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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8 is/are rejected under 35 U.S.C. 102(a)(1) & 102(a)(2) as being anticipated by Lee (Lee et al., Hydrogel Check-Valves for the Treatment of Hydrocephalic Fluid Retention with Wireless Fully-Passive Sensor for the Intracranial Pressure Measurement, Gels 2022, 8, 276. https://doi.org/10.3390/gels8050276)’.
In regards to claim 1, Lee teaches a valve monitoring system, comprising: (abstract, ‘methods evaluate’ s a valve used in treating hydrocephalus’)
a sensor that generates a signal expressive of indirect operational characteristics of a valve device, the valve device being positioned between a first cavity and a second cavity of a bodily system for facilitating drainage of a fluid from the first cavity to the second cavity; and (abstract; 1.0 Introduction, 2.12 In Vitro Animal Model Setup; fig. 1(a-b), ‘shows a pressure sensor and a hydrogel valve between a 1st cavity (superior sagittal sinus) and 2nd cavity (sub arachnoid space) of the dura-mater.’; fig 2. (a-b))
a processor in communication with a memory and the sensor, the memory including instructions executable by the processor to: access signal data indicative of the signal generated by the sensor; (fig.2(a-b), ‘pc’, ‘data acquisition module’, ‘amplifier’; 2. Results and discussion)
compare the signal data to a behavioral model associated with the valve device, the behavioral model connecting the indirect operational characteristics of the valve device expressed by the signal data with a parametric behavior characteristic of the valve device with respect to the bodily system; and infer a value of the parametric behavior characteristic of the valve device based on a comparison between the signal data and the behavioral model. (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
In regards to claim 2, Lee teaches a valve monitoring system of claim 1, (see claim rejection 1) wherein the indirect operational characteristics of the valve device include one or more of: an opening time of the valve device associated with an opening action of the valve device over one or more cycles; (fig. 1 (b), ‘Basic operation of the valve at a cross-sectional view. When the hydrogel becomes hydrated, the swollen hydrogel structure closes the hole, forming the closed valve. When the pressure in the SAS reaches higher than the SSS over the threshold, namely, cracking pressure (PƬ), ΔP > PƬ, the swollen hydrogel valve becomes open and CSF can flow unidirectionally from SAS to SSS. When the SAS has lower pressure than the SSS by less than a differential threshold, (PƬ), ΔP < PƬ, the valve is closed and blocks the CSF flow as the pressure difference cannot open the valve.’)
a closing time of the valve device associated with a closing action of the valve device over the one or more cycles; and a flow rate of the fluid through the valve device over the one or more cycles. (fig. 1 (b), ‘Basic operation of the valve at a cross-sectional view. When the hydrogel becomes hydrated, the swollen hydrogel structure closes the hole, forming the closed valve. When the pressure in the SAS reaches higher than the SSS over the threshold, namely, cracking pressure (PƬ), ΔP > PƬ, the swollen hydrogel valve becomes open and CSF can flow unidirectionally from SAS to SSS. When the SAS has lower pressure than the SSS by less than a differential threshold, (PƬ), ΔP < PƬ, the valve is closed and blocks the CSF flow as the pressure difference cannot open the valve.’)
In regards to claim 3, Lee teaches a valve monitoring system of claim 1, (see claim rejection 1) wherein the parametric behavior characteristics of the valve device include one or more of: an intracavity pressure associated with the first cavity over one or more cycles; (abstract; pages 1-5; fig(s) 1-3)
a cracking pressure of the valve device; and (fig. 1 (b), cracking pressure (PƬ), ΔP > PƬ or (PƬ), ΔP < PƬ)
a reverse flow rate associated with backflow of the fluid from the second cavity to the first cavity over the one or more cycles. (abstract, ‘The valves are designed to achieve a non-zero cracking pressure and no reverse flow leakage by using hydrogel swelling.’)
In regards to claim 5, Lee teaches a valve monitoring system of claim 1, (see claim rejection 1) the memory further including instructions executable by the processor to: (fig.2(a-b), ‘pc’, ‘data acquisition module’, ‘amplifier’; 2. Results and discussion)
infer, based on the value of the parametric behavior characteristic of the valve device and based on the behavioral model, a type of operational state of the valve device. (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
In regards to claim 6, Lee teaches a valve monitoring system of claim 1, (see claim rejection 1) the memory further including instructions executable by the processor to: (fig.2(a-b), ‘pc’, ‘data acquisition module’, ‘amplifier’; 2. Results and discussion)
construct, based on the value of the parametric behavior characteristic of the valve device and based on the behavioral model, a graphic for display at a display device in communication with the processor that shows the indirect operational characteristics of the valve device and the value of the parametric behavior characteristic of the valve device with respect to time. (2. Results and Discussion; 2.2 Hydrodynamic Vave Characteristics; Table 1 Summary of specifications for hydrogel valves tested; fig. 4; 2.5 Long-Term Functional Tests, ‘running times’)
In regards to claim 7, Lee teaches a valve monitoring system of claim 1, (see claim rejection 1) the memory further including instructions executable by the processor to: (fig.2(a-b), ‘pc’, ‘data acquisition module’, ‘amplifier’; 2. Results and discussion)
infer, based on the value of the parametric behavior characteristic of the valve device and based on the behavioral model, a remaining lifetime of the valve device. (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
In regards to claim 8, Lee teaches a valve monitoring system of claim 1, (see claim rejection 1) the memory further including instructions executable by the processor to: (fig.2(a-b), ‘pc’, ‘data acquisition module’, ‘amplifier’; 2. Results and discussion)
correlate the indirect operational characteristics of the valve device over one or more cycles with a series of postural changes associated with the bodily system; and (2. Results and Discussion; 2.2 Hydrodynamic Vave Characteristics; Table 1 Summary of specifications for hydrogel valves tested; fig. 4; 2.5 Long-Term Functional Tests, ‘running times’)
compare, in view of correlation between the indirect operational characteristics and the series of postural changes, the behavioral model connecting the indirect operational characteristics of the valve device expressed by the signal data with parametric behavior characteristics of the valve device with respect to the bodily system. (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee et al., Hydrogel Check-Valves for the Treatment of Hydrocephalic Fluid Retention with Wireless Fully-Passive Sensor for the Intracranial Pressure Measurement, Gels 2022, 8, 276. https://doi.org/10.3390/gels8050276), in view of, Krishnan et al., (Continuous, noninvasive wireless monitoring of flow of cerebrospinal fluid through shunts in patients with hydrocephalus, npj Digital Medicine (2020) 29).
Lee teaches:
In regards to claim 9, Lee teaches a valve monitoring system of claim 8, (claim rejection 8) the memory further including instructions executable by the processor to: (fig.2(a-b), ‘pc’, ‘data acquisition module’, ‘amplifier’; 2. Results and discussion)
It would have been obvious before the effective filing date of the invention for Lee to provide a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
Lee does not teach:
prompt, by an interface in communication with the processor, a user of the valve device to perform the series of postural changes; and
access the signal data indicative of the signal generated by the sensor upon performance of the series of postural changes.
Krishnan teaches:
prompt, by an interface in communication with the processor, a user of the valve device to perform the series of postural changes; and (Krishnan: fig. 1(e),’utilizes a smartphone for readout and communication for fitness of a shunt/valve.’)
access the signal data indicative of the signal generated by the sensor upon performance of the series of postural changes. (Krishnan: fig. 1(e),’utilizes a smartphone for readout and communication for fitness of a shunt/valve.’)
It would have been obvious before the effective filing date of the invention for Krishnan to provide an interface for a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee et al., Hydrogel Check-Valves for the Treatment of Hydrocephalic Fluid Retention with Wireless Fully-Passive Sensor for the Intracranial Pressure Measurement, Gels 2022, 8, 276. https://doi.org/10.3390/gels8050276), in view of, Guo (US-20240214079), in view of, Aralar et al., (Assessment of Ventriculoperitoneal Shunt Function Using Ultrasound Characterization of Valve Interface Oscillation as a Proxy. Cureus 10(2): e2205. DOI 10.7759/cureus.2205, February 19, 2018).
Lee teaches:
In regards to claim 4, Lee teaches a valve monitoring system of claim 1, (see claim rejection 1) wherein the sensor is selected from:
Although Lee teaches a valve system the implementation of an ultrasound or acoustic sensor is not specifically discussed in the opening and closing of the valve. However, it discloses the use of RF backscattering technology to generate a voltage signal with pressure measurement vales.
It would have been obvious before the effective filing date of the invention for Lee to provide a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
Lee does not teach:
an acoustic sensor that generates the signal upon audio detection of an opening action or a closing action of the valve device; and
an ultrasound sensor that generates the signal expressive of the fluid flow through the valve device; and wherein the signal is readable by a computing system upon interrogation of the sensor.
Aralar teaches:
an acoustic sensor that generates the signal upon audio detection of an opening action or a closing action of the valve device; and (pages 1-4, ‘The use of ultrasound imaging in identifying shunt function was proposed in the early 1980s [8], but the modality has failed to gain clinical adoption. In more contemporary studies, Hartman et al. [9] demonstrated ex vivo that contrast-enhanced ultrasound could be useful in detecting physiologic flow, or lack thereof, in a malfunction state. The feasibility of Doppler measurements has also been described [10], which uses microbubble contrast to enhance the measurement’; pages 4-5, ‘flow state simulation’, ‘data analysis’)
an ultrasound sensor that generates the signal expressive of the fluid flow through the valve device; and wherein the signal is readable by a computing system upon interrogation of the sensor. (fig. 1, ‘ultrasound transducer’; pages 1-4, ‘Ultrasound data taken from the pressure relief valve were analyzed to determine differences in the displacement of valve components over time between flow states’; pages 4-5, ‘flow state simulation’, ‘data analysis’)
It would have been obvious before the effective filing date of the invention for Arala to provide an acoustic or ultrasound sensor for a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 102(a)(1) & 102(a)(2) as being anticipated by Lee (Lee et al., Hydrogel Check-Valves for the Treatment of Hydrocephalic Fluid Retention with Wireless Fully-Passive Sensor for the Intracranial Pressure Measurement, Gels 2022, 8, 276. https://doi.org/10.3390/gels8050276)’.
In regards to claim 10, Lee teaches a method of inferring a value of a parametric behavior characteristic that indicates function of a valve device using a behavioral model of the valve device, the method comprising: (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
accessing signal data indicative of a signal generated by a sensor, the signal being expressive of one or more indirect operational characteristics of a valve device, the valve device being positioned between a first cavity and a second cavity of a bodily system for facilitating drainage of fluid from the first cavity to the second cavity; (abstract; 1.0 Introduction, 2.12 In Vitro Animal Model Setup; fig. 1(a-b), ‘shows a pressure sensor and a hydrogel valve between a 1st cavity (superior sagittal sinus) and 2nd cavity (sub arachnoid space) of the dura-mater.’; fig 2. (a-b))
comparing the signal data to a behavioral model associated with the valve device, the behavioral model connecting the one or more indirect operational characteristics of the valve device expressed by the signal data with one or more parametric behavior characteristics associated with the valve device with respect to the bodily system; and (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
inferring a value of a parametric behavior characteristic of the one or more parametric behavior characteristics associated with the valve device based on comparison between the signal data and the behavioral model. (fig. 2(a) Experimental setup for evaluation of valve functionality; 2.12 In Vitro Animal Model Setup; fig. 3; 2.2 Hydrodynamic Valve Characteristics, ‘bench-top testing’; fig. fig 4(a-b); Table 1, ‘Bench-top vs sheep brain’)
In regards to claim 11, Lee teaches a method of claim 10, (see claim rejection 1) wherein the one or more indirect operational characteristics of the valve device includes one or more of: (abstract)
an opening time of the valve device associated with an opening action of the valve device over one or more cycles; (fig. 1 (b), ‘Basic operation of the valve at a cross-sectional view. When the hydrogel becomes hydrated, the swollen hydrogel structure closes the hole, forming the closed valve. When the pressure in the SAS reaches higher than the SSS over the threshold, namely, cracking pressure (PƬ), ΔP > PƬ, the swollen hydrogel valve becomes open and CSF can flow unidirectionally from SAS to SSS. When the SAS has lower pressure than the SSS by less than a differential threshold, (PƬ), ΔP < PƬ, the valve is closed and blocks the CSF flow as the pressure difference cannot open the valve.’)
a closing time of the valve device associated with a closing action of the valve device over the one or more cycles; and a flow rate of fluid through the valve device over the one or more cycles. (fig. 1 (b), ‘Basic operation of the valve at a cross-sectional view. When the hydrogel becomes hydrated, the swollen hydrogel structure closes the hole, forming the closed valve. When the pressure in the SAS reaches higher than the SSS over the threshold, namely, cracking pressure (PƬ), ΔP > PƬ, the swollen hydrogel valve becomes open and CSF can flow unidirectionally from SAS to SSS. When the SAS has lower pressure than the SSS by less than a differential threshold, (PƬ), ΔP < PƬ, the valve is closed and blocks the CSF flow as the pressure difference cannot open the valve.’)
In regards to claim 12, Lee teaches a method of claim 10, (see claim rejection 10) wherein the one or more parametric behavior characteristics of the valve device includes one or more of: (abstract; pages 1-5; fig(s) 1-3)
an intracavity pressure associated with the first cavity over one or more cycles; (abstract; pages 1-5; fig(s) 1-3)
a cracking pressure of the valve device; and (fig. 1 (b), cracking pressure (PƬ), ΔP > PƬ or (PƬ), ΔP < PƬ)
a reverse flow rate associated with backflow of fluid from the second cavity to the first cavity over the one or more cycles. (abstract, ‘The valves are designed to achieve a non-zero cracking pressure and no reverse flow leakage by using hydrogel swelling.’)
In regards to claim 13, Lee teaches a method of claim 10, (see claim rejection 10) further comprising:
correlating the one or more indirect operational characteristics of the valve device over one or more cycles with a series of postural changes associated with the bodily system; and (2. Results and Discussion; 2.2 Hydrodynamic Vave Characteristics; Table 1 Summary of specifications for hydrogel valves tested; fig. 4; 2.5 Long-Term Functional Tests, ‘running times’)
comparing, in view of correlation between the one or more indirect operational characteristics and the series of postural changes, the behavioral model connecting the one or more indirect operational characteristics of the valve device expressed by the signal data with parametric behavior characteristics of the valve device with respect to the bodily system. . (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee et al., Hydrogel Check-Valves for the Treatment of Hydrocephalic Fluid Retention with Wireless Fully-Passive Sensor for the Intracranial Pressure Measurement, Gels 2022, 8, 276. https://doi.org/10.3390/gels8050276), in view of, Wolf (US-10016135).
In regards to claim 14, Lee teaches a method of developing a behavioral model for use in inferring a value of a parametric behavior characteristic that indicates function of a valve device, comprising: (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
an intracavity pressure associated with a first cavity of the animal bodily system; and (abstract; pages 1-5; fig(s) 1-3)
a set of indirect operational characteristics of the valve device, including timestamps associated with an opening action of the valve device or a closing action of the valve device over the plurality of cycles, and fluid flow through the valve device; and (fig. 1 (b), ‘Basic operation of the valve at a cross-sectional view. When the hydrogel becomes hydrated, the swollen hydrogel structure closes the hole, forming the closed valve. When the pressure in the SAS reaches higher than the SSS over the threshold, namely, cracking pressure (PƬ), ΔP > PƬ, the swollen hydrogel valve becomes open and CSF can flow unidirectionally from SAS to SSS. When the SAS has lower pressure than the SSS by less than a differential threshold, (PƬ), ΔP < PƬ, the valve is closed and blocks the CSF flow as the pressure difference cannot open the valve.’)
constructing a behavioral model for the valve device representing connections between the intracavity pressure and the set of indirect operational characteristics of the set of operational characteristics. (fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, ‘The basic hydrodynamic response of the hydrogel valve was measured and displayed the valve operation within the target range in terms of normal CSF drainage in bench-top testing (Figure 4a) and in an in vitro fixed sheep brain (Figure 4b). To evaluate the valve in more realistic patient conditions, the valve was tested in the emulated biological fluids, all based on CSF with various additives known to generate occlusion-based failures in traditional shunts: Water, CSF, CSF + Calcium (1.1 mM), CSF + Blood (5% v/v), CSF + Fibronectin (7.5 μg/mL), and CSF + All additives (Calcium + Fibronectin + Blood) at ~37 °C [20–22].’; ‘Essentially the measured parameter by the sensor of system can be compared with the expected in-vitro data.’)
It would have been obvious before the effective filing date of the invention for Lee to provide a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
Lee does not teach:
measuring, by a plurality of sensors associated with a valve device implanted within an animal bodily system over a plurality of cycles, a set of operational characteristics associated with the valve device including:
Wolf teaches:
measuring, by a plurality of sensors associated with a valve device implanted within an animal bodily system over a plurality of cycles, a set of operational characteristics associated with the valve device including: (39-41 col. 1 recites: ‘A number of technologies currently exist to monitor brain pressure. Many of these rely on invasive techniques with percutaneously implanted sensors.’; 25-29 co. 4, ‘different types of sensors can be placed.’)
It would have been obvious before the effective filing date of the invention for wolf to provide a plurality of sensors for a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
In regards to claim 15, Lee & Wolf teach a method of claim 14, (see claim rejection 14) wherein the behavioral model expresses a correlation between the set of operational characteristics and a series of postural changes exhibited by the animal bodily system. (Lee: abstract; 1.0 Introduction, 2.12 In Vitro Animal Model Setup; fig. 1(a-b), ‘shows a pressure sensor and a hydrogel valve between a 1st cavity (superior sagittal sinus) and 2nd cavity (sub arachnoid space) of the dura-mater.’; fig 2. (a-b); fig. 3, ‘the hydrogel valve was evaluated in an in vitro setting using a fixed sheep brain’ ; 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics)
measuring, by a plurality of sensors associated with a valve device implanted within an animal bodily system over a plurality of cycles, a set of operational characteristics associated with the valve device including: (Wolf: 39-41 col. 1 recites: ‘A number of technologies currently exist to monitor brain pressure. Many of these rely on invasive techniques with percutaneously implanted sensors.’; 25-29 co. 4, ‘different types of sensors can be placed.’)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee et al., Hydrogel Check-Valves for the Treatment of Hydrocephalic Fluid Retention with Wireless Fully-Passive Sensor for the Intracranial Pressure Measurement, Gels 2022, 8, 276. https://doi.org/10.3390/gels8050276), in view of, Wolf (US-10016135), in further view of, Guo (US-20240214079).
Lee & Wolf teach:
In regards to claim 16, Lee & Wolf teach a method of claim 14, (see claim 14)
Although Lee teaches retrieving parameters using a passive sensor and uses the values to determine pressure and the status of a valve/shunt. Moreover, does teach 2.1.2. In Vitro Animal Model Setup, 2.2. Hydrodynamic valve characteristics, to evaluate the valve in more realistic patient conditions, where the measured parameters by the sensor of system can be compared with the expected in-vitro data.’ However, it is not specifically shown an equivalent circuit behavioral model.
It would have been obvious before the effective filing date of the invention for Lee & Wolf to provide a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
Lee & Wolf do not teach:
wherein the behavioral model incorporates an equivalent circuit behavioral model in terms of an equivalent circuit model of the valve device and the animal bodily system, the equivalent circuit behavioral model representing connections between one or more design parameters of the valve device, one or more bodily system parameters including intracavity pressure, and one or more equivalent circuit parametric behavioral characteristics of the valve device.
Guo teaches:
wherein the behavioral model incorporates an equivalent circuit behavioral model in terms of an equivalent circuit model of the valve device and the animal bodily system, the equivalent circuit behavioral model representing connections between one or more design parameters of the valve device, one or more bodily system parameters including intracavity pressure, and one or more equivalent circuit parametric behavioral characteristics of the valve device. (abstract; 100 fig. 1, ‘system 100 is an Adaptive Machine Learning for Dynamic Wireless Communication Configuration which employs 3 wireless communication devices 110-113 which comprise a database 130, server 120 and a network 150 which comprises a test bed system 160; para(s) [0014-0015], ‘the testbed system is configured to collect the parameter data from the wireless device synonymous to the implantable sensors & implements a machine learning model where the system updates a wireless configuration decision model according to its embodiment.’)
It would have been obvious before the effective filing date of the invention for Guo to provide an equivalent circuit behavioral model for a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
In regards to claim 17, Lee, Wolf & Guo teach a method of claim 16, (see claim rejection 16) the method further comprising:
Guo teaches simulating operation of the equivalent circuit model of the valve device; (Guo: para(s) [0003, 0017-0018, 0037-0038, 0055], ‘Wi-Fi testbed to simulate signal emission or reception of the test device to simulate signal performance indicated by the signal strength value, signal metrics, or other device usage information’)
Guo teaches varying one or more bodily system parameters of the equivalent circuit model; (Guo: para(s) [0004, 0014, 0017, 0019-0021], ‘the technology is capable of updating, configuring and varying system parameters implementing a machine learning model.’)
Guo teaches observing, based on simulated operation of the equivalent circuit model of the valve device, one or more equivalent circuit parametric behavioral characteristics of the equivalent circuit model responsive to variation of the one or more bodily system parameters; and (Guo: para(s) [0061-0062]; 160 fig. 1, ‘test bed system’)
Guo teaches correlating the one or more bodily system parameters of the equivalent circuit model with the one or more equivalent circuit parametric behavioral characteristics of the valve device of the equivalent circuit model. (Guo: para(s) [0061-0062]; 160 fig. 1, ‘test bed system’; para(s) [0004, 0014, 0017, 0019-0021], ‘the technology is capable of configuring system parameters.’)
In regards to claim 18, Lee, Wolf, & Guo teach a method of claim 16, (see claim rejection 16) Guo teaches wherein the behavioral model incorporates connections between the equivalent circuit behavioral model and the set of operational characteristics associated with the valve device and the animal bodily system. (Guo: para(s) [0061-0062]; 160 fig. 1, ‘test bed system’; para(s) [0004, 0014, 0017, 0019-0021], ‘the technology is capable of configuring system parameters.’)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee et al., Hydrogel Check-Valves for the Treatment of Hydrocephalic Fluid Retention with Wireless Fully-Passive Sensor for the Intracranial Pressure Measurement, Gels 2022, 8, 276. https://doi.org/10.3390/gels8050276), in view of, Wolf (US-10016135), in further view of, Guo (US-20240214079-A1).
Lee & Wolf teach:
In regards to claim 19, Lee & Wolf teach a method of claim 14, (see claim rejection 14)
It would have been obvious before the effective filing date of the invention for Lee & Wolf to provide a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
Lee & Wolf don’t teach:
wherein the behavioral model incorporates a testbed behavioral model in terms of a testbed model of the valve device and the animal bodily system, the testbed behavioral model representing connections between one or more design parameters of the valve device, one or more bodily system parameters including intracavity pressure, and one or more testbed parametric behavioral characteristics of the valve device based on the testbed model.
Guo teaches:
wherein the behavioral model incorporates a testbed behavioral model in terms of a testbed model of the valve device and the animal bodily system, the testbed behavioral model representing connections between one or more design parameters of the valve device, one or more bodily system parameters including intracavity pressure, and one or more testbed parametric behavioral characteristics of the valve device based on the testbed model. (Guo: para(s) [0004, 0014, 0017, 0019-0021], ‘the technology is capable of updating, configuring and varying system parameters implementing a machine learning model.’; abstract; 100 fig. 1, ‘system 100 is an Adaptive Machine Learning for Dynamic Wireless Communication Configuration which employs 3 wireless communication devices 110-113 which comprise a database 130, server 120 and a network 150 which comprises a test bed system 160; para(s) [0014-0015], ‘the testbed system is configured to collect the parameter data from the wireless device synonymous to the implantable sensors & implements a machine learning model where the system updates a wireless configuration decision model according to its embodiment.’)
It would have been obvious before the effective filing date of the invention for Guo to incorporate a testbed behavioral model for a method to determine the intracranial pressure measurement for neurological diseases such as hydrocephalus and the like, and to provide a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures.
In regards to claim 20, Lee, Wolf & Guo teach a method of claim 19, (see claim rejection 19) further comprising:
Guo teaches simulating operation of the testbed model of the valve device; (Guo: para(s) [0003, 0017-0018, 0037-0038, 0055], ‘Wi-Fi testbed to simulate signal emission or reception of the test device to simulate signal performance indicated by the signal strength value, signal metrics, or other device usage information’)
varying the one or more bodily system parameters of the testbed model; (Guo: para(s) [0004, 0014, 0017, 0019-0021], ‘the technology is capable of updating, configuring and varying system parameters implementing a machine learning model.’)
measuring the one or more testbed parametric behavioral characteristics of the valve device of the testbed model responsive to variation of the one or more bodily system parameters; and (Guo: para(s) [0061-0062]; 160 fig. 1, ‘test bed system’; para(s) [0004, 0014, 0017, 0019-0021], ‘the technology is capable of configuring system parameters.’)
correlating the one or more bodily system parameters of the testbed behavioral model with the one or more testbed parametric behavioral characteristics of the valve device of the testbed model. (Guo: para(s) [0061-0062]; 160 fig. 1, ‘test bed system’; para(s) [0004, 0014, 0017, 0019-0021], ‘the technology is capable of configuring system parameters.’)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references cited Shields (US-9851019), Kusko (US-9852245), Sudharsan (US-20140358581) and Li (US-20120004896) references further describe a method of implantable self-monitoring systems to detect pressure and flow characteristics, and a method to evaluate the operational function of a valve/shunt to monitor efficiency and avoid mechanical malfunctions and failures as described by the claims.
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/K.C.B/Examiner, Art Unit 2852
/STEPHANIE E BLOSS/Supervisory Primary Examiner, Art Unit 2852