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 9/17/25, applicant amended claims 1, 3, 5, 6, 8, 9, 11, 13, 15, and 20, and canceled claims 2, 4, 14, and 16. In a supplemental reply filed 9/30/2025, applicant further amended claims 9 and 17. Claims 1, 3, 5-13, 15, and 17-20 are currently pending.
Response to Arguments
Applicant's arguments filed 9/17/2025 have been fully considered but they are not persuasive.
First, applicant argues that Maurer does not disclose the limitation “wherein an axis of the blood inlet and an axis of the blood outlet coincide with an axis of the blood oxygenation chamber. However, at least the portion of the blood outlet (i.e. the section that connects to the lower interval; space of the housing) coincides with the axis of the oxygenation chamber. The examiner notes that the coincidental axes of the blood inlet, blood outlet, and oxygenation chamber were clearly labeled in the annotated figure 7 of Maurer that was included in the previous office action. This annotated figure has been reproduced below.
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Annotated Figure 7B of Maurer
Second, Applicant argues that Maurer does not disclose “the upper end face and the lower end face of the oxygenation chamber are respectively provided with a first origice plate and a second orifice plate for respectively communicating the oxygenation chamber with the upper interval space and the communicating the oxygenation chamber with the lower interval space,” as recited in claim 1. This argument has not been found persuasive because, as discussed in the rejection of Claims 4 and 16 in the Non-Final Rejection, Maurer clearly suggests that the use of orifice plates in addition to or in place of the swirl distributer 30 ensures efficient distribution of the blood stream across the entire cross section of the oxygenation chamber (paragraphs [0057] and [0159]).
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, 13, 15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maurer et al. (US 2016/0095969).
With respect to Claims 1 and 13, Maurer teaches an extracorporeal membrane device (Figures 7a-7b) comprising an oxygenator 1 (see Abstract), the oxygenator comprising:
a housing 2 an upper end cover (the upper portion of cover 20, above oxygenation chamber 10, and 40) of the housing 2 being provided with a blood inlet 4.1, and a lower end cover (the lower portion of cover 20, below the oxygenation chamber 10) being provided with a blood outlet 4.2 (Figure 7B; paragraphs [0141-0142]); and
an oxygenation chamber 10, arranged in the housing 2, wherein an axis of the blood inlet 4.1 and an axis of the blood outlet 4.2 coincide with the axis of the oxygenation chamber 10 (see Figures 7A-7B; paragraphs [0141-0142]; the coincidental axes of the blood inlet, blood outlet, and oxygenation chamber are illustrated by the dashed line in the annotated figure below);
wherein an upper interval space is formed between the upper end cover (20, 40) and an upper end face of the oxygenation chamber 10, and a lower interval space is formed between the lower end cover 20 and a lower end face of the oxygenation chamber (see the annotated Figure 7 above). The spaces of the blood inlet 4.1 and blood outlet 4.2 are gradually reduced in directions away from the upper and lower interval spaces, respectively (see Figure 7B).
Maurer does not specifically teach in the embodiment of Figures 7A-7B that the upper end face and the lower end face of the oxygenation chamber are respectively provided with a first orifice plate and a second orifice plate for respectively communicating the oxygenation chamber 10 with the upper and lower interval spaces.
However, in a different embodiment (Figures 11-14), Maurer teaches a similar oxygenator 101 comprising an oxygenation chamber 110 disposed between upper and lower covers 120 (Figure 14). The upper end face and lower end face of the oxygenation chamber 110 each comprise an orifice plate 130 for respectively communicating the oxygenation chamber 110 with the upper and lower interval spaces (Figure 14). Specifically, Maurer teaches that these first and second orifice plates each comprise a plurality of orifices 131 that provide uniform distribution of blood, thereby increasing efficiency of the device by spreading blood flow evenly across the oxygenation chamber 110 (Figure 14, paragraphs [0057] and [0159])). 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 the oxygenator of Maurer’s Figures 7A-7B to have a pair of orifice plates on opposing sides of the oxygenation chamber, as suggested by Maurer in the embodiment of Figures 11-14, in order to efficiently distribute the blood stream across the entire cross section of the oxygenation chamber (paragraphs [0057] and [0159]).
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Annotated Figure 7B of Maurer
With respect to Claims 3 and 15, Maurer teaches that an inner surface of the lower end cover 20 is a tapered face, and the blood outlet 4.2 is the lowest point of the tapered face (Figure 7b; paragraph [0053]).
With respect to Claims 5 and 17, Maurer appears to show first and second gas exchange cavities between a side face of the oxygenation chamber 20 and a side face of the housing (see the chambers between potting material 11 and the sidewall of the housing on each side of the oxygenation chamber 11; Figure 7B) and one or more gas exchange lumens (see the port at the top left of Figure 7B). Maurer, however, does not explicitly disclose in Figures 7A-7B a first gas exchange cavity and a second gas exchange cavity formed between a side face of the oxygenation chamber and a side face of the housing and used to exchange gas with an outside of the housing.
However, Maurer’s embodiment of Figures 11-14 further teaches that the oxygenator may comprise a gas inlet 5.1 in communication with a first gas exchange cavity and gas outlet 5.2 in communication with a second gas exchange cavity (paragraphs [0157-0160]; see the annotated figure below). This configuration allows oxygen to be passed from the inlet, through the fiber bundle of the oxygenation chamber, and through the outlet, thereby allowing blood to be oxygenated. 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 embodiment of Figures 7A-7B to have the gas inlet/outlet and gas exchange cavity configuration of Maurer’s Figures 11-14. Figures 7A-7B do not show specifics of this portion of the device, and one of ordinary skill in the art would have understood that a configuration similar to that of Figures 11-14 could be used.
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Annotated Figure 13A of Maurer
With respect to Claims 6 and 18, Maurer as modified above teaches that a plurality of hollow permeable tubes 13 (hollow fibers) are arranged in the oxygenation chamber 10 in a horizontal direction, one end of each of the tubes in communication with the first gas exchange cavity and the other end in communication with the second gas exchange cavity. Specifically, each layer 12 of hollow fibers 13 comprises a plurality of parallel, horizontally-extending tubes that allows gas to be moved from the gas inlet to the gas outlet. See Figures 1-6C and 12A-12B; paragraphs [0125-0140], [0151], and [0157].
With respect to Claims 7 and 19, Maurer teaches that the plurality of hollow fibers 13 are arranged in a plurality of layers 12, wherein each layer is in a crossed arrangement with another layer (Figures 1-6C and 12A-12B; paragraphs [0125-0140], especially [0132]).
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Maurer in view of Corey (US 6,117,390).
With respect to Claims 8 and 20, Maurer further teaches that hollow fiber modules of this type may be used for a variety of purposes including oxygenation and heat exchange [0084], and further teaches that the device may be a combined apparatus with both an oxygenator and a heat exchange that uses two or more fluid sources for gas exchange and heat exchange [0084]. Maurer, however, does not specifically teach that the embodiment of Figures 7A-7B has a heat exchanger chamber arranged in the housing such that a lower end face of the heat exchanger is connected to an upper end face of the oxygenation chamber and an axis of the heat exchange chamber coincides with the axis of the oxygenation chamber.
Corey teaches an extracorporeal oxygenator/heat exchanger module comprising an oxygenator (28, 29, 30, 31, 32) and a heat exchanger (24, 25, 26, 27) disposed in an alternating configuration, wherein the axis of the oxygenator and heat exchanger portions coincides with the axis of the inlet and outlet (Figures 6-9). Specifically, at least one portion of the heat exchanger (24-27) is disposed directly above an oxygenation chamber (28-32), such that the lower end face of the heat exchanger is connected to the upper end face of the oxygenator. This configuration allows blood to be oxygenated and warmed simultaneously, as is commonplace in the art (Column 2, Lines 25-37; Column 3, Lines 17-49; Column 3, Line 65 through Column 4, Line 17). 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 Maurer’s oxygenator module to have a heat exchange chamber disposed in the housing such that the lower end face of the heat exchange chamber is connected to an upper end face of the oxygenation chamber and the axis of the heat exchanger coincides with the axis of the oxygenation chamber, as suggested by Corey, in order to provide a well-known means for warming the blood as it passes through the oxygenator.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Maurer and Corey as applied to claim 8 above, and further in view of Constentino (US 5,162,101).
With respect to Claim 9, Maurer and Corey reasonably suggest the oxygenator/heat exchanger module as claimed, and Maurer further suggests that orifice plates 130 may be provided at the upper and lower surfaces of the oxygenator (see the rejection of Claim 1 above). Maurer and Corey, however, do not specifically teach that an upper end face of the heat exchange chamber is provided with a third orifice plate.
Constentino teaches an oxygenator/heat exchanger device 10 comprising an oxygenator chamber 12/50 and a heat exchange chamber 14/96 (Figures 1-4). The device comprises three orifice plates (60, 16, 100) that form a sandwich configuration with the oxygenator 50 and heat exchanger portions. Specifically, the orifice plates (60, 16, 100) are arranged such that the upper and lower surfaces of both the heat exchanger and oxygenator are covered by orifice plates (Figures 1-4). The use of three orifice plates in this manner helps to control fluid distribution through and maintain pack density of the oxygenator and heat exchanger layers (Column 5, Line 41 through Column 6, Line 36; Column 9, Line 67 through Column 10, Line 28; Column 11, Line 65 through Column 12, Line 3). 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 oxygenator of Maurer and Corey to have three orifice plates disposed in a sandwich configuration with the oxygenator and heat exchanger, as suggested by Constentino, in order to control blood flow distribution and maintain the packing density of the tubular elements in the device.
With respect to Claim 10, Corey further teaches that the heat exchange chamber comprises a first heat exchange cavity 46 and a second heat exchange cavity 48 formed between a side face of the heat exchange chamber and the side face of the housing, wherein these cavities are connected to a water inlet fitting 44 and a water outlet fitting 48, respectively, so that water can be provided from outside the housing for heat exchange (Figures 1, 6, 7, and 11; Column 5, Lines 9-31). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to incorporate this structure into the Maurer’s device for the reasons set forth above with respect to Claim 8, and because doing so would provide means for supplying and removing heat exchange liquid from the heat exchanger.
With respect to Claim 11, Corey further teaches that the heat exchange chamber comprises a plurality of heat exchange tubes arranged in the heat exchange chamber in a horizontal direction (see 24-27 in Figures 6-9; Column 3, Lines 17-33; Column 3, Line 65 through Column 4, Line 7). One end of each of the heat exchange tubes communicates with the first heat exchange cavity, and the other end of each tube communicates with the second heat exchange cavity.
With respect to Claim 12, the combination of Maurer, Corey, and Constentino set forth above does not teach the plurality of heat exchange tubes being arranged in a layered and crossed manner. However, Maurer teaches that fiber layers may optimally be arranged at 45-60 degrees provides enhanced transfer efficiency [0034] and that a layered, crossed configuration of this type is particularly effective when functioning as a heat exchanger [0035]. Therefore, in the context of Maurer’s hexagonal housing, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application provide Corey’s heat exchange tubes in a layered, crossed configuration, as doing so would provide optimized heat exchange between blood and the fluid inside the tubes.
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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