DETAILED ACTION
For this Office action, Claims 1-19 and 21 are pending. Claim 21 is new, and Claim 20 is canceled.
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 .
Election/Restrictions
The restriction requirement mailed 23 March 2026 is now considered moot and hereby withdrawn after applicant’s cancellation of Claim 20. Claims 1-19 and 21 will be examined within this Office action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-13, 15-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Peesapati et al. (herein referred to as “Peesapati”, US entry of WO 2020/219298, found in IDS filed 02/15/2024) in view of Jordan et al. (herein referred to as “Jordan”, “Electroencephalographic Order Pattern Analysis for the Separation of Consciousness and Unconsciousness”, Anesthesiology, V109, No. 6, December 2008, pages 1014-1022; found in IDS filed 02/15/2024).
Regarding instant Claim 1, Peesapati discloses a method for detecting an oxygen-related event experienced during a hemodialysis procedure (Abstract; system for monitoring fistulas or grafts during hemodialysis/peritoneal dialysis), the method comprising:
sensing an attribute of blood of a patient within a portion of an extracorporeal circuit during a hemodialysis procedure over a first time period, and analyzing the attribute to provide a plurality of oxygen saturation levels for the patient over the first time period (Figure 1B; Figure 6; Paragraphs [0020]-[0021]; Paragraph [0098]; plurality of sensors 112-x may be blood saturations sensors); and
analyzing the plurality of oxygen saturation levels, wherein the analysis at least in part includes determining whether one or more of the plurality of oxygen saturation levels is less than a predetermined threshold level by a predetermined amount (Paragraph [0037]; Paragraph [0040]; Paragraph [0078]; Paragraphs [0094]-[0095]; upon detection of abnormal thresholds, including below predetermined threshold, client device 208 will enter caution state or alarm state based on readings).
However, Peesapati is silent on the application of one or more of a recurrence-based metric and a complexity-based metric to identify a possible medical condition of the patient; and determining whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels.
Jordan discloses electroencephalographic order pattern analysis for the separation of consciousness and unconsciousness in the same field of endeavor as the instant application, as it solves the mutual problem of monitoring patients for medical conditions (Abstract; Page 4, Col. 1, Page 7, Col. 1). Jordan further discloses the application of a recurrence-based metric as a means to identify a potential medical condition of a patient (Figure 1; Page 4, Col. 1, Page 7, Col. 1; see electrode positions and signals used to determine sleep condition of patient; order recurrence rate and order phase coupling charts).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the analysis of Peesapati by applying a recurrence-based metric as taught by Jordan because Jordan discloses such a metric will aid in identifying a potential condition of the patient (Jordan, Col. 4, Col. 7).
However, the combined references are silent on determining whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels.
Lynn discloses a system and method for automatic detection of a plurality of SP02 detection and a plurality of SP02 time series pattern types in the same field of endeavor as the instant application, as it solves the mutual problem of monitoring a patient’s condition (Abstract). Lynn further discloses the determination of whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels in order to accurately determine whether the condition of the patient, in particular life threatening conditions (Paragraph [0013]; Paragraphs [0060]-[0062]; Paragraphs [0245]-[0246]; see sleep apnea, hypoxemia, hypoxia, etc. and detection methods).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Peesapati to further include determining whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels as taught by Lynn because Lynn discloses such determination allows for the detection of a condition of a patient, in particular a life threatening condition (Lynn, Paragraph [0013]; Paragraphs [0060]-[0062]; Paragraphs [0245]-[0246]).
Regarding instant Claim 2, Claim 1, upon which Claim 2 is dependent, has been rejected above. The combined references further disclose wherein the oxygen-related event includes one or more of hypoxemia, apnea, hypopnea, and hypoxia (Lynn, Paragraph [0013]; Paragraph [0059]; at least apnea and hypoxia).
Regarding instant Claim 3, Claim 1, upon which Claim 3 is dependent, has been rejected above. The combined references further disclose wherein the first time period includes one or more episodes of sleep for the patient, and wherein the one or more medical conditions includes sleep apnea syndrome (Lynn, Paragraphs [0201]-[0206]; Paragraphs [0216]-[0223]).
Regarding instant Claim 4, Claim 1, upon which Claim 4 is dependent, has been rejected above. The combined references further disclose comprising conducting a time-series analysis on the plurality of oxygen saturation levels for the patient over the first time period, the time series-analysis including at least calculating a complexity metric (Peesapati, Figure 1B; Figure 6; Paragraphs [0020]-[0021]; Paragraph [0098]; Jordan, Figure 1; Page 7, Col. 1; see probability distribution produced by time-series analysis in Jordan, which would indicate oxygen saturation levels in Peesapati).
Regarding instant Claim 5, Claim 4, upon which Claim 5 is dependent, has been rejected above. The combined references further disclose wherein each of the time series analyses are collectively used to detect sleep apnea syndrome (Lynn, Paragraphs [0216]-[0223]; sleep apnea is detected).
Regarding instant Claim 6, Claim 1, upon which Claim 6 is dependent, has been rejected above. The combined references further disclose comprising conducting a time-series analysis on the plurality of oxygen saturation levels for the patient over at least the first time period, the time-series analysis including calculating a complexity metric including at least permutation entropy (Peesapati, Figure 1B; Figure 6; Paragraphs [0020]-[0021]; Paragraph [0098]; Jordan, Background; Figure 1; Page 7, Col. 1; permutation entropy used in complexity metric).
Regarding instant Claim 7, Claim 1, upon which Claim 7 is dependent, has been rejected above. The combined references further disclose comprising a time-series analysis on the plurality of oxygen levels for the patient over at least the first time period, and detecting an onset of intradialytic sleep apnea syndrome characterized by one or more intermittent patterns in oxygen saturation levels based on the time-series analysis (Peesapati, Figure 1B; Figure 6; Paragraphs [0020]-[0021]; Paragraph [0098]; Lynn, Paragraph [0222]-[0225]; see sleep apnea detection in Lynn).
Regarding instant Claim 8, Claim 1, upon which Claim 8 is dependent, has been rejected above. The combined references further disclose monitoring the patient to determine whether the patient is sleeping (Lynn, Paragraphs [0249]-[0250]).
Regarding instant Claim 9, Claim 1, upon which Claim 9 is dependent, has been rejected above. The combined references further disclose comprising a notification regarding the oxygen-related event experienced during the hemodialysis procedure (Peesapati, Abstract; Figure 1A; Paragraph [0019]; notification can be sent to client device 108 during procedure).
Regarding instant Claim 10, Claim 1, upon which Claim 10 is dependent, has been rejected above. The combined references further disclose comprising an intervention for the patient (Lynn, Paragraph [0085]; intervention can include waking a patient).
Regarding instant Claim 11, Claim 10, upon which Claim 11 is dependent, has been rejected above. The combined references further disclose wherein the intervention can include at least awakening the patient from sleep (Lynn, Paragraph [0085]; intervention can include waking a patient).
Regarding instant Claim 12, Claim 10, upon which Claim 12 is dependent, has been rejected above. The combined references further disclose wherein the intervention is based on information obtained in a current hemodialysis procedure (Peesapati, Abstract; Figure 2; Paragraph [0019]; intervention can occur during a current hemodialysis procedure).
Regarding instant Claim 13, Claim 10, upon which Claim 13 is dependent, has been rejected above. The combined references disclose wherein the intervention is based at least in part on information obtained over a plurality of previous hemodialysis procedures (Peesapati, Paragraph [0066]; readings can be stored in memory and later analyzed).
Regarding instant Claim 15, Claim 1, upon which Claim 15 is dependent, has been rejected above. The combined references further disclose wherein the attribute itself is oxygen saturation (Peesapati, Figure 1B; Figure 6; Paragraphs [0020]-[0021]; Paragraph [0098]; plurality of sensors 112-x may be blood/oxygen saturation sensors).
Regarding instant Claim 16, Claim 1, upon which Claim 16 is dependent, has been rejected above. The combined references further disclose wherein the attribute is sensed at a frequency of 1 Hertz (Hz) (Lynn, Paragraph [0235]; 1 Hertz is within the range wherein the signal can be sensed).
Regarding instant Claim 17, Claim 1, upon which Claim 17 is dependent, has been rejected above. The combined references further disclose wherein the predetermined amount is about 3% below the predetermined threshold (Peesapati, Paragraph [0049]; 3% is within the 1% deviation range required for initiation of caution state).
Regarding instant Claim 18, Peesapati discloses a system (Abstract; system for monitoring a vascular access), comprising:
an extracorporeal circuit connected to a patient for performing a hemodialysis procedure (Paragraph [0006]; dialysis machine);
a dialysis machine within the extracorporeal machine (Paragraph [0006]; dialysis machine);
a blood monitor within the extracorporeal circuit (Figure 1B; Figure 6; Paragraphs [0020]-[0021]; Paragraph [0098]; plurality of sensors 112-x); and
a computing resource configured to receive data from the blood monitor related to a plurality of oxygen saturation levels for the patient over a first time period (Figure 1B; Figure 6; Paragraphs [0020]-[0021]; Paragraph [0098]; plurality of sensors 112-x may be blood saturations sensors), the computing resource comprising computer-executable code embodied in a non-transitory computer readable medium that, when executing on the computing resource, performs the steps of: analyzing the oxygen saturation levels, wherein the analysis at least in part includes determining whether one or more of the plurality of oxygen saturation levels is less than a predetermined threshold level by a predetermined amount (Paragraph [0037]; Paragraph [0040]; Paragraph [0078]; Paragraphs [0094]-[0095]; upon detection of abnormal thresholds, including below predetermined threshold, client device 208 will enter caution state or alarm state based on readings).
However, Peesapati is silent on the application of one or more of a recurrence-based metric and a complexity-based metric to identify a possible medical condition of the patient; and determining whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels.
Jordan discloses electroencephalographic order pattern analysis for the separation of consciousness and unconsciousness in the same field of endeavor as the instant application, as it solves the mutual problem of monitoring patients for medical conditions (Abstract; Page 4, Col. 1, Page 7, Col. 1). Jordan further discloses the application of a recurrence-based metric as a means to identify a potential medical condition of a patient (Figure 1; Page 4, Col. 1, Page 7, Col. 1; see electrode positions and signals used to determine sleep condition of patient; order recurrence rate and order phase coupling charts).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the analysis of Peesapati by applying a recurrence-based metric as taught by Jordan because Jordan discloses such a metric will aid in identifying a potential condition of the patient (Jordan, Col. 4, Col. 7).
However, the combined references are silent on determining whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels.
Lynn discloses a system and method for automatic detection of a plurality of SP02 detection and a plurality of SP02 time series pattern types in the same field of endeavor as the instant application, as it solves the mutual problem of monitoring a patient’s condition (Abstract). Lynn further discloses the determination of whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels in order to accurately determine whether the condition of the patient, in particular life threatening conditions (Paragraph [0013]; Paragraphs [0060]-[0062]; Paragraphs [0245]-[0246]; see sleep apnea, hypoxemia, hypoxia, etc. and detection methods).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Peesapati to further include determining whether the patient has one or more medical conditions based on the oxygen-related event experienced during the hemodialysis procedure on the analysis of the plurality of oxygen saturated levels as taught by Lynn because Lynn discloses such determination allows for the detection of a condition of a patient, in particular a life threatening condition (Lynn, Paragraph [0013]; Paragraphs [0060]-[0062]; Paragraphs [0245]-[0246]).
Regarding instant Claim 19, Claim 18, upon which Claim 19 is dependent, has been rejected above. The combined references further disclose wherein the computing resource is disposed remote from the blood monitor, and communicates with the blood monitor over a data network (Peesapati, Paragraph [0006]; Paragraph [0118]; see external networks and wireless connections).
Regarding instant Claim 21, Claim 18, upon which Claim 21 is dependent, has been rejected above. The combined references further disclose comprising an intervention mechanism configured to provide an intervention for a patient based on the analysis of the plurality of oxygen saturation levels, wherein the intervention includes at least awakening the patient (Lynn, Paragraph [0085]; intervention can include waking a patient).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Peesapati et al. (herein referred to as “Peesapati”, US entry of WO 2020/219298, found in IDS filed 02/15/2024) in view of Jordan et al. (herein referred to as “Jordan”, “Electroencephalographic Order Pattern Analysis for the Separation of Consciousness and Unconsciousness”, Anesthesiology, V109, No. 6, December 2008, pages 1014-1022; found in IDS filed 02/15/2024) as applied to claim 1 above, and further in view of Bene (US Pat Pub. 2011/0269167).
Regarding instant Claim 14, Claim 1, upon which Claim 14 is dependent, has been rejected above. However, the combined references are silent on the attribute including hemoglobin.
Bene discloses a medical apparatus for extracorporeal blood treatment and method for determining a blood parameter value in a medical apparatus thereof in the same field of endeavor as the instant application, as it solves the mutual problem of monitoring blood parameters (Abstract). Bene further discloses the monitoring of hemoglobin concentration, as it allows to show the effectiveness and correctness of the blood treatment (Paragraph [0125]; Paragraph [0174]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the attribute of Peesapati to include hemoglobin as taught by Bene because Bene discloses monitoring hemoglobin allows to show the effectiveness and correctness of the blood treatment (Bene, Paragraph [0125]; Paragraph [0174]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD C GURTOWSKI whose telephone number is (571)272-3189. The examiner can normally be reached 9:00 am-5:30pm.
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/RICHARD C GURTOWSKI/Primary Examiner, Art Unit 1773 05/14/2026
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