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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/10/2026 has been entered.
Response to Arguments
Applicant’s amendment filed 02/10/2026 has been accepted and entered.
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. Berg and Mizutani are cited to teach the newly added limitations, as set forth below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “roughened outer surface of the hollow fibers includes a plurality of raised protuberances non-uniformly arranged about the outer surface of the hollow fibers” and “wherein the roughened outer surface of the hollow fibers is corrugated and 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” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
Claims 21 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the roughened outer surface" in line 13. There is insufficient antecedent basis for this limitation in the claim. Claim 22 recites the limitation “a roughened outer surface” and it is unclear if this limitation is intended to refer to the “the roughened outer surface” of Claim 21 or if this is a different “roughened outer surface”. For the purpose of compact prosecution, these roughened outer surface are interpreted as the same roughened outer surface.
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 Berg (WO 2006/012920).
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 about the outer surface 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 about the outer surface of the hollow fibers.
Berg teaches a hollow fiber (filtration membrane 1, Figs. 2 and 8; ¶ [0026]; several membranes 1 can be grouped together in a bundle to form a filtration module) with a roughened outer surface (9, Fig. 2) that includes a plurality of raised protuberances (thickenings 10, Figs. 2 and 8) non-uniformly arranged (¶ [0012]) about the outer surface (9, Fig. 2) of the hollow fibers (1, Fig. 2). The thickenings allow the fibers to be physically spaced apart from one another, and cause turbulent flow (¶ [0011]). Berg indicates the thickenings can be equally or non-equally spaced, indicating that both equal and unequal spacing causes turbulent flow and improves filtration (¶ [0011-0012, 0026]).
Therefore, it would have been obvious to modify the roughened outer surface of the hollow fibers of Federspiel/Matheis to include a plurality of raised protuberances non-uniformly arranged about the outer surface of the hollow fibers, as taught by Berg. These raised protuberances allow the fibers to be physically spaced apart from one another, and cause turbulent flow (as motivated by Berg ¶ [0011]).
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/Berg discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Federspiel/Matheis/Berg 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 about the outer surface 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 plurality of raised protuberances are randomly arranged about the outer surface of the hollow fibers.
Berg teaches a hollow fiber (filtration membrane 1, Figs. 2 and 8; ¶ [0026]; several membranes 1 can be grouped together in a bundle to form a filtration module) with a roughened outer surface (9, Fig. 2) that includes a plurality of raised protuberances (thickenings 10, Figs. 2 and 8) randomly arranged (¶ [0012]) about the outer surface (9, Fig. 2) of the hollow fibers (1, Fig. 2). The thickenings allow the fibers to be physically spaced apart from one another, and cause turbulent flow (¶ [0011]). Berg indicates the thickenings can be equally or non-equally spaced, indicating that both equal and unequal spacing causes turbulent flow and improves filtration (¶ [0011-0012, 0026]).
Therefore, it would have been obvious to modify the roughened outer surface of the hollow fibers of Federspiel/Matheis to include a plurality of raised protuberances randomly arranged about the outer surface of the hollow fibers, as taught by Berg. These raised protuberances allow the fibers to be physically spaced apart from one another, and cause turbulent flow (as motivated by Berg ¶ [0011]).
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) further in view of Mizutani et al (EP 0321447).
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. 3-5) has a roughened outer surface (24, 38, 46, Figs. 3a, 4, and 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 and 5) of the hollow fibers (20, Figs. 4 and 5) is corrugated and includes a series of ridges and valleys separating the 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 hollow fibers include 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 hollow fibers include 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.
Mizutani teaches a hollow fiber usable for dialysis (¶ [0001-0002]), where the hollow fiber can include multiple fins that have different heights (¶ [0015, 0019]), and wherein the fins can form a spiral shape (¶ [0018]). The presence of fins on the fibers improves the separation efficiency of the fibers (¶ [0009]).
Therefore, it would have been obvious to modify the heights of some of the ridges of Federspiel/Matheis to be different from the heights of the other ridges, as taught by Mizutani. This improves the separation efficiency of the fibers (as motivated by Mizutani ¶ [0009]). Mizutani indicates that the heights of the fins can all be the same or can be different, indicating that equal or different heights are both capable of improving the separation efficiency of the fibers (¶ [0015, 0019]).
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/Mizutani discloses the claimed invention substantially as claimed as set forth above for Claim 11.
The combination of Federspiel/Matheis/Mizutani 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
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781