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
The Amendment filed on 2/3/2026 has been entered. Claims 1-13 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection previously set forth in the non-final Office Action mailed 11/5/2025.
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 is 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.
Claim 11 recites “a condensing section” in lines 1-2 and claim 1 recites “a condensing section.” Claim 11 is therefore unclear if the condensing section recited in claim 11 is the same or different from the condensing section recited in claim 1. For examination purposes, they are interpreted to be the same.
Claim 11 recites “a product storage section” in line 2 and claim 1 recites “a product storage section.” Claim 11 is therefore unclear if the product storage section recited in claim 11 is the same or different from the product storage section recited in claim 1. For examination purposes, they are interpreted to be the same.
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.
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.
Claim(s) 1-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over unpublished and abandoned US Application No. 11/937232 which was filed on 11/8/2007, by applicants/assignee Baxter International Inc., hereinafter Childers in view of United States Application Publication No. 2007/0012556, hereinafter Lum. US Application No. 11/937232 was disclosed to the public on 8/20/2009 as it was incorporated by reference into United States Application Publication No. 2009/0206023. See 37 CFR 1.14 (a)(1)(iv), MPEP § 2127 and MPEP § 901.02.
Regarding claim 1, Childers teaches a medical system (figure 9) comprising; a distillation device (figure 3a) including a distillation device processor (the portion item 41 which controls the system for making distilled water), an evaporator (item 24), a condenser (item 23), and a purified product water heat exchanger (item 22) having a source fluid flow path and a purified product water flow path in thermal communication with one another (figure 3a), wherein the condenser comprising a condenser housing (the housing of item 23) defining a condensing section (item 23); at least one concentrate fluid (items 62a and 63a); a medical treatment device (item H) including a treatment fluid preparation circuit (figure 6) in selective fluid communication (paragraph [0053]), via a point of use valve (item 61b), with the purified product water flow path (item 61a) and a medical treatment device processor (the portion item 41 which controls the system for preparing the dialysis solution), configured to command mixing of the at least one concentrate and purified water to generate a prescribed treatment fluid with the treatment fluid preparation circuit (paragraph [0040]); a communications link (item 41) between the medical treatment device processor of the medical treatment device and the distillation device processor (the portion item 41 which controls the system for making distilled water) of the distillation device, the medical treatment device processor configured to transmit distinct mode command messages to the distillation device processor (paragraph [0040]), each distinct mode command message including an explicit mode identifier selected from a finite set of enumerated treatment modes (paragraph [0041], the operating points sent are considered to be the distinct mode command messages), the distinct mode commands being differentiated from one another to correspond to a desired treatment mode (paragraph [0041], the operating points sent are considered to be the distinct mode command messages); a sensor assembly (the T below item 28 and the C below the label 22b) in communication with the purified product water flow path (figure 3a); and a source valve (item 21c) fluidly connecting a fluid source to the source fluid flow path (figure 3a), the distillation device processor configured to receive the distinct mode command messages form the medical treatment device processor (paragraphs [0040]-[0041]); receive data from the sensor assembly (paragraphs [0040]-[0041]), actuate the source valve based at least in part on the explicit mode identifier and data from the sensor assembly; and govern operational parameters of the distillation device based at least in part on the mode identifier and the data (paragraphs [0040]-[0041]), wherein the distillation processor executes mode dependent control logic that differs between at least a first enumerated treatment mode and a second enumerated treatment mode (paragraphs [0040]-[0041]).
Childers fails to teach the condenser housing defining a product storage section integrated within the condenser housing, the product storage section comprising a condensate accumulation section fluidically coupled to the condensing section via an internal passage defined by the condenser housing.
Lum teaches a water processing apparatus with a condenser housing (the housing surrounding all of item 10) with a storage tank (item 100) and condenser section (item 90) and internal passage within the housing and the storage tank which collects water from the condenser and the storage tank has a volume of 6 gallons (Lum, paragraph [0083]) so that the distillation system can be cycled and the water stored when the distillation system is off (Lum, paragraph [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a product storage tank with a volume of 6 gallons to the condenser housing with internal passage (the entire housing of Childers) of Childers because it would allow for the distillation system to be cycled and the water stored when the distillation system is off (Lum, paragraph [0083]).
Regarding claim 2, Childers teaches wherein the sensor assembly includes at least one temperature sensor (the T below item 28) and at least one conductivity sensor (the C below the label 22b).
Regarding claim 3, Childers teaches wherein the distillation device processor configured to actuate the source valve based at least in part on the mode commands and temperature data from the sensor assembly (paragraphs [0040]-[0041]).
Regarding claim 4, Childers teaches wherein the distillation device processor configured to actuate the source valve based at least in part on the mode commands and data from the sensor assembly and a target set point for purified water (paragraphs [0040]-[0041]).
Regarding claim 5, Childers teaches wherein the target set point is a temperature set point (paragraphs [0040]-[0041]).
Regarding claim 6, Childers teaches wherein the target set point is determined by the distillation device processor based on the mode commands (paragraphs [0040]-[0041]).
Regarding claim 7, Childers teaches wherein the target set point based off a first mode command of the mode commands is in a range of 20-35°C (paragraph [0028]) and a target set point based off a second mode command of the mode commands is greater than 90°C (paragraph [0028]).
Regarding claim 8, Childers teaches wherein the medical treatment device is a dialysis machine (paragraph [0053]).
Regarding claim 9, Childers teaches wherein the medical treatment device is a hemodialysis device (paragraph [0053]).
Regarding claim 10, Childers teaches wherein the treatment fluid is a dialysis fluid (paragraph [0040]).
Regarding claim 11, modified Childers teaches wherein the condenser includes a condensing section (see supra) and a product storage section (see supra), the product storage section having a volume of at least one liter (see supra).
Regarding claim 13, Childers teaches wherein the distillation device processor is further configured to govern operation of a concentrate outlet valve of the distillation device based at least in part on the mode commands (paragraphs [0040]-[0041]).
Claim(s) 1-11 and 13 is/are additionally rejected under 35 U.S.C. 103 as being unpatentable over Childers in view of Lum and United States Application Publication No. 2002/0085952, hereinafter Ellingboe.
Regarding claim 1, Childers teaches a medical system (figure 9) comprising; a distillation device (figure 3a) including a processor (item 41), an evaporator (item 24), a condenser (item 23), and a purified product water heat exchanger (item 22) having a source fluid flow path and a purified product water flow path in thermal communication with one another (figure 3a); at least one concentrate fluid (items 62a and 63a); a medical treatment device (item H) including a treatment fluid preparation circuit (figure 6) in selective fluid communication (paragraph [0053]), via a point of use valve (item 61b), with the purified product water flow path (item 61a) and the processor (item 41), configured to command mixing of the at least one concentrate and purified water to generate a prescribed treatment fluid with the treatment fluid preparation circuit (paragraph [0040]); the processor configured to transmit distinct mode command messages to the processor (paragraph [0040]) each distinct mode command message including an explicit mode identifier selected from a finite set of enumerated treatment modes (paragraph [0041], the operating points sent are considered to be the distinct mode command messages), the distinct mode commands being differentiated from one another to correspond to a desired treatment mode (paragraph [0041], the operating points sent are considered to be the distinct mode command messages); a sensor assembly (the T below item 28 and the C below the label 22b) in communication with the purified product water flow path (figure 3a); and a source valve (item 21c) fluidly connecting a fluid source to the source fluid flow path (figure 3a), the distillation device processor configured to receive the distinct mode command messages form the medical treatment device processor (paragraphs [0040]-[0041]); receive data from the sensor assembly (paragraphs [0040]-[0041]), actuate the source valve based at least in part on the explicit mode identifier and data from the sensor assembly; and govern operational parameters of the distillation device based at least in part on the mode identifier and the data (paragraphs [0040]-[0041]), wherein the distillation processor executes mode dependent control logic that differs between at least a first enumerated treatment mode and a second enumerated treatment mode (paragraphs [0040]-[0041]).
Childers fails to teach the condenser housing defining a product storage section integrated within the condenser housing, the product storage section comprising a condensate accumulation section fluidically coupled to the condensing section via an internal passage defined by the condenser housing.
Lum teaches a water processing apparatus with a condenser housing (the housing surrounding all of item 10) with a storage tank (item 100) and condenser section (item 90) and internal passage within the housing and the storage tank which collects water from the condenser and the storage tank has a volume of 6 gallons (Lum, paragraph [0083]) so that the distillation system can be cycled and the water stored when the distillation system is off (Lum, paragraph [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a product storage tank with a volume of 6 gallons to the condenser housing with internal passage (the entire housing of Childers) of Childers because it would allow for the distillation system to be cycled and the water stored when the distillation system is off (Lum, paragraph [0083]).
If it is determined that Childers fails to teach both a distillation device processor and a medical treatment device process and a communications link between the medical treatment device processor of the medical treatment device and the distillation device processor, then Childers would fail to teach these limitations.
Ellingboe teaches a blood perfusion system which utilizes a control unit which includes a plurality of processors and a communications network between each of the processors so that the monitor/control processors can be separately provided for automated monitor and control so that each part of the device has a separate controller which does not interfere with the other (Ellingbor, paragraph [0212]).
Examiner further finds that the prior art contained a device/method/product (i.e., multiple processors each controlling a portion of the device with a communication link between them) which differed from the claimed device by the substitution of component(s) (i.e., a single processor) with other component(s) (i.e., multiple processors each controlling a portion of the device with a communication link between them), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a single processor with multiple processors each controlling a portion of the device with a communication link between them), and the results of the substitution (i.e., controlling the system) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the single processor of reference Childers with multiple processors each controlling a portion of the device with a communication link between them of reference Ellingboe, since the result would have been predictable. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized multiple processors each controlling an aspect of the device (one for the medical treatment device and another for the distillation device) with a communication link between them because it would allow for the processors to be separately provided for automated monitor and control so that each part of the device has a separate controller which does not interfere with the other (Ellingbore, paragraph [0212]).
Regarding claim 2, Childers teaches wherein the sensor assembly includes at least one temperature sensor (the T below item 28) and at least one conductivity sensor (the C below the label 22b).
Regarding claim 3, modified Childers teaches wherein the distillation device processor configured to actuate the source valve based at least in part on the mode commands and temperature data from the sensor assembly (paragraphs [0040]-[0041]).
Regarding claim 4, modified Childers teaches wherein the distillation device processor configured to actuate the source valve based at least in part on the mode commands and data from the sensor assembly and a target set point for purified water (paragraphs [0040]-[0041]).
Regarding claim 5, modified Childers teaches wherein the target set point is a temperature set point (paragraphs [0040]-[0041]).
Regarding claim 6, modified Childers teaches wherein the target set point is determined by the distillation device processor based on the mode commands (paragraphs [0040]-[0041]).
Regarding claim 7, modified Childers teaches wherein the target set point based off a first mode command of the mode commands is in a range of 20-35°C (paragraph [0028]) and a target set point based off a second mode command of the mode commands is greater than 90°C (paragraph [0028]).
Regarding claim 8, Childers teaches wherein the medical treatment device is a dialysis machine (paragraph [0053]).
Regarding claim 9, Childers teaches wherein the medical treatment device is a hemodialysis device (paragraph [0053]).
Regarding claim 10, Childers teaches wherein the treatment fluid is a dialysis fluid (paragraph [0040]).
Regarding claim 11, modified Childers teaches wherein the condenser includes a condensing section (see supra) and a product storage section (see supra), the product storage section having a volume of at least one liter (see supra).
Regarding claim 13, modified Childers teaches wherein the distillation device processor is further configured to govern operation of a concentrate outlet valve of the distillation device based at least in part on the mode commands (paragraphs [0040]-[0041]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Childers with or without Elingboe in view of United States Application Publication No. 2017/0153056, hereinafter Kim.
Regarding claim 12, Childers teaches all limitations of claim 1; however, Childers with or without Elingboe fail to teach wherein the distillation device processor is further configured to govern operation of a compressor motor of the distillation device based at least in part on the mode commands.
Kim teaches a device which utilizes an inverter type compressor which varies a drive frequency of the compressor unit and is able to adjust the cooling capacity and therefore cooling of the purified water can be performed efficiently and thus power consumption is reduced (Kim, paragraph [0068]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a compressor with compressor motor to the device of Childers because it would allow for the adjustment of the cooling capacity and therefore cooling of the purified water can be performed efficiently and thus power consumption is reduced (Kim, paragraph [0068]). The distillation device processor of Childers controls all aspects of the distillation device and therefore would also govern the operation of the compressor motor based in part on the mode commands.
Response to Arguments
Applicant's arguments filed 2/3/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument Childers’ fails to teach transmission of a command message; inclusion within that message of an explicit mode identifier selected from a finite enumerated set, and execution of different control logic by the distillation device processor depending on the identified mode is not found persuasive. The claim has not specified what is meant by “an explicit mode identifier” and the a “set of operating points” can be considered to be an explicit mode identifier as the set of operating points would identify the mode for which the device to operate in. Further, there would be a finite enumerated set as there would be a select number of sets of operating points programmed within the device and these sets are considered to be finite set.
Regarding applicant’s argument that Lum fails to teach an integrated condenser-housing/internal-passage architecture required by claims 1 and 11 is not persuasive. The claim has not specified what is not included within the condenser housing and therefore, the housing surrounding the device itself of modified Childers is considered to be the “condenser housing” and therefore the storage tank added to the device along with the internal passage would be within the condenser housing reading on the instant limitations.
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 D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796