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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 26th, 2026 has been entered.
Claim Status
The amendment filed on February 26th, 2026 has been entered. Claims 12, 16-22, 24-26, 30-38 are currently pending and under consideration. Claims 1-11, 13-15, 23, and 27-29 have been cancelled. Claims 12, 24, 25, 31 have been amended.
Claim Objections
Claims 12 and 25 objected to because of the following informalities: The equations presented in the claim language are distorted such as they are difficult to decipher the characters within the equation. Appropriate correction is required.
Response to Arguments
Applicant’s arguments with respect to Soykan and Ramdeen but are not found to be persuasive.
Applicant argues that the equation 3 is distance from any of the claimed formulas, however, the examiner has found that the teaches of Ramdeen would have rendered the first equation presented in the amended claim limitations obvious to one of ordinary skill in the art. See below rejection of claim 12 and 25.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12, 16-22, 24-26, 30-34, 36, and 38 are rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The independent claim(s) 1 and 25 recite(s) a mathematical formula defined in MPEP 2106.04(a) as falling under enumerated grouping 1 of abstract ideas.
Regarding claim 12, this judicial exception is not integrated into a practical application because the claim is directed toward the abstract idea of a mathematical equation being performed on a computing device, however the computing device amounts to nothing more than a generic computer, generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and just generally link the use of the judicial exception to the computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Further Regarding claim 12 additional elements consist of a storage device and/or an input device configured for storing or entering parameter values of the patient, a computing device, configured for calculating the interdialytic sodium intake of the patient, and an output device for outputting a signal to control or a communication device are well known, routine and conventional computer functions as evidenced by the court decisions listed in MPEP § 2106.05(d) that state storing and retrieving information in memory, performing calculations, and receiving or transmitting date (i.e. output) are well known and conventional functions of a computer and do not add significantly more to the exception.
Regarding claim 16, the additional elements consist of a display device and the output device being configured to display, output, and/or store the interdialytic sodium intake on the display device. These additional elements are determined to be an addition of insignificant post-solution activity as the activity of outputting a calculated value to a display to display information is a well-understood and conventional as evidenced by Shoda (U.S. Publication 2018/0215003), herein referred to as Shoda, stating in ¶0059 that a well-known computer includes an output device for outputting and displaying information and a memory configured for storing various types of information. As such these limitations do not add significantly more to the exception.
Regarding claim 17, the additional element of the display device being the communication device does not amount to significantly more as communicating a value through displaying it is well-understood and conventional to the use of a computer as evidenced by Shoda that well-known computers include output device for outputting and displaying information and displaying a value would inherently communicate it. As such these limitations do not add significantly more to the exception.
Regarding claim 18, the additional element of the communication device comprising at least one of: a monitor, a display, a storage element, or a database is determined to be an insignificant extra-solution activity that does not amount to an inventive concept as communicating through the use of a monitor, display, printer, or database are well-understood and conventional processes of utilizing computers and storage elements are generic components of a computer as evidenced by Shoda ¶0059.
Regarding claim 19, additional elements of the output device is configured to output, store, and/or to display on the display device, calculated values, wherein the calculated values comprise the interdialytic sodium intake, while also stating a qualitative and/or quantitative accuracy of the displayed, outputted, and/or stored calculated values do not amount to significantly more. The output, storing, and displaying of information is a well-understood function of computers as evidenced by Shoda ¶0059, and the calculation of values is a well-known basic function of computers (Shoda ¶0059 arithmetic operation function of CPU; MPEP 2106.5d(II) performing calculations is most basic function of computer). The additional limitation of a qualitative and/or quantitative accuracy is a function of an equation for determining the qualitative and/or quantitative accuracy represents a formula that is input into the computer and then calculated being drawn toward an abstract idea and being performed by a generic computer capable of being calculated. As such these limitations do not amount to significantly more.
Regarding claim 20, the additional elements of stating the qualitative and/or quantitative accuracy of the displayed, outputted, and/or stored values comprises specifying a value range, confidence interval, size of an error, an uncertainty, a possible value range, a standard deviation, a variance, do not amount to significantly more as the specifying of these values amounts to simply displaying the values on a display device which is well-known function of a computer as evidenced by Shoda ¶0059. The additional limitations of color coding and traffic light display do not amount to significantly more as they are considered an insignificant extra-solution activity that describes a method of displaying data that is well known in the art as evidenced by Rockwood (U.S. Publication 2007/0289551 that describes a traffic light display color coding indicator system where “green means go” and “red means stop” as being well-known indicator system.
Regarding claim 21, the additional elements of stating the qualitative and/or quantitative accuracy of the displayed, outputted, and or stored values is or includes specifying the color coding, wherein the color coding comprises multiple colors do not amount to significantly more as they are considered an insignificant extra-solution activity that describes a method of displaying data that is well known in the art as evidenced by Rockwood (U.S. Publication 2007/0289551 that describes a traffic light display color coding indicator system where “green means go” and “red means stop” as being well-known indicator system.
Regarding claim 22, the additional element of the output device for outputting the signal to control the communication device is configured for stating a prescription based on the interdialytic sodium intake does not amount to significantly more as the term “prescription” is broadly interpreted to mean instruction and as such the claim simply describes displaying an instruction based on the interdialytic sodium intake which can be interpreted as simply displaying the result of the calculation and displaying of a calculation by a computer is a well-understood function of computers as evidenced by Shoda ¶0059, (Shoda ¶0059 arithmetic operation function of CPU and display well known; MPEP 2106.5d(II) performing calculations is most basic function of computer, MPEP 2106.05 claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible)
Regarding claim 24, the additional element of configured for reading values of at least one of the following parameters: the distribution volume of the patient,; the interdialytic liquid excess; the plasma sodium concentration at the beginning of the current dialysis session; the plasma sodium concentration at the end of the previous dialysis session; the accumulated residual urine excretion between the current dialysis session n and the previous dialysis session; the sodium concentration in urine; or a number of days between the end of the previous dialysis session and the current dialysis session, determined by a current date and a stored date of the previous dialysis session does not amount to significantly more as the limitation only requires that the calculation device, i.e. a computer, be capable of reading, i.e. process, data input which is a well-understood and routine activity of a computer processor which results from the gathering of data, inputting, and performing calculations (MPEP 2106.5d(II) performing calculations is most basic function of computer MPEP 2106.05 mere data gathering found to be insignificant extra-solution activity).
Regarding claim 25, this judicial exception is not integrated into a practical application because the claim is directed toward the abstract idea of a mathematical equation being performed on a computing device, however the computing device amounts to nothing more than a generic computer, generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and just generally link the use of the judicial exception to the computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Additional elements consist of a storage device and/or an input device configured for storing or entering parameter values of the patient, a computing device, configured for calculating the interdialytic sodium intake of the patient, and an output device for outputting a signal to control or a communication device are well known, routine and conventional computer functions as evidenced by the court decisions listed in MPEP § 2106.05(d) that state storing and retrieving information in memory, performing calculations, and receiving or transmitting date (i.e. output) are well known and conventional functions of a computer and do not add significantly more to the exception. The additional limitations of the medical blood treatment apparatus do not amount to more than generally linking the use of a judicial exception a to a particular field of use. There is currently no claim language drawn toward how the judicial exception provides any affect to the blood treatment apparatus or is linked to the blood treatment apparatus with the current claim language just amounting to calculating the judicial exception and being “connected to in signal transmission or comprising a calculation device”. The claim language thus just generally links the judicial exception to the field of use of the medical blood treatment apparatus and does not apply the judicial exception to the medical apparatus and does not integrate it into a practical application. The additional elements of the medical blood treatment apparatus are not applied to or with the claimed machine and do not add significantly more to the exception (See MPEP 2106.5).
Regarding claim 26, the additional elements of the medical treatment apparatus being suitable and/or configured to execute a hemodialysis, a hemofiltration, a hemodiafiltration, or a separation method do not provide any limitation that claim language drawn toward how the judicial exception provides any affect to the blood treatment apparatus or is linked to the blood treatment apparatus with the current claim language just amounting to further limiting the medical apparatus that was disclosed in claim 25 without any correlation to applying the judicial exception. The claim language thus just generally links the judicial exception to the field of use of the medical blood treatment apparatus and does not apply the judicial exception to the medical apparatus and does not integrate it into a practical application. The additional elements of the medical blood treatment apparatus are not applied to or with the claimed machine and do not add significantly more to the exception (See MPEP 2106.5).
Regarding claim 30, the additional elements consist of a display device and the output device being configured to display, output, and/or store the interdialytic sodium intake on the display device. These additional elements are determined to be an addition of insignificant post-solution activity as the activity of outputting a calculated value to a display to display information is a well-understood and conventional as evidenced by Shoda (U.S. Publication 2018/0215003), herein referred to as Shoda, stating in ¶0059 that a well-known computer includes an output device for outputting and displaying information and a memory configured for storing various types of information. As such these limitations do not add significantly more to the exception.
Regarding claim 31, the additional element of configured for reading values of at least one of the following parameters: the distribution volume of the patient; the interdialytic liquid excess; the plasma sodium concentration at the beginning of the current dialysis session; the plasma sodium concentration at the end of the previous dialysis session; the accumulated residual urine excretion between the current dialysis session n and the previous dialysis session; the sodium concentration in urine; or a number of days between the end of the previous dialysis session and the current dialysis session, determined by a current date and a stored date of the previous dialysis session does not amount to significantly more as the limitation only requires that the calculation device, i.e. a computer, be capable of reading, i.e. process, data input which is a well-understood and routine activity of a computer processor which results from the gathering of data, inputting, and performing calculations (MPEP 2106.5d(II) performing calculations is most basic function of computer MPEP 2106.05 mere data gathering found to be insignificant extra-solution activity).
Regarding claim 32, the additional elements of the at least one dialysis liquid inlet line and the dialysate outlet line are connected in fluid communication with each other by a connector do not provide any limitation that claim language drawn toward how the judicial exception provides any affect to the blood treatment apparatus or is linked to the blood treatment apparatus with the current claim language just amounting to further limiting the medical apparatus that was disclosed in claim 25 without any correlation to applying the judicial exception. The claim language thus just generally links the judicial exception to the field of use of the medical blood treatment apparatus and does not apply the judicial exception to the medical apparatus and does not integrate it into a practical application. The additional elements of the medical blood treatment apparatus are not applied to or with the claimed machine and do not add significantly more to the exception (See MPEP 2106.5).
Regarding claim 33, the additional elements of the computing device being configured for calculating an interdialytic liquid intake of the patient do not amount to significantly more as the calculation of the interdialytic liquid intake is a mathematical equation being performed on a computing device, however the computing device amounts to nothing more than a generic computer, generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and just generally link the use of the judicial exception to the computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as detailed in MPEP § 2106.05(d) that state storing and retrieving information in memory, performing calculations, and receiving or transmitting date (i.e. output) are well known and conventional functions of a computer and do not add significantly more to the exception.
Regarding claim 34, the additional elements of the computing device being configured for calculating an interdialytic liquid intake of the patient do not amount to significantly more as the calculation of the interdialytic liquid intake is a mathematical equation being performed on a computing device, however the computing device amounts to nothing more than a generic computer, generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and just generally link the use of the judicial exception to the computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as detailed in MPEP § 2106.05(d) that state storing and retrieving information in memory, performing calculations, and receiving or transmitting date (i.e. output) are well known and conventional functions of a computer and do not add significantly more to the exception.
Regarding claim 36, the additional elements of the computing device being configured to be in signal communication with the medical blood treatment apparatus to repeatedly query or receive from the medical blood treatment apparatus, during the current dialysis session, values of one or more parameters measured by the medical blood treatment apparatus to repeatedly calculate the interdialytic sodium intake of the current dialysis session do not amount to significantly more as the communication with the medical blood treatment apparatus just generally links the judicial exception to the field of use of the medical blood treatment apparatus and does not apply the judicial exception to the medical apparatus and does not integrate it into a practical application and the repeated query and receipt of data measured by the medical blood treatment apparatus to repeatedly calculate the interdialytic sodium intake is considered a well-understood extra solution activity in that receiving or transmitting data and performing repetitive calculation have been determined by the courts to be well-understood, routine, and conventional functions of a computer (see MPEP 2106.05(d)(II)(i-ii).
Regarding claim 38, the additional elements of the computing device being configured to be in signal communication with the medical blood treatment apparatus to repeatedly query or receive from the medical blood treatment apparatus, during the current dialysis session, values of one or more parameters measured by the medical blood treatment apparatus to repeatedly calculate the interdialytic sodium intake of the current dialysis session do not amount to significantly more as the communication with the medical blood treatment apparatus just generally links the judicial exception to the field of use of the medical blood treatment apparatus and does not apply the judicial exception to the medical apparatus and does not integrate it into a practical application and the repeated query and receipt of data measured by the medical blood treatment apparatus to repeatedly calculate the interdialytic sodium intake is considered a well-understood extra solution activity in that receiving or transmitting data and performing repetitive calculation have been determined by the courts to be well-understood, routine, and conventional functions of a computer (see MPEP 2106.05(d)(II)(i-ii).
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.
Claims 12, 16-20, 22, 24, 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Soykan (U.S. Publication 2015/0149096) in view of Ramdeen et al. (Non-Patent Literature, Estimates of Interdialytic Sodium and Water Intake Based on the Balance Principle, ASAIO Journal 1998, Pgs. 812-817; See attached annotated document).
Regarding claim 12, Soykan discloses a calculation device (system performing steps of Figure 28) for determining an interdialytic liquid intake (¶0339, change in fluid levels of the patient during an interdialytic window), the calculation device comprising: a storage device 1707 and an input device 1703 configured for storing (¶0328 organize and store the date from the processor) and entering (¶0325 manual entry through user interface) parameter values of said patient; a computing device 1706, configured for calculating an interdialytic liquid intake of said patient (¶0339, system compares fluid level over time period to historical fluid level, change in fluid levels during an interdialytic window); and an output device (1707, ¶0328 network prepares and transmits data in desired output form to handheld device) for outputting a signal to control a medical blood treatment apparatus (¶0311 output of chart to dialysis machine display; ¶0330 dialysis machine can implement changes to dialysis session based on the received data, thus data output to dialysis machine acts as signal to control apparatus).
Soykan does not expressly disclose calculating the interdialytic sodium intake of the patient, wherein the interdialytic sodium intake of the patient is calculated using one of the following formulas:
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However, Ramdeen et al., in the same field of endeavor of interdialytic liquid intake, teaches computing interdialytic sodium intake of the patient based on interdialytic liquid intake (see annotation 1) utilizing the following equations:
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In these equations Na intake represents the interdialytic sodium intake (Page 182 sodium consumed in the interdialytic interval) with V representing the water volume of the patient post dialysis (Page 812 V and [Na]post are respectively body water and serum sodium concentration at the end of a dialysis session), V+ ΔW representing predialysis water volume of the patient (Page 812 predialysis body water will be V+ ΔW), [Na]pre representing serum sodium pre dialysis (Page 812 predialysis serum sodium concentration is [Na]pre), [Na]post indicating body sodium post dialysis (Page 812 V and [Na]post are respectively body water and serum sodium concentration at the end of a dialysis session), UV representing interdialytic urine volume (i.e. Vurine, Page 813 UV is the interdialytic urine volume), and [Na]ur representing urinary sodium concentration (Page 813 [Na]ur is the urinary sodium concentration). The equation of
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The equation
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as stated by the applicants specification has the interpretation of interdialytic sodium intake (Minter) is equal to distribution volume, i.e. the water content of the patient without overhydration, at the beginning the current dialysis session (Vpre(n)) times the plasma sodium concentration at the beginning of the current dialysis session (Cpre(n)) minus the water content of the patient at the end of a previous dialysis session (Vpost(n-1) multiplied by the plasma sodium concentration at the end of the previous dialysis session (Cpost(n-1)) plus the summation of the accumulated residual urine excretion between the current dialysis session and the previous dialysis session times the sodium concentration in the urine.
The equations of Ramdeen teaches the amount of sodium consumed (i.e. the interdialytic sodium intake) being equal to the difference in body sodium between pre-dialysis and post dialysis plus the amount of sodium lost in the urine (Page 812) wherein body sodium pre-dialysis is calculated as body water post dialysis plus interdialytic weight gain which is equivalent to net water intake (Page 812 net water intake equal to ΔW) and as such is equivalent to patient volume predialysis as body water post dialysis from previous session plus the net water intake equals body volume pre-dialysis of current dialysis session times serum sodium concentration pre dialysis of current dialysis session and wherein body sodium post dialysis is defined as water volume of the patient post previous dialysis session (V) times serum sodium concentration post previous dialysis session plus the amount of sodium lost in the urine during the interdialytic interval which is defined as interdialytic urine volume times the urinary sodium concentration wherein urine volume is a summation of a 72 hr urinary collection (Page 813 one 72 hr urinary collection) for the purpose of correcting hyponatremia or hypernatremia (annotation 4) and shows that interdialytic fluid gain of the patients is directly proportional to the interdialytic sodium intake
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation of interdialytic liquid intake of Soykan to have further computed interdialytic sodium intake of the patient, as taught by Ramdeen, for the purpose of correcting hyponatremia or hypernatremia in the patient (annotation 4 of attached Ramdeen document).
Soykan in view of Ramdeen do not expressly disclose repeatedly calculating interdialytic sodium intake, however, Soykan further teaches performing both electrolyte management and fluid management concurrently and the monitoring of these levels occurring periodically (¶0308 monitored periodically) suggesting that repeated monitoring and calculation is performed to respond to increases and decreases of electrolyte levels and to manage rate and magnitude of fluid change. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have repeatedly calculated interdialytic sodium intake as Ramdeen has shown that interdialytic sodium intake is directly related to the fluid level of the interdialytic liquid intake and Soykan teaches repeatedly calculating interdialytic liquid intake and electrolyte levels in order to ensure fluid removal rate and magnitude are occurring at a pace which would prevent arrythmia, as such repeatedly calculating the level of sodium and thus the level of sodium intake during the dialysis session would have been obvious for the purpose of achieving a proper rate of fluid and sodium removal.
Examiner notes that while Ramdeen suggests using serum sodium concentrations obtaining serum sodium concentration levels is equivalent to plasma sodium concentration levels as serum is simply plasma that has been allowed to clot with the clotting factors removed from the liquid portion and as such serum sodium concentration is equal to plasma sodium concentration.
Regarding claim 16, Soykan in view of Ramdeen suggest the calculation device according to claim 12. Soykan further discloses the output device is configured to display parameters on a display device (¶0311 dialysis machine display).
It would have been obvious to one of ordinary skill in the art to have displayed the interdialytic sodium intake on output device for the purpose of enabling physicians to see the parameter of interdialytic sodium intake (¶0312 enables physicians or other user to see medical parameters) which would have the benefit allowing the physician to monitor the parameter to correcting hyponatremia or hypernatremia in the patient (annotation 4 of attached Ramdeen document).
Regarding claim 17, Soykan in view of Ramdeen suggest the calculation device according to claim 12. Soykan further discloses the display device is a communication device (communicates with output device to display chart).
Regarding claim 18, Soykan in view of Ramdeen suggest the calculation device according to claim 12. Soykan further discloses the communication device comprises a display (¶0311 dialysis machine display).
Regarding claim 19, Soykan in view of Ramdeen suggest the calculation device according to claim 17. Soykan in view of Ramdeen does not expressly disclose stating a qualitative and/or quantitative accuracy of the displayed, outputted, and/or stored calculated values.
However, Ramdeen further teaches computing the plasma sodium concentration prevalent at a beginning of a dialysis session ([Na]pre) wherein a size of an error due to potassium level interactions is calculated (see page 814, annotation 2).
While Soykan in view of Ramdeen do not expressly disclose stating the quantitative accuracy of the calculated value for interdialytic sodium intake, it would have been obvious to one of ordinary skill in the art to have displayed this value in conjunction with the calculated interdialytic liquid intake for the purpose of giving the caregiver/user an idea of how potassium levels in the patient could impact the accuracy of the calculated value.
Regarding claim 20, Soykan in view of Ramdeen suggests the calculation device according to claim 19. Ramdeen further suggests the quantitative accuracy of the displayed value including the size of an error (see page 814, annotation 3).
Regarding claim 22, Soykan in view of Ramdeen suggests the calculation device according to claim 12. Soykan further discloses the output device for outputting a signal to control the communication device is configured for stating a prescription based on the interdialytic liquid intake (¶0303 rapid fluid level signals need to prescribe increase dialysis frequency thus stating prescription).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have also configured the communication device for stating a prescription based on the interdialytic sodium intake for the purpose of prescribing treatment for correcting hyponatremia or hypernatremia (annotation 4 of attached Ramdeen document).
Regarding claim 24, Soykan in view of Ramdeen suggests the calculation device according to claim 12. Soykan further discloses the calculation device being configured for reading values of the following parameters: interdialytic liquid excess (¶0302 increase in fluid level between dialysis sessions).
Regarding claim 34, Soykan in view of Ramdeen suggest the medical blood treatment apparatus according to claim 12. Soykan discloses the computing device being configured for calculating an interdialytic liquid intake of said patient (¶0339, system compares fluid level over time period to historical fluid level).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation of interdialytic liquid intake of Soykan to have further computed interdialytic sodium intake of the patient, as taught by Ramdeen, for the purpose of correcting hyponatremia or hypernatremia in the patient (annotation 4 of attached Ramdeen document).
Regarding claim 35, Soykan in view of Ramdeen suggest the medical blood treatment apparatus according to claim 12. Soykan further discloses the output device being configured for controlling the medical blood treatment apparatus, via the signals outputted by said output device to the medical blood treatment apparatus, such that a dialysis session carried out by the medical blood treatment apparatus (carried out by dialysis system) ends once a determined liquid intake has been withdrawn from treated blood (¶0302 automatically increases fluid removal to ensure that dry weight is reached during the current session which marks the end of dialysis).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the output device of Soykan to be configured for controlling the medical blood treatment apparatus, via the signals outputted by said output device to the medical blood treatment apparatus ends once a determined interdialytic sodium intake has been withdrawn from treated blood the purpose of prescribing treatment for correcting hyponatremia or hypernatremia (annotation 4 of attached Ramdeen document) and preventing large changes in interdialytic weight (Ramdeen Page 812).
Regarding claim 36, Soykan in view of Ramdeen suggest the medical blood treatment apparatus according to claim 12. Soykan further discloses the computing device is configured to be in signal communication with the medical blood treatment apparatus (¶0281 real time information from a patient obtained during a dialysis session, dialysis system may include sensors for detecting physiological parameters, information detected directly uploaded to processor wirelessly) such as to repeatedly receive from the medical blood treatment apparatus (¶0281 real-time suggests that the detected information from the sensors is continuously monitoring and sending information to the processor, ¶0080 continuously monitoring, ¶0254 continuously updates) during a dialysis session carried out by the medical blood treatment apparatus, values of one or more parameters (values of patient fluid levels are impedance values ¶0038, ¶0156 measured by impedance measurement module 1407) measured by the medical blood treatment apparatus (impedance measurement module 1407), to repeatedly calculate the interdialytic liquid intake (Fig. 18 shows output charting values measured during dialysis session, the continuous monitoring and output of values related to fluid levels thus specifies the calculation of the interdialytic liquid intake, ¶0339 system compares the patient fluid level, impedance, over a recent time period to the historical fluid level, impedance, in step 1908 to determine a correct course of action to take in response to the patient fluid level in step 1909, adjustments to patient dry weight through ultrafiltration speed 1911 can be made automatically, adjustments suggests multiple adjustments and Fig. 28 suggests that these adjustments are due to triggering atrial fibrillation or arrhythmia events so would necessarily repeat calculation to adjust during an arrhythmia event) of the dialysis session (¶0340 compares rate and magnitude of the decrease in patient fluid level during dialysis to the historical data showing occurrence during the dialysis session) based on values of the one or more parameters (impedance values), wherein the one or more parameters comprise a diffusive transfer between dialysate and blood during the dialysis session (impedance levels measure the relative fluid level of the patient so determining magnitude of the decrease in patient fluid level ¶0340 through impedance levels inherently would comprise any diffusive transfer between dialysate and blood during the dialysis session as the change in fluid levels is due to diffusive transfer of fluid between blood and dialysate would change the impedance of the patient). Soykan also discloses repeatedly taking measurement of electrolyte levels to monitor electrolyte or other blood solutes in the patient and determine the effect of dialysis on the concentration of these solutes ¶0341.
Soykan in view of Ramdeen do not expressly disclose repeatedly calculating interdialytic sodium intake, however, Soykan further teaches performing both electrolyte management and fluid management concurrently and the monitoring of these levels occurring periodically (¶0308 monitored periodically) suggesting that repeated monitoring and calculation is performed to respond to increases and decreases of electrolyte levels and to manage rate and magnitude of fluid change. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have repeatedly calculated interdialytic sodium intake as Ramdeen has shown that interdialytic sodium intake is directly related to the fluid level of the interdialytic liquid intake and Soykan teaches repeatedly calculating interdialytic liquid intake and electrolyte levels in order to ensure fluid removal rate and magnitude are occurring at a pace which would prevent arrythmia, as such repeatedly calculating the level of sodium and thus the level of sodium intake during the dialysis session would have been obvious for the purpose of achieving a proper rate of fluid and sodium removal.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Soykan (U.S. Publication 2020/0330668) in view of Ramdeen et al. (Non-Patent Literature, Estimates of Interdialytic Sodium and Water Intake Based on the Balance Principle, ASAIO Journal 1998, Pgs. 812-817; See attached annotated document) and further in view of Stewart et al. (U.S. Publication 2017/0086700).
Regarding claim 21, Soykan in view of Ramdeen suggests the calculation device according to claim 19. Soykan in view of Ramdeen do not expressly suggest the quantitative accuracy being color coded or the color coding comprising multiple colors.
However, Stewart, in the same field of endeavor of data display, discloses using the colors green, yellow, and red to indicated values with on lower and higher ends of a spectrum of values for the purpose of visually indicating the extent to which the displayed value is within an acceptable range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the displayed value of Soykan in view of Ramdeen to have been color coded as taught by Stewart for the purpose of indicated to the user/physician whether the value falls within an acceptable or non-acceptable range.
Claim(s) 25-26, 30-33 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Soykan (U.S. Publication 2015/0149096) in view of in view of Ramdeen et al. (Non-Patent Literature, Estimates of Interdialytic Sodium and Water Intake Based on the Balance Principle, ASAIO Journal 1998, Pgs. 812-817; See attached annotated document) and Wallenborg et al. (U.S. Publication 2019/0374697).
Regarding claim 25, Soykan discloses a medical blood treatment apparatus comprising a dialysis machine and a control device (system performing steps of Figure 28) wherein the control device is configured for prompting or effecting a blood treatment using the medical blood treatment apparatus (¶0303 rapid fluid level prompt prescription of increase dialysis frequency) wherein for the purpose of which the control device comprises a calculation device comprising: a storage device 1707 and an input device 1703 configured for storing (¶0328 organize and store the date from the processor) and entering (¶0325manual entry through user interface) parameter values of said patient; a computing device 1706, configured for calculating an interdialytic liquid intake of said patient (¶0339, system compares fluid level over time period to historical fluid level); and an output device (1707, ¶0328 network up prepares and transmits data in desired output form to handheld device) for outputting a signal to control a medical blood treatment apparatus (¶0311 output of chart to dialysis machine display).
Soykan does not expressly disclose calculating the interdialytic sodium intake of the patient, wherein the interdialytic sodium intake of the patient is calculated using one of the following formulas:
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However, Ramdeen et al., in the same field of endeavor of interdialytic liquid intake, teaches computing interdialytic sodium intake of the patient based on interdialytic liquid intake (see annotation 1) utilizing the following equations:
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In these equations Na intake represents the interdialytic sodium intake (Page 182 sodium consumed in the interdialytic interval) with V representing the water volume of the patient post dialysis (Page 812 V and [Na]post are respectively body water and serum sodium concentration at the end of a dialysis session), V+ ΔW representing predialysis water volume of the patient (Page 812 predialysis body water will be V+ ΔW), [Na]pre representing serum sodium pre dialysis (Page 812 predialysis serum sodium concentration is [Na]pre), [Na]post indicating body sodium post dialysis (Page 812 V and [Na]post are respectively body water and serum sodium concentration at the end of a dialysis session), UV representing interdialytic urine volume (i.e. Vurine, Page 813 UV is the interdialytic urine volume), and [Na]ur representing urinary sodium concentration (Page 813 [Na]ur is the urinary sodium concentration). The equation of
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as stated by the applicants specification has the interpretation of interdialytic sodium intake (Minter) is equal to distribution volume, i.e. the water content of the patient without overhydration, at the beginning the current dialysis session (Vpre(n)) times the plasma sodium concentration at the beginning of the current dialysis session (Cpre(n)) minus the water content of the patient at the end of a previous dialysis session (Vpost(n-1) multiplied by the plasma sodium concentration at the end of the previous dialysis session (Cpost(n-1)) plus the summation of the accumulated residual urine excretion between the current dialysis session and the previous dialysis session times the sodium concentration in the urine.
The equations of Ramdeen teaches the amount of sodium consumed (i.e. the interdialytic sodium intake) being equal to the difference in body sodium between pre-dialysis and post dialysis plus the amount of sodium lost in the urine (Page 812) wherein body sodium pre-dialysis is calculated as body water post dialysis plus interdialytic weight gain which is equivalent to net water intake (Page 812 net water intake equal to ΔW) and as such is equivalent to patient volume predialysis as body water post dialysis from previous session plus the net water intake equals body volume pre-dialysis of current dialysis session times serum sodium concentration pre dialysis of current dialysis session and wherein body sodium post dialysis is defined as water volume of the patient post previous dialysis session (V) times serum sodium concentration post previous dialysis session plus the amount of sodium lost in the urine during the interdialytic interval which is defined as interdialytic urine volume times the urinary sodium concentration wherein urine volume is a summation of a 72 hr urinary collection (Page 813 one 72 hr urinary collection) for the purpose of correcting hyponatremia or hypernatremia (annotation 4) and shows that interdialytic fluid gain of the patients is directly proportional to the interdialytic sodium intake
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation of interdialytic liquid intake of Soykan to have further computed interdialytic sodium intake of the patient, as taught by Ramdeen, for the purpose of correcting hyponatremia or hypernatremia in the patient (annotation 4 of attached Ramdeen document).
Soykan does not expressly disclose the details of the medical blood treatment apparatus other than it being used for dialysis and comprising a semi-permeable membrane to which on one side dialysate is flowed and the other side blood.
However, Wallenborg, in the same field of endeavor of hemodialysis, discloses a medical blood treatment apparatus (Fig. 1) for performing dialysis (Abstract, dialysis) comprising fluid lines which encompass at least one dialysis liquid inlet line 8 and a dialysate outlet line 13; at least one conveying device 25 for conveying a dialysis liquid (¶0273 dialysis fluid pump) within the dialysis liquid inlet line 8; wherein the medical blood treatment apparatus is configured to be connected to a dialysis liquid chamber 4 of a blood filter 15 respectively by the dialysis liquid inlet line and the dialysate outlet line, wherein the blood filter comprises a blood chamber 3, wherein dialysis liquid chamber and blood chamber are separated from each other by a semipermeable membrane 5.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dialysis machine of Soykan that performs the function of performing dialysis on the patient for the dialysis machine of Wallenborg since these elements perform the same function of performing dialysis on a patient. Simply substituting one dialysis means for another would yield the predictable result of allowing a(n) system to perform dialysis. See MPEP 2143.
Regarding claim 26, Soykan in view of Ramdeen and Wallenborg suggest the medical blood treatment apparatus according to claim 25. Wallenborg further suggests the medical blood treatment apparatus being suitable and configured to execute hemodialysis (¶0002, hemodialysis).
Regarding claim 30, Soykan in view of Ramdeen and Wallenborg suggest the medical blood treatment apparatus according to claim 25. Soykan further discloses the output device is configured to display the interdialytic liquid intake on a display device (¶0311 dialysis machine display).
It would have been obvious to one of ordinary skill in the art to have displayed the interdialytic sodium intake on output device for the purpose of enabling physicians to see the parameter of interdialytic sodium intake (¶0312 enables physicians or other user to see medical parameters) which would have the benefit allowing the physician to monitor the parameter to correcting hyponatremia or hypernatremia in the patient (annotation 4 of attached Ramdeen document).
Regarding claim 31, Soykan in view of Ramdeen and Wallenborg suggest the medical blood treatment apparatus according to claim 25. Soykan further discloses the medical blood treatment apparatus being configured for reading values of the following parameters: interdialytic liquid excess (¶0302 increase in fluid level between dialysis sessions).
Regarding claim 32, Soykan in view of Ramdeen and Wallenborg suggest the medical blood treatment apparatus according to claim 25. Wallenborg further suggests the dialysis liquid inlet line and the dialysate outlet line connected in fluid communication with each other by a connector (connected by blood filter 15 which acts as connector).
Regarding claim 33, Soykan in view of Ramdeen and Wallenborg suggest the medical blood treatment apparatus according to claim 25. Soykan discloses the computing device being configured for calculating an interdialytic liquid intake of said patient (¶0339, system compares fluid level over time period to historical fluid level).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation of interdialytic liquid intake of Soykan to have further calculated interdialytic sodium intake of the patient, as taught by Ramdeen, for the purpose of correcting hyponatremia or hypernatremia in the patient (annotation 4 of attached Ramdeen document).
Regarding claim 37, Soykan in view of Ramdeen and Wallenborg suggest the medical blood treatment apparatus according to claim 25. Soykan further discloses the output device being configured for controlling the medical blood treatment apparatus, via the signals outputted by said output device to the medical blood treatment apparatus, such that a dialysis session carried out by the medical blood treatment apparatus (carried out by dialysis system) ends once a determined liquid intake has been withdrawn from treated blood (¶0302 automatically increases fluid removal to ensure that dry weight is reached during the current session which marks the end of dialysis).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the output device of Soykan to be configured for controlling the medical blood treatment apparatus, via the signals outputted by said output device to the medical blood treatment apparatus ends once a determined interdialytic sodium intake has been withdrawn from treated blood the purpose of prescribing treatment for correcting hyponatremia or hypernatremia (annotation 4 of attached Ramdeen document) and preventing large changes in interdialytic weight (Ramdeen Page 812).
Regarding claim 38, Soykan in view of Ramdeen and Wallenborg suggest the medical blood treatment apparatus according to claim 25. Soykan further discloses the computing device is configured to be in signal communication with the medical blood treatment apparatus (¶0281 real time information from a patient obtained during a dialysis session, dialysis system may include sensors for detecting physiological parameters, information detected directly uploaded to processor wirelessly) such as to repeatedly receive from the medical blood treatment apparatus (¶0281 real-time suggests that the detected information from the sensors is continuously monitoring and sending information to the processor, ¶0080 continuously monitoring, ¶0254 continuously updates) during a dialysis session carried out by the medical blood treatment apparatus, values of one or more parameters (values of patient fluid levels are impedance values ¶0038, ¶0156 measured by impedance measurement module 1407) measured by the medical blood treatment apparatus (impedance measurement module 1407), to repeatedly calculate the interdialytic liquid intake (Fig. 18 shows output charting values measured during dialysis session, the continuous monitoring and output of values related to fluid levels thus specifies the calculation of the interdialytic liquid intake, ¶0339 system compares the patient fluid level, impedance, over a recent time period to the historical fluid level, impedance, in step 1908 to determine a correct course of action to take in response to the patient fluid level in step 1909, adjustments to patient dry weight through ultrafiltration speed 1911 can be made automatically, adjustments suggests multiple adjustments and Fig. 28 suggests that these adjustments are due to triggering atrial fibrillation or arrhythmia events so would necessarily repeat calculation to adjust during an arrhythmia event) of the dialysis session (¶0340 compares rate and magnitude of the decrease in patient fluid level during dialysis to the historical data showing occurrence during the dialysis session) based on values of the one or more parameters (impedance values), wherein the one or more parameters comprise a diffusive transfer between dialysate and blood during the dialysis session (impedance levels measure the relative fluid level of the patient so determining magnitude of the decrease in patient fluid level ¶0340 through impedance levels inherently would comprise any diffusive transfer between dialysate and blood during the dialysis session as the change in fluid levels is due to diffusive transfer of fluid between blood and dialysate would change the impedance of the patient). Soykan also discloses repeatedly taking measurement of electrolyte levels to monitor electrolyte or other blood solutes in the patient and determine the effect of dialysis on the concentration of these solutes ¶0341.
Soykan in view of Ramdeen do not expressly disclose repeatedly calculating interdialytic sodium intake, however, Soykan further teaches performing both electrolyte management and fluid management concurrently and the monitoring of these levels occurring periodically (¶0308 monitored periodically) suggesting that repeated monitoring and calculation is performed to respond to increases and decreases of electrolyte levels and to manage rate and magnitude of fluid change. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have repeatedly calculated interdialytic sodium intake as Ramdeen has shown that interdialytic sodium intake is directly related to the fluid level of the interdialytic liquid intake and Soykan teaches repeatedly calculating interdialytic liquid intake and electrolyte levels in order to ensure fluid removal rate and magnitude are occurring at a pace which would prevent arrythmia, as such repeatedly calculating the level of sodium and thus the level of sodium intake during the dialysis session would have been obvious for the purpose of achieving a proper rate of fluid and sodium removal.
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 PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781