DETAILED ACTION
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-12, 14-17, 19-28 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over WO-2019/157113A1.
Regarding claim 1, WO-2019/157113 discloses a method of monitoring health of corneal tissue (evaluate corneal conditions, [0058]), the method comprising measuring a first state of health indicator of a region of the corneal tissue during a first period of time, wherein the first state of health indicator is a first tissue thickness of the region (determine thickness of microlayers of the cornea, [0064]), measuring a second state of health indicator of the region during a second period of time after the first period of time, wherein the second state of health indicator is a second tissue thickness of the region (previously generated thickness maps, [0069]), generating a health map of the region based on the first and second state of health indicators, the health map indicative of a change between the first and second state of health indicators as measured from the first period of time to the second period of time in the region of the cornea (thickness map compared to previously generated thickness maps to track progression or stability, [0069]), and displaying, on a user interface, the health map of the region as a user-interactive map (display thickness map, [0069]). WO-2019/157113 discloses all the claimed limitations except wherein the user interface configured to receive user input regarding a user-selected subregion of the corneal tissue located within the user-interactive map and display additional information corresponding to the user-selected subregion. However, the feature of selecting a subregion would have been obvious to one skilled in the art. Therefore, it would have been obvious to one of ordinary skill in the art to implement this feature for design purpose.
Regarding claim 3, WO-2019/157113 further discloses wherein the first and second state of health indicators are measured by obtaining cross-sectional images of the region of the corneal tissue at the first and second periods of time (cross-sectional OCT images, [0090]).
Regarding claim 4, WO-2019/157113 further discloses wherein the cross-sectional images of the region of the corneal tissue at the first and second periods of time include: (a) a first set of cross-sectional images of the region taken at the first period of time and (b) a second set of cross-sectional images of the region taken at the second period of time, the method further comprising comparing the first set of cross-sectional images with the second set of cross-sectional images to generate the health map (cross-sectional OCT images, [0090]).
Regarding claim 5, WO-2019/157113 further discloses wherein the region includes at least one sublayer of the corneal tissue that is being monitored, and the first state of health indicator and the second state of health indicator are associated with the at least one sublayer (determines the thickness for biologically-defined microlayers of the cornea, [0064]).
Regarding claim 6, WO-2019/157113 further discloses wherein the at least one sublayer comprises one or more of: an external sublayer, internal sublayer, or an intermediate sublayer disposed between the external and internal sublayers (determines the thickness for biologically-defined microlayers of the cornea, [0064]).
Regarding claim 7, WO-2019/157113 further comprises calculating, based on the health map of the region of the cornea, a rate of change between the first and second state of health indicators from the first period of time to the second period of time (comparisons of thickness maps taken at different times, depicting minimums, maximums, indices, ratios, deviations, differences, [0069]).
Regarding claim 8, WO-2019/157113 further comprises determining, based on the second state of health indicator and the rate of change of the region, a predicted state of health indicator of the region during a third period of time after the second period of time (comparison of thickness maps leading to a diagnosis, [0069]).
Regarding claim 9, WO-2019/157113 further comprises measuring one or more intermediate state of health indicators of the region at one or more times between the first and second periods of time, wherein the health map is indicative of consecutive changes among the intermediate state of health indicators (plurality of previously generated thickness maps, [0069]).
Regarding claim 10, WO-2019/157113 discloses all the claimed limitations except for outputting the consecutive changes among the first state of health indicator, the second state of health indicator, and the intermediate state of health indicator as a graph with respect to time. However, a graph with respect to time is well within the knowledge of one skilled in the art. Therefore, it would have been obvious to one of ordinary skill in the art to implement graphing to compare the changes between the indicators.
Regarding claim 11, WO-2019/157113 further comprises locating, on the health map, at least one subregion within the region of the cornea exhibiting a change in the first and second state of health indicators exceeding a threshold range; and displaying, on a user interface, the at least one subregion superimposed on the health map (thickness maps compared to thresholds, [0069]).
Regarding claim 12, WO-2019/157113 further comprises determining, based on the health map and the change between the first and second state of health indicators, a diagnosis of the region of the corneal tissue, the diagnosis selectable from a list of corneal diseases stored in a memory unit; and displaying, on a user interface, the diagnosis and the health map (comparison of thickness maps leading to a diagnosis, [0069]).
Regarding claim 14, WO-2019/157113 further discloses wherein the health map is a topographic map of the region (three-dimensional mapping scheme, [0069]).
Regarding claim 15, WO-2019/157113 further discloses wherein the state of health indicators are measured via optical coherence tomography (OCT) (OCT, [0069]).
Regarding claim 16, WO-2019/157113 discloses all the claimed limitations except for calculating a percentage change between the first state of health indicator of the region and the second state of health indicator of the region, wherein the first state of health indicator is associated with the first period of time before a corneal implant is implanted, and the second tissue state of health indicator is associated with the second period of time after the corneal implant is implanted, determining that the percentage change is below a predetermined threshold, and displaying, on a user interface, a notification that the region of the cornea is experiencing tissue loss after the corneal implant. However, the steps of calculating, determining and displaying would have been an obvious choice for one skilled in the art to solve the respective technical problem. Therefore, it would have been obvious to one of ordinary skill in the art to implement these steps for the purpose of notifying any tissue loss after the corneal implant.
Regarding claim 17, WO-2019/157113 discloses a corneal tissue health monitoring system (evaluate corneal conditions, [0058]) comprising a corneal measurement device configured to measure a first state of health indicator of a region of the corneal tissue during a first period of time and a second state of health indicator of the region during a second period of time after the first period of time, wherein the first state of health indicator is a first tissue thickness of the region(determine thickness of microlayers of the cornea, [0064]), and the second state of health indicator is a second tissue thickness of the region (previously generated thickness maps, [0069]), and a processing unit configured to receive the first and second state of health indicators from the corneal measurement device and generate a health map of the region based on the first and second state of health indicators, the health map indicative of a change between the first and second state of health indicators as measured from the first period of time to the second period of time in the region of the cornea (thickness map compared to previously generated thickness maps to track progression or stability, [0069]), ]), and displaying, on a user interface, the health map of the region as a user-interactive map (display thickness map, [0069]). WO-2019/157113 discloses all the claimed limitations except wherein the user interface configured to receive user input regarding a user-selected subregion of the corneal tissue located within the user-interactive map and display additional information corresponding to the user-selected subregion. However, the feature of selecting a subregion would have been obvious to one skilled in the art. Therefore, it would have been obvious to one of ordinary skill in the art to implement this feature for design purpose.
Regarding claim 19, WO-2019/157113 further discloses wherein the first and second state of health indicators are measured by obtaining cross-sectional images of the region of the corneal tissue at the first and second periods of time (cross-sectional OCT images, [0090]).
Regarding claim 20, WO-2019/157113 further discloses wherein the cross-sectional images of the region of the corneal tissue at the first and second periods of time include: (a) a first set of cross-sectional images of the region taken at the first period of time and (b) a second set of cross-sectional images of the region taken at the second period of time, the method further comprising comparing the first set of cross-sectional images with the second set of cross-sectional images to generate the health map (cross-sectional OCT images, [0090]).
Regarding claim 21, WO-2019/157113 further discloses wherein the region includes at least one sublayer of the corneal tissue that is being monitored, and the first state of health indicator and the second state of health indicator are associated with the at least one sublayer (determines the thickness for biologically-defined microlayers of the cornea, [0064]).
Regarding claim 22, WO-2019/157113 further discloses wherein the at least one sublayer comprises one or more of: an external sublayer, internal sublayer, or an intermediate sublayer disposed between the external and internal sublayers (determines the thickness for biologically-defined microlayers of the cornea, [0064]).
Regarding claim 23, WO-2019/157113 further discloses that the processing unit further configured to calculate, based on the health map of the region, a rate of change between the first and second state of health indicators from the first period of time to the second period of time (comparisons of thickness maps taken at different times, depicting minimums, maximums, indices, ratios, deviations, differences, [0069]).
Regarding claim 24, WO-2019/157113 further discloses that the processing unit further configured to determine, based on the second state of health indicator and the rate of change of the region, a predicted state of health indicator of the region during a third period of time after the second period of time (comparison of thickness maps leading to a diagnosis, [0069]).
Regarding claim 25, WO-2019/157113 further discloses that the corneal measurement device further configured to measure one or more intermediate state of health indicators of the region between the first and second periods of time, wherein the health map is indicative of consecutive changes among the intermediate state of health indicators (plurality of previously generated thickness maps, [0069]).
Regarding claim 26, WO-2019/157113 discloses all the claimed limitations except that the processing unit further configured to output the consecutive changes among the first state of health indicator, the second state of health indicator, and the intermediate state of health indicators as a graph with respect to time. However, a graph with respect to time is well within the knowledge of one skilled in the art. Therefore, it would have been obvious to one of ordinary skill in the art to implement graphing to compare the changes between the indicators.
Regarding claim 27, WO-2019/157113 further discloses that the processing unit further configured to locate, on the health map, at least one subregion within the region of the cornea exhibiting a change in the first and second state of health indicators exceeding a threshold range, the corneal tissue health monitoring system further comprising a user interface configured to display the at least one subregion superimposed on the health map (thickness maps compared to thresholds, [0069]).
Regarding claim 28, WO-2019/157113 further comprises a memory unit configured to store a list of corneal diseases, the processing unit further configured to determine, based on the health map and the change between the first and second state of health indicators, a diagnosis on the region of the corneal tissue, the diagnosis selectable from the list of corneal diseases stored in the memory unit, and the corneal tissue health monitoring system further comprising a user interface configured to display the diagnosis and the health map (comparison of thickness maps leading to a diagnosis, [0069]).
Regarding claim 30, WO-2019/157113 further discloses that the user interface further configured to open a new window displaying the additional information in response to detecting the user input, wherein the additional information is a user- selected cross-sectional image of the region on the user-interactive map (display thickness map, [0069]).
Regarding claim 31, WO-2019/157113 further discloses wherein the health map is a topographic map of the region (three-dimensional mapping scheme, [0069]).
Regarding claim 32, WO-2019/157113 further discloses wherein the state of health indicators are measured via optical coherence tomography (OCT) (OCT, [0069]).
Regarding claim 33, WO-2019/157113 discloses all the claimed limitations except for a user interface wherein the processing unit is configured to calculating a percentage change between the first state of health indicator of the region and the second state of health indicator of the region, wherein the first state of health indicator is associated with the first period of time before a corneal implant is implanted, and the second tissue state of health indicator is associated with the second period of time after the corneal implant is implanted, determining that the percentage change is below a predetermined threshold, and displaying, on a user interface, a notification that the region of the cornea is experiencing tissue loss after the corneal implant. However, the steps of calculating, determining and displaying would have been an obvious choice for one skilled in the art to solve the respective technical problem. Therefore, it would have been obvious to one of ordinary skill in the art to implement these steps for the purpose of notifying any tissue loss after the corneal implant.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACK DINH whose telephone number is (571)272-2327. The examiner can normally be reached Monday - Friday 9am-5pm.
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/JACK DINH/Primary Examiner, Art Unit 2872 7/29/26
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