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 .
This action is in response to Applicant’s amendments filed 04/21/2026.
Claims 1-43 are cancelled.
Claims 44, 57, and 63 are currently amended.
Claims 44-67 are being examined in this Office Action.
Claim Objections
Claim 56-67 are objected to because of the following informalities:
Claim 56 recites “A method for monitoring the amount of fluid used” in the preamble, this should read “A method for monitoring an
Claim 62 recites “A system for monitoring the amount of fluid used” in the preamble, this should read “A system for monitoring an
All remaining claims are objected to by virtue of their dependence on an objected claim.
Appropriate correction is required.
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.
Claims 46-49, 55, 57, 58, 61, 63, 64, and 67 are 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 46 recites the limitation “the encoder” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 49 recites the limitation “the encoder” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 55 recites the limitation “the amount of fluid remaining” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear how “the amount of fluid remaining” is determined since there is no recited step tying “removed” to “remaining” (e.g., subtracting from the inputted fluid source volume).
Claim 57 recites the limitation “the calculated accumulated irrigation flow” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 57 recites the limitation “negative irrigation”, it is unclear what this is referring to. Is “negative irrigation” referring to aspiration, backflow, a negative sign in a formula, etc.? For the purposes of examination, Examiner interprets negative irrigation to be aspiration.
Claim 58 recites the limitation “accumulated irrigation flow” in the formula. There is insufficient antecedent basis for this limitation in the claim. Additionally, “Count of Total Number of Accumulated Values” is an entirely new undefined variable, it is unclear exactly which values are accumulated and counted as only a singular “accumulated irrigation flow rate” is recited in claim 56. Furthermore, “Elapsed Time” is divided by 60 with no units specified. Without knowing if the elapsed time is in seconds or minutes, the output is not definite.
Claim 61 recites the limitation “the amount of fluid remaining” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear how “the amount of fluid remaining” is determined since there is no recited step tying “removed” to “remaining” (e.g., subtracting from the inputted fluid source volume).
Claim 63 recites the limitation “the calculated accumulated irrigation flow” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 63 recites the limitation “negative irrigation”, it is unclear what this is referring to. Is “negative irrigation” referring to aspiration, backflow, a negative sign in a formula, etc.? For the purposes of examination, Examiner interprets negative irrigation to be aspiration.
Claim 64 recites the limitation “Accumulated Irrigation Flow” in the formula. There is insufficient antecedent basis for this limitation in the claim. Additionally, “Count of Total Number of Accumulated Values” is an entirely new undefined variable, it is unclear exactly which values are accumulated and counted as only a singular “accumulated irrigation flow rate” is recited in claim 62. Furthermore, “Elapsed Time” is divided by 60 with no units specified. Without knowing if the elapsed time is in seconds or minutes, the output is not definite.
Claim 67 recites the limitation “the amount of fluid remaining” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 56-67 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 56 recites the following limitations which can be considered an abstract idea:
starting a timer;
calculating an accumulated irrigation flow rate;
stopping… the timer;
acquiring a total elapsed time; and
calculating a total amount of irrigation fluid used during the surgical procedure.
The above limitations are considered abstract ideas because they amount to mere observations of an interval in conjunction with a mathematical calculation (re: the relationship between an accumulated flow rate and an elapsed time can be used to calculate a corresponding fluid volume), and because each of the steps required in claim 56 could be performed mentally, as none of the steps require any physical structure/components and merely refer to the general concepts of observing time and calculating a resulting amount.
The additional limitations of claim 56 that could be considered non-abstract are that the method recites “starting a surgical procedure with a known volume of irrigation fluid in a fluid source”, “administering the irrigation fluid”, and “stopping the administering of irrigation fluid”. However, none of these limitations are enough to indicate that the abstract ideas are integrated into a practical application. The limitation of starting the procedure with a known volume is a mere instruction to input a data value prior to performing the remaining steps. Furthermore, the steps of administering and stopping the administration of irrigation fluid can be considered a step of generally linking the judicial exception to a particular field of use and technological environment, namely, ophthalmic surgery (see MPEP 2106.05(h)), as the claim recites no additional element, e.g. a console, pump, valve, etc. that uses or is controlled by the result of the calculation steps. Because the claim recites an abstract concept and the additional elements fail to amount to significantly more as set forth above, the claims as an ordered combination fail to meet the requirement of 35 U.S.C. § 101.
Claims 57-61, i.e. the claims that depend on claim 56, do not provide limitations that would amount to significantly more than a judicial exception. For example, claim 57 generically requires that the accumulated irrigation flow is a sum of positive irrigation and negative irrigation, which falls within the judicial exception of a mathematical concept, as summing two valves is itself a mathematical concept. Claim 58 is drawn to the abstract idea of a mathematical concept, reciting the specific formula by which the amount of irrigation fluid is determined. Claims 59-60 are drawn to the abstract idea of receiving and using data, as the known volume of irrigation fluid is either carried over from a previous procedure or input by a user, both of which constitute insignificant extra-solution activity. Claim 61 is drawn to generically link the use of the judicial exception to a particular technological environment or field of use – See MPEP 2106.05(h) (claim 61 does not specifically link the warning step to any specific portion of claim 56 – for example the warning of claim 61 could be completely separate from the calculating steps of claim 56, as the claim does not recite that the warning is generated using the calculated total amount of irrigation fluid used).
Claim 62 recites an instrument host configured to perform the following functions, which can be considered an abstract idea:
start a timer;
calculate an accumulated irrigation flow rate;
stop… the timer;
acquire a total elapsed time; and
calculate a total amount of irrigation fluid used during the surgical procedure.
The above limitations are considered abstract ideas because they amount to mere observations of an interval in conjunction with a mathematical calculation (re: the relationship between an accumulated flow rate and an elapsed time can be used to calculate a corresponding fluid volume), and because each of the steps required in claim 62 could be performed mentally, as none of the steps require any physical structure/components and merely refer to the general concepts of observing time and calculating a resulting amount.
The additional limitations of claim 62 that could be considered non-abstract are “a fluid source coupled with a surgical console having a known volume of irrigation fluid”, “an irrigation pump fluidly coupled with the fluid source and in communication with an encoder for tracking the activation time of the irrigation pump”, “an instrument host”, “start a surgical procedure with the known volume of irrigation fluid in the fluid source”, “administer irrigation fluid”, and “stop the administering of irrigation fluid”. However, none of these limitations are enough to indicate that the abstract ideas are integrated into a practical application. The fluid source, surgical console, irrigation pump, and encoder are recited generically and are described in the Applicant’s specification as performing their well understood expected functions without any indication that these components are anything other than off the shelf, conventional componentry. The encoder’s function of tracking pump activation time is mere data gathering and can be considered a step of adding insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)), as the claim does not recite that this tracked value, or any of the claimed calculations derived from it, are used to control, adjust, or otherwise affect the pump, fluid source, or any other component of the system. Furthermore, the limitations of administering and stopping the administering of irrigation fluid, and starting the procedure with the known volume, can be considered a step of generally linking the judicial exception to a particular technological environment or field of use, namely ophthalmic surgery (see MPEP 2106.05(h)). Because the claim recites an abstract concept and the additional elements fail to amount to significantly more as set forth above, the claim as an ordered combination fails to meet the requirement of 35 U.S.C. § 101.
Claims 63-67, i.e. the claims that depend on claim 62, do not provide limitations that would amount to significantly more than a judicial exception. For example, claim 63 generically requires that the accumulated irrigation flow is a sum of positive and negative irrigation, which falls within the judicial exception of a mathematical concept, as summing two valves is itself a mathematical concept. Claim 64 is drawn to the abstract idea of a mathematical concept, reciting the specific formula by which the amount of irrigation fluid is determined. Claims 65-66 are drawn to the abstract idea of receiving and using data, as the known volume of irrigation fluid is either carried over from a previous procedure or input by a user, both of which constitute insignificant extra-solution activity. Claim 67 is drawn to generically link the use of the judicial exception to a particular technological environment or field of use – See MPEP 2106.05(h) (claim 67 does not specifically link the warning step to any specific portion of claim 62 – for example the warning of claim 67 could be completely separate from the calculating steps of claim 62, as the claim does not recite that the warning is generated using the calculated total amount of irrigation fluid used).
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) 44-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehta et al. (Pub. No. US 20190099547 A1, herein Mehta) in view of Dam-Huisman (Pub. No. US 20200360594 A1) further in view of Mallough et al. (Pub. No. US 20160220751 A1, herein Mallough).
Regarding Claim 44, Mehta discloses a method for monitoring an amount of fluid used during an ophthalmic surgical procedure (Paragraph [0017]), comprising:
inputting into a surgical console (850) a volume of a fluid source (30) in communication with the surgical console (Paragraph [0090]);
attaching to the surgical console a cassette (“fluid pack 855 may be in the form of a cassette which may be removably attached to surgical console 850” – Paragraph [0128], Fig. 8);
receiving by the surgical console an encoder value for tracking use of at least one pump (“The system may use a pump (e.g. a flow based (peristaltic) or vacuum based (Venturi) pump) to transfer fluid from the BSS container to the pressurized infusion tank inside the fluidics pack 855, as illustrated in FIG. 8. The present invention, via the console 850, for example, may track the starting and ending encoder counts to determine the amount of fluid transferred to the tank” – Paragraph [0120]).
Mehta does not expressly disclose a cassette having a known fluid capacity,
Dam-Huisman teaches a cassette (8) having a known fluid capacity (“The fluid level indicator 50 can be arranged within the cassette 8 in which the chamber 10 is provided. The fluid level indicator 50 may be configured to measure the fluid level remote from the fluid/air interface W within the chamber 10 … the skilled person will appreciate that other fluid level indicating arrangements are possible.” – Paragraph [0028]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a method for monitoring an amount of fluid used during an ophthalmic surgical procedure disclosed by Mehta to include a cassette having a known fluid capacity as taught by Dam-Huisman so that a user may monitor the fluid level within the chamber (Dam-Huisman, Paragraph [0039]).
Modified Mehta in view of Dam-Huisman does not expressly disclose a plurality of state indications of an irrigation valve control; and
calculating the amount of fluid removed from the fluid source by summing the plurality of state indications and the fluid capacity of the cassette.
Mallough teaches a plurality of state indications of an irrigation valve control (“An irrigation on/off pinch valve 48 may generally include a short segment of a flexible conduit of cassette 250, which can be engaged and actuated by an actuator of console 115” – Paragraph [0038], Fig. 2B); and
calculating the amount of fluid removed from the fluid source by summing the plurality of state indications and the fluid capacity of the cassette (“An estimation of flow rate from irrigation source 151 may be calculated using the various factors discussed above (e.g., IV pole height, pump speed, valving, pressure).” – Paragraph [0054]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for monitoring an amount of fluid used during an ophthalmic surgical procedure disclosed by Mehta to include a plurality of state indications of an irrigation valve control and calculating the amount of fluid removed from the fluid source by summing the plurality of state indications and the fluid capacity of the cassette as taught by Mallough so that a user may know an accurate amount of fluid from an irrigation source used and may be warned when the fluid source reaches a certain volume (Mallough, Paragraph [0054]).
Regarding Claim 45, modified Mehta in view Dam-Huisman and Mallough discloses the method of claim 44, wherein each state indication is indicative of an open or closed valve position (“An irrigation on/off pinch valve 48” – Paragraph [0038]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Mehta wherein each state indication is indicative of an open or closed valve position as taught by Mallough so that the lumen of the fluid source may be opened or closed (Mallough, Paragraph [0038]).
Regarding Claim 46, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 44, wherein the encoder (Mehta, 830) tracks activity of a drainage pump that is in communication with the cassette (Mehta, “the intraoperative pressure management algorithm may measure the difference between sensor 861 and sensor 860 along the aspiration fluid path to calculate actual aspiration flow rate in real-time. This method may be used for both Peristaltic and Venturi based aspiration.” – Paragraph [0102]).
Regarding Claim 47, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 46, wherein the activity of the drainage pump is selected from the group consisting of pump runtime, pump speed, and direction (Mehta, “the intraoperative pressure management algorithm may measure the difference between sensor 861 and sensor 860 along the aspiration fluid path to calculate actual aspiration flow rate in real-time.” – Paragraph [0102], rate in which the aspiration flow is measured is interpreted to be some measurement of time i.e. mL/sec, accounting for both pump speed and runtime).
Regarding Claim 48, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 46, wherein the calculating the amount of fluid removed from the fluid source further includes summing the amount of fluid associated with the encoder tracked activity of the drainage pump (Mehta, Paragraph [0021]).
Regarding Claim 49, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 44, wherein the encoder tracks activity of an irrigation pump that is in communication with the cassette (Mehta, “the intraoperative pressure management algorithm, which may be resident in surgical console 850 … may continuously measure and adjust the irrigation pressure of system through the IOP management controller 930 ... The IOP management controller 930 may control the pump 810” – Paragraph [0095]).
Regarding Claim 50, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 49, wherein the calculating the amount of fluid removed from the fluid source further includes summing the amount of fluid associated with the encoder tracked activity of the irrigation pump (Mehta, Paragraph [0120]).
Regarding Claim 51, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 44, wherein the calculating the amount of fluid removed from the fluid source further includes summing the amount of fluid associated with wound leakage (Mallough, “as aspiration flow may not be consistent, and/or may experience fluid loss during a surgical procedure. Nevertheless, these general inconsistencies may be compensated for by having the system continuously monitor aspiration flows together with irrigation flows. By calculating an average differential between aspiration and irrigation flows, a weighted flow value may be calculated and applied to the aspirational flow to ensure relative consistency.” – Paragraph [0061], “fluid loss may occur through wound leakage.” – Paragraph [0057]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Mehta in view of Dam-Huisman wherein the calculating the amount of fluid removed from the fluid source further includes summing the amount of fluid associated with wound leakage as taught by Mallough so that measurements may be taken to increase accuracy that accounts for fluid leakage (Mallough, Paragraph [0065]).
Regarding Claim 52, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 44, wherein the fluid capacity of the cassette includes a handpiece volume (Mehta, “the irrigation source 30 is configured to supply a predetermined amount of fluid to the handpiece 20 for use during a surgical operation” – Paragraph [0044]) and an aspiration and irrigation tubing (Mehta, Aspiration Line and Irrigation Line respectively in Fig. 8).
Regarding Claim 53, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 44, wherein the volume of the fluid source is an initial size of the fluid source coupled with the surgical console (Mehta, “surgical console 850 may be in communication with irrigation source 30 “– Paragraph [0090], Fig.8).
Regarding Claim 54, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 44, wherein the volume of the fluid source is carried over from a previous ophthalmic surgical procedure (Examiner interprets that a procedure begins from the administration of irrigation fluid and ends when administration of irrigation fluid ceases, therefore, once irrigation flow begins to initiate a second procedure, users are able to determine remaining volume within the irrigation source from the calculation step in claim 44 and determine a remaining volume within the fluid source).
Regarding Claim 55, modified Mehta in view of Dam-Huisman and Mallough discloses the method of claim 44, further comprising providing a warning when the amount of fluid remaining in the fluid source drops below a threshold value (Dam-Huisman, “An empty bottle warning system may issue a warning signal or alarm when a predetermined volume of irrigation fluid has been delivered by the velocity controller 220. The extracted volume can be calculated based on the initial quantity of irrigation fluid in the infusion bottle 210 and the amount of the fluid delivered to the chamber 10 by the velocity controller 220. A warning can be issued when the volume of fluid delivered approaches the total initial volume of the infusion bottle 210.” – Paragraph [0035]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Mehta in view of Mallough further comprising providing a warning when the amount of fluid remaining in the fluid source drops below a threshold value as taught by Dam-Huisman so that a user is able to know when a certain amount of fluid is left within the fluid source (Dam-Huisman, Paragraph [0035]).
Claim(s) 56-59 and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallough in view of Sorensen et al. (Pub. No. US 20170042733 A1, herein Sorensen).
Regarding Claim 56, Mallough discloses a method for monitoring the amount of fluid used or remaining in a fluid source during an ophthalmic surgical procedure (Paragraph [0054]), comprising:
starting a surgical procedure with a known volume of an irrigation fluid in a fluid source (Paragraph [0043]);
administering the irrigation fluid (“The probe tip has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from console 115 and/or cassette 250 into the eye” – Paragraph [0023]);
starting a timer (“The method may comprise the steps of determining in the processor a volume of fluid in the irrigation source, receiving in the processor sensed measurements regarding a rate of fluid flow over time from the irrigation source” – Paragraph [0011], Examiner interprets that since the processor is able to sense a rate of fluid flower over time, a running timer is capable of being started in order to determine how much fluid has flowed during a period of time);
calculating an accumulated irrigation flow rate (Paragraph [0054]);
stopping the timer (processor capable of stopping timer, Paragraphs [0043], [0056]);
acquiring a total elapsed time (processer capable of acquiring a total elapsed time, Paragraphs [0043], [0056]); and
calculating a total amount of irrigation fluid used during the surgical procedure (“Based on a configuration of host settings for a volume of the initial irrigation source, the system may provide various levels of warnings or errors based on a volume or percentage of irrigation fluid used” – Paragraph [0054], in order to determine when to provide a warning, host must determine how much fluid is used during the procedure).
Mallough does not expressly disclose stopping the administering of irrigation fluid.
Sorensen teaches of a multipurpose valve (562) used to control aspiration and irrigation (Paragraph [0091]) which may be rotated to close off irrigation (Paragraph [0091]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for monitoring the amount of fluid used or remaining in a fluid source during an ophthalmic procedure disclosed by Mallough to include stopping the administering of irrigation fluid as taught by Sorensen so that a user is able to desirably control irrigation, starting and stopping administration of irrigation fluid (Sorensen, Paragraph [0091]).
Regarding Claim 57, modified Mallough in view of Sorensen discloses the method of claim 56, wherein the calculated accumulated irrigation flow is a sum of a positive irrigation and negative irrigation (Mallough, “By calculating an average differential between aspiration and irrigation flows, a weighted flow value may be calculated and applied to the aspirational flow to ensure relative consistency.” – Paragraph [0061]).
Regarding Claim 58, modified Mallough in view of Sorensen discloses the method of claim 56.
Modified Mallough in view of Sorensen does not expressly disclose wherein the amount of irrigation fluid used during the surgical procedure is determined by the following formula:
PNG
media_image1.png
84
704
media_image1.png
Greyscale
However, Mallough discloses a processor configured to receive sensed measurements regarding a rate of fluid flow over time from the irrigation source and processes the rate of fluid flow relative to the determined volume to indicate capacity (Mallough, Paragraph [0010]). Mallough further discloses that this processing is taken, via flow sensors, over the course of the procedure and not a single static value (Mallough, “If the irrigation fluid in use is reduced in response to the notification, the system processor may automatically update 301 the time accordingly” – Paragraph [0056]), Examiner interprets that the processor is capable of repeated sampling of the flow rate as the procedure progresses.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine solution use by processing the rate of fluid flow relative to the determined volume using the sampled flow sensor data, disclosed by Mallough, and multiplying that by the elapsed time in which they were collected, then dividing by 60 to obtain an appropriate unit (e.g. seconds) in order to accurately track the amount of fluid used in the surgical procedure.
Regarding Claim 59, modified Mallough in view of Sorensen discloses the method of claim 56, wherein the known volume of irrigation fluid is carried over from a previous surgical procedure (Examiner interprets that the procedure begins from the administration of the irrigation fluid and ends when administration of the irrigation fluid ceases, therefore, once irrigation flow begins to initiate a second procedure, users are able to determine remaining volume in the irrigation source from the calculation step in claim 56 and by taking the difference from the initial fluid source volume to determine remaining volume within the fluid source).
Regarding Claim 61, modified Mallough in view of Sorensen discloses the method of claim 56, further comprising providing a warning when the amount of fluid in the fluid source drops below a threshold value (Mallough, Paragraph [0055]).
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallough in view of Sorensen further in view of Mehta.
Regarding Claim 60, modified Mallough in view of Sorensen discloses the method of claim 56.
Modified Mallough in view of Sorensen does not expressly disclose wherein the known volume of irrigation fluid is inputted by a user.
Mehta teaches wherein the known volume of irrigation fluid is inputted by a user (Paragraph [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Mallough in view of Sorensen wherein the known volume of irrigation fluid is inputted by a user as taught by Mehta in order to determine an amount of fluid transferred from the irrigation source to an infusion tank (Paragraph [0021]).
Claim(s) 62-65, and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallough in view of Dam-Huisman further in view of Sorensen.
Regarding Claim 62, Mallough discloses a system for monitoring the amount of fluid used during an ophthalmic surgical procedure (Paragraph [0054], Fig. 2A), comprising:
a fluid source (112) coupled with a surgical console (115) having a known volume of irrigation fluid (Paragraph [0043]);
an irrigation pump (203) fluidly coupled with the fluid source (Fig. 2A); and
an instrument host (Processor within controller 125, Paragraph [0026]) configured to:
start a surgical procedure with the known volume of irrigation fluid in the fluid source (Paragraph [0043]);
administer irrigation fluid (“The probe tip has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from console 115 and/or cassette 250 into the eye” – Paragraph [0023]);
start a timer (“The method may comprise the steps of determining in the processor a volume of fluid in the irrigation source, receiving in the processor sensed measurements regarding a rate of fluid flow over time from the irrigation source” – Paragraph [0011], Examiner interprets that since the processor is able to sense a rate of fluid flower over time, a running timer is capable of being started in order to determine how much fluid has flowed during a period of time);
calculate an accumulated irrigation flow rate (Paragraph [0056]);
stop the timer (processor capable of stopping timer, Paragraphs [0043], [0056]);
acquire a total elapsed time (processer capable of acquiring a total elapsed time, Paragraphs [0043], [0056]); and
calculate a total amount of irrigation fluid used during the surgical procedure (“Based on a configuration of host settings for a volume of the initial irrigation source, the system may provide various levels of warnings or errors based on a volume or percentage of irrigation fluid used” – Paragraph [0054], in order to determine when to provide a warning, host must determine how much fluid is used during the procedure).
Mallough does not expressly disclose the irrigation pump fluidly coupled with the fluid source and in communication with an encoder for tracking the activation time of the irrigation pump.
Dam-Huisman teaches the irrigation pump (212) fluidly coupled with the fluid source (210, Paragraph [0020]) and in communication with an encoder (220) for tracking the activation time of the irrigation pump (Paragraph [0031]-[0033], Fig. 2).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention before the effective filing date of the claimed invention to modify the system disclosed by Mallough wherein the irrigation pump fluidly coupled with the fluid source and in communication with an encoder for tracking the activation time of the irrigation pump as taught by Dam-Huisman so that the irrigation pump in order to determine the proper infusion rate of irrigation fluid to the eye (Dam-Huisman, Paragraph [0032]).
Modified Mallough in view of Dam-Huisman does not expressly disclose stopping the administering of irrigation fluid.
Sorensen teaches of a multipurpose valve (562) used to control aspiration and irrigation (Paragraph [0091]) which may be rotated to close off irrigation (Paragraph [0091]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system for monitoring the amount of fluid used or remaining in a fluid source during an ophthalmic procedure disclosed by modified Mallough in view of Dam-Huisman to include stopping the administering of irrigation fluid as taught by Sorensen so that a user is able to desirably control irrigation, starting and stopping administration of irrigation fluid (Sorensen, Paragraph [0091]).
Regarding Claim 63, modified Mallough in view of Dam-Huisman and Sorensen discloses the system of claim 62, wherein the calculated accumulated irrigation flow is a sum of a positive irrigation and negative irrigation (Mallough, Paragraph [0061]).
Regarding Claim 64, modified Mallough in view of Dam-Huisman and Sorensen discloses the system of claim 62.
Modified Mallough in view of Dam-Huisman and Sorensen does not expressly disclose wherein the amount of irrigation fluid used during the surgical procedure is determined by the following formula:
PNG
media_image1.png
84
704
media_image1.png
Greyscale
However, Mallough discloses a processor configured to receive sensed measurements regarding a rate of fluid flow over time from the irrigation source and processes the rate of fluid flow relative to the determined volume to indicate capacity (Mallough, Paragraph [0010]). Mallough further discloses that this processing is taken, via flow sensors, over the course of the procedure and not a single static value (Mallough, “If the irrigation fluid in use is reduced in response to the notification, the system processor may automatically update 301 the time accordingly” – Paragraph [0056]), Examiner interprets that the processor is capable of repeated sampling of the flow rate as the procedure progresses.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine solution use by processing the rate of fluid flow relative to the determined volume using the sampled flow sensor data, disclosed by Mallough, and multiplying that by the elapsed time in which they were collected, then dividing by 60 to obtain an appropriate unit (e.g. seconds) in order to accurately track the amount of fluid used in the surgical procedure.
Regarding Claim 65, modified Mallough in view of Dam-Huisman and Sorensen discloses the system of claim 62, wherein the known volume of irrigation fluid is carried over from a previous surgical procedure (Examiner interprets that the procedure begins from the administration of the irrigation fluid and ends when administration of the irrigation fluid ceases, therefore, once irrigation flow begins to initiate a second procedure, users are able to determine remaining volume in the irrigation source from the calculation step in claim 56 and by taking the difference from the initial fluid source volume to determine remaining volume within the fluid source).
Regarding Claim 67, modified Mallough in view of Dam-Huisman and Sorensen discloses the system of claim 62, further comprising providing a warning when the amount of fluid remaining in the fluid source drops below a threshold value (Mallough, Paragraph [0055]).
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallough in view of Dam-Huisman and Sorensen, further in view of Mehta.
Regarding Claim 66, modified Mallough in view of Dam-Huisman and Sorensen discloses the system of claim 62.
Modified Mallough in view of Dam-Huisman and Sorensen does not expressly disclose wherein the known volume of the irrigation fluid is inputted by a user.
Mehta teaches wherein the known volume of irrigation fluid is inputted by a user (Paragraph [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Mallough in view of Dam-Huisman and Sorensen wherein the known volume of irrigation fluid is inputted by a user as taught by Mehta in order to determine an amount of fluid transferred from the irrigation source to an infusion tank (Paragraph [0021]).
Response to Arguments
Applicant’s arguments filed 4/21/2026 have been fully considered.
In regards to Applicant’s argument that:
“Accordingly, when read in light of the specification, "state indication" has a readily understood scope: it is an indication of the irrigation valve's state (e.g., open/closed/partially open) as used by the irrigation valve control during the procedure, and a "plurality" simply reflects that multiple such indications are received over time. Claim 44 is therefore not indefinite, and Applicant respectfully requests that the § 112(b) rejection of claim 44 be withdrawn.” and
“These disclosures supply clear intrinsic context for the functional recitations in claim 62 and confirm that the "instrument host configured to" language has a definite, objective meaning to a person of ordinary skill, namely, an instrument host (controller/processor) programmed to execute the described timer/encoder-based fluid-usage tracking operations. Accordingly, the Applicant respectfully requests that the § 112(b) rejection of claim 62 (and, by dependency, claims 63-67) be withdrawn.”
These arguments are persuasive and the previous 112(b) rejections are withdrawn.
In regards to Applicant’s argument that:
“Independent claim 62 has the same or similar features discussed in claim 56, and thus, for the same reasons, Applicant submits that claim 62 is allowable over the cited references.
Claims 57-61 are dependent upon claim 56 and claims 63-67 are dependent upon claim 62, and the Applicant believes these claims are allowable over the cited references of record for the same reasons provided above.”
These arguments are persuasive and the previous 102 rejection for claims 56-67 have been withdrawn. However, upon further search and consideration, a new ground of rejection is made in view of Mallough, Sorensen, and Dam-Huisman.
In regards to Applicant’s argument that:
“Claims 45-55 are dependent upon claim 44, and the Applicant believes these claims are allowable over the cited references of record for the same reasons provided above.
Claims 60 is dependent upon claim 56 and claim 66 is dependent upon claim 62, and the Applicant believes these claims are allowable over the cited references of record for the same reasons provided above.
Based on the arguments presented above, withdrawal of the § 103 rejection of claims 44- 55, 60, and 66 is respectfully requested”.
This argument is persuasive and the previous 103 rejection for claims 44-55, 60, and 66 is withdrawn. However, upon further search and consideration, a new ground of rejection is made in view of Mehta, Dam-Huisman, and Mallough.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
