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.
Claim 14 is 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.
Claim 14 recites the limitation "the diaphragm," however, “a diaphragm” was not recited in any preceding claims. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer (US 20210267639).
Regarding claim 1, Fischer discloses an insufflator for delivering surgical gas from a gas source to a patient's body cavity during a surgical procedure (Fig. 2: insufflator system 1), comprising: an electrically variable safety valve (Figs. 7A-B: valves 770 and Figs. 9A-B: valves 970 of the cannula 15 of Fig. 2; para. [0148], second half of paragraph, the solenoid valves being electrically controlled) adapted and configured to prevent over-pressurization of the patient's body cavity during the surgical procedure by venting the surgical gas in the patient's body cavity to atmosphere when a cracking pressure of the variable safety valve is exceeded (para. [0148], second half of paragraph; para. [0154], last sentence).
Regarding claim 10, Fischer discloses an insufflator as recited in claim 1, as described above, further comprising a control valve for controlling the delivery of surgical gas from the insufflator to the patient's body cavity (Fischer: 21; para. [0125], last three sentences).
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US 20210267639) in view of Hill (US 20180134149).
Regarding claim 2, Fischer discloses an insufflator as recited in claim 1, as described above, but fails to disclose details of the valve actuation comprising a motor.
Hill teaches an analogous pressure relief valve mechanism, wherein the variable safety valve (Fig. 1: 43 and 44) includes an electric motor for intra-operatively adjusting the cracking pressure of the variable safety valve (para. [0055], sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valves (770 and 970) of the Fischer system by replacing the binary solenoid actuation with a more variable stepper motor actuation, as taught by Hill, in order to achieve greater control over the degree of pressure relief (Hill: para. [0057], sentences 6-7).
Claims 3-9 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US 20210267639) in view of Hill (US 20180134149) in further view of Barnes (US 20210178110).
Regarding claim 3, Fischer in view of Hill teaches an insufflator as recited in claim 2, as described above, further comprising a motor controller for commanding the electric motor (Fischer: para. [0148], sentences 7-8; Hill: controller 50 of valves 43/44; para. [0057], last two sentences), however. Fischer in view of Hill fails to explicitly teach the controller adjusting the cracking pressure of the valve based on feedback.
Barnes teaches an analogous system with a pressure relief valve (Fig. 1: pressure relief valve 100) with a controller (para. [0451], last two sentences) to adjust the cracking pressure of the variable safety valve based upon a feedback signal (para. [0421], last two sentences; para. [0451], last two sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the variable pressure relief valve of the Fischer-Hill combination by incorporating the real-time adjustment of the valve’s cracking pressure based on sensor data from the system, as taught by Barnes, in order to reduce pressure drops to maintain safe inflation in the patient (Barnes: paras. [0334] and [0317]).
Regarding claim 4, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 3, as described above, wherein the feedback signal is provided by an input signal from an operator (Barnes: para. [0407], 157 being user adjustable; para. [0371], sentence 5, the length of 157 being directly related to the increase/decrease in the threshold of the pressure relief valve; or, alternatively, para. [0320], adjusting the threshold based off of user adjustment of the area of the outlets).
Regarding claim 5, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 3, as described above, wherein the feedback signal is provided by a signal from a sensor (Barnes: paras. [0451] and [0161]-[0164]).
Regarding claim 6, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 4, as described above, wherein the motor controller commands the electric motor to adjust the cracking pressure of the variable safety valve based on an operator selected cracking pressure selected from a set of at least two discrete cracking pressure set points (Barnes: para. [0321], the binary of the removable covers creating discrete pressure set points that can be selected between based on how many covers are removed by the user).
Regarding claim 7, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 5, as described above, wherein the motor controller commands the electric motor to adjust cracking pressure of the variable safety valve based upon a feedback signal from a flow sensor and/or a pressure sensor (Barnes: para. [0161], based on flow rate sensor feedback; 150 pressure sensing mechanism, para. [0364], sentence 2, based on pressure sensor feedback).
Regarding claim 8, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 7, as described above, further comprising a flow sensor for monitoring a flow rate of the surgical gas delivered to the patient's body cavity (Barnes: para. [0161]).
Regarding claim 9, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 7, as described above, further comprising a pressure sensor for monitoring the pressure of the surgical gas delivered to the patient's body cavity (Barnes: 150 pressure sensing mechanism, para. [0364], sentence 2).
Regarding claim 15, Fischer discloses an insufflator for delivering surgical gas from a gas source to a patient's body cavity during a surgical procedure (Fig. 2: insufflator system 1), comprising: a) a variable safety valve adapted and configured to prevent over- pressurization of the patient's body cavity during the surgical procedure by venting the surgical gas in the patient's body cavity to atmosphere when a cracking pressure of the variable safety valve is exceeded (Figs. 7A-B: valves 770 and Figs. 9A-B: valves 970 of the cannula 15 of Fig. 2; para. [0148], second half of paragraph; para. [0154], last sentence); but fails to explicitly disclose an electric motor for adjusting the cracking pressure of the valve.
Hill teaches an analogous pressure relief valve mechanism, comprising b) an electric motor for intra-operatively adjusting the cracking pressure of the variable safety valve (para. [0055], sentence 1, valves 43 and 44); and c) a motor controller for commanding the electric motor to adjust the variable safety valve (controller 50 of valves 43/44; para. [0057], last two sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valves (770 and 970) of the Fischer system by replacing the binary solenoid actuation with a more variable stepper motor actuation, as taught by Hill, in order to achieve greater control over the degree of pressure relief (Hill: para. [0057], sentences 6-7). However, Fisher in view of Hill fails to explicitly teach that the cracking pressure of the valve is based upon user selection.
Barnes teaches an analogous system with a pressure relief valve (Fig. 1: pressure relief valve 100) with a controller (para. [0451], last two sentences) to adjust the cracking pressure of the variable safety valve based upon an operator selected cracking pressure (para. [0407], 157 being user adjustable; para. [0371], sentence 5, the length of 157 being directly related to the increase/decrease in the threshold of the pressure relief valve; or, alternatively, para. [0320], adjusting the threshold based off of user adjustment of the area of the outlets). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the variable pressure relief valve of the Fischer-Hill combination by incorporating the real-time adjustment of the valve’s cracking pressure, as taught by Barnes, in order to reduce pressure drops to maintain safe inflation in the patient (Barnes: paras. [0334] and [0317]).
Regarding claim 16, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 15, as described above, wherein the operator selected cracking pressure is selected from a set of at least two discrete cracking pressure set points (Barnes: para. [0321], the binary of the removable covers creating discrete pressure set points that can be selected between based on how many covers are removed by the user).
Regarding claim 17, Fischer discloses an insufflator for delivering surgical gas from a gas source to a patient's body cavity during a surgical procedure (Fig. 2: insufflator system 1), comprising: a) a variable safety valve adapted and configured to prevent over- pressurization of the patient's body cavity during the surgical procedure by venting the surgical gas in the patient's body cavity to atmosphere when a cracking pressure of the variable safety valve is exceeded (Figs. 7A-B: valves 770 and Figs. 9A-B: valves 970 of the cannula 15 of Fig. 2; para. [0148], second half of paragraph; para. [0154], last sentence); but fails to explicitly disclose an electric motor for adjusting the cracking pressure of the valve.
Hill teaches an analogous pressure relief valve mechanism, comprising b) an electric motor for intra-operatively adjusting the cracking pressure of the variable safety valve (para. [0055], sentence 1, valves 43 and 44); and c) a motor controller for commanding the electric motor to adjust the variable safety valve (controller 50 of valves 43/44; para. [0057], last two sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valves (770 and 970) of the Fischer system by replacing the binary solenoid actuation with a more variable stepper motor actuation, as taught by Hill, in order to achieve greater control over the degree of pressure relief (Hill: para. [0057], sentences 6-7). However, Fisher in view of Hill fails to explicitly teach that the cracking pressure of the valve is based upon feedback form a sensor.
Barnes teaches an analogous system with a pressure relief valve (Fig. 1: pressure relief valve 100) with a controller (para. [0451], last two sentences) to adjust the cracking pressure of the variable safety valve based upon a feedback signal from a sensor (para. [0421], last two sentences; para. [0451], last two sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the variable pressure relief valve of the Fischer-Hill combination by incorporating the real-time adjustment of the valve’s cracking pressure based on sensor data from the system, as taught by Barnes, in order to reduce pressure drops to maintain safe inflation in the patient (Barnes: paras. [0334] and [0317]).
Regarding claim 18, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 17, as described above, wherein the feedback signal is generated by a flow sensor and/or a pressure sensor (Barnes: para. [0161], based on flow rate sensor feedback; 150 pressure sensing mechanism, para. [0364], sentence 2, based on pressure sensor feedback).
Regarding claim 19, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 18, as described above, further comprising a flow sensor for monitoring a flow rate of the surgical gas delivered to the patient's body cavity (Barnes: para. [0161]).
Regarding claim 20, Fischer in view of Hill in further view of Barnes teaches an insufflator as recited in claim 18, as described above, further comprising a pressure sensor for monitoring the pressure of the surgical gas delivered to the patient's body cavity (Barnes: 150 pressure sensing mechanism, para. [0364], sentence 2).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US 20210267639) in view of Hill (US 20180134149) in further view of Creedon (WO 2020249813).
Regarding claim 12, Fischer in view of Hill teaches an insufflator as recited in claim 2, as described above, wherein the electric motor is a stepper motor (Hill: para. [0055], sentence 1), but fails to explicitly teach the structures of the motorized valve having a lead screw.
Creedon teaches an analogous system with a pressure relief valve (Fig. 4: pressure relief valve 50; pg. 16, lines 30-33) that translates rotary motion into linear motion by way of a lead screw (Fig. 4: lead screw 52; pg. 17, lines 3-19). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stepper motor driven Fischer-Hill valve by incorporating the valve opening/closing structures of the lead screw, as taught by Creedon, such that the motor and controllers taught by Fischer-Hill drive the Creedon lead screw, in order to allow for precise linear movements of the opening/closing force of the valve and greater control of the pressure release rate.
Regarding claim 13, Fischer in view of Hill in further view of Creedon teaches an insufflator as recited in claim 12, as described above, wherein the lead screw drives a pressure plate in contact with one end of a valve spring (Creedon: Fig. 4: lead screw 52 driving plate 51, spring 38), effectively changing an installed length of the valve spring (Creedon: pg. 17, lines 3-19).
Regarding claim 14, Fischer in view of Hill in further view of Creedon an insufflator as recited in claim 13, as described above, wherein shortening the installed length of the valve spring linearly correlates with increasing the cracking pressure of the variable safety valve, which permits gas flow when the gas pressure acting against a front face of the diaphragm exceeds a spring force applied to a back side of the diaphragm (Creedon: pg. 17, lines 3-19; the diaphragm being 36 of Fig. 4).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US 20210267639) in view of Baier (US 5013294).
Regarding claim 11, Fischer discloses an insufflator as recited in claim 1, as described above, but fails to explicitly disclose a pressure regulator.
Baier teaches an analogous insufflator system, further comprising a pressure regulator for controlling the pressure of surgical gas delivered to the insufflator from the gas source (claim 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Fischer insufflator system by incorporating a pressure regulator, as taught by Baier, in order to ensure the gas source is released at a controlled and safe pressure to avoid damage to the system or harm to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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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.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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