DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed September 10, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: claim 1 has been amended to recite that the control module is configured to label the physiological samples from the one or more sensors. This concept does not appear to be supported by the originally filed specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
optical sensor
chemical sensor
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: line 6 of the claim recites a valve module “operable coupled”. It appears that the language should be “operably coupled”. Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the originally filed specification fails to provide proper antecedent basis for the term “label”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite that the control module is configured to label the physiological samples from the one or more sensors. A control module configured to label physiological samples was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 1-4, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915).
With reference to claim 1, Saul discloses a cerebrospinal fluid shunt (figure 3) comprising:
a proximal conduit configured to be implanted in fluid communication at a distal end with a brain ventricle of a patient and a distal conduit configured to be implanted in fluid communication at a distal end with a reservoir (figure 3);
a dynamically controlled valve module operably coupled to the proximal end of the proximal conduit and the proximal end of the distal conduit, the dynamically controlled valve module selectively operable to permit fluid communication between the distal conduit and the proximal conduit [0012];
a pressure sensor (40) configured to detect a transient pressure in the ventricle [0009-0010; 0034];
one or more sensors operatively coupled to the proximal conduit and configured to collect physiological signals from the patient [0036];
one or more actuators (48) operatively coupled to the proximal conduit and configured to perform actions based on control signals [0034];
a control module in operable communication with the dynamically controlled valve [0033], the pressure sensor [0034], the one or more sensors [0036] and the one or more actuators [0035].
Saul discloses that the control module may be configured to analyze a pressure waveform [0012], detect and characterize transient pressure events [0024], extract a value (page 5, cl. 9), adjust operation of the valve [0012], collect signal from the one or more sensors [0036], and operate the one or more actuator based on a signal from the sensor as set forth in [0034].
The difference between Saul and claim 1 is the provision that the control module is configured to store and label the physiological signals from the one or more sensors.
It would have been obvious to one of ordinary skill in the art at the time of the invention to configure the microprocessor of Saul to store and label the physiological signals from the one or more sensors as desired since Saul discloses that the microprocessor may be programmed to perform a variety of different functions as set forth in [0035].
It is noted that Saul utilizes a microprocessor which is the same element utilized in the instant application to be configured to perform the recited functions.
The recited microprocessor needs only to be “configured to” perform the recited functions. As the element disclosed by Saul is the same as recited in the instant application, one of ordinary skill in the art would reasonably expect the microprocessor of Saul to be fully capable of being able to be configured to perform the same functions as claimed.
While Saul does provide a control module configured to analyze a pressure waveform and the pressure sensor such that, in response to detecting a transient pressure event in the ventricle that meets at least one criterion determined as a function of a predetermined control profile, then the dynamically controlled valve is operated to provide a corresponding predetermined flow profile between the distal conduit and the proximal conduit as set forth in [0033].
As to claim 2, Saul discloses a cerebrospinal fluid shunt wherein:
the transient pressure event comprises a transient pressure maximum generated by bodily motion of the patient, the at least one criterion comprises a pressure change over time threshold [0009-0012], and the dynamically controlled valve is operated to at least partially interrupt flow from the ventricle into the reservoir as set forth in [0012].
Regarding claim 3, Saul discloses a cerebrospinal fluid shunt wherein the dynamically controlled valve module comprises a plurality of valves as set forth in [0034].
With respect to claim 4, Saul discloses a cerebrospinal fluid shunt wherein the reservoir comprises a body cavity as shown in figure 3.
As to claim 12, Saul discloses a cerebrospinal fluid shunt wherein the one or more actuators further comprise a valve actuator as set forth in [0039].
With reference to claim 19, Saul discloses a cerebrospinal fluid shunt wherein the one or more actuators further comprise a switch as set forth in [0037].
Claims 5, 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915) and further in view of Browd et al. (US 2013/0197422).
With reference to claim 5, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claim 5 is the provision that the shunt further comprises a backflush reservoir.
Browd et al. (hereinafter “Browd”) teaches an analogous cerebrospinal fluid shunt further comprising a backflush reservoir [0060], wherein:
the dynamically controlled valve module is further in selective fluid communication with the backflush reservoir, and, the predetermined flow profile is further configured such that the dynamically control valve module is operated to cause fluid from the backflush reservoir to be discharged through at least the proximal end of the proximal conduit in response to the transient pressure event as set forth in [0072-0073].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with a backflush reservoir as taught by Browd in order to clear obstructions and loosen undesirable build-up and/or debris as taught by Brown in [0071].
With reference to claim 13, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claim 13 is the provision that the shunt further comprises a pump.
Browd teaches an analogous cerebrospinal fluid shunt further comprising a pump as set forth in [0041].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with a pump as taught by Browd in order to facilitate body fluid flow through the drainage system as taught by Brown in [0041].
With reference to claim 18, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claim 18 is the provision that the one or more sensors further comprises a specific type of actuator.
It is initially noted that Saul discloses the general teaching of providing on or more actuators as set forth in the rejection of claim 1. The substitution of a different type of actuator to produce desired result is considered to be within the level of ordinary skill in the art since the purpose of the actuator would continue to be fulfilled despite the specific technology of the actuator.
Nevertheless, Browd teaches analogous cerebrospinal fluid system including a displacement (i.e., piezo-electric) actuator as set forth in [0049].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with the displacement actuator as taught by Browd for the benefits associated with the use of piezo-electric actuators as taught by Browd in [0049].
Claims 6 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915) and further in view of Theodore et al. (US 2023/0363711).
With reference to claims 6 and 9-10, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claims 6 and 9-10 is the provision that the one or more sensors further comprises a specific type of sensor.
It is initially noted that Saul discloses the general teaching of providing on or more sensors as set forth in the rejection of claim 1. The substitution of a different type of sensor to produce desired result is considered to be within the level of ordinary skill in the art.
Nevertheless, Theodore et al. (hereinafter “Theodore”) discloses analogous cerebrospinal fluid system including a volume monitor (cl. 6) in [0082], a force sensor (cl.9) in the form of an accelerometry sensor, and a spatial sensor (cl. 10) in the form of an electromyography sensor as set forth in [0085].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with the desired sensor(s) as taught by Theodore in order to provide effective monitory and treatment of a patient as taught by Theodore in [0006].
Claims 7-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915) and further in view of Ericson et al. (US 6,533,733).
With reference to claims 7-8 and 11, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claims 7-8 and 11 is the provision that the one or more sensors further comprises a specific type of sensor.
It is initially noted that Saul discloses the general teaching of providing on or more sensors as set forth in the rejection of claim 1. The substitution of a different type of sensor to produce desired result is considered to be within the level of ordinary skill in the art.
Nevertheless, Ericson et al. (hereinafter “Ericson”) teaches an analogous cerebrospinal fluid shunt system that includes an optical sensor (cl. 7), an acoustic sensor (cl. 8) and/or a chemical sensor (cl. 11) as set forth in col. 7, lines 10-20.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with the desired sensor(s) as taught by Ericson in order to easily integrate and combine additional modes of physiological measurements as taught by Ericson in col. 7, lines 1-3.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915) and further in view of Hyde et al. (US 2012/0238936).
With reference to claim 16, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claim 16 is the provision that the one or more actuators further comprises a specific type of emitter.
It is initially noted that Saul discloses the general teaching of providing on or more actuators as set forth in the rejection of claim 1. The substitution of a different type of actuator to produce desired result is considered to be within the level of ordinary skill in the art since the purpose of the actuator would continue to be fulfilled despite the specific technology of the actuator.
Nevertheless, Hyde et al. (hereinafter “Hyde) teaches analogous cerebrospinal fluid system wherein the one or more actuators includes an optical emitter (cl. 14) and/or an electric emitter (cl. 15) as set forth in [0258].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with the specific actuators as taught by Hyde in order to conveniently and effectively emit one more energy stimuli as taught by Hyde in [0255].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915) and further in view of Burnett (US 2003/0163079).
With reference to claim 16, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claim 16 is the provision that the one or more sensors further comprises a specific type of actuator.
It is initially noted that Saul discloses the general teaching of providing on or more actuators as set forth in the rejection of claim 1. The substitution of a different type of actuator to produce desired result is considered to be within the level of ordinary skill in the art since the purpose of the actuator would continue to be fulfilled despite the specific technology of the actuator.
Nevertheless, Burnett teaches analogous cerebrospinal fluid system wherein the one or more actuators includes a pharmaceutical dispenser as set forth in [0035].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with the pharmaceutical dispenser as taught by Burnett in order to conveniently and effectively prevent the spread of infection between body cavities as taught by Burnett in [0035].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915) and further in view of Gharib et al. (US 2005/0277865).
With reference to claim 17, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claim 17 is the provision that the one or more sensors further comprises a specific type of actuator.
It is initially noted that Saul discloses the general teaching of providing on or more actuators as set forth in the rejection of claim 1. The substitution of a different type of actuator to produce desired result is considered to be within the level of ordinary skill in the art since the purpose of the actuator would continue to be fulfilled despite the specific technology of the actuator.
Nevertheless, Gharib et al. (hereinafter “Gharib”) discloses analogous cerebrospinal fluid system including a pneumatic actuator as set forth in [0081].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with the pneumatic actuator as taught by Gharib to provide a more reliable operation as taught by Gharib in [0081].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Saul (US 2003/0032915) and further in view of Morse et al. (US 2023/0132409).
With reference to claim 20, Saul teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Saul and claim 20 is the provision that the one or more sensors further comprises a specific type of sensor.
It is initially noted that Saul discloses the general teaching of providing on or more sensors as set forth in the rejection of claim 1. The substitution of a different type of sensor to produce desired result is considered to be within the level of ordinary skill in the art.
Nevertheless, Morse et al. (hereinafter “Morse”) teaches an analogous cerebrospinal fluid shunt system that includes a lab-on-a-chip sensor as set forth in [0088].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the shunt of Saul with a lab-on-a-chip sensor as taught by Morse in order to easily provide the system with a customizable sensor assembly as taught by Moses in [0008].
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL.
See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781