DETAILED ACTION
Status of Claims:
Claims 1-19 are pending.
Claims 1, 4, 7, 8, and 13-20 are amended.
This Action is Made Final.
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 .
Response to Arguments
Applicant's arguments filed 5/29/2026 have been fully considered but they are not persuasive. The applicant argues that Richards is not a hemofilter and is designed form separating magnetically labeled biological cells. This argument is not persuasive because “hemofilter” is the intended use of the filter, not a structural limitation. As Richards can filter blood it can function as a hemofilter, therefore this limitation is met. Further Richards explicitly teaches that the invention can be used to filter “biological fluids such as blood” (see col. 5 line 55). The inclusion of a specific example, such as CD34+ in Richards does not teach away from other embodiments in Richards.
The applicant argues that Richards never process whole blood directly and never contemplates passing red blood cells through the filter. This argument is not persuasive because Richards teaches treating blood (see col. 5 lines 55) and explicitly teaches that red blood cells (erythrocytes) being separated (see col. 5 lines 46-52). The claims do not require that the labyrinthine flow pathway extend to the outlet of the filter or the red blood cells not be retained by the filter.
The applicant argues that Richards is designed to process dilute suspense from bone marrow, not whole blood or red blood cells. This argument is not persuasive because Richards teaching a bone marrow example does not discount Richards explicitly stating that the device can be used for blood and red blood cells (see at least col. 5 line 55 and col. 5 line 46-52).
The applicant argues that Richards device does not anticipate claim 16 because the target cells do not pass through the filter. This argument is not persuasive because it is directed to limitations that have not been claimed.
Regarding Claim 19 the applicant argues that Richards does not anticipated the rejection because Richards does not teach a hemofilter. This argument is not persuasive for the same reasons as stated above in regards to claim 16.
The applicant argues that the claimed viscoelastic drag force is not an inherent characteristic because any forces in a dilute suspension of Richards are different from blood cells in whole blood. This argument is not persuasive the claims are directed to the apparatus, not the process of separating whole blood. The applicant is correct that the viscoelastic forces will be different for different fluids, however as the viscoelastic drag force is a process limitation dependent on the fluid being separated and the flow rate of the fluid it only adds patentable weight to the extent that the prior art must be capable of the same limitation. As Richards teaches an equivalent structure as disclosed in the instant invention (a stack of magnetizable meshes through which fluid flows) Richards would be capable of the same drag forces.
The applicant argues that the design “contemplates selection of mesh weave configuration to archives the recited relationship between magnetic retarding forces and viscoelastic drag forces” and Richards does not address drag forces at all. This argument is not persuasive because drag forces are inherently present when fluid is flowing through a device and because at least some of the sub-first volumes inherently overlap at least some of the sub-second volumes because meshes contributing to the viscoelastic drag forces are also contributing to the magnetic field.
The applicant again argues that Richards does not anticipate claim 19 because Richards does not process whole blood. This argument is not persuasive because whole blood is a process limitation and the claims are directed to a system. Richards is capable of processing whole blood, therefore this limitation is met. Further Richards explicitly teaches that the device can be used to filter blood (see col. 5 line 55).
The applicant argues that Richards does not contemplate any design objective related to the relationship between magnetic regarding force and viscoelastic drag force. This argument is not persuasive because the prior art does not need to need to disclose the same properties for an apparatus to be anticipated. A newly discovered property or relationship does not make an old apparatus new and the prior art does not need to have the same goals for a disclosed structure to be anticipated.
Regarding claim 1 the applicant argues that neither Richards not Gandini teach od suggest the configuration recited in claim 1. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant argues that modifying Richards with a permanent magnet, as disclosed by Gandini would require extensive reconfiguration of Richards because Richards has “conical ends”. This argument is not persuasive because the conical ends of Richards are not magnetic (non-magnetizable wires 36) (see Richards col. 3 lines 46-46). Only the cylindrical filter chamber 16 has the magnetizable wire meshes (see col. 3 line 65-col. 4 line 1). Therefore there is a flat surface on which to place a perpendicular magnet.
The applicant argues that replacing the solenoidal magnet if Richards with a permanent magnet on the surface would fundamentally alter the orientation of the magnetic field relative to the wires and fluid flow. This argument is not persuasive because the magnetic field would be oriented the same if replaced by a permanent magnet on the surface of the cylindrical filter chamber, and because Gandini teaches that one skilled in the art would know how to orient a magnet to create the desired magnetic field orientation (see Gandini para. 0050).
The applicant argues that Richards and Gandini are not analogous inventions in the art of hemofilters. This argument is not persuasive because Richards discloses filtering blood (see col. 5 line 55).
The applicant argues that the combination of Richards and Gandini is improper because they operate on completely different and incompatible principles, specifically that Richards has the magnetic field parallel to the fluid flow and Gandini is perpendicular to the fluid flow. This argument is not persuasive because Gandini does not limit the direction of the magnetic field relative to the fluid flow but states that it can be “uniform along the length or width…as will be appreciated by one skilled in the art” (see Gandini para. 0050).
The applicant argues that one would not combine Richards with Gandini because Gandini diverts magnetic particles towards the chamber walls with Richards uses a magnetic field to retain particles on the mesh within the chamber. This argument is not persuasive because both references use external magnets to magnetize wires and use the magnetized wires to attract magnetic particles. As the magnet in Gandini is being used for the same effect (creating a magnetic field and magnetizing a wire) as in Richards one skilled in the art would have found it obvious to replace the magnet of Richards with the magnet of Gandini.
The applicant argues that the orientation of the magnetic field relative to the flow and magnetic meshes is significant. This argument is not persuasive because the claim orientation is the same as that disclosed by Richards.
The double patenting rejections are withdrawn in view of the approved terminal disclaimers.
The drawing objections and 112 rejections are withdrawn in view of the amendments.
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 –
Claim(s) 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richards et al (USPN 5,439,586).
Regarding Claim 16:
Richards teaches the hemofilter comprising: a labyrinthine (no straight flow paths) (see col. 4 lines 6-9) laminar flow (see col. 3 lines 36-39) pathway configured such that each individual red blood cell passing through the hemofilter traverses the flow pathway (blood is filtered therefore red blood cells traverse the pathway) (see col. 5 lines 46-52, and 55); wherein the hemofilter is designed to produce a uniform flow characteristic at a millimeter-scale length so as to avoid dead-spots and eddies, and to maintain a predetermined rate of flow overall (flow is uniformly distributed) (see col. 2 lines 12-15).
Regarding Claim 17:
Richards teaches the hemofilter of claim 16 wherein the flow pathway causes a red blood cell to deviate from an unimpeded flow of the red blood cell by more than three times the diameter of the red blood cell (wires in the mesh are 50 to 150 microns and no clear channels an flow through the array, therefore blood cells deviate by at least 25 microns to pass each mesh layer) (see Richards col. 4 lines 42-47, col. 9 lines 1-7).
Regarding Claim 18:
Richards teaches the hemofilter of claim 16 wherein the flow pathway causes a red blood cell to deviate from an unimpeded flow by more than about 20 microns (wires in the mesh are 50 to 150 microns and no clear channels an flow through the array, therefore blood cells deviate by at least 25 microns to pass each mesh layer) (see Richards col. 4 lines 42-47, col. 9 lines 1-7).
Regarding Claim 19:
Richards teaches an apparatus comprising: a hemofilter comprising a first volume (volume in the filter chamber) through which blood flows wherein there exists a plurality of sub- first volumes within which the blood is exposed to a magnetic field so as to produce an increased magnetic retarding force on the blood relative to the average magnetic field of the volume (wires are magnetizable, wherefore the magnetic forces near the wires would increase) (see col. 3 line 66-col. 4 line 9, col. 4 lines 42-45); and a second volume (volume in filter chamber 16) through which blood flows wherein there exists a plurality of sub-second volumes (volumes closer to the wires of the filter meshes in filter chamber 16), within which the blood experiences a lower viscoelastic drag force compared to the average drag force of the volume (a sub-volume is interpreted as the location next to each filter mesh); wherein at least some of the sub-first volumes and at least some of the sub-second-volumes are spatially overlapping. Although Richards does not explicitly refer to viscoelastic drag force the change in the drag force is a property of the structure of the apparatus dependent on the flow rate and material being filtered. As the apparatus of the prior art has the same structure as the instant invention (fluid passing through magnetizable filter meshes) the drag forces would decrease in relation to the filter meshes the same . As the claims requires that the first and second sub-volumes are “substantially coincident” the first and second volumes are interpreted as being substantially the same location.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Richards et al (USPN 5,439,586) in view of Gandini (US 2010/0331753).
Regarding Claim 1:
Richards teaches the hemofilter system comprising: a hemofilter comprising (hemofilter is the intended use of the system, not a structural feature): a container (filter device 10) having a first surface (surface of the conical funnel 14), a second surface (surface of the conical funnel 18), and one or more wall surfaces (surface of the cylindrical filter chamber 16) (see col. 3 lines 35-39, 64-66, col. 4 lines 10-11, fig, 1), the first surface, the second surface and the one or more wall surfaces defining a container volume (see fig. 1); an input port (input opening 20) in fluid communication with the container (see col. 3 lines 36-41); an output port (output opening 44) in fluid communication with the container (see col. 4 lines 14-18); a filter bed comprising a plurality of planar magnetic meshes (wire meshes 26) stacked in close juxtaposition and positioned within the container volume (see col. 3 line 64-col. 4 line 9); a first input conduit (line connected to input port that carries the fluid entering the device) in fluid communication with the input port (see col. 3 lines 36-41, fig. 1); a first output conduit (line connected to the output port is inherent to remove the fluid from the filter) (see fig. 1) in fluid communication with the output port, wherein a magnetic field is produced that is oriented relative to the planar magnetic meshes (magnetic field B) (see col. 5 lines 11-17, fig. 1).
Richards does not teach that the magnetic field is produced by a first magnet positioned on a first surface of the container or explicitly teach input and output conduits.
Gandini teaches a hemofilter system comprising a container (separation chambers) (see para. 0053) having a first surface (all solids have at least one surface); a first magnet positioned on the first surface of the container (permanent magnets that supply a magnetic field) (see para. 0049, 0078). Gandini further teaches that input and output conduits (tubing) are used to transfer blood into and out of the hemofilter (see para. 0048).
Richards and Gandini are analogous inventions in the art of magnetic hemofilters. It would have been obvious to one skilled in the art to add the magnet of Gandini to the first surface of Richards because it is the simple substitution of one magnetic field generation device with another magnetic field generating device, obviously resulting in a magnetic field being produced through the magnetic meshes with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). It would have further been obvious to one skilled in the art to add the tubing (conduits) of Gandini to the input port and output port of Richards because it is the simple addition of a known element to a known device, obviously resulting in the ability for blood to be passed through the filter with an expectation of success. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 2:
Richards, as previously modified, teaches the hemofilter system of claim 1.
Richards does not teach a pump in the input conduit.
Gandini teaches a pump on the input conduit (see para. 0057).
It would have been obvious to one skilled in the art to add the pump of Gandini to the input conduit of Richards (as previously modified) because it allows the pressure to be maintained at that needed to withdraw and return the blood being treated (see Gandini para. 0057).
Regarding Claim 3:
Richards, as previously modified, teaches the hemofilter system of claim 1.
Richards does not teach a saline drip unit in fluid communication with the input conduit.
Gandini teaches a saline drip unit (saline solution) in fluid communication with the input conduit (see para. 0048)
It would have been obvious to one skilled in the art to add the saline drip unit of Gandini to the input conduit of Richards (as previously modified) because it allows the tubing to be cleaned before use (see Gandini para. 0048) and because it is the simple addition of a known feature to a known device, obviously resulting in ability to add saline to the filter with an expectation of success.
Regarding Claim 6:
Richards, as previously modified, teaches the hemofilter system of claim 1.
Richards does not teach a pressure sensor in fluid communication with the output conduit.
Gandini teaches a pressure sensor (gauges) in fluid communication with the output conduit (see para. 0059).
It would have been obvious to one skilled in the art to add the pressure sensor of Gandini to the output conduit of Richards (as previously modified) because it allows the pressure of the blood flow to be monitored (see Gandini para. 0059) and because it is the simple addition of a known feature to a known device, obviously resulting in ability to adjust the pumping pressure with an expectation of success.
Regarding Claim 7:
Richards, as previously modified, teaches the hemofilter system of claim 1 wherein the input port is in one of the first surface (in the first surface), the second surface, or the one or more wall surfaces (see Richards fig. 1).
Regarding Claim 8:
Richards, as previously modified, teaches the hemofilter system of claim 1 wherein the input port is in one of the one or more wall surfaces (the surface of the conical funnel is also a wall) (see Richards fig. 1).
Regarding Claim 9:
Richards, as previously modified, teaches the hemofilter of claim 1 wherein fluid flow between the input and the output ports is perpendicular to the plane of the mesh (see Richards fig. 1).
Regarding Claim 10:
Richards, as previously modified, teaches the hemofilter of claim 1 wherein fluid flow between the input and the output ports is parallel (along the length of) to the plane of the mesh (see Richards col. 5 lines 18-21).
Regarding Claim 11:
Richards, as previously modified, teaches the hemofilter of claim 1 wherein fluid flow between the input and the output ports is oblique (both along the length and transverse) to the plane of the mesh (see Richards col. 5 lines 18-21).
Regarding Claim 12:
Richards, as previously modified, teaches the hemofilter of claim 1.
Richards does not teach a second magnet positions on the second surface of the container.
Gandini teaches using multiple magnets (an array) on the surface of the container (see para. 0049).
It would have been obvious to one skilled in the art before the effective filing date of the invention to add a second magnet to the second surface of Richards, as taught by Gandini, because it is a simple duplication of parts without changing the relative function (and additional magnet will add a correspond increase to the magnetic field).
Regarding Claim 13:
Richards teaches the hemofilter system comprising: a hemofilter comprising (hemofilter is the intended use of the system, not an additional structure): a container (filter device 10) having a first surface (surface of the conical funnel 14), a second surface (surface of the conical funnel 18), and one or more wall surfaces (surface of the cylindrical filter chamber 16) (see col. 3 lines 35-39, 64-66, col. 4 lines 10-11, fig, 1), the second surface and the one or more wall surfaces defining a volume (se fig. 1); an input port (input opening 20) in fluid communication with the container (see col. 3 lines 36-41); an output port (output opening 44) in fluid communication with the container (see col. 4 lines 14-18); a filter bed comprising a plurality of planar magnetic meshes (wire meshes 26) stacked in juxtaposition and positioned within the container volume (see col. 3 line 64-col. 4 line 9) and arranged in layers between first and second surfaces (see fig. 1).
Richards does not teach that the planar magnetic meshes are coplanar with the first and second surfaces; and a first magnet positioned on the first surface of the container.
Gandini teaches a hemofilter system comprising a container (separation chambers) (see para. 0053) having a first surface (all solids have at least one surface); a first magnet positioned on the first surface of the container (permanent magnets that supply a magnetic field) (see para. 0049, 0078).
Richards and Gandini are analogous inventions in the art of magnetic hemofilters. It would have been obvious to one skilled in the art to add the magnet of Gandini to the first surface of Richards because it is the simple substitution of one magnetic field generation device with another magnetic field generating device, obviously resulting in a magnetic field being produced through the magnetic meshes with an expectation of success. It would have further been obvious to one skilled in the art to position a first surface and second surface of the container of Richard coplanar with the meshes because it is a simple change in shape (from fully conical to conical will a flat portion) without changing the relative function of the apparatus. Absent persuasive evidence changes in shape are a matter of choice which a person skilled in the art would have found obvious (see MPEP 2144.04)
Regarding Claim 14:
Richards, as previously modified, teaches the hemofilter system of claim 13 wherein the first magnet produces a magnetic field (B) that is oriented substantially perpendicular to the planar magnetic meshes (see Richards fig. 1, col. 5 lines 12-17).
Regarding Claim 15:
Richards, as previously modified, teaches the hemofilter system of claim 13.
Richards does not teach a second magnet positions on the second surface of the container.
Gandini teaches using multiple magnets (an array) on the surface of the container (see para. 0049).
It would have been obvious to one skilled in the art before the effective filing date of the invention to add a second magnet to the second surface of Richards, as taught by Gandini, because it is a simple duplication of parts without changing the relative function (an additional magnet will add a corresponding increase to the magnetic field).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Richards et al (USPN 5,439,586) in view of Gandini (US 2010/0331753) as applied to claim 3 above, and further in view of Robinson et al (US 2012/0065482).
Regarding Claim 4:
Richards, as previously modified, teaches the hemofilter of claim 3.
The combination does not explicitly teach the saline drip unit comprises a saline reservoir and a syringe pump connected in fluid communication with the first input conduit through a T-junction.
Robinson teaches a hemofilter comprising a saline drip unit comprises a saline reservoir (bag of saline 6) (see para. 0310) and a syringe pump (syringe pump 5) connected in fluid communication with a first conduit (blood loop) through a T-junction (see fig. 3, para. 0311-0312).
Richards, Gandini, and Robinson are analogous inventions in the art of treating blood. It would have been obvious to replace the saline drip unit of Richards (as previously modified) with that of Robinson because it is the simple substitution of a known structure for adding saline to a conduit with another in a system that requires the addition of saline to a conduit with obvious results and an expectation of success.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Richards et al (USPN 5,439,586) in view of Gandini (US 2010/0331753) as applied to claim 3 above, and further in view of Macpherson et al (US 2010/0210989).
Regarding Claim 5:
Richards, as previously modified, teaches the hemofilter of claim 1.
The combination does not teach an air detector in fluid communication with an output conduit.
Macpherson teaches a system of treating blood comprising an air detector in fluid communication with an output conduit (return path) (see para. 0061).
Richards, Gandini, and Macpherson are analogous inventions in the art of treating blood, It would have been obvious to one skilled in the art before the effective filing date of the invention to add the air detector of Macpherson to the output conduit of Richards (as previously modified) because it is desirable to insure that the blood is not exposed to air (see Gandini para. 0036) and because it is the simple addition of a known feature (an air detector) to a known device, obviously resulting in the ability to detect air in the output from the filter, with an expectation of success).
Conclusion
THIS ACTION IS MADE FINAL. 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 CLAIRE A NORRIS whose telephone number is (571)272-5133. The examiner can normally be reached M-Th 7:30-5 F: 8-12.
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/CLAIRE A NORRIS/Primary Examiner, Art Unit 1779 6/20/2026
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