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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 8-11, 13-17, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Vij et al (US 2012/0197580) in view of W.O.M. World of Medicine, Stryker (NPL “Pneumoclear – CO2 conditioning insufflator”, hereinafter ‘Stryker’, provided by applicant).
Regarding claim 1, Vij discloses:
An insufflator (110; Fig. 1) for minimally invasive surgery, comprising: a) a gas connection with proportional valve (¶0033 – “gas regulators or valves”); c) a gas supply line (112) for gas from the gas connection with gas flow sensor (¶0032 – “flow sensor”); d) a suction device with adjustable suction power (¶0033 – “expiratory module” suctions air out); f) an electronic control unit (102, 120); g) a display device (118); and h) an interface to a remote computer (122), wherein the electronic control unit (120) transmits current settings of the insufflator (110) to the remote computer (122) via the interface (¶0054 - “the software module 120 on ventilation system 101 sends the response data to the testing device 122”); wherein the remote computer (122) simulates treatment of a patient and transmits operating values resulting from the simulation back to the insufflator (110) via the interface (¶0065, 0069 – remote device 122 is simulation system 300 of Fig. 3); and wherein the display device (118) of the insufflator (110) displays the simulated operating values (¶0041 – output device displays parameters of the system).
Vij discloses all of the elements of the claim but is silent regarding “a first trocar,” “pressure sensor,” and “a second trocar with suction hose, connected to the suction device with adjustable suction power.” However, Stryker teaches an insufflation system (Fig. 4-4, page 26), thus being in the same field of endeavor, comprising a first trocar (insufflation trocar, Fig. 5-3) and a second trocar (second trocar, Fig. 5-3) in order to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed (5.5, page 31). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a first and second trocar as taught by Stryker in order to provide sufficient structure to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed, as recognized by Stryker.
Stryker further teaches using a pressure sensor (1, Fig. 10-1, page 59) in an insufflation system in order to monitor the system during use. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a pressure sensor as taught by Stryker in order to provide sufficient structure to monitor the pressure in the system during use.
Regarding claim 2, Vij in view of Stryker discloses:
The insufflator according to claim 1, wherein the insufflator (110) indicates visually and/or acoustically when a simulation is performed (¶0038, 0041 – the device receives simulation commands, and the data of the system can be outputted on the display 118).
Regarding claim 3, Vij in view of Stryker discloses:
The insufflator according to claim 1, wherein the insufflator completely blocks a gas flow during simulation (¶0042 – the control unit 120, 102 and remote device 122 can be operated independently of display 118 and sensor 116, which means that there is no gas flow during simulation as the system processes data “as if it were the monitored data”, see ¶0038).
Regarding claim 6, Vij in view of Stryker discloses:
The insufflator according to claim 1, wherein the remote computer (122) performs the simulation of the treatment by means of software (120; ¶0042).
Regarding claim 8, Vij in view of Stryker discloses:
The insufflator according to claim 1, wherein the remote computer (122) also simulates device, accessory and/or sequence errors as part of the simulation (¶0094).
Regarding claim 9, Vij discloses:
An insufflator (110; Fig. 1) for minimally invasive surgery, comprising: a) a gas connection with proportional valve (¶0033 – “gas regulators or valves”); c) a gas supply line (112) for gas from the gas connection with gas flow sensor (¶0032 – “flow sensor”); d) a suction device with adjustable suction power (¶0033 – “expiratory module” suctions air out); f) an electronic control unit (102, 120); g) a display device (118); and h) an interface to a remote computer (122), wherein the electronic control unit (120) runs software (120) which simulates treatment of a patient on the basis of current settings of the insufflator (110) (¶0054 - “the software module 120 on ventilation system 101 sends the response data to the testing device 122”) and displays operating values resulting from the simulation on the display device (118) of the insufflator (110) and on the remote computer (122) (¶0041 – output device displays parameters of the system).
Vij discloses all of the elements of the claim but is silent regarding “a first trocar,” “pressure sensor,” and “a second trocar with suction hose, connected to the suction device with adjustable suction power.” However, Stryker teaches an insufflation system (Fig. 4-4, page 26), thus being in the same field of endeavor, comprising a first trocar (insufflation trocar, Fig. 5-3) and a second trocar (second trocar, Fig. 5-3) in order to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed (5.5, page 31). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a first and second trocar as taught by Stryker in order to provide sufficient structure to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed, as recognized by Stryker.
Stryker further teaches using a pressure sensor (1, Fig. 10-1, page 59) in an insufflation system in order to monitor the system during use. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a pressure sensor as taught by Stryker in order to provide sufficient structure to monitor the pressure in the system during use.
Regarding claim 10, Vij in view of Stryker discloses:
The insufflator according to claim 9, wherein the insufflator (110) visually and/or acoustically indicates when a simulation is being performed (¶0038, 0041 – the device receives simulation commands, and the data of the system can be outputted on the display 118).
Regarding claim 11, Vij in view of Stryker discloses:
The insufflator according to claim 9, wherein the insufflator completely blocks a gas flow during the simulation (¶0042 – the control unit 120, 102 and remote device 122 can be operated independently of display 118 and sensor 116, which means that there is no gas flow during simulation as the system processes data “as if it were the monitored data”, see ¶0038).
Regarding claim 13, Vij in view of Stryker discloses:
The insufflator according to claim 9, wherein the remote computer (122) also simulates device, accessory and/or sequence failures during the simulation (¶0094).
Regarding claim 14, Vij discloses:
A medical device fluid pump (110; Fig. 1; an insufflator is a pump for air, which is a fluid) for minimally invasive surgery, comprising: a) a fluid reservoir (¶0033 – source of gas); c) a fluid supply line (112) for fluid from the reservoir with flow sensor (¶0032 – “flow sensor”); d) a liquid suction device with adjustable suction power (¶0033 – “expiratory module” suctions air out, and the suction device is fully capable of suctioning liquid); f) an electronic control unit (102, 120); g) a display unit (118); and h) an interface to a remote computer (122), wherein the electronic control unit (120) communicates current settings of the medical device fluid pump to the remote computer via the interface (¶0054 - “the software module 120 on ventilation system 101 sends the response data to the testing device 122”); wherein the remote computer (122) simulates treatment of a patient and transmits operating values resulting from the simulation back to the medical fluid pump via the interface (¶0065, 0069 – remote device 122 is simulation system 300 of Fig. 3); and wherein the display unit (118) of the medical device fluid pump displays the simulated operating values (¶0041 – output device displays parameters of the system).
Vij discloses all of the elements of the claim but is silent regarding “a first trocar,” “pressure sensor,” and “a second trocar with suction hose, connected to the suction device with adjustable suction power.” However, Stryker teaches an insufflation system (Fig. 4-4, page 26), thus being in the same field of endeavor, comprising a first trocar (insufflation trocar, Fig. 5-3) and a second trocar (second trocar, Fig. 5-3) in order to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed (5.5, page 31). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a first and second trocar as taught by Stryker in order to provide sufficient structure to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed, as recognized by Stryker.
Stryker further teaches using a pressure sensor (1, Fig. 10-1, page 59) in an insufflation system in order to monitor the system during use. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a pressure sensor as taught by Stryker in order to provide sufficient structure to monitor the pressure in the system during use.
Regarding claim 15, Vij discloses:
A medical device fluid pump (110; Fig. 1; an insufflator is a pump for air, which is a fluid) for minimally invasive surgery, comprising: a) a fluid reservoir (¶0033 – source of gas); c) a fluid supply line (112) for fluid from the reservoir with flow sensor (¶0032 – “flow sensor”); d) a liquid suction device with adjustable suction power (¶0033 – “expiratory module” suctions air out, and the suction device is fully capable of suctioning liquid); f) an electronic control unit (102, 120); g) a display unit (118); and h) an interface to a remote computer (122), wherein the electronic control unit (120) runs software (120) which simulates treatment of a patient based on the current settings of the medical fluid pump (¶0054 - “the software module 120 on ventilation system 101 sends the response data to the testing device 122”) and displays the operating values resulting from the simulation on the display unit (118) of the medical fluid pump and on the remote computer (122) (¶0041 – output device displays parameters of the system).
Vij discloses all of the elements of the claim but is silent regarding “a first trocar,” “pressure sensor,” and “a second trocar with suction hose, connected to the suction device with adjustable suction power.” However, Stryker teaches an insufflation system (Fig. 4-4, page 26), thus being in the same field of endeavor, comprising a first trocar (insufflation trocar, Fig. 5-3) and a second trocar (second trocar, Fig. 5-3) in order to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed (5.5, page 31). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a first and second trocar as taught by Stryker in order to provide sufficient structure to ensure a sufficient supply of fresh air and to evacuate surgical smoke as needed, as recognized by Stryker.
Stryker further teaches using a pressure sensor (1, Fig. 10-1, page 59) in an insufflation system in order to monitor the system during use. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a pressure sensor as taught by Stryker in order to provide sufficient structure to monitor the pressure in the system during use.
Regarding claim 16, Vij in view of Stryker discloses:
The medical fluid pump according to claim 15, wherein the medical fluid pump (110) visually and/or audibly indicates when a simulation is being performed (¶0038, 0041 – the device receives simulation commands, and the data of the system can be outputted on the display 118).
Regarding claim 17, Vij in view of Stryker discloses:
The medical fluid pump according to claim 15, wherein the medical fluid pump completely blocks gas flow during simulation (¶0042 – the control unit 120, 102 and remote device 122 can be operated independently of display 118 and sensor 116, which means that there is no gas flow during simulation as the system processes data “as if it were the monitored data”, see ¶0038).
Regarding claim 20, Vij in view of Stryker discloses:
The medical fluid pump according to claim 15, wherein the remote computer (122) performs the simulation of the treatment by means of software (120; ¶0042).
Regarding claim 22, Vij in view of Stryker discloses:
The medical device fluid pump according to claim 14, wherein the remote computer (122) also simulates device, accessory, and/or procedure errors as part of the simulation (¶0094).
Claims 4, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vij in view of Stryker further in view of Zamierows et al (US 2015/0206457).
Regarding claim 4, Vij in view of Stryker discloses the insufflator according to claim 1 but is silent regarding “wherein the insufflator is connected to a dummy during simulation.” However, Zamierows teaches a simulation system (Abstract), thus being in the same field of endeavor, that uses a mannequin in order to provide training exercises for patient simulation (¶0007). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Vij to incorporate connecting the system to a mannequin as taught by Zamierows in order to provide training exercises for patient simulation, as recognized by Zamierows.
Regarding claim 12, Vij in view of Stryker discloses the insufflator according to claim 9 but is silent regarding “wherein the insufflator is connected to a dummy during simulation.” However, Zamierows teaches a simulation system (Abstract), thus being in the same field of endeavor, that uses a mannequin in order to provide training exercises for patient simulation (¶0007). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Vij to incorporate connecting the system to a mannequin as taught by Zamierows in order to provide training exercises for patient simulation, as recognized by Zamierows.
Regarding claim 18, Vij in view of Stryker discloses the medical fluid pump according to claim 15 but is silent regarding “wherein the medical fluid pump is connected to a dummy during simulation.” However, Zamierows teaches a simulation system (Abstract), thus being in the same field of endeavor, that uses a mannequin in order to provide training exercises for patient simulation (¶0007). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Vij to incorporate connecting the system to a mannequin as taught by Zamierows in order to provide training exercises for patient simulation, as recognized by Zamierows.
Claims 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Vij in view of Stryker further in view of Rockwell et al (US 6141584).
Regarding claim 7, Vij in view of Stryker discloses the insufflator according to claim 1 but is silent regarding “wherein the insufflator additionally comprises a voice or video connection to the remote computer.” However, Rockwell teaches a medical device with a test system (Abstract), thus being in the same field of endeavor, that incorporates an audio recording, which is a voice connection, to an external device in order to record the events of use to provide a complete summary of the use (Col. 10:1-9). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a voice connection as taught by Rockwell in order to provide sufficient structure to record use of the device for future training, as recognized by Rockwell.
Regarding claim 21, Vij in view of Stryker discloses the medical device fluid pump according to claim 14 but is silent regarding “wherein the medical device fluid pump additionally comprises a voice or video connection to the remote computer.” However, Rockwell teaches a medical device with a test system (Abstract), thus being in the same field of endeavor, that incorporates an audio recording, which is a voice connection, to an external device in order to record the events of use to provide a complete summary of the use (Col. 10:1-9). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Vij to incorporate a voice connection as taught by Rockwell in order to provide sufficient structure to record use of the device for future training, as recognized by Rockwell.
Allowable Subject Matter
Claims 5 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783