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
In the reply filed 4/17/2026, Applicant amended claims 1, 14, and 24, and added new claims 28-29. Claims 1-29 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-29 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. The rejection below has been modified in response to Applicant’s amendments to the claims.
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, 7, 10-15, 17, 20-23, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Maurer (US 2016/0095969) in view of Elgas (US 5,922,202) and Huang et al. (US 2008/0035568).
With respect to Claim 1, Maurer teaches a device 1 for extracorporeal conditioning of blood (specifically a blood oxygenator; see Abstract; see the embodiments of Figures 7a-7b), the device comprising:
a housing 2 comprising a fluid inlet 4.1 and a fluid outlet 4.2, the housing defining an internal chamber (the interior of housing 2; Figure 7b);
a fiber assembly (10, 17) disposed within the internal chamber, the fiber assembly having a peripheral edge the outer edge of fiber assembly 10, adjacent potting material 11; Figures 7a-7b);
potting material 22 disposed throughout the peripheral edge to create at least a portion of a circumferential seal that defines a flow path through the fiber assembly that has a substantially circular cross-sectional shape (Figures 4a; paragraphs 0125-0142], wherein:
the fluid inlet 4.1 defines an inlet lumen in fluid communication with the flow path (Figure 7b; the flow path is illustrated by flow arrows “B”); and
the fluid outlet 4.2 defines an outlet lumen in fluid communication with the flow path (Figure 7b; the flow path is illustrated by flow arrows “B”).
Maurer further teaches that the fiber assembly of the device may be configured to provide both gas (oxygen) exchange and heat exchange (paragraphs [0025], [0035], and [0084]). Maurer, however, does not specifically teach a sensor module disposed on at least one of the fluid inlet or the fluid outlet to measure a property of fluid flowing through the at least one of the fluid inlet or the fluid outlet.
Elgas teaches a blood oxygenator and heat exchange module that is configured to provide surgical support by maintaining a patient’s blood at a predetermined temperature while replacing carbon dioxide with oxygen (Column 1, Lines 4-36).
Specifically, temperature is monitored by a temperature sensing module 36 that is mounted on the blood outlet 32, the temperature sensing module comprising a thermistor or other temperature sensing device, thereby allowing the temperature of the blood to be precisely monitored and regulated (Figures 2-3; Column 4, Lines 41-49). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s blood oxygenator device to have a sensor module with a temperature sensor therein disposed on the blood outlet of the device, as suggested by Elgas, in order to allow the temperature of the blood to be precisely monitored and regulated (Column 4, Lines 41-49).
Maurer also does not specifically teach that the housing comprises a window configured to enable visual observation of fluid within the housing. However, Huang teaches an apparatus for extracorporeal treatment of blood, which is in the same field of endeavor. The apparatus comprises a housing 100 having a blood flow path extending from a blood inlet 112, through a plurality of tubular membranes 130, and to a blood outlet 122, and a treatment fluid flow path extending from an inlet 124 to a chamber 102 surrounding the tubular membranes 130, to an outlet 126 (Figures 1-2; Abstract and paragraphs [0089-0091]). Specifically, Huang teaches that the housing 100 comprises an inlet cap 104 containing the blood inlet 112 and an outlet cap 106 containing the blood outlet 122 (Figure 1; paragraph [0075]), wherein the inlet cap 104 and outlet cap 106 may be made from a translucent material, thereby defining windows that enable visual inspection of the interior of the filter module (paragraph [0075]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s extracorporeal conditioning device to have translucent windows adjacent the blood inlet and/or blood outlet, as suggested by Huang, in order to enable visual inspection of the interior of the filter module (paragraph [0075]).
With respect to Claim 2, Maurer and Elgas as combined above reasonably suggest the use of a sensor module comprising a temperature sensor (Elgas: Figures 2-3; Column 4, Lines 41-49). See the rejection of Claim 1 above.
With respect to Claim 3, Elgas teaches that the temperature of the outgoing blood “can be monitored by a circuit” of the temperature sensing device 36 (Column 4, Lines 45-48), but Maurer and Elgas do not specifically teach that the sensor is operably connected to a controller by an electrical or wireless connection, and wherein the controller is adapted to process information relating to the one or more sensors and display the information on a panel viewable by a user.
However, the examiner takes official notice that it is notoriously well known in the art, and capable of instantaneous and unquestionable demonstration, to have a controller receive data from a sensor and display that data on a panel that is viewable by a user. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the extracorporeal conditioning device of Maurer and Elgas to have a controller receive data from a sensor and display that data on a panel that is viewable by a user, as is commonplace in the art, in order to provide a well-known means for allowing the user to monitor the blood temperature at the outlet of the device.
With respect to Claim 5, Maurer and Elgas as combined above reasonably suggest the use of a sensor module 36 comprising a temperature sensor that is disposed at the fluid outlet 32 of the device (Elgas: Figures 2-3; Column 4, Lines 41-49). See the rejection of Claim 1 above.
With respect to Claim 7, Maurer and Elgas as combined above reasonably suggest that the property of the fluid comprises temperature, and wherein the sensor module comprises a temperature sensor to measure the temperature of the fluid flowing through the fluid outlet. Specifically, Elgas teaches temperature sensor module 36 configured to measure the temperature of blood flowing through the blood outlet 32 Figures 2-3; Column 4, Lines 41-49). See the rejection of Claim 1 above.
With respect to Claim 10, Maurer teaches that the housing 2 comprises a substantially square housing with one or more rounded corners (Figures 7a-7b).
With respect to Claim 11, Maurer teaches that the housing 2 comprises a first side (adjacent inlet 4.1), a second side (adjacent outlet 4.2), and four sidewalls connecting the first side to the second side (Figures 7a-7b), wherein the first side and the second side are substantially square-shaped, wherein the fluid inlet is disposed on the first side, and wherein the fluid outlet is disposed on the second side (Figures 7a-7b).
With respect to Claim 12, Maurer teaches the device as claimed, wherein the device further comprises a gas inlet and a gas outlet (paragraph [0042]; one of the gas inlet or outlet is generically shown in the top left corner of the housing in Figure 7b). However, Maurer’s embodiment of Figures 7a-7b does not specifically illustrate that the gas inlet and gas outlet are disposed on one of the four sidewalls of the housing.
In a different embodiment (Figures 12A-14), Maurer teaches a similar configuration for the blood oxygenation device wherein the gas inlet 5.1 and gas outlet 5.2 are disposed on a sidewall of the device (Figure 13A; paragraph [0157]), such that they are in fluid communication with the hollow fibers of the oxygenator module to allow fluid to pass through the interiors of the hollow fibers to allow gas exchange to occur [0050]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s blood oxygenator to have the gas inlet and gas outlet disposed in the sidewalls thereof, as suggested by Maurer in the embodiment of Figures 12A-14), in order to provide a well-known configuration for the inlet and outlet that allow oxygen or other fluids to pass through the hollow fibers during use.
With respect to Claim 13, Maurer teaches that the fiber assembly (10, 17) comprises a plurality of fibers the fiber assembly comprises a fiber bundle 17 that comprises a plurality of fiber mats 16, each mat comprising a plurality of hollow fibers (Figures 4a-6c; paragraphs [0132-0140]).
With respect to Claim 14, Maurer teaches a device 1 for extracorporeal conditioning of blood (specifically a blood oxygenator; see Abstract; see the embodiments of Figures 7a-7b), the device comprising:
a housing 2 comprising a first side (adjacent inlet 4.1), a second side (adjacent outlet 4.2) opposite the first side, the first side comprising a fluid inlet 4.1, and the second side comprising a fluid outlet 4.2 (Figures 7a-7b), wherein the housing defines an internal chamber (the interior of housing 2; Figure 7b);
a fiber assembly (10, 17) disposed within the internal chamber, the fiber assembly having a peripheral edge the outer edge of fiber assembly 10, adjacent potting material 11; Figures 7a-7b);
potting material 22 disposed throughout the peripheral edge to create at least a portion of a circumferential seal that defines a flow path through the fiber assembly that has a substantially circular cross-sectional shape (Figures 4a; paragraphs 0125-0142], wherein:
the fluid inlet 4.1 defines an inlet lumen in fluid communication with the flow path (Figure 7b; the flow path is illustrated by flow arrows “B”); and
the fluid outlet 4.2 defines an outlet lumen in fluid communication with the flow path (Figure 7b; the flow path is illustrated by flow arrows “B”).
Maurer further teaches that the fiber assembly of the device may be configured to provide both gas (oxygen) exchange and heat exchange (paragraphs [0025], [0035], and [0084]). Maurer, however, does not specifically teach a sensor module disposed on at least one of the fluid inlet or the fluid outlet to measure a property of fluid flowing through the at least one of the fluid inlet or the fluid outlet.
Elgas teaches a blood oxygenator and heat exchange module that is configured to provide surgical support by maintaining a patient’s blood at a predetermined temperature while replacing carbon dioxide with oxygen (Column 1, Lines 4-36).
Specifically, temperature is monitored by a temperature sensing module 36 that is mounted on the blood outlet 32, the temperature sensing module comprising a thermistor or other temperature sensing device, thereby allowing the temperature of the blood to be precisely monitored and regulated (Figures 2-3; Column 4, Lines 41-49). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s blood oxygenator device to have a sensor module with a temperature sensor therein disposed on the blood outlet of the device, as suggested by Elgas, in order to allow the temperature of the blood to be precisely monitored and regulated (Column 4, Lines 41-49).
Maurer also does not specifically teach that the housing comprises a window configured to enable visual observation of fluid within the housing. However, Huang teaches an apparatus for extracorporeal treatment of blood, which is in the same field of endeavor. The apparatus comprises a housing 100 having a blood flow path extending from a blood inlet 112, through a plurality of tubular membranes 130, and to a blood outlet 122, and a treatment fluid flow path extending from an inlet 124 to a chamber 102 surrounding the tubular membranes 130, to an outlet 126 (Figures 1-2; Abstract and paragraphs [0089-0091]). Specifically, Huang teaches that the housing 100 comprises an inlet cap 104 containing the blood inlet 112 and an outlet cap 106 containing the blood outlet 122 (Figure 1; paragraph [0075]), wherein the inlet cap 104 and outlet cap 106 may be made from a translucent material, thereby defining windows that enable visual inspection of the interior of the filter module (paragraph [0075]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s extracorporeal conditioning device to have translucent windows adjacent the blood inlet and/or blood outlet, as suggested by Huang, in order to enable visual inspection of the interior of the filter module (paragraph [0075]).
With respect to Claim 15, Elgas teaches that the temperature of the outgoing blood “can be monitored by a circuit” of the temperature sensing device 36 (Column 4, Lines 45-48), but Maurer and Elgas do not specifically teach that the sensor is operably connected to a controller by an electrical or wireless connection, and wherein the controller is adapted to process information relating to the one or more sensors and display the information on a panel viewable by a user.
However, the examiner takes official notice that it is notoriously well known in the art, and capable of instantaneous and unquestionable demonstration, to have a controller receive data from a sensor and display that data on a panel that is viewable by a user. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the extracorporeal conditioning device of Maurer and Elgas to have a controller receive data from a sensor and display that data on a panel that is viewable by a user, as is commonplace in the art, in order to provide a well-known means for allowing the user to monitor the blood temperature at the outlet of the device.
With respect to Claim 17, Maurer and Elgas as combined above reasonably suggest that the property of the fluid comprises temperature, and wherein the sensor module comprises a temperature sensor to measure the temperature of the fluid flowing through the fluid outlet. Specifically, Elgas teaches temperature sensor module 36 configured to measure the temperature of blood flowing through the blood outlet 32 Figures 2-3; Column 4, Lines 41-49). See the rejection of Claim 14 above.
With respect to Claim 20, Maurer teaches that the housing 2 comprises a substantially square housing with one or more rounded corners (Figures 7a-7b).
With respect to Claim 21, Maurer teaches that the housing 2 comprises a first side (adjacent inlet 4.1), a second side (adjacent outlet 4.2), and four sidewalls connecting the first side to the second side (Figures 7a-7b), wherein the first side and the second side are substantially square-shaped, wherein the fluid inlet is disposed on the first side, and wherein the fluid outlet is disposed on the second side (Figures 7a-7b).
With respect to Claim 22, Maurer teaches the device as claimed, wherein the device further comprises a gas inlet and a gas outlet (paragraph [0042]; one of the gas inlet or outlet is generically shown in the top left corner of the housing in Figure 7b). However, Maurer’s embodiment of Figures 7a-7b does not specifically illustrate that the gas inlet and gas outlet are disposed on one of the four sidewalls of the housing.
In a different embodiment (Figures 12A-14), Maurer teaches a similar configuration for the blood oxygenation device wherein the gas inlet 5.1 and gas outlet 5.2 are disposed on a sidewall of the device (Figure 13A; paragraph [0157]), such that they are in fluid communication with the hollow fibers of the oxygenator module to allow fluid to pass through the interiors of the hollow fibers to allow gas exchange to occur [0050]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s blood oxygenator to have the gas inlet and gas outlet disposed in the sidewalls thereof, as suggested by Maurer in the embodiment of Figures 12A-14), in order to provide a well-known configuration for the inlet and outlet that allow oxygen or other fluids to pass through the hollow fibers during use.
With respect to Claim 23, Maurer teaches that the fiber assembly (10, 17) comprises a plurality of fibers the fiber assembly comprises a fiber bundle 17 that comprises a plurality of fiber mats 16, each mat comprising a plurality of hollow fibers (Figures 4a-6c; paragraphs [0132-0140]).
With respect to Claim 28, the combination of Maurer, Elgas, and Huang as set forth above with respect to reasonably suggests the device as claimed, wherein Huang’s fluid inlet 112 is formed into a transparent window 104 (inlet cap 104 is made from a transparent material, thereby forming a window; paragraph [0075]), and is configured to provide fluid access to the flow path (Figure 1; paragraphs [0089-0091]).
With respect to Claim 29, the combination of Maurer, Elgas, and Huang as set forth above with respect to Claim 1 reasonably suggests the device as claimed, wherein Huang’s fluid outlet 122 is formed into a transparent window 106 (outlet cap 106 is made from a transparent material, thereby forming a window; paragraph [0075]), and is configured to provide fluid egress from the flow path (Figure 1; paragraphs [0089-0091]).
Claims 4, 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Maurer, Elgas, and Huang as applied to claims 1 and 14 above, and further in view of Kirchhof (US 2005/0004480).
With respect to Claims 4-6 and 16, Maurer, Elgas, and Huang reasonably suggest the device of each of claims 1 and 14, but do not specifically teach that the sensor module comprises a pressure sensor for measuring the pressure of the fluid flowing through the outlet.
Kirchhof teaches a similar blood oxygenation device (Abstract, paragraph [0010]; Figure 1) comprising a plurality of sensors that are configured for controlling and monitoring blood flow through the system (paragraph [0040]). Specifically, the plurality of sensors comprise inlet and outlet temperature sensors (similar to Elgas’ device), as well as inlet and outlet pressure sensors for measuring at least the pressure of blood flowing through the fluid outlet of the device [0041]. It would have been obvious to further modify the blood oxygenator device of Maurer, Elgas, and Huang to additionally provide a pressure sensor in the sensor module for measuring pressure of fluid flowing through the outlet, as well as to provide a litany of other pressure and oxygen saturation sensors disposed throughout the flow paths, as suggested by Kirchhof, in order to provide a well-known means for allowing a controller to automatically monitor and control flow through the system in response to sensed pressures.
Claims 8, 9, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Maurer, Elgas, and Huang as applied to claims 1 and 14 above, and further in view of Muramoto (US 5,084,244).
With respect to Claims 8, 9, 18, and 19, Maurer, Elgas, and Huang reasonably suggest the device of each of claims 1 and 14, but do not specifically teach that the fluid inlet is offset from the center axis of the flow path or that the fluid inlet is disposed adjacent the periphery of the flow path and is configured to create circumferential flow of fluid entering the flow path.
Muramoto teaches a blood oxygenator (Abstract; Figure 3) comprising an inlet region 19 and an outlet region 17 (Figure 3), wherein the inlet region 19 comprises blood inlet port 26 that is offset from the center axis of and disposed adjacent the periphery of the blood flow path, such that it is configured to create circumferential flow of fluid entering the flow path (Figures 4a-4b). Specifically, the offset blood inlet is configured to cause blood to swirl through the inlet region, thereby removing air bubbles and uniformly distributing the blood in the chamber as it enters the fiber assembly (Column 5, Lines 29-38; Column 6, Lines 2-20; Column 6, Lines 27-31). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to replace the swirl distributor 30 of Maurer’s blood oxygenator with Muramoto’s offset blood inlet that is configured to create a circumferential flow and evenly distribute blood to the fibers, as suggested by Muramoto, in order to provide a well-known, alternate means for uniformly distributing blood from the inlet to the fiber assembly while simultaneously removing any entrained air bubbles (Column 5, Lines 29-38; Column 6, Lines 2-20; Column 6, Lines 27-31).
Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Maurer in view of Elgas, Kirchhof, Huang, and Muramoto.
With respect to Claim 24, Maurer teaches a device for extracorporeal conditioning of blood (specifically a blood oxygenator; see Abstract; see the embodiments of Figures 7a-7b), the device comprising:
a housing 2 defining an internal chamber (the interior defined within housing 2) and comprising a first side (adjacent inlet 4.1) a second side (adjacent outlet 4.2) and four sidewalls connecting the first side to the second side (Figure 7a), the first side including a fluid inlet 4.1 and the second side including a fluid outlet 4.2 (Figures 7a-7b);
a fiber assembly (10, 17) disposed within the internal chamber, the fiber assembly having a peripheral edge the outer edge of fiber assembly 10, adjacent potting material 11; Figures 7a-7b);
potting material 22 disposed throughout the peripheral edge to create at least a portion of a circumferential seal that defines a flow path through the fiber assembly that has a substantially circular cross-sectional shape (Figures 4a; paragraphs 0125-0142], wherein:
the fluid inlet 4.1 defines an inlet lumen in fluid communication with the flow path (Figure 7b; the flow path is illustrated by flow arrows “B”); and
the fluid outlet 4.2 defines an outlet lumen in fluid communication with the flow path (Figure 7b; the flow path is illustrated by flow arrows “B”); and
a gas inlet and a gas outlet disposed on the housing (paragraphs [0042] and [0050]; one of the inlet or outlet is generically illustrated on the upper left corner of the housing in Figure 7b).
Maurer further teaches that the fiber assembly of the device may be configured to provide both gas (oxygen) exchange and heat exchange (paragraphs [0025], [0035], and [0084]). Maurer, however, does not teach a temperature sensor disposed on the fluid outlet to measure the temperature of fluid flowing through the fluid outlet.
Elgas teaches a blood oxygenator and heat exchange module that is configured to provide surgical support by maintaining a patient’s blood at a predetermined temperature while replacing carbon dioxide with oxygen (Column 1, Lines 4-36).
Specifically, temperature is monitored by a temperature sensing module 36 that is mounted on the blood outlet 32, the temperature sensing module comprising a thermistor or other temperature sensing device, thereby allowing the temperature of the blood to be precisely monitored and regulated (Figures 2-3; Column 4, Lines 41-49). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s blood oxygenator device to have a sensor module with a temperature sensor therein disposed on the blood outlet of the device, as suggested by Elgas, in order to allow the temperature of the blood to be precisely monitored and regulated (Column 4, Lines 41-49).
Maurer also does not specifically teach that the housing comprises a window configured to enable visual observation of fluid within the housing. However, Huang teaches an apparatus for extracorporeal treatment of blood, which is in the same field of endeavor. The apparatus comprises a housing 100 having a blood flow path extending from a blood inlet 112, through a plurality of tubular membranes 130, and to a blood outlet 122, and a treatment fluid flow path extending from an inlet 124 to a chamber 102 surrounding the tubular membranes 130, to an outlet 126 (Figures 1-2; Abstract and paragraphs [0089-0091]). Specifically, Huang teaches that the housing 100 comprises an inlet cap 104 containing the blood inlet 112 and an outlet cap 106 containing the blood outlet 122 (Figure 1; paragraph [0075]), wherein the inlet cap 104 and outlet cap 106 may be made from a translucent material, thereby defining windows that enable visual inspection of the interior of the filter module (paragraph [0075]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s extracorporeal conditioning device to have translucent windows adjacent the blood inlet and/or blood outlet, as suggested by Huang, in order to enable visual inspection of the interior of the filter module (paragraph [0075]).
Maurer also does not teach a pressure sensor disposed on the fluid outlet to measure the pressure of fluid flowing through the outlet. Kirchoff teaches a similar blood oxygenation device (Abstract, paragraph [0010]; Figure 1) comprising a plurality of sensors that are configured for controlling and monitoring blood flow through the system (paragraph [0040]). Specifically, the plurality of sensors comprise inlet and outlet temperature sensors (similar to Elgas’ device), as well as inlet and outlet pressure sensors for measuring at least the pressure of blood flowing through the fluid outlet of the device [0041]. It would have been obvious to further modify the blood oxygenator device of Maurer, Elgas, and Huang to additionally provide a pressure sensor in the sensor module for measuring pressure of fluid flowing through the outlet, as well as to provide a litany of other pressure and oxygen saturation sensors disposed throughout the flow paths, as suggested by Kirchhof, in order to provide a well-known means for allowing a controller to automatically monitor and control flow through the system in response to sensed pressures.
Maurer also does not specifically teach that the fluid inlet is disposed near a periphery of the flow path and is configured to create a circumferential flow of fluid entering the flow path. Muramoto teaches a blood oxygenator (Abstract; Figure 3) comprising an inlet region 19 and an outlet region 17 (Figure 3), wherein the inlet region 19 comprises blood inlet port 26 that is offset from the center axis of and disposed near the periphery of the blood flow path, such that it is configured to create circumferential flow of fluid entering the flow path (Figures 4a-4b). Specifically, the offset blood inlet is configured to cause blood to swirl through the inlet region, thereby removing air bubbles and uniformly distributing the blood in the chamber as it enters the fiber assembly (Column 5, Lines 29-38; Column 6, Lines 2-20; Column 6, Lines 27-31). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to replace the swirl distributor 30 of Maurer’s blood oxygenator with Muramoto’s offset blood inlet that is configured to create a circumferential flow and evenly distribute blood to the fibers, as suggested by Muramoto, in order to provide a well-known, alternate means for uniformly distributing blood from the inlet to the fiber assembly while simultaneously removing any entrained air bubbles (Column 5, Lines 29-38; Column 6, Lines 2-20; Column 6, Lines 27-31).
With respect to Claim 25, Maurer teaches that the housing 2 comprises a substantially square housing with one or more rounded corners (Figures 7a-7b).
With respect to Claim 26, Maurer teaches the device as claimed, wherein the device further comprises a gas inlet and a gas outlet (paragraph [0042]; one of the gas inlet or outlet is generically shown at the top left corner of the housing in Figure 7b). However, Maurer’s embodiment of Figures 7a-7b does not specifically illustrate that the gas inlet and gas outlet are disposed on one of the four sidewalls of the housing.
In a different embodiment (Figures 12A-14), Maurer teaches a similar configuration for the blood oxygenation device wherein the gas inlet 5.1 and gas outlet 5.2 are disposed on a sidewall of the device (Figure 13A; paragraph [0157]), such that they are in fluid communication with the hollow fibers of the oxygenator module to allow fluid to pass through the interiors of the hollow fibers to allow gas exchange to occur [0050]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Maurer’s blood oxygenator to have the gas inlet and gas outlet disposed in the sidewalls thereof, as suggested by Maurer in the embodiment of Figures 12A-14), in order to provide a well-known configuration for the inlet and outlet that allow oxygen or other fluids to pass through the hollow fibers during use.
With respect to Claim 27, Maurer teaches that the fiber assembly (10, 17) comprises a plurality of fibers the fiber assembly comprises a fiber bundle 17 that comprises a plurality of fiber mats 16, each mat comprising a plurality of hollow fibers (Figures 4a-6c; paragraphs [0132-0140]).
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 Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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