and a surgical instrument (Figure 8, relay modules 30a); wherein the surgical instrument includes a microcontroller (Figures 3A-3D, controller 34) configured to: build a mesh network including the surgical instrument and the sensors (Figure 8, mesh network 16, Paragraph 0096); detect a failure event associated with the surgical instrument or one of the sensors; wherein the failure event includes movement external to a designated area (Paragraphs 0109-0110) and failures of a battery of at least one of the sensors (Paragraphs 0236-0237); and in response to detecting the failure event associated with the surgical instrument or one of the sensors, removing the surgical instrument or one of the sensors from the mesh network (Paragraphs 0204 and 0211) and generating a message indicating that not all sensors are at a location external to the body of the patient (Paragraph 0110). Weisner also teaches that doing so would provide the advantage of a self-healing system (Paragraph 0211).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system and method of Livneh such that the surgical instrument includes a microcontroller configured to: build a mesh network including the surgical instrument and the sensors; detect a failure event associated with the surgical instrument or one of the sensors; wherein the failure event includes movement external to the body of the patient and failures of a battery of at least one of the sensors; and in response to detecting the failure event associated with the surgical instrument or one of the sensors, removing the surgical instrument or one of the sensors from the mesh network and generating a message indicating that not all sensors are at a location external to the body of the patient as taught by Weisner in order to provide the advantage of a self-healing system (Weisner, Paragraph 0211).
Claims 5 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh as applied to claim 1 above, and further in view of DiSilvestro et al. (US 20180192256 A1 – previously cited), hereinafter “DiSilvestro”.
Regarding claim 5, Livneh fails to teach wherein the second communication device includes a microcontroller that is adapted to configure the sensors to only communicate with the second communication device.
DiSilvestro teaches a surgical system (Figure 1, Paragraph 0002) comprising sensors configured to be placed within a body of a patient (Figure 1, medical instruments and implants 201-20N and 301-30N); and a surgical instrument including a microcontroller (Figure 1, communications controller 12) that configures the sensors to only communicate with the surgical instrument (Paragraph 0017 lines 11-23). DiSilvestro also teaches that doing so would help ensure that the sensors are being used properly and the procedure is being correctly carried out (Paragraph 0019 lines 1-9).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Livneh such that the second communication device includes a microcontroller that is adapted to configure the sensors to only communicate with the second communication device as taught by DiSilvestro in order to ensure that the sensors are being used properly and the procedure is being correctly carried out (DiSilvestro, Paragraph 0019 lines 1-9).
Regarding claims 16-17, Livneh fails to teach periodically receiving, at the first antenna of the surgical instrument, a low power signal including secure keys that cannot be detected outside the body of the patient to initiate secure communication between the surgical instrument and the sensors, identification and status information from the second antennas of the sensors.
DiSilvestro teaches a surgical communications method (Claims 4-13) comprising periodically receiving at a first antenna (Figure 3, antenna 70), a low-power signal including secure keys which cannot be connected outside of the body of a patient (Paragraph 0017 line 27-35 “device identification code”), identification and status information (Paragraph 0018 “medical instrument model…as well as any functional information relating to the operability, operating state and/or operation condition”) from the second antenna (Figure 3, antenna 70) of sensors (Figure 1, medical instruments and implants 201-20N and 301-30N). Doing so would allow for monitoring how well the sensors are working during a medical procedure.
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Livneh to periodically receive, at the first antenna of the surgical instrument, a low power signal including secure keys that cannot be detected outside the body of the patient to initiate secure communication between the surgical instrument and the sensors, and identification and status information from the second antennas of the sensors as taught by DiSilvestro in order to allow for monitoring how well the sensors are working during a medical procedure.
Regarding claim 18, Livneh teaches a surgical communication method (Figure 21), comprising: receiving, through a first antenna (Figure 1, outer antenna 116) disposed at a proximal portion of a surgical instrument (Figure 1, transdermal antenna 110), the surgical instrument having a distal portion configured to be disposed within a body of a patient (Figure 1, mammalian body 100) and the proximal portion configured to be disposed external to the body of the patient in use, low-power EM sensor signals (Figure 1, data transmission 109); and transmitting, from the first antenna of the surgical instrument, an EM signal to an instrumentation system (Figure 1, receiver 119 and display 122) disposed external to the body of the patient (Paragraph 0037 lines 2-4) in use, the EM signal including EM sensor signals received by the first antenna from second antennas of the sensors (Figure 1, data transmission 109 indicate some form of a communicating antenna in order to allow for the data to be transmitted to antenna 115). However, Livneh fails to teach wherein the EM signals include secure keys that cannot be detected outside of the body of the patient to initiate secure communication between the surgical instrument and sensors placed within the body of the patient.
DiSilvestro teaches a surgical communications method (Claims 4-13) comprising receiving, at a first antenna (Figure 3, antenna 70) of a surgical instrument (Figure 1, communications controller 12), a low-power EM signal including secure keys which cannot be connected outside of the body of a patient to initiate secure communication between the surgical instrument and sensors (Figure 1, medical instruments and implants 201-20N and 301-30N) placed within the body of the patient (Paragraph 0017 line 27-35 “device identification code”). DiSilvestro also teaches that doing so would allow monitoring of the presence of the sensors (Paragraph 0017 lines 27-35).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Livneh such that the EM signals include secure keys that cannot be detected outside of the body of the patient to initiate secure communication between the surgical instrument and sensors placed within the body of the patient as taught by DiSilvestro in order to allow for monitoring of the presence of the sensors (DiSilvestro, Paragraph 0017 lines 27-35).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh in view of DiSilvestro as applied to claim 18 above, and further in view of Weisner.
Regarding claim 19, Livneh, as modified by DiSilvestro hereinabove, teaches identifying sensors within the body of the patient (DiSilvestro, Paragraph 0017 line 27-35 “device identification code”), but fails to teach detecting movement of the surgical instrument to a location external to the body of the patient in use; in response to detecting movement of the surgical instrument to a location external to the body of the patient in use, determining that not all sensors are at a location external to the body of the patient; and in response to determining that not all sensors are at a location external to the body of the patient in use, generating a message indicating that not all sensors are at a location external to the body of the patient.
Weisner teaches a surgical communications method (Abstract) comprising: detecting movement of a surgical instrument (Figure 8, relay modules 30a) external to a designated area (Paragraphs 0109-0110); and in response to detecting movement from the surgical instrument to a location external to the body of the patient, determining and generating a message indicating that not all sensors are at a location external to the body of the patient (Paragraph 0110). Doing so would help ensure correct positioning of the sensors and that the surgical procedure is carried out properly.
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Livneh as modified by DiSilvestro to include detecting movement of the surgical instrument to a location external to the body of the patient; in response to detecting movement of the surgical instrument to a location external to the body of the patient, determining that not all sensors are at a location external to the body of the patient; and in response to determining that not all sensors are at a location external to the body of the patient, generating a message indicating that not all sensors are at a location external to the body of the patient as taught by Weisner in order to ensure correct positioning of the sensors and that the surgical procedure is carried out properly.
Regarding claim 20, Livneh, as modified by DiSilvestro hereinabove, fails to teach building a mesh network of the surgical instruments and the sensors.
Weisner teaches a surgical communications method (Abstract) comprising: building a mesh network (Figure 8, mesh network 16, Paragraph 0096) including the surgical instrument (Figure 8, relay modules 30a) and the sensors (Figure 8, medical devices 200a-200h, Paragraph 0197). Weisner also teaches that doing so would provide the advantage of a self-healing system (Paragraph 0211).
It would have been prima facia obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Livneh as modified by DiSilvestro to include building a mesh network of the surgical instruments and the sensors as taught by Weisner in order to provide the advantage of a self-healing system (Weisner, Paragraph 0211).
Response to Arguments
Applicant's arguments filed 04 August 2025 have been fully considered and they are not persuasive. Applicant argues that the outer antenna 116 of Livneh is not a “communication device configured to communicate with the camera devices 106 inside the body cavity 108”. The claims as written do not require that the proximal, external antenna directly communicate with the sensors. The claims require that the “second communication device” as a whole communicates with the sensors.
The “second communication device” taught by Livneh includes elements 110, 115, 116, and the “coaxial cable, a waveguide or a combination of coaxial cables and waveguides” connecting the inner antenna 115 and outer antenna 116 (as per paragraph [0039]). The second communication device of 110+115+116 communicates with the sensors via the first and second antennas (the data obtained by the sensors implanted in the body of the patient are communicated to antenna 116 via antenna 115 and the coaxial cables and/or waveguide) and includes a second antenna (antenna 116) disposed at a proximal portion of the surgical instrument that is external to the body of the patient when in use.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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