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 § 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 1-3, 15-18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wisniewski (US 20170021122 A1).
Regarding claim 1, Wisniewski discloses a sensor arrangement for a medical device (As set forth in Abstract, [0001], and [0022]), the sensor arrangement comprising: a sensor unit (FIG. 1 Gas sampling apparatus 26 as set forth in [0022]) for determining a carbon dioxide concentration in a measured gas (As set forth in [0022] and [0031]); a branch line (FIG. 1 Gas sampling line 24 as set forth in [0022], the circuit tubing portion 20 as set forth in [0018], and the gas pathway in device 10 extending between the first port 42 and second port 46 as set forth in [0036]) for branching off the measured gas from a main line of the medical device (FIG. 1 The airway securing device 22, gas supply line 14, and return line 16 as set forth in [0018]) and for sending the branched-off measured gas to the sensor unit (FIG. 1 Gas sampling line 24 connected to a gas sampling apparatus 26 is typically connectable to the device 10 to enable the apparatus 26 to measure, inter alia, carbon dioxide levels in the gas as set forth in [0022]); and at least one heat and moisture exchanger filter (FIG. 1 The heat and moisture exchange means 54 of device 10; a filter heat and moisture exchange (FHME) device as set forth in [0015] and [0017]) for filtering the branched-off measured gas.
Regarding claim 2, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski further discloses, wherein the at least one heat and moisture exchanger filter is arranged in the branch line (FIG. 1 Gas sampling line 24 connected to a gas sampling apparatus 26 is typically connectable to the device 10 as set forth in [0022]; the first port 42 is a breathing system facing port connectable to the breathing system via line 20 as set forth in [0025]).
Regarding claim 3, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski further discloses, wherein the branch line has a main line-side end section (‘A’ in the annotated figure below) for connecting the branch line to the main line (FIG. 1. The second port 46 is connectable to device 22 in a spigot socket fashion as set forth in [0025]) and a sensor-side end section (‘B’ in the annotated figure below) for connecting the branch line to the sensor unit (FIG. 1 Sampling line 24 is connected to conventional sampling apparatus 26 as set forth in [0037]), wherein the at least one heat and moisture exchanger filter is arranged at the main line-side end section (As set forth in [0025], [0036], and shown in FIG. 1).
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Regarding claim 15, Wisniewski discloses a medical device for ventilating a person (As set forth in [0017]), the medical device (FIG. 1 The breathing circuit for ventilating a patient 12 with a gas) comprising: a main line for sending inhalation gas and for sending exhalation gas (FIG. 1 The airway securing device 22, gas supply line 14, and return line 16 as set forth in [0018], the arrows in FIG. 1 indicating the inhalation and exhalation gas flow); and a sensor arrangement (As set forth in Abstract, [0001], and [0022]) comprising: a sensor unit configured to determine a carbon dioxide concentration in a measured gas (FIG. 1 Gas sampling apparatus 26 as set forth in [0022] and [0031]); a branch line configured to branch off the measured gas from the main line and to guide the branched-off measured gas to the sensor unit (FIG. 1 Gas sampling line 24 as set forth in [0022], the circuit tubing portion 20 as set forth in [0018], and the gas pathway in device 10 extending between the first port 42 and second port 46 as set forth in [0036]); and at least one heat and moisture exchanger filter configured to filter the branched-off measured gas (FIG. 1 The heat and moisture exchange means 54 of device 10; a filter heat and moisture exchange (FHME) device as set forth in [0015] and [0017]).
Regarding claim 16, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Wisniewski further discloses, wherein the main line (FIG. 1 The airway securing device 22, gas supply line 14, and return line 16 as set forth in [0018], the arrows in FIG. 1 indicating the inhalation and exhalation gas flow) has an inhalation gas line section (FIG. 1 The airway securing device 22 and gas supply line 14 as set forth in [0018], the arrows in FIG. 1 indicating the inhalation gas flow) for sending the inhalation gas and a total gas line section for sending the inhalation gas as well as the exhalation gas (FIG. 1 The airway securing device 22 and return line 16 as set forth in [0018], the arrows in FIG. 1 indicating the inhalation and exhalation gas flow), wherein the branch line is configured for branching off the measured gas from the total gas line section (FIG. 1 Gas sampling line 24 as set forth in [0022], the circuit tubing portion 20 as set forth in [0018], and the gas pathway in device 10 extending between the first port 42 and second port 46 as set forth in [0036]).
Regarding claim 17, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 16 above.
Wisniewski further discloses, wherein the at least one heat and moisture exchanger filter is located within the total gas line section (FIG. 1 The heat and moisture exchange means 54 of device 10; a filter heat and moisture exchange (FHME) device as set forth in [0015] and [0017] located between the airway securing device 22 and the gas supply line 14 and return line 16 as shown in the figure).
Regarding claim 18, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 16 above.
Wisniewski further discloses, wherein at least one part of the branch line (FIG. 1 Gas sampling line 24 as set forth in [0022], the circuit tubing portion 20 as set forth in [0018], and the gas pathway in device 10 extending between the first port 42 and second port 46 as set forth in [0036]) extends within the main line from the total gas line section into the inhalation gas line section (FIG. 1 The circuit tubing portion 20 as set forth in [0018] and the gas pathway in device 10 extending between the first port 42 and second port 46 as set forth in [0036] extends between/within the airway securing device 22 and the return line 16 and gas supply line 14, as shown in the figure).
Regarding claim 21, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Wisniewski further discloses, wherein the medical device is configured as a ventilator (As set forth in [0017]).
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 4-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) as applied to claim 1.
Regarding claim 4, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski further discloses, wherein the branch line has a main line-side end section (‘A’ in the annotated figure below) for connecting the branch line to the main line (FIG. 1 The second port 46 is connectable to device 22 in a spigot socket fashion as set forth in [0025]) and a sensor-side end section (‘B’ in the annotated figure below) for connecting the branch line to the sensor unit (FIG. 1 Sampling line 24 is connected to conventional sampling apparatus 26 as set forth in [0037]), wherein the at least one heat and moisture exchanger filter is a first heat and moisture exchanger filter at the main line-side end section (As set forth in [0025], [0036], and shown in FIG. 1).
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Wisniewski fails to explicitly disclose that the arrangement further comprises a second heat and moisture exchanger filter at and/or in the sensor-side end section.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include a second heat and moisture exchanger filter at and/or in the sensor-side end section since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Doing so would further allow for the retention of at least some of the heat and moisture from air exhaled by the patient in the branch line (As set forth in [0029]).
Regarding claim 5, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Wisniewski further discloses, wherein the first heat and moisture exchanger filter (FIG. 1 The heat and moisture exchange means 54 of device 10; a filter heat and moisture exchange (FHME) device as set forth in [0015] and [0017]) is arranged in the main line-side end section of the branch line (FIG. 1. The second port 46 of device 10 is connectable to device 22 as set forth in [0025]) in the form of a hose insert (FIG. 1 (FIG. 1. The second port 46 is connectable to device 22 in a spigot socket fashion as set forth in [0025]); a spigot/socket fashion could include the connection type of a hose insert given the male/female end connection, where the hose comprises the male/spigot end, and the port of the HME comprises the female/socket end).
Wisniewski as modified is silent as to the dimensions of the lines and filter and therefore fails to explicitly disclose, wherein the branch line has, when viewed in the flow direction of the measured gas through the branch line, a larger internal diameter at an area of the heat and moisture exchanger filter than in an area located downstream of the heat and moisture exchanger filter.
However, though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Wisniewski clearly depicts the breathing circuit affixed to the patient (Fig. 1). In reference to the patients (12) head shown in the figure, it is clear that the sampling line (24) has a smaller internal diameter than the circuit tubing portion (20), second port (46), and the gas pathway in device (10) extending between the first port (42) and second port (46). Given the reference FIG. 1, it would be apparent that the branch line has, when viewed in the flow direction of the measured gas through the branch line, a larger internal diameter at an area of the heat and moisture exchanger filter than in an area located downstream of the heat and moisture exchanger filter.
Regarding claim 6, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Wisniewski as modified is silent as to the dimensions of its components and fails to explicitly disclose, wherein the internal diameter of the branch line has a value in a range of 2 mm to 4 mm at an area of the first heat and moisture exchanger filter and the internal diameter of the branch line has a value in a range of 0.5 mm to 2 mm downstream of the first heat and moisture exchanger filter.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the tubing dimensions of the device of Wisniewski to be wherein the internal diameter of the branch line has a value in a range of 2 mm to 4 mm at an area of the first heat and moisture exchanger filter and the internal diameter of the branch line has a value in a range of 0.5 mm to 2 mm downstream of the first heat and moisture exchanger filter, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the specific range of 2 mm to 4 mm, or 0.5 mm to 2 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the tube dimensions would be for ensuring condensate doesn’t interfere with the performance of the device and making it so that the dead space is as small as possible, corresponding to a short measuring delay as referenced in [0020] of the specification. The specification, and even states that the branch line in areas upstream of the heat and moisture exchanger filter and at an area of the heat and moisture exchanger filter can have the same internal diameter in [0021]. Further, it appears Wisniewski would perform equally well. MPEP 2144.05(II).
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 discover the optimal workable ranges since the general conditions of the claimed method are disclosed in the prior art (See MPEP § 2144.05.II.A).
Regarding claim 7, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski further discloses, wherein the at least one heat and moisture exchanger filter is configured in the form of a hose insert in the main line-side end section of the branch line (FIG. 1. The second port 46 of device 10 is connectable to device 22 as set forth in [0025]) in the form of a hose insert (FIG. 1 (FIG. 1. The second port 46 is connectable to device 22 in a spigot socket fashion as set forth in [0025]); a spigot/socket fashion could include the connection type of a hose insert given the male/female end connection, where the hose comprises the male/spigot end, and the port of the HME comprises the female/socket end).
Wisniewski as modified is silent as to the dimensions of the lines and filter and therefore fails to explicitly disclose, wherein the branch line has, when viewed in the flow direction of the measured gas through the branch line, a larger internal diameter in an area located upstream of the at least one heat and moisture exchanger filter than downstream of the at least one heat and moisture exchanger filter.
However, though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Wisniewski clearly depicts the breathing circuit affixed to the patient (Fig. 1). In reference to the patients (12) head shown in the figure, it is clear that the sampling line (24) has a smaller internal diameter than the circuit tubing portion (20), second port (46), and the gas pathway in device (10) extending between the first port (42) and second port (46). Given the reference FIG. 1, it would be apparent that the branch line has, when viewed in the flow direction of the measured gas through the branch line, a larger internal diameter in an area located upstream of the at least one heat and moisture exchanger filter than downstream of the at least one heat and moisture exchanger filter.
Regarding claim 8, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Wisniewski as modified is silent as to the dimensions of its components and fails to explicitly disclose, wherein the internal diameter of the branch line upstream of the at least one heat and moisture exchanger filter has a value in a range of 1.5 mm to 4 mm and the internal diameter of the branch line downstream of the at least one heat and moisture exchanger filter has a value in a range of 0.5 mm to 2 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the tubing dimensions of the device of Wisniewski to be wherein the internal diameter of the branch line has a value in a range of 1.5 mm to 4 mm at an area of the first heat and moisture exchanger filter and the internal diameter of the branch line has a value in a range of 0.5 mm to 2 mm downstream of the first heat and moisture exchanger filter since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the specific range of 1.5 mm to 4 mm, or 0.5 mm to 2 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the tube dimensions would be for ensuring condensate doesn’t interfere with the performance of the device and making it so that the dead space is as small as possible, corresponding to a short measuring delay as referenced in [0021] of the specification. The specification even states that the branch line in areas upstream of the heat and moisture exchanger filter and at an area of the heat and moisture exchanger filter can have the same internal diameter in [0021]. Further, it appears Wisniewski would perform equally well. MPEP 2144.05(II).
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 discover the optimal workable ranges since the general conditions of the claimed method are disclosed in the prior art (See MPEP § 2144.05.II.A) and there are a finite number of identified, predictable solutions to ensure condensate doesn’t interfere with the performance of the device and making it so that the dead space is as small as possible when provided with specific dimensions in reference to the internal diameter of the tubes.
Regarding claim 9, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski is silent as to the dimensions of its components and fails to explicitly disclose, wherein the at least one heat and moisture exchanger filter has a length in a range of 8 mm to 20 mm and a width in a range of 2 mm to 6 mm.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the heat and moisture exchanger filter have a length in a range of 8 mm to 20 mm and a width in a range of 2 mm to 6 mm in the device of Wisniewski because Applicant has not disclosed that the specific dimensions provide an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states that the heat and moisture exchanger filters used are dimensioned for patient gas streams of a flow of measured gas in a range of, e.g., 30 mL/min to 100 mL/min, and especially in a range of 40 mL/min to 70 mL/min from [0022] of the specification. One of ordinary skill in the art, furthermore, would have expected the dimensions of Wisniewski, and Applicant's dimensions, to perform equally well because both mechanisms perform the same function of ensuring the filter is dimensioned to allow for a specific rate of flow for the gas within the system.
Therefore, it would have been prima facie obvious to modify Wisniewski to obtain the invention as specified in claim 9, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired gas flow and thus fails to patentably distinguish over the prior art of Wisniewski.
Regarding claim 10, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski is silent as to the dimensions of its components and fails to explicitly disclose, wherein the branch line has a hose line with a length in a range of 80 cm to 150 cm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the tubing dimensions of the device of Wisniewski to be wherein the branch line has a hose line with a length in a range of 80 cm to 150 cm, for the purpose of ensuring an effective buffering effect can be achieved concerning the desired temperature and/or moisture compensation as referenced in [0023] of the specification, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the specific range of 80 cm to 150 cm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the tube dimensions would be for ensuring an effective buffering effect can be achieved. Further, it appears Wisniewski would perform equally well. MPEP 2144.05(II).
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 discover the optimal workable ranges since the general conditions of the claimed method are disclosed in the prior art (See MPEP § 2144.05.II.A).
Regarding claim 13, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski further discloses the branch line has a spigot socket connection for establishing a fluid connection with the main line (FIG. 1 The second port 46 is connectable to device 22 in a spigot socket fashion as set forth in [0025]).
Wisniewski fails to explicitly disclose wherein the exact type of spigot socket connection is a luer lock fitting.
However, Wisniewski teaches a luer lock fitting between different components within the device (FIG. 1-2 The sampling member 64 may define a luer lock 66 attachable to the gas sampling port 56 with a sealed fit as set forth in [0032]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the branch line and main line of Wisniewski to incorporate the teaching of Colman and include wherein the fitting is specifically a luer lock fitting (FIG. 1-2 The sampling member 64 may define a luer lock 66 attachable to the gas sampling port 56 with a sealed fit as set forth in [0032]). Doing so would provide a sealed fit and make for easy attachment (As set forth in [0032]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) as applied to claim 1, in view of Mantell (US 20040153027 A1).
Regarding claim 11, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski is silent as to the material composition of the device components and fails to explicitly disclose, wherein the branch line has a hose line made of silicone or at least predominantly formed of silicone.
However, Mantell teaches wherein a hose line is made of silicone (Mantell: As set forth in [0026]).
Wisniewski and Mantell are both considered to be analogous to the claimed invention because they are in the same field of medical tubing provided for gas delivery to a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the branch line of Wisniewski to incorporate the teaching of Mantell and include wherein the hose line is made of silicone (Mantell: As set forth in [0026]). Doing so would ensure the reusability and flexibility of the tubing (Mantell: As set forth in [0026]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) as applied to claim 1, in view of Colman (US 20090312662 A1).
Regarding claim 12, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski is silent as to the material composition of the device components and fails to explicitly disclose, wherein the branch line has a hose line with a PVC coating on an outer circumferential surface of the hose line.
However, Colman teaches wherein the branch line has a hose line with a PVC coating on an outer circumferential surface of the hose line (Colman: FIG. 1 The outlet tube 120 is made from flexible PVC as set forth in [0045]; the tube being made of PVC indicating that the PVC would be coating an outer circumferential surface of the hose line).
Wisniewski and Colman are both considered to be analogous to the claimed invention because they are in the same field of medical tubing in a system for sampling and analysis of exhaled breath. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the branch line of Wisniewski to incorporate the teaching of Colman and include wherein the branch line has a hose line with a PVC coating on an outer circumferential surface of the hose line (Colman: FIG. 1 The outlet tube 120 is made from flexible PVC as set forth in [0045]; the tube being made of PVC indicating that the PVC would be coating an outer circumferential surface of the hose line). Doing so would provide the tubing with flexible PVC for ease in handling and cost considerations (Colman: As set forth in [0045]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) as applied to claim 1, in view of Natale (WO 9903525 A1).
Regarding claim 14, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Wisniewski is silent as to the material composition of the heat and moisture exchange means and fails to explicitly disclose, the at least one heat and moisture exchanger filter comprises has a microporous plastic foam.
However, Natale teaches wherein the heat and moisture exchanger filter comprises has a microporous plastic foam (Natale: The heat and moisture exchange element can comprise a urethane plastic foam as set forth on page 15 lines 6-14).
Wisniewski and Natale are both considered to be analogous to the claimed invention because they are in the same field of heat and moisture exchange filters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat and moisture exchange means of Wisniewski to incorporate the teaching of Natale and include, wherein the heat and moisture exchanger filter comprises has a microporous plastic foam (Natale: The heat and moisture exchange element can comprise a urethane plastic foam as set forth on page 15 lines 6-14). Doing so provides a known filter media suitable for use in the filter arrangement (Natale: As set forth on page 15 lines 6-14).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) as applied to claim 16, in view of Bowman (US 20120097156 A1).
Regarding claim 19, Wisniewski discloses the claimed invention substantially as claimed as set forth for claim 16 above.
Wisniewski fails to explicitly disclose wherein an exhalation valve is configured in the total gas line section for releasing exhalation gas from the medical device into the area surrounding the medical device, wherein the at least one heat and moisture exchanger filter is formed in the exhalation valve.
However, Bowman teaches an exhalation valve (Bowman: FIG. 8a Shows a portion of the user interface defining the HME cavity, with vent 80 as set forth in [0070]) for releasing exhalation gas from the medical device into the area surrounding the medical device (Bowman: As set forth in [0070]), wherein the at least one heat and moisture exchanger filter is formed in the exhalation valve (Bowman: FIG. 8C HME element 70 as set forth in [0070]).
Wisniewski and Bowman are both considered to be analogous to the claimed invention because they are in the same field of apparatuses utilizing heat and moisture exchangers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device (10), connected to the airway securing device (22) of the total gas line section, containing the heat and moisture exchange means of Wisniewski to incorporate the teaching of Bowman and include an exhalation valve (Bowman: FIG. 8a Shows a portion of the user interface defining the HME cavity, with vent 80 as set forth in [0070]) for releasing exhalation gas from the medical device into the area surrounding the medical device (Bowman: As set forth in [0070]), wherein the at least one heat and moisture exchanger filter is formed in the exhalation valve (Bowman: FIG. 8C HME element 70 as set forth in [0070]). Doing so would allow for a majority of the carbon dioxide to be vented off (Bowman: As set forth in [0070]).
Regarding claim 20, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 19 above.
Wisniewski as modified by Bowman further teaches, wherein the branch line is connected to the exhalation valve for branching off the measured gas from the main line (Bowman is modifying the device 10 of Wisniewski to be an exhalation valve; the branch line of Wisniewski which includes FIG. 1 Gas sampling line 24 as set forth in [0022] and the circuit tubing portion 20 as set forth in [0018] are directly in communication with device 10 as shown in FIG. 1).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) in view of Bowman (US 20120097156 A1).
Regarding claim 22, Wisniewski discloses a medical device in accordance with claim 15 (See rejection for claim 15 above).
Wisniewski fails to explicitly disclose an exhalation valve for releasing exhalation gas from the medical device into an area surrounding the medical device, the exhalation valve comprising, having a heat and moisture exchanger filter integrated into the exhalation valve for filtering a measured gas branched off from the medical device via the exhalation valve.
However, Bowman teaches an exhalation valve (Bowman: FIG. 8a Shows a portion of the user interface defining the HME cavity, with vent 80 as set forth in [0070]) for releasing exhalation gas from the medical device into an area surrounding the medical device (Bowman: As set forth in [0070]), the exhalation valve comprising, having a heat and moisture exchanger filter integrated into the exhalation valve (Bowman: FIG. 8C HME element 70 as set forth in [0070]) for filtering a measured gas from the medical device via the exhalation valve (Bowman: The HME element 70 of the portion of the user interface is generally configured to collect moisture and heat from expired air as set forth in [0071]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device (10), connected to the airway securing device (22) of the total gas line section, containing the heat and moisture exchange means for the branched of gas of Wisniewski to incorporate the teaching of Bowman and include an exhalation valve (Bowman: FIG. 8a Shows a portion of the user interface defining the HME cavity, with vent 80 as set forth in [0070]) for releasing exhalation gas from the medical device into an area surrounding the medical device (Bowman: As set forth in [0070]), the exhalation valve comprising, having a heat and moisture exchanger filter integrated into the exhalation valve (Bowman: FIG. 8C HME element 70 as set forth in [0070]) for filtering a measured gas from the medical device via the exhalation valve (Bowman: The HME element 70 of the portion of the user interface is generally configured to collect moisture and heat from expired air as set forth in [0071]). Doing so would allow for a majority of the carbon dioxide to be vented off (Bowman: As set forth in [0070]).
Regarding claim 23, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 22 above.
Wisniewski as modified by Bowman further teaches the exhalation valve (The device 10 of Wisniewski as modified by Bowman to be an exhalation valve) further comprising: a valve port for connecting the branch line for branching off the measured gas from the main line of the medical device through the heat and moisture exchanger filter (FIG. 3 Gas sampling port 56 on device 10 containing the heat and moisture exchange means 54, connects to the sampling line 24 portion of the branch line as set forth in [0031]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) in view of Bowman (US 20120097156 A1) as applied to claim 22, in further view of Natale (WO 9903525 A1).
Regarding claim 24, Wisniewski as modified discloses the claimed invention substantially as claimed as set forth for claim 22 above.
Wisniewski as modified is silent as to the material composition of components within the device and fails to explicitly disclose, wherein the integrated heat and moisture exchanger filter comprises a microporous plastic foam.
However, Natale teaches wherein the heat and moisture exchanger filter comprises has a microporous plastic foam (Natale: The heat and moisture exchange element can comprise a urethane plastic foam as set forth on page 15 lines 6-14).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat and moisture exchange means of Wisniewski to incorporate the teaching of Natale and include, wherein the heat and moisture exchanger filter comprises has a microporous plastic foam (Natale: The heat and moisture exchange element can comprise a urethane plastic foam as set forth on page 15 lines 6-14). Doing so provides a known filter media suitable for use in the filter arrangement (Natale: As set forth on page 15 lines 6-14).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122 A1) in view of Hubert (US 3035569 A).
Regarding claim 25, Wisniewski discloses a process for determining a carbon dioxide concentration in a measured gas (As set forth in [0022] and [0031], the capnogram 32 representing concentration), the process comprising the steps of: providing a sensor arrangement (As set forth in Abstract, [0001], and [0022]) comprising a sensor unit (FIG. 1 Gas sampling apparatus 26 as set forth in [0022]), a branch line (FIG. 1 Gas sampling line 24 as set forth in [0022], the circuit tubing portion 20 as set forth in [0018], and the gas pathway in device 10 extending between the first port 42 and second port 46 as set forth in [0036]) configured to branch off the measured gas from a main line of a medical device (FIG. 1 The airway securing device 22, gas supply line 14, and return line 16 as set forth in [0018]) and to guide the branched-off measured gas to the sensor unit (FIG. 1 Gas sampling line 24 connected to a gas sampling apparatus 26 is typically connectable to the device 10 to enable the apparatus 26 to measure, inter alia, carbon dioxide levels in the gas as set forth in [0022]), and a moisture exchanger filter configured to filter the branched-off measured gas (FIG. 1 The heat and moisture exchange means 54 of device 10; a filter heat and moisture exchange (FHME) device as set forth in [0015] and [0017]).
Wisniewski fails to explicitly disclose that the carbon dioxide concentration is determined by measuring heat conductivity of the exhalation gas with the sensor unit.
However, Hubert teaches determining carbon dioxide concentration by measuring heat conductivity of the exhalation gas (Hubert: As set forth in column 1 lines 18-35)
Wisniewski and Hubert are both considered to be analogous to the claimed invention because they are in the same field of apparatus for determining carbon dioxide in exhaled air. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of carbon dioxide concentration determination and sensor unit of Wisniewski to incorporate the teaching of Hubert and include determining carbon dioxide concentration by measuring heat conductivity of the exhalation gas (Hubert: As set forth in column 1 lines 18-35). Doing so provides a known method of carbon dioxide concentration determination suitable for use in the presence of a sensor unit with the means of acquiring data regarding the heat conductivity of the exhalation gas.
Conclusion
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785