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 Arguments
Applicant’s arguments with respect to claim(s) 9-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim 11,12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 11, the heating unit comprises a first heater and a second heater. The examiner notes that in view of the amendments to claim 9, a first heating unit and a second heating unit are provided as making up the heating unit. Therefore, it is unclear if that a first and second heater of the heating unit in claim 11 is the same as the first and second heating unit. Based on applicant’s spec, para 0042, it appears that heater 125, interpreted to be upstream is a first heater unit, and heater 41, interpreted to be downstream, is a second heater unit, where commercial power is applied to the first heater unit and battery power is applied to the second heater unit. Therefore, it is interpreted that the first and second heater of claim 11 are the first and second heating unit introduced in claim 9. Appropriate correction is requested.
Regarding claim 12, the heating unit comprises “a shared heating unit”. Based on the language it is unclear if the shared heating unit is additional to the first and second heating unit of claim 9 or is claiming that the first and second heating unit of claim 9 are a shared unit. Based on applicant’s specification para. 0048, the shared heating unit comprises both a first and second heating unit, and thus it is interpreted that the claim 12 requires that the first and second heating unit function as a shared heating unit, not that the claim requires an additional shared heating unit.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11,13 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 11, said claim fails to further limit claim 9. Claim 11 requires the first heater unit to be supplied with commercial source electric power and the second heater unit is supplied with power from an auxiliary source. Per the amendments to claim 9, this limitation is now required in claim 9. Per the 112b interpretation, the heater units in claim 11 are interpreted to be the same as the heating units in claim 9, and thus claim 11 fails to further limit the claims.
Regarding claim 13, said claim fails to further limit claim 9. Claim 13 requires that the heating unit is arranged at a plurality of places within the flow route. Per the amendment to claim 9, the heating unit comprises a first heating unit located upstream and a second heating unit located downstream, thus having the heating unit located at a plurality of places within the route. Thus claim 13 fails to further limit claim 9.
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.
Claim(s) 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobro, applied in the previous office action, in view of Gillerfalk et al. US 5948247, hereafter Gillerfalk.
Regarding Claim 9 Hobro discloses a blood purification apparatus including a blood purifier (dialyzer per abstract, para. 0012,0031, 0037), the blood purification apparatus comprising: a disinfector (fluid flow pump 220) that causes a disinfection liquid to flow along a flow route of the blood purifier to disinfect the flow route (para. 0021 where disinfecting fluid may be flown through the device and para. 0047, where thermal disinfection may be conducted using the same system where pump 220 is activated by the controller to move hot fluid for disinfection through the flow path. Pump 226 also helps move said fluid), a heating unit that heats the disinfection liquid (heater 205, see also para. 0047), and a controller that controls a blood purification treatment of the blood purifier (para. 0041 where control of the system is done via the controller) and also controls a disinfection process of the disinfector and a heating process of the heating unit (para. 0047, where the controller controls the heater to heat the fluid), wherein the heating unit is configured to be supplied with electric power from a storage type battery as an auxiliary power source (para. 0022 where an external power supply and/or a battery is used to power the heater) and generate heat in addition to being supplied with electric power from a commercial power source and generating heat to heat the disinfection liquid (para. 0022, see also para 0053, 0057, where external power is used to provide energy); wherein the controller executes a charging process for charging the auxiliary power source (para. 0067, where a mode of operation includes a state in which the batteries are charged) while maintaining the disinfection liquid at a predetermined temperature for a desired period by supplying power from only the commercial power source to the heating unit after a temperature of the disinfection liquid is raised to a predetermined temperature by supplying power from the commercial power source and the auxiliary power source to the heating unit (para. 0052, 0067, where the controller used power from the battery and/or external source to heat fluid up to a desired temperature). The examiner notes that as the heating power may come from the external source and the battery may be in a charging state, one operational state of the device occurs when the heat is provided by the external source and the battery is charging, thus reading to the claimed limitation.
Per the amendments filed 06/01/2026, the claims now require 1) wherein the blood purifier maintains a single flow route for the blood purification treatment, from the introduction to the discharge of blood in the flow route, and also circulates the disinfection liquid from upstream to downstream in the flow route for the disinfection process to disinfect the flow route and 2) wherein the heating unit comprises a first heating unit installed upstream of the flow route of the blood purifier and a second heating unit installed downstream of the flow route of the blood purifier, wherein the first heating unit is powered by the commercial power supply and the second heating unit is powered by the auxiliary power supply.
The examiner notes that regarding 1) the embodiment of figure 2 of Hobro comprises a single flow route from inlet (201) to outlet (227), where conduit (223) connects the upstream and downstream portions (para. 0047). Per para. 0047, said connection allows for disinfection of both portions by letting the heated fluid flow through the system. Thus, Hobro reads to amendment 1). Regarding amendment 2), while Hobro figure 2 has two heating elements (206 and 207), both are upstream in the system. Hobro does, in figure 3, disclose a second heater (305). While the upstream and downstream portions are connected in normal use through (301) or through a dialyzer (para. 0049), in the disinfection process, the system is separated into two separate circulation loops where the first heater heats fluid to disinfect the upstream portion and the second heater heats fluid to disinfect the downstream portion (para. 0050). Thus, it would not have been obvious to use the embodiment of figure 3 to modify the embodiment of figure 2 of Hobro. The examiner however, relies on Gillerfalk.
Gillerfalk teaches a disinfection system for a dialysis machine and is thus considered analogous to the claimed invention. Gillerfalk teaches that the system comprises a heater (9) for heating a first circuit, where, as seen in the figure said heater is interpreted to be upstream of both pump (21) and connection to a dialyzer (column 3 lines 55-57, where tubing 13 connects to one end of a dialyzer). Gillerfalk teaches a second heater (43 see figure 2) interpreted to be downstream of said pump and dialyzer (column 3 lines 65-67, where tubing 13 connects to one end of a dialyzer). Gillerfalk figure 3 depicts an embodiment where “ Certain dialysis machines lack the bypass-conduit 27 which is replaced by a shunt conduit directly from the outlet of the supply conduit 11 to the inlet of the return conduit 28” (column 6, lines 14-16). In this configuration it can be seen (figure 3) that the upstream and downstream portions are directly connected. Therefore, as Gillerfalk teaches a second heater in a downstream portion to heat said portion (column 5, lines 35-50) may be used in disinfection of a dialysis system, where the system includes a connection between an upstream and downstream portion, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a downstream heating component in the circuit of the embodiment of figure 2 of Hobro. Doing so would merely involve combining prior art elements according to known methods to yield predictable results (that being heating of a downstream portion of a dialysis circuit), and thus a prima face case of obviousness exists.
The examiner notes that Hobro teaches, in conditions where a second heater is provided, energy may be provided from both the battery unit and mains (external power supply) to both the first and second heater (para. 0053). It is interpreted that power from both the external and battery source are applied to both units and therefore the first unit receives power from at least the commercial source and the second unit receives power from at least the auxiliary source.
Regarding Claim 10 Hobro and Gillerfalk teach the blood purification apparatus according to claim 9, wherein: the auxiliary power source is shared by the blood purifier and the heating unit (abstract, where the battery unit previously disclosed may provide power for at least a portion of functional units within the system, including a dialysis monitor performing treatment via a dialyzer (para 0012)). As the dialyzer is the blood purifier, and the battery may power the dialysis monitor controlling treatment via the dialyzer, it is interpreted that the battery may control both the heating unit and the purifier.
Regarding Claim 11 Hobro and Gillerfalk teach, the blood purification apparatus according to claim 9, wherein: the heating unit comprises a first heater unit that is supplied with electric power from a commercial power source and generates heat, and a second heater unit that is supplied with electric power from the auxiliary power source and generates heat. The examiner notes that Hobro teaches, in conditions where a second heater is provided, energy may be provided from both the battery unit and mains (external power supply) to both the first and second heater (para. 0053). It is interpreted that power from both the external and battery source are applied to both units and therefore the first unit receives power from at least the commercial source and the second unit receives power from at least the auxiliary source.
Regarding Claim 12 Hobro and Gillerfalk teach the blood purification apparatus according to claim 9, wherein: the heating unit comprises a shared heater unit that is supplied with electric power from a commercial power source and electric power from the auxiliary power source and generates heat. The examiner notes that Hobro teaches, in conditions where a second heater is provided, energy may be provided from both the battery unit and mains (external power supply) to both the first and second heater (para. 0053). It is interpreted that power from both the external and battery source are applied to both units and therefore the heater units are a shared heater unit.
Regarding Claim 13 Hobro and Gillerfalk teach the blood purification apparatus according to claim 9, wherein: the heating unit is arranged at a plurality of places within the flow route. The examiner notes that per the rejection of claim 9, upon combination with Gillerfalk, the system would comprise two heaters located at different points of the flow path and thus reads to the claimed limitation.
Regarding Claim 14 Hobro and Gillerfalk teach the blood purification apparatus according to claim 9, comprising: a temperature sensor (Hobro, 219) for detecting a temperature of a disinfection liquid within the flow route on a downstream side of the heating unit within the flow route (Hobro, para. 0061), wherein the controller controls a heating process of the heating unit so as to maintain a temperature of a disinfection liquid within the flow route at a desired temperature or higher for a desired time period or longer which are set in advance, based on detection information of the temperature sensor (Hobro, para. 0065). The examiner notes that sensor 219, per paragraph 0061 is for detecting temperature of the fluid in the system. Per para. 0065, the temperature sensor signals to the controller the temperature parameter sensed, such that it is a proper temperature for operation (37 degrees Celsius for disinfection per the same citation. However, per the citation the sensor of 0061 and 0065 are not necessarily the same sensor. The examiner notes that as Hobro discloses (para. 0061) that a temperature sensor located downstream may detect temperature of a heated fluid and the controller operates the system based on said detected temperature, and Hobro further discloses that a temperature sensor may be used to determine proper disinfection temperature, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the temperature sensor (219) to also determine the temperature of disinfecting fluid when a disinfecting mode is being run through the system, such as to ensure proper temperature of the disinfecting fluid.
Regarding Claim 15 Hobro and Gillerfalk teach the blood purification apparatus according to claim 14, wherein: the controller supplies electric power to the heating unit according to a temperature of a disinfection liquid within the flow route based on the detection information of the temperature sensor. As detailed under the rejection of claim 14, the controller controls the system (heater in this scenario) such that the fluid is heated to a desired level. Per para. 0065, a desired heating temperature (based on sensed data) is about 37 degrees Celsius for disinfection.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobro and Gillerfalk in view of Jang US 2016/0243303 and Harvey et al. US 2005/0177275, hereafter Jang and Harvey, respectively.
Regarding Claim 16 Hobro and Gillerfalk teach the blood purification apparatus according to claim 9, comprising a battery as the auxiliary power source, wherein the controller performs control processing for at least one of stopping heating according to at least one of a remaining amount of stored electricity in the battery and a deterioration status of the battery. The examiner notes that as detailed under the rejections of claim 9 above, para. 0067 discloses a mode of operation induced by the controller includes a state in which the batteries are being charged. Therefore Hobro at least discloses the stopping of heating via the battery such that the battery can be charged. (per para. 0067 charger unit will only be connected to battery unit and charge only when the unit is not providing power to the heating element)
However, Hobro fails to disclose a detector for detecting a remaining amount of stored electricity in the battery and a status notification according to at least one of a remaining amount of stored electricity in the battery and a deterioration status of the battery.
Jang teaches a fluid system using a pump system and is thus considered analogous to the claimed invention. Jang teaches where said device is operated via a battery (para. 0012 0020) and where said device comprises a displayer for displaying remaining battery power (para. 0049). Further per para. 0049, when said battery power is low, an alarm is activated. Therefore, as Jang teaches that battery powered systems may provide visual representations of battery life and provide alerts when battery power is low, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide battery status and alerts on the display (para. 0031 of Hobro) for the battery of Hobro to allow a user to monitor the system. The examiner notes that while Jang has some means of monitoring the battery life such that it can be displayed, no specific detector is disclosed.
Harvey teaches a battery-operated device and is thus considered analogous to the claimed invention. Harvey teaches that the system may include various sensors for the control unit, including a battery power level sensor which measures battery power level (para. 0043). Therefore, as Harvey teaches that a sensor is known in the art to be used for measuring battery power level, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a battery level sensor to provide said information to the controller of Hobro and Jang in order to display said data, as taught by Jang.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobro and Gillerfalk in view of Jang and Harvey, and further in view of Meyer et al. US 20160166753, hereafter Meyer.
Regarding Claim 17 Hobro discloses the blood purification apparatus according to claim 9, but fails to specifically disclose a cleaning unit that cleans the disinfection liquid by causing water at normal temperature to flow along a flow route of the disinfection liquid, wherein the controller is configured to control a cleaning process of the cleaning unit so that the cleaning unit performs the cleaning process before or after the disinfection process of the disinfector or performs the cleaning process before and after the disinfection process of the disinfector.
Meyer teaches a dialysis system and is thus considered analogous to the claimed invention. Meyer teaches that after dialysis, it is common to have a disinfectant run through the system (para. 0082). Before the next treatment, it is import to flush the potential leftover disinfectant out of the device (para. 0082). Meyer teaches per the same para. 0082 citation that this is accomplished by filling and priming the system with water from a reservoir where said water may be tap water (thus interpreted to be water at a normal temperature). Further, per para. 0013 the water system (as used for flushing detailed above) may be operated by the controller of the system. Therefore, as Hobro teaches that disinfecting agents may be included in the disinfecting of the system (Hobro para. 0031) and Meyer teaches that it is known in the art to use water to flush out a system after disinfection of the system involving a disinfectant being flown through the system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the water system of Meyer with the dialysis and disinfecting system of Hobro. Doing so would merely involve the use of known technique (water flushing after disinfection) to improve similar devices (dialysis systems) in the same way (remove any leftover chemicals) and thus a prima facie case of obviousness exists.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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