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 . 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 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.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/532,799 application filed on December 7, 2023. Claims 1-21 are pending and have been fully considered. The examined claims are directed to an apparatus.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 12/07/2023 (2), 10/24/2025, 02/05/2026 and 03/05/2026. Please refer to the signed copy of the PTO-1449 form attached herewith.
Claim Interpretation
The examined claims are apparatus/system claims requiring only the positively recited structural components, although structured with physical features that can perform the stated functions or accomplish the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Also, a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Of course, in the patentability analysis of these apparatus/system claims, functional features are considered/not ignored and Applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
The recited fluid and dialysate, for example, are considered materials potentially contained within, transient or passing through, generated or produced, or otherwise worked upon by the apparatus/system rather than structural components of the apparatus.
According to the MPEP §2115 [R-2], a material or article worked upon does not limit apparatus claims: Expressions relating an apparatus to contents thereof during an intended operation are of no significance in determining patentability of apparatus claims. Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)).
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I. Unless otherwise specified, any citation to Applicant’s specification will generally refer to the original and any substitute or amended specification rather than a published application.
Examiner interprets limitations such as ‘configured,’ ‘configured to’ and/or ‘configured for’ as similar or equivalent to ‘set up to,’ ‘designed to,’ ‘capable of,’ or simply ‘can,’ in the context of an appropriate reference.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. The inventive entity for a particular application is based on some contribution to at least one of the claims made by each of the named inventors. MPEP §2137.01.
Claims 1, 2 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Busby et al. (US20110040244, Busby) in view of Childers et al. (US20100010426, Childers) (IDS of 12/07/2023) and Fulkerson et al. (US20140138294, Fulkerson).
Note that these are apparatus claims. In the patentability analysis below, the italicized portions represent functional aspects, whereas the bolded portions represent structure. The analysis considers the alternate concepts of the various potential embodiments in a particular reference.
Regarding claims 1, 2 and 4-7, Busby discloses a system (Abstract, Figs 1-30M), comprising:
a dialysis machine configured to provide dialysis treatments for respective patients, the dialysis treatments including utilization of a membrane between a fluid to be purified on one side of the membrane and a dialysate on another side of the membrane ([0006], [0005], [0019], [0020], [0024], [0028], [0036], where the dialyzer is a membrane);
wherein each dialysis machine comprises:
one or more actuators, including a pump ([0021], [0024], [0027], [0089], where an actuator 24 and a pump 20 are disclosed);
one or more sensors, including a sensor configured to obtain data relating to the pump and other devices ([0024], [0084], [0104], [0159]); and
a first processor configured to control the one or more actuators ([0024]).
Therefore, Busby discloses the claimed invention, except:
a plurality of dialysis machines; and
each dialysis machine of the plurality of dialysis machines comprises a sensor configured to obtain data relating to wear of the pump.
Regarding item i), a plurality of dialysis machines is merely a duplication of an existing part with little patentable significance unless a new and unexpected result is produced. Here one would expect additional convenience and efficiency in simultaneously monitoring several machines. Busby also mentions the use of automated peritoneal dialysis (APD) machines, in the background section, implying the potential use of a plurality of dialysis machines ([0009], [0010]). Additionally, Busby uses a plurality of other devices such as tubes, processors, sensors, valve chambers, cams and supply bags ([0022], [0024], [0032], [0081]).
Also, Childers discloses a peritoneal dialysis system including: a plurality of automated peritoneal dialysis ("APD") machines, and a server computer in communication with the APD machines, the APD machines programmed to inform the server computer of how much dialysate is consumed (Abstract, [0159], [0160]).
When the claimed invention was effectively filed, it would have been obvious to one of ordinary skill in the art to employ a plurality of dialysis machines as an effective and efficient way to simultaneously monitor multiple patients and dialysis machines.
Regarding item ii), Fulkerson discloses a portable dialysis machine having a detachable controller unit and base unit (Abstract, Figs). Traditional portable dialysis systems are cumbersome and not always reliable ([0018]-[0020]). Also, the systems' interfaces and methods of using disposable components are subject to misuse and/or errors in usage by patients (Id.).
In one embodiment, the dialysis machine comprising a first unit in data communication with a second unit ([0066]). Fulkerson also discloses the potential use of actuators in cooperation with a valve component that has an open position and a closed position and wherein said valve component comprises an orifice closing member adjacent to an orifice through which fluid can flow, a displacement member having a first portion and a second portion, where the actuator is employed for generating a magnetic field to move the displacement member toward a first magnet, cause said first portion to press against the orifice closing member, and cause the orifice closing member to close said orifice ([0035], [0037]).
Fulkerson teaches a dialysis system comprising at least one processor and a memory for storing programmatic instructions which, when executed, communicates with a software application layer 7805 ([0574]). The software application layer 7805 interfaces with a master controller 7810 that is in data communication with a plurality of field programmable gate arrays responsible for controlling various pumps, sensors, and valves (Control FPGAs) 7815 and in data communication with a plurality of field programmable gate arrays responsible for monitoring the operation of various pumps, sensors, and valves for failure states or states which exceed accepted operational parameters 7820 (Safety FPGAs) (Id.). This failure state monitoring of the pump is tantamount to obtaining data related to the wear of the pump.
At the time when the claimed invention was effectively filed, it would have been obvious to an ordinarily skilled artisan to include a plurality of sensor configured to obtain appropriate machine and patient data for monitoring patients and the status of the respective and necessary monitoring components, and in particular configured to obtain data relating to the wear of the pump since the wear of the pump influences pump failure and pump failure is one of the states that exceeds accepted operational parameters, and is thus an obvious safety concern for potentially affected dialysis patients, such that monitoring for wear of the pump would provide improved safety feature thereby helping to ensure patient safety (Fulkerson, [0015], [0180], [0215], [0218]).
Additional Disclosures Included: Claim 2: The system according to claim 1, further comprising:
a monitoring system in communication with the plurality of dialysis machines;
wherein each of the plurality of dialysis machines includes at least one communication interface connected to a network for communicating with the monitoring system (Busby, [0037], [0084]-[0087], [0311], [0319]); Claim 4: The one or more sensors of a respective dialysis machine further comprise a moisture sensor configured to obtain data relating to corrosion of electronics of the respective dialysis machine (Fulkerson, [0033], [0057]); Claim 5: The one or more sensors of a respective dialysis machine further comprise a length sensor configured to obtain data relating to linearity of the length sensor (claim 1 analysis, where it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ any suitable sensor as an engineering choice); Claim 6: The plurality of dialysis machines include one or more peritoneal dialysis machines and/or one or more hemodialysis machines (Busby, [0338], [0342]; Childers, Abstract, [0004], [0005], [0012]; Fulkerson, [0071], [0444]); Claim 7: The system according to claim 2, wherein the monitoring system comprises:
a database storing respective data specific to each of the plurality of dialysis machines, wherein the respective data includes machine data, error codes, operational data, environmental data, consumables data, network data, treatment data (Childers, [0135]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Busby et al. (US20110040244) in view of Childers et al. (US20100010426) and Fulkerson et al. (US20140138294), as applied to claim 2 above, in view of Goldberg et al. (US20160042154, Goldberg).
Regarding claim 3, Busby, Childers and Fulkerson combined discloses or suggests the system according to claim 2, except wherein each dialysis machine of the plurality of dialysis machines further comprises a compressor, and the one or more sensors of a respective dialysis machine further comprise an air pressure sensor configured to obtain data relating to performance of the compressor.
Busby discloses one or more air detection sensor ([0024], [0099]) and Fulkerson discloses a sensor in the form of a pressure transducer ([0033], [0056]) but they don’t specify a compressor. Busby also discussed the use of negative and positive pressure ([0028], [0088], [0089], [0095], [0218], [0020], [0232], [0255]). Also, to purge air from between the membranes, the system 10, 100 also provides a positive pressure source (Busby, [0220]).
Goldberg discloses integrated modular health platforms and methods of their use, where the platform may include one or more sensors (120) configured to monitor a patient usage of a medical device (110); a communication unit (130) communicatively coupled to the one or more sensors (120); and a processing unit (200) configured to receive a first communication from the communication unit (120), the communication being indicative of the patient usage of the medical device (110), to compare the patient usage of the medical device (110) with an expected usage of the medical device (110); and to generate a second communication indicative of a difference between the patient usage and the prescribed usage (Abstract). One can employ the platform in dialysis monitoring ([0068], [0094], [0122]). The system may include a compressor and an associated air pressure sensor, where the sensor would be configured to obtain data relating to performance of the compressor, such as power consumption ([0065], [0066]).
At the time when the claimed invention was effectively filed, it would have been obvious to an ordinarily skilled artisan to include a compressor and an air pressure sensor, as claimed, and as depicted in Goldberg, to safely generate, regulate, and control negative and/or positive pressure in all aspects of the system, including pumps, fluid removal and dialysate delivery such that the respective fluids are moved through the system at a safe and effective rate.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Busby et al. (US20110040244) in view of Childers et al. (US20100010426) and Fulkerson et al. (US20140138294), as applied to claim 2 above, in view of Tanenbaum et al. (US20160206800, Tanenbaum), Noack et al. (US20190125950) (each in IDS of 12/07/2023) and Wolff et al. (US 20130303961, Wolff).
Regarding claims 8-10, Busby, Childers and Fulkerson combined discloses or suggests the system according to claim 2, wherein the monitoring system comprises: a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium, wherein the instructions, when executed by the second processor, facilitate performance of the following by the monitoring system:
receiving respective data from each of the plurality of dialysis machines (claim 1 analysis; Childers, [0011], [0015], [0020], [0024], [0025], [0027], [0032], [0095]);
storing first machine-specific data specific to a first dialysis machine of the plurality of dialysis machines in a machine-specific manner (Childers, [0011], [0012], [0020], [0028], [0071], [0163], [0195], [0201]); except
analyzing the first machine-specific data and providing the first machine-specific data in a machine-specific manner to medical personnel, wherein analyzing the first machine-specific data and providing the first machine-specific data in the machine-specific manner to medical personnel comprises:
analyzing a pressure profile of a membrane pump of the first dialysis machine based on first sensor data corresponding to the first dialysis machine; and
providing a notification regarding replacement of the membrane pump of the first dialysis machine based on the analyzed pressure profile.
Tanenbaum discloses a remote monitoring mobile application that may be installed and executed on a remote interface device (Abstract). By streaming a log of the treatment data, attending health care practitioners/providers (HCPs) may have continual access to the dialysis machine and patient data at the treatment center (Id., [0004]). Tanenbaum further discloses the potential to analyze machine-specific data and provide the machine-specific data in a machine-specific manner to medical personnel ([0003], [0004], [0020], [0021], [0023], [0045]).
Tanenbaum’s system employs sensors in association with a controller (Tanenbaum, [0021], [0044]). Thus, Tanenbaum monitoring system should be capable of receiving and analyzing any suitable data from sensors associated with a dialysis machine ([0044]). In Tanenbaum, certain patient parameters, including blood pressure, are monitored ([0044]). Also attending medical personnel or HCPs have continued access to the dialysis machines ([0045]). The HCP is notified about significant changes or rates of change in treatment parameters before the changes exceed the dialysis machine's set alarm limits ([0006], [0049]). An alarm may be set for various dialysis machine thresholds ([0007], [0008], [0037] – [0039], [0048]).
Noack discloses a medical treatment device and a method for monitoring a medical treatment device, comprising a fluid system, which has a monitoring apparatus 27 for monitoring the treatment device, wherein the monitoring apparatus 27 is configured such that monitoring is based on the evaluation of the pressure in the fluid system of the medical treatment device (Noack, Abstract). The treatment device is characterized by a compliance-determining apparatus 28 for determining the compliance in the fluid system, part of the fluid system or parts of the fluid system, wherein the compliance-determining apparatus 28 cooperates with the monitoring apparatus 27 in such a manner that the pressure-based monitoring takes place depending on the compliance of the fluid system (Id.). The monitoring apparatus 27 and the compliance-determining apparatus 28 control the individual components of the blood-treatment device (Noack, [0048]). Noack uses pressure profiles in association with pressure sensors ([0054]). The blood pump 6 and/or substituate pump 35 is operated such that a maximum permissible pressure limiting value and/or pressure gradient of the dialyser 1 is not exceeded, in order to avoid damaging the semi-permeable membrane 4 (Id.).
To supplement and support Noack and with respect to the concept of pressure profiles, Wolf discloses a blood treatment unit and method for attaining the best possible predetermined substitution target during the ultrafiltration of blood (Wolff, Abstract). According to the invention, a method and a blood treatment unit for the implementation of the method is provided, wherein it is determined by detection of pressure measurement values in the blood treatment unit whether the calculated substitution target is achieved at the end of the dialysis session or not and in case of the result that the calculated substitution target cannot be achieved with the current dialysis parameters, an adjustment of the flow rate of blood, dialysate and/or substituate is performed in order to achieve the substitution target for a given treatment time in an optimal way or modify the treatment time for the given substitution target as little as possible (Id.).
It was found that the measurement and analysis of the pressure measurement values, e.g. generated also by a blood pump P in the system, provides information on the flow properties in a blood treatment unit ([0057]). Based on this measured pressure signals at a blood treatment unit, an optimal substitution target can be determined during a dialysis (Id.). If in the process of the dialysis session disturbances occur, it can be readjusted, if necessary (Id.). Here the blood pump is analogous to a membrane pump. Continuous pressure monitoring with sensors and appropriate adjustment occurs, such that the pressure profile must be between a specified tolerance level during therapy (Wolff, [0294], [0304]).
In view of the disclosures of Noack and Wolff and the knowledge that pressure in a membrane pump of a dialysis machine is an important machine-specific parameter (Noack, [0006], [0021]; Wolff, [0057]) and that a patient’s pressure profile during treatment is important (Wolff, [0294]), it would have been obvious to one of ordinary skill in the art at the time of the effective filing of the claimed invention to employ the monitoring system to analyze a pressure profile of a membrane pump of a first dialysis machine of the plurality of dialysis machines based on first sensor data corresponding to the first dialysis machine, and to provide a notification regarding replacement of the membrane pump of the first dialysis machine based on the analyzed pressure profile, to increase safety and reliability of the dialysis procedure and to avoid unnecessary complications (Tanenbaum, [0049]; Noack, [0006]; Wolff, [0057], [0243]).
Additional Disclosures Included: Claim 9: A result of analyzing the first machine- specific data is utilized for adjusting treatment or patient care (claim 8 analysis); and Claim 10: The processor-executable instructions, when executed by the second processor, further facilitate performance of the following by the monitoring system: sorting the respective data from the plurality of dialysis machines by machine (claim 8 analysis).
Regarding claims 11 and 12, Busby, Childers, Fulkerson, Tanenbaum, Noack and Wolff combined discloses or suggests the system according to claim 2, wherein the monitoring system comprises:
a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium, wherein the processor-executable instructions, when executed by the second processor, facilitate performance of the following by the monitoring receiving respective data from each of the plurality of dialysis machines:
storing first machine-specific data specific to a first dialysis machine of the plurality of dialysis machines in a machine-specific manner (claim 8 analysis);
analyzing the first machine-specific data and providing the first machine-specific data in a machine-specific manner to medical personnel (claim 8 analysis), except wherein analyzing the first machine--specific data and providing the first machine-specific data in the machine-specific manner to medical personnel comprises:
detecting, based on fault data of the first machine-specific data, faulty training as to usage of the first dialysis machine and in response to detecting faulty training, providing a notification that a patient corresponding to the first dialysis machine needs training: wherein detecting faulty training as to usage of the first dialysis machine is based on:
detecting a number of wake up calls and/or determining a rise in a dwell-time diagram;
detecting shortfalls in prescribed input volumes and/or evaluating switching points between infusion and drainage over a plurality of infusions and/or determining whether a treatment is succeeding, a number of error messages recorded, and/or a period of time between providing a treatment and commencement of the treatment.
However, detecting faulty training, wake up calls, and shortfalls in prescribed input volumes etc. are routine parameters that a HCP can input into a monitoring system. Determining whether a treatment is succeeding is analogous to reducing complications (Tanenbaum, [0006], [0049]). Also, the monitoring system would be capable of these functions where no additional structure is presented.
Since training to use a machine is a necessary requirement, particularly for a complex dialysis machine or a plurality of such machine, and because such machines machine themselves or their associated software could malfunction, it would be prudent to determine and understand the difference between a training issue and a machine or a software issue, when assessing potential dialysis machine problems.
Therefore, at the time of the effective filing of the claimed invention, an ordinarily skilled artisan would have found it obvious to detect faulty use or training as to usage, as well as any reasonably related and other useful parameters such as wake-up calls and shortfalls, and to determine whether a treatment is succeeding etc., where these operations are routine engineering choices within the purview of one of ordinary skill.
Additional Disclosures Included: Claim 12: A result of analyzing the first machine-specific data is utilized for adjusting treatment or patient care (claims 8 and 11 analyses).
Claims 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Busby et al. (US20110040244) in view of Childers et al. (US20100010426), Fulkerson et al. (US20140138294), Tanenbaum et al. (US20160206800), Noack et al. (US20190125950) and Wolff et al. (US20130303961), as applied to claims 2 and 11 above, further in view of Basaglia (US20110028881)(IDS of 12/07/2023).
Regarding claims 13-21, Busby, Childers, Fulkerson, Tanenbaum, Noack and Wolff combined discloses or suggests the system according to claim 2, except wherein the processor-executable instructions when executed by the second processor, further facilitate performance of the following by the monitoring system:
sorting the respective data from the plurality of dialysis machines by machine.
Basaglia discloses a medical apparatus comprising a machine for treatment of fluids provided with means (3) for treating a patient's blood which exhibit a control unit (4) for sending command signals and receiving information relating to the treatment on the patient (Basaglia, Abstract). A remote unit (7) can selectively take control of a predetermined number of functions of the medical machine and the control unit (4) is predisposed to selectively inhibit a remote control means (10) from taking or maintaining control of the functions of the medical machine in consequence of the operating configuration of the machine (Id.). An ID datum must be included among the data exchanged by the medical machine 2 with the remote unit, and the machine 2 will include a list of predefined identification data, to each item of which a respective access authorization to the medical machine will be associated ([0135], [0136]). Some users might only be authorised to view the GUI, while others might be authorised to view all machine data but without any authority to intervene ([0139]). Thus, levels of access can be defined, for example for medical personnel, nurses, technical staff controlling and maintaining the machine, or net system administrators ([0140], [0141]).
Also, Childers discloses a peritoneal dialysis system 10 that includes a plurality of automated peritoneal dialysis ("APD") machines 104, and a server computer in communication with the APD machines, the APD machines programmed to inform the server computer of how much dialysate is consumed over a first delivery period, the server computer configured to use the amounts consumed to determine dialysate delivery amounts for the plurality of APD machines for a second delivery period (Abstract, [0064]). System 10 also performs automated regimen generation 14 ([0065]). System 10 allows the doctor/clinician to prescribe values for clinical targets and therapy inputs, such as patient fill volume, total therapy volume, total therapy time, etc., and generates a table, containing all therapies that meet all of the clinical requirements ([0116]). The table of therapies that meet all of the clinical requirements can then be automatically filtered and sorted based upon parameters such as total night therapy time, therapy solution cost, therapy weight, etc. (Id.).
When the claimed invention was effectively filed, it would have been obvious to one of ordinary skill in the art to use any suitable method to access the data, including sorting the machine-specific data by machine, for any desired reason such as to allow specific access be specific personnel or to filter specific therapies, as suggested by Basaglia and Childers, since these are traditional design choices and because sorting is a well-known method of organizing medical and other data.
Additional Disclosures Included: Claim 14: The monitoring system comprises:
a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium, wherein the processor-executable instructions, when executed by the second processor, facilitate performance of the following by the monitoring system:
receiving respective data from each of the plurality of dialysis machines (claim 8 analysis);
storing first machine-specific data specific to a first dialysis machine of the plurality of dialysis machines in a machine-specific manner (claim 8 analysis);
analyzing the first machine-specific data and providing the first machine-specific data in a machine-specific manner to medical personnel, wherein analyzing the first machine-specific data and providing the first machine-specific data in the machine-specific manner to medical personnel comprises:
analyzing machine-specific data from respective dialysis machines from different locations (Tanenbaum, [0007]-[0009], where remote monitoring implies the possibility of machines from different locations); and
based on analyzing the machine-specific data from the respective dialysis machines from different locations, determining a problem associated with a location or environment corresponding to the first dialysis machine (claim 8 and 11 analyses); Claim 15: A result of analyzing the first machine-specific data is utilized for adjusting treatment or patient care (claim 8 and 9 analyses); Claim 16: The processor-executable instructions, when executed by the second processor, further facilitate performance of the following by the monitoring system:
sorting the respective data from the plurality of dialysis machines by machine (claim 13 analysis); Claim 17: The monitoring system comprises:
a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium (claim 8 analysis), wherein the processor-executable instructions, when executed by the second processor, facilitate performance of the following by the monitoring system:
receiving respective data from each of the plurality of dialysis machines (claim 8 analysis);
storing first machine-specific data specific to a first dialysis machine of the plurality of dialysis machines in a machine-specific manner, wherein the first machine-specific data includes fault data (claim 1 and 8 analysis; Busby, [0288]; Tanenbaum, [0006], [0048], [0049])); and
detecting, based on the fault data, faulty training as to usage of the first dialysis machine based on detecting a number of wakeup calls and/or determining a rise in a dwell-time diagram (this is a manner of operating the system, where no additional structure is presented); Claim 18: The monitoring system comprises:
a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium (claim 8 analysis), wherein the processor-executable instructions, when executed by the second processor, facilitate performance of the following by the monitoring system:
receiving respective data from each of the plurality of dialysis machines (claim 8 analysis);
storing first machine-specific data specific toa first dialysis machine of the plurality of dialysis machines in a machine-specific manner, wherein the first machine-specific data includes fault data (claims 8 and 11 analyses); and
detecting, based on the fault data. faulty training as to usage of the first dialysis machine based on detecting shortfalls in prescribed input volumes and/or evaluating switching points between infusion and drainage over a plurality of infusions (claims 8 and 11 analyses); Claim 19: The monitoring system comprises:
a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium (claim 8 analysis), wherein the processor-executable instructions, when executed by the second processor, facilitate performance of the following by the monitoring system:
receiving respective data from each of the plurality of dialysis machines (claims 8 and 11 analyses);
storing first machine data specific to a first dialysis machine of the plurality of dialysis machines in a machine-specific manner, wherein the first machine-specific data includes fault data (Busby, [0288]; Tanenbaum, [0006], [0048], [0049]); and
detecting, based on the fault data, faulty training as to usage of the first dialysis machine based on determining whether a treatment is succeeding, a number of error messages recorded, and/or a period of time between providing a treatment and commencement of the treatment (claim 8 and 11 analyses); Claim 20: The monitoring system comprises:
a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium (claim 8 analysis), wherein the processor-executable instructions, when executed by the second processor, facilitate performance of the following by the monitoring system:
receiving respective data from each of the plurality of dialysis machines (claims 8 and 11 analyses);
storing first machine-specific data specific to a first dialysis machine of the plurality of dialysis machines in a machine-specific manner, wherein the first machine-specific data includes fault data (claim 11 analysis);
detecting how frequently faults occur with respect to the first dialysis machine within a time period (claims 8 and 11 analyses; also, no additional structure is claimed and the system is capable of this function); and
requesting additional information from the first dialysis machine based on the detected frequency (claim 8 and 11 analyses); and Claim 21:The monitoring system comprises:
a second processor configured to execute processor-executable instructions stored on a non-transitory storage medium (claim 8 analysis), wherein the processor-executable instructions, when executed by the second processor, facilitate performance of the following by the monitoring system:
receiving respective data from each of the plurality of dialysis machines (claims 8 and 11 analyses);
storing first machine-specific data specific to a first dialysis machine of the plurality of dialysis machines in a machine-specific manner, wherein the first machine-specific data includes fault data (claims 8 and 11 analyses);
detecting how frequently faults occur with respect to the first dialysis machine within a time period (the system is capable of this function); and
estimating acuteness or urgency of a fault based on the detected frequency (claim 8 and 11 analyses; the system is capable of this function, particularly since no additional structure is claimed).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-19 of U.S. Patent No. US 10,770,174. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and application recite the same or similar limitations relating to a dialysis monitoring system and determining the amount of wear associated with a pump. Moreover, one of ordinary skill would have recognized and found it obvious that a monitoring system would include one or more actuators associated with the pump and sensors to measure the various parameters and that one could apply the monitoring to more than one or a plurality of dialysis machines since this is merely a duplication of parts with little patentable significance unless such duplication is expected to achieve an unexpected result.
Conclusion
Examiner recommends that Applicant carefully review each identified reference and all objections/rejections before responding to this office action to properly advance the case in light of the pertinent objections/rejections and the prior art. With respect to the patentability analysis, Examiner has attempted to claim map to one or more of the most suitable structures or portions of a reference. However, with respect to all OAs, Examiner notes that citations to specific pages, columns, paragraphs, lines, figures or reference numerals, in any prior art or evidentiary reference, and any interpretation of such references, should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably disclosed and/or suggested to one having ordinary skill in the art. The use of publications and patents as references is not limited to what one or more applicant/inventor/patentee describes as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. MPEP §2123.
Examiner further recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAYDEN BREWSTER/Examiner, AU 1779
Prosecution Insights