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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/2026 has been entered.
Response to Amendment
The amendment filed 05/14/2026 has been entered. Claim 9 has been amended. Claim 11 is cancelled. Claims 1-10, 12-20 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to independent claims 1, 9 and 18 have been considered but are moot because the new ground of rejection does not rely on Kim as the primary reference for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made citing Mortensen.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-7, 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mortensen et al. (Pub. No.: US 2004/0052681 A1).
Regarding claim 1, Mortensen discloses (fig. 8), an oxygenator (heart/lung blood gas exchanger 400), comprising:
A housing (404) extending from a first end (406) to a second end (408) (¶ 0098, fig. 8); and
A bundle of hollow gas exchange fibers (hollow fiber assembly 402) between the first end and the second end (¶ 0099, fig. 8);
Wherein at least a portion of the housing (intermediate sidewall 434) is configured to selectively move from a neutral position in the absence of any force applied to the portion of the housing to a radially inward position with respect to the bundle of hollow gas exchange fibers and to a radially outward position with respect to the bundle of hollow gas exchange fibers, wherein the radially outward position is radially outward of the neutral position (¶ 0112-¶ 0113).
Regarding claim 2, Mortensen discloses wherein the housing includes a flexible portion disposed between the first and second end (intermediate sidewall 434, ¶ 0109).
Regarding claim 4, Mortensen discloses wherein a wall of the housing (intermediate sidewall 434) extending between the first and the second end is configured to shift between the radially inward and outward positions (¶ 0109).
Regarding claim 5, Mortensen discloses wherein the housing includes an actuation apparatus (pump, ¶ 0113) configured to selectively move the portion of the housing radially with respect to the bundle of hollow gas exchange fibers (¶ 0113).
Regarding claim 6, Mortensen discloses wherein the actuation apparatus is configured to operate in a cyclical manner (¶ 0114).
Regarding claim 7, Mortensen discloses wherein the actuation apparatus is configured to operate in a variable manner (¶ 0114).
Regarding claim 9, Mortensen discloses (fig. 8) an oxygenator (heart/lung blood gas exchanger 400), comprising:
A rigid housing (outer sidewall 410, ¶ 0108) extending from a first end (412) to a second end (414) (¶ 0098, fig. 8);
A first cover (end cap 420) coupled directly to the first end of the rigid housing and a second cover (end cap 422) coupled directly to the second end of the rigid housing (¶ 0098, fig. 8);
A flexible housing (intermediate sidewall 434, ¶ 0109) disposed within the rigid housing (fig. 8); and
A bundle of hollow gas exchange fibers (12) extending between the first end and the second end within the rigid housing (plurality of hollow fibers 12, ¶ 0099, fig. 8);
Wherein at least a portion of the flexible housing is configured to selectively move radially with respect to the bundle of hollow gas exchange fibers (¶ 0109).
Regarding claim 10, Mortensen discloses wherein the flexible housing is disposed radially outward of the bundle of hollow gas exchange fibers (¶ 0100) and a fluid is disposed between the rigid housing and the flexible housing (¶ 0113), wherein changes in pressure of the fluid causes at least the portion of the flexible housing to move radially with respect to the bundle of hollow gas exchange fibers (¶ 0113).
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.
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) 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortensen, as applied to claim 5 above, and further in view of Hattler (US Pat. No.: 5,376,069).
Regarding claim 3, Mortensen fails to disclose wherein the housing includes a second flexible portion disposed between the first end and the second end, wherein the second flexible portion is configured to selectively move radially with respect to the bundle of hollow gas exchange fibers independently of the flexible portion.
Hattler teaches discloses (fig. 6-10) an oxygenator (10) and thus in the same field of endeavor, comprising:
A housing (characterized by balloons 20, 25) extending from a first end to a second end (fig. 10); and
A bundle of hollow gas exchange fibers (14, col. 3, ln. 39-43) extending between the first end and the second end (fig. 6);
Wherein at least a portion of the housing is configured to selectively move radially with respect to the bundle of hollow gas exchange fibers (see portion adjacent balloon ballons 20, 25, col. 5, ln. 65-67);
Wherein the housing further includes a flexible portion (first balloon 20) disposed between the first and second end (fig. 10); and
Wherein the housing further includes a second flexible portion (second balloon 25) disposed between the first and second end (fig. 10), wherein the second flexible portion is configured to selectively move radially with respect to the bundle of hollow gas exchange fibers independently of the flexible portion (col. 7, ln. 14-20), wherein the flexible portion and the second flexible portion are configured to be inflated asynchronously so that resulting turbulence in the patient’s bloodstream is maximized (col. 7, ln. 20-24).
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 housing of Mortensen such that it includes a second flexible portion disposed between the first end and the second end, wherein the second flexible portion is configured to selectively move radially with respect to the bundle of hollow gas exchange fibers independently of the flexible portion, as taught by Hattler, in order to allow turbulence in the patient’s bloodstream is maximized (Hattler col. 7, ln. 20-24).
Regarding claim 8, Mortensen fails to disclose wherein the actuation apparatus comprises a plurality of rings disposed between the first end and the second end, wherein the plurality of rings is configured to move radially with respect to the bundle of hollow gas exchange fibers sequentially along the bundle of hollow gas exchange fibers.
Hattler teaches discloses (fig. 6-10) an oxygenator (10) and thus in the same field of endeavor, comprising:
A housing (characterized by balloons 20, 25) extending from a first end to a second end (fig. 10); and
A bundle of hollow gas exchange fibers (14, col. 3, ln. 39-43) extending between the first end and the second end (fig. 6);
Wherein at least a portion of the housing is configured to selectively move radially with respect to the bundle of hollow gas exchange fibers (see portion adjacent balloon ballons 20, 25, col. 5, ln. 65-67);
Wherein the housing includes an actuation apparatus (balloons 20, 25) configured to selectively move radially with respect to the bundle of hollow gas exchange fibers (col. 6, ln. 65-67); and
Wherein the actuation apparatus comprises a plurality of rings disposed between the first end and the second end (fig. 10, first inflation balloon and second inflation balloon 25 form rings, fig. 7), wherein the plurality of rings is configured to move radially with respect to the bundle of hollow gas exchange fibers sequentially along the bundle of hollow gas exchange fibers (col. 7, ln. 14-25), in order to allow for the plurality of rings to be inflated asynchronously so that resulting turbulence in the patient’s blood stream is maximized (col. 7, ln. 20-25).
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 actuation apparatus of Mortensen such that it comprises a plurality of rings disposed between the first end and the second end, wherein the plurality of rings is configured to move radially with respect to the bundle of hollow gas exchange fibers sequentially along the bundle of hollow gas exchange fibers, as taught by Hattler, in order to allow for the plurality of rings to be inflated asynchronously so that resulting turbulence in the patient’s blood stream is maximized (Hattler col. 7, ln. 20-25).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortensen, as applied to claim 1 above, and further in view of Kim et al. (Pub. No.: WO 2009/110652 A1).
Regarding claim 12, Mortensen fails to disclose wherein the flexible housing includes an expandable bladder formed within a wall of the flexible housing.
Kim teaches (fig. 2-3) an oxygenator (100) and thus in the same field of endeavor, comprising: a flexible housing (inner housing 111 and expansion member 120), wherein the flexible housing includes an expandable bladder (expansion member 120) formed within a wall of the flexible housing (¶ 28), in order to allow for blood to circulate (¶ 38-¶ 40).
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 flexible housing of Mortensen such that it includes an expandable bladder formed within a wall of the flexible housing, as taught by Kim, in order to allow for blood to circulate (Kim ¶ 38-¶ 40).
Regarding claim 13, Mortensen in view of Kim disclose wherein the expandable bladder is configured to receive an inflation fluid therein such that changes in pressure or volume of the inflation fluid within the expandable bladder cause at least a portion of the wall of the flexible housing to move radially with respect to the bundle of hollow gas exchange fibers (Kim ¶ 28-29).
Regarding claim 14, Mortensen in view of Kim disclose wherein the expandable bladder is disposed at a position radially outward of the bundle of hollow gas exchange fibers (Mortensen fig. 8, flexible housing is positioned radially outward of the bundle of hollow gas exchange fibers ¶ 0100).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortensen, as applied to claim 9 above, and further in view of Hattler et al. (US Pat. No.: 5,501,663), hereinafter Hattler ‘663.
Regarding claim 15, Mortensen fails to disclose in the embodiment of fig. 8 an annular ring disposed in contact with the flexible housing, wherein the annular ring is moveable axially along the flexible housing.
However, Mortensen discloses (fig. 1) an embodiment of an oxygenator (100), comprising: a flexible housing (104, ¶ 0049); and an annular ring (band) disposed in contact with the flexible housing (¶ 0041), in order to create a narrow portion that provides a disturbed flow pattern which allows the blood to mix and make repeated contact with the outer surfaces of the plurality of hollow fibers (¶ 0041).
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 embodiment of fig. 8 of Mortensen such that it comprises an annular ring disposed in contact with the flexible housing, as taught by the embodiment of fig. 1 of Mortensen, in order to create a narrow portion that provides a disturbed flow pattern which allows the blood to mix and make repeated contact with the outer surfaces of the plurality of hollow fibers (Mortensen ¶ 0041).
Mortensen fails to disclose wherein the annular ring is movable axially along the flexible housing.
Hattler ‘663 teaches (fig. 1-5) an oxygenator (abstract) and thus in the same field of endeavor, comprising an inflatable balloon (48) that is an annular ring (fig. 4-5), wherein the inflatable balloon is movable axially (col. 6, ln. 39-41) in order to allow for optimal gas transfer (col. 6, ln. 39-46).
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 annular ring of Mortensen such that it is movable axially along the flexible housing, as taught by Hattler ‘663, in order to allow for optimal gas transfer (Hattler ‘663, col. 6, ln. 39-46).
Regarding claim 16, Mortensen in view of Hattler ‘663 fail to explicitly disclose wherein the annular ring is disposed around the bundle of hollow gas exchange fibers between the rigid housing and the flexible housing and has an axial length less than a length of the flexible housing; wherein the flexible housing has a first diameter in an unconstrained configuration; wherein the annular ring has an inner diameter less than the first diameter of the flexible housing such that the annular ring radially constricts a portion of the flexible housing disposed therein to a second diameter than the first diameter.
However, as discussed in claim 15 above, 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 embodiment of fig. 8 of Mortensen with the embodiment of fig. 1 of Mortensen.
Mortensen (fig. 1) further teaches wherein the annular ring is disposed around the bundle of hollow gas exchange fibers (fig. 1, ¶ 0041) and has an axial length less than a length of the flexible housing (fig. 1, ¶ 0041);
Wherein the flexible housing has a first diameter in an unconstrained configuration (see diameter of expanded portion 1552, ¶ 0041);
Wherein the annular ring has an inner diameter less than the first diameter of the flexible housing such that the annular ring radially constricts a portion of the flexible housing disposed therein to a second diameter (see diameter of narrow portion 154) less than the first diameter (fig. 1, ¶ 0041);
Wherein the second diameter is configured provide a disturbed flow pattern which allows the blood to mix and make repeated contact with the outer surfaces of the plurality of hollow fibers (¶ 0041).
Further, the modification of Mortensen fig. 8 with Mortensen fig. 1 configures the annular ring to be disposed around the bundle of hollow gas exchange fibers between the rigid housing and the flexible housing since Mortensen fig. 1 disposed the annular ring around the flexible housing and Mortensen fig. 8 disposes the flexible housing inside the rigid housing.
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 oxygenator of Mortensen in view of Hattler ‘663 such that wherein the annular ring is disposed around the bundle of hollow gas exchange fibers between the rigid housing and the flexible housing and has an axial length less than a length of the flexible housing; wherein the flexible housing has a first diameter in an unconstrained configuration; wherein the annular ring has an inner diameter less than the first diameter of the flexible housing such that the annular ring radially constricts a portion of the flexible housing disposed therein to a second diameter than the first diameter, as taught by Mortensen fig. 1, in order to provide a disturbed flow pattern which allows the blood to mix and make repeated contact with the outer surfaces of the plurality of hollow fibers (Mortensen ¶ 0041).
Regarding claim 17, Mortensen in view of Hattler ‘663 fail to explicitly disclose wherein the annular ring is disposed within the flexible housing and has an axial length less than a length of the flexible housing; wherein the flexible housing has a first diameter in an unconstrained configuration; wherein the annular ring has an outer diameter greater than the first diameter of the flexible housing such that the annular ring radially expands a portion of the flexible housing to a second diameter greater than the first diameter.
However, as discussed in claim 15 above, 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 embodiment of fig. 8 of Mortensen with the embodiment of fig. 1 of Mortensen.
Mortensen (fig. 1) further teaches wherein the annular ring has an axial length less than a length of the flexible housing (fig. 1, ¶ 0041).
Further, Hattler ‘663 teaches that the annular ring is disposed within a flexible housing (characterized by fibers 42), wherein the flexible housing has a first diameter in an unconstrained configuration (fig. 3); wherein the annular ring has an outer diameter greater than the first diameter of the flexible housing such that the annular ring radially expands a portion of the flexible housing to a second diameter greater than the first diameter (fig. 2, col. 5, ln. 30-45), the annular ring configured to improve gas transfer (col. 5, ln. 30-45).
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 annular ring of Mortensen in view of Hattler ‘663 such that it is disposed within the flexible housing and has an axial length less than a length of the flexible housing; wherein the flexible housing has a first diameter in an unconstrained configuration; wherein the annular ring has an outer diameter greater than the first diameter of the flexible housing such that the annular ring radially expands a portion of the flexible housing to a second diameter greater than the first diameter, as taught by Mortensen fig. 1 and Hattler ‘663 as such arrangement of the annular ring is suitable for improving gas transfer (Hattler ‘663, col. 5, ln. 30-45).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortensen in view of Hattler ‘663.
Regarding claim 18, Mortensen discloses an oxygenator (100), comprising:
A housing (104) extending from a first end (106) to a second end (108); and
A bundle of hollow gas exchange fibers (hollow fiber assembly 102) extending between the first end and the second end (fig. 1, ¶ 0035);
Wherein a plurality of radially inward constrictions (narrow portion 154) are selectively formable in the housing between the first and the second end around the bundle of hollow gas exchange fibers (¶ 0041).
Mortensen fails to disclose wherein the plurality of radially inward constrictions are configured to move axially between the first end and the second end.
Hattler ‘663 teaches (fig. 1-2) an oxygenator (abstract) and thus in the same field of endeavor, comprising an inflatable balloon (48), wherein the inflatable balloon is configured to move axially between a first end (manifold 46) and a second end (manifold 44) (col. 6, ln. 39-41) in order to allow for optimal gas transfer (col. 6, ln. 39-46).
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 plurality of radially inward constrictions of Mortensen such that it is configured to move axially between the first end and the second end, as taught by Hattler ‘663, in order to allow for optimal gas transfer (Hattler ‘663, col. 6, ln. 39-46).
Regarding claim 19, Mortensen discloses wherein forming the plurality of radially inward constrictions causes mixing of blood flowing from a blood inlet port (146) towards a blood outlet port (148) (¶ 0038, ¶ 0041).
Regarding claim 20, the limitation “wherein moving the plurality of radially inward constrictions axially between the first end and the second end creates a pressure wave within blood flowing form the blood inlet port towards the blood outlet port” relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The plurality of radially inward constrictions of Mortensen in view of Hattler ‘663 is axially movable and is capable of creating a pressure wave within blood flowing form the blood inlet port towards the blood outlet port and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kashefi-Khorasani et al. (Pub. No.: US 2010/0106072 A1) discloses an oxygenator having an expandable member.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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