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 .
Information Disclosure Statement
An information disclosure statement has not been received. If the applicant is aware of any prior art or any other co-pending applications not already of record, he/she is reminded of his/her duty under 37 CFR 1.56 to disclose the same.
Specification Objection
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. This may result in slightly longer titles, but the loss in brevity of title will be more than offset by the gain in its informative value in indexing, classifying, searching, etc. If a satisfactory title is not supplied by the applicant, the Examiner may, at the time of allowance, change the title by an Examiner’s amendment. See MPEP § 1302.04(a).
The following title is suggested: Submerged Pressure Based Leakage Testing of a Medical Device.
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.
Claims 1-12 & 17-19 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 & 17 recite a similar set of unclear limitations “an input device that receives an input indicating an amount of time elapsed since the medical device was used in a medical procedure” and the limitation “control circuitry that determines a pass or fail result of the leak test on the medical device based on sensor data received from the pressure sensor, the temperature sensed by the temperature sensor and the input received by the input device” which is functionally unclear. The input device is the structure capable of receiving a time elapsed among other inputs so is the “amount of time elapsed” required in the pass or fail result? Clarity is needed on what is required to determine a pass or fail result of the leak test. Examiner looks to the specification and determines [0042] a threshold of time lapsed since the medical device was used in a medical procedure is required for the leak pass or fail determination.
Claim 6 recites an element of “the absolute sensor” which is unclear and the element seems to refer to the previously cited “absolute pressure sensor”. Consistent use of terms are needed for clarity.
All dependent claims are rejected for their dependence on a rejected base 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 13 is rejected under 35 U.S.C. 102 (a)(1&2) as being anticipated by Moritomo (US 20200337527: “Moritomo”).
Claim 13. Moritomo discloses a method (Fig. 3) of performing a leak test on a medical device (Fig. 1: 10) with a leak testing device (10 endoscope)[0004], comprising the steps of: pressurizing [0038] an interior volume (S304)[0048] that is at least partially defined by the medical device (10) [0028 & 0048]; receiving sensor data from a pressure sensor (105) in fluid communication with the interior volume [0048]; sensing a temperature of water within a water bath in which the medical device (10) is submerged [0052-0054]; and determining a pass or fail result of the leak test based on the sensed temperature of the water and the sensor data received from the pressure sensor (105) [0060, 0062 & 0064].
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 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moritomo (US 20200337527: “Moritomo”) in view of Grezler (US 20010032494: “Grezler”) and in further view of Antonioli (US 20180271356: “Antonioli”).
Claim 1. Moritomo discloses a leak testing device (Figs. 1 & 2) for performing a leak test on a medical device (10)[0004], comprising: an air unit (104) configured to provide air [0038]; an airflow assembly (2, 106 & 107) operably coupled to the air unit (104)[0035], defining an airflow passage [0038], and being configured to convey air [0042] from the air unit (104) to a medical device (10) selectively engaged with the airflow assembly (2, 106 & 107) [0048]; a pressure sensor (105) in fluid communication with air disposed within an interior volume that is defined by the airflow assembly (2, 106 & 107) [0052-0054] and the medical device (10) [0038 & 0048]; a temperature sensor [0052-0054] that senses a temperature of water within a water bath within which the medical device is submerged [0052-0054]; an input device (102) that receives an input [0032] and control circuitry (101) that determines a pass or fail result of the leak test on the medical device (10) based on sensor data received from the pressure sensor (105), the temperature sensed by the temperature sensor [0052-0054], and the input received by the input device (102)[0060, 0062 & 0064]. Moritomo does not explicitly disclose
1) the air unit is an air compressor configured to provide compressed air.
2) the input device that receives an input indicating an amount of time elapsed since the medical device was used in a medical procedure.
With regard to 1) Grezler teaches a leak detection system evaluates the integrity of an endoscope based on pressure [Abstract]. Grezler further teaches the air unit (22) is an air compressor (22) configured to provide compressed air [0030].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Grezler’s air compressor for compressing air as Moritomo’s air unit because an air compressor provides compressed air at a reliable fixed rate and pressure which allows for reliable analysis of pressure drops across the leakage monitored device.
With regard to 2) Antonioli teaches a computer systems and software for controlling an endoscope integrity tester [Abstract]. Antonioli further teaches the input device (30) that receives an input indicating an amount of time elapsed (e.g. continuous clock for tagging procedural times is running elapsed time) since the medical device was used in a medical procedure [0053: The collected data sent from the control module 30 to the procedure room computer system may include date, start time, stop time, tool ID #, patient identification information, pressure vs. time data, and any other available data] & [0048: This includes the ability to log performance of the tool 2 over a timed interval made retrievable through any of the aforementioned techniques].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Antonioli’s time logging of a medical procedure with Moritomo ’s, as modified, leakage testing because the active status improves testing efficiency by establishing recent usage requires regular leakage testing for the active medical device.
Claim 12. Dependent on the leak testing device of claim 1. Moritomo further discloses the medical device (10) is an endoscope [0004].
Claims 2-7 & 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Moritomo in view of Grezler and Antonioli and in further view of Gocho (US 20050056081: “Gocho”).
Claim 2. Dependent on the leak testing device of claim 1. Moritomo, as modified, does not explicitly disclose:
the pressure sensor is a differential pressure sensor.
Gocho teaches testing leakage with pressure to determine whether or not a gas is leaking from the endoscope on the basis of the amount of gas leaking based on the pressure difference [0028]. Gocho further teaches the pressure sensor (Fig. 14 with reference to Fig. 7 for discussion: 45) is a differential pressure sensor [0103] & [0116].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gocho’s differential pressure sensor with pressurized gas and a reference pressure point with Moritomo’s, as modified, pressure sensing because the fixed compressed air pressure point to one pressure sensor port while second port measures the pressure to the endoscope to determine presence of a pressure leak improves leakage measurement with a reliable fixed pressure point [Gocho 100].
Claim 3. Dependent on the leak testing device of claim 2.
Moritomo, as modified, does not explicitly disclose:
the differential pressure sensor senses a difference in pressure between the compressed air disposed within the interior volume that is defined by the airflow assembly and the medical device and compressed air that is disposed within a secondary interior volume defined by the airflow assembly, and wherein the control circuitry determines the pass or fail result of the leak test based on the sensed difference in pressure.
Gocho teaches testing leakage with pressure to determine whether or not a gas is leaking from the endoscope on the basis of the amount of gas leaking based on the pressure difference [0028]. Gocho further teaches the pressure sensor (Fig. 14 with reference to Fig. 7 for discussion: 45) is a differential pressure sensor [0103] & [0116] senses a difference in pressure between the compressed air disposed within the interior volume (102) that is defined by the airflow assembly (61) and the medical device (102) and compressed air that is disposed within a secondary interior volume (49) defined by the airflow assembly (61), and wherein the control circuitry (50) determines the pass or fail result of the leak test based on the sensed difference in pressure [0014 & 0017].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gocho’s differential pressure sensor with pressurized gas and a reference pressure point with Moritomo’s, as modified, pressure sensing because the fixed compressed air pressure point to one pressure sensor port while second port measures the pressure to the endoscope to determine presence of a pressure leak improves leakage measurement with a reliable fixed pressure point [Gocho 100].
Claim 4. Dependent on the leak testing device of claim 3. Moritomo further discloses a first valve (106) operable between an open condition and a closed condition [0038], wherein the first valve (106) partitions the airflow passage into a proximal portion disposed between the first valve (106) and the air unit (104) and a distal portion that is not in fluid communication with the air unit (104)[0038]. Moritomo, as modified, does not explicitly disclose:
a second valve operable between an open condition and a closed condition, wherein the second valve partitions the distal portion of the airflow passage into a first distal portion that is a portion of the interior volume and a second distal portion that is at least a portion of the secondary interior volume.
Gocho teaches testing leakage with pressure to determine whether or not a gas is leaking from the endoscope on the basis of the amount of gas leaking based on the pressure difference [0028]. Gocho further teaches a second valve (Fig. 14: 43) operable between an open condition and a closed condition [0104] wherein the second valve (43) partitions the distal portion of the airflow passage into a first distal portion that is a portion of the interior volume (101) and a second distal portion that is at least a portion of the secondary interior volume (49)[0104].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gocho’s differential pressure sensor with pressurized gas and a reference pressure point and a separating valve with Moritomo’s, as modified, pressure sensing because a valve separating the fixed compressed air pressure point to one pressure sensor port while second port measures the pressure to the endoscope to determine presence of a pressure leak improves leakage measurement with a reliable fixed pressure point [Gocho 100].
Claim 5. Dependent on the leak testing device of claim 4. Moritomo further discloses the proximal portion of the airflow passage (2) is in fluid communication with the air unit (104) in the closed condition of the first valve (106) [0037-0038].
Claims 6 & 7. Dependent on the leak testing device of claim 4. Moritomo, as modified, does not explicitly disclose:
at least one of a gauge pressure sensor and an absolute pressure sensor that is in fluid communication with the first distal portion of the airflow passage in the closed condition of the first valve and the closed condition of the second valve, the at least one of the gauge pressure sensor and the absolute sensor being configured to sense the pressure of compressed air in fluid communication with the at least one of the gauge pressure sensor and the absolute pressure sensor and the control circuitry further determines the pass or fail result of the leak test based on the pressure sensed by the at least one of the gauge pressure sensor and the absolute pressure sensor.
Gocho teaches testing leakage with pressure to determine whether or not a gas is leaking from the endoscope on the basis of the amount of gas leaking based on the pressure difference [0028]. Gocho further teaches at least one of a gauge pressure sensor (Fig. 14: 52) that is in fluid communication with the first distal portion of the airflow passage in the closed condition of the first valve (42) and the closed condition of the second valve (43), the at least one of the gauge pressure sensor (52) being configured to sense the pressure of compressed air in fluid communication with the at least one of the gauge pressure sensor (52) [0104] and the control circuitry (50) further determines the pass or fail result of the leak test based on the pressure sensed by the at least one of the gauge pressure sensor (52) [0127].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gocho’s both gauge pressure sensor and differential pressure sensor with pressurized gas and a reference pressure point and a separating valve with Moritomo’s, as modified, pressure sensing because a gauge pressure sensor along with a differential pressure sensor to measure a pressure leak improves leakage measurement and reliability with a direct measurement of the endoscope when the reference point is not available [Gocho 100].
Claim 10. Dependent on the leak testing device of claim 3. Moritomo further discloses the control circuitry (101) determines the pass or fail result of the leak test [0060, 0062 & 0064] based on the sensed difference in pressure [0058] as a function of the sensed temperature [0052-0054].
Claim 11. Dependent on the leak testing device of claim 10. Moritomo further discloses the control circuitry (101) determines the pass or fail result of the leak test [0060, 0062 & 0064] based on the sensed difference in pressure as a function of time [0058].
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Moritomo in view of Grezler, Antonioli and Gocho and in further view of Feld (US 7901349: “Feld”).
Claims 8 & 9. Dependent on the leak testing device of claim 4. Moritomo, as modified, does not explicitly disclose:
the airflow assembly comprises: a manifold that defines the proximal portion, first distal portion, and second distal portion of the airflow passage, the manifold being a single unitary body and the manifold defines a plurality of bore holes that form the proximal portion, first distal portion, and second distal portion of the airflow passage.
Feld teaches an apparatus and method for detecting connectivity in a channel in an endoscope [Abstract]. Feld further teaches the airflow assembly (Fig. 6: 38) comprises: a manifold (38) that defines the proximal portion (branching via valves internal to 38), first distal portion (inputs from pressure source), and second distal portion (outputs to endoscope) of the airflow passage (38), the manifold (38) being a single unitary body [Col. 3 lines 25-35] block with and the manifold defines a plurality of bore holes that form the proximal portion (branching via valves internal to 38, first distal portion (inputs from pressure source),, and second distal portion (outputs to endoscope) of the airflow passage [Col. 3 lines 25-35].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Feld’s unitary manifold connection block with Moritomo’s, as modified, air passages because a manifold connection block provides a reliable and protected connection block for configuring the air passages between the air source and the monitored device
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Moritomo in further view of Gocho (US 20050056081: “Gocho”).
Claim 14. Dependent on the method of claim 13. Moritomo does not explicitly disclose:
the pressure sensor is a differential pressure sensor that senses a difference in pressure between compressed air within the interior volume and compressed air within a secondary interior volume that is not in fluid communication with the medical device.
Gocho teaches testing leakage with pressure to determine whether or not a gas is leaking from the endoscope on the basis of the amount of gas leaking based on the pressure difference [0028]. Gocho further teaches the pressure sensor (Fig. 14 with reference to Fig. 7 for discussion: 45) is a differential pressure sensor [0103] & [0116] senses a difference in pressure between the compressed air disposed within the interior volume (102) that is defined by the airflow assembly (61) and the medical device (102) and compressed air that is disposed within a secondary interior volume (49) volume that is not in fluid communication (valve 43 cuts communication between the two interior volumes) with the medical device (102) [0014 & 0017].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Gocho’s differential pressure sensor with pressurized gas and a reference pressure point with Moritomo’s, as modified, pressure sensing because the fixed compressed air pressure point to one pressure sensor port while second port measures the pressure to the endoscope to determine presence of a pressure leak improves leakage measurement with a reliable fixed pressure point [Gocho 100].
Claim 15. Dependent on the method of claim 14. Moritomo further discloses the pass or fail result of the leak test [0060, 0062 & 0064] is determined based on the sensed difference in pressure [0058: change in pressure within a time period] as a function of the sensed temperature [0052-0054].
Claim 16. Dependent on the method of claim 14. Moritomo further discloses the pass or fail result of the leak test [0060, 0062 & 0064] is determined based on the sensed difference in pressure as a function of time [0058: change in pressure within a time period].
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Moritomo in view of Antonioli (US 20180271356: “Antonioli”).
Claim 17. Dependent on the method of claim 13. Moritomo further discloses the pass or fail result of the leak test is determined based on the received input [0060, 0062 & 0064] Moritomo, as modified, does not explicitly disclose:
receiving, via an input device, an input indicating an amount of time elapsed since the medical device was used in a medical procedure.
Antonioli teaches a computer systems and software for controlling an endoscope integrity tester [Abstract]. Antonioli further teaches receiving, via the input device (30) an input indicating an amount of time elapsed (e.g. continuous clock for tagging procedural times is running elapsed time) since the medical device was used in a medical procedure [0053: The collected data sent from the control module 30 to the procedure room computer system may include date, start time, stop time, tool ID #, patient identification information, pressure vs. time data, and any other available data] & [0048: This includes the ability to log performance of the tool 2 over a timed interval made retrievable through any of the aforementioned techniques].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Antonioli’s time logging of a medical procedure with Moritomo ’s, as modified, leakage testing because the active status improves testing efficiency by establishing recent usage requires regular leakage testing for the active medical device.
Claim 18. Dependent on the method of claim 17. Moritomo further discloses the input device (102) is a human-machine interface of the leak testing device [0048].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Moritomo in view of Antonioli and in further view of Williams (US 20040118413: “Williams”).
Claim 19. Dependent on the method of claim 18. Moritomo further discloses the human-machine interface (102)[0048: LCD display]. Moritomo, as modified, does not explicitly disclose:
the human-machine interface comprises a touchscreen.
Williams teaches monitoring an endoscope to detect air leaking into the at least one channel comprises monitoring the pressure within the channel [0009]. Williams further teaches the human-machine interface (22) for the system comprises a touchscreen (22)[0019: The visual display 22 is preferably combined with a touch screen input device] & [0048].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use William’s input interface of a touchscreen with Moritomo ’s input display because a touchscreen is a space efficient input and output device for use in a compact work environment.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Moritomo (US 20200337527: “Moritomo”) in view of Grezler (US 20010032494: “Grezler”).
Claim 20. Moritomo discloses a leak testing device (Figs. 1 & 2) for performing a leak test on a medical device (10: endoscope), comprising: an air unit (104) configured to provide air [0035: The air pump 104 has a function of supplying air into the endoscope device 10 to increase the pressure inside the endoscope device 10 (pressurizing function)]; an airflow assembly (2, 106 & 107) operably coupled to the air unit (104) and configured to convey air from the air to a medical device (10)[0035] selectively engaged with the airflow assembly (2, 106 & 107)[0038]; a pressure sensor (105) in fluid communication with air disposed within an interior volume that is defined by at least a portion of the airflow assembly (2, 106 & 107)[0038 & 0048] and the medical device (10) [0038 & 0048] a temperature sensor [0052-0054] that senses a temperature of water within a water bath within which the medical device (10) is submerged [0052-0054]; and control circuitry (101) that determines a pass or fail result of the leak test [[0060, 0062 & 0064] on the medical device (10) based on sensor data received from the pressure sensor (105) and the temperature sensed by the temperature sensor [0052-0054]. Moritomo does not explicitly disclose:
the air unit is an air compressor configured to provide compressed air.
Grezler teaches a leak detection system evaluates the integrity of an endoscope based on pressure [Abstract]. Grezler further teaches the air unit (22) is an air compressor (22) configured to provide compressed air [0030].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use Grezler’s air compressor for compressing air as Moritomo’s air unit because an air compressor provides compressed air at a reliable fixed rate and pressure which allows for reliable analysis of pressure drops across the leakage monitored device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Monica S Young whose telephone number is (303)297-4785. The examiner can normally be reached M-F 08:30-05:30 MST.
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/MONICA S YOUNG/Examiner, Art Unit 2855
/PETER J MACCHIAROLO/Supervisory Patent Examiner, Art Unit 2855
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