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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 31, 2025has been entered.
Response to Arguments
Applicant's arguments filed 1-6,19 have been fully considered but they are not persuasive.
The applicant argues that Silverberg is directed to measuring drained fluid whereas Peret is directed to a device for fluid infusion and therefore the two devices have opposing functionalities and one having ordinary skill in the art would not suggest to combine them. The examiner respectfully disagrees. While the examiner does agree with the assertation that Silverberg is directed to drained fluid and Peret is directed to infusing fluid, no teaching used in the rejection is specifically directed to the process of infusing a fluid. Rather the teachings of Peret are used to show that fluid flow characteristics may be measured using a system comprising sensors, cameras, and processor. While the flow of Silverberg and Peret may be in different directions, the fluid is still flowing, and the camera as disclosed in Peret is simply capturing an image of the fluid. Said capturing of an image of the fluid is not specific to only infusion, and may be reasonably be applied to any fluid flow pathway, as is done in the rejection of claim 1. Therefore the rejection is upheld.
The applicant further argues that as Peret is not directed to neurology or CSF one of ordinary skill in the art would not combine said art with Silverberg. The examiner reiterates that the teaching of Peret is used to show obvious a fluid measurement system using a camera, sensors, and a processor, not an infusion system being combined with a drainage system. As the camera captures images of fluid flowing, and fluid is flowing in both art references, it is interpreted that the camera of Peret would be capable of capturing images of any fluid flowing and as such is combined with Silverberg to do so.
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 20 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 20 recites the limitation "the duty cycle" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that claim 20, dependent from claim 1, recites “the duty cycle”. However neither claim 1 nor 20 define “a duty cycle” and as such “the duty cycle” lacks antecedent basis. It is interpreted that the duty cycle refers to an operation of the device where the valve is opened, per claim 1.
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.
Claim(s) 1-6, 19-20, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverberg et al. US 20040068221 A1 (hereinafter referred to as Silverberg) in view of Peret et al. US 20130310990 A1 (hereinafter referred to as Peret).
Regarding claim 1, Silverberg discloses
A cerebrospinal fluid (CSF) drainage system (abstract) comprising: a first conduit having a proximal end and a distal end (ventricular catheter 12 of Fig. 8, referred to as “access component 12” paragraph 0043; the proximal end is considered the top of the conduit, and the distal end is considered the end of the conduit that feeds into accumulator 252 (paragraph 0054)); a first collection chamber (accumulator 252 of Fig. 8) coupled to the distal end of the first conduit (paragraph 0054 and Figs. 8 and 10, where conduit 12 is coupled to the accumulator 252) and configured to collect the CSF transported by the first conduit (paragraph 0054): a first valve (valve 250 in Fig. 8) positioned on the first conduit (Fig. 8) and configured to control flow of the CSF into the first collection chamber (paragraph 0055); and a means of controlling the first valve (controller 260 for operating the valve 250 paragraph 0052) to open the first valve until the processor determines that a predetermined amount of CSF has been drained from the patient (paragraph 49, wherein the valves can be operated in response to “measured drainage of the CSF during any period the valve is open”). The current embodiment of Silverberg fails to directly disclose a method of measuring the flow rate of CSF.
However, in an alternate embodiment, Silverberg teaches a method of measuring flow rate of CSF (flow or detection component 80 of Fig. 4 and paragraph 0045). Therefore as Silverberg teaches that a second embodiment of the system is known to provide a means of measuring flow rate, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 8 of Silverberg to include the flow detection component 80 of Fig. 4 of Silverberg in order to ensure proper flow of CSF (which, for Silverberg, would be to ensure the fluid is removed at a relatively low, constant rate (lines 22-29, paragraph 44)). Examiner notes all the embodiments of Silverberg involve controlling the flow rate of CSF in some manner (for example, by using the valve 250 and the flow restrictor 270 of Fig. 8 (paragraphs 52 and 53)).
Silverberg fails disclose wherein the cerebrospinal fluid (CSF) drainage system also comprises: a camera configured to capture an image of the CSF collected within the first collection chamber; and a processor coupled to the camera, wherein the processor is configured to measure a flow rate of the CSF based on the image, and wherein the processor is configured to open the first valve until the processor determines that a predetermined amount of CSF has been drained.
Peret teaches monitoring, regulating, or controlling fluid flow (abstract, para. 0124), and is thus considered analogous to the claimed invention. Peret teaches a camera (355 of Fig. 68A) configured to capture an image of the CSF collected within the first collection chamber (drip chamber 357 of Fig. 68A); and a processor (abstract, para. 0190, 0622) coupled to the camera (the “one or more processors are operatively coupled to the image sensor” (abstract, para. 0190,0619), wherein the image sensor is considered a camera (paragraph 0619-0620, wherein component 355 of Fig. 68A is referred to as both a camera and an image sensor)) wherein the processor is configured to open the first valve until the processor determines that a predetermined amount of CSF has been drained (see paragraph 0191 wherein Peret teaches the processor estimates the flow rate (see “[t]he one or more processors are configured to estimate a flow of fluid” in the abstract) based on the image sensor (see paragraph 0619 wherein any of the methods disclosed in Peret may be used by the flow meter and camera, paragraph 0234 wherein Peret teaches counting pixels within a subset of pixels in the drip chamber to determine the volume of a drop in the drip chamber, and paragraph 440 wherein the volume of the drop is combined with the number of drops to get total volume over time to calculate flow rate; therefore, the flow rate is measured based on the image); also see the abstract, wherein Peret teaches the processor can actuate the valve of the system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the flow rate measurement method of Silverberg (the flow or detection component 80 of Fig. 4 and paragraph 0045) for the flow rate measurement method of Peret; This substation would yield the predictable result of obtaining a measurement of the flow rate into the chamber. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, B.).
Regarding claim 2, Silverberg and Peret teach
The invention of claim 1. Silverberg further discloses wherein the processor (controller 260 for operating the valve 250 (paragraph 0052)) is further configured to close the first valve (paragraph 0052) after a predetermined amount of CSF is collected by the first collection chamber (paragraph 0025, wherein “the desired CSF volume to be removed may be controlled by measuring the volume of CSF which has been removed over time”). Silverberg also discloses closing the valve before a first predetermined period of time has elapsed, as discussed in regards to claim 1 (paragraph 0025; see also lines 7-10 of paragraph 19, wherein the removal of CSF volumes can occur after different successive time periods), but does not disclose wherein the processor is configured to close after a predetermined amount of CSF is collected and before a first predetermined period of time has elapsed. However, as Silverberg discloses closing the valve based on predetermined time periods and closing the valve based on the amount of CSF drained from the patient, Silverberg is capable of both functions, and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the configuration of Silverberg to combine both functions to provide an additional failsafe in the device to prevent the removal of too much cerebrospinal fluid from the patient. Additionally, paragraph 0050 of Silverberg, discloses the valve maybe closed after the sensor has determined that a target volume has been drained, which would be effective “so long as the maximum 15-minute and hourly depletion volumes are not exceeded” provides additional motivation for the aforementioned combination.
Regarding claim 3, Silverberg and Peret teach
The invention of claim 1. The examiner notes once the combination of Silverberg in view of Peret is made, the device will include wherein the processor is further configured to determine a count of pixels defining the CSF collected within the first collection chamber on the image to measure the flow rate of the CSF because the flow rate determination of Peret as combined with Silverberg involves counting pixels of the fluid to define volume characteristics of that fluid (Peret paragraph 0619 wherein any of the methods disclosed in Peret may be used by the flow meter and camera, paragraph 0234 wherein Peret teaches counting pixels within a subset of pixels in the drip chamber to determine the volume of a drop in the drip chamber, and paragraph 0440 wherein the volume of the drop is combined with the number of drops to get total volume over time to calculate flow rate; therefore, the flow rate is measured based on a count of pixels, and if this method were used in Silverberg, the pixels would be defining droplets of CSF collected).
Regarding claim 4, Silverberg and Peret teach
The invention of claim 1. Peret further discloses wherein the processor is further configured to adjust one or more properties of the image (see Peret paragraph 0305, wherein the processor is configured to filter the image to determine which pixels are part of a drop) to increase visibility of the pixels prior to determining the count of the pixels (see Peret Fig. 82A, wherein the pixels in an image are filtered prior to counting pixels to determine drop size). Examiner notes once the combination of Silverberg in view of Peret is made, it would include wherein the processor is further configured to adjust one or more properties of the image to increase visibility of the pixels prior to determining the count because the image adjustment step is part of the process of measuring flow rate using a camera described in Peret (See Peret step 807 in Fig. 82A, which occurs prior to the determination of the drop size in step 810 and therefore prior to the determination of flow rate described in paragraph 440).
Regarding claim 5, Silverberg and Peret teach
The invention of claim 1. Silverberg further discloses the system further comprising a second valve (Silverberg valve 254 of Fig. 8) configured to allow the first collection chamber to collect the CSF in a closed position and drain the collected CSF in an open position (Silverberg paragraph 0055), and wherein the processor is further configured to open the second valve upon the determination of the predetermined amount of the CSF being drained from the patient (considered to be when the “accumulator will fill entirely” of Silverberg paragraph 0055, at which point the valve 254 will open to permit a draining of the accumulator).
Regarding claim 6, Silverberg and Peret teach
The invention of claim 1. Silverberg further discloses the system comprising a second conduit (Silverberg catheter 14 of Fig. 8) having a proximal end and a distal end (considered the beginning and end of conduit 14, in a similar manner to how the first conduit proximal and distal ends are detailed under the rejection of claim 1), the second conduit configured to receive the CSF from the first collection chamber from the proximal end (see the arrow exiting accumulator 252 in Fig. 8 of Silverberg, determined to be the proximal end of a second conduit as the first conduit was considered to empty into accumulator 252 (Silverberg paragraph 0054)) and a second collection chamber coupled to the distal end of the second conduit (see Silverberg paragraph 0023, wherein Silverberg discloses the device can include “one or more accumulators in combination with one or more on-off valves”) and configured to collect the CSF transported by the second conduit (see 14 of Fig. 8, which receives fluid from the first chamber, and paragraph 0023), wherein the second valve is positioned on the second conduit (see Fig. 8, wherein valve 254 is positioned on conduit 14).
Regarding claim 19, Silverberg and Peret teach
The invention of claim 1. The combination as made in regards to claim 1 further discloses wherein the processor is further configured to open and close the first valve based on a predetermined duty cycle (see paragraph 0025 of Silverberg, which discloses “closing the valve after a predetermined period of time has elapsed”; also see paragraph 0019 of Silverberg, which discloses the removal of CSF volumes can occur after different successive time periods).
Regarding claim 20, Silverberg and Peret teach
The CSF drainage system of claim 1 wherein the duty cycle is adjustable by a user (Silverberg para. 0050). The examiner notes that per Silverberg para. 0050-0051, the system is controlled by opening and closing of the valve to allow flow of CSF, where it may be desirable to alter the valve opening times, where said periods may include once a day, twice a day, up to 2x10^8 times a day, but preferably 50 times or fewer. Therefore, it is interpreted that Silverberg teaches that a duty cycle of the device (valve being opened) is customizable (adjustable) as desired. See also para. 0053, where multiple cycles of drainage may be performed in a day, ranging from one to four or more cycles in a day.
Regarding claim 24, Silverberg and Peret teach
The CSF drainage system of claim 1 wherein the camera is coupled with a light source that is directed through the fluid. The examiner notes that as seen in figured 23 of Peret, and as detailed in para. 0341 and 0510, there is a light source used within the imaging system of Peret, where the light source shines through the drip chamber and into the camera. Therefore as it was found obvious to combine the image capturing system of Peret with the system of Silverberg per the rejection of claim 1, and said image capturing system of Peret is taught to further include a light source coupled with the camera, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the system combination with said light source.
Claim(s) 21,22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverberg in view of Peret and further in view of Shachar US 2014/0303455, hereafter Shachar.
Regarding claim 21, Silverberg and Peret teach
The CSF drainage system of claim 1 but fails to disclose the system further comprising a sensor coupled to the camera and configured to determine a wavelength of a color of the CSF from the image.
Shachar teaches a CSF system and is thus considered analogous to the claimed invention. Shachar teaches that it is beneficial in a CSF system to comprise a means of infection detecting such that said infections can be detected early and therefore treated easily, lessen cost, and lessen morbidity (para. 0020). The system of Shachar teaches that a sensor comprising a spectrophotometer is used to determine if infections are present in the CSF by identifying the color/pigmentation of the CSF (para 0039, see also claim 4 of Shachar). Shachar further teaches that said CSF data collected may be provided to a physician in real time or stored on a memory card (para. 0039), where said memory card may communicate data wirelessly (para 0051). Said data communication may be transferred to a processing unit, where said unit can process the state of the system including alarms based on abnormal conditions (para. 0051, 0058). Therefore as Shachar teaches that monitoring data and transmitting said data in real time to a processor is beneficial in early detection of CSF infections to lower cost and mortality, and more easily treat infections, it would have been obvious to provide the monitoring system of Silverberg with a spectrophotometer to determine the color of the CSF and provide data to a memory and processor to determine the state of the CSF to aid in the aforementioned benefits of infection detection.
Regarding claim 22, Silverberg, Peret, and Shachar teach
The CSF drainage system of claim 21. The examiner notes that as detailed under the rejection of claim 21, Shachar teaches that teaches that said CSF data collected may be provided to a physician in real time or stored on a memory card (para. 0039), where said memory card may communicate data wirelessly (para 0051). Said data communication may be transferred to a processing unit, where said unit can process the state of the system including alarms based on abnormal conditions (para. 0051, 0058). As it was found obvious to combine the CSF monitoring and processing system for infections with the device of Silverberg and Peret, the combination of arts teach that the system further comprises a memory configured to store a database including wavelength data or wavelength range data and diagnostic data associated with each of the wavelength data or each of the wavelength range data, and a processor configured to determine a diagnosis based on the wavelength of the color of the CSF and the database, per the claim limitation.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over [Silverberg in view of Peret and further in view of Bray US 4893630, hereafter Bray.
Regarding claim 23, Silverberg and Peret teach
The CSF drainage system of claim 1, wherein the processor is configured to repeatedly open and close the first valve when the intracranial pressure is at or above a predetermined pressure for a predetermined period to reduce the intracranial pressure (para 0050). The examiner notes that per para. 0050 of Silverberg, the valve may be repeatedly opened to allow for drainage of CSF. Further, per paragraph 0015 of Silverberg, the device is configured to drain CSF so long as the pressure level is above a preselected level (75mmH20 in this case), where the device is configured to operate and drain fluid at pressures higher than said level, specifically at night when the pressure may reach 200mmH20, per the same paragraph 0015.
However, there is no clear disclosure of a intracranial pressure sensor measuring said pressure.
Bray teaches an apparatus and method of the invention provides means for measuring changes in cerebral compliance and changes in cerebral blood flow in a patient on a continuous on-line real time basis and means for simultaneously recording the intracranial pressure (column 2, lines 33-37), and is thus considered analogous to the claimed invention. Bray teaches that said device comprises a sensor tube through which intracranial fluid flows through, where said tube transmits the intracranial pressure to a pressure transducer at the end of the tube to detect signal and information relating to changes in intracranial pressure. Therefore as Bray teaches that intracranial pressure sensors are used to transmit data indicative of intracranial pressure through tubes, and Silverberg operation is based on a patients intracranial pressure (as detailed above under the same rejection para. 0015 of Silverberg), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the intracranial tubing of Silverberg with an intracranial pressure sensor to determine the patients intracranial pressure and changes to said pressure such that the device can be operated to aid in treatment.
Conclusion
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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