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 . The objection and rejections from the Office Action of 1/28/2026 are hereby withdrawn. New grounds for rejection are presented below.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/12/2026 has been entered.
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.
Claim 37 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claims are directed to a computer program per se [see MPEP 2106 – “Non-limiting examples of claims that are not directed to one of the statutory categories: … iv. a computer program per se, Gottschalk v. Benson, 409 U.S. at 72, 175 USPQ at 676-77”]. See MPEP 2106.03 – “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Claims 19, 21-26, 28-29, 31-37, and 39-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the abstract idea of a mental process and/or mathematical algorithm for determining/adjusting a dialysis ultrafiltration rate based on retinal vessel analysis.
This judicial exception is not integrated into a practical application because no steps are recited that would amount to an improvement to the functioning of the underlying dialysis machine.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no specific measurement technique/device is recited in performing the retinal analysis that must be performed in implementing the algorithm. The recited computer components amount to the recitation of general-purpose computer components for performing the algorithm and do not serve to amount to significantly more than the recitation of the abstract idea itself (see Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 19, 21-26, 28-35, 37, and 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parisotto et al. (US 20160199562 A1)[hereinafter “Parisotto”], Hsu et al. (US 20110026789 A1)[hereinafter “Hsu”], and Fathalla et al., Cardiovascular Risk Prediction based on Retinal Vessel Analysis using Machine Learning, IEEE, 2016 [hereinafter “Fathalla”](disclosed and supplied by the Applicant on 9/18/2023).
Regarding Claim 19, Parisotto discloses a dialysis machine that takes patient blood pressure as an input and adjusts operation of the dialysis machine based on the patient’s blood pressure [Paragraphs [0061] and [0114]-[0119]].
Hsu discloses a medical assessment device that uses images of the human eye to characterize retinal blood vessels as an indication of the patient’s blood pressure [Paragraph [0001] – “The present invention relate to systems and methods for analyzing retinal images, and for obtaining from them information characterizing retinal blood vessels which may be useful in forming a diagnosis of a medical condition.”Abstract – “A second aspect uses fractal analysis of retinal images to provide vascular disease risk prediction, such as, but not limited to, diabetes and hypertension.”Paragraph [0004] – “It is also known that the branching patterns of retinal arterial and venous systems have fractal characteristics. A fractal is a geometrical pattern comprised of smaller parts or units which resemble the larger whole. Fractals have been used to characterise diverse natural shapes such as the branching patterns of trees, the shapes of coastlines, the pattern of electrocardiograph tracings as well as retinal microcirculation. The fractal (or fractional) dimension (D) is one measure associated with fractals and has a range of definitions. However, it can be considered as a statistical quantity that provides an indication of how completely a fractal appears to fill the space occupied by the fractal as finer and finer scales are zoomed in upon. In other words, the fractal dimension can be considered as the number of smaller units comprising the larger unit that fit into that larger unit. The fractal dimension is always smaller than the number of dimensions in which the fractal being considered exists.”Paragraph [0085] – “FIG. 24 shows a graph of refined multifractal capacity dimension in a whole sample of participants plotted against systolic blood pressure.”Paragraph [0180] – “The correlation of the raw and refined multifractal capacity dimension D.sub.0 with a range of systemic and ocular factors were examined, including age, SBP, DBP, refractive error and arteriolar and venular calibre.”Paragraph [0183] – “FIG. 24 shows a graph of refined D.sub.0 in the whole sample plotted against SBP. The inverse relationship of the refined D.sub.0 with SBP shows D.sub.0 decreasing by 0.004 per 10 mmHg increase in SBP.”Paragraph [0184] – “The multi-fractal dimension shows strong correlation with SBP, DBP and age, as well as with CRAE and CRVE. Indeed, the correlation of multi-fractal dimension with SBP and DBP is even higher than that of CRAE with SBP and DBP suggesting that calculating the multi-fractal capacity dimension is better than CRAE for detecting early changes in CVD. Embodiments of the present invention can also detect differences in the multifractal dimension in persons with and without hypertension even in this small sample.”]. Hsu teaches the use of a percent ratio of a maximum venous dilatation and/or a maximum arterial dilation of the patient to a base diameter of a vessel of the patient in the correlation of retinal characteristics to blood pressure [Paragraph [0003] – “Arterioles and venules are small branches of the main retinal arteries and veins respectively and their condition is indicative of the smaller blood vessels in the body. Measuring the diameter or widths of the arterioles and venules from detailed digital retinal images and calculating the arteriolar-to-venular diameter ratio (AVR) is one method of quantifying the imbalance between retinal arteriolar and venular calibre size. This measure can vary with different retinal vessels taken into calculation. More importantly, AVR provides information only on one aspect of retinal vascular change, namely retinal vessel calibre, and does not take into account the many structural alterations in the retinal vasculature.”Either of the retinal arteriolar and venular calibre size amounting to the recited “base diameter” for which the other is compared to. Alternatively, monitoring for “retinal vascular change” would amount to comparing the vessel calibres to previously measured calibres.
Paragraph [0125] – “AVR.sub.B:This ratio is given by CRVE.sub.B/CRAE.sub.B.”Paragraph [0132] – “AVR.sub.C: This ratio is given by CRVE.sub.C/CRAE.sub.C.”Paragraph [0184] – “The multi-fractal dimension shows strong correlation with SBP, DBP and age, as well as with CRAE and CRVE.”].
It would have been obvious to use the device/methods of Hsu to provide an indication of patient blood pressure and overall health when performing dialysis control in order to ensure a beneficial outcome for a dialysis patient.
Parisotto, as modified, would disclose a medical system for specifying adjustable values of a blood treatment apparatus [Paragraph [0020] – “In another aspect, a medical fluid treatment machine includes a pump configured to pump medical fluid to and from a patient. … The control unit is also configured to modify operation of the medical fluid treatment machine based on the patient assessment score.”], the medical system comprising:
a calculation device with an input interface configured to receive results [Paragraph [0020] – “The medical fluid treatment machine also includes an input device configured to receive patient assessment information concerning one or more subjective characteristics of the patient. The medical fluid treatment machine also includes a control unit that is in communication with the pump and the input device.”] determined by a diagnostic device for performing a retinal vessel analysis of a patient, wherein the results comprise a percent ratio of a maximum venous dilatation and/or a maximum arterial dilation of the patient to a base diameter of a vessel of the patient [Per Hsu];
an output interface for outputting an ultrafiltration rate for treatment of the patient by the blood treatment apparatus [Paragraph [0006] – “In some implementations, treatment parameters of the medical fluid treatment machine include blood flow rate, ultrafiltration rate, blood pressure monitoring rate, and vascular access monitoring.”Paragraph [0007] – “In some implementations, modifying operation of the medical fluid treatment machine includes causing a message to be displayed that suggests an adjustment of a treatment parameter of the medical fluid treatment machine.”];
wherein the calculation device is programmed to:
determine, based on the results being entered or read in via the input interface [Blood pressure from Hsu used as an indication of patient health], the ultrafiltration rate for the treatment of the patient [Paragraph [0127] – “In an attempt to maximize the efficiency of the dialysis treatment, it is beneficial for the hemodialysis machine 102 to employ the maximum ultrafiltration rate that the patient can safely handle. However, substantially or fully complex patients are more prone to issues during treatment and may not be capable of handling a relatively high ultrafiltration rate. Accordingly, the ultrafiltration rate can be adjusted based on the patient's Combined Patient Assessment Score.”]; and
output the ultrafiltration rate via the output interface [Paragraph [0007] – “In some implementations, modifying operation of the medical fluid treatment machine includes causing a message to be displayed that suggests an adjustment of a treatment parameter of the medical fluid treatment machine.”Paragraph [0127] – “If the patient's Combined Patient Assessment Score is over 3.5, the hemodialysis machine 102 displays a notification on the touch screen 118 suggesting that the ultrafiltration rate should be decreased. The notification includes one or more suggestions of appropriate ultrafiltration rates that can be applied. The ultrafiltration rate is not adjusted unless the caregiver accepts one of the suggestions.”].
Parisotto and Hsu fail to disclose determining whether the percent ratio of the maximum venous dilatation and/or the maximum arterial dilation is within a subdivision out of a group of subdivisions comprising: a lower subdivision, a middle subdivision, and an upper subdivision; determining, based on the determined subdivision, a function defining the ultrafiltration rate for the treatment of the patient over time.
However, Fathalla discloses quantifying cardiovascular risk [Section IV on Pages 881-882] by measuring retinal venous dilatation and/or arterial dilation [Page 882 – “Retinal vessel reactivity was measured using the Dynamic Vessel Analyser (DVA); IMEDOS GmbH, Jena, Germany [8]. For each subject, both artery and vein responses were measured over a period of 350 seconds, including three cycles F1, F2 and F3 of flicker light stimulation. Retinal vessel diameters were recorded at a frequency of 25 readings/sec.”] and classifying risk into a lower subdivision, a middle subdivision, and an upper subdivision [Page 882 – Low Risk (LR), Medium Risk (MR), and High Risk (HR)] based on vessel diameter dilation [Page 882 – “Baseline Diameter Fluctuation BDF = difference between maximum baseline vessel diameter and minimum baseline vessel diameter.”]. It would have been obvious to use such an approach in adjusting ultrafiltration rate per the function of Parisotto [Paragraph [0127] – “In an attempt to maximize the efficiency of the dialysis treatment, it is beneficial for the hemodialysis machine 102 to employ the maximum ultrafiltration rate that the patient can safely handle. However, substantially or fully complex patients are more prone to issues during treatment and may not be capable of handling a relatively high ultrafiltration rate. Accordingly, the ultrafiltration rate can be adjusted based on the patient's Combined Patient Assessment Score.”] in order to ensure a beneficial outcome for a dialysis patient.
Regarding Claim 21, Parisotto discloses a display device configured to display the results and/or the ultrafiltration rate [Paragraph [0007] – “In some implementations, modifying operation of the medical fluid treatment machine includes causing a message to be displayed that suggests an adjustment of a treatment parameter of the medical fluid treatment machine.”Paragraph [0127] – “If the patient's Combined Patient Assessment Score is over 3.5, the hemodialysis machine 102 displays a notification on the touch screen 118 suggesting that the ultrafiltration rate should be decreased. The notification includes one or more suggestions of appropriate ultrafiltration rates that can be applied. The ultrafiltration rate is not adjusted unless the caregiver accepts one of the suggestions.”].
Regarding Claim 22, Parisotto discloses that the output interface comprises a visual or graphical interface for the user or is connected to a graphical display device [Paragraph [0007] – “In some implementations, modifying operation of the medical fluid treatment machine includes causing a message to be displayed that suggests an adjustment of a treatment parameter of the medical fluid treatment machine.”].
Regarding Claim 23, Parisotto discloses that the output interface comprises an interface with a control device or closed-loop control device of the blood treatment apparatus [Paragraph [0020] – “The medical fluid treatment machine also includes an input device configured to receive patient assessment information concerning one or more subjective characteristics of the patient. The medical fluid treatment machine also includes a control unit that is in communication with the pump and the input device. The control unit configured to determine a patient assessment score based on the patient assessment information. The control unit is also configured to modify operation of the medical fluid treatment machine based on the patient assessment score.”].
Regarding Claim 24, Parisotto discloses that the output interface comprises an interface with a server, a network protocol, and/or a data storage [Paragraph [0037] – “The system also includes a central server in communication with the medical fluid treatment machines. The central server is configured to receive the patient assessment scores and the patient assessment information from the medical fluid treatment machines.”].
Regarding Claim 25, Parisotto discloses that the medical system comprises a mobile device, handheld device, cell phone, smartphone, tablet, and/or an application suitable therefor [Paragraph [0036] – “In another aspect, a computer-readable storage medium stores a computer program. The computer program includes instructions for causing a computer to receive patient assessment information concerning one or more subjective characteristics of a patient. The computer program also includes instructions for causing the computer to determine a patient assessment score based on the received patient assessment information. The computer program also includes instructions for causing the computer to modify operation of a medical fluid treatment machine based on the patient assessment score.”].
Regarding Claim 26, Hsu discloses the diagnostic device for executing the retinal vessel analysis of the patient [Paragraph [0001] – “The present invention relate to systems and methods for analyzing retinal images, and for obtaining from them information characterizing retinal blood vessels which may be useful in forming a diagnosis of a medical condition.”].
Regarding Claim 28, Parisotto discloses that the medical system is a control device or closed-loop control device of the blood treatment apparatus or part thereof, encompasses the control device or closed-loop control device, or is in signal communication therewith [Paragraph [0020] – “The medical fluid treatment machine also includes an input device configured to receive patient assessment information concerning one or more subjective characteristics of the patient. The medical fluid treatment machine also includes a control unit that is in communication with the pump and the input device. The control unit configured to determine a patient assessment score based on the patient assessment information. The control unit is also configured to modify operation of the medical fluid treatment machine based on the patient assessment score.”].
Regarding Claim 29, Parisotto discloses that the control device or closed-loop control device is programmed to control or regulate the blood treatment apparatus, which comprises a conveying device for a liquid on the basis of the ultrafiltration rate [Paragraph [0020] – “The medical fluid treatment machine also includes an input device configured to receive patient assessment information concerning one or more subjective characteristics of the patient. The medical fluid treatment machine also includes a control unit that is in communication with the pump and the input device. The control unit configured to determine a patient assessment score based on the patient assessment information. The control unit is also configured to modify operation of the medical fluid treatment machine based on the patient assessment score.”Paragraph [0115] – “If, for example, the pressure of the blood on the venous side is less than or equal to 200 mmHg, the patient's Combined Patient Assessment Score is over 3.5, and symptoms of vascular access are present, the hemodialysis machine 102 adjusts the blood flow rate such that the pressure of the blood on the venous side rises to at least 200 mmHg. The processor 125 of the hemodialysis machine 102 sends an instruction to the blood pump 132 to adjust the blood flow rate accordingly, thereby reducing the risk of arteriovenous fistula/graft damage.”See Paragraph [0128].].
Regarding Claim 30, Parisotto discloses that the conveying device comprises an ultrafiltration pump, a blood pump and/or a dialysis liquid pump [Paragraph [0115] – “If, for example, the pressure of the blood on the venous side is less than or equal to 200 mmHg, the patient's Combined Patient Assessment Score is over 3.5, and symptoms of vascular access are present, the hemodialysis machine 102 adjusts the blood flow rate such that the pressure of the blood on the venous side rises to at least 200 mmHg. The processor 125 of the hemodialysis machine 102 sends an instruction to the blood pump 132 to adjust the blood flow rate accordingly, thereby reducing the risk of arteriovenous fistula/graft damage.”].
Regarding Claim 31, Parisotto discloses a blood treatment apparatus, embodied as a dialysis apparatus, comprising, or connected to, the medical system according to claim 19 [Paragraph [0059] – “Referring to FIG. 1, a hemodialysis system 100 includes a hemodialysis machine 102.”].
Regarding Claim 32, Parisotto discloses a hemodialysis apparatus, hemofiltration apparatus or hemodiafiltration apparatus, an apparatus for acute renal replacement therapy, for chronic renal replacement therapy, or for continuous renal replacement therapy (CRRT) [Paragraph [0059] – “Referring to FIG. 1, a hemodialysis system 100 includes a hemodialysis machine 102.”].
Regarding Claim 33, Parisotto discloses a treatment system comprising: one or several blood treatment apparatuses, each embodied as a dialysis apparatus [Paragraph [0059] – “Referring to FIG. 1, a hemodialysis system 100 includes a hemodialysis machine 102.”]; and a medical system according to claim 19; wherein at least one or more of the blood treatment apparatuses and the medical system are separate from each other [Paragraph [0060] – “The processor 125 is configured to receive data that is input via the touch screen 118 and the control panel 120 and control the hemodialysis machine 102 based on the received data. For example, the processor 125 can adjust the operating parameters of the hemodialysis machine 102.”].
Regarding Claim 34, Parisotto, as modified, discloses a method for preparing for an upcoming treatment or treatment session of a patient [Abstract – “A method comprising: receiving patient assessment information concerning one or more subjective characteristics of a patient; determining a patient assessment score based on the received patient assessment information; and modifying operation of a medical fluid treatment machine based on the patient assessment score.”], which is to be carried out by using a blood treatment apparatus [Paragraph [0059] – “Referring to FIG. 1, a hemodialysis system 100 includes a hemodialysis machine 102.”], the method comprising:
providing a medical system according to claim 19 [Paragraph [0059] – “Referring to FIG. 1, a hemodialysis system 100 includes a hemodialysis machine 102.”];
entering at least one result determined by the diagnostic device into the input interface of the calculation device [Per Hsu], the at least one result comprising the percent ratio of a maximum venous dilatation and/or a maximum arterial dilation of the patient to a base diameter of a vessel of the patient in the correlation of retinal characteristics to blood pressure [Paragraph [0003] of Hsu – “Arterioles and venules are small branches of the main retinal arteries and veins respectively and their condition is indicative of the smaller blood vessels in the body. Measuring the diameter or widths of the arterioles and venules from detailed digital retinal images and calculating the arteriolar-to-venular diameter ratio (AVR) is one method of quantifying the imbalance between retinal arteriolar and venular calibre size. This measure can vary with different retinal vessels taken into calculation. More importantly, AVR provides information only on one aspect of retinal vascular change, namely retinal vessel calibre, and does not take into account the many structural alterations in the retinal vasculature.”Either of the retinal arteriolar and venular calibre size amounting to the recited “base diameter” for which the other is compared to. Alternatively, monitoring for “retinal vascular change” would amount to comparing the vessel calibres to previously measured calibres.Paragraph [0125] of Hsu – “AVR.sub.B:This ratio is given by CRVE.sub.B/CRAE.sub.B.”Paragraph [0132] of Hsu – “AVR.sub.C: This ratio is given by CRVE.sub.C/CRAE.sub.C.”Paragraph [0184] of Hsu – “The multi-fractal dimension shows strong correlation with SBP, DBP and age, as well as with CRAE and CRVE.”];
reading, from the output interface, the ultrafiltration rate for the treatment of the patient using the blood treatment apparatus [Paragraph [0007] – “In some implementations, modifying operation of the medical fluid treatment machine includes causing a message to be displayed that suggests an adjustment of a treatment parameter of the medical fluid treatment machine.”Paragraph [0127] – “If the patient's Combined Patient Assessment Score is over 3.5, the hemodialysis machine 102 displays a notification on the touch screen 118 suggesting that the ultrafiltration rate should be decreased. The notification includes one or more suggestions of appropriate ultrafiltration rates that can be applied. The ultrafiltration rate is not adjusted unless the caregiver accepts one of the suggestions.”]; and
entering the ultrafiltration rate as a set value into an input interface of the blood treatment apparatus [Paragraph [0060] – “The processor 125 is configured to receive data that is input via the touch screen 118 and the control panel 120 and control the hemodialysis machine 102 based on the received data. For example, the processor 125 can adjust the operating parameters of the hemodialysis machine 102.” (i.e., performing a parameter change as indicated in light of Hsu)Paragraph [0127] – “If the patient's Combined Patient Assessment Score is over 3.5, the hemodialysis machine 102 displays a notification on the touch screen 118 suggesting that the ultrafiltration rate should be decreased. The notification includes one or more suggestions of appropriate ultrafiltration rates that can be applied. The ultrafiltration rate is not adjusted unless the caregiver accepts one of the suggestions.”].
Regarding Claim 35, Parisotto discloses a non-transitory digital storage medium, with electronically readable control signals, designed to interact with a programmable computer system such that a conventional calculation device is reprogrammed into a calculation device of a medical system according to claim 19 [Paragraph [0036] – “In another aspect, a computer-readable storage medium stores a computer program. The computer program includes instructions for causing a computer to receive patient assessment information concerning one or more subjective characteristics of a patient. The computer program also includes instructions for causing the computer to determine a patient assessment score based on the received patient assessment information. The computer program also includes instructions for causing the computer to modify operation of a medical fluid treatment machine based on the patient assessment score.”].
Regarding Claim 37, Parisotto discloses a non-transitory computer program product for interacting with a programmable computer system such that a conventional calculation device is reprogrammed into a calculation device of a medical system according to claim 19 [Paragraph [0036] – “In another aspect, a computer-readable storage medium stores a computer program. The computer program includes instructions for causing a computer to receive patient assessment information concerning one or more subjective characteristics of a patient. The computer program also includes instructions for causing the computer to determine a patient assessment score based on the received patient assessment information. The computer program also includes instructions for causing the computer to modify operation of a medical fluid treatment machine based on the patient assessment score.”].
Regarding Claim 39, Fathalla discloses that the group of subdivisions comprises a lower tertile, a middle tertile, and an upper tertile [Page 882 – Low Risk (LR), Medium Risk (MR), and High Risk (HR)].
Regarding Claim 40, Fathalla discloses the use of an upper tertile [Page 882 – Low Risk (LR), Medium Risk (MR), and High Risk (HR)] based on vessel diameter dilation [Page 882 – “Baseline Diameter Fluctuation BDF = difference between maximum baseline vessel diameter and minimum baseline vessel diameter.”] and that high risk patients exhibit a loss of vessel elasticity [Page 883 – “The behaviour of the vessels of the high risk representative shows loss of elasticity expected with reduced vascular health.” High-elasticity diameter fluctuations would reflect a low risk patient.], but fails to disclose that, upon a determination that the percent ratio of the maximum venous dilatation and/or the maximum arterial dilation is within the upper tertile, the determined function comprises a constant ultrafiltration rate.
However, Parisotto discloses performing ultrafiltration at a maximum rate for a healthy patient [Paragraph [0124] – “In an attempt to maximize the efficiency of the dialysis treatment, it is beneficial for the hemodialysis machine 102 to employ the maximum ultrafiltration rate that the patient can safely handle. However, substantially or fully complex patients are more prone to issues during treatment and may not be capable of handling a relatively high ultrafiltration rate.”]. It would have been obvious to perform ultrafiltration at a high and constant ultrafiltration rate in order to safely speed up the dialysis treatment.
Regarding Claim 41, Fathalla discloses the use of an middle tertile [Page 882 – Low Risk (LR), Medium Risk (MR), and High Risk (HR)] based on vessel diameter dilation [Page 882 – “Baseline Diameter Fluctuation BDF = difference between maximum baseline vessel diameter and minimum baseline vessel diameter.”] and that high risk patients exhibit a loss of vessel elasticity [Page 883 – “The behaviour of the vessels of the high risk representative shows loss of elasticity expected with reduced vascular health.” High-elasticity diameter fluctuations would reflect a low risk patient.], but fails to disclose that, upon a determination that the percent ratio of the maximum venous dilatation and/or the maximum arterial dilation is within the middle tertile, the determined function comprises a curve in which the ultrafiltration rate decreases over time.
However, Parisotto discloses performing ultrafiltration at a reduced rate for an unhealthy patient [Paragraph [0124] – “If the patient's Combined Patient Assessment Score is over 3.5, the hemodialysis machine 102 displays a notification on the touch screen 118 suggesting that the ultrafiltration rate should be decreased. The notification includes one or more suggestions of appropriate ultrafiltration rates that can be applied.” See Fig. 10.]. It would have been obvious to decrease ultrafiltration rate over time in order to safely continue the dialysis treatment.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parisotto et al. (US 20160199562 A1)[hereinafter “Parisotto”], Hsu et al. (US 20110026789 A1)[hereinafter “Hsu”], Fathalla et al., Cardiovascular Risk Prediction based on Retinal Vessel Analysis using Machine Learning, IEEE, 2016 [hereinafter “Fathalla”](disclosed and supplied by the Applicant on 9/18/2023), and Vidyadhara et al. (US 20190250928 A1)[hereinafter “Vidyadhara”].
Regarding Claim 36, Parisotto fails to disclose the digital storage medium of claim 35, in the form of a floppy disk, CD or DVD, EPROM, FRAM or SSD.
However, Vidyadhara discloses such devices as storage media [See Paragraphs [0025]-[0027]]. It would have been obvious to use such devices for storing a computer program because they are viable options for such a purpose.
Response to Arguments
Applicant argues:
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Examiner’s Response:
The corresponding objection is hereby withdrawn.
Applicant argues:
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131
787
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Examiner’s Response:
The corresponding rejection is hereby withdrawn.
Applicant argues:
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302
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Examiner’s Response:
New grounds for rejection of Claim 37 under 35 USC 101 are presented above. The rejection of Claim 38 under 35 USC 101 is hereby withdrawn.
Applicant argues:
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Examiner’s Response:
The Examiner respectfully disagrees as the instant claims do not recite the use of the abstract idea result in a manner which meaningfully improves dialysis and patient safety (with the exclusion of the use of ultrafiltration rate in Claim 29 as specifically recited in Claim 30). The rejection of Claim 30 under 35 USC 101 has been withdrawn.
Applicant argues:
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335
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Examiner’s Response:
The Examiner agrees. New grounds for rejection are presented above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chen et al., Ocular changes during hemodialysis in patients with end-stage renal disease, BMC Ophthalmology, 2018
US 20140194804 A1 – Chronic Access System For Extracorporeal Treatment Of Blood Including A Continuously Wearable Hemodialyzer
Knudtson et al., Revised formulas for summarizing retinal vessel diameters, Current Eye Research, 2003
US 6602424 B1 – Safety Device For A Blood Treatment Machine And A Method Of Increasing The Safety Of A Blood Treatment Machine (See the discussion of Figs. 3 and 6)
Pechauer et al., Detecting Blood Flow Response to Stimulation of the Human Eye, BioMed Research International, 2015
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE ROBERT QUIGLEY whose telephone number is (313)446-4879. The examiner can normally be reached 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arleen Vazquez can be reached at (571) 272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE R QUIGLEY/Primary Examiner, Art Unit 2857
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