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 .
Response to Amendment
The amendment filed on 4/2/2026 has been entered. Claims 1, 3-10, and 12-20 are pending in the application. Claims 2, 11, and 21 are cancelled.
Claim Objections
Claims 1, 4, 16, 18, and 20 are objected to because of the following informalities:
-Claim 1, line 5: please correct “the pressure regulator that is configured” to “the pressure regulator, wherein the pressure regulator is configured”
-Claim 1, lines 16-17: please correct “the gas” to “the insufflation gas”
-Claim 4, line 4: please correct “the pressure” to “a pressure”
-Claim 4, lines 4-5: please correct “the insufflator gas” to “the insufflation gas”
-Claim 16, line 13: please correct “the gas” to “gas”
-Claim 18, line 2: please correct “the limited variable volume” to “the limited and mechanically variable internal volume”
-Claim 18, line 4: please correct “the limited variable volume” to “the limited and mechanically variable internal volume”
-Claim 20, lines 1-2: please correct “the limited variable volume” to “the limited and mechanically variable internal volume”
Appropriate correction is required.
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 1, 3-10, and 12-20 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.
Claim 1 recites the limitation "the buffered amount of insufflation gas" in line 21. There is insufficient antecedent basis for this limitation in the claim. It is unclear what is meant by this limitation since buffering is not introduced prior to line 21. For examination purposes, the Examiner interprets “the buffered amount of insufflation gas” as “the amount of the overpressured insufflation gas”.
Claim 1 recites the limitation “the buffered insufflation gas” in lines 23-24. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this is intended to be the same element as “the buffered amount of insufflation gas” in line 21. It is also unclear what is meant by the buffered insufflation gas/the buffered amount of insufflation gas as described in the first 112(b) rejection of claim 1 above. For examination purposes, the Examiner interprets “the buffered insufflation gas” in lines 23-24 as “the amount of the overpressured insufflation gas”.
Claims 3-10, 12-15, 18, and 20 are rejected by virtue of their dependency on rejected claim 1.
Claim 16 recites the limitation “wherein the insufflator apparatus comprises a pressure regulator having a limited variable volume comprises a compliance reservoir having a limited and mechanically variable internal volume” in lines 3-11. The grammar of this limitation is unclear. It is further unclear whether the limited variable volume is the same as the limited and mechanically variable internal volume, which is further unclear in line 22 which recites “the limited variable volume”. For examination purposes, the Examiner interprets “wherein the insufflator apparatus comprises a pressure regulator having a limited variable volume comprises a compliance reservoir having a limited and mechanically variable internal volume” in lines 3-11 as “wherein the insufflator apparatus comprises a pressure regulator comprising a compliance reservoir having a limited and mechanically variable internal volume”. The Examiner further interprets “the limited variable volume” in line 22 as “the limited and mechanically variable internal volume”.
Claim 16 recites the limitation “the input mechanism” in line 13. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the input mechanism” as “an input mechanism attachable to the human body”.
Claim 16 recites the limitation "the buffered amount of insufflation gas" in lines 16-17. There is insufficient antecedent basis for this limitation in the claim. It is unclear what is meant by this limitation since buffering is not introduced prior to lines 16-17. For examination purposes, the Examiner interprets “the buffered amount of insufflation gas” to “the amount of the overpressured insufflation gas”.
Claim 16 recites the limitation “the buffered insufflation gas” in line 18. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this is intended to be the same element as “the buffered amount of insufflation gas” in lines 16-17. It is also unclear what is meant by the buffered insufflation gas/the buffered amount of insufflation gas as described in the third 112(b) rejection of claim 16 above. For examination purposes, the Examiner interprets “the buffered insufflation gas” in line 18 as “the amount of the overpressured insufflation gas”.
Claim 16 recites the limitation “the set average pressure level” in line 19. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the set average pressure level” as “a set average pressure level”.
Claims 17 and 19 are rejected by virtue of their dependency on rejected claim 16.
Claim 17 recites “the limited variable volume” in each of lines 2, 3-4, and 4. As described in the first 112(b) rejection of claim 16 above, it is unclear whether the limited variable volume and the limited and mechanically variable internal volume are intended to be the same structures. For examination purposes, the Examiner interprets each recitation of “the limited variable volume” in claim 17 as “the limited and mechanically variable internal volume”.
Claim 17 recites “the buffered insufflation gas” in line 4. As described in the fourth 112(b) rejection of claim 16 above, the term “the buffered insufflation gas” is unclear. For examination purposes, the Examiner interprets “the buffered insufflation gas” as “the amount of the overpressured insufflation gas”.
Claim 18 recites “the buffered insufflation gas” in line 2. As described in the second 112(b) rejection of claim 1 above, the term “the buffered insufflation gas” is unclear. For examination purposes, the Examiner interprets “the buffered insufflation gas” as “the amount of the overpressured insufflation gas”.
Claim 19 recites “the limited variable volume” in line 1. As described in the first 112(b) rejection of claim 16 above, it is unclear whether the limited variable volume and the limited and mechanically variable internal volume are intended to be the same structures. For examination purposes, the Examiner interprets “the limited variable volume” in claim 17 as “the limited and mechanically variable internal volume”.
Claim 19 recites the limitation "the removed amount" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear what is meant by this limitation. For examination purposes, the Examiner interprets “the removed amount” as “the amount”.
Claim 20 recites the limitation "the removed amount" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear what is meant by this limitation. For examination purposes, the Examiner interprets “the removed amount” as “the amount”.
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.
Claims 16-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stearns et al. (US 2007/0088275 A1, hereinafter referred to as “Stearns ‘275”).
Regarding claim 16, Stearns ‘275 discloses a method of operating an insufflator apparatus (see Figs. 7a-c and 43) comprising an insufflation gas supply (gas cylinder 4360) intended to expose an intended structure within a cavity of a human body, wherein the insufflator apparatus (see Figs. 7a-c and 43) comprises a pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) comprising a compliance reservoir (upper chamber 712) having a limited and mechanically variable internal volume that forms a compliance mechanism of the pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) (see par. [0105]-[0106], the volume of the upper chamber 712 varies depending on the abdominal pressure and set point pressure), the compliance reservoir (upper chamber 712) being fluidly coupled to the input mechanism (trocar 4310) such that the gas can flow bidirectionally between the cavity and the compliance reservoir (upper chamber 712) in response to pressure variations in the cavity (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712 such that upper chamber 712 expands; when abdominal pressure is lower than the set point pressure, gas flows out of upper chamber 712 such that upper chamber 712 contracts), the compliance reservoir (upper chamber 712) being configured to expand when an amount of overpressured insufflation gas flows from the cavity into the compliance reservoir (upper chamber 712) and to contract to return the buffered amount of insufflation gas from the compliance reservoir (upper chamber 712) back into to the cavity, thereby temporarily buffering the overpressured insufflation gas and subsequently returning the buffered insufflation gas to the cavity so as to maintain the set average pressure level in the cavity and to thereby avoid transient pressure deviations from the set average pressure level in the cavity (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712 such that upper chamber 712 expands; when abdominal pressure is lower than the set point pressure, gas flows out of upper chamber 712 such that upper chamber 712 contracts):
controlling a pressure within the cavity (see par. [0105]-[0106], [0145]), and
controlling a pressure and/or a volume of the limited variable volume (see par. [0105]-[0106], [0145]).
Regarding claim 17, Stearns ‘275 discloses the method of claim 16 wherein, during the controlling the pressure and/or the volume of the limited variable volume forming the compliance mechanism (upper chamber 712 forms the compliance mechanism and has a limited variable volume, see par. [0105]-[0106]), the pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) returns, by generating an increasing pressure gradient between the limited variable volume and the cavity, the buffered insufflation gas from the limited variable volume to the cavity to maintain the set average pressure level in the cavity (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712; when abdominal pressure is lower than the set point pressure, the gas flows out of upper chamber 712 and into the cavity).
Regarding claim 19, Stearns ‘275 discloses the method of claim 16, wherein the limited variable volume forming the compliance mechanism (upper chamber 712 forms the compliance mechanism and has a limited variable volume, see par. [0105]-[0106]) varies under influence of the removed amount of the overpressured insufflation gas (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712 such that upper chamber 712 expands; when abdominal pressure is lower than the set point pressure, gas flows out of upper chamber 712 such that upper chamber 712 contracts).
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, 3, 5-10, 12, 15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stearns et al. (US 2007/0088275 A1, hereinafter referred to as “Stearns ‘275”) in view of Stearns et al. (US 2018/0296245 A1, hereinafter referred to as “Stearns ‘245”).
Regarding claim 1, Stearns ‘275 discloses an insufflator apparatus (see Figs. 7a-c and 43) for exposing structures within a cavity of a human body for an endoscopic procedure (see par. [0011], [0145]), the insufflator apparatus comprising:
an insufflation gas supply valve (valve 4361) that is configured to provide insufflation gas to a pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) (see par. [0145]);
the pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) that is configured to supply the insufflation gas into the cavity via an input mechanism (trocar 4310) attachable to the human body (see Fig. 43, par. [0034], [0145]);
wherein the pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) comprises a compliance reservoir (upper chamber 712) having a limited and mechanically variable internal volume that forms a compliance mechanism of the pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) (see par. [0105]-[0106], the volume of the upper chamber 712 varies depending on the abdominal pressure and set point pressure), the compliance reservoir (upper chamber 712) being fluidly coupled to the input mechanism (trocar 4310) such that the gas can flow bidirectionally between the cavity and the compliance reservoir (upper chamber 712) in response to pressure variations in the cavity (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712 such that upper chamber 712 expands; when abdominal pressure is lower than the set point pressure, gas flows out of upper chamber 712 such that upper chamber 712 contracts), the compliance reservoir (upper chamber 712) being configured to expand when an amount of overpressured insufflation gas flows from the cavity into the compliance reservoir (upper chamber 712) and to contract to return the buffered amount of insufflation gas from the compliance reservoir (upper chamber 712) back into to the cavity, thereby temporarily buffering the overpressured insufflation gas and subsequently returning the buffered insufflation gas to the cavity so as to maintain the set average pressure level in the cavity and to thereby avoid transient pressure deviations from the set average pressure level in the cavity (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712 such that upper chamber 712 expands; when abdominal pressure is lower than the set point pressure, gas flows out of upper chamber 712 such that upper chamber 712 contracts).
However, Stearns ‘275 fails to expressly state a sensing apparatus configured to sense a pressure level in the cavity; an insufflator vent mechanism configured to release excess insufflation gas volume returning from the pressure regulator; and an insufflator controller configured to adjust, in real time, an insufflation rate of the insufflation gas, using the insufflation gas supply valve and the insufflator vent mechanism, to insufflate at a set average pressure level in the cavity in accordance with the pressure level in the cavity sensed by the sensing apparatus.
Stearns ‘245 teaches an insufflator apparatus (see Fig. 32) comprising a sensing apparatus (see par. [0183], a pressure sensor can be provided relative to gauge 3225) configured to sense a pressure level in the cavity (see Fig. 32, par. [0183]); an insufflator vent mechanism (insufflation relief valve 3263) configured to release excess insufflation gas volume returning from the pressure regulator (diaphragm valve 3261) (see Fig. 32, par. [0184]); and an insufflator controller (see par. [0183]-[0184], the pressure sensor and insufflation relief valve 3263 are electrically/electro-mechanically controlled) configured to adjust, in real time, an insufflation rate of the insufflation gas, using the insufflation gas supply valve (pressure regulator 2870, see also Fig. 28) and the insufflator vent mechanism (insufflation relief valve 3263), to insufflate at a set average pressure level in the cavity in accordance with the pressure level in the cavity sensed by the sensing apparatus (see par. [0183], a pressure sensor can be provided relative to gauge 3225) (see par. [0156] and [0183]-[0184], valves 3263 and 2870 are electro-mechanically controlled and affect the flow rate of gas through the system).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the insufflator apparatus of Stearns ‘275 to include a sensing apparatus configured to sense a pressure level in the cavity; an insufflator vent mechanism configured to release excess insufflation gas volume returning from the pressure regulator; and an insufflator controller configured to adjust, in real time, an insufflation rate of the insufflation gas, using the insufflation gas supply valve and the insufflator vent mechanism, to insufflate at a set average pressure level in the cavity in accordance with the pressure level in the cavity sensed by the sensing apparatus, as taught by Stearns ‘245, in order to provide additional safety mechanisms to further reduce the risk of overpressure scenarios and quickly relieve excess pressure (see Stearns ‘245 par. [0183]-[0184]).
Regarding claim 3, modified Stearns ‘275 teaches the insufflator apparatus of claim 1 substantially as claimed. Modified Stearns ‘275 further teaches wherein the compliance reservoir (Stearns ‘275, upper chamber 712) comprises a piston-controlled cylinder (Stearns ‘275, see Figs. 7a-c and 43, a cylindrical shaft of piston 750 partially extends through the upper chamber 712) communicatively coupled to the input mechanism (Stearns ‘275, trocar 4310), and wherein a piston (Stearns ‘275, knob and spring arrangement 730 acts on the shaft of plunger 750 in a manner which can be considered a piston, see par. [0105]-[0106]), which controls the piston-controlled cylinder (Stearns ‘275, see Figs. 7a-c and 43, a cylindrical shaft of piston 750 partially extends through the upper chamber 712), is actively controlled by the insufflator controller in accordance with the pressure level sensed by the sensing apparatus (Stearns ‘245, see par. [0183], a pressure sensor can be provided relative to gauge 3225) (see Stearns ‘275 Figs. 7a-c and 43, par. [0105]-[0106], [0145]; see Stearns ‘245 par. [0156] and [0183]-[0184]; see previous modifications in rejection of claim 1 above).
Regarding claim 5, modified Stearns ‘275 teaches the insufflator apparatus of claim 1 substantially as claimed. Stearns ‘275 further teaches wherein a return gas flow is provided via an output channel (conduit 4324) that is at least partially distinct from the input mechanism (trocar 4310) (see Fig. 43, par. [0145]).
Regarding claim 6, modified Stearns ‘275 teaches the insufflator apparatus of claim 5 substantially as claimed. Stearns ‘275 further teaches wherein the output channel (conduit 4324) and the input mechanism (trocar 4310) are configured to originate from a single orifice connected to the cavity (see Figs. 4 and 43, trocar 4310 is insertable into a single orifice of the patient cavity and conduit 4324 communicates with the patient cavity through the trocar 4310).
Regarding claim 7, modified Stearns ‘275 teaches the insufflator apparatus of claim 5 substantially as claimed. Stearns ‘275 further teaches wherein the output channel (conduit 4324) and the input mechanism (trocar 4310) are configured to originate from distinct orifices connected to the cavity (note: this is a functional limitation and not structurally required; conduit 4324 can be connected to a separate, additional trocar as shown in Fig. 40).
Regarding claim 8, modified Stearns ‘275 teaches the insufflator apparatus of claim 5 substantially as claimed. However, modified Stearns ‘275 fails to state wherein the pressure regulator further comprises a fan or a compressor provided in the output channel aimed at providing a pressure difference across the output channel to promote gas circulation.
Stearns ‘275 teaches an additional embodiment of an insufflator apparatus (see Fig. 41) wherein the pressure regulator (pressure regulator 4030 and compressor 4161 together regulate pressure in the insufflator apparatus, see par. [0137]-[0138]) further comprises a compressor (compressor 4161) provided in the output channel (conduit 4011) aimed at providing a pressure difference across the output channel (conduit 4011) to promote gas circulation (see Fig. 41, par. [0137]-[0138], [0141]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the insufflator apparatus of modified Stearns ‘275 to include a compressor, as taught by the embodiment of Fig. 41 of Stearns ‘275, in order to allow the insufflator apparatus to be compatible with central hospital gas supply systems (see Stearns ‘275 par. [0137]).
Regarding claim 9, modified Stearns ‘275 teaches the insufflator apparatus of claim 5 substantially as claimed. However, modified Stearns ‘275 fails to state wherein a gas filter is provided in at least one of the output channel or the input mechanism.
Stearns ‘245 teaches an insufflator apparatus (see Fig. 32) wherein a gas filter (filter elements 3282a-c) is provided in the output channel (lines 3283, 3285) (see Fig. 32, par. [0179]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the insufflator apparatus of modified Stearns ‘275 to include a gas filter in the output channel, as taught by Stearns ‘245, in order to filter particulate matter from the recirculated air which allows for clean air to be recirculated and a clear view of the patient cavity to be maintained (see Stearns ‘245 par. [0192]).
Regarding claim 10, modified Stearns ‘275 teaches the insufflator apparatus of claim 5 substantially as claimed. However, modified Stearns ‘275 fails to state wherein a return gas regulator valve is provided in the output channel
Stearns ‘245 teaches an insufflator apparatus (see Fig. 32) wherein a return gas regulator valve (bypass valve 3260) is provided in the output channel (lines 3283, 3285) (see Fig. 32, par. [0183]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the insufflator apparatus of modified Stearns ‘275 to include a return gas regulator valve in the output channel, as taught by Stearns ‘245, in order to further prevent overpressure scenarios (see Stearns ‘245 par. [0183]).
Regarding claim 12, modified Stearns ‘275 teaches the insufflator apparatus according to claim 1 substantially as claimed. Modified Stearns ‘275 further teaches wherein the insufflator controller (Stearns ‘245, see par. [0183]-[0184], the pressure sensor and insufflation relief valve 3263 are electrically/electro-mechanically controlled) is arranged to adapt, in real-time with respect to the insufflator apparatus, at least one of the group consisting of: a gas flow, a gas output volume, and a gas output pressure (Stearns ‘245 see par. [0156] and [0183]-[0184], valves 3263 and 2870 are electro-mechanically controlled and affect the flow, volume, and pressure of gas through the system, see previous modifications in rejection of claim 1 above).
Regarding claim 15, modified Stearns ‘275 teaches the insufflator apparatus of claim 1 substantially as claimed. Stearns ‘275 further teaches wherein the input mechanism (trocar 4310) comprises a trocar that can be sealingly inserted in the cavity (see Fig. 43, par. [0145], [0147]).
Regarding claim 18, modified Stearns ‘275 teaches the insufflator apparatus of claim 1 substantially as claimed. Stearns ‘275 further teaches wherein the pressure regulator (diaphragm valve 4330, shown in more detail as diaphragm valve 700 in Figs. 7a-c) is configured to return the buffered insufflation gas from the limited variable volume forming the compliance mechanism (upper chamber 712 forms the compliance mechanism and has a limited variable volume, see par. [0105]-[0106]) to the cavity by generating an increasing pressure gradient between the limited variable volume and the cavity to maintain the set average pressure level in the cavity (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712; when abdominal pressure is lower than the set point pressure, the gas flows out of upper chamber 712 and into the cavity).
Regarding claim 20, modified Stearns ‘275 teaches the insufflator apparatus of claim 1 substantially as claimed. Stearns ‘275 further teaches wherein the limited variable volume forming the compliance mechanism (upper chamber 712 forms the compliance mechanism and has a limited variable volume, see par. [0105]-[0106]) varies under influence of the removed amount of the overpressured insufflation gas (see Figs. 7a-c and 43, par. [0105]-[0106], [0145]; when abdominal pressure is higher than the set point pressure, gas flows into upper chamber 712 such that upper chamber 712 expands; when abdominal pressure is lower than the set point pressure, gas flows out of upper chamber 712 such that upper chamber 712 contracts).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Stearns et al. (US 2007/0088275 A1, hereinafter referred to as “Stearns ‘275”) in view of Stearns et al. (US 2018/0296245 A1, hereinafter referred to as “Stearns ‘245”), as applied to claim 1 above, further in view of Diemunsch (US 2005/0171466 A1).
Regarding claim 4, modified Stearns ‘275 teaches the insufflator apparatus according to claim 1 substantially as claimed. However, modified Stearns ‘275 fails to state wherein the pressure regulator comprises a fan provided between the compliance reservoir and the input mechanism, and wherein the fan is controlled by the insufflator controller to increase the pressure of the insufflator gas from the compliance reservoir toward the input mechanism in accordance with the pressure level sensed by the sensing apparatus, to provide a controllable pressure difference over the fan to thereby counteract the transient pressure deviations from the set average pressure level.
Diemunsch teaches an insufflator apparatus (see Fig. 1) wherein the pressure regulator (charging device 12) comprises a fan (blower, see par. [0015] and [0039]) provided between the compliance reservoir (chamber 20) and the input mechanism (cannula 30) (see par. [0015] and [0039]), and wherein the fan (blower, see par. [0015] and [0039]) is controlled by the insufflator controller (control unit 90) to increase the pressure of the insufflator gas from the compliance reservoir (chamber 20) towards the input mechanism (cannula 30) in accordance with the pressure level sensed by the sensing apparatus (measuring device 93) (see par. [0015] and [0039]-[0040]), to provide a controllable pressure difference over the fan (blower, see par. [0015] and [0039]) to thereby counteract the transient pressure deviations from the set average pressure level (see par. [0032], control unit 90 controls the apparatus 10 and thus the fan (par. [0015] and [0039]) in response to pressure sensed by measuring device 93).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure regulator of the insufflator apparatus of modified Stearns ‘275 to include a fan controllable by the insufflator controller in accordance with the sensed pressure, as taught by Diemunsch, in order to provide the energy for moving the insufflation gas through the system (see Diemunsch par. [0015] and [0039]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Stearns et al. (US 2007/0088275 A1, hereinafter referred to as “Stearns ‘275”) in view of Stearns et al. (US 2018/0296245 A1, hereinafter referred to as “Stearns ‘245”), as applied to claim 1 above, further in view of Van Weteringen et al. (WO 2017/014623 A1).
Regarding claim 13, modified Stearns ‘275 teaches the insufflator apparatus according to claim 1 substantially as claimed. However, modified Stearns ‘275 fails to state wherein the sensing apparatus is further arranged to measure, in real-time at a frequency of at least twice a breathing frequency and with respect to an insufflation gas output, at least one of the group consisting of: a gas flow, a gas output volume, and a gas output pressure.
Van Weteringen teaches an insufflator apparatus (see Fig. 1) wherein the sensing apparatus (sensor 51) is further arranged to measure, in real-time at a frequency of at least twice a breathing frequency and with respect to an insufflation gas output, at least one of the group consisting of: a gas flow, a gas output volume, and a gas output pressure (page 7 lines 18-21; page 9 lines 1-8; page 10 lines 22-26).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the insufflator apparatus of modified Stearns ‘275 to include wherein the sensing apparatus is further arranged to measure, in real-time at a frequency of at least twice a breathing frequency and with respect to an insufflation gas output, at least one of the group consisting of: a gas flow, a gas output volume, and a gas output pressure, as taught by Van Weteringen, in order to get accurate, continuous sensor readings by suppressing body motion as the patient breathes (see Van Weteringen page 7 lines 18-21; page 9 lines 1-8; page 10 lines 22-26).
Regarding claim 14, modified Stearns ‘275 teaches the insufflator apparatus according to claim 1 substantially as claimed. However, modified Stearns ‘275 fails to state wherein the sensing apparatus is further arranged to measure, with respect to a distal part of the input mechanism, at least two parameters taken from the group consisting of: a gas flow, a gas output volume, a gas output pressure, and a gas temperature.
Van Weteringen teaches an insufflator apparatus (see Fig. 1) wherein the sensing apparatus (sensor 51) is further arranged to measure, with respect to a distal part of the input mechanism (input mechanism 20), at least two parameters taken from the group consisting of: a gas flow, a gas output volume, a gas output pressure, and a gas temperature (page 7 lines 18-21; page 9 lines 1-8; page 10 lines 22-26).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the insufflator apparatus of modified Stearns ‘275 to include wherein the sensing apparatus is further arranged to measure, with respect to a distal part of the input mechanism, at least two parameters taken from the group consisting of: a gas flow, a gas output volume, a gas output pressure, and a gas temperature, as taught by Van Weteringen, in order to get accurate, continuous sensor readings by suppressing body motion as the patient breathes (see Van Weteringen page 7 lines 18-21; page 9 lines 1-8; page 10 lines 22-26).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 16 have been considered but are moot because the new ground of rejection does not rely on 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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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, Kevin Sirmons can be reached at (571) 272-4965. 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.
/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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