DETAILED CORRESPONDENCE
This is a non-final office action on merits in response to the arguments and/or amendments filed on 1/22/2026 and the request for continued examination filed on 1/22/2026.
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 .
Status of claims
Claims 2 and 15 are cancelled. Amendments to claims 1, 12, and 18 are acknowledged and have been carefully considered. Claims 1, 3-14, and 16-18 are pending and considered below.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/22/2026 has been entered.
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 1, 3-14, and 16-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Under step 1, the analysis is based on MPEP 2106.03, and claims 1, 3-11 are drawn to a method, claims 12-14, 16-17 are drawn to an ophthalmic surgical system, and claim 18 is drawn to a computer program product. Thus, each claim, on its face, is directed to one of the statutory categories (i.e., useful process, machine, manufacture, or composition of matter) of 35 U.S.C. 101.
Step 2A Prong One
Claims 1 and 12 recite the limitations of determining when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value; calculating an overall measurement based on the pressure values; wherein the overall measurement indicates the eye chamber pressure stability. These limitations, as drafted, are processes that, under their broadest reasonable interpretations, cover performance of the limitations in the mind or by using a pen and paper. The claims encompass a user observing when irrigation is absent or below a threshold, organizing or tallying pressure values, and evaluating whether those values indicate pressure stability in their mind or by using a pen and paper. Thus, the claims recite a mental process which is an abstract idea.
Independent claim 18 recites identical or nearly identical steps with respect to claim 1 (and therefore also recite limitations that fall within this subject matter grouping of abstract ideas), and this claim is therefore determined to recite an abstract idea under the same analysis.
Under Step 2A Prong Two
The claimed limitations, as per method claim 1, include the steps of:
providing an ophthalmic surgical system comprising a handpiece, a surgical console coupled with the handpiece, and at least one sensor coupled with the handpiece and in communication with the surgical console;
determining when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value;
obtaining a plurality of pressure values from a first sensor during the ophthalmic procedure when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during the ophthalmic procedure;
calculating an overall measurement based on the pressure values; and
displaying on a display device a graphic representation of the overall measurement comprising a histogram of the pressure values, wherein the overall measurement indicates the eye chamber pressure stability.
The claimed limitations, as per method claim 12, include:
a phacoemulsification probe having a needle at its distal end, the needle configured to be inserted into an eye of a patient; a pressure sensor; and
a processor, configured to repeatedly:
determine when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value;
obtain a plurality of pressure values from the pressure sensor when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during a surgical procedure;
calculate an overall measurement for the surgical procedure based on the pressure values; and
displaying on a display device a graphic representation of the overall measurement comprising a histogram of the pressure values, wherein the overall measurement indicates eye pressure stability.
Examiner Note: underlined elements indicate additional elements of the claimed invention identified as performing the steps of the claimed invention.
The judicial exception expressed in claim 12 is not integrated into a practical application. In particular, the claim recites an additional element, using a processor to obtain a plurality of pressure values, calculate an overall measurement based on the pressure values, and display a graphic representation of the overall measurement. The processor is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of receiving data, performing calculations, and presenting results) such that it amounts no more than instructions to apply the exception using a generic computer component. Accordingly, alone and in combination, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The judicial exception expressed in claim 1 and 12 is not integrated into a practical application. The abstract idea is merely carried out in a technical environment or field (i.e., an ophthalmic surgical procedure using an ophthalmic surgical system (claim 1) and an ophthalmic surgical system including a phacoemulsification probe and pressure sensor (claim 12)), however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment (see MPEP 2106.05(h)). The additional elements that are carried out in a technical environment includes providing an ophthalmic surgical system comprising a handpiece, a surgical console coupled with the handpiece, and at least one sensor coupled with the handpiece and in communication with the surgical console (claim 1) and a phacoemulsification probe having a needle at its distal end, the needle configured to be inserted into an eye of a patient; a pressure sensor (claim 12). Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claims 1 and 12 are not integrated into a practical application. The claims recite the additional elements of obtaining a plurality of pressure values from a first sensor during the ophthalmic procedure when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during the ophthalmic procedure (claim 1), obtain a plurality of pressure values from the pressure sensor when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during a surgical procedure (claim 12), displaying on a display device a graphic representation of the overall measurement comprising a histogram of the pressure values (claims 1 and 12). These limitations are recited at a high level of generality (i.e., as a general means of collecting data and presenting results), and amounts to merely data gathering and post-solution output, which are forms of insignificant extra-solution activities. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
Therefore, under step 2A, the claims are directed to the abstract idea, and require further analysis under Step 2B.
Under step 2B
Claim 1 does not include an additional element that is sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to obtain a plurality of pressure values, calculate an overall measurement based on the pressure values, and display a graphic representation or the overall measurement amounts to no more than instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claims 1 and 12 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the abstract idea is merely carried out in a technical environment or field, however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Thus, even when viewed as a whole, nothing in the claims add significantly more (i.e., an inventive concept) to the abstract idea.
For claims 1 and 12, under step 2B, the additional elements of obtaining a plurality of pressure values from a first sensor during the ophthalmic procedure when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during the ophthalmic procedure (claim 1), obtain a plurality of pressure values from the pressure sensor when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during a surgical procedure (claim 12), displaying on a display device a graphic representation of the overall measurement comprising a histogram of the pressure values (claims 1 and 12) have been evaluated. The system comprising a processor performs a general function of receiving intraocular pressure sensor data for displaying the resulting histogram, which represents a well-understood, routine, and conventional activity in the field of medical monitoring and data analysis systems. The specification discloses that the processor is used in its ordinary capacity as a data input device and does not describe any improvement to the computer itself or to the functioning of the overall computer system (see page 9). Also noted in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016), merely collecting information for analysis without a technological improvement and displaying results does not add significantly more to an abstract idea. The use of the method and system is no more than collecting pressure data, analyzing the data to evaluate stability, and presenting the results does not integrate the abstract idea into a practical application. Therefore, the claims do not recite an inventive concept and are not patent eligible.
Claims 4, 6-8, 13-14, recite no further additional elements, and only further narrow the abstract idea. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for reasons similar to those explained above, and do not amount to significantly more than the narrowed abstract idea for reasons similar to those explained above.
Claims 3, 5, 9-11, 16-17 recite the additional element of displaying a curve representing a rim of the histogram (claim 3), displaying additional information (claim 5), the at least one sensor is a first sensor and further comprising a second sensor located externally to the ophthalmic surgical system (claim 9), displaying a second overall measurement taken while using different equipment during the surgical procedure (claim 10), further comprising displaying a second overall measurement taken during another surgical procedure (claim 11), wherein the processor is further configured to display a second overall measurement taken during the surgical procedure (claim 16), wherein the processor is further configured to display a second overall measurement taken during another surgical procedure (claim 17). However, these additional elements amount to implementing an abstract idea on a generic computing device, mere linking to a particular environment, or mere displaying an output (i.e., an insignificant extra-solution activity)). As such, these additional elements, when considered individually or in combination with the prior devices, do not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
Thus, as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Therefore, the claims here fail to contain any additional element(s) or combination of additional elements that can be considered as significantly more and the claims are rejected under 35 U.S.C. 101 for lacking eligible subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over by Mehta et al. (U.S. Publication 2019/0099547 A1), referred to hereinafter as Mehta, in view of Kuebler et al. (U.S. Publication 2022/0254503 A1), referred to hereinafter as Kuebler, and Walsh et al. (International Publication No. WO 2010/117386 A1), referred to hereinafter as Walsh.
Regarding claim 1, Mehta teaches a method for evaluating eye chamber pressure stability during an ophthalmic procedure, comprising (Mehta [0040] “As discussed herein, a stable intraoperative TOP may be of critical importance in order to maintain a stable anterior chamber pressure during phacoemulsification. A stable intraoperative TOP may be a function of fluid inflow and outflow such that the volume, and in turn the pressure of anterior chamber, remains stable when a chamber is at or near equilibrium.” and [0041] “Further, parameters directed towards TOP, occlusion, and post occlusion surge detection would provide a better fluidics control and in turn lead to improved anterior chamber stability, thereby providing comfort to a patient, an operating surgeon and ensure safety while using phacoemulsification systems.”):
providing an ophthalmic surgical system comprising a handpiece, a surgical console coupled with the handpiece, and at least one sensor coupled with the handpiece and in communication with the surgical console (Mehta [0042] “For example, an embodiment is a phacoemulsification surgical system that comprises an integrated high-speed control module for a phacoemulsification or vitrectomy handpiece that is configured to be inserted into a patient's eye during the phacoemulsification procedure. The system may further comprise one or more sensor(s) to detect variables about the function and operation of the system, such as the rate of fluid flow before and after the fluid flows through the handpiece, and a processor that can collect such variables and/or receive additional variables as inputs from a user, in order to determine the static TOP and dynamic TOP of the anterior chamber of the patient's eye during surgery. The system may further comprise a processor that may control, adjust or set various characteristics of the system to control a phacoemulsification or a high-speed pneumatic or electronic vitrectomy handpiece based on the static TOP and/or dynamic IOP measurements determined.” and Mehta [0014] “The present invention provides a system for detecting intraocular pressure during surgery, the system comprising, a surgical console, having at least one system bus communicatively connected to at least one computing processor capable of accessing at least one computing memory associated with the at least one computing processor, a surgical handpiece having at a distal end and a proximal end, the proximal end being communicatively connected to at least one irrigation line and at least one aspiration line, a first sensor in communication with a portion of the at least one aspiration line or the at least one irrigation line for providing a first measurement value, a second sensor in communication with the at least one aspiration line providing a second measurement value”);
obtaining a plurality of pressure values from a first sensor during the ophthalmic procedure, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during the ophthalmic procedure (Mehta [0014] “a first sensor in communication with a portion of the at least one aspiration line or the at least one irrigation line for providing a first measurement value, a second sensor in communication with the at least one aspiration line providing a second measurement value; and, a third sensor in communication with the at least one irrigation line or at least one aspiration line for providing a third measurement value, wherein an intraocular pressure at a surgical site is calculated in accordance with at least two of the first measurement value, the second measurement value, or the third measurement value.”);
calculating an overall measurement based on the pressure values (Mehta [0014] “wherein an intraocular pressure at a surgical site is calculated in accordance with at least two of the first measurement value, the second measurement value, or the third measurement value”); and
displaying on a display device a graphic representation of the overall measurement, wherein the overall measurement indicates the eye chamber pressure stability (Mehta [0013] In an embodiment of the present invention, the system may further comprise a graphical user interface for receiving and displaying an alert associated with a change in irrigation pressure. The alert may comprise an audible component. In an embodiment, an alert may be provided when at least one of the first measurement value or second measurement value is at or near atmospheric pressure.” and Mehta [0015] “Wound leakage may be determined by the size of the incision made during the surgery and the system may calculate a total intraocular pressure at distinct time points before and during the surgery.” and Mehta [0129] “As illustrated in FIG. 13, the activation of reduced pressure mechanism 1230 may lessen the drop in pressure experienced by a partial or full occlusion during phacoemulsification surgery. The graph illustrated in FIG. 13 shows a steep negative change in system pressure sans activation of reduced pressure mechanism 1230 as illustrated by the dashed line. The solid line illustrated in FIG. 13 illustrates system pressure with activation of the reduced pressure mechanism 1230.” Mehta [0015] “Wound leakage may be determined by the size of the incision made during the surgery and the system may calculate a total intraocular pressure at distinct time points before and during the surgery. A target intraocular pressure may be maintained by adjusting one selected from the group consisting of irrigation reservoir height, aspiration pressure and irrigation pressure.” and Mehta [0129] “In an embodiment of the present invention, the amount of momentary fluid pressure and the duration of time the applying time of the irrigation source may be adjusted by the reduced pressure mechanism 1230 with the amount of pressure and time related to the compensation volume and the speed of the mechanism. As illustrated in FIG. 13, the activation of reduced pressure mechanism 1230 may lessen the drop in pressure experienced by a partial or full occlusion during phacoemulsification surgery. The graph illustrated in FIG. 13 shows a steep negative change in system pressure sans activation of reduced pressure mechanism 1230 as illustrated by the dashed line. The solid line illustrated in FIG. 13 illustrates system pressure with activation of the reduced pressure mechanism 1230.” and [0088] “For example, the present invention may increase infusion pressure (irrigation) or reduce the aspiration flow and/or vacuum upon the detection of a post occlusion surge event. Each of these aforementioned elements may be used to improve intraoperative TOP management throughout surgery. For example, using a pressurized irrigation source with the present invention may provide the capability of quickly increasing and/or decreasing irrigation pressure to maintain anterior chamber stability during post occlusion surge events, for example.” and [0119] “The infusion pressure may be limited to a certain upper bound to ensure that pressure is within acceptable range—an upper bound which may be set by the user of the system. When the occlusion break occurs, the additional infusion flow may help to reduce the drop in the intraoperative pressure, thus providing greater anterior chamber stability.”).
Mehta fails to explicitly teach determining when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value; when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value; and comprising a histogram of the values.
Kuebler teaches determining when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value ((Kuebler [0065] “The curve 202 intersects a first threshold value S1 at the location 203. The curve 204 intersects a second threshold value S2 at the location 205, the second threshold value S2 being higher than the first threshold value S1. Diagram 300 shows at which time points an intersection point occurs between the curve 202 with the first threshold value S1 and the curve 204 with the second threshold value S2. The curve 202 intersects the first threshold value S1 after expiration of a predetermined first time point. In the situation shown in FIG. 2, the curve 202 intersects the first threshold value S1 at the time point T1. The curve 204 intersects the second threshold value S2 after expiration of a predetermined second time point. In the situation shown in FIG. 2, the curve 204 intersects the second threshold value S2 at the time point T2. Thus, when both threshold values S1 and S2 are exceeded, it is possible to relatively safely conclude that an irrigation fluid is flowing in the irrigation fluid line 8. This conclusion can be drawn on the basis of the curve profile in the third diagram 300. When a threshold value is exceeded, there is an abrupt jump in the curve 301. When the threshold value S2 is exceeded, there is a first jump (see 305), and, when the first threshold value S1 is exceeded, there is a second jump (see 303).” Kuebler [0066] “When only the threshold value S2 of the curve 204 is exceeded, and not the threshold value S1 of the curve 202, this is an indication that the rise in the curve 202 has already ended after expiration of the first time point. This shows that the elastic partition element 12 no longer moves in the direction of the first measuring device and the volumetric flow in the irrigation fluid line is interrupted.” Kuebler [0067] “However, if a relatively constant volumetric flow is present in the irrigation fluid line 8, the convolved quantity of the derivative of the first measurement signal reaches a constantly high value (see 206). If the first convolution function device 51 is now supplied with a first measurement signal which, after the convolution with the first convolution function device 51, is below the second threshold value S2 (see 207) and also below the first threshold value S1 (see 208), the curve 301 abruptly sinks back again (see 307 and 308). It can be identified from this that a volumetric flow of the irrigation fluid 3 in the irrigation fluid line 8 has decreased.” and Kuebler [0006] “The start of an occlusion or the breakup of an occlusion can be identified by detection of measurement signals in an ophthalmosurgical system. For example, a pressure or a volumetric flow in an irrigation fluid line or an aspiration fluid line can be detected. It is particularly expedient if the derivation of a pressure profile or volumetric flow is performed over time, since a change of the signal profile can be rapidly identified in this way. However, a signal profile for pressure and volumetric flow always has a noise, and therefore a derivation of such a signal can lead to high deflections. There is therefore a relatively high probability of a supposedly significant change of pressure or change of volumetric flow being wrongly interpreted. A status description of an ophthalmosurgical system, as determined on this basis, can lead to hectic switching processes and therefore to complications during phacoemulsification.”);
when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value (Kuebler [0065] “The curve 202 intersects a first threshold value S1 at the location 203. The curve 204 intersects a second threshold value S2 at the location 205, the second threshold value S2 being higher than the first threshold value S1. Diagram 300 shows at which time points an intersection point occurs between the curve 202 with the first threshold value S1 and the curve 204 with the second threshold value S2. The curve 202 intersects the first threshold value S1 after expiration of a predetermined first time point. In the situation shown in FIG. 2, the curve 202 intersects the first threshold value S1 at the time point T1. The curve 204 intersects the second threshold value S2 after expiration of a predetermined second time point. In the situation shown in FIG. 2, the curve 204 intersects the second threshold value S2 at the time point T2. Thus, when both threshold values S1 and S2 are exceeded, it is possible to relatively safely conclude that an irrigation fluid is flowing in the irrigation fluid line 8. This conclusion can be drawn on the basis of the curve profile in the third diagram 300. When a threshold value is exceeded, there is an abrupt jump in the curve 301. When the threshold value S2 is exceeded, there is a first jump (see 305), and, when the first threshold value S1 is exceeded, there is a second jump (see 303).” Kuebler [0066] “When only the threshold value S2 of the curve 204 is exceeded, and not the threshold value S1 of the curve 202, this is an indication that the rise in the curve 202 has already ended after expiration of the first time point. This shows that the elastic partition element 12 no longer moves in the direction of the first measuring device and the volumetric flow in the irrigation fluid line is interrupted.” Kuebler [0067] “However, if a relatively constant volumetric flow is present in the irrigation fluid line 8, the convolved quantity of the derivative of the first measurement signal reaches a constantly high value (see 206). If the first convolution function device 51 is now supplied with a first measurement signal which, after the convolution with the first convolution function device 51, is below the second threshold value S2 (see 207) and also below the first threshold value S1 (see 208), the curve 301 abruptly sinks back again (see 307 and 308). It can be identified from this that a volumetric flow of the irrigation fluid 3 in the irrigation fluid line 8 has decreased.” and Kuebler [0006] “The start of an occlusion or the breakup of an occlusion can be identified by detection of measurement signals in an ophthalmosurgical system. For example, a pressure or a volumetric flow in an irrigation fluid line or an aspiration fluid line can be detected. It is particularly expedient if the derivation of a pressure profile or volumetric flow is performed over time, since a change of the signal profile can be rapidly identified in this way. However, a signal profile for pressure and volumetric flow always has a noise, and therefore a derivation of such a signal can lead to high deflections. There is therefore a relatively high probability of a supposedly significant change of pressure or change of volumetric flow being wrongly interpreted. A status description of an ophthalmosurgical system, as determined on this basis, can lead to hectic switching processes and therefore to complications during phacoemulsification.”).
Walsh teaches comprising a histogram of the values (Walsh [0203] “The term "histogram' as used herein generally refers to an algorithm, curve, or data or other representation of a frequency distribution for a particular variable, for example, retinal thickness. In some cases, the variable is divided into ranges, interval classes, and/or points on a graph (along the X-axis) for which the frequency of occurrence is represented by a rectangular column or location of points; the height of the column and/or point along the Y-axis is proportional to or otherwise indicative of the frequency of observations within the range or interval. "Histograms," as referred to herein, can comprise measured data obtained, for example, from scanning the eyes of a user, or can comprise data obtained from a population of people. Histograms of the former case can be analyzed to determine the mean, minimum, or maximum values, and analyze changes in slope or detect shapes or curvatures of the histogram curve. Histograms of the latter case can be used to determine the frequency of obsen1ation of a measured value in a surveyed sample.”).
Mehta teaches a method for evaluating intraocular pressure (IOP) stability during an ophthalmic procedure, including providing an ophthalmic surgical system with a handpiece, console, and sensors, obtaining a plurality of pressure measurements during the procedure, and calculating pressure values indicative of intraocular pressure conditions. Mehta further teaches displaying pressure information via a graphical user interface. However, Mehta does not explicitly teach determining when irrigation fluid is not being conveyed or when an irrigation rate is below a threshold value, nor explicitly performing the pressure evaluation conditioned on such irrigation states.
Kuebler teaches detecting operating states of an ophthalmic fluidic system, including determining whether irrigation fluid is flowing, reduced, or interrupted, based on threshold analysis of pressure or flow-related signals. Kuebler further explains that pressure and flow signals are evaluated over time to identify system conditions such as occlusion or reduced flow, and that accurate interpretation of these conditions is important for safe operation of the surgical system. A person of ordinary skill in the art would have recognized that the irrigation flow conditions identified by Kuebler correspond to different operating states of the surgical system, and that it is beneficial to evaluate pressure behavior under those states. Accordingly, it would have been obvious to obtain and analyze the pressure measurements of Mehta under the specific irrigation conditions identified by Kuebler (when irrigation is reduced or not being conveyed), as evaluating sensor data under particular system operating conditions is a routine and well-understood practice in system monitoring, diagnostics, and control of medical fluidic systems. This represents a predictable use of prior art elements according to their established functions.
Walsh teaches generating and displaying histograms to represent distributions of measured ophthalmic data and to analyze variability, frequency, and trends in such data. A person of ordinary skill in the art would have been motivated to apply Walsh’s histogram visualization to the pressure measurements of Mehta in order to provide an intuitive representation of pressure stability over time, since histograms are a well-known technique for visualizing distributions of measured values. Applying Walsh’s known visualization technique to Mehta’s pressure data yields the predictable result of improved interpretability of pressure stability during the procedure. Therefore, the combination of Mehta, Kuebler, and Walsh teaches or renders obvious all limitations of claim 1.
Regarding claim 3, Mehta, Kuebler, and Walsh teach the invention in claim 1, as discussed above, and further teach further comprising displaying a curve representing a rim of the histogram (Walsh [0203] “The term "histogram' as used herein generally refers to an algorithm, curve, or data or other representation of a frequency distribution for a particular variable, for example, retinal thickness. In some cases, the variable is divided into ranges, interval classes, and/or points on a graph (along the X-axis) for which the frequency of occurrence is represented by a rectangular column or location of points; the height of the column and/or point along the Y-axis is proportional to or otherwise indicative of the frequency of observations within the range or interval. "Histograms," as referred to herein, can comprise measured data obtained, for example, from scanning the eyes of a user, or can comprise data obtained from a population of people. Histograms of the former case can be analyzed to determine the mean, minimum, or maximum values, and analyze changes in slope or detect shapes or curvatures of the histogram curve. Histograms of the latter case can be used to determine the frequency of obsen1ation of a measured value in a surveyed sample.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to display a curve representing a rim of the histogram as taught by Walsh. Walsh teaches that histogram data may be analyzed to determine shapes, slopes, and curvatures of the histogram curve, which corresponds to the overall contour or outer boundary of the histogram distribution. A person of ordinary skill in the art would have recognized that such a curve represents the “rim” or outline of the histogram and would have been motivated to display this curve to enhance visualization and interpretation of the data. Displaying additional graphical features such as curves or overlays derived from histogram data is a well-known and routine data visualization technique used to improve readability and facilitate identification of trends and variability, and thus represents a predictable use of prior art elements according to their established functions.
Regarding claim 4, Mehta, Kuebler, and Walsh teach the invention in claim 1, as discussed above, and further teach wherein the ophthalmic procedure is a phacoemulsification procedure (Mehta [0011] “The present invention provides a system for detecting intraocular pressure events during phacoemulsification surgery.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to perform the method during a phacoemulsification procedure as taught by Mehta, which discloses systems and methods for monitoring intraocular pressure specifically during phacoemulsification surgery. A person of ordinary skill in the art would have recognized that the pressure monitoring and evaluation techniques described in Mehta are applicable to phacoemulsification procedures, where maintaining stable intraocular pressure is critical, and thus would have been motivated to apply the method in that surgical context as a predictable use of the prior art according to its intended purpose.
Regarding claim 5, Mehta, Kuebler, and Walsh teach the invention in claim 1, as discussed above, and further teach further comprising displaying additional information (Mehta [0013] In an embodiment of the present invention, the system may further comprise a graphical user interface for receiving and displaying an alert associated with a change in irrigation pressure.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to further display additional information as taught by Mehta, which discloses presenting alerts and other information related to intraocular pressure conditions via a graphical user interface. A person of ordinary skill in the art would have been motivated to provide additional information with primary measurement data in order to enhance user awareness, interpretation, and usability of the system, as displaying supplementary information such as alerts, indicators, or related data is a well-known and routine practice in medical device interfaces, representing a predictable use of known display techniques according to their established functions.
Regarding claim 6, Mehta, Kuebler, and Walsh teach the invention in claim 5, as discussed above, and further teach wherein the additional information is an instantaneous pressure value (Mehta [0013] “In an embodiment of the present invention, the system may further comprise a graphical user interface for receiving and displaying an alert associated with a change in irrigation pressure. The alert may comprise an audible component. In an embodiment, an alert may be provided when at least one of the first measurement value or second measurement value is at or near atmospheric pressure.” and Mehta [0018] The present invention provides a system for detecting a line abnormality by providing a system comprising a surgical console, having at least one system bus communicatively connected to at least one computing processor capable of accessing at least one computing memory associated with the at least one computing processor, a surgical handpiece having a distal end and a proximal end, the proximal end being communicatively connected to at least one line, a first sensor in communication with the at least one line and the at least one surgical tool located proximate to the surgical handpiece for providing a first measurement value, and a second sensor in communication with the at least line and located proximate to the surgical console for providing a second measurement value.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to display the additional information as an instantaneous pressure value based on the teachings of Mehta, which discloses detecting intraocular pressure using sensors during a surgical procedure and presenting pressure-related information via a graphical user interface. A person of ordinary skill in the art would have recognized that such systems implicitly generate pressure measurements in real time and would have been motivated to display the current or instantaneous pressure value to provide immediate feedback to the user, as displaying real time sensor data is a well-known and routine practice in medical monitoring systems to enable timely decision making, thereby representing a predictable use of prior art elements according to their established functions.
Regarding claim 7, Mehta, Kuebler, and Walsh teach the invention in claim 5, as discussed above, and further teach wherein the additional information comprises an average pressure value (Mehta [0013] “In an embodiment of the present invention, the system may further comprise a graphical user interface for receiving and displaying an alert associated with a change in irrigation pressure. The alert may comprise an audible component. In an embodiment, an alert may be provided when at least one of the first measurement value or second measurement value is at or near atmospheric pressure.”, Mehta [0102] “In an embodiment of the present invention, 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. The fluid flow between two points of measurement along the aspiration line with a known radius and length may be directly related to pressure difference. Thus, an increase in fluid flow may result in a higher pressure difference between two points and vice versa. Similarly, if the aspiration line is fully or at least partially occluded the pressure difference between two points may approach zero. Using the Hagen-Poiseuille law of fluid dynamics.”, and Mehta [0103] “Wherein ΔP=Average (sensor 861)−Average (sensor 860); r=inner radius of the aspiration tubing; L=length of aspiration tubing from sensor 860 to sensor 861; Q=flow rate of the fluid (i.e., water or BSS); and μ=viscosity of the fluid (i.e., water or BSS).”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to display the additional information as an average pressure value based on the teachings of Mehta, which discloses calculating pressure values including averages of sensor measurements and presenting pressure information via a graphical user interface. A person of ordinary skill in the art would have been motivated to display such calculated average values to enhance interpretation of pressure behavior, as presenting processed sensor data such as averages is a well-known and routine practice in medical monitoring systems. Displaying average values provides a more stable and representative indication of system conditions and thus represents a predictable use of prior art elements according to their established functions.
Regarding claim 8, Mehta, Kuebler, and Walsh teach the invention in claim 5, as discussed above, and further teach wherein the additional information comprises a standard deviation of the pressure values (Mehta [0013] “In an embodiment of the present invention, the system may further comprise a graphical user interface for receiving and displaying an alert associated with a change in irrigation pressure. The alert may comprise an audible component. In an embodiment, an alert may be provided when at least one of the first measurement value or second measurement value is at or near atmospheric pressure.”, Mehta [0102] “In an embodiment of the present invention, 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. The fluid flow between two points of measurement along the aspiration line with a known radius and length may be directly related to pressure difference. Thus, an increase in fluid flow may result in a higher pressure difference between two points and vice versa. Similarly, if the aspiration line is fully or at least partially occluded the pressure difference between two points may approach zero. Using the Hagen-Poiseuille law of fluid dynamics.”, and Mehta [0103] “Wherein ΔP=Average (sensor 861)−Average (sensor 860); r=inner radius of the aspiration tubing; L=length of aspiration tubing from sensor 860 to sensor 861; Q=flow rate of the fluid (i.e., water or BSS); and μ=viscosity of the fluid (i.e., water or BSS).”). and
Walsh [0454] “For subjects suffering from retinal disease, the OCT-based ophthalmic testing center system can be configured to track other non-foveal detectable structures with OCT to the subject's fixation stability during the fixation stability test. Various statistics could be calculated from this point cloud including total distance moved per unit time, average distance from centroid, standard deviation of interval movements, or the like. Other measurements and/or analyses are possible.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to display the additional information as a standard deviation of the pressure values based on the teachings of Mehta in view of Walsh. Mehta teaches obtaining and processing intraocular pressure measurements and presenting pressure information via a graphical user interface. Walsh teaches calculating statistical metrics, including standard deviation, from ophthalmic measurement data to quantify variability and dispersion. A person of ordinary skill in the art would have been motivated to apply such a known statistical measure to Mehta’s pressure data in order to quantify variation in pressure over time, as standard deviation is a well-known and routine technique for evaluating stability and variability of measured data. Applying this known statistical analysis to pressure measurements represents a predictable use of prior art elements according to their established functions, yielding the expected result of improved assessment of pressure stability during the procedure.
Regarding claim 9, Mehta, Kuebler, and Walsh teach the invention in claim 1, as discussed above, and further teach wherein the at least one sensor is a first sensor and further comprising a second sensor located externally to the ophthalmic surgical system (Mehta [0011] “The present invention provides a system for detecting intraocular pressure events during phacoemulsification surgery. The system comprises a surgical console, having at least one system bus communicatively connected to at least one computing processor capable of accessing at least one computing memory associated with the at least one computing processor, a surgical handpiece having a distal end and a proximal end, the proximal end being communicatively connected to at least one irrigation line and at least one aspiration line; a first sensor in communication with one of the at least one aspiration line or the at least one irrigation line, and a second sensor in communication with the at least one aspiration line and optionally located proximate to the surgical console, wherein the first sensor and second sensor are capable of providing a first measurement value and a second measurement value, respectively;”, and Mehta [0051] “In illustrative embodiments, the system 100 may include a sensor system 52 configured in a variety of ways or located in various locations. For example, the sensor system 52 may include at least a first sensor, e.g. a strain gauge, 54 in communication with the irrigation line 32 and a second sensor, e.g. a strain gauge, 56 in communication with the aspiration line 42, as illustrated for example in FIG. 2. Other locations for the sensors 54 and 56 are envisioned anywhere in the system 100 and may be in communication with one or more irrigation and/or aspiration lines via different mechanism, e.g. on the handpiece 20, at an end of the handpiece 20, proximate or near the end of the handpiece 20, on or within the surgical console, within one or more irrigation lines and/or an aspiration lines and/or portions thereof, attached to or otherwise coupled with one or more irrigation and/or aspiration lines, resident in line with one or more irrigation and/or aspiration lines, etc., and may be configured to determine a variety of variables that may be used to determine intraoperative IOP measurements in the eye, as discussed below. This information may be relayed from the sensor system 52 to the control module 60 to be used in the determination of IOP measurements. The sensor system 52 may also include sensors to detect other aspects of the components used in the system, e.g. type of pump used, type of sleeve used, gauge of needle tip (size), etc. In another embodiment, the sensor system 52 may include only a first sensor located along the irrigation line 32 or the aspiration line 42.” and
Walsh [0237] “Accordingly, in some embodiments, an optical coherence tomography system (for example, that of Figure 1 or 3) comprises a sensor or tracker. The sensor or tracker may determine a position of the user, one or two eyes of the user, and/or one or more structures (for example, a retina, pupil, cornea, or lens) of the user's eye. In some embodiments, the sensor or tracker is positioned on or attached to main body 106, zero gravity arm 116, or even eyecup 120. In some embodiments, the sensor or tracker is a device separate from the main body 106. In some embodiments, the sensor or tracker is attached to or comprised within the system shown in Figure 3.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the ophthalmic surgical system of Mehta to include a second sensor located externally to the system, as suggested by Walsh. Mehta teaches the use of multiple sensors positioned at various locations throughout the surgical system, including along irrigation and aspiration lines, within the console, or at the handpiece, thereby showing that sensor placement is flexible and may be selected based on measurement needs. Walsh further teaches that sensors in ophthalmic environments may be implemented as separate devices external to the primary system. A person of ordinary skill in the art would have been motivated to extend Mehta’s flexible sensor placement to include an external sensor in order to provide independent or supplementary measurements, enable validation or comparison of sensor data, and improve overall monitoring reliability. This modification represents a predictable use of known sensor configurations according to their established functions and would have yielded the expected result of enhanced measurement versatility without requiring undue experimentation or inventive skill.
Regarding claim 10, Mehta, Kuebler, and Walsh teach the invention in claim 1, as discussed above, and further teach further comprising displaying a second overall measurement taken while using different equipment during the surgical procedure (Mehta [0039] “In other illustrative embodiments, the system can determine various parameters of the system through internal sub-systems (e.g. sensors) to collect information about various components of the system and display such information on the user interface.”, Mehta [0066] “Another factor for consideration in the determination of TOP measurement is tip size. In illustrative embodiments, the tip 24 of the handpiece 20 may be interchangeable with several other interchangeable tips 24 that have different features or characteristics. These tips 24 may have predetermined or uniform shapes and port sizes/locations based on the specific tip selected, so that a certain tip size is an industry standard and is known to have industry standard dimensions and features. Each of the different tip sizes may include or provide benefit in the way of different features that assist with performing the surgical operation. Such tips 24 are generally known to be of uniform sizes or types in the industry, such that certain tips 24 may be considered advantageous for certain surgical maneuvers or operations. Tips of uniform size or type may be identified by specific name or product number to be an industry standard design. Surgeons or other users of such tips may have industry knowledge of the types of tips available and their varying characteristics, and may rely on the uniformity of tip types from operation to operation.” and
Kuebler [0031] “It is thus possible to take account also of a second measurement signal, which is detected on an aspiration fluid line. This is advantageous since, with a first evaluation signal and a second evaluation signal, a redundancy is achieved which permits a still more reliable detection of an occlusion or of an occlusion breakthrough.” and Kuebler [0032] “According to an exemplary embodiment of the disclosure, the first measurement signal or the second measurement signal is a displacement signal of a displacement sensor for determining a fluid level or for determining a membrane position. As an alternative, the first measurement signal or the second measurement signal is a volume signal of a sensor for determining a volume of a fluid chamber. This is advantageous since the control module device can thus be used in a diaphragm pump.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the ophthalmic surgical system of Mehta to display a second overall measurement taken while using different equipment during the surgical procedure in view of Kuebler. Mehta teaches collecting and displaying system parameters on a user interface and further teaches the use of interchangeable surgical components, such as handpiece tips having different characteristics, which represent different equipment configurations that affect system performance. Kuebler teaches utilizing multiple measurement signals to improve reliability through redundancy and evaluation of system conditions. In view of these teachings, a person of ordinary skill in the art would have been motivated to obtain and display multiple measurements corresponding to different equipment configurations in order to evaluate performance, verify consistency of measurements, and improve surgical reliability. Displaying a second overall measurement for a different equipment configuration represents a predictable use of known techniques, specifically, collecting and presenting multiple measurement datasets, to compare system behavior under varying conditions, and would have yielded the expected benefit of enhanced monitoring and assessment without requiring inventive skill.
Regarding claim 11, Mehta, Kuebler, and Walsh teach the invention in claim 1, as discussed above, and further teach further comprising displaying a second overall measurement taken during another surgical procedure (Mehta [0039] “In other illustrative embodiments, the system can determine various parameters of the system through internal sub-systems (e.g. sensors) to collect information about various components of the system and display such information on the user interface.”, Mehta [0014] “a first sensor in communication with a portion of the at least one aspiration line or the at least one irrigation line for providing a first measurement value, a second sensor in communication with the at least one aspiration line providing a second measurement value; and, a third sensor in communication with the at least one irrigation line or at least one aspiration line for providing a third measurement value, wherein an intraocular pressure at a surgical site is calculated in accordance with at least two of the first measurement value, the second measurement value, or the third measurement value.”
Walsh [0477] “With reference to Figure 47, in various embodiments, the OCT-based ophthalmic testing center system can be configured to compare the static perimetry test data to a normative database to detem1ine patterns of deviation and/or generate risk assessments and/or clinical reports. In various embodiments, the OCT-based ophthalmic testing center system can be configured to analyze, compare, and/or add the static perimetry test data to other data, such as the subject" s ophthalmic history data that is stored on a subject's input card or retrieved from a historical database or other history-taking modules incorporated into the OCT-based ophthalmic testing center system. In various embodiments, the OCT-based ophthalmic testing center system can be configured to automatically conduct a static perimetry test based on ophthalmic history. For example, if the subject has glaucoma or the like, the OCT-based ophthalmic testing center system can be configured to record and/or store such information so that the OCT-based ophthalmic testing center system can be configured to automatically perform a static perimetry test based on the record. In another example, if the patient has a family history of glaucoma or the like, and such information is stored within the subject's ophthalmic history database, the OCT-based ophthalmic testing center system can be configured to automatically perform a static preliminary test. The OCT based ophthalmic testing center system can be configured to generate various statistics or comparisons based on the measured static perimetry test data, which may be combined with data from the nonnative database or historical data source.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the ophthalmic surgical system of Mehta to display a second overall measurement taken during another surgical procedure in view of Walsh. Mehta teaches obtaining intraocular pressure measurements during a surgical procedure and displaying system parameters and measurement information on a user interface. Walsh teaches storing ophthalmic measurement data and comparing current measurement data with previously acquired data from prior sessions or historical records to analyze patterns and generate clinical insights. In view of these teachings, a person of ordinary skill in the art would have been motivated to store and subsequently display measurement results from multiple procedures, including prior procedures, in order to enable comparison, assess consistency of system performance, and improve clinical evaluation and decision-making. Displaying a second overall measurement from another surgical procedure represents a predictable use of known data storage and comparison techniques to extend Mehta’s system for longitudinal or cross procedure analysis, yielding the expected benefit of enhanced monitoring and evaluation without requiring inventive skill.
Regarding claim 12, Mehta teaches an ophthalmic surgical system, comprising (Mehta [0042] “For example, an embodiment is a phacoemulsification surgical system that comprises an integrated high-speed control module for a phacoemulsification or vitrectomy handpiece that is configured to be inserted into a patient's eye during the phacoemulsification procedure.”):
a phacoemulsification probe having a needle at its distal end, the needle configured to be inserted into an eye of a patient (Mehta [0110] “In an embodiment of the present invention, occlusion and post occlusion surge detection and mitigation may be obtained through the use of sensors (pressure, vacuum, and/or flow) proximate to the surgical site, preferably on the distal end of the handpiece. As discussed above, occlusion and post occlusion surge detection may be detected in both peristaltic and Venturi based aspiration. By way of example, during aspiration outflow, an occlusion may be created when the handpiece tip is blocked by small fragment of cataract particulate. The blocked tip may cause a vacuum to build in the aspiration line. If the occlusion breaks, the stored the stored energy in the tubing pulls fluid from the anterior chamber. The volume of fluid that the aspiration tubing pulls depends on how much the tubing deformed during the occlusion. This deformation in conjunction with the occlusion itself causes a post occlusion surge in the aspiration line and a drop in intraoperative pressure inside the anterior chamber of the patient's eye.”);
a pressure sensor; and a processor, configured to repeatedly (Mehta [0090] “In an embodiment of the present invention, one or more pressure sensors may be used within a surgical system and may provide data which may be used to control aspects of the surgical system.” and Mehta [0042] “The system may further comprise a processor that may control, adjust or set various characteristics of the system to control a phacoemulsification or a high-speed pneumatic or electronic vitrectomy handpiece based on the static TOP and/or dynamic IOP measurements determined.”);
obtain a plurality of pressure values from the pressure sensor, each of the plurality of pressure values indicating an intraocular pressure (IOP) measurement taken during a surgical procedure (Mehta [0014] “a first sensor in communication with a portion of the at least one aspiration line or the at least one irrigation line for providing a first measurement value, a second sensor in communication with the at least one aspiration line providing a second measurement value; and, a third sensor in communication with the at least one irrigation line or at least one aspiration line for providing a third measurement value, wherein an intraocular pressure at a surgical site is calculated in accordance with at least two of the first measurement value, the second measurement value, or the third measurement value.”);
calculate an overall measurement for the surgical procedure based on the pressure values (Mehta [0014] “wherein an intraocular pressure at a surgical site is calculated in accordance with at least two of the first measurement value, the second measurement value, or the third measurement value”); and
displaying on a display device a graphic representation of the overall measurement, wherein the overall measurement indicates eye pressure stability (Mehta [0013] In an embodiment of the present invention, the system may further comprise a graphical user interface for receiving and displaying an alert associated with a change in irrigation pressure. The alert may comprise an audible component. In an embodiment, an alert may be provided when at least one of the first measurement value or second measurement value is at or near atmospheric pressure.” and Mehta [0015] “Wound leakage may be determined by the size of the incision made during the surgery and the system may calculate a total intraocular pressure at distinct time points before and during the surgery.” and Mehta [0129] “As illustrated in FIG. 13, the activation of reduced pressure mechanism 1230 may lessen the drop in pressure experienced by a partial or full occlusion during phacoemulsification surgery. The graph illustrated in FIG. 13 shows a steep negative change in system pressure sans activation of reduced pressure mechanism 1230 as illustrated by the dashed line. The solid line illustrated in FIG. 13 illustrates system pressure with activation of the reduced pressure mechanism 1230.”).
Mehta fails to explicitly teach determine when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value; when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value; and comprising a histogram of the values.
Kuebler teaches determine when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value ((Kuebler [0065] “The curve 202 intersects a first threshold value S1 at the location 203. The curve 204 intersects a second threshold value S2 at the location 205, the second threshold value S2 being higher than the first threshold value S1. Diagram 300 shows at which time points an intersection point occurs between the curve 202 with the first threshold value S1 and the curve 204 with the second threshold value S2. The curve 202 intersects the first threshold value S1 after expiration of a predetermined first time point. In the situation shown in FIG. 2, the curve 202 intersects the first threshold value S1 at the time point T1. The curve 204 intersects the second threshold value S2 after expiration of a predetermined second time point. In the situation shown in FIG. 2, the curve 204 intersects the second threshold value S2 at the time point T2. Thus, when both threshold values S1 and S2 are exceeded, it is possible to relatively safely conclude that an irrigation fluid is flowing in the irrigation fluid line 8. This conclusion can be drawn on the basis of the curve profile in the third diagram 300. When a threshold value is exceeded, there is an abrupt jump in the curve 301. When the threshold value S2 is exceeded, there is a first jump (see 305), and, when the first threshold value S1 is exceeded, there is a second jump (see 303).” Kuebler [0066] “When only the threshold value S2 of the curve 204 is exceeded, and not the threshold value S1 of the curve 202, this is an indication that the rise in the curve 202 has already ended after expiration of the first time point. This shows that the elastic partition element 12 no longer moves in the direction of the first measuring device and the volumetric flow in the irrigation fluid line is interrupted.” Kuebler [0067] “However, if a relatively constant volumetric flow is present in the irrigation fluid line 8, the convolved quantity of the derivative of the first measurement signal reaches a constantly high value (see 206). If the first convolution function device 51 is now supplied with a first measurement signal which, after the convolution with the first convolution function device 51, is below the second threshold value S2 (see 207) and also below the first threshold value S1 (see 208), the curve 301 abruptly sinks back again (see 307 and 308). It can be identified from this that a volumetric flow of the irrigation fluid 3 in the irrigation fluid line 8 has decreased.” and Kuebler [0006] “The start of an occlusion or the breakup of an occlusion can be identified by detection of measurement signals in an ophthalmosurgical system. For example, a pressure or a volumetric flow in an irrigation fluid line or an aspiration fluid line can be detected. It is particularly expedient if the derivation of a pressure profile or volumetric flow is performed over time, since a change of the signal profile can be rapidly identified in this way. However, a signal profile for pressure and volumetric flow always has a noise, and therefore a derivation of such a signal can lead to high deflections. There is therefore a relatively high probability of a supposedly significant change of pressure or change of volumetric flow being wrongly interpreted. A status description of an ophthalmosurgical system, as determined on this basis, can lead to hectic switching processes and therefore to complications during phacoemulsification.”); and
when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold value (Kuebler [0065] “The curve 202 intersects a first threshold value S1 at the location 203. The curve 204 intersects a second threshold value S2 at the location 205, the second threshold value S2 being higher than the first threshold value S1. Diagram 300 shows at which time points an intersection point occurs between the curve 202 with the first threshold value S1 and the curve 204 with the second threshold value S2. The curve 202 intersects the first threshold value S1 after expiration of a predetermined first time point. In the situation shown in FIG. 2, the curve 202 intersects the first threshold value S1 at the time point T1. The curve 204 intersects the second threshold value S2 after expiration of a predetermined second time point. In the situation shown in FIG. 2, the curve 204 intersects the second threshold value S2 at the time point T2. Thus, when both threshold values S1 and S2 are exceeded, it is possible to relatively safely conclude that an irrigation fluid is flowing in the irrigation fluid line 8. This conclusion can be drawn on the basis of the curve profile in the third diagram 300. When a threshold value is exceeded, there is an abrupt jump in the curve 301. When the threshold value S2 is exceeded, there is a first jump (see 305), and, when the first threshold value S1 is exceeded, there is a second jump (see 303).” Kuebler [0066] “When only the threshold value S2 of the curve 204 is exceeded, and not the threshold value S1 of the curve 202, this is an indication that the rise in the curve 202 has already ended after expiration of the first time point. This shows that the elastic partition element 12 no longer moves in the direction of the first measuring device and the volumetric flow in the irrigation fluid line is interrupted.” Kuebler [0067] “However, if a relatively constant volumetric flow is present in the irrigation fluid line 8, the convolved quantity of the derivative of the first measurement signal reaches a constantly high value (see 206). If the first convolution function device 51 is now supplied with a first measurement signal which, after the convolution with the first convolution function device 51, is below the second threshold value S2 (see 207) and also below the first threshold value S1 (see 208), the curve 301 abruptly sinks back again (see 307 and 308). It can be identified from this that a volumetric flow of the irrigation fluid 3 in the irrigation fluid line 8 has decreased.” and Kuebler [0006] “The start of an occlusion or the breakup of an occlusion can be identified by detection of measurement signals in an ophthalmosurgical system. For example, a pressure or a volumetric flow in an irrigation fluid line or an aspiration fluid line can be detected. It is particularly expedient if the derivation of a pressure profile or volumetric flow is performed over time, since a change of the signal profile can be rapidly identified in this way. However, a signal profile for pressure and volumetric flow always has a noise, and therefore a derivation of such a signal can lead to high deflections. There is therefore a relatively high probability of a supposedly significant change of pressure or change of volumetric flow being wrongly interpreted. A status description of an ophthalmosurgical system, as determined on this basis, can lead to hectic switching processes and therefore to complications during phacoemulsification.”).
Walsh teaches comprising a histogram of the values (Walsh [0203] “The term "histogram' as used herein generally refers to an algorithm, curve, or data or other representation of a frequency distribution for a particular variable, for example, retinal thickness. In some cases, the variable is divided into ranges, interval classes, and/or points on a graph (along the X-axis) for which the frequency of occurrence is represented by a rectangular column or location of points; the height of the column and/or point along the Y-axis is proportional to or otherwise indicative of the frequency of observations within the range or interval. "Histograms," as referred to herein, can comprise measured data obtained, for example, from scanning the eyes of a user, or can comprise data obtained from a population of people. Histograms of the former case can be analyzed to determine the mean, minimum, or maximum values, and analyze changes in slope or detect shapes or curvatures of the histogram curve. Histograms of the latter case can be used to determine the frequency of obsen1ation of a measured value in a surveyed sample.”).
Mehta teaches an ophthalmic surgical system comprising a phacoemulsification probe having a needle configured to be inserted into an eye of a patient, one or more pressure sensors, and a processor configured to obtain intraocular pressure (IOP) measurements and calculate pressure values during a surgical procedure. Mehta further teaches presenting pressure information via a graphical user interface. However, Mehta does not explicitly teach determining when irrigation fluid is not being conveyed or when an irrigation rate is below a threshold value, nor explicitly configuring the processor to obtain and analyze pressure values conditioned on such irrigation states.
Kuebler teaches detecting operating states of an ophthalmic fluidic system, including determining whether irrigation fluid is flowing, reduced, or interrupted based on threshold analysis of pressure or flow-related signals. Kuebler further teaches evaluating pressure or flow signal profiles over time to identify system conditions such as occlusion or reduced flow. A person of ordinary skill in the art would have recognized that these irrigation flow conditions correspond to different operating states of the surgical system, and that evaluating pressure behavior under such states provides useful diagnostic and control information. Accordingly, it would have been obvious to configure the processor of Mehta to determine irrigation conditions as taught by Kuebler and to obtain and analyze pressure measurements under those identified conditions (when irrigation is reduced or not being conveyed), as evaluating sensor data under particular system operating states is a routine and well-understood practice in system monitoring and control of medical fluidic systems. This represents a predictable use of prior art elements according to their established functions.
Walsh teaches generating and displaying histograms to represent distributions of measured ophthalmic data and to analyze variability and trends. A person of ordinary skill in the art would have been motivated to apply Walsh’s histogram visualization to the pressure data obtained in Mehta in order to provide an intuitive representation of pressure stability over time. Applying this known visualization technique to Mehta’s system yields the predictable result of improved interpretability of pressure stability during the surgical procedure. Therefore, the combination of Mehta, Kuebler, and Walsh teaches or renders obvious all limitations of claim 12.
Regarding claim 13, Mehta, Kuebler, and Walsh teach the invention in claim 12, as discussed above, and further teach wherein the pressure sensor is external to the phacoemulsification probe (Mehta [0123] “In an embodiment of the present invention, both irrigation and aspiration pressure sensors may be placed away from the handpiece.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to position the pressure sensor external to the phacoemulsification probe, as taught by Mehta. Mehta discloses that pressure sensors may be placed away from the handpiece, thereby showing that sensor placement is not limited to the probe itself and may be varied based on design considerations. A person of ordinary skill in the art would have recognized that placing the sensor external to the probe represents a known and predictable design alternative that can facilitate ease of integration and measurement flexibility within the surgical system. Selecting such a placement would have been a routine optimization of sensor location according to known techniques, yielding predictable results without requiring inventive skill.
Regarding claim 14, Mehta, Kuebler, and Walsh teach the invention in claim 12, as discussed above, and further teach wherein the pressure sensor is comprised in the phacoemulsification probe (Mehta [0051] “In illustrative embodiments, the system 100 may include a sensor system 52 configured in a variety of ways or located in various locations. For example, the sensor system 52 may include at least a first sensor, e.g. a strain gauge, 54 in communication with the irrigation line 32 and a second sensor, e.g. a strain gauge, 56 in communication with the aspiration line 42, as illustrated for example in FIG. 2. Other locations for the sensors 54 and 56 are envisioned anywhere in the system 100 and may be in communication with one or more irrigation and/or aspiration lines via different mechanism, e.g. on the handpiece 20, at an end of the handpiece 20, proximate or near the end of the handpiece 20, on or within the surgical console, within one or more irrigation lines and/or an aspiration lines and/or portions thereof, attached to or otherwise coupled with one or more irrigation and/or aspiration lines, resident in line with one or more irrigation and/or aspiration lines, etc., and may be configured to determine a variety of variables that may be used to determine intraoperative IOP measurements in the eye, as discussed below. This information may be relayed from the sensor system 52 to the control module 60 to be used in the determination of IOP measurements. The sensor system 52 may also include sensors to detect other aspects of the components used in the system, e.g. type of pump used, type of sleeve used, gauge of needle tip (size), etc. In another embodiment, the sensor system 52 may include only a first sensor located along the irrigation line 32 or the aspiration line 42.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to configure the pressure sensor to be comprised in the phacoemulsification probe in view of Mehta. Mehta teaches that sensors in an ophthalmic surgical system may be positioned in a variety of locations, including on the handpiece, at an end of the handpiece, or proximate to the handpiece, thereby showing that sensor placement is flexible and not limited to a single fixed location. In view of this flexibility, a person of ordinary skill in the art would have recognized that integrating the sensor directly into the probe (the handpiece) represents a predictable design variation along the continuum of disclosed placements, specifically to position the sensor closer to the surgical site. This integration would have been motivated by the desire to improve measurement accuracy, responsiveness, and reliability of intraocular pressure readings. Accordingly, configuring the sensor to be comprised in the phacoemulsification probe would have been an obvious modification of Mehta’s system, involving no more than the predictable use of known sensor placement techniques to achieve expected results.
Regarding claim 16, Mehta, Kuebler, and Walsh teach the invention in claim 12, as discussed above, and further teach wherein the processor is further configured to display a second overall measurement taken during the surgical procedure (Mehta [0039] “For example, the TOP may be segmented into static and dynamic during a phacoemulsification procedure, static TOP being primarily impacted by the fluid inflow with small amount of outflow and dynamic TOP being primarily impacted by fluid outflow. In illustrative embodiments, the system and method include means for calculating the static TOP, dynamic TOP, and/or total TOP through information provided by a user (e.g. a surgeon) of the system or information collected by a control module of the system. In illustrative embodiments, the system and method include a graphical user interface or other user interface that permits a user to insert information about various components of the system. In other illustrative embodiments, the system can determine various parameters of the system through internal sub-systems (e.g. sensors) to collect information about various components of the system and display such information on the user interface.”, and
Kuebler [0031] “It is thus possible to take account also of a second measurement signal, which is detected on an aspiration fluid line. This is advantageous since, with a first evaluation signal and a second evaluation signal, a redundancy is achieved which permits a still more reliable detection of an occlusion or of an occlusion breakthrough.” and Kuebler [0032] “According to an exemplary embodiment of the disclosure, the first measurement signal or the second measurement signal is a displacement signal of a displacement sensor for determining a fluid level or for determining a membrane position. As an alternative, the first measurement signal or the second measurement signal is a volume signal of a sensor for determining a volume of a fluid chamber. This is advantageous since the control module device can thus be used in a diaphragm pump.”).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to configure the processor of Mehta to display a second overall measurement during the surgical procedure in view of Kuebler. Mehta teaches calculating and displaying multiple intraoperative pressure parameters, including static, dynamic, and total intraocular pressure values, on a user interface during a phacoemulsification procedure, thereby showing that multiple measurements may be generated and presented to a user. Kuebler further teaches obtaining and utilizing multiple measurement signals for evaluating system conditions, such as detecting occlusion events, in order to improve reliability through redundancy. In view of these teachings, a person of ordinary skill in the art would have been motivated to generate and display multiple overall measurements derived from available sensor data during the procedure to enhance monitoring, provide additional insight into system performance, and improve surgical decision-making. Displaying a second overall measurement during the surgical procedure represents a predictable use of known techniques for processing and presenting multiple data streams, yielding the expected benefit of improved accuracy and reliability without requiring inventive skill.
Claims 17-18 are analogous to claims 11-12, thus claims 17-18 are similarly analyzed and rejected in a manner consistent with the rejection of claims 11-12.
Response to Arguments
Applicant’s arguments and amendments, see Remarks/Amendments submitted 1/22/2026 with respect to the rejection of claims 1, 3-14, 16-18 have been carefully considered and are addressed below.
Claim Rejections - 35 USC § 101
Applicant’s arguments have been fully considered but are not persuasive. Applicant states that the claimed steps cannot be performed in the human mind because they involve real time surgical conditions and sensor measurements. The limitations of “determining when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold,” “calculating an overall measurement based on pressure values,” and evaluating whether the measurement “indicates the eye pressure stability” recite observation, evaluation, and judgment. These are mental processes, even when performed with a sensor. The presence of data acquisition hardware does not remove the claim from the mental process category, and the claim recites the analysis and interpretation of information.
Applicant further states that the claim is directed to a specific technological method performed in a physical surgical environment. This argument is unpersuasive because limiting an abstract idea to a particular technological environment, such as an ophthalmic surgical system or procedure, does not render the claim non abstract (MPEP §2106.05(h)). The claim does not recite any improvement to the functioning of these components or to the operation of the surgical system itself, but instead uses them as tools to gather information for subsequent analysis.
With respect to Applicant’s statement on determining irrigation conditions and selectively obtaining pressure values, these limitations do not integrate the abstract idea into a practical application. The claimed step of determining when irrigation fluid is not being conveyed or is below a threshold specifies when data is collected. It does not recite controlling irrigation, modifying sensor operation, or improving measurement technology. Rather, it represents a version of data gathering, which remains an example of insignificant pre-solution activity (MPEP §2106.05(g)). Selecting particular conditions under which data is collected does not constitute a technological improvement, but instead limits the data set used in the abstract analysis.
Applicant’s statement that the invention improves surgical monitoring accuracy and safety is also not supported by the claim language. The alleged improvement resides in the information derived from analyzing and presenting pressure data (via a histogram), rather than in any improvement to the underlying technology. As noted in Electric Power Group, LLC v. Alstom S.A., collecting information, analyzing it, and displaying results, without more, does not constitute patent eligible subject matter. The claim is directed to collecting pressure data, analyzing it to evaluate stability, and presenting the results, which falls within this framework.
Lastly, Applicant’s statement that the claimed combination is nonconventional is not persuasive. The additional element, the processor, is described in the specification as performing its ordinary functions of data collection, processing, and output. The claim does not recite any specialized hardware, unconventional arrangement, or improvement to computer or sensor functionality. Accordingly, when considered individually and as an ordered combination, the additional elements amount to no more than implementing the abstract idea using well-understood, routine, and conventional components. Therefore, the claims do not recite significantly more than the abstract idea, and the rejection under 35 U.S.C. §101 is maintained.
Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but are not persuasive. Applicant states that the cited references fail to disclose or suggest “determining when an irrigation fluid is not being conveyed or an irrigation rate is below a threshold value” and “obtaining a plurality of pressure values from a first sensor during the ophthalmic procedure when the irrigation fluid is not being conveyed or when the irrigation rate is below a threshold.” However, as set forth in the rejection, Mehta teaches an ophthalmic surgical system that monitors intraocular pressure and fluid dynamics, including parameters associated with irrigation and aspiration flow, occlusion events, and pressure stability during phacoemulsification. Mehta relies on sensor derived measurements of fluid flow and pressure to evaluate intraoperative conditions and chamber stability. Kuebler further teaches evaluating fluid flow conditions in an ophthalmic system using threshold analysis of measurement signals, including determining when volumetric flow is reduced or interrupted based on comparisons to threshold values and signal behavior over time. Kuebler discloses that such threshold determinations identify conditions where irrigation flow is decreased or absent, including occlusion states.
With these teachings, it would have been obvious to a person of ordinary skill in the art to incorporate Kuebler’s threshold fluid condition detection into Mehta’s pressure monitoring system in order to more reliably identify specific fluid states (low or absent irrigation flow) during surgery. Further, it would have been an obvious and routine implementation to obtain or analyze intraocular pressure measurements under those identified conditions, as do this represents a predictable use of known sensor gating or filtering techniques to improve measurement accuracy and relevance. Both references address the same general problem, monitoring and managing intraocular pressure and fluid dynamics during ophthalmic procedures, and the combination applies known signal evaluation techniques (threshold detection and condition analysis) to Mehta’s system to yield the predictable result of improved pressure stability assessment.
Applicant’s argument that Walsh is non-analogous is also unpersuasive. Walsh teaches the use of histograms and statistical representations for analyzing ophthalmic measurement data. A person of ordinary skill in the art would have recognized that Walsh’s histogram visualization is applicable to Mehta’s collected pressure data, as both involve the analysis and presentation of physiological measurement distributions. Applying Walsh’s known histogram techniques to Mehta’s pressure measurements would have been a predictable use of prior art elements to improve visualization and interpretation of intraocular pressure stability over time. Accordingly, the combination of Mehta, Kuebler, and Walsh teaches or renders obvious the claimed limitations, and the rejection under 35 U.S.C. § 103 is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
Boukhny et al. (U.S. Patent Publication 2010/0268388 A1) teaches a surgical system that detect occlusions events in real time and automatically adjust handpiece power or stroke, based on temperature predications from irrigation flow or sensed load, to prevent overheating and maintain safe operations.
Rathjen et al. (U.S. Patent Publication 2002/0193675 A1) teaches a device and method for determining intraocular pressure by using an array of micro-electromechanical pressure sensors placed on the eye to measure spatially resolved pressure values, from which overall pressure and pressure distribution profiles are calculated and graphically displayed.
Escaf et al. (U.S. Patent Publication 2018/0228647 A1) teaches a system and method for delivering viscoelastic materials into the eye based on the intraocular pressure, thereby minimizing the need for the surgeon to manually manage this aspect of the procedure.
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/K.R.L./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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