DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments filed on 06/23/2026 have been fully considered. Claims 1-3, 5, 10, 13-14, 20-23, 25, 28, 30-31, 38, 40-42, and 45 are pending in this application. Claims 1-3, 10, 13-14, 20, 23, 30, 38, 40-41, and 45 are amended. Claims 4, 6-9, 11-12, 15-19, 24, 26-27, 29, 32-37, 39, 43-44, and 46-55 are cancelled.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 1, 20, and 38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, amendment of the independent claims 1, 20, and 38 now requiring the regulating element comprising wax and in direct contact with the tubing.
The amendments to claims 2, 3, 10, 13, and 14 overcome the claim objections of record. The claim objections to claims 2-3, 10, and 13-14 are now withdrawn.
Though overall the same prior art references are used herein, at least applicant’s amended independent claims 1, 20, and 38 required a change in the grounds of rejection as detailed below in the prior art rejection.
Claim Objections
Claim 42 is objected to because of the following informalities:
Claim 42, line 1: “a valve” should read “the valve”. Appropriate correction is required.
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.
Claim(s) 1, 5, 13-14, 20, 28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (Publication No. US 2002/0052563 A1) in view of Ilios et al. (Publication No. US 2015/0202082 A1).
Regarding claim 1, Penn teaches a valve for regulating cerebrospinal fluid flow (control device 104 to control flow of CSF fluid; Paragraph 0104-0105; Figure 18), comprising: a tubing, configured to allow fluid flow therethrough (catheter 2 tubing; Figure 18; Paragraph 0104-0105). Penn does not teach a temperature controlled regulating element in direct contact with the tubing, the temperature controlled regulating element comprising a wax; and an actuator, arranged proximate to the temperature controlled regulating element, the actuator being configured to manipulate a parameter associated with the temperature controlled regulating element.
However, Ilios teaches a temperature controlled regulating element in direct contact with the tubing (membrane 220 with ferromagnet fluid 218 that is a ferrowax that is in direct contact with tubing 104 and opens and closes the valve based on the temperature of the valve; Paragraph 0059 and 0071), the temperature controlled regulating element comprising a wax (ferromagnet fluid 218 is a ferrowax; Paragraph 0071); and an actuator, arranged proximate to the temperature controlled regulating element (magnets 210/208 are actuators that are proximate to membrane 220 with ferromagnet fluid 218; Figure 2A; Paragraph 0058-0059 and 0071), the actuator being configured to manipulate a parameter associated with the temperature controlled regulating element (magnets 210/208 configured to change phase of ferrowax by adjusting the polarity of the magnets; Paragraphs 0059-0061 and 0071).
Penn and Ilios are considered to be analogous to the claimed invention because they are in the same field of fluidic valve devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn to incorporate the teachings of Ilios and have the valve of Penn to have the temperature regulating element and the actuator of Ilios on the tubing of Penn. This allows for the valve to be calibrated to the desired opening and closing pressures for microfluidic operations (Ilios; Paragraph 0052-0053).
Regarding claim 5, Penn in view of Ilios teaches the valve of claim 1. The combination of Penn in view of Ilios further teaches further comprising a sensor, wherein the sensor comprises at least one of a temperature sensor, a flowrate sensor, or a pressure sensor (Penn; sensor 16 is a pressure sensor; Figure 18; Paragraph 0107).
Regarding claim 13, Penn in view of Ilios teaches the valve of claim 1. The combination of Penn in view of Ilios further teaches wherein the wax comprises at least one additive (Ilios; ferrowax comprises the additive of ferrite particles in wax; Paragraph 0071).
Regarding claim 14, Penn in view of Ilios teaches the valve of claim 1. The combination of Penn in view of Ilios further teaches wherein the temperature controlled regulating element is configured to regulate resistance to the fluid flowing through the tubing, wherein the resistance is independent of intracranial pressure associated with a patient (Ilios; ferromagnet fluid 218 that is ferrowax in membrane 220 regulates resistance to fluid flow based on temperature of wax, independent of intracranial pressure; Figure 2A; Paragraph 0071).
Regarding claim 20, Penn teaches a system for regulating cerebrospinal fluid flow (system for regulating cerebrospinal fluid; Figure 18), comprising: a data processing device (external device 14; Figure 18; Paragraph 0103), configured to collect one or more biometric indicators associated with a patient, the biometric indicators selected from a heart rate, a blood pressure, a posture indicator, an exercise indicator, and an endogenous brain pressure (sensor 16 delivers data to external device 14, where the data is an intracranial pressure/endogenous brain pressure; Figure 18; Paragraph 0077-0078 and 0103-0104); and a valve for regulating the fluid flow (control device 104 to control flow of CSF fluid; Paragraph 0104-0105; Figure 18), comprising: a tubing, configured to allow fluid flow therethrough (catheter 2 tubing; Figure 18; Paragraph 0104-0105); and a control component, configured to communicate with the data processing device and other devices and to control the actuator (probe 12 communicates with an external device 14 and to control control device 104; Figure 18; Paragraph 0103-0106). Penn does not teach a regulating element comprising a wax, the regulating element in direct contact with the tubing; an actuator, arranged proximate to the regulating element, the actuator being configured to manipulate a parameter associated with the regulating element.
However, Ilios teaches a regulating element comprising a wax (ferromagnet fluid 218 is a ferrowax; Paragraph 0071), the regulating element in direct contact with the tubing (membrane 220 with ferromagnet fluid 218 that is a ferrowax that is in direct contact with tubing 104 and opens and closes the valve based on the temperature of the valve; Paragraph 0059 and 0071); an actuator, arranged proximate to the temperature controlled regulating element (magnets 210/208 are actuators that are proximate to membrane 220 with ferromagnet fluid 218; Figure 2A; Paragraph 0058-0059 and 0071), the actuator being configured to manipulate a parameter associated with the regulating element (magnets 210/208 configured to change phase of ferrowax by adjusting the polarity of the magnets; Paragraphs 0059-0061 and 0071).
Penn and Ilios are considered to be analogous to the claimed invention because they are in the same field of fluidic valve devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn to incorporate the teachings of Ilios and have the valve of Penn to have the temperature regulating element and the actuator of Ilios on the tubing of Penn. This allows for the valve to be calibrated to the desired opening and closing pressures for microfluidic operations (Ilios; Paragraph 0052-0053).
Regarding claim 28, Penn in view of Ilios teaches the system of claim 20. The combination of Penn in view of Ilios further teaches wherein the valve further comprises a sensor, wherein the sensor comprises at least one of a temperature sensor, a flowrate sensor, or a pressure sensor (Penn; sensor 16 is a pressure sensor; Figure 18; Paragraph 0107).
Regarding claim 30, Penn in view of Ilios teaches the system of claim 20. The combination of Penn in view of Ilios further teaches wherein the wax comprises at least one additive (Ilios; ferrowax comprises the additive of ferrite particles in wax; Paragraph 0071).
Regarding claim 31, Penn in view of Ilios teaches the system of claim 20. The combination of Penn in view of Ilios further teaches wherein the regulating element is configured to regulate resistance to the fluid flowing through the tubing, wherein the resistance is independent of intracranial pressure associated with a patient (Ilios; ferromagnet fluid 218 that is ferrowax in membrane 220 regulates resistance to fluid flow based on temperature of wax, independent of intracranial pressure; Figure 2A; Paragraph 0071).
Claim(s) 2-3, 22, 25, 38, 41-42, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (Publication No. US 2002/0052563 A1) in view of Ilios et al. (Publication No. US 2015/0202082 A1), as applied to claim 1 and 20 above, and further in view of Saul et al. (Publication No. US 2017/0021145 A1).
Regarding claim 2, Penn in view of Ilios teaches the valve of claim 1. The combination of Penn in view of Ilios further teaches further comprising: a control component, configured to communicate with an external data processing device and to control the actuator (Penn; probe 12 communicates with an external device 14 and to control control device 104; Figure 18; Paragraph 0103-0106), the external data processing device being configured to: collect one or more biometric indicators associated with a patient, the biometric indicators selected from a heart rate, a blood pressure, a posture indicator, an exercise indicator, and an endogenous brain pressure (Penn; sensor 16 delivers data to external device 14, where the data is an intracranial pressure/endogenous brain pressure; Figure 18; Paragraph 0077-0078 and 0103-0104). The combination of Penn in view of Ilios does not teach calculate an estimated fluid production rate based on the one or more biometric indicators associated with the patient; calculate a desired value for the temperature controlled regulating element based on the estimated fluid production rate; and send the desired value to the control component.
However, Saul teaches calculate an estimated fluid production rate based on the one or more biometric indicators associated with the patient (cerebrospinal fluid volume is measured based on pressure measurements; Paragraph 0008 and 0015-0016); calculate a desired value for the temperature controlled regulating element based on the estimated fluid production rate (device can determine if the device should operate based on the flow parameter or pressure measured in the cerebrospinal fluid and send a value to the controller to activate thermal actuator and heat valve; Paragraph 0015-0016); and send the desired value to the control component (actuator can receive activation value to heat valve from the controller; Paragraph 0015-0016, 0021-0022, and 0057-0058; Figure 2).
Saul and Penn in view of Ilios considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios to have the to incorporate the teachings of Saul and have the external data processing device of Penn in view of Ilios to have the calculating steps of Saul. This allows for the automatic control of the valve based on the operational mode that is determined by external controller based on the data collected (Saul; Paragraph 0011 and 0014-0016).
Regarding claim 3, Penn in view of Ilios and Saul teaches the valve of claim 2. The combination of Penn in view of Ilios and Saul does not teach further comprising a housing comprising an insulating element configured to reduce heat conduction between the housing and an environment, wherein the housing is configured to accommodate the tubing, the temperature controlled regulating element, the actuator, and the control component.
However, Saul teaches further comprising a housing (housing of valve; Figure 16) comprising an insulating element configured to reduce heat conduction between the housing and an environment (insulated chamber 1620 prevents heat to escape from housing into the environment; Figure 16; Paragraph 0074-0075), wherein the housing is configured to accommodate the tubing, the regulating element, the actuator, and the control component (housing of Figure 16 of Saul contains tubing of Figure 20 of Saul, Nitinol valve of Figure 16 of Saul, valve drive, and controller – valve drive and controller are both in the internal device, thus located in the same housing, as shown in Figure 2; Paragraph 0058, 0074-0075, and 0106).
Penn in view of Ilios and Saul considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios and Saul to have the to incorporate the teachings of Saul and have the valve of Penn in view of Ilios and Saul to have the insulating housing of Saul. This allows for the reduction of the thermal loss in the device during use (Saul; Paragraph 0074-0075).
Regarding claim 22, Penn in view of Ilios teaches the system of claim 20. The combination of Penn in view of Ilios does not teach wherein the data processing device is further configured to: calculate an estimated fluid production rate based on the one or more biometric indicators associated with the patient; calculate a desired value based on the estimated fluid production rate; and send the desired value to the control component.
However, Saul teaches wherein the data processing device is further configured to: calculate an estimated fluid production rate based on the one or more biometric indicators associated with the patient (cerebrospinal fluid volume is measured based on pressure measurements; Paragraph 0008 and 0015-0016); calculate a desired value based on the estimated fluid production rate (cerebrospinal fluid volume is measured based on pressure measurements; Paragraph 0008 and 0015-0016); and send the desired value to the control component (actuator can receive activation value to heat valve from the controller; Paragraph 0015-0016, 0021-0022, and 0057-0058; Figure 2).
Saul and Penn in view of Ilios considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios to have the to incorporate the teachings of Saul and have the external data processing device of Penn in view of Ilios to have the calculating steps of Saul. This allows for the automatic control of the valve based on the operational mode that is determined by external controller based on the data collected (Saul; Paragraph 0011 and 0014-0016).
Regarding claim 25, Penn in view of Ilios teaches the system of claim 20. The combination of Penn in view of Ilios does not teach wherein the valve further comprises a housing comprising an insulating element configured to reduce heat conduction between the housing and an environment and, wherein, the housing is configured to accommodate the tubing, the regulating element, the actuator, and the control component.
However, Saul teaches wherein the valve further comprises a housing (housing of valve; Figure 16) comprising an insulating element configured to reduce heat conduction between the housing and an environment and (insulated chamber 1620 prevents heat to escape from housing into the environment; Figure 16; Paragraph 0074-0075), wherein, the housing is configured to accommodate the tubing, the regulating element, the actuator, and the control component (housing of Figure 16 of Saul contains tubing of Figure 20 of Saul, Nitinol valve of Figure 16 of Saul, valve drive, and controller – valve drive and controller are both in the internal device, thus located in the same housing, as shown in Figure 2; Paragraph 0058, 0074-0075, and 0106).
Penn in view of Ilios and Saul considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios and Saul to have the to incorporate the teachings of Saul and have the valve of Penn in view of Ilios and Saul to have the insulating housing of Saul. This allows for the reduction of the thermal loss in the device during use (Saul; Paragraph 0074-0075).
Regarding claim 38, Penn teaches a method for regulating fluid flow (method of using control device 104 to control flow of CSF fluid; Paragraph 0104-0105; Figure 18), comprising: collecting one or more biometric indicators associated with a patient; the one or more biometric indicators selected from a heart rate, a blood pressure, a posture indicator, an exercise indicator, and an endogenous brain pressure (sensor 16 delivers data to external device 14, where the data is an intracranial pressure/endogenous brain pressure; Figure 18; Paragraph 0077-0078 and 0103-0104); a valve for regulating fluid flowing therethrough (control device 104 to control flow of CSF fluid; Paragraph 0104-0105; Figure 18), the valve including a tubing, configured to allow fluid flow therethrough (catheter 2 tubing; Figure 18; Paragraph 0104-0105); and the control component, configured to communicate with other devices and to control the actuator (probe 12 communicates with an external device 14 and to control control device 104; Figure 18; Paragraph 0103-0106). Penn does not teach calculating an estimated fluid production rate based on the one or more biometric indicators associated with the patient, calculating a desired value based on the estimated fluid production rate; and sending the desired value of a regulating element to a control component within the valve for regulating fluid flowing therethrough, the regulating element comprising a wax, the regulating element in direct contact with the tubing; an actuator, arranged proximate to the regulating element, the actuator being configured to manipulate a parameter associated with the regulating element;.
However, Ilios teaches a regulating element (membrane 220 with ferromagnet fluid 218; Figure 2A; Paragraph 0058-0059 and 0071), the regulating element comprising a wax (ferromagnet fluid 218 is a ferrowax; Paragraph 0071), the regulating element in direct contact with the tubing (membrane 220 with ferromagnet fluid 218 that is a ferrowax that is in direct contact with tubing 104 and opens and closes the valve based on the temperature of the valve; Paragraph 0059 and 0071); an actuator, arranged proximate to the regulating element (magnets 210/208 are actuators that are proximate to membrane 220 with ferromagnet fluid 218; Figure 2A; Paragraph 0058-0059 and 0071), the actuator being configured to manipulate a parameter associated with the regulating element (magnets 210/208 configured to change phase of ferrowax by adjusting the polarity of the magnets; Paragraphs 0059-0061 and 0071).
Penn and Ilios are considered to be analogous to the claimed invention because they are in the same field of fluidic valve devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn to incorporate the teachings of Ilios and have the valve of Penn to have the temperature regulating element and the actuator of Ilios on the tubing of Penn. This allows for the valve to be calibrated to the desired opening and closing pressures for microfluidic operations (Ilios; Paragraph 0052-0053).
The combination of Penn in view of Ilios does not teach calculating an estimated fluid production rate based on the one or more biometric indicators associated with the patient, calculating a desired value based on the estimated fluid production rate; and sending the desired value of a regulating element to the control component within the valve for regulating fluid flowing therethrough.
However, Saul teaches calculating an estimated fluid production rate based on the one or more biometric indicators associated with the patient (cerebrospinal fluid volume is measured based on pressure measurements; Paragraph 0008 and 0015-0016), calculating a desired value based on the estimated fluid production rate (device can determine if the device should operate based on the flow parameter or pressure measured in the cerebrospinal fluid and send a value to the controller to activate thermal actuator and heat valve; Paragraph 0015-0016); and sending the desired value of a regulating element to the control component for regulating fluid flowing therethrough (actuator can receive activation value to heat valve from the controller; Paragraph 0015-0016, 0021-0022, and 0057-0058; Figure 2).
Saul and Penn in view of Ilios considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios to have the to incorporate the teachings of Saul and have the external data processing device of Penn in view of Ilios to have the calculating steps of Saul. This allows for the automatic control of the valve based on the operational mode that is determined by external controller based on the data collected (Saul; Paragraph 0011 and 0014-0016).
The combination of Penn in view of Ilios and Saul further teaches the control component within the valve for regulating fluid flowing therethrough (Penn; probe 12 has a microprocessor 102 that is connected into the control device 104; Paragraph 0105-0107; Figure 18).
Regarding claim 41, Penn in view of Ilios and Saul teaches the method of claim 38. The combination of Penn in view of Ilios and Saul further teaches wherein the wax comprises at least one additive (Ilios; ferrowax comprises the additive of ferrite particles in wax; Paragraph 0071).
Regarding claim 42, Penn in view of Ilios and Saul teaches the method of claim 38. The combination of Penn in view of Ilios and Saul further teaches wherein communicating with a valve to regulate fluid flowing therethrough comprises controlling the regulating element to regulate resistance to the fluid flowing through the tubing, and wherein the resistance is independent of intracranial pressure associated with the patient (Ilios; ferromagnet fluid 218 that is ferrowax in membrane 220 regulates resistance to fluid flow based on temperature of wax, independent of intracranial pressure; Figure 2A; Paragraph 0071).
Regarding claim 45, Penn in view of Ilios and Saul teaches the method of claim 38. The combination of Penn in view of Ilios and Saul further teaches further comprising: receiving, by the control component of the valve, the desired value for the regulating element from a data processing device (Penn; desired pressure value is received by microprocessor 102 which is the pre-determined range from the external device; Figure 18; Paragraphs 0082-0085, 0103, and 0106-0107); controlling, by the control component of the valve, the actuator to actuate the regulating element (Penn; microprocessor 102 controls control device 104 and actuator of Ilios to actuate the regulating element of Ilios; Paragraph 0106-0107; Figure 18); sensing, by a sensor, a parameter associated with the regulating element (Penn; sensor 16 delivers data to external device 14, where the data is an intracranial pressure/endogenous brain pressure; Figure 18; Paragraph 0077-0078 and 0103-0104); determining, by the control component of the valve, that the parameter associated with the regulating element is within a threshold range of the desired value for the regulating element (Penn; microprocessor 102 determines if pressure sensed by sensor 16 is within range of the predetermined pressure; Paragraph 0106-0107); and stopping, by the control component of the valve, the actuator upon determining that the parameter associated with the regulating element is within a threshold range of the desired value (Penn; microprocessor 102 can stop actuator of Ilios when pressure is within range; Paragraph 0106-0107).
Claim(s) 10, 23, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (Publication No. US 2002/0052563 A1) in view of Ilios et al. (Publication No. US 2015/0202082 A1) and Saul et al. (Publication No. US 2017/0021145 A1), as applied to claim 2, 22, and 38 above, and further in view of Lattanzio et al. (Publication No. US 2009/0275924 A1).
Regarding claim 10, Penn in view of Ilios and Saul teaches the valve of claim 2. The combination of Penn in view of Ilios and Saul does not teach wherein the desired value comprises a desired temperature and wherein the parameter associated with the temperature controlled regulating element is a temperature of the temperature regulating element.
However, Lattanzio teaches wherein the desired value comprises a desired temperature and wherein the parameter associated with the temperature controlled regulating element is a temperature of the temperature regulating element (sensor can obtain temperature measurement and switch valve based on temperature measurement that is desired to be achieved; Paragraph 0014, 0051, 0060, and 0077).
Penn in view of Ilios and Saul and Lattanzio are considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios and Saul to have the to incorporate the teachings of Lattanzio and have the device of Penn in view of Ilios and Saul to additional contain the temperature sensor of Lattanzio, with the controller of Saul being able to control the valve, based on the desired temperature, as taught by Lattanzio. This allows the device to detect abnormal changes of temperature in the body and treat the temperature difference using the device (Lattanzio; Paragraph 0051 and 0077). Regarding claim 23, Penn in view of Ilios and Saul teaches the system of claim 22. The combination of Penn in view of Ilios and Saul does not teach wherein the desired value comprises a desired temperature; and wherein the parameter associated with the regulating element is a temperature of the regulating element.
However, Lattanzio teaches wherein the desired value comprises a desired temperature; and wherein the parameter associated with the regulating element is a temperature of the regulating element (sensor can obtain temperature measurement and switch valve based on temperature measurement that is desired to be achieved; Paragraph 0014, 0051, 0060, and 0077).
Penn in view of Ilios and Saul and Lattanzio are considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios and Saul to have the to incorporate the teachings of Lattanzio and have the device of Penn in view of Ilios and Saul to additional contain the temperature sensor of Lattanzio, with the controller of Saul being able to control the valve, based on the desired temperature, as taught by Lattanzio. This allows the device to detect abnormal changes of temperature in the body and treat the temperature difference using the device (Lattanzio; Paragraph 0051 and 0077). Regarding claim 40, Penn in view of Ilios and Saul teaches the method of claim 38. The combination of Penn in view of Ilios and Saul does not teach wherein the desired value comprises a desired temperature; and wherein the parameter associated with the regulating element is temperature of the regulating element.
However, Lattanzio teaches wherein the desired value comprises a desired temperature; and wherein the parameter associated with the regulating element is temperature of the regulating element (sensor can obtain temperature measurement and switch valve based on temperature measurement that is desired to be achieved; Paragraph 0014, 0051, 0060, and 0077).
Penn in view of Ilios and Saul and Lattanzio are considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts/valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios and Saul to have the to incorporate the teachings of Lattanzio and have the device of Penn in view of Ilios and Saul to additional contain the temperature sensor of Lattanzio, with the controller of Saul being able to control the valve, based on the desired temperature, as taught by Lattanzio. This allows the device to detect abnormal changes of temperature in the body and treat the temperature difference using the device (Lattanzio; Paragraph 0051 and 0077).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Penn et al. (Publication No. US 2002/0052563 A1) in view of Ilios et al. (Publication No. US 2015/0202082 A1), as applied to claim 20 above, and further in view of Samoocha et al. (Publication No. US 2021/0046277 A1).
Regarding claim 21, Penn in view of Ilios teaches the system of claim 20. The combination of Penn in view of Ilios does not teach wherein the data processing device comprises a wearable device.
However, Samoocha teaches wherein the data processing device comprises a wearable device (external activation unit 900 is mounted on a headset 902 and contains processing circuitry; Figure 2 and 9; Paragraph 0454-0455).
Penn in view of Ilios and Samoocha are considered to be analogous to the claimed invention because they are in the same field of cerebrospinal fluid shunts. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Penn in view of Ilios to have the to incorporate the teachings of Samoocha and have the device of Saul to mount the external device of Penn in view of Ilios on a headset, as taught by Samoocha. This allows for the device to be portable and allows for a strong connection between the shunt and the data processing device (Samoocha; Paragraph 0454-0455).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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