DETAILED CORRESPONDENCE
Status of Claims:
Claims 1-19 are pending.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,265,457. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Claim 1:
The claims of the patent disclose the hemofilter system comprising: a container having a first surface, a second surface, and one or more wall surfaces, the first surface, the second surface and the one or more wall surfaces defining a container volume; an input port in fluid communication with the container; an output port in fluid communication with the container; a filter bed comprising a plurality of planar magnetic meshes stacked in close juxtaposition and positioned within the container volume; a first magnet positioned on a first surface of the container; a first input conduit in fluid communication with the input port; a first output conduit in fluid communication with the output port, wherein the first magnet produces a magnetic field that is oriented relative to the planar magnetic meshes (see claim 1). The additional limitations claimed by the patent are not excluded for the instant claims.
Regarding Claims 2-12:
Claims 2-12 directly correspond to claims 2-12 of the patent.
Regarding Claim 13:
The claims of the patent disclose the hemofilter comprising: a container having a first surface, a second surface, and one or more wall surfaces, the first surface, the second surface and the one or more wall surfaces defining a volume; an input port in fluid communication with the container; an output port in fluid communication with the container; a filter bed comprising a plurality of planar magnetic meshes stacked in close juxtaposition and positioned within the container volume and coplanar with the first and second surfaces; and a first magnet positioned on the first surface of the container (see claim 13). The additional limitations claimed by the patent are not excluded for the instant claims.
Regarding Claims 14 and 15:
Claims 14 and 15 of the instant invention directly correspond to claims 14 and 15 of the patent.
Regarding Claim 16:
The claims of the patent disclose the hemofilter comprising: a labyrinthine laminar flow pathway for each individual red blood cell that passes through the filter; wherein the filter 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 sufficient rate of flow overall (see claim 16). The additional limitations claimed by the patent are not excluded for the instant claims.
Regarding Claims 17 and 18:
Claims 17 and 18 directly correspond to claims 17 and 18 of the patent.
Regarding Claim 19:
The claims of the patent disclose the hemofilter comprising :a first volume 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; and a second volume through which blood flows wherein there exists a plurality of sub- second volumes within which the blood experiences a lower viscoelastic drag force compared to the average drag force of the volume; wherein the first and second sub-volumes are substantially coincident in space (see claim 19). The additional limitations claimed by the patent are not excluded for the instant claims.
Claims 1, 7-9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,986,585. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Claim 1:
The claims of the patent disclose the hemofilter system comprising: a container (housing) having a first surface, a second surface, and one or more wall surfaces, the first surface, the second surface and the one or more wall surfaces defining a container volume (one or more volumes); an input port in fluid communication with the container; an output port in fluid communication with the container; a filter bed comprising a plurality of planar magnetic meshes stacked in close juxtaposition and positioned within the container volume (stack of plurality of meshes); a first magnet (first permanent magnet) positioned on a first surface of the container; a first input conduit (blood is received therefore there is a conduit) in fluid communication with the input port; a first output conduit (blood flows out the therefore there is an output conduit) in fluid communication with the output port, wherein the first magnet produces a magnetic field that is oriented relative to the planar magnetic meshes (see claim 1).
Regarding Claim 7:
The claims of the patent disclose the hemofilter system of claim 1 wherein the input port is in a surface (see claim 1). A port is inherently in a surface as it has to pass through something. The surface of the claim is not limited to any specific surface.
Regarding Claim 8:
The claims of the patent disclose the hemofilter system of claim 1 wherein the input port is in a wall (see claim 1). The input port is in the housing, therefore it is in a wall. The term “wall” is interpreted as any solid surface.
Regarding Claim 9:
The claims of the patent disclose the hemofilter of claim 1 wherein fluid flow between the input and the output ports is perpendicular to the plane of the mesh (received blood flows.. perpendicular…) (see claim 1).
Regarding Claim 12:
The claims of the patent disclose the hemofilter of claim 1 further comprising a second magnet positioned on the second surface of the container (see claim 12).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a filter bed…coplanar with the first and second surfaces” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding Claim 1:
The claim states that the meshes are “stacked in close juxtaposition” the term “close” renders the claim indefinite because it is not clear what distance of separation would be considered “close”.
Line 8 refers to “a first surface” this limitation renders the claim indefinite because there is already antecedent basis for a first surface. It is therefore not clear if it is the same surface or a different surface.
Regarding Claim 4:
The claim states that the “syringe pump [is] connected in parallel fluid communication…through a T-junction” it is not clear how flow through a T-junction can be parallel.
The claim refers the “the first conduit” there is insufficient antecedent basis for this limitation within the claims. It is not clear if the “first conduit” is the “first input” or “first output” conduit.
Regarding Claim 7:
The claim states “the input port is in a surface”. The phrase “a surface” renders the claim indefinite because it is not clear it is referring to “the first surface”, “the second surface”, any surface excluding the first or second or any surface.
Regarding Claim 8:
The claim refers to “a wall”. It is not clear if this is one of the “one or more wall surfaces” of claim 1, or a different wall.
Regarding Claim 13:
The claim states that the meshes are “stacked in close juxtaposition” the term “close” renders the claim indefinite because it is not clear what distance of separation would be considered “close”.
The claim states “filter bed comprising a plurality of planar magnetic meshes stacked in close juxtaposition and positioned within the container volume and coplanar with the first and second surfaces”. It is not clear how a stack of magnetic meshes can be coplanar with a first and second surface. In a stack each of the plurality of planar meshes would be in a different plane and could therefore not be coplanar with the first and second surfaces. It appears from the figures and specification that the first and second surface are parallel to the stack of magnetic meshes.
Regarding Claim 16:
The claim refers to “the filter”. There is insufficient antecedent basis for this limitation within the claims. It is not clear if the “filter” is the “hemofilter” or a component of the hemofilter.
The claim states “for each individual red blood cell”. It is not clear if red blood cells are a required part of the hemofilter or what is being acted upon by the hemofilter.
The claim states “the filter is designed…to maintain a sufficient rate of flow”. The term “sufficient” renders the claim indefinite because it is not clear what range of flow rates would be considered sufficient and what the need to be sufficient for.
Regarding Claims 17 and 18:
The claims depend from claim 15, however they refer to “the flow pathway”. There is insufficient antecedent basis for this limitation within the claim. Basis for the “labyrinthine laminar flow pathway” is provided in claim 16.
The claims refer to “its unimpeded flow”. It is not clear what the unimpeded flow is limited to, therefore it is not clear how the deviation is determined.
Regarding Claim 19:
The claim refers to “a first volume,” “a second volume,” and “the volume.” there is no antecedent basis for “the volume” (lines 4 and 7) and it is not clear what the term is directed to.
The claims state “the first and second sub-volumes are substantially coincident in space”. It is therefore not clear how, or if, the first sub volume and second sub volume are distinct structural features if they located in the same space. It is further not clear if the first volume and second volume are required to include distinct volumes or if they are the same volume. For the purposes of examination the first volume and second volume will be interpreted as being open to the same location.
The remaining claims are indefinite as they depend from an indefinite claim.
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 and 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 for each individual red blood cell that passes through the filter; wherein the filter 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 sufficient rate of flow overall (flow is uniformly distributed) (see col. 2 lines 12-15).
Regarding Claim 19:
Richards teaches the 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 the first and second sub-volumes are substantially coincident in space. 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, 6-15, 17 and 18 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 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 a surface (in the first surface) (see Richards fig. 1).
Regarding Claim 8:
Richards, as previously modified, teaches the hemofilter system of claim 1 wherein the input port is in a wall (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 comprising: 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 close juxtaposition and positioned within the container volume (see col. 3 line 64-col. 4 line 9) and positioned within the container volume (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 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 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).
Regarding Claim 17:
Richards, as modified, teaches the hemofilter of claim 15 wherein the flow pathway causes a red blood cell to deviate from its unimpeded flow 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 but 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, as modified, teaches the hemofilter of claim 15 wherein the flow pathway causes a red blood cell to deviate from its 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 but deviate by at least 25 microns to pass each mesh layer) (see Richards col. 4 lines 42-47, col. 9 lines 1-7).
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 parallel fluid communication with the first 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 parallel 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
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 11/20/2025