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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 23, 2026 has been entered.
Status of Claims
Claims 1, 4-8, 10-15 and 18-23 are pending and currently under consideration for patentability.
Claims 1, 10, 15, and 22 have been amended.
Response to Amendment
The examiner accepts the applicant’s amendment regarding the 112f rejection. The 112f rejection is therefor withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-8, 10-15 and 18-23 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.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: control module, and memory module in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The applicant’s specification notes “the control module may include one or more outputs, such as a wireless output transceiver 78 and/or a wired output 82” (paragraph [0025] and “The control module 66 may further include a display or further output 94” (paragraph [0028])
And the applicant’s specification notes “The memory 72 may include a system or mechanism to store a selected data, such as a sensor data 100 from the sensor 44” (paragraph [0029])
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claims 1, 3-8, 10-15, 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Penn (WO 0207596 A1) in view of Varadan (US 20060212097 A1) in view of Zhou (US 20120029587 A1) in view of Hyde (US 20120238936 A1).
Regarding Claim 1, Penn teaches a system for continuously (Page 2 lines 8-10) controlling a hydrocephalus shunt system (abstract), comprising:
a the brain sensor coupled to a (sensor, 16) lead (lead is implicit as the sensor must be attaches to the electronics case 42 via a lead or cable) and configured to sense electrical brain activity of a subject and generate a sensor signal (page 10, line 18-20) based upon the electrical brain activity;
a control system (10) comprising:
having a control module (external device, 14) operably disposed therein, the control module configured to execute instructions (sensor electronics, 58) (page 13, lines 1-12);
, the control module including a memory module (storage device, 78) operably disposed therein, the memory (page 18, lines 25-29: predetermined pressure and temperature measurements are transmitted to the control module in the external device for processing);
an input connection (input from external device, 14 implicitly connected to sensors) configured to receive the signal from the brain sensor and the lead(microprocessor (102) from the brain(16)) (figure 20);
wherein the control module is operable to evaluate and/or analyze the sensor signal of the electrical signal from the brain to generate a control signal (page 19, lines 13-15) to operate a flow control (104) (page 19, line 6: pump or valve).
wherein the flow control is configured to include a closed feedback loop (Page 20, lines 9-14: control device can respond to a response or sensed parameter) to continuously control a flow of a material through the hydrocephalus shunt system (page 19, line 23-24) based upon continuous feedback from the brain sensor and the lead to provide a continuous active feedback control (Page 20, lines 9-14: control device can respond to a response or sensed parameter) (Page 13 ln. 13-20).
where the control module is configured to execute instructions:
is configured to continuously monitor the received sensor signal (Penn, figure 18) (Penn, page 19, lines 16-22) (Page 13 ln. 13-20);
continuously determine whether the sensor signal is within a selected threshold via a continuous monitoring loop (Penn, figure 18) (Penn, page 19, lines 16-22);
when the sensor signal is outside of the selected threshold, the control module configured to the control signal to change operation of the flow control system based upon the electrical brain feedback from the sensor lead (Penn, figure 18) (Penn, page 19, lines 16-22).
Penn fails to teach wherein the brain electrode is configured to sense an electrical signal from a brain of the subject, wherein the sensor signal of the electrical brain activity to generate a control signal based on electrical brain activity feedback from the brain electrode and the lead. In the same field of endeavor, namely physiological sensors, Varadan teaches a system to monitor and treat physical activities, and medical and physiological conditions (paragraph 0001) wherein the sensor (sensor, 14) (figure 3) is configured to sense electrical brain activity of the subject (paragraph 0028), wherein the sensor (14) signal of the electrical brain activity to generate a control signal (paragraph 0042) based on electrical brain activity feedback from the sensor (paragraph 0028 and 0042). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Penn so that the sensor is configured to sense electrical brain activity, and add a control system and control signal similar to that disclosed by Varadan so that the electrical brain signal can be transmitted to a system to adjust treatment (as motivated by Varadan, paragraph 0028).
Penn fails to explicitly teach wherein the sensor is a brain electrode. However Varadan teaches wherein the sensor is a brain electrode with leads (paragraph [0008]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the sensors of Penn with brain electrodes, similar to Varadan in order to control the frequency of electrical signals transmitted to electrodes of the lead (motivated by Varadan, paragraph [0009]).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor of Penn that senses parameters of the brain to then analyze and control the system, for the sensor of Varadan since these mechanisms perform the same function of returning a signal from the brain to be processes and stored in the system. Simply substituting one sensor for another for another would yield the predicable result of allowing the device to analyze and store data regarding electrical brain activity. See MPEP 2143.
The limitations of “input connection configured to receive the sensor signal from the sensor brain electrode and the lead from the brain ” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Penn in view of Varadan discloses all the structure as claimed, and is further used within the brain of a patient (Abstract). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a sensor that can be implanted in the brain and sense electrical brain signals). It would be obvious to one having ordinary skill in the art to replace the sensors of Penn in view of Varadan with sensors that are able to detect electrical signals from the brain.
Penn and Varadan fail to teach wherein historical signal data is analyzed and stored. In the same field of endeavor, Zhou teaches a system and method for continuously monitoring nerve signal data wherein historical signal data is analyzed and stored (paragraph [0039]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Penn to store and analyze historical data, similar to Zhou for use in delivering, adjusting, controlling, initiating, and/or terminating therapy (as motivated by Zhou, paragraph [0039]).
In the same field of endeavor, Hyde teaches real time monitoring device wherein the control system includes a transceiver having a physical layer configured to transmit the historical data at a selected time (paragraph [0126]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Varadan wherein the control system includes a transceiver having a physical layer configured to transmit the historical data at a selected time similar to Hyde, to report status as continuous time intervals.
Regarding Claim 4, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 1. Penn further teaches wherein the flow control is a valve (page 19, line 6: pump or valve).
Regarding Claim 5, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 4. The combination further teaches wherein the valve includes a valve portion (Penn, page 19, line 6: pump or valve) configured to be adjusted to change an opening pressure of the valve based on the electrical brain feedback from the brain electrode (Varadan, paragraph 0024 and 0042) and the control signal from the control module (Penn, page 19, lines 13-15).
Penn fails to explicitly teach wherein the sensor is a brain electrode. However Varadan teaches wherein the sensor is a brain electrode with leads (paragraph [0008]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the sensors of Penn with brain electrodes, similar to Varadan in order to control the frequency of electrical signals transmitted to electrodes of the lead (motivated by Varadan, paragraph [0009]).
Regarding Claim 6, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 3. Penn further teaches wherein the flow control is a pump (page 19, line 6: pump or valve).
Regarding Claim 7, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 1. The combination further comprising: a catheter (Penn, 2) configured to be positioned in a ventricle (Penn, 4) (Penn ,figure 18) of a brain of the subject (Penn, page 20: line 15-16); wherein the brain electrode and the lead is formed integrally with the catheter (Penn, 16) (Penn, figure 18) to sense the electrical signal from the brain (Varadan, paragraph 0042).
Penn fails to explicitly teach wherein the sensor is a brain electrode. However Varadan teaches wherein the sensor is a brain electrode with leads (paragraph [0008]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the sensors of Penn with brain electrodes, similar to Varadan in order to control the frequency of electrical signals transmitted to electrodes of the lead (motivated by Varadan, paragraph [0009]).
Regarding Claim 8, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 1. Penn further teaches wherein the control module (14) configured to execute instructions is configured to the sensor signal of the electrical signal from the brain to a look up table of brain parameters stored in the memory module (page 18, lines 25-29: predetermined pressure and temperature measurements are transmitted to the control module in the external device for processing to be compared to sensor input) (78).
Regarding Claim 10, Penn in view of Varadan, Zhou, and Hyde teaches the system of Claim 1. Penn further teaches wherein, once the control module executes instructions to the transceiver to update and store historical data regarding the sensor signal at a selected time, the historical data regarding the sensor is updated over time (page 18, lines 25-29).
Regarding Claim 11, Penn in view of Varadan, Zhou, and Hyde teaches the system of Claim 1. Penn further teaches wherein a transceiver (transmitter, 60) configured to either transmit a signal from the control system or receive a signal (page 10, lines 16- 20).
Regarding Claim 12, Penn in view of Varadan, Zhou, and Hyde teaches the system of Claim 1. Penn further teaches further comprising: a programmer (external device, 14) separate from the control system configured to at least one of transmit a signal to the control system or received a signal from the control system (page 18, lines 17-21).
Regarding Claim 13, Penn in view of Varadan, Zhou, and Hyde teaches the system of Claim 12. Penn further teaches wherein the programmer (14) is configured to transmit a new application to the control system (figure 18) to evaluate and/or analyze the sensor signal to generate the control signal to operate the flow control (page 19, lines 19-22).
Regarding Claim 14, Penn in view of Varadan, Zhou, and Hyde teaches a method for controlling a hydrocephalus shunt system (abstract) with the system of Claim 1. The combination further teaches configuring the brain electrode and the lead(Penn, 16) for implantation in a brain of the subject (Penn, page 20: line 15-16); and executing the instructions to control the flow control based on the evaluation and/or analysis of the sensor signal (Penn, page 18, lines 25-29) of from the brain (Varadan, paragraph 0042).
Regarding Claim 15, Penn teaches a method for continuously controlling a hydrocephalus shunt system (abstract) (Page 13 ln. 13-20), comprising:
executing instructions with a control module (14) to evaluate and/or analyze the sensor signal to generate a control signal (page 10, lines 13-15) to operate a flow control (page 19, line 6);
recalling the instructions from a memory module (78) that is configured to store the instructions (page 18, lines 25-29); and
generating a control signal to operate the flow control in a closed feedback loop (Page 20, lines 3-14) based on the evaluation and/or analyze the sensor signal.(page 19, lines 13-15), wherein the flow control is configured to control a flow of a material through the hydrocephalus shunt system (page 19, line 23-24).
based upon feedback from the sensor lead to provide a continuous active feedback control (Page 20, lines 3-14) (Page 13 ln. 13-20).
where the control module is configured to execute instructions includes:
continuously monitoring the received sensor signal (Penn, figure 18) (Penn, page 19, lines 16-22) (Page 13 ln. 13-20);
continuously determining whether the sensor signal is within a selected threshold via a continuous monitoring loop (Penn, figure 18) (Penn, page 19, lines 16-22) (Page 13 ln. 13-20);
when the sensor signal is outside of the selected threshold, generating the control signal to change operation of the flow control system based upon the electrical brain feedback from the sensor lead (Penn, figure 18) (Penn, page 19, lines 16-22).
Penn fails to teach wherein receiving electrical brain activity signals from a brain of a subject with a brain electrode implanted in the brain of the subject to generate a brain sensor signal based upon the electrical brain activity signals. Varadan teaches a system to monitor and treat physical activities, and medical and physiological conditions (paragraph 0001) wherein the sensor (sensor, 14) (figure 3) is configured to sense electrical brain activity of the subject (paragraph 0028), wherein the sensor (14) signal of the electrical brain activity to generate a control signal (paragraph 0042). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor of Penn so that the sensor is configured to sense a physiological signal similar to that disclosed by Varadan so that the electrical brain signal can be transmitted to a system to adjust treatment (as motivated by Varadan, paragraph 0028).
Penn fails to explicitly teach receiving electrical brain activity signals from a brain of a subject with a brain electrode implanted in the brain of the subject to generate a brain sensor signal based upon the electrical brain activity signals . However Varadan teaches receiving electrical brain activity signals from a brain of a subject with a brain electrode implanted in the brain of the subject to generate a brain sensor signal based upon the electrical brain activity signals
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor of Penn that senses parameters of the brain to then analyze and control the system, for the sensor of Varadan since these mechanisms perform the same function of returning a signal from the brain to be processes and stored in the system. Simply substituting one resilient return means for another would yield the predicable result of allowing the device to analyze and store data regarding electrical brain activity. See MPEP 2143.
Penn and Varadan fail to teach receiving historical signal data from a control system, control signal to operate a based on the analysis between the brain sensor signal and historical signal data. In the same field of endeavor, Zhou teaches a system and method for receiving historical signal data from a control system, control signal to operate a based on the analysis between the brain sensor signal and historical signal data (paragraph [0039]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Penn to store and analyze historical data, similar to Zhou for use in delivering, adjusting, controlling, initiating, and/or terminating therapy (as motivated by Zhou, paragraph [0039]).’
In the same field of endeavor, Hyde teaches real time monitoring device transmitting the historical data to the control system using a transceiver having a physical layer and operably associated with the control system, the transceiver configured to transmit the historical data at a selected time (paragraph [0126]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Varadan wherein the control system includes a transceiver having a physical layer configured to transmit the historical data at a selected time similar to Hyde, to report status as continuous time intervals.
Regarding Claim 18, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 15. Penn further teaches transmitting the control signal to control the flow actively control (104) (figure 18) ; wherein the flow control is a valve (page 19, line 6).
Regarding Claim 19, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 18. Penn further teaches configuring the valve as the flow control (104) (page 19, line 6).
Regarding Claim 20, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 15. Penn further teaches transmitting the control signal to actively control the flow control (104) (figure 18); wherein the flow control (104) is a pump (page 19, line 6).
Regarding Claim 21, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 20. Penn further teaches configuring the pump as the flow control (page 19, line 6).
Regarding Claim 22, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 15. Penn further teaches a generating a new application; transmitting the new application to the memory module (78); and configuring the control module (14) to execute the new application (page 18, lines 17-21) as the instructions to evaluate and/or analyze the sensor signal to generate a control signal to operate a flow control (page 19, lines 19-22). Varadan already teaches application of the device in the brain as recited in claim 15.
Penn and Varadan fail to teach wherein historical signal data is analyzed and stored. In the same field of endeavor, Zhou teaches a system and method for continuously monitoring nerve signal data wherein historical signal data is analyzed and stored (paragraph [0039]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Penn to store and analyze historical data, similar to Zhou for use in delivering, adjusting, controlling, initiating, and/or terminating therapy (as motivated by Zhou, paragraph [0039]).
Regarding Claim 23, Penn in view of Varadan, Zhou, and Hyde teaches the method of Claim 15. Penn further comprising: generating a warning signal regarding at least one of operation of the control module (14), the received sensor signal, the generated control signal, or combinations thereof (page 14 line 27- Page 15 line 2). Varadan already teaches application of the device in the brain as recited in claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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/KATE ELIZABETH STRACHAN/ Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781