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 .
Amendment Entered
In response to the amendment filed on May 5th, 2026, amended claim 1 and new claims 5-10 are entered. Claims 3-4 are cancelled.
Response to Arguments
Applicant's remarks and amendments with respect to the abstract objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites “the pressure increase” in line 2, but should read “the increase in pressure”
Claim 9 recites “the calculated rate” in line 3, but should read “the calculated rate of pressure increase”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 recites “wherein the control unit is configured to evaluate the dynamics of the pressure increase by calculating a rate of pressure increase, and to display the warning signal only if the calculated rate exceeds a predetermined rate threshold” in lines 1-4. However, there is insufficient support for these limitations. Although [0020] of the Applicant’s Specification recites “it is also possible to include the dynamics of the increase in pressure to determine a muscle contraction. The muscle contractions induced here lead to a relatively fast increase in pressure compared to the regular increase in pressure caused by a change in the insufflation or desufflation parameters. Therefore, evaluating the rate of increase in pressure allows a more accurate classification of the causes of the increase in pressure”, there is no disclosure of “calculating a rate of pressure increase, and to display the warning signal only if the calculated rate exceeds a predetermined rate threshold” present in the specification.
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 1-2 and 5-10 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 increase in pressure” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim.
The term “approximately” in claim 6 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 7 recites “display the warning signal only after” in line 2. Similarly, claim 9 recites “display the warning signal only if” in line 3. These claims are both dependent on independent claim 1, which had already recited different conditions that were required for the warning signal to be displayed. Therefore, it is unclear as to whether the display of the “warning signal” would still require all the conditions present in the independent claim as well as the dependent claim, or if the “warning signal” is “only” displayed after the specific limitations of the dependent claim are met. Clarification is requested.
Claim 9 recites the limitation “the dynamics” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the patient’s muscle relaxation” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-2, 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over O’Dea (U.S. Publication No. 2019/0060585; previously cited) in view of Bischof (U.S. Publication No. 2021/0267638).
Regarding Claim 1, O’Dea discloses an insufflation device for use in medical technology (A method and apparatus for insufflating a cavity in the body of a human or animal subject; Abstract) comprising
an insufflator (insufflator 10; [0155]) for introducing insufflation gas into a body cavity (cavity 2; the cavity 2 is the peritoneal cavity of the subject; [0154]; The apparatus 1 comprises an insufflator 10 for delivering an insufflating fluid, which in this embodiment of the invention comprises an insufflating gas, which in this case is compressed air for maintaining the cavity 2 insufflated; [0155]),
a control unit (microcontroller 18; [0157]; [0165]),
an insufflation line (supply conduit 17; [0156-0158]) and a desufflation line (discharge conduit 53; [0177]),
wherein the desufflation line is connected to a suction pump (the discharge control means comprises a vacuum pump 52 which is connected to the outlet port 30 from the second trocar 6 by a discharge conduit 53; [0177]),
wherein the insufflation line and the desufflation line each have a pressure sensor (pressure sensor 40; [0178-0180]; Figure 2; While the pressure sensors 40 have been described as being located on the distal end of the first trocar 5 in the embodiments of FIGS. 1 to 4, and on the distal end of the communicating conduit 84 of the embodiment of FIGS. 5 and 6…it is envisaged that the pressure sensor 40 may be located on the second trocar 6; [0218]),
wherein the insufflator displays a warning signal when (i) pressure in the body cavity exceeds a threshold value (predefined maximum pressure; [0168]) above a set target value (predefined minimum pressure; [0168]) and (ii) the control unit determines that the increase in pressure is not caused by a change in volume flows (if the signals read by the microcontroller 18 from the pressure sensor 40 are indicative of the pressure in the cavity 2 reaching or just exceeding the predefined maximum pressure, the microcontroller 18 operates the piezoelectric sounder 45 to produce an audible alarm signal; [0179-0180]; While the alerting means has been described as comprising a piezoelectric sounder, any other suitable alarm generating means may be provided, and in certain cases, it is envisaged that the alarm generating means as well as or instead of producing an audible alarm signal may produce a visual alarm signal, or could produce both an audible and a visual alarm signal; [0241]).
O’Dea fails to teach wherein the insufflation line and the desufflation line each have a volume flow sensor.
In a similar technical field, Bischof teaches an insufflation device with intelligent control of smoke evacuation (Abstract), wherein the insufflation line and the desufflation line each have a volume flow sensor (The present invention relates to an insufflator for minimally invasive surgery, including a) a pressure and flow rate-regulating unit equipped with a proportional valve, a pressure sensor and a flow rate measurement device, b) a supply line with an optional filter and connection to a first trocar, c) a second trocar with an evacuation hose and an optional filter, connected to an evacuation device with controllable evacuation power, d) an optional flow rate measurement device in the evacuation line, e) an electronic or mechanical regulating unit, and f) a novel method for adjustment of the evacuation volumetric flow rate; [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the volume flow sensor teachings of Bischof into the invention of O’Dea in order to control the volumetric flow rate of the insufflation and the evacuation (Bischof [0003-0006]).
Regarding Claim 2, O’Dea discloses wherein the threshold value is 10, 20, 30, 40, or 50 mm Hg (In one aspect of the invention the predefined maximum pressure lies in the range of 15 mmHg to 30 mmHg. Preferably, the predefined maximum pressure lies in the range of 20 mmHg to 30 mmHg. Advantageously, the predefined maximum pressure is approximately 20 mmHg; [0032]; Typically, the predefined maximum pressure is set at a value in the range of 15 mm mercury and 30 mm mercury and more typically in the range of 20 mm mercury to 30 mm mercury, and, in general, is set at a value of approximately 20 mm mercury; [0168]).
Regarding Claim 5, O’Dea discloses wherein the control unit is further configured to, in response to the warning signal, automatically reduce the pressure in the body cavity to a second pressure level (predefined working pressure) that is above the set target value (if the signals read by the microcontroller 18 from the pressure sensor 40 are indicative of the pressure in the cavity 2 reaching or just exceeding the predefined maximum pressure, the microcontroller 18 operates the piezoelectric sounder 45 to produce an audible alarm signal, and operates the vacuum pump 52 to draw insufflating air from the cavity 2 and also operates the flow control valve 16 to shut off the supply of insufflating air to the cavity 2, until the pressure of the insufflating air in the cavity 2 falls to or just below the predefined working pressure; [0180]; In one aspect of the invention the predefined working pressure lies in the range of 5 mmHg to 15 mmHg. Preferably, the predefined working pressure lies in the range of 10 mmHg to 15 mmHg. Advantageously, the predefined working pressure is approximately 15 mmHg. In one aspect of the invention the predefined maximum pressure lies in the range of 15 mmHg to 30 mmHg. Preferably, the predefined maximum pressure lies in the range of 20 mmHg to 30 mmHg. Advantageously, the predefined maximum pressure is approximately 20 mmHg; [0031-0032]; the predefined minimum pressure lies in the range of 5 mmHg to 15 mmHg. Preferably, the predefined minimum pressure lies in the range of 5 mmHg to 10 mmHg. Advantageously, the predefined minimum pressure is approximately 10 mmHg; [0072]; [0168]; Examiner’s Note: The “second pressure level” in the current application would be equivalent to the “predefined working pressure” of O’Dea, and the “set target value” in the current application would be equivalent to the “predefined minimum pressure” of O’Dea).
Regarding Claim 6, O’Dea discloses wherein the second pressure level is approximately 10 mm Hg above the set target value (if the signals read by the microcontroller 18 from the pressure sensor 40 are indicative of the pressure in the cavity 2 reaching or just exceeding the predefined maximum pressure, the microcontroller 18 operates the piezoelectric sounder 45 to produce an audible alarm signal, and operates the vacuum pump 52 to draw insufflating air from the cavity 2 and also operates the flow control valve 16 to shut off the supply of insufflating air to the cavity 2, until the pressure of the insufflating air in the cavity 2 falls to or just below the predefined working pressure; [0180]; In one aspect of the invention the predefined working pressure lies in the range of 5 mmHg to 15 mmHg. Preferably, the predefined working pressure lies in the range of 10 mmHg to 15 mmHg. Advantageously, the predefined working pressure is approximately 15 mmHg. In one aspect of the invention the predefined maximum pressure lies in the range of 15 mmHg to 30 mmHg. Preferably, the predefined maximum pressure lies in the range of 20 mmHg to 30 mmHg. Advantageously, the predefined maximum pressure is approximately 20 mmHg; [0031-0032]; the predefined minimum pressure lies in the range of 5 mmHg to 15 mmHg. Preferably, the predefined minimum pressure lies in the range of 5 mmHg to 10 mmHg. Advantageously, the predefined minimum pressure is approximately 10 mmHg; [0072]; Examiner’s Note: The “second pressure level” in the current application would be equivalent to the “predefined working pressure” of O’Dea, and the “set target value” in the current application would be equivalent to the “predefined minimum pressure” of O’Dea. O’Dea teaches wherein the predefined working pressure is preferably between 10 mmHg to 15 mmHg and wherein the predefined minimum pressure is preferably between 5 mmHg to 10 mmHg. Therefore, if the predefined working pressure was 15 mmHg and the predefined minimum pressure was 5 mmHg, the predefined working pressure would be 10 mmHg above the predefined minimum pressure).
Regarding Claim 7, O’Dea discloses wherein the control unit is configured to display the warning signal only after detecting either at least two separate pressure pulses exceeding the threshold value within a predetermined time period, or a single pressure increase lasting longer than a predefined duration (It will also be appreciated that a predefined time may elapse during which the pressure in the cavity vessel, lumen or organ may exceed the predefined maximum pressure or fall below the predefined minimum pressure before an alarm signal is sounded and such a predefined time period would be dependent upon the lumen, vessel cavity or organ in which the procedure is being carried out, and on the procedure being carried out; [0240]).
Regarding Claim 8, O’Dea discloses wherein the predefined duration is between 15 and 20 seconds (Preferably, the predefined time is selectable; [0014]; the predefined time period which the timer 65 is to be set to time, is inputted through the interface keypad 44 and typically would be in the range of 100 milliseconds to 20 seconds; [0187]; a predefined time period would be dependent upon the lumen, vessel cavity or organ in which the procedure is being carried out, and on the procedure being carried out; [0240]).
Regarding Claim 10, O’Dea discloses wherein the warning signal comprises a visual message on a display instructing an operator to check the patient's muscle relaxation (if the signals read by the microcontroller 18 from the pressure sensor 40 are indicative of the pressure in the cavity 2 reaching or just exceeding the predefined maximum pressure, the microcontroller 18 operates the piezoelectric sounder 45 to produce an audible alarm signal; [0179-0180]; While the alerting means has been described as comprising a piezoelectric sounder, any other suitable alarm generating means may be provided, and in certain cases, it is envisaged that the alarm generating means as well as or instead of producing an audible alarm signal may produce a visual alarm signal, or could produce both an audible and a visual alarm signal; [0241]; Examiner’s Note: The Examiner notes wherein the limitation “instructing an operator to check the patient's muscle relaxation” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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