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 § 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.
Claims 2 and 30-35 are 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.
In claim 2, it is unclear how “a target location” is related to that on line 2 of claim 1. They are treated as the same.
In claims 30-35, it is unclear how each instance of “a predetermined level” is related to that of claim 29. They are treated as the same.
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.
Claim(s) 1, 4, 8, 11, 12, 16-19, 21, 22, 37 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mantell et al (US 5,292,304).
Regarding claim 1, Mantell discloses a system for creating separation between biological surfaces (insufflator), the system comprising: a hollow body configured for delivery of a fluid to a target location (input trocar – Col.3 ll 31-33); a fluid supply 10/12 in fluid-communication with the hollow body (fig 1); a control element configured to control delivery of fluid through the hollow body (such as any of the various valves, including 42/54/62/70); at least one first sensor configured to measure at least one parameter of the fluid flowing through the hollow body (flow sensor 108); at least one second sensor configured to measure at least one parameter of an environment of the hollow body (pressure sensors 82 and 112); and a feedback control module (part of sensor which energizes valves, including choosing which ones to actuate – Col.2 ll 37 to Col.3 ll 25 and Col.3 ll 37-47; especially Col.2 ll 58-62) configured to receive information from one or more of the at least one first sensor or the at least one of the second sensor to control at least one operational function of the system (flow rate and pressure as per Col.2 ll 37 to Col.3 ll 25).
Regarding claim 4, wherein the hollow body further comprises an electrical connection to the feedback control module (Col.2 ll 50-51).
Regarding claim 8, wherein the delivered fluid comprises carbon dioxide (Col.1 ll 61).
Regarding claim 11, wherein at least one first or second sensor comprises a flow meter 108.
Regarding claim 12, wherein at least one first or second sensor comprises a pressure sensor 82/108.
Regarding claim 16, wherein the information received by the feedback control module comprises one or more of a position, an impedance, a temperature, a flow rate, a flow volume, or a pressure (pressure and flow rate as choosing which valve of 42/56/64/72/80 includes choosing the different flow rates of said valves).
Regarding claim 17, wherein the control element is configured to actuate a flow of the fluid through the hollow body in response to an effect of the feedback control module (Col.2 ll 37 to Col.3 ll 25 and Col.3 ll 37-47).
Regarding claim 18, wherein the control element is configured to dynamically modulate a flow of the fluid through the hollow body in response to an effect of the feedback control module (Col.2 ll 37 to Col.3 ll 25 and Col.3 ll 37-47).
Regarding claim 19, wherein the control element is configured to actuate a flow of the fluid through the hollow body in response to a user interaction with the system (Col.2 ll 37 to Col.3 ll 25 and Col.3 ll 37-47).
Regarding claim 21, wherein the control element comprises at least one actuatable valve 42 configured to control the delivery of fluid through the hollow body.
Regarding claim 22, wherein the control element comprises an adjustable pressure gauge 82 configured to control the delivery of fluid through the hollow body (Col.2 ll 37 to Col.3 ll 25 and Col.3 ll 37-47).
Regarding claim 37, wherein the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of a visual indication to a display (Col.3 ll 30).
Regarding claim 38, wherein the visual indication comprises one or more of a temperature adjacent the hollow body, a pressure adjacent the hollow body, a pressure adjacent the fluid supply, a volumetric flow rate, a fluid volume, a measure of time, a measure of distance, a measure of position, an image, or an indication of an operational state of the system for creating separation between biological surfaces (a pressure adjacent the hollow body – fig 1).
Claim(s) 1, 4, 8, 12, 16-27, 29, 32, 36-38 and 41-43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’dea (US 2018/0280634).
Regarding claim 1, O’dea discloses a system for creating separation between biological surfaces (insufflator), the system comprising: a hollow body 7 configured for delivery of a fluid to a target location (fig 1); a fluid supply 10/12 in fluid-communication with the hollow body (fig 1, via line 14); a control element 13/16 configured to control delivery of fluid through the hollow body (as the valves open/close); at least one first sensor 15 configured to measure at least one parameter of the fluid flowing through the hollow body (pressure, ¶103); at least one second sensor 23 configured to measure at least one parameter of an environment of the hollow body (pressure, ¶105); and a feedback control module 18 configured to receive information from one or more of the at least one first sensor or the at least one of the second sensor to control at least one operational function of the system (¶104).
Regarding claim 4, wherein the hollow body further comprises an electrical connection 19 to the feedback control module (fig 1).
Regarding claim 8, wherein the delivered fluid comprises carbon dioxide (¶52).
Regarding claim 12, wherein at least one first or second sensor comprises a pressure sensor (¶103, ¶105).
Regarding claim 16, wherein the information received by the feedback control module comprises one or more of a position, an impedance, a temperature, a flow rate, a flow volume, or a pressure (¶104).
Regarding claim 17, wherein the control element is configured to actuate a flow of the fluid through the hollow body in response to an effect of the feedback control module (¶104 – flow control valve 16 responsive to pressure sensor 15).
Regarding claim 18, wherein the control element is configured to dynamically modulate a flow of the fluid through the hollow body in response to an effect of the feedback control module (¶104).
Regarding claim 19, wherein the control element is configured to actuate a flow of the fluid through the hollow body in response to a user interaction with the system (¶104, first predefined pressure is set by user interaction and system is responsive to first pressure).
Regarding claim 20, wherein the control element is configured to dynamically modulate a flow of the fluid through the hollow body in response to a user interaction with the system (¶104, user interaction is setting the predefined pressure)
Regarding claim 21, wherein the control element comprises at least one actuatable valve 16 configured to control the delivery of fluid through the hollow body (¶104).
Regarding claim 22, wherein the control element comprises an adjustable pressure gauge configured to control the delivery of fluid through the hollow body (¶104, pressure threshold is adjustable).
Regarding claim 23, wherein the control element comprises at least one depressible button configured to control the delivery of fluid through the hollow body (keypad interface - ¶104).
Regarding claim 24, wherein the control element comprises at least one electronic switch configured to control the delivery of fluid through the hollow body in response to a user interaction with the system (keypad interface/touchscreen 20 - ¶104).
Regarding claim 25, wherein the control element comprises at least one electronic switch configured to control the delivery of fluid through the hollow body in response to a wireless signal received by the system (keypad interface/touchscreen 20 - ¶104).
Regarding claims 26 and 27, wherein the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of an alarm and the alarm comprises one or more of an audible alarm, a visual alarm, or a haptic alarm (an audible alarm in response to the pressure sensor - ¶112).
Regarding claims 29 and 32, the alarm is activated when the information received from the one or more sensors approach or reach a predetermined level; the alarm is activated when pressure measurements approach or reach a predetermined level (¶112).
Regarding claim 36, wherein the alarm is activated based on an operational state of the system for creating separation between biological surfaces (¶112 – system generating too much pressure).
Regarding claim 37, wherein the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of a visual indication to a display (when in alarm state, flash - ¶175).
Regarding claim 38, wherein the visual indication comprises one or more of a temperature adjacent the hollow body, a pressure adjacent the hollow body, a pressure adjacent the fluid supply, a volumetric flow rate, a fluid volume, a measure of time, a measure of distance, a measure of position, an image, or an indication of an operational state of the system for creating separation between biological surfaces (a pressure adjacent the hollow body ¶104).
Regarding claims 41 and 42, the feedback control module is configured to cause wireless transmission, based at least on the information received from the one or more sensors, of parameter measurements to an external receiver, the parameter measurements wirelessly transmitted to an external receiver comprise one or more of a temperature adjacent the hollow body, a pressure adjacent the hollow body, a pressure adjacent the fluid supply, a volumetric flow rate, a fluid volume, a measure of time, a measure of distance, a measure of position, an image, or an indication of an operational state of the system for creating separation between biological surfaces (wireless - ¶27, pressure - ¶106/¶111).
Regarding claim 43, wherein the fluid supply in fluid-communication with the hollow body comprises a canister of pressurized gas (compressed air vessel 12 - ¶102).
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) 2 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantell et al (US 5,292,304) in view of Ravikumar et al (US 2011/0160538).
Regarding claim 2, while Mantell substantially discloses the invention as claimed, it does not disclose wherein the hollow body comprises a needle configured to access a target location.
Mantell discloses use of a “trochar” but it is unclear if such can be considered a needle.
Ravikumar discloses a needle which may be used for insufflation (¶118, ¶119, fig 41, fig 42).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that the hollow body comprise a needle configured to access a target location as taught by Ravikumar to allow the hollow body to puncture the skin of the patient.
Regarding claims 5-7, wherein the hollow body further comprises an anchoring mechanism.
While Mantell substantially discloses the invention as claimed, it does not disclose the hollow body further comprises an anchoring mechanism disposed adjacent an end of the hollow body and configured to releasably secure the hollow body to a biological surface.
Ravikumar discloses a hollow body which comprises an anchoring mechanism 1140/1240a/1240b disposed adjacent an end of the hollow body (figs 41 and 42) and configured to releasably secure the hollow body to a biological surface (inflation and deflation - ¶118 and ¶119).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that the hollow body further comprises an anchoring mechanism disposed adjacent an end of the hollow body and configured to releasably secure the hollow body to a biological surface as taught by Ravikumar to allow the hollow body to be better secured in place in use then later removed easily.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantell et al (US 5,292,304) in view of Hameed et al (US 2007/0244424).
Regarding claim 3, while Mantell substantially discloses the invention as claimed, it does not disclose the hollow body further comprises an electrical connection to the fluid supply.
Hameed discloses an insufflation device where the fluid supply pressure is monitored 31 (fig 2) and both the flow controller 24 and pressure controller 25 are electrically connected to the control unit (fig 2).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that the hollow body further comprises an electrical connection to the fluid supply as taught by Hameed to allow the input pressure to be monitored and adjusted as necessary.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantell et al (US 5,292,304) in view of Smyth et al (US 2014/0141094)
Regarding claim 9, while Mantell substantially discloses the invention as claimed, it does not disclose wherein the delivered fluid comprises a hydrogel material.
Smyth discloses insufflating hydrogel material (¶42) in order to treat lower respiratory tract infections (¶7).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that the delivered fluid comprises a hydrogel material as taught by Smyth to assist in treating lower respiratory tract infections.
Claim(s) 10, 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantell et al (US 5,292,304) in view of Nir et al (US 2018/0271603).
Regarding claim 10, while Mantell substantially discloses the invention as claimed, it does not disclose wherein at least one first or second sensor comprises a three-dimensional position sensor.
Nir discloses a device which is used for laparoscopic surgery (¶197) including insufflation (¶198). Included among the tools are a sensor and processing means to calculated a 3D position of the surgical tool (¶207).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that at least one first or second sensor comprises a three-dimensional position sensor as taught by Nir to ensure the appropriate tissue is targeted.
Regarding claims 37 and 38, while Mantell substantially discloses the invention as claimed, it does not disclose wherein the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of a visual indication to a display, nor wherein the visual indication comprises one or more of a temperature adjacent the hollow body, a pressure adjacent the hollow body, a pressure adjacent the fluid supply, a volumetric flow rate, a fluid volume, a measure of time, a measure of distance, a measure of position, an image, or an indication of an operational state of the system for creating separation between biological surfaces.
Nir discloses a device which is used for laparoscopic surgery (¶197) including insufflation (¶198). Included among the tools are a sensor and processing means to calculated a 3D position of the surgical tool (¶207).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of a visual indication to a display, the visual indication comprising a measure of position and/or an image as taught by Nir to ensure the appropriate tissue is targeted.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantell et al (US 5,292,304) in view of Franke et al (US 2015/0265334).
Regarding claims 13 and 14, while Mantell substantially discloses the invention as claimed, it does not disclose wherein at least one first or second sensor comprises an impedance sensor nor a temperature sensor.
Franke discloses a device for assessing and treating tissue which has an expandable member 315 that can be expanded by insufflation (¶53). The expandable member comprises sensors which can be impedance and/or temperature sensors which can be used to detect a presence/amount of therapy delivered (¶59).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that wherein at least one first or second sensor comprises an impedance sensor and/or a temperature sensor as taught by Franke to allow the device to assess tissue with which it comes into contact.
Regarding claim 15, while Mantell substantially discloses the invention as claimed, it does not disclose wherein the hollow body further comprises at least one radiopaque marker.
Franke discloses using radiopaque material so the device may be visualized under fluoroscopic guidance (¶39).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Mantell such that the hollow body further comprises at least one radiopaque marker as taught by Franke so that it may be visualized under fluoroscopic guidance.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’dea (US 2018/0280634) in view of Wright et al (US 2021/0259789).
Regarding claim 28, while O’dea substantially discloses the invention as claimed, it does not disclose wherein the alarm comprises a set of escalating alarms.
Wright discloses using a set of escalating alarms depending on by how much the predetermined threshold is exceeded (¶56).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify O’dea such that the alarm comprises a set of escalating alarms as taught by Wright to alert the user as the pressure continues to exceed the predetermined threshold by larger amounts to communicate the issue is getting worse.
Claim(s) 30 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’dea (US 2018/0280634) in view of Franke et al (US 2015/0265334).
Regarding claims 30 and 33, while O’dea substantially discloses the invention as claimed, it does not disclose wherein the alarm is activated when temperature and/or impedance measurements approach or reach a predetermined level.
O’dea discloses alarms for predetermined thresholds on useful properties (pressure specifically - ¶112).
Franke discloses a device for assessing and treating tissue which has an expandable member 315 that can be expanded by insufflation (¶53). The expandable member comprises sensors which can be impedance and/or temperature sensors which are used to detect an amount/efficacy of treatment (¶59).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify O’dea such that the alarm is activated when temperature and/or impedance measurements approach or reach a predetermined level as taught by O’dea/Franke to allow the device to assess the state of the tissue, including an amount of treatment when the insufflation device is used with energy delivery to innervated tissue, and alert the use if too much damage is caused.
Claim(s) 31 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’dea (US 2018/0280634) in view of Mantell et al (US 5,292,304
Regarding claims 31 and 34, while O’dea substantially discloses the invention as claimed, it does not disclose wherein the alarm is activated when flow rate (or fluid volume) measurements approach or reach a predetermined level.
O’dea discloses alarms for predetermined thresholds on useful properties (pressure specifically - ¶112).
Mantell discloses use of a flow sensor 108 to monitor flow. Flow is also a fluid volume over time.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify O’dea such that the alarm is activated when flow rate/fluid flow volume measurements approach or reach a predetermined level as taught by O’dea and Mantell and O’dea to prevent damage to a patient caused by flow rate.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’dea (US 2018/0280634) in view of Nir et al (US 2018/0271603).
Regarding claim 35, while O’dea substantially discloses the invention as claimed, it does not disclose wherein the alarm is activated when a measure of distance approaches or reaches a predetermined level.
O’dea discloses alarms for predetermined thresholds on useful properties (pressure specifically - ¶112).
Nir discloses a device which is used for laparoscopic surgery (¶197) including insufflation (¶198). Included among the tools are a sensor and processing means to calculated a 3D position of the surgical tool (¶207).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify O’dea such that the alarm is activated when a measure of distance approaches or reaches a predetermined level as taught by O’dea and Nir to alert a user when the wrong area is being targeted.
Claim(s) 39 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’dea (US 2018/0280634) in view of Lwin et al (US 2019/0053861).
Regarding claims 39 and 40, while O’dea substantially discloses the invention as claimed, it does not disclose wherein the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of parameter measurements to a data storage system, nor wherein the parameter measurements recorded in the data storage system comprise one or more of a temperature adjacent the hollow body, a pressure adjacent the hollow body, a pressure adjacent the fluid supply, a volumetric flow rate, a fluid volume, a measure of time, a measure of distance, a measure of position, an image, or an indication of an operational state of the system for creating separation between biological surfaces.
Lwin discloses the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of parameter measurements to a data storage system (¶109 and ¶110; for data analysis, calibration, etc), wherein the parameter measurements recorded in the data storage system is that recorded by the system (in the case of O’dea such includes a pressure adjacent the fluid supply which is also an indication of an operational state of the system for creating separation between biological surfaces).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify O’dea such that the feedback control module is configured to cause output, based at least on the information received from the one or more sensors, of parameter measurements to a data storage system, and wherein the parameter measurements recorded in the data storage system comprise a pressure adjacent the hollow body and an indication of an operational state of the system for creating separation between biological surfaces as taught by Lwin to allow the pressure to be reviewed after the procedure and used to improve future procedures (also allow it to be determined how many times the pressure threshold was reached/exceeded).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783