DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed 10/10/25. Claims 16-36 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/10/2025 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a calculation unit programmed to…” (claims 16-19; 25-27); display device for displaying (claim 28); medical treatment apparatus (claims 29-31, claim 34); control device or closed control device programmed to adjust…(claim 34)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 16-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (US 20200268959 A1) in view of Rau et al (US 20240350054 A1)
Claims 16 Yu teaches a patient monitor system, comprising:
at least one collecting device configured and programmed to collect: behavior-related data of a patient and vital parameters of the patient; (par. 70; par. 158; par. 182-184-collects information on patient hydration, and prescription compliance- Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior)
an output device; and (par. 25; the present system includes a scale and blood pressure taker that output weight and blood pressure information, respectively, wirelessly to the APD machine using a wireless technology such as Bluetooth™, WiFi™, Zigbee™ technology. The wireless link is provided via radio frequency transmission in one embodiment. In an alternative embodiment, the weight and blood pressure information are provided via a wired connection between the scale and blood pressure taker and the APD machine.)
a calculation unit, programmed to:
receive the behavior-related data and/or the vital parameters collected by the at least one collecting device; (par. 71; par. 158)
generate instructions, based on the behavior-related data and the vital parameters to control or regulate a medical treatment apparatus; and (par. 71-73; par. 184- The programming can be configured to escalate the warnings if the patient continues with this behavior, let the patient know that the dialysis center 120 is being notified, and notify the dialysis center accordingly. The instrument 104 can likewise be programmed to warn the patient if the patient skips too many treatments and notify the dialysis center 120 if the missed treatments continue.)
output the instructions using the output device, ( par. 31-32; par. 71- APD machine and/or clinical software monitors the patient therapy trending data and generates alerts when any of the vital parameters falls outside a physician's preset range (or outside of the range in combination with other alert filtering criteria described herein); par. 72.)
wherein the calculation unit is further programmed to generate the instructions and to output the instructions using the output device in response to when (i) at least one datum of behavior-related data of the patient, is not within a predetermined behavior-related data value range and/or is beyond a predetermined behavior-related data limit value, (par. 182-184-Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior…System 10 knows accordingly if the lower than expected UF is due to compliance issues or potential therapy prescription issues. In an embodiment in which the patient chooses to pick which prescription to run on a given day, the dialysis instrument 104 can be programmed to provide a warning to the patient when the patient runs the low UF prescription too often (low UF prescription may be less demanding than standard UF prescription). The programming can be configured to escalate the warnings if the patient continues with this behavior, let the patient know that the dialysis center 120 is being notified, and notify the dialysis center accordingly; See also Fig. 24-25, par. 184-185)
and (ii) at least one parameter of the vital parameters of the patient, is not within a predetermined vital parameter value range and/or lie beyond a predetermined vital parameter limit value. (par. 71- APD machine and/or clinical software monitors the patient therapy trending data and generates alerts when any of the vital parameters falls outside a physician's preset range (or outside of the range in combination with other alert filtering criteria described herein); par. 182-184; See also Fig. 24-25, par. 184-185)
Claim 16 has been further amended to recite: wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment.
Yu discloses the use of cell phones and Bluetooth devices (par. 10- the present system includes a scale and blood pressure taker that output weight and blood pressure information, respectively, wirelessly to the APD machine using a wireless technology such as Bluetooth™, WiFi™, Zigbee™ technology.; par. 69) but does not expressly disclose: wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment.
Rau discloses a system for gathering patient data wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment. (par. 145- Another variant of RERAS is a wearable multi-sensor data fused device designed to monitor and record patients' vital parameters, sleep patterns and patient reported changes in their daily life patterns over a specific time period. This device has the ability to monitor continuously some or all the parameters selected and configured by the physician and alert the patients when certain predetermined thresholds for these monitored parameters are exceeded by linking the wearable RERAS to portable devices, such as, smartphones, tablets and other computing devices; par. 154) At the time of the effective filing data of the application, it would have been obvious to one of ordinary skill in the art to modify the system of Yu with the teaching of Rau to include at least one collecting device that is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment. One would have been motivated to include this feature to allow for real-time measurement of objective, autonomic physiological parameters that monitor illnesses and health changes in ways not previously contemplated and from a patient in different settings. (Rau: par. 4)
Claim 17 Yu teaches the patient monitor system according to claim 16, wherein the calculation unit is programmed to initiate or trigger the collecting device in order to collect the behavior-related data and/or vital parameters using the collecting device at a point in time at which the patient is not being treated by the medical treatment apparatus in a treatment session, or between two successive treatment sessions by the medical treatment apparatus. (par. 70; par. 104; par. 158-161)
Claim 18. Yu teaches the patient monitor system according to claim 16, wherein the calculation unit is programmed to detect or evaluate the vital parameters, or a part thereof, only in the event that the calculation unit has recognized that the detected behavior-related data, or a part thereof, do not lie in the predetermined behavior-related data value range and/or lie beyond the predetermined behavior-related data limit value, and/or wherein the calculation unit is programmed to collect or evaluate the behavior-related data, or a part thereof only in the event that the calculation unit has recognized that the collected vital parameters, or a part thereof, do not lie in the predetermined vital parameter value range and/or lie beyond the predetermined vital parameter limit value. (par. 164-165)
Claim 19. Yu teaches he patient monitor system according to claim 16, wherein the collecting device is configured and programmed to automatically collect the behavior-related data and vital parameters of the patient. (par. 158-162; Fig. 24-25, par. 182-185, esp. par. 184)
Claim 20. Yu and Rau teach the patient monitor system according to claim 19 as explained. Yu discloses the use of cell phones and Bluetooth devices (par. 10- the present system includes a scale and blood pressure taker that output weight and blood pressure information, respectively, wirelessly to the APD machine using a wireless technology such as Bluetooth™, WiFi™, Zigbee™ technology.; par. 69) but does not expressly disclose: wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment.
Rau discloses a system for gathering patient data wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment. (par. 145- Another variant of RERAS is a wearable multi-sensor data fused device designed to monitor and record patients' vital parameters, sleep patterns and patient reported changes in their daily life patterns over a specific time period. This device has the ability to monitor continuously some or all the parameters selected and configured by the physician and alert the patients when certain predetermined thresholds for these monitored parameters are exceeded by linking the wearable RERAS to portable devices, such as, smartphones, tablets and other computing devices; par. 154) At the time of the effective filing data of the application, it would have been obvious to one of ordinary skill in the art to modify the system of Yu with the teaching of Rau to include at least one collecting device that is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment. One would have been motivated to include this feature to allow for real-time measurement of objective, autonomic physiological parameters that monitor illnesses and health changes in ways not previously contemplated and from a patient in different settings. (Rau: par. 4)
Claim 21. Yu teaches the patient monitor system according to claim 16, wherein the behavior-related data includes one or more of: sleep data, movement data, activity data, a parameter of a medication intake, food intake data and fluid intake data; (par. 74-75: If the patient is capable, the APD system can be set to allow the patient to run a prescription tailored to the day's activities. If the patient exercises heavily on certain days, losing large amounts of body fluids via sweat, the patient can run a lower UF treatment that evening, perhaps saving the patient from having to perform a day exchange the next day; par. 182-184)
and wherein the vital parameters includes one or more of cardiovascular data, heart rate, heart rate variability, QT wave, blood pulse wave, oxygen saturation, respiratory rate, respiratory amplitude, galvanic skin response, weight, body temperature and blood pressure. (par. 9-11; Fig. 1 (22))
Claim 22. Yu teaches The patient monitor system according to claim 21, wherein the activity data comprises a number of steps taken per day. (par. 217)
Claim 23. Yu teaches The patient monitor system according to claim 21, wherein the parameter of the medication intake comprises a regularity of the medication intake. (par. 217)
Claim 24. Yu teaches The patient monitor system according to claim 16, further comprising a storage device for storing: the behavior-related data and/or vital parameters of the patient collected by the collecting device, behavior-related data and/or vital parameters of the patient collected in the past, behavior-related data and/or vital parameters obtained from patient collectives, limit values, and value ranges. (par. 71-73
Claim 25 Yu teaches The patient monitor system according to claim 16, wherein the calculation unit is configured to compare the behavior-related data and/or the vital parameters of a current or most recently viewed period with the behavior-related data and/or vital parameters of past time periods of the patient, and wherein the result of the comparison is evaluated based on the behavior-related data value range, the behavior-related data limit value, the vital parameter value range, and/or the vital parameter limit value. (par. 71-73)
Claim 26. Yu teaches The patient monitor system according to claim 16, wherein the calculation unit is configured to compare the behavior-related data and/or the vital parameters of a current or most recently viewed period with the behavior-related data or the vital parameters of a patient collective, and wherein the result of the comparison is evaluated based on the behavior-related data value range, the behavior-related data limit value, the vital parameter value range, and/or the vital parameter limit value( par. 71-73; par .164-165
Claim 27. Yu teaches The patient monitor system according to claim 16, wherein the calculation unit is programmed to calculate a patient's probability of an occurrence of diseases or secondary diseases based on the behavior-related data and/or the vital parameters, and is further programmed in order to output an instruction if the patient's probability of the occurrence of diseases or secondary diseases exceeds a predetermined disease limit value. (par. 71-73; par .164-165)
Claim 28. Yu teaches a display device for displaying at least one instruction for controlling or regulating a medical treatment apparatus, wherein the display device is part of a patient monitor system according to claim 16 and/or is in signal communication with the output device of a patient monitor system according to claim 16. (par. 25; Fig. 22-23; 26-27)
Claim 29. Yu teaches a medical treatment apparatus with the display device according to claim 28 and/or in signal communication with the display device according to claim 28. (par. 130, 133-134; Fig. 22-23; 26-27)
Claim 30. Yu teaches a medical treatment apparatus having a patient monitor system according to claim 16 and/or in signal communication with the patient monitor system according to claim 16. (par. 130, 133-134; Fig. 22-23; 26-27)
Claim 31 Yu teaches the medical treatment apparatus according to claim 29, embodied as a blood treatment apparatus. (abstract-dialysis machine)
Claim 32 Yu teaches the medical treatment apparatus according to claim 30, embodied as a dialysis apparatus, hemodialysis apparatus, hemofiltration apparatus, hemodiafiltration apparatus or as an apparatus for chronic renal replacement therapy, for apheresis, or for whole blood adsorption treatment or as a treatment apparatus for peritoneal dialysis. (par. 65)
Claim 33. Yu teaches the medical treatment apparatus according to claim 31, embodied for plasmapheresis treatment. (par. 103-104-intended use language; no functional)
Claim 34 Yu teaches the medical treatment apparatus according to claim 29, comprising a control device or closed-loop control device which is programmed to adjust or set at least one treatment parameter based on the instructions outputted by the calculation unit. (par. 27-Rx adjust module; par. 165-168)
Claim 35 Yu teaches a method for preparing a treatment or treatment session of a patient to be performed by a medical treatment apparatus, the method comprising:
detecting, by a collecting device, behavior-related data at least one point in time at which the patient is not being treated by the medical treatment apparatus in a treatment session, or between two successive treatments or treatment sessions by the medical treatment apparatus; (par. 11- reference to previous day’s treatment; par. 25-26; par. 90- the PET 12 of the present disclosure begins with a UF versus dwell time evaluation performed over the course of two treatments (e.g., two evenings or back to back) by directly estimating the patient's fluid transport parameters and correlating the measured parameters with other PET results; par. 158; par. 182-184-collects information on patient hydration, and prescription compliance- Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior)
collecting vital parameters at least one point in time at which the patient is not being treated by the medical treatment apparatus in the treatment session, or between two successive treatments or treatment sessions by the medical treatment apparatus; (par. 70;par. 90 par. 158; par. 182-184-collects information on patient hydration, and prescription compliance- Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior)
outputting instructions in response to when:
(i) at least one datum of behavior-related data of the patient, is not within a predetermined behavior-related data value range and/or is beyond a predetermined behavior-related data limit value, (par. 31; par. 71- APD machine and/or clinical software monitors the patient therapy trending data and generates alerts when any of the vital parameters falls outside a physician's preset range (or outside of the range in combination with other alert filtering criteria described herein); par. 72; par. 182-184-Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior…System 10 knows accordingly if the lower than expected UF is due to compliance issues or potential therapy prescription issues. In an embodiment in which the patient chooses to pick which prescription to run on a given day, the dialysis instrument 104 can be programmed to provide a warning to the patient when the patient runs the low UF prescription too often (low UF prescription may be less demanding than standard UF prescription). The programming can be configured to escalate the warnings if the patient continues with this behavior, let the patient know that the dialysis center 120 is being notified, and notify the dialysis center accordingly; See also Fig. 24-25, par. 184-185);and
(ii) at least one parameter of the vital parameters of the patient, is not within a predetermined vital parameter value range and/or lie beyond a predetermined vital parameter limit value. (par. 71- APD machine and/or clinical software monitors the patient therapy trending data and generates alerts when any of the vital parameters falls outside a physician's preset range (or outside of the range in combination with other alert filtering criteria described herein); par. 182-184; See also Fig. 24-25, par. 184-185)
Claim 35 has been further amended to recite: wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment.
Yu discloses the use of cell phones and Bluetooth devices (par. 10- the present system includes a scale and blood pressure taker that output weight and blood pressure information, respectively, wirelessly to the APD machine using a wireless technology such as Bluetooth™, WiFi™, Zigbee™ technology.; par. 69) but does not expressly disclose: wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment.
Rau discloses a system for gathering patient data wherein the at least one collecting device is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment. (par. 145- Another variant of RERAS is a wearable multi-sensor data fused device designed to monitor and record patients' vital parameters, sleep patterns and patient reported changes in their daily life patterns over a specific time period. This device has the ability to monitor continuously some or all the parameters selected and configured by the physician and alert the patients when certain predetermined thresholds for these monitored parameters are exceeded by linking the wearable RERAS to portable devices, such as, smartphones, tablets and other computing devices; par. 154) At the time of the effective filing data of the application, it would have been obvious to one of ordinary skill in the art to modify the system of Yu with the teaching of Rau to include at least one collecting device that is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment. One would have been motivated to include this feature to allow for real-time measurement of objective, autonomic physiological parameters that monitor illnesses and health changes in ways not previously contemplated and from a patient in different settings. (Rau: par. 4)
Claim 36 Yu and Rau in combination teaches the method according to claim 35, as explained. Yu teaches wherein the method is carried out using a patient monitor system comprising:
the at least one collecting device which is configured and/or programmed to collect: the behavior-related data of the patient and/or the vital parameters of the patient (par. 70; par. 158; par. 182-184-collects information on patient hydration, and prescription compliance- Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior) ;;
an output device; (par. 25; the present system includes a scale and blood pressure taker that output weight and blood pressure information, respectively, wirelessly to the APD machine using a wireless technology such as Bluetooth™, WiFi™, Zigbee™ technology. The wireless link is provided via radio frequency transmission in one embodiment. In an alternative embodiment, the weight and blood pressure information are provided via a wired connection between the scale and blood pressure taker and the APD machine.) and
a calculation unit, programmed to:
receive the behavior-related data and/or the vital parameters collected by the at least one collecting device; (par. 71; par. 158)
generate the instructions in order to control or regulate the medical treatment apparatus; (par. 71-73; par. 184- The programming can be configured to escalate the warnings if the patient continues with this behavior, let the patient know that the dialysis center 120 is being notified, and notify the dialysis center accordingly. The instrument 104 can likewise be programmed to warn the patient if the patient skips too many treatments and notify the dialysis center 120 if the missed treatments continue.)
and
output the instructions using the output device; ( par. 31-32; par. 71- APD machine and/or clinical software monitors the patient therapy trending data and generates alerts when any of the vital parameters falls outside a physician's preset range (or outside of the range in combination with other alert filtering criteria described herein); par. 72.)
wherein the calculation unit is further programmed to generate the instructions and/or to have the instructions output by the output device. (par. 182-184-Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior…System 10 knows accordingly if the lower than expected UF is due to compliance issues or potential therapy prescription issues. In an embodiment in which the patient chooses to pick which prescription to run on a given day, the dialysis instrument 104 can be programmed to provide a warning to the patient when the patient runs the low UF prescription too often (low UF prescription may be less demanding than standard UF prescription). The programming can be configured to escalate the warnings if the patient continues with this behavior, let the patient know that the dialysis center 120 is being notified, and notify the dialysis center accordingly; See also Fig. 24-25, par. 184-185)
Response to Arguments
Applicant's arguments filed 10/10/25 have been fully considered but they are not persuasive.
(A) Applicant argues that the Yu reference does not disclose: the calculation unit is further programmed to generate the instructions using the output device in response to when two types of data are outside of a range, as currently recited.
In response, the Examiner respectfully disagrees that the Yu reference fails to teach the newly recited limitations. While applicant argues that the Yu reference does not disclose collecting “behavior-related data” as distinct from “vital parameters.” However, the applicant’s disclosure fails to provide a particular definition for “behavior-related data.” Moreover, the disclosure explains that behavior related data are “the behavior-related data are, or include, sleep data, movement data, data on the perception of stress, data on, in particular, regular, medication intake and/or data on the patient's intake of food and/or liquid.” (par. 40 of US 20230395252 A1) The citations from the Yu reference include both behavioral and vital parameters.
Moreover, the Yu reference discloses that the system monitors and alerts the user regarding trends in monitored data values. (Fig. 22-23; Fig. 26; par. 127; par. 177-179- One specific example of an alert algorithm is: the thirty day rolling average UF…has fallen by ten percent, and the actual UF (base line) has been below the lower limit for three of the past seven days while performing either the standard UF prescription or the high UF prescription; par. 221) Yu further discloses: Patients whose UF is below target because they are running a low UF therapy too often, or are skipping therapies, need to be told in a timely manner to change their behavior…System 10 knows accordingly if the lower than expected UF is due to compliance issues or potential therapy prescription issues. In an embodiment in which the patient chooses to pick which prescription to run on a given day, the dialysis instrument 104 can be programmed to provide a warning to the patient when the patient runs the low UF prescription too often (low UF prescription may be less demanding than standard UF prescription). The programming can be configured to escalate the warnings if the patient continues with this behavior, let the patient know that the dialysis center 120 is being notified, and notify the dialysis center accordingly; (par. 182-184; See also Fig. 24-25, par. 184-185)
Additionally, Yu discloses that the questions asked of the user and information/response provided by the user are associated with value ranges (i.e. very high, high low, moderate) (See par. 217) Applicant does not specifically claim which numerical values, ranges or scores are encompassed by the claimed invention. The claims have been given the broadest reasonable interpretation, and the art has been applied accordingly.
(B ) Applicant argues that Yu does not describe that "the behavior-related data are or encompass sleep data, movement data, activity data, a parameter of a medication intake, and/or data on food and/or fluid intake."
In response, the examiner disagrees. As described in par. 9-11, Yu discloses collecting data on “[t]he trends can track any one or more of UF removed, body weight blood pressure and prescription used. “ It is noted that the prior art need not disclose all of the recited limitations, as the claim contains optional (and/or) language. Moreover the disclosure does not provide particular definitions for the types of data.
(C) Applicant argues that the Yu reference does not disclose that the system includes at least one collecting device that is a portable device comprising one or more of: a wristband, wristwatch, mobile phone, and part of a garment.
The examiner has provided new grounds of rejection to address the language of the amendment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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/Rachel L. Porter/Primary Examiner, Art Unit 3684