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 Arguments
Applicant’s arguments, see remarks, filed 10, with respect to the rejection(s) of claim(s) 13-15 have been fully considered and are not persuasive.
Regarding the 102 rejection, applicant argues that claim 13 has been amended to recite similar limitations to claim 1 and thus the 102 rejection should be withdrawn. However the examiner notes that claim 1 requires the sensor in a second section of the aspiration channel, where claim 13, as amended, only requires the sensor in the aspiration portion. The examiner notes that the Bui reference was brought into claim 1 (thus making it a 103) to teach this sensor location. As detailed below, Wilson does disclose a sensor in the aspiration portion, just not in the section defined under the limitation of claim 1. As such claim 13 remains a 102 rejection.
Applicant’s arguments with respect to claim(s) 1-4,6,7-9,11-12 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. The examiner notes that the rejection was updated in view of Wilson citations to read to the newly amended limitations.
Applicant further argues that even in combination of Wilson and Bui, “neither reference is specific as to the respectively claimed conditions being used to (1) control an operation of the valve to reduce the fluid connectivity between the inlet port and the outlet port, and (2) control the operation of the valve to increase the fluid connectivity between the inlet port and the outlet port.” As further detailed under the rejection of claim 1 below, Wilson para. 0033,0035, discloses that the controller uses sensed parameters to adjust the valve position (more opened, fully opening, more closed, fully closed), such that the fluid parameters sensed by the sensors fall within preset or operator set values. As such it is interpreted that the controller increases/decreases the fluid connectivity of the system through the valve (by opening/closing the valve), to achieve desired fluid parameters. As such Wilson and Bui read to the claim 1 limitation.
Claim Objections
Claim 8,9 objected to because of the following informalities:
Claims 8 and 9 depend from claim 7, which was cancelled. While it is clear that the limitations in claim 7 were brought into claim 1, the dependency of claims 8 and 9 remained from claim 7. As such, for purposes of examination, it is interpreted that claims 8 and 9 depend from claim 1. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wilson, provided in the previous office action.
Regarding claim 13, Wilson discloses
A phacoemulsification fluid dynamics cartridge apparatus configured to be removably coupled with a phacoemulsification probe (para. 0010, figure 3 cartridge (406) removable from body/probe (305), and comprising: an aspiration inlet port and an aspiration outlet port (wherein the inlet port and the outlet port are interpreted as the openings on the distal (310) and proximal (315) end of body (305) through which the aspiration line (375) extends through), the aspiration inlet port being configured to be removably coupled with an aspiration channel (375) of the phacoemulsification probe (para. 0036 where the cartridge comprises part of the aspiration line, thus making the aspiration line removably coupled to the aspiration port), the aspiration outlet port being configured to be coupled with an aspiration tubing line (370); an aspiration channel section fluidically connecting the aspiration inlet port to the aspiration outlet port (375 seen connecting the defined inlet and outlet port, see annotated figure below); an irrigation inlet port and an irrigation outlet port (wherein the inlet port and the outlet port are interpreted as the openings on the distal (310) and proximal (315) end of body (305) through which the irrigation line (345) extends through), the irrigation inlet port being configured to be coupled with an irrigation tubing line (345), the irrigation outlet port being configured to be removably coupled with an irrigation channel of the phacoemulsification probe (para. 0036 where the cartridge comprises part of the irrigation line, thus making the aspiration line removably coupled to the aspiration port); an irrigation channel section fluidically connecting the irrigation inlet port to the irrigation outlet port (345 seen connecting the defined inlet and outlet ports); and a valve disposed in the aspiration channel section (aspiration valve (390) para. 0028) and configured to selectively control fluid connectivity in the aspiration channel section between the aspiration inlet port and the aspiration outlet port (para. 0034, where based on sensed pressure controls the valve to open/close to increase/decrease flow rate). The examiner notes that selectively opening/closing the valve as desired to change parameters is interpreted as selectively controlling the fluid connectivity.
The examiner notes that Wilson discloses a sensor (aspiration sensor (392)) configured to provide a signal indicative of a fluid metric in the aspiration channel (para. 0034). The examiner notes that per paragraph 0034, the sensor (392) detects a pressure in the aspiration conduit (seen in figure 3 and previously disclosed (See rejection of claim 1 and 2) to be in direct fluid communication with the second section of the aspiration channel). Wilson further discloses and a controller (controller 405) configured to selectively control the fluid connectivity between the inlet port and the outlet port responsively to the fluid metric (para. 0034, where based on sensed pressure controls the valve to open/close to increase/decrease flow rate). The examiner notes that selectively opening/closing the valve is interpreted as selectively controlling the fluid connectivity between the inlet and outlet port.
The limitation of “wherein the valve is configured to be operated to reduce fluid connectivity between the inlet port and the outlet port upon a rate of change of the fluid metric in the aspiration channel section passing a given rate of change, and wherein the valve is configured to be operated to increase fluid connectivity between the inlet port and the outlet port upon the fluid metric in the aspiration channel section passing a given value” is disclosed in Wilson para. 0033 and 0035. Per these citations the controller of Wilson receives pressure and/or flow information from the sensors (sensor of Wilson and obviously combined sensor of Bui) to operate the pump, the valve, or both (para. 0035) to achieve desired operating parameters. Per para. 0033 specifically, the controller controls the valve to move positions (more open, fully open, more closed, fully closed) as a means to control both the desired pressure and desired flow to the eye. The examiner further notes that per para. 0031, these desired operating parameters are pre-set or input by an operator. Therefore it is understood by the examiner that the controller of Wilson alters the position of the valve depending on the deviation from the set operating parameter (i.e. adjusting the valve to lower/raise the pressure or flow to the desired level). The examiner notes that therefore the controller is detecting a change in the operating parameters (and thus detects a rate of change as the rate of change is interpreted as the deviation from the set parameter) and adjusting the valve (reducing or increasing fluid connectivity by opening/closing or partially open/closing the valve) based on said change. As such, Wilson reads to the claimed limitation.
Regarding claim 14, Wilson discloses
The phacoemulsification fluid dynamics cartridge apparatus according to claim 13, further comprising a bypass channel fluidically connecting the irrigation channel section to the aspiration channel section and configured to allow a portion of the irrigation fluid in the irrigation channel section to enter the aspiration channel section (figure 3, shunt line and irrigation valve (396) seen as the dotted line in figure 3, see annotated figure under the rejection of claim 13).
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Regarding claim 15, Wilson discloses
The phacoemulsification fluid dynamics cartridge apparatus according to claim 14, wherein the bypass channel fluidically connects the irrigation channel section to the aspiration channel section at a region between the valve and the aspiration outlet port (Fig 3, where the bypass channel connects between the valve (390) and the outlet port defined under the rejection of claim 13 and as seen in the annotated figure under the rejection of claim 13).
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) 1-4,6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson, provided in the previous office action, in view of Bui US 2002/0019607, hereafter Bui, provided in the IDS.
Regarding claim 1, Wilson discloses
A phacoemulsification system (abstract), comprising a phacoemulsification probe including (figure 3 (110)): a distal end (310) comprising a needle (320 (defined as a cutting tip, where the cutting tip may be a cutting needle) (para. 0025, 0026)); an irrigation channel configured to convey irrigation fluid to the distal end (irrigation path 345); an aspiration channel configured to convey eye fluid and waste matter away from the distal end (aspiration path 375), wherein the aspiration channel comprises a first section and a second section(wherein the first section is the section between the distal end (310) and valve (390) and the second section is the section between valve (390) and proximal end (315)) an inlet port and an outlet port, wherein the first section of the aspiration channel is coupled with the inlet port and the distal end, and wherein the second section of the aspiration channel is coupled with the outlet port (wherein the inlet port and the outlet port are interpreted as the openings on the distal (310) and proximal (315) end of body (305) through which the aspiration line extend through); a valve configured to selectively control fluid connectivity in the aspiration channel between the inlet port and the outlet port (aspiration valve (390) para. 0028); and a bypass channel coupled with the irrigation channel and the second section of the aspiration channel and configured to allow a portion of the irrigation fluid in the irrigation channel to enter the second section of the aspiration channel (figure 3, shunt line and irrigation valve (396) seen as the dotted line in figure 3).
The examiner notes that Wilson discloses a sensor (aspiration sensor (392)) configured to provide a signal indicative of a fluid metric in the second section of the aspiration channel (para. 0034). The examiner notes that per paragraph 0034, the sensor (392) detects a pressure in the aspiration conduit (seen in figure 3 and previously disclosed (See rejection of claim 1 and 2) to be in direct fluid communication with the second section of the aspiration channel). Wilson further discloses and a controller (controller 405) configured to selectively control the fluid connectivity between the inlet port and the outlet port responsively to the fluid metric (para. 0034, where based on sensed pressure controls the valve to open/close to increase/decrease flow rate). The examiner notes that selectively opening/closing the valve is interpreted as selectively controlling the fluid connectivity between the inlet and outlet port. However, Wilson fails to disclose that the sensor is in the second portion of the aspiration channel.
Bui teaches an ocular irrigation system and is thus considered analogous to the claimed invention Bui teaches the use of pressure sensors (fig. 1 (27) and 34) for sensing pressure in the aspiration line (where sensor 27 determines the aspiration line pressure per para. 0011), where said sensor may be coupled to the controller (36), the controller processing the signals received (para. 0013). Per claims 1 and 13 of Bui, the controller varies said pump speed in response to a variation in the irrigation line pressure sensed by said pressure sensor, therefore indicating that the signals received by the controller (per para. 0013) are used in controlling the operation of the system in order to maintain a pressure within a desired range (para. 0018-0019). The examiner notes that the pressure sensor (27) of Bui if seen to be located adjacent to a pump and external container (24 and 26), and between said components and a valve (46). Therefore as Bui teaches that a controller may be programmed to control the system in response to sensed pressure in an aspiration channel, where said sensor is located in an interpreted second portion of the aspiration channel (between the valve and container), 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 device of Wilson with a pressure sensor in the second portion of the aspiration channel as a means to measure pressure within the channel and provide feedback to the controller on how to operate the pump. The examiner notes that as the controller of Wilson is configured to receive signals from sensors to operate components of the device, said sensor would provide data regarding control on the operation of the device.
The examiner notes that per the amendments filed 10/08/2025, Wilson reads to the limitations. The limitation of “wherein the controller is configured to detect a rate of change of the fluid metric in the second section of the aspiration channel, and control an operation of the valve to reduce the fluid connectivity between the inlet port and the outlet port responsively to the detected rate of change passing a given rate of change, and wherein the controller is configured to control the operation of the valve to increase the fluid connectivity between the inlet port and the outlet port responsively to the fluid metric in the second section of the aspiration channel passing a given value” is disclosed in Wilson para. 0033 and 0035. Per these citations the controller of Wilson receives pressure and/or flow information from the sensors (sensor of Wilson and obviously combined sensor of Bui) to operate the pump, the valve, or both (para. 0035) to achieve desired operating parameters. Per para. 0033 specifically, the controller controls the valve to move positions (more open, fully open, more closed, fully closed) as a means to control both the desired pressure and desired flow to the eye. The examiner further notes that per para. 0031, these desired operating parameters are pre-set or input by an operator. Therefore it is understood by the examiner that the controller of Wilson alters the position of the valve depending on the deviation from the set operating parameter (i.e. adjusting the valve to lower/raise the pressure or flow to the desired level). The examiner notes that therefore the controller is detecting a change in the operating parameters (and thus detects a rate of change as the rate of change is interpreted as the deviation from the set parameter) and adjusting the valve (reducing or increasing fluid connectivity by opening/closing or partially open/closing the valve) based on said change. As such, Wilson and Bui read to the claimed limitation.
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Regarding claim 2, Wilson and Bui teach
The phacoemulsification system according to claim 1, further comprising: an aspiration tubing line configured to be coupled with the second section (Wilson aspiration conduit (370) seen connected with defined second section); and a pumping sub-system (pump 360) configured to be coupled with the aspiration tubing line and pump the eye fluid and waste matter away from the distal end via the aspiration tubing line and the aspiration channel (Wilson para. 0028-0029, where the pump is connected to both irrigation and aspiration lines, and where the pump removes fluid from the surgical site through the aspiration pathway into the drain reservoir) .
Regarding claim 3, Wilson and Bui teach
The phacoemulsification system according to claim 1, wherein the bypass channel is configured to allow the portion of the irrigation fluid in the irrigation channel to enter the second section of the aspiration channel even when the valve is closed (Wilson para. 0040). Per para. 0040, the shunt line may allow fluid to pass (bleed irrigation fluid) to the aspiration line when the aspiration valve (390) is closed.
Regarding claim 4, Wilson and Bui teach
The phacoemulsification system according to claim 1, wherein the bypass channel provides a permanent fluid connection between the irrigation channel and the second section of the aspiration channel. The examiner notes that as seen in figure 3 of Wilson, the defined bypass channel (shunt line) is connected to the second section of the aspiration channel, and is therefore interpreted as providing a permanent fluid connection between the two channels.
Regarding claim 6, Wilson and Bui teach
The phacoemulsification system according to claim 1, wherein the fluid metric is a pressure level. The examiner notes that as detailed under the rejection of claim 1, the sensor of Bui, found obvious to combine with Wilson is disclosed to be a pressure sensor and thus measures a pressure level.
Regarding claim 8, Wilson and Bui teach
The phacoemulsification system according to claim 7, wherein the controller is configured to reduce the fluid connectivity between the inlet port and the outlet port by repeatedly opening and closing the valve. The examiner notes that as detailed under the rejection of claim 1, the controller controls the vale to open/close to reach a desired target parameter. As such it is interpreted that the valve would be repeatedly opened and closed throughout the treatment to achieve the target value. However, should applicant disagree with this interpretation the examiner notes that per the MPEP section 2114 section II “"[A]pparatus 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) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Wilson discloses a probe comprising an aspiration and irrigation channel, where the aspiration channel comprises a valve, and a controller for selectively controlling the valve in response to sensed and target parameters, thus reducing fluid connectivity over time, and it is interpreted repeated opening and closing of the valve to reduce fluid connectivity is functional language, Wilson discloses the claimed invention. The examiner notes that as pressure in the aspiration line was found to be a parameter per the obviousness rejection under claim 1 in view of Bui, the controller would still perform the same function based on the parameter (that being aspiration line pressure).
Regarding claim 9, Wilson and Bui teach
The phacoemulsification system according to claim 1, wherein the controller is configured to reduce the fluid connectivity between the inlet port and the outlet port responsively to the detected rate of change passing a given rate of change (Wilson para. 0033-0034). The examiner notes that as detailed under the rejection of claim 7, the controller selectively opens/closes the valve in the aspiration channel to adjust the parameters to a target level. Therefore it is interpreted that the target level (pressure) is too high (passes above the target), the controller would close the valve, thus lowering the fluid connectivity while also lowering the sensed parameter (flow rate or pressure) to an acceptable level. The examiner notes that Wilson further discloses that while the portion of the irrigation fluid in the irrigation channel enters the second section of the aspiration channel via the bypass channel increasing the fluid metric in the second section of the aspiration channel (Wilson para. 0040). Per paragraph 0040, the bypass channel (shunt line) bleeds irrigation fluid into the aspiration line (defined as the second portion per rejection of claim 1). The examiner notes that the influx of fluid into the second portion of the aspiration line though the defined bypass line would increase the fluid metric (pressure) as the influx of fluid would lead to a change in pressure. The examiner notes that as pressure in the aspiration line was found to be a parameter per the obviousness rejection under claim 1 in view of Bui, the controller would still perform the same function based on the parameter (that being aspiration line pressure).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Bui and further in view of Zanger et al. US 5649905, hereafter Zanger, where Zanger is provided in the IDS.
Regarding claim 11, Wilson and Bui teach
The phacoemulsification system according to claim 1, wherein the phacoemulsification probe further comprises a probe body (Wilson figure 3, (305)) and a fluid dynamics (406) cartridge configured to be removably connected to the probe body (Wilson para. 0036), the fluid dynamics cartridge comprising the valve, the sensor, and the bypass channel. The examiner notes that while it is not expressly disclosed that the cartridge comprises the valve, sensor, and bypass channel, Wilson discloses that the cartridge comprises both a portion of the irrigation and aspiration channels. The examiner notes that while the valve, sensor, and bypass channels are all connected to or comprise a portion of the aspiration and irrigation channels respectively, Wilson does not explicitly disclose that they are a part of cartridge. The examiner notes that per MPEP 2144.04 Section VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.) Therefore, as the valve, sensor, and bypass channels comprise portions of the aspiration and irrigation channels, and the removable cartridge of Wilson is disclosed to comprise a portion of both the irrigation and aspiration channels, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the cartridge to comprise the portion of the irrigation and aspiration channels comprising the valve, sensor, and bypass channel.
Should applicant disagree, a second rejection is made in view of Zanger.
Zanger teaches a system for regulating intraocular pressure and is thus considered analogous to the claimed invention. Zanger (Fig. 1) teaches that the device comprises a cassette (10) connecting with an irrigation line (22) and an aspiration line (24), where a diaphragm (figure 3 (74)) connects to both lines and may be actuated to divert irrigation flow (column 5, lines 16-24). The examiner notes that as said diaphragm selectively controls fluid flow, it is interpreted as a valve. Further, per column 6, lines 5-10, the diaphragm acts a tool to monitor and measure pressure and as such can also be interpreted as a sensor. As seen in figure 1, the cassette is removable from the main body. The examiner further notes that the irrigation channel can be seen branching into the diaphragm in figure 1, this branch is interpreted as the bypass channel. Therefore as Zanger teaches that a removable and replaceable cassette is provided with a sensor, valve, and bypass channel, where such cassettes enhance reliability of the fluidic connections (column 1, line 48-51), it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the removable cartridge of Wilson to comprise the valve, sensor, and bypass channel.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Bui and Zanger, and further in view of Traxinger US 2005/0118048, hereafter Traxinger.
Regarding claim 12, Wilson, Bui, and Zanger teach
The phacoemulsification system according to claim 11, wherein the fluid dynamics cartridge comprises the controller. The examiner notes that as seen in figure 3 of Wilson and as detailed under para. 0026 and 0030 of Wilson, the controller is part of the fluidics system and in communication with the sensors of the device, as well as control the valve. As detailed under the rejection of claim 11, per MPEP 2144.04 Section VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.) Therefore, as the controller is connected to the valve and sensors, and it was found obvious to rearrange the cartridge of Wilson to include such components, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the cartridge to further comprise the controller.
Should applicant disagree a further rejection if made in view of Traxinger.
Traxinger discloses a fluidic cassette for ophthalmic surgery and is thus considered analogous to the claimed invention. Traxinger teaches that a cartridge may comprise sensors and even an embedded processor to aid in the functioning of the device (para. 0062). Therefore as Traxinger teaches that it is known in the art for processors for controlling and operating sensors and other components in a fluidics delivery system may be located on removable cartridges, it would have been obvious to one of ordinary skill to place the controller of Wilson on the removable cartridge.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781