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 .
Status of Application
Applicant submitted a petition for revival on 09/16/2025 which was approved. Accordingly, the application is revived and examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Species I, directed to claims 1-8, 11-18, and 20-25 in the reply filed on 09/16/2025 is acknowledged.
Status of Claims
Claims 1-25 are pending and examined on the merits.
Claims 9-10 and 19 are withdrawn for being drawn to non-elected species.
Information Disclosure Statement
No information disclosure statement (IDS) was submitted by Applicant.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In claim 21, line 8, “means for communicating the CSF pressure in the brain” is treated as an implanted optical terminus and an optical cable communicating the implanted optical sensor with the implanted terminus”, or equivalents (see para. [0035] of Applicant’s Specification).
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swoboda (U.S. Pre Grant Pub. No. 2017/0219450 A1).
Regarding claim 1, Swoboda teaches A ventricular shunt having a valve to regulate flow of cerebral spinal fluid (CSF) from the brain of a patient (see at least para. [0054-0056]) for treatment of hydrocephalus (see para. [0012]) comprising:
a ventricular catheter for transferring CSF from a brain ventricle of a patient (see catheter 102 in Fig. 3A and para. [0056]);
an implanted pressure and/or temperature sensor (see sensor assemblies 106 in Fig. 3A and para. [0055]) communicated with the CSF to measure pressure and/or temperature respectively of the CSF (see at least para. [0057]);
a wireless data transmitter to transmit the measured pressure and/or temperature to an attending physician and/or patient (see wireless communications link 126 in para. [0055]); and
a drainage catheter communicated to the valve for draining the CSF from the brain (para. [0055] teaches a drainage system 100; Fig. 3A shows a drainage catheter, such as at numeral 115).
Regarding claim 2, Swoboda teaches the invention as discussed above in claim 1. Additionally, Swoboda teaches where ventricular catheter has a catheter tip (as at numeral 115 in Fig. 3A), where the valve has an inlet (see para. [0054]), and where the pressure sensor is disposed at or near the ventricular catheter tip and/or at or near the inlet of the valve (see para. [0054]), so that a low pressure measurement by the pressure sensor at either the catheter tip and/or at or near the inlet of the valve less than a predetermined magnitude is reported by the wireless data transmitter as a clogged ventricular catheter to the attending physician and/or patient (para. [0055] teaches that a controller 110 is configured to read measurements taken from the pressure sensor and to adjust the valve device 104 to clear obstructions and that the controller 110 is coupled to a wireless communications link 126 which allows sensor data to be monitored remotely).
Regarding claim 4, Swoboda teaches the invention as discussed above in claim 1. Additionally, Swoboda teaches where ventricular catheter has a catheter tip (as at numeral 115 in Fig. 3A), where the valve has an inlet and outlet (see para. [0054]), and where the pressure sensor includes multiple pressure sensors (para. [0054] teaches at least one or more sensors), selected ones of the multiple pressure sensors being disposed at or near the ventricular catheter tip and/or at or near the inlet and/or outlet of the valve (see para. [0054]), so that a high pressure measurement by selected ones of the multiple pressure sensors at or near the ventricular catheter tip and/or at or near the inlet of the valve greater than a predetermined magnitude is reported by the wireless data transmitter as a clogged valve to the attending physician and/or patient, or a high pressure measurement by selected ones of the multiple pressure sensors at or near the outlet of the valve greater than a predetermined magnitude is reported by the wireless data transmitter as a clogged drainage catheter to the attending physician and/or patient (para. [0055] teaches that a controller 110 is configured to read measurements taken from the pressure sensor and to adjust the valve device 104 to clear obstructions and that the controller 110 is coupled to a wireless communications link 126 which allows sensor data to be monitored remotely).
Claims 11, 12, 14, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sadanand (U.S. Pre Grant Pub. No. 2014/0276346 A1).
Regarding claim 11, Sadanand teaches A method of using a ventricular shunt (see cerebral shunt 102 in Fig. 1 and para. [0031]) having a controllable valve (see Abstract and para. [0032]) to regulate flow of cerebral spinal fluid (CSF) from the brain of a patient (se para. [0031]) for treatment of hydrocephalus (see para. [0006]) comprising:
delivering CSF from the ventricle of a brain of a patient through a ventricular catheter (see para. [0031]);
measuring pressure and/or temperature of the CSF using a pressure sensor and/or temperature sensor respectively (see at least para. [0039]) communicated to the ventricular catheter as delivered to the pressure and/or temperature sensor (see para. [0031] teachings that the valve assembly 104 is connected with catheter 108; para. [0039] that sensor assembly 216 is positioned at valve assembly 104);
transmitting the measured pressure and/or temperature to a physician and/or patient using a wireless data transmitter (para. [0074] teaches components for wireless communication that may transfer data through a wireless local area network);
regulating flow of the CSF using a controllable valve (see valve assembly 104 in para. [0032]) communicated to the pressure sensor and/or temperature sensor (para. [0039] that sensor assembly 216 is positioned at valve assembly 104); and
transferring the CSF through a drainage catheter communicated to the controllable valve to a body situs for CSF absorption (see at least para. [0031]).
Regarding claim 12, Sadanand teaches the method as discussed above in claim 11. Additionally Sadanand teaches where measuring pressure of the CSF determines if a low-pressure measurement by the pressure sensor is less than a predetermined magnitude (see para. [0037]) and reporting the determined low pressure using the wireless data transmitter to the attending physician and/or patient (para. [0074] teaches components for wireless communication that may transfer data through a wireless local area network) as a clogged ventricular catheter (para. [0037] teaches that when CSF pressure within valve assembly 104 is above a predetermined threshold value, the gate opens so that CSF can flow through pressure valve 214; therefore, when a clog is detected, CSF pressure will increase above a predetermined threshold value).
Regarding claim 14, Sadanand teaches the method as discussed above in claim 11. Additionally Sadanand teaches where measuring pressure of the CSF determines if a high-pressure measurement by the pressure sensor is greater than a predetermined magnitude (see para. [0037]) and reporting the determined high pressure to the attending physician using the wireless data transmitter to the attending physician (para. [0074] teaches components for wireless communication that may transfer data through a wireless local area network) as a clogged programmable valve or clogged peritoneal tubing (para. [0037] teaches that when CSF pressure within valve assembly 104 is above a predetermined threshold value, the gate opens so that CSF can flow through pressure valve 214; therefore, when a clog is detected, CSF pressure will increase above a predetermined threshold value).
Regarding claim 18, Sadanand teaches the method as discussed above in claim 11. Additionally Sadanand teaches where regulating flow of the CSF using a controllable valve communicated to the pressure sensor and/or temperature sensor is performed by physician and/or patient intervention in an open loop control of the valve (para. [0057] teaches that a user may adjust the pressure valve threshold so that a lower CSF pressure is required to open the pressure valve 214).
Regarding claim 20, Sadanand teaches the method as discussed above in claim 11. Additionally Sadanand teaches where the ventricular catheter has a catheter tip (as at numeral 112 in Fig. 1), and the valve has an inlet and outlet (at least inherent), where the pressure and/or temperature sensor include a plurality of pressure sensors communicated to the CSF (see sensor assembly 216 at least in para. [0039]; an assembly typically has more than one component) at or near the catheter tip, the inlet or the outlet of the valve (see at least para. [0044]), where measuring pressure and/or temperature of the CSF is performed at or near the catheter tip, the inlet or the outlet of the valve (see at least para. [0044]), and where regulating flow of the CSF using a controllable valve communicated to the pressure sensor and/or temperature sensor is performed based on an interpreted operational status of the shunt based on pressure and/or temperature measurements at or near the catheter tip, and/or the inlet or the outlet of the valve (see at least para. [0044] teaching different locations for positioning the sensor assembly 216).
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.
Claims 3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Swoboda (U.S. Pre Grant Pub. No. 2017/0219450 A1) in view of Shachar ‘455 (U.S. Pre Grant Pub. No. 2014/0303455 A1).
Regarding claims 3 and 5, Swoboda teaches the invention as discussed above in claims 2 and 4, respectively. However, Swoboda fails to teach where the predetermined magnitude is 0 to 15 mmHg, as required by the claim.
Shachar ‘455 teaches an analogous CSF monitoring device comprising a pressure sensor (see Abstract) that monitors for obstruction in the shunt (see para. [0030]). Shachar ‘455 further teaches that normal intercranial pressure is in the 0-15 mmHg range, that when intercranial pressure is over 15-20 mmHg, intervention is needed to reduce the pressure (see para. [0006]), and that the safety threshold of pressure is 18 mmHg (see para. [0030]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swoboda to incorporate the teachings of Shachar ‘455 by making the predetermined magnitude 0-15 mmHg at least because such is the known CSF pressure at equilibrium, as taught by Shachar ‘455 (see para. [0006]; as applied to claim 3). Additionally, while Shachar ‘455 teaches that the safety threshold of pressure is 18 mmHg (see para. [0030]), it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see also MPEP 2144.05(I); (as applied to claim 5).
Regarding claim 6, Swoboda teaches the invention as discussed above in claim 1. However, Swoboda fails to teach a temperature sensor, as required by the claim.
Shachar ‘455 teaches an analogous CSF monitoring device (see Abstract) comprising a temperature sensor (see sensor 9 at least in para. [0062]) that is used to monitor the temperature of CSF (see para. [0062]). Shachar ‘455 further teaches that increased temperature is an indication of an infectious process (see para. [0062]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swoboda to incorporate the teachings of Shachar ‘455 by including a temperature sensor that would cause a high temperature measurement by the temperature sensor greater than a predetermined magnitude is reported by the wireless data transmitter as an infection in the patient at least in order to be able to monitor temperature of CSF which would indicate whether an infection is present or not, as taught by Shachar ‘455 (see para. [0030]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Swoboda (U.S. Pre Grant Pub. No. 2017/0219450 A1) in view of Shachar ‘455 (U.S. Pre Grant Pub. No. 2014/0303455 A1), as applied above to claim 6, and further in view of Funane (U.S. Pre Grant Pub. No. 2018/0256911 A1).
Regarding claim 7, Swoboda in view of Shachar ‘455 teaches the invention as discussed above in claim 6. However, Swoboda in view of Shachar ‘455 fails to teach where the predetermined magnitude is > 400C, as required by the claim.
Funane teaches an analogous medical device in the same field of endeavor of medical devices (see Abstract). Funane teaches that it is unsafe for an internal body temperature to exceed 400C (see para. [0051]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swoboda in view of Shachar ‘455 to incorporate the teachings of Funane by making the predetermined magnitude 400C at least because Funane teaches that it is unsafe for an internal body temperature to exceed 400C (see para. [0051]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Swoboda (U.S. Pre Grant Pub. No. 2017/0219450 A1) in view of Kassem (U.S. Pre Grant Pub. No. 2009/0112308 A1).
Regarding claim 8, Swoboda teaches the invention as discussed above in claim 1. Additionally, Swoboda teaches:
an implantable body (see pressure sensor 300 in Fig. 4A and para. [0057]) including:
a wireless transceiver (see transceiver 122 in para. [0057]);
a battery (see BAT in Fig. 4A and para. [0061]);
a battery charger circuit coupled to the battery and to the wireless transceiver (see para. [0061]);
a power reducing circuit (see para. [0061] teaching that the battery is rechargeable; therefore, a power reducing circuit is present);
and a programmable microcontroller (see microcontroller 330 in Fig. 4A and para. [0061]) coupled to the wireless transceiver, power reducing circuit and to the pressure sensor and/or temperature sensor (see para. [0061] teaching that the microcontroller communicates with different components of the sensor 300), where the microcontroller is programmable to collect, store and/or transmit data from the pressure sensor and/or temperature sensor and to control operation of the wireless transceiver and the pressure sensor and/or temperature sensor (para. [0087] teaches that the microcontroller controls calibration procedure, acquires signals from the sensor and communicates with a remote interface device; therefore, the microcontroller is collecting, storing, and transmitting data),
whereby measured pressure and/or temperature of the CSF relating to the operational status of the shunt is wirelessly reported to a physician and/or patient for interventional response (see para. [0055] teaching that controller 110 is coupled to a wireless communications link 126 to be monitored and/or analyzed remotely).
However, Swoboda fails to teach an external RFID scanner or an RFID transceiver, as required by the claim.
Kassem teaches an analogous implantable valve and sensor (see Abstract) comprising an RFID tag that includes an antenna for communicating stored data to an external reading device (see para. [0007]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Swoboda to incorporate the teachings of Kassem by including an external RFID scanner (in the form of an antenna) and by substituting the wireless transceiver for an RFID one at least because such components are well known in the art, as evidenced by their disclosure in Kassem (see at least para. [0007]) and in order to provide convenient and reliable access to data related to the implantable valve, as taught by Kassem (see para. [0023]).
Claims 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sadanand (U.S. Pre Grant Pub. No. 2014/0276346 A1) in view of Shachar ‘455 (U.S. Pre Grant Pub. No. 2014/0303455 A1).
Regarding claims 13 and 15, Swoboda teaches the method as discussed above in claims 12 and 14, respectively. However, Swoboda fails to teach where the predetermined magnitude is 0 to 15 mmHg, as required by the claim.
Shachar ‘455 teaches an analogous CSF monitoring device comprising a pressure sensor (see Abstract) that monitors for obstruction in the shunt (see para. [0030]). Shachar ‘455 further teaches that normal intercranial pressure is in the 0-15 mmHg range, that when intercranial pressure is over 15-20 mmHg, intervention is needed to reduce the pressure (see para. [0006]), and that the safety threshold of pressure is 18 mmHg (see para. [0030]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Swoboda to incorporate the teachings of Shachar ‘455 by making the predetermined magnitude less than 0 mmHg at least because such is the known CSF pressure at equilibrium, as taught by Shachar ‘455 (see para. [0006]; as applied to claim 13). Additionally, while Shachar ‘455 teaches that the safety threshold of pressure is 18 mmHg (see para. [0030]), it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see also MPEP 2144.05(I); (as applied to claim 15).
Regarding claim 16, Sadanand teaches the method as discussed above in claim 11. However, Sadanand fails to explicitly teach a temperature sensor, as required by the claim.
Shachar ‘455 teaches an analogous CSF monitoring device (see Abstract) comprising a temperature sensor (see sensor 9 at least in para. [0062]) that is used to monitor the temperature of CSF (see para. [0062]). Shachar ‘455 further teaches that increased temperature is an indication of an infectious process (see para. [0062]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sadanand to incorporate the teachings of Shachar ‘455 by including the step of where measuring the temperature determines if a high temperature measurement by the temperature sensor is greater than a predetermined magnitude and reporting the high temperature to the physician and/or patient using the wireless data transmitter as an infection in the patient at least in order to be able to monitor temperature of CSF which would indicate whether an infection is present or not, as taught by Shachar ‘455 (see para. [0030]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sadanand (U.S. Pre Grant Pub. No. 2014/0276346 A1) in view of Shachar ‘455 (U.S. Pre Grant Pub. No. 2014/0303455 A1), as applied above to claim 6, and further in view of Funane (U.S. Pre Grant Pub. No. 2018/0256911 A1).
Regarding claim 17, Sadanand in view of Shachar ‘455 teaches the method as discussed above in claim 16. However, Sadanand in view of Shachar ‘455 fails to teach where the predetermined magnitude is > 400C, as required by the claim.
Funane teaches an analogous medical device in the same field of endeavor of medical devices (see Abstract). Funane teaches that it is unsafe for an internal body temperature to exceed 400C (see para. [0051]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sadanand in view of Shachar ‘455 to incorporate the teachings of Funane by making the predetermined magnitude 400C at least because Funane teaches that it is unsafe for an internal body temperature to exceed 400C (see para. [0051]).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shachar (U.S. Pre Grant Pub. No. 2017/0325685 A1) in view of Giftakis (U.S. Pre Grant Pub. No. 2010/0121214 A1).
Regarding claim 21, Shachar teaches: An optical sensor system (see at least para. [0008]) comprising:
an implanted optical sensor (see para. [0006]) for receiving light and returning phase shifted light (see para. [0006]);
source of light for generating light communicated to the optical sensor (see para. [0006]);
an exterior reader (see metronomic biofeedback pump MBP in para. [0006]) for reading the CSF pressure in the brain as indicated in the returned phase shifted light from the optical sensor (see para. [0006]);
and means for communicating the CSF pressure in the brain (see optical fibers and photo diode in para. [0006]) as indicated in the returned phase shifted light from the optical sensor to the reader or for communicating the returned phase shifted light from the optical sensor to the reader (para. [0006] teaches that the receiving photo diode converts returning light that passed through the CSF into an electrical signal to be analyzed by the MBP).
However, Shachar fails to explicitly teach that the optical sensor system is for measuring CSF pressure in the brain of a patient or that the implanted optical sensor’s receiving of light and returning phase shifted light is indicative of the CSF pressure in the brain, as required by the claim.
Giftakis teaches an analogous device for monitoring trends in intercranial pressure (see Abstract) comprising leads 20 that are placed within brain 28 to position pressure sensors 25, 27 which are capable of sensing pressure changes within cranium 32 (see para. [0049]). Giftakis further teaches that the pressure sensors 25, 27 may be optical pressure sensors that include a pressure-sensitive diaphragm that changes diffraction grating based on pressure exerted on the diaphragm (see para. [0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shachar to incorporate the teachings of Giftakis by simply substituting the implanted optical sensor of Shachar for the optical pressure sensor of Giftakis with the predictable result being that the sensor is able to monitor intercranial pressure, as taught by Giftakis (see para. [0049]) and as desired by Shachar (see for example optical and pressure sensor in para. [0007]).
Regarding claim 22, Shachar in view of Giftakis teaches the invention as discussed above in claim 21. Additionally, Shachar teaches where the source of light is exterior to the patient (see para. [0006] teaching that the LEDs are on the metronomic biofeedback pump MBP) and where the means for communicating the returned phase shifted light from the optical sensor to the reader comprises an optical cable (see para. [0006]). However, Shachar fails to explicitly teach where the means for communicating the returned phase shifted light from the optical sensor to the reader comprises an implanted optical terminus and an optical cable communicating the implanted optical sensor with the implanted terminus, the exterior reader optically coupling with the implanted terminus, as required by the claim.
Giftakis teaches that leads 20 are placed within brain 28 to position pressure sensors 25, 27 such that pressure sensors 25, 27 are capable of sensing pressure changes within cranium 32 (see para. [0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shachar in view of Giftakis to further incorporate the teachings of Giftakis by implanting an optical terminus at least in order to measure intercranial pressure and to prevent intercranial pressure, as taught by Giftakis (see para. [0049]).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Shachar (U.S. Pre Grant Pub. No. 2017/0325685 A1) in view of Giftakis (U.S. Pre Grant Pub. No. 2010/0121214 A1), as applied above to claim 21, and further in view of Nova (U.S. Patent No. 6,340,588 B1).
Regarding claim 23, Shachar in view of Giftakis teaches the invention as discussed above in claim 21. Additionally, Shachar teaches where the means for communicating the CSF pressure in the brain as indicated in the returned phase shifted light from the optical sensor to the reader comprises an implanted wireless communication circuit electromagnetically communicating with the exterior reader (see at least claim 15). Shachar further teaches that the optical sensor has one or more LEDs (see para. [0056]). However, Shachar fails to explicitly teach that the source of light is implanted in the patient, as required by the claim.
Giftakis teaches that leads 20 may be placed within brain 28 to position pressure sensors 25, 27 (see para. [0049]). Giftakis further teaches that optical pressure sensors may be carried by leads 20 (Id.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shachar in view of Giftakis to further incorporate the teachings of Giftakis by implanting the leads 20 in the patient at least in order to position the optical pressure sensor, as taught by Giftakis (see para. [0049]).
Regarding claim 24, Shachar in view of Giftakis teaches the invention as discussed above in claim 23. Additionally, Shachar in view of Giftakis teaches where the source of light and means for communicating the CSF pressure are included within a single implanted housing (para. [0048] of Giftakis teaches that housing 34 includes one or more sensing electrodes) and that the housing is implanted (see at least para. [0054] of Giftakis).
Regarding claim 25, Shachar in view of Giftakis teaches the invention as discussed above in claim 23. Additionally, Shachar in view of Giftakis teaches where the source of light and means for communicating the CSF pressure are included within a plurality of intercommunicated implanted housings (para. [0095] teaches that more than one intercommunicative housing is used).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Geiger (U.S. Pre Grant Pub. No. 2006/0020239 A1) – Cerebral Spinal Fluid Flow Sensing Device.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781