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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/5/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/5/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 6, Applicant contends that Bourne does not expressly disclose the limitations of wherein the processor is configured to “set a reflux pressure for the aspiration pump based on the estimated IOP“ on the grounds that Bourne does not provide an express disclosure of this step being performed by the processor. While the processor is capable of producing a reflux by altering the speed and direction of the impeller motor (see Bourne Para. [0038] and [0042]), Bourne provides no express disclosure of a “setting” step performed by the processor based on the estimated IOP.
The Examiner respectfully disagrees. While Bourne does not provide an express recitation of “setting a reflux pressure”, the Examiner contends that this is an implicit step performed by the processor. In Para. [0021], [0029], [0038]-[0040] and [0042], Bourne discloses wherein the control system (103) uses pressure information received from sensor 392 (indicative of the IOP) to detect whether a clog or occlusion is present at the tip of the phacoemulsification needle. Based on the recorded pressure, the control system determines and sets a speed and/or direction of the impeller pump (342) to regulate the IOP (i.e., the speed and/or direction of the impeller pump is regulated to maintain a set IOP). In response to a clog or occlusion at the tip of the needle, the control system directs the impeller to reverse flow (generating reflux) and change/alter its speed to attempt to clear the occlusion. In setting an impeller speed, the processor is thereby “setting” the reflux pressure applied to the system by the impeller pump. Whether the speed, and associated pressure, may vary based on the pressure readings received by the control system, the control system ultimately “sets” the reflux pressure applied to the system by virtue of setting/altering the impeller pump speed. As currently presented, the term “set” does not reference or include any specific steps (e.g., the processor, based on the IOP, algorithmically determines an optimal reflux pressure to be applied to clear the detected clog over a set time interval and saves this value in a database to be retrieved whenever a clog is detected) and thus does not provide constraints to narrow the interpretation of “setting” a reflux pressure to a direct computational step performed in data-flow by the processor. Until further limitations are incorporated into the limitations of claims 1 and 6, the indirect “setting” of a reflux pressure based on altering the speed of the impeller pump is seen to read on the claims, as presented.
Applicant additionally contends that none of either Bourne or Hopkins discloses the limitations of “setting a reflux pressure for the aspiration pump for one predefined time duration based on the estimated IOP, and to repel the clogging by controlling the aspiration pump to apply the reflux pressure for the one predefined time duration” (incorporated from previously-recited Claims 3 and 8, rejected under Hopkins) on the grounds that Hopkins discloses a “fully repeatable” reflux pressure pulse which is different and distinct from a reflux pressure for a single time duration. The pressure profile of Hopkins is “pre-defined” in contrast to Claim 1 which requires the “predetermined” time duration be based on the estimated IOP.
The Examiner respectfully disagrees with the interpretation of the “one predefined time duration” in the context of the currently-presented claim language. Hopkins provides a disclosure of wherein a pulse-type reflux profile generates a reflux pressure when desired (see Hopkins Para. [0010] and [0012]). The Examiner contends that each “pulse” of reflux pressure can be defined as a “pre-defined time duration” which takes place over the length of time taken to undergo said single reflux pulse. Since Bourne was not specific as to the length of time the reflux pressure is to be applied upon detection of a clog, Hopkins provides supplementary disclosure of a pulse-style frequency that achieves sufficient reflux within the shared field of endeavor. The “repeatable” nature of the reflux pulse does not appear to teach away from the claim limitations, as currently presented. As the aspiration sensor(s) of Bourne transmit data indicative if IOP (in detecting a clog), after each reflux pulse (and associated time duration) occurs, the control system adjusts to determine whether additional, repeated pulses may be required based on the data received from said aspiration sensors. Since the pulse occurs over a given time period, each pulse is thereby understood to constitute a “pre-defined time duration” until further limitations are incorporated into the claims to prevent such an interpretation.
Applicant additionally contends that Bourne does not provide a disclosure of wherein the processor detects that the clogging was repelled based on a reading from the aspiration sensors on the grounds that Bourne provides no express disclosure that the control system “detects” that the clog has been repelled.
The Examiner respectfully disagrees. As disclosed in Para. [0038] and [0042], Bourne discloses wherein the control system (103) may “detect” an occlusion when the pressure within the aspiration conduit (as measured by the aspiration sensor) drops below a selected level. The Examiner contends that pressure readings provided by the aspiration sensor allow the control system to detect whether a clog is present or not. As expressly disclosed, the control system alters a speed of the aspiration pump when the aspiration sensor detects a drop in pressure within the aspiration conduit. If no reduction in pressure is detected, the control system would not be aware of or detecting a clog and would continue to operate normally. Upon alteration of the aspiration pump to attempt to clear the clog, the control system would maintain the altered aspiration pump speed/direction until the pressure within the aspiration conduit returns to a normal, pre-set value. The Examiner contends that upon repelling of the clog, the only way the control system would know to shut off would be to receive updated pressure readings from the aspiration sensor indicative of a successfully repelled clog (i.e., in the form of an updated pressure reading). This updated pressure reading of a normal, pre-reduced pressure within the aspiration conduit would indicate to the control system that the clog has been repelled to allow the aspiration pump to be re-adjusted for normal operation. While this indirect “detection” via the aspiration sensor pressure readings may differ from the “detecting” step of the claimed invention, until further limitations are incorporated to further define this “detecting” step, the currently-applied interpretation is seen to read on the currently-recited claim limitations.
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.
Claim(s) 1, 5-6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourne (US 2017/0367885 A1)(previously of record) in view of Gordon (US 2018/0028359 A1)(previously of record), further in view of Banko (US 2019/0133822 A1)(previously of record), further in view of Hopkins (US 2009/0124962 A1) (previously of record).
Regarding claim 1, Bourne discloses:
A phacoemulsification system (system 100, see Fig. 1), comprising:
a phacoemulsification probe (handpiece 112, see Fig. 3) having a distal end configured for insertion into an eye of a patient (see Para. [0025] mentioning wherein a distal portion 326 of the handpiece 112 is configured to emulsify tissue within a patient’s eye), the probe comprising:
an irrigation channel (irrigation passage 334, see Fig. 3, see also Para. [0026]) for irrigating the eye with irrigation fluid (see Para. [0026]);
an aspiration channel (aspiration conduit 340, see Fig. 3, see also Para. [0028]) for evacuating material from the eye (see Para. [0028]);
an aspiration sensor (sensor 392, see Fig. 3), which is coupled with the aspiration channel and is configured to measure a value indicative of a pressure in the aspiration channel (see Para. [0038]-[0039] mentioning wherein the sensor 392 may be located within the aspiration conduit 340 to provide IOP feedback to control system 103);
an aspiration pump (impeller pump 342, see Fig. 3) configured to evacuate the material from the aspiration channel (see Para. [0028] and [0040]); and
a processor (control system 103, see Fig. 2), which is configured to detect a clogging of the aspiration channel using the aspiration sensor (see Para. [0042]), to estimate an intra-ocular pressure (IOP) of the eye using the aspiration sensor (see Para. [0039] mentioning wherein the sensor 392 sends pressure information to the control system 103, wherein the pressure information of the sensor 392 is indicative of IOP), to set a reflux pressure for the aspiration pump based on the estimated IOP and to repel the clogging by controlling the aspiration pump to apply the reflux (see Para. [0021], [0029], [0038]-[0040] and [0042] mentioning wherein the control system 103 uses pressure information received from sensor 392 (indicative of the IOP) to detect whether a clog or occlusion is present at the tip of the phacoemulsification needle; based on the recorded pressure, the control system determines and sets a speed and/or direction of the impeller pump 342 to regulate the IOP (i.e., the speed and/or direction of the impeller pump is regulated to maintain a set IOP). In response to a clog or occlusion at the tip of the needle, the control system directs the impeller to reverse flow (generating reflux) and change/alter its speed to attempt to clear the occlusion (i.e., a speed of the impeller pump is “set” by the control system to attempt to clear the occlusion at the output speed set by the control system); the speed of the impeller pump would generate an associated pressure being applied to the surgical site which is understood to constitute a “set reflux pressure” to successfully repel the clog);
wherein the processor is further configured to detect that clogging was repelled based on a reading from the aspiration sensor (see Para. [0038] and [0042] mentioning wherein the aspiration sensor is configured to detect when a clog is present within the system; the control system adjusts the impeller motor to attempt to clear the clog in response to this detection; when the clog is cleared, the sensor would record a normal flow rate to indicate that the clog has been cleared due to continuously tracking said aspiration system; said data is relayed to the control system to reduce the chances of a post-occlusion surge), and to restore nominal operation of the aspiration pump (see Para. [0038] and [0042] mentioning wherein the control system is configured to, upon detection of a clog, alter the impeller motor to attempt to clear said clog; when the clog is cleared and no longer detected by the aspiration sensor, the control system would return the impeller motor to normal function).
However, Bourne does not expressly disclose:
an irrigation sensor, which is coupled with the irrigation channel and is configured to measure a parameter indicative of a pressure of the irrigation fluid; and
an irrigation pump configured to flow the irrigation fluid to the irrigation channel;
wherein the processor to estimates the intra-ocular pressure (IOP) of the eye using the irrigation sensor; and
wherein the processor utilizes and applies the set reflux pressure, based on the estimated IOP, for a predefined time duration.
In the same field of endeavor, namely phacoemulsification devices for operating within a patient’s eye, Gordon teaches wherein a phacoemulsification device comprising an irrigation pressure sensor sends signals to a processor to estimate an intraocular pressure (IOP) within an eye since the characteristics of the irrigation passage are known (see Para. [0076]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Bourne to comprise an irrigation pressure sensor within the irrigation channel as taught and suggested by Gordon to, in this case, communicate with the control system of Bourne to provide feedback pertaining to the irrigation pressure being applied to an eye (IOP) to allow the control system to be aware of the pressure being applied by the irrigation sensor to prevent damage to the eye.
In the same field of endeavor, namely phacoemulsification devices, Banko teaches wherein a phacoemulsification device may comprise separate irrigation (see Para. [0040]) and aspiration pumps (see Para. [0068] and [0070]), wherein the irrigation pump is configured to provide pressure for the delivery of irrigation fluid to supply forced irrigation of the fluid into the eye (see Para. [0040], [0068] and [0070]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Bourne to include an irrigation pump that is separate from the aspiration pump as taught and suggested by Banko to, in this case, provide a method to force irrigation fluid into an eye by providing a pressurized system, allowing for a more controlled, powerful method of controlling the flow of irrigation fluid (see Banko Para. [0040], [0068] and [0070]).
In the same field of endeavor, namely reflux control systems for surgical assemblies, Hopkins teaches wherein a processor may provide a pre-defined reflux pressure profile in a pulsed manner that is fully repeatable (see Para. [0010] and [0012]) to generate a reflux pressure when desired (see Para. [0012]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the control system of Bourne to be configured to, upon detection of a clog within the aspiration channel, apply reflux pressure for pre-defined amount of time in a pulsed manner, as taught and suggested by Hopkins, to generate effective reflux (see Hopkins Para. [0012]). As Bourne is silent as to how long said reflux pressure is applied to clear a clog at the tip of the device, one of ordinary skill would have looked to known methods in the art to achieve an effective reflux configuration. The disclosure of Hopkins teaches a known method for generating reflux in a pulsed manner to clear a clog and one of ordinary skill would have applied this known teaching to fill in for the method of reflux of Bourne. In the incorporated system, once each pulse sequence has been applied, the control system, upon receiving input from the aspiration sensor, would cease all further reflux pulses upon determining the clog is no longer present.
Regarding claim 5, the combination of Bourne, Gordon, Banko and Hopkins disclose the invention of claim 1, Bourne further discloses wherein the distal end comprises a hollow needle (needle 324, see Fig. 3), and wherein the aspiration channel traverses an internal lumen of the needle (see Bourne Fig. 3, see also Para. [0028]).
Regarding claim 6, Bourne discloses:
A phacoemulsification method, comprising:
inserting into an eye of a patient a distal end of phacoemulsification probe (handpiece 112, see Fig. 3, see also Para. [0025] mentioning wherein a distal portion 326 of the handpiece 112 is configured to emulsify tissue within a patient’s eye), the probe comprising:
an irrigation channel (irrigation passage 334, see Fig. 3, see also Para. [0026]) for irrigating the eye with irrigation fluid (see Para. [0026]);
an aspiration channel (aspiration conduit 340, see Fig. 3, see also Para. [0028]) for evacuating material from the eye (see Para. [0028]);
an aspiration sensor (sensor 392, see Fig. 3), which is coupled with the aspiration channel and is configured to measure a value indicative of a pressure in the aspiration channel (see Para. [0038]-[0039] mentioning wherein the sensor 392 may be located within the aspiration conduit 340 to provide IOP feedback to control system 103);
using an aspiration pump (impeller pump 342, see Fig. 3), evacuating the material from the aspiration channel (see Para. [0028] and [0040]);
detecting a clogging of the aspiration channel using the aspiration sensor (see Para. [0042] mentioning wherein sensor 392 detects clogs within the aspiration channel and relays the information to control system 103); and
setting a reflux pressure for the aspiration pump based on the estimated IOP, and repelling the clogging by controlling the aspiration pump to apply the reflux pressure (see Para. [0021], [0029], [0038]-[0040] and [0042] mentioning wherein the control system 103 uses pressure information received from sensor 392 (indicative of the IOP) to detect whether a clog or occlusion is present at the tip of the phacoemulsification needle; based on the recorded pressure, the control system determines and sets a speed and/or direction of the impeller pump 342 to regulate the IOP (i.e., the speed and/or direction of the impeller pump is regulated to maintain a set IOP). In response to a clog or occlusion at the tip of the needle, the control system directs the impeller to reverse flow (generating reflux) and change/alter its speed to attempt to clear the occlusion (i.e., a speed of the impeller pump is “set” by the control system to attempt to clear the occlusion at the output speed set by the control system); the speed of the impeller pump would generate an associated pressure being applied to the surgical site which is understood to constitute a “set reflux pressure” to successfully repel the clog);
detecting that the clogging was repelled base on a reading from the aspiration sensor (see Para. [0038] and [0042] mentioning wherein the aspiration sensor is configured to detect when a clog is present within the system; the control system adjusts the impeller motor to attempt to clear the clog in response to this detection; when the clog is cleared, the sensor would record a normal flow rate to indicate that the clog has been cleared due to continuously tracking said aspiration system and said data is relayed to the control system so as to reduce the chances of a post-occlusion surge), and restoring nominal operation of the aspiration pump (see Para. [0038] and [0042] mentioning wherein the control system is configured to, upon detection of a clog, alter the impeller motor to attempt to clear said clog; when the clog is cleared and no longer detected by the aspiration sensor, the control system would return the impeller motor to normal function).
However, Bourne does not expressly disclose:
an irrigation sensor, which is coupled with the irrigation channel and is configured to measure a parameter indicative of a pressure of the irrigation fluid; and
using an irrigation pump, flowing the irrigation fluid to the irrigation channel;
estimating an intra-ocular pressure (IOP) of the eye using the irrigation sensor; and
wherein the processor utilizes and applies the set reflux pressure, based on the estimated IOP, for a predefined time duration.
In the same field of endeavor, namely phacoemulsification devices for operating within a patient’s eye, Gordon teaches wherein a phacoemulsification device comprising an irrigation pressure sensor sends signals to a processor to estimate an intraocular pressure (IOP) within an eye since the characteristics of the irrigation passage are known (see Para. [0076]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Bourne to comprise an irrigation pressure sensor within the irrigation channel as taught and suggested by Gordon to, in this case, communicate with the control system of Bourne to provide feedback as to the irrigation pressure being applied to an eye (IOP) to allow the control system to be aware of the pressure being applied by the irrigation sensor to prevent damage to the eye.
In the same field of endeavor, namely phacoemulsification devices, Banko teaches wherein a phacoemulsification device may comprise separate irrigation (see Para. [0040]) and aspiration pumps (see Para. [0068] and [0070]), wherein the irrigation pump is configured to provide pressure for the delivery of irrigation fluid to supply forced irrigation of the fluid into the eye (see Para. [0040], [0068] and [0070]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Bourne to include an irrigation pump that is separate from the aspiration pump as taught and suggested by Banko to, in this case, provide a method to force irrigation fluid into an eye by providing a pressurized system, allowing for a more controlled, powerful method of controlling the flow of irrigation fluid (see Banko Para. [0040], [0068] and [0070]).
In the same field of endeavor, namely reflux control systems for surgical assemblies, Hopkins teaches wherein a processor may provide a pre-defined reflux pressure profile in a pulsed manner that is fully repeatable (see Para. [0010] and [0012]) to generate a reflux pressure when desired (see Para. [0012]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the control system of Bourne to be configured to, upon detection of a clog within the aspiration channel, apply reflux pressure for pre-defined amount of time in a pulsed manner, as taught and suggested by Hopkins, to generate effective reflux (see Hopkins Para. [0012]). As Bourne is silent as to how long said reflux pressure is applied to clear a clog at the tip of the device, one of ordinary skill would have looked to known methods in the art to achieve an effective reflux configuration. The disclosure of Hopkins teaches a known method for generating reflux in a pulsed manner to clear a clog and one of ordinary skill would have applied this known teaching to fill in for the method of reflux of Bourne. In the incorporated system, once each pulse sequence has been applied, the control system, upon receiving input from the aspiration sensor, would cease all further reflux pulses upon determining the clog is no longer present.
Regarding claim 10, the combination of Bourne, Gordon, Banko and Hopkins disclose the method of claim 6, Bourne further discloses wherein the distal end comprises a hollow needle (needle 324, see Fig. 3), and wherein the aspiration channel traverses an internal lumen of the needle (see Bourne Fig. 3, see also Para. [0028]).
Claim(s) 2 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourne (US 2017/0367885 A1)(previously of record) in view of Gordon (US 2018/0028359 A1)(previously of record), further in view of Banko (US 2019/0133822 A1)(previously of record), further in view of Hopkins (US 2009/0124962 A1)(previously of record), further in view of Rockley (US 2014/0276897 A1)(previously of record).
Regarding claim 2, the combination of Bourne, Gordon, Banko and Hopkins disclose all of the limitations of the invention of claim 1.
However, while Bourne discloses wherein the control system sets a reflux pressure when an occlusion is present in a fluid channel and is able to cause the pump motor to increase, decrease or maintain a flow rate at a desired flow rate based on a measured or calculated parameter indicative of pressure at the surgical site (i.e., intraocular pressure within the eye) (see Para. [0038]), Bourne does not expressly disclose wherein the processor is configured to set the reflux pressure to be a predefined pressure above the estimated IOP.
In the same field of endeavor, namely reflux-pressure adjustment systems for use in surgical devices, Rockley teaches wherein a control system may increase an applied ocular reflux pressure to a level greater than the pressure within the eye (IOP), which would cause fluid to move towards the eye, thereby providing venting or reflux (see Para. [0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the control system of Bourne to be configured to, in response to a clog or occlusion at the tip of the phacoemulsification needle, increase the reflux pressure to a level greater than the IOP, since Rockley discloses wherein such a configuration would cause a reflux, which would repel the occlusion from the tip of the device. As Bourne is silent in regards to a specific method as to how altering the speed of the impeller pump would cause reflux to clear an occlusion, one of ordinary skill in the art would have looked to known methods for generating reflux to clear said occlusion. In this case, Rockley teaches wherein a known method for generating reflux is to have an applied reflux pressure be greater than that of the IOP.
In the same field of endeavor, namely reflux control systems for surgical assemblies, Hopkins further teaches wherein a processor may provide a pre-defined reflux pressure profile for the surgical system (see Para. [0010] and [0012]) to generate a reflux pressure when desired (see Para. [0012]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the control system of Bourne, as modified by Rockley, to have set a reflux pressure pre-determined level (i.e., to a level above the IOP, as modified by Rockley) to cause reflux and clear a clog or occlusion at the distal tip of the needle of Bourne. One of ordinary skill would have looked to known methods for generating reflux, and having a pre-defined pressure that is known to be capable of clearing an occlusion would aid in effectively clearing a clog from the device.
Regarding claim 7, the combination of Bourne, Gordon, Banko and Hopkins disclose all of the limitations of the method of claim 6.
However, while Bourne discloses wherein the control system sets a reflux pressure when an occlusion is present in a fluid channel and is able to cause the pump motor to increase, decrease or maintain a flow rate at a desired flow rate based on a measured or calculated parameter indicative of pressure at the surgical site (i.e., intraocular pressure within the eye) (see Para. [0038]), Bourne does not expressly disclose wherein the processor is configured to set the reflux pressure to be a predefined pressure above the estimated IOP.
However, in the same field of endeavor, namely reflux-pressure adjustment systems for use in surgical devices, Rockley teaches wherein a control system may increase an applied ocular reflux pressure to a level greater than the pressure within the eye (IOP), which would cause fluid to move towards the eye, thereby providing venting or reflux (see Para. [0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the control system of Bourne to be configured to, in response to a clog or occlusion at the tip of the phacoemulsification needle, increase the reflux pressure to a level greater than the IOP, since Rockley discloses wherein such a configuration would cause a reflux, which would repel the occlusion from the tip of the device. As Bourne is silent in regards to a specific method as to how altering the speed of the impeller pump would cause reflux to clear an occlusion, one of ordinary skill in the art would have looked to known methods for generating reflux to clear said occlusion. In this case, Rockley teaches wherein a known method for generating reflux is to have an applied reflux pressure be greater than that of the IOP.
In the same field of endeavor, namely reflux control systems for surgical assemblies, Hopkins further teaches wherein a processor may provide a pre-defined reflux pressure profile for the surgical system (see Para. [0010] and [0012]) to generate a reflux pressure when desired (see Para. [0012]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the control system of Bourne, as modified by Rockley, to have set a reflux pressure pre-determined level (i.e., to a level above the IOP, as modified by Rockley) to cause reflux and clear a clog or occlusion at the distal tip of the needle of Bourne. One of ordinary skill would have looked to known methods for generating reflux, and having a pre-defined pressure that is known to be capable of clearing an occlusion would aid in effectively clearing a clog from the device.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourne (US 2017/0367885 A1) in view of Gordon (US 2018/0028359 A1), further in view of Banko (US 2019/0133822 A1), further in view of Hopkins (US 2009/0124962 A1)(previously of record), further in view of Rockley (US 2014/0276897 A1)(previously of record), further in view of Gonzalez (US 2020/0260954 A1)(previously of record).
Regarding claim 11, the combination of Bourne, Gordon, Banko, Rockley and Hopkins disclose all of the limitations of the invention of claim 2.
However, while Bourne, as modified by Rockley and Hopkins discloses wherein a method for generating flux is to apply a pre-defined reflux pressure be greater than that of the IOP, which would cause fluid to move towards the eye, none of the combination expressly discloses wherein the predefined pressure above the estimated IOP is less than 20 mmHg.
In the field of endeavor of ocular surgical procedures, Gonzalez teaches wherein a normal IOP within a healthy eye is within a range of between 12-18 mmHg (see Para. [0002]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pre-defined reflux pressure of Bourne, as modified by Rockley and Hopkins, to be less than 20 mmHg as Gonzalez provides a teaching within the art that a typical IOP is less than 20 mmHg. To avoid damage to the eye by providing a pressure exceeding this normal range, it would have been obvious to one of ordinary skill in the art to have modified the pre-defined reflux pressure to be less than 20mmHg.
Regarding claim 12, the combination of Bourne, Gordon, Banko, Rockley and Hopkins disclose all of the limitations of the invention of claim 7.
However, while Bourne, as modified by Rockley and Hopkins discloses wherein a method for generating flux is to apply a pre-defined reflux pressure be greater than that of the IOP, which would cause fluid to move towards the eye, none of the combination expressly discloses wherein the predefined pressure above the estimated IOP is less than 20 mmHg.
In the field of endeavor of ocular surgical procedures, Gonzalez teaches wherein a normal IOP within a healthy eye is within a range of between 12-18 mmHg (see Para. [0002]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pre-defined reflux pressure of Bourne, as modified by Rockley and Hopkins, to be less than 20 mmHg as Gonzalez provides a teaching within the art that a typical IOP is less than 20 mmHg. To avoid damage to the eye by providing a pressure exceeding this normal range, it would have been obvious to one of ordinary skill in the art to have modified the pre-defined reflux pressure to be less than 20mmHg.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2023/0201443 A1 to Algawi, US 2022/0133537 A1 to Govari, US 2015/0038894 A1 to Urich and US 8267891 B2 to Dimalanta all disclose phacoemulsification devices comprising a clogging-detecting feature.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771