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 .
Election/Restrictions
Claims 14-15, 27, 28-31 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 February 2025.
Claims 1-13, 16-26 are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “includes a membrane that can be interfaced to a pressure sensor located in the drain to measure the fluid pressure” that renders the claim indefinite. Specifically, the use of the term “can be interfaced” makes the claim unclear whether the claims require the portion following “can be interfaced”. In an effort to compact prosecution, the limitation will be interpreted as --includes a membrane--.
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.
Claims 1-13 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Golden (US 2021/0060315).
Regarding claim 1, Golden discloses a method for draining body fluid from a patient, the method based on a desired ICP target pressure and being independent of fluid volume drained (figure 2A, [0034]), the method comprising the steps of:
measuring an intracranial pressure through a connection (134, [0039]) to an external pressure monitor, sensor, or transducer or to an internal sensor or transducer (152, 146, 132, figure 2A, [0038-0039]);
and allowing a fixed amount of fluid to drain through the pressure of the patient’s body ([0040-0042]) and/or a gravity-oriented system wherein fluid flows to the drain positioned physically below the patient:
measuring the amount of fluid drained ([0039]):
closing the drain ([0027]; and
repeating this process until the desired ICP target pressure is achieved ([0039-0040]).
This embodiment does not disclose if the pressure exceeds the desired target pressure, opening a drain.
Golden teaches the prior art embodiment (figures 1A) if the pressure exceeds the desired target pressure, opening a drain ([0027][, valves 20 exist to start/stop flow).
Golden provides multiple embodiments and acknowledges the prior art uses a drain that controls the flow of material ([0027]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden by utilizing the drain and valve in order to control the flow of material.
Regarding claim 2, the first embodiment of Golden relied upon does not teach the drain is comprised of a disposable cassette that comprises a proximal valve, a graduated body, and a distal valve.
Golden teaches the prior art embodiment (figures 2A-2C) if the pressure exceeds the desired target pressure, opening a drain ([0027][, valves 20 exist to start/stop flow and exist in the embodiments in figures 2A-2C), the drain having proximal valve and distal valve (20, [0027], figures 1A) and a graduated body (18).
Golden provides multiple embodiments and acknowledges the prior art uses a drain that controls the flow of material ([0027]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden by utilizing the drain and valve in order to control the flow of material.
Regarding claim 3, Golden further teaches the second embodiment wherein opening the drain comprises opening the proximal valve and leaving the distal valve closed to accumulate the body fluid into the cassette, so that a user may visually inspect the volume of body fluid ([0027-0028], the user can independently actuate either valve, and visually inspect the body liquid in the drip chamber (18).
Golden provides multiple embodiments and acknowledges the prior art uses a drain that controls the flow of material ([0027]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden by utilizing the drain and valve in order to control the flow of material.
Regarding claim 4, Golden further discloses wherein a proximal portion of the disposable cassette comprises a pressure sensor above the proximal valve (134 appear to be measuring at a spot that is near the head rather than the location of the valve which would be midway between the head and the collection container).
Regarding claim 5, Golden discloses the proximal portion of the drain includes a membrane (112, the inlet would be a membrane).
Regarding claim 6, Golden discloses wherein a maximum amount of body fluid drained per opening of the drain is variable ([0034], the height is adjusted which makes the body fluid drained per opening be variable).
Regarding claim 7, Golden does not disclose this embodiment wherein an opening and closing periodicity of the drain is variable.
Golden teaches the prior art embodiment (figures 1A) wherein an opening and closing periodicity of the drain is variable ([0027], [0035]).
Golden provides multiple embodiments and acknowledges the prior art uses a drain that controls the flow of material ([0027]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden by utilizing the drain and valve in order to control the flow of material.
Regarding claim 8, Golden discloses wherein a measured volume of body fluid drained correlates to the visual volume accumulated ([0048]).
Regarding claim 9, Golden discloses wherein the proximal valve is closed and the distal valve is opened to evacuate a contents of the graduated body into a drainage collection bag.
Golden further teaches the second embodiment wherein the proximal valve is closed and the distal valve is opened to evacuate a contents of the graduated body into a drainage collection bag (126, [0027-0028], the user can independently actuate either valve, and visually inspect the body liquid in the drip chamber (18).
Golden provides multiple embodiments and acknowledges the prior art uses a drain that controls the flow of material ([0027]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden by utilizing the drain and valve in order to control the flow of material.
Regarding claim 10, Golden discloses wherein the volume of body fluid evacuated is recorded (126, figure 2A, has markings).
Regarding claim 11, Golden discloses wherein a total volume of the drainage collection bag is known, and the total volume evacuated is monitored, and a user of the drain is notified of required drainage collection bag changes as the drainage collection bag fills ([0036-0037], the user can necessarily change the bag when the bag is full).
Regarding claim 12-13 and 16, Golden discloses wherein the method further comprises a mechanism for optically aligning the drain (116, figure 1A) to a patient's interventricular foramen, the mechanism including but not limited to a laser pointer (118) affixed to at least one point on the drain ([0029]), wherein the mechanism for optically aligning the drain further comprises a means to adjust a height of the mechanism for optically aligning the drain (116) without adjusting a physical height of the drain ([0036]), said height adjustment of the mechanism for optically aligning the drain being detected by the drain ([0036]), wherein the mechanism for optically aligning the drain further comprises a camera, a sensor, or other means of detecting a position of a head of the patient (134, [0040]) and monitoring it over time, which produces either an automated adjustment or a prompt to a user to adjust the position of the mechanism for optically aligning the drain ([0040]).
Regarding claim 17, Golden discloses wherein a user can manually apply a fixed adjustment to a plurality of values of the ICP pressure to compensate for over or understatement of the ICP (152, user can use the display to adjust the system, [0038]).
Regarding claim 18, Golden discloses wherein the drain automatically adjusts between an ICP monitoring system (134) that is interior to a ventricular system of the patient, and a pressure transducer that is located exterior to the ventricular system (146, [0041]).
Claims 19-26 are rejected under 35 U.S.C. 103 as being unpatentable over Golden in view of Daniels (US 2020/0297982).
Regarding claim 19-20, Golden does not teach wherein the ICP is actively monitored for normalized ICP waveform patterns (claim 19) and wherein an alarm is generated when the normalized ICP waveform patterns do not meet the normalized patterns (claim 20).
Daniels discloses a method of measuring ICP wherein the ICP is actively monitored for normalized ICP waveform patterns ([0038]) and wherein an alarm is generated when the normalized ICP waveform patterns do not meet the normalized patterns ([0037]).
Daniels implements a way to measure and record data and makes adjustments based on said data ([0023], [0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden with the monitoring system of Golden in order to obtain more data and allow more adjustments to treatment.
Regarding claims 21-24, Golden does not teach wherein a CSF drainage is applied as a therapeutic correction to abnormal ICP waveform patterns (claim 21), wherein a user defines a trial period for the CSF drainage to correct the abnormal ICP waveform patterns (claim 22) ([0026]), wherein an alarm is generated when the trial period has ended and the normalized ICP waveform patterns remains abnormal (claim 23), wherein an alarm is generated if the ICP waveform patterns worsen relative to the normalized ICP waveform patterns (claim 24).
Daniels further teaches CSF drainage is applied as a therapeutic correction to abnormal ICP waveform patterns ([0023], [0038-0039]), wherein a user defines a trial period for the CSF drainage to correct the abnormal ICP waveform patterns ([0026]), wherein an alarm is generated when the trial period has ended and the normalized ICP waveform patterns remains abnormal ([0026] user sets timing, and when the period has ended and waveform shows undesirable data then alarm will sound since monitoring is continuous, [0022], [0037]), wherein an alarm is generated if the ICP waveform patterns worsen relative to the normalized ICP waveform patterns ([0022], [0037]).
Daniels implements a way to measure and record data and makes adjustments based on said data ([0023], [0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden with the monitoring system of Golden in order to obtain more data and allow more adjustments to treatment.
Regarding claims 25-26, Golden does not teach wherein the user selects a defined ICP pattern tolerance during or after application of CSF drainage to correct the ICP pattern (claim 25) and wherein a different or escalated alarm is generated if the ICP pattern exceeds a specific tolerance (claim 26).
Daniels teaches wherein the user selects a defined ICP pattern tolerance during or after application of CSF drainage to correct the ICP pattern ([0023]) and wherein a different or escalated alarm is generated if the ICP pattern exceeds a specific tolerance ([0022], [0037], multiple alarms used, able to use different alarms for low/high values).
Daniels implements a way to measure and record data and makes adjustments based on said data ([0023], [0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Golden with the monitoring system of Golden in order to obtain more data and allow more adjustments to treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/ Primary Examiner, Art Unit 3781