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 .
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.
Claims 1, 10, 13, 15, 16, 17, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (US20200086028A1; hereinafter “Norman”) in view of Baird et al. (US20200180977A1; hereinafter “Baird”).
Independent claim 1 recites, “A peritoneal dialysis ("PD") system (10) comprising: a PD machine (20); a patient line (50) extending from the PD machine (20); and a filter set (100) in fluid communication with the patient line (50), the filter set (100) including a filter membrane (120) positioned and arranged such that fresh PD fluid flows through the filter membrane (120) into a filtered fluid compartment (106f), wherein the filtered fluid compartment (106f) includes an outlet (106o) to a port (106p), and wherein the port (106p) is in fluid communication with a circumferential used PD fluid channel (106c) positioned and arranged to carry used PD fluid around the filter membrane (120) without contacting, or limiting contact with, the filter membrane (120).” Independent claim 1 has been rejected in the following manner:
A PD machine, patient line, fresh-fluid filter membrane, and a used-fluid bypass.
Norman discloses the primary PD-system architecture. Norman states: “In one embodiment, a peritoneal dialysis system and method are provided having point of use dialysis fluid production. The system includes a cycler and a water purifier.” (Norman ¶ [0016].) Norman also states: “The disposable set may include (i) a patient line that extends from the cassette to a patient line connector,” (Norman ¶ [0019].) Norman discloses the fresh-fluid membrane route and a separate used-fluid bypass. Specifically, Norman states: “A fresh dialysis fluid pathway through one or more membrane of the filter is provided to deliver filtered fresh dialysis fluid to the patient. Used dialysis fluid on the other hand flows through the filter housing via a different, parallel pathway, which bypasses the one or more membrane of the filter.” (Norman ¶ [0022].) Norman further states: “fluid flowing in the first direction exits the filter from the interior region of the membrane housing and fluid flowing in the second direction bypasses the membrane housing via the second fluid pathway.” (Norman ¶ [0054].)
The outlet and port.
Norman discloses a first and second port on the filter housing: “housing 102 includes an elongated enclosure 104 sealed at two ends by a first port cap 106 and a second port cap 112. First port cap 106 includes a first port 108 and defines a first manifold or open area 110, while second port cap 112 includes a second port 114 and defines a second manifold or open area 116.” (Norman ¶ [0096].) Norman further states: “Collection channel 146 in turn funnels the filtered dialysis fluid to first one-way valve 150 a, after which the filtered dialysis fluid exits filter 100 into a downstream segment of patient line 50 as has been discussed herein.” (Norman ¶ [0109].)
The circumferential used-PD-fluid-channel gap.
Norman does not expressly disclose the claim’s “circumferential used PD fluid channel (106c) positioned and arranged to carry used PD fluid around the filter membrane (120).” Norman instead expressly identifies “a different, parallel pathway” that “bypasses” the membrane. (Norman ¶ [0022].) Baird fills the channel-geometry gap by disclosing: “Between the grooves 62a, 64a is a first filter cap fluid channel 66 also formed in the outer surface of the first portion 58 of the filter cap 56. The first fluid channel 66 encircles at least a substantial portion (over about 70% of the total circumference) of the cap 56 and preferably extends around a circumference of that cap 56 at the location of that first channel. The first filter cap fluid channel 66 may be located in the same orthogonal plane as the first fluid passages 28, 48 and is in fluid communication with the first fluid passages 28, 48.” (Baird ¶ [0082].)
Motivation to combine. It would have been obvious to modify Norman’s used-fluid bypass with Baird’s known circumferential filter-cap channel so that the bypass is routed around the filter assembly through a channel that extends around the cap. Norman expressly identifies that the bypass avoids “clogging of the filter” and avoids filtering substances from the used fluid. (Norman ¶ [0021].) Baird expressly teaches a filter-cap fluid channel that “encircles at least a substantial portion” of the cap and is in fluid communication with the fluid passages. (Baird ¶ [0082].) A person of ordinary skill would have been motivated to use that known channel geometry in Norman’s filter housing to route used PD fluid around the membrane while maintaining Norman’s stated bypass function.
In relation to claim 10, this claim depends from claim 1 and further recites: “which includes at least one rib (106r) located within the filtered fluid compartment (106f) for supporting the filter membrane (120).” Claim 10 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A support member in the filtered-fluid region for supporting the membrane.
Norman discloses the added membrane-support structure. Norman states: “Grid housing 134 includes a plurality of baffles 136 that extend across grid housing 134 and separate filtered dialysis fluid that has flowed through filter membranes 140 and 142 into plural fluid channels 144 forming interior region 126 of fresh dialysis fluid pathway 120. Baffles 136 help support the thin filter membranes 140 and 142.” (Norman ¶ [0108].) Norman further states: “To maintain baffles 136 in their illustrated separated and generally parallel relationship, plural cross-braces 138 may be provided.” (Norman ¶ [0109].)
Motivation to combine. A person of ordinary skill would have been motivated to include Norman’s baffle and cross-brace membrane-support structure in the incorporated filter configuration because Norman expressly states that the baffles “help support the thin filter membranes.” (Norman ¶ [0108].) The support structure preserves the filtered-fluid flow channels while supporting the membrane.
In relation to claim 13, this claim depends from claim 1 and further recites: “wherein the filter set (100) is configured to connect directly to a patient's transfer set, or wherein the filter set (100) includes a flexible tube (108) configured to connect to the patient's transfer set.” Claim 13 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
Filter-to-transfer-set connection.
Norman discloses the first alternative of the claim. Norman states: “Once fresh dialysis fluid is prepared and verified, patient line 50 including sterile sterilizing grade filter 100 is primed with fresh dialysis fluid, after which patient P may connect patient line connector 52 to transfer set 54 for treatment.” (Norman ¶ [0091].)
Motivation to combine. A person of ordinary skill would have been motivated to use the expressly stated Norman connection of the patient line containing filter 100 to transfer set 54 in the incorporated filter system so that filtered fresh dialysate may be delivered through the patient-line assembly to the patient’s transfer set.
In relation to claim 15, this claim depends from claim 1 and further recites: “wherein the PD machine (20) is configured to close a used PD fluid valve (26b) during a patient fill, urging filtered fresh PD fluid to flow to the port (106p) instead of along the circumferential used PD fluid channel (106c).” Claim 15 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
Fresh-fill operation closes the used-fluid valve and directs fresh fluid through the filtered route.
Norman discloses the added directionally controlled operation. Norman states: “second one-way valve 150b is oriented such that it opens under negative pressure of the used dialysis fluid pulled through used dialysis fluid pathway 118 by pumping cassette 42.” (Norman ¶ [0100].) Norman further states: “The orientation of one-way valve 150b however is such that valve 150b is closed under positive pressure from pumping cassette 42 pushing fresh dialysis fluid into filter 100 via second port 114 of second port cap 112. In this manner, all fresh dialysis fluid is forced to travel through fresh dialysis fluid pathway 120 including its filtering membranes.” (Norman ¶ [0100].)
Motivation to combine. A person of ordinary skill would have been motivated to use Norman’s expressly stated valve operation in the incorporated channel structure because it closes the used-fluid path under fresh-fluid pressure and forces the fresh fluid through “its filtering membranes.” (Norman ¶ [0100].) In the Norman–Baird combination, that operation directs fresh fluid away from the circumferential used-fluid bypass channel and through the filter membranes.
In relation to claim 16, this claim depends from claim 1 and further recites: “wherein the PD machine (20) is configured to close a fresh PD fluid valve (26a) during a patient drain, urging used PD fluid to flow along the circumferential used PD fluid channel (106c) instead of into the filtered fluid compartment (106f).” Claim 16 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
Patient-drain operation closes the fresh-fluid valve and directs used fluid through the bypass.
Norman discloses the added directionally controlled operation. Norman states: “first one-way valve 150a is oriented such that it opens under positive pressure of the fresh dialysis fluid delivered through fresh dialysis fluid pathway 120 by pumping cassette 42.” (Norman ¶ [0099].) Norman further states: “The orientation of one-way valve 150a however is such that valve 150a is closed under negative pressure from pumping cassette 42 pulling used dialysis fluid into filter 100 via first port 108 of first port cap 106. In this manner, used dialysis fluid is prevented from entering fresh dialysis fluid pathway 120 and contacting the filter membranes.” (Norman ¶ [0099].)
Motivation to combine. A person of ordinary skill would have been motivated to use Norman’s expressly stated drain operation in the incorporated channel structure because it prevents used dialysis fluid from entering the fresh pathway and from contacting the membranes. (Norman ¶ [0099].) In the Norman–Baird combination, the used fluid is thereby directed to the circumferential bypass channel rather than to the filtered-fluid region.
In relation to claim 17, this claim depends from claim 1 and further recites: “wherein the filter membrane (120) is a sterilizing grade filter membrane or a bacteria reduction filter membrane.” Claim 17 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
Sterilizing-grade filter membrane.
Norman discloses the additional filter grade. Norman states: “It is yet another advantage of the present disclosure to provide an improved medical fluid delivery system having a sterile sterilizing grade filter in the patient line.” (Norman ¶ [0068].) Norman also states: “patient line 50 including sterile sterilizing grade filter 100 is primed with fresh dialysis fluid.” (Norman ¶ [0091].)
Motivation to combine. A person of ordinary skill would have been motivated to use Norman’s expressly disclosed “sterile sterilizing grade filter” in the incorporated PD patient-line filter system to provide the same filtration function in the fresh-fluid path before patient delivery.
In relation to independent claim 18, this claim recites: “A filter set (100) comprising: a filtered fluid compartment (106f) including an outlet (1060); a filter membrane (120) positioned and arranged such that fresh PD fluid flows through the filter membrane (120) into the filtered fluid compartment (106f); and a circumferential used PD fluid channel (106c) in fluid communication with the outlet (106o), the circumferential used PD fluid channel (106c) positioned and arranged to carry used PD fluid around the filter membrane (120) without contacting, or limiting contact with, the filter membrane (120).” Claim 18 has been rejected in the following manner:
Filter housing, filter membrane, filtered-fluid region, and separate used-fluid bypass.
Norman states: “filter housing 102 in one embodiment forms a used dialysis fluid pathway 118 and houses a fresh dialysis fluid pathway 120.” (Norman ¶ [0097].) Norman further states: “fresh dialysis fluid flows downwardly from first, upper branch 122 though multiple generally parallel passageways created by a first filter membrane and an inner grid into an interior region 126 of fresh dialysis fluid pathway 120.” (Norman ¶ [0097].) Norman further states: “The orientation of one-way valve 150a however is such that valve 150a is closed under negative pressure from pumping cassette 42 pulling used dialysis fluid into filter 100 via first port 108 of first port cap 106. In this manner, used dialysis fluid is prevented from entering fresh dialysis fluid pathway 120 and contacting the filter membranes.” (Norman ¶ [0099].)
The circumferential used-fluid-channel gap.
Norman does not expressly disclose that its used dialysis fluid pathway is a circumferential channel around the filter membrane. Baird fills this gap by disclosing “Between the grooves 62a, 64a is a first filter cap fluid channel 66 also formed in the outer surface of the first portion 58 of the filter cap 56. The first fluid channel 66 encircles at least a substantial portion (over about 70% of the total circumference) of the cap 56 and preferably extends around a circumference of that cap 56 at the location of that first channel.” (Baird ¶ [0082].)
Motivation to combine. A person of ordinary skill would have been motivated to incorporate Baird’s circumferential channel geometry into Norman’s used-fluid bypass housing to route used fluid around the filter assembly while preserving Norman’s expressly stated result that used fluid is “prevented from entering fresh dialysis fluid pathway 120 and contacting the filter membranes.” (Norman ¶ [0099].)
In relation to claim 19, this claim depends from claim 18 and further recites: “which includes a port (106p), wherein the outlet (106o) is in fluid communication with the port (106p), and wherein the circumferential used PD fluid channel (106c) is in fluid communication with the port (106p).” Claim 19 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 18 is incorporated herein.
Filter port and fluid communication with the circumferential channel.
Norman discloses a filter port and the filtered-fluid exit: “First port cap 106 includes a first port 108 and defines a first manifold or open area 110.” (Norman ¶ [0096].) Norman further states: “Collection channel 146 in turn funnels the filtered dialysis fluid to first one-way valve 150 a, after which the filtered dialysis fluid exits filter 100 into a downstream segment of patient line 50 as has been discussed herein.” (Norman ¶ [0109].)
The incorporated Norman–Baird combination provides the circumferential channel and its fluid communication with an associated passage. Baird states: “The first filter cap fluid channel 66 may be located in the same orthogonal plane as the first fluid passages 28, 48 and is in fluid communication with the first fluid passages 28, 48.” (Baird ¶ [0082].) Baird further states: “One or more filter first cap openings 68 extend inward through the walls of the first portion 58 of filter cap 56 to place a first internal passage 70 of filter cap 56 in fluid communication with the annular channel 66 and first fluid passages 48 and 28.” (Baird ¶ [0082].)
Motivation to combine. A person of ordinary skill would have been motivated to use Baird’s expressly stated channel-to-passage connection in the incorporated Norman–Baird filter assembly to provide the claimed port/channel fluid communication while preserving the separate fresh-fluid and used-fluid paths.
Claim 2, 3, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (US20200086028A1; hereinafter “Norman”) in view of Baird et al. (US20200180977A1; hereinafter “Baird”), as discussed above, and in further view of Childers et al. (US20090012458A1; hereinafter “Childers”).
In relation to claim 2, this claim depends from claim 1 and further recites: “wherein the patient line (50) is a dual lumen patient line including a fresh PD fluid lumen (52) and a used PD fluid lumen (54), the used PD fluid lumen (54) placed in fluid communication with the circumferential used PD fluid channel (106c).” Claim 2 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 over Norman in view of Baird is incorporated herein.
A dual-lumen patient line having fresh and used lumens.
The Norman–Baird combination does not expressly disclose the claim’s dual-lumen patient line. Childers fills this gap. Childers states: “The system includes an improved priming procedure using a patient line having dual lumens. During the patient line prime, fluid flows down one lumen away from a disposable cassette and back up the other lumen towards the cassette forming a closed loop feedback that indicates when priming is complete.” (Childers ¶ [0015].) Childers further states: “the patient line shown here as having fill lumen 52a (terminating in a female connector 56 as described above) and drain lumen 52b (terminating in a spike connector 58 as described above) are split apart and connected to the patient’s transfer set 82.” (Childers ¶ [0123].)
Motivation to combine. A person of ordinary skill would have been motivated to use Childers’s dual-lumen patient line with Norman’s fresh-fluid membrane route and separate used-fluid bypass so that the respective fresh and used streams have separately identified lumens. Childers expressly states that the dual-lumen line “eliminates the volume of spent effluent fluid that is pushed back (recirculated) when the instrument cycles from drain to fill.” (Childers ¶ [0015].) That teaching supplies a direct operational reason to combine it with Norman’s membrane-bypass architecture.
In relation to claim 3, this claim depends from claim 2 and further recites: “wherein the filter set (100) includes a fresh PD fluid port (104f) for fluid communication with the fresh PD fluid lumen (52) and a used PD fluid port (104u) for fluid communication with the used PD fluid lumen (54).” Claim 3 has been rejected in the following manner:
Base rejection incorporated.
The rejections of claims 1 and 2 are incorporated herein.
Separate fresh-fluid and used-fluid ports.
Norman discloses the additional two-port filter architecture. Norman states: “In the illustrated embodiment, housing 102 includes an elongated enclosure 104 sealed at two ends by a first port cap 106 and a second port cap 112. First port cap 106 includes a first port 108 and defines a first manifold or open area 110, while second port cap 112 includes a second port 114 and defines a second manifold or open area 116.” (Norman ¶ [0096].) Norman further states: “Fresh dialysis fluid exiting one-way valve 150a flows through first port 108 of first port cap 106 and a segment of patient line 50 to patient P.” (Norman ¶ [0099].) Norman also states: “Used dialysis fluid exiting one-way valve 150b flows through second port 114 of second port cap 112 and a segment of patient line 50 to disposable cassette 42.” (Norman ¶ [0100].)
Motivation to combine. The incorporated combination already provides separate fill and drain lumens from Childers and separate fresh/used fluid paths from Norman. A person of ordinary skill would have been motivated to use Norman’s expressly identified first and second ports to connect those separate lumens to their respective paths, thereby retaining the fresh-fluid filtering route and the used-fluid bypass route without reintroducing effluent to the filtered route.
In relation to claim 4, this claim depends from claim 3 and further recites: “wherein the circumferential used PD fluid channel (106c) is in fluid communication with the used PD fluid port (104u).” Claim 4 has been rejected in the following manner:
Base rejection incorporated.
The rejections of claims 1–3 are incorporated herein.
Fluid communication between a circumferential channel and a port/path.
The incorporated Norman–Baird–Childers combination provides the circumferential channel and its fluid communication with an associated passage. Baird states: “Between the grooves 62a, 64a is a first filter cap fluid channel 66 also formed in the outer surface of the first portion 58 of the filter cap 56. The first fluid channel 66 encircles at least a substantial portion (over about 70% of the total circumference) of the cap 56 and preferably extends around a circumference of that cap 56 at the location of that first channel.” (Baird ¶ [0082].) Baird further states: “One or more filter first cap openings 68 extend inward through the walls of the first portion 58 of filter cap 56 to place a first internal passage 70 of filter cap 56 in fluid communication with the annular channel 66 and first fluid passages 48 and 28.” (Baird ¶ [0082].)
Motivation to combine. A person of ordinary skill would have been motivated to place Norman’s used-fluid port/path in fluid communication with the circumferential bypass channel using Baird’s expressly disclosed channel-to-passage connection. That modification creates an identified fluid route between the port and the bypass channel while preserving Norman’s directionally controlled fresh-fluid filtering and used-fluid bypass.
In relation to claim 5, this claim depends from claim 1 and further recites: “wherein the port (106p) extends to the circumferential used PD fluid channel (106c).” Claim 5 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A port extending to the circumferential channel.
The incorporated Norman–Baird combination provides a port/path connection to the circumferential channel. Baird states: “The first filter cap fluid channel 66 may be located in the same orthogonal plane as the first fluid passages 28, 48 and is in fluid communication with the first fluid passages 28, 48.” (Baird ¶ [0082].) Baird further states: “One or more filter first cap openings 68 extend inward through the walls of the first portion 58 of filter cap 56 to place a first internal passage 70 of filter cap 56 in fluid communication with the annular channel 66 and first fluid passages 48 and 28.” (Baird ¶ [0082].)
Motivation to combine. A person of ordinary skill would have been motivated to implement the port-to-channel connection of Baird in the Norman–Baird filter housing so that the port provides a direct, defined fluid connection to the channel that carries the used fluid around the filter assembly.
Allowable Subject Matter
Independent claim 20 is allowable over the prior art of record. The following is an examiner’s statement of reasons for allowance:
In relation to claim 20, the prior art of record does not disclose or suggest, inter alia, the step of forcing fresh PD fluid through a filter membrane (120) of the filter set (100), so that the fresh PD fluid displaces air towards a used PD fluid lumen (54) of the dual lumen patient line (50).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 6, 11, and 14 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is an examiner’s statement of reasons for allowance:
In relation to claim 6 [and dependent claims 7, 8, and 9], the prior art of record does not disclose or suggest, the limitation: “wherein the circumferential used PD fluid channel (106c) is located between a continuous inner wall (106i) and a continuous outer sidewall (106s).”
In relation to claim 11 [and dependent claim 12], the prior art of record does not disclose or suggest the limitation: “wherein the filter membrane (120) is a flat sheet filter membrane, and wherein the filter set (100) includes a pressurization compartment (106e) located on an opposing side of the flat sheet filter membrane from the filtered fluid compartment (106f).”
In relation to claim 14, the prior art of record does not disclose or suggest the limitation: “wherein the PD machine (20) includes a pressure sensor (28b) positioned and arranged to sense pressure of the fresh PD fluid downstream from the filter membrane (120) during a patient fill.”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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