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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Rejected Claims: 1-6, 8-10, 12-14, and 16
Withdrawn Claims: 7 and 17-19
Cancelled Claims: 11 and 15
Response to Amendment
The amendment filed on 09 MARCH 2026 have been entered.
In view of the amendment to the claims, the amendment of claim 1 and the cancellation of claim 11 have been acknowledged.
In view of the amendment to claim 1, the rejections under 35 U.S.C. 103 has been modified.
Response to Arguments
Applicant’s arguments filed on 09 MARCH 2026 have been fully considered.
Applicant argues that Yokoyama and Botelho do not teach that a filter assembly is free of anti-foaming agents because Yokoyama teaches that an upper layer includes anti-foaming agents to control foam and so the antifoaming agent is integral to the assembly of Yokoyama and so instant claim 1 is now allowable (Arguments filed 09 MARCH 2026, Page 7 to Page 9, Paragraph 2).
Applicant’s arguments with respect to instant claim 1 and the negative limitation of the inclusion of anti-foaming agents 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. Yokoyama explicitly teaches the negative effects of continuous contact of anti-foaming agents with blood and teaches the minimization of such contact. The newly cited art Lichte teaches that it is well known in the art to use the same type of filters but with smaller meshes in order to exclude the use of an anti-foaming agent. Since Yokoyama teaches against the use of antifoaming agents due to blood damage, Yokoyama does not teach away from their exclusion. Therefore, instant claim 1 is not allowable.
Applicant argues that instant claim 1 is allowable and so the dependent claims are also allowable (Arguments filed 09 MARCH 2026, Page 9, Paragraph 4).
Regarding Applicant’s argument, instant claim 1 is not allowable and so the dependent claims are also not allowable.
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, 2, 5, 10, 12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama et al US Patent No. US 6908446 B2 (hereinafter Yokoyama), in view of Botelho et al US Patent No. US 6554963 B1 (hereinafter Botelho) in view of Lichte US Patent No. US 5279601 A (hereinafter Lichte).
Regarding Claim 1, Yokoyama teaches a blood reservoir (i.e., a filter assembly; Fig. 1, #1) with a housing (i.e., a filter holder; Fig. 1, #2) comprising a filter and defoaming device (i.e., a filter system; Fig. 2, #7a) where the filter and defoaming device is in contact with the housing (i.e., wherein the filter system and the filter holder are in contact with each other; Fig. 1, #2 and 7a; Col. 4, Lines 24- 29). Yokoyama further teaches a filtering and defoaming device (Fig. 2, #7a) that contains and filtering member (Fig. 2, #15) and a defoaming member (i.e., wherein the filter system consists of at least two layers; Fig. 2, #16; Col. 5, lines 66-67 to Col. 6, Lines 1-6) where the filtering member (Fig. 3, #15) is disposed outside of the defoaming member (i.e., wherein the mesh filter layer is arranged downstream of the defoaming layer; Fig. 3, #16; Col. 7, Lines 21-24; Col. 7, Lines 50-52) and the filtering member is formed of a porous material having sufficiently high blood permeability such as a mesh or woven fabric (i.e., wherein the second layer is a mesh filter layer; Col. 6 Lines 66-67 to Col. 7, Lines 1-7). Yokoyama continues to teach that the defoaming member may be made from various porous materials such as mesh or woven fabric (i.e., wherein the first layer is a defoaming layer made of a woven open mesh fabric; Col. 7, Lines 66-67 to Col. 8, Lines 1-6). Yokoyama further teaches a partition member (Figs. 2 and 3, #19) that contacts the defoaming member and a potting member (Fig. 2, #18) that contacts both the defoaming member and the filtering member which are structural pieces of the filtering and defoaming device and are extensions of the housing (i.e., wherein the filter holder contacts the defoaming layer and the mesh filter layer downstream of the defoaming layer; Fig. 2, #2; Paragraphs 0077-0078, 0091).
Yokoyama further teaches that the blood passes through a vented blood filtering member without contacting an antifoaming agent (Abstract) and that minimizing blood contact with antifoaming agents to reduce damage to blood (Paragraph 0131).
Yokoyama does not teach wherein the first layer is made of a monofilament woven open mesh fabric and with an embossed three-dimensional structure, in particular configured for entrapping foam built up in the body fluid.
However, Botelho teaches that monofilament woven fabrics (i.e., a monofilament woven open mesh fabric; Fig. 5, #10) such as polyester yarns may be embossed (i.e., with an embossed three-dimensional structure) as shown in Fig. 5 to change the permeability of the fabric to air (Col. 3, Lines 32-50) which can be affected by carefully controlling the compression in the patterned areas of the fabric (Col. 5, Lines 20-44).
Botelho is analogous to the claimed invention because it pertains to a device for embossing industrial process fabric (Abstract) such as filtration fabrics and filtration cloths (Col. 1, Lines 8-28). It would have been obvious to one of ordinary skill in the art at the time of filing of the instant claimed invention to modify the defoaming member taught by Yokoyama with the embossed monofilament woven fabrics taught by Botelho because the embossed monofilament woven fabrics can have carefully controlled permeability to air.
Yokoyama in view of Botelho does not explicitly teach wherein the filter assembly is free of anti-foaming agents.
However, Lichte teaches that pore volume or mesh size of a filter media that has the purpose of breaking up bubbles is variable and optimizable wherein larger pore sizes are used when anti-foam coatings are used and smaller mesh sizes are used without a coating (Col. 8, Lines 37-60).
Lichte is analogous to the claimed invention because it pertains to a reservoir for the reinfusion of blood drawn from a patient (Col. 5, Line 61 to Col. 6, Line 11). It would have been obvious to one of ordinary skill in the art at the time of filing of the instant claimed invention to modify the defoaming member made obvious by Yokoyama in view of Botelho to use a finer mesh and to exclude an anti-foam agent as taught by Lichte because Lichte teaches that mesh size is optimizable and Yokoyama teaches that it is not desirable to contact blood with antifoaming agents.
Regarding Claim 2, Yokoyama further teaches a mesh size of 15 - 300 µm for effectively removing bubbles (i.e., characterized in that the defoaming layer comprises a mesh opening between 100 - 500 µm, in particular between 150 - 400 µm, in particular between 200 - 350 µm, and more particularly between 250-300 µm; Col. 9, Lines 58-67 to Col. 10, Lines 1-7) and that the pore size of the defoaming member (Fig. 4, #10) can be from 30 µm to 2 mm (Col. 7, Lines 66-67 to Col. 8, Lines 1-10). Yokoyama in view of Botelho does not explicitly teach the range of a mesh opening between 100 - 500 µm in the instant claim. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the average degree of branching that corresponds to the claimed range while experimenting with the range taught by Yokoyama in view of Botelho.
Regarding Claim 5, Yokoyama further teaches a mesh size of 20 - 200 µm for the size of the venous blood filtering member (Fig. 4, #9; Col. 9, Lines 49-67 to Col. 10, Lines 1-4). Yokoyama does not teach the explicit mesh size of 20 and 150 µm in the instant claim. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the mesh size that corresponds to the claimed mesh size with the mesh sizes taught by Yokoyama.
Regarding Claim 10, Yokoyama further teaches a ladder-like frame member (Fig. 4, #12) to support the venous blood filtering member (Fig. 4, #9) which is low in rigidity (i.e., ; Col. 10, Lines 8-13) where the material of the ladder-like frame member is the same as the lead-in tube (Fig. 4, #8) which may be selected from polymeric materials (i.e., wherein the filter holder is made from plastic; Col. 6, Lines 48-60).
Furthermore, the limitation “is over-molded over at least a part of the filter system” is directed toward a product-by-process claim and is therefore not subject to patentability because the patentability of the product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP 2113(I)).
Regarding Claim 12, Yokoyama further teaches where the material of the ladder-like frame member is the same as the lead-in tube (Fig. 4, #8) which may be selected from polymeric materials such as polycarbonate and acrylic-butadiene-styrene copolymer (i.e., wherein said plastic is selected from ABS or polycarbonate; Col. 6, Lines 48-60).
Regarding Claim 14, Yokoyama further teaches a defoaming member (Figs. 7 and 8, #32) which has pores that appear to be randomly distributed from both a side view cross section and a top view cross section. As such, the pores are not distributed in a planar arrangement (i.e., wherein said defoaming layer includes pores distributed in a non-planar arrangement).
Regarding Claim 16, Yokoyama further teaches the use of the device for filtering and defoaming blood that comes from the interior of the heart or drawn off from a large vein (i.e., wherein the body fluid is blood; Abstract).
Furthermore, the limitation “wherein the body fluid is blood” is directed toward materials or articles worked upon by the claimed invention and is therefore not subject to patentability. The inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims (In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) and thus holds no patentable weight. See MPEP §2115.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Botelho in view of Lichte as applied to claim 1 above, and further in view of Rupp et al US Patent Application No. US 20180078886 A1 (hereinafter Rupp).
Regarding Claim 3, Yokoyama in view of Botelho in view of Lichte does not teach the defoaming layer is made of monofilament fibers with a diameter between 100-350 µm, in particular 150 - 300 µm, more particularly 200- 300 µm.
However, Rupp teaches a woven mesh of polyester fibers with a wire diameter of 145 µm (i.e., the defoaming layer is made of monofilament fibers with a diameter between 100-350 µm; Paragraph 0106) for the purpose of ensuring permeability to whole blood, plasma, and serum (Paragraph 0105).
Rupp is analogous to the claimed invention because it pertains to a whole blood filtering media (Abstract) where filters are used to remove blood clots, particles, and gas bubbles (Paragraph 0003). It would have been obvious to one of ordinary skill in the art at the time of filing of the instant claimed invention to modify the defoaming member as taught by Yokoyama in view of Botelho in view of Lichte with the wire diameter taught by Rupp because the fiber diameter would ensure the permeability of the defoaming member to whole blood, plasma, and serum.
Regarding Claim 4, Yokoyama in view of Botelho in view of Lichte does not teach the defoaming layer has a mesh count between 10-50 n/cm, in particular between 10-30 n/cm, more particularly between 10-20 n/cm.
However, Rupp teaches a woven mesh of polyester fibers with a mesh count of 23/cm (i.e., the defoaming layer has a mesh count between 10-50 n/cm, in particular between 10-30 n/cm; Paragraph 0106) for the purpose of ensuring permeability to whole blood, plasma, and serum (Paragraph 0105).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant claimed invention to modify the defoaming member as taught by Yokoyama in view of Botelho in view of Lichte with the wire diameter taught by Rupp because the fiber diameter would ensure the permeability of the defoaming member to whole blood, plasma, and serum.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Botelho in view of Lichte as applied to claim 1 above, and further in view of Steg, Jr. et al US Patent No. US 5411472 A (hereinafter Steg, Jr).
Regarding Claim 6, Yokoyama in view of Botelho in view of Lichte does not teach wherein the filter assembly further comprises a prefilter layer arranged downstream of the defoaming layer and upstream of the mesh filter layer, wherein said mesh filter layer has a mesh size of approximately 40 µm.
However, Steg, Jr. teaches a defoamer and filter module (Fig. 7, #120) which includes a cylindrical defoamer and filter (Fig. 7, #162) comprised of three or more concentric layers, in which the first layer may be made of a thermoset or woven olefin material coated with an antifoam (i.e., the defoaming layer), the third layer is a concentrically wrapped woven polyester 30 or 40 micron filter material (i.e., the mesh filter layer, wherein said mesh filter layer has a mesh size of approximately 40 µm), and the third layer may be preceded by a pre-filter layer (i.e., a prefilter layer) of about 80 – 100 microns (i.e., a prefilter layer arranged downstream of the defoaming layer and upstream of the mesh filter layer; Col. 7, Lines 15-34). Steg, Jr. further teaches that the defoamer and filter module permits a smaller volume for the module and a much more responsive control system (Col. 8, Lines 45-58).
Steg, jr. is analogous to the claimed invention because it pertains to a blood recovery system for filtering and recovering blood (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing of the instant claimed invention to modify the filter and defoaming device as taught by Yokoyama in view of Botelho in view of Lichte with the prefilter layer and mesh size of the mesh layer as taught by Steg, Jr. because the extra layer permits a smaller volume for the module which makes the control system more responsive.
Regarding Claim 9, Steg, Jr. further teaches the third layer may be preceded by a pre-filter layer (i.e., a prefilter layer) of about 80 – 100 microns (i.e., the pore size of the prefilter layer is in a range of between 20 and 150 µm; Col. 7, Lines 15-34).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Botelho in view of Lichte in view of Steg, Jr. as applied to claim 6 above, and further in view of Zambianchi et al US Patent Application No. US 20140299556 A1 (hereinafter Zambianchi).
Regarding Claim 8, Yokoyama in view of Botelho in view of Lichte in view of Steg, Jr. does not teach wherein the prefilter layer comprises a spunbond nonwoven fabric.
However, Zambianchi teaches that often pre-filters are made of spunbond fibers (i.e., wherein the prefilter layer comprises a spunbond nonwoven fabric) because these fibers typically have a comparably large diameter and are therefore better suited for pre-filtration applications (Paragraph 0012) such as the removal of platelets for the prevention of blood clots (Paragraph 0005) or non-cellular substances (Paragraph 0006).
Zambianchi is analogous to the claimed invention because it pertains to a blood filter system (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing of the instant claimed invention to modify the pre-filter layer as taught by Yokoyama in view of Botelho in view of Lichte in view of Steg, Jr. with the spunbond fibers as taught by Zambianchi because the spunbond fibers would improve the pre-filtering of components such as platelets and non-cellular substances.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Botelho in view of Lichte as applied to claim 1 above, and further in view of Mizoguchi US Patent Application No. US 20170348639 A1 (hereinafter Mizoguchi).
Regarding Claim 13, Yokoyama in view of Botelho in view of Lichte does not teach wherein said defoaming layer has a thickness of 150-650 µm, in particular 200-500 µm, in particular 250-400 µm, in particular 300-350 µm.
However, Mizoguchi teaches a filter member (Fig. 1, #41A) used as an air bubble removing means (i.e., wherein said defoaming layer; Paragraph 0049) that has a thickness of 0.05 to 0.5 mm, or 50 to 500 µm, (Paragraph 0067) for the purpose of being formed such that the filter member more reliably captures air bubbles and makes the blood more easily pass through the filter (Paragraph 0066). Mizoguchi does not teach the explicit thickness range of 150-650 µm in the instant claim. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected a thickness that corresponds to the claimed range while experimenting with the range taught by Mizoguchi.
Mizoguchi is analogous to the claimed invention because it pertains to a blood processing device (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing of the instant claimed invention to modify the defoaming member as taught by Yokoyama in view of Botelho in view of Lichte to have the thickness taught by Mizoguchi because the thickness would make the filter member more reliably capture air bubbles and make the blood more easily pass through the filter.
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.
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/A.A.G./ Examiner, Art Unit 1777
/Ryan B Huang/ Primary Examiner, Art Unit 1777
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