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 Arguments
Applicant’s amendment filed 06/04/2026 is accepted and entered. Applicant’s amendments to the drawings have overcome the previous drawing objections and the previous drawing objections have been withdrawn. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 1, 11, and 21 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.
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.
Claim(s) 1, 6, 8, 9, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Federspiel et al (WO 00/01472) in view of Matheis et al (US 2018/0117231) further in view of Sado et al (US 4342723).
Regarding Claim 1, Federspiel discloses a blood oxygenator (page 2, lines 30-31 indicate the hollow fiber membrane is used in a blood oxygenator) comprising:
a gas exchange medium having a plurality of hollow fibers (page 6, lines 1-2 indicate the oxygenator uses a plurality of the hollow fiber membranes 20);
wherein each of the hollow fibers (20, Fig. 3a) has a roughened outer surface (24, Fig. 3a) configured to decrease a thickness of a boundary layer at an interface between blood at the roughened outer surface and increase a gas exchange rate at the interface relative to hollow fibers having a smooth outer surface (page 2, lines 24-29, page 6 lines 1-5; since the hollow fibers have a roughened outer surface and are described as disrupting the boundary layer and increasing gas exchange by introducing convection currents locally to the fiber surface, which is substantially similar to what is occurring in Applicant’s invention, the fibers of Federspiel can be said to be configured to decrease a thickness of the boundary layer), wherein the roughened outer surface (24, Fig. 3a) of the hollow fibers (20, Fig. 3a) includes a plurality of raised protuberances (28, Fig. 3a).
Federspiel is silent whether the blood oxygenator comprises a housing having a blood inlet, a blood outlet, a gas inlet, and a gas outlet, wherein the plurality of hollow fibers in the gas exchange medium are in fluid communication with the gas inlet and the gas outlet, and wherein the plurality of hollow fibers is arranged in the housing in a plurality of rows such that a direction of blood flow between the blood inlet and the blood outlet extends across each hollow fiber in a plane perpendicular to a direction of gas flow through each hollow fiber of each of the rows of hollow fibers, and wherein the roughened outer surface of the hollow fibers includes a plurality of raised protuberances non-uniformly arranged around the outer surface and along a longitudinal length of the hollow fibers.
Matheis teaches a blood oxygenator (1, Fig. 2), thus being in the same field of endeavor, with a housing (2, Fig. 2) having a blood inlet (31, Fig. 2), a blood outlet (41, Fig. 2), a gas inlet (one of connectors 35, Fig. 2), and a gas outlet (the other of connectors 35, Fig. 2), wherein the plurality of hollow fibers in the gas exchange medium are in fluid communication with the gas inlet and the gas outlet (¶ [0072-0076, 0088, 0095]; each fiber of mats 19 and 21 are in communication with the gas inlet and gas outlet, Fig. 1), and wherein the plurality of hollow fibers are arranged in the housing in a plurality of rows (mats 19 and 21, Fig. 1) such that a direction of blood flow (4, Fig. 1; ¶ [0073]) between the blood inlet (31, Fig. 2) and the blood outlet (41, Fig. 2) extends across each hollow fiber (each fiber forming mats 19 and 21, Fig. 1) in a plane perpendicular to a direction of gas flow (10, Fig. 1; ¶ [0076]) through each hollow fiber (each fiber forming mats 19 and 21, Fig. 1) of each of the rows of hollow fibers (mats 19 and 21, Fig. 1). This structure forms a compact blood oxygenator that still allows for efficient blood oxygenation (¶ [0073-0076]).
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 generic blood oxygenator of Federspiel to have a housing having a blood inlet, a blood outlet, a gas inlet, and a gas outlet, wherein the plurality of hollow fibers are in fluid communication with the gas inlet and gas outlet, and wherein the plurality of hollow fibers are arranged in the housing such that a direction of blood flow between the blood inlet and the blood outlet extends across each hollow fiber in a plane perpendicular to a direction of gas flow through each hollow fiber of each of the rows of hollow fibers, as taught by Matheis, to allow for a more compact blood oxygenator that still allows for efficient blood oxygenation (¶ [0073-0076]).
Federspiel/Matheis is silent wherein the roughened outer surface of the hollow fibers includes a plurality of raised protuberances non-uniformly arranged around the outer surface and along a longitudinal length of the hollow fibers.
Sado teaches gas exchange members, thus being in the same field of endeavor, with a plurality of protrusions (14, Figs. 10-11) non-uniformly arranged on the surface (Col. 4 lines 40-66). This random distribution ensures that the members never stick and adhere to neighboring members, and the random protrusions create turbulent flow that improves the efficiency of gas exchange (Col. 4 lines 40-66).
Therefore, it would have been obvious to modify the hollow fibers of Federspiel/Matheis to have the plurality of protuberances be non-uniformly arranged around the outer surface and along a longitudinal length of the hollow fibers, as taught by Sado, to ensure the fibers do not stick and adhere to neighboring fibers and to improve the gas exchange due to the turbulence generated by the random distribution of the protuberances, as taught by Sado (Col. 4 lines 40-66).
Regarding Claim 6, Federspiel further discloses an inner surface (26, Fig. 3a) of each fiber is smooth (as seen in Fig. 3a).
Regarding Claims 8 and 9, the combination of Federspiel/Matheis/Sado discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Federspiel/Matheis/Sado further discloses the plurality of hollow fibers (fibers of each mat 19 and 21, Matheis Fig. 2) rows of fibers (mats 19 and 21, Matheis Fig. 1) are stacked on top of each other with each row (mats 19 and 21, Matheis Fig. 1) angled relative to the rows in contact therewith, wherein adjacent rows are oriented perpendicular to one another (as seen in Matheis Fig. 1).
Regarding Claims 21 and 22, Federspiel discloses a blood oxygenator (page 2, lines 30-31 indicate the hollow fiber membrane is used in a blood oxygenator) comprising:
a gas exchange medium having a plurality of hollow fibers (page 6, lines 1-2 indicate the oxygenator uses a plurality of the hollow fiber membranes 20);
wherein each of the hollow fibers (20, Fig. 3a) has a roughened outer surface (24, Fig. 3a) configured to decrease a thickness of a boundary layer at an interface between blood at the roughened outer surface and increase a gas exchange rate at the interface relative to hollow fibers having a smooth outer surface (page 2, lines 24-29, page 6 lines 1-5; since the hollow fibers have a roughened outer surface and are described as disrupting the boundary layer and increasing gas exchange by introducing convection currents locally to the fiber surface, which is substantially similar to what is occurring in Applicant’s invention, the fibers of Federspiel can be said to be configured to decrease a thickness of the boundary layer), wherein the roughened outer surface (24, Fig. 3a) of the hollow fibers (20, Fig. 3a) includes a plurality of raised protuberances (28, Fig. 3a).
Federspiel is silent whether the blood oxygenator comprises a rectangular housing having a blood inlet, a blood outlet, a gas inlet, and a gas outlet, wherein the plurality of hollow fibers in the gas exchange medium are in fluid communication with the gas inlet and the gas outlet, and wherein the plurality of hollow fibers is arranged in the housing in a plurality of distinct rows, wherein the hollow fibers of any one of the rows are arranged substantially parallel with each other, wherein the hollow fibers of one row are arranged substantially perpendicular to the hollow fibers of an adjacent row; and wherein a direction of blood flow between the blood inlet and the blood outlet extends across each hollow fiber in a plane perpendicular to a direction of gas flow through each hollow fiber of each of the rows of hollow fibers, and wherein the roughened outer surface of the hollow fibers includes a plurality of raised protuberances randomly arranged around the outer surface and along a longitudinal length of the hollow fibers.
Matheis teaches a blood oxygenator (1, Fig. 2), thus being in the same field of endeavor, with a rectangular housing (2, Fig. 2; ¶ [0058]) having a blood inlet (31, Fig. 2), a blood outlet (41, Fig. 2), a gas inlet (one of connectors 35, Fig. 2), and a gas outlet (the other of connectors 35, Fig. 2), wherein the plurality of hollow fibers in the gas exchange medium are in fluid communication with the gas inlet and the gas outlet (¶ [0072-0076, 0088, 0095]; each fiber of mats 19 and 21 are in communication with the gas inlet and gas outlet, Fig. 1), and wherein the plurality of hollow fibers are arranged in the housing in a plurality of distinct rows (mats 19 and 21, Fig. 1), wherein the hollow fibers (each fiber of mats 19 and 21, Fig. 1) of any one of the rows (mats 19 and 21, Fig. 1) are arranged substantially parallel with each other (as seen in Fig. 1); wherein the hollow fibers (each fiber of mats 19 and 21, Fig. 1) of one row are arranged substantially perpendicular to the hollow fibers (each fiber of mats 19 and 21, Fig. 1) of an adjacent row (as seen in Fig. 1); and wherein a direction of blood flow (4, Fig. 1; ¶ [0073]) between the blood inlet (31, Fig. 2) and the blood outlet (41, Fig. 2) extends across each hollow fiber (each fiber forming mats 19 and 21, Fig. 1) in a plane perpendicular to a direction of gas flow (10, Fig. 1; ¶ [0076]) through each hollow fiber (each fiber forming mats 19 and 21, Fig. 1) of each of the rows of hollow fibers (mats 19 and 21, Fig. 1). This structure forms a compact blood oxygenator that still allows for efficient blood oxygenation (¶ [0073-0076]).
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 generic blood oxygenator of Federspiel to have a rectangular housing having a blood inlet, a blood outlet, a gas inlet, and a gas outlet, wherein the plurality of hollow fibers are in fluid communication with the gas inlet and gas outlet, and wherein the plurality of hollow fibers is layered in a plurality of distinct rows, wherein the hollow fibers of any one of the rows are arranged substantially parallel with each other, wherein the hollow fibers of one row are arranged substantially perpendicular to the hollow fibers of an adjacent row; and wherein a direction of blood flow between the blood inlet and the blood outlet extends across each hollow fiber in a plane perpendicular to a direction of gas flow through any of the hollow fibers of any of the rows of hollow fibers, as taught by Matheis, to allow for a more compact blood oxygenator that still allows for efficient blood oxygenation (¶ [0073-0076]).
Federspiel/Matheis is silent wherein the roughened outer surface of the hollow fibers includes a plurality of raised protuberances randomly arranged around the outer surface and along a longitudinal length of the hollow fibers.
Sado teaches gas exchange members, thus being in the same field of endeavor, with a plurality of protrusions (14, Figs. 10-11) randomly arranged on the surface (Col. 4 lines 40-66). This random distribution ensures that the members never stick and adhere to neighboring members, and the random protrusions create turbulent flow that improves the efficiency of gas exchange (Col. 4 lines 40-66).
Therefore, it would have been obvious to modify the hollow fibers of Federspiel/Matheis to have the plurality of protuberances be randomly arranged around the outer surface and along a longitudinal length of the hollow fibers, as taught by Sado, to ensure the fibers do not stick and adhere to neighboring fibers and to improve the gas exchange due to the turbulence generated by the random distribution of the protuberances, as taught by Sado (Col. 4 lines 40-66).
Claim(s) 11 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Federspiel et al (WO 00/01472) in view of Matheis et al (US 2018/0117231).
Regarding Claim 11, Federspiel discloses a blood oxygenator (page 2, lines 30-31 indicate the hollow fiber membrane is used in a blood oxygenator) comprising:
a gas exchange medium having a plurality of elongate hollow fibers (page 6, lines 1-2 indicate the oxygenator uses a plurality of the hollow fiber membranes 20);
wherein each of the hollow fibers (20, Figs. 4-5) has a roughened outer surface (38, 46, Figs. 4-5) configured to decrease a thickness of a boundary layer at an interface between blood at the roughened outer surface and increase a gas exchange rate at the interface relative to hollow fibers having a smooth outer surface (page 2, lines 24-29, page 6 lines 1-5; since the hollow fibers have a roughened outer surface and are described as disrupting the boundary layer and increasing gas exchange by introducing convection currents locally to the fiber surface, which is substantially similar to what is occurring in Applicant’s invention, the fibers of Federspiel can be said to be configured to decrease a thickness of the boundary layer), wherein the roughened outer surface (38, 46, Figs. 4-5) of the hollow fibers (20, Figs. 4-5) is corrugated and includes a series of corrugation ridges and valleys separated by valleys (see Image 1).
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Image 1: Annotated Figs. 4 and 5 of Federspiel
Federspiel is silent whether the blood oxygenator comprises a housing having a blood inlet, a blood outlet disposed opposite the blood inlet, a gas inlet, and a gas outlet disposed opposite the gas inlet, wherein the plurality of hollow fibers in the gas exchange medium are in fluid communication with the gas inlet and the gas outlet, and wherein the plurality of hollow fibers is arranged in the housing such that a direction of blood flow between the blood inlet and the blood outlet extends across each hollow fiber in a plane perpendicular to a direction of gas flow through each of the hollow fibers, and whether the series of corrugation ridges includes a first ridge separated from a second ridge by a first valley, and wherein the first ridge has a first height extending radially away from the outer surface of the hollow fiber, and wherein the second ridge has a second height extending radially away from the outer surface of the hollow fiber, and wherein the second height is different from the first height.
Matheis teaches a blood oxygenator (1, Fig. 2), thus being in the same field of endeavor, with a housing (2, Fig. 2) having a blood inlet (31, Fig. 2), a blood outlet (41, Fig. 2) disposed opposite the blood inlet (31, Fig. 2), a gas inlet (one of connectors 35, Fig. 2), and a gas outlet (the other of connectors 35, Fig. 2) disposed opposite the gas inlet (Fig. 2), wherein the plurality of hollow fibers in the gas exchange medium are in fluid communication with the gas inlet and the gas outlet (¶ [0072-0076, 0088, 0095]; each fiber of mats 19 and 21 are in communication with the gas inlet and gas outlet, Fig. 1), and wherein the plurality of hollow fibers are arranged in the housing such that a direction of blood flow (4, Fig. 1; ¶ [0073]) between the blood inlet (31, Fig. 2) and the blood outlet (41, Fig. 2) extends across each hollow fiber (each fiber forming mats 19 and 21, Fig. 1) in a plane perpendicular to a direction of gas flow (10, Fig. 1; ¶ [0076]) through each of the hollow fibers (each fiber forming mats 19 and 21, Fig. 1). This structure forms a compact blood oxygenator that still allows for efficient blood oxygenation (¶ [0073-0076]).
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 generic blood oxygenator of Federspiel to have a housing having a blood inlet, a blood outlet, a gas inlet, and a gas outlet, wherein the plurality of hollow fibers are in fluid communication with the gas inlet and gas outlet, and wherein the plurality of hollow fibers are arranged in the housing such that a direction of blood flow between the blood inlet and the blood outlet extends across each hollow fiber in a plane perpendicular to a direction of gas flow through each of the hollow fibers, as taught by Matheis, to allow for a more compact blood oxygenator that still allows for efficient blood oxygenation (¶ [0073-0076]).
Federspiel/Matheis is silent whether the series of corrugation ridges includes a first ridge separated from a second ridge by a first valley, and wherein the first ridge has a first height extending radially away from the outer surface of the hollow fiber, and wherein the second ridge has a second height extending radially away from the outer surface of the hollow fiber, and wherein the second height is different from the first height.
However, one of ordinary skill in the art would have found it obvious to modify the ridges of Federspiel/Matheis to have the first ridge have a first height, the second ridge have a second height, wherein the second height is different from the first height, and wherein the first and second ridges alternate in the corrugation series. One of ordinary skill in the art would find this obvious to try, as there are a finite number of identified, predictable solutions for the heights of the ridges (either all ridges are the same height, all ridges are different heights, or ridges are divided into sets with each set having a different height). Having the first ridges have a first height and the second ridges have a second height different from the first height, where these ridges alternate in the corrugation series, would be additionally be obvious to one of ordinary skill in the art as using different ridge heights would additionally increase the flow disturbance caused by the ridges. Since Federspiel seeks to create flow disruptions to increase turbulence and increase gas exchange, one of ordinary skill in the art would be motivated to try having two different height ridges to create even more flow disruption than all equal height ridges.
Regarding Claim 14, Federspiel further discloses the ridges and valleys (see Image 1) extend circumferentially around each fiber (as seen in Fig. 5).
Regarding Claim 15, Federspiel further discloses the ridges and valleys (see Image 1) extend helically around each fiber (as seen in Fig. 4).
Regarding Claim 16, Federspiel further discloses an inner surface of each fiber is smooth (as seen in Figs. 4-5).
Regarding Claims 17-19, the combination of Federspiel/Matheis discloses the claimed invention substantially as claimed as set forth above for Claim 11.
The combination of Federspiel/Matheis further discloses the plurality of hollow fibers (fibers of each mat 19 and 21, Matheis Fig. 2) rows of fibers (mats 19 and 21, Matheis Fig. 1) are stacked on top of each other with each row (mats 19 and 21, Matheis Fig. 1) angled relative to the rows in contact therewith, wherein adjacent rows are oriented perpendicular to one another (as seen in Matheis Fig. 1).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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