DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed April 1, 2026.
Status of Claims
1. Claims 1. 2, 5-20, 23-25 and 28-30 are pending and currently under consideration for patentability.
Claims 3, 4, 21, 22, 26 and 27 are canceled as of the April 1, 2026 claim amendment.
Response to Arguments
2. Applicant's arguments filed April 1, 2026 have been fully considered but they are not persuasive.
With regard to applicant’s argument that Browd fails to teach “a patient interface assembly comprising at least one wearable pressure sensor assembly configured for attaching proximate to a patient anatomical marker,” examiner respectfully disagrees. Applicant provides a specific definition for “a patient anatomical marker” of the type recited in claim 1 as “a physiological attribute or feature that is non-invasively identifiable and for which there may be clinical significance relative to an internal position.” However, as previously cited by examiner in the rejection of claim 3 in the most recent Office action, Browd not only suggests the wearable pressure sensors (106) is configured for attaching proximate to a torso (at cited [0030] and seen in Fig. 1B), or in a sub-clavicular pocket ([0027] and seen in Fig. 1A), for ease of exchange of the wearable pressure assembly as the patient grows, and negates the need to shave the patient's scalp to perform cranial surgery in the event that a component requires replacement or repair, and thus avoids the need for repeated incisions in the scalp that can cause devascularization, poor wound healing, and/or infection ([0027]). According to applicant’s definition, a patient’s torso and sub-clavicular pocket would clearly be considered to one having ordinary skill in the art as being anatomical markers, as well as being proximate to other patient anatomical markers, such as the ribs, belly button, waist, hips, sternum, neck, shoulders, etc.
With further regard to applicant’s argument that Browd does not teach sensors in direct fluid communication with body fluid, as presently required by amended claim 1, examiner agrees. However, these limitations were taken from canceled claim 4 and incorporated into claim 1 – and claim 4 was previously rejected under 35 U.S.C. 103 as being unpatentable over Browd in view of Burnett et al. (WO 2014/210453 A2), where examiner also stated that Browd fails to explicitly disclose that the pressure sensor is in direct fluid communication with the body fluid, and Burnett is relied upon as a secondary reference for rejection. With regard to applicant’s argument that “Burnett teaches a system with sensors contained within air-filled lumens. While paragraphs [0142] & [0149] of Burnett mention possible fluid sensing in the bed-mounted urinary receptacle, Burrnett fails to teach how this would be achieved given the system disclosed, nor does Burrnett teach in-line fluid sensing. As a result, Burnett does not teach or suggest to one of skill in the art to modify Browd to include inline fluid sensing,” examiner respectfully disagrees. As cited by examiner in the rejection of claim 4 from most recent Office action, the Abstract of Burnett clearly discloses “Sensing Foley catheter variations are described herein which may comprise a fluid chamber defining a receiving channel and a port fluidly coupled to a drainage lumen of the catheter such that the receiving channel is in fluid communication with the drainage opening. A pressure sensing mechanism located within the fluid chamber may comprise a pressure sensing mechanism which is configured to detect fluid pressure when body fluid, such as urine, is introduced into the drainage opening of the catheter and is received within the receiving channel and impinges upon the pressure sensing mechanism.” Burnett also discloses multiple sensing catheter variations with a pressure sensor (2708, 2908, 3008) in direct fluid communication with the body fluid (Fig. 27A; [0223]; Figs. 29A-C; [0227]; Figs. 30A-B; [0231]). Accordingly, one having ordinary skill in the art would agree that Burnett discloses in-line fluid sensing as required by the claim, and examiner maintains that the teachings of Burnett render obvious the use of in-line fluid sensors within the system of Browd, in order to make exposure assessment more convenient and comprehensive thereby providing better opportunity for deriving critical diagnostic information, as suggested by Burnett in paragraphs [0066] and [0176]. Such a modification to Browd would be readily achieved through a replacement of “sensors 106 [that] can measure pressure within the catheter 102, flow rate of the body fluid through the catheter 102, and/or other desired measurements associated with body fluid drainage through the drainage system 100” (Browd [0028]) with in-line fluid sensors, similar to that disclosed by Burnett, at comparable locations relative to the valve, with a reasonable expectation of success.
With regard to applicant’s argument that one skilled in the art would recognize the sensor configuration of Cherian to be an electrical subassembly intended for installation on a printed circuit board assembly or similar to be manufactured into a device, therefore Cherian only appears to disclose interchangeable components at the manufacturing level rather than an interchangeable assembled end product as recited in claim 19, and accordingly Cherian fails to teach how such a sensor would be integrated directly into a medical device at the bedside by a clinical user such as a nurse; examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “an interchangeable assembled end product”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 19 merely calls for “at least one customizable sensor assembly configured for integration of an interchangeable sensor subassembly.” Cherian, in the analogous field of chemical sensors with replaceable chips (abstract) and teaches at least one customizable sensor assembly (at least one customizable sensor assembly configured for integration of an interchangeable sensor subassembly...chemical sensor, 34 may detect just one chemical or it may have multiple sensors adjacent each other on the same die to sense dozens of different chemicals with a single sensor, Col. 2, Ln. 59 through Col. 3, Ln. 12) configured for integration of an interchangeable sensor subassembly (first semiconductor die, 32 is a replaceable semiconductor die, Col. 3, Lns. 48-62). One having ordinary skill in the art would understand that such a sensor would be integrated into the at least one wearable pressure sensor assembly (positioned proximate to the valve device, 104 can be used to derive ICP, [0030]) of Browd with a reasonable expectation of success.
With regard to applicant’s argument that Browd fails to teach any relationship between ICP, CSF drainage and gait such that there is no motivation or suggestion in Browd to consider Lee in the first instance, nor is there any teaching in Browd nor Lee as to how Lee’s sensor assembly could be integrated into Browd without changing the principle of operation of Browd, examiner respectfully disagrees. In response to applicant's argument that Lee appears to teach a device with a much larger footprint than would be possible for one of ordinary skill in the art to incorporate into the device taught by Browd in order to modify Browd and arrive at the features of claim 23, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, examiner is not intending to take the exact motion sensor assembly of Lee and bodily incorporate it directly into the system of Browd, rather examiner is taking the combined teachings of Browd and Lee and stating what would have been suggested to those of ordinary skill in the art; namely, that it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Browd to include at least one wearable motion sensor assembly, similar to that taught by Lee, in order to provide a friendly interface to the medical providers to study interlimb coordination for pathological gait analysis and make medical decisions based on both the visual observation and automatic calculation, as suggested by Lee in the Introduction and Page 2. Further, in paragraphs [0030] and [0032] of Browd, an orientation sensor is clearly suggested for measuring the ICP of the patient regardless of orientation, whether it be standing, lying or in-between. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “orientation and movement of body cavity and associated regions such as lumbar, not extremities”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim merely calls for “at least one wearable motion sensor assembly.”
With regard to applicant’s argument that claim 28 that Mjosund’s conclusion itself acknowledges it has not demonstrated a method for measuring more complex movements or subtle changes associated with treatment changes, thus claim 28 is independently allowable, examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a method for measuring more complex movements or subtle changes associated with treatment changes as required for Normal Pressure Hydrocephalus surgical assessment”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim merely calls for “wherein the at least one wearable motion sensor assembly is configured to be worn at an anatomical marker for the lumbar region.”
As a final matter, with regard to applicant’s argument against the rejection of claim 30, that one having ordinary skill in the art would be familiar with normal pressure hydrocephalus as named in claim 30 as a specific clinical condition not addressed by Bowd, examiner respectfully disagrees. Browd, as modified by Lee, discloses the system of claim 29, wherein Browd further discloses that the control system assembly is configured to detect normal pressure hydrocephalus that may be improved by a shunt (controller 110, e.g., a microprocessor, can read the measurements taken from the sensors 106...controller 110 can compare pressure measurements from the sensors 106 with a desired ICP, [0033]; Treatment for hydrocephalus generally requires the installation of a CSF shunt that drains CSF, [0004]; the control system is capable of detecting normal pressure hydrocephalus).
Accordingly, the grounds of rejection previously presented are maintained herein.
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.
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.
3. Claim(s) 1, 2, 5-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Browd in view of Burnett et al. (WO 2014/210453 A2; copy on-file provided by applicant).
4. With regard to claim 1, Browd discloses a body fluid management system (100; [0002]; abstract), comprising: a control system assembly (controller, 110, Fig. 1A, 1B) for real-time monitoring of a pressure of a body fluid (110 can manage body fluid flow in real-time to maintain the ICP, [0033]); a patient interface assembly (catheter, 102 connected to housing, 128, Fig. 1A) comprising at least one wearable pressure sensor assembly (sensors, 106 that are positioned proximate to the valve device, 104 in the torso of the patient, 101 can be used to derive ICP, [0030]) configured for attaching proximate to a patient anatomical marker (sensors, 106 that are positioned proximate to the valve device, 104 in the torso of the patient, 101, [0027]; [0030], Figs. 1A, 1B); and at least one sensor assembly (additional sensors, 236 can be coupled to other portions of the catheter, 102, [0051]) configured for detecting at least one parameter of the body fluid (additional sensors, 236...measure additional pressures, flow rates, and/or other desired properties of the flow through the valve device 104, [0051]).
While Browd discloses that the wearable pressure sensor assembly comprises at least one pressure sensor (sensors, 106 can measure pressure within the catheter 102; [0028]), Browd fails to explicitly disclose that the pressure sensor is in direct fluid communication with the body fluid.
However, Burnett is in the field of sensing catheters (abstract; Figs. 27A, 29A-C, 30A-B), and teaches the pressure sensor (2708, 2908, 3008) is in direct fluid communication with the body fluid (pressure sensor is in fluid communication with the urine lumen of a Foley catheter, Fig. 27A; [0223]; Figs. 29A-C; [0227]; Figs. 30A-B; [0231]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wearable pressure sensor assembly disclosed by Browd to include pressure sensor is in direct fluid communication with the body fluid, similar to that taught by Burnett, in order to make exposure assessment more convenient and comprehensive thereby providing better opportunity for deriving critical diagnostic information, as suggested by Burnett in paragraphs [0066] and [0176].
a pressure sensor (2708, 2908, 3008) in direct fluid communication with the body fluid (Fig. 27A; [0223]; Figs. 29A-C; [0227]; Figs. 30A-B; [0231]). Accordingly, one having ordinary skill in the art would agree that Burnett discloses in-line fluid sensing as required by the claim, and examiner maintains that the teachings of Burnett render obvious the use of in-line fluid sensors within the system of Browd, in order to make exposure assessment more convenient and comprehensive thereby providing better opportunity for deriving critical diagnostic information, as suggested by Burnett in paragraphs [0066] and [0176].
5. With regard to claim 2, Browd discloses the system of claim 1, wherein the control system assembly (110) comprises integrated control of drainage of the body fluid ([0033]).
6. With regard to claim 5, Browd discloses the system of claim 1, wherein the control system (110) is configured for monitoring for changes in pressure of the body fluid (the controller 110 can compare pressure measurements from the sensors 106 with a desired ICP to determine whether to incrementally open or close the valve device, 104, [0033]).
7. With regard to claim 6, Browd discloses the system of claim 1, but fails to explicitly disclose wherein the at least one sensor assembly is an analyte sensor assembly in direct fluid communication with the body fluid.
However, Burnett is in the field of sensing catheters (abstract) and teaches the at least one sensor assembly is an analyte sensor assembly (Foley type catheter further includes one or more analyte sensors, [0019]) in direct fluid communication with the body fluid (analyte sensor in fluid communication with the receiving channel, Claim 14; [0007]; [0038-0040]).
Accordingly, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the at least one sensor assembly disclosed by Browd to include the at least one sensor assembly as an analyte sensor assembly in direct fluid communication with the body fluid, similar to that taught by Burnett, in order to make exposure assessment more convenient and comprehensive thereby providing better opportunity for deriving critical diagnostic information, such as sensing analytes of clinical significance, as suggested by Burnett in paragraphs [0007], [0038-0040] and [0176].
8. With regard to claim 7, Browd as modified by Burnett discloses the system of claim 6, wherein the control system assembly comprises integrated control of drainage of the body fluid ([0033] of Browd).
9. With regard to Claim 8, Browd as modified by Burnett discloses the system of claim 6, but fails to explicitly disclose wherein the analyte sensor is disposed within a sealed fluid path of the body fluid.
However, Burnett is in the field of sensing catheters (abstract) and teaches the analyte sensor is disposed within a sealed fluid path of the body fluid (analyte sensor in fluid communication with the receiving channel, Claim 14; Foley type catheter with a pressure sensor and one or more analyte sensors, [0038], the pressure sensing catheter may have a balloon for sealing the urine drainage tumen of the Foley type catheter, [0235]).
Accordingly, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analyte sensor disclosed by Browd in view of Burnett to include the analyte sensor disposed within a sealed fluid path of the body fluid, similar to that taught by Burnett, in order to provide a durable system with liquid-tight seal thereby avoiding fluid leaks and infections, as suggested by Burnett in paragraphs [0072-0074].
10. With regard to Claim 9, Browd as modified by Burnett discloses the system of claim 6, but fails to explicitly disclose wherein the analyte sensor assembly is configured for detecting salinity of the body fluid.
However, Burnett is in the field of sensing catheters (abstract) and teaches the analyte sensor assembly is configured for detecting Salinity of the body fluid (disclosed technology include sensors for analytes of any clinical significance...analyte selected from a group including pH, a gas, an electrolyte, [0019]).
Accordingly, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analyte sensor disclosed by Browd in view of Burnett to be configured for detecting salinity of the body fluid, similar to that taught by Burnett, in order to detect and monitor critical analyte parameters thereby alerting healthcare provider about potential health risks or conditions, as suggested by Burnett in paragraphs [0072-0074].
11. With regard to Claim 10, Browd as modified by Burnett discloses the system of claim 6, but fails to explicitly disclose wherein the analyte sensor assembly is configured for detecting glucose level of the body fluid.
However, Burnett is in the field of sensing catheters (abstract) and teaches the analyte sensor assembly is configured for detecting glucose level of the body fluid (disclosed technology include sensors for analytes of any clinical significance...analytes may include glucose, [0019]).
Accordingly, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analyte sensor disclosed by Browd in view of Burnett to be configured for detecting glucose levels of the body fluid, similar to that taught by Burnett, in order to detect and monitor critical analyte parameters thereby alerting healthcare provider about potential health risks or conditions, as suggested by Burnett in paragraphs [0019] and [0072-0074].
12. With regard to claim 11, Browd as modified by Burnett discloses the system of claim 6, but fails to explicitly disclose wherein the analyte sensor assembly is configured for detecting protein concentration of the body fluid.
However, Burnett is in the field of sensing catheters (abstract) and teaches the analyte sensor assembly is configured for detecting protein concentration of the body fluid (Sensors within the catheter or within the collection reservoir may also detect...protein, [0073]).
Accordingly, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analyte sensor disclosed by Browd in view of Burnett to be configured for detecting protein concentrations of the body fluid, similar to that taught by Burnett, in order to detect and monitor critical analyte parameters thereby alerting healthcare provider about potential health risks or conditions, as suggested by Burnett in paragraphs [0019] and [0072-0074].
13. With regard to claim 17, Browd discloses the system of claim 1, wherein the control system (110) communicates a quantitative value derived from the sensor assembly (controller, 110...can read the measurements taken from the sensors, 106 e.g., pressure, flow rate, orientation, etc., [0033]).
14. Claim(s) 12-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Browd in view of Burnett, as applied to claim 1 above, and further in view of Burnett et al. (USPGPUB 2019/0321588; hereinafter referred to as ‘Potrero’).
15. With regard to claims 12-16, Browd in view of Burnett discloses the system of claim 1, but fail to explicitly disclose that the at least one sensor assembly is a physiological sensor assembly (claim 12): configured for detecting color of the body fluid (claim 13); configured to detect opacity of the body fluid (claim 14); configured for detecting particulate in the body fluid (claim 15); or configured for detecting oxygen concentration in the body fluid (claim 16).
However, Potrero is in an analogous field of devices for analyzing body fluids (abstract), and teaches a physiological sensor assembly (drug residue may be detected in the collected urine using appropriate sensors, [0183]): configured for detecting color of the body fluid (other substances or characteristics of the collected urine which may be sensed include color, [0183]); configured to detect opacity of the body fluid (other substances or characteristics of the collected urine which may be sensed include color, [0183]); configured for detecting particulate in the body fluid (drug residue may be detected in the collected urine using appropriate sensors, [0183]); or configured for detecting oxygen concentration in the body fluid (sensors… delivering other forms of physiological data… oxygen saturation, [0114]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the at least one sensor assembly disclosed by Browd in view of Burnett to include a physiological sensor configured to detect color, opacity, particulates, and/or oxygen saturation within the body fluid, similar to that disclosed by Potrero, in order to in order to detect and monitor critical physiological parameters thereby alerting healthcare provider about potential health risks or conditions, as suggested by Portrero in paragraphs [0010], [0183] and [0214].
16. With regard to claim 18, Browd in view of Burnett discloses the system of claim 1, but fails to explicitly disclose that the control system communicates a qualitative parameter from the sensor assembly.
However, Potrero is in the field of devices for analyzing body fluids (abstract) and teaches the control system communicates a qualitative parameter from the sensor assembly (Electrical or optical fiber leads...allows communication of sensing signals between distally disposed sensors...further communication to a data processing apparatus or controller, [0110]; Any type of sensor may be used to sense any substance or quality of the collected urine; [0182]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the control system disclosed by Browd in view of Burnett to communicate a qualitative parameter from the sensor assembly, similar to that disclosed by Potrero, in order to sense any quality of the collected urine in real-time, to derive critical diagnostic information thereby enabling the healthcare provider in diagnosis and prognosis of potential diseases and take all necessary measures to improve the patient's condition at proper time, as suggested by Portrero in paragraphs [0010], [0182] and [0214].
17. Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Browd in view of Cherian et al. (US 8,650,953).
18. With regard to claim 19, Browd discloses a body fluid management system (100; [0002]; abstract), comprising: a control system assembly (controller, 110, Fig. 1A) for real-time monitoring of a pressure of a body fluid (110 can manage body fluid flow in real-time to maintain the ICP, [0033]); a patient interface assembly (catheter, 102 connected to housing, 128, Fig. 1A) comprising at least one wearable pressure sensor assembly (sensors, 106 that are positioned proximate to the valve device, 104 in the torso of the patient, 101 can be used to derive ICP, [0030]); and at least one sensor assembly (additional sensors, 236 can be coupled to other portions of the catheter, 102, [0051]) configured for detecting at least one parameter of the body fluid (additional sensors, 236...measure additional pressures, flow rates, and/or other desired properties of the flow through the valve device 104, [0051]).
However, Browd fails to explicitly disclose at least one customizable sensor assembly configured for integration of an interchangeable sensor assembly.
Cherian, in the analogous field of chemical sensors with replaceable chips (abstract) and teaches at least one customizable sensor assembly (at least one customizable sensor assembly configured for integration of an interchangeable sensor subassembly...chemical sensor, 34 may detect just one chemical or it may have multiple sensors adjacent each other on the same die to sense dozens of different chemicals with a single sensor, Col. 2, Ln. 59 through Col. 3, Ln. 12) configured for integration of an interchangeable sensor subassembly (first semiconductor die, 32 is a replaceable semiconductor die, Col. 3, Lns. 48-62).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Browd to include at least one customizable sensor assembly configured for integration of an interchangeable sensor subassembly, similar to that taught by Cherian, in order to provide a system that can be used in an inexpensive manner to perform multiple chemical detections through simple interchangeable parts (Col. 8, Lns. 30-40, Cherian).
19. With regard to claim 20, Browd as modified by Cherian discloses the system of claim 19, but fails to explicitly disclose the interchangeable sensor subassembly is an interchangeable analyte detection subassembly.
However, Cherian is in the field of chemical sensors with replaceable chips (abstract) and teaches the interchangeable sensor subassembly is an interchangeable analyte detection subassembly (Col. 8, Lns. 9-29).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the interchangeable sensor subassembly disclosed by Browd in view of Cherian to include an interchangeable analyte detection subassembly, similar to that taught by Cherian, in order to provide a system that can be used in an inexpensive manner to perform multiple chemical detections (Col. 8, Lns. 30-40, Cherian).
20. Claim(s) 23-25, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Browd in view of Lee et al. (A Fully Wireless Wearable Motion Tracking System with 3D Human Model for Gait Analysis, Vol. 12, Issue 12, Pg. 4051. 12 June 2021 (12.06.2021). [Retrieved on 14.01.2023]. Retrieved from the internet: entire document; cited within applicant’s IDS).
21. With regard to claim 23, Browd discloses a body fluid management system (100; [0002]; abstract), comprising: a control system assembly (controller, 110, Fig. 1A) for real-time monitoring of a pressure of a body fluid (110 can manage body fluid flow in real-time to maintain the ICP, [0033]); a patient interface assembly (catheter, 102 connected to housing, 128, Fig. 1A) comprising at least one wearable pressure sensor assembly (sensors, 106 that are positioned proximate to the valve device, 104 in the torso of the patient, 101 can be used to derive ICP, [0030]); and at least one sensor assembly (additional sensors, 236 can be coupled to other portions of the catheter, 102, [0051]) configured for detecting at least one parameter of the body fluid (additional sensors, 236...measure additional pressures, flow rates, and/or other desired properties of the flow through the valve device 104, [0051]).
However, Browd fails to explicitly disclose at least one wearable motion sensor assembly.
Lee, in the analogous field of wearable motion tracking systems and teaches at least one wearable motion sensor assembly (abstract)
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Browd to include at least one wearable motion sensor assembly, similar to that taught by Lee, in order to provide a friendly interface to the medical providers to study interlimb coordination for pathological gait analysis and make medical decisions based on bath the visual observation and automatic calculation, as suggested by Lee in the Introduction and Page 2.
22. With regard to claim 24, Browd, as modified by Lee above, discloses the system of claim 23, wherein Browd further discloses that the patient interface assembly comprises at least one orientation sensor (drainage system 100 can also include an orientation sensor, [0032]) configured to detect an orientation of a bady cavity containing the body fluid and movement of the body cavity (orientation sensor is used to determine the angle of repose standing, lying, or therebetween, [0032]; the orientation sensor is structurally capable of determining the orientation and movement of fluid containing body cavity).
23. With regard to claim 25, Browd, as modified by Lee above, discloses the system of claim 23, but fails to explicitly disclose wherein the wearable motion sensor assembly comprises at least one motion sensor configured to detect movement of the body.
However, Lee is in the field of wearable motion tracking systems (abstract) and teaches at least one motion sensor configured to detect movement of the body (wearable motion sensors can record detailed limb movement of the individual patient, introduction, Pg. 2).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wearable motion sensor assembly disclosed by Browd in view of Lee to include at least one motion sensor configured to detect movement of the body, similar to that taught by Lee, in order to provide a friendly interface to the medical providers to study interlimb coordination for pathological gait analysis and make medical decisions based on bath the visual observation and automatic calculation, as suggested by Lee in the Introduction and Page 2.
24. With regard to claim 29, Browd, as modified by Lee above, discloses the system of claim 23, but fails to explicitly disclose wherein the control system assembly is configured to derive gait from patient interface assembly inputs.
However, Lee is in the field of wearable motion tracking systems (abstract) and teaches the control system assembly is configured to derive gait from patient interface assembly inputs (microcontroller organizes the input data from the sensor...reconstructing the 3D model and performing gait analysis, Hardware Design, Pgs. 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the control system assembly disclosed by Browd in view of Lee to be configured to derive gait from patient interface assembly inputs, similar to that taught by Lee, in order to provide a friendly interface to the medical providers to study interlimb coordination for pathological gait analysis and make medical decisions based on bath the visual observation and automatic calculation, as suggested by Lee in the Introduction and Page 2.
25. With regard to claim 30, Browd, as modified by Lee above, discloses the system of claim 29, wherein Browd further discloses that the control system assembly is configured to detect normal pressure hydrocephalus that may be improved by a shunt (controller 110, e.g., a microprocessor, can read the measurements taken from the sensors 106...controller 110 can compare pressure measurements from the sensors 106 with a desired ICP, [0033]; Treatment for hydrocephalus generally requires the installation of a CSF shunt that drains CSF, [0004]; the control system is capable of detecting normal pressure hydrocephalus).
26. Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Browd in view of Lee, as applied to claim 23 above, and further in view of Mjosund et al. (Clinically acceptable agreement between the ViMove wireless motion sensor system and the Vicon motion capture system when measuring lumbar region inclination motion in the sagittal and coronal planes, BMC Musculoskeletal Disorders, Vol. 18, Pg. 124. 21 March 2017 (21.03.2017). [Retrieved on 17 January 2023]. Retrieved from the internet: entire document; supplied by applicant within IDS).
27. With regard to claim 28, Browd in view of Lee disclose the system of claim 23, but fails to explicitly disclose wherein the at least one wearable motion sensor assembly is configured to be worn at the lumbar region.
However, Mjosund is in the analogous field of wireless motion sensor systems (abstract) and teaches the at least one wearable motion sensor assembly is configured to be worn at the lumbar region (ViMove sensors were attached to each participant's skin at spina! levels T12 and $2, Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the at least one wearable motion sensor assembly disclosed by Browd in view of Lee to be configured to be worn at the lumbar region, similar to that taught by Mjosund, in order to measure the activity levels and lumbar inclination motion in daily life to determine the nature of the impairments that require remediation, as suggested by Mjosund throughout the disclosure.
Conclusion
28. 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.
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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