DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 30 March 2026 has been entered. Claim(s) 46-48 is/are currently amended. Claim(s) 3-8, 11, 14-15, 18-23, 26, 29-30, 33-38, 41 and 44-45 was/were previously canceled. No new claims have been added. Claim(s) 1-2, 9-10, 12-13, 16-17, 24-25, 27-28, 31-32, 39-40, 42-43 and 46-48 remain(s) pending.
Objections and/or Rejections Withdrawn
Objections to the drawings and objections to the claims not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted replacement drawings sheet(s).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1-2, 10, 12, 16-17, 25, 27, 31-32, 40 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0276439 A1 (previously cited, Miesel) in view of US 2010/0312084 A1 (previously cited, Radojicic).
Regarding claims 1 and 12, Miesel discloses and/or suggests a method for monitoring cardiopulmonary function of a patient based on cerebrospinal fluid (CSF) pressures, the method comprising:
fluidly communicating a first catheter with a first CSF access site of the patient (¶ [0084] a first of a plurality of intrathecal and/or intracerebroventricular catheters);
fluidly communicating a second catheter with a second CSF access site of the patient (¶ [0084] a second of a plurality of intrathecal and/or intracerebroventricular catheters);
providing, using a first pressure sensor in fluid communication with the first catheter, first pressure readings associated with the first CSF access site and providing, using a second pressure sensor in fluid communication with the second catheter, second pressure readings associated with the second CSF access site (¶ [0084] pressure sensor(s) coupled to each of the first and second catheters to measure pressure changes with the CSF of the patient); and
determining a cardiopulmonary function parameter associated with the patient based on pressure signals derived from at least one of the pressure readings, wherein the cardiopulmonary function parameter comprises heart rate and/or respiration rate (¶¶ [0157]-[0158] CSF pressure may be analyzed to monitor the heart rate and breathing rate of a patient 12).
While Miesel discloses/suggests providing first and second catheters with respective first and second pressure sensors, as noted above, Miesel does not expressly disclose determining the cardiopulmonary function parameter(s) based on first and second pressure signals derived from the first and second pressure readings.
Radojicic discloses a comparable method comprising fluidly coupling at least one catheter with at least one CSF access site of the patient and providing, using at least one pressure sensor in fluid communication with the at least one catheter, pressure readings associated with the at least one CSF access site (e.g., ¶ [0012] lumbar catheter coupled to medical probe sensing intrathecal pressure). Radojicic further discloses acquiring readings from at least two pressure sensors enables comparing pressure signals derived from the readings of each pressure sensor to increase accuracy of determined parameters (e.g., ¶ [0074] combinations of medical probes are possible, such that signals from the respective probes could be compared to each other to cancel out noise, as well as be compared to an external signal).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Miesel with determining the cardiopulmonary function parameter(s) based on first and second pressure signals derived from the first and second pressure readings as taught/suggested by Radojicic in order to improve the accuracy/reliability of the pressure signals and/or parameter(s) determined therefrom.
Regarding claims 16 and 27, Miesel discloses and/or suggests a system for monitoring cardiopulmonary function of a patient based on CSF pressures, the system comprising:
a first catheter for fluidly communicating with a first CSF access site of the patient (¶ [0084] a first of a plurality of intrathecal and/or intracerebroventricular catheters);
a second catheter for fluidly communicating with a second CSF access site of the patient (¶ [0084] a second of a plurality of intrathecal and/or intracerebroventricular catheters);
a first pressure sensor in fluid communication with the first catheter to provide first pressure readings associated with the first CSF access site and a second pressure sensor in fluid communication with the second catheter to provide second pressure readings associated with the second CSF access site (¶ [0084] pressure sensor(s) coupled to each of the catheters to measure pressure changes with the CSF of the patient); and
a physiological parameter monitor operatively coupled to receive the first and second pressure readings from the first and second pressure sensors (¶¶ [0074]-[0075] each of sensors 40 is coupled to IMD 14 and provides signals thereto) and to determine a cardiopulmonary function parameter associated with the patient based on first and second pressure signals derived from the first and second pressure readings, wherein the cardiopulmonary function parameter comprises heart rate and/or respiration rate (¶¶ [0157]-[0158] CSF pressure may be analyzed to monitor the heart rate and breathing rate of a patient 12).
While Miesel discloses/suggests the system may comprise first and second catheters with respective first and second pressure sensors, as noted above, Miesel does not expressly disclose the monitor determines the cardiopulmonary function parameter(s) therefrom.
Radojicic discloses a comparable system comprising at least one catheter for fluidly communicating with at least one CSF access site of the patient and at least one pressure sensor in fluid communication with the catheter(s) to provide pressure readings associated with the at least one CSF access site (e.g., ¶ [0012] lumbar catheter coupled to medical probe sensing intrathecal pressure). Radojicic further discloses acquiring readings from at least two pressure sensors enables comparing pressure signals derived from the readings of each pressure sensor to increase accuracy of determined parameters (e.g., ¶ [0074] combinations of medical probes are possible, such that signals from the respective probes could be compared to each other to cancel out noise, as well as be compared to an external signal).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Miesel with the monitor determining the cardio-pulmonary function parameter(s) associated with the patient based on first and second pressure signals derived from received first and second pressure readings as taught/suggested by Radojicic in order to improve the accuracy/reliability of the pressure signals and/or parameter(s) determined therefrom.
Regarding claims 31 and 42, Miesel discloses and/or suggests a computer program product comprising at least one tangible, non-transitory computer-readable medium having embodied therein computer program instructions for monitoring cardiopulmonary function of a patient based on cerebrospinal fluid (CSF) pressures, which, when executed by at least one processor of a computer system (e.g., Fig. 2, IMD 14, or processor 46 thereof; ¶ [0072]; etc.), causes the computer system to perform a method comprising:
receiving, from a first pressure sensor in fluid communication with a first catheter, first pressure readings associated with a first CSF access site (¶ [0084] a first of a plurality of intrathecal and/or intracerebroventricular catheters and its respective sensor(s); ¶¶ [0074]-[0075] each of sensors 40 is coupled to IMD 14 and provides signals thereto; etc.);
receiving, from a second pressure sensor in fluid communication with a second catheter, second pressure readings associated with a second CSF access site (¶ [0084] a first of a plurality of intrathecal and/or intracerebroventricular catheters and its respective sensor(s); ¶¶ [0074]-[0075] each of sensors 40 is coupled to IMD 14 and provides signals thereto; etc.); and
determining a cardiopulmonary function parameter associated with the patient based on pressure signals derived from at least one of the pressure readings, wherein the cardiopulmonary function parameter comprises heart rate and/or respiration rate (¶¶ [0157]-[0158] CSF pressure may be analyzed to monitor the heart rate and breathing rate of a patient 12).
While Miesel discloses/suggests providing first and second catheters having respective first and second pressure sensors, as noted above, Miesel does not expressly disclose determining the cardiopulmonary function parameter(s) based on first and second pressure signals derived from the first and second pressure readings.
Radojicic discloses a comparable method comprising fluidly coupling at least one catheter with at least one CSF access site of the patient and providing, using at least one pressure sensor in fluid communication with the at least one catheter, pressure readings associated with the at least one CSF access site (e.g., ¶ [0012] lumbar catheter coupled to medical probe sensing intrathecal pressure). Radojicic further discloses acquiring readings from at least two pressure sensors enables comparing pressure signals derived from the readings of each pressure sensor to increase accuracy of determined parameters (e.g., ¶ [0074] combinations of medical probes are possible, such that signals from the respective probes could be compared to each other to cancel out noise, as well as be compared to an external signal).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Miesel with determining the cardiopulmonary function parameter(s) based on first and second pressure signals derived from the first and second pressure readings as taught/suggested by Radojicic in order to improve the accuracy/reliability of the pressure signals and/or parameter(s) determined therefrom.
Regarding claims 2, 17 and 32, Miesel as modified discloses/suggests the first CSF access site is associated with a brain ventricle of the patient (¶ [0084] one of the catheters may comprise an intracerebroventricular catheter) and the second CSF access site is associated with the patient's lumbar (¶ [0084] one of the catheters may comprise an intrathecal catheter, which encompasses lumbar catheters, as evidenced throughout Radojicic, i.e., "lumbar intrathecal catheter").
Regarding claims 10, 25 and 40, Miesel as modified discloses/suggests a catheter has a first end coupled with the first CSF access site (e.g., ¶ [0084] the catheters may comprise an intracerebroventricular catheter) and a second end coupled with the second CSF access site (e.g., ¶ [0084] the catheters may comprise an intrathecal, e.g., lumbar catheter), the first pressure sensor being closer to the first end than the second end, and the second pressure sensor being closer to the second end than the first end (e.g., ¶ [0084] a respective sensor(s) of each of said catheters). The examiner notes the limitation "a catheter" of the above-noted claims has been interpreted to encompass separate first and second catheters of a fluid circuit as disclosed by Miesel, consistent with Applicant's specification (e.g., ¶ [0097] as published).
Claim(s) 9, 24, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miesel in view of Radojicic as applied to claim(s) 1, 16 and 31 above; and/or over Miesel in view of Radojicic as applied to claim(s) 1, 16 and 31 above, and further in view of US 2017/0135635 A1 (previously cited, Bostick).
Regarding claims 9, 24, and 39, Miesel as modified discloses/suggests the limitations of claims 1, 16 and 31, respectively, as discussed above, but does not expressly disclose the method further comprises taking a baseline reading using the first and/or second pressure signals to determine a baseline for the cardiopulmonary function parameter, and storing the baseline reading in a database. However, Miesel discloses respective thresholds for measured parameters that are used to distinguish between patient states (e.g., asleep or awake) may be stored in said memory (e.g., ¶¶ [0087]-[0088]).
Bostick discloses/suggests a method comprising taking a baseline reading using sensor signals to determine a baseline for the cardiopulmonary function parameter, and storing the baseline reading in a database (e.g., ¶ [0057] storing historical sensor data, and any baselines, e.g., resting heart rate, derived therefrom, in persistent memory). Bostick, similar to Miesel, discloses comparing current sensor values to the stored baseline, or a threshold based thereon, to distinguish between patient states (e.g., ¶ [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Miesel with the method further comprises taking a baseline reading using the first and/or second pressure signals to determine a baseline for the cardiopulmonary function parameter, and storing the baseline reading in a database as taught and/or suggested by Bostick as a simple substitution of one known method for distinguishing between patient states for another to yield no more than predictable results. See MPEP 2143(I)(B).
Alternatively/Additionally, Radojicic discloses analyzing physiological data and generating warning signals in event the physiological data falls outside of expected norms. Since one of ordinary skill in the art would readily appreciate "expected norms" for physiological data, such as heart and respiration rates, differ among subjects due to normal intersubject variability, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Miesel with taking a baseline reading using the first and/or second pressure signals to determine a baseline for the cardiopulmonary function parameter, and storing the baseline reading in a database as taught/suggested by Radojicic in order to facilitate alerting the patient or medical personnel of a significant deviation from expected parameter values (Radojicic, ¶ [0074]).
Claim(s) 10, 13, 25, 28, 40 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miesel in view of Radojicic as applied to claim(s) 1, 16 and 31 above, and/or over Miesel in view of Radojicic as applied to claim(s) 1, 16 and 31 above, and further in view of US 2018/0185058 A1 (previously cited, Anand).
Regarding claims 10, 25 and 40, Miesel as modified discloses/suggests the limitations of said claims, as discussed above. Alternatively/Additionally, Anand discloses a catheter (Fig. 20, catheter 102) comprising a first pressure sensor coupled with the catheter and providing pressure readings associated with a first CSF access site of a patient (e.g., ¶ [0139] sensor 108D) and a second pressure sensor coupled with the catheter and providing pressure readings associated with a second CSF access site of a patient (e.g., ¶ [0139] sensor 108P), wherein a catheter has a first end coupled with the first CSF access site (e.g., distal end of the catheter) and a second end coupled with the second CSF access site (e.g., proximal end of the catheter), the first pressure sensor being closer to the first end than the second end, and the second pressure sensor being closer to the second end than the first end (e.g., Fig. 20A; ¶ [0139] where sensors 108P and 108D are mounted adjacent to ports 112P and 112D, respectively).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Miesel with a catheter having a first end coupled with the first CSF access site and a second end coupled with the second CSF access site, the first pressure sensor being closer to the first end than the second end, and the second pressure sensor being closer to the second end than the first end as taught/suggested by Anand in order to facilitate delivering multiple drugs, delivering the same drug with substantially instantaneous distribution along the entire spinal column, contain an infused drug in a given area of the spine, etc. (Anand, ¶ [0139]-[0147]), while maintaining the capability of measuring CSF pressure in at least two sites for increased accuracy (see discussion of claim 1 above; Anand, ¶ [0152]; etc.).
Regarding claims 13, 28, and 43, Miesel as modified discloses/suggests the method further comprises fluidly communicating a third catheter with a third CSF access site of the patient; detecting, using a third pressure sensor in fluid communication with the third catheter, third pressures and producing third pressure signals based on the third pressures (e.g., Miesel, ¶ [0084] "one or more…catheters" encompasses three catheters having a respective sensor(s)); and using the third pressure signals in combination with the first pressure signals and the second pressure signals to determine the cardiopulmonary function parameter (e.g., Radojicic, ¶ [0074] improving accuracy/reliability of pressure signals and/or parameter(s) derived therefrom by utilizing multiple sensors, see discussion of independent claims above).
Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Miesel with a third catheter for fluidly communicating with a third CSF access site of the patient; and a third pressure sensor in fluid communication with the third catheter to provide third pressure readings associated with the first CSF access site, wherein the physiological parameter monitor is further configured for receiving the third pressure readings from the third pressure sensor and determining the cardiopulmonary function parameter associated with the patient based on third pressure signals derived from the third pressure readings in combination with the first and second pressure signals because Applicant has not disclosed that including a third catheter, third pressure sensor, and third pressure signals therefrom provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with any number of catheters and/or CSF access sites because either arrangement enables measuring pressure and/or a cardiopulmonary parameter(s) with increased accuracy.
Further alternatively/additionally, Anand discloses a system comprising a first catheter having a first sensor coupled thereto providing first pressure readings associated with a first CSF access site (Fig. 20, catheter 102, or portion thereof including sensor 108P); a second catheter having a second sensor coupled thereto providing second pressure readings associated with a second CSF access site (Fig. 20, catheter 102, or portion thereof including sensor 108M); and a third catheter having a third sensor coupled thereto providing third pressure readings associated with a third CSF access site (Fig. 20, catheter 102, or portion thereof including sensor 108D); and a physiological parameter monitor operatively coupled to receive the first, second and third pressure readings from the first, second and third pressure sensors (¶ [0139] controller 104 or other device). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Miesel with a third catheter for fluidly communicating with a third CSF access site of the patient; and a third pressure sensor in fluid communication with the third catheter to provide third pressure readings associated with the first CSF access site, wherein the physiological parameter monitor is further configured for receiving the third pressure readings from the third pressure sensor and determining the cardiopulmonary function parameter associated with the patient based on third pressure signals derived from the third pressure readings in combination with the first and second pressure signals as taught and/or suggested by Anand in order to facilitate delivering multiple drugs, delivering the same drug with substantially instantaneous distribution along the entire spinal column, contain an infused drug in a given area of the spine, etc. (Anand, ¶ [0139]-[0147]), while maintaining the ability to measure CSF pressure in at least two sites for increased accuracy (see discussion of claim 1 above; Anand, ¶ [0152]; etc.).
Claim(s) 46-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miesel in view of Radojicic as applied to claim(s) 1, 16 and 31 above, and further in view of US 2020/0397307 A1 (previously cited, Haartsen).
Regarding claims 46-48, Miesel as modified discloses/suggests the limitations of claims 1, 16 and 31, as discussed above, but does not expressly disclose the step(s) by which the cardio-pulmonary function parameter(s) are determined. However, Miesel discloses higher frequency fluctuations (e.g. 40 to 150 beats per minute) in the overall CSF pressure signal can be identified as the heart rate while lower frequency fluctuations (e.g. 3 to 20 breaths per minute) in said signal are the breathing rate, and the physiological parameter monitor (IMD 14) may be configured to employ filters, transformations, or other signal processing techniques to identify the heart rate and breathing rate from the CSF pressure signal (e.g., ¶ [0158]).
Haartsen discloses applying a Fourier Transform to first and second signals containing a cardiac component (i.e., PPG sensor signals, throughout document) to determine heart rate (e.g., Figs. 9-11; ¶¶ [0045]-[0047]; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Miesel with the physiological parameter monitor being configured to determining a cardiopulmonary function parameter(s) by applying a Fourier Transform to the first and second pressure signals as taught/suggested by Haartsen as a simple substitution of one known method for identifying periodicity or frequency fluctuations in the CSF pressure signal in a given range for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to claims 1, 16, and 31, Applicant contends, "The portion of Radojicic cited by the Office concerns comparison of outputs from multiple pressure probes, including for cancellation of noise or comparison to an external signal. That is a teaching directed to signal checking or refinement. It is not a teaching of determining a cardiopulmonary function parameter as a function of first and second pressure signals derived from pressure readings at first and second CSF access sites" and further submits, "The Examiner's rationale for combination also falls short. A general assertion that multiple sensors may improve accuracy or reliability may support adding redundancy or signal validation, but it does not explain why a person of ordinary skill would have modified Miesel to arrive at the claimed determination based on first and second pressure signals" (Remarks, pgs. 14-15).
The examiner respectfully disagrees. As noted in the rejection of record, Miesel discloses each of the first and second pressure signals are acquired, but merely does not expressly disclose each signal is used in determining the cardiopulmonary function parameter(s). Radojicic discloses and/or suggests acquiring readings from at least two pressure sensors enables comparing pressure signals derived from the readings of each pressure sensor to increase accuracy of determined parameters. The proposed modification in view of Radojicic is to use all of the relevant existing data Miesel (e.g., each of the first and second pressure signals) in determining the cardiopulmonary function parameter(s) to increase the accuracy/reliability of said determination(s). There is no particular method or means of determination required by claims 1, 16, and 31, nor is any particular method or means of determination proposed in view of the disclosure of Radojicic in the rejections of record. All that is required is that the determination is based on both signals. Even if the disclosure of Radojicic only reasonably discloses and/or suggests "signal checking or refinement," as Applicant contends, using one of the first and second pressure signal to "check" or "refine" the other of said signals, and then determining the cardiopulmonary function parameter(s) from the checked or refined pressure signal meets the limitations of claims 1, 16, and 31. However, contrary to Applicant's assertions, Radojicic does not appear to limit comparing signals and cancelling noise to only raw sensor signal, but more generally "signals from the respective probes" (e.g., ¶ [0074]). Radojicic discloses said signals may include a pressure waveform (e.g., ¶ [0071], ¶ [0074]); pulsatile components of said pressure (e.g., ¶ [0074]); average pressures (e.g., ¶ [0074]); beat to beat variation (e.g., ¶ [0074]); Fourier transforms (e.g., ¶ [0074]); etc.
With respect to the remaining pending claims, Applicant submits said claims are allowable at least due to their dependence on independent claims 1, 16, and 31. The examiner respectfully disagrees for at least the reasons noted above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: cited on the PTO-892 mailed herewith, US 2019/0029547 A1 to Watarai discloses determining a cardiopulmonary function parameter(s) (e.g., heart rate, respiratory rate) associated with a patient based on first and second signals acquired from a plurality of detection units, for example, by averaging a cardiopulmonary function parameter determined from the signal output by each unit to increase the accuracy of the determined parameter(s) (e.g., Fig. 11; ¶ 0088]); and US 2013/0139817 A1 to von Blumenthal discloses determining a cardiopulmonary function parameter(s) (e.g., SPO2) associated with a patient based on first and second signals acquired from a plurality of detection units, for example, by comparing said parameter or an additional parameter (e.g., heart rate) determined from each of the first and second signals for selection or averaging (e.g., ¶ [0009]). An English machine translation of Non-Patent Literature Cite No. 3 on the IDS filed 18 April 2025 is also cited on said PTO-892 and mailed herewith.
THIS ACTION IS MADE FINAL. 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 Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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