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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 in the reply filed on 03/06/2026 is acknowledged.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Izumi (JP 2021023470A) in view of Kneifel (US 20030209480 A1).
Regarding Claim 1, Izumi discloses 1. An oxygenation device for use in connection with extracorporeal blood circulation (Fig 1, artificial lung 1), the device comprising: a potted body including a first alignment feature defining an alignment axis (Fig 1-4, hollow fiber bundles 20, 30 comprise edges 211 and 311, which define an alignment axis); an oxygenator module (Fig 1, gas exchange unit 3) comprising a plurality of semi-circular hollow fiber mat layers including a second alignment feature configured to align with the first alignment feature of the potted body, such that each of the plurality of hollow fiber mat layers is oriented with respect to the alignment axis (Figs 1-8, plurality of hollow fiber membranes 32 each have a flat side that enables alignment with edge 311. Any one of the axes X, Y indicated in Figs 2-7 or the axis defined by the blood inlet port 212b and blood outlet port 313b in fig 1 is regarded as an alignment axis); a heat exchanger module (Fig 1 heat exchanger 2) comprising at least two of the plurality of circular hollow fibers mat layers (Fig 1-4, plurality of hollow fiber membranes 22); a blood inlet port positioned adjacent a first end of the potted body (Fig 1 blood inlet 212 b); a blood outlet port positioned adjacent a second end of the potted body that is opposite the first end (Fig 1 blood outlet 313b); a gas inlet port (Fig 5, fluid introduction port 314a) and a gas outlet port (Fig 5, fluid discharge port 315a) configured for guiding a gas mixture through a plurality of hollow fibers of the plurality of hollow fiber mat layers (¶[0046] 314 forms an introduction path for introducing oxygen for gas exchange); and a fluid inlet port and a fluid outlet port configured for providing and removing H/C fluid through a portion of the potted body (Fig 2-3 ¶[0046] fluid inlet port 214/214a an fluid outlet port 215/215a. 214 forms an introduction path for introducing heat medium); wherein a first layer of the plurality of hollow fiber mat layers comprises a first plurality of parallel hollow fibers disposed at a first angle relative to a direction orthogonal to the alignment axis (Fig 4-7, 7 221A, 221B. If the alignment axis is X, Y is the orthogonal direction and the first angle is Angle θ1 of layer 221b) and a second layer of the plurality of hollow fiber mat layers includes a second plurality of parallel hollow fibers disposed at a second angle relative to a direction orthogonal to the alignment axis (Fig 4-7 ¶[0020-0021] 321A, 321B, If the alignment axis is X, Y is the orthogonal direction and the second angle is Angle θ2 of layer 221b) the first and second angles disposed on opposite sides of a direction orthogonal to the alignment axis (Fig 4-8B. Angles θ1-θ2 may be oriented in opposite directions orthogonal to the alignment axis as shown in Figs 8A-B wherein the overlapping fibers are oriented in opposite directions).
Izumi does not explicitly disclose that the hollow fiber mat layers are circular.
However, Kneifel teaches a device using hollow fiber mat layers, thus from a similar field of endeavor, wherein the hollow fiber mat layers are circular (Figs 1-2 frame 16 and hollow fiber membrane 13 are circular) because they are very advantageous with respect to the manufacture of the frames and the hollow fiber elements disposed therein (¶[0013]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Izumi so that the hollow fiber mat layers are circular, as taught by Kneifel because they are very advantageous with respect to the manufacture of the frames and the hollow fiber elements disposed therein (as motivated by Kneifel ¶[0013]).
Regarding Claim 2, Izumi/Kneifel discloses that the gas mixture is configured to pass through the at least two of the plurality of hollow fiber mat layers of the oxygenator module (Fig 5-6, gas flows into fluid introduction port 314a of oxygenator 3, through hollow fiber mat layers in the oxygenator, and out of fluid discharge port 315a).
Regarding Claim 3, Izumi/Kneifel discloses that the H/C fluid is configured to pass through the at least two of the plurality of hollow fiber mat layers of the heat exchanger module (Fig 1-2, H/C fluid flows into fluid introduction port 214a of heat exchange section 2, through hollow fiber mat layers in the heat exchange section 2, and out of fluid discharge port 215a).
Regarding Claim 7, Izumi/Kneifel discloses a first housing portion placed adjacent the first end of the potted body (Fig 1, housing body 21 is adjacent the first end of 20/30) and a second housing portion positioned adjacent the second end of the potted body (Fig 1, housing body 31 is adjacent the second end of 20/30).
Regarding Claim 8, Izumi/Kneifel discloses that the plurality of hollow fiber mat layers each comprise a plurality of threads coupled to the plurality of hollow fibers (¶[0017-0018 threads are used to join the hollow fibers 221 and 321).
Regarding Claim 9, Izumi/Kneifel does not explicitly teach that the plurality of threads are aligned at an angle that is not orthogonal to the alignment of the plurality of hollow fibers.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify device of Izumi/Kneifel so that the plurality of threads are aligned at an angle that is not orthogonal to the alignment of the plurality of hollow fibers because there are a finite number of solutions to coupling the plurality of threads to the plurality of hollow fibers (2 solutions: either aligned at an angle that is not orthogonal to the alignment of the plurality of hollow fibers or aligned at an angle that is orthogonal to the alignment of the plurality of hollow fibers) and one of ordinary skill would have a reasonable expectation of success to achieve coupling the plurality of hollow fibers and would achieve a predictable result of joining the hollow fibers 221 and 321 of the hollow mat layers (Izumi ¶[0017-0018]).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Izumi (JP 2021023470A) in view of Kneifel (US 20030209480 A1), further in view of Kim (KR 20060015888 A).
Regarding Claim 4, Izumi/Kneifel is silent whether the potted body further comprises a distribution grid positioned between the blood inlet port and the heat exchanger module.
However, Kim teaches a filtering apparatus using hollow fiber membranes, thus from a similar field of endeavor, wherein the potted body further comprises a distribution grid positioned between the blood inlet port and the heat exchanger module (Figs 3, 6, hollow fiber membrane cartridge 110 includes upper hollow fiber distribution grating 114 disposed between inlet port 121 and hollow fiber membrane module 112) to improve the filtration rate and removal rate of contaminants (page 6, para 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Izumi/Kneifel so that the potted body further comprises a distribution grid positioned between the blood inlet port and the heat exchanger module, as taught by Kim to improve the filtration rate and removal rate of contaminants (as taught by Kim, page 6, para 3). In combination, due to its placement directly below the inlet port, the distribution grid taught by Kim would be in between the blood inlet port and heat exchanger module of Izumi/Kneifel.
Regarding Claim 6, Izumi/Kneifel is silent whether the potted body further comprises a collection grid positioned between the oxygenator module and the blood outlet port.
However, Kim teaches a filtering apparatus using hollow fiber membranes, thus from a similar field of endeavor, wherein the potted body further comprises a collection grid positioned between the oxygenator module and the blood outlet port (Figs 3, 7, hollow fiber membrane cartridge 110 includes lower hollow fiber distribution grating 115 disposed between outlet cap 130 and hollow fiber membrane module 112) to improve the filtration rate and removal rate of contaminants (page 6, para 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Izumi/Kneifel so that the potted body further comprises a collection grid positioned between the oxygenator module and the blood outlet port, as taught by Kim to improve the filtration rate and removal rate of contaminants (as taught by Kim, page 6, para 3). In combination, due to its placement directly below the inlet port, the distribution grid taught by Kim would be in between the blood outlet port and oxygenator module of Izumi/Kneifel.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Izumi (JP 2021023470A) in view of Kneifel (US 20030209480 A1), further in view of Marseille (US 20190160217 A1).
Regarding Izumi/Kneifel is silent whether the potted body further comprises a separation grid positioned between the heat exchanger module and the oxygenator module.
However, Marseille teaches an oxygenation device using hollow fiber membranes, thus from the same field of endeavor, wherein the potted body further comprises a separation grid positioned between the heat exchanger module and the oxygenator module (Fig 5A ¶[0070] hollow fiber modules 42 and 43 are separated by a separation layer 44, which may be a grid or mesh) to enable the user to switch between or disconnect one of the hollow fiber modules (¶[0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Izumi/Kneifel so that the potted body further comprises a separation grid positioned between the heat exchanger module and the oxygenator module, as taught by Marseille to enable the user to switch between or disconnect one of the hollow fiber modules (as motivated by Marseille ¶[0068]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/ Supervisory Patent Examiner, Art Unit 3781
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