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 .
Status of Claims
Claims 1-15 are currently pending. Claims 1, 3, 6, and 13 are currently amended. No new subject matter is added.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites “an overflow region” in line 9 should be “the
Claim 13 recites “a portion of blood entering the blood filter element” in lines 10 should be “the portion of blood entering the blood filter element” (replacing “a” with “the”).
Claim 13 recites “a separate portion of the blood which has entered the blood filter element” in line 12 should be “the separate portion of the blood which has entered the blood filter element” (replacing “a” with “the”).
Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see pg. 1, filed 02/02/2026, with respect to Claim 1 have been fully considered and are persuasive. The claim objection of Claim 1 has been withdrawn.
Applicant’s arguments, see pgs.1-5, filed 02/02/2026, with respect to the rejection(s) of Claims 1 and 13 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yokomizo et al. (WO 2015137307 A1).
Specifically, applicant argues in the Non-Final rejection filed 10/01/2025 that Yokomizo et al. (US 20120067810 A1) fails to teach the inner and outer layers being “permeable layers”. The applicant also states that Yokomizo does not include any region that could be reasonably interpreted as an “overflow region”. As discussed below, Yokomizo et al. (WO 2015137307 A1) teaches an “overflow region” as shown in annotated Figure 2, and further interprets the outer layer to incorporate an outlet port 11a and inner layer to incorporate inlet port 9a which allows the outer and inner layer to be permeable. Yokomizo et al. (WO 2015137307 A1) is then used as a teaching reference to disclose the outlet and inlet ports to be located in the “overflow regions” to read on the newly amended limitations.
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.
Claims 1-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo et al. (US 20120067810 A1), hereinafter referred to as “Yokomizo 810” in view of Rosenberg (US 3765537 A) and in further view of Yokomizo et al. (WO 2015137307 A1), hereinafter referred to as “Yokomizo 307”.
Regarding Claim 1, Yokomizo 810 teaches a filter element forming a blood filter element (blood processing filter 1A-B; blood processing filter 1B according to the second embodiment includes substantially the same elements and structures as the blood processing filter 1A according to the first embodiment, see Paragraph [0102]; Figures 2 and 9), which is configured in the form of a pocket or tube with an inner space (inside of the flexible container 3, see Figure 2) extending in a longitudinal direction (see Figure 2) and having a multilayer structure which comprises a permeable outer layer (flow channel securing sheet 21 and an outlet port 11a in which an outlet flow channel 11b that allows the inside and the outside to communicate is formed is sealed in the outlet-side container 11, see Paragraph [0055]; Figures 3 and 9), a permeable inner layer (inlet-side container 9 having an inlet port 9a in which an inlet flow channel 9b that allows the inside and the outside to communicate is formed is sealed in the inlet-side container 9, see Paragraph [0054]; Figure 3) and at least one intermediate layer (filter element 5) which is arranged between the permeable outer layer and the permeable inner layer (see Figure 2), wherein the filter element has a predetermined axial length (see Figure 2) and the permeable outer layer and the permeable inner layer each have the predetermined axial length (see Figure 2) and permit blood flow therethrough,
wherein the intermediate layer is formed axially shorter than the permeable outer layer and the permeable inner layer (filter element 5 is axially shorter than the outside seal 13 and inside seal 15, see Figure 2) along with a formation of an overflow region which is arranged at an axial upper end area of the blood filter element (see below), wherein an upper edge of the intermediate layer (a protruding nonwoven fabric portion 5c, see Figure 2) is axially spaced downwards from an upper edge of the permeable outer layer and the permeable inner layer (spaced below upper edge of outer and inner layer, see below), in that the permeable outer layer, the permeable inner layer and the intermediate layer are firmly connected to one another along at least one longitudinal edge along with the formation of a longitudinal connecting seam (the inlet-side container 9, the filter element 5, and the flow channel securing sheet 21 are sealed in close contact with each other, and as a result a band-shaped inside seal part 13 is formed along the periphery of the filter element 5, see Paragraph [0104]), and in that the permeable outer layer and the permeable inner layer are firmly connected to one another along their upper edge along with a formation of an upper transverse connecting seam (the flow channel securing sheet 21 is clamped and adhered between the periphery of the inlet-side container 9 and the periphery of the outlet-side container 11, thereby form an outside seal part 15, see Paragraph [0106]), wherein the upper edge of the intermediate layer is arranged free and unconnected between the permeable outer layer and the permeable inner layer (a
PNG
media_image1.png
644
479
media_image1.png
Greyscale
protruding nonwoven fabric portion 5c that is a surplus portion of the filter element 5 protrudes to the outside of the inside seal part 13 within the flexible container 3, see Paragraph 0056]; Figure 2).
However, Yokomizo does not explicitly disclose the intermediate layer which is configured as a fine-pored filter element.
Rosenberg teaches a disposable filter element (see Abstract; Figure 3) comprising an intermediate layer (filter sheet 42) is configured as a fine-pored filter element (the second filter 42 sheet is a woven open-mesh square-weave fabric with a pore size within the range from about 20 to about 50 microns, see Col. 3 ln 49-54).
Yokomizo and Rosenberg are analogous art because both teach a filtering element having an intermediate filter layer.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the intermediate filter layer of Yokomizo and further include the intermediate layer being a fine pored filter element, as taught by Rosenberg. Rosenberg teaches the fine pore filter is capable of passing human blood at a high flow rate and useful in human blood transfusion systems, to remove undesired suspended particles, substantially without removal of normal and desirable blood components (see Abstract).
Yokomizo 810 and Rosenberg teaches all of the limitations as discussed above and Yokomizo 810 teaches a permeable outer layer (an outlet port 11a in which an outlet flow channel 11b that allows the inside and the outside to communicate is formed is sealed in the outlet-side container 11, see Paragraph [0055]; Figure 3) and a permeable inner layer (inlet-side container 9 having an inlet port 9a in which an inlet flow channel 9b that allows the inside and the outside to communicate is formed is sealed in the inlet-side container 9, see Paragraph [0054]; Figure 3).
However, Yokomizo 810 and Rosenberg do not explicitly disclose permitting a portion of blood filling the blood filter element which rises axially above the upper edge of the intermediate layer to bypass the intermediate layer and flow out through the permeable inner and outer layers, and thus out from the blood filter element, while a separate portion of the blood continues to flow through all of the permeable inner and outer layers and the intermediate layer.
Yokomizo 307 teaches a filter (see Abstract; Figures 4 and 7) including: a permeable outer layer (outlet side container 11 and outlet side frame sheet 7 having an outlet port 4, see Figure 4), a permeable inner layer (inlet side container 9 and inlet side frame sheet 10 having an inlet port 2, see Figure 4), and permitting a portion of blood filling the blood filter element which rises axially above the upper edge of the intermediate layer to bypass the intermediate layer and flow out through the permeable inner and outer layers, and thus out from the blood filter element (inlet port 2 and outlet port 4 allows blood to enter/exit above the filter element 5, see Figure 4), while a separate portion of the blood continues to flow through all of the permeable inner and outer layers and the intermediate layer (outlet side frame sheet 7 and inlet side frame sheet 10 having channel holes 7a and 10a respectively to allow blood to flow through the inner, outer and filter layer, see Figure 4).
Yokomizo 810, Rosenberg, and Yokomizo 370 are analogous art because all teaches a filtering element having an intermediate filter layer.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the permeable outer layer and permeable inner layer of Yokomizo 810 and further include wherein the permeable layers permits a portion of blood filling the blood filter element which rises axially above the upper edge of the intermediate layer to bypass the intermediate layer and flow out through the permeable inner and outer layers, and thus out from the blood filter element, as taught by Yokomizo 370. Yokomizo 370 teaches it is beneficial for the inlet tube/outlet tube to be configured as such since a general tube can be used for the inlet port and the outlet port, the manufacturing cost can be reduced as compared with the case of using a port having a complicated structure formed by injection molding (see pg. 8 second to last paragraph).
Regarding Claim 2, Modified Yokomizo 810 teaches all of the limitations as discussed above in claim 1 and Yokomizo 810 further teaches wherein the outer layer (21), the inner layer (9) and/or the intermediate layer (5) are firmly connected to one another at their lower edge along with the formation of a lower transverse connecting seam (outside seal 13 also forms a lower transverse connecting seam, see Figures 2 and 9-10).
Regarding Claim 3, Modified Yokomizo 810 teaches all of the limitations as discussed above in claim 1 and Yokomizo 810 further teaches wherein a structure (container 3) composed of two halves (left half and right half, see above) is provided; and in that the two halves are firmly connected to one another along the two longitudinal edges along with the formation of two longitudinal connecting seams (connected to one another by inside seal part 13, see above).
Regarding Claim 4, Modified Yokomizo 810 teaches all of the limitations as discussed above in claim 1. However, Modified Yokomizo 810 does not explicitly disclose wherein an axial length of the overflow region is between 5% to 30% of the axial length of the filter element.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Modified Yokomizo 810 to have an axial length of the overflow region is between 5% to 30% of the axial length of the filter element since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Modified Yokomizo would not operate differently with the claimed axial length of the overflow region and since the axial length of the overflow region is intended to be a space where there is no intermediate layer the device would function appropriately having the claimed axial length of the overflow region. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the axial length of the overflow region is “between” 5% to 30% be within the claimed ranges (specification pg. 4 paragraph 4).
Regarding Claim 5, Modified Yokomizo 810 teaches all of the limitations as discussed above in claim 1 and Yokomizo 810 further teaches wherein at least one connecting seam is formed by ultrasonic welding (formation of the inside seal part 13 or outside seal 15 can be done by ultrasonic welding, see Paragraph [0090]-[0091]).
Regarding Claim 6, Modified Yokomizo 810 teaches all of the limitations as discussed above in claim 2 and Yokomizo 810 further teaches wherein the lower transverse connecting seam is configured to form a closed bottom (see Figures 2 and 9-10).
Regarding Claim 7, Modified Yokomizo 810 teach all of the limitations as discussed above in claim 1 and Yokomizo 810 further teaches wherein the filter element comprising a filter woven fabric, a filter membrane, a filter knitted fabric and/or a non-woven filter fabric (a filter element made from nonwoven fabric, see Paragraph [0007]).
Regarding Claim 8, Modified Yokomizo 810 teaches all of the limitations as discussed above in claim 1 and Rosenberg further teaches a disposable filter element (see Abstract; Figure 3) comprising an intermediate layer (filter sheet 42) wherein the aperture or pore size of the filter element is between 10 µm and 400 µm, in particular between 25 and 60 µm (the second filter 42 sheet is a woven open-mesh square-weave fabric with a pore size within the range from about 20 to about 50 microns, see Col. 3 ln 49-54).
Regarding Claim 9, Modified Yokomizo 810 teaches all of the limitations of claim 1. However, Yokomizo 810 does not explicitly disclose wherein the outer layer and/or the inner layer is formed as a woven fabric, knitted fabric, net, grate and/or nonwoven fabric.
Rosenberg teaches a disposable filter element (see Abstract; Figure 3) comprising and outer layer (the spacer 44), inner layer (filter sheet 41), and intermediate layer (filter sheet 42), wherein the outer layer and/or the inner layer is formed as a woven fabric, knitted fabric, net, grate and/or nonwoven fabric (filter sheet 41 of extruded polypropylene netting, spacer 44 is also made of extruded polypropylene netting, see Col. 6 ln 25-30).
Modified Yokomizo and Rosenberg are analogous art because both teach a filtering element having an intermediate filter layer.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the outer and inner layer of modified Yokomizo and further include wherein the outer layer and/or the inner layer is formed as a net, as taught by Rosenberg. Rosenberg teaches its beneficial for the spacer being any sheet having an uneven surface, such as dimpled, ridged, or quilted, and with large openings therethrough, can be used. Extruded, cast and molded netting are useful. The surface of the spacer or support is sufficiently uneven so as to provide drainage and prevent blocking of the medium and fine filer sheets by the support sheet (see Col. 4 ln 37-45).
Regarding Claim 10, Modified Yokomizo 810 teaches all of the limitations of claim 1 and Yokomizo 810 further teaches wherein the material of the intermediate layer is a polymeric material, in particular polyester or polyamide (the filter element can be four sheets of polyester nonwoven fabric, see Paragraph [0123]).
However, Modified Yokomizo 810 does not explicitly disclose wherein the material of the outer layer, and the inner layer is a polymeric material, in particular polyester or polyamide.
Rosenberg teaches a disposable filter element (see Abstract; Figure 3) comprising an outer layer (the spacer 44) and inner layer (filter sheet 41), wherein the outer layer, and the inner layer is a polymeric material, in particular polyester or polyamide (the first filter sheet 41 and the spacer 44 can be made from polyester, see Col. 3 ln 19-25; see Col. 4 ln 37-42).
Modified Yokomizo 810 and Rosenberg are analogous art because both teach a filtering element having an intermediate filter layer.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the outer and inner layer of Modified Yokomizo 810 and further include wherein the outer layer and/or the inner layer is a polymeric material, in particular polyester or polyamide, as taught by Rosenberg. Rosenberg teaches The ethylene glycol-terephthalic acid polyester monofilaments are preferred because of their availability and low cost (see Col. 4 ln 1-4).
Regarding Claim 11, Modified Yokomizo 810 teaches all of the limitations of claim 1. However, Modified Yokomizo 810 does not explicitly disclose wherein the material of the intermediate layer, the outer layer and the inner layer is the same.
Rosenberg teaches a disposable filter element (see Abstract; Figure 3) comprising and outer layer (the spacer 44), inner layer (filter sheet 41), and intermediate layer (filter layer 42) wherein the material of the intermediate layer, the outer layer and the inner layer is the same (the first filter sheet 41 and the spacer 44 can be made from polyester, see Col. 3 ln 19-25; see Col. 4 ln 37-42; and the second filter sheet 42 is a woven open-mesh square-weave fabric which can be made of polyester, see Col. 3 ln 49-53).
Modified Yokomizo 810 and Rosenberg are analogous art because both teach a filtering element having an intermediate filter layer.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the outer, inner, and intermediate layer of Modified Yokomizo 810 and further include wherein the material of the intermediate layer, the outer layer and the inner layer is the same, as taught by Rosenberg. Rosenberg teaches capable of passing human blood at a high flow rate and useful in human blood transfusion systems, to remove undesired suspended particles, substantially without removal of normal and desirable blood components (see Abstract) and the ethylene glycol-terephthalic acid polyester monofilaments are preferred because of their availability and low cost (see Col. 4 ln 1-4)..
Regarding Claim 13, Modified Yokomizo 810 teaches all of the limitations, as discussed above in claim 1 and Yokomizo 810 further teaches a method for producing the filter element, in particular the blood filter element, according to claim 1, wherein the outer layer (9) and the inner layer (21) form permeable layers which are firmly connected to one another at their upper edges along with the formation of an upper transverse connecting seam (the inlet-side container 9, the filter element 5, and the flow channel securing sheet 21 are sealed in close contact with each other, and as a result a band-shaped inside seal part 13 is formed along the periphery of the filter element 5, see Paragraph [0104]), wherein the intermediate layer is arranged in an intermediate space between the outer layer and the inner layer to form an additional filter layer (filter element 5 between inlet side container 9 and sheet 21, see Figure 9), and an upper edge of the intermediate layer remains free and unattached (a protruding nonwoven fabric portion 5c that is a surplus portion of the filter element 5 protrudes to the outside of the inside seal part 13 within the flexible container 3, see Paragraph 0056]; Figure 2 and 9), and wherein an overflow region is formed above the upper edge of the intermediate layer (see annotated Figure 2 above).
Yokomizo 307 further teaches a portion of blood entering the blood filter element which rises above an axial height of the intermediate layer exits the blood filter element by flowing through the permeable inner and outer layers (inlet port 2 and outlet port 4 allows blood to enter/exit above the filter element 5, see Figure 4), while a separate portion of the blood which has entered the blood filter element continues flowing through the intermediate layer and the inner and outer permeable layers (outlet side frame sheet 7 and inlet side frame sheet 10 having channel holes 7a and 10a respectively to allow blood to flow through the inner, outer and filter layer, see Figure 4).
Regarding Claim 14, Modified Yokomizo 810 teaches all of the limitations, as discussed above in claim 13 and Yokomizo 810 further teaches wherein the outer layer, the inner layer and/or the intermediate layer are connected at their outer edges by ultrasonic welding, thermal welding, adhesive bonding and/or hot bonding (formation of the inside seal part 13 can be done by ultrasonic welding, see Paragraph [0090]).
Regarding Claim 15, Modified Yokomizo 810 teach all of the limitations, as discussed above in claim 13 and Yokomizo 810 further teaches wherein by connecting the layers a pocket- or tube-shaped intermediate shape with external connecting seams is formed (pocket shape container 3 hold the filter 5 with inside seal parts 13, see Figures 2 and 9), and in that the intermediate shape is turned inside out to form the filter element (filter 5 expands outwards, see Figure 2 and 5), wherein the connecting seams are turned inwards (inside seal parts 13 are formed inwards, see Figures 2 and 9).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Modified Yokomizo 810 as applied to claim 1 above, and further in view of Davis (GB 2222962 A).
Regarding Claim 12, Modified Yokomizo 810 teach all of the limitations of claim 1. However, Modified Yokomizo 810 does not explicitly disclose wherein an aperture size of the outer layer and/or the inner layer is between 100 pm and 400 pm, in particular between 150 pm and 300 pm.
Davis teaches a filter element (fluid administration unit 1) comprises a outer and inner layer (outer filter 8 which enables the unit also to filter blood) and an intermediate layer (fine filter 6, which filters parenteral solutions being administered to a patient), wherein an aperture size of the outer layer and/or the inner layer is between 100 µm and 400 µm, in particular between 150 µm and 300 µm (the pore size of the outer filter 8 is typically being 180µm, see Col. 7 ln 14-17).
Modified Yokomizo 810 and Davis are analogous art because all teach a filter element with a multiple layers.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the outer and inner layer of Modified Yokomizo 810 and further include an aperture size of the outer layer and/or the inner layer is between 100 µm and 400 µm, in particular between 150 µm and 300 µm, as taught by Davis. Davis teaches the pore size is such that the outer filter is effective in filtering blood or blood derivatives without blocking (see Col. 7 ln 17-19).
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 ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC RASSAVONG/ (6/16/2026)Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
Prosecution Insights