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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 30, 2026 has been entered.
Response to Arguments
Applicant's arguments filed May 30, 2026 have been fully considered but they are not persuasive. Amendments to the current set of claims has changed the scope of the claimed invention of the independent claims, but a modification of the previous prior art rejection using the same interpretation reads upon the claimed invention.
On page 6 of the Remarks section, as indicated by the page number at the bottom of each page, Applicant discusses the previous interview, as well as the amendment made to address the previous 112(b) rejection. In response, the Examiner has withdrawn the 112(b) rejection.
On page 7, Applicant argues against the previous 102 anticipatory rejection of independent Claim 1 using Donato et al., (“Donato”, US 2020/0147287), regarding the newly amended limitation “the passage openings” “at each of the end regions”. Applicant argues that Donato does not disclose multiple passage openings at each end region as now claimed. The Examiner notes that while Donato does not disclose this feature, newly found secondary reference Hahmann et al., (“Hahmann”, US 2009/0050556), discloses this limitation instead, in a 103 prior art combination as demonstrated in the prior art rejection section below. Thus, the Examiner finds Applicant’s argument here moot.
On pages 7-9, Applicant discusses the other previously made 103 prior art rejections for various dependent claims, but does not present specific arguments against the disclosures or combinations made in those rejections. Thus, the Examiner considers these remarks moot.
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) 1-8, 11, 13, 16 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donato et al., (“Donato”, US 2020/0147287), in view of Hahmann et al., (“Hahmann”, US 2009/0050556).
Regarding Claims 1-8, 11, 13, 16 & 18, Donato discloses a hollow fiber membrane filter, (See Abstract), comprising a cylindrical housing that extends along a central axis in the longitudinal direction, with a housing interior space, and end regions comprising a first end region with a first end and a second end region with a second end, (Cylindrical Housing with interior and two ends, See Figure 1, See paragraph [0100] & [0037]), a plurality of hollow fiber membranes, (Hollow fiber membranes in housing, See Figure 1, See paragraph [0100] & [0037]), having an inner diameter of 150 to 190 pm, (See Abstract and See paragraph [0130]; Donato anticipates the claimed range from 168 to 175 microns), and a wall thickness of 25 to 38 pm, (See Abstract and See paragraph [0130]; Donato anticipates the claimed range from 25 to 26 microns), the hollow fiber membranes being arranged in the cylindrical housing, (Hollow fiber membranes in housing, See Figure 1, See paragraph [0130]), and embedded in a sealing manner in the first end region and in the second end region of the cylindrical housing in a respective potting compound in a potting zone, (See paragraph [0100]; either end of the membrane is encapsulated/sealed by potting material), and ends of the hollow fiber membranes being open, so that lumina of the hollow fiber membranes form a first flow space, (See paragraph [0100]; second flow space formed by fiber cavities), and the housing interior space surrounding the hollow fiber membranes forms a second flow space, (See paragraph [0100]; first flow space surrounding membranes on outside), first inflow or outflow spaces, each adjoining with a respective front end of the first and second end of the cylindrical housing and the potting zone, which are in fluid communication with the first flow space of the hollow fiber membrane filter, (See paragraph [0100]; the flow space above and below said potting material which is in flow communication with said fiber cavities), wherein first liquid access points are for conducting liquid into/out of the first inflow or outflow spaces, (See paragraph [0100]; blood inlet and outlet, to cause blood to enter the fiber membranes and flow therethrough), second inflow or outflow spaces surrounding the first and the second end region of the cylindrical housing which are in fluid communication with a second flow region, wherein second liquid access points are for conducting liquid into/out of the second inflow or outflow space, (See paragraph [0100]; “the dialysate inlet and dialysate outlet are designed to allow dialysate to flow into an interior of the dialyzer, bathing the exterior surfaces of the fibers…dialysate flowing on the outside of the membranes”), a respective seal that separates the first inflow or outflow spaces from the second inflow or outflow spaces, (See paragraph [0100] & [0002]), passage openings through the cylindrical housing at the end regions which form the fluid communication between the second inflow and/or outflow spaces and the second flow space, (See paragraph [0100]; caps include space between caps and bundle and inlet/outlet and membrane lumina), the passage openings arranged on isolated and/or opposite sections or circumferentially on the end regions of the cylindrical housing, (See Figure 1, See Abstract, See paragraph [0130], either ends of hollow fibers are at opposite ends of the housing), wherein that the aspect ratio of an actual effective length of the hollow fiber membranes and an inner diameter of the cylindrical housing is 8 to 12, (See Abstract and paragraph [0130]; “effective length (L) within the hemodialyzer within the range of 207-287 mm” and See paragraph [0015] & [0136]; “a housing with an inner diameter…within the range of 31-35 mm”, resulting in a ratio of 5.91 to 9.25, overlapping/anticipating the claimed range from 8 to 9.25).
Donato does not disclose the passage openings at each of the end regions, the passage openings arranged on the isolated and/or opposite sections or circumferentially at each of the end regions.
Hahmann discloses the passage openings at each of the end regions, the passage openings arranged on the isolated and/or opposite sections or circumferentially at each of the end regions, (Indentations/Notches/Ports 5 arranged annularly/circumferentially around Hollow Fiber Bundle, See Figures 1-4, and/or Radial Bore Holes 41/Bore Holes 39 also circumferentially arranged and entering space/chamber of Hollow Fiber Bundle, See Figure 6, See paragraph [0043]; and/or paragraphs [0044] & [0045], Hahmann).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of Donato by incorporating the passage openings at each of the end regions, the passage openings arranged on the isolated and/or opposite sections or circumferentially at each of the end regions as in Hahmann in order to provide “essentially equal partial quantities of the fluid [that] can enter and exit through the cross-sections”, (See paragraph [0016], Hahmann), and “to assure that there is no dead space in the annular space in which air bubbles can collect”, (See paragraph [0026], Hahmann).
Additional Disclosures Included:
Claim 2: The hollow fiber membrane filter as set forth in claim 1 wherein a membrane surface area of the hollow fiber membrane filter is 1.2 to 2 m2, (See Abstract and paragraph [0130]; Donato anticipates the claimed range from 1.64 to 1.73 m2).
Claim 3: The hollow fiber membrane filter as set forth in claim 1 wherein the effective length of the hollow fiber membranes is 270 to 320 mm, (See Abstract and paragraph [0130]; “effective length (L) within the hemodialyzer within the range of 207-287 mm”; Donato anticipates/overlaps the claimed range at 270 to 287 mm).
Claim 4: The hollow fiber membrane filter as set forth in claim 1, wherein the inner diameter of the cylindrical housing is 25 to 35 mm, (See paragraph [0015] & [0136]; “a housing with an inner diameter…within the range of 31-35 mm”; anticipating/overlapping the claimed range from 31 to 35 mm).
Claim 5: The hollow fiber membrane filter (100) as set forth in claim 1 wherein a packing density of the hollow fiber membranes is 50 to 70%, (See Abstract and See paragraph [0130]; “a packing density within the range of 57.5-60.0%, anticipating the claimed range at those values).
Claim 6: The hollow fiber membrane filter (100) as set forth in claim 1, wherein the hollow fiber membranes have a wave-like shape, wherein an amplitude of the wave-like shape of the hollow fiber membranes is 0.1 to 0.5 mm, (See paragraph [0158]; “an amplitude in the range of from 0.1 to 0.5 mm”), and a wavelength of the wave-like shape of the hollow fiber membranes is 5 to 10 mm, (See paragraph [0158]; “a wavelength in the range of from 6 to 9 mm”, anticipating the claimed range at those values).
Claim 7: The hollow fiber membrane filter as set forth in claim 1, wherein, in the end regions of the cylindrical housing, a ratio of a sum of flow cross sections of all passage openings to a flow cross section of at least one of the second inflow or outflow spaces lies in the range of 0.5:1 to 7:1, (See Abstract, See paragraph [0130], etc; selecting an inner diameter of 168 microns for the hollow fibers, 25 microns for the wall thickness, and 31 mm for the inner wall housing and 60% for packing densities, the overall interior space of the housing was calculated using pi*r2, which was pi*(31/2)2 = 754.4 mm2, a packing density of 60% would yield an overall cross-sectional area of the membranes as 452.6 mm2, calculating the cross-sectional area of each hollow fiber membrane as 0.0292 mm2, and dividing the ratio of 452.6 by 0.292 yields 15,500 membranes total. Then, taking the interior opening cross-sectional area of each hollow fiber would be 0.0221 mm2, and multiplying by 15500 to get the overall cross-sectional opening area of 343.4 mm2. This results in a ratio of 343.4 mm2: (754.4 mm2 – 343.4 mm2) or 0.84:1, anticipating the claimed range at this value).
Claim 8: The hollow fiber membrane filter as set forth in claim 7, wherein, in the end regions of the cylindrical housing, the second inflow or outflow spaces, starting from the second liquid access points to the central axis of the cylindrical housing, form a rotationally symmetrical circumferential space, (Arrows of blood entering/exiting ports at either end/endcap and cross-sectional view demonstrates circumferential view of membranes, See Figure 1, See paragraph [0100]).
Claim 11: The hollow fiber membrane filter as set forth in claim 1, wherein a sum of flow cross sections of all passage openings is 10 to 350 mm2, See Abstract, See paragraph [0130], etc; selecting an inner diameter of 168 microns for the hollow fibers, 25 microns for the wall thickness, and 31 mm for the inner wall housing and 60% for packing densities, the overall interior space of the housing was calculated using pi*r2, which was pi*(31/2)2 = 754.4 mm2, a packing density of 60% would yield an overall cross-sectional area of the membranes as 452.6 mm2, calculating the cross-sectional area of each hollow fiber membrane as 0.0292 mm2, and dividing the ratio of 452.6 by 0.292 yields 15,500 membranes total. Then, taking the interior opening cross-sectional area of each hollow fiber would be 0.0221 mm2, and multiplying by 15500 to get the overall cross-sectional opening area of 343.4 mm2, anticipating the claimed range at this value).
Claim 13: The hollow fiber membrane filter as set forth in claim 1, wherein the first and the second inflow or outflow space in the first end region of the cylindrical housing and the first and the second inflow or outflow space in the second end region of the cylindrical housing are respectively enclosed by a first and a second end cap, (See paragraph [0100]; either end of the dialyzer has an end cap surrounding any spaces at either end).
Claim 16: The hollow fiber membrane filter as set forth in claim 1, wherein a ratio of a sum of flow cross sections of all passage openings to a flow cross section of at least of the one second inflow or outflow spaces lies in a range of 0.75:1 to 5:1, (See Abstract, See paragraph [0130], etc; selecting an inner diameter of 168 microns for the hollow fibers, 25 microns for the wall thickness, and 31 mm for the inner wall housing and 60% for packing densities, the overall interior space of the housing was calculated using pi*r2, which was pi*(31/2)2 = 754.4 mm2, a packing density of 60% would yield an overall cross-sectional area of the membranes as 452.6 mm2, calculating the cross-sectional area of each hollow fiber membrane, pi*(175 micron diameter/2)2 as 0.0314 mm2, and dividing the ratio of 452.6 by 0.0314 yields 14,414 membranes total. Then, taking the interior opening cross-sectional area of each hollow fiber would be 0.024 mm2, and multiplying by 14,414 to get the overall cross-sectional opening area of 346.5 mm2. This results in a ratio of 346.5 mm2: (754.4 mm2 – 346.5 mm2) or 0.84:1, anticipating the claimed range at this value).
Claim 18: The hollow fiber membrane filter as set forth in claim 8, wherein the rotationally symmetrical circumferential space is an annular gap, (Gaps shown in cross-sectional view of membranes versus cylindrical housing which will form at either end as well, See Figure 1, See paragraph [0100]).
Claims 10 & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donato et al., (“Donato”, US 2020/0147287), in view of Hahmann et al., (“Hahmann”, US 2009/0050556), in further view of Buck et al., (“Buck”, US 2015/0165106).
Regarding Claim 10, modified Donato discloses the hollow fiber membrane filter as set forth in claim 1, but does not disclose wherein said first end region, and optionally said second end region, is divided into a proximal end region, a distal end region, and a transition region disposed between said proximal and distal end regions, wherein one end of the distal end regions of the first and/or second end region corresponds to the respective end of the cylindrical housing, and the distal end region has an inner diameter at least 2% larger than an inner diameter of the proximal end region.
Buck discloses wherein said first end region, and optionally said second end region, is divided into a proximal end region, a distal end region, and a transition region disposed between said proximal and distal end regions, wherein one end of the distal end regions of the first and/or second end region corresponds to the respective end of the cylindrical housing, and the distal end region has an inner diameter at least 2% larger than an inner diameter of the proximal end region, (End portion of Housing is widest at edge, has a transitional narrowing portion, and a narrowest portion where it meets the midbody of the housing, See Figure 4, B diameter is 49.6 mm and midbody diameter is 38 mm, and 49.6 is more than 2% larger than 38, See paragraph [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of modified Donato by incorporating wherein said first end region, and optionally said second end region, is divided into a proximal end region, a distal end region, and a transition region disposed between said proximal and distal end regions, wherein one end of the distal end regions of the first and/or second end region corresponds to the respective end of the cylindrical housing, and the distal end region has an inner diameter at least 2% larger than an inner diameter of the proximal end region as in Buck in order to provide “optimized construction” and “optimized performance”, (See paragraphs [0006] & [0007], Buck).
Regarding Claim 12, modified Donato discloses the hollow fiber membrane filter as set forth in claim 1 but does not disclose wherein a flow cross section of the second inflow or outflow spaces is 20 to 50 mm2.
Buck discloses wherein a flow cross section of the second inflow or outflow spaces is 20 to 50 mm2, (See paragraph [0040], Buck; diameter of the inlet for the end cap is 3.7 mm, which has a cross-sectional area of pi*(3.7)2 = 43 mm2, anticipating the claimed range).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of modified Donato by incorporating wherein a flow cross section of the second inflow or outflow spaces is 20 to 50 mm2 as in Buck in order to provide “optimized construction” and “optimized performance”, (See paragraphs [0006] & [0007], Buck).
Claim(s) 14 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donato et al., (“Donato”, US 2020/0147287), in view of Hahmann et al., (“Hahmann”, US 2009/0050556), in further view of Oshida et al., (“Oshida”, US 5,552,047).
Regarding Claim 14, modified Donato discloses the hollow fiber membrane filter as set forth in claim 13 but does not explicitly disclose wherein the first and the second end cap adjoin an annular outer circumferential projection on the first end and on the second end region of the cylindrical housing in a positive, liquid-tight manner.
Oshida discloses wherein the first and the second end cap adjoin an annular outer circumferential projection on the first end and on the second end region of the cylindrical housing in a positive, liquid-tight manner, (Caps 9/10 adjoin housing 2 at its external annular/circumferential edge at either side, See Figure 1-3, See column 4, lines 34-42, lines 57-67, column 7, lines 106, lines 16-20, Oshida).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of modified Donato by incorporating wherein the first and the second end cap adjoin an annular outer circumferential projection on the first end and on the second end region of the cylindrical housing in a positive, liquid-tight manner as in Oshida to “prevent any blood leakage between the cap and the housing after sterilization even when some improperly located hollow filaments or fine foreign particles are present”, (See column 1, lines 57-62, Oshida).
Regarding Claim 15, modified Donato discloses the hollow fiber membrane filter as set forth in claim 13 but does not explicitly disclose wherein the first and the second end cap positively adjoin the first end and the second end, respectively, of the cylindrical housing, particularly in a liquid-tight manner, along an inner circumferential circular line.
Oshida discloses wherein the first and the second end cap positively adjoin the first end and the second end, respectively, of the cylindrical housing, particularly in a liquid-tight manner, along an inner circumferential circular line, (Caps 9/10 adjoin housing 2 at its external annular/circumferential edge at either side, See Figure 1-3, See column 4, lines 34-42, lines 57-67, column 7, lines 106, lines 16-20, Oshida).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of modified Donato by incorporating wherein the first and the second end cap positively adjoin the first end and the second end, respectively, of the cylindrical housing, particularly in a liquid-tight manner, along an inner circumferential circular line as in Oshida to “prevent any blood leakage between the cap and the housing after sterilization even when some improperly located hollow filaments or fine foreign particles are present”, (See column 1, lines 57-62, Oshida).
Claim(s) 17, 19 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donato et al., (“Donato”, US 2020/0147287), in view of Hahmann et al., (“Hahmann”, US 2009/0050556), in further view of Kugelmann et al., (“Kugelmann”, US 2008/0145926).
Regarding Claim 17, modified Donato discloses the hollow fiber membrane filter as set forth in claim 1, but does not disclose wherein a ratio of a sum of flow cross sections of all passage openings to a flow cross section of at least one of the second inflow or outflow spaces lies in a range of 1:1 to 3:1.
Kugelmann discloses wherein a ratio of a sum of flow cross sections of all passage openings to a flow cross section of at least one of the second inflow or outflow spaces lies in a range of 1:1 to 3:1, (See paragraph [0008], [0031], & [0073]; The inside diameter of an individual hollow fiber is selected at 250 microns, the diameter of the overall hollow fiber bundle is 34 mm and 11,000 total hollow fiber membranes are selected. Since there are 12 fibers per mm2, and 11,000 membranes, the total cross-sectional area is 11,000 / 12 or 916.7 mm2. The cross-sectional area of an individual hollow fiber is pi*(250/2/1000 (microns/mm))2 = 0.049 mm2, and multiplied by 11,000 would result in a total cross-sectional area of the hollow fiber openings as 539.7 mm2 and the resultant ratio is 539.7 : (916.7 – 539.7) or 1.43:1, making obvious the claimed range at that value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of modified Donato by incorporating wherein a ratio of a sum of flow cross sections of all passage openings to a flow cross section of at least one of the second inflow or outflow spaces lies in a range of 1:1 to 3:1 as in Kugelmann in order to achieve “a particularly favorable mass transfer”, (See paragraph [0008], Kugelmann), and “results in a correspondingly higher pressure in the hollow fiber membranes and leads to an increase of the pressure difference across the hollow fiber membranes and thus to an increase of the convective exchange”, (See paragraph [0025], Kugelmann).
Regarding Claim 19, modified Donato disclose the hollow fiber membrane filter as set forth in claim 1, but does not disclose wherein a sum of flow cross sections of all passage openings is 15 to 200 mm2.
Kugelmann discloses wherein a sum of flow cross sections of all passage openings is 15 to 200 mm2, (See paragraph [0008], [0031], & [0073]; The inside diameter of the hollow fiber is selected at 100 microns, and the outside diameter is selected at 250 microns. The number of hollow fibers is selected at 11,000. The cross-sectional area of the lumina is pi*(100 microns/2/1000 (microns/mm))2 = 0.00785 mm2 which means multiplied by 11000 is a total area of 86.35 mm2, which anticipates the claimed range at this value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of modified Donato by incorporating wherein a sum of flow cross sections of all passage openings is 15 to 200 mm2 as in Kugelmann in order to achieve “a particularly favorable mass transfer”, (See paragraph [0008], Kugelmann), and “results in a correspondingly higher pressure in the hollow fiber membranes and leads to an increase of the pressure difference across the hollow fiber membranes and thus to an increase of the convective exchange”, (See paragraph [0025], Kugelmann).
Regarding Claim 20, modified Donato disclose the hollow fiber membrane filter as set forth in claim 1, but does not disclose wherein a sum of flow cross sections of all passage openings is 20 to 110 mm2.
Kugelmann discloses wherein a sum of flow cross sections of all passage openings is 20 to 110 mm2, (See paragraph [0008], [0031], & [0073]; The inside diameter of the hollow fiber is selected at 100 microns, and the outside diameter is selected at 250 microns. The number of hollow fibers is selected at 11,000. The cross-sectional area of the lumina is pi*(100 microns/2/1000 (microns/mm))2 = 0.00785 mm2 which means multiplied by 11000 is a total area of 86.35 mm2, which anticipates the claimed range at this value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the hollow fiber membrane filter of modified Donato by incorporating wherein a sum of flow cross sections of all passage openings is 20 to 110 mm2 as in Kugelmann in order to achieve “a particularly favorable mass transfer”, (See paragraph [0008], Kugelmann), and “results in a correspondingly higher pressure in the hollow fiber membranes and leads to an increase of the pressure difference across the hollow fiber membranes and thus to an increase of the convective exchange”, (See paragraph [0025], Kugelmann).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779
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