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 .
Response to Amendment
Applicant’s amendment filed on 01 JULY 2026 has been entered.
Pending Claims: 1-4, 6-11, 13-18, and 20
Cancelled Claims: 5, 12, and 19
Response to Arguments
Applicant’s arguments filed on 01 JULY 2026 have been fully considered.
Applicant argues, regarding instant claims 1 and 16, that Mantle does not teach detecting an occlusion in a transfer set when both conditions (i) and (ii) are met, which are (i) an occlusion detected in a fill lumen and (ii) an occlusion in a return lumen because Mantle detects inflow and outflow blockages in the lumen of a catheter while not specifically stating that the occlusion is in the transfer set when both lumens are blocked. Rather, Mantle teaches the detection of a total blockage in the patient line when both conditions (i) and (ii) are met. Therefore, Mantle does render instant claims 1 and 16 and so instant claims 1 and 16 are allowable (Arguments filed 01 JULY 2026, Pages 7-9).
Regarding Applicant’s argument, Mantle is not used to teach the pressure system that Applicant asserts is the issue. Instead, Mantle is only used to teach the detection of the derived total occlusion that occurs when both the fill and return lumens are occluded. In this case, Wallenas teaches the required pressure sensors and the detection of occlusions according to the conditions (i) and (ii) of instant claims 1 and 16. The third condition (iii) is a derived condition which one of ordinary skill in the art would be motivated to modify into Wallenas because Mantle teaches that a dual blockage is non-recoverable and requires outside intervention to fix. Furthermore, the teaching of Mantle for detecting the blockages in the inflow direction of the inflow lumen (Fig. 1, #19) and outflow direction of the outflow lumen (Fig. 1, #18; Paragraph 0044) encompasses blockages in the sterile tubing (Fig. 1, #110, 130; Paragraphs 0044 and 0046) on those directions. The blockage is designated as a blockage in the IN or OUT direction of the inflow and/or outflow lumens. As shown in the Fig. 1, which has been marked up, below, the occlusion detection includes the entire line leading to both the inflow and outflow lumens. As there is only one pressure sensor required in each of the fill and return lines, the system can only diagnose that the line is blocked and not exactly where in the line the blockage has occurred, and Mantle teaches the total blockage condition of the system side of the catheter (as opposed to the body side of the catheter) which is equivalent to condition (iii) of instant claims 1 and 16 because the blockage can occur from the lumen and to the sterile tubing. Even if the location of the pressure system were limited by instant claims 1 and 16, which it is not, Mantle would still teach the detection of occlusions in the transfer set which could be applied to Wallenas because Wallenas has the requisite pressure sensors on the fill and return lumens. Therefore, instant claims 1 and 16 are not allowable.
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Applicant argues that instant claim 2-4, 6-11, 13-15, 17-18, and 20 are allowable because they depend upon instant claims 1 and 16 (Arguments filed 01 JULY 2026, Page 9, Paragraph 2).
Regarding Applicant’s argument, instant claims 1 and 16 are not allowable and so instant claims 2-4, 6-11, 13-15, 17-18, and 20 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 1-4, 6-11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wallenas et al, US Patent Application No. 20170072125 A1 (hereinafter Wallenas), in view of Burbank et al, US Patent Application No. 20150005699 A1 (hereinafter Burbank), in view of Mantle, US Patent Application No. 20060161107 A1 (hereinafter Mantle).
Regarding Claim 1, Wallenas teaches that an apparatus for peritoneal ultrafiltration (i.e., a peritoneal dialysis ("PD") system comprising; Paragraph 0001)
is arranged in enclosures (i.e., a housing)
designated by broken lines (Fig. 2; Paragraph 0041) that includes a flow pump (i.e., a PD fluid pump housed by the housing; Fig. 2, #65; Paragraph 0075)
and two catheter lines (Fig. 2, #53a and 53b) which can be arranged as a dual lumen catheter as is well-known (i.e., a dual lumen patient line extending from the housing; Paragraph 0073) in which the fluid enters the peritoneal cavity through the second catheter (i.e., the dual lumen patient line including a fill lumen Fig. 2, #53b) and out from the first catheter (i.e., and a return lumen; Fig. 2, #53a; Paragraph 0075)
with an intermittent tube (i.e., a PD fluid fill line in fluid communication with the fill lumen and an outlet of the PD fluid pump; Fig. 2, #84)
and patient line (i.e., connected to a transfer set; a PD fluid return line in fluid communication with the return lumen and an inlet of the PD fluid pump; Fig. 2, #82)
connecting the catheters to the apparatus, with pressure sensors arranged in ports (i.e., a fill pressure sensor configured to detect PD fluid pressure along the PD fluid fill line; a return pressure sensor configured to detect PD fluid pressure along the PD fluid return line; Fig. 2, #73 and 86) in order to monitor pressure in the lines (Paragraph 0089)
and discusses that a pressure meter may be used for controlling the operation of the flow pump (Paragraph 0093) and that pressure at various points is used to diagnose problems such as occlusions (i.e., to determine if one of the fill lumen or the return lumen of the dual lumen patient line is occluded; Paragraphs 0089-0094).
Wallenas further teaches that a partial occlusion would result in a high filling pressure and low emptying pressure which may trigger an alarm (i.e., wherein the control unit is configured to determine (i) an occlusion in the fill lumen if the output from the fill pressure sensor meets or exceeds a first predetermined pressure amount, (ii) an occlusion in the return lumen if the output from the return pressure sensor is less than a second predetermined pressure amount; Paragraphs 0090-0092).
Wallenas does not explicitly teach a control unit configured to use outputs from the fill and return pressure sensors and a user interface in operable communication with the control unit, the control unit configured to cause, after determining one of the occlusions in the fill lumen, the return lumen, or the transfer set, the user interface to provide an alarm indicating whether the fill lumen is occluded, the return lumen is occluded, or a transfer set is occluded.
However, Burbank teaches a controller (i.e., a control unit; Fig. 1, #116) for regulating flow rate which receives pressure measurements (i.e., configured to use outputs from the fill and return pressure sensors) and applies feedback control to the pump for the purpose of ensuring that the patient’s peritoneal cavity is not over-pressurized (Paragraphs 0055-0057). Burbank further teaches that a user interface is utilized to reference alarms outputs that refer to kinks, obstructions or other types of problems with detailed explanations (i.e., a user interface in operable communication with the control unit, the control unit configured to cause, after determining the occlusion, the user interface to provide an alarm indicating whether the fill lumen is occluded, the return lumen is occluded, or a transfer set is occluded; Paragraph 0162).
Burbank is analogous to the claimed invention because it pertains to an automated peritoneal dialysis system (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the peritoneal ultrafiltration apparatus as taught by Wallenas with the controller as taught by Burbank because the controller would ensure that the patient’s peritoneal cavity is not over-pressurized.
Wallenas in view of Burbank do not explicitly teach (iii) an occlusion in a patient's transfer set if both (i) and (ii) are met. Wallenas teaches multiple pressure sensors and the detection of the individual faults (i) and (ii), but does not explicitly teach the derived fault (iii) when both (i) and (ii) are combined.
However, Mantle teaches that it is known, while using a double-barreled catheter for continuous flow dialysis (Paragraph 0025) to include pressure monitoring wherein when pressure is out of control the catheters are tested individually by pressure response to diagnose blockages including blockage of outflow lumen in the OUT and IN directions and the blockage of the inflow lumen in the OUT and IN directions, wherein a blockage of the inflow or outflow of both lumens is non-recoverable and an alarm is signaled (i.e., iii) an occlusion in a patient's transfer set if both (i) and (ii) are met; Paragraph 0070) for the purpose of improving safety by switching the control of the pumps to a manual operation (Paragraph 0069).
Mantle is analogous to the claimed invention because it pertains to devices and processes for automated extracorporeal recirculation and chemical manipulation of biological liquids, specifically including liquid pumped to and from the peritoneum (Abstract and Paragraph 0001). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the apparatus for peritoneal ultrafiltration made obvious by Wallenas in view of Burbank with the derived alarm to alert of a blockage of the inflow/outflow lumens of the double-barreled catheter as taught by Mantle because the alert would allow the operator to respond to a non-recoverable position with manual pump operation to improve safety.
Regarding Claim 2, Burbank further teaches that the controller applies feedback control to the pump (i.e., wherein the control unit is further configured to operate the PD fluid pump; Paragraphs 0055-0057) and that low or no flow events trigger alarms (i.e., and to determine if the PD fluid pump is pumping PD fluid or not pumping PD fluid; Paragraph 0161).
Regarding Claim 3, Wallenas further teaches in Fig. 2 that the intermittent line (Fig. 2, #84) and the patient line (Fig. 2, #82) clearly extend into the dotted line enclosure (i.e., wherein the PD fluid fill line is located within the housing).
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Regarding Claim 4, Wallenas further teaches in Fig. 2 that the intermittent line (Fig. 2, #84) and the patient line (Fig. 2, #82) clearly extend into the dotted line enclosure (i.e., wherein the PD fluid return line is located within the housing).
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Regarding Claim 6, Wallenas further teaches that pressure should not be high during standstill of the flow pump and should normally be higher than or equal to atmospheric pressure (i.e., wherein the control unit is configured to compare the outputs from the fill and return pressure sensors when the PD fluid pump is not being actuated, and wherein the control unit determines an absence of an occlusion in the return lumen and the fill lumen when the outputs from the fill and return pressure sensors are the same or almost the same; Paragraphs 0089-0090).
Regarding Claim 7, Wallenas further teaches that a partial occlusion would result in a high filling pressure and low emptying pressure which may trigger an alarm (Paragraph 0091) and that when sudden and unexpected deviation of pressure is measured, an alarm is activated (i.e., wherein the control unit is configured to compare the outputs from the fill and return pressure sensors when the PD fluid pump is being actuated, and wherein the control unit determines an absence of an occlusion in the return lumen and the fill lumen when the outputs from the fill and return pressure sensors are different by a pressure drop amount; Paragraph 0094).
Regarding Claim 8, Wallenas further teaches that the flow pump may continuously circulate peritoneal fluid into and out of the peritoneal cavity by operating the flow pump in the clockwise direction and by opening the intermittent valve (i.e., wherein the PD fluid pump, the PD fluid fill line, the fill lumen, the PD fluid return line and the return lumen form a closed loop; Fig. 2, #68; Paragraph 0075) and that the pressure is measured at the connections to the patient line and intermittent line and the catheters (i.e., and wherein the pressure drop amount includes a pressure drop in both the fill lumen and the return lumen; Paragraph 0089).
Regarding Claim 9, Burbank further teaches a valve (Fig. 19, #P1) located on the drain line (Fig. 19, #862; Paragraph 0151) with automatic control of the valves (a valve under control of the control unit, the valve positioned to close the PD fluid return line; Paragraph 0153).
Furthermore, the limitation “wherein the pressure drop amount includes a pressure drop in the fill lumen but not the return lumen while the return lumen is closed by the valve” is a contingent limitation and as long as the structure of the prior art apparatus is capable of performing the function, then the limitation is rendered obvious (Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016)). See MPEP 2111.04(II).
Regarding Claim 10, Wallenas further teaches that a partial occlusion would result in a high filling pressure and low emptying pressure which may trigger an alarm (i.e., the output from the fill pressure sensor meets or exceeds the first predetermined pressure amount when the output from the fill pressure sensor is greater than an expected output from the fill pressure sensor by at least a first predetermined amount, and wherein the output from the return pressure sensor is less than a second predetermined pressure amount when the output from the return pressure sensor is less than an expected output from the return pressure sensor by at least a second predetermined amount; Paragraphs 0090-0092).
Regarding Claim 11, Wallenas further teaches that the normal pressures are always above or at atmospheric pressure (i.e., wherein the first and second predetermined amounts are at least substantially the same; Paragraph 0090).
Regarding Claim 13, Wallenas further teaches that the normal pressures are always above or at atmospheric pressure (i.e., wherein the first and second predetermined amounts are at least substantially the same; Paragraph 0090).
Regarding Claim 14, Burbank further teaches fill/drain line tubing with connectors (i.e., connector; Fig. 3B, #326 and 324) at the peritoneal catheter (i.e., at the distal end; Fig. 3B, #322; Paragraph 0064) where variations are known to have separated fill and drain lines, each having a respective lumen that merge at the peritoneal catheter (i.e., wherein the fill lumen and the return lumen of the dual lumen patient line merge into a single lumen in a connector located at the distal end of the dual lumen patient line; Paragraph 0067).
Regarding Claim 15, Burbank further teaches fill/drain line tubing with connectors (i.e., connector; Fig. 3B, #326 and 324) at the peritoneal catheter (i.e., at a distal end; Fig. 3B, #322; Paragraph 0064) where variations are known to have separated fill and drain lines, each having a respective lumen that merge at the peritoneal catheter (i.e., wherein the fill lumen and the return lumen of the dual lumen patient line extend into a connector located at the distal end of the dual lumen patient line; the connector configured to connect to the transfer set for performing continuous flow peritoneal dialysis Paragraph 0067).
Regarding Claim 16, Wallenas teaches that an apparatus for peritoneal ultrafiltration (i.e., a peritoneal dialysis ("PD") system comprising; Paragraph 0001)
is arranged in enclosures (i.e., a housing)
designated by broken lines (Fig. 2; Paragraph 0041) that includes a flow pump (i.e., a PD fluid pump housed by the housing; Fig. 2, #65; Paragraph 0075)
and two catheter lines (Fig. 2, #53a and 53b) which can be arranged as a dual lumen catheter as is well-known (i.e., a dual lumen patient line extending from the housing; Paragraph 0073) in which the fluid enters the peritoneal cavity through the second catheter (i.e., the dual lumen patient line including a fill lumen Fig. 2, #53b) and out from the first catheter (i.e., and a return lumen; Fig. 2, #53a; Paragraph 0075) with an intermittent tube (Fig. 2, #84) and patient line (i.e., connected to a transfer set; Fig. 2, #82)
connecting the catheters to the apparatus, with pressure sensors arranged in ports (i.e., a fill pressure sensor configured to detect PD fluid pressure in the fill lumen of the dual lumen patient line; a return pressure sensor configured to detect PD fluid pressure in the return lumen of the dual lumen patient line; Fig. 2, #73 and 86)
in order to monitor pressure in the lines (Paragraph 0089) and discusses that a pressure meter may be used for controlling the operation of the flow pump (Paragraph 0093) and that pressure at various points is used to diagnose problems such as occlusions (i.e., to determine if one of the fill lumen or the return lumen of the dual lumen patient line is occluded; Paragraphs 0089-0094).
Wallenas further teaches that a partial occlusion would result in a high filling pressure and low emptying pressure which may trigger an alarm (i.e., wherein the control unit is configured to determine (i) an occlusion in the fill lumen if the output from the fill pressure sensor meets or exceeds a first predetermined pressure amount, (ii) an occlusion in the return lumen if the output from the return pressure sensor is less than a second predetermined pressure amount; Paragraphs 0090-0092).
Wallenas does not explicitly teach a control unit configured to use outputs from the fill and return pressure sensors and a user interface in operable communication with the control unit, the control unit configured to cause, after determining the occlusion, the user interface to provide an alarm indicating whether the fill lumen is occluded, the return lumen is occluded, or a transfer set is occluded.
However, Burbank teaches a controller (i.e., a control unit; Fig. 1, #116) for regulating flow rate which receives pressure measurements (i.e., configured to use outputs from the fill and return pressure sensors) and applies feedback control to the pump for the purpose of ensuring that the patient’s peritoneal cavity is not over-pressurized (Paragraphs 0055-0057). Burbank further teaches that a user interface is utilized to reference alarms outputs that refer to kinks, obstructions or other types of problems with detailed explanations (i.e., a user interface in operable communication with the control unit, the control unit configured to cause, after determining one of the occlusions in the fill lumen, the return lumen, or the transfer set, the user interface to provide an alarm indicating whether the fill lumen is occluded, the return lumen is occluded, or a transfer set is occluded; Paragraph 0162).
Burbank is analogous to the claimed invention because it pertains to an automated peritoneal dialysis system (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the peritoneal ultrafiltration apparatus as taught by Wallenas with the controller as taught by Burbank because the controller would ensure that the patient’s peritoneal cavity is not over-pressurized.
Wallenas in view of Burbank do not explicitly teach (iii) an occlusion in a patient's transfer set if both (i) and (ii) are met. Wallenas teaches multiple pressure sensors and the detection of the individual faults (i) and (ii), but does not explicitly teach the derived fault (iii) when both (i) and (ii) are combined.
However, Mantle teaches that it is known, while using a double-barreled catheter for continuous flow dialysis (Paragraph 0025) to include pressure monitoring wherein when pressure is out of control the catheters are tested individually by pressure response to diagnose blockages including blockage of outflow lumen in the OUT and IN directions and the blockage of the inflow lumen in the OUT and IN directions, wherein a blockage of the inflow or outflow of both lumens is non-recoverable and an alarm is signaled (i.e., iii) an occlusion in a patient's transfer set if both (i) and (ii) are met; Paragraph 0070) for the purpose of improving safety by switching the control of the pumps to a manual operation (Paragraph 0069).
Mantle is analogous to the claimed invention because it pertains to devices and processes for automated extracorporeal recirculation and chemical manipulation of biological liquids, specifically including liquid pumped to and from the peritoneum (Abstract and Paragraph 0001). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the apparatus for peritoneal ultrafiltration made obvious by Wallenas in view of Burbank with the derived alarm to alert of a blockage of the inflow/outflow lumens of the double-barreled catheter as taught by Mantle because the alert would allow the operator to respond to a non-recoverable position with manual pump operation to improve safety.
Regarding Claim 17, Wallenas further teaches that a partial occlusion would result in a high filling pressure and low emptying pressure which may trigger an alarm (i.e., the output from the fill pressure sensor meets or exceeds the first predetermined pressure amount when the output from the fill pressure sensor is greater than an expected output from the fill pressure sensor by at least a first predetermined amount, and wherein the output from the return pressure sensor is less than a second predetermined pressure amount when the output from the return pressure sensor is less than an expected output from the return pressure sensor by at least a second predetermined amount; Paragraphs 0090-0092).
Regarding Claim 18, Wallenas further teaches that the normal pressures are always above or at atmospheric pressure (i.e., wherein the first and second predetermined amounts are at least substantially the same; Paragraph 0090).
Regarding Claim 20, Wallenas further teaches that the normal pressures are always above or at atmospheric pressure (i.e., wherein the first and second predetermined amounts are at least substantially the same; Paragraph 0090).
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.
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/A.A.G./ Examiner, Art Unit 1772
/Ryan B Huang/ Primary Examiner, Art Unit 1772
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