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 § 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 1-7 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Besser et al. (USPGPub 2019/0328620) in view of Calzi et al. (USPGPub 2022/0031489) and Caluser (USPGPub 2018/0193098) above, and further in view of Cohen (USPGPub 2011/0237933).
Re Claim 1, Besser discloses an enteral tube positioning guidance system (Besser Abstract) comprising: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area (Besser ¶ 0015; Claim 1); wherein said electromagnetic field generator is external to the patient (Besser Figs. 2A-2E, element 202 is external to patient); a wirelessly connected reference sensor (204) of a first type (Besser ¶ 0008-0009, 0059) configured for attaching to a location on top of the subject's upper torso (Besser Figs. 2A-2E; wherein reference sensor 204 is positioned on a subject's torso - ¶ 0083), wherein the reference sensor (204) is configured to sense the electromagnetic field generated by the field generator (Besser ¶ 0059-0061, 0080 - "the computer receives signals from reference sensor 204 [...] and then aligns an anatomical map representative of the subject's torso according to the marked anatomic locations and the signal of the registration sensor"); and a registration sensor (206) of a second type having 3 degrees of freedom (Besser ¶ 0070, 0076, 0078 - wherein system 200 is similar to that of system 100, and "stylus sensor 206 may be manually operated to mark at least three anatomic locations over the patient's skin"), the registration sensor (206) being configured to sense the electromagnetic field and to transmit information indicative of its location (Besser ¶ 0080 - "the computer receives signals from [...] registration sensor 206 and then aligns an anatomical map representative of the subject's torso according to the marked anatomic locations and the signal of the registration sensor'), wherein the registration sensor is utilized to mark a location of a xiphoid process and to mark a location of a point on side of the subject's torso (Besser ¶ 0036; Claim 2).
Besser further discloses a processing circuitry configured to: calculate a width of the subject's torso based on the locations of the xiphoid process and the point on the side of the subject's torso marked by the registration sensor (Besser ¶ 0079-0080, 0089; Claim 1); determine a plane defined by signals obtained from the reference sensor, and by the location of the xiphoid process marked by the registration sensor (Besser ¶ 0091-0099); calculate a vector N normal to the plane (Besser ¶ 0091-0099); and display a diagram of the subject's upper body indicating the location of the subject's xiphoid process and suprasternal notch, wherein the diagram takes into consideration the calculated width of the subject's torso and the location of one or both of the reference sensors (Besser ¶ 0015, 0019-0026, 0062; Claim 8), and determine in real-time, by changes in the strength of the electromagnetic field sensed by the electromagnetic sensor, a location, direction and/or insertion path of a tip of the enteral tube relative to one or both of the reference sensors, and project the location, direction and/or insertion path over the diagram, using vector N to determine the projection direction (Besser ¶ 0021, 0033-0036, 0067).
However, Besser fails to disclose at least two reference sensors wherein the at least two reference sensors are configured for attaching to two locations on top of the subject's torso. Calzi discloses an intragastric device positioning guidance system (Besser Abstract) comprising at least two wirelessly connected reference sensors (1015) configured for attaching to two locations on top of the subject's torso (Calzi ¶ 0156-0166 - wherein paragraph 0157 describes the sensors being wireless and paragraph 0166 describes several sensors being used) wherein multiple reference sensors provide enhanced accuracy of location, redundancy in the event of failure of one of the reference sensors, or simpler calibration (Calzi ¶ 0166). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the reference sensor of Besser to be at least two reference sensors configured for attaching to two locations on top of the subject's torso as disclosed by Calzi to provide enhanced accuracy of location, redundancy in the event of failure of one of the reference sensors, or simpler calibration (Calzi ¶ 0166).
Besser fails to disclose wherein determining the plane is independent of information regarding the angle of the registration sensor. Caluser teaches a positioning system comprising an electromagnetic field generator (42) configured to generate an electromagnetic field covering a treatment area (Caluser ¶ 0045), a reference sensor (46), a registration sensor (48), and a processing circuitry (36) configured to determine a plane defined by signals obtained from the reference sensor (46), and by the location of the xiphoid process marked by the registration sensor (48) (Caluser ¶ 0044), wherein determining the plane is independent of information regarding an angle of the registration sensor (48) (Caluser ¶ 0044-0045, 0047), the configuration for the instant recording of target coordinates seen in an image in relation to anatomical features (Caluser ¶ 0006). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processing circuitry of Besser such that determining the plane is independent of information regarding the angle of the registration sensor as disclosed by Caluser, wherein the processing circuitry of Caluser allows for the instant recording of target coordinates seen in an image in relation to anatomical features (Caluser ¶ 0006).
In addition, Besser in view of Calzi and Caluser fail to disclose taking into consideration relative movement between the at least two reference sensors. Cohen discloses a system (10) comprising a medical positioning system (20) (Cohen Fig. 1) configured to acquire positioning data of reference sensors (24-1, 24-2, 24-3, 24-4) wherein the system takes into consideration relative movement between the reference sensors so as to allow motion compensation for gross patient body movements and/or respiration-induced movements (Cohen ¶ 0026-0029). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the positioning guidance system comprising a reference sensor of Besser in view of Calzi to take into consideration relative movement between the at least two reference sensors, the consideration of relative movement between sensors as disclosed by Cohen so as to allow motion compensation for gross patient body movements and/or respiration-induced movements (Cohen ¶ 0026-0029).
Re Claim 2, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 1. Besser discloses wherein the registration sensor is further utilized to mark the suprasternal notch (Besser ¶ 0007, 0016-0018; Claim 2).
Re Claim 3, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 1. Besser discloses wherein the diagram shows a frontal upper view of the subject's torso, a side view of the subject's torso and/or an axial view of the subject's torso and the location, direction and/or insertion path of the tip of the enteral tube in each view, as calculated by tracking the location of the tip sensor (Besser ¶ 0011, 0030; Claim 4).
Re Claim 4, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 1. Besser discloses a monitor configured to display the diagram (Besser ¶ 0010, 0067; Claim 5).
Re Claim 5, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 1. Besser discloses wherein the registration sensor is incorporated into a tip of a stylus configured to be manually operated (Besser ¶ 0043, 0070).
Re Claim 6, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 1. Besser discloses wherein the processing circuitry is further configured to calculate the position of the suprasternal notch based on the signals obtained from the at least two reference sensors (Besser Abstract; ¶ 0007, 0016, 0019-0021, 0026, 0033; Claim 9).
Re Claim 7, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 1. Besser discloses wherein the location on the subject's upper torso is at or near the subject's claviculae (Besser ¶ 0014, 0019; Claim 7).
Re Claim 14, Besser discloses a processing circuitry (Besser ¶ 0007, 0019-0021) configured to: receive signals from a wired or wirelessly connected reference sensor (204) of a first type attached to a location on top of the subject's upper torso (Besser Figs. 2A-2E; ¶ 0008, 0009, 0059; Figs. 2A-2E; wherein reference sensor 204 is positioned on a subject's torso - ¶ 0083) and exposed to an electromagnetic field (Besser ¶ 0015; Claim 1); receive information indicative of a location of a xiphoid process and of a location of a point on a side of the subject's torso, each marked by a registration sensor (206) of a second type having 3 degrees of freedom (Besser ¶ 0070, 0076, 0078 - wherein system 200 is similar to that of system 100, and "stylus sensor 206 may be manually operated to mark at least three anatomic locations over the patient's skin"), the registration sensor being configured to sense an electromagnetic field generated by a field generator (Besser ¶ 0036, 0080; Claim 2); calculate a width of the subject's torso based on the location of the xiphoid process and the point on the side of the subject's torso marked by the registration sensor (206) (Besser ¶ 0079-0080, 0089; Claim 1).
Besser further teaches produce a diagram of the subject's upper body indicating the
location of the subject's xiphoid process and suprasternal notch (Besser ¶ 0015, 0019-0026,
0062; Claim 8); determine a plane defined by signals received from the reference sensor, and
by the location of the xiphoid process marked by the registration sensor (Besser ¶ 0091-0099);
calculate a vector N normal to the plane (Besser ¶ 0091-0099); receive signals from an enteral
tube comprising an electromagnetic tip sensor (Besser ¶ 0015, 0019-0026, 0062; Claim 8),
determine in real-time, by changes in the strength of the electromagnetic field sensed by the
electromagnetic sensor, a location, direction and/or insertion path of a tip of the enteral tube
relative to the reference sensor, and project the location, direction and/or insertion path over
the diagram, using vector N to determine the projection direction (Besser ¶ 0021, 0033-0036,
0067).
However, Besser fails to disclose at least two reference sensors configured for attaching to two locations on top of the subject's torso. Calzi discloses an intragastric device positioning guidance system (Besser Abstract) comprising at least two wirelessly connected reference sensors (1015) configured for attaching to two locations on top of the subject's torso (Calzi ¶ 0156-0166 - wherein paragraph 0157 describes the sensors being wireless and paragraph 0166 describes several sensors being used) wherein multiple reference sensors provide enhanced accuracy of location, redundancy in the event of failure of one of the reference sensors, or simpler calibration (Calzi ¶ 0166). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the reference sensor of Besser to be at least two reference sensors configured for attaching to two locations on top of the subject's torso as disclosed by Calzi to provide enhanced accuracy of location, redundancy in the event of failure of one of the reference sensors, or simpler calibration (Calzi ¶ 0166).
Besser fails to disclose wherein determining the plane is independent of information regarding the angle of the registration sensor. Caluser teaches a positioning system comprising an electromagnetic field generator (42) configured to generate an electromagnetic field covering a treatment area (Caluser ¶ 0045), a reference sensor (46), a registration sensor (48), and a processing circuitry (36) configured to determine a plane defined by signals obtained from the reference sensor (46), and by the location of the xiphoid process marked by the registration sensor (48) (Caluser ¶ 0044), wherein determining the plane is independent of information regarding an angle of the registration sensor (48) (Caluser ¶ 0044-0045, 0047), the configuration for the instant recording of target coordinates seen in an image in relation to anatomical features (Caluser ¶ 0006). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processing circuitry of Besser such that determining the plane is independent of information regarding the angle of the registration sensor as disclosed by Caluser, wherein the processing circuitry of Caluser allows for the instant recording of target coordinates seen in an image in relation to anatomical features (Caluser ¶ 0006).
In addition, Besser in view of Calzi and Caluser fail to disclose taking into consideration relative movement between the at least two reference sensors. Cohen discloses a system (10) comprising a medical positioning system (20) (Cohen Fig. 1) configured to acquire positioning data of reference sensors (24-1, 24-2, 24-3, 24-4) wherein the system takes into consideration relative movement between the reference sensors so as to allow motion compensation for gross patient body movements and/or respiration-induced movements (Cohen ¶ 0026-0029). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the processing circuitry for receiving signals from two reference sensors of a first type of Besser in view of Calzi to take into consideration relative movement between the at least two reference sensors, the consideration of relative movement between sensors as disclosed by Cohen so as to allow motion compensation for gross patient body movements and/or respiration-induced movements (Cohen ¶ 0026-0029).
Re Claim 15, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 14. Besser discloses wherein the processing circuitry is further configured to receive an indication of a location of the suprasternal notch marked by the registration sensor (Besser ¶ 0007, 0016-0018; Claim 2).
Re Claim 16, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 14. Besser discloses wherein the diagram shows a frontal upper view of the subject's torso, a side view of the subject's torso and/or an axial view of the subject's torso (Besser ¶ 0011, 0030; Claim 4).
Re Claim 17, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 14. Besser discloses calculating the position of the suprasternal notch, based on the signals obtained from the at least two reference sensors (Besser Abstract; ¶ 0007, 0016, 0019-0021, 0026, 0033; Claim 9).
Re Claim 18, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 14. Besser discloses wherein the location on the subject's upper torso is at or near the subject's claviculae (Besser ¶ 0014, 0019; Claim 7).
Re Claim 19, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 1. Claim 1 of the present case recites the limitation "two wired or wirelessly connected reference sensors of a first type configured for attaching to two locations on top of the subject's torso" in Lines 4-6. The term "configured for attaching to two locations on top of the subject's torso" is a functional limitation well within the ordinary skill of the art. Therefore, examiner is concluding that the two locations being on opposite sides of a line connecting the xiphoid process and the suprasternal notch of the subject is an inherent characteristic of the prior art Besser in view of Calzi above and further in view of Cohen. The two wired or wirelessly connected reference sensors of a first type of Besser in view of Calzi above and further in view of Cohen possesses the functionally defined limitations of Claim 19, namely placement "on opposite sides of a line connecting the xiphoid process and the suprasternal notch of the subject." See MPEP 2114(I).
Re Claim 20, Besser in view of Calzi and Caluser above and further in view of Cohen teach all of the limitations of Claim 14. Claim 14 of the present case recites the limitation "two wired or wirelessly connected reference sensors of a first type attached to two locations on top of the subject's torso" in Lines 4-6. The term "attached to two locations on top of the subject's torso" is a functional limitation well within the ordinary skill of the art. Therefore, examiner is concluding that the two locations being on opposite sides of a line connecting the xiphoid process and the suprasternal notch of the subject is an inherent characteristic of the prior art Besser in view of Calzi above and further in view of Cohen. The two wired or wirelessly connected reference sensors of a first type of Besser in view of Calzi above and further in view of Cohen possesses the functionally defined limitations of Claim 20, namely placement "on opposite sides of a line connecting the xiphoid process and the suprasternal notch of the subject." See MPEP 2114(I).
Response to Arguments
Applicant’s arguments with respect to Claims 1-7 and 14-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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